RULES AND REGULATIONS
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 27]
Reporting of AIDS, HIV Test Results, CD4 T-Lymphocyte Counts and Perinatal Exposure of Newborns to HIV
[32 Pa.B. 3597]
The Department of Health (Department), with the approval of the Advisory Health Board (Board), adopts amendments to Chapter 27 (relating to communicable and noncommunicable diseases) to read as set forth in Annex A.
A. Purpose and Background
The Department's regulations require name reporting of individuals who: (1) have had positive test results established from any test approved by the Food and Drug Administration (FDA) to establish the presence of the Human Immunodeficiency Virus (HIV); (2) have low CD4 T-lymphocyte cell counts as described in this Preamble; or (3) are pregnant women who have had positive HIV test results and whose newborns have been perinatally exposed to HIV. The regulations also clarify that cases of Acquired Immune Deficiency Syndrome (AIDS) are reportable based on the case definition of the Centers for Disease Prevention and Control (CDC). Reports of AIDS include reports of presumptive diagnoses of AIDS based on the presence of an AIDS defining illness (for example, Kaposi's sarcoma) with laboratory confirmation of HIV.
In holding to its proposal to require reporting of these conditions and infections by name, the Department is following recommendations of the CDC for reporting HIV infection and AIDS. See ''Morbidity and Mortality Weekly Report'' (MMWR) 1999; 48 (No. RR 13) ''Guidelines for Human Immunodeficiency Virus case surveillance, including monitoring for HIV infection and AIDS'' (Guidelines) p. 12. Reporting by name is also consistent with the Department's requirements for the 52 other diseases and conditions (including AIDS, which is reportable by name) currently reportable in this Commonwealth. The Commonwealth joins 34 other states that require confidential name-based reporting for HIV infection. The Ryan White CARE Act (42 U.S.C.A. §§ 300ff-21--300ff-37), one of the Department's primary funding streams for HIV services, requires the inclusion of HIV incidence data in determining the funding formula for state grants. Having accurate data obtained through name reporting will help assure that the Department receives the full funding to which it is entitled.
Collecting this data systematically provides the Department with the most accurate picture of the prevalence of HIV/AIDS. This will enhance the Department's ability to develop, implement and evaluate community-based public health interventions for HIV-infected persons and at-risk partners. The information also provides the Department and local health departments with enhanced opportunities to provide case management services for HIV-infected persons and their at-risk partners. These services include helping assure that HIV-infected persons are linked into appropriate community-based medical and social service support systems, including partner notification services, thus helping slow the progression of HIV infection to life-threatening AIDS and preventing the further spread of disease.
The majority of comments the Department received on its proposed amendments dealt with the Department's decision to require reporting by name. Other general comments were received on a variety of topics: the Department's decision to require reporting electronically; the confidentiality and security of the information reported; the cost of the proposed rulemaking and the lack of an exception in the proposed regulations to name reporting for research projects. The Department will discuss these general comments before addressing comments addressed to specific provisions of the proposed amendments.
The Department's rulemaking relating to HIV reporting and the other reporting addressed in these regulations is a very specific amendment to its broader regulations governing prevention, control and reporting of communicable and noncommunicable diseases within this Commonwealth. The Department proposed sweeping changes to update the entire regulatory scheme relating to communicable and noncommunicable diseases at 30 Pa.B. 2715 (May 27, 2000). Final-form rulemaking followed and those amendments were published and went into effect at 32 Pa.B. 491 (January 26, 2002). Because of the importance of HIV reporting to the Commonwealth, the Department could not wait to propose additional amendments to Chapter 27 relating to HIV reporting until after the adoption of the broad changes to Chapter 27.
The timing of the Department's proposed rulemaking relating to HIV reporting, therefore, required that the Department propose changes to Chapter 27 as it read prior to the January 26, 2002, amendments. Consequently, in most cases, the text of regulations to which the Department is now adopting amendments is not the same text to which the Department proposed amendments.
In response to a comment from the Independent Regulatory Review Commission (IRRC) asking how the Department would coordinate the two sets of rulemaking, and upon advice from IRRC, the Department has drafted Annex A to show only amendments to the current text of regulations that were altered following the proposed rulemaking.
The Department received many comments objecting to its proposal to require reporting by name of perinatal exposure of newborns to HIV, certain HIV test results and CD4 T-lymphocyte cell counts. These comments came from various groups of persons as well as individuals, including providers, legislators, one local health department and public interest groups.
The Department also received comments in support of its proposed amendments. Various professional medical associations, provider groups, local health departments and public interest groups supported the Department's proposal to require reporting by name. The Health and Welfare Committee of the Pennsylvania State Senate supported the proposals contingent upon the Department taking appropriate steps to make anonymous testing a readily available option to those who might otherwise avoid HIV testing, and ensuring that information regarding anonymous testing is available to at risk populations.
The Department has listed the comments both in opposition to and in support of confidential name reporting in this Preamble, eliminating repetitive remarks where possible, and has answered these comments in one comprehensive response.
Comments in Opposition
The Department should justify the need for names and addresses of individuals in the reports and then explain how the reports will be maintained.
Research shows that requiring name reporting deters people from taking HIV tests. Requiring name reporting will undermine hard work done in the Delaware Valley to encourage people to access HIV services. There are 10 states and territories that have chosen to require reports by unique identifier, including Maryland, Vermont, Illinois and California, and this method of reporting does provide accurate data.
Name reporting will delay treatment. The outcry by medical providers, service providers and people living with HIV/AIDS is telling. It is inconceivable that name reporting will not harm lives.
HIV reporting is necessary, but not by name. The Allegheny County Health Department's approach of requiring reporting by unique identifier is better, and should be followed.
Name reporting, even with the availability of anonymous test sites, frightens people, and will deter persons from getting tested, because they are not convinced that confidentiality can be assured.
Name-based reporting will cause women to refuse or forgo prenatal care. This is a concern because convincing pregnant women to take an HIV test has reduced the number of vertical transmissions of HIV.
The Department should explain why a reporting system based on unique identifiers will not accomplish its objectives. Supporters recognize that anonymous testing should augment name-based reporting. But a unique identifier system would reduce the need for anonymous testing.
The CDC recognizes that a unique identifier system will provide necessary information to the public health system to control the spread of disease. The Department should institute a unique identifier system.
Because peer review publications are evenly split on the question of whether persons will be deterred from testing by required name reporting, the Department should err on the side of caution and develop a unique identifier system.
A unique identifier system would protect the confidentiality of persons living with HIV while also providing effective tracking of the epidemic. The Commonwealth could benefit from the California experience where reporting is done by a unique identifier.
A unique identifier system will not cause the Department to lose funding. The Department will only lose funding if no information is reported by the Department to the Federal government. Funding will be a problem under a name reporting system, because, if less people choose to be tested, the Department will have less cases to report. The Department must set up a system that encourages the maximum number of persons to be tested.
Reporting by unique identifier in the initial phase of the continuum of care provides the most precise data available, ensuring that credible information is secured for planning and capturing maximum funding resources.
Although some reported figures show ''improved'' statistics regarding HIV cases after name reporting is instituted, these figures are misleading. Most often this methodology followed a period of no required reporting, so an improvement in statistics would occur as a matter of course.
The Department's decision to propose name reporting as the method by which cases of HIV would be reported goes contrary to public testimony offered at the Department's meetings. Ninety-five percent of the people at those public meetings opposed name reporting.
Reporting by name will increase the potential for breaches of confidentiality. Discrimination could occur if the security and confidentiality of information maintained by the Department was breached in some way.
Disenfranchised populations will not be tested if there is the slightest indication that their names could become public knowledge. This will harm the most marginalized populations, including, for example, persons who use illegal drugs.
Name reporting threatens the right to privacy.
Name reporting interferes with the physician-patient relationship.
Comments in Support
Confidential name reporting will enhance the Department's opportunities to provide case management services to patients, including getting patients into more services and tracking them to determine quality of care, without fear of breach of confidentiality.
The Department has been thorough in its review of the benefits and shortcomings of reporting based on names and on unique identifiers. The Department has prudently made the determination that name reporting is the best option, based on public health reasons. Public perception and fear should not drive policy.
Name reporting in delivering direct medical and respite care allows medical professionals to treat HIV clients in the same manner as clients treated for all other communicable diseases, providing the same standard of care.
The Department is to be commended for providing assistance to local health departments through the implementation of these regulations. Name-based reporting will give local health departments information that they now have to guess at. Name-based reporting allows provision of case management services to infected persons and their partners.
The product of ongoing and systematic collection of the information that will result from name-reporting is valid, timely and complete data, and is the key facet to any disease surveillance system. The problem in this Commonwealth has been the fact that HIV was not reportable, despite the fact that sound epidemiologic principles and public health practice necessitates the reporting of communicable diseases that are a public health concern. A name-based reporting system of people with infectious diseases has great potential to benefit both the individual and the public health system. A name-reporting system would result in more people benefiting from early intervention programs.
In a unique identifier system, persons tested anonymously supply in a code, parts of the name, Social Security number, date of birth, sex and race. The non-name identifier system is not anonymous as it may be possibly linked to a specific individual. To do record follow-up for missing information, such as HIV risk, or to provide follow-up care, coded records need to be linked to an individual's name. This is usually found in a log maintained by providers or other reporting sources. Multiple logs with names may create multiple opportunities for breaches of confidentiality.
Name-based reporting would enable public health employees to find and counsel people who are tested but do not return for their results; would enable public health employees to interview clients to assess their need for a variety of community services, including, for example, housing, transportation, medical treatment, tuberculosis testing, and other assistance; could aid partner notification programs; and would aid public health employees in educating HIV-infected women about the risks of pregnancy, and how to minimize the risks of transmission.
Data from a 1998 study of the implementation of name-based HIV reporting in Louisiana, Nevada, New Jersey, Tennessee, Michigan and Nebraska indicated that the impact of surveillance on those seeking HIV testing will be small, and should not hinder HIV prevention efforts.
The impact of HIV-reporting by name is likely to vary from community to community, and risk group to risk group. What matters, however, is that prevention practices can help someone, somewhere, at sometime, and this can only happen with name-based reporting. To allow the Commonwealth to target programs and resources most effectively, the public health system must keep pace with where the HIV epidemic is going. Improvement of the ability to track early HIV infection before it progresses to AIDS is essential.
The Department should be congratulated for its strong leadership in the face of opposition. Only confidential name-based reporting has the capability of contributing to the control of HIV transmission. The Department can perform contact tracing and partner notification, assist in linkages to treatment and other services, including prevention, case management, and assistance with medication compliance. Name-reporting allows the Department to provide outreach to infected persons, obtain risk factor history information, eliminate duplicate reports and monitor disease trends.
The Department can be trusted to use every mechanism available to it to ensure the confidentiality of reported information, as it has done with information reported on AIDS patients.
Confidential name-based reporting is similar to other reporting requirements in the Commonwealth, and follows the recommendations established by the CDC. The Commonwealth will join 34 other states who also require name-based reporting. Name-based reporting allows for the most accurate tracking and will promote increased opportunities for disease intervention, and for funding.
Attempts to control the spread of HIV should not be entangled with politics. The Department's regulations will correct that, and allow epidemiologists to finally understand the extent of the spread of the infection in the Commonwealth. Name reporting allows for critical health practices, such as contact tracing, confirmation of treatment and assurance of services.
A unique identifier reporting system has failed in Texas, and is believed by the state medical society and the health officers of Maryland to be failing there as well. Codes within a unique identifier system require maintenance by providers of lists of names and codes, which increases the chances of breaches of confidentiality. A confidential name-based system is more secure and more confidential.
The Department has not changed these regulations based on these comments. The Department is aware that the majority of the persons presenting testimony at the public meetings it held prior to proposed rulemaking were not in favor of name reporting. The Department did consider these comments in coming to its decision to propose confidential name reporting of the diseases, infections and conditions addressed in this rulemaking. The Department has carefully reviewed all known options for reporting HIV. After considering all of the information, concerns and recommendations that it received, as well as its own expertise and experience, the Department concluded that confidential name-based reporting is the best method for reporting HIV in this Commonwealth.
The Department disagrees that a unique identifier system would neither cause the Department to lose funding nor be less accurate than a system of reporting by name. A confidential name-based reporting system collects more accurate data since availability of the patient's name facilitates timely completeness of case reporting and allows the Department to review and eliminate duplicate case reports. If data is not timely, it is neither complete nor accurate for the Department's purposes. The data obtained under name-based reporting is more appropriate for the Department's needs. It fosters a more complete and accurate description of the epidemic for prevention and care planning, resource allocation, trend analysis and increased Federal funding; and Department facilitation of linkage to prevention and care services.
Further, the funding the Department obtains is better spent on prevention and treatment efforts than on developing a unique identifier reporting system. The confidential name-reporting system, which is already in place for other diseases, including AIDS, can provide accurate data at relatively small cost. Spending funds to develop a unique identifier based-reporting system is neither effective nor efficient in the fight to prevent and control the spread of HIV and AIDS.
A reporting system based on unique identifiers would be complex in comparison with the name-based systems currently in place, and would create problems for providers who are used to the current system of name-based reporting. This could lead to untimely reporting and underreporting, which, in turn, could lead to a loss in funding. Cases not reported before a certain date during each grant period are lost to the Department for the purposes of funding.
The confidentiality and security of data kept in secure Department databases is greater than data maintained in the multiple lists linking names of cases to unique identifiers, which would most likely need to be developed and maintained at multiple provider sites to accomplish linkage of individuals with health care and other services, and to allow for follow-up. Therefore, name-based reporting is better able to meet the higher standards for confidentiality and security set by the CDC.
Name-based reporting will also be easier for providers and for public health agencies to use than a system based on unique identifiers. Reporters in this Commonwealth have used name-based reporting for AIDS and all other reportable diseases and conditions. While reporting by unique identifier would require the development of a new reporting system, and would require additional logs or other systems by which providers could cross check unique identifiers with names, name-based reporting will simply add additional diseases, infections or conditions to the current reporting system. Name-based reporting will eliminate the need for extensive training and the creation of separate databases to maintain logs of names and will allow for complete reporting by the provider.
With respect to concerns that name-based reporting will deter persons from seeking testing and will delay treatment, there is no conclusive evidence to show that name reporting does deter persons from seeking an HIV test. There is, however, growing evidence showing that name-based reporting can facilitate structured programs for linkage to care and prevention services. The Department will monitor the potential for deterrence of test seeking behavior on an ongoing basis using a CDC protocol that is available for HIV reporting states. Further, the Department will seek to ensure that anonymous testing is available throughout this Commonwealth for those persons who choose not to test under their own names.
The availability of anonymous HIV testing sites is more fully explained in the discussion of § 27.32b (relating to confidential and anonymous testing). However, the Department commits to ensuring that anonymous HIV testing will be available to individuals in every county who choose to be tested anonymously, rather than confidentially.
Concerns that confidential name-based reporting will interfere with the physician-patient relationship, and the right to privacy, are addressed in the Department's responses to comments on § 27.32e (relating to record audits). Although the comments on that section were specifically directed to the Department's authority to ''look back'' at providers' records from the effective date of the regulations to January 1, 2000, the Department's response applies to these more general statements as well.
Concerns that information reported to the Department will be disclosed improperly and that discrimination will occur are without foundation based upon the Department's record. Several commentators have acknowledged that the Department's record on confidentiality is ''sterling.'' The Department agrees with the commentators who have stated that public perception and fear should not drive public policy. The Department understands concerns that information could be used to discriminate against individuals. The Department takes its responsibility not to release information reported to it very seriously.
There is a misperception among some persons that confidential name-based reporting is a threat to privacy and widespread discrimination will follow its implementation. The Department intends to combat this misperception by a public information campaign. The Department is exploring ways to reassure the public that HIV/AIDS reporting data are maintained under the highest security and confidentiality standards. There has never been a violation of privacy from the public health reporting system in this Commonwealth in 20 years of name-based AIDS reporting.
Finally, the Department currently meets, and will ensure that it continues to meet, CDC standards for security for reportable information.
Electronic reporting and security
Given the Department's record with HIV software systems in the area of HIV services, specifically Lifeplan, we question whether systems implementation will accurately track the data in question.
The Department has not changed the regulations in response to this comment. The Bureau of Epidemiology has an excellent track record on the implementation of its surveillance responsibilities and use of software for tracking purposes. The Lifeplan system is a client-level data system used to report to the Department and then to the Health Resources and Services Administration (HRSA) data on client care services. The CDC -provided HARS software application is a proven, Nationally used tool. It is used to collect surveillance data.
We have used the HARS system with the Allegheny County Health Department, and we find it difficult to implement in a clinic setting. Data retrieval is difficult.
The Department has not changed the regulations in response to this comment. HARS software is a surveillance application and is not intended to be used by providers for clinic management. The Department will prepare a subset of HARS to be used by providers so that reporting will be easier for them.
Even if electronic reporting simplifies the reporting process, there will be a need for additional computers to report remotely.
The Department has not changed the regulations in response to this comment. The Department understands that additional computers may be necessary for some providers. The Department, however, believes that the simplification of the reporting process outweighs any minor cost incurred by individual providers.
The Department needs to ensure that reports can be submitted even if some of the information is not available.
Reporters will be able to submit reports electronically, even if all the information is not provided. The Department will continue to follow-up on case reports of HIV with missing information, as it currently does for other diseases.
The Department should develop and communicate a plan regarding how it intends to provide software and training.
The Department agrees with the comment, and will be working with representatives of stakeholders to both formulate and implement software delivery and training.
Not all providers may be able to submit reports electronically. The Department should develop a mechanism that will allow for submission of reports in another manner.
The Department will work with those providers unable to submit reports electronically. The Department is prepared to accept a diskette by mail from those providers without internet service. The Department's general regulation on reporting (28 Pa. Code § 27.4) allows for reporting incomplete information on cases by telephone although complete reporting will be required electronically through, for example, the use of diskettes, or through the use of a telephone number provided by the Department at no charge which would permit access to a web-based application to be used for reporting.
The regulations should specify security standards applicable to required electronic transmissions.
The regulations fail to describe the security systems that will be used to protect the medical information that will be transmitted electronically.
How will electronic reporting be done, and how will the Department assure the confidentiality and security of electronically reported information?
Security of medical information and confidentiality of medical records and disease reports is a concern for providers and the Department and local health departments. The Department is well aware of its responsibility to protect the confidentiality of the reports and information submitted to it. The security of electronic reporting will be accomplished through the use of encryption, and also the use of a digital certificate for each provider, which has, as part of its configuration, imbedded security similar to that used by banks for the electronic transfer of funds. This security, often referred to as PKI (Personal Key Identification), requires two keys to open files. One is held by the provider, the other by the Department. This same PKI process will be used for all electronic disease reporting to the Department. It is state-of-the-art technology.
The Department must include in its regulations a commitment to meet CDC data security standards.
The Department has not changed the regulation in response to this comment. The Department already meets CDC security standards for HIV/AIDS case reports. As a condition of its CDC surveillance grant, the Department must meet these requirements and adhere to them. As confirmed by the CDC, the Department is in compliance with these CDC requirements as of the last site visit from the CDC, which occurred in May of 2000. The county and municipal departments of health, which will act as local morbidity report offices (LMROs), are also in compliance with these standards, as of the Department's latest audit of each department.
What equipment and software will providers be required to use, how much training will be required, and how often will it be offered? How much will this cost, and who will bear the cost, the Department or the reporters?
The Department will provide the software to the provider free-of-charge. Instruction booklets or sheets will accompany the software. The Department will develop training schedules in consultation with stakeholder groups. The only cost to the provider will be transportation to the training site, and the cost of a computer with sufficient operating capacity and speed and an internet connection. It is expected that most providers will be able to use their existing computers for disease reporting. The Department is, however, prepared to accept diskettes by mail for those providers without internet service.
How will these regulations affect previously tested persons already in care? How will they assure the confidentiality of their medical records?
Although the Department has had a positive record on confidentiality, the current regulations change the protections offered previously. Individuals who are HIV infected have faced discrimination once their HIV status has been learned.
If the Department goes forward with name reporting, measures to strengthen Statewide privacy protections for public health data must be examined immediately.
The Department has not changed the regulations in response to these comments. Persons previously tested and in care will either be located through the Department's audit back to January 1, 2000, when additional testing is done to monitor the individual's status, or when the individual progresses from HIV to AIDS.
The Department has required the reporting of AIDS cases for roughly 20 years. The proven system for AIDS reporting has a 20-year track record of security and confidentiality, which includes stringent security and confidentiality features required by the CDC. The Department will protect the information reported on HIV in the same way, using the same CDC security standards, as they relate to HIV reporting. The security and confidentiality of the information will be maintained and, where necessary, improved to adequately handle the confidentiality of HIV case reports.
Since laboratories will now be required to transmit patient information, there is an increased risk for a breach of confidentiality. Although the ability to carry out this function is an integral part of laboratory services, the additional paper trails required by the newly mandated information sheets will challenge the ability to protect patient rights. The mere existence of special sheets attached to patient specimens may draw attention to the specimens, thus potentially violating patient confidentiality.
Laboratories will be required to report results to the Department electronically. The patient information that will be sent to laboratories by providers is standard identifying information that is sent to laboratories in the normal course of business. The reason for including in the regulations language specifically requiring providers to submit this information to laboratories upon specimen submission is to ensure that this information is available for laboratories to send to the Department. This information is necessary to make the process of reviewing laboratory data for repeat case reports effective so that there is no need to contact providers about cases that have already been reported.
Laboratories will transmit this information to the Department electronically through secure data transmission portals. The system of electronic laboratory data transmission adopted by the Department is part of a National electronic laboratory reporting system being established by collaborating states and laboratories in conjunction with the CDC. The system meets the highest security and confidentiality standards for patient laboratory data transmission, as required by the CDC.
HIV reporting will not compromise confidentiality because appropriate safeguards currently exist. Reporting for other sexually transmitted diseases is required now, and we are not aware of any breach of confidentiality. National studies show that states with name reporting have not experienced any confidentiality problems.
The Department agrees with the commentator.
It will take a good deal of time and resources to implement the regulations. The Department is requiring the reporting of all test results. Requiring duplicate reports seems costly. The regulations do not discuss the cost of this reporting, or how it will be funded. Providers with large numbers of patients will be adversely affected.
These regulations will have a major human and financial resources impact on high morbidity areas like Philadelphia. The Department does not say how it will financially support dual reporting.
The cost implications of the regulations are underestimated.
Our reporting system has been facilitated through cooperation with the Allegheny County Health Department, which performs onsite data collection. Given the number of patients to whom we provide care, the information being required by these regulations will create an unmanageable workload for the clinic staff. Further, there is no provision for increasing staff in county health departments to collect this data.
The Department does not believe the cost implications are underestimated, and has not changed the regulations in response to the comments. Further, these regulations are an addition to the existing list of over 50 reportable diseases, infections and conditions, and, for most reporters, additional infrastructure to accomplish this reporting should not be necessary.
The Department is sensitive, however, to provider concerns regarding funding. The Department has included in its budget funding to the local health departments, including Philadelphia County, for increased staff to handle additional workload. With respect to the comment relating to the large number of patients and clinic workload for private providers, current HIV cases will only need to be reported as they meet the AIDS case definition. The Department expects that will occur over an extended period of time and will not cause an undue burden. Further, county health departments will assist where that is possible. Electronic reporting by providers will limit any increased workload, since much of the information the Department is requiring will be collected for the patient's medical record, whether or not a reporting requirement exists.
With respect to the requirement that both laboratories and providers report the same case, the Department's reasons for requiring reporting by different types of reporters is discussed at greater length in responding to specific comments regarding multiple reporting and duplication of reports.
There will be an increased burden on research units and laboratories to implement reporting, including staff time and the cost of dedicated computer equipment and telephone lines for remote reporting.
The Department has not changed the regulations in response to this comment. Dedicated computers and phone lines are not necessary, but password protection on provider databases is recommended. If the provider has an Internet Service Provider, the cost will be minimal.
The Department should not require reporting of a case by more than one reporter.
The fiscal impact and purpose of the requirement of multiple reporters is not clear. Many persons may file reports on the same individual. What is the need for numerous reports on a single case? What are the costs to the private sector when multiple reporters file and prepare reports? What will be the costs of effectively processing data from thousands of reporters in order to eliminate duplication?
Does the Department have a plan to figure out what to do when multiple reports are made of a single case?
The Department currently requires the reporting by more than one type of reporter for every disease, infection and condition that is reportable under the law. This ensures that the Department will receive all the available material information relating to a case. The Department is concerned that if reporters ''self-censor,'' based on their assumption that another person will make the report, there could be under-reporting. This would jeopardize the ability of the public health system to positively impact the health of infected individuals and their contacts. If the departments are unaware of cases, they will be unable to offer or provide counseling and referral information services to the providers who treated those cases. It is better to get multiple reports providing the same information on a case, than to receive a single incomplete report.
With respect to the cost of reviewing several case reports to establish a single case file, that is a function which the Department currently performs for AIDS case reports. The Department has software that performs this function for it. There should be no additional cost to the Commonwealth from filtering information from several case reports to develop a single comprehensive record.
Informed consent remains a hallmark of HIV testing protocols recommended by the CDC, and legislation relating to HIV testing. A system that allows individuals to bypass obtaining informed consent may undermine the trust and confidence between patients and their health care providers. Until the right of a patient to decline testing on a voluntary basis is revoked, the Department should not establish a system that may compromise this right.
The Department has not changed the regulations in response to this comment. The regulations do not in any way prohibit or prevent a health care provider from obtaining consent from a patient before performing an HIV test. The Confidentiality of HIV-Related Information Act (35 P. S. §§ 7601--7612) (Act 148) still applies to the offering and provision of HIV testing, to the manner in which the results are given to the person tested, and to whether or not the information may be released to others. The regulations do not require an individual to take an HIV test of any kind, nor do they require an individual to take a test that will result in the name of the individual being reported to the Department. If a confidential test is chosen by the individual, the regulations require that the information establishing the presence of HIV be reported to the Department by the individual's name. The regulations also require that the same results from an anonymous test be reported, although not by name. This is consistent with the requirements of Act 148.
The regulations do not address problems that would arise for research programs if research programs are required to report the names of individuals who test positive for HIV infection or who have CD4 T-lymphocyte counts below a certain level. The regulations could alter a person's willingness to participate in a research project. The regulations should be modified to exclude research projects and research laboratories from reporting under an individual's name, data acquired for research purposes. This would not impact on the goal of reporting. Individuals participating in these studies would have been reported anonymously by their primary care provider or physician. Also, persons participating in these research projects already know their status, and, if they are positive, will be counseled to obtain medical care and will be provided information to facilitate their entry into the health care system.
Research studies use unique identifiers for all tests, and no demographic data is currently provided to diagnostic laboratories. Provision of such data to a laboratory is prohibited by informed consent documents signed by research subjects. Laboratories may be unable to accept additional information given terms of contracts and systems in place.
Research laboratories currently have no system in place to report communicable diseases. Data is generated solely for research protocols. All clinically relevant data is sent to the primary care provider after receiving written permission from the research subject.
Requiring that research facilities report HIV status will threaten their relationship with individuals who volunteer to participate in studies, and may result in an increase in HIV-infected individuals who are not receiving appropriate care.
New York has included a research exemption in its state statute.
The Department has considered the comments recommending that research studies be exempted from reporting by name. The Department has decided against including such an exemption in the regulations. The Department has not provided for such exemptions for the reporting of other diseases, including AIDS. The Department does not believe that, at this time, there is sufficient evidence to show that the granting of such exemptions would further the public health purpose intended by these regulations. The Department, however, in determining whether such an exemption should be added at some future time, will consider any credible evidence research studies are able to provide to demonstrate that exempting research studies from name reporting from HIV will hamper the prevention and control of the spread of HIV. The Department understands that certain research studies begun prior to the effective date of these regulations may have been instituted under protocols that would prohibit the release of the information that the Department is requiring. The Department will not require those studies to alter their protocols.
Section 27.1. Definitions.
This section includes definitions for Chapter 27. Three of the definitions proposed in the proposed rulemaking upon which this final rulemaking is predicated have already been adopted. They were adopted at 32 Pa.B. 491 (January 26, 2002). Those terms were ''district office,'' ''local health department'' and ''local morbidity reporting office (LMRO).'' Those terms and definitions, therefore, appear in the annex as existing regulation. A few commentators recommended changes to those definitions. The Department had either previously made the changes which were adopted in its final rulemaking on January 26, 2002, or has chosen not to revise the regulations. Those comments are discussed in greater detail below.
The Department should include the CDC case definition for AIDS in the regulations, rather than simply referring to it.
The case definition for ''AIDS'' is the CDC definition. That definition is 15 pages long, and changes with new surveillance requirements or scientific needs. The Department has created a definition for ''AIDS'' in this section that incorporates by reference the CDC definition for ''AIDS'' published in its Morbidity and Mortality Weekly Report (MMWR). This should enable persons to locate that definition if necessary. Historically, the CDC has revised the definition and published the revisions in the MMWR. Consequently, the Department has included with this definition a statement that it will publish references to the CDC MMWR updates to the case definition in the Pennsylvania Bulletin within 30 days of their publication.
The references for the current CDC case definitions are as follows:
CDC. 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults. MMWR 1992;41 (RR-17).
CDC. 1994 Revised Classification System for Human Immunodeficiency Virus Infection in Children Less Than 13 Years of Age. MMWR 1994;43 (RR-12).
CDC. CDC Guidelines for National Human Immunodeficiency Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome. MMWR 1999;48 (RR-13).
The Department should expand the definition of ''local morbidity reporting office (LMRO)'' to minimize the potential for reporting to state health centers or other entities perceived to be county health departments. Inadvertent reporting to county offices might breach confidentiality, particularly in rural counties.
The Department has not changed the definition in response to this comment. The definition of ''LMRO'' included in the regulations specifically identifies the district offices of the Department and the county/municipal health departments as LMROs. A list of these entities is available from the Department upon request, and the Department will publish a list in the Pennsylvania Bulletin. The Department does not agree that confusion will be likely to occur, especially since, with the exception of very few diseases, infections and conditions, all reporting is made to the LMROs.
The last sentence of the definition for ''local health departments'' referring to the Department maintaining a list, is substantive, and should be moved to the body of the regulations.
The Department agrees with this comment. The sentence was deleted from the definition adopted on January 26, 2002.
To determine that a newborn has been exposed to HIV, as set forth in the definition for ''perinatal exposure of a newborn to HIV,'' appears to require a subjective judgment by a broad array of persons. Substantive questions involving risk should not be included in a definition. Reporters who are qualified to make the risk determination should be listed in the substantive part of the regulation.
Only information about newborns that come to term is useful in preventing a vertical transmission. Therefore, the definition should read as follows: ''possible vertical transmission--potentially exposing a fetus to HIV during pregnancy of an HIV positive woman, regardless of the final serostatus of the infant.''
The Department has changed the definition to read: ''The exposure of a newborn indicated by a positive HIV test result for the pregnant woman or mother of a newborn.'' The Department has made this change to clarify that, in determining whether a perinatal exposure has occurred, there is no determination of risk made. A newborn is considered exposed to HIV if the mother is HIV positive. The question of whether the child actually becomes HIV positive is a separate matter.
The Department has not changed the term defined to ''potential vertical transmission.'' ''Potential vertical transmission'' is a term broader than ''perinatal exposure.'' While ''potential vertical transmission'' applies to all types of mother-to-child transmission, ''perinatal exposure'' is limited to potential transmission in a perinatal setting. The Department has changed the definition to clarify that it is referring to potential perinatal transmissions by using the term ''perinatal exposure.''
The Department disagrees that only information regarding a newborn that has come to term is useful in preventing a vertical transmission. The Department is requiring reporting of perinatal exposures, that is, potential perinatal transmissions. Information obtained on the status of the mother is instrumental in making prevention therapies available to the mother for the fetus.
Further, since some of these treatments are suspected of causing mutations in some children, reporting perinatal exposures will enable the Department to follow the women who tested positive and their children to collect data on this concern, and on the efficacy of other treatments. That information could provide data on whether, how, and why this occurs, and could lead to the development of safer treatment.
The Department should add definitions for the following terms: ''unique identifier;'' ''confidential testing;'' ''anonymous testing;'' and ''State-designated anonymous testing sites.''
As has already been discussed, the Department has decided against the use of a unique identifier system in favor of a system of confidential name reporting. Therefore, the addition of a definition for the term ''unique identifier'' is not necessary.
The Department has added definitions of ''anonymous HIV testing,'' ''confidential HIV testing,'' and ''State-designated anonymous HIV testing site'' to eliminate confusion regarding anonymous and confidential testing, and the sites at which each or both may occur.
In anonymous HIV testing, an individual is informed that a fictitious name may be used to provide consent for the test. Although the individual is asked to provide information regarding age, sex, race, county, zip code, state of residence and the reason why the person believes that they are at risk for HIV, the individual may refuse to provide any of this information. Only an assigned number that is not linked to the person's identifying information identifies the person's written test result.
In confidential testing, the person signs a consent form with his or her name. Identifying information is collected and reported to the Department.
Anonymous HIV testing may only be conducted at a State-designated anonymous HIV-testing site. A State-designated anonymous HIV testing site is a testing site that has agreed to abide by the Department's guidelines for HIV testing, which are based on the CDC's guidelines, and that is supported by the Department, either through direct funding, or by having the laboratory tests paid for by the Department at the Department's contracted testing laboratory. Sites receiving other forms of public funding, for example, funding directly from the Federal government, or funding that does not require adherence to the Department's guidelines relating to anonymous testing, are not State-designated anonymous HIV-testing sites.
State-designated anonymous HIV testing sites allow for the Department and local health departments to be linked to an HIV case quickly, without the patient's name, since that individual has already become part of the public health system by his choice of testing site. The difficulties which reporting by unique identifier would raise for public health staff in obtaining the timely information that would make involvement of the departments in the case useful, do not apply to an individual being tested anonymously in a forum linked to the Department or local health departments.
Section 27.2. Reportable diseases.
As proposed, this section would have added the diseases, infections and conditions addressed in these regulations to the general list of reportable diseases, infections and conditions in that section. The Department, at 32 Pa. B. 491 removed that general list from § 27.2. These regulations require no amendment to that section as it now reads. The addition to the list of diseases, infections and conditions required to be reported within the Commonwealth of the four reportable matters addressed in this rulemaking is accomplished by amending §§ 27.21a, 27.22 and 27.32a.
Section 27.21a was not included in the proposed rulemaking relating to HIV reporting (31 Pa. B. 2126 (April 21, 2001)). It is a new regulation added by the January 26, 2002 amendments to Chapter 27. This rulemaking amends that section to accomplish what proposed revisions to § 27.2 were intended to accomplish: the inclusion of general reporting requirements relating to HIV, certain CD4 T-lymphocyte counts, and perinatal exposure of newborns to HIV, and the clarification of reporting requirements relating to AIDS. More specific requirements for the reporting of those diseases, infections and conditions appear in new § 27.32a.
Because the few comments received regarding proposed § 27.2 apply to §§ 27.21a, 27.22 and 27.32a equally, those comments and these three sections will be discussed here.
Requiring reporting of low CD4 T-lymphocyte counts brings noninfected persons into the HIV/AIDS surveillance system. This could encourage inexperienced providers to use the CD4 T-lymphocyte test as a screening tool.
Requiring the reporting of low CD4 T-lymphocyte counts could cause the Department to contact parents of children with low CD4 T-lymphocyte counts and cause concern when the low count could be for a reason other than HIV or AIDS.
Reporting low CD4 T-lymphocyte counts, including results for persons who do not have HIV or AIDS, is burdensome for oncologists and other physicians who care for cancer patients. It is unclear what the Department intends to do with this information, when it relates to cancer patients. Will it be referred to the Cancer Registry?
The Department has not changed the regulations in response to these comments. CD4 T-lymphocyte counts of less than 200 cells/µL or of less than 14% of total lymphocytes, without other AIDS-defining illnesses, is an AIDS-defining condition in HIV positive persons. It is also an indication of severe immunosuppression that places the patient at risk for secondary infections. Low CD4 T-lymphocyte counts have a high ''predictive value positive'' and are mostly indicative of HIV/AIDS; more than 80% of low CD4 T-lymphocyte count test results are among HIV positive persons. Therefore, it is appropriate to require reporting of low CD4 T-lymphocyte counts. Reporting of low CD4 T-lymphocyte counts is now a standard component of HIV/AIDS reporting practices in many states that require CD4 T-lymphocyte tests to be reported.
The primary exception to this high predictive value is in specialized cancer treatment centers. Prevention of unnecessary reporting from such centers will be handled administratively by exempting specific facilities or clinics from reporting CD4 T-lymphocyte results based on documented results of audits indicating that that facility's yield of HIV/AIDS cases from CD4 T-lymphocyte results is low. In addition, it is the Department's public health responsibility to monitor trends of potential adverse public health outcomes from the population of vulnerable persons with severe immunosuppression regardless of HIV status. The Department will destroy reports of low CD4 T-lymphocyte results that it determines do not coincide with the presence of HIV.
Further, the Department will not send to the Caner Registry information on cases reported because of the CD4 T-lymphocyte reporting requirement. The Cancer Registry is static. The Department does not undertake active cancer surveillance, nor does it track the impact of courses of treatment, as it does through HIV and AIDS reporting. Therefore, information relating to changing CD4 T-lymphocyte counts is not useful with respect to cancer cases.
All CD4 T-lymphocyte counts should be reportable, and not just those under 200 cells/µL or 14% of all T-lymphocytes.
The Department has not changed the regulations in response to this comment. The Department has followed the CDC guidelines in the promulgation of the requirement that CD4 T-lymphocyte cell counts of equal to or less than 200, or 14% of total lymphocytes be reported. The Department is using CD4 T-lymphocyte counts as a marker for HIV disease. Counts over the limits the Department has included in the regulations would not be an accurate indicator for HIV. They could be indicative of too many other infections and conditions to be useful as an HIV marker.
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