Summary of Assessment of Public Comments

Thirty-three comments were received by the Department of Health on the revised Part 63 regulations published in the December 15, 1999 State Register. Many comments focused on issues which had been raised in the initial promulgation of the regulations and which have already been considered and addressed in the December 15th Assessment of Public Comment. Significant among these comments were: recommending use of a unique identifier rather than patient name in the reporting process; including a definition of a minor in the regulations; amending the informed consent form to state that there are no penalties for not providing partner names; requiring informed consent for reportable tests other than HIV antibody positive; questioning the Department's authority to require all specified laboratory tests to be reported; questioning the Department's authority to interview index patients; the inclusion of domestic violence issues in pretest counseling; inclusion of the domestic violence protocols in regulation; and questioning the authority to allow disclosure to persons occupationally exposed.

In summary, the Department's response to comments received are as follows:

Definitions:

One commenter requested a definition of domestic violence (DV) be added. The Office for the Prevention of Domestic Violence (OPDV) is the lead agency on DV. The Department has worked closely with OPDV and accepts its definition.

One commenter suggested the definition of health care provider be amended to refer to a provider of diagnostic medical or health care services. In response, section 63.4 applies only to health care providers who order diagnostic tests.

Confidentiality

Some commenters inquired about an enforcement protocol for breaches of identifiable program data. The Department is developing procedures for monitoring breaks in protocol by staff and possible confidentiality breaches. Resolution will utilize the Department's existing enforcement mechanisms.

One commenter suggested all disclosures of HIV information be recorded in the medical record. Both PHL section 18 and PHL Article 27-F address the recording of disclosures in the medical record.

Some commenters said that only correctional personnel directly involved in medical care be provided HIV status of inmates, probationers and parolees. Strict confidentiality protections govern access to HIV-related information and do not provide for non-medical correctional staff to obtain names and HIV status of inmates Further, existing regulations for the pertinent state agencies limit the disclosure of HIV-related information.

A comment was received that data security policies should be subject to community input. Data security will conform to the technical requirements of the Centers for Disease Control and Prevention (CDC) and will incorporate the best available electronic and other safeguards. General community input is not appropriate.

One person commented that county health departments needed to maintain all program data for an unlimited time. The Department finds maintaining contact names for no longer than a one-year period is sufficient.

One commenter questioned how reporting sources would maintain confidentiality. PHL Article 27-F limits disclosure of HIV-related information.

The Office for Families and Children Services (OFCS) questioned its access to HIV information. Appropriate access for foster care and adoption remains unchanged.

One comment recommended amending section 63.5(a) to prevent DV information from being shared with insurance companies. Disclosure to insurance companies is authorized in PHL 2782 only "to the extent necessary to reimburse." If the DV information is part of the HIV record and not necessary for reimbursement, it must be withheld.

Some commented the regulations contain specific requirements for DV involving minors. Medical practice precautions are not suitable for regulatory promulgation. The Department will develop guidance materials regarding minors.

Pre-Post-Test Counseling

Some commenters suggested that standards for counseling special populations, such as adolescents and immigrants, be in regulation. It is not feasible to address all groups specifically in regulatory language. The Department is incorporating guidance in its educational brochures, guidance materials and training programs.

One commented that the regulations limit giving HIV information concerning a minor to parents and guardians. This issue is addressed in Article 27-F, section 2782(4)(e) and in NYCRR section 63.6(g). The statute requires such disclosure to be "in the best interest of the protected individual," which requires a case-by-case determination.

Surveillance/Reporting Issues

Two commenters, indicated that since a CD4<500 is not part of the national HIV surveillance case definition, it should be deleted from the regulations. CD4<500 is an indicator of HIV-related illness in CDC's clinical staging classification for HIV. Chapter 163 requires reporting of HIV-related illness, providing the basis for reporting this test.

A commenter said providers do not routinely communicate a patient's diagnosis to laboratories. Therefore, laboratories could not know whether of not CD4 tests were HIV related In certain situations, e.g. laboratories in cancer hospitals, this circumstance occurs and would constitute an exception in section 63.4(a)(4).

Some comments said that newborn HIV test results and the mothers of HIV positive newborns should not be reported. Neither will be reported to the HIV registry based on newborn antibody positive test results.

Another commenter sought clarification as to whether the index case gets reported when PN is deferred based on risk of DV. The statute does not authorize such deferral.

Partner Notification (PN) Issues

Some writers recommended limiting the information given to the contact during PN. The regulation, section 63.8(a), does not allow the name or any other information to be disclosed.

Some commenters urged recognition of special populations (e.g., youth, immigrants). Special populations present unique circumstances, but PN must rely on a case-by-case assessment. Guidance and training materials are being prepared.

One comment suggested that local health departments be certified as capable of implementing the regulations. Local health departments will submit their procedures regarding PN to the State for approval. The Department will provide local public health staff with comprehensive training. Funding has also been provided.

Three comments said the regulations did not define a statewide standard of cases meriting PN. PHL section 2133, states that the municipal health commissioner or department's district health officer, "upon a determination that such reported case ... merits contact tracing ... shall ... " Although the regulations provide guidelines as to which cases merit PN, they cannot preempt the judgment of local health officers.

Regulations specifically governing PN occurring in congregate facilities were also recommended. Since congregate facilities are varied, specific regulations covering each type of congregate facility are inappropriate. Guidance is being developed.

One commenter suggested purging partner names when there is no confirmation that PN has occurred. The regulations, section 63.80) require destruction of partner names no later than one year following case closure. Case closure may include some situations when notification has not occurred.

One commenter suggested that persons be afforded a fair hearing if they disagreed that their case merited PN. There is no legally recognized right not to have a known partner notified.

One commenter raised an issue concerning physician liability for professional judgment as to whether reasonable arrangements had been made to address the safety of persons with a DV risk (section 63.8 (b)). PHL section 2136, states that "any person who in good faith complies with this title shall be immune from civil and criminal liability for any action taken in compliance with its provisions." Since PHL section 2137 addresses DV recognition, identification and screening, it is likely that a court would find that judgments made about proceeding with PN in cases where there is concern about DV, made in good faith, are covered by protections of PHL section 2136.

A commenter said that regulations should require Child Protective Services be notified when a parent or guardian is determined to be a contact of a minor. Mandated and voluntary reporters of child abuse are already addressed in Social Services Law.

A commenter suggested that for children in foster care the person with capacity to consent to medical care be advised of the child's possible exposure to HIV to enable access to necessary HIV counseling and testing. This disclosure may not be appropriate in all cases since a minor who has been determined to have "the capacity to consent" (PHL section 278 1) may consent to the HIV test. Once the results of the HIV test are known, a subsequent decision to inform parties who can legally consent to health care can be made.

Domestic Violence (DV) Issues

The issue of whether all DV information might be protected from disclosure under PHL Article 27-F or Article 21, Title III was raised. The Department can only extend such protection in regulation as provided for in statute. DV information which is integrated into HIV information, such that disclosure of the HIV status of a person would necessarily disclose DV information would likely be found by a court to be protected under the HIV law.

Consent Form and Related Issues

Some commenters suggested the consent form include more specific DV information. The form does discuss DV in relation to PN and includes a toll-free number for information regarding DV services. One commenter suggested amending the consent form to indicate that consent for the test could be withdrawn any time. Another suggested that a patient's right to withdraw consent for HIV testing is contradicted by allowing PN to proceed if posttest counseling is not done. A patient's right to withdraw ' consent for testing exists until such test is performed. In rare cases, both the provider and the Department will have knowledge of the test result and also have information that contacts exist. In such cases, the law permits notification of the partner, without identifying the protected person.

One commenter stated that section 63.3(f), addressing situations when HIV testing is intended to aid in clinical disease monitoring and when pre- and posttest counseling may be tailored to the needs of the patient, erodes patient rights by permitting a provider to determine adequate pre- and posttest counseling. In fact, the Department believes this refinement better informs and protects patients by recognizing individual patient needs in situations where the HIV testing is repetitive and on going.

Occupational Exposure Issues

A commenter advised that baseline testing of the exposed person be required for disclosures to HIV in occupational settings. This is currently the case. However, if results of baseline testing are not available and HIV information about the source of exposure is necessary for immediate treatment decisions or for decisions on continuation of post-exposure prophylactic treatment, then disclosure is permitted.

Other commenters suggested that disclosure in cases of possible occupational exposure should include persons employed by funeral establishments, as well as parties/facilities regulated by the Department of Education and local school district and local boards of education. These additional settings pose little risk of HIV transmission. One reason this section is limited to organized, licensed settings is to ensure that there is no abuse of the ability to access HIV information. The Department believes it prudent to limit the ability to disclose to closely controlled, recognized high risk occupations.

Resources

One commenter noted that all hospitals should receive Medicaid payments for pre and posttest counseling and DV screening. Under the HIV Primary Care Medicaid Program, all Article 28 facilities are eligible to receive enhanced Medicaid reimbursement for pre- and posttest counseling. Multiple sessions can be billed with supporting documentation.

Two commenters noted that the Department should ensure that managed care plans and private insurance carriers reimburse for test counseling and DV screening. All capitated rates for Medicaid managed care include HIV counseling and testing. The Department of Health will notify the Department of Insurance of the change related to this new law and recommend that regulated insurance carriers act accordingly.

Anonymous Counseling and Testing

Commenters concerned about availability and accessibility of anonymous HIV counseling and testing recommended an expedited process for approving community organizations to offer this service. The Department is closely monitoring demand for anonymous testing and counseling sites. Ensuring access to sites operated by public health staff will be a priority for the Department and resources will be allocated to meet demands.

Evaluation

Five comments were received which emphasized the need for evaluation of the HIV Reporting and PN program. The Department of Health will itself conduct program evaluation, including the impact of the program on rates of HIV testing in the State and the outcome and impact of the PN process.

Effective Date:

These regulations will have an effective date of June 1, 2000.