By Christopher Guadagnino, Ph.D.

Published May 2001

• React to this article in the Discussion Forum.

Robert S. Zimmerman is Pennsylvania Secretary of Health.

PND: What is Pennsylvania’s HIV reporting policy?

RSZ: Pennsylvania has no HIV reporting, and that’s what the issue of the day is. We do have AIDS case reporting which is done in accordance with Centers for Disease Control’s (CDC’s) criteria for defining an AIDS case. That’s been reportable since 1981. What we’re looking to do now is to determine a way to report HIV, since HIV infection occurs well before AIDS cases develop. We announced in March that it was our intention to move forward with a regulatory proposal to make HIV confidentially reportable by name. The alternative that we decided not to pursue was HIV reporting by unique identifier or unique code.

PND: What will the proposal process entail?

RSZ: The Health Department currently requires the reporting of over 50 different conditions and diseases, all of which are reportable to us confidentially by name—exactly in the same method that we’re proposing for HIV reporting. Because there was such a great deal of interest in HIV reporting and the method that would eventually be chosen, we decided to signal in advance of putting out a proposed regulatory package that we were preparing one to release. We would publish in the Pennsylvania Bulletin a regulatory package with the background as to why we’re seeking the regulatory authority and the details of the regulation. Normally, there’s a 30-day public comment period. We would also send it to the Pa. House and Senate Health and Welfare committees, and Health and Human Service committees, as well as to the Independent Regulatory Review Commission (IRRC).

We plan to propose the regulation package at the end of April. After the 30-day public comment period, the standing committees in the Pa. Legislature have 20 days and the IRRC has ten days to review and provide comments to us. We review all the comments, make changes that we feel are appropriate and prepare a final regulatory package for approval. That package goes back almost the same path. The standing legislative committees have 20 days to complete a review. They sometimes hold hearings, either during that period or the previous period in which they have the document. The IRRC also has ten days. The IRRC must have a public hearing before taking a vote to approve or disapprove the regulations.

PND: What would the policy require physicians and other health care providers to do?

RSZ: It would require them to do something that’s very familiar to them: report various tests to us, which they would normally do for over 50 conditions already. There are various times that a physician in the normal practice of medicine might be concerned about the HIV status of an individual and either do or refer the patient for HIV counseling and testing. When they receive or are made aware of the result, we would expect them to report by name and various demographic data, the HIV status of that person if in fact there is a confirmatory test that is positive. The lab would be required to report that positive test to us with the name of the patient and various demographic data about the patient. There is also a variety of other tests that are used to determine HIV and to assess the progress of the HIV infection that are reportable: HIV viral load or PCR test, CD4 and T-cell tests. T-cell tests with counts less than 200, or a percentage of less than 14 percent, would be reportable. Perinatal HIV-positive status would also be reportable to us. If an individual appeared in a physician’s office for a pregnancy test and, based on the physician’s knowledge and interview with the patient, the physician may recommend HIV testing for the pregnant woman to intervene and prevent infection during the pregnancy or to do things that will successfully prevent passing that HIV status on to the unborn child or to the child when it is born. Sometimes the presence of HIV in a pregnant woman might not be known until a woman presents in a delivery room, and we’d want to know at that point as well.

PND: Critics of your proposal believe that name reporting would deter individuals who have not visited a physician, or who are otherwise not yet in the health care system, from seeking HIV testing. What is your response to that concern?

RSZ: Right now, we have completely anonymous HIV testing and counseling available throughout the Commonwealth. We would continue to offer, even under a confidential name reporting system, anonymous HIV testing in our government-sponsored clinics to people who are concerned about their HIV status so that they’re not deterred from testing, and they will continue to have the option to go to one of those instead of going to a physician office or another site that might have to report that status, confidentially by name. The government-funded testing sites won’t be a regular part of the surveillance system we want to create with name-based reporting.

There are several reasons to do HIV testing in the first place. First of all, to assure the person that doesn’t have HIV that they do not. To have a teachable moment in which our counseling and testing people can engage them in a discussion of how to protect themselves and prevent HIV infection. If they are HIV-positive, it gives them an opportunity to discuss several things with the individual: to connect them with clinical care so they can manage and monitor their HIV status and do what can be done to prevent it from progressing to an AIDS case. In addition, we have the opportunity to talk about how that individual can protect their partners from getting HIV infection from them. In many cases, the individual is very concerned about how to do partner notification, and we offer assistance with voluntary partner notification. Nationally, CDC estimates that almost 80 percent of persons tested for HIV do so in the private sector. They don’t wander into a public clinic where we would have the opportunity and the teachable moment to immediately engage the person and connect them with the health care system.

PND: Is any data from the government-sponsored clinics reported to you?

RSZ: We want to know how many people they’re seeing; the age, race, and basic demographic data. But we’re not using that to determine if they’re a first time and only visit, versus a previous visit. Obviously, if someone comes in for an HIV test, we’re going to encourage them to come back for the results and to have the post-test counseling regardless of what their HIV status is.

PND: How accessible are Pa.’s government-run clinics?

RSZ: I think there are between 80 and 100 clinic sites throughout the state at any given time. Some we run directly and some are run by county or municipal health departments. Others are run with our partners through contract. So, they are fairly widespread and accessible.

PND: Do you anticipate a larger flow of individuals to the anonymous sites simply to avoid name reporting?

RSZ: No, we don’t expect a larger number. That hasn’t been the experience in the other states that have pursued confidential name reporting. But, we are prepared if that would occur. We’re going to assist our county and municipal health departments with additional funds to do voluntary partner notification activities, counseling, testing, and so forth. We actually do have funds in the coming year’s budget to expand the capability of them to respond if that would happen.

PND: Critics of confidential name reporting contend that unique identifier codes would accomplish the same function as name reporting without deterring individuals from HIV testing. Why not use codes rather than names?

RSZ: Name reporting allows us to more accurately track the epidemic, to do early case finding and linkage to prevention and care, and it allows us to allocate resources more effectively than under a non-name-based reporting system. A name-based reporting system would better meet the CDC’s data accuracy and validity standards. They, as well as other parts of the federal government, will begin using HIV data. They currently use AIDS data and projected HIV data in order to target funding and intervention resources. In 2005, I believe, they’re going to require HIV reporting as the basis for funding. When you use name-based reporting, you virtually eliminate duplicate counts and it permits our public health people to get back to the source if the epidemic risk or the AIDS-defining illness data is incomplete. A lot of times, for the reportable diseases and conditions, we’ll get partial data from a physician or from a lab. The only way we’re able to complete the data and understand what’s being reported to us is if we’re able to get back to that individual. It also allows us to do trend analysis earlier.

PND: What is it about names that is more accurate than unique identifier codes?

RSZ: If physician X at location X reports an HIV test result for a patient along with all the demographic data that goes with that patient, we’re able to reconnect with that physician to learn more and assist in the care of that patient. It’s very important to have a name and a provider so we can follow back when we need to follow back. If I’m already in a care system, my name is already known. Another advantage of name reporting is to ease the ability of the physician in a laboratory to report in the same way as they do for all 50-plus other reportable conditions. It also has less implementation burden and costs on county, municipal and state health departments because a unique identifier system would require us to find a way to train physicians, laboratories, hospitals and other organizations that would acquire HIV data to establish a unique code for each new patient and to fill out the form differently. Many of them will maintain different files because, in most cases where a unique identifier is used by states, for some period of time the clinic or the physician is required to create logs that allow them to unmask the unique identifier in order to do data validation and early follow-back. When the state goes back and says, "We don’t understand this form. The unique identifier is filled out wrong," the physician might maintain separate records of people for whom he has created unique identifiers, which arguably creates greater concerns about breach of confidentiality than if it was a regular name in a case file, because they can always go back and find their patients’ files. Any time you create a log system to allow you follow-back for a short period of time, the tendency is to create a separate file, filing system, or aggregate of files. Quite frankly, I think that presents a more efficient opportunity for breach of confidentiality than simply having a clinical file on an individual for whom you’ve already reported their HIV status. In addition, there are only a few states that meet CDC’s stringent requirements for data validity and unique identifier systems are not fail-safe in terms of providing unduplicated counts.

PND: A number of AIDS service organizations are skeptical that confidentiality of name-based reporting can be assured. What is your response to that concern?

RSZ: In Pennsylvania, not only do we have general laws to protect confidentiality under our reportable conditions law, but we also have Act 148, which was specifically designed and passed to protect the confidentiality of HIV-related information. That Act overlays our basic confidentiality laws that prohibit us from disclosing a person’s HIV status or any other HIV-related information to other government or private agencies, police, welfare agencies, insurance companies, employers or anyone else. In addition, there has been almost no evidence that name-based reporting in the 34 states that already do it has led to any breaches of confidentiality. There might have been one case in one state years ago—I believe it might have been Florida. Although it’s understandable that individuals would have concern about confidentiality on something this sensitive, it is not based in any reality. We empathize with their concern, and that’s why we’re going to great pains to make the anonymous testing sites available. CDC has funded studies in every state that does HIV reporting to determine the extent to which testing has been suppressed. We intend to take advantage of those studies and monitor testing. In states that use HIV name-based reporting, there has been no evidence of any significant decrease in testing. Although we as a Commonwealth arrive at this conclusion late in the process compared to 34 other states, we have the benefit of looking at the experience in those 34 states and it tells us that, if this is handled appropriately, there should not be concerns about either confidentiality or suppressed testing.

PND: If the regulatory process goes in your favor, what is the earliest date that these regulations would be implemented?

RSZ: We’re looking at January 2002. The Pennsylvania Medical Society, the Hospital & Healthsystem Association of Pennsylvania and a number of other provider organizations have supported the use of confidential name-based reporting. We would hope that they do so again during the regulatory process because I think it’s very important for public confidence that there is a consensus among the public health and medical communities that this is the way to go.