Summary - Amendment of Part 63 of Title 10 NYCRR

The proposed amendments to 10 NYCRR Part 63 revise the existing regulations to conform to and implement Chapter 163 of the Laws of 1998, which amends both Public Health Law Articles 21 and 27-F. Significant changes are itemized as follows:

Section 63.1 - Definitions: The definitions of "HIV infection", "contact", "contact tracing", "municipal health commissioner" and "district health officer" remain as proposed in the initial promulgation. In addition, the term "sperm bank" has been deleted from the definition (section 63.1(i)) of health facility since it is included as an organ procurement agency. Nurse practitioners, physician assistants and midwives have been included in the definition of "diagnostic provider" (section 63.1(j)). In section 63.1(p), county commissioners must follow guidelines acceptable to the commissioner.

An "authorized public health official" is defined in section 63.1(s).Section 63.2 - Application: The regulations indicate that the amendments authorizing HIV reporting and contact notification do not apply retroactively to HIV information received by the department under 10 NYCRR Subpart 24-1.

Section 63.3 - HIV-related testing: The revised regulations clarify that physicians and other diagnostic providers must provide laboratories with the names and addresses of the source of the specimen. Informed consent to an HIV test must include information concerning the mandated reporting of HIV tests and also inform the test subject that, if positive, he/she will be asked to cooperate in contact notification activities which includes known contacts, including a spouse and other named contacts. Post test counseling must include the fact that HIV reporting is legally required, a discussion of the need and benefits of notifying contacts, the availability of medical and psychological assistance, prevention services, including location and phone numbers, partner notification options, a domestic violence screen, and perinatal transmission. Revisions clarify that the identity of the index case is not disclosed.

Section 63.4 - Filing of reports: The amendments require the reporting of cases of HIV infection, AIDS or HIV-related illness by physicians and other diagnostic providers as soon as possible after post-test counseling but no later than 21 days after a provider's receipt of a positive laboratory result or after diagnosis. Laboratories periodically must report confirmed positive HIV antibody tests, positive HIV nucleic acid (RNA or DNA) detection tests and CD4 lymphocyte counts less than 500, unless known to be performed for reasons other than HIV infection. All reports shall include names and addresses of the infected person and of known contacts, information on domestic violence submitted in conformance with a protocol specified by the commissioner and such other information as may be specified by the commissioner as required for epidemiologic investigation, case finding and partner notification. Anonymous test results from state approved anonymous testing sites are excluded. The amendments provide that reports and additional information, including domestic violence (DV) information, maintained by the commissioner or his/her designated representative shall be kept confidential, pursuant to Article 21, Title III, except for epidemiological monitoring and partner notification activities.

Section 63.5 - Disclosure pursuant to a release: The revised amendments clarify confidentiality relating to DV information and that releases made by physicians or their agents need not be accompanied by a prohibition on redisclosure statement.

Section 63.6 - Confidentiality and disclosure: The amendments note that disclosures are permitted to health care providers for care and treatment to a contact, according to protocol in section 63.8. Disclosure by physicians or their agents to public health officials or to contacts is authorized when made pursuant to Article 21, Title III or Article 27-F. Revisions limit disclosures made at the request of a physician to information about contacts and permit sending only information of potential exposure (not the identity of the index case) out of state for the purpose of notifying partners.

Section 63.7 - Documentation of HIV-related information and disclosures: Technical numbering changes only.

Section 63.8 - Contact notification: The existing regulations are amended to set forth three mechanisms for contact notification:

(1) for contacts identified through Article 21 reporting;

(2) for contacts identified by physicians and other diagnostic providers in the course of their ongoing practices; and

(3) when an exposure incident occurs to staff, employees or volunteers in the performance of employment or professional duties in a medical or dental office or in a regulated facility or if the person is an emergency response employee.

In the first situation, section 63.8(a) revisions clarify that DV information required for an approved DV screen will not be disclosed except pursuant to Article 21, Title III. Physicians must report risk and contact information as specified by the commissioner, who shall forward the information to the county health commissioner. The local commissioners shall determine cases meriting contact notification in order to protect the public health. Important factors in such decisions are:

(1) known contacts, including spouses, reported by a diagnostic provider; and

(2) situations involving persons with newly diagnosed HIV infections.

Contact notification must be consistent with guidelines acceptable to the commissioner, which are sensitive to the needs of minors, institutionalized persons and other vulnerable population. The notification can only proceed if in the judgment of the health official, consulting with a provider, referrals, efforts or reasonable arrangements have been made such that it can be carried out safely; information from a DV service provider obtained via a signed release shall also be considered, if available. If a person fails to return for post-test counseling, the public health official determines, in consultation with the physician, whether to proceed with notification of known contacts. Communication, if necessary, with the person must occur in a private and safe manner. A physician or public health officer has no obligation or liability to identify or locate any contact, except as provided pursuant to Article 21, Title III. Information identifying contacts shall not be maintained at the state or local level for more than one year following completion of contact notification. When notifying contacts exposed to potentially infected blood/organs, a federally mandated recipient notification program or a commissioner approved protocol shall be sufficient. Organizations may disclose HIV status of a donation to a donor's provider for the purposes of notifying known contacts of a donor.

When sexual or needle sharing contacts are notified under authority in PHL section 2782(4), the amendments mirror the specific changes required by Chapter 163. Partner notification continues to be authorized in involuntary cases. No disclosure of index names may occur.

Domestic violence screening must also take place. In the third situation, a request for disclosure may be made by staff, employees or volunteers working in a medical or dental office (including correctional services medical staff) or in a regulated facility to their medical provider or to the medical officer designated by the facility. Revisions clarify emergency medical employees continue to be governed by federal regulation. The incident must have occurred in the performance of employment or professional duties and on record with supervisory staff. Disclosure to an exposed person may occur if:

(1) the information relates to initiation or continuation of treatment; and

(2) the exposed person is either HIV negative or unknown.

If the exposed person's status is unknown, he/she must consent to an HIV test. The incident must involve a listed body substance which has come into contact with mucus membranes, non-intact skin or the vascular system of another. The provider of the source may consult with the local health officer. If consultation occurs, agreement must exist if the information is to be disclosed. Revisions note that redisclosure is limited and index names are not released. If the disclosure is in writing, no names shall appear on documentation provided to the exposed person.

Section 63.9 - Health care provider and health facility policy and procedures: The amendments require initial employee education and annual inservice education regarding Article 21, Title III.

Section 63.10 - Significant risk: The amendments categorize occupational settings where barrier techniques are not breached as not being significant risk situations. A significant risk situation exists when blood/organs are not conclusively tested for HIV.

Section 63.11 - Approved forms: The revised informed consent form clarifies that a negative HIV antibody test may not show recent infection, and should be repeated three months after last exposure to HIV. "Preliminary test results" and the option of converting anonymous tests to confidential tests are noted on the form. Language addressing the need for confidential testing in order to enter into treatment has been deleted. The form states that positive test results are reported to the State and that the infected person will be asked to cooperate in partner notification activities. The issue of domestic violence is raised on the form. The deferral of partner notification for a time period sufficient to allow access to domestic violence prevention services is noted. The release form is unchanged.

Section 63.12 - Separability: This provision states that if any section, clause or provision of the regulations are held to be unconstitutional or ineffective in whole or in part, other sections shall be nevertheless valid and effective.