Revised Regulatory Impact Statement

Statutory Authority:

Public Health Law (PHL) section 2139 authorizes the State Commissioner of Health to promulgate rules and regulations as shall be necessary to effectuate Article 21, Title III of the Public Health Law.

Article 21, Title III requires the reporting of human immunodeficiency virus (HIV), HIV related illness and acquired immune deficiency syndrome (AIDS) to the State Commissioner of Health. The law also 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. Expanded reporting of HIV infection, HIV related illness and AIDS also will permit the State to monitor disease progression since persons will be reported at various clinically significant stages of the disease. Knowledge about the prevalence and timing of HIV related illnesses will enhance the State's ability tomonitor the effectiveness of current therapies and to plan for health care needs.

This statute will facilitate early public health interventions such as partner notification, HIV counselor testing, referral and treatment of infected contacts, and patient education to prevent future transmission of HIV.

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. This system has provided complete and high quality data on the characteristics of persons with AIDS, the end stage of HIV infection. AIDS surveillance data are used to monitor the increase in AIDS by demographic characteristics and geography, to track the changes that have occurred with major shifts in the epidemic to minority communities, women and injection drug users, to classify geographic areas by level of risk for HIV to better target prevention and treatment programs, and to determine New York's share of federal AIDS funding, among other things.

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 10 years for persons to progress from HIV to AIDS. AIDS data therefore reflect disease transmission patterns in the past and not the current situation. By relying on an AIDS case surveillance system, emerging epidemics in specific geographic areas, racial/ethnic groups and age groups, particularly adolescents, may be detected only years later.

Recent dramatic clinical improvements seen with combination therapies for HIV infection have significantly slowed progression to AIDS in many persons with HIV, thereby further reducing the value of AIDS data in tracking the HIV epidemic. The availability of effective therapies makes it important to have current data on HIV infection and 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 to 10 NYCRR, Part 63, which implement Chapter 163 of the Laws of 1998, would institute reporting of persons with HIV infection to the State by physicians and laboratories in a manner similar to current AIDS case reporting. Reporting of the initial determination of HIV infection, indicated by a confirmed positive HIV antibody test result, of HIV-related illness, indicated by viral load testing or CD4 cell count less than 500 test results, and of AIDS, according to the current AIDS case definition 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 newly diagnosed HIV infection will enable New York State to monitor the stage of illness at initial diagnosis, which is related to the accessibility of HIV counseling and testing and the need for outreach and education. Such data will also help assess the adequacy and inform the development of geographically accessible comprehensive HIV health care and support services. In addition, these data will help to identify population groups and geographic areas which are at particular risk of HIV and in need of prevention services, and will enable evaluation of prevention programs directed at those populations/areas. Data on persons currently infected with HIV and who have HIV-related illness, whether or not their illness has progressed to AIDS, will facilitate assessment of health care needs for persons with HIV and the degree to which health care is being accessed. These data will enable determination of the rate at which persons are progressing from HIV to AIDS, which may be related to the adequacy of care, as well as 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 also establish a system of more routine contact or partner notification assistance efforts based on surveillance reports. Partner notification is a public health prevention strategy, originally developed in response to sexually transmitted diseases (STDs) like syphilis and gonorrhea. It is based on the reporting of known contacts and the provision of information about partners by infected persons, elicited by public health workers who then attempt to contact and inform those partners of their possible exposure to disease. The source of exposure is never identified in this process. The goal of partner notification in STD control is to provide curative treatment to contacts before the development of symptoms and further transmission of infection.

HIV partner assistance services, including partner notification, differ from those for STD control in that curative treatment is not available and HIV infection is lifelong. Therefore, HIV partner assistance efforts focus on ensuring that contacts are informed of their possible exposure and are 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 to reduce their future risk for HIV infection. In addition to sexual partners, needle sharing partners are a focus of HIV partner notification activities.

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. Because 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. Therefore, health care providers and ancillary staff, as well as community-based support services program personnel play important roles in these ongoing efforts because of their ongoing contact with infected persons.

Article 27-F of the Public Health Law established a framework for HIV partner notification efforts in New York State. That system permitted infected persons, health care providers and public health officials to conduct partner notification. The State and New York City partner notification programs provide assistance on request. However, it has been difficult to document the success of these partner notification efforts. Utilization of the State and New York City programs has been small compared to the estimated number of newly infected persons in the State. There is no way to document the number of partners notified by infected persons or health care providers. Finally, reports in the medical literature indicate that a significant number of HIV- infected persons may not inform partners of their status.

The proposed rules authorize contact tracing as required by Chapter 163 for those reported cases of HIV infection when it is found to be merited to protect the public health. A mechanism for physicians to report contacts and verify such notification to the health department will enable physicians, if they choose, to be involved in partner notification activities with their patient from the point of diagnosis, and will establish a pattern of discussion of partner issues as a part of ongoing care.

Contact tracing is a process whereby health department partner assistance staff notify contacts reported by the physician or work with the reporting health care provider to obtain the cooperation of persons with HIV to provide any names of partners in need of notification, a process called partner elicitation. Circumstances which would 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. An additional factor required by the legislation is a screen for domestic violence. An indication of a risk of domestic violence shall be an important consideration in the determination of which cases merit contact tracing and in the decision to notify specific contacts. In situations where a risk of domestic violence has beenidentified, referrals, efforts or reasonable arrangements must be made in the professional judgment of the health official in consultation with the reporting physician before notification can proceed. Contact tracing for persons who have been exposed to circumstances that present risk of transmission of HIV is provided for in Chapter 163. Such circumstances involve occupational settings (e.g., health care workers, firefighters, police). The need to expeditiously make medically appropriate clinical decisions with respect to treatment of exposed persons is addressed through a protocol which seeks to confirm the exposure incident and if confirmed, permits disclosure between treating diagnostic providers or authorized facility staff.

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. Currently AIDS is reportable; approximately 9,000 cases are reported in NYC and 3,000 are reported in the rest of NYS each year. It is estimated that an 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 requirements. 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 is expected that it will take approximately five days for a computer programmer to modify existing systems at each reporting laboratory to include the new tests. With the cost of a programmer at approximately $70 per hour, including fringe benefits and overhead, the cost per laboratory will be approximately $2,800.

The ongoing cost of reporting would increase due to reporting occurring more frequently than the current monthly reporting requirement. Once the electronic procedure to create the file for reporting is developed, it would operate similarly to the current CD4 file extract. Laboratory personnel would need to spend approximately 60 minutes per week for file transfers to report the data to NYS. With the cost of a laboratory technician at $30 per hour, including fringe benefits and overhead, the cost would be approximately $30 per week. It is expected that the equipment and computers currently used to perform CD4 reporting would be used to perform the expanded reporting. 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.

It is estimated that about 30 commercial and hospital laboratories will initiate electronic reporting for HIV case reporting. For each of these laboratories, it is estimated that ten days of computer programmer support will be needed to develop the computer software program to create the file to be transmitted to the NYSDOH. At the $70 per hour programmer cost, each of these laboratories will incur 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. These laboratories will need to generate a hardcopy list of patient names and test results. These lists would then be mailed to the NYSDOH following established protocols to ensure confidentiality. Laboratory personnel would need to spend approximately 60 minutes per week for report generation and mailing. With the cost of a laboratory technician at $30 per hour, the cost would be approximately $30 per week.

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. Currently, the great majority of AIDS cases are initially reported by laboratories, hospitals and clinics. It is anticipated that clinics and physicians' offices will see a significant increase in reports being made since the initial HIV diagnosis is more often made in the outpatient than hospital setting. It is expected that no more than five minutes will be spent completing the report form, from information in the patient's record. At a nurse's salary, including fringe and overhead, of approximately $60 per hour, the cost is estimated at $5 per report.

Physicians, clinics and hospitals will continue to incur minor costs associated with providing medical records for review by surveillance staff. The information provided on the form (modified DOH 2193 or equivalent) and all laboratory reports requires a surveillance site visit to review the medical information and obtain additional information that is necessary to confirm the HIV/AIDS case and ascertain the patient's risk factors that may have led to infection. The facility makes the charts available for review; most often, the state or local health unit surveillance staff review the medical records without further assistance from the provider. While the number of medical records to be made available by the provider will increase with HIV reporting, these costs are not substantial. In those cases where documentation in the medical record is missing, additional time to interview the provider may be necessary. Provider interviews, less than five minutes in length, occur occasionally with current AIDS reporting. The cost is estimated to be $8 per interview, based on a $100 per hour salary for physicians, including fringe benefits and overhead.

Partner Notification Assistance Costs:

The existing provisions of Article 27-F of the Public Health Law require that partner notification be addressed as part of the post-test counseling of HIV infected persons. Published HIV clinical guidelines describing the current standard of care with respect to HIV partner notification also indicate the importance of addressing partner notification throughout the course of clinical care. Physicians likely to diagnose the largest number of HIV infected patients will be staff members of licensed health care facilities that are eligible for Medicaid reimbursement for HIV positive post-test counseling, at an average rate of $72 per 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 specific Medicaid reimbursement for post-test counseling of HIV infected persons, at an average rate of $41. Therefore, Medicaid reimbursement is available to many physicians addressing partner notification as part of HIV test counseling.

The partner notification component of this proposed regulation adds some specific responsibilities for physicians: informing infected patients that they will be requested to cooperate in contact notification efforts and screening for risk of domestic violence, reporting known contacts on a form provided by the NYSDOH, and communicating with public health officials regarding the plan developed with the patient for notification of partners and the disposition of the plan. The time involved in exercising these responsibilities 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 who choose to directly assist the patient in notifying partners would incur additional costs, estimated at $100 for one hour of time per partner notified. This would usually occur with the partner coming into the office, and could, for Medicaid patients, be billed as a pre-test counseling visit for the partner. It is anticipated that the great majority of partner notification plans will not involve physician time in directly notifying partners, as the assistance of trained public health staff will be sought to locate and notify partners, or patients will self-notify partners.

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

The NYS and NYC Departments of Health currently collect AIDS case information, check reports for accuracy and transmit required information (without identifying information) to the Centers for Disease Control and Prevention. The new requirements for HIV case reporting and for all cases to be reported to the State Health Commissioner necessitate that the NYC registry, which is currently maintained separately in NYC, be transferred into the NYS surveillance registry. While this will initially result in a five-fold increase in the size of the registry, it is not expected that any additional resources will be required for this activity because it will occur electronically. Some additional costs for computer programming will be incurred with the need to routinely unduplicate new NYC cases with the statewide registry.

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 AIDSsurveillance and function similarly to State surveillance staff located in all NYSDOH regional offices. AIDS surveillance staff (State, NYC, Suffolk and Onondaga) are currently responsible for validating and completing the AIDS case reports based on either laboratory or provider reports and review of the medical records. These responsibilities will be the same for the reporting of HIV, with the addition of collecting the names of known contacts. It is anticipated that there will be an approximate doubling of the workload on the State and specified local health unit staff to handle theadditional processing of HIV reports. This additional workload is, in large part, being addressed by a re-engineering of the surveillance system which will reduce the amount of time spent unduplicating cases and reviewing case report forms sent into the central office of the NYSDOH. The system involves assigning cases to the regional offices and the three local health units for surveillance. The regional field staff will contact the attending provider or his/her office staff and arrange a site visit to review the case. Once the case has been reviewed and the report form completed, the form is forwarded to central office of the NYSDOH where it is entered into the surveillance registry. Significant strides have been made to fully utilize electronic data handling practices, which minimizes the need for new field staff for this purpose. While the plan is to have the HIV surveillance system build upon and be incorporated into the current AIDS surveillance program, 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 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). On average, field staff are capable of completing up to 100 index patient partner notification processes per year. The process for each index case involves a series of tasks including prenotification preparation (laboratory visitation, provider consultation, report form completion), index patient interview, counseling and referral, and the actual field work involved in locating, notifying and counseling partners regarding their possible exposure and testing options, and completing the required documentation regarding the results of the notification assistance process. Of the estimated 11,000 newly diagnosed HIV infections reported each year, it is estimated that 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 new field positions, located in local health units and NYSDOH regional offices, will be required to address the increased workload, as well as program management staff to assume duties associated with overall program direction, information systems, administration, and evaluation.

Education, Training and Technical Assistance:

The NYSDOH will incur costs in launching a multi-media, statewide education campaign to provide information to consumers and providers about how HIV reporting will be implemented, how partner notification assistance will work, and to emphasize the benefits of knowing one's HIVstatus and early entry into care for HIV infected persons. This campaign will include training sessions, public service announcements, brochures and posters, available in various languages. These efforts will also include collaborative educational activities with professional medical and trade associations and in-service training for public health staff with direct responsibilities for program implementation.

Other State Agencies:

Other State agencies will need to review their respective regulations and to revise them in accordance with Chapter 163 of the Laws of 1998 and these proposed 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, that have responsibilities for populations at extremely high risk of HIV infection, may incur some costs in developing specific models that foster partner notification assistance for individuals who will need special arrangements for accessing these services. These two agencies will also need to ensure all staff are trained regarding the new law and its implementation.

Local Government Mandates:

For the 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 to Part 63 of 10 NYCRR, local 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, consistent with NYSDOH guidelines; performing necessary contact tracing in accordance with NYSDOH protocols; informing contacts that they may have been exposed to HIV and providing access to counseling and testing as well as essential information including the nature of HIV infection, modes of transmission, risk reduction measures, referral resources for health and human services; conveying necessary information concerning exposed partners/contacts to other counties/municipalities as appropriate; verifying referrals; submitting such reports as the NYSDOH may deem necessary; and maintaining confidentiality of information. Local governments which perform/conduct confidential HIV counseling, testing, referral and partner notification services as direct services to individuals will be required to report names of cases and contacts to the NYSDOH consistent with procedures and on forms specified by the State Health Commissioner. They will also be required to screen for risk of domestic violence in accordance with protocols determined by the NYSDOH and the State Office for the Prevention of Domestic Violence (OPDV).

Paperwork:

The reporting of HIV and collection of names of exposed contacts/partners by physicians to the NYSDOH will occur on the existing AIDS Confidential Case Report Form (DOH-2193 or equivalent) which will be modified for AIDS/HIV reporting. Space for recording contact names known by physicians will be added.

Laboratory reporting of test results indicative of HIV infection, HIV related illness or AIDS will occur to the extent possible by electronic means, building on the current system of electronic reporting to the NYSDOH of CD4 cell test results less than 200 for AIDS reporting. Initially, laboratories already reporting electronically will expand reporting to the full complement of reportable HIV test results. Laboratories not currently reporting electronically will report by paper forms. Every effort will be made to move all laboratories to electronic reporting in the future to ease the reporting burden.

The forwarding of case reports from the State to local health departments will occur via the Health Information Network (HIN), a secure electronic system already in place. The system is constructed such that counties may view and add to their own data on the system, but data do not actually reside at the local health department. This system minimizes the need for paper copies of identified information at the local level.

Minimizing paper copies of identified information will also occur as a result of strict data security protocols that will be enforced. Surveillance and partner notification reports will be maintained according to these protocols at the state level with a minimum of data maintained at the local level.

Duplication:

Relevant NYS requirements regarding HIV counseling, testing, referral and partner notification are found in Article 27-F of the Public Health Law and in current Part 63 of 10 NYCRR. Article 27-F sets forth a series of definitions related to HIV/AIDS and related testing, specifies steps involved in HIV testing and in pre- and post-test counseling, and it outlines requirements of informed consent, confidentiality and specific circumstances surrounding disclosure of HIV-related information. Current Part 63 provides additional details concerning these topics.

Federal requirements for receipt of HIV/AIDS surveillance funds by states is specified in the U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Program Announcement 706, HIV/AIDS Surveillance and Serosurveillance Cooperative Agreements. Program Announcement 706 references a number of federal publications including program requirements for surveillance which are contained in federal standards for security and protection of data and guidelines for national surveillance.

Similarly, federal requirements pertaining to HIV testing are specific to the U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Program Announcement 99004, Human Immunodeficiency Virus (HIV) Prevention Projects which sets forth requirements for the NYS HIV Prevention Cooperative Agreement received annually from the CDC. Program announcement 99004 conveys specific requirements related to state uses of federal funding for HIV counseling, testing, referral, and partner counseling and referral. All recipients of federal funds must provide HIV counseling, testing, referral, and partner counseling and referral services consistent with the CDC HIV Counseling,

Testing and Referral Standards and Guidelines published in May, 1994. Additional guidance is provided by numerous other federal documents. Alternatives: To the extent possible, the new program mandated by Chapter 163 will be incorporated into and built upon the existing AIDS surveillance and partner notification assistance program. Reporting and partner notification are mandated by law. From December 1997 to March 1998, the AIDS Institute and the NYS AIDS Advisory Council held seven day-long meetings to discuss various methods of developing an HIV surveillance system. The committee consisted of epidemiologists, physicians, public health officials, consumer advocacy groups, hospital representatives and others. The majority of the committee, largely consumers and the advocacy community endorsed a "unique identifier" system as opposed to the minority positions for a "names based" system, supported by many physicians and public health officials. The choice of a "names based" system at this time was due to the need for accuracy and the ability to access individual records for necessary follow-up. "Unique identifier" systems had been proven to be deficient in providing complete and unduplicated reports as noted in a 1/9/98 Morbidity and Mortality Weekly Report of a three-year evaluation of unique identifier systems in Texas and Maryland. 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 administrative or legislative 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.

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
Phone: (518) 473-7488
Fax: (518) 486-4834
Email: B0019b@health.state.ny.us

Regulatory Flexibility Analysis for Small Businesses and Local Governments

Effect of Rule:

The proposed rule will affect local health departments serving counties with health commissioners and it will also impact NYC. The state will be responsible for operating the program in the 44 counties in the state without a health commissioner. It will also affect physicians, physician assistants, nurse practitioners, and nurse midwives, clinics and hospitals that will report on behalf of their physicians and other such mandated health providers and clinical laboratories. Physicians, nurse practitioners, nurse midwives and physician assistants in private practice are generally small businesses. There are roughly six hospitals that employ less than 100 people each in NYS. There are no data about how many of the approximately 397 clinics statewide could be classified as small businesses. There are approximately seven laboratories in NYS which are approved for HIV related testing identified as small businesses.

Compliance Requirements:

Under the proposed rule, county health commissioners and the NYC health commissioner will be required to perform a number of activities including: receiving reports from the NYSDOH; determining whether or not reported cases merit contact tracing to protect the public health, consistent with NYSDOH guidelines; performing necessary contact tracing in accordance with NYSDOH guidelines; informing contacts of essential information such as the nature of HIV infection, modes of transmission, risk reduction measures, referral resources for health and human services; conveying necessary information concerning exposed partners/contacts to other counties/municipalities as required; verifying referrals; submitting such reports as the NYSDOH may deem necessary; consulting with providers of possible source patients for HIV occupational transmission; and maintaining confidentiality of information.

Local governments which perform/conduct confidential HIV counseling, testing, referral and partner notification services as direct services to individuals will be required to report names of cases and contacts to the NYSDOH consistent with department procedures and on forms specified by the State Health Commissioner. They will also be required to screen for risk of domestic violence in accordance with protocols determined by the NYSDOH and the State Office for the Prevention of Domestic Violence (OPDV).

Physicians and other providers authorized by law to order diagnostic tests or make a medical diagnosis, and laboratories which are small businesses will be required to report all initial cases of HIV, HIV-related illness and AIDS, and provide information on these cases as well as the names, if any, of sex and/or needle sharing partners, including spouses, named by individuals with HIV and AIDS. Physicians will also be expected to provide information on plans for notification of those partners that they may have been exposed to HIV and AIDS. Health care providers who are small businesses will be asked to make medical records available for government staff to gather necessary information.

Professional Services:

No additional professional services on the part of providers will be required for the reporting and partner notification provisions. Providers will be able to use existing staff. New York City and the larger counties with health commissioners that opt to directly provide services mandated by the new legislation will require the professional services of additional public health staff qualified to conduct the approved surveillance and partner notification assistance activities described in detail in the Regulatory Impact Statement accompanying this statement.

Compliance Costs:

Compliance costs for the affected laboratories, private physicians offices, clinics and hospitals will be minimal. It is likely that the laboratories classified as small businesses, due to the expected low volume of case reports from these entities, will report by hardcopy, at an estimated cost of $30 per week for report generation and mailing.

Private physicians offices, based on experience with AIDS case reporting, are likely to generate only 5%, or about 550, of the expected 11,000 HIV case reports. Assuming five minutes for completing the required form, from information in the patient's record, the cost is estimated at $5 per report, based on a $60 per hour nurse's salary. Minor costs are incurred for providing medical records for review by surveillance staff in order to confirm and complete case reports. In rare instances, a provider interview may be necessary when documentation to complete a case report is missing from

the medical record. The cost of a five-minute interview is estimated at $8, based on a $100 hourly salary for physicians. Private physicians may incur additional costs, estimated at $50-$100 per case, in carrying out specific responsibilities associated with partner notification, which include informing infected persons that they will be requested to cooperate in contact notification efforts and that they will be screened for risk of domestic violence, reporting known contacts on a form provided by the NYSDOH, and communicating with public health officials regarding the plan developed with the patient for notification, and ultimate disposition of the plan. Qualified office-based physicians can cover some of these costs by enrolling in the HIV Enhanced Fees for Physicians Program, which provides Medicaid reimbursement for HIV-specific services. (See "Cost" section in the accompanying Regulatory Impact Statement for additional information and method of estimating costs.) Similar unit costs will be incurred by those hospitals and clinics that meet the definition of small businesses and report on behalf of their physicians and other mandated health providers. Licensed health care facilities that are eligible for Medicaid reimbursement for HIV-specific services can recover some of these costs through the $72 rate available for HIV-positive post-test counseling.

There will be some new costs incurred by the larger counties with health commissioners (13 counties plus New York City) that opt to directly provide services mandated by the new legislation. Costs will vary depending on the range of activities assumed by these local health units and the incidence of HIV infection in the locality. The NYSDOH will assume direct operational responsibilities for the 44 counties without a health commissioner, thereby eliminating the need for new resources at the local level in these counties.

Economic and Technological Feasibility:

Small businesses and local governments will be provided with necessary forms and instructions to comply with reporting requirements. In large part, these forms and instructions are being created in a fashion which builds upon already-existing forms and protocols. NYSDOH staff will be available to provide necessary instruction and technical assistance.

Minimizing Adverse Impact:

Chapter 163 of the Laws of 1998 requires statewide reporting of all initial cases of HIV infection, HIV related illness and AIDS. Planning for implementation of Chapter 163 of the Laws of 1998 will minimize adverse impact upon local county health departments, physicians and clinical laboratories by taking into consideration and building upon existing public health and health care programs and mechanisms.

For example, the law calls for reporting of HIV infection, HIV-related illness, and AIDS to the NYSDOH. State staff will determine duplicate reports on individuals, thereby saving local time and effort that would otherwise be required. NYSDOH will provide guidelines, protocols, forms and procedures, including guidelines for local assessment of which cases merit contact tracing to protect the public health. Keeping medical providers involved and engaged in partner notification, means that, to the extent possible, some partner notification will be provided in the context of the on-going relationship between the HIV-infected individual and his/her care provider. Building upon this long-term relationship will also enable any future partners to be notified. For counties without physician health commissioners, locally situated state staff will be mobilized to collect surveillance information and provide partner assistance services, including partner notification.

Small Business and Local Government Participation:

Small businesses and local governments have had numerous opportunities to participate in discussions of policy and practical implications of HIV reporting and enhanced HIV partner notification. For example, during 1997-98, the NYS AIDS Advisory Council held several full-day meetings of a specially convened HIV Surveillance Workgroup which were open to the public. Local health department representatives as well as physicians and others discussed salient issues at these meetings. In July, 1998, the AIDS Advisory Council held a statewide community hearing on HIV reporting and partner notification accessible to all areas of the state via a specially arranged 1-800 call in system and provision for the submission of written testimony.

A workshop on HIV partner notification at the Statewide HIV/AIDS Policy Conference drew a standing room only audience from all areas of the state. Partner notification has also been a frequently discussed topic among members of the NYS HIV Prevention Planning Group (PPG). A presentation on the new law was made at the August, 1998 meeting of the PPG Executive Committee and an update was provided at the November, 1998 meeting of the full PPG.

Recent consultations have included meetings with representatives of numerous organizations, many of which have statewide constituencies. These consultations have included discussions with agencies and organizations such as the NYS Association of County Health Officials, Healthcare Association of NYS, Greater NY Hospital Association, Medical Society of the State of NY, Family Planning Advocates of NYS, Inc., Planned Parenthood of NYC, Inc., New York AIDS Coalition, NYC Department of Health and Mental Hygiene, Harlem Directors Group, Gay Men's Health Crisis, Inc., training agencies under contract to the NYS AIDS Institute and the Centers for Disease Control and Prevention. In addition, on September 22 a meeting was held with representatives of numerous AIDS service organizations in NYC including the AIDS and Adolescents Network, Lambda Legal Defense Fund, South Brooklyn Legal Services, Legal Services for NYC, Act Up/HIV Human Rights Project, Minority Task Force on AIDS, and the NYC Gay and Lesbian Antiviolence Project.

On December 2, 1998, a day-long intensive consultation regarding provisions of section 2137, Domestic Violence Recognition, was held in Albany. Participants included representatives of a variety of organizations, including many of those already listed above, as well as others such as the Rockland Family Shelter, NYC Coalition Against Domestic Violence, AIDS Related Community Services, League of Women Voters of NYS, Partnership to Prevent Domestic Violence, Oxford Health Plan, Grace Smith House, Bedford Stuyvesant Family Health Center, My Sister's Place and the Whitney M. Young Jr. Health Center. Representatives of the Centers for Disease Control and Prevention, California Office on AIDS, Nassau County Department of Health and the NYC Department of Health were also present. The department has considered all comments received in this process in development of the proposed rule.

Rural Area Flexibility Analysis

Types and Estimated Numbers of Rural Areas:

The proposed rule will affect local health departments serving all 62 counties of New York State, including those serving rural areas. However, the State will be responsible for operating the program in the 44 counties in the State without health commissioners. These are predominantly rural counties. It will also affect physicians and other providers authorized by law to order diagnostic tests or make a medical diagnosis (e.g., physician assistants, nurse practitioners, and nurse midwives), clinics and hospitals that report for their physicians and other mandated providers, and clinical laboratories in rural areas. There are approximately six hospitals that employ fewer than 100 people each in NYS. Data is not available about how many of the 397 clinics statewide are small businesses. Approximately eight laboratories in rural areas would be affected.

Reporting, Recordkeeping and Other Compliance Requirements and Professional Services:

Under the proposed rule, county 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, consistent with NYSDOH guidelines and protocols; performing necessary contact tracing in accordance with NYSDOH protocols; informing contacts of essential information such as the nature of HIV infection, modes of transmission, risk reduction measures, referral resources for health and human services; conveying necessary information concerning exposed partners/contacts to other counties/municipalities as required; verifying referrals; submitting such reports as the NYSDOH may deem necessary; and maintaining confidentiality of information.

Local governments which perform/conduct confidential HIV counseling, testing, referral and partner notification services as direct services to individuals will be required to report names of cases and contacts to the NYSDOH consistent with department procedures and on forms specified by the State Health Commissioner. They will also be required to screen for risk of domestic violence in accordance with protocols determined by the NYSDOH and the State Office for the Prevention of Domestic Violence (OPDV). Physicians and other providers authorized by law to order diagnostic tests or make a medical diagnosis and laboratories will be required to report all initial cases of HIV, HIV-related illness and AIDS, and provide information on these cases as well as the names, if any, of sex and/or needle sharing partners, including spouses, named by individuals with HIV and AIDS. Physicians will also be expected to provide information on plans for notification of those partners that they may have been exposed to HIV and AIDS.

Costs:

Costs for laboratories, private physicians, clinics and hospitals that report for their physicians and mandated health providers in rural areas will be minimal due to the relatively low volume of HIV incidence in these areas. Approximately 25% of new cases of HIV outside New York City are expected to occur in non-urban counties. It is likely that laboratories in rural areas, due to the expected low volume of case reports from these entities, will report by hardcopy, at an estimated cost of $30 per week for report generation and mailing.

Private physicians, based on experience with AIDS case reporting, are likely to generate only 5%, or about 550, of the expected 11,000 HIV case reports. It is expected that less than 1% of HIV case reports will emanate from physicians offices in rural areas. Assuming five minutes for completing the required form, from information in the patient's record, the cost is estimated at $5 per report, based on a $60 per hour nurse's salary. Minor costs are incurred for providing medical records for review by surveillance staff in order to confirm and complete case reports. In rare instances, a provider interview may be necessary when documentation to complete a case report is missing from the medical record. The cost of a five-minute interview is estimated at $8, based on a $100 hourly salary for physicians. Private physicians may incur additional costs, estimated at $50-$100 per case, in carrying out specific responsibilities associated with partner notification, which include informing infected persons that they will be requested to cooperate in contact notification efforts and that they will be screened for risk of domestic violence, reporting known contacts on a form provided by the NYSDOH, and communicating with public health officials regarding the plan developed with the patient for notification, and ultimate disposition of the plan. Qualified office-based physicians can recover some of these costs by enrolling in the HIV Enhanced Fees for Physicians Program, which provides Medicaid reimbursement for HIV-specific services. (See "Cost" section in the accompanying Regulatory Impact Statement for additional information and method of estimating costs.) Similar unit costs will be incurred by hospitals and clinics in rural areas. Licensed health care facilities that are eligible for Medicaid reimbursement for HIV-specific services can recover some of these costs through the $72 average rate available for HIV-positive post-test counseling.

The need for new resources at the local government level in rural areas will be eliminated as the State Health Department will assume direct operational responsibilities for the 44 rural counties without a health commissioner.

Minimizing Adverse Impact:

The agency considered the approaches contained in section 202-bb(2) of SAPA and found them inapplicable. Chapter 163 of the Laws of 1998 requires statewide reporting of all initial cases of HIV infection, HIV related illness and AIDS.

Impact on rural counties will be minimized in part by the State health department assuming responsibility for the operation of the program in the 44 counties in the state which do not have a health commissioner. These counties are predominantly in rural areas of the state.

Reporting and recordkeeping requirements will be minimized by relying on the existing Health Information Network (HIN) computer network established by the State health department which has links to all counties.

Planning for implementation of Chapter 163 will minimize adverse impact upon local county health departments, physicians and clinical laboratories by taking into consideration and building upon existing public health and health care programs and mechanisms. For example, the law calls for reporting of HIV infection, HIV-related illness, and AIDS to the state. State staff will determine duplicate reports on individuals, thereby saving local time and effort that would otherwise be required. NYSDOH will provide guidelines, protocols, forms and procedures, including guidelines for local assessment of which cases merit contact tracing to protect the public health. Keeping medical providers involved and engaged in partner notification, as currently required by Article 27-F of the Public Health Law, means that, to the extent possible, some partner notification will be provided in the context of the on-going relationship between the HIV-infected individual and his/her care provider. Building upon this long-term relationship will also enable any future partners to be notified. For counties without physician health commissioners locally situated state staff will collect surveillance information and provide partner assistance services, including partner notification.

Adverse impact on rural area residents will also be minimized by provisions providing strict confidentiality protections to information pertaining to reporting of HIV infection, HIV-related illness and AIDS and to the identities and status of partners named as contacts. The proposed regulations contain specific purposes for which information collected pursuant to the new law may be used. Article 27-F of the Public Health Law provides further protection of HIV-related information. Limited access by authorized and trained personnel well-versed in HIV confidentiality at the individual county level will be a program feature. Preservation of anonymous testing and continued availability of partner assistance services, including partner notification, within the anonymous option, will also mitigate negative impacts.

Rural Area Participation:

Public and private interests in rural areas have been afforded numerous opportunities to participate in discussions about HIV surveillance and about HIV partner notification. During 1997-98 the NYS AIDS Advisory Council held several full-day meetings of a specially convened HIV Surveillance Workgroup addressing HIV reporting and partner notification issues, which were open to the public. Local health department representatives as well as physicians and others discussed salient issues at these meetings. In July, 1998, the AIDS Advisory Council held a statewide community hearing on HIV reporting and partner notification accessible to all areas of the state via a specially arranged 1-800 call in system and provision for the submission of written testimony.

A workshop on HIV partner notification at the Statewide HIV/AIDS Policy Conference drew a standing room only audience from all areas of the state. Partner notification has also been a frequently discussed topic among members of the State HIV Prevention Planning Group (PPG), which includes meaningful participation from rural areas. A presentation on the new law was also made at the August, 1998 meeting of the PPG Executive Committee.

Recent consultations have included meetings with representatives of such organizations as the NYS Association of County Health Officials, Healthcare Association of NYS, Greater NY Hospital Association, Medical Society of the State of NY, and the NYS Clinical Laboratory Association. Each of these organizations has a statewide constituency, including rural areas. The department has considered all comments received in this process in development of the proposed rule. Recent consultations have included meetings with representatives of numerous organizations, many of which have statewide constituencies. These consultations have included discussions with agencies and organizations such as the NYS Association of County Health Officials, Healthcare Association of NYS, Greater NY Hospital Association, Medical Society of the State of NY, Family Planning Advocates of NYS, Inc., Planned Parenthood of NYC, Inc., New York AIDS Coalition, NYC Department of Health and Mental Hygiene, Harlem Directors Group, Gay Men's Health Crisis, Inc., training agencies under contract to the NYS AIDS Institute and the Centers for Disease Control and Prevention. In addition, on September 22 a meeting was held with representatives of numerous AIDS service organizations in NYC including the AIDS and Adolescents Network, Lambda Legal Defense Fund, South Brooklyn Legal Services, Legal Services for NYC, Act Up/HIV Human Rights Project, Minority Task Force on AIDS, and the NYC Gay and Lesbian Antiviolence Project.

On December 2, 1998, a day-long intensive consultation regarding provisions of section 2137, Domestic Violence Recognition, was held in Albany. Participants included representatives of a variety of organizations, including many of those already listed above, as well as others such as the Rockland Family Shelter, NYC Coalition Against Domestic Violence, AIDS Related Community Services, League of Women Voters of NYS, Partnership to Prevent Domestic Violence, Oxford Health Plan, Grace Smith House, Bedford Stuyvesant Family Health Center, My Sister's Place and the Whitney M. Young Jr. Health Center. Representatives of the Centers for Disease Control and Prevention, California Office on AIDS, Nassau County Department of Health and the NYC Department of Health and Mental Hygiene were also present. The department has considered all comments received in this process in development of the proposed rule.

Job Impact Statement

A Job Impact Statement is not required. The proposed rule will not have a substantial adverse impact on jobs and employment opportunities based upon its nature and purpose. Public Health Law Section 2193 authorizes the State Commissioner of Health to promulgate rules and regulations as shall be necessary to effectuate Article 21, Title III of the Public Health Law.

Article 21, Title III requires the reporting of human immunodeficiency virus (HIV), HIV related illness and acquired immune deficiency syndrome (AIDS) to the Department of Health. The law also authorizes reporting of known contacts of persons with HIV, HIV related illness or AIDS and the notification of contacts when merited to protect the public health.

The proposed rule may have a positive impact on jobs and employment opportunities. Some new field positions, located in local health units and NYSDOH regional offices, will be required to address the increased workload, as well as program management staff to assume duties associated with overall program direction, information systems, administration and evaluation.