Clinic operators say the majority of their customers have health insurance, but come to the clinics to avoid the inconvenience and wait times inherent in scheduling an office visit with their primary care physician. Clinics typically have contracts with major insurers and accept the same copayment the patient would have paid to their physician office, while the clinics generally charge patients without insurance between $50 to $80 for a clinic visit, less than they would be billed if they sought care at an emergency room.

These clinics fill in a perceived gap in convenience and could motivate people to seek care they may have foregone, while increasing access to care by the uninsured or underinsured, and reducing inappropriate emergency room utilization. Conversely, the clinics could reduce the frequency of patients’ visits to primary care physicians, who are more familiar with their health histories and conditions, who are less likely to miss serious health conditions during diagnosis, and who can more completely meet their preventive care needs.

The American Medical Association (AMA) and the American Academy of Family Physicians (AAFP) have issued normative guidelines for retail-based health clinics, which the industry says it has embraced, while the American Academy of Pediatrics (AAP) opposes retail-based clinics as an appropriate source of medical care and strongly discourages their use.

One local health system – AtlantiCare – has responded by establishing its own RBCs, while other health systems in New Jersey are reportedly exploring possible affiliations with clinic operators which have not yet entered the state.

RBC expansion comes at a time when, according to a declaration last month by the American College of Physicians (ACP), the U.S. health care system is facing a collapse of primary care medicine, with few new physicians going into primary care and many of those currently in practice leaving the field or planning to retire in the near future.

If the number of RBCs in New Jersey and around the country grows as rapidly as their operators project, this curious market phenomenon could have increasingly important implications for primary care physicians and their relationship with patients; as well as quality, cost and continuity of care.

While critics decry the possibility that RBCs could erode the relationship between patients and their primary care physicians, clinic operators declare that their use of evidence-based guidelines, electronic health records and physician referral networks actually strengthens patient-centered care and promotes the "medical home" model of care endorsed by the ACP – access to longitudinal and comprehensive care that is anchored by a personal physician who is responsible and accountable for managing the care of the patient.

Centers Proliferating

There are about 200 RBCs operating across the country, according to the Convenient Care Association – a new national trade association that seeks to develop a branding and marketing strategy to promote the centers, and to establish uniform quality performance standards for them. Retail stores around the country that are housing the clinics include Wal-Mart, Target, Walgreens, Eckerd, Duane Reade and regional supermarket chains.

In New Jersey, CVS Corp. has opened ten MinuteClinics – in the Bergen-Passaic, Middlesex-Monmouth, and Newark metropolitan regions – while the company operates 146 clinics in 18 states, and hopes to continue to expand in New Jersey, according to Jim Woodburn, M.D., MS, MinuteClinic’s chief medical officer. Begun in Minnesota in 2000, MinuteClinic has experienced its most significant growth in the past two years, and has "high hopes" for urban markets with concentrated populations in New Jersey, New York and Pennsylvania, he says.

About 75 percent of MinuteClinics’ New Jersey patients have health insurance and the company has contracts with Medicare and most private insurers, while it is currently in negotiations with Horizon Blue Cross Blue Shield of New Jersey, says Woodburn. Most treatments cost between $49 and $59, while MinuteClinic accepts as payment in full co-payments from patients whose insurers have contracts with the company.

"Ease of access is the need we meet, and it is among the highest-valued patient desire to get a high-quality care visit and be out of the door with a prescription – if appropriate – within 25 minutes," says Woodburn, who notes that many patients have experienced delays ranging from hours to a day or more to see their primary care physician. Patients also report that the clinic is an affordable alternative to a hospital emergency department visit, while 93 percent of patients have rated their satisfaction with care at MinuteClinic as excellent, and seven percent as good, adds Woodburn.

The clinic’s nurse practitioners take a medical history of every patient (who must be 18 months and older – an industry standard), diagnose them just as they would within in a physician’s office, and refer patients whose condition is beyond the scope of the clinic – such as an asthmatic with significant airway restriction – to an urgent care center or emergency room, which happens less than five percent of the time, says Woodburn. MinuteClinic assumes liability for those patients until the moment they enter the urgent care facility, he adds.

MinuteClinic adheres to nationally-established best practice guidelines for the conditions it treats – including allergies, bronchitis, pink eye, strep throat, bladder and sinus infections, swimmer’s ear, flu, mononucleosis, minor skin infections and rashes, and others – and embeds the guidelines into a clinical decision support tool which creates an electronic medical record for every patient, says Woodburn. That medical record summary is sent to a primary care physician if a patient has one and gives their permission, which represents between two-thirds and three-quarters of MinuteClinic’s patients, he adds.

Patients who do not have a primary care physician are offered the names of several who are board-certified in the region and who are accepting new patients, based upon outreach efforts by Woodburn when a new MinuteClinic opens. Fewer than one percent of a region’s primary care physicians typically respond to the outreach and agree to be on MinuteClinic’s referral database, he adds.

Clinic staff operate under a collaborative agreement with a local medical director who is available by phone or pager for consultation, and who does periodic randomized chart review and gives feedback to the nurse practitioners about their treatment and prescription decisions, says Woodburn.

The clinics do not treat chronic conditions, which Woodburn says are the proper domain of a primary care medical home, and by handling the simpler cases, the RBC model should leave physicians more time to focus on conditions "crying out" for greater ease of access – including chronic care, obesity, smoking cessation, adolescent emotional care, eating disorders and chemical dependency, says Woodburn.

The market niche of RBCs is to offer services to patients with illnesses that are "acute, self-limited and well-defined," says Charles Peck, M.D., chief medical officer of Take Care Health Systems, which operates 36 clinics in Pennsylvania, Illinois and Missouri, and hopes to have 250 clinics by the end of this year. Typical patients, he says, include a 14-year-old with a 24-hour fever, a six-year-old pulling at his ear for 12 hours, or a 48-year-old female with a rash on the upper arm; while an elderly person with swollen legs and acute shortness of breath would be referred to an emergency room or urgicenter.

Among the things Take Care Health looks for when selecting a market for its clinics is a dearth of primary care physicians and a large proportion of non-urgent visits to an emergency room or urgicenter, and the company surveys where its patients would have gone if a Take Care Health clinic were not available, says Peck. About 60 percent of its patients say they would have gone to the emergency room, while about 10 percent say they would not have sought care, he notes. Surprisingly, about 80 to 85 percent of Take Care Health’s patients have health insurance – largely the same population that has been seeking care at the emergency room, he adds.

"We wouldn’t be in business if people were getting the kind of health care services they need, when they need it," says Peck. "If physicians don’t want to have to worry about companies like us, they have to make some alterations in their practice," like scheduling open slots throughout the day, he adds.

Health systems are beginning to respond to RBCs cropping up in their service areas. "We saw this as a potential competitive threat, and we wanted to be ahead of the competition by offering the highest quality services," says Don Parker, president and CEO of AtlantiCare Health Services, a sister company of southeastern New Jersey’s largest health care system, which includes some 450 staff physicians, two hospitals and a health plan.

About five months ago, AtlantiCare partnered with the parent company of ShopRite and opened a HealthRite clinic in Somers Point, with plans to open six more in the region by the first quarter of 2008, says Parker.

AtlantiCare is also in discussions with health systems outside of its service area to explore the possibility of franchising the HealthRite model, he notes. Part of that model is based upon the belief that there is healing potential in integrating health care with food services – by attacking obesity, for example – and AtlantiCare is working with ShopRite to create nutritional tours of its stores, and isles of specially marketed healthy foods, says Parker.

Parker believes that the RBC model is more effectively implemented by health systems, which have existing referral networks and fully integrated health services. After diagnosis and treatment by the HealthRite clinic’s nurse practitioner, a medical record is sent electronically or faxed to the patient’s primary care physician or, if they don’t have one, the clinic offers a choice from AtlantiCare’s medical staff, says Parker.

About two to three percent of HealthRite patients have been referred out to physicians or to an AtlantiCare urgent care center or emergency department, while AtlantiCare promotes a telephone Access Center offering advice to patients about which level of care they should seek for their condition, including the HealthRite clinic, says Parker. "We do not want these clinics to become medical homes. They are all about quick access for minor ailments," and patients who come back several times for the same ailment are referred to a primary care physician, he notes. "Our interest is to keep the relationship going with your primary care physician, not to substitute for them," Parker adds.

There are two collaborating physicians for the Somers Point HealthRite – one family physician and one pediatrician – who are available for consultation by telephone, develop protocols based on AAFP practice guidelines, and review charts on a monthly basis for adherence to practice guidelines, says Parker.

For those without health insurance, the clinic charges $55 for most of its services, while about 80 percent of HealthRite’s patients do have health insurance, and the clinic currently has contracts with Medicare and Horizon, says Parker.

Another national RBC operator – RediClinic – operates within Wal-Mart, Walgreens, Duane Reade and H-E-B grocery stores in five states – New York, Texas, Arkansas, Oklahoma and Georgia – and expects to enter Virginia and to have 40 clinics running nationwide by the end of February, according to Christopher Kersey, M.D., MBA, RediClinic’s chief medical officer.

RediClinic has co-branded its marketing materials with large health systems including Memorial Hermann in Houston and Hillcrest in Tulsa, as well as with physician groups, and Kersey says the company has had inquiries from large New Jersey health systems about possible partnership arrangements.

About 40 to 50 percent of RediClinic’s patients do not have insurance, and many would not have gone to see a physician, says Kersey, who notes that some of its markets have populations with particularly high uninsured rates. A typical patient would be a "rushed mother with children that need an antibiotic," he notes. Like other RBCs, RediClinic creates an electronic health record for each visit and if given permission sends it to a patient’s primary care physician. Patients without a doctor are referred to RediClinic’s supervising physicians, to free clinics, and to local physicians with whom it has referral network arrangements, Kersey adds.

Impacts and Concerns

Suspicions linger about whether the market-driven trend of RBC growth will be bad for patients and physicians, although outright opposition within the medical community seems to be restricted to the AAP.

As prescription drugs have become a transformative treatment in health care, large retail locations with pharmacies have capitalized on the business opportunity to prescribe them, in a health care setting offering convenience and low cost, according to Sherry Glied, Ph.D., Department of Health Policy and Management, Columbia University, and a grantee of the Commonwealth Fund. Scrutiny should be paid to the possibility of a conflict of interest, namely, whether the clinics will be pushing the drugs, she adds.

The proliferation of RBCs is a symptom of a larger problem of access to the traditional health care delivery system, and New Jersey has one of the nation’s lowest per capita supply of primary care physicians in the nation, according to David Swee, M.D., Associate Dean of Education at UMDNJ’s Robert Wood Johnson Medical School, and head of the Medical Society of New Jersey’s Council on Medical Service.

Since primary care physicians are very busy, any reduction in visits from slightly ill patients who instead go to RBCs is not likely to have a significant economic impact on their practices, believes Swee, but the larger problem remains: "We need better support for the state’s primary care infrastructure," he says, pointing to national quality indicators that put New Jersey at the bottom for primary care quality and near the top for cost. "The U.S. has to decide whether it wants a primary care-based health care system," he adds.

According to a study commissioned by AtlantiCare, there will be a shortage of 27 primary care physicians over the next five years in Atlantic and northern Cape May counties, says Parker. He characterizes HealthRite clinics as well-adapted to the region’s "unusual casino environment" in which patients frequently seek care after physicians’ normal business hours, and he says the clinics will join AtlantiCare’s urgicenters in "picking up the slack."

"The baby boomer population will overwhelm our system, unless we get innovative and responsive to ways of offering care at different levels and costs," says Parker.

Maintaining an adequate supply of nurse practitioners to staff RBCs may also become difficult in the future, as demand for them is already escalating, given the 80-hour-per-week work limit on medical residents and an increasing demand for nurses in primary care settings, according to Linda H Aiken, Ph.D., RN, Director of the Center for Health Outcomes and Policy Research, University of Pennsylvania. The growing demand has fueled enrollments in nurse practitioner programs, and that trend needs to continue, while salaries of nurse practitioners are also rising as competition intensifies among hospitals looking to hire them – which Aiken says may eventually dampen the popular idea that nurses can deliver primary care at vastly lower costs than primary care physicians.

Nurse practitioners have been shown to lower the cost of care by 30 percent or more, depending on their setting or nature of practice, by ordering significantly fewer tests and prescriptions than do physicians, says Aiken, although the defined set of treatments offered at RBCs may limit the potential for those cost savings.

Hundreds of studies in the medical literature demonstrate that nurse practitioners and physician assistants provide care with as good, or better, outcomes as primary care physicians, while their performance has been demonstrated in a variety of settings without on-site physicians, such as occupational health and school health clinics, says Aiken. By working "upstream" at the fullest level of their expertise, nurse practitioners can blunt the shortages of primary care physicians, who in turn can blunt the shortage of specialists by using advances in diagnostic and therapeutic technologies to perform many of the services they now refer to specialists and hospitals, says Aiken. The primary care physicians AtlantiCare has spoken to believe that RBCs will help them to concentrate on more complex and chronic cases, says Parker.

Swee is concerned that RBCs may erode quality of care if patients forgo the benefits of their physicians’ preventive care guidance by seeing them only for more serious illnesses. While he assumes that RBC staff are well-supervised by off-site physicians, Swee says that nurse practitioners are most effective when working side-by-side with physicians, whose offices have more resources than RBCs to distinguish minor illnesses from major ones, and he adds that it can be difficult for patients to distinguish when they are ill enough to warrant going to a physician or emergency room instead of an RBC.

"We don’t think that we discourage primary care physician visits," says MinuteClinic’s Woodburn. "We’re committed to coordination of care by sharing a patient’s medical record with their primary care physician electronically within minutes, and we support and help people get access to a medical home," he notes. "The conditions we treat are generally amenable to a one-time evaluation and treatment plan, and the patient is the one who has the most interest in follow-up with a physician if their condition does not get better," he adds.

AAP remains concerned that RBCs will lead to fragmentation of care, and strongly discourages their use as an appropriate source of medical care for infants, children and adolescents. Among AAP’s concerns are that RBCs will lead to episodic care for children with special health care needs and chronic diseases – who may not be readily identifiable; lack of access to a complete and accessible health record; use of tests for the purposes of diagnosis without proper follow-up; exposure of patients with contagious diseases in a commercial retail environment with little or no isolation; and missed opportunities for pediatricians who see a child for something minor to discuss health issues with the family, catch up on immunizations, and identify undetected illness.

Aiken questions the degree to which continuity of care benefits are preserved under the traditional employer-based health care system, as patients often change providers when they change insurers, while physicians change jobs, or are under great pressure to spend no more than 15 minutes with a patient. The potential of RBCs to accelerate care fragmentation remains unknown and should be evaluated, says Aiken, but she notes that consumer preferences are important in health promotion and disease prevention, and the benefit of more accessible, timely care may override concerns of care fragmentation.

AAP concedes that the shifting economic and organizational dynamics of the current health care system will likely support the continued existence and expansion of RBCs, and it has issued a set of principles for their operation:

· Refer the patient back to the pediatrician or other primary care physician for all future care, or assist the family in establishing contact with one.

· Promptly communicate with the patient’s pediatrician or other primary care physician within 24 hours of the visit, including reason for visit, diagnosis and disposition, findings, laboratory results (if any), and an indication as to whether any follow-up is needed.

· Use evidence-based medicine, including AAP clinical guidelines and those it endorses.

· Take precautions to prevent the spread of contagious diseases, and comply with all health care facility standards (e.g., hygiene, safety, Occupational Safety and Health Administration regulations).

· Avoid offering financial incentives for visits to RBCs in lieu of visits to pediatricians’ or other primary care physicians’ offices.

Other medical societies seem to be guardedly supportive of RBCs, and have released their own guidelines.

The AMA regards RBCs to be consistent with its policy on "pluralism" in health care delivery, which supports "free market competition among all modes of health care delivery and financing, with the growth of any one system determined by the number of people who prefer that mode of delivery, and not determined by preferential federal subsidy, regulations, or promotion." In that light, RBCs may be seen as one end of the spectrum of the health care market, with "concierge care" – prepaid personal access to a menu of physician services – on the other end. The AMA noted that many physicians have responded to RBCs by beginning to evaluate making changes to their practices in order to become more accessible to patients, such as extending office hours to evenings and/or the weekends, and creating early morning sick call hours to accommodate patients without appointments.

The AMA noted, however, that many physicians also remain concerned about the impact RBCs may have on their practices, the physician-patient relationship, the coordination of care for patients, and the potential implications of store-based health clinics that "cherry pick" locations that primarily have an affluent customer base.

To help promote safe and effective operation of RBCs, the AMA urged any entity that operates store-based health clinics to adhere to the following principles:

· Have a well-defined and limited scope of clinical services, consistent with state scope of practice laws.

· Use standardized medical protocols derived from evidence-based practice guidelines to insure patient safety and quality of care.

· Establish arrangements by which their health care practitioners have direct access to and supervision by those with medical degrees (M.D. and D.O.), as consistent with state laws.

· Establish protocols for ensuring continuity of care with practicing physicians within the local community.

· Establish a referral system with physician practices or other facilities for appropriate treatment if the patient’s conditions or symptoms are beyond the scope of services provided by the clinic.

· Clearly inform patients in advance of the qualifications of the health care practitioners who are providing care, as well as any limitation in the types of illnesses that can be diagnosed and treated.

· Establish appropriate sanitation and hygienic guidelines and facilities to insure the safety of patients.

· Be encouraged to use electronic health records as a means of communicating patient information and facilitating continuity of care.

· Encourage patients to establish care with a primary care physician to ensure continuity of care.

Rather than attempting to stop the RBC model from emerging in the marketplace, the AAFP also released a set of desired attributes for such clinics, largely mirrored by the AMA’s list: well-defined and limited scope of clinical practices, evidence-based medicine, team-based approach – including formal connection with physician practices in the local community, referral system to physician practices and other entities appropriate to the patient’s symptoms, and use of electronic health records.

AMA and AAFP standards are used by almost all RBC companies, according to AtlantiCare’s Parker, who is a founding executive board member of the Convenient Care Association, and he says it is likely that the association will achieve its goal of establishing uniform quality performance standards for the industry.