Revised Summary of Regulatory Impact Statement

 

Statutory Authority: Public Health Law (PHL) section 2139 authorizes the State Commissioner of Health to promulgate rules and regulations as necessary to effectuate Article 21, Title III of the Public Health Law, requiring the reporting of human immunodeficiency virus (HIV), HIV related illness andacquired immune deficiency syndrome (AIDS) to the State Commissioner of Health.

The law authorizes reporting of known contacts of persons with HIV, HIV-related illness or AIDS and the conducting of contact notification when merited to protect the public health. Chapter 163 of the Laws of 1998 also amends PHL Article 27-F to broaden the definition of "contact" to provide for certain disclosures of HIV-related information.

Legislative Objectives:

This expanded reporting of HIV infection allows more accurate epidemiologic surveillance to better monitor the HIV epidemic and to provide the basis for targeted planning, resource allocation and evaluation of future public health initiatives at both the state and the federal levels. This statute will facilitate early public health intervention such as partner notification assistance and referrals for testing and treatment.

Needs and Benefits:

Since 1983, public health surveillance for the HIV epidemic in New York State has been carried out through the reporting of persons meeting the national surveillance case definition for AIDS to the New York State Department of Health (NYSDOH), and to the New York City Department of Health and Mental Hygiene (NYCDOHMH) as the state's designee. Focusing on surveillance of AIDS cases, however, is an inadequate method to track the current status of the overall HIV epidemic because it takes an average of ten years for persons to progress from HIV to AIDS. Currently, comprehensive data is unavailable regarding emerging epidemics in specific geographic areas or in various racial/ethnic groups and age categories. The recent availability of effective therapies makes it important to have current data on newly diagnosed individuals to ensure adequate access to the health care system. In addition, efforts to appropriately target HIV prevention activities and to evaluate those prevention efforts would be greatly aided by current information on HIV infections.

The proposed amendments require reporting of persons with HIV infection to the State by physicians and laboratories. Reporting of the initial determination of HIV infection, indicated by a confirmed positive HIV antibody test result, of HIV-related illness, indicated by positive viral load testing or CD4 cell count less than 500 test results, and of AIDS, according to the current AIDS case definition including laboratory reporting of CD4 count less than 200, will provide timely data on all phases of the continuum of HIV disease in New York and closely follows the national HIV surveillance case definition.

Information about the clinical characteristics of persons with diagnosed HIV infection will enable New York State to monitor the stage of illness at initial diagnosis and to assess the location and adequacy of comprehensive HIV health care and support services. These data will also assist in evaluating the impact of potential public health threats like antiretroviral drug resistance. Finally, comprehensive data on the HIV epidemic will illustrate the overall magnitude of HIV disease in New York State and the need for a continuing public health response.

The proposed rules establish a system of more routine contact or partner notification assistance efforts based on surveillance reports. It is based on the reporting of known contacts and the provision of information about partners by infected persons, elicited by their physician or public health workers, who then attempt to contact and inform those partners of their possible exposure to disease. The source of exposure is not identified in this process. Partner assistance efforts focus on ensuring that contacts are informed of their possible exposure and offered HIV counseling and testing, that infected contacts are referred for health care and other supportive services, and that uninfected contacts are referred for prevention education and counseling. Timely notification of exposed partners and assistance in accessing services are particularly important and beneficial today due to the dramatic clinical improvements in treating HIV with combination therapies and the significant reduction in perinatal transmission with the use of antiretroviral therapy during pregnancy, at delivery, and to the newborn. Since HIV infection and the risk of transmitting infection to partners is lifelong, efforts to help HIV infected persons inform and protect current and future partners must be ongoing, and involve the continuing efforts of health care providers and community-based support services programs.

Existing NYS law permitted infected persons, health care providers and public health officials to conduct partner notification. However, it has been difficult to document the success of these partner notification efforts since the number of partners notified by infected persons or by health care providers is unknown. Further, reports in the medical literature indicate that a significant number of HIV infected persons may not be informing partners of their status.

The proposed rules authorize contact tracing for reported cases of HIV infection when merited to protect the public health. Physicians will report contacts and verify any notification to these contacts to the health department.

Circumstances which merit priority consideration for partner notification include:

(1) known contacts, including spouses, as reported by a physician or other diagnostic provider; and

(2) newly diagnosed HIV infections.

Persons who may be in particularly vulnerable situations, for example, adolescents, will most probably require additional support services as part of the partner notification process. Finally, an indication of a risk of domestic violence is an important consideration in the determination of which cases merit contact tracing and in the decision to notify specific contacts. When a risk of domestic violence is identified, notification is deferred unless and until referrals, efforts or reasonable arrangements are made in the professional judgment of the health official in consultation with the reporting physician.

Contact tracing for persons who have been exposed to circumstances that present risk of transmission of HIV is also provided for in Chapter 163. Such circumstances have been defined as occupational settings (e.g., health care workers, firefighters, police). This approach mirrors existing legislation in many other states, as well as requirements under the Ryan White CARE Act for emergency response personnel.

COSTS:

Costs to Regulated Parties: Surveillance Costs

Surveillance costs include costs associated with reporting of HIV and AIDS cases by mandated reporters, and costs associated with on-site follow-up at providers' offices to gather surveillance data on newly reported cases. An estimated additional 11,000 newly diagnosed cases of HIV will be reported annually (9,000 in NYC, and 2,000 in the rest of NYS) under the new reporting eequirements. Additional new reports on persons with HIV-related illness will occur, the bulk of them in the first few years of the program.

Laboratory Costs Associated with Reporting

Commercial and hospital clinical laboratories will provide the bulk of HIV reporting. When HIV surveillance is fully implemented, most will report electronically. The 26 laboratories which currently report CD4 less than 200 electronically will need to adapt their current electronic CD4 reporting system to also report HIV antibody and viral load tests, as well as expand CD4 reporting to include reports with counts below 500. It may take approximately five days for modification of existing systems at each reporting laboratory to include the new tests. This cost per laboratory will be approximately $2,800. Laboratory personnel would also need to spend approximately 60 minutes per week for file transfers to report the data to NYS at a cost of approximately $30 per week. In some cases, laboratories would have to upgrade hardware and software. For these labs, the cost of upgrading is estimated at $2,000 per laboratory.

About 30 commercial and hospital laboratories will initiate electronic reporting for HIV case reporting, expending ten days of computer programmer support for development of software at a cost of approximately $5,600. An estimated $4,000 would be required for those laboratories that need to purchase state-of-the art computer hardware to initiate electronic reporting.

Approximately 50 commercial and hospital laboratories will initially report by hardcopy. Estimated time to generate reports is one hour per week at a cost of $30 per week for laboratory technician time.

Physicians, Clinics and Hospitals

Physicians, clinics and hospitals (who report on behalf of mandated reporters) will do so using the NYS form (modified DOH 2193 or equivalent), by phone to surveillance staff, or directly to surveillance staff during routine visits to their offices or facilities, involving about five minutes per form. A nurse's completion of the form would require about five minutes, or $5 per report.

Minor costs associated with providing medical records for review by surveillance staff will also be incurred. While the number of medical records to be made available by the provider will increase with HIV reporting, these costs are not substantial. When documentation in the medical record is missing, additional time to interview the provider may be necessary. Provider interviews generally take less than five minutes and occur only occasionally.This costs out at approximately $8 per interview, based on a $100 per hour salary for physicians.

Partner Notification Assistance Costs

Existing law requires that partner notification be addressed as part of post-test counseling, and Medicaid reimbursement is available to many physicians addressing partner notification as part of HIV test counseling. Staff members of most licensed health care facilities may claim Medicaid reimbursement at an average rate of $72 per post-test counseling session. If more than one post-test counseling session with the infected patient is needed, these sessions can be billed under Medicaid with supporting documentation in the record. Office-based physicians enrolled in the HIV Enhanced Fees for Physicians Program are also eligible for Medicaid reimbursement for test counseling, at an average rate of $41.

The time involved in new provider responsibilities related to partner notification is estimated at 30 minutes per HIV infected patient. At the $100 per hour physician salary, these activities would cost $50 per HIV infected patient. A subset of patients, estimated at 25%, might require a second 30-minute session to adequately address partner notification issues. For these patients, the cost would total $100. For HIV positive patients covered by Medicaid, time spent in arranging partner notification assistance is appropriately billed as a post-test counseling visit.

Physicians choosing to assist patients in directly notifying partners would incur additional costs, estimated at $100 for one hour of time per partner notified. This could, for Medicaid patients, be billed as a pre-test counseling visit for the partner. However, it is likely that providers will often rely on trained public health staff to locate and notify partners, or that patients will self-notify partners.

Costs to the State, the Department of Health and Local Health Units: Surveillance Activities

Current surveillance of AIDS cases is handled by State staff, except for NYC, Suffolk and Onondaga Counties, where local health unit surveillance staff have been authorized by the state to conduct AIDS surveillance and function similarly to State field surveillance staff. These field staff responsibilities for validating cases and gathering surveillance information will continue for the reporting of HIV, with the addition of collecting the names of known contacts. While HIV reporting is expected to double the current workload, significant strides have been made to fully utilize electronic data handling practices, which minimizes the need for new field staff for this purpose. However, some new personnel and computer costs will be incurred at both the NYSDOH and local health unit level.

The State Health Department will also incur some costs in conducting a study to assess the feasibility of developing a system to permanently encode the names of the index cases after they have been reported and all surveillance and partner notification activities have been completed. This study is being undertaken to ensure all approaches to ensuring confidentiality have been fully explored.

Partner Notification Activities

Partner notification assistance conducted by public health officials will be provided by health department field staff which currently are assigned to the state Partner Assistance Program (PNAP) and New York City Contact Notification Assistance Program (CNAP), and by staff working under local health commissioners. On average, field staff are capable of completing up to 100 index patient partner notification processes per year. Of the estimated 11,000 newly diagnosed HIV infections reported each year, about 80%, or 8,800, will request or require notification assistance for the estimated 2.5 partners per reported index case (22,000 partners in total). Some program management staff and new field positions, located in local health units and NYSDOH regional offices, will be required.

Education, Training and Technical Assistance

The NYSDOH will incur the costs of a multi-media, statewide education campaign to provide information to consumers and providers about how HIV reporting and partner notification will be implemented, and to emphasize the benefits of knowing one's HIV status and early entry into care for HIV infected persons. This campaign will include training sessions, and public service announcements and written education materials including brochures and posters will be available in various languages.

Other State Agencies

Other State agencies will review their respective regulations and revise them in accordance with Chapter 163 of the Laws of 1998 and Part 63 regulations. It is expected that these activities will be undertaken by existing staff, and costs absorbed within existing budgets. Some State agencies, such as the Department of Correctional Services and the Office of Alcohol and Substance Abuse Services, may incur some costs in developing specific models that foster partner notification assistance.

Local Government Mandates:

For purposes of implementing Chapter 163 and these proposed regulations, the 13 counties in New York, plus New York City, which have health commissioners are mandated to carry out certain activities. In the remaining 44 counties without health commissioners, these functions will be carried out by state health department staff.

Under the proposed amendments county/NYC health commissioners will be required to perform a number of activities including: receiving reports from NYSDOH; determining whether or not reported cases merit contact tracing to protect the public health and conducting notifications, consistent with NYSDOH guidelines; screening for risk of domestic violence; informing contacts that they may have been exposed to HIV and providing access to counseling and testing and other referrals as needed.

Paperwork:

The reporting of HIV and collection of names of exposed contacts/partners by physicians to the NYSDOH will occur on the existing NYS Form (DOH-2193 or equivalent) which will be modified for AIDS/HIV reporting. Laboratory reporting of test results indicative of HIV infection, HIV related illness or AIDS will generally occur electronically. Laboratories not currently reporting electronically will report by paper forms. Efforts will be made by the department to promote all laboratories to report electronically as soon as possible. Strict data security protocols will govern all electronic and paper reporting.

Duplication:

These regulations do not duplicate existing NYS regulations. Related regulations are found in Part 63 of 10 NYCRR, which provides additional details concerning confidentiality and partner notification. Federal requirements are linked to permissible State use of federal funds. U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Program Announcement 706 references standards for security and protection of data and guidelines for national surveillance. The CDC Program Announcement 99004 sets forth requirements for the NYS HIV Prevention Cooperative Agreement related to federal funding for counseling, testing, referral, and partner counseling.

Alternatives:

No reliable viable alternatives exist since reporting and partner notification are mandated by law. However, a "unique identifier" system was considered at length. A series of advisory meetings were held in 1997 and 1998 on this issue. A majority of the advisory group, largely consumers and the advocacy community, endorsed a "unique identifier" system as opposed to the minority position for a "names based" system, supported by many physicians and public health officials. The choice of a "names based" system at this time is due to the need for accuracy and the need to access individual records for necessary follow-up. "Unique identifier" systems have been proven to be deficient in providing complete and unduplicated reports in Texas and Maryland as noted in a 1/9/98 Morbidity and Mortality Weekly Report. Coded systems also raise privacy concerns since lists of infected persons must be maintained in possibly unsecure provider offices across the State.

Federal Standards:

With one exception, there are no federal laws specifically governing HIV reporting, reporting of AIDS case information or counseling, testing, referral and partner notification services. The Ryan White CARE Reauthorization Act of 1996, Public Law 104-146, section 8(a), requires that States take action to require a good faith effort be made to notify a spouse of a known HIV-infected patient that such a spouse may have been exposed to the human immunodeficiency virus and should seek testing. The statute defines a spouse as any individual who is the marriage partner, as defined by state law, of an HIV-infected person, or who has been the marriage partner of that person at any time within the 10-year period prior to the diagnosis of HIV infection. Absence of a good faith effort jeopardizes federal funding.

The federal government does establish surveillance case definitions for HIV and AIDS reporting. Use of these definitions is strongly recommended to states to assure comparable data from all states at the federal level. The federal government has used these definitions to certify State case counts for the purposes of allocating federal funding.

Compliance Schedule:

Chapter 163 of the Laws of 1998 takes effect January 3, 1999. The proposed rules will implement this law once they are finalized.

Contact Person:
William Johnson
NYS Department of Health
Office of Regulatory Reform
Empire State Plaza
2415 Corning Tower
Albany, NY 12237-0097
(518) 473-7488
(518) 486-4834 FAX
B0019b@health.state.ny.us