Physicians News » Headline http://www.physiciansnews.com Tue, 07 Feb 2012 16:44:06 +0000 en hourly 1 http://wordpress.org/?v=3.2.1 The Treatment of Solid Tumors: Some Recent Approaches http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/ http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/#comments Tue, 07 Feb 2012 16:14:45 +0000 Physicians News http://www.physiciansnews.com/?p=4595 By Punit Dhillon At some point in their lives, one in five people will suffer from skin cancer, and the fraction is steadily rising.  In spite of innovation in sunscreen technology and public attention to the need to be shielded from the sun, data reported recently by Dermatology Times show a rise in the average American lifetime risk of one skin cancer variety—invasive melanoma—from 1/600 in 1960 to 1/50 in 2008.  Despite previous diagnosis and innovations in approaches to treatment, the age-adjusted number of annual deaths per 100,000 population is rising.  Additionally, the expense to the healthcare system and society continues to increase.  As U.S. and European populations age, the incidence of skin cancer and other solid tumor cancers will grow.  According to the latest United States Cancer Statistics, published by the Centers for Disease Control and Prevention in 2007, the top 10 cancer types (based on incidence rate) are in the solid tumor category; today the priority is probably even higher.  Thus, there are clear medical needs going unmet and the creation of novel, cost-efficient and patient-friendly treatments remain a top priority for both the healthcare community and patients. Various challenges of traditional treatments The treatment of solid tumor cancers, which range from melanoma and Merkel cell carcinoma to cutaneous T-cell lymphoma, continues to be a substantial challenge for physicians.  For example, in spite of innovations in drug discovery and development, it is still challenging to simply deliver efficient drugs into cancer cells in a safe and effective manner.  Meanwhile, today’s therapeutic approaches—involving surgery, radiation therapy and chemotherapy—each have characteristic and major drawbacks. Surgery, the current first-line treatment for localized and operable tumors or lesions, requires resecting the tumor mass and a surrounding boundary of healthy tissue to make sure that no cancer cells remain at the tumor site.  Surgery can potentially cause physical disfigurement and/or debilitating effects on organ function, and the patient quality of life has been demonstrated to be negatively impacted.  Also, surgery can require an expensive and long hospital stay. Radiation therapy is occasionally used in conjunction with surgery to shrink a tumor prior to surgical removal, or afterward to destroy any cancer cells that might remain.  Yet surgery plus radiation can damage important normal tissues like nerves, blood vessels, or vital organs such as the heart that are within the designated zone of treatment.  Radiation is also a costly therapeutic approach, and demands substantial expertise, precautionary measures and infrastructure to administer.  Radiation entails major complications, such as nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the potential for the formation of new cancerous lesions. Those who get radiation to the heart often suffer from various types of heart failure in subsequent years. Typically, chemotherapy is a secondary or palliative treatment to help mitigate systemic or metastatic tumor growth, whereas surgery and radiation may be considered local treatments.  In response to cancer’s spread, physicians will administer chemotherapeutic agents that circulate throughout the body, systemically and in high concentrations, to counter the challenge that some chemotherapeutic agents have in reaching and penetrating the cell membrane to trigger cell death.  Yet the system-wide use of chemotherapeutics frequently has major side effects by killing healthy as well as cancerous cells.  This systemic and non-targeted administration of anticancer agents can trigger alopecia; nausea; vomiting; myelosuppression; and drug resistance.  Chemotherapy is curative for only a few tumor types. Additionally, all of these conventional treatments are only minimally effective on aggressive types of cutaneous cancers, especially in later stages of the disease. Some potential approaches We now offer an abbreviated look at some current approaches to override these challenges in treating solid tumors. One possible strategy for solid tumor treatment involves a new class of small-molecule drug candidates called vascular disrupting agents.  Via interaction with vascular endothelial cytoskeletal proteins, these agents may selectively target and collapse tumor vasculature, thereby depriving the tumor of oxygen and causing death of the tumor cells. Another approach involves the use of new therapeutic monoclonal antibody candidates that target CD27, a member of the tumor necrosis factor (TNF) receptor superfamily.  Anti-CD27 monoclonal antibodies have been demonstrated to effectively promote anticancer immunity in mouse models when combined with T cell receptor stimulation.  In addition, CD27 is overexpressed in various lymphomas and leukemias and can be targeted for direct activity by anti-CD27 monoclonal antibodies with effector function against those cancers.  There are many other antibody drugs on the market, some also with linked toxins or radiation. A third tactic involves the creation of an orally available nucleoside analogue for various cancers including solid tumors.  This agent could act through a novel DNA single-strand breaking mechanism, leading to the production of DNA double strand breaks (DSBs) and/or DNA repair checkpoint activation; unrepaired DSBs go on to cause apoptosis or programmed cell death. Alternatively, solid tumors could be treated using a technique called tumor ablation, which involves destroying the tumor inside the body via various approaches.  Radioactive pellets, shorter than an inch and approximately the width of a pin, can be inserted into the tumor; the pellet subsequently emits lethal radioactive atoms that irradiate the tumor from the inside out.  As the tumor breaks down, it starts to release antigens that trigger an immune response against the cancer cells.  Sometimes, the body also develops an immune memory against the future return of tumor cells.  Another proposed ablation technique, called “pulsed electric current ablation,” involves the insertion of electrodes into tumors, which subsequently emit very high-energy electrical currents; these currents create a physical reaction that destroys the tumor cells. A separate approach involves applying local heating to the tumor using radio frequency techniques.  In this instance, a thermal energy delivery device can be focused and targeted according to the shape, size and position of a specific tumor.  Adjusting the frequency, phase, and amplitude of the radio waves, combined with different applicators and adjustment of the patient’s position, could conceivably permit a doctor to optimize the delivery of damaging energy into the tumor. Cancer scientists are also interested in attacking solid tumors by delivering drugs specifically into diseased tissues. Such a targeted approach can result in more efficient therapy while using smaller drug doses with fewer negative side effects.  For example, in animal studies, immune-deficient mice carrying human forms of various cancers have been simultaneously injected with a range of anticancer agents and a peptide known as iRGD.  iRGD can find and attach itself to receptors on solid tumor cancer cells and later activate their internal transport systems so that the peptide is essentially passed through cell after cell, moving progressively deeper into the tumor structure.  Anticancer drugs lingering near the peptide molecules may also get pulled into and through the tumor mass by this transport mechanism, enabling them to attack cancer cells previously beyond their reach. By their nature and cellular architecture, solid tumors are equipped to limit the efficacy of most anticancer drugs.  Tumors have poor vascular systems, which reduces exposure to drugs that have been administered into the circulation.  The lesions are densely fibrous, which serves as a physical barrier against transport.  Also, the tumors have high internal pressures, causing further physical challenges to any molecule attempting to enter the lesion.  The iRGD peptide is designed to act like a key, switching on the internal transport mechanism of the cells so that they absorb anything that is proximal to certain cell surface receptors.  Researchers believe the iRGD peptide could penetrate many tumor types and might be useful in treating most solid tumor cancers.  An encouraging aspect of this approach is that both the peptide and anticancer drugs are effective together without being chemically attached. Yet another promising strategy for treating solid tumor cancers involves targeting the tumor itself without affecting any of the surrounding healthy tissue.  This ensures that the drug or therapeutic agent is absorbed at once by the cancer cells and not normal tissues.  One such targeted therapy could harness a physiologic process known as “electroporation.”  Derived from the words “electric” and “pore,” this involves applying a brief electric field to the cancerous cell.  The electrical pulse triggers the temporary creation of pores in the cell’s outer membrane—pores that close again within seconds once the electric field is discontinued.  These transient pores can improve uptake of various drugs more than a thousand-fold. Several electroporation systems have been manufactured that consist of a generator that creates the pulsed electric field, and various handheld applicators with electrode needles at their proximal ends.  The applicator delivers a controlled electric pulse to the cancer cells, thus causing any cancer cells within the affected region to undergo electroporation.  The cell takes up therapeutic agents within the region of electroporation. This technology platform is being developed for use in two varieties of anticancer therapies:  electrochemotherapy and electroimmunotherapy.  In the former, an anticancer drug is injected into a targeted tumor; the lesion is then electroporated and the drug carries out its planned mechanism of action in killing the cell.  As a result of the targeted, local therapy, the amount of drug needed to kill the cells is substantially less than that required in traditional, non-targeted chemotherapy.  The lower quantity of systemic drug (cytotoxic agent) reduces harmful side effects linked to traditional chemotherapy. Electroimmunotherapy, the second application of electroporation, involves the use of a gene encoding a specific cytokine, a substance known to boost the human immune system against cancer cells.  An immune response can have both a local and a distant effect against cancerous cells.  These therapeutic approaches have been shown to be safe and effective across various types of tumors.  Both patient outcomes and pharmacoeconomic benefits are substantial.  This technology is in clinical testing in North America and is available for commercial sale in some European countries. Therapies such as those discussed here may provide a compelling set of novel approaches to the treatment of solid tumor cancers. ### Punit Dhillon is President and CEO of OncoSec Medical Inc., a biotechnology company developing its advanced-stage Oncology Medical System (OMS) ElectroOncology therapies to treat skin cancer and other solid tumor cancers. He can be reached at pdhillon@oncosec.com.]]> http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/feed/ 0 Growing Organs In The Lab: A potential end to immune rejection http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/ http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/#comments Sat, 03 Dec 2011 18:06:55 +0000 Physicians News http://www.physiciansnews.com/?p=4453 By David Green Last June, Andemarian T. Beyene, 36-year-old man with tracheal cancer received a special gift:  a brand new trachea, made from a synthetic scaffold seeded with his own stem cells.  Following this surgery—the first of its kind—he made a full recovery and was discharged from the hospital four weeks later.  The procedure made international headlines, and shone a much-needed spotlight on two important problems that it might help in part to resolve:  long wait times for organ transplants, and immune rejection of implanted organs.  In what follows, we offer a brief overview of these issues, look a bit closer at the surgery itself, and ponder some of the implications. As of November 2011, the Organ Procurement and Transplantation Network, a division of the U.S. Department of Health & Human Services, is reporting that over 112,000 Americans are waiting for an organ transplant.  At the same time, the average annual expense per patient of immunosuppressive drugs—administered following a transplant to prevent the body from rejecting the new organ—is more than ,000, and in some cases can reach as high as ,000, according to the American Society of Transplant Surgeons. These sobering statistics are driving a campaign within the biomedical research community for innovation. A complex and technologically advanced organ allocation system links patients with organs donated by strangers.  The  shortage of organs causes most patients to wait for a transplant, and waiting times vary widely for many reasons. The amount of time a patient waits does not reflect how well as transplant center or organ procurement organization is doing its job; each patient’s situation is different.  Some patients are more ill than others when they are put on the transplant waiting list.  Some patients get sick more quickly than other patients, or respond differently to treatments.  Patients may have medical conditions that make it harder to find a good match for them. How long a patient waits can depend on a multitude of factors.  These can include blood type (some are rarer than others); tissue type; height and weight of transplant candidate; size of donated organ; medical urgency; time on the waiting list; the distance between the donor’s hospital and the potential donor organ; how many donors there are in the local area over a period of time; and the transplant center’s criteria for accepting organ offers.  Depending on the kind of organ needed, some factors are more important than others.  Under certain circumstances, special allowances are made for children. Since 1984, the nonprofit United Network for Organ Sharing (UNOS), located in Richmond, Virginia, has operated the Organ Procurement and Transplantation Network, under a contract with the Division of Transplantation in the Department of Health and Human Services.  UNOS maintains a central computer network containing the names of all patients waiting for kidney, heart, liver, lung, intestine, pancreas and multiple-organ transplants.  Patients on the waiting list are in end-stage organ failure and have been evaluated by a transplant physician and hospitals in the U.S. where organ transplants are performed. Another major guiding principle in organ allocation is: local patients first.  The U.S. is divided into 11 geographic regions, each served by a federally designated organ procurement organization, which is responsible for coordinating all organ donations.  With the exception of perfectly matched kidneys and the most urgent liver patients, first priority goes to patients at transplant hospitals located in the region served by the organ procurement organization.  Next in priority are patients in areas served by nearby organ procurement organizations; and finally, only if no patients in these communities can use the organ, it is offered to patients elsewhere in the country. Such locally oriented allocation makes medical sense because less time between donor and recipient usually means more chance of a successful transplant as well as fewer complications that could threaten the viability of the organ.  Eighty percent of all organs are donated and used in the same geographic area. Organ transplant recipients must take immunosuppressive drugs every day for the life of their transplant.  Failure to take these medications significantly increases the risk of rejection.  These drugs are not without side effects and risks.  Because the majority of them act non-selectively, the immune system is less able to resist infections and the spread of malignant cells.  There are also other side effects, such as hypertension, dyslipidemia, hyperglycemia, peptic ulcers, and liver and kidney injury.  The immunosupressive drugs also interact with other medicines and affect their metabolism and action. Immunosuppressive drugs can be classified into five groups—glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins, and other drugs—each with their own specific uses. For example, in pharmacological doses, glucocorticoids are used to suppress various allergic, inflammatory and autoimmune disorders.  They are also administered as posttransplantory immunosuppressants to prevent acute transplant rejection and graft versus host disease.  Nevertheless, they do not prevent infection and also inhibit later reparative processes.  Cyostatics inhibit cell division.  In immunotherapy, they are used in smaller doses than in the treatment of malignant diseases, and they affect the proliferation of both T cells and B cells.  Antibodies are sometimes used as a quick and potent immunosuppressive therapy to prevent the acute rejection reactions as well as a targeted treatment of lymphoproliferative or autoimmune disorders.  The drugs acting on immunophilins include cyclosporin, tacrolimus and sirolimus, whereas additional drugs used as immunosuppressants include interferons, opioids, TNF binding proteins and mycophenolate. In light of the challenges posed by transplant wait lists and the need to choose the optimal immunosuppressive therapy to facilitate transplants, it is significant that for the first time ever, a patient was recently given a new trachea made from a synthetic scaffold seeded with his own stem cells.  As noted earlier, the patient, 36-year old Andemarian T. Beyene, made a full recovery and was discharged from the hospital following the operation.  The operation was performed on June 9, 2011 at Karolinska University Hospital in Stockholm, Sweden, by Paolo Macchiarini, MD, PhD, Professor of Regenerative Surgery at the Advanced Center of Translational Regenerative Medicine at Karolinska Institutet, Stockholm, Sweden, and colleagues (Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioarti?cial nanocomposite: a proof-of-concept study. Lancet 2011; Published online November 22, 2011 DOI:10.1016/S0140-6736(11)61715-7). Previous transplants of tissue-engineered tracheas have been performed, but on those occasions the tracheas used were taken from organ donors and then reseeded with the patients’ own stem cells. For example, in 2008, 30-year-old Claudia Castillo successfully underwent this type of procedure in Spain (Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008; 372: 2023-2030). The international team involved Professor Alexander Seifalian from University College London who designed and built the nanocomposite tracheal scaffold, and Harvard Bioscience of Holliston, Massachusetts, which produced a specifically designed, shoebox-sized bioreactor used to seed the scaffold with the patient’s own stem cells.  The cells were grown on the scaffold inside the bioreactor for approximately two days; the scaffold was rotated while its surface was soaked with stem cells obtained from a bone marrow biopsy from the patient’s hip.  The patient’s stem cells settled into the pores within the scaffold and began to grow into each other, slowly transforming from individual cells into genuine tissue.  A few days after the implantation of the new trachea, the man’s own blood vessels actually started to grow into it, transforming the new organ into a part of his own body.  Because the cells used to regenerate the trachea were the patient’s own, there was no rejection of the transplant and the patient was not taking immunosuppressive drugs. The patient had been suffering from late-stage tracheal cancer.  Despite maximum treatment with radiation therapy, the tumor had reached approximately 6 cm in length and was extending to the main bronchus.  It was progressing and almost completely blocked the trachea.  Since no suitable donor windpipe was available, the transplantation of the synthetic tissue-engineered trachea was performed as the last possible option for the patient, referred by Professor Tomas Gudbjartsson of Landspitali University Hospital (Iceland) who was also part of the surgical team. The successful transplantation of tissue-engineered synthetic organs, referred to as regenerative medicine, could open new and very promising therapeutic possibilities for the thousands of patients who suffer from tracheal cancer or other conditions that destroy, block or constrict the airway. It is extremely important to note that this procedure is still experimental and will need to be sanctioned by the U.S. Food and Drug Administration for the more than 100,000 Americans who are waiting for organ transplants to benefit from it. What does tomorrow hold for this type of medical technology?  For the immediate future, the scaffold approach to generating synthetic body parts will be limited to growing tubular organs such as trachea and blood vessels, rather than more complex organs such as kidneys and livers.  However, other types of organs may become a practical option in time. Transplantations of tissue-engineered windpipes—and potentially other tubular organs like esophagus, blood vessels and urethras—with synthetic scaffolds in combination with the patient’s own stem cells, as a standard procedure, means that patients would not have to wait for a suitable donor organ.  This would be a substantial benefit for patients since they could benefit from earlier surgery and have a greater chance of cure.  In addition to treating adult patients, tissue-engineered synthetic trachea transplants would, not least, be of great value for children, since the availability of donor tracheas is much lower than for adult patients. If this scenario unfolds as some predict, it might mean the start of a new era in the treatment of thousands of patients whose lives and health will be improved.   ### David Green is President of Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine.  He can be reached at dgreen@harvardbioscience.com.]]> http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/feed/ 1 What You and Your Patients Need to Know About Bisphenol A http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/ http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/#comments Mon, 07 Nov 2011 14:28:00 +0000 Physicians News http://www.physiciansnews.com/?p=4379 By Rebecca Roberts, Ph.D. Bisphenol A (BPA) is an environmental estrogen that can affect development and health by disrupting normal hormonal signaling.  Estrogen, working at very low blood concentrations, triggers responses in cells and tissues and is critical during fetal development and in normal health and reproduction.  BPA binds to the same cellular receptors as estrogen and may lead to detrimental health effects. In June of this year, the American Medical Association formally recognized BPA as an endocrine-disrupting agent.  Physicians can play an important role in educating their patients about this pervasive environmental contaminant.  The first steps are to understand the potential health risks of BPA and how to limit those risks through simple lifestyle changes. BPA is used in the production of polycarbonate plastics and epoxy resins.  Many consumer products, such as some reusable water bottles, baby bottles, toys, cell phones, and DVDs, contain BPA.  BPA is also found in the inner linings of metal food cans.1 The epoxy lining protects the metal can from rust and corrosion which may taint the food.  It is present in various medical devices as well, including incubators, blood oxygenators, and dialysis machines.  Given its wide uses, BPA ranks among the highest volume chemicals manufactured worldwide. Although present in countless products, none of which is intended for consumption, the primary route of exposure is through ingestion.  BPA has been shown to leach from products that contain it, such as food cans, into the foodstuffs stored in the container.1,2 When the food is then consumed, BPA enters the body through the digestive tract. A 2007 survey by the Centers for Disease Control found that approximately 92% of Americans have detectable levels of BPA in their bodies.3 The survey is considered representative of the United States population even though it included only people older than six years old.  It is notable, however, that the children (ages 6-11 years) in this study displayed the highest levels of BPA of all populations investigated.  BPA has been found in placental tissue and fetal blood as well, indicating that fetuses are being exposed as a result of maternal exposure.4 An additional study looked at the levels of BPA in infants – specifically in premature infants housed in Neonatal Intensive Care Units.5 It was found that these infants displayed the highest level of BPA in their bodies of all populations. Exposure to BPA has been studied on many levels, from effects on individual cells, to tissues and whole organisms.  While most health studies regarding exposure to BPA are done in laboratory animals, the few human epidemiological studies reveal a relationship between BPA exposure and polycystic ovary syndrome, repeated miscarriage, and heart disease.6-8 Additionally, BPA causes a human breast cancer cell line to proliferate, suggesting that estrogen-sensitive tissues and cells in the human body may react similarly.9 Many animal studies focus on the effect of BPA exposure during fetal development as this is a time when cells and tissues are especially susceptible to alterations in the hormonal environment.  Not only does BPA disrupt proper functioning of the placenta during gestation, but offspring of animals that are exposed to BPA during pregnancy exhibit many deleterious health effects.10 Male offspring have enlarged prostates and malformed urethra.11, 12 Moreover, they are at a higher risk of developing prostate cancer. BPA exposure alters the genital tract of female offspring.11, 12 Exposed females also enter puberty earlier.12 Exposure affects brain development and, as a result, some behavioral differences typically seen between males and females are lost in offspring exposed to BPA in the uterus.13 Based on the clear effects of BPA exposure on the development of fetuses in animals, similar effects on human development are plausible.  Indeed, BPA has been found in the bloodstream, placenta, cord blood, and fetal blood of humans at levels that are within the range studied in many of the animal models.5
While hundreds of studies, most focusing on animal models, point to the harmful health effects of BPA, there has been controversy over the past decade and a half regarding safety of the compound in humans.  Nevertheless, scientific review panels have determined that some detrimental health effects may occur in humans.14-16 Likely human health effects that have been vetted through these review panels include advanced puberty in females14, 15 , effects on the brain and behavior15, 16, mammary gland and prostate abnormalities, and reproductive effects in males and females. Beyond the immediate developmental effects of BPA exposure in utero, evidence is beginning elucidate long-term effects of early-life exposure to BPA, potentially through the modification of epigenetic programming via altered DNA methylation.16, 17 One study suggests that such detrimental modifications may be counteracted by maternal nutrient supplementation.18 Nevertheless, these changes may result in alterations that are passed on transgenerationally, resulting in adverse health effects in subsequent generations who, themselves, may not have been directly exposed to BPA.17, 19 Given the putative adverse health effects of BPA exposure, the U.S. Environmental Protection Agency added BPA to its “Chemicals of Concern” list under the Toxic Substances Control Act in 2010.20 The U.S. Department of Health and Human Services website also posted “Information for Parents” on how to minimize their infant’s exposure to BPA.21 Humans are typically exposed to about 0.001 milligrams of BPA per kilogram of body weight per day.  This is 50 times lower than the ‘safe’ limit set by the EPA and the Food and Drug Administration.  Unfortunately, this level of exposure is still significantly higher than the low doses that have been shown to cause adverse health effects. The concern of exposure is highest when fetuses, infants, and children are considered because of the adverse effects of BPA on normal developmental processes early in life. It is clear that infants and children are burdened with the highest levels of BPA.  This is likely due to several factors.  First, the ability infants and children to metabolically detoxify contaminants such as BPA is not yet mature.  While BPA will ultimately be removed from the blood through a liver-mediated process, BPA stays in the system of infants and children longer than in adults.16 Second, when compared to adults, infants and children consume proportionately more food when their overall body size is taken into account and therefore bodily concentrations are higher.  The milk, formula, or food that is the main staple of an infant may be stored in containers (baby bottles, sippy cups) that are made with BPA.3, 22, 23 Infants and young children are also more likely to mouth plastic products, such as toys, that are not necessarily meant to be put in the mouth. BPA can also pass from the mother to the fetus.5 In addition, breast milk can transmit BPA to an infant.24 Given this, it is not only the child, but the pregnant or nursing mother, that need to be protected from BPA exposure.  Since the children cannot be responsible for making choices regarding BPA, clear information must be provided to parents (and potential parents) so that they can made the educated choices needed to protect themselves and their children. Fortunately, BPA is metabolized and cleared from the body so decreasing daily exposure to BPA can make a difference in overall body levels.25, 26 In Japan, industries voluntarily reduced BPA use in their products between 1998 and 2003 and studies showed a dramatic decline in body levels of BPA in the population.27, 28 Educating your patients about a few simple lifestyle changes can make a difference in their overall BPA exposure and potentially reduce their risk for adverse health effects. First, opting for fresh and frozen food rather than canned food is a big step. 22 While damage and age of food cans does not appear to greatly increase the amount of BPA leached into food, the initial packaging and sterilization techniques do release significant levels of BPA into canned food.22, 1 Second, minimizing the use of polycarbonate plastics food and beverage containers will also help.  Polycarbonate plastics are usually hard, clear, and shatter-resistant.  They may be labeled with recycle number 7, although not all number 7 products contain BPA. Third, learning about the proper care and use of containers can curtail exposure.  Heat and wear increases the leaching rate of BPA into the food or beverage stored in the container, so polycarbonate plastics should not be microwaved or put through the dishwasher and they should not be used if visibly scratched.29, 2 Parents and caregivers should also be provided information in protecting infants and children from unnecessary BPA contact.  Powdered infant formula is usually not stored in containers made from BPA, but some premade liquid infant formulas are packaged in BPA-containing bottles, and such formula has been shown to be tainted.24 In September 2011, a report from the Breast Cancer Fund revealed that many children’s canned food items contained BPA.30 Children are also more likely to mouth plastic products, such as toys or the hard plastic portion of a pacifier.  Caregivers should be mindful of products aimed at children that may contain BPA, such as sippy cups, tableware, and toys.3, 22, 26 Thankfully, manufacturers are increasingly labeling products as “BPA-free”.  The American Medical Association adopted a new policy in 2011 supporting continued industry efforts to produce BPA-free baby products as well as a total ban on the sale of such products. As of 2011, ten states have passed legislation limiting the use of BPA in products aimed at children.  Pennsylvania has similar legislation, spearheaded by Representative Lawrence Curry, that is currently in the House Health Committee.  In New Jersey, Senator Linda Greenstein introduced a related bill in 2010 that has been referred to the Senate Commerce Committee. While the current BPA legislation is an important step, the direct education of patients about BPA and the simple steps that can be taken to minimize their BPA exposure may lead to health improvements within the community.   ###
Rebecca Roberts, Ph. D., is an Associate Professor in the Department of Biology and Coordinator of the Biochemistry and Molecular Biology Program at Ursinus College in Collegeville, PA, where she studies the effect of hormonal regulation of the immune system, with a focus on the roles of estrogen and bisphenol A in Systemic Lupus Erythematosus. She has been active in educating the public about bisphenol A and recently presented expert testimony to the Pennsylvania House of Representatives Democratic Policy Committee regarding toxin-free toddler and baby products.
 
    Citations 1. Goodson, A., H. Robin, W. Summerfield, and I. Cooper, 2004. Migration of bisphenol A from can coatings – effects of damage, storage conditions and heating.  Food Addit Contam, v. 21(10), pp. 1015-26. 2. Brede, C., P. Fjeldal, I. Skjevrak, and H. Herikstad. 2003 Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushing. Food Addit Contam, v. 20(7), pp. 684-9. 3. Calafat AM, Ye X, Wong L-Y, Reidy JA, Needham LL, 2007. Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003–2004. Environ Health Perspect, v. 116(1): doi:10.1289/ehp.10753 4. Calafat A.M., J. Weuve, X. Ye, L.T. Jia, H. Hu, S. Ringer, K. Huttner, and R. Hauser, 2009.  Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants.  Environ Health Perspect, v. 117, pp. 639-644. 5. Schonfelder, G., W. Wittfoht, H. Hopp, C.E. Talsness, M. Paul, and I. Chahoud, 2002. Parent bisphenol A accumulation in the human maternal-fetal-placental unit. Environ Health Perspect, v. 110(11), pp. A703-7. 6. Takeuchi, T., O. Tsutsumi, Y. Ikezuki, Y. Takai, and Y. Taketani, 2004. Positive relationship between androgen and the endocrine disruptor, bisphenol A, in normal women and women with ovarian dysfunction. Endocr J., v. 51, pp. 165-169. 7. Sugiura-Ogasawara, M., Y. Ozaki, S. Sonta, T. Makino, and K. Suzumori, 2005. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod, v. 20, pp.2325-2329. 8. Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., Galloway, T.S. (2010). Association of urinary bisphenol a concentration with heart disease: evidence from NHANES 1003/06. PLoS One, v. 5(1), pp8673. 9. Singleton, D.W., Y. Feng, Y. Chen, S.J. Busch, A.V. Lee, A. Puga, and S.A. Khan, 2004.Bisphenol-A and estradiol exert novel gene regulation in human MCF-7 derived breast cancer cells. Mol Cell Endocrinol, v. 221(1-2), pp. 47-55. 10. Lee, C.K., S.H. Kim, D.H. Moon, J.H. Kim, B.C. Son, D.H. Kim, C.H. Lee, H.D. Kim, J.W. Kim, J.E. Kim, and C.U. Lee, 2005. Effects of bisphenol A on the placental function and reproduction in rats. J Prev Med Pub Health. v. 38(3), pp. 330-336. 11. Markey, C.M., P.R. Wadia, B.S. Rubin, C. Sonnenscheine, and A.M. Soto, 2005. Long Term Effects of Fetal Exposure to Low Doses of the Xenoestrogen Bisphenol-A in the Female Mouse Genital Tract. Biol Reprod, v. 72(6), pp. 1344-51. 12. Nikaido, Y., K. Yoshizawa, N. Danbara, M. Tsujita-Kyutoku, T. uri, N. Uehara, and A.Tsubura, 2004. Effects of maternal xenoestrogen exposure on development of the reproductive tract and mammary gland in female CD-1 mouse offspring. Reprod Toxicol, v. 18(6), pp. 803-811. 13. Rubin, B.S., J.R. Lenkowski, C.M. Schaeberle, L.N. Vandenberg, P.M. Ronsheim, and A.M. Soto, 2006. Evidence of altered brain sexual differentiation in mice exposed perinatally to low, environmentally relevant levels of bisphenol A. Endocrinology, v.147(8), pp. 3681-3691. 14. National Toxicology Program’s Report of the Endocrine Disruptors Low Dose Peer Review (2001). 15. U.S. Department of Health and Human Services, National Institutes of Health, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction.  NTP-CERHR monograph on the potential human reproductive and developmental effects of bisphenol A (NIH Publication No. 08-5994). 16. Vom Saal, F.S. et al., 2007. Chapel Hill bisphenol A expert panel consensus statement: Integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure.  Reproductive Toxicology, v. 24, pp. 131-138. 17. Kudakovic, M. and F.A. Champagne, 2011. Epigenetic perspective on the developmental effects of bisphenol A. Brain, Behavior, and Immunity. V. 25(6), pp. 1084-93. 18. Dolinoy, D.C., D. Huang, and R.L. Jirtle, 2007. Maternal nutrient supplementation counteracts bisphenol A-induced DNA hypomethylation in early development. PNAS, v. 104(32), pp. 13056-13061. 19. Walker, D.M. and A.C. Gore, 2011. Transgenerational neuroendocrine disruption of reproduction. Nat Rev Endocrinol. v. 7(4), pp197-207. 20. U.S. Environmental Protection Agency, 2010. Bisphenol A (BPA) action plan summary. 21. U.S. Department of Health and Human Services, 2010. Bisphenol A (BPA) information for parents. 22. Vandenberg, L.N., R. Hauser, M. Marcus, N. Olea, and W.V. Welshons, 2007. Human exposure to bisphenol A (BPA). Reproductive Toxicology, v. 24, pp. 139-177. 23. Kuo, H.W. and W.H. Ding, 2004. Trace determination of bisphenol A and phytoestrogens in infant formula powders by gas chromatography-mass spectrometery.  J. Chromatogr A, v. 1027, pp. 67-74. 24. Houlihan, J., 2007. Toxic plastics chemical in infant formula.  Environmental Working Group. 25. Carwile JL, Luu HT, Bassett LS, Driscoll DA, Yuan C, Chang JY, Ye X, Calafat AM, Michels KB, 2009. Polycarbonate bottle use and urinary bisphenol A concentrations. Environ Health Perspect, v. 117(9), pp. 1368-1372. 26. Vökel, Wl, Kiraoglu, M., Fromme, H., 2011. Determination of free and total bisphenol A in urine of infants. Environ Res, v. 111(1), pp.143-148. 27. Matsumoto A KN, Kitagawa K, Isse T, Oyama T, Foureman GL, Morita M, Kawamoto T. 2003. Bisphenol A levels in human urine. Environ Health Perspect 111(1): 101-4. 28. Research Center for Chemical Risk Management (2005). Bisphenol A Risk Assessment Document. AIST Risk Assessment Document Comprehensive Chemical Substance Assessment and Management Program. Japan. 29. Lyons, G.. 2000. Bisphenol A:  A Known Endocrine Disruptor. WWF European Toxics Programme: Godalming, Surrey. p. 37 30. Breast Cancer Fund (2011).  BPA in Kids’ Canned Food.  ]]> http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/feed/ 3 Retroactive Adverse Benefit Denials Under ERISA http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/ http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/#comments Tue, 06 Sep 2011 15:35:42 +0000 Physicians News http://www.physiciansnews.com/?p=4242 By Franklin J Rooks J. PT, MBA, Esq. Introduction The insurer’s denial of previously authorized benefits is one of the most frustrating experiences for a medical practice’s billing staff.  But, on the frustration scale, there is another insurance company practice that can push it over the top: retroactive benefit denials that occur after the insurance company has already made payment.  From the insurer’s perspective, a retroactive denial made after the provider has received payment results in an overpayment to the provider, which must be repaid.  To make matters worse, insurance carriers sometimes recoup their payments in ways that create billing system nightmares.  Instead of asking the provider to write a check to the insurer for “improperly” paid benefits, some insurers use “negative remittances.” Negative remittances are where an insurer takes back a benefit payment by offsetting other compensable claims.  Negative remittances are generally cumbersome for providers because they require several billing system adjustments involving more than one patient account.  Recoupment of prior payments is not unique to group health insurers.  Medicare also has a recoupment process for overpayments.[1] With Medicare, the provider receives demand letter, and recoupment cannot begin until 41 days after the provider’s receipt of that notice.  Similarly, for patients covered under an ERISA plan, notice and appeal rights are also required.[2] The insurer cannot just unilaterally recoup benefits by offsetting the benefits due on another patient’s account.    [Note: where applicable, the information provided below assumes that the practice has complied with all of the insurance carrier’s claims filing guidelines and denials are not administrative or technical denials of a claim.] ERISA The Employee Income Security Act, or ERISA, was enacted in 1974 to protect employees’ rights in their employer-sponsored benefit plans.[3] ERISA does not require employers to provide employee benefit plans.[4] Rather, it regulates them. For covered plans, ERISA sets forth substantive regulatory requirements, along with mechanisms to provide access to Federal courts, sanctions, and exclusive remedies.[5] ERISA protects employees’ benefits through uniformity.  These protections supersede and take precedence over any state laws which govern benefit plans.[6] Specifically, ERISA supersedes applicable state law in three areas:  (1) laws mandating employee benefit structures or their administration; (2) laws that regulate ERISA plans; and (3) laws providing alternate enforcement mechanisms other than those provided by ERISA.[7] ERISA allows plan beneficiaries to bring a civil action to “recover benefits due to him under the terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future benefits under the terms of the plan.”[8] If applicable to the insurance plan, the practice should examine ERISA’s protections when challenging an insurer’s recoupment of previously paid benefits. Denials: Adverse Benefit Determinations Under ERISA, benefit denials are termed “adverse benefit determinations.”  In ERISA parlance, this means “[a] denial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit, including any such denial, reduction, termination.”[9] An adverse benefit determination is also a “[f]ailure to provide or make payment that is based on a determination of a participant's or beneficiary's eligibility to participate in a plan. . .”[10] For group health plans, this also includes a “[d]enial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit resulting from the application of any utilization review. . .” [11] Adverse benefit determination also applies to the denial of any treatment because the plan considers it to be “[e]xperimental or investigational or not medically necessary or appropriate.”[12] All of the preceding trigger ERISA protections. There is a limited period in which the insurer can make an adverse benefit determination.  Generally, adverse benefit determinations must be made within 90 days of the health plan’s receipt of the claim, unless special circumstances exist which necessitate an extension of time.[13] Adverse benefit determinations for group health plans are to be made “within a reasonable period of time, but not later than 30 days after receipt of the claim.”[14] Prior to the expiration of this 30 day period, the insurer may extend its time to make an adverse benefit determination by up to 15 days.[15] The notification must provide the specific reason(s) for the adverse determination, referencing the specific plan provisions upon which the insurer’s determination is based.[16] The notice must provide the plan beneficiary with a description of any additional material or information necessary to satisfy the claim and an explanation of why such material or information is necessary.[17] The insurer must also furnish a description of the plan's review procedures and the applicable time limits. [18] The insurer must provide appeal rights.  The beneficiary is entitled to a “[r]easonable opportunity to appeal an adverse benefit determination . . . under which there will be a full and fair review of the claim and the adverse benefit determination.”[19] After the receipt of an adverse benefit determination notification, the claimant has at least 60 days to appeal the decision.[20] ERISA also requires the notification to include a statement of the claimant's right to bring a civil action under section 502(a) of the ERISA Act following an adverse benefit determination that is under review. [21] Recoupment: Compliance with ERISA Under ERISA, any determination that a claim should not be paid in full constitutes an adverse benefit determination.[22] A retroactive benefit denial is an insurer’s adverse determination that the patient’s benefits should not have been paid.  Retroactive adverse benefit determinations, without adhering to the notification and appeal processes, violate the protections afforded by ERISA.  Some insurers, however, contend that a repayment demand letter alone does not constitute an adverse benefit determination.[23] Where no funds are recovered or offset, some insurers may claim that overpayment letters alone do not trigger ERISA’s notice and appeal rights.[24] But, when recoupment efforts go beyond making a repayment demand and result in the offsetting of other compensable claims, the insurer must comply with ERISA protections requiring a “full and fair review.”[25] However, if the provider agreement clearly indicates that the provider is ineligible to deliver the service, and it was paid in error, ERISA may not be implicated.[26] State law may govern in this instance. “Mistaken authorization” is another basis under which an insurer might attempt to retroactively deny or recoup payments.  Provider agreements generally dictate the authorization procedures that the provider must follow in order to receive payment.  Medical providers rely on the benefit authorizations and pre-approvals they receive from the insurance carrier to reasonably determine that payment will be forthcoming.  Arguably, insurance plans have a duty to their participating providers to generate complete and accurate information via the provider’s verification of benefits.  The insurer’s retroactive assertion that authorization was “erroneous” places the provider in a precarious position.  If unsuccessful in the appeals process with the insurer, the provider could do nothing, and absorb the loss.  Or, the practice could pursue the patient.  Nothing in ERISA prohibits a provider from billing patients for services that are not covered under the benefit plan.[27] But, the provider’s contract may contain language prohibiting such recourse.   In the alternative, the provider could attempt to pursue the insurer under two potential courses of action – under ERISA or under state law.   ERISA also governs the provider’s allegations of an insurer’s improper processing of claims for plan benefits.[28] Adverse Benefit Determinations: The Right to Payment versus Rate of Payment ERISA distinguishes between “right to payment” issues and “rate of payment” issues.   “Right to payment” issues are created when an insurer fails to honor the patient’s benefit or when the insurer denies the patient’s claim.[29] Both of these situations constitute adverse benefit determinations.  A claim denial can be prospective or retrospective. The insurer’s prospective or retrospective denial of plan benefits triggers ERISA’s notification and appeal protections.  The “right to payment” is not a contract issue; it does not raise independent contractual duties outside of ERISA.  This falls squarely within the regulatory scheme of ERISA.[30] In contrast, “rate of payment” issues are contractual in nature.  The participating provider agreement creates a contractual duty that is independent of ERISA.  For a participating provider, fee schedule disputes do not necessarily involve ERISA.[31] An insurer’s recoupment of overpayments based on the contractual fee schedule is not a denial of benefits.  This type of payment dispute is a matter of contract law, where the underlying provider contract controls the payment provisions. ERISA’s notification and appeals processes are not controlling.  State law, and not ERISA, would most likely determine the outcome where the claims originate from this independent legal duty.[32] However, for providers who are not participating, underpayments or overpayments may implicate ERISA’s protections.  Between a non-participating provider and an insurance plan, there is no contract governing payment terms or fee schedules.  In the absence of a provider contract, the insurer does not have any independent contractual duties relative to the provider’s claims.[33] An out-of-network provider’s claims based on the underpayment of a claim likely raises a “right to payment” issue under ERISA.[34] In assessing which course of action to take, the provider must determine whether the insurer’s action has created a “right to payment” issue or one involving the “rate of payment.” Repayment Demands Based on Fraud Repayment demands based on fraud present a different issue entirely.  In the instance of fraud allegations, the insurer is generally attempting to recover the entire benefit paid to the provider.  An insurer’s repayment demand based on perceived fraud is a retroactive determination involving a dispute over “benefits due” when it involves specific claims.  ERISA provides the exclusive remedy only where the “claims are derived entirely from the particular rights and obligations established by the plan.”[35] That is, for ERISA to be applicable, a specific beneficiary with benefits arising under a benefit plan must be at issue.  The insurer may bring fraud allegations against the provider under state law where the claims are independent of any benefit belonging to a plan beneficiary. For example, an insurer may claim that the provider systematically renders services which defraud the insurer. (e.g., a general practice of billing for services not rendered).  In those instances, state fraud statutes may give rise to a duty independent of ERISA, which could allow state law, rather than ERISA, govern the dispute.[36] The resolution of fraud claims may depend on the provider’s conduct, rather than the terms and conditions of the beneficiary’s ERISA plan. [37] However, where recoupment of previously paid benefits appears to be an effort by the insurer to enforce the plan’s terms for specific beneficiaries, ERISA may govern an insurer’s efforts.[38] Facts and circumstances will dictate whether Federal or state law applies. Provider’s Options Medical providers are not beneficiaries of an ERISA plan.  An ERISA plan is independent of any participating provider agreement that may exist between the insurer and the medical provider.  Ordinarily, a person who is not a party to a contract would not have any rights under that contract.  With patients and medical providers, the patient’s assignment of benefits confers rights to the medical provider under the patient’s health care plan.  Under an assignment of benefits, the medical provider stands in the shoes of the patient, and may seek to enforce payment of the patient’s benefits.[39] Through a valid assignment, the provider may avail itself to the applicable ERISA protections on behalf of the patient.[40] The provider should insist on the insurer’s compliance with ERISA’s protections.  A paper trail should be maintained to document all of the provider’s efforts in resolving the disputed claim.  The provider should also document all of the insurer’s actions as well.  Failing resolution between the provider and the insurer, the provider could challenge the insurer’s retroactive denial of coverage under section 502 of ERISA.  A number of courts have held that ERISA governs a provider’s claims for benefits where the insurer’s representations have “the effect of orally modifying the express terms of an ERISA plan and increasing plan benefits for participants or beneficiaries who claim to have been misled.”[41] In plain language, this means that the insurer’s representations could create a benefit in situation where ordinarily no benefit existed.   Provider agreements define “covered services” for which the insurer will reimburse when performed by the provider.  With respect to the plan beneficiary, however, covered services are defined under the ERISA plan, not by the provider agreement. An insurer may claim that ERISA procedures are inapplicable by contending that the terms of the provider agreement control repayment and recoupment.  ERISA’s language appears to be contrary to that assertion.[42] To the extent that ERISA does not control, the provider could elect to pursue state law claims under a negligent misrepresentation theory if recoupment is based on the insurer’s erroneous or mistaken authorizations.  A number of courts have held that providers may maintain state law claims against an insurer based on erroneous verifications of coverage and erroneous information pertaining to the existence and extent of coverage.[43] A provider’s state law claim may be appropriate not because of the patient’s coverage, but because there is no ERISA coverage.  A key distinction that must be made is whether the insurer’s decision is actually an adverse benefit determination or an interpretation of the terms of the provider agreement.[44] Conclusion Providers should always attempt to clarify, understand and resolve claims issues by dealing directly with the insurance carrier.  ERISA protections are only available for plans that are, by statute, ERISA plans.  Otherwise, state law governs.  If the plan falls under ERISA, the medical provider may challenge the insurer’s adverse benefit determination and take advantage of all of the notification, denial substantiation requirements, and appeal rights.  The provider should attempt to understand the insurer’s reasoning behind its repayment demands to determine whether it constitutes an adverse benefit determination. The provider may have a cause of action for the insurer’ actions regarding an ERISA beneficiary that may be brought under a state law claim if certain facts and circumstances exist.   Providers should recognize the distinction between disputes arising out of the right to payment versus the rate of payment.  For participating providers, “rate of payment” issues may implicate state law because of the existence of a contract.  For non-participating providers, where no contract exists, the payment dispute may fall into the “right to payment” category and implicate ERISA.     About the author: Franklin J. Rooks Jr., PT, MBA, Esq. is a physical therapist and practicing attorney in Philadelphia, Pennsylvania.  Prior to his practice of law, Frank was a founding partner of PRO Physical Therapy, a Wilmington, Delaware based operator of physical therapy clinics.  This article is not legal advice.  ERISA is an expansive area of the law.  This article is intended to provide only very general, non-specific legal information.  This article does not cover all the issues related to the topic discussed.  The specific facts that apply to your situation determine the outcome.  This article does not create any attorney client relationship between you and the author.  Frank can be contacted at fjrooks@gmail.com  
[1] See The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 935; 42 U.S.C. § 1395ddd(f).
[2] Not all plans are covered under ERISA.
[3] H.R. Rep. 93-533, 93rd Cong., 2nd Sess. 1974.
[4] 70 C.J.S. Pensions § 19.
[5] See Aetna v. Davila, 542 U.S. 200, 208 (2004).
[6] 29 U.S.C. § 1144(a).
[7] Arizona State Carpenters Pension Trust Fund v. Citibank, 125 F.3d 715, 723 (9th 1997)
[8] 29 U.S.C. § 1132(a)(1)(B).
[9] 29 C.F.R. § 2560.503-1(m)(4)
[10] Id.
[11] Id.
[12] Id.
[13] 29 C.F.R. § 2560.503–1 (f)(1).
[14] 29 C.F.R. § 2560.503–1 (f)(2)(iii)(B).
[15] Id.
[16] 29 C.F.R. § 2560.503-1(g)(1)(i)(ii)
[17] 29 C.F.R. § 2560.503-1(g)(1)(iiI)
[18] 29 C.F.R. § 2560.503-1(g)(1)(iv)
[19] 29 C.F.R. § 2560.503-1(h)
[20] 29 C.F.R. § 2560.503–1 (h)(2)(i).
[21] 29 C.F.R. § 2560.503-1(h)
[22] 29 C.F.R. § 2560.503-1(m)(4).
[23] See Association of New Jersey Chiropractors v. Aetna, 2011 WL 2489954 at *8 (D.N.J.). “[T]he Court is not persuaded that dismissal of Plaintiffs' ERISA claims is warranted at this time. While Aetna has raised questions as to the viability of Plaintiffs' ERISA claims, the Court concludes that a more complete factual picture regarding Aetna's “recoupment”/anti-fraud efforts is necessary to ultimately resolve the issue.” Id. at *9.
[24] Id.
[25] 29 U.S.C. § 1133(2). “[E]very employee benefit plan shall afford a reasonable opportunity to any participant whose claim for benefits has been denied for a full and fair review by the appropriate named fiduciary of the decision denying the claim.”
[26] Cf. Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393, 402 (3rd Cir. 2004). Under a breach of provider agreement, a “[r]ight to recovery, if it exists, depends entirely on the operation of [provider agreements] executed by the Plan that are independent of the Plan itself.”
[27] Central States Southeast and Southwest Areas Health and Welfare Fund v. Pathology Laboratories of Arkansas, 71 F.3d 1251, 1253 (7th Cir. 1995)
[28] Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 48 (1987).
[29] 29 C.F.R. § 2560.503-1(m)(4)
[30] Id.
[31] See Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393 (3rd Cir. 2004), citing Blue Cross of California v. Anesthesia Care Associates Medical Group Inc., 187 F.3d 1045 (9th Cir. 1999), holding  “Providers' claims, which arise from the terms of their provider agreements and could not be asserted by their patient-assignors, are not claims for benefits under the terms of ERISA plans.”
[32] Id.
[33] See Sportscare of America P.C. v. Multiplan, 2011 WL 223724 (D. N.J.), discussing that out-of-network provider’s claims for underpayment fell under ERISA.
[34] Crossroads of Texas v. Great West Life and Annuity Insurance Co., 467 F.Supp.2d 705, 710 (S.D. Tex. 2006).
[35] Horizon Blue Cross Blue Shield v. East Brunswick Surgery Center, 623 F. Supp. 2d 568, 578 (D. N.J. 2009).
[36] Aetna Health Inc. v. Health Goals Chiropractic Center, 2011 WL 1343047 at * 6(D.N.J.)
[37] Id.
[38] Sereboff v. Mid Atlantic Medical Services Inc., 547 U.S. 356, 361 (2006).
[39] Horizon Blue Cross Blue Shield v. East Brunswick Surgery Center, 623 F. Supp. 2d 568, 575 (D. N.J. 2009).
[40] Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393, 407 (3rd Cir. 2004). “Almost every circuit to have considered the question has held that a health care provider can assert a claim under § 502(a) where a beneficiary or participant has assigned to the provider that individual's rights to benefits under the plan”
[41] Memorial Hospital System v. Northbrook Life Insurance Co., 904 F.2d 236, 245 (5th Cir. 1990).
[42] See 29 U.S.C. § 1132(a)(3). “A civil action may be brought by a beneficiary to enjoin any act or practice which violates any provision of this subchapter or the terms of a plan.” [emphasis added]
[43] See Hospitals and Clinics v. Archstone Communities LLC, 2011 WL 1748432  at * 3 (N.D. Cal.) See  Blue Cross of Cal. v. Anesthesia Care Assoc. Med. Group, Inc., 187 F.3d 1045, 1047 (9th Cir.1999); The Meadows v. Employers Health Ins., 47 F.3d 1006, 1011 (9th Cir.1995).
[44] See Pennsylvania Chiropractic Ass’n v. Blue Cross Blue Shield Ass’n, 713 F. Supp. 2d 734 (N.D. Ill. 2010).
 ]]> http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/feed/ 0 How To Negotiate The Restrictive Covenant In Your Employment Contract http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/ http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/#comments Mon, 01 Aug 2011 15:20:28 +0000 Physicians News http://www.physiciansnews.com/?p=4202 By Martha Swartz, M.S.S., J.D.   With economic pressures on physicians mounting and regulatory incentives to affiliate with larger entities expanding, an increasing number of physicians are becoming employees of larger medical groups or health care systems. Restrictive covenants are becoming a mainstay of physician employment agreements. While the American Medical Association Council of Ethical and Judicial Affairs has found them to “disrupt continuity of care, and potentially deprive the public of medical services”, it has found them “unethical” only if they are “excessive in geographic scope or duration … or if they fail to make reasonable accommodation of patients’ choice of physician.” At least eight states have invalidated restrictive covenants, including three that have specifically enacted statutes banning them; however, courts in New Jersey and Pennsylvania have upheld them as recently as 2005. Restrictive covenants never benefit employees and in an ideal world, you would want to delete them entirely from your employment contract. However, in most cases, this cannot be achieved; therefore, if you are becoming an employee in Pennsylvania or New Jersey, you might benefit from some helpful pointers about how to negotiate restrictive covenants. What is a Restrictive Covenant? A restrictive covenant is a provision in an employment or purchase agreement that prohibits you from practicing medicine within a certain geographic area for a specified amount of time. Restrictive covenants are designed to protect the economic interest of your employer who is assumed to have spent time and money training you, introducing you to its patients and sharing confidential information to you. Pennsylvania and New Jersey Law. Both Pennsylvania and New Jersey recognize the validity of restrictive covenants under certain conditions. In Community Hospital Group, Inc. v. Jay More, M.D., 183 N.J. 36, 869 A.2d 884 (NJ 2005), Dr. More, a neurosurgeon, left his employment at Community Hospital Group and joined a neurosurgery practice within the geographic area and time restricted by the restrictive covenant in his employment contract. The New Jersey Supreme Court concluded that a physician’s employer had a protectable interest in "protecting the investment in the training of a physician" in addition to traditionally recognized interests in confidential business information and affirmed the contract’s 2 year time period restriction; however, it “bluelined” the agreement, that is, it modified the agreement, to reduce the 30 mile geographic restriction so that Dr. More would be permitted to cover the Somerset Hospital emergency room that relied on his coverage to be able to provide neurosurgery services to its patients, thus protecting what the court viewed as the public interest. The Pennsylvania Superior Court in Wellspan Health vs. Bayliss, 869 A. 2d 884(PA Super 2008) agreed that physician restrictive covenants are permissible and enjoined Dr. Bayliss, a perinatologist, from practicing in Adams and York counties where Wellspan drew many of its patients since it concluded that a patient referral base was a legitimate interest of Wellspan; however, it “bluelined” the restrictive covenant to permit Dr. Bayliss to practice in Lancaster County because Wellspan didn’t compete with him in Lancaster County for maternal-fetal patients; thus, Wellspan did not have a legitimate business interest in preventing Dr. Bayliss from practicing in Lancaster County. The bottom line is that, in Pennsylvania and New Jersey, restrictive covenants are likely to withstand judicial challenge if they protect a legitimate business interest of the employer, they don’t unduly harm the employed physician, they are “reasonable” in geographic scope and duration, and their enforcement won’t harm the public. However, many of the restrictive covenants proposed by employers arguably fail to satisfy these requirements and therein lies the negotiating opportunity. Legitimate Business Interest of Employer/Scope of Practice.  Most restrictive covenants include some variation of language that restricts the employed physician from “directly or indirectly, as an employee, employer, contractor, consultant, agent, principal, shareholder, corporate officer, director, or in any other individual or representative capacity, engage or participate in any business or practice” that competes with the employer.  Since protecting the employer’s legitimate business interest is at the core of the restrictive covenant, the first question to ask is what kind of business opportunities would “compete” with your employer? Not every form of medical practice or facility in which you might practice post-employment is likely to compete with your employer. For example, if, as an anesthesiologist you are employed by an anesthesiology group that limits its practice to hospital settings, you can argue that the group should not be able to prevent you from practicing at an outpatient pain clinic within the restricted area after you leave the practice. If you are a pulmonologist who is employed by a hospitalist group, the group arguably does not have a legitimate reason to prevent you from opening a general pulmonology practice within the restricted area. Thus, one approach is to list in the agreement the types of facilities that the employer considers to be a competitive threat. Another approach is to carve out certain types of facilities that don’t threaten your employer’s business. For example, if you are employed by a pediatric practice that provides outpatient care primarily, you should be able to practice as a facility-based pediatrician. If you are employed by an internal medicine group that provides outpatient and hospital inpatient services only, you should be able to become the medical director of a nursing home in the restricted area. You might also identify in the agreement specific institutions at which you would be permitted to work. Another approach is to propose, as the perinatologist defendant successfully argued in Wellspan, that your employer’s legitimate business interest does not extend to geographic areas from which it draws no patients. This might mean limiting the mileage restriction, the applicable counties, or some other geographic delineation in the restrictive covenant. Geographic scope. Restrictive covenants address geographic limitations in many ways: they might set a mileage radius from: 1) a group’s primary office; 2) each of the group’s offices; 3) each of the group’s offices currently existing or developed in the future; or 4) each of the hospitals or other facilities at which any member of the group practices. Or, rather than a mileage restriction, the restriction might be defined by counties. The first step is to map out the circumference of the restriction and note the medical facilities that are located within the proposed restricted area. Are there certain facilities or practices that you think you might want to join if this particular employment arrangement doesn’t work out? Note where these facilities or practices are located in relation to the proposed restricted area. For example, an employer might impose a 10 mile restriction from its primary office at 100 Montgomery Ave. in Ardmore, PA. If the facilities at which you might want to work post-employment are located 8 miles from the employer’s primary office, try to reduce the geographic scope to 7 miles. Once the restrictive covenant is measured from more than one central point, for example, from all of the practice’s offices, the geographic restriction is increased exponentially. Thus, you should try to limit the restriction either to the practice’s principal office or to those offices or hospitals in which you primarily practiced as an employee within the last 12 months of your employment. Be especially careful about agreeing to be restricted from practicing within a certain number of miles from the employer’s future offices since introduces a degree of uncertainty that makes it difficult for you to evaluate the impact of the restriction. What might be considered a “reasonable” geographic restriction in a rural area may not be considered “reasonable” in an urban area. Thus, while a Pennsylvania court upheld a 50 mile restriction in rural Pennsylvania in Geisinger Clinic v. DiCuccio, 414 Pa. Super. 85, 606 A.2d 509, 518 (1992), it is unlikely that such an expansive restricted area would be considered reasonable in an urban setting. Time. Most physician contracts restrict physicians from competing during the term of their employment and for one to two years thereafter; under most circumstances, this restriction would probably withstand a court challenge. However, if you have a one year contract, it might not be reasonable for the employer to impose a restrictive covenant that is longer than your initial agreement. Also, if you leave the practice within a short period of time, that is, before you’ve received the benefit of being trained by the employer, the restrictive covenant should not apply at all. You can argue for “tiered” applicability, that is, if you leave during the first year (especially if you are new to the area or just finishing your residency so that your ability to develop a significant practice within the first year is limited), no restrictive covenant should apply. If you leave during the second year, a one year restriction should apply; the two year restriction should apply only if you have been employed for at least 2 years by the employer imposing the restriction. Triggers. One point that many physicians fail to consider in negotiating restrictive covenants is the circumstances under which the restrictive covenant is triggered.  It is arguably fair for the restrictive covenant to apply if: 1) the employed physician leaves without cause (thus arguably “leaving the employer in the lurch”); or 2) the employer terminates the physician with cause (other than alleged physician incompetence) since the physician may have been able to prevent her termination. However, if the employed physician leaves due to the employer’s breach of the agreement, the restrictive covenant should not apply. (This means that you also have to pay attention to the contract’s termination provisions since many physician agreements fail to include a provision permitting the physician to terminate for cause, a necessary prerequisite to invoking this trigger.) Similarly, if the employer terminates the physician for no reason, e.g. the employer overestimated its patient volume, the physician should not be penalized by being subject to a restrictive covenant.  Finally, if the employer terminates the physician because the employer alleges that the physician was incompetent, no restrictive covenant should apply because an “incompetent” physician presumably cannot be a competitive threat to the employer. In addition, restrictive covenant should not apply if the employer ceases to provide the type of specialized services that the physician provides. For example, if a hospital discontinues its obstetrics services, the employed obstetrician-gynecologist should be able to practice obstetrics anywhere without being subject to a restrictive covenant. Public Interest. In contrast to the American Medical Association, the American Bar Association has a longstanding rule prohibiting restrictive covenants in lawyers’ contracts, concluding that they inappropriately intrude upon the lawyer-client relationship and restrict the public's right to choose an attorney. Several commentators have argued that the public’s right to choose a physician is at least as important as the public’s right to choose an attorney. However, while judges see themselves as appropriate arbiters of lawyers’ rights, they have usually deferred to the AMA’s judgment about what is ethical for physicians. Nevertheless, in deciding whether a restrictive covenant is enforceable, courts invariably consider whether enforcement of the restrictive covenant is likely to injure the public. The More court specifically reduced the mileage restriction in Dr. More’s restrictive covenant precisely because his skills as a neurosurgeon were needed to provide coverage in a particular hospital’s emergency room. In an earlier Pennsylvania case, New Castle Orthopedic Assoc. v. Burns, 481 Pa. 460, 469, 392 A.2d 1383, 1387 (1978), the Pennsylvania Supreme Court reversed the grant of a preliminary injunction that would have prevented an orthopedic surgeon from practicing within a certain geographic area because it concluded that there was a shortage of orthopedic specialists in the geographic area; the orthopedic surgeon was permitted to practice in the restricted area to avoid harm to the public.  Considering the great weight often given to potential public harm by courts, you might be able to negotiate the complete elimination of a restrictive covenant if you are practicing in a rural area with a shortage of physicians in your specialty. Restrictive Covenants and Recruitment Agreements. If your compensation in your employment agreement with a medical practice is subsidized under a recruitment agreement with a local hospital, the restrictive covenant must comply with the Stark law. Under an older version of the Stark Law, a medical practice could not include a restrictive covenant in its employment agreement with a physician whose compensation was subsidized by a local hospital. However, after 2007, this requirement was modified, so that restrictions are now permitted provided that they do not unreasonably restrict the physician’s ability to practice in the geographic area served by the hospital. Failure to comply with state law would be considered evidence that the restrictive covenant is not “reasonable.” Liquidated Damages. An increasingly number of restrictive covenants include liquidated damages clauses. These clauses permit the physician to “buy her way out of the restrictive covenant.” The amount required to be paid should relate to the costs incurred by the employer in terms of patients lost due to the physician’s departure and recruitment and training of a replacement physician. One possible way of calculating these damages is to relate them to the physician’s annual compensation while she was an employee. Consideration.  Restrictive covenants are valid only if they are part of another agreement, e.g. a purchase agreement or an employment agreement, because they must be accompanied by adequate consideration, i.e. payment. Generally, the salary offered by the employer in the initial employment agreement is considered adequate consideration. However, if an employer subsequently tries to add a restrictive covenant to an employment agreement, it will not be upheld unless the employer provides additional payment to the employee. Dispute Resolution. Litigation is expensive and time-consuming. It is generally in all of the parties’ interests to expedite the resolution of disputes involving restrictive covenants. The American Health Lawyer Association has dispute resolution services that include both mediation and arbitration. Starting with mediation in these types of disputes often means a faster and more equitable resolution. ### The Law Office of Martha Swartz (www.swartzhealthlaw.com) concentrates on the regulatory and business aspects on health care.    ]]> http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/feed/ 0 Preferred Provider Contracting: Beware Of Rental Networks And Third Party Guarantors http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/ http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/#comments Thu, 14 Jul 2011 11:54:28 +0000 Physicians News http://www.physiciansnews.com/?p=4179 By Martha Swartz, M.S.S., J.D. What is a PPO? As a health care institution or individual provider, it is difficult to provide services in Pennsylvania and New Jersey without participating in at least one preferred provider network (PPO).  PPOs are a form of managed care in which: an intermediary (PPO) forms a network of health care providers and connects the health care providers to third party payers such as insurance companies, employers, and third party administrators (Payers). The providers offer their services to the PPO at a discounted rate because they expect Payers to steer patients to them as a result and thus, to increase their patient volume. The health care providers that are on the PPO’s panel of providers are “in-network” and, because of the negotiated discounts, patients who go to them for services pay less than they pay for similar services offered by health care providers who are not on the PPO panel, or are “out of network”. A PPO can be a “win-win” for patients and health care providers in that individual patients who seek services from in-network providers save money and in-network providers potentially receive increased revenues as the result of increased patient volume which results from the PPO’s marketing of their services as being “in-network” and thus less expensive. What is a Rental Network? The above arrangement falls apart if the PPO fails to market the health care provider’s services as “in network” or if the PPO makes the discounts available to Payers that are not part of the health care provider’s marketing plan, that is, if the PPO “rents out” the provider’s discount without the provider’s knowledge or consent.  When this happens, health care providers find themselves providing services to individuals for which they expect to receive a certain reimbursement amount, only to find out at time of payment that the individual’s Payer has accessed a discount to which it is not entitled. The PPO may even have made your discount available or “rented out” your discounts to Payers with which you already have a negotiated an agreement at a higher rate. Providers thereby end up with the “short end” of the bargain, that is, they give discounts, but don’t receive a higher volume of patients in return. Back in 2005, a number of commentators began to warn physicians of “silent PPOs”, that is, arrangements in which a PPO with which a physician contracts to be on a PPO panel makes the discounts the physician negotiated with that PPO available to other Payers, without the Physician’s consent. However, many times a physician unwittingly agrees to make her negotiated discounts available to other Payers in a PPO’s “rental network” because the physician fails to read the fine print in the contract proposed by the PPO. Are Rental Networks “legal”? In 2008, to avoid the regulation and possible banning of “silent PPO”s, the American Medical Association and the American Association of Preferred Provider Organizations lobbied the National Conference of Insurance Legislators (NCOIL) to adopt a Model Act to Regulate the Secondary Market in Physician Discounts. Under the model law, an intermediary contracting with a physician who wishes to make the terms of its contract available to other Payers must state in its contract with the physician that the intermediary contracting entity:
  • is permitted to enter into an agreement with a Payer allowing the Payer to access the physician’s discounted rates;
  • will contractually obligate the Payer renting access to a provider network to abide by the terms of the original contract between the intermediary and the physician; .
  • will provide the Payer with the relevant terms of the original contract with the physician with which the Payer is obligated to comply;
  • will provide the physician with a continually updated list of entities that have access to the physician’s discounts, including all additions and deletions;
  • will obligate all Payers to note on their Explanation of Benefit forms the source of their contractual discounts.
A number of state legislatures have adopted forms of the NCOIL Model Act, including Connecticut, Colorado, Florida, Indiana and Ohio. Other states including Arkansas, California, Kentucky, Louisiana, Maryland, Minnesota, North Carolina, Oklahoma, South Carolina, Texas and Virginia, have enacted laws that limit or prohibit silent PPOs. So far, there is no similar legislation in either Pennsylvania or New Jersey. In addition to legislature-passed laws, several state and federal courts have issued decisions rejecting a Payer’s right to make discounted payments to a health care provider when the discount was “sold” to the Payer without the health care provider’s knowledge. Although none of these cases arose in either New Jersey or Pennsylvania, they provide insights as to how a local court might view this issue. In at least two of the cases, HCA Health Services of Georgia v. Employers Health Insurance Company, 240 F. 3d 982 (11th Cir 2001) and Mitzan v. Medview Services, Inc., 1999 WL 33105613 (Mass. Super, June 16, 1999), the courts based their analyses on whether the insurer that had accessed the provider’s discounts had been in the position to steer patients to the provider, thus providing the physicians with the “benefits of their bargain”. What can physicians do to gain the benefits but avoid the risks caused by rental networks? Review your PPO agreements carefully, preferably with the assistance of an attorney, to ascertain if the PPO intends to “rent” your negotiated discounts to Payers. If it is determined that the agreement does permit the “renting” of your discounts, make sure that your agreement with the PPO:
  • makes it clear that the discount you’re offering the PPO is in exchange for the PPO requiring the Payers with which it contracts to steer patients to you as an “in network” participating provider
  • obligates the PPO to require all Payers to identify you in all of their written material as an “in network” provider
  • makes it clear that the payment terms that you agree to in the PPO agreement are confidential and may not be disclosed without your express written consent, except to a list of Payers that you have approved
  • obligates the PPO to provide you with a list of all Payers, updated throughout the term of the contract
  • obligates the PPO to refrain from contracting with any entities with which you have an existing agreement that provides higher payment rates
  • requires the PPO to contractually obligate all of its Payers to comply with the terms of the PPO’s agreement with you, including payment procedures, UR procedures, underpayment recoupment, etc.
  • obligates Payers to note on their EOBs the source of their discounts
  • clarifies which UR procedures applies to your contract, i.e. those of the intermediary or those of the Payer
  • obligates the PPO to conduct financial due diligence regarding the Payers to which it makes your discounts available to you to reduce the chances that a Payer will fail to make timely and accurate payments
  • obligates the PPO to advocate on your behalf if a Payer fails to make timely and accurate payments
  • requires Payers to pay your full charges if they fail to pay you within the agreed upon time limit
  • permits you to discontinue discounts to, and to terminate your relationship with, any Payer or any Payer’s product if the Payer fails to make timely and accurate payments
Third party Guarantors of Copayments. Another type of arrangement that recently has been introduced locally can also be a “win-win” for patients and health care providers. At least one local PPO is now offering a program in which a patient’s copayment is paid by the Payer, thus relieving the provider of the expense and inconvenience of collecting the copayment from the patient itself.  Because their costs will be reduced, some providers may be willing to accept lower reimbursement rates as a result of this arrangement.  Since physicians don’t refer patients to insurers, the promise of such a potential benefit to physicians doesn’t implicate state or federal anti-kickback statutes. However, practical problems can arise if it is unclear to the provider or the patient that an entity other than the provider will be seeking the copayment from the patient.  Thus, the provider’s agreement with the PPO should require the PPO to obligate its Payers to: 1) inform the patients in writing to expect a bill for the copayment from the Payer; and 2) specify on the patient’s ID card the Payer that is responsible for paying the patient’s copayment, so that the provider is aware that it is not responsible for collecting the patient’s copayment. Also, since the provider has no direct contract with the Payer that is paying the patient’s copayment, the provider must rely on the PPO to obligate the Payer contractually to pay the patient’s copayment to the provider in a timely fashion. Furthermore, the PPO’s agreement with the provider should confirm that the provider is no longer obligated to collect these copayments. Negotiating your PPO Agreement. Many physicians fail to read their PPO (and other types of third party payer) contracts carefully because they assume they have no ability to negotiate with large insurance companies and other payers. Remember, however, if a Payer needs the type of specialty or subspecialty services that you provide in the geographic area in which you provide services, you may have more leverage than you think. ### The Law Office of Martha Swartz (www.swartzhealthlaw.com) concentrates on the regulatory and business aspects on health care.  ]]> http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/feed/ 1 Urgent Care Centers, a Merging Trend in Health Care http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/ http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/#comments Fri, 17 Jun 2011 14:08:24 +0000 Physicians News http://www.physiciansnews.com/?p=4134 By Lucia F. Bruno, J.D., LL.M., M.B.A. Urgent care medicine has emerged as one of the fastest growing specialties in the United States.  Many family practitioners view this new form of health care as a convenient compromise to the traditional practice of medicine; absent the time and travel between offices, nursing homes and hospitals.  Likewise, emergency room physicians perceive urgent care medicine as a viable way to use their triage skills without the stress associated with a hospital setting. With approximately 8,700 urgent care centers (UCCs) nationwide and an increased percentage throughout Pennsylvania and New Jersey, many physicians question the financial incentives and legal complexities unique to this practice of medicine.  This article will address some of these growing concerns. Ownership Structure:  Choose Your Destiny Wisely Innovation is the principle source of differentiation and competitive advantage; innovative structuring of a UCC is no exception.  Amongst the plethora of buyouts, mergers, acquisitions, and joint ventures, investors need to weigh structuring options and management models carefully, as future profitability swings in the balance.    Currently, only a select number of states require physician ownership of UCCs: Texas; California; Ohio; Colorado; Iowa; Illinois; New York; and New Jersey.  The 2010 survey released by the Urgent Care Association of America (UCAA) indicates that physician or group physician ownership accounts for approximately 50% of structuring, with the remaining as follows:  Hospitals 27.9%; Corporations 13.5%; Non-physician individuals 7.7%; and Franchises 1.0%.[1] So what makes one ownership structure more profitable than another? Hospital-based UCCs are part of an existing operation; therefore, the hospital’s tax identification number is also used by the UCC which can lead to billing complications amongst other regulatory issues.[2] In contrast, freestanding UCCs are independently incorporated, maintain their own tax identification and management structure, and can bill accordingly. Although a myriad of other factors influence profitability including: overhead expenditures; reimbursement rates; and the accurate use of CTP codes; the answer to profitability lies in the fundamental accounting principal of net income, also known as net profit, (Total Revenue - Total Expenses = Net Income). This is the amount of money left in your pocket after all expenses have been paid. When deciding which ownership structure to select, investors must balance the initiative of the UCC with the financial goals and objectives of its investors.  Regardless of structure, increasing patient volume and holding operating expenses below the level of collections will increase profitability.[3] Historically, hospital-based UCCs have failed to keep operating expenses down; as a result they struggle to break even and in the worst case scenario suffer financial loss and eventually close.[4] Licensing:  The EMTALA Distinction Licensing isn’t just a mere technicality; it is a precursor of how you’ll do business.  Currently, only one state, Arizona, has an Urgent Care License requirement.  Other states such as Illinois, Delaware, and New Hampshire have placed restrictions on how UCCs can be identified and marketed to the public. In determining how to license a health care facility many jurisdictions examine ownership interest, business structure, size of the facility, and the nature of the care provided.  Since UCC practitioners specialize in the treatment of disease, illness and/or injury on an episodic basis and don’t provide obstetric services, in-hospital admissions, long term management of chronic diseases or other conditions requiring continuity of care, practitioners need only maintain state licensure necessary to practice medicine, in addition to a license to operate the lab or other diagnostic imaging equipment, where applicable. Unlike physician-owned UCCs, hospitals may offer urgent care as an extension of the emergency department, as a fully controlled ancillary service, as an equity joint venture, or as a landlord/tenant.   Many hospital-based UCCs, or those situated on the hospital campus (or within 250 feet), are considered Type B Emergency Departments subject to specific licensing requirements, as well as EMTALA (Emergency Medical Treatment and Labor Act) statutes and JCAHO (Joint Commission on Accreditation of Healthcare Organizations) guidelines. The Centers for Medicare and Medicaid Services (CMS) defines a “Dedicated Emergency Department” as any department or facility of the hospital, regardless of whether it is located on or off the main hospital campus, that meets at least one of the following requirements: (1)  It is licensed by the state where it is located, under applicable state law, as an emergency room or emergency department; (2)  It is held out to the public (by name, posted signs, advertising or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; or (3) During the calendar year immediately preceding the calendar in which a determination is made (based on a representative sample of patient visits that occurred during that calendar year)  it provides at least one third (1/3) of all of its outpatient visits for the treatment of emergency medical conditions on an urgent basis, without requiring an appointment.[5] It is important to keep in mind that there are three distinct parts to the third criterion set forth by CMS. In order to be categorized as a “Dedicated Emergency Department” a UCC must meet all three parts, not just one or two.  Therefore, investors must ask themselves the following: (1) are over 1/3 of the patient visits on an urgent basis; (2) without an appointment; and (3) for the treatment of an emergency medical condition?  Many will answer "yes" to the first two components, but almost all will answer “no” to the last component given the nature of care provided.  Based on the last response, those UCCs are not “Dedicated Emergency Departments” for licensing or EMTALA purposes.[6] Regulations:  What You Don’t Know Could Hurt You Irrespective of the applicability of EMTALA or JCAHO, there are a whole host of other federal regulations that govern the day-to-day activities of urgent care medicine.  Although ownership interest frequently dictates the regulations for which investors must comply, such as STARK and anti-kickback laws, others apply across the board. All UCCs must comply with the privacy measures of the Health Insurance Portability and Accountability Act (HIPAA) and the security mandates of the Health Information Technology for Economic and Clinical Health Act (HITECH).  UCCs that operate a laboratory for blood tests or other related diagnoses must also adhere to Clinical Laboratory Improvement Amendment (CLIA) guidelines, in addition to Drug Enforcement Agency (DEA) mandates for the storage and dispensation of narcotics.  Finally, if the UCC provides services to Medicare or Medicaid patients, it must comply with the conditions of participation and reimbursement.   Knowing the rules of the game ahead of time can mean the difference between victory and defeat. Coding:  Not Just a Numbers Game One of the best ways to increase revenue in a UCC is to optimize billing and coding.  When negotiating a contract with a managed care organization it is incumbent upon UCC owners to make certain that reimbursement amounts and payment codes are specified in the contract. CMS has designated two HCPCS (Healthcare Common Procedure Coding System) codes for UCC use: S9083 - for global fees, irrespective of the treatment provided; and S9088, an “add on code,” for reimbursement of expenses unique to the practice of urgent care medicine, such as increased overhead and wage costs. Although these codes were never intended for submission to, or reimbursement by, Medicare or Medicaid many managed care organizations, such as United Health Care, now refuse to reimburse freestanding UCCs for anything other than professional procedure codes.[7] For those unfortunate enough to be caught up in the denial process, attempting to negotiate a reasonable compromise or a slight increase in fee schedule may be their only alternative. Marketing to Increase Revenue:  The “Me First” Mentality In today’s competitive economy traditional healthcare marketing strategies no longer work.   As more consumers gravitate towards urgent care medicine as a less costly, more convenient, option to traditional healthcare investors need to stay one step ahead of the competition in order to finish ahead of the pack. Since urgent care medicine is premised on consumer choice, a successful marketing plan will focus on customer service and convenience as a top priority.   A clear vision of your goals and objectives will give you more than just direction; it will give you a marketing framework that you can build your UCC around.  A few simple strategies to effectively market your UCC are as follows:
  1. Identify your niche market:  UCCs would do well to aggressively promote services to consumers with young children by marketing themselves as conveniently located and offering extended service hours.  Other targeted audiences include local employers and HR directors interested in pre-employment physicals, drug screening and immunization programs.
  2. Set up a website:  Yellow book advertising simply doesn’t fit the mind of today’s consumer. Today, consumers search online before they do anything else; therefore, it is crucial to develop a website and list your site with several directories and search engines.  If you do not list your website, it will become an orphan site that is not known and rarely visited by revenue- generating consumers.
  3. Signage: One of the most important marketing elements is a large, well-lit, sign prominently displayed in high traffic areas.  Since zoning restrictions regulate outdoor advertising, it is important to check with your local municipality regarding restrictions before you purchase a property or sign a lease for your UCC.
  4. Free Press: The local media is an invaluable asset in marketing your UCC.  Get to know local reporters, and let them know that you are available to do interviews for TV or newspaper stories on relevant healthcare topics.  Unlike other forms of media, this is completely free and has the greatest potential to reach a mass audience.[8]
As UCCs continue to expand across the country, the fields are ripe for investors to harvest the infinite possibilities posed by this merging trend in health care. ### Lucia Francesca Bruno, JD, LLM, MBA, is Principal Shareholder of Physicians' Legal Group, LLC (www.physicianslegalgroup.com).  She can be reached at(215) 688-3909.  
[1] Urgent Care Benchmarking & Statistics, http://www.ucaoa.org/resources_stats.php (Aug. 2010)
[2] Tony Barber, Pros & Cons to Freestanding vs. Provider-Based Models, (Mar. 2011)
[3] Brent Cosens, Financial Lesson in Urgent Care and Occupational Medicine, (Jan. 2009)
[4] Robin M. Weinick, Phd., Renee M. Bentancourt, BA, No Appointment Needed, The Resurgence of Urgent Care Centers in the United States, (Sept. 2007)
[5] 42 CFR Parts 413, 482, and 489 [CMS-1063-F] RIN 0938-AM34, https://www.cms.gov/EMTALA/Downloads/CMS-1063-F.pdf
[6] http://www.practicevelocity.com/urgent_care/coding/type_b_ed.php
[7] Urgent Care Policy-New, UHC Network Bulletin, Vol. 29, Jan.2009, pg.3
[8] http://www.practicevelocity.com/resources/marketing.php
 ]]> http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/feed/ 0 Preparing for ICD-10: Performing a Baseline MR Documentation Assessment http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/ http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/#comments Wed, 08 Jun 2011 14:46:18 +0000 Physicians News http://www.physiciansnews.com/?p=4112 By Michael G. Calahan, PA, MBA No longer just a rumor, the switch-over from ICD-9-CM to ICD-10-CM is now a sure deal and the established start date remains October 1, 2013.  Providers must be an active part of the conversion process, as many of the issues to be tackled are provider-driven.  Take, for example, medical record (MR) documentation.  MR documentation represents the beginning, middle and end of the current ICD-9-CM life cycle; it is foundational to the entire process of diagnosis coding and nothing materialized to date promises to change with ICD-10.  Provider documentation will initiate the assignment of codes, will drive the assessment of medical necessity for payment of services, and will serve to validate those services upon review by oversight entities.  With recovery funds now actively worked into the front-end of the government’s budget versus being considered “found” money, the advent of ICD-10 will not slow down or alter the federal government’s plans to audit providers. To prepare for ICD-10, performing a baseline MR documentation assessment can get the physician practices off to a good start.  This assessment will help expose areas where the providers need to strengthen their MR documentation.  Additional benefits can be realized, too.  One such benefit is the isolation of “missed opportunities” for diagnosis (ICD-9-CM) and service (CPT) coding.  These are diagnoses and services that should have been “captured” but were missed.  Likewise, services reported but under-documented enough so that the billing of them could be questioned by an outside reviewer such as an OIG, RAC or CERT auditor may be found.  The focus, however, will be on the documentation of diagnostic statements supporting the final-assigned ICD-9-CM codes, and how that documentation will likewise support the impending ICD-10-CM codes.  Case selection, i.e., determining which dates-of-service to review, should be accomplished by analyzing frequency reports generated by the billing system to assess the practice’s top 25 to 50 ICD-9-CM codes. In preparing source documents for the MR documentation review, remember the final-reported ICD-9-CM codes for each case selected may need to be compared with information contained on the practice superbills.  This form is the source document and data facilitator for billing information, which in turn gets translated to the CMS-1500 claim forms submitted to payers.  However, errors in the translation of data from the MR to the superbill are not rare.  And, even though this is a documentation review for comparing ICD-9 to ICD-10, the claim forms for each date-of-service should also be on hand.  The CMS-1500s are important source documents for comparing what was reported to the payers versus what the MR documentation holds as the actual case data. At a minimum then, the following source documents are needed to carry out a full MR documentation assessment:
  • Original MR documentation (e.g., office visit note)
  • Ancillary documents such as provider orders, operative reports, pathology reports, radiology reports, etc., if germane to the office visit
  • Practice superbils or encounter forms (i.e., the “charge tickets”)
  • CMS-1500 claim form copies.
  [caption id="attachment_4113" align="alignleft" width="207" caption="."][/caption] To perform a comparison-and-contrast of ICD-9-CM to ICD-10-CM codes, an ICD-10 tool will be needed.  This can be a pre-2013 ICD-10-CM book, an encoder with ICD-10 mapping, or the public CMS files that include listings of the ICD-10-CM/PCS codes as well as “GEM” files (general equivalency mapping spreadsheets), tying ICD-9 and ICD-10 together. Now select a patient date-of-service and prepare the array of MR documentation, the superbill and a copy of the CMS-1500 claim form.  Scan the progress (office visit) note for the recorded diagnostic data.  Most of the reportable ICD-9-CM codes listed on the CMS-1500 claim form and encircled on the superbill arise out of the diagnostic statement(s) noted under the “Assessment” section (if providers follow the SOAP note format), or alternatively the “Impressions” or “Diagnoses” sections. Also scan the History section of the office visit note.  Within the History component of the typical patient office encounter, there are four distinct elements required to be documented for most evaluation and management (E/M) services:  chief complaint (CC), review of systems (ROS), past, family and social history (PFSH) and history of present illness (HPI).  Commonly, a chronic but current/ongoing diagnosis impacting current care will be listed within the elements of the History, and not carried down or re-listed in the diagnostic area found under the Assessment section.  This “bad habit” should be avoided if possible, since it often confuses coders as well as outside medical reviewers. At this juncture let’s look at a case study to demonstrate the comparison process.  For illustration purposes we will use a patient with diabetes mellitus, type-II (DM-II), coded to ICD-9-CM code 250.00; no other ICD-9-CM codes were assigned or are listed on the CMS-1500 claim form for this particular office visit.  In this scenario, the patient’s CC is “Here for F/U of DM” and in fact, the “Impression” line states “DM-II, doing well on current regimen.”  However, the patient also has essential hypertension and is undergoing active treatment for this condition as evidenced by a note under the “Plan” section:  “Increase HCTZ to 50mg (25 mg b.i.d.).”  A quick glance under the History reveals the physician documented a correlating diagnosis in the ROS as “CV – HTN on HCTZ 25 mg q.d.”  Further, under “vitals” in the constitutional section of the progress note the annotation “Bp – 130/100 sitting x 2” is found.  Your conclusion in reviewing these notes is that the HTN did, in fact, impact the current care and therefore two diagnoses for this office visit should have been coded: DM and HTN. In relation to the DM-II, a finger stick test (glucometery) was normal.  There was no change in the condition, and therefore the DM-II remains coded to ICD-9-CM code “250.00 Diabetes mellitus without mention of complication, type II or unspecified type, not stated as uncontrolled.”  Under ICD-9-CM coding, the main methodology of coding diabetes mellitus is to (a) ascertain the “type” (i.e., type I juvenile DM or type II adult-onset DM) and then (b) code it according to status of control, as in “not stated as uncontrolled” (250.00) or “uncontrolled” (250.02).  This methodology is anticipated to hold true under ICD-10-CM as well, but the descriptor changes somewhat.  ICD-9-CM code 250.00 maps to ICD-10-CM code “E11.9 Type 2 diabetes mellitus without complications,” or to ICD-10-CM code “E13.9 Other specified diabetes mellitus without complications.”  DM-II now stated as “uncontrolled” under ICD-9-CM code 250.02 maps to ICD-10-CM code “E11.65 Type 2 diabetes mellitus with hyperglycemia.”  The analysis:  diabetes mellitus – depending on type, status and how specific the provider has been in his/her documentation – can be coded in several ways under ICD-10-CM.  The term “hyperglycemia” appears to be key in this classification when the DM is not under control.  As with ICD-9-CM coding now, the more specific the MR documentation the more accurate the coding; this holds true in ICD-10-CM coding. For the HTN uncovered as not being reported but was documented and impacted current care, the ICD-9-CM code in this case is 401.9.  There is no annotation or indication of concurrent hypertensive heart disease or chronic kidney disease, or any combination thereof.  Under the current ICD-9-CM coding structure, because the descriptors “benign” (ICD-9-CM code 401.1) or “malignant” (ICD-9-CM code 401.0) were not recorded in the MR documentation with the acronym “HTN,” the official coding instructions state the unspecified ICD-9-CM code 401.9 must be reported for “essential hypertension.”  Now compare this code with the anticipated requirements and information under ICD-10-CM.  The descriptors “benign” and malignant” no longer apply in ICD-10-CM coding.  The full description mapped to the current ICD-9-CM code series for essential hypertension (401.0, 401.1 and 401.9) match up to “I10 Essential (Primary) Hypertension.”  What will be required in terms of MR documentation for accurate ICD-10-CM coding?  First, establishing the hypertension as “essential” appears tantamount to getting it coded correctly; this classification should be established in the MR documentation.  Secondly, ensuring the current state of hypertension is not etiologically connected to hypertensive heart disease, chronic kidney disease or a combination of these two is vital for correct coding (these conditions map to other ICD-10-CM codes). Performing as the “auditor” you have that the ICD-9-CM code for HTN was not reported, and you further find it was not encircled on the superbill.  The lesson buried in this for providers?  The MR documentation should be as clear, concise and explicit as possible, especially when summarizing the impressions or diagnoses.  The CC should be amended at the time of service, especially when initially recorded by ancillary staff, to reflect all of the reasons for the patient’s presentation.  A lesson herein for coders, too, is that often corroborating information is found between the History and Plan sections of the note, and both should be reviewed for possible “missed diagnosis opportunities” for ICD-9 and ICD-10 coding purposes.  Lastly, do not rely solely upon the superbills for diagnostic information. In many instances ICD-10-CM promises to impose greater specificity on diagnosis code descriptions and assignment; therefore, a correlating level of specificity is expected to be found in the MR documentation.  Performing a baseline MR documentation assessment is often a rewarding exercise in preparation for ICD-10 conversion. ###   Michael G. Calahan is currently the Director of Physician Services at Kforce Healthcare, Inc., working in the Washington DC Metro area. Also on the Board of the ICD-10 Monitor, he specializes in compliance, revenue cycle management, CDI, coding, and billing in the physician and facility arenas. He may be contacted by e-mail at mcalahan@kforce.com.  ]]> http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/feed/ 2 ACOs: The Good, the Bad and the Ugly http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/ http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/#comments Wed, 11 May 2011 00:30:29 +0000 Physicians News http://www.physiciansnews.com/?p=4067 [caption id="attachment_2742" align="alignleft" width="240" caption="."][/caption] By Ron Wince Although Accountable Care Organizations (ACOs) have been discussed for years, health care reform has put them in the spotlight. Now, health care leaders are trying to determine the best way to move forward and transition to this new model of care. While the idea behind ACOs is to get the provider and payer chain working together to provide better-coordinated, more seamless care, the various definitions of an ACO are widely varied. From the perspective of a Medicare/Medicaid patient, there is a major attraction to the current perception of ACOs. In principle, patients should have a reasonable expectation of higher quality care delivered at a lower cost if they choose a provider enrolled in an ACO. From the provider and insurance standpoint, the choice to form or join an ACO is not quite as clear cut. On the upside, any provider or insurer that is part of an ACO could see significant cost reductions, shared savings, and quality improvement, evident in both internal operations and the care they deliver to patients. Providers will also have a better ability to compete for the pool of Medicare/Medicaid patients, which will only continue to grow as more baby boomers reach retirement age. However, from what we do know, there are several positives and negatives that providers and payers must consider. The most pervasive problem is that there is no blueprint that administrators can follow to point them in the right direction when creating an ACO. Even with the recent release of the final ruling, there remains much that is left to the organizations involved.  We do know that ACOs must: -       Serve a minimum of 5,000 patients -       Consent to be part of an ACO for at least three years -       Follow either a one-sided or two-sided risk model -       Measure and report over 65 metrics (up from only eight)   But even with these minimums the “how” to forming or participating in an ACO has yet to be answered for most organizations that may opt in.  For instance, hospital administrators could create an ACO by buying one or more physician practices while, conversely, group practices or networks of physician practices could take the lead, enrolling a hospital as a partner. Supposing that administrators decide to form an ACO, the next hurdle is putting into place the required infrastructure. There are requirements for creating certain leadership and management structures that include both clinical and management personnel. Administrators will need to put into motion processes that demonstrate that they are practicing evidence-based medicine and coordinating care, as well as confirm that they are “patient centered,” another term for which there is no clear definition yet. Even more challenging could be combining the cultures of the different groups. How people work together can be a bigger factor in determining the ultimate success or failure of an effort than what they do. Before organizations determine what their ACO will look like, they need to first determine how they are going to formulate the partnership. For instance, one aspect of contention is the negotiation of agreements about how decision making and potential savings will be shared across members of the ACO. One group may have a standard practice of buying whatever’s cheapest while another may have a “buying whatever each physician wants” policy. If these two groups coalesce within the same ACO, which guideline should take precedence? Furthermore, staff and patient management strategies are different across the industry. Once organizations join together in an ACO, administrators will have to discuss managerial operations to ensure all employees and patients feel the benefits. Minor details, such as courtesy calls to patients or internal celebrations for staff, will have to be unified in order for the ACO to function as one seamless entity. In addition to cultural changes, ACOs will drive a marriage of technology. It won’t be possible for a hospital and a physician group to work together under the ACO system if they are operating two completely different technology systems. How do you shift from one technology to another? Who will manage the overall process and future IT system? How will organizations share patient information while accommodating regulations? These are decisions administrators will have to make when forming an ACO, many of which will impact the overall efficiency of the organization. From a process standpoint, ACOs have the potential to streamline many functions on an organizational level. Physician groups tend to have quicker billing practices because they depend on cash flow. Hospitals, on the other hand, often take weeks to make payments. With the joining of the two in an ACO, an improved billing process will be key to ensure physician practices aren’t losing cash flow because of poor process management. Furthermore, administrators will need to become masters of business intelligence, including measuring what’s important, collecting and reporting data and using the data to improve their organizations, not just for compliance.  Given that unknowns and uncertainties are guaranteed, administrators must practice certain survival skills such as how to learn faster on the fly and collaborate at all levels. Agility will be an imperative skill for administrators as rules continue to change. Looking at both sides of the argument, there is the potential for significant gains on both the cost and quality fronts, as well as the ability to maintain or grow a practice’s Medicare/Medicaid patient base against the need for putting in an enormous amount of work up front. ACOs were developed to help the patient and to ensure that our hospitals and physicians can continue to provide quality care, even as risks, such as an aging population, strain our health care system. In addition to a continued dedication to quality care, patients will see lower costs. ACOs will ensure that patients are receiving the care they need, rather than what helps the organization make more money. Providers may also experience success in the new era of ACOs. It will help them successfully manage the influx of patients and transformation of patient care without having to worry about increasing costs. While it hasn’t been defined yet, there may be a future opportunity for providers to garner incentives when meeting the guidelines of ACOs. This will only better the care patients receive. Whatever an organization’s view on ACOs is, they must accept that they will become part of the future of health care in this country, and must begin building or strengthening the skills and capabilities that will be needed to win on that new playing field. ### Ron Wince is President & CEO of Guidon Performance Solutions.  ]]> http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/feed/ 2 What Providers Need to Know About ICD-10 http://www.physiciansnews.com Tue, 07 Feb 2012 16:44:06 +0000 en hourly 1 http://wordpress.org/?v=3.2.1 Physicians News » Headline http://www.physiciansnews.com Tue, 07 Feb 2012 16:44:06 +0000 en hourly 1 http://wordpress.org/?v=3.2.1 The Treatment of Solid Tumors: Some Recent Approaches http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/ http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/#comments Tue, 07 Feb 2012 16:14:45 +0000 Physicians News http://www.physiciansnews.com/?p=4595 By Punit Dhillon At some point in their lives, one in five people will suffer from skin cancer, and the fraction is steadily rising.  In spite of innovation in sunscreen technology and public attention to the need to be shielded from the sun, data reported recently by Dermatology Times show a rise in the average American lifetime risk of one skin cancer variety—invasive melanoma—from 1/600 in 1960 to 1/50 in 2008.  Despite previous diagnosis and innovations in approaches to treatment, the age-adjusted number of annual deaths per 100,000 population is rising.  Additionally, the expense to the healthcare system and society continues to increase.  As U.S. and European populations age, the incidence of skin cancer and other solid tumor cancers will grow.  According to the latest United States Cancer Statistics, published by the Centers for Disease Control and Prevention in 2007, the top 10 cancer types (based on incidence rate) are in the solid tumor category; today the priority is probably even higher.  Thus, there are clear medical needs going unmet and the creation of novel, cost-efficient and patient-friendly treatments remain a top priority for both the healthcare community and patients. Various challenges of traditional treatments The treatment of solid tumor cancers, which range from melanoma and Merkel cell carcinoma to cutaneous T-cell lymphoma, continues to be a substantial challenge for physicians.  For example, in spite of innovations in drug discovery and development, it is still challenging to simply deliver efficient drugs into cancer cells in a safe and effective manner.  Meanwhile, today’s therapeutic approaches—involving surgery, radiation therapy and chemotherapy—each have characteristic and major drawbacks. Surgery, the current first-line treatment for localized and operable tumors or lesions, requires resecting the tumor mass and a surrounding boundary of healthy tissue to make sure that no cancer cells remain at the tumor site.  Surgery can potentially cause physical disfigurement and/or debilitating effects on organ function, and the patient quality of life has been demonstrated to be negatively impacted.  Also, surgery can require an expensive and long hospital stay. Radiation therapy is occasionally used in conjunction with surgery to shrink a tumor prior to surgical removal, or afterward to destroy any cancer cells that might remain.  Yet surgery plus radiation can damage important normal tissues like nerves, blood vessels, or vital organs such as the heart that are within the designated zone of treatment.  Radiation is also a costly therapeutic approach, and demands substantial expertise, precautionary measures and infrastructure to administer.  Radiation entails major complications, such as nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the potential for the formation of new cancerous lesions. Those who get radiation to the heart often suffer from various types of heart failure in subsequent years. Typically, chemotherapy is a secondary or palliative treatment to help mitigate systemic or metastatic tumor growth, whereas surgery and radiation may be considered local treatments.  In response to cancer’s spread, physicians will administer chemotherapeutic agents that circulate throughout the body, systemically and in high concentrations, to counter the challenge that some chemotherapeutic agents have in reaching and penetrating the cell membrane to trigger cell death.  Yet the system-wide use of chemotherapeutics frequently has major side effects by killing healthy as well as cancerous cells.  This systemic and non-targeted administration of anticancer agents can trigger alopecia; nausea; vomiting; myelosuppression; and drug resistance.  Chemotherapy is curative for only a few tumor types. Additionally, all of these conventional treatments are only minimally effective on aggressive types of cutaneous cancers, especially in later stages of the disease. Some potential approaches We now offer an abbreviated look at some current approaches to override these challenges in treating solid tumors. One possible strategy for solid tumor treatment involves a new class of small-molecule drug candidates called vascular disrupting agents.  Via interaction with vascular endothelial cytoskeletal proteins, these agents may selectively target and collapse tumor vasculature, thereby depriving the tumor of oxygen and causing death of the tumor cells. Another approach involves the use of new therapeutic monoclonal antibody candidates that target CD27, a member of the tumor necrosis factor (TNF) receptor superfamily.  Anti-CD27 monoclonal antibodies have been demonstrated to effectively promote anticancer immunity in mouse models when combined with T cell receptor stimulation.  In addition, CD27 is overexpressed in various lymphomas and leukemias and can be targeted for direct activity by anti-CD27 monoclonal antibodies with effector function against those cancers.  There are many other antibody drugs on the market, some also with linked toxins or radiation. A third tactic involves the creation of an orally available nucleoside analogue for various cancers including solid tumors.  This agent could act through a novel DNA single-strand breaking mechanism, leading to the production of DNA double strand breaks (DSBs) and/or DNA repair checkpoint activation; unrepaired DSBs go on to cause apoptosis or programmed cell death. Alternatively, solid tumors could be treated using a technique called tumor ablation, which involves destroying the tumor inside the body via various approaches.  Radioactive pellets, shorter than an inch and approximately the width of a pin, can be inserted into the tumor; the pellet subsequently emits lethal radioactive atoms that irradiate the tumor from the inside out.  As the tumor breaks down, it starts to release antigens that trigger an immune response against the cancer cells.  Sometimes, the body also develops an immune memory against the future return of tumor cells.  Another proposed ablation technique, called “pulsed electric current ablation,” involves the insertion of electrodes into tumors, which subsequently emit very high-energy electrical currents; these currents create a physical reaction that destroys the tumor cells. A separate approach involves applying local heating to the tumor using radio frequency techniques.  In this instance, a thermal energy delivery device can be focused and targeted according to the shape, size and position of a specific tumor.  Adjusting the frequency, phase, and amplitude of the radio waves, combined with different applicators and adjustment of the patient’s position, could conceivably permit a doctor to optimize the delivery of damaging energy into the tumor. Cancer scientists are also interested in attacking solid tumors by delivering drugs specifically into diseased tissues. Such a targeted approach can result in more efficient therapy while using smaller drug doses with fewer negative side effects.  For example, in animal studies, immune-deficient mice carrying human forms of various cancers have been simultaneously injected with a range of anticancer agents and a peptide known as iRGD.  iRGD can find and attach itself to receptors on solid tumor cancer cells and later activate their internal transport systems so that the peptide is essentially passed through cell after cell, moving progressively deeper into the tumor structure.  Anticancer drugs lingering near the peptide molecules may also get pulled into and through the tumor mass by this transport mechanism, enabling them to attack cancer cells previously beyond their reach. By their nature and cellular architecture, solid tumors are equipped to limit the efficacy of most anticancer drugs.  Tumors have poor vascular systems, which reduces exposure to drugs that have been administered into the circulation.  The lesions are densely fibrous, which serves as a physical barrier against transport.  Also, the tumors have high internal pressures, causing further physical challenges to any molecule attempting to enter the lesion.  The iRGD peptide is designed to act like a key, switching on the internal transport mechanism of the cells so that they absorb anything that is proximal to certain cell surface receptors.  Researchers believe the iRGD peptide could penetrate many tumor types and might be useful in treating most solid tumor cancers.  An encouraging aspect of this approach is that both the peptide and anticancer drugs are effective together without being chemically attached. Yet another promising strategy for treating solid tumor cancers involves targeting the tumor itself without affecting any of the surrounding healthy tissue.  This ensures that the drug or therapeutic agent is absorbed at once by the cancer cells and not normal tissues.  One such targeted therapy could harness a physiologic process known as “electroporation.”  Derived from the words “electric” and “pore,” this involves applying a brief electric field to the cancerous cell.  The electrical pulse triggers the temporary creation of pores in the cell’s outer membrane—pores that close again within seconds once the electric field is discontinued.  These transient pores can improve uptake of various drugs more than a thousand-fold. Several electroporation systems have been manufactured that consist of a generator that creates the pulsed electric field, and various handheld applicators with electrode needles at their proximal ends.  The applicator delivers a controlled electric pulse to the cancer cells, thus causing any cancer cells within the affected region to undergo electroporation.  The cell takes up therapeutic agents within the region of electroporation. This technology platform is being developed for use in two varieties of anticancer therapies:  electrochemotherapy and electroimmunotherapy.  In the former, an anticancer drug is injected into a targeted tumor; the lesion is then electroporated and the drug carries out its planned mechanism of action in killing the cell.  As a result of the targeted, local therapy, the amount of drug needed to kill the cells is substantially less than that required in traditional, non-targeted chemotherapy.  The lower quantity of systemic drug (cytotoxic agent) reduces harmful side effects linked to traditional chemotherapy. Electroimmunotherapy, the second application of electroporation, involves the use of a gene encoding a specific cytokine, a substance known to boost the human immune system against cancer cells.  An immune response can have both a local and a distant effect against cancerous cells.  These therapeutic approaches have been shown to be safe and effective across various types of tumors.  Both patient outcomes and pharmacoeconomic benefits are substantial.  This technology is in clinical testing in North America and is available for commercial sale in some European countries. Therapies such as those discussed here may provide a compelling set of novel approaches to the treatment of solid tumor cancers. ### Punit Dhillon is President and CEO of OncoSec Medical Inc., a biotechnology company developing its advanced-stage Oncology Medical System (OMS) ElectroOncology therapies to treat skin cancer and other solid tumor cancers. He can be reached at pdhillon@oncosec.com.]]> http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/feed/ 0 Growing Organs In The Lab: A potential end to immune rejection http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/ http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/#comments Sat, 03 Dec 2011 18:06:55 +0000 Physicians News http://www.physiciansnews.com/?p=4453 By David Green Last June, Andemarian T. Beyene, 36-year-old man with tracheal cancer received a special gift:  a brand new trachea, made from a synthetic scaffold seeded with his own stem cells.  Following this surgery—the first of its kind—he made a full recovery and was discharged from the hospital four weeks later.  The procedure made international headlines, and shone a much-needed spotlight on two important problems that it might help in part to resolve:  long wait times for organ transplants, and immune rejection of implanted organs.  In what follows, we offer a brief overview of these issues, look a bit closer at the surgery itself, and ponder some of the implications. As of November 2011, the Organ Procurement and Transplantation Network, a division of the U.S. Department of Health & Human Services, is reporting that over 112,000 Americans are waiting for an organ transplant.  At the same time, the average annual expense per patient of immunosuppressive drugs—administered following a transplant to prevent the body from rejecting the new organ—is more than ,000, and in some cases can reach as high as ,000, according to the American Society of Transplant Surgeons. These sobering statistics are driving a campaign within the biomedical research community for innovation. A complex and technologically advanced organ allocation system links patients with organs donated by strangers.  The  shortage of organs causes most patients to wait for a transplant, and waiting times vary widely for many reasons. The amount of time a patient waits does not reflect how well as transplant center or organ procurement organization is doing its job; each patient’s situation is different.  Some patients are more ill than others when they are put on the transplant waiting list.  Some patients get sick more quickly than other patients, or respond differently to treatments.  Patients may have medical conditions that make it harder to find a good match for them. How long a patient waits can depend on a multitude of factors.  These can include blood type (some are rarer than others); tissue type; height and weight of transplant candidate; size of donated organ; medical urgency; time on the waiting list; the distance between the donor’s hospital and the potential donor organ; how many donors there are in the local area over a period of time; and the transplant center’s criteria for accepting organ offers.  Depending on the kind of organ needed, some factors are more important than others.  Under certain circumstances, special allowances are made for children. Since 1984, the nonprofit United Network for Organ Sharing (UNOS), located in Richmond, Virginia, has operated the Organ Procurement and Transplantation Network, under a contract with the Division of Transplantation in the Department of Health and Human Services.  UNOS maintains a central computer network containing the names of all patients waiting for kidney, heart, liver, lung, intestine, pancreas and multiple-organ transplants.  Patients on the waiting list are in end-stage organ failure and have been evaluated by a transplant physician and hospitals in the U.S. where organ transplants are performed. Another major guiding principle in organ allocation is: local patients first.  The U.S. is divided into 11 geographic regions, each served by a federally designated organ procurement organization, which is responsible for coordinating all organ donations.  With the exception of perfectly matched kidneys and the most urgent liver patients, first priority goes to patients at transplant hospitals located in the region served by the organ procurement organization.  Next in priority are patients in areas served by nearby organ procurement organizations; and finally, only if no patients in these communities can use the organ, it is offered to patients elsewhere in the country. Such locally oriented allocation makes medical sense because less time between donor and recipient usually means more chance of a successful transplant as well as fewer complications that could threaten the viability of the organ.  Eighty percent of all organs are donated and used in the same geographic area. Organ transplant recipients must take immunosuppressive drugs every day for the life of their transplant.  Failure to take these medications significantly increases the risk of rejection.  These drugs are not without side effects and risks.  Because the majority of them act non-selectively, the immune system is less able to resist infections and the spread of malignant cells.  There are also other side effects, such as hypertension, dyslipidemia, hyperglycemia, peptic ulcers, and liver and kidney injury.  The immunosupressive drugs also interact with other medicines and affect their metabolism and action. Immunosuppressive drugs can be classified into five groups—glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins, and other drugs—each with their own specific uses. For example, in pharmacological doses, glucocorticoids are used to suppress various allergic, inflammatory and autoimmune disorders.  They are also administered as posttransplantory immunosuppressants to prevent acute transplant rejection and graft versus host disease.  Nevertheless, they do not prevent infection and also inhibit later reparative processes.  Cyostatics inhibit cell division.  In immunotherapy, they are used in smaller doses than in the treatment of malignant diseases, and they affect the proliferation of both T cells and B cells.  Antibodies are sometimes used as a quick and potent immunosuppressive therapy to prevent the acute rejection reactions as well as a targeted treatment of lymphoproliferative or autoimmune disorders.  The drugs acting on immunophilins include cyclosporin, tacrolimus and sirolimus, whereas additional drugs used as immunosuppressants include interferons, opioids, TNF binding proteins and mycophenolate. In light of the challenges posed by transplant wait lists and the need to choose the optimal immunosuppressive therapy to facilitate transplants, it is significant that for the first time ever, a patient was recently given a new trachea made from a synthetic scaffold seeded with his own stem cells.  As noted earlier, the patient, 36-year old Andemarian T. Beyene, made a full recovery and was discharged from the hospital following the operation.  The operation was performed on June 9, 2011 at Karolinska University Hospital in Stockholm, Sweden, by Paolo Macchiarini, MD, PhD, Professor of Regenerative Surgery at the Advanced Center of Translational Regenerative Medicine at Karolinska Institutet, Stockholm, Sweden, and colleagues (Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioarti?cial nanocomposite: a proof-of-concept study. Lancet 2011; Published online November 22, 2011 DOI:10.1016/S0140-6736(11)61715-7). Previous transplants of tissue-engineered tracheas have been performed, but on those occasions the tracheas used were taken from organ donors and then reseeded with the patients’ own stem cells. For example, in 2008, 30-year-old Claudia Castillo successfully underwent this type of procedure in Spain (Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008; 372: 2023-2030). The international team involved Professor Alexander Seifalian from University College London who designed and built the nanocomposite tracheal scaffold, and Harvard Bioscience of Holliston, Massachusetts, which produced a specifically designed, shoebox-sized bioreactor used to seed the scaffold with the patient’s own stem cells.  The cells were grown on the scaffold inside the bioreactor for approximately two days; the scaffold was rotated while its surface was soaked with stem cells obtained from a bone marrow biopsy from the patient’s hip.  The patient’s stem cells settled into the pores within the scaffold and began to grow into each other, slowly transforming from individual cells into genuine tissue.  A few days after the implantation of the new trachea, the man’s own blood vessels actually started to grow into it, transforming the new organ into a part of his own body.  Because the cells used to regenerate the trachea were the patient’s own, there was no rejection of the transplant and the patient was not taking immunosuppressive drugs. The patient had been suffering from late-stage tracheal cancer.  Despite maximum treatment with radiation therapy, the tumor had reached approximately 6 cm in length and was extending to the main bronchus.  It was progressing and almost completely blocked the trachea.  Since no suitable donor windpipe was available, the transplantation of the synthetic tissue-engineered trachea was performed as the last possible option for the patient, referred by Professor Tomas Gudbjartsson of Landspitali University Hospital (Iceland) who was also part of the surgical team. The successful transplantation of tissue-engineered synthetic organs, referred to as regenerative medicine, could open new and very promising therapeutic possibilities for the thousands of patients who suffer from tracheal cancer or other conditions that destroy, block or constrict the airway. It is extremely important to note that this procedure is still experimental and will need to be sanctioned by the U.S. Food and Drug Administration for the more than 100,000 Americans who are waiting for organ transplants to benefit from it. What does tomorrow hold for this type of medical technology?  For the immediate future, the scaffold approach to generating synthetic body parts will be limited to growing tubular organs such as trachea and blood vessels, rather than more complex organs such as kidneys and livers.  However, other types of organs may become a practical option in time. Transplantations of tissue-engineered windpipes—and potentially other tubular organs like esophagus, blood vessels and urethras—with synthetic scaffolds in combination with the patient’s own stem cells, as a standard procedure, means that patients would not have to wait for a suitable donor organ.  This would be a substantial benefit for patients since they could benefit from earlier surgery and have a greater chance of cure.  In addition to treating adult patients, tissue-engineered synthetic trachea transplants would, not least, be of great value for children, since the availability of donor tracheas is much lower than for adult patients. If this scenario unfolds as some predict, it might mean the start of a new era in the treatment of thousands of patients whose lives and health will be improved.   ### David Green is President of Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine.  He can be reached at dgreen@harvardbioscience.com.]]> http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/feed/ 1 What You and Your Patients Need to Know About Bisphenol A http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/ http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/#comments Mon, 07 Nov 2011 14:28:00 +0000 Physicians News http://www.physiciansnews.com/?p=4379 By Rebecca Roberts, Ph.D. Bisphenol A (BPA) is an environmental estrogen that can affect development and health by disrupting normal hormonal signaling.  Estrogen, working at very low blood concentrations, triggers responses in cells and tissues and is critical during fetal development and in normal health and reproduction.  BPA binds to the same cellular receptors as estrogen and may lead to detrimental health effects. In June of this year, the American Medical Association formally recognized BPA as an endocrine-disrupting agent.  Physicians can play an important role in educating their patients about this pervasive environmental contaminant.  The first steps are to understand the potential health risks of BPA and how to limit those risks through simple lifestyle changes. BPA is used in the production of polycarbonate plastics and epoxy resins.  Many consumer products, such as some reusable water bottles, baby bottles, toys, cell phones, and DVDs, contain BPA.  BPA is also found in the inner linings of metal food cans.1 The epoxy lining protects the metal can from rust and corrosion which may taint the food.  It is present in various medical devices as well, including incubators, blood oxygenators, and dialysis machines.  Given its wide uses, BPA ranks among the highest volume chemicals manufactured worldwide. Although present in countless products, none of which is intended for consumption, the primary route of exposure is through ingestion.  BPA has been shown to leach from products that contain it, such as food cans, into the foodstuffs stored in the container.1,2 When the food is then consumed, BPA enters the body through the digestive tract. A 2007 survey by the Centers for Disease Control found that approximately 92% of Americans have detectable levels of BPA in their bodies.3 The survey is considered representative of the United States population even though it included only people older than six years old.  It is notable, however, that the children (ages 6-11 years) in this study displayed the highest levels of BPA of all populations investigated.  BPA has been found in placental tissue and fetal blood as well, indicating that fetuses are being exposed as a result of maternal exposure.4 An additional study looked at the levels of BPA in infants – specifically in premature infants housed in Neonatal Intensive Care Units.5 It was found that these infants displayed the highest level of BPA in their bodies of all populations. Exposure to BPA has been studied on many levels, from effects on individual cells, to tissues and whole organisms.  While most health studies regarding exposure to BPA are done in laboratory animals, the few human epidemiological studies reveal a relationship between BPA exposure and polycystic ovary syndrome, repeated miscarriage, and heart disease.6-8 Additionally, BPA causes a human breast cancer cell line to proliferate, suggesting that estrogen-sensitive tissues and cells in the human body may react similarly.9 Many animal studies focus on the effect of BPA exposure during fetal development as this is a time when cells and tissues are especially susceptible to alterations in the hormonal environment.  Not only does BPA disrupt proper functioning of the placenta during gestation, but offspring of animals that are exposed to BPA during pregnancy exhibit many deleterious health effects.10 Male offspring have enlarged prostates and malformed urethra.11, 12 Moreover, they are at a higher risk of developing prostate cancer. BPA exposure alters the genital tract of female offspring.11, 12 Exposed females also enter puberty earlier.12 Exposure affects brain development and, as a result, some behavioral differences typically seen between males and females are lost in offspring exposed to BPA in the uterus.13 Based on the clear effects of BPA exposure on the development of fetuses in animals, similar effects on human development are plausible.  Indeed, BPA has been found in the bloodstream, placenta, cord blood, and fetal blood of humans at levels that are within the range studied in many of the animal models.5
While hundreds of studies, most focusing on animal models, point to the harmful health effects of BPA, there has been controversy over the past decade and a half regarding safety of the compound in humans.  Nevertheless, scientific review panels have determined that some detrimental health effects may occur in humans.14-16 Likely human health effects that have been vetted through these review panels include advanced puberty in females14, 15 , effects on the brain and behavior15, 16, mammary gland and prostate abnormalities, and reproductive effects in males and females. Beyond the immediate developmental effects of BPA exposure in utero, evidence is beginning elucidate long-term effects of early-life exposure to BPA, potentially through the modification of epigenetic programming via altered DNA methylation.16, 17 One study suggests that such detrimental modifications may be counteracted by maternal nutrient supplementation.18 Nevertheless, these changes may result in alterations that are passed on transgenerationally, resulting in adverse health effects in subsequent generations who, themselves, may not have been directly exposed to BPA.17, 19 Given the putative adverse health effects of BPA exposure, the U.S. Environmental Protection Agency added BPA to its “Chemicals of Concern” list under the Toxic Substances Control Act in 2010.20 The U.S. Department of Health and Human Services website also posted “Information for Parents” on how to minimize their infant’s exposure to BPA.21 Humans are typically exposed to about 0.001 milligrams of BPA per kilogram of body weight per day.  This is 50 times lower than the ‘safe’ limit set by the EPA and the Food and Drug Administration.  Unfortunately, this level of exposure is still significantly higher than the low doses that have been shown to cause adverse health effects. The concern of exposure is highest when fetuses, infants, and children are considered because of the adverse effects of BPA on normal developmental processes early in life. It is clear that infants and children are burdened with the highest levels of BPA.  This is likely due to several factors.  First, the ability infants and children to metabolically detoxify contaminants such as BPA is not yet mature.  While BPA will ultimately be removed from the blood through a liver-mediated process, BPA stays in the system of infants and children longer than in adults.16 Second, when compared to adults, infants and children consume proportionately more food when their overall body size is taken into account and therefore bodily concentrations are higher.  The milk, formula, or food that is the main staple of an infant may be stored in containers (baby bottles, sippy cups) that are made with BPA.3, 22, 23 Infants and young children are also more likely to mouth plastic products, such as toys, that are not necessarily meant to be put in the mouth. BPA can also pass from the mother to the fetus.5 In addition, breast milk can transmit BPA to an infant.24 Given this, it is not only the child, but the pregnant or nursing mother, that need to be protected from BPA exposure.  Since the children cannot be responsible for making choices regarding BPA, clear information must be provided to parents (and potential parents) so that they can made the educated choices needed to protect themselves and their children. Fortunately, BPA is metabolized and cleared from the body so decreasing daily exposure to BPA can make a difference in overall body levels.25, 26 In Japan, industries voluntarily reduced BPA use in their products between 1998 and 2003 and studies showed a dramatic decline in body levels of BPA in the population.27, 28 Educating your patients about a few simple lifestyle changes can make a difference in their overall BPA exposure and potentially reduce their risk for adverse health effects. First, opting for fresh and frozen food rather than canned food is a big step. 22 While damage and age of food cans does not appear to greatly increase the amount of BPA leached into food, the initial packaging and sterilization techniques do release significant levels of BPA into canned food.22, 1 Second, minimizing the use of polycarbonate plastics food and beverage containers will also help.  Polycarbonate plastics are usually hard, clear, and shatter-resistant.  They may be labeled with recycle number 7, although not all number 7 products contain BPA. Third, learning about the proper care and use of containers can curtail exposure.  Heat and wear increases the leaching rate of BPA into the food or beverage stored in the container, so polycarbonate plastics should not be microwaved or put through the dishwasher and they should not be used if visibly scratched.29, 2 Parents and caregivers should also be provided information in protecting infants and children from unnecessary BPA contact.  Powdered infant formula is usually not stored in containers made from BPA, but some premade liquid infant formulas are packaged in BPA-containing bottles, and such formula has been shown to be tainted.24 In September 2011, a report from the Breast Cancer Fund revealed that many children’s canned food items contained BPA.30 Children are also more likely to mouth plastic products, such as toys or the hard plastic portion of a pacifier.  Caregivers should be mindful of products aimed at children that may contain BPA, such as sippy cups, tableware, and toys.3, 22, 26 Thankfully, manufacturers are increasingly labeling products as “BPA-free”.  The American Medical Association adopted a new policy in 2011 supporting continued industry efforts to produce BPA-free baby products as well as a total ban on the sale of such products. As of 2011, ten states have passed legislation limiting the use of BPA in products aimed at children.  Pennsylvania has similar legislation, spearheaded by Representative Lawrence Curry, that is currently in the House Health Committee.  In New Jersey, Senator Linda Greenstein introduced a related bill in 2010 that has been referred to the Senate Commerce Committee. While the current BPA legislation is an important step, the direct education of patients about BPA and the simple steps that can be taken to minimize their BPA exposure may lead to health improvements within the community.   ###
Rebecca Roberts, Ph. D., is an Associate Professor in the Department of Biology and Coordinator of the Biochemistry and Molecular Biology Program at Ursinus College in Collegeville, PA, where she studies the effect of hormonal regulation of the immune system, with a focus on the roles of estrogen and bisphenol A in Systemic Lupus Erythematosus. She has been active in educating the public about bisphenol A and recently presented expert testimony to the Pennsylvania House of Representatives Democratic Policy Committee regarding toxin-free toddler and baby products.
 
    Citations 1. Goodson, A., H. Robin, W. Summerfield, and I. Cooper, 2004. Migration of bisphenol A from can coatings – effects of damage, storage conditions and heating.  Food Addit Contam, v. 21(10), pp. 1015-26. 2. Brede, C., P. Fjeldal, I. Skjevrak, and H. Herikstad. 2003 Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushing. Food Addit Contam, v. 20(7), pp. 684-9. 3. Calafat AM, Ye X, Wong L-Y, Reidy JA, Needham LL, 2007. Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003–2004. Environ Health Perspect, v. 116(1): doi:10.1289/ehp.10753 4. Calafat A.M., J. Weuve, X. Ye, L.T. Jia, H. Hu, S. Ringer, K. Huttner, and R. Hauser, 2009.  Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants.  Environ Health Perspect, v. 117, pp. 639-644. 5. Schonfelder, G., W. Wittfoht, H. Hopp, C.E. Talsness, M. Paul, and I. Chahoud, 2002. Parent bisphenol A accumulation in the human maternal-fetal-placental unit. Environ Health Perspect, v. 110(11), pp. A703-7. 6. Takeuchi, T., O. Tsutsumi, Y. Ikezuki, Y. Takai, and Y. Taketani, 2004. Positive relationship between androgen and the endocrine disruptor, bisphenol A, in normal women and women with ovarian dysfunction. Endocr J., v. 51, pp. 165-169. 7. Sugiura-Ogasawara, M., Y. Ozaki, S. Sonta, T. Makino, and K. Suzumori, 2005. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod, v. 20, pp.2325-2329. 8. Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., Galloway, T.S. (2010). Association of urinary bisphenol a concentration with heart disease: evidence from NHANES 1003/06. PLoS One, v. 5(1), pp8673. 9. Singleton, D.W., Y. Feng, Y. Chen, S.J. Busch, A.V. Lee, A. Puga, and S.A. Khan, 2004.Bisphenol-A and estradiol exert novel gene regulation in human MCF-7 derived breast cancer cells. Mol Cell Endocrinol, v. 221(1-2), pp. 47-55. 10. Lee, C.K., S.H. Kim, D.H. Moon, J.H. Kim, B.C. Son, D.H. Kim, C.H. Lee, H.D. Kim, J.W. Kim, J.E. Kim, and C.U. Lee, 2005. Effects of bisphenol A on the placental function and reproduction in rats. J Prev Med Pub Health. v. 38(3), pp. 330-336. 11. Markey, C.M., P.R. Wadia, B.S. Rubin, C. Sonnenscheine, and A.M. Soto, 2005. Long Term Effects of Fetal Exposure to Low Doses of the Xenoestrogen Bisphenol-A in the Female Mouse Genital Tract. Biol Reprod, v. 72(6), pp. 1344-51. 12. Nikaido, Y., K. Yoshizawa, N. Danbara, M. Tsujita-Kyutoku, T. uri, N. Uehara, and A.Tsubura, 2004. Effects of maternal xenoestrogen exposure on development of the reproductive tract and mammary gland in female CD-1 mouse offspring. Reprod Toxicol, v. 18(6), pp. 803-811. 13. Rubin, B.S., J.R. Lenkowski, C.M. Schaeberle, L.N. Vandenberg, P.M. Ronsheim, and A.M. Soto, 2006. Evidence of altered brain sexual differentiation in mice exposed perinatally to low, environmentally relevant levels of bisphenol A. Endocrinology, v.147(8), pp. 3681-3691. 14. National Toxicology Program’s Report of the Endocrine Disruptors Low Dose Peer Review (2001). 15. U.S. Department of Health and Human Services, National Institutes of Health, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction.  NTP-CERHR monograph on the potential human reproductive and developmental effects of bisphenol A (NIH Publication No. 08-5994). 16. Vom Saal, F.S. et al., 2007. Chapel Hill bisphenol A expert panel consensus statement: Integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure.  Reproductive Toxicology, v. 24, pp. 131-138. 17. Kudakovic, M. and F.A. Champagne, 2011. Epigenetic perspective on the developmental effects of bisphenol A. Brain, Behavior, and Immunity. V. 25(6), pp. 1084-93. 18. Dolinoy, D.C., D. Huang, and R.L. Jirtle, 2007. Maternal nutrient supplementation counteracts bisphenol A-induced DNA hypomethylation in early development. PNAS, v. 104(32), pp. 13056-13061. 19. Walker, D.M. and A.C. Gore, 2011. Transgenerational neuroendocrine disruption of reproduction. Nat Rev Endocrinol. v. 7(4), pp197-207. 20. U.S. Environmental Protection Agency, 2010. Bisphenol A (BPA) action plan summary. 21. U.S. Department of Health and Human Services, 2010. Bisphenol A (BPA) information for parents. 22. Vandenberg, L.N., R. Hauser, M. Marcus, N. Olea, and W.V. Welshons, 2007. Human exposure to bisphenol A (BPA). Reproductive Toxicology, v. 24, pp. 139-177. 23. Kuo, H.W. and W.H. Ding, 2004. Trace determination of bisphenol A and phytoestrogens in infant formula powders by gas chromatography-mass spectrometery.  J. Chromatogr A, v. 1027, pp. 67-74. 24. Houlihan, J., 2007. Toxic plastics chemical in infant formula.  Environmental Working Group. 25. Carwile JL, Luu HT, Bassett LS, Driscoll DA, Yuan C, Chang JY, Ye X, Calafat AM, Michels KB, 2009. Polycarbonate bottle use and urinary bisphenol A concentrations. Environ Health Perspect, v. 117(9), pp. 1368-1372. 26. Vökel, Wl, Kiraoglu, M., Fromme, H., 2011. Determination of free and total bisphenol A in urine of infants. Environ Res, v. 111(1), pp.143-148. 27. Matsumoto A KN, Kitagawa K, Isse T, Oyama T, Foureman GL, Morita M, Kawamoto T. 2003. Bisphenol A levels in human urine. Environ Health Perspect 111(1): 101-4. 28. Research Center for Chemical Risk Management (2005). Bisphenol A Risk Assessment Document. AIST Risk Assessment Document Comprehensive Chemical Substance Assessment and Management Program. Japan. 29. Lyons, G.. 2000. Bisphenol A:  A Known Endocrine Disruptor. WWF European Toxics Programme: Godalming, Surrey. p. 37 30. Breast Cancer Fund (2011).  BPA in Kids’ Canned Food.  ]]> http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/feed/ 3 Retroactive Adverse Benefit Denials Under ERISA http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/ http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/#comments Tue, 06 Sep 2011 15:35:42 +0000 Physicians News http://www.physiciansnews.com/?p=4242 By Franklin J Rooks J. PT, MBA, Esq. Introduction The insurer’s denial of previously authorized benefits is one of the most frustrating experiences for a medical practice’s billing staff.  But, on the frustration scale, there is another insurance company practice that can push it over the top: retroactive benefit denials that occur after the insurance company has already made payment.  From the insurer’s perspective, a retroactive denial made after the provider has received payment results in an overpayment to the provider, which must be repaid.  To make matters worse, insurance carriers sometimes recoup their payments in ways that create billing system nightmares.  Instead of asking the provider to write a check to the insurer for “improperly” paid benefits, some insurers use “negative remittances.” Negative remittances are where an insurer takes back a benefit payment by offsetting other compensable claims.  Negative remittances are generally cumbersome for providers because they require several billing system adjustments involving more than one patient account.  Recoupment of prior payments is not unique to group health insurers.  Medicare also has a recoupment process for overpayments.[1] With Medicare, the provider receives demand letter, and recoupment cannot begin until 41 days after the provider’s receipt of that notice.  Similarly, for patients covered under an ERISA plan, notice and appeal rights are also required.[2] The insurer cannot just unilaterally recoup benefits by offsetting the benefits due on another patient’s account.    [Note: where applicable, the information provided below assumes that the practice has complied with all of the insurance carrier’s claims filing guidelines and denials are not administrative or technical denials of a claim.] ERISA The Employee Income Security Act, or ERISA, was enacted in 1974 to protect employees’ rights in their employer-sponsored benefit plans.[3] ERISA does not require employers to provide employee benefit plans.[4] Rather, it regulates them. For covered plans, ERISA sets forth substantive regulatory requirements, along with mechanisms to provide access to Federal courts, sanctions, and exclusive remedies.[5] ERISA protects employees’ benefits through uniformity.  These protections supersede and take precedence over any state laws which govern benefit plans.[6] Specifically, ERISA supersedes applicable state law in three areas:  (1) laws mandating employee benefit structures or their administration; (2) laws that regulate ERISA plans; and (3) laws providing alternate enforcement mechanisms other than those provided by ERISA.[7] ERISA allows plan beneficiaries to bring a civil action to “recover benefits due to him under the terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future benefits under the terms of the plan.”[8] If applicable to the insurance plan, the practice should examine ERISA’s protections when challenging an insurer’s recoupment of previously paid benefits. Denials: Adverse Benefit Determinations Under ERISA, benefit denials are termed “adverse benefit determinations.”  In ERISA parlance, this means “[a] denial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit, including any such denial, reduction, termination.”[9] An adverse benefit determination is also a “[f]ailure to provide or make payment that is based on a determination of a participant's or beneficiary's eligibility to participate in a plan. . .”[10] For group health plans, this also includes a “[d]enial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit resulting from the application of any utilization review. . .” [11] Adverse benefit determination also applies to the denial of any treatment because the plan considers it to be “[e]xperimental or investigational or not medically necessary or appropriate.”[12] All of the preceding trigger ERISA protections. There is a limited period in which the insurer can make an adverse benefit determination.  Generally, adverse benefit determinations must be made within 90 days of the health plan’s receipt of the claim, unless special circumstances exist which necessitate an extension of time.[13] Adverse benefit determinations for group health plans are to be made “within a reasonable period of time, but not later than 30 days after receipt of the claim.”[14] Prior to the expiration of this 30 day period, the insurer may extend its time to make an adverse benefit determination by up to 15 days.[15] The notification must provide the specific reason(s) for the adverse determination, referencing the specific plan provisions upon which the insurer’s determination is based.[16] The notice must provide the plan beneficiary with a description of any additional material or information necessary to satisfy the claim and an explanation of why such material or information is necessary.[17] The insurer must also furnish a description of the plan's review procedures and the applicable time limits. [18] The insurer must provide appeal rights.  The beneficiary is entitled to a “[r]easonable opportunity to appeal an adverse benefit determination . . . under which there will be a full and fair review of the claim and the adverse benefit determination.”[19] After the receipt of an adverse benefit determination notification, the claimant has at least 60 days to appeal the decision.[20] ERISA also requires the notification to include a statement of the claimant's right to bring a civil action under section 502(a) of the ERISA Act following an adverse benefit determination that is under review. [21] Recoupment: Compliance with ERISA Under ERISA, any determination that a claim should not be paid in full constitutes an adverse benefit determination.[22] A retroactive benefit denial is an insurer’s adverse determination that the patient’s benefits should not have been paid.  Retroactive adverse benefit determinations, without adhering to the notification and appeal processes, violate the protections afforded by ERISA.  Some insurers, however, contend that a repayment demand letter alone does not constitute an adverse benefit determination.[23] Where no funds are recovered or offset, some insurers may claim that overpayment letters alone do not trigger ERISA’s notice and appeal rights.[24] But, when recoupment efforts go beyond making a repayment demand and result in the offsetting of other compensable claims, the insurer must comply with ERISA protections requiring a “full and fair review.”[25] However, if the provider agreement clearly indicates that the provider is ineligible to deliver the service, and it was paid in error, ERISA may not be implicated.[26] State law may govern in this instance. “Mistaken authorization” is another basis under which an insurer might attempt to retroactively deny or recoup payments.  Provider agreements generally dictate the authorization procedures that the provider must follow in order to receive payment.  Medical providers rely on the benefit authorizations and pre-approvals they receive from the insurance carrier to reasonably determine that payment will be forthcoming.  Arguably, insurance plans have a duty to their participating providers to generate complete and accurate information via the provider’s verification of benefits.  The insurer’s retroactive assertion that authorization was “erroneous” places the provider in a precarious position.  If unsuccessful in the appeals process with the insurer, the provider could do nothing, and absorb the loss.  Or, the practice could pursue the patient.  Nothing in ERISA prohibits a provider from billing patients for services that are not covered under the benefit plan.[27] But, the provider’s contract may contain language prohibiting such recourse.   In the alternative, the provider could attempt to pursue the insurer under two potential courses of action – under ERISA or under state law.   ERISA also governs the provider’s allegations of an insurer’s improper processing of claims for plan benefits.[28] Adverse Benefit Determinations: The Right to Payment versus Rate of Payment ERISA distinguishes between “right to payment” issues and “rate of payment” issues.   “Right to payment” issues are created when an insurer fails to honor the patient’s benefit or when the insurer denies the patient’s claim.[29] Both of these situations constitute adverse benefit determinations.  A claim denial can be prospective or retrospective. The insurer’s prospective or retrospective denial of plan benefits triggers ERISA’s notification and appeal protections.  The “right to payment” is not a contract issue; it does not raise independent contractual duties outside of ERISA.  This falls squarely within the regulatory scheme of ERISA.[30] In contrast, “rate of payment” issues are contractual in nature.  The participating provider agreement creates a contractual duty that is independent of ERISA.  For a participating provider, fee schedule disputes do not necessarily involve ERISA.[31] An insurer’s recoupment of overpayments based on the contractual fee schedule is not a denial of benefits.  This type of payment dispute is a matter of contract law, where the underlying provider contract controls the payment provisions. ERISA’s notification and appeals processes are not controlling.  State law, and not ERISA, would most likely determine the outcome where the claims originate from this independent legal duty.[32] However, for providers who are not participating, underpayments or overpayments may implicate ERISA’s protections.  Between a non-participating provider and an insurance plan, there is no contract governing payment terms or fee schedules.  In the absence of a provider contract, the insurer does not have any independent contractual duties relative to the provider’s claims.[33] An out-of-network provider’s claims based on the underpayment of a claim likely raises a “right to payment” issue under ERISA.[34] In assessing which course of action to take, the provider must determine whether the insurer’s action has created a “right to payment” issue or one involving the “rate of payment.” Repayment Demands Based on Fraud Repayment demands based on fraud present a different issue entirely.  In the instance of fraud allegations, the insurer is generally attempting to recover the entire benefit paid to the provider.  An insurer’s repayment demand based on perceived fraud is a retroactive determination involving a dispute over “benefits due” when it involves specific claims.  ERISA provides the exclusive remedy only where the “claims are derived entirely from the particular rights and obligations established by the plan.”[35] That is, for ERISA to be applicable, a specific beneficiary with benefits arising under a benefit plan must be at issue.  The insurer may bring fraud allegations against the provider under state law where the claims are independent of any benefit belonging to a plan beneficiary. For example, an insurer may claim that the provider systematically renders services which defraud the insurer. (e.g., a general practice of billing for services not rendered).  In those instances, state fraud statutes may give rise to a duty independent of ERISA, which could allow state law, rather than ERISA, govern the dispute.[36] The resolution of fraud claims may depend on the provider’s conduct, rather than the terms and conditions of the beneficiary’s ERISA plan. [37] However, where recoupment of previously paid benefits appears to be an effort by the insurer to enforce the plan’s terms for specific beneficiaries, ERISA may govern an insurer’s efforts.[38] Facts and circumstances will dictate whether Federal or state law applies. Provider’s Options Medical providers are not beneficiaries of an ERISA plan.  An ERISA plan is independent of any participating provider agreement that may exist between the insurer and the medical provider.  Ordinarily, a person who is not a party to a contract would not have any rights under that contract.  With patients and medical providers, the patient’s assignment of benefits confers rights to the medical provider under the patient’s health care plan.  Under an assignment of benefits, the medical provider stands in the shoes of the patient, and may seek to enforce payment of the patient’s benefits.[39] Through a valid assignment, the provider may avail itself to the applicable ERISA protections on behalf of the patient.[40] The provider should insist on the insurer’s compliance with ERISA’s protections.  A paper trail should be maintained to document all of the provider’s efforts in resolving the disputed claim.  The provider should also document all of the insurer’s actions as well.  Failing resolution between the provider and the insurer, the provider could challenge the insurer’s retroactive denial of coverage under section 502 of ERISA.  A number of courts have held that ERISA governs a provider’s claims for benefits where the insurer’s representations have “the effect of orally modifying the express terms of an ERISA plan and increasing plan benefits for participants or beneficiaries who claim to have been misled.”[41] In plain language, this means that the insurer’s representations could create a benefit in situation where ordinarily no benefit existed.   Provider agreements define “covered services” for which the insurer will reimburse when performed by the provider.  With respect to the plan beneficiary, however, covered services are defined under the ERISA plan, not by the provider agreement. An insurer may claim that ERISA procedures are inapplicable by contending that the terms of the provider agreement control repayment and recoupment.  ERISA’s language appears to be contrary to that assertion.[42] To the extent that ERISA does not control, the provider could elect to pursue state law claims under a negligent misrepresentation theory if recoupment is based on the insurer’s erroneous or mistaken authorizations.  A number of courts have held that providers may maintain state law claims against an insurer based on erroneous verifications of coverage and erroneous information pertaining to the existence and extent of coverage.[43] A provider’s state law claim may be appropriate not because of the patient’s coverage, but because there is no ERISA coverage.  A key distinction that must be made is whether the insurer’s decision is actually an adverse benefit determination or an interpretation of the terms of the provider agreement.[44] Conclusion Providers should always attempt to clarify, understand and resolve claims issues by dealing directly with the insurance carrier.  ERISA protections are only available for plans that are, by statute, ERISA plans.  Otherwise, state law governs.  If the plan falls under ERISA, the medical provider may challenge the insurer’s adverse benefit determination and take advantage of all of the notification, denial substantiation requirements, and appeal rights.  The provider should attempt to understand the insurer’s reasoning behind its repayment demands to determine whether it constitutes an adverse benefit determination. The provider may have a cause of action for the insurer’ actions regarding an ERISA beneficiary that may be brought under a state law claim if certain facts and circumstances exist.   Providers should recognize the distinction between disputes arising out of the right to payment versus the rate of payment.  For participating providers, “rate of payment” issues may implicate state law because of the existence of a contract.  For non-participating providers, where no contract exists, the payment dispute may fall into the “right to payment” category and implicate ERISA.     About the author: Franklin J. Rooks Jr., PT, MBA, Esq. is a physical therapist and practicing attorney in Philadelphia, Pennsylvania.  Prior to his practice of law, Frank was a founding partner of PRO Physical Therapy, a Wilmington, Delaware based operator of physical therapy clinics.  This article is not legal advice.  ERISA is an expansive area of the law.  This article is intended to provide only very general, non-specific legal information.  This article does not cover all the issues related to the topic discussed.  The specific facts that apply to your situation determine the outcome.  This article does not create any attorney client relationship between you and the author.  Frank can be contacted at fjrooks@gmail.com  
[1] See The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 935; 42 U.S.C. § 1395ddd(f).
[2] Not all plans are covered under ERISA.
[3] H.R. Rep. 93-533, 93rd Cong., 2nd Sess. 1974.
[4] 70 C.J.S. Pensions § 19.
[5] See Aetna v. Davila, 542 U.S. 200, 208 (2004).
[6] 29 U.S.C. § 1144(a).
[7] Arizona State Carpenters Pension Trust Fund v. Citibank, 125 F.3d 715, 723 (9th 1997)
[8] 29 U.S.C. § 1132(a)(1)(B).
[9] 29 C.F.R. § 2560.503-1(m)(4)
[10] Id.
[11] Id.
[12] Id.
[13] 29 C.F.R. § 2560.503–1 (f)(1).
[14] 29 C.F.R. § 2560.503–1 (f)(2)(iii)(B).
[15] Id.
[16] 29 C.F.R. § 2560.503-1(g)(1)(i)(ii)
[17] 29 C.F.R. § 2560.503-1(g)(1)(iiI)
[18] 29 C.F.R. § 2560.503-1(g)(1)(iv)
[19] 29 C.F.R. § 2560.503-1(h)
[20] 29 C.F.R. § 2560.503–1 (h)(2)(i).
[21] 29 C.F.R. § 2560.503-1(h)
[22] 29 C.F.R. § 2560.503-1(m)(4).
[23] See Association of New Jersey Chiropractors v. Aetna, 2011 WL 2489954 at *8 (D.N.J.). “[T]he Court is not persuaded that dismissal of Plaintiffs' ERISA claims is warranted at this time. While Aetna has raised questions as to the viability of Plaintiffs' ERISA claims, the Court concludes that a more complete factual picture regarding Aetna's “recoupment”/anti-fraud efforts is necessary to ultimately resolve the issue.” Id. at *9.
[24] Id.
[25] 29 U.S.C. § 1133(2). “[E]very employee benefit plan shall afford a reasonable opportunity to any participant whose claim for benefits has been denied for a full and fair review by the appropriate named fiduciary of the decision denying the claim.”
[26] Cf. Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393, 402 (3rd Cir. 2004). Under a breach of provider agreement, a “[r]ight to recovery, if it exists, depends entirely on the operation of [provider agreements] executed by the Plan that are independent of the Plan itself.”
[27] Central States Southeast and Southwest Areas Health and Welfare Fund v. Pathology Laboratories of Arkansas, 71 F.3d 1251, 1253 (7th Cir. 1995)
[28] Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 48 (1987).
[29] 29 C.F.R. § 2560.503-1(m)(4)
[30] Id.
[31] See Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393 (3rd Cir. 2004), citing Blue Cross of California v. Anesthesia Care Associates Medical Group Inc., 187 F.3d 1045 (9th Cir. 1999), holding  “Providers' claims, which arise from the terms of their provider agreements and could not be asserted by their patient-assignors, are not claims for benefits under the terms of ERISA plans.”
[32] Id.
[33] See Sportscare of America P.C. v. Multiplan, 2011 WL 223724 (D. N.J.), discussing that out-of-network provider’s claims for underpayment fell under ERISA.
[34] Crossroads of Texas v. Great West Life and Annuity Insurance Co., 467 F.Supp.2d 705, 710 (S.D. Tex. 2006).
[35] Horizon Blue Cross Blue Shield v. East Brunswick Surgery Center, 623 F. Supp. 2d 568, 578 (D. N.J. 2009).
[36] Aetna Health Inc. v. Health Goals Chiropractic Center, 2011 WL 1343047 at * 6(D.N.J.)
[37] Id.
[38] Sereboff v. Mid Atlantic Medical Services Inc., 547 U.S. 356, 361 (2006).
[39] Horizon Blue Cross Blue Shield v. East Brunswick Surgery Center, 623 F. Supp. 2d 568, 575 (D. N.J. 2009).
[40] Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393, 407 (3rd Cir. 2004). “Almost every circuit to have considered the question has held that a health care provider can assert a claim under § 502(a) where a beneficiary or participant has assigned to the provider that individual's rights to benefits under the plan”
[41] Memorial Hospital System v. Northbrook Life Insurance Co., 904 F.2d 236, 245 (5th Cir. 1990).
[42] See 29 U.S.C. § 1132(a)(3). “A civil action may be brought by a beneficiary to enjoin any act or practice which violates any provision of this subchapter or the terms of a plan.” [emphasis added]
[43] See Hospitals and Clinics v. Archstone Communities LLC, 2011 WL 1748432  at * 3 (N.D. Cal.) See  Blue Cross of Cal. v. Anesthesia Care Assoc. Med. Group, Inc., 187 F.3d 1045, 1047 (9th Cir.1999); The Meadows v. Employers Health Ins., 47 F.3d 1006, 1011 (9th Cir.1995).
[44] See Pennsylvania Chiropractic Ass’n v. Blue Cross Blue Shield Ass’n, 713 F. Supp. 2d 734 (N.D. Ill. 2010).
 ]]> http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/feed/ 0 How To Negotiate The Restrictive Covenant In Your Employment Contract http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/ http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/#comments Mon, 01 Aug 2011 15:20:28 +0000 Physicians News http://www.physiciansnews.com/?p=4202 By Martha Swartz, M.S.S., J.D.   With economic pressures on physicians mounting and regulatory incentives to affiliate with larger entities expanding, an increasing number of physicians are becoming employees of larger medical groups or health care systems. Restrictive covenants are becoming a mainstay of physician employment agreements. While the American Medical Association Council of Ethical and Judicial Affairs has found them to “disrupt continuity of care, and potentially deprive the public of medical services”, it has found them “unethical” only if they are “excessive in geographic scope or duration … or if they fail to make reasonable accommodation of patients’ choice of physician.” At least eight states have invalidated restrictive covenants, including three that have specifically enacted statutes banning them; however, courts in New Jersey and Pennsylvania have upheld them as recently as 2005. Restrictive covenants never benefit employees and in an ideal world, you would want to delete them entirely from your employment contract. However, in most cases, this cannot be achieved; therefore, if you are becoming an employee in Pennsylvania or New Jersey, you might benefit from some helpful pointers about how to negotiate restrictive covenants. What is a Restrictive Covenant? A restrictive covenant is a provision in an employment or purchase agreement that prohibits you from practicing medicine within a certain geographic area for a specified amount of time. Restrictive covenants are designed to protect the economic interest of your employer who is assumed to have spent time and money training you, introducing you to its patients and sharing confidential information to you. Pennsylvania and New Jersey Law. Both Pennsylvania and New Jersey recognize the validity of restrictive covenants under certain conditions. In Community Hospital Group, Inc. v. Jay More, M.D., 183 N.J. 36, 869 A.2d 884 (NJ 2005), Dr. More, a neurosurgeon, left his employment at Community Hospital Group and joined a neurosurgery practice within the geographic area and time restricted by the restrictive covenant in his employment contract. The New Jersey Supreme Court concluded that a physician’s employer had a protectable interest in "protecting the investment in the training of a physician" in addition to traditionally recognized interests in confidential business information and affirmed the contract’s 2 year time period restriction; however, it “bluelined” the agreement, that is, it modified the agreement, to reduce the 30 mile geographic restriction so that Dr. More would be permitted to cover the Somerset Hospital emergency room that relied on his coverage to be able to provide neurosurgery services to its patients, thus protecting what the court viewed as the public interest. The Pennsylvania Superior Court in Wellspan Health vs. Bayliss, 869 A. 2d 884(PA Super 2008) agreed that physician restrictive covenants are permissible and enjoined Dr. Bayliss, a perinatologist, from practicing in Adams and York counties where Wellspan drew many of its patients since it concluded that a patient referral base was a legitimate interest of Wellspan; however, it “bluelined” the restrictive covenant to permit Dr. Bayliss to practice in Lancaster County because Wellspan didn’t compete with him in Lancaster County for maternal-fetal patients; thus, Wellspan did not have a legitimate business interest in preventing Dr. Bayliss from practicing in Lancaster County. The bottom line is that, in Pennsylvania and New Jersey, restrictive covenants are likely to withstand judicial challenge if they protect a legitimate business interest of the employer, they don’t unduly harm the employed physician, they are “reasonable” in geographic scope and duration, and their enforcement won’t harm the public. However, many of the restrictive covenants proposed by employers arguably fail to satisfy these requirements and therein lies the negotiating opportunity. Legitimate Business Interest of Employer/Scope of Practice.  Most restrictive covenants include some variation of language that restricts the employed physician from “directly or indirectly, as an employee, employer, contractor, consultant, agent, principal, shareholder, corporate officer, director, or in any other individual or representative capacity, engage or participate in any business or practice” that competes with the employer.  Since protecting the employer’s legitimate business interest is at the core of the restrictive covenant, the first question to ask is what kind of business opportunities would “compete” with your employer? Not every form of medical practice or facility in which you might practice post-employment is likely to compete with your employer. For example, if, as an anesthesiologist you are employed by an anesthesiology group that limits its practice to hospital settings, you can argue that the group should not be able to prevent you from practicing at an outpatient pain clinic within the restricted area after you leave the practice. If you are a pulmonologist who is employed by a hospitalist group, the group arguably does not have a legitimate reason to prevent you from opening a general pulmonology practice within the restricted area. Thus, one approach is to list in the agreement the types of facilities that the employer considers to be a competitive threat. Another approach is to carve out certain types of facilities that don’t threaten your employer’s business. For example, if you are employed by a pediatric practice that provides outpatient care primarily, you should be able to practice as a facility-based pediatrician. If you are employed by an internal medicine group that provides outpatient and hospital inpatient services only, you should be able to become the medical director of a nursing home in the restricted area. You might also identify in the agreement specific institutions at which you would be permitted to work. Another approach is to propose, as the perinatologist defendant successfully argued in Wellspan, that your employer’s legitimate business interest does not extend to geographic areas from which it draws no patients. This might mean limiting the mileage restriction, the applicable counties, or some other geographic delineation in the restrictive covenant. Geographic scope. Restrictive covenants address geographic limitations in many ways: they might set a mileage radius from: 1) a group’s primary office; 2) each of the group’s offices; 3) each of the group’s offices currently existing or developed in the future; or 4) each of the hospitals or other facilities at which any member of the group practices. Or, rather than a mileage restriction, the restriction might be defined by counties. The first step is to map out the circumference of the restriction and note the medical facilities that are located within the proposed restricted area. Are there certain facilities or practices that you think you might want to join if this particular employment arrangement doesn’t work out? Note where these facilities or practices are located in relation to the proposed restricted area. For example, an employer might impose a 10 mile restriction from its primary office at 100 Montgomery Ave. in Ardmore, PA. If the facilities at which you might want to work post-employment are located 8 miles from the employer’s primary office, try to reduce the geographic scope to 7 miles. Once the restrictive covenant is measured from more than one central point, for example, from all of the practice’s offices, the geographic restriction is increased exponentially. Thus, you should try to limit the restriction either to the practice’s principal office or to those offices or hospitals in which you primarily practiced as an employee within the last 12 months of your employment. Be especially careful about agreeing to be restricted from practicing within a certain number of miles from the employer’s future offices since introduces a degree of uncertainty that makes it difficult for you to evaluate the impact of the restriction. What might be considered a “reasonable” geographic restriction in a rural area may not be considered “reasonable” in an urban area. Thus, while a Pennsylvania court upheld a 50 mile restriction in rural Pennsylvania in Geisinger Clinic v. DiCuccio, 414 Pa. Super. 85, 606 A.2d 509, 518 (1992), it is unlikely that such an expansive restricted area would be considered reasonable in an urban setting. Time. Most physician contracts restrict physicians from competing during the term of their employment and for one to two years thereafter; under most circumstances, this restriction would probably withstand a court challenge. However, if you have a one year contract, it might not be reasonable for the employer to impose a restrictive covenant that is longer than your initial agreement. Also, if you leave the practice within a short period of time, that is, before you’ve received the benefit of being trained by the employer, the restrictive covenant should not apply at all. You can argue for “tiered” applicability, that is, if you leave during the first year (especially if you are new to the area or just finishing your residency so that your ability to develop a significant practice within the first year is limited), no restrictive covenant should apply. If you leave during the second year, a one year restriction should apply; the two year restriction should apply only if you have been employed for at least 2 years by the employer imposing the restriction. Triggers. One point that many physicians fail to consider in negotiating restrictive covenants is the circumstances under which the restrictive covenant is triggered.  It is arguably fair for the restrictive covenant to apply if: 1) the employed physician leaves without cause (thus arguably “leaving the employer in the lurch”); or 2) the employer terminates the physician with cause (other than alleged physician incompetence) since the physician may have been able to prevent her termination. However, if the employed physician leaves due to the employer’s breach of the agreement, the restrictive covenant should not apply. (This means that you also have to pay attention to the contract’s termination provisions since many physician agreements fail to include a provision permitting the physician to terminate for cause, a necessary prerequisite to invoking this trigger.) Similarly, if the employer terminates the physician for no reason, e.g. the employer overestimated its patient volume, the physician should not be penalized by being subject to a restrictive covenant.  Finally, if the employer terminates the physician because the employer alleges that the physician was incompetent, no restrictive covenant should apply because an “incompetent” physician presumably cannot be a competitive threat to the employer. In addition, restrictive covenant should not apply if the employer ceases to provide the type of specialized services that the physician provides. For example, if a hospital discontinues its obstetrics services, the employed obstetrician-gynecologist should be able to practice obstetrics anywhere without being subject to a restrictive covenant. Public Interest. In contrast to the American Medical Association, the American Bar Association has a longstanding rule prohibiting restrictive covenants in lawyers’ contracts, concluding that they inappropriately intrude upon the lawyer-client relationship and restrict the public's right to choose an attorney. Several commentators have argued that the public’s right to choose a physician is at least as important as the public’s right to choose an attorney. However, while judges see themselves as appropriate arbiters of lawyers’ rights, they have usually deferred to the AMA’s judgment about what is ethical for physicians. Nevertheless, in deciding whether a restrictive covenant is enforceable, courts invariably consider whether enforcement of the restrictive covenant is likely to injure the public. The More court specifically reduced the mileage restriction in Dr. More’s restrictive covenant precisely because his skills as a neurosurgeon were needed to provide coverage in a particular hospital’s emergency room. In an earlier Pennsylvania case, New Castle Orthopedic Assoc. v. Burns, 481 Pa. 460, 469, 392 A.2d 1383, 1387 (1978), the Pennsylvania Supreme Court reversed the grant of a preliminary injunction that would have prevented an orthopedic surgeon from practicing within a certain geographic area because it concluded that there was a shortage of orthopedic specialists in the geographic area; the orthopedic surgeon was permitted to practice in the restricted area to avoid harm to the public.  Considering the great weight often given to potential public harm by courts, you might be able to negotiate the complete elimination of a restrictive covenant if you are practicing in a rural area with a shortage of physicians in your specialty. Restrictive Covenants and Recruitment Agreements. If your compensation in your employment agreement with a medical practice is subsidized under a recruitment agreement with a local hospital, the restrictive covenant must comply with the Stark law. Under an older version of the Stark Law, a medical practice could not include a restrictive covenant in its employment agreement with a physician whose compensation was subsidized by a local hospital. However, after 2007, this requirement was modified, so that restrictions are now permitted provided that they do not unreasonably restrict the physician’s ability to practice in the geographic area served by the hospital. Failure to comply with state law would be considered evidence that the restrictive covenant is not “reasonable.” Liquidated Damages. An increasingly number of restrictive covenants include liquidated damages clauses. These clauses permit the physician to “buy her way out of the restrictive covenant.” The amount required to be paid should relate to the costs incurred by the employer in terms of patients lost due to the physician’s departure and recruitment and training of a replacement physician. One possible way of calculating these damages is to relate them to the physician’s annual compensation while she was an employee. Consideration.  Restrictive covenants are valid only if they are part of another agreement, e.g. a purchase agreement or an employment agreement, because they must be accompanied by adequate consideration, i.e. payment. Generally, the salary offered by the employer in the initial employment agreement is considered adequate consideration. However, if an employer subsequently tries to add a restrictive covenant to an employment agreement, it will not be upheld unless the employer provides additional payment to the employee. Dispute Resolution. Litigation is expensive and time-consuming. It is generally in all of the parties’ interests to expedite the resolution of disputes involving restrictive covenants. The American Health Lawyer Association has dispute resolution services that include both mediation and arbitration. Starting with mediation in these types of disputes often means a faster and more equitable resolution. ### The Law Office of Martha Swartz (www.swartzhealthlaw.com) concentrates on the regulatory and business aspects on health care.    ]]> http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/feed/ 0 Preferred Provider Contracting: Beware Of Rental Networks And Third Party Guarantors http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/ http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/#comments Thu, 14 Jul 2011 11:54:28 +0000 Physicians News http://www.physiciansnews.com/?p=4179 By Martha Swartz, M.S.S., J.D. What is a PPO? As a health care institution or individual provider, it is difficult to provide services in Pennsylvania and New Jersey without participating in at least one preferred provider network (PPO).  PPOs are a form of managed care in which: an intermediary (PPO) forms a network of health care providers and connects the health care providers to third party payers such as insurance companies, employers, and third party administrators (Payers). The providers offer their services to the PPO at a discounted rate because they expect Payers to steer patients to them as a result and thus, to increase their patient volume. The health care providers that are on the PPO’s panel of providers are “in-network” and, because of the negotiated discounts, patients who go to them for services pay less than they pay for similar services offered by health care providers who are not on the PPO panel, or are “out of network”. A PPO can be a “win-win” for patients and health care providers in that individual patients who seek services from in-network providers save money and in-network providers potentially receive increased revenues as the result of increased patient volume which results from the PPO’s marketing of their services as being “in-network” and thus less expensive. What is a Rental Network? The above arrangement falls apart if the PPO fails to market the health care provider’s services as “in network” or if the PPO makes the discounts available to Payers that are not part of the health care provider’s marketing plan, that is, if the PPO “rents out” the provider’s discount without the provider’s knowledge or consent.  When this happens, health care providers find themselves providing services to individuals for which they expect to receive a certain reimbursement amount, only to find out at time of payment that the individual’s Payer has accessed a discount to which it is not entitled. The PPO may even have made your discount available or “rented out” your discounts to Payers with which you already have a negotiated an agreement at a higher rate. Providers thereby end up with the “short end” of the bargain, that is, they give discounts, but don’t receive a higher volume of patients in return. Back in 2005, a number of commentators began to warn physicians of “silent PPOs”, that is, arrangements in which a PPO with which a physician contracts to be on a PPO panel makes the discounts the physician negotiated with that PPO available to other Payers, without the Physician’s consent. However, many times a physician unwittingly agrees to make her negotiated discounts available to other Payers in a PPO’s “rental network” because the physician fails to read the fine print in the contract proposed by the PPO. Are Rental Networks “legal”? In 2008, to avoid the regulation and possible banning of “silent PPO”s, the American Medical Association and the American Association of Preferred Provider Organizations lobbied the National Conference of Insurance Legislators (NCOIL) to adopt a Model Act to Regulate the Secondary Market in Physician Discounts. Under the model law, an intermediary contracting with a physician who wishes to make the terms of its contract available to other Payers must state in its contract with the physician that the intermediary contracting entity:
  • is permitted to enter into an agreement with a Payer allowing the Payer to access the physician’s discounted rates;
  • will contractually obligate the Payer renting access to a provider network to abide by the terms of the original contract between the intermediary and the physician; .
  • will provide the Payer with the relevant terms of the original contract with the physician with which the Payer is obligated to comply;
  • will provide the physician with a continually updated list of entities that have access to the physician’s discounts, including all additions and deletions;
  • will obligate all Payers to note on their Explanation of Benefit forms the source of their contractual discounts.
A number of state legislatures have adopted forms of the NCOIL Model Act, including Connecticut, Colorado, Florida, Indiana and Ohio. Other states including Arkansas, California, Kentucky, Louisiana, Maryland, Minnesota, North Carolina, Oklahoma, South Carolina, Texas and Virginia, have enacted laws that limit or prohibit silent PPOs. So far, there is no similar legislation in either Pennsylvania or New Jersey. In addition to legislature-passed laws, several state and federal courts have issued decisions rejecting a Payer’s right to make discounted payments to a health care provider when the discount was “sold” to the Payer without the health care provider’s knowledge. Although none of these cases arose in either New Jersey or Pennsylvania, they provide insights as to how a local court might view this issue. In at least two of the cases, HCA Health Services of Georgia v. Employers Health Insurance Company, 240 F. 3d 982 (11th Cir 2001) and Mitzan v. Medview Services, Inc., 1999 WL 33105613 (Mass. Super, June 16, 1999), the courts based their analyses on whether the insurer that had accessed the provider’s discounts had been in the position to steer patients to the provider, thus providing the physicians with the “benefits of their bargain”. What can physicians do to gain the benefits but avoid the risks caused by rental networks? Review your PPO agreements carefully, preferably with the assistance of an attorney, to ascertain if the PPO intends to “rent” your negotiated discounts to Payers. If it is determined that the agreement does permit the “renting” of your discounts, make sure that your agreement with the PPO:
  • makes it clear that the discount you’re offering the PPO is in exchange for the PPO requiring the Payers with which it contracts to steer patients to you as an “in network” participating provider
  • obligates the PPO to require all Payers to identify you in all of their written material as an “in network” provider
  • makes it clear that the payment terms that you agree to in the PPO agreement are confidential and may not be disclosed without your express written consent, except to a list of Payers that you have approved
  • obligates the PPO to provide you with a list of all Payers, updated throughout the term of the contract
  • obligates the PPO to refrain from contracting with any entities with which you have an existing agreement that provides higher payment rates
  • requires the PPO to contractually obligate all of its Payers to comply with the terms of the PPO’s agreement with you, including payment procedures, UR procedures, underpayment recoupment, etc.
  • obligates Payers to note on their EOBs the source of their discounts
  • clarifies which UR procedures applies to your contract, i.e. those of the intermediary or those of the Payer
  • obligates the PPO to conduct financial due diligence regarding the Payers to which it makes your discounts available to you to reduce the chances that a Payer will fail to make timely and accurate payments
  • obligates the PPO to advocate on your behalf if a Payer fails to make timely and accurate payments
  • requires Payers to pay your full charges if they fail to pay you within the agreed upon time limit
  • permits you to discontinue discounts to, and to terminate your relationship with, any Payer or any Payer’s product if the Payer fails to make timely and accurate payments
Third party Guarantors of Copayments. Another type of arrangement that recently has been introduced locally can also be a “win-win” for patients and health care providers. At least one local PPO is now offering a program in which a patient’s copayment is paid by the Payer, thus relieving the provider of the expense and inconvenience of collecting the copayment from the patient itself.  Because their costs will be reduced, some providers may be willing to accept lower reimbursement rates as a result of this arrangement.  Since physicians don’t refer patients to insurers, the promise of such a potential benefit to physicians doesn’t implicate state or federal anti-kickback statutes. However, practical problems can arise if it is unclear to the provider or the patient that an entity other than the provider will be seeking the copayment from the patient.  Thus, the provider’s agreement with the PPO should require the PPO to obligate its Payers to: 1) inform the patients in writing to expect a bill for the copayment from the Payer; and 2) specify on the patient’s ID card the Payer that is responsible for paying the patient’s copayment, so that the provider is aware that it is not responsible for collecting the patient’s copayment. Also, since the provider has no direct contract with the Payer that is paying the patient’s copayment, the provider must rely on the PPO to obligate the Payer contractually to pay the patient’s copayment to the provider in a timely fashion. Furthermore, the PPO’s agreement with the provider should confirm that the provider is no longer obligated to collect these copayments. Negotiating your PPO Agreement. Many physicians fail to read their PPO (and other types of third party payer) contracts carefully because they assume they have no ability to negotiate with large insurance companies and other payers. Remember, however, if a Payer needs the type of specialty or subspecialty services that you provide in the geographic area in which you provide services, you may have more leverage than you think. ### The Law Office of Martha Swartz (www.swartzhealthlaw.com) concentrates on the regulatory and business aspects on health care.  ]]> http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/feed/ 1 Urgent Care Centers, a Merging Trend in Health Care http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/ http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/#comments Fri, 17 Jun 2011 14:08:24 +0000 Physicians News http://www.physiciansnews.com/?p=4134 By Lucia F. Bruno, J.D., LL.M., M.B.A. Urgent care medicine has emerged as one of the fastest growing specialties in the United States.  Many family practitioners view this new form of health care as a convenient compromise to the traditional practice of medicine; absent the time and travel between offices, nursing homes and hospitals.  Likewise, emergency room physicians perceive urgent care medicine as a viable way to use their triage skills without the stress associated with a hospital setting. With approximately 8,700 urgent care centers (UCCs) nationwide and an increased percentage throughout Pennsylvania and New Jersey, many physicians question the financial incentives and legal complexities unique to this practice of medicine.  This article will address some of these growing concerns. Ownership Structure:  Choose Your Destiny Wisely Innovation is the principle source of differentiation and competitive advantage; innovative structuring of a UCC is no exception.  Amongst the plethora of buyouts, mergers, acquisitions, and joint ventures, investors need to weigh structuring options and management models carefully, as future profitability swings in the balance.    Currently, only a select number of states require physician ownership of UCCs: Texas; California; Ohio; Colorado; Iowa; Illinois; New York; and New Jersey.  The 2010 survey released by the Urgent Care Association of America (UCAA) indicates that physician or group physician ownership accounts for approximately 50% of structuring, with the remaining as follows:  Hospitals 27.9%; Corporations 13.5%; Non-physician individuals 7.7%; and Franchises 1.0%.[1] So what makes one ownership structure more profitable than another? Hospital-based UCCs are part of an existing operation; therefore, the hospital’s tax identification number is also used by the UCC which can lead to billing complications amongst other regulatory issues.[2] In contrast, freestanding UCCs are independently incorporated, maintain their own tax identification and management structure, and can bill accordingly. Although a myriad of other factors influence profitability including: overhead expenditures; reimbursement rates; and the accurate use of CTP codes; the answer to profitability lies in the fundamental accounting principal of net income, also known as net profit, (Total Revenue - Total Expenses = Net Income). This is the amount of money left in your pocket after all expenses have been paid. When deciding which ownership structure to select, investors must balance the initiative of the UCC with the financial goals and objectives of its investors.  Regardless of structure, increasing patient volume and holding operating expenses below the level of collections will increase profitability.[3] Historically, hospital-based UCCs have failed to keep operating expenses down; as a result they struggle to break even and in the worst case scenario suffer financial loss and eventually close.[4] Licensing:  The EMTALA Distinction Licensing isn’t just a mere technicality; it is a precursor of how you’ll do business.  Currently, only one state, Arizona, has an Urgent Care License requirement.  Other states such as Illinois, Delaware, and New Hampshire have placed restrictions on how UCCs can be identified and marketed to the public. In determining how to license a health care facility many jurisdictions examine ownership interest, business structure, size of the facility, and the nature of the care provided.  Since UCC practitioners specialize in the treatment of disease, illness and/or injury on an episodic basis and don’t provide obstetric services, in-hospital admissions, long term management of chronic diseases or other conditions requiring continuity of care, practitioners need only maintain state licensure necessary to practice medicine, in addition to a license to operate the lab or other diagnostic imaging equipment, where applicable. Unlike physician-owned UCCs, hospitals may offer urgent care as an extension of the emergency department, as a fully controlled ancillary service, as an equity joint venture, or as a landlord/tenant.   Many hospital-based UCCs, or those situated on the hospital campus (or within 250 feet), are considered Type B Emergency Departments subject to specific licensing requirements, as well as EMTALA (Emergency Medical Treatment and Labor Act) statutes and JCAHO (Joint Commission on Accreditation of Healthcare Organizations) guidelines. The Centers for Medicare and Medicaid Services (CMS) defines a “Dedicated Emergency Department” as any department or facility of the hospital, regardless of whether it is located on or off the main hospital campus, that meets at least one of the following requirements: (1)  It is licensed by the state where it is located, under applicable state law, as an emergency room or emergency department; (2)  It is held out to the public (by name, posted signs, advertising or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; or (3) During the calendar year immediately preceding the calendar in which a determination is made (based on a representative sample of patient visits that occurred during that calendar year)  it provides at least one third (1/3) of all of its outpatient visits for the treatment of emergency medical conditions on an urgent basis, without requiring an appointment.[5] It is important to keep in mind that there are three distinct parts to the third criterion set forth by CMS. In order to be categorized as a “Dedicated Emergency Department” a UCC must meet all three parts, not just one or two.  Therefore, investors must ask themselves the following: (1) are over 1/3 of the patient visits on an urgent basis; (2) without an appointment; and (3) for the treatment of an emergency medical condition?  Many will answer "yes" to the first two components, but almost all will answer “no” to the last component given the nature of care provided.  Based on the last response, those UCCs are not “Dedicated Emergency Departments” for licensing or EMTALA purposes.[6] Regulations:  What You Don’t Know Could Hurt You Irrespective of the applicability of EMTALA or JCAHO, there are a whole host of other federal regulations that govern the day-to-day activities of urgent care medicine.  Although ownership interest frequently dictates the regulations for which investors must comply, such as STARK and anti-kickback laws, others apply across the board. All UCCs must comply with the privacy measures of the Health Insurance Portability and Accountability Act (HIPAA) and the security mandates of the Health Information Technology for Economic and Clinical Health Act (HITECH).  UCCs that operate a laboratory for blood tests or other related diagnoses must also adhere to Clinical Laboratory Improvement Amendment (CLIA) guidelines, in addition to Drug Enforcement Agency (DEA) mandates for the storage and dispensation of narcotics.  Finally, if the UCC provides services to Medicare or Medicaid patients, it must comply with the conditions of participation and reimbursement.   Knowing the rules of the game ahead of time can mean the difference between victory and defeat. Coding:  Not Just a Numbers Game One of the best ways to increase revenue in a UCC is to optimize billing and coding.  When negotiating a contract with a managed care organization it is incumbent upon UCC owners to make certain that reimbursement amounts and payment codes are specified in the contract. CMS has designated two HCPCS (Healthcare Common Procedure Coding System) codes for UCC use: S9083 - for global fees, irrespective of the treatment provided; and S9088, an “add on code,” for reimbursement of expenses unique to the practice of urgent care medicine, such as increased overhead and wage costs. Although these codes were never intended for submission to, or reimbursement by, Medicare or Medicaid many managed care organizations, such as United Health Care, now refuse to reimburse freestanding UCCs for anything other than professional procedure codes.[7] For those unfortunate enough to be caught up in the denial process, attempting to negotiate a reasonable compromise or a slight increase in fee schedule may be their only alternative. Marketing to Increase Revenue:  The “Me First” Mentality In today’s competitive economy traditional healthcare marketing strategies no longer work.   As more consumers gravitate towards urgent care medicine as a less costly, more convenient, option to traditional healthcare investors need to stay one step ahead of the competition in order to finish ahead of the pack. Since urgent care medicine is premised on consumer choice, a successful marketing plan will focus on customer service and convenience as a top priority.   A clear vision of your goals and objectives will give you more than just direction; it will give you a marketing framework that you can build your UCC around.  A few simple strategies to effectively market your UCC are as follows:
  1. Identify your niche market:  UCCs would do well to aggressively promote services to consumers with young children by marketing themselves as conveniently located and offering extended service hours.  Other targeted audiences include local employers and HR directors interested in pre-employment physicals, drug screening and immunization programs.
  2. Set up a website:  Yellow book advertising simply doesn’t fit the mind of today’s consumer. Today, consumers search online before they do anything else; therefore, it is crucial to develop a website and list your site with several directories and search engines.  If you do not list your website, it will become an orphan site that is not known and rarely visited by revenue- generating consumers.
  3. Signage: One of the most important marketing elements is a large, well-lit, sign prominently displayed in high traffic areas.  Since zoning restrictions regulate outdoor advertising, it is important to check with your local municipality regarding restrictions before you purchase a property or sign a lease for your UCC.
  4. Free Press: The local media is an invaluable asset in marketing your UCC.  Get to know local reporters, and let them know that you are available to do interviews for TV or newspaper stories on relevant healthcare topics.  Unlike other forms of media, this is completely free and has the greatest potential to reach a mass audience.[8]
As UCCs continue to expand across the country, the fields are ripe for investors to harvest the infinite possibilities posed by this merging trend in health care. ### Lucia Francesca Bruno, JD, LLM, MBA, is Principal Shareholder of Physicians' Legal Group, LLC (www.physicianslegalgroup.com).  She can be reached at(215) 688-3909.  
[1] Urgent Care Benchmarking & Statistics, http://www.ucaoa.org/resources_stats.php (Aug. 2010)
[2] Tony Barber, Pros & Cons to Freestanding vs. Provider-Based Models, (Mar. 2011)
[3] Brent Cosens, Financial Lesson in Urgent Care and Occupational Medicine, (Jan. 2009)
[4] Robin M. Weinick, Phd., Renee M. Bentancourt, BA, No Appointment Needed, The Resurgence of Urgent Care Centers in the United States, (Sept. 2007)
[5] 42 CFR Parts 413, 482, and 489 [CMS-1063-F] RIN 0938-AM34, https://www.cms.gov/EMTALA/Downloads/CMS-1063-F.pdf
[6] http://www.practicevelocity.com/urgent_care/coding/type_b_ed.php
[7] Urgent Care Policy-New, UHC Network Bulletin, Vol. 29, Jan.2009, pg.3
[8] http://www.practicevelocity.com/resources/marketing.php
 ]]> http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/feed/ 0 Preparing for ICD-10: Performing a Baseline MR Documentation Assessment http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/ http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/#comments Wed, 08 Jun 2011 14:46:18 +0000 Physicians News http://www.physiciansnews.com/?p=4112 By Michael G. Calahan, PA, MBA No longer just a rumor, the switch-over from ICD-9-CM to ICD-10-CM is now a sure deal and the established start date remains October 1, 2013.  Providers must be an active part of the conversion process, as many of the issues to be tackled are provider-driven.  Take, for example, medical record (MR) documentation.  MR documentation represents the beginning, middle and end of the current ICD-9-CM life cycle; it is foundational to the entire process of diagnosis coding and nothing materialized to date promises to change with ICD-10.  Provider documentation will initiate the assignment of codes, will drive the assessment of medical necessity for payment of services, and will serve to validate those services upon review by oversight entities.  With recovery funds now actively worked into the front-end of the government’s budget versus being considered “found” money, the advent of ICD-10 will not slow down or alter the federal government’s plans to audit providers. To prepare for ICD-10, performing a baseline MR documentation assessment can get the physician practices off to a good start.  This assessment will help expose areas where the providers need to strengthen their MR documentation.  Additional benefits can be realized, too.  One such benefit is the isolation of “missed opportunities” for diagnosis (ICD-9-CM) and service (CPT) coding.  These are diagnoses and services that should have been “captured” but were missed.  Likewise, services reported but under-documented enough so that the billing of them could be questioned by an outside reviewer such as an OIG, RAC or CERT auditor may be found.  The focus, however, will be on the documentation of diagnostic statements supporting the final-assigned ICD-9-CM codes, and how that documentation will likewise support the impending ICD-10-CM codes.  Case selection, i.e., determining which dates-of-service to review, should be accomplished by analyzing frequency reports generated by the billing system to assess the practice’s top 25 to 50 ICD-9-CM codes. In preparing source documents for the MR documentation review, remember the final-reported ICD-9-CM codes for each case selected may need to be compared with information contained on the practice superbills.  This form is the source document and data facilitator for billing information, which in turn gets translated to the CMS-1500 claim forms submitted to payers.  However, errors in the translation of data from the MR to the superbill are not rare.  And, even though this is a documentation review for comparing ICD-9 to ICD-10, the claim forms for each date-of-service should also be on hand.  The CMS-1500s are important source documents for comparing what was reported to the payers versus what the MR documentation holds as the actual case data. At a minimum then, the following source documents are needed to carry out a full MR documentation assessment:
  • Original MR documentation (e.g., office visit note)
  • Ancillary documents such as provider orders, operative reports, pathology reports, radiology reports, etc., if germane to the office visit
  • Practice superbils or encounter forms (i.e., the “charge tickets”)
  • CMS-1500 claim form copies.
  [caption id="attachment_4113" align="alignleft" width="207" caption="."][/caption] To perform a comparison-and-contrast of ICD-9-CM to ICD-10-CM codes, an ICD-10 tool will be needed.  This can be a pre-2013 ICD-10-CM book, an encoder with ICD-10 mapping, or the public CMS files that include listings of the ICD-10-CM/PCS codes as well as “GEM” files (general equivalency mapping spreadsheets), tying ICD-9 and ICD-10 together. Now select a patient date-of-service and prepare the array of MR documentation, the superbill and a copy of the CMS-1500 claim form.  Scan the progress (office visit) note for the recorded diagnostic data.  Most of the reportable ICD-9-CM codes listed on the CMS-1500 claim form and encircled on the superbill arise out of the diagnostic statement(s) noted under the “Assessment” section (if providers follow the SOAP note format), or alternatively the “Impressions” or “Diagnoses” sections. Also scan the History section of the office visit note.  Within the History component of the typical patient office encounter, there are four distinct elements required to be documented for most evaluation and management (E/M) services:  chief complaint (CC), review of systems (ROS), past, family and social history (PFSH) and history of present illness (HPI).  Commonly, a chronic but current/ongoing diagnosis impacting current care will be listed within the elements of the History, and not carried down or re-listed in the diagnostic area found under the Assessment section.  This “bad habit” should be avoided if possible, since it often confuses coders as well as outside medical reviewers. At this juncture let’s look at a case study to demonstrate the comparison process.  For illustration purposes we will use a patient with diabetes mellitus, type-II (DM-II), coded to ICD-9-CM code 250.00; no other ICD-9-CM codes were assigned or are listed on the CMS-1500 claim form for this particular office visit.  In this scenario, the patient’s CC is “Here for F/U of DM” and in fact, the “Impression” line states “DM-II, doing well on current regimen.”  However, the patient also has essential hypertension and is undergoing active treatment for this condition as evidenced by a note under the “Plan” section:  “Increase HCTZ to 50mg (25 mg b.i.d.).”  A quick glance under the History reveals the physician documented a correlating diagnosis in the ROS as “CV – HTN on HCTZ 25 mg q.d.”  Further, under “vitals” in the constitutional section of the progress note the annotation “Bp – 130/100 sitting x 2” is found.  Your conclusion in reviewing these notes is that the HTN did, in fact, impact the current care and therefore two diagnoses for this office visit should have been coded: DM and HTN. In relation to the DM-II, a finger stick test (glucometery) was normal.  There was no change in the condition, and therefore the DM-II remains coded to ICD-9-CM code “250.00 Diabetes mellitus without mention of complication, type II or unspecified type, not stated as uncontrolled.”  Under ICD-9-CM coding, the main methodology of coding diabetes mellitus is to (a) ascertain the “type” (i.e., type I juvenile DM or type II adult-onset DM) and then (b) code it according to status of control, as in “not stated as uncontrolled” (250.00) or “uncontrolled” (250.02).  This methodology is anticipated to hold true under ICD-10-CM as well, but the descriptor changes somewhat.  ICD-9-CM code 250.00 maps to ICD-10-CM code “E11.9 Type 2 diabetes mellitus without complications,” or to ICD-10-CM code “E13.9 Other specified diabetes mellitus without complications.”  DM-II now stated as “uncontrolled” under ICD-9-CM code 250.02 maps to ICD-10-CM code “E11.65 Type 2 diabetes mellitus with hyperglycemia.”  The analysis:  diabetes mellitus – depending on type, status and how specific the provider has been in his/her documentation – can be coded in several ways under ICD-10-CM.  The term “hyperglycemia” appears to be key in this classification when the DM is not under control.  As with ICD-9-CM coding now, the more specific the MR documentation the more accurate the coding; this holds true in ICD-10-CM coding. For the HTN uncovered as not being reported but was documented and impacted current care, the ICD-9-CM code in this case is 401.9.  There is no annotation or indication of concurrent hypertensive heart disease or chronic kidney disease, or any combination thereof.  Under the current ICD-9-CM coding structure, because the descriptors “benign” (ICD-9-CM code 401.1) or “malignant” (ICD-9-CM code 401.0) were not recorded in the MR documentation with the acronym “HTN,” the official coding instructions state the unspecified ICD-9-CM code 401.9 must be reported for “essential hypertension.”  Now compare this code with the anticipated requirements and information under ICD-10-CM.  The descriptors “benign” and malignant” no longer apply in ICD-10-CM coding.  The full description mapped to the current ICD-9-CM code series for essential hypertension (401.0, 401.1 and 401.9) match up to “I10 Essential (Primary) Hypertension.”  What will be required in terms of MR documentation for accurate ICD-10-CM coding?  First, establishing the hypertension as “essential” appears tantamount to getting it coded correctly; this classification should be established in the MR documentation.  Secondly, ensuring the current state of hypertension is not etiologically connected to hypertensive heart disease, chronic kidney disease or a combination of these two is vital for correct coding (these conditions map to other ICD-10-CM codes). Performing as the “auditor” you have that the ICD-9-CM code for HTN was not reported, and you further find it was not encircled on the superbill.  The lesson buried in this for providers?  The MR documentation should be as clear, concise and explicit as possible, especially when summarizing the impressions or diagnoses.  The CC should be amended at the time of service, especially when initially recorded by ancillary staff, to reflect all of the reasons for the patient’s presentation.  A lesson herein for coders, too, is that often corroborating information is found between the History and Plan sections of the note, and both should be reviewed for possible “missed diagnosis opportunities” for ICD-9 and ICD-10 coding purposes.  Lastly, do not rely solely upon the superbills for diagnostic information. In many instances ICD-10-CM promises to impose greater specificity on diagnosis code descriptions and assignment; therefore, a correlating level of specificity is expected to be found in the MR documentation.  Performing a baseline MR documentation assessment is often a rewarding exercise in preparation for ICD-10 conversion. ###   Michael G. Calahan is currently the Director of Physician Services at Kforce Healthcare, Inc., working in the Washington DC Metro area. Also on the Board of the ICD-10 Monitor, he specializes in compliance, revenue cycle management, CDI, coding, and billing in the physician and facility arenas. He may be contacted by e-mail at mcalahan@kforce.com.  ]]> http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/feed/ 2 ACOs: The Good, the Bad and the Ugly http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/ http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/#comments Wed, 11 May 2011 00:30:29 +0000 Physicians News http://www.physiciansnews.com/?p=4067 [caption id="attachment_2742" align="alignleft" width="240" caption="."][/caption] By Ron Wince Although Accountable Care Organizations (ACOs) have been discussed for years, health care reform has put them in the spotlight. Now, health care leaders are trying to determine the best way to move forward and transition to this new model of care. While the idea behind ACOs is to get the provider and payer chain working together to provide better-coordinated, more seamless care, the various definitions of an ACO are widely varied. From the perspective of a Medicare/Medicaid patient, there is a major attraction to the current perception of ACOs. In principle, patients should have a reasonable expectation of higher quality care delivered at a lower cost if they choose a provider enrolled in an ACO. From the provider and insurance standpoint, the choice to form or join an ACO is not quite as clear cut. On the upside, any provider or insurer that is part of an ACO could see significant cost reductions, shared savings, and quality improvement, evident in both internal operations and the care they deliver to patients. Providers will also have a better ability to compete for the pool of Medicare/Medicaid patients, which will only continue to grow as more baby boomers reach retirement age. However, from what we do know, there are several positives and negatives that providers and payers must consider. The most pervasive problem is that there is no blueprint that administrators can follow to point them in the right direction when creating an ACO. Even with the recent release of the final ruling, there remains much that is left to the organizations involved.  We do know that ACOs must: -       Serve a minimum of 5,000 patients -       Consent to be part of an ACO for at least three years -       Follow either a one-sided or two-sided risk model -       Measure and report over 65 metrics (up from only eight)   But even with these minimums the “how” to forming or participating in an ACO has yet to be answered for most organizations that may opt in.  For instance, hospital administrators could create an ACO by buying one or more physician practices while, conversely, group practices or networks of physician practices could take the lead, enrolling a hospital as a partner. Supposing that administrators decide to form an ACO, the next hurdle is putting into place the required infrastructure. There are requirements for creating certain leadership and management structures that include both clinical and management personnel. Administrators will need to put into motion processes that demonstrate that they are practicing evidence-based medicine and coordinating care, as well as confirm that they are “patient centered,” another term for which there is no clear definition yet. Even more challenging could be combining the cultures of the different groups. How people work together can be a bigger factor in determining the ultimate success or failure of an effort than what they do. Before organizations determine what their ACO will look like, they need to first determine how they are going to formulate the partnership. For instance, one aspect of contention is the negotiation of agreements about how decision making and potential savings will be shared across members of the ACO. One group may have a standard practice of buying whatever’s cheapest while another may have a “buying whatever each physician wants” policy. If these two groups coalesce within the same ACO, which guideline should take precedence? Furthermore, staff and patient management strategies are different across the industry. Once organizations join together in an ACO, administrators will have to discuss managerial operations to ensure all employees and patients feel the benefits. Minor details, such as courtesy calls to patients or internal celebrations for staff, will have to be unified in order for the ACO to function as one seamless entity. In addition to cultural changes, ACOs will drive a marriage of technology. It won’t be possible for a hospital and a physician group to work together under the ACO system if they are operating two completely different technology systems. How do you shift from one technology to another? Who will manage the overall process and future IT system? How will organizations share patient information while accommodating regulations? These are decisions administrators will have to make when forming an ACO, many of which will impact the overall efficiency of the organization. From a process standpoint, ACOs have the potential to streamline many functions on an organizational level. Physician groups tend to have quicker billing practices because they depend on cash flow. Hospitals, on the other hand, often take weeks to make payments. With the joining of the two in an ACO, an improved billing process will be key to ensure physician practices aren’t losing cash flow because of poor process management. Furthermore, administrators will need to become masters of business intelligence, including measuring what’s important, collecting and reporting data and using the data to improve their organizations, not just for compliance.  Given that unknowns and uncertainties are guaranteed, administrators must practice certain survival skills such as how to learn faster on the fly and collaborate at all levels. Agility will be an imperative skill for administrators as rules continue to change. Looking at both sides of the argument, there is the potential for significant gains on both the cost and quality fronts, as well as the ability to maintain or grow a practice’s Medicare/Medicaid patient base against the need for putting in an enormous amount of work up front. ACOs were developed to help the patient and to ensure that our hospitals and physicians can continue to provide quality care, even as risks, such as an aging population, strain our health care system. In addition to a continued dedication to quality care, patients will see lower costs. ACOs will ensure that patients are receiving the care they need, rather than what helps the organization make more money. Providers may also experience success in the new era of ACOs. It will help them successfully manage the influx of patients and transformation of patient care without having to worry about increasing costs. While it hasn’t been defined yet, there may be a future opportunity for providers to garner incentives when meeting the guidelines of ACOs. This will only better the care patients receive. Whatever an organization’s view on ACOs is, they must accept that they will become part of the future of health care in this country, and must begin building or strengthening the skills and capabilities that will be needed to win on that new playing field. ### Ron Wince is President & CEO of Guidon Performance Solutions.  ]]> http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/feed/ 2 What Providers Need to Know About ICD-10 http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/ http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/#comments Tue, 07 Feb 2012 16:14:45 +0000 Physicians News http://www.physiciansnews.com/?p=4595 By Punit Dhillon At some point in their lives, one in five people will suffer from skin cancer, and the fraction is steadily rising.  In spite of innovation in sunscreen technology and public attention to the need to be shielded from the sun, data reported recently by Dermatology Times show a rise in the average American lifetime risk of one skin cancer variety—invasive melanoma—from 1/600 in 1960 to 1/50 in 2008.  Despite previous diagnosis and innovations in approaches to treatment, the age-adjusted number of annual deaths per 100,000 population is rising.  Additionally, the expense to the healthcare system and society continues to increase.  As U.S. and European populations age, the incidence of skin cancer and other solid tumor cancers will grow.  According to the latest United States Cancer Statistics, published by the Centers for Disease Control and Prevention in 2007, the top 10 cancer types (based on incidence rate) are in the solid tumor category; today the priority is probably even higher.  Thus, there are clear medical needs going unmet and the creation of novel, cost-efficient and patient-friendly treatments remain a top priority for both the healthcare community and patients. Various challenges of traditional treatments The treatment of solid tumor cancers, which range from melanoma and Merkel cell carcinoma to cutaneous T-cell lymphoma, continues to be a substantial challenge for physicians.  For example, in spite of innovations in drug discovery and development, it is still challenging to simply deliver efficient drugs into cancer cells in a safe and effective manner.  Meanwhile, today’s therapeutic approaches—involving surgery, radiation therapy and chemotherapy—each have characteristic and major drawbacks. Surgery, the current first-line treatment for localized and operable tumors or lesions, requires resecting the tumor mass and a surrounding boundary of healthy tissue to make sure that no cancer cells remain at the tumor site.  Surgery can potentially cause physical disfigurement and/or debilitating effects on organ function, and the patient quality of life has been demonstrated to be negatively impacted.  Also, surgery can require an expensive and long hospital stay. Radiation therapy is occasionally used in conjunction with surgery to shrink a tumor prior to surgical removal, or afterward to destroy any cancer cells that might remain.  Yet surgery plus radiation can damage important normal tissues like nerves, blood vessels, or vital organs such as the heart that are within the designated zone of treatment.  Radiation is also a costly therapeutic approach, and demands substantial expertise, precautionary measures and infrastructure to administer.  Radiation entails major complications, such as nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the potential for the formation of new cancerous lesions. Those who get radiation to the heart often suffer from various types of heart failure in subsequent years. Typically, chemotherapy is a secondary or palliative treatment to help mitigate systemic or metastatic tumor growth, whereas surgery and radiation may be considered local treatments.  In response to cancer’s spread, physicians will administer chemotherapeutic agents that circulate throughout the body, systemically and in high concentrations, to counter the challenge that some chemotherapeutic agents have in reaching and penetrating the cell membrane to trigger cell death.  Yet the system-wide use of chemotherapeutics frequently has major side effects by killing healthy as well as cancerous cells.  This systemic and non-targeted administration of anticancer agents can trigger alopecia; nausea; vomiting; myelosuppression; and drug resistance.  Chemotherapy is curative for only a few tumor types. Additionally, all of these conventional treatments are only minimally effective on aggressive types of cutaneous cancers, especially in later stages of the disease. Some potential approaches We now offer an abbreviated look at some current approaches to override these challenges in treating solid tumors. One possible strategy for solid tumor treatment involves a new class of small-molecule drug candidates called vascular disrupting agents.  Via interaction with vascular endothelial cytoskeletal proteins, these agents may selectively target and collapse tumor vasculature, thereby depriving the tumor of oxygen and causing death of the tumor cells. Another approach involves the use of new therapeutic monoclonal antibody candidates that target CD27, a member of the tumor necrosis factor (TNF) receptor superfamily.  Anti-CD27 monoclonal antibodies have been demonstrated to effectively promote anticancer immunity in mouse models when combined with T cell receptor stimulation.  In addition, CD27 is overexpressed in various lymphomas and leukemias and can be targeted for direct activity by anti-CD27 monoclonal antibodies with effector function against those cancers.  There are many other antibody drugs on the market, some also with linked toxins or radiation. A third tactic involves the creation of an orally available nucleoside analogue for various cancers including solid tumors.  This agent could act through a novel DNA single-strand breaking mechanism, leading to the production of DNA double strand breaks (DSBs) and/or DNA repair checkpoint activation; unrepaired DSBs go on to cause apoptosis or programmed cell death. Alternatively, solid tumors could be treated using a technique called tumor ablation, which involves destroying the tumor inside the body via various approaches.  Radioactive pellets, shorter than an inch and approximately the width of a pin, can be inserted into the tumor; the pellet subsequently emits lethal radioactive atoms that irradiate the tumor from the inside out.  As the tumor breaks down, it starts to release antigens that trigger an immune response against the cancer cells.  Sometimes, the body also develops an immune memory against the future return of tumor cells.  Another proposed ablation technique, called “pulsed electric current ablation,” involves the insertion of electrodes into tumors, which subsequently emit very high-energy electrical currents; these currents create a physical reaction that destroys the tumor cells. A separate approach involves applying local heating to the tumor using radio frequency techniques.  In this instance, a thermal energy delivery device can be focused and targeted according to the shape, size and position of a specific tumor.  Adjusting the frequency, phase, and amplitude of the radio waves, combined with different applicators and adjustment of the patient’s position, could conceivably permit a doctor to optimize the delivery of damaging energy into the tumor. Cancer scientists are also interested in attacking solid tumors by delivering drugs specifically into diseased tissues. Such a targeted approach can result in more efficient therapy while using smaller drug doses with fewer negative side effects.  For example, in animal studies, immune-deficient mice carrying human forms of various cancers have been simultaneously injected with a range of anticancer agents and a peptide known as iRGD.  iRGD can find and attach itself to receptors on solid tumor cancer cells and later activate their internal transport systems so that the peptide is essentially passed through cell after cell, moving progressively deeper into the tumor structure.  Anticancer drugs lingering near the peptide molecules may also get pulled into and through the tumor mass by this transport mechanism, enabling them to attack cancer cells previously beyond their reach. By their nature and cellular architecture, solid tumors are equipped to limit the efficacy of most anticancer drugs.  Tumors have poor vascular systems, which reduces exposure to drugs that have been administered into the circulation.  The lesions are densely fibrous, which serves as a physical barrier against transport.  Also, the tumors have high internal pressures, causing further physical challenges to any molecule attempting to enter the lesion.  The iRGD peptide is designed to act like a key, switching on the internal transport mechanism of the cells so that they absorb anything that is proximal to certain cell surface receptors.  Researchers believe the iRGD peptide could penetrate many tumor types and might be useful in treating most solid tumor cancers.  An encouraging aspect of this approach is that both the peptide and anticancer drugs are effective together without being chemically attached. Yet another promising strategy for treating solid tumor cancers involves targeting the tumor itself without affecting any of the surrounding healthy tissue.  This ensures that the drug or therapeutic agent is absorbed at once by the cancer cells and not normal tissues.  One such targeted therapy could harness a physiologic process known as “electroporation.”  Derived from the words “electric” and “pore,” this involves applying a brief electric field to the cancerous cell.  The electrical pulse triggers the temporary creation of pores in the cell’s outer membrane—pores that close again within seconds once the electric field is discontinued.  These transient pores can improve uptake of various drugs more than a thousand-fold. Several electroporation systems have been manufactured that consist of a generator that creates the pulsed electric field, and various handheld applicators with electrode needles at their proximal ends.  The applicator delivers a controlled electric pulse to the cancer cells, thus causing any cancer cells within the affected region to undergo electroporation.  The cell takes up therapeutic agents within the region of electroporation. This technology platform is being developed for use in two varieties of anticancer therapies:  electrochemotherapy and electroimmunotherapy.  In the former, an anticancer drug is injected into a targeted tumor; the lesion is then electroporated and the drug carries out its planned mechanism of action in killing the cell.  As a result of the targeted, local therapy, the amount of drug needed to kill the cells is substantially less than that required in traditional, non-targeted chemotherapy.  The lower quantity of systemic drug (cytotoxic agent) reduces harmful side effects linked to traditional chemotherapy. Electroimmunotherapy, the second application of electroporation, involves the use of a gene encoding a specific cytokine, a substance known to boost the human immune system against cancer cells.  An immune response can have both a local and a distant effect against cancerous cells.  These therapeutic approaches have been shown to be safe and effective across various types of tumors.  Both patient outcomes and pharmacoeconomic benefits are substantial.  This technology is in clinical testing in North America and is available for commercial sale in some European countries. Therapies such as those discussed here may provide a compelling set of novel approaches to the treatment of solid tumor cancers. ### Punit Dhillon is President and CEO of OncoSec Medical Inc., a biotechnology company developing its advanced-stage Oncology Medical System (OMS) ElectroOncology therapies to treat skin cancer and other solid tumor cancers. He can be reached at pdhillon@oncosec.com.]]> http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/feed/ 0 Physicians News » Headline http://www.physiciansnews.com Tue, 07 Feb 2012 16:44:06 +0000 en hourly 1 http://wordpress.org/?v=3.2.1 The Treatment of Solid Tumors: Some Recent Approaches http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/ http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/#comments Tue, 07 Feb 2012 16:14:45 +0000 Physicians News http://www.physiciansnews.com/?p=4595 By Punit Dhillon At some point in their lives, one in five people will suffer from skin cancer, and the fraction is steadily rising.  In spite of innovation in sunscreen technology and public attention to the need to be shielded from the sun, data reported recently by Dermatology Times show a rise in the average American lifetime risk of one skin cancer variety—invasive melanoma—from 1/600 in 1960 to 1/50 in 2008.  Despite previous diagnosis and innovations in approaches to treatment, the age-adjusted number of annual deaths per 100,000 population is rising.  Additionally, the expense to the healthcare system and society continues to increase.  As U.S. and European populations age, the incidence of skin cancer and other solid tumor cancers will grow.  According to the latest United States Cancer Statistics, published by the Centers for Disease Control and Prevention in 2007, the top 10 cancer types (based on incidence rate) are in the solid tumor category; today the priority is probably even higher.  Thus, there are clear medical needs going unmet and the creation of novel, cost-efficient and patient-friendly treatments remain a top priority for both the healthcare community and patients. Various challenges of traditional treatments The treatment of solid tumor cancers, which range from melanoma and Merkel cell carcinoma to cutaneous T-cell lymphoma, continues to be a substantial challenge for physicians.  For example, in spite of innovations in drug discovery and development, it is still challenging to simply deliver efficient drugs into cancer cells in a safe and effective manner.  Meanwhile, today’s therapeutic approaches—involving surgery, radiation therapy and chemotherapy—each have characteristic and major drawbacks. Surgery, the current first-line treatment for localized and operable tumors or lesions, requires resecting the tumor mass and a surrounding boundary of healthy tissue to make sure that no cancer cells remain at the tumor site.  Surgery can potentially cause physical disfigurement and/or debilitating effects on organ function, and the patient quality of life has been demonstrated to be negatively impacted.  Also, surgery can require an expensive and long hospital stay. Radiation therapy is occasionally used in conjunction with surgery to shrink a tumor prior to surgical removal, or afterward to destroy any cancer cells that might remain.  Yet surgery plus radiation can damage important normal tissues like nerves, blood vessels, or vital organs such as the heart that are within the designated zone of treatment.  Radiation is also a costly therapeutic approach, and demands substantial expertise, precautionary measures and infrastructure to administer.  Radiation entails major complications, such as nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the potential for the formation of new cancerous lesions. Those who get radiation to the heart often suffer from various types of heart failure in subsequent years. Typically, chemotherapy is a secondary or palliative treatment to help mitigate systemic or metastatic tumor growth, whereas surgery and radiation may be considered local treatments.  In response to cancer’s spread, physicians will administer chemotherapeutic agents that circulate throughout the body, systemically and in high concentrations, to counter the challenge that some chemotherapeutic agents have in reaching and penetrating the cell membrane to trigger cell death.  Yet the system-wide use of chemotherapeutics frequently has major side effects by killing healthy as well as cancerous cells.  This systemic and non-targeted administration of anticancer agents can trigger alopecia; nausea; vomiting; myelosuppression; and drug resistance.  Chemotherapy is curative for only a few tumor types. Additionally, all of these conventional treatments are only minimally effective on aggressive types of cutaneous cancers, especially in later stages of the disease. Some potential approaches We now offer an abbreviated look at some current approaches to override these challenges in treating solid tumors. One possible strategy for solid tumor treatment involves a new class of small-molecule drug candidates called vascular disrupting agents.  Via interaction with vascular endothelial cytoskeletal proteins, these agents may selectively target and collapse tumor vasculature, thereby depriving the tumor of oxygen and causing death of the tumor cells. Another approach involves the use of new therapeutic monoclonal antibody candidates that target CD27, a member of the tumor necrosis factor (TNF) receptor superfamily.  Anti-CD27 monoclonal antibodies have been demonstrated to effectively promote anticancer immunity in mouse models when combined with T cell receptor stimulation.  In addition, CD27 is overexpressed in various lymphomas and leukemias and can be targeted for direct activity by anti-CD27 monoclonal antibodies with effector function against those cancers.  There are many other antibody drugs on the market, some also with linked toxins or radiation. A third tactic involves the creation of an orally available nucleoside analogue for various cancers including solid tumors.  This agent could act through a novel DNA single-strand breaking mechanism, leading to the production of DNA double strand breaks (DSBs) and/or DNA repair checkpoint activation; unrepaired DSBs go on to cause apoptosis or programmed cell death. Alternatively, solid tumors could be treated using a technique called tumor ablation, which involves destroying the tumor inside the body via various approaches.  Radioactive pellets, shorter than an inch and approximately the width of a pin, can be inserted into the tumor; the pellet subsequently emits lethal radioactive atoms that irradiate the tumor from the inside out.  As the tumor breaks down, it starts to release antigens that trigger an immune response against the cancer cells.  Sometimes, the body also develops an immune memory against the future return of tumor cells.  Another proposed ablation technique, called “pulsed electric current ablation,” involves the insertion of electrodes into tumors, which subsequently emit very high-energy electrical currents; these currents create a physical reaction that destroys the tumor cells. A separate approach involves applying local heating to the tumor using radio frequency techniques.  In this instance, a thermal energy delivery device can be focused and targeted according to the shape, size and position of a specific tumor.  Adjusting the frequency, phase, and amplitude of the radio waves, combined with different applicators and adjustment of the patient’s position, could conceivably permit a doctor to optimize the delivery of damaging energy into the tumor. Cancer scientists are also interested in attacking solid tumors by delivering drugs specifically into diseased tissues. Such a targeted approach can result in more efficient therapy while using smaller drug doses with fewer negative side effects.  For example, in animal studies, immune-deficient mice carrying human forms of various cancers have been simultaneously injected with a range of anticancer agents and a peptide known as iRGD.  iRGD can find and attach itself to receptors on solid tumor cancer cells and later activate their internal transport systems so that the peptide is essentially passed through cell after cell, moving progressively deeper into the tumor structure.  Anticancer drugs lingering near the peptide molecules may also get pulled into and through the tumor mass by this transport mechanism, enabling them to attack cancer cells previously beyond their reach. By their nature and cellular architecture, solid tumors are equipped to limit the efficacy of most anticancer drugs.  Tumors have poor vascular systems, which reduces exposure to drugs that have been administered into the circulation.  The lesions are densely fibrous, which serves as a physical barrier against transport.  Also, the tumors have high internal pressures, causing further physical challenges to any molecule attempting to enter the lesion.  The iRGD peptide is designed to act like a key, switching on the internal transport mechanism of the cells so that they absorb anything that is proximal to certain cell surface receptors.  Researchers believe the iRGD peptide could penetrate many tumor types and might be useful in treating most solid tumor cancers.  An encouraging aspect of this approach is that both the peptide and anticancer drugs are effective together without being chemically attached. Yet another promising strategy for treating solid tumor cancers involves targeting the tumor itself without affecting any of the surrounding healthy tissue.  This ensures that the drug or therapeutic agent is absorbed at once by the cancer cells and not normal tissues.  One such targeted therapy could harness a physiologic process known as “electroporation.”  Derived from the words “electric” and “pore,” this involves applying a brief electric field to the cancerous cell.  The electrical pulse triggers the temporary creation of pores in the cell’s outer membrane—pores that close again within seconds once the electric field is discontinued.  These transient pores can improve uptake of various drugs more than a thousand-fold. Several electroporation systems have been manufactured that consist of a generator that creates the pulsed electric field, and various handheld applicators with electrode needles at their proximal ends.  The applicator delivers a controlled electric pulse to the cancer cells, thus causing any cancer cells within the affected region to undergo electroporation.  The cell takes up therapeutic agents within the region of electroporation. This technology platform is being developed for use in two varieties of anticancer therapies:  electrochemotherapy and electroimmunotherapy.  In the former, an anticancer drug is injected into a targeted tumor; the lesion is then electroporated and the drug carries out its planned mechanism of action in killing the cell.  As a result of the targeted, local therapy, the amount of drug needed to kill the cells is substantially less than that required in traditional, non-targeted chemotherapy.  The lower quantity of systemic drug (cytotoxic agent) reduces harmful side effects linked to traditional chemotherapy. Electroimmunotherapy, the second application of electroporation, involves the use of a gene encoding a specific cytokine, a substance known to boost the human immune system against cancer cells.  An immune response can have both a local and a distant effect against cancerous cells.  These therapeutic approaches have been shown to be safe and effective across various types of tumors.  Both patient outcomes and pharmacoeconomic benefits are substantial.  This technology is in clinical testing in North America and is available for commercial sale in some European countries. Therapies such as those discussed here may provide a compelling set of novel approaches to the treatment of solid tumor cancers. ### Punit Dhillon is President and CEO of OncoSec Medical Inc., a biotechnology company developing its advanced-stage Oncology Medical System (OMS) ElectroOncology therapies to treat skin cancer and other solid tumor cancers. He can be reached at pdhillon@oncosec.com.]]> http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/feed/ 0 Growing Organs In The Lab: A potential end to immune rejection http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/ http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/#comments Sat, 03 Dec 2011 18:06:55 +0000 Physicians News http://www.physiciansnews.com/?p=4453 By David Green Last June, Andemarian T. Beyene, 36-year-old man with tracheal cancer received a special gift:  a brand new trachea, made from a synthetic scaffold seeded with his own stem cells.  Following this surgery—the first of its kind—he made a full recovery and was discharged from the hospital four weeks later.  The procedure made international headlines, and shone a much-needed spotlight on two important problems that it might help in part to resolve:  long wait times for organ transplants, and immune rejection of implanted organs.  In what follows, we offer a brief overview of these issues, look a bit closer at the surgery itself, and ponder some of the implications. As of November 2011, the Organ Procurement and Transplantation Network, a division of the U.S. Department of Health & Human Services, is reporting that over 112,000 Americans are waiting for an organ transplant.  At the same time, the average annual expense per patient of immunosuppressive drugs—administered following a transplant to prevent the body from rejecting the new organ—is more than ,000, and in some cases can reach as high as ,000, according to the American Society of Transplant Surgeons. These sobering statistics are driving a campaign within the biomedical research community for innovation. A complex and technologically advanced organ allocation system links patients with organs donated by strangers.  The  shortage of organs causes most patients to wait for a transplant, and waiting times vary widely for many reasons. The amount of time a patient waits does not reflect how well as transplant center or organ procurement organization is doing its job; each patient’s situation is different.  Some patients are more ill than others when they are put on the transplant waiting list.  Some patients get sick more quickly than other patients, or respond differently to treatments.  Patients may have medical conditions that make it harder to find a good match for them. How long a patient waits can depend on a multitude of factors.  These can include blood type (some are rarer than others); tissue type; height and weight of transplant candidate; size of donated organ; medical urgency; time on the waiting list; the distance between the donor’s hospital and the potential donor organ; how many donors there are in the local area over a period of time; and the transplant center’s criteria for accepting organ offers.  Depending on the kind of organ needed, some factors are more important than others.  Under certain circumstances, special allowances are made for children. Since 1984, the nonprofit United Network for Organ Sharing (UNOS), located in Richmond, Virginia, has operated the Organ Procurement and Transplantation Network, under a contract with the Division of Transplantation in the Department of Health and Human Services.  UNOS maintains a central computer network containing the names of all patients waiting for kidney, heart, liver, lung, intestine, pancreas and multiple-organ transplants.  Patients on the waiting list are in end-stage organ failure and have been evaluated by a transplant physician and hospitals in the U.S. where organ transplants are performed. Another major guiding principle in organ allocation is: local patients first.  The U.S. is divided into 11 geographic regions, each served by a federally designated organ procurement organization, which is responsible for coordinating all organ donations.  With the exception of perfectly matched kidneys and the most urgent liver patients, first priority goes to patients at transplant hospitals located in the region served by the organ procurement organization.  Next in priority are patients in areas served by nearby organ procurement organizations; and finally, only if no patients in these communities can use the organ, it is offered to patients elsewhere in the country. Such locally oriented allocation makes medical sense because less time between donor and recipient usually means more chance of a successful transplant as well as fewer complications that could threaten the viability of the organ.  Eighty percent of all organs are donated and used in the same geographic area. Organ transplant recipients must take immunosuppressive drugs every day for the life of their transplant.  Failure to take these medications significantly increases the risk of rejection.  These drugs are not without side effects and risks.  Because the majority of them act non-selectively, the immune system is less able to resist infections and the spread of malignant cells.  There are also other side effects, such as hypertension, dyslipidemia, hyperglycemia, peptic ulcers, and liver and kidney injury.  The immunosupressive drugs also interact with other medicines and affect their metabolism and action. Immunosuppressive drugs can be classified into five groups—glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins, and other drugs—each with their own specific uses. For example, in pharmacological doses, glucocorticoids are used to suppress various allergic, inflammatory and autoimmune disorders.  They are also administered as posttransplantory immunosuppressants to prevent acute transplant rejection and graft versus host disease.  Nevertheless, they do not prevent infection and also inhibit later reparative processes.  Cyostatics inhibit cell division.  In immunotherapy, they are used in smaller doses than in the treatment of malignant diseases, and they affect the proliferation of both T cells and B cells.  Antibodies are sometimes used as a quick and potent immunosuppressive therapy to prevent the acute rejection reactions as well as a targeted treatment of lymphoproliferative or autoimmune disorders.  The drugs acting on immunophilins include cyclosporin, tacrolimus and sirolimus, whereas additional drugs used as immunosuppressants include interferons, opioids, TNF binding proteins and mycophenolate. In light of the challenges posed by transplant wait lists and the need to choose the optimal immunosuppressive therapy to facilitate transplants, it is significant that for the first time ever, a patient was recently given a new trachea made from a synthetic scaffold seeded with his own stem cells.  As noted earlier, the patient, 36-year old Andemarian T. Beyene, made a full recovery and was discharged from the hospital following the operation.  The operation was performed on June 9, 2011 at Karolinska University Hospital in Stockholm, Sweden, by Paolo Macchiarini, MD, PhD, Professor of Regenerative Surgery at the Advanced Center of Translational Regenerative Medicine at Karolinska Institutet, Stockholm, Sweden, and colleagues (Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioarti?cial nanocomposite: a proof-of-concept study. Lancet 2011; Published online November 22, 2011 DOI:10.1016/S0140-6736(11)61715-7). Previous transplants of tissue-engineered tracheas have been performed, but on those occasions the tracheas used were taken from organ donors and then reseeded with the patients’ own stem cells. For example, in 2008, 30-year-old Claudia Castillo successfully underwent this type of procedure in Spain (Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008; 372: 2023-2030). The international team involved Professor Alexander Seifalian from University College London who designed and built the nanocomposite tracheal scaffold, and Harvard Bioscience of Holliston, Massachusetts, which produced a specifically designed, shoebox-sized bioreactor used to seed the scaffold with the patient’s own stem cells.  The cells were grown on the scaffold inside the bioreactor for approximately two days; the scaffold was rotated while its surface was soaked with stem cells obtained from a bone marrow biopsy from the patient’s hip.  The patient’s stem cells settled into the pores within the scaffold and began to grow into each other, slowly transforming from individual cells into genuine tissue.  A few days after the implantation of the new trachea, the man’s own blood vessels actually started to grow into it, transforming the new organ into a part of his own body.  Because the cells used to regenerate the trachea were the patient’s own, there was no rejection of the transplant and the patient was not taking immunosuppressive drugs. The patient had been suffering from late-stage tracheal cancer.  Despite maximum treatment with radiation therapy, the tumor had reached approximately 6 cm in length and was extending to the main bronchus.  It was progressing and almost completely blocked the trachea.  Since no suitable donor windpipe was available, the transplantation of the synthetic tissue-engineered trachea was performed as the last possible option for the patient, referred by Professor Tomas Gudbjartsson of Landspitali University Hospital (Iceland) who was also part of the surgical team. The successful transplantation of tissue-engineered synthetic organs, referred to as regenerative medicine, could open new and very promising therapeutic possibilities for the thousands of patients who suffer from tracheal cancer or other conditions that destroy, block or constrict the airway. It is extremely important to note that this procedure is still experimental and will need to be sanctioned by the U.S. Food and Drug Administration for the more than 100,000 Americans who are waiting for organ transplants to benefit from it. What does tomorrow hold for this type of medical technology?  For the immediate future, the scaffold approach to generating synthetic body parts will be limited to growing tubular organs such as trachea and blood vessels, rather than more complex organs such as kidneys and livers.  However, other types of organs may become a practical option in time. Transplantations of tissue-engineered windpipes—and potentially other tubular organs like esophagus, blood vessels and urethras—with synthetic scaffolds in combination with the patient’s own stem cells, as a standard procedure, means that patients would not have to wait for a suitable donor organ.  This would be a substantial benefit for patients since they could benefit from earlier surgery and have a greater chance of cure.  In addition to treating adult patients, tissue-engineered synthetic trachea transplants would, not least, be of great value for children, since the availability of donor tracheas is much lower than for adult patients. If this scenario unfolds as some predict, it might mean the start of a new era in the treatment of thousands of patients whose lives and health will be improved.   ### David Green is President of Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine.  He can be reached at dgreen@harvardbioscience.com.]]> http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/feed/ 1 What You and Your Patients Need to Know About Bisphenol A http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/ http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/#comments Mon, 07 Nov 2011 14:28:00 +0000 Physicians News http://www.physiciansnews.com/?p=4379 By Rebecca Roberts, Ph.D. Bisphenol A (BPA) is an environmental estrogen that can affect development and health by disrupting normal hormonal signaling.  Estrogen, working at very low blood concentrations, triggers responses in cells and tissues and is critical during fetal development and in normal health and reproduction.  BPA binds to the same cellular receptors as estrogen and may lead to detrimental health effects. In June of this year, the American Medical Association formally recognized BPA as an endocrine-disrupting agent.  Physicians can play an important role in educating their patients about this pervasive environmental contaminant.  The first steps are to understand the potential health risks of BPA and how to limit those risks through simple lifestyle changes. BPA is used in the production of polycarbonate plastics and epoxy resins.  Many consumer products, such as some reusable water bottles, baby bottles, toys, cell phones, and DVDs, contain BPA.  BPA is also found in the inner linings of metal food cans.1 The epoxy lining protects the metal can from rust and corrosion which may taint the food.  It is present in various medical devices as well, including incubators, blood oxygenators, and dialysis machines.  Given its wide uses, BPA ranks among the highest volume chemicals manufactured worldwide. Although present in countless products, none of which is intended for consumption, the primary route of exposure is through ingestion.  BPA has been shown to leach from products that contain it, such as food cans, into the foodstuffs stored in the container.1,2 When the food is then consumed, BPA enters the body through the digestive tract. A 2007 survey by the Centers for Disease Control found that approximately 92% of Americans have detectable levels of BPA in their bodies.3 The survey is considered representative of the United States population even though it included only people older than six years old.  It is notable, however, that the children (ages 6-11 years) in this study displayed the highest levels of BPA of all populations investigated.  BPA has been found in placental tissue and fetal blood as well, indicating that fetuses are being exposed as a result of maternal exposure.4 An additional study looked at the levels of BPA in infants – specifically in premature infants housed in Neonatal Intensive Care Units.5 It was found that these infants displayed the highest level of BPA in their bodies of all populations. Exposure to BPA has been studied on many levels, from effects on individual cells, to tissues and whole organisms.  While most health studies regarding exposure to BPA are done in laboratory animals, the few human epidemiological studies reveal a relationship between BPA exposure and polycystic ovary syndrome, repeated miscarriage, and heart disease.6-8 Additionally, BPA causes a human breast cancer cell line to proliferate, suggesting that estrogen-sensitive tissues and cells in the human body may react similarly.9 Many animal studies focus on the effect of BPA exposure during fetal development as this is a time when cells and tissues are especially susceptible to alterations in the hormonal environment.  Not only does BPA disrupt proper functioning of the placenta during gestation, but offspring of animals that are exposed to BPA during pregnancy exhibit many deleterious health effects.10 Male offspring have enlarged prostates and malformed urethra.11, 12 Moreover, they are at a higher risk of developing prostate cancer. BPA exposure alters the genital tract of female offspring.11, 12 Exposed females also enter puberty earlier.12 Exposure affects brain development and, as a result, some behavioral differences typically seen between males and females are lost in offspring exposed to BPA in the uterus.13 Based on the clear effects of BPA exposure on the development of fetuses in animals, similar effects on human development are plausible.  Indeed, BPA has been found in the bloodstream, placenta, cord blood, and fetal blood of humans at levels that are within the range studied in many of the animal models.5
While hundreds of studies, most focusing on animal models, point to the harmful health effects of BPA, there has been controversy over the past decade and a half regarding safety of the compound in humans.  Nevertheless, scientific review panels have determined that some detrimental health effects may occur in humans.14-16 Likely human health effects that have been vetted through these review panels include advanced puberty in females14, 15 , effects on the brain and behavior15, 16, mammary gland and prostate abnormalities, and reproductive effects in males and females. Beyond the immediate developmental effects of BPA exposure in utero, evidence is beginning elucidate long-term effects of early-life exposure to BPA, potentially through the modification of epigenetic programming via altered DNA methylation.16, 17 One study suggests that such detrimental modifications may be counteracted by maternal nutrient supplementation.18 Nevertheless, these changes may result in alterations that are passed on transgenerationally, resulting in adverse health effects in subsequent generations who, themselves, may not have been directly exposed to BPA.17, 19 Given the putative adverse health effects of BPA exposure, the U.S. Environmental Protection Agency added BPA to its “Chemicals of Concern” list under the Toxic Substances Control Act in 2010.20 The U.S. Department of Health and Human Services website also posted “Information for Parents” on how to minimize their infant’s exposure to BPA.21 Humans are typically exposed to about 0.001 milligrams of BPA per kilogram of body weight per day.  This is 50 times lower than the ‘safe’ limit set by the EPA and the Food and Drug Administration.  Unfortunately, this level of exposure is still significantly higher than the low doses that have been shown to cause adverse health effects. The concern of exposure is highest when fetuses, infants, and children are considered because of the adverse effects of BPA on normal developmental processes early in life. It is clear that infants and children are burdened with the highest levels of BPA.  This is likely due to several factors.  First, the ability infants and children to metabolically detoxify contaminants such as BPA is not yet mature.  While BPA will ultimately be removed from the blood through a liver-mediated process, BPA stays in the system of infants and children longer than in adults.16 Second, when compared to adults, infants and children consume proportionately more food when their overall body size is taken into account and therefore bodily concentrations are higher.  The milk, formula, or food that is the main staple of an infant may be stored in containers (baby bottles, sippy cups) that are made with BPA.3, 22, 23 Infants and young children are also more likely to mouth plastic products, such as toys, that are not necessarily meant to be put in the mouth. BPA can also pass from the mother to the fetus.5 In addition, breast milk can transmit BPA to an infant.24 Given this, it is not only the child, but the pregnant or nursing mother, that need to be protected from BPA exposure.  Since the children cannot be responsible for making choices regarding BPA, clear information must be provided to parents (and potential parents) so that they can made the educated choices needed to protect themselves and their children. Fortunately, BPA is metabolized and cleared from the body so decreasing daily exposure to BPA can make a difference in overall body levels.25, 26 In Japan, industries voluntarily reduced BPA use in their products between 1998 and 2003 and studies showed a dramatic decline in body levels of BPA in the population.27, 28 Educating your patients about a few simple lifestyle changes can make a difference in their overall BPA exposure and potentially reduce their risk for adverse health effects. First, opting for fresh and frozen food rather than canned food is a big step. 22 While damage and age of food cans does not appear to greatly increase the amount of BPA leached into food, the initial packaging and sterilization techniques do release significant levels of BPA into canned food.22, 1 Second, minimizing the use of polycarbonate plastics food and beverage containers will also help.  Polycarbonate plastics are usually hard, clear, and shatter-resistant.  They may be labeled with recycle number 7, although not all number 7 products contain BPA. Third, learning about the proper care and use of containers can curtail exposure.  Heat and wear increases the leaching rate of BPA into the food or beverage stored in the container, so polycarbonate plastics should not be microwaved or put through the dishwasher and they should not be used if visibly scratched.29, 2 Parents and caregivers should also be provided information in protecting infants and children from unnecessary BPA contact.  Powdered infant formula is usually not stored in containers made from BPA, but some premade liquid infant formulas are packaged in BPA-containing bottles, and such formula has been shown to be tainted.24 In September 2011, a report from the Breast Cancer Fund revealed that many children’s canned food items contained BPA.30 Children are also more likely to mouth plastic products, such as toys or the hard plastic portion of a pacifier.  Caregivers should be mindful of products aimed at children that may contain BPA, such as sippy cups, tableware, and toys.3, 22, 26 Thankfully, manufacturers are increasingly labeling products as “BPA-free”.  The American Medical Association adopted a new policy in 2011 supporting continued industry efforts to produce BPA-free baby products as well as a total ban on the sale of such products. As of 2011, ten states have passed legislation limiting the use of BPA in products aimed at children.  Pennsylvania has similar legislation, spearheaded by Representative Lawrence Curry, that is currently in the House Health Committee.  In New Jersey, Senator Linda Greenstein introduced a related bill in 2010 that has been referred to the Senate Commerce Committee. While the current BPA legislation is an important step, the direct education of patients about BPA and the simple steps that can be taken to minimize their BPA exposure may lead to health improvements within the community.   ###
Rebecca Roberts, Ph. D., is an Associate Professor in the Department of Biology and Coordinator of the Biochemistry and Molecular Biology Program at Ursinus College in Collegeville, PA, where she studies the effect of hormonal regulation of the immune system, with a focus on the roles of estrogen and bisphenol A in Systemic Lupus Erythematosus. She has been active in educating the public about bisphenol A and recently presented expert testimony to the Pennsylvania House of Representatives Democratic Policy Committee regarding toxin-free toddler and baby products.
 
    Citations 1. Goodson, A., H. Robin, W. Summerfield, and I. Cooper, 2004. Migration of bisphenol A from can coatings – effects of damage, storage conditions and heating.  Food Addit Contam, v. 21(10), pp. 1015-26. 2. Brede, C., P. Fjeldal, I. Skjevrak, and H. Herikstad. 2003 Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushing. Food Addit Contam, v. 20(7), pp. 684-9. 3. Calafat AM, Ye X, Wong L-Y, Reidy JA, Needham LL, 2007. Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003–2004. Environ Health Perspect, v. 116(1): doi:10.1289/ehp.10753 4. Calafat A.M., J. Weuve, X. Ye, L.T. Jia, H. Hu, S. Ringer, K. Huttner, and R. Hauser, 2009.  Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants.  Environ Health Perspect, v. 117, pp. 639-644. 5. Schonfelder, G., W. Wittfoht, H. Hopp, C.E. Talsness, M. Paul, and I. Chahoud, 2002. Parent bisphenol A accumulation in the human maternal-fetal-placental unit. Environ Health Perspect, v. 110(11), pp. A703-7. 6. Takeuchi, T., O. Tsutsumi, Y. Ikezuki, Y. Takai, and Y. Taketani, 2004. Positive relationship between androgen and the endocrine disruptor, bisphenol A, in normal women and women with ovarian dysfunction. Endocr J., v. 51, pp. 165-169. 7. Sugiura-Ogasawara, M., Y. Ozaki, S. Sonta, T. Makino, and K. Suzumori, 2005. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod, v. 20, pp.2325-2329. 8. Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., Galloway, T.S. (2010). Association of urinary bisphenol a concentration with heart disease: evidence from NHANES 1003/06. PLoS One, v. 5(1), pp8673. 9. Singleton, D.W., Y. Feng, Y. Chen, S.J. Busch, A.V. Lee, A. Puga, and S.A. Khan, 2004.Bisphenol-A and estradiol exert novel gene regulation in human MCF-7 derived breast cancer cells. Mol Cell Endocrinol, v. 221(1-2), pp. 47-55. 10. Lee, C.K., S.H. Kim, D.H. Moon, J.H. Kim, B.C. Son, D.H. Kim, C.H. Lee, H.D. Kim, J.W. Kim, J.E. Kim, and C.U. Lee, 2005. Effects of bisphenol A on the placental function and reproduction in rats. J Prev Med Pub Health. v. 38(3), pp. 330-336. 11. Markey, C.M., P.R. Wadia, B.S. Rubin, C. Sonnenscheine, and A.M. Soto, 2005. Long Term Effects of Fetal Exposure to Low Doses of the Xenoestrogen Bisphenol-A in the Female Mouse Genital Tract. Biol Reprod, v. 72(6), pp. 1344-51. 12. Nikaido, Y., K. Yoshizawa, N. Danbara, M. Tsujita-Kyutoku, T. uri, N. Uehara, and A.Tsubura, 2004. Effects of maternal xenoestrogen exposure on development of the reproductive tract and mammary gland in female CD-1 mouse offspring. Reprod Toxicol, v. 18(6), pp. 803-811. 13. Rubin, B.S., J.R. Lenkowski, C.M. Schaeberle, L.N. Vandenberg, P.M. Ronsheim, and A.M. Soto, 2006. Evidence of altered brain sexual differentiation in mice exposed perinatally to low, environmentally relevant levels of bisphenol A. Endocrinology, v.147(8), pp. 3681-3691. 14. National Toxicology Program’s Report of the Endocrine Disruptors Low Dose Peer Review (2001). 15. U.S. Department of Health and Human Services, National Institutes of Health, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction.  NTP-CERHR monograph on the potential human reproductive and developmental effects of bisphenol A (NIH Publication No. 08-5994). 16. Vom Saal, F.S. et al., 2007. Chapel Hill bisphenol A expert panel consensus statement: Integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure.  Reproductive Toxicology, v. 24, pp. 131-138. 17. Kudakovic, M. and F.A. Champagne, 2011. Epigenetic perspective on the developmental effects of bisphenol A. Brain, Behavior, and Immunity. V. 25(6), pp. 1084-93. 18. Dolinoy, D.C., D. Huang, and R.L. Jirtle, 2007. Maternal nutrient supplementation counteracts bisphenol A-induced DNA hypomethylation in early development. PNAS, v. 104(32), pp. 13056-13061. 19. Walker, D.M. and A.C. Gore, 2011. Transgenerational neuroendocrine disruption of reproduction. Nat Rev Endocrinol. v. 7(4), pp197-207. 20. U.S. Environmental Protection Agency, 2010. Bisphenol A (BPA) action plan summary. 21. U.S. Department of Health and Human Services, 2010. Bisphenol A (BPA) information for parents. 22. Vandenberg, L.N., R. Hauser, M. Marcus, N. Olea, and W.V. Welshons, 2007. Human exposure to bisphenol A (BPA). Reproductive Toxicology, v. 24, pp. 139-177. 23. Kuo, H.W. and W.H. Ding, 2004. Trace determination of bisphenol A and phytoestrogens in infant formula powders by gas chromatography-mass spectrometery.  J. Chromatogr A, v. 1027, pp. 67-74. 24. Houlihan, J., 2007. Toxic plastics chemical in infant formula.  Environmental Working Group. 25. Carwile JL, Luu HT, Bassett LS, Driscoll DA, Yuan C, Chang JY, Ye X, Calafat AM, Michels KB, 2009. Polycarbonate bottle use and urinary bisphenol A concentrations. Environ Health Perspect, v. 117(9), pp. 1368-1372. 26. Vökel, Wl, Kiraoglu, M., Fromme, H., 2011. Determination of free and total bisphenol A in urine of infants. Environ Res, v. 111(1), pp.143-148. 27. Matsumoto A KN, Kitagawa K, Isse T, Oyama T, Foureman GL, Morita M, Kawamoto T. 2003. Bisphenol A levels in human urine. Environ Health Perspect 111(1): 101-4. 28. Research Center for Chemical Risk Management (2005). Bisphenol A Risk Assessment Document. AIST Risk Assessment Document Comprehensive Chemical Substance Assessment and Management Program. Japan. 29. Lyons, G.. 2000. Bisphenol A:  A Known Endocrine Disruptor. WWF European Toxics Programme: Godalming, Surrey. p. 37 30. Breast Cancer Fund (2011).  BPA in Kids’ Canned Food.  ]]> http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/feed/ 3 Retroactive Adverse Benefit Denials Under ERISA http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/ http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/#comments Tue, 06 Sep 2011 15:35:42 +0000 Physicians News http://www.physiciansnews.com/?p=4242 By Franklin J Rooks J. PT, MBA, Esq. Introduction The insurer’s denial of previously authorized benefits is one of the most frustrating experiences for a medical practice’s billing staff.  But, on the frustration scale, there is another insurance company practice that can push it over the top: retroactive benefit denials that occur after the insurance company has already made payment.  From the insurer’s perspective, a retroactive denial made after the provider has received payment results in an overpayment to the provider, which must be repaid.  To make matters worse, insurance carriers sometimes recoup their payments in ways that create billing system nightmares.  Instead of asking the provider to write a check to the insurer for “improperly” paid benefits, some insurers use “negative remittances.” Negative remittances are where an insurer takes back a benefit payment by offsetting other compensable claims.  Negative remittances are generally cumbersome for providers because they require several billing system adjustments involving more than one patient account.  Recoupment of prior payments is not unique to group health insurers.  Medicare also has a recoupment process for overpayments.[1] With Medicare, the provider receives demand letter, and recoupment cannot begin until 41 days after the provider’s receipt of that notice.  Similarly, for patients covered under an ERISA plan, notice and appeal rights are also required.[2] The insurer cannot just unilaterally recoup benefits by offsetting the benefits due on another patient’s account.    [Note: where applicable, the information provided below assumes that the practice has complied with all of the insurance carrier’s claims filing guidelines and denials are not administrative or technical denials of a claim.] ERISA The Employee Income Security Act, or ERISA, was enacted in 1974 to protect employees’ rights in their employer-sponsored benefit plans.[3] ERISA does not require employers to provide employee benefit plans.[4] Rather, it regulates them. For covered plans, ERISA sets forth substantive regulatory requirements, along with mechanisms to provide access to Federal courts, sanctions, and exclusive remedies.[5] ERISA protects employees’ benefits through uniformity.  These protections supersede and take precedence over any state laws which govern benefit plans.[6] Specifically, ERISA supersedes applicable state law in three areas:  (1) laws mandating employee benefit structures or their administration; (2) laws that regulate ERISA plans; and (3) laws providing alternate enforcement mechanisms other than those provided by ERISA.[7] ERISA allows plan beneficiaries to bring a civil action to “recover benefits due to him under the terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future benefits under the terms of the plan.”[8] If applicable to the insurance plan, the practice should examine ERISA’s protections when challenging an insurer’s recoupment of previously paid benefits. Denials: Adverse Benefit Determinations Under ERISA, benefit denials are termed “adverse benefit determinations.”  In ERISA parlance, this means “[a] denial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit, including any such denial, reduction, termination.”[9] An adverse benefit determination is also a “[f]ailure to provide or make payment that is based on a determination of a participant's or beneficiary's eligibility to participate in a plan. . .”[10] For group health plans, this also includes a “[d]enial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit resulting from the application of any utilization review. . .” [11] Adverse benefit determination also applies to the denial of any treatment because the plan considers it to be “[e]xperimental or investigational or not medically necessary or appropriate.”[12] All of the preceding trigger ERISA protections. There is a limited period in which the insurer can make an adverse benefit determination.  Generally, adverse benefit determinations must be made within 90 days of the health plan’s receipt of the claim, unless special circumstances exist which necessitate an extension of time.[13] Adverse benefit determinations for group health plans are to be made “within a reasonable period of time, but not later than 30 days after receipt of the claim.”[14] Prior to the expiration of this 30 day period, the insurer may extend its time to make an adverse benefit determination by up to 15 days.[15] The notification must provide the specific reason(s) for the adverse determination, referencing the specific plan provisions upon which the insurer’s determination is based.[16] The notice must provide the plan beneficiary with a description of any additional material or information necessary to satisfy the claim and an explanation of why such material or information is necessary.[17] The insurer must also furnish a description of the plan's review procedures and the applicable time limits. [18] The insurer must provide appeal rights.  The beneficiary is entitled to a “[r]easonable opportunity to appeal an adverse benefit determination . . . under which there will be a full and fair review of the claim and the adverse benefit determination.”[19] After the receipt of an adverse benefit determination notification, the claimant has at least 60 days to appeal the decision.[20] ERISA also requires the notification to include a statement of the claimant's right to bring a civil action under section 502(a) of the ERISA Act following an adverse benefit determination that is under review. [21] Recoupment: Compliance with ERISA Under ERISA, any determination that a claim should not be paid in full constitutes an adverse benefit determination.[22] A retroactive benefit denial is an insurer’s adverse determination that the patient’s benefits should not have been paid.  Retroactive adverse benefit determinations, without adhering to the notification and appeal processes, violate the protections afforded by ERISA.  Some insurers, however, contend that a repayment demand letter alone does not constitute an adverse benefit determination.[23] Where no funds are recovered or offset, some insurers may claim that overpayment letters alone do not trigger ERISA’s notice and appeal rights.[24] But, when recoupment efforts go beyond making a repayment demand and result in the offsetting of other compensable claims, the insurer must comply with ERISA protections requiring a “full and fair review.”[25] However, if the provider agreement clearly indicates that the provider is ineligible to deliver the service, and it was paid in error, ERISA may not be implicated.[26] State law may govern in this instance. “Mistaken authorization” is another basis under which an insurer might attempt to retroactively deny or recoup payments.  Provider agreements generally dictate the authorization procedures that the provider must follow in order to receive payment.  Medical providers rely on the benefit authorizations and pre-approvals they receive from the insurance carrier to reasonably determine that payment will be forthcoming.  Arguably, insurance plans have a duty to their participating providers to generate complete and accurate information via the provider’s verification of benefits.  The insurer’s retroactive assertion that authorization was “erroneous” places the provider in a precarious position.  If unsuccessful in the appeals process with the insurer, the provider could do nothing, and absorb the loss.  Or, the practice could pursue the patient.  Nothing in ERISA prohibits a provider from billing patients for services that are not covered under the benefit plan.[27] But, the provider’s contract may contain language prohibiting such recourse.   In the alternative, the provider could attempt to pursue the insurer under two potential courses of action – under ERISA or under state law.   ERISA also governs the provider’s allegations of an insurer’s improper processing of claims for plan benefits.[28] Adverse Benefit Determinations: The Right to Payment versus Rate of Payment ERISA distinguishes between “right to payment” issues and “rate of payment” issues.   “Right to payment” issues are created when an insurer fails to honor the patient’s benefit or when the insurer denies the patient’s claim.[29] Both of these situations constitute adverse benefit determinations.  A claim denial can be prospective or retrospective. The insurer’s prospective or retrospective denial of plan benefits triggers ERISA’s notification and appeal protections.  The “right to payment” is not a contract issue; it does not raise independent contractual duties outside of ERISA.  This falls squarely within the regulatory scheme of ERISA.[30] In contrast, “rate of payment” issues are contractual in nature.  The participating provider agreement creates a contractual duty that is independent of ERISA.  For a participating provider, fee schedule disputes do not necessarily involve ERISA.[31] An insurer’s recoupment of overpayments based on the contractual fee schedule is not a denial of benefits.  This type of payment dispute is a matter of contract law, where the underlying provider contract controls the payment provisions. ERISA’s notification and appeals processes are not controlling.  State law, and not ERISA, would most likely determine the outcome where the claims originate from this independent legal duty.[32] However, for providers who are not participating, underpayments or overpayments may implicate ERISA’s protections.  Between a non-participating provider and an insurance plan, there is no contract governing payment terms or fee schedules.  In the absence of a provider contract, the insurer does not have any independent contractual duties relative to the provider’s claims.[33] An out-of-network provider’s claims based on the underpayment of a claim likely raises a “right to payment” issue under ERISA.[34] In assessing which course of action to take, the provider must determine whether the insurer’s action has created a “right to payment” issue or one involving the “rate of payment.” Repayment Demands Based on Fraud Repayment demands based on fraud present a different issue entirely.  In the instance of fraud allegations, the insurer is generally attempting to recover the entire benefit paid to the provider.  An insurer’s repayment demand based on perceived fraud is a retroactive determination involving a dispute over “benefits due” when it involves specific claims.  ERISA provides the exclusive remedy only where the “claims are derived entirely from the particular rights and obligations established by the plan.”[35] That is, for ERISA to be applicable, a specific beneficiary with benefits arising under a benefit plan must be at issue.  The insurer may bring fraud allegations against the provider under state law where the claims are independent of any benefit belonging to a plan beneficiary. For example, an insurer may claim that the provider systematically renders services which defraud the insurer. (e.g., a general practice of billing for services not rendered).  In those instances, state fraud statutes may give rise to a duty independent of ERISA, which could allow state law, rather than ERISA, govern the dispute.[36] The resolution of fraud claims may depend on the provider’s conduct, rather than the terms and conditions of the beneficiary’s ERISA plan. [37] However, where recoupment of previously paid benefits appears to be an effort by the insurer to enforce the plan’s terms for specific beneficiaries, ERISA may govern an insurer’s efforts.[38] Facts and circumstances will dictate whether Federal or state law applies. Provider’s Options Medical providers are not beneficiaries of an ERISA plan.  An ERISA plan is independent of any participating provider agreement that may exist between the insurer and the medical provider.  Ordinarily, a person who is not a party to a contract would not have any rights under that contract.  With patients and medical providers, the patient’s assignment of benefits confers rights to the medical provider under the patient’s health care plan.  Under an assignment of benefits, the medical provider stands in the shoes of the patient, and may seek to enforce payment of the patient’s benefits.[39] Through a valid assignment, the provider may avail itself to the applicable ERISA protections on behalf of the patient.[40] The provider should insist on the insurer’s compliance with ERISA’s protections.  A paper trail should be maintained to document all of the provider’s efforts in resolving the disputed claim.  The provider should also document all of the insurer’s actions as well.  Failing resolution between the provider and the insurer, the provider could challenge the insurer’s retroactive denial of coverage under section 502 of ERISA.  A number of courts have held that ERISA governs a provider’s claims for benefits where the insurer’s representations have “the effect of orally modifying the express terms of an ERISA plan and increasing plan benefits for participants or beneficiaries who claim to have been misled.”[41] In plain language, this means that the insurer’s representations could create a benefit in situation where ordinarily no benefit existed.   Provider agreements define “covered services” for which the insurer will reimburse when performed by the provider.  With respect to the plan beneficiary, however, covered services are defined under the ERISA plan, not by the provider agreement. An insurer may claim that ERISA procedures are inapplicable by contending that the terms of the provider agreement control repayment and recoupment.  ERISA’s language appears to be contrary to that assertion.[42] To the extent that ERISA does not control, the provider could elect to pursue state law claims under a negligent misrepresentation theory if recoupment is based on the insurer’s erroneous or mistaken authorizations.  A number of courts have held that providers may maintain state law claims against an insurer based on erroneous verifications of coverage and erroneous information pertaining to the existence and extent of coverage.[43] A provider’s state law claim may be appropriate not because of the patient’s coverage, but because there is no ERISA coverage.  A key distinction that must be made is whether the insurer’s decision is actually an adverse benefit determination or an interpretation of the terms of the provider agreement.[44] Conclusion Providers should always attempt to clarify, understand and resolve claims issues by dealing directly with the insurance carrier.  ERISA protections are only available for plans that are, by statute, ERISA plans.  Otherwise, state law governs.  If the plan falls under ERISA, the medical provider may challenge the insurer’s adverse benefit determination and take advantage of all of the notification, denial substantiation requirements, and appeal rights.  The provider should attempt to understand the insurer’s reasoning behind its repayment demands to determine whether it constitutes an adverse benefit determination. The provider may have a cause of action for the insurer’ actions regarding an ERISA beneficiary that may be brought under a state law claim if certain facts and circumstances exist.   Providers should recognize the distinction between disputes arising out of the right to payment versus the rate of payment.  For participating providers, “rate of payment” issues may implicate state law because of the existence of a contract.  For non-participating providers, where no contract exists, the payment dispute may fall into the “right to payment” category and implicate ERISA.     About the author: Franklin J. Rooks Jr., PT, MBA, Esq. is a physical therapist and practicing attorney in Philadelphia, Pennsylvania.  Prior to his practice of law, Frank was a founding partner of PRO Physical Therapy, a Wilmington, Delaware based operator of physical therapy clinics.  This article is not legal advice.  ERISA is an expansive area of the law.  This article is intended to provide only very general, non-specific legal information.  This article does not cover all the issues related to the topic discussed.  The specific facts that apply to your situation determine the outcome.  This article does not create any attorney client relationship between you and the author.  Frank can be contacted at fjrooks@gmail.com  
[1] See The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 935; 42 U.S.C. § 1395ddd(f).
[2] Not all plans are covered under ERISA.
[3] H.R. Rep. 93-533, 93rd Cong., 2nd Sess. 1974.
[4] 70 C.J.S. Pensions § 19.
[5] See Aetna v. Davila, 542 U.S. 200, 208 (2004).
[6] 29 U.S.C. § 1144(a).
[7] Arizona State Carpenters Pension Trust Fund v. Citibank, 125 F.3d 715, 723 (9th 1997)
[8] 29 U.S.C. § 1132(a)(1)(B).
[9] 29 C.F.R. § 2560.503-1(m)(4)
[10] Id.
[11] Id.
[12] Id.
[13] 29 C.F.R. § 2560.503–1 (f)(1).
[14] 29 C.F.R. § 2560.503–1 (f)(2)(iii)(B).
[15] Id.
[16] 29 C.F.R. § 2560.503-1(g)(1)(i)(ii)
[17] 29 C.F.R. § 2560.503-1(g)(1)(iiI)
[18] 29 C.F.R. § 2560.503-1(g)(1)(iv)
[19] 29 C.F.R. § 2560.503-1(h)
[20] 29 C.F.R. § 2560.503–1 (h)(2)(i).
[21] 29 C.F.R. § 2560.503-1(h)
[22] 29 C.F.R. § 2560.503-1(m)(4).
[23] See Association of New Jersey Chiropractors v. Aetna, 2011 WL 2489954 at *8 (D.N.J.). “[T]he Court is not persuaded that dismissal of Plaintiffs' ERISA claims is warranted at this time. While Aetna has raised questions as to the viability of Plaintiffs' ERISA claims, the Court concludes that a more complete factual picture regarding Aetna's “recoupment”/anti-fraud efforts is necessary to ultimately resolve the issue.” Id. at *9.
[24] Id.
[25] 29 U.S.C. § 1133(2). “[E]very employee benefit plan shall afford a reasonable opportunity to any participant whose claim for benefits has been denied for a full and fair review by the appropriate named fiduciary of the decision denying the claim.”
[26] Cf. Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393, 402 (3rd Cir. 2004). Under a breach of provider agreement, a “[r]ight to recovery, if it exists, depends entirely on the operation of [provider agreements] executed by the Plan that are independent of the Plan itself.”
[27] Central States Southeast and Southwest Areas Health and Welfare Fund v. Pathology Laboratories of Arkansas, 71 F.3d 1251, 1253 (7th Cir. 1995)
[28] Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 48 (1987).
[29] 29 C.F.R. § 2560.503-1(m)(4)
[30] Id.
[31] See Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393 (3rd Cir. 2004), citing Blue Cross of California v. Anesthesia Care Associates Medical Group Inc., 187 F.3d 1045 (9th Cir. 1999), holding  “Providers' claims, which arise from the terms of their provider agreements and could not be asserted by their patient-assignors, are not claims for benefits under the terms of ERISA plans.”
[32] Id.
[33] See Sportscare of America P.C. v. Multiplan, 2011 WL 223724 (D. N.J.), discussing that out-of-network provider’s claims for underpayment fell under ERISA.
[34] Crossroads of Texas v. Great West Life and Annuity Insurance Co., 467 F.Supp.2d 705, 710 (S.D. Tex. 2006).
[35] Horizon Blue Cross Blue Shield v. East Brunswick Surgery Center, 623 F. Supp. 2d 568, 578 (D. N.J. 2009).
[36] Aetna Health Inc. v. Health Goals Chiropractic Center, 2011 WL 1343047 at * 6(D.N.J.)
[37] Id.
[38] Sereboff v. Mid Atlantic Medical Services Inc., 547 U.S. 356, 361 (2006).
[39] Horizon Blue Cross Blue Shield v. East Brunswick Surgery Center, 623 F. Supp. 2d 568, 575 (D. N.J. 2009).
[40] Pascack Valley Hospital, Inc. v. Local 464A UFCW Welfare Reimbursement Plan, 388 F.3d 393, 407 (3rd Cir. 2004). “Almost every circuit to have considered the question has held that a health care provider can assert a claim under § 502(a) where a beneficiary or participant has assigned to the provider that individual's rights to benefits under the plan”
[41] Memorial Hospital System v. Northbrook Life Insurance Co., 904 F.2d 236, 245 (5th Cir. 1990).
[42] See 29 U.S.C. § 1132(a)(3). “A civil action may be brought by a beneficiary to enjoin any act or practice which violates any provision of this subchapter or the terms of a plan.” [emphasis added]
[43] See Hospitals and Clinics v. Archstone Communities LLC, 2011 WL 1748432  at * 3 (N.D. Cal.) See  Blue Cross of Cal. v. Anesthesia Care Assoc. Med. Group, Inc., 187 F.3d 1045, 1047 (9th Cir.1999); The Meadows v. Employers Health Ins., 47 F.3d 1006, 1011 (9th Cir.1995).
[44] See Pennsylvania Chiropractic Ass’n v. Blue Cross Blue Shield Ass’n, 713 F. Supp. 2d 734 (N.D. Ill. 2010).
 ]]> http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/feed/ 0 How To Negotiate The Restrictive Covenant In Your Employment Contract http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/ http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/#comments Mon, 01 Aug 2011 15:20:28 +0000 Physicians News http://www.physiciansnews.com/?p=4202 By Martha Swartz, M.S.S., J.D.   With economic pressures on physicians mounting and regulatory incentives to affiliate with larger entities expanding, an increasing number of physicians are becoming employees of larger medical groups or health care systems. Restrictive covenants are becoming a mainstay of physician employment agreements. While the American Medical Association Council of Ethical and Judicial Affairs has found them to “disrupt continuity of care, and potentially deprive the public of medical services”, it has found them “unethical” only if they are “excessive in geographic scope or duration … or if they fail to make reasonable accommodation of patients’ choice of physician.” At least eight states have invalidated restrictive covenants, including three that have specifically enacted statutes banning them; however, courts in New Jersey and Pennsylvania have upheld them as recently as 2005. Restrictive covenants never benefit employees and in an ideal world, you would want to delete them entirely from your employment contract. However, in most cases, this cannot be achieved; therefore, if you are becoming an employee in Pennsylvania or New Jersey, you might benefit from some helpful pointers about how to negotiate restrictive covenants. What is a Restrictive Covenant? A restrictive covenant is a provision in an employment or purchase agreement that prohibits you from practicing medicine within a certain geographic area for a specified amount of time. Restrictive covenants are designed to protect the economic interest of your employer who is assumed to have spent time and money training you, introducing you to its patients and sharing confidential information to you. Pennsylvania and New Jersey Law. Both Pennsylvania and New Jersey recognize the validity of restrictive covenants under certain conditions. In Community Hospital Group, Inc. v. Jay More, M.D., 183 N.J. 36, 869 A.2d 884 (NJ 2005), Dr. More, a neurosurgeon, left his employment at Community Hospital Group and joined a neurosurgery practice within the geographic area and time restricted by the restrictive covenant in his employment contract. The New Jersey Supreme Court concluded that a physician’s employer had a protectable interest in "protecting the investment in the training of a physician" in addition to traditionally recognized interests in confidential business information and affirmed the contract’s 2 year time period restriction; however, it “bluelined” the agreement, that is, it modified the agreement, to reduce the 30 mile geographic restriction so that Dr. More would be permitted to cover the Somerset Hospital emergency room that relied on his coverage to be able to provide neurosurgery services to its patients, thus protecting what the court viewed as the public interest. The Pennsylvania Superior Court in Wellspan Health vs. Bayliss, 869 A. 2d 884(PA Super 2008) agreed that physician restrictive covenants are permissible and enjoined Dr. Bayliss, a perinatologist, from practicing in Adams and York counties where Wellspan drew many of its patients since it concluded that a patient referral base was a legitimate interest of Wellspan; however, it “bluelined” the restrictive covenant to permit Dr. Bayliss to practice in Lancaster County because Wellspan didn’t compete with him in Lancaster County for maternal-fetal patients; thus, Wellspan did not have a legitimate business interest in preventing Dr. Bayliss from practicing in Lancaster County. The bottom line is that, in Pennsylvania and New Jersey, restrictive covenants are likely to withstand judicial challenge if they protect a legitimate business interest of the employer, they don’t unduly harm the employed physician, they are “reasonable” in geographic scope and duration, and their enforcement won’t harm the public. However, many of the restrictive covenants proposed by employers arguably fail to satisfy these requirements and therein lies the negotiating opportunity. Legitimate Business Interest of Employer/Scope of Practice.  Most restrictive covenants include some variation of language that restricts the employed physician from “directly or indirectly, as an employee, employer, contractor, consultant, agent, principal, shareholder, corporate officer, director, or in any other individual or representative capacity, engage or participate in any business or practice” that competes with the employer.  Since protecting the employer’s legitimate business interest is at the core of the restrictive covenant, the first question to ask is what kind of business opportunities would “compete” with your employer? Not every form of medical practice or facility in which you might practice post-employment is likely to compete with your employer. For example, if, as an anesthesiologist you are employed by an anesthesiology group that limits its practice to hospital settings, you can argue that the group should not be able to prevent you from practicing at an outpatient pain clinic within the restricted area after you leave the practice. If you are a pulmonologist who is employed by a hospitalist group, the group arguably does not have a legitimate reason to prevent you from opening a general pulmonology practice within the restricted area. Thus, one approach is to list in the agreement the types of facilities that the employer considers to be a competitive threat. Another approach is to carve out certain types of facilities that don’t threaten your employer’s business. For example, if you are employed by a pediatric practice that provides outpatient care primarily, you should be able to practice as a facility-based pediatrician. If you are employed by an internal medicine group that provides outpatient and hospital inpatient services only, you should be able to become the medical director of a nursing home in the restricted area. You might also identify in the agreement specific institutions at which you would be permitted to work. Another approach is to propose, as the perinatologist defendant successfully argued in Wellspan, that your employer’s legitimate business interest does not extend to geographic areas from which it draws no patients. This might mean limiting the mileage restriction, the applicable counties, or some other geographic delineation in the restrictive covenant. Geographic scope. Restrictive covenants address geographic limitations in many ways: they might set a mileage radius from: 1) a group’s primary office; 2) each of the group’s offices; 3) each of the group’s offices currently existing or developed in the future; or 4) each of the hospitals or other facilities at which any member of the group practices. Or, rather than a mileage restriction, the restriction might be defined by counties. The first step is to map out the circumference of the restriction and note the medical facilities that are located within the proposed restricted area. Are there certain facilities or practices that you think you might want to join if this particular employment arrangement doesn’t work out? Note where these facilities or practices are located in relation to the proposed restricted area. For example, an employer might impose a 10 mile restriction from its primary office at 100 Montgomery Ave. in Ardmore, PA. If the facilities at which you might want to work post-employment are located 8 miles from the employer’s primary office, try to reduce the geographic scope to 7 miles. Once the restrictive covenant is measured from more than one central point, for example, from all of the practice’s offices, the geographic restriction is increased exponentially. Thus, you should try to limit the restriction either to the practice’s principal office or to those offices or hospitals in which you primarily practiced as an employee within the last 12 months of your employment. Be especially careful about agreeing to be restricted from practicing within a certain number of miles from the employer’s future offices since introduces a degree of uncertainty that makes it difficult for you to evaluate the impact of the restriction. What might be considered a “reasonable” geographic restriction in a rural area may not be considered “reasonable” in an urban area. Thus, while a Pennsylvania court upheld a 50 mile restriction in rural Pennsylvania in Geisinger Clinic v. DiCuccio, 414 Pa. Super. 85, 606 A.2d 509, 518 (1992), it is unlikely that such an expansive restricted area would be considered reasonable in an urban setting. Time. Most physician contracts restrict physicians from competing during the term of their employment and for one to two years thereafter; under most circumstances, this restriction would probably withstand a court challenge. However, if you have a one year contract, it might not be reasonable for the employer to impose a restrictive covenant that is longer than your initial agreement. Also, if you leave the practice within a short period of time, that is, before you’ve received the benefit of being trained by the employer, the restrictive covenant should not apply at all. You can argue for “tiered” applicability, that is, if you leave during the first year (especially if you are new to the area or just finishing your residency so that your ability to develop a significant practice within the first year is limited), no restrictive covenant should apply. If you leave during the second year, a one year restriction should apply; the two year restriction should apply only if you have been employed for at least 2 years by the employer imposing the restriction. Triggers. One point that many physicians fail to consider in negotiating restrictive covenants is the circumstances under which the restrictive covenant is triggered.  It is arguably fair for the restrictive covenant to apply if: 1) the employed physician leaves without cause (thus arguably “leaving the employer in the lurch”); or 2) the employer terminates the physician with cause (other than alleged physician incompetence) since the physician may have been able to prevent her termination. However, if the employed physician leaves due to the employer’s breach of the agreement, the restrictive covenant should not apply. (This means that you also have to pay attention to the contract’s termination provisions since many physician agreements fail to include a provision permitting the physician to terminate for cause, a necessary prerequisite to invoking this trigger.) Similarly, if the employer terminates the physician for no reason, e.g. the employer overestimated its patient volume, the physician should not be penalized by being subject to a restrictive covenant.  Finally, if the employer terminates the physician because the employer alleges that the physician was incompetent, no restrictive covenant should apply because an “incompetent” physician presumably cannot be a competitive threat to the employer. In addition, restrictive covenant should not apply if the employer ceases to provide the type of specialized services that the physician provides. For example, if a hospital discontinues its obstetrics services, the employed obstetrician-gynecologist should be able to practice obstetrics anywhere without being subject to a restrictive covenant. Public Interest. In contrast to the American Medical Association, the American Bar Association has a longstanding rule prohibiting restrictive covenants in lawyers’ contracts, concluding that they inappropriately intrude upon the lawyer-client relationship and restrict the public's right to choose an attorney. Several commentators have argued that the public’s right to choose a physician is at least as important as the public’s right to choose an attorney. However, while judges see themselves as appropriate arbiters of lawyers’ rights, they have usually deferred to the AMA’s judgment about what is ethical for physicians. Nevertheless, in deciding whether a restrictive covenant is enforceable, courts invariably consider whether enforcement of the restrictive covenant is likely to injure the public. The More court specifically reduced the mileage restriction in Dr. More’s restrictive covenant precisely because his skills as a neurosurgeon were needed to provide coverage in a particular hospital’s emergency room. In an earlier Pennsylvania case, New Castle Orthopedic Assoc. v. Burns, 481 Pa. 460, 469, 392 A.2d 1383, 1387 (1978), the Pennsylvania Supreme Court reversed the grant of a preliminary injunction that would have prevented an orthopedic surgeon from practicing within a certain geographic area because it concluded that there was a shortage of orthopedic specialists in the geographic area; the orthopedic surgeon was permitted to practice in the restricted area to avoid harm to the public.  Considering the great weight often given to potential public harm by courts, you might be able to negotiate the complete elimination of a restrictive covenant if you are practicing in a rural area with a shortage of physicians in your specialty. Restrictive Covenants and Recruitment Agreements. If your compensation in your employment agreement with a medical practice is subsidized under a recruitment agreement with a local hospital, the restrictive covenant must comply with the Stark law. Under an older version of the Stark Law, a medical practice could not include a restrictive covenant in its employment agreement with a physician whose compensation was subsidized by a local hospital. However, after 2007, this requirement was modified, so that restrictions are now permitted provided that they do not unreasonably restrict the physician’s ability to practice in the geographic area served by the hospital. Failure to comply with state law would be considered evidence that the restrictive covenant is not “reasonable.” Liquidated Damages. An increasingly number of restrictive covenants include liquidated damages clauses. These clauses permit the physician to “buy her way out of the restrictive covenant.” The amount required to be paid should relate to the costs incurred by the employer in terms of patients lost due to the physician’s departure and recruitment and training of a replacement physician. One possible way of calculating these damages is to relate them to the physician’s annual compensation while she was an employee. Consideration.  Restrictive covenants are valid only if they are part of another agreement, e.g. a purchase agreement or an employment agreement, because they must be accompanied by adequate consideration, i.e. payment. Generally, the salary offered by the employer in the initial employment agreement is considered adequate consideration. However, if an employer subsequently tries to add a restrictive covenant to an employment agreement, it will not be upheld unless the employer provides additional payment to the employee. Dispute Resolution. Litigation is expensive and time-consuming. It is generally in all of the parties’ interests to expedite the resolution of disputes involving restrictive covenants. The American Health Lawyer Association has dispute resolution services that include both mediation and arbitration. Starting with mediation in these types of disputes often means a faster and more equitable resolution. ### The Law Office of Martha Swartz (www.swartzhealthlaw.com) concentrates on the regulatory and business aspects on health care.    ]]> http://www.physiciansnews.com/2011/08/01/how-to-negotiate-the-restrictive-covenant-in-your-employment-contract/feed/ 0 Preferred Provider Contracting: Beware Of Rental Networks And Third Party Guarantors http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/ http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/#comments Thu, 14 Jul 2011 11:54:28 +0000 Physicians News http://www.physiciansnews.com/?p=4179 By Martha Swartz, M.S.S., J.D. What is a PPO? As a health care institution or individual provider, it is difficult to provide services in Pennsylvania and New Jersey without participating in at least one preferred provider network (PPO).  PPOs are a form of managed care in which: an intermediary (PPO) forms a network of health care providers and connects the health care providers to third party payers such as insurance companies, employers, and third party administrators (Payers). The providers offer their services to the PPO at a discounted rate because they expect Payers to steer patients to them as a result and thus, to increase their patient volume. The health care providers that are on the PPO’s panel of providers are “in-network” and, because of the negotiated discounts, patients who go to them for services pay less than they pay for similar services offered by health care providers who are not on the PPO panel, or are “out of network”. A PPO can be a “win-win” for patients and health care providers in that individual patients who seek services from in-network providers save money and in-network providers potentially receive increased revenues as the result of increased patient volume which results from the PPO’s marketing of their services as being “in-network” and thus less expensive. What is a Rental Network? The above arrangement falls apart if the PPO fails to market the health care provider’s services as “in network” or if the PPO makes the discounts available to Payers that are not part of the health care provider’s marketing plan, that is, if the PPO “rents out” the provider’s discount without the provider’s knowledge or consent.  When this happens, health care providers find themselves providing services to individuals for which they expect to receive a certain reimbursement amount, only to find out at time of payment that the individual’s Payer has accessed a discount to which it is not entitled. The PPO may even have made your discount available or “rented out” your discounts to Payers with which you already have a negotiated an agreement at a higher rate. Providers thereby end up with the “short end” of the bargain, that is, they give discounts, but don’t receive a higher volume of patients in return. Back in 2005, a number of commentators began to warn physicians of “silent PPOs”, that is, arrangements in which a PPO with which a physician contracts to be on a PPO panel makes the discounts the physician negotiated with that PPO available to other Payers, without the Physician’s consent. However, many times a physician unwittingly agrees to make her negotiated discounts available to other Payers in a PPO’s “rental network” because the physician fails to read the fine print in the contract proposed by the PPO. Are Rental Networks “legal”? In 2008, to avoid the regulation and possible banning of “silent PPO”s, the American Medical Association and the American Association of Preferred Provider Organizations lobbied the National Conference of Insurance Legislators (NCOIL) to adopt a Model Act to Regulate the Secondary Market in Physician Discounts. Under the model law, an intermediary contracting with a physician who wishes to make the terms of its contract available to other Payers must state in its contract with the physician that the intermediary contracting entity:
  • is permitted to enter into an agreement with a Payer allowing the Payer to access the physician’s discounted rates;
  • will contractually obligate the Payer renting access to a provider network to abide by the terms of the original contract between the intermediary and the physician; .
  • will provide the Payer with the relevant terms of the original contract with the physician with which the Payer is obligated to comply;
  • will provide the physician with a continually updated list of entities that have access to the physician’s discounts, including all additions and deletions;
  • will obligate all Payers to note on their Explanation of Benefit forms the source of their contractual discounts.
A number of state legislatures have adopted forms of the NCOIL Model Act, including Connecticut, Colorado, Florida, Indiana and Ohio. Other states including Arkansas, California, Kentucky, Louisiana, Maryland, Minnesota, North Carolina, Oklahoma, South Carolina, Texas and Virginia, have enacted laws that limit or prohibit silent PPOs. So far, there is no similar legislation in either Pennsylvania or New Jersey. In addition to legislature-passed laws, several state and federal courts have issued decisions rejecting a Payer’s right to make discounted payments to a health care provider when the discount was “sold” to the Payer without the health care provider’s knowledge. Although none of these cases arose in either New Jersey or Pennsylvania, they provide insights as to how a local court might view this issue. In at least two of the cases, HCA Health Services of Georgia v. Employers Health Insurance Company, 240 F. 3d 982 (11th Cir 2001) and Mitzan v. Medview Services, Inc., 1999 WL 33105613 (Mass. Super, June 16, 1999), the courts based their analyses on whether the insurer that had accessed the provider’s discounts had been in the position to steer patients to the provider, thus providing the physicians with the “benefits of their bargain”. What can physicians do to gain the benefits but avoid the risks caused by rental networks? Review your PPO agreements carefully, preferably with the assistance of an attorney, to ascertain if the PPO intends to “rent” your negotiated discounts to Payers. If it is determined that the agreement does permit the “renting” of your discounts, make sure that your agreement with the PPO:
  • makes it clear that the discount you’re offering the PPO is in exchange for the PPO requiring the Payers with which it contracts to steer patients to you as an “in network” participating provider
  • obligates the PPO to require all Payers to identify you in all of their written material as an “in network” provider
  • makes it clear that the payment terms that you agree to in the PPO agreement are confidential and may not be disclosed without your express written consent, except to a list of Payers that you have approved
  • obligates the PPO to provide you with a list of all Payers, updated throughout the term of the contract
  • obligates the PPO to refrain from contracting with any entities with which you have an existing agreement that provides higher payment rates
  • requires the PPO to contractually obligate all of its Payers to comply with the terms of the PPO’s agreement with you, including payment procedures, UR procedures, underpayment recoupment, etc.
  • obligates Payers to note on their EOBs the source of their discounts
  • clarifies which UR procedures applies to your contract, i.e. those of the intermediary or those of the Payer
  • obligates the PPO to conduct financial due diligence regarding the Payers to which it makes your discounts available to you to reduce the chances that a Payer will fail to make timely and accurate payments
  • obligates the PPO to advocate on your behalf if a Payer fails to make timely and accurate payments
  • requires Payers to pay your full charges if they fail to pay you within the agreed upon time limit
  • permits you to discontinue discounts to, and to terminate your relationship with, any Payer or any Payer’s product if the Payer fails to make timely and accurate payments
Third party Guarantors of Copayments. Another type of arrangement that recently has been introduced locally can also be a “win-win” for patients and health care providers. At least one local PPO is now offering a program in which a patient’s copayment is paid by the Payer, thus relieving the provider of the expense and inconvenience of collecting the copayment from the patient itself.  Because their costs will be reduced, some providers may be willing to accept lower reimbursement rates as a result of this arrangement.  Since physicians don’t refer patients to insurers, the promise of such a potential benefit to physicians doesn’t implicate state or federal anti-kickback statutes. However, practical problems can arise if it is unclear to the provider or the patient that an entity other than the provider will be seeking the copayment from the patient.  Thus, the provider’s agreement with the PPO should require the PPO to obligate its Payers to: 1) inform the patients in writing to expect a bill for the copayment from the Payer; and 2) specify on the patient’s ID card the Payer that is responsible for paying the patient’s copayment, so that the provider is aware that it is not responsible for collecting the patient’s copayment. Also, since the provider has no direct contract with the Payer that is paying the patient’s copayment, the provider must rely on the PPO to obligate the Payer contractually to pay the patient’s copayment to the provider in a timely fashion. Furthermore, the PPO’s agreement with the provider should confirm that the provider is no longer obligated to collect these copayments. Negotiating your PPO Agreement. Many physicians fail to read their PPO (and other types of third party payer) contracts carefully because they assume they have no ability to negotiate with large insurance companies and other payers. Remember, however, if a Payer needs the type of specialty or subspecialty services that you provide in the geographic area in which you provide services, you may have more leverage than you think. ### The Law Office of Martha Swartz (www.swartzhealthlaw.com) concentrates on the regulatory and business aspects on health care.  ]]> http://www.physiciansnews.com/2011/07/14/preferred-provider-contracting-beware-of-rental-networks-and-third-party-guarantors/feed/ 1 Urgent Care Centers, a Merging Trend in Health Care http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/ http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/#comments Fri, 17 Jun 2011 14:08:24 +0000 Physicians News http://www.physiciansnews.com/?p=4134 By Lucia F. Bruno, J.D., LL.M., M.B.A. Urgent care medicine has emerged as one of the fastest growing specialties in the United States.  Many family practitioners view this new form of health care as a convenient compromise to the traditional practice of medicine; absent the time and travel between offices, nursing homes and hospitals.  Likewise, emergency room physicians perceive urgent care medicine as a viable way to use their triage skills without the stress associated with a hospital setting. With approximately 8,700 urgent care centers (UCCs) nationwide and an increased percentage throughout Pennsylvania and New Jersey, many physicians question the financial incentives and legal complexities unique to this practice of medicine.  This article will address some of these growing concerns. Ownership Structure:  Choose Your Destiny Wisely Innovation is the principle source of differentiation and competitive advantage; innovative structuring of a UCC is no exception.  Amongst the plethora of buyouts, mergers, acquisitions, and joint ventures, investors need to weigh structuring options and management models carefully, as future profitability swings in the balance.    Currently, only a select number of states require physician ownership of UCCs: Texas; California; Ohio; Colorado; Iowa; Illinois; New York; and New Jersey.  The 2010 survey released by the Urgent Care Association of America (UCAA) indicates that physician or group physician ownership accounts for approximately 50% of structuring, with the remaining as follows:  Hospitals 27.9%; Corporations 13.5%; Non-physician individuals 7.7%; and Franchises 1.0%.[1] So what makes one ownership structure more profitable than another? Hospital-based UCCs are part of an existing operation; therefore, the hospital’s tax identification number is also used by the UCC which can lead to billing complications amongst other regulatory issues.[2] In contrast, freestanding UCCs are independently incorporated, maintain their own tax identification and management structure, and can bill accordingly. Although a myriad of other factors influence profitability including: overhead expenditures; reimbursement rates; and the accurate use of CTP codes; the answer to profitability lies in the fundamental accounting principal of net income, also known as net profit, (Total Revenue - Total Expenses = Net Income). This is the amount of money left in your pocket after all expenses have been paid. When deciding which ownership structure to select, investors must balance the initiative of the UCC with the financial goals and objectives of its investors.  Regardless of structure, increasing patient volume and holding operating expenses below the level of collections will increase profitability.[3] Historically, hospital-based UCCs have failed to keep operating expenses down; as a result they struggle to break even and in the worst case scenario suffer financial loss and eventually close.[4] Licensing:  The EMTALA Distinction Licensing isn’t just a mere technicality; it is a precursor of how you’ll do business.  Currently, only one state, Arizona, has an Urgent Care License requirement.  Other states such as Illinois, Delaware, and New Hampshire have placed restrictions on how UCCs can be identified and marketed to the public. In determining how to license a health care facility many jurisdictions examine ownership interest, business structure, size of the facility, and the nature of the care provided.  Since UCC practitioners specialize in the treatment of disease, illness and/or injury on an episodic basis and don’t provide obstetric services, in-hospital admissions, long term management of chronic diseases or other conditions requiring continuity of care, practitioners need only maintain state licensure necessary to practice medicine, in addition to a license to operate the lab or other diagnostic imaging equipment, where applicable. Unlike physician-owned UCCs, hospitals may offer urgent care as an extension of the emergency department, as a fully controlled ancillary service, as an equity joint venture, or as a landlord/tenant.   Many hospital-based UCCs, or those situated on the hospital campus (or within 250 feet), are considered Type B Emergency Departments subject to specific licensing requirements, as well as EMTALA (Emergency Medical Treatment and Labor Act) statutes and JCAHO (Joint Commission on Accreditation of Healthcare Organizations) guidelines. The Centers for Medicare and Medicaid Services (CMS) defines a “Dedicated Emergency Department” as any department or facility of the hospital, regardless of whether it is located on or off the main hospital campus, that meets at least one of the following requirements: (1)  It is licensed by the state where it is located, under applicable state law, as an emergency room or emergency department; (2)  It is held out to the public (by name, posted signs, advertising or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; or (3) During the calendar year immediately preceding the calendar in which a determination is made (based on a representative sample of patient visits that occurred during that calendar year)  it provides at least one third (1/3) of all of its outpatient visits for the treatment of emergency medical conditions on an urgent basis, without requiring an appointment.[5] It is important to keep in mind that there are three distinct parts to the third criterion set forth by CMS. In order to be categorized as a “Dedicated Emergency Department” a UCC must meet all three parts, not just one or two.  Therefore, investors must ask themselves the following: (1) are over 1/3 of the patient visits on an urgent basis; (2) without an appointment; and (3) for the treatment of an emergency medical condition?  Many will answer "yes" to the first two components, but almost all will answer “no” to the last component given the nature of care provided.  Based on the last response, those UCCs are not “Dedicated Emergency Departments” for licensing or EMTALA purposes.[6] Regulations:  What You Don’t Know Could Hurt You Irrespective of the applicability of EMTALA or JCAHO, there are a whole host of other federal regulations that govern the day-to-day activities of urgent care medicine.  Although ownership interest frequently dictates the regulations for which investors must comply, such as STARK and anti-kickback laws, others apply across the board. All UCCs must comply with the privacy measures of the Health Insurance Portability and Accountability Act (HIPAA) and the security mandates of the Health Information Technology for Economic and Clinical Health Act (HITECH).  UCCs that operate a laboratory for blood tests or other related diagnoses must also adhere to Clinical Laboratory Improvement Amendment (CLIA) guidelines, in addition to Drug Enforcement Agency (DEA) mandates for the storage and dispensation of narcotics.  Finally, if the UCC provides services to Medicare or Medicaid patients, it must comply with the conditions of participation and reimbursement.   Knowing the rules of the game ahead of time can mean the difference between victory and defeat. Coding:  Not Just a Numbers Game One of the best ways to increase revenue in a UCC is to optimize billing and coding.  When negotiating a contract with a managed care organization it is incumbent upon UCC owners to make certain that reimbursement amounts and payment codes are specified in the contract. CMS has designated two HCPCS (Healthcare Common Procedure Coding System) codes for UCC use: S9083 - for global fees, irrespective of the treatment provided; and S9088, an “add on code,” for reimbursement of expenses unique to the practice of urgent care medicine, such as increased overhead and wage costs. Although these codes were never intended for submission to, or reimbursement by, Medicare or Medicaid many managed care organizations, such as United Health Care, now refuse to reimburse freestanding UCCs for anything other than professional procedure codes.[7] For those unfortunate enough to be caught up in the denial process, attempting to negotiate a reasonable compromise or a slight increase in fee schedule may be their only alternative. Marketing to Increase Revenue:  The “Me First” Mentality In today’s competitive economy traditional healthcare marketing strategies no longer work.   As more consumers gravitate towards urgent care medicine as a less costly, more convenient, option to traditional healthcare investors need to stay one step ahead of the competition in order to finish ahead of the pack. Since urgent care medicine is premised on consumer choice, a successful marketing plan will focus on customer service and convenience as a top priority.   A clear vision of your goals and objectives will give you more than just direction; it will give you a marketing framework that you can build your UCC around.  A few simple strategies to effectively market your UCC are as follows:
  1. Identify your niche market:  UCCs would do well to aggressively promote services to consumers with young children by marketing themselves as conveniently located and offering extended service hours.  Other targeted audiences include local employers and HR directors interested in pre-employment physicals, drug screening and immunization programs.
  2. Set up a website:  Yellow book advertising simply doesn’t fit the mind of today’s consumer. Today, consumers search online before they do anything else; therefore, it is crucial to develop a website and list your site with several directories and search engines.  If you do not list your website, it will become an orphan site that is not known and rarely visited by revenue- generating consumers.
  3. Signage: One of the most important marketing elements is a large, well-lit, sign prominently displayed in high traffic areas.  Since zoning restrictions regulate outdoor advertising, it is important to check with your local municipality regarding restrictions before you purchase a property or sign a lease for your UCC.
  4. Free Press: The local media is an invaluable asset in marketing your UCC.  Get to know local reporters, and let them know that you are available to do interviews for TV or newspaper stories on relevant healthcare topics.  Unlike other forms of media, this is completely free and has the greatest potential to reach a mass audience.[8]
As UCCs continue to expand across the country, the fields are ripe for investors to harvest the infinite possibilities posed by this merging trend in health care. ### Lucia Francesca Bruno, JD, LLM, MBA, is Principal Shareholder of Physicians' Legal Group, LLC (www.physicianslegalgroup.com).  She can be reached at(215) 688-3909.  
[1] Urgent Care Benchmarking & Statistics, http://www.ucaoa.org/resources_stats.php (Aug. 2010)
[2] Tony Barber, Pros & Cons to Freestanding vs. Provider-Based Models, (Mar. 2011)
[3] Brent Cosens, Financial Lesson in Urgent Care and Occupational Medicine, (Jan. 2009)
[4] Robin M. Weinick, Phd., Renee M. Bentancourt, BA, No Appointment Needed, The Resurgence of Urgent Care Centers in the United States, (Sept. 2007)
[5] 42 CFR Parts 413, 482, and 489 [CMS-1063-F] RIN 0938-AM34, https://www.cms.gov/EMTALA/Downloads/CMS-1063-F.pdf
[6] http://www.practicevelocity.com/urgent_care/coding/type_b_ed.php
[7] Urgent Care Policy-New, UHC Network Bulletin, Vol. 29, Jan.2009, pg.3
[8] http://www.practicevelocity.com/resources/marketing.php
 ]]> http://www.physiciansnews.com/2011/06/17/urgent-care-centers-a-merging-trend-in-health-care/feed/ 0 Preparing for ICD-10: Performing a Baseline MR Documentation Assessment http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/ http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/#comments Wed, 08 Jun 2011 14:46:18 +0000 Physicians News http://www.physiciansnews.com/?p=4112 By Michael G. Calahan, PA, MBA No longer just a rumor, the switch-over from ICD-9-CM to ICD-10-CM is now a sure deal and the established start date remains October 1, 2013.  Providers must be an active part of the conversion process, as many of the issues to be tackled are provider-driven.  Take, for example, medical record (MR) documentation.  MR documentation represents the beginning, middle and end of the current ICD-9-CM life cycle; it is foundational to the entire process of diagnosis coding and nothing materialized to date promises to change with ICD-10.  Provider documentation will initiate the assignment of codes, will drive the assessment of medical necessity for payment of services, and will serve to validate those services upon review by oversight entities.  With recovery funds now actively worked into the front-end of the government’s budget versus being considered “found” money, the advent of ICD-10 will not slow down or alter the federal government’s plans to audit providers. To prepare for ICD-10, performing a baseline MR documentation assessment can get the physician practices off to a good start.  This assessment will help expose areas where the providers need to strengthen their MR documentation.  Additional benefits can be realized, too.  One such benefit is the isolation of “missed opportunities” for diagnosis (ICD-9-CM) and service (CPT) coding.  These are diagnoses and services that should have been “captured” but were missed.  Likewise, services reported but under-documented enough so that the billing of them could be questioned by an outside reviewer such as an OIG, RAC or CERT auditor may be found.  The focus, however, will be on the documentation of diagnostic statements supporting the final-assigned ICD-9-CM codes, and how that documentation will likewise support the impending ICD-10-CM codes.  Case selection, i.e., determining which dates-of-service to review, should be accomplished by analyzing frequency reports generated by the billing system to assess the practice’s top 25 to 50 ICD-9-CM codes. In preparing source documents for the MR documentation review, remember the final-reported ICD-9-CM codes for each case selected may need to be compared with information contained on the practice superbills.  This form is the source document and data facilitator for billing information, which in turn gets translated to the CMS-1500 claim forms submitted to payers.  However, errors in the translation of data from the MR to the superbill are not rare.  And, even though this is a documentation review for comparing ICD-9 to ICD-10, the claim forms for each date-of-service should also be on hand.  The CMS-1500s are important source documents for comparing what was reported to the payers versus what the MR documentation holds as the actual case data. At a minimum then, the following source documents are needed to carry out a full MR documentation assessment:
  • Original MR documentation (e.g., office visit note)
  • Ancillary documents such as provider orders, operative reports, pathology reports, radiology reports, etc., if germane to the office visit
  • Practice superbils or encounter forms (i.e., the “charge tickets”)
  • CMS-1500 claim form copies.
  [caption id="attachment_4113" align="alignleft" width="207" caption="."][/caption] To perform a comparison-and-contrast of ICD-9-CM to ICD-10-CM codes, an ICD-10 tool will be needed.  This can be a pre-2013 ICD-10-CM book, an encoder with ICD-10 mapping, or the public CMS files that include listings of the ICD-10-CM/PCS codes as well as “GEM” files (general equivalency mapping spreadsheets), tying ICD-9 and ICD-10 together. Now select a patient date-of-service and prepare the array of MR documentation, the superbill and a copy of the CMS-1500 claim form.  Scan the progress (office visit) note for the recorded diagnostic data.  Most of the reportable ICD-9-CM codes listed on the CMS-1500 claim form and encircled on the superbill arise out of the diagnostic statement(s) noted under the “Assessment” section (if providers follow the SOAP note format), or alternatively the “Impressions” or “Diagnoses” sections. Also scan the History section of the office visit note.  Within the History component of the typical patient office encounter, there are four distinct elements required to be documented for most evaluation and management (E/M) services:  chief complaint (CC), review of systems (ROS), past, family and social history (PFSH) and history of present illness (HPI).  Commonly, a chronic but current/ongoing diagnosis impacting current care will be listed within the elements of the History, and not carried down or re-listed in the diagnostic area found under the Assessment section.  This “bad habit” should be avoided if possible, since it often confuses coders as well as outside medical reviewers. At this juncture let’s look at a case study to demonstrate the comparison process.  For illustration purposes we will use a patient with diabetes mellitus, type-II (DM-II), coded to ICD-9-CM code 250.00; no other ICD-9-CM codes were assigned or are listed on the CMS-1500 claim form for this particular office visit.  In this scenario, the patient’s CC is “Here for F/U of DM” and in fact, the “Impression” line states “DM-II, doing well on current regimen.”  However, the patient also has essential hypertension and is undergoing active treatment for this condition as evidenced by a note under the “Plan” section:  “Increase HCTZ to 50mg (25 mg b.i.d.).”  A quick glance under the History reveals the physician documented a correlating diagnosis in the ROS as “CV – HTN on HCTZ 25 mg q.d.”  Further, under “vitals” in the constitutional section of the progress note the annotation “Bp – 130/100 sitting x 2” is found.  Your conclusion in reviewing these notes is that the HTN did, in fact, impact the current care and therefore two diagnoses for this office visit should have been coded: DM and HTN. In relation to the DM-II, a finger stick test (glucometery) was normal.  There was no change in the condition, and therefore the DM-II remains coded to ICD-9-CM code “250.00 Diabetes mellitus without mention of complication, type II or unspecified type, not stated as uncontrolled.”  Under ICD-9-CM coding, the main methodology of coding diabetes mellitus is to (a) ascertain the “type” (i.e., type I juvenile DM or type II adult-onset DM) and then (b) code it according to status of control, as in “not stated as uncontrolled” (250.00) or “uncontrolled” (250.02).  This methodology is anticipated to hold true under ICD-10-CM as well, but the descriptor changes somewhat.  ICD-9-CM code 250.00 maps to ICD-10-CM code “E11.9 Type 2 diabetes mellitus without complications,” or to ICD-10-CM code “E13.9 Other specified diabetes mellitus without complications.”  DM-II now stated as “uncontrolled” under ICD-9-CM code 250.02 maps to ICD-10-CM code “E11.65 Type 2 diabetes mellitus with hyperglycemia.”  The analysis:  diabetes mellitus – depending on type, status and how specific the provider has been in his/her documentation – can be coded in several ways under ICD-10-CM.  The term “hyperglycemia” appears to be key in this classification when the DM is not under control.  As with ICD-9-CM coding now, the more specific the MR documentation the more accurate the coding; this holds true in ICD-10-CM coding. For the HTN uncovered as not being reported but was documented and impacted current care, the ICD-9-CM code in this case is 401.9.  There is no annotation or indication of concurrent hypertensive heart disease or chronic kidney disease, or any combination thereof.  Under the current ICD-9-CM coding structure, because the descriptors “benign” (ICD-9-CM code 401.1) or “malignant” (ICD-9-CM code 401.0) were not recorded in the MR documentation with the acronym “HTN,” the official coding instructions state the unspecified ICD-9-CM code 401.9 must be reported for “essential hypertension.”  Now compare this code with the anticipated requirements and information under ICD-10-CM.  The descriptors “benign” and malignant” no longer apply in ICD-10-CM coding.  The full description mapped to the current ICD-9-CM code series for essential hypertension (401.0, 401.1 and 401.9) match up to “I10 Essential (Primary) Hypertension.”  What will be required in terms of MR documentation for accurate ICD-10-CM coding?  First, establishing the hypertension as “essential” appears tantamount to getting it coded correctly; this classification should be established in the MR documentation.  Secondly, ensuring the current state of hypertension is not etiologically connected to hypertensive heart disease, chronic kidney disease or a combination of these two is vital for correct coding (these conditions map to other ICD-10-CM codes). Performing as the “auditor” you have that the ICD-9-CM code for HTN was not reported, and you further find it was not encircled on the superbill.  The lesson buried in this for providers?  The MR documentation should be as clear, concise and explicit as possible, especially when summarizing the impressions or diagnoses.  The CC should be amended at the time of service, especially when initially recorded by ancillary staff, to reflect all of the reasons for the patient’s presentation.  A lesson herein for coders, too, is that often corroborating information is found between the History and Plan sections of the note, and both should be reviewed for possible “missed diagnosis opportunities” for ICD-9 and ICD-10 coding purposes.  Lastly, do not rely solely upon the superbills for diagnostic information. In many instances ICD-10-CM promises to impose greater specificity on diagnosis code descriptions and assignment; therefore, a correlating level of specificity is expected to be found in the MR documentation.  Performing a baseline MR documentation assessment is often a rewarding exercise in preparation for ICD-10 conversion. ###   Michael G. Calahan is currently the Director of Physician Services at Kforce Healthcare, Inc., working in the Washington DC Metro area. Also on the Board of the ICD-10 Monitor, he specializes in compliance, revenue cycle management, CDI, coding, and billing in the physician and facility arenas. He may be contacted by e-mail at mcalahan@kforce.com.  ]]> http://www.physiciansnews.com/2011/06/08/preparing-for-icd-10-performing-a-baseline-mr-documentation-assessment/feed/ 2 ACOs: The Good, the Bad and the Ugly http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/ http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/#comments Wed, 11 May 2011 00:30:29 +0000 Physicians News http://www.physiciansnews.com/?p=4067 [caption id="attachment_2742" align="alignleft" width="240" caption="."][/caption] By Ron Wince Although Accountable Care Organizations (ACOs) have been discussed for years, health care reform has put them in the spotlight. Now, health care leaders are trying to determine the best way to move forward and transition to this new model of care. While the idea behind ACOs is to get the provider and payer chain working together to provide better-coordinated, more seamless care, the various definitions of an ACO are widely varied. From the perspective of a Medicare/Medicaid patient, there is a major attraction to the current perception of ACOs. In principle, patients should have a reasonable expectation of higher quality care delivered at a lower cost if they choose a provider enrolled in an ACO. From the provider and insurance standpoint, the choice to form or join an ACO is not quite as clear cut. On the upside, any provider or insurer that is part of an ACO could see significant cost reductions, shared savings, and quality improvement, evident in both internal operations and the care they deliver to patients. Providers will also have a better ability to compete for the pool of Medicare/Medicaid patients, which will only continue to grow as more baby boomers reach retirement age. However, from what we do know, there are several positives and negatives that providers and payers must consider. The most pervasive problem is that there is no blueprint that administrators can follow to point them in the right direction when creating an ACO. Even with the recent release of the final ruling, there remains much that is left to the organizations involved.  We do know that ACOs must: -       Serve a minimum of 5,000 patients -       Consent to be part of an ACO for at least three years -       Follow either a one-sided or two-sided risk model -       Measure and report over 65 metrics (up from only eight)   But even with these minimums the “how” to forming or participating in an ACO has yet to be answered for most organizations that may opt in.  For instance, hospital administrators could create an ACO by buying one or more physician practices while, conversely, group practices or networks of physician practices could take the lead, enrolling a hospital as a partner. Supposing that administrators decide to form an ACO, the next hurdle is putting into place the required infrastructure. There are requirements for creating certain leadership and management structures that include both clinical and management personnel. Administrators will need to put into motion processes that demonstrate that they are practicing evidence-based medicine and coordinating care, as well as confirm that they are “patient centered,” another term for which there is no clear definition yet. Even more challenging could be combining the cultures of the different groups. How people work together can be a bigger factor in determining the ultimate success or failure of an effort than what they do. Before organizations determine what their ACO will look like, they need to first determine how they are going to formulate the partnership. For instance, one aspect of contention is the negotiation of agreements about how decision making and potential savings will be shared across members of the ACO. One group may have a standard practice of buying whatever’s cheapest while another may have a “buying whatever each physician wants” policy. If these two groups coalesce within the same ACO, which guideline should take precedence? Furthermore, staff and patient management strategies are different across the industry. Once organizations join together in an ACO, administrators will have to discuss managerial operations to ensure all employees and patients feel the benefits. Minor details, such as courtesy calls to patients or internal celebrations for staff, will have to be unified in order for the ACO to function as one seamless entity. In addition to cultural changes, ACOs will drive a marriage of technology. It won’t be possible for a hospital and a physician group to work together under the ACO system if they are operating two completely different technology systems. How do you shift from one technology to another? Who will manage the overall process and future IT system? How will organizations share patient information while accommodating regulations? These are decisions administrators will have to make when forming an ACO, many of which will impact the overall efficiency of the organization. From a process standpoint, ACOs have the potential to streamline many functions on an organizational level. Physician groups tend to have quicker billing practices because they depend on cash flow. Hospitals, on the other hand, often take weeks to make payments. With the joining of the two in an ACO, an improved billing process will be key to ensure physician practices aren’t losing cash flow because of poor process management. Furthermore, administrators will need to become masters of business intelligence, including measuring what’s important, collecting and reporting data and using the data to improve their organizations, not just for compliance.  Given that unknowns and uncertainties are guaranteed, administrators must practice certain survival skills such as how to learn faster on the fly and collaborate at all levels. Agility will be an imperative skill for administrators as rules continue to change. Looking at both sides of the argument, there is the potential for significant gains on both the cost and quality fronts, as well as the ability to maintain or grow a practice’s Medicare/Medicaid patient base against the need for putting in an enormous amount of work up front. ACOs were developed to help the patient and to ensure that our hospitals and physicians can continue to provide quality care, even as risks, such as an aging population, strain our health care system. In addition to a continued dedication to quality care, patients will see lower costs. ACOs will ensure that patients are receiving the care they need, rather than what helps the organization make more money. Providers may also experience success in the new era of ACOs. It will help them successfully manage the influx of patients and transformation of patient care without having to worry about increasing costs. While it hasn’t been defined yet, there may be a future opportunity for providers to garner incentives when meeting the guidelines of ACOs. This will only better the care patients receive. Whatever an organization’s view on ACOs is, they must accept that they will become part of the future of health care in this country, and must begin building or strengthening the skills and capabilities that will be needed to win on that new playing field. ### Ron Wince is President & CEO of Guidon Performance Solutions.  ]]> http://www.physiciansnews.com/2011/05/10/acos-the-good-the-bad-and-the-ugly/feed/ 2 What Providers Need to Know About ICD-10 http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/ http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/#comments Sat, 03 Dec 2011 18:06:55 +0000 Physicians News http://www.physiciansnews.com/?p=4453 By David Green Last June, Andemarian T. Beyene, 36-year-old man with tracheal cancer received a special gift:  a brand new trachea, made from a synthetic scaffold seeded with his own stem cells.  Following this surgery—the first of its kind—he made a full recovery and was discharged from the hospital four weeks later.  The procedure made international headlines, and shone a much-needed spotlight on two important problems that it might help in part to resolve:  long wait times for organ transplants, and immune rejection of implanted organs.  In what follows, we offer a brief overview of these issues, look a bit closer at the surgery itself, and ponder some of the implications. As of November 2011, the Organ Procurement and Transplantation Network, a division of the U.S. Department of Health & Human Services, is reporting that over 112,000 Americans are waiting for an organ transplant.  At the same time, the average annual expense per patient of immunosuppressive drugs—administered following a transplant to prevent the body from rejecting the new organ—is more than $11,000, and in some cases can reach as high as $25,000, according to the American Society of Transplant Surgeons. These sobering statistics are driving a campaign within the biomedical research community for innovation. A complex and technologically advanced organ allocation system links patients with organs donated by strangers.  The  shortage of organs causes most patients to wait for a transplant, and waiting times vary widely for many reasons. The amount of time a patient waits does not reflect how well as transplant center or organ procurement organization is doing its job; each patient’s situation is different.  Some patients are more ill than others when they are put on the transplant waiting list.  Some patients get sick more quickly than other patients, or respond differently to treatments.  Patients may have medical conditions that make it harder to find a good match for them. How long a patient waits can depend on a multitude of factors.  These can include blood type (some are rarer than others); tissue type; height and weight of transplant candidate; size of donated organ; medical urgency; time on the waiting list; the distance between the donor’s hospital and the potential donor organ; how many donors there are in the local area over a period of time; and the transplant center’s criteria for accepting organ offers.  Depending on the kind of organ needed, some factors are more important than others.  Under certain circumstances, special allowances are made for children. Since 1984, the nonprofit United Network for Organ Sharing (UNOS), located in Richmond, Virginia, has operated the Organ Procurement and Transplantation Network, under a contract with the Division of Transplantation in the Department of Health and Human Services.  UNOS maintains a central computer network containing the names of all patients waiting for kidney, heart, liver, lung, intestine, pancreas and multiple-organ transplants.  Patients on the waiting list are in end-stage organ failure and have been evaluated by a transplant physician and hospitals in the U.S. where organ transplants are performed. Another major guiding principle in organ allocation is: local patients first.  The U.S. is divided into 11 geographic regions, each served by a federally designated organ procurement organization, which is responsible for coordinating all organ donations.  With the exception of perfectly matched kidneys and the most urgent liver patients, first priority goes to patients at transplant hospitals located in the region served by the organ procurement organization.  Next in priority are patients in areas served by nearby organ procurement organizations; and finally, only if no patients in these communities can use the organ, it is offered to patients elsewhere in the country. Such locally oriented allocation makes medical sense because less time between donor and recipient usually means more chance of a successful transplant as well as fewer complications that could threaten the viability of the organ.  Eighty percent of all organs are donated and used in the same geographic area. Organ transplant recipients must take immunosuppressive drugs every day for the life of their transplant.  Failure to take these medications significantly increases the risk of rejection.  These drugs are not without side effects and risks.  Because the majority of them act non-selectively, the immune system is less able to resist infections and the spread of malignant cells.  There are also other side effects, such as hypertension, dyslipidemia, hyperglycemia, peptic ulcers, and liver and kidney injury.  The immunosupressive drugs also interact with other medicines and affect their metabolism and action. Immunosuppressive drugs can be classified into five groups—glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins, and other drugs—each with their own specific uses. For example, in pharmacological doses, glucocorticoids are used to suppress various allergic, inflammatory and autoimmune disorders.  They are also administered as posttransplantory immunosuppressants to prevent acute transplant rejection and graft versus host disease.  Nevertheless, they do not prevent infection and also inhibit later reparative processes.  Cyostatics inhibit cell division.  In immunotherapy, they are used in smaller doses than in the treatment of malignant diseases, and they affect the proliferation of both T cells and B cells.  Antibodies are sometimes used as a quick and potent immunosuppressive therapy to prevent the acute rejection reactions as well as a targeted treatment of lymphoproliferative or autoimmune disorders.  The drugs acting on immunophilins include cyclosporin, tacrolimus and sirolimus, whereas additional drugs used as immunosuppressants include interferons, opioids, TNF binding proteins and mycophenolate. In light of the challenges posed by transplant wait lists and the need to choose the optimal immunosuppressive therapy to facilitate transplants, it is significant that for the first time ever, a patient was recently given a new trachea made from a synthetic scaffold seeded with his own stem cells.  As noted earlier, the patient, 36-year old Andemarian T. Beyene, made a full recovery and was discharged from the hospital following the operation.  The operation was performed on June 9, 2011 at Karolinska University Hospital in Stockholm, Sweden, by Paolo Macchiarini, MD, PhD, Professor of Regenerative Surgery at the Advanced Center of Translational Regenerative Medicine at Karolinska Institutet, Stockholm, Sweden, and colleagues (Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioarti?cial nanocomposite: a proof-of-concept study. Lancet 2011; Published online November 22, 2011 DOI:10.1016/S0140-6736(11)61715-7). Previous transplants of tissue-engineered tracheas have been performed, but on those occasions the tracheas used were taken from organ donors and then reseeded with the patients’ own stem cells. For example, in 2008, 30-year-old Claudia Castillo successfully underwent this type of procedure in Spain (Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008; 372: 2023-2030). The international team involved Professor Alexander Seifalian from University College London who designed and built the nanocomposite tracheal scaffold, and Harvard Bioscience of Holliston, Massachusetts, which produced a specifically designed, shoebox-sized bioreactor used to seed the scaffold with the patient’s own stem cells.  The cells were grown on the scaffold inside the bioreactor for approximately two days; the scaffold was rotated while its surface was soaked with stem cells obtained from a bone marrow biopsy from the patient’s hip.  The patient’s stem cells settled into the pores within the scaffold and began to grow into each other, slowly transforming from individual cells into genuine tissue.  A few days after the implantation of the new trachea, the man’s own blood vessels actually started to grow into it, transforming the new organ into a part of his own body.  Because the cells used to regenerate the trachea were the patient’s own, there was no rejection of the transplant and the patient was not taking immunosuppressive drugs. The patient had been suffering from late-stage tracheal cancer.  Despite maximum treatment with radiation therapy, the tumor had reached approximately 6 cm in length and was extending to the main bronchus.  It was progressing and almost completely blocked the trachea.  Since no suitable donor windpipe was available, the transplantation of the synthetic tissue-engineered trachea was performed as the last possible option for the patient, referred by Professor Tomas Gudbjartsson of Landspitali University Hospital (Iceland) who was also part of the surgical team. The successful transplantation of tissue-engineered synthetic organs, referred to as regenerative medicine, could open new and very promising therapeutic possibilities for the thousands of patients who suffer from tracheal cancer or other conditions that destroy, block or constrict the airway. It is extremely important to note that this procedure is still experimental and will need to be sanctioned by the U.S. Food and Drug Administration for the more than 100,000 Americans who are waiting for organ transplants to benefit from it. What does tomorrow hold for this type of medical technology?  For the immediate future, the scaffold approach to generating synthetic body parts will be limited to growing tubular organs such as trachea and blood vessels, rather than more complex organs such as kidneys and livers.  However, other types of organs may become a practical option in time. Transplantations of tissue-engineered windpipes—and potentially other tubular organs like esophagus, blood vessels and urethras—with synthetic scaffolds in combination with the patient’s own stem cells, as a standard procedure, means that patients would not have to wait for a suitable donor organ.  This would be a substantial benefit for patients since they could benefit from earlier surgery and have a greater chance of cure.  In addition to treating adult patients, tissue-engineered synthetic trachea transplants would, not least, be of great value for children, since the availability of donor tracheas is much lower than for adult patients. If this scenario unfolds as some predict, it might mean the start of a new era in the treatment of thousands of patients whose lives and health will be improved.   ### David Green is President of Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine.  He can be reached at dgreen@harvardbioscience.com.]]> http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/feed/ 1 Physicians News » Headline http://www.physiciansnews.com Tue, 07 Feb 2012 16:44:06 +0000 en hourly 1 http://wordpress.org/?v=3.2.1 The Treatment of Solid Tumors: Some Recent Approaches http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/ http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/#comments Tue, 07 Feb 2012 16:14:45 +0000 Physicians News http://www.physiciansnews.com/?p=4595 By Punit Dhillon At some point in their lives, one in five people will suffer from skin cancer, and the fraction is steadily rising.  In spite of innovation in sunscreen technology and public attention to the need to be shielded from the sun, data reported recently by Dermatology Times show a rise in the average American lifetime risk of one skin cancer variety—invasive melanoma—from 1/600 in 1960 to 1/50 in 2008.  Despite previous diagnosis and innovations in approaches to treatment, the age-adjusted number of annual deaths per 100,000 population is rising.  Additionally, the expense to the healthcare system and society continues to increase.  As U.S. and European populations age, the incidence of skin cancer and other solid tumor cancers will grow.  According to the latest United States Cancer Statistics, published by the Centers for Disease Control and Prevention in 2007, the top 10 cancer types (based on incidence rate) are in the solid tumor category; today the priority is probably even higher.  Thus, there are clear medical needs going unmet and the creation of novel, cost-efficient and patient-friendly treatments remain a top priority for both the healthcare community and patients. Various challenges of traditional treatments The treatment of solid tumor cancers, which range from melanoma and Merkel cell carcinoma to cutaneous T-cell lymphoma, continues to be a substantial challenge for physicians.  For example, in spite of innovations in drug discovery and development, it is still challenging to simply deliver efficient drugs into cancer cells in a safe and effective manner.  Meanwhile, today’s therapeutic approaches—involving surgery, radiation therapy and chemotherapy—each have characteristic and major drawbacks. Surgery, the current first-line treatment for localized and operable tumors or lesions, requires resecting the tumor mass and a surrounding boundary of healthy tissue to make sure that no cancer cells remain at the tumor site.  Surgery can potentially cause physical disfigurement and/or debilitating effects on organ function, and the patient quality of life has been demonstrated to be negatively impacted.  Also, surgery can require an expensive and long hospital stay. Radiation therapy is occasionally used in conjunction with surgery to shrink a tumor prior to surgical removal, or afterward to destroy any cancer cells that might remain.  Yet surgery plus radiation can damage important normal tissues like nerves, blood vessels, or vital organs such as the heart that are within the designated zone of treatment.  Radiation is also a costly therapeutic approach, and demands substantial expertise, precautionary measures and infrastructure to administer.  Radiation entails major complications, such as nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the potential for the formation of new cancerous lesions. Those who get radiation to the heart often suffer from various types of heart failure in subsequent years. Typically, chemotherapy is a secondary or palliative treatment to help mitigate systemic or metastatic tumor growth, whereas surgery and radiation may be considered local treatments.  In response to cancer’s spread, physicians will administer chemotherapeutic agents that circulate throughout the body, systemically and in high concentrations, to counter the challenge that some chemotherapeutic agents have in reaching and penetrating the cell membrane to trigger cell death.  Yet the system-wide use of chemotherapeutics frequently has major side effects by killing healthy as well as cancerous cells.  This systemic and non-targeted administration of anticancer agents can trigger alopecia; nausea; vomiting; myelosuppression; and drug resistance.  Chemotherapy is curative for only a few tumor types. Additionally, all of these conventional treatments are only minimally effective on aggressive types of cutaneous cancers, especially in later stages of the disease. Some potential approaches We now offer an abbreviated look at some current approaches to override these challenges in treating solid tumors. One possible strategy for solid tumor treatment involves a new class of small-molecule drug candidates called vascular disrupting agents.  Via interaction with vascular endothelial cytoskeletal proteins, these agents may selectively target and collapse tumor vasculature, thereby depriving the tumor of oxygen and causing death of the tumor cells. Another approach involves the use of new therapeutic monoclonal antibody candidates that target CD27, a member of the tumor necrosis factor (TNF) receptor superfamily.  Anti-CD27 monoclonal antibodies have been demonstrated to effectively promote anticancer immunity in mouse models when combined with T cell receptor stimulation.  In addition, CD27 is overexpressed in various lymphomas and leukemias and can be targeted for direct activity by anti-CD27 monoclonal antibodies with effector function against those cancers.  There are many other antibody drugs on the market, some also with linked toxins or radiation. A third tactic involves the creation of an orally available nucleoside analogue for various cancers including solid tumors.  This agent could act through a novel DNA single-strand breaking mechanism, leading to the production of DNA double strand breaks (DSBs) and/or DNA repair checkpoint activation; unrepaired DSBs go on to cause apoptosis or programmed cell death. Alternatively, solid tumors could be treated using a technique called tumor ablation, which involves destroying the tumor inside the body via various approaches.  Radioactive pellets, shorter than an inch and approximately the width of a pin, can be inserted into the tumor; the pellet subsequently emits lethal radioactive atoms that irradiate the tumor from the inside out.  As the tumor breaks down, it starts to release antigens that trigger an immune response against the cancer cells.  Sometimes, the body also develops an immune memory against the future return of tumor cells.  Another proposed ablation technique, called “pulsed electric current ablation,” involves the insertion of electrodes into tumors, which subsequently emit very high-energy electrical currents; these currents create a physical reaction that destroys the tumor cells. A separate approach involves applying local heating to the tumor using radio frequency techniques.  In this instance, a thermal energy delivery device can be focused and targeted according to the shape, size and position of a specific tumor.  Adjusting the frequency, phase, and amplitude of the radio waves, combined with different applicators and adjustment of the patient’s position, could conceivably permit a doctor to optimize the delivery of damaging energy into the tumor. Cancer scientists are also interested in attacking solid tumors by delivering drugs specifically into diseased tissues. Such a targeted approach can result in more efficient therapy while using smaller drug doses with fewer negative side effects.  For example, in animal studies, immune-deficient mice carrying human forms of various cancers have been simultaneously injected with a range of anticancer agents and a peptide known as iRGD.  iRGD can find and attach itself to receptors on solid tumor cancer cells and later activate their internal transport systems so that the peptide is essentially passed through cell after cell, moving progressively deeper into the tumor structure.  Anticancer drugs lingering near the peptide molecules may also get pulled into and through the tumor mass by this transport mechanism, enabling them to attack cancer cells previously beyond their reach. By their nature and cellular architecture, solid tumors are equipped to limit the efficacy of most anticancer drugs.  Tumors have poor vascular systems, which reduces exposure to drugs that have been administered into the circulation.  The lesions are densely fibrous, which serves as a physical barrier against transport.  Also, the tumors have high internal pressures, causing further physical challenges to any molecule attempting to enter the lesion.  The iRGD peptide is designed to act like a key, switching on the internal transport mechanism of the cells so that they absorb anything that is proximal to certain cell surface receptors.  Researchers believe the iRGD peptide could penetrate many tumor types and might be useful in treating most solid tumor cancers.  An encouraging aspect of this approach is that both the peptide and anticancer drugs are effective together without being chemically attached. Yet another promising strategy for treating solid tumor cancers involves targeting the tumor itself without affecting any of the surrounding healthy tissue.  This ensures that the drug or therapeutic agent is absorbed at once by the cancer cells and not normal tissues.  One such targeted therapy could harness a physiologic process known as “electroporation.”  Derived from the words “electric” and “pore,” this involves applying a brief electric field to the cancerous cell.  The electrical pulse triggers the temporary creation of pores in the cell’s outer membrane—pores that close again within seconds once the electric field is discontinued.  These transient pores can improve uptake of various drugs more than a thousand-fold. Several electroporation systems have been manufactured that consist of a generator that creates the pulsed electric field, and various handheld applicators with electrode needles at their proximal ends.  The applicator delivers a controlled electric pulse to the cancer cells, thus causing any cancer cells within the affected region to undergo electroporation.  The cell takes up therapeutic agents within the region of electroporation. This technology platform is being developed for use in two varieties of anticancer therapies:  electrochemotherapy and electroimmunotherapy.  In the former, an anticancer drug is injected into a targeted tumor; the lesion is then electroporated and the drug carries out its planned mechanism of action in killing the cell.  As a result of the targeted, local therapy, the amount of drug needed to kill the cells is substantially less than that required in traditional, non-targeted chemotherapy.  The lower quantity of systemic drug (cytotoxic agent) reduces harmful side effects linked to traditional chemotherapy. Electroimmunotherapy, the second application of electroporation, involves the use of a gene encoding a specific cytokine, a substance known to boost the human immune system against cancer cells.  An immune response can have both a local and a distant effect against cancerous cells.  These therapeutic approaches have been shown to be safe and effective across various types of tumors.  Both patient outcomes and pharmacoeconomic benefits are substantial.  This technology is in clinical testing in North America and is available for commercial sale in some European countries. Therapies such as those discussed here may provide a compelling set of novel approaches to the treatment of solid tumor cancers. ### Punit Dhillon is President and CEO of OncoSec Medical Inc., a biotechnology company developing its advanced-stage Oncology Medical System (OMS) ElectroOncology therapies to treat skin cancer and other solid tumor cancers. He can be reached at pdhillon@oncosec.com.]]> http://www.physiciansnews.com/2012/02/07/the-treatment-of-solid-tumors-some-recent-approaches/feed/ 0 Growing Organs In The Lab: A potential end to immune rejection http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/ http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/#comments Sat, 03 Dec 2011 18:06:55 +0000 Physicians News http://www.physiciansnews.com/?p=4453 By David Green Last June, Andemarian T. Beyene, 36-year-old man with tracheal cancer received a special gift:  a brand new trachea, made from a synthetic scaffold seeded with his own stem cells.  Following this surgery—the first of its kind—he made a full recovery and was discharged from the hospital four weeks later.  The procedure made international headlines, and shone a much-needed spotlight on two important problems that it might help in part to resolve:  long wait times for organ transplants, and immune rejection of implanted organs.  In what follows, we offer a brief overview of these issues, look a bit closer at the surgery itself, and ponder some of the implications. As of November 2011, the Organ Procurement and Transplantation Network, a division of the U.S. Department of Health & Human Services, is reporting that over 112,000 Americans are waiting for an organ transplant.  At the same time, the average annual expense per patient of immunosuppressive drugs—administered following a transplant to prevent the body from rejecting the new organ—is more than ,000, and in some cases can reach as high as ,000, according to the American Society of Transplant Surgeons. These sobering statistics are driving a campaign within the biomedical research community for innovation. A complex and technologically advanced organ allocation system links patients with organs donated by strangers.  The  shortage of organs causes most patients to wait for a transplant, and waiting times vary widely for many reasons. The amount of time a patient waits does not reflect how well as transplant center or organ procurement organization is doing its job; each patient’s situation is different.  Some patients are more ill than others when they are put on the transplant waiting list.  Some patients get sick more quickly than other patients, or respond differently to treatments.  Patients may have medical conditions that make it harder to find a good match for them. How long a patient waits can depend on a multitude of factors.  These can include blood type (some are rarer than others); tissue type; height and weight of transplant candidate; size of donated organ; medical urgency; time on the waiting list; the distance between the donor’s hospital and the potential donor organ; how many donors there are in the local area over a period of time; and the transplant center’s criteria for accepting organ offers.  Depending on the kind of organ needed, some factors are more important than others.  Under certain circumstances, special allowances are made for children. Since 1984, the nonprofit United Network for Organ Sharing (UNOS), located in Richmond, Virginia, has operated the Organ Procurement and Transplantation Network, under a contract with the Division of Transplantation in the Department of Health and Human Services.  UNOS maintains a central computer network containing the names of all patients waiting for kidney, heart, liver, lung, intestine, pancreas and multiple-organ transplants.  Patients on the waiting list are in end-stage organ failure and have been evaluated by a transplant physician and hospitals in the U.S. where organ transplants are performed. Another major guiding principle in organ allocation is: local patients first.  The U.S. is divided into 11 geographic regions, each served by a federally designated organ procurement organization, which is responsible for coordinating all organ donations.  With the exception of perfectly matched kidneys and the most urgent liver patients, first priority goes to patients at transplant hospitals located in the region served by the organ procurement organization.  Next in priority are patients in areas served by nearby organ procurement organizations; and finally, only if no patients in these communities can use the organ, it is offered to patients elsewhere in the country. Such locally oriented allocation makes medical sense because less time between donor and recipient usually means more chance of a successful transplant as well as fewer complications that could threaten the viability of the organ.  Eighty percent of all organs are donated and used in the same geographic area. Organ transplant recipients must take immunosuppressive drugs every day for the life of their transplant.  Failure to take these medications significantly increases the risk of rejection.  These drugs are not without side effects and risks.  Because the majority of them act non-selectively, the immune system is less able to resist infections and the spread of malignant cells.  There are also other side effects, such as hypertension, dyslipidemia, hyperglycemia, peptic ulcers, and liver and kidney injury.  The immunosupressive drugs also interact with other medicines and affect their metabolism and action. Immunosuppressive drugs can be classified into five groups—glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins, and other drugs—each with their own specific uses. For example, in pharmacological doses, glucocorticoids are used to suppress various allergic, inflammatory and autoimmune disorders.  They are also administered as posttransplantory immunosuppressants to prevent acute transplant rejection and graft versus host disease.  Nevertheless, they do not prevent infection and also inhibit later reparative processes.  Cyostatics inhibit cell division.  In immunotherapy, they are used in smaller doses than in the treatment of malignant diseases, and they affect the proliferation of both T cells and B cells.  Antibodies are sometimes used as a quick and potent immunosuppressive therapy to prevent the acute rejection reactions as well as a targeted treatment of lymphoproliferative or autoimmune disorders.  The drugs acting on immunophilins include cyclosporin, tacrolimus and sirolimus, whereas additional drugs used as immunosuppressants include interferons, opioids, TNF binding proteins and mycophenolate. In light of the challenges posed by transplant wait lists and the need to choose the optimal immunosuppressive therapy to facilitate transplants, it is significant that for the first time ever, a patient was recently given a new trachea made from a synthetic scaffold seeded with his own stem cells.  As noted earlier, the patient, 36-year old Andemarian T. Beyene, made a full recovery and was discharged from the hospital following the operation.  The operation was performed on June 9, 2011 at Karolinska University Hospital in Stockholm, Sweden, by Paolo Macchiarini, MD, PhD, Professor of Regenerative Surgery at the Advanced Center of Translational Regenerative Medicine at Karolinska Institutet, Stockholm, Sweden, and colleagues (Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioarti?cial nanocomposite: a proof-of-concept study. Lancet 2011; Published online November 22, 2011 DOI:10.1016/S0140-6736(11)61715-7). Previous transplants of tissue-engineered tracheas have been performed, but on those occasions the tracheas used were taken from organ donors and then reseeded with the patients’ own stem cells. For example, in 2008, 30-year-old Claudia Castillo successfully underwent this type of procedure in Spain (Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008; 372: 2023-2030). The international team involved Professor Alexander Seifalian from University College London who designed and built the nanocomposite tracheal scaffold, and Harvard Bioscience of Holliston, Massachusetts, which produced a specifically designed, shoebox-sized bioreactor used to seed the scaffold with the patient’s own stem cells.  The cells were grown on the scaffold inside the bioreactor for approximately two days; the scaffold was rotated while its surface was soaked with stem cells obtained from a bone marrow biopsy from the patient’s hip.  The patient’s stem cells settled into the pores within the scaffold and began to grow into each other, slowly transforming from individual cells into genuine tissue.  A few days after the implantation of the new trachea, the man’s own blood vessels actually started to grow into it, transforming the new organ into a part of his own body.  Because the cells used to regenerate the trachea were the patient’s own, there was no rejection of the transplant and the patient was not taking immunosuppressive drugs. The patient had been suffering from late-stage tracheal cancer.  Despite maximum treatment with radiation therapy, the tumor had reached approximately 6 cm in length and was extending to the main bronchus.  It was progressing and almost completely blocked the trachea.  Since no suitable donor windpipe was available, the transplantation of the synthetic tissue-engineered trachea was performed as the last possible option for the patient, referred by Professor Tomas Gudbjartsson of Landspitali University Hospital (Iceland) who was also part of the surgical team. The successful transplantation of tissue-engineered synthetic organs, referred to as regenerative medicine, could open new and very promising therapeutic possibilities for the thousands of patients who suffer from tracheal cancer or other conditions that destroy, block or constrict the airway. It is extremely important to note that this procedure is still experimental and will need to be sanctioned by the U.S. Food and Drug Administration for the more than 100,000 Americans who are waiting for organ transplants to benefit from it. What does tomorrow hold for this type of medical technology?  For the immediate future, the scaffold approach to generating synthetic body parts will be limited to growing tubular organs such as trachea and blood vessels, rather than more complex organs such as kidneys and livers.  However, other types of organs may become a practical option in time. Transplantations of tissue-engineered windpipes—and potentially other tubular organs like esophagus, blood vessels and urethras—with synthetic scaffolds in combination with the patient’s own stem cells, as a standard procedure, means that patients would not have to wait for a suitable donor organ.  This would be a substantial benefit for patients since they could benefit from earlier surgery and have a greater chance of cure.  In addition to treating adult patients, tissue-engineered synthetic trachea transplants would, not least, be of great value for children, since the availability of donor tracheas is much lower than for adult patients. If this scenario unfolds as some predict, it might mean the start of a new era in the treatment of thousands of patients whose lives and health will be improved.   ### David Green is President of Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine.  He can be reached at dgreen@harvardbioscience.com.]]> http://www.physiciansnews.com/2011/12/03/growing-organs-in-the-lab-a-potential-end-to-immune-rejection/feed/ 1 What You and Your Patients Need to Know About Bisphenol A http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/ http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/#comments Mon, 07 Nov 2011 14:28:00 +0000 Physicians News http://www.physiciansnews.com/?p=4379 By Rebecca Roberts, Ph.D. Bisphenol A (BPA) is an environmental estrogen that can affect development and health by disrupting normal hormonal signaling.  Estrogen, working at very low blood concentrations, triggers responses in cells and tissues and is critical during fetal development and in normal health and reproduction.  BPA binds to the same cellular receptors as estrogen and may lead to detrimental health effects. In June of this year, the American Medical Association formally recognized BPA as an endocrine-disrupting agent.  Physicians can play an important role in educating their patients about this pervasive environmental contaminant.  The first steps are to understand the potential health risks of BPA and how to limit those risks through simple lifestyle changes. BPA is used in the production of polycarbonate plastics and epoxy resins.  Many consumer products, such as some reusable water bottles, baby bottles, toys, cell phones, and DVDs, contain BPA.  BPA is also found in the inner linings of metal food cans.1 The epoxy lining protects the metal can from rust and corrosion which may taint the food.  It is present in various medical devices as well, including incubators, blood oxygenators, and dialysis machines.  Given its wide uses, BPA ranks among the highest volume chemicals manufactured worldwide. Although present in countless products, none of which is intended for consumption, the primary route of exposure is through ingestion.  BPA has been shown to leach from products that contain it, such as food cans, into the foodstuffs stored in the container.1,2 When the food is then consumed, BPA enters the body through the digestive tract. A 2007 survey by the Centers for Disease Control found that approximately 92% of Americans have detectable levels of BPA in their bodies.3 The survey is considered representative of the United States population even though it included only people older than six years old.  It is notable, however, that the children (ages 6-11 years) in this study displayed the highest levels of BPA of all populations investigated.  BPA has been found in placental tissue and fetal blood as well, indicating that fetuses are being exposed as a result of maternal exposure.4 An additional study looked at the levels of BPA in infants – specifically in premature infants housed in Neonatal Intensive Care Units.5 It was found that these infants displayed the highest level of BPA in their bodies of all populations. Exposure to BPA has been studied on many levels, from effects on individual cells, to tissues and whole organisms.  While most health studies regarding exposure to BPA are done in laboratory animals, the few human epidemiological studies reveal a relationship between BPA exposure and polycystic ovary syndrome, repeated miscarriage, and heart disease.6-8 Additionally, BPA causes a human breast cancer cell line to proliferate, suggesting that estrogen-sensitive tissues and cells in the human body may react similarly.9 Many animal studies focus on the effect of BPA exposure during fetal development as this is a time when cells and tissues are especially susceptible to alterations in the hormonal environment.  Not only does BPA disrupt proper functioning of the placenta during gestation, but offspring of animals that are exposed to BPA during pregnancy exhibit many deleterious health effects.10 Male offspring have enlarged prostates and malformed urethra.11, 12 Moreover, they are at a higher risk of developing prostate cancer. BPA exposure alters the genital tract of female offspring.11, 12 Exposed females also enter puberty earlier.12 Exposure affects brain development and, as a result, some behavioral differences typically seen between males and females are lost in offspring exposed to BPA in the uterus.13 Based on the clear effects of BPA exposure on the development of fetuses in animals, similar effects on human development are plausible.  Indeed, BPA has been found in the bloodstream, placenta, cord blood, and fetal blood of humans at levels that are within the range studied in many of the animal models.5
While hundreds of studies, most focusing on animal models, point to the harmful health effects of BPA, there has been controversy over the past decade and a half regarding safety of the compound in humans.  Nevertheless, scientific review panels have determined that some detrimental health effects may occur in humans.14-16 Likely human health effects that have been vetted through these review panels include advanced puberty in females14, 15 , effects on the brain and behavior15, 16, mammary gland and prostate abnormalities, and reproductive effects in males and females. Beyond the immediate developmental effects of BPA exposure in utero, evidence is beginning elucidate long-term effects of early-life exposure to BPA, potentially through the modification of epigenetic programming via altered DNA methylation.16, 17 One study suggests that such detrimental modifications may be counteracted by maternal nutrient supplementation.18 Nevertheless, these changes may result in alterations that are passed on transgenerationally, resulting in adverse health effects in subsequent generations who, themselves, may not have been directly exposed to BPA.17, 19 Given the putative adverse health effects of BPA exposure, the U.S. Environmental Protection Agency added BPA to its “Chemicals of Concern” list under the Toxic Substances Control Act in 2010.20 The U.S. Department of Health and Human Services website also posted “Information for Parents” on how to minimize their infant’s exposure to BPA.21 Humans are typically exposed to about 0.001 milligrams of BPA per kilogram of body weight per day.  This is 50 times lower than the ‘safe’ limit set by the EPA and the Food and Drug Administration.  Unfortunately, this level of exposure is still significantly higher than the low doses that have been shown to cause adverse health effects. The concern of exposure is highest when fetuses, infants, and children are considered because of the adverse effects of BPA on normal developmental processes early in life. It is clear that infants and children are burdened with the highest levels of BPA.  This is likely due to several factors.  First, the ability infants and children to metabolically detoxify contaminants such as BPA is not yet mature.  While BPA will ultimately be removed from the blood through a liver-mediated process, BPA stays in the system of infants and children longer than in adults.16 Second, when compared to adults, infants and children consume proportionately more food when their overall body size is taken into account and therefore bodily concentrations are higher.  The milk, formula, or food that is the main staple of an infant may be stored in containers (baby bottles, sippy cups) that are made with BPA.3, 22, 23 Infants and young children are also more likely to mouth plastic products, such as toys, that are not necessarily meant to be put in the mouth. BPA can also pass from the mother to the fetus.5 In addition, breast milk can transmit BPA to an infant.24 Given this, it is not only the child, but the pregnant or nursing mother, that need to be protected from BPA exposure.  Since the children cannot be responsible for making choices regarding BPA, clear information must be provided to parents (and potential parents) so that they can made the educated choices needed to protect themselves and their children. Fortunately, BPA is metabolized and cleared from the body so decreasing daily exposure to BPA can make a difference in overall body levels.25, 26 In Japan, industries voluntarily reduced BPA use in their products between 1998 and 2003 and studies showed a dramatic decline in body levels of BPA in the population.27, 28 Educating your patients about a few simple lifestyle changes can make a difference in their overall BPA exposure and potentially reduce their risk for adverse health effects. First, opting for fresh and frozen food rather than canned food is a big step. 22 While damage and age of food cans does not appear to greatly increase the amount of BPA leached into food, the initial packaging and sterilization techniques do release significant levels of BPA into canned food.22, 1 Second, minimizing the use of polycarbonate plastics food and beverage containers will also help.  Polycarbonate plastics are usually hard, clear, and shatter-resistant.  They may be labeled with recycle number 7, although not all number 7 products contain BPA. Third, learning about the proper care and use of containers can curtail exposure.  Heat and wear increases the leaching rate of BPA into the food or beverage stored in the container, so polycarbonate plastics should not be microwaved or put through the dishwasher and they should not be used if visibly scratched.29, 2 Parents and caregivers should also be provided information in protecting infants and children from unnecessary BPA contact.  Powdered infant formula is usually not stored in containers made from BPA, but some premade liquid infant formulas are packaged in BPA-containing bottles, and such formula has been shown to be tainted.24 In September 2011, a report from the Breast Cancer Fund revealed that many children’s canned food items contained BPA.30 Children are also more likely to mouth plastic products, such as toys or the hard plastic portion of a pacifier.  Caregivers should be mindful of products aimed at children that may contain BPA, such as sippy cups, tableware, and toys.3, 22, 26 Thankfully, manufacturers are increasingly labeling products as “BPA-free”.  The American Medical Association adopted a new policy in 2011 supporting continued industry efforts to produce BPA-free baby products as well as a total ban on the sale of such products. As of 2011, ten states have passed legislation limiting the use of BPA in products aimed at children.  Pennsylvania has similar legislation, spearheaded by Representative Lawrence Curry, that is currently in the House Health Committee.  In New Jersey, Senator Linda Greenstein introduced a related bill in 2010 that has been referred to the Senate Commerce Committee. While the current BPA legislation is an important step, the direct education of patients about BPA and the simple steps that can be taken to minimize their BPA exposure may lead to health improvements within the community.   ###
Rebecca Roberts, Ph. D., is an Associate Professor in the Department of Biology and Coordinator of the Biochemistry and Molecular Biology Program at Ursinus College in Collegeville, PA, where she studies the effect of hormonal regulation of the immune system, with a focus on the roles of estrogen and bisphenol A in Systemic Lupus Erythematosus. She has been active in educating the public about bisphenol A and recently presented expert testimony to the Pennsylvania House of Representatives Democratic Policy Committee regarding toxin-free toddler and baby products.
 
    Citations 1. Goodson, A., H. Robin, W. Summerfield, and I. Cooper, 2004. Migration of bisphenol A from can coatings – effects of damage, storage conditions and heating.  Food Addit Contam, v. 21(10), pp. 1015-26. 2. Brede, C., P. Fjeldal, I. Skjevrak, and H. Herikstad. 2003 Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushing. Food Addit Contam, v. 20(7), pp. 684-9. 3. Calafat AM, Ye X, Wong L-Y, Reidy JA, Needham LL, 2007. Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003–2004. Environ Health Perspect, v. 116(1): doi:10.1289/ehp.10753 4. Calafat A.M., J. Weuve, X. Ye, L.T. Jia, H. Hu, S. Ringer, K. Huttner, and R. Hauser, 2009.  Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants.  Environ Health Perspect, v. 117, pp. 639-644. 5. Schonfelder, G., W. Wittfoht, H. Hopp, C.E. Talsness, M. Paul, and I. Chahoud, 2002. Parent bisphenol A accumulation in the human maternal-fetal-placental unit. Environ Health Perspect, v. 110(11), pp. A703-7. 6. Takeuchi, T., O. Tsutsumi, Y. Ikezuki, Y. Takai, and Y. Taketani, 2004. Positive relationship between androgen and the endocrine disruptor, bisphenol A, in normal women and women with ovarian dysfunction. Endocr J., v. 51, pp. 165-169. 7. Sugiura-Ogasawara, M., Y. Ozaki, S. Sonta, T. Makino, and K. Suzumori, 2005. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod, v. 20, pp.2325-2329. 8. Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., Galloway, T.S. (2010). Association of urinary bisphenol a concentration with heart disease: evidence from NHANES 1003/06. PLoS One, v. 5(1), pp8673. 9. Singleton, D.W., Y. Feng, Y. Chen, S.J. Busch, A.V. Lee, A. Puga, and S.A. Khan, 2004.Bisphenol-A and estradiol exert novel gene regulation in human MCF-7 derived breast cancer cells. Mol Cell Endocrinol, v. 221(1-2), pp. 47-55. 10. Lee, C.K., S.H. Kim, D.H. Moon, J.H. Kim, B.C. Son, D.H. Kim, C.H. Lee, H.D. Kim, J.W. Kim, J.E. Kim, and C.U. Lee, 2005. Effects of bisphenol A on the placental function and reproduction in rats. J Prev Med Pub Health. v. 38(3), pp. 330-336. 11. Markey, C.M., P.R. Wadia, B.S. Rubin, C. Sonnenscheine, and A.M. Soto, 2005. Long Term Effects of Fetal Exposure to Low Doses of the Xenoestrogen Bisphenol-A in the Female Mouse Genital Tract. Biol Reprod, v. 72(6), pp. 1344-51. 12. Nikaido, Y., K. Yoshizawa, N. Danbara, M. Tsujita-Kyutoku, T. uri, N. Uehara, and A.Tsubura, 2004. Effects of maternal xenoestrogen exposure on development of the reproductive tract and mammary gland in female CD-1 mouse offspring. Reprod Toxicol, v. 18(6), pp. 803-811. 13. Rubin, B.S., J.R. Lenkowski, C.M. Schaeberle, L.N. Vandenberg, P.M. Ronsheim, and A.M. Soto, 2006. Evidence of altered brain sexual differentiation in mice exposed perinatally to low, environmentally relevant levels of bisphenol A. Endocrinology, v.147(8), pp. 3681-3691. 14. National Toxicology Program’s Report of the Endocrine Disruptors Low Dose Peer Review (2001). 15. U.S. Department of Health and Human Services, National Institutes of Health, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction.  NTP-CERHR monograph on the potential human reproductive and developmental effects of bisphenol A (NIH Publication No. 08-5994). 16. Vom Saal, F.S. et al., 2007. Chapel Hill bisphenol A expert panel consensus statement: Integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure.  Reproductive Toxicology, v. 24, pp. 131-138. 17. Kudakovic, M. and F.A. Champagne, 2011. Epigenetic perspective on the developmental effects of bisphenol A. Brain, Behavior, and Immunity. V. 25(6), pp. 1084-93. 18. Dolinoy, D.C., D. Huang, and R.L. Jirtle, 2007. Maternal nutrient supplementation counteracts bisphenol A-induced DNA hypomethylation in early development. PNAS, v. 104(32), pp. 13056-13061. 19. Walker, D.M. and A.C. Gore, 2011. Transgenerational neuroendocrine disruption of reproduction. Nat Rev Endocrinol. v. 7(4), pp197-207. 20. U.S. Environmental Protection Agency, 2010. Bisphenol A (BPA) action plan summary. 21. U.S. Department of Health and Human Services, 2010. Bisphenol A (BPA) information for parents. 22. Vandenberg, L.N., R. Hauser, M. Marcus, N. Olea, and W.V. Welshons, 2007. Human exposure to bisphenol A (BPA). Reproductive Toxicology, v. 24, pp. 139-177. 23. Kuo, H.W. and W.H. Ding, 2004. Trace determination of bisphenol A and phytoestrogens in infant formula powders by gas chromatography-mass spectrometery.  J. Chromatogr A, v. 1027, pp. 67-74. 24. Houlihan, J., 2007. Toxic plastics chemical in infant formula.  Environmental Working Group. 25. Carwile JL, Luu HT, Bassett LS, Driscoll DA, Yuan C, Chang JY, Ye X, Calafat AM, Michels KB, 2009. Polycarbonate bottle use and urinary bisphenol A concentrations. Environ Health Perspect, v. 117(9), pp. 1368-1372. 26. Vökel, Wl, Kiraoglu, M., Fromme, H., 2011. Determination of free and total bisphenol A in urine of infants. Environ Res, v. 111(1), pp.143-148. 27. Matsumoto A KN, Kitagawa K, Isse T, Oyama T, Foureman GL, Morita M, Kawamoto T. 2003. Bisphenol A levels in human urine. Environ Health Perspect 111(1): 101-4. 28. Research Center for Chemical Risk Management (2005). Bisphenol A Risk Assessment Document. AIST Risk Assessment Document Comprehensive Chemical Substance Assessment and Management Program. Japan. 29. Lyons, G.. 2000. Bisphenol A:  A Known Endocrine Disruptor. WWF European Toxics Programme: Godalming, Surrey. p. 37 30. Breast Cancer Fund (2011).  BPA in Kids’ Canned Food.  ]]> http://www.physiciansnews.com/2011/11/07/what-you-and-your-patients-need-to-know-about-bisphenol-a/feed/ 3 Retroactive Adverse Benefit Denials Under ERISA http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/ http://www.physiciansnews.com/2011/09/06/retroactive-adverse-benefit-denials-under-erisa/#comments Tue, 06 Sep 2011 15:35:42 +0000 Physicians News http://www.physiciansnews.com/?p=4242 By Franklin J Rooks J. PT, MBA, Esq. Introduction The insurer’s denial of previously authorized benefits is one of the most frustrating experiences for a medical practice’s billing staff.  But, on the frustration scale, there is another insurance company practice that can push it over the top: retroactive benefit denials that occur after the insurance company has already made payment.  From the insurer’s perspective, a retroactive denial made after the provider has received payment results in an overpayment to the provider, which must be repaid.  To make matters worse, insurance carriers sometimes recoup their payments in ways that create billing system nightmares.  Instead of asking the provider to write a check to the insurer for “improperly” paid benefits, some insurers use “negative remittances.” Negative remittances are where an insurer takes back a benefit payment by offsetting other compensable claims.  Negative remittances are generally cumbersome for providers because they require several billing system adjustments involving more than one patient account.  Recoupment of prior payments is not unique to group health insurers.  Medicare also has a recoupment process for overpayments.[1] With Medicare, the provider receives demand letter, and recoupment cannot begin until 41 days after the provider’s receipt of that notice.  Similarly, for patients covered under an ERISA plan, notice and appeal rights are also required.[2] The insurer cannot just unilaterally recoup benefits by offsetting the benefits due on another patient’s account.    [Note: where applicable, the information provided below assumes that the practice has complied with all of the insurance carrier’s claims filing guidelines and denials are not administrative or technical denials of a claim.] ERISA The Employee Income Security Act, or ERISA, was enacted in 1974 to protect employees’ rights in their employer-sponsored benefit plans.[3] ERISA does not require employers to provide employee benefit plans.[4] Rather, it regulates them. For covered plans, ERISA sets forth substantive regulatory requirements, along with mechanisms to provide access to Federal courts, sanctions, and exclusive remedies.[5] ERISA protects employees’ benefits through uniformity.  These protections supersede and take precedence over any state laws which govern benefit plans.[6] Specifically, ERISA supersedes applicable state law in three areas:  (1) laws mandating employee benefit structures or their administration; (2) laws that regulate ERISA plans; and (3) laws providing alternate enforcement mechanisms other than those provided by ERISA.[7] ERISA allows plan beneficiaries to bring a civil action to “recover benefits due to him under the terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future benefits under the terms of the plan.”[8] If applicable to the insurance plan, the practice should examine ERISA’s protections when challenging an insurer’s recoupment of previously paid benefits. Denials: Adverse Benefit Determinations Under ERISA, benefit denials are termed “adverse benefit determinations.”  In ERISA parlance, this means “[a] denial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit, including any such denial, reduction, termination.”[9] An adverse benefit determination is also a “[f]ailure to provide or make payment that is based on a determination of a participant's or beneficiary's eligibility to participate in a plan. . .”[10] For group health plans, this also includes a “[d]enial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit resulting from the application of any utilization review. . .” [11] Adverse benefit determination also applies to the denial of any treatment because the plan considers it to be “[e]xperimental or investigational or not medically necessary or appropriate.”[12] All of the preceding trigger ERISA protections. There is a limited period in which the insurer can make an adverse benefit determination.  Generally, adverse benefit determinations must be made within 90 days of the health plan’s receipt of the claim, unless special circumstances exist which necessitate an extension of time.[13] Adverse benefit determinations for group health plans are to be made “within a reasonable period of time, but not later than 30 days after receipt of the claim.”[14] Prior to the expiration of this 30 day period, the insurer may extend its time to make an adverse benefit determination by up to 15 days.[15] The notification must provide the specific reason(s) for the adverse determination, referencing the specific plan provisions upon which the insurer’s determination is based.[16] The notice must provide the plan beneficiary with a description of any additional material or information necessary to satisfy the claim and an explanation of why such material or information is necessary.[17] The insurer must also furnish a description of the plan's review procedures and the applicable time limits. [18] The insurer must provide appeal rights.  The beneficiary is entitled to a “[r]easonable opportunity to appeal an adverse benefit determination . . . under which there will be a full and fair review of the claim and the adverse benefit determination.”[19] After the receipt of an adverse benefit determination notification, the claimant has at least 60 days to appeal the decision.[20] ERISA also requires the notification to include a statement of the claimant's right to bring a civil action under section 502(a) of the ERISA Act following an adverse benefit determination that is under review. [21] Recoupment: Compliance with ERISA Under ERISA, any determination that a claim should not be paid in full constitutes an adverse benefit determination.[22] A retroactive benefit denial is an insurer’s adverse determination that the patient’s benefits should not have been paid.  Retroactive adverse benefit determinations, without adhering to the notification and appeal processes, violate the protections afforded by ERISA.  Some insurers, however, contend that a repayment demand letter alone does not constitute an adverse benefit determination.[23] Where no funds are recovered or offset, some insurers may claim that overpayment letters alone do not trigger ERISA’s notice and appeal rights.[24] But, when recoupment efforts go beyond making a repayment demand and result in the offsetting of other compensable claims, the insurer must comply with ERISA protections requiring a “full and fair review.”[25] However, if the provider agreement clearly indicates that the provider is ineligible to deliver the service, and it was paid in error, ERISA may not be implicated.[26] State law may govern in this instance. “Mistaken authorization” is another basis under which an insurer might attempt to retroactively deny or recoup payments.  Provider agreements generally dictate the authorization procedures that the provider must follow in order to receive payment.  Medical providers rely on the benefit authorizations and pre-approvals they receive from the insurance carrier to reasonably determine that payment will be forthcoming.  Arguably, insurance plans have a duty to their participating providers to generate complete and accurate information via the provider’s verification of benefits.  The insurer’s retroactive assertion that authorization was “erroneous” places the provider in a precarious position.  If unsuccessful in the appeals process with the insurer, the provider could do nothing, and absorb the loss.  Or, the practice could pursue the patient.  Nothing in ERISA prohibits a provider from billing patients for services that are not covered under the benefit plan.[27] But, the provider’s contract may contain language prohibiting such recourse.   In the alternative, the provider could attempt to pursue the insurer under two potential courses of action – under ERISA or under state law.   ERISA also governs the provider’s allegations of an insurer’s improper processing of claims for plan benefits.[28] Adverse Benefit Determinations: The Right to Payment versus Rate of Payment ERISA distinguishes between “right to payment” issues and “rate of payment” issues.   “Right to payment” issues are created when an insurer fails to honor the patient’s benefit or when the insurer denies the patient’s claim.[29] Both of these situations constitute adverse benefit determinations.  A claim denial can be prospective or retrospective. The insurer’s prospective or retrospective denial of plan benefits triggers ERISA’s notification and appeal protections.  The “right to payment” is not a contract issue; it does not raise independent contractual duties outside of ERISA.  This falls squarely within the regulatory scheme of ERISA.[30] In contrast, “rate of payment” issues are contractual in nature.  The participating provider agreement creates a contractual duty that is independent of ERISA.  For a participating provider, fee schedule disputes do not necessarily involve ERISA.[31] An insurer’s recoupment of overpayments based on the contractual fee schedule is not a denial of benefits.  This type of payment dispute is a matter of contract law, where the underlying provider contract controls the payment provisions. ERISA’s notification and appeals processes are not controlling.  State law, and not ERISA, would most likely determine the outcome where the claims originate from this independent legal duty.[32] However, for providers who are not participating, underpayments or overpayments may implicate ERISA’s protections.  Between a non-participating provider and an insurance plan, there is no contract governing payment terms or fee schedules.  In the absence of a provider contract, the insurer does not have any independent contractual duties relative to the provider’s claims.[33] An out-of-network provider’s claims based on the underpayment of a claim likely raises a “right to payment” issue under ERISA.[34] In assessing which course of action to take, the provider must determine whether the insurer’s action has created a “right to payment” issue or one involving the “rate of payment.” Repayment Demands Based on Fraud Repayment demands based on fraud present a different issue entirely.  In the instance of fraud allegations, the insurer is generally attempting to recover the entire benefit paid to the provider.  An insurer’s repayment demand based on perceived fraud is a retroactive determination involving a dispute over “benefits due” when it involves specific claims.  ERISA provides the exclusive remedy only where the “claims are derived entirely from the particular rights and obligations established by the plan.”[35] That is, for ERISA to be applicable, a specific beneficiary with benefits arising under a benefit plan must be at issue.  The insurer may bring fraud allegations against the provider under state law where the claims are independent of any benefit belonging to a plan beneficiary. For example, an insurer may claim that the provider systematically renders services which defraud the insurer. (e.g., a general practice of billing for services not rendered).  In those instances, state fraud statutes may give rise to a duty independent of ERISA, which could allow state law, rather than ERISA, govern the dispute.[36] The resolution of fraud claims may depend on the provider’s conduct, rather than the terms and conditions of the beneficiary’s ERISA plan. [37] However, where recoupment of previously paid benefits appears to be an effort by the insurer to enforce the plan’s terms for specific beneficiaries, ERISA may govern an insurer’s efforts.[38] Facts and circumstances will dictate whether Federal or state law applies. Provider’s Options Medical providers are not beneficiaries of an ERISA plan.  An ERISA plan is independent of any participating provider agreement that may exist between the insurer and the medical provider.  Ordinarily, a person who is not a party to a contract would not have any rights under that contract.  With patients and medical providers, the patient’s assignment of benefits confers rights to the medical provider under the patient’s health care plan.  Under an assignment of benefits, the medical provider stands in the shoes of the patient, and may seek to enforce payment of the patient’s benefits.[39] Through a valid assignment, the provider may avail itself to the applicable ERISA protections on behalf of the patient.[40] The provider should insist on the insurer’s compliance with ERISA’s protections.  A paper trail should be maintained to document all of the provider’s efforts in resolving the disputed claim.  The provider should also document all of the insurer’s actions as well.  Failing resolution between the provider and the insurer, the provider could challenge the insurer’s retroactive denial of coverage under section 502 of ERISA.  A number of courts have held that ERISA governs a provider’s claims for benefits where the insurer’s representations have “the effect of orally modifying the express terms of an ERISA plan and increasing plan benefits for participants or beneficiaries who claim to have been misled.”[41] In plain language, this means that the insurer’s representations could create a benefit in situation where ordinarily no benefit existed.   Provider agreements define “covered services” for which the insurer will reimburse when performed by the provider.  With respect to the plan beneficiary, however, covered services are defined under the ERISA plan, not by the provider agreement. An insurer may claim that ERISA procedures are inapplicable by contending that the terms of the provider agreement control repayment and recoupment.  ERISA’s language appears to be contrary to that assertion.[42] To the extent that ERISA does not control, the provider could elect to pursue state law claims under a negligent misrepresentation theory if recoupment is based on the insurer’s erroneous or mistaken authorizations.  A number of courts have held that providers may maintain state law claims against an insurer based on erroneous verifications of coverage and erroneous information pertaining to the existence and extent of coverage.[43] A provider’s state law claim may be appropriate not because of the patient’s coverage, but because there is no ERISA coverage.  A key distinction that must be made is whether the insurer’s decision is actually an adverse benefit determination or an interpretation of the terms of the provider agreement.[44] Conclusion Providers should always attempt to clarify, understand and resolve claims issues by dealing directly with the insurance carrier.  ERISA protections are only available for plans that are, by statute, ERISA plans.  Otherwise, state law governs.  If the plan falls under ERISA, the medical provider may challenge the insurer’s adverse benefit determination and take advantage of all of the notification, denial substantiation requirements, and appeal rights.  The provider should attempt to understand the insurer’s reasoning behind its repayment demands to determine whether it constitutes an adverse benefit determination. The provider may have a cause of action for the insurer’ actions regarding an ERISA beneficiary that may be brought under a state law claim if certain facts and circumstances exist.   Providers should recognize the distinction between disputes arising out of the right to payment versus the rate of payment.  For participating providers, “rate of payment” issues may implicate state law because of the existence of a contract.  For non-participating providers, where no contract exists, the payment dispute may fall into t