S5836 HANNON¦¦¦¦¦¦¦¦¦¦¦¦¦¦ No Same as Departmental Bill # 172 Department of Health (Internal # 4 - 2005) ON FILE: 01/04/06 Public Health Law TITLE....Authorizes grants for expanded HIV services to women and children; and provides for an exception to informed consent for HIV testing in limited occupational exposure 06/20/05 REFERRED TO RULES 01/04/06 REFERRED TO HEALTH

HANNON Amd S71, Chap 731 of 1993; amd S2781, Pub Health L Authorizes grants for expanded HIV services to women and children, including adolescents; and provides for an exception to informed consent for HIV testing in limited occupational exposure situations. Department of Health

STATE OF NEW YORK _______________________________________________________________________ _ 5836 2005-2006 Regular Sessions

IN SENATE June 20, 2005 ___________ Introduced by Sen. HANNON -- (at request of the Department of Health) -read twice and ordered printed, and when printed to be committed to the Committee on Rules AN ACT to amend chapter 731 of the laws of

1993,

relating

to

special program

for

HIV services for infants and pregnant women, in

relation to authorizing grants for expanded HIV services to women and children, including adolescents; and to amend the public health law, in relation testing

to authorizing an exception to informed consent in limited occupational exposure situations

for

HIV

The People of the State of New York, represented in Senate and Assembly, do enact as follows: 1 Section 1. Section 71 of chapter 731 of the laws of 1993, relating to 2 special program for HIV services for infants and pregnant women, is 3 amended to read as follows: 4 § 71. Special program for HIV services for [infants and pregnant] 5 women and children, including adolescents. The commissioner, pursuant 6 to a request for proposal, shall make grants to programs to provide HIV 7 services for [infants and pregnant] women and children, including 8 adolescents which may include outreach and education concerning HIV 9 infection, modes of transmission, the benefits of early diagnosis and 10 medical intervention and the availability of services in the community 11 for [infants] children, including adolescents and women, including those 12 in need of prenatal and postpartum services. Such programs may make 13 referrals for and may deliver medical and other appropriate services to 14 assist such women and [infants] children, including adolescents. The 15 commissioner is authorized to make grants within amounts available 16 therefor to hospitals, community-based organizations and community 17 service programs for programs authorized under this section. 18 § 2. Subdivision 6 of section 2781 of the public health law is amended 19 by adding a new paragraph (e) to read as follows: EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD10504-02-5 S. 5836

2

1 (e) in situations involving occupational exposures as described in 2 departmental regulations, when the person who is the potential source of 3 the occupational exposure is unable to provide consent or when obtaining 4 consent from a legal representative, if any, would result in a delay in

5 appropriate medical treatment of the exposed person, as determined by a 6 provider of the exposed person, either the exposed person's medical 7 provider or the medical provider of the source person shall order an HIV 8 related test of the source person and the results of such test shall be 9 disclosed to the medical provider of the exposed person, to the exposed 10 person, to the source person, if possible, and to his/her medical 11 provider, and to the source person's legal representative, if any. Any 12 further redisclosure of the HIV status of the source person is prohibit13 ed except in compliance with this article and title three of article 14 twenty-one of this chapter. Counseling must be provided in accordance 15 with this article. 16 § 3. This act shall take effect immediately.

NEW YORK STATE SENATE INTRODUCER'S MEMORANDUM IN SUPPORT submitted in accordance with Senate Rule VI. Sec 1 BILL NUMBER: S5836 SPONSOR: HANNON¦¦¦¦¦¦¦¦¦¦¦¦¦¦

TITLE OF BILL: An act to amend chapter 731 of the laws of 1993, relating to special program for HIV services for infants and pregnant women, in relation to authorizing grants for expanded HIV services to women and children, including adolescents; and to amend the public health law, in relation to authorizing an exception to informed consent for HIV testing in limited occupational exposure situations

PURPOSE: The purpose of the bill is bring current legislative authority in Section 71 of Chapter 731 of the Laws of 1993 to permit grants to provide continuity of care in the treatment of HIV (described in paragraph "a" below). Additionally, the bill, as described in paragraph labeled "b" below, amends Article 27-F of the NYS Public Health Law (PHL), regarding exceptions to the requirements of written informed consent to permit HIV testing in certain cases of potential occupational exposure involving staff, employees or volunteers in medical and other professional settings. Numerous situations have arisen when individuals who may be the source of a significant occupational risk exposure to others are

unable to provide consent (lack capacity to consent) on their own and no health care proxy has been named, is not readily available, or when seeking appointment of a party to consent would cause a delay in appropriate medical treatment for the exposed party.

SUMMARY OF PROVISIONS: Section one of the bill amends Section 71 Chapter 731 of the Laws of 1993 to expand the permissible scope of grants for HIV services beyond pregnant women and infants to include women and children, including adolescents. Such programs may provide HIV prevention education, counseling and testing, and referrals for medical and other appropriate services to assist women and their children. These programs may also provide on-going care and supportive services subsequent to pregnancy for women identified as HIV positive, and for children and adolescence identified as HIV positive. The Commissioner is authorized to make grants within amounts available to hospitals, community-based organizations and community service programs authorized under this section. Section two amends Section 2781 of Article 27-F of the PHL to expand the circumstances under which HIV/AIDS testing may be permitted without first obtaining written consent, to include testing of an individual who may be a potential source of occupational exposure, who lacks capacity to consent to testing themselves and for whom there is no person available and authorized pursuant to law to consent to health care decisions for such individual (following reasonable and timely efforts to identify such an individual). Testing without consent in this instance will only be permitted when an individual has been determined to be the source of significant occupational risk exposure through potentially infectious blood or bodily fluid. Section three provides an immediate effective date. EXISTING LAW: a. Section 71 currently provides funding for special programs for HIV services to infants and pregnant women. The Commissioner may make grants to programs to provide HIV services for infants and pregnant women which may include outreach and education concerning HIV infection, modes of transmission, the benefits of early diagnosis and medical intervention and the availability of services in the community for infants and women in need of prenatal and postpartum care. b. Provisions of New York State PHL enacted in 1986 require written informed consent for HIV testing in all cases, except under certain specified circumstances. Specifically, PHL 2781 states: "except as provided in section three thousand one hundred twenty-one of the civil practice law and rules, or unless otherwise specifically authorized or required by a state or federal law, no person shall order the performance of an HIV -related test without first receiving the

written, informed consent of the subject of the test who has capacity to consent or, when the subject lacks capacity to consent, of a person authorized pursuant to law to consent to health care for such individual... ." Current Exceptions to Required Consent: There are currently eight situations specified in statute under which consent is not required: 1. Court-ordered testing pursuant to CPL section 3121 (examination of a party to litigation after the initiation of a court action in which mental or physical condition is in controversy). 2. When testing without informed consent is specifically authorized or required by State or federal law. 3. For testing related to procuring, processing, distributing or use of a human body or body part for use in medical research or therapy, or for transplantation to persons, provided that the test results are communicated to the tested persons - post-test counseling is required. 4. For research if the identity of the test subject is not known and cannot be retrieved by the researcher. 5. For testing a deceased person to determine cause of death or for epidemiological purposes. 6. For a court order to test in connection with the Criminal Procedures Law (Sec. 390.15) or with Family Court Act (Sec. 347.1) regarding a conviction for a sexual or deviant sexual offense (PHL Sec. 2785-a, enacted in 1995). 7. Comprehensive testing of all newborns in New York State pursuant to PHL section 2500-f enacted in 1996. 8. Testing may be permitted without consent pursuant to PHL Sec. 2504 in the event of a medical emergency and an attempt to secure consent would result in delay of treatment which would increase the risk to the person's life or health. LEGISLATIVE HISTORY: a. Grant legislation was enacted in 1993 and became effective January 1, 1994. b. No legislative history exists regarding HIV testing in certain occupational exposures. STATEMENT IN SUPPORT: a. New York State's strategy for the provision of HIV services for pregnant women and infants includes a combination of regulatory and grant programs. Since passage of Section 71 of Chapter 731 of the Laws of 1993, regulations have been adopted that require all regulated prenatal care providers to provide HIV counseling, with a clinical recommendation to test, all prenatal care patients; expedited testing of women in labor and delivery settings in cases where an HIV test result from prenatal care is not available; and universal newborn testing as a safety net. These regulations were adopted because of evidence that perinatal HIV transmission is significantly reduced by initiating antiretroviral therapy (ART) during labor or soon after delivery, even if ART was not taken

during prenatal care. In addition to changes in regulation since the law was passed, there have also been substantial advances in the treatment of HIV, with lifesustaining treatments available for all persons with HIV. These treatments, often funded by grants, have extended the lives of the HIV positive women and infants identified in the course of various regulatory initiatives. In fact, the life sustaining treatments that have led to a decline in new infections among infants have also resulted in perinatally infected infants living into adolescence and beyond. The evolution of the epidemic and the success of the State's programs serving pregnant women and infants result in the need to revise the legislative language to reflect the advances of the last ten years in terms of the clinical management of HIV, as well as the grant and regulatory environment within which the programs operate. Grant funding must be used to complement the regulatory approach and to provide ongoing care and support to those women and children identified as HIV positive. A narrow interpretation of the legislation as it currently reads might preclude the provision of ongoing HIV care and services to women and their children, including adolescent children. The legislative language must be changed to authorize a broader purpose, specifically the ongoing provision of HIV services to women subsequent to pregnancy and the ongoing provision of HIV services to children beyond infancy into childhood and adolescent years. This broader language will ensure the health and safety of these populations b. Current health regulations, 10 N.Y.C.R.R. §63.8 (m), permit disclosure of HIV test information which exists in a patient's medical record to listed categories of exposed persons in the event of a documented occupational exposure. Exposed persons who may receive information of a patient's HIV status under these regulations are: staff, employees or volunteers 1) in medical or dental offices; 2) in facilities regulated by the Department of Health, Office of Mental Health, Office of Mental Retardation and Developmental Disabilities, Office of Children and Family Services, Office of Alcoholism and Substance Abuse Services and the Department of Correctional Services; and 3) involved in the emergency response system, e.g. EMT, fire, police. This bill would enable providers, not only to disclose existing information, but also to test a comatose or incompetent patient, without an available legal representative, for the treatment benefit of this same defined group of staff, employees and volunteers who have documented an occupational exposure. New testing technology provides critical information to providers treating exposed persons. The recently approved HIV Rapid Test allows for preliminary HIV test results in less than thirty minutes, providing an immediate source of information on which to base a decision to initiate prophylactic therapy. In the case of a significant risk of occupational exposure, current therapeutic recommendations are to begin antiretroviral medications as soon as possible, ideally within two hours (New York State Department of Health, AIDS Institute, Clinical Guidelines, September 2003). The existence of highly effective antiretroviral medications

has been shown to statistically lessen the chance of contracting disease if administered quickly. These medications may have side effects and should not be initiated unless clearly indicated. Consequently, immediate testing in the case of an occupational exposure is necessary to allow medications to be initiated quickly, thus realizing their maximum potential effectiveness. When the source patient is unable to give consent, the resulting lack of information on which to base post-exposure prophylactic treatment can be injurious to the exposed individual. Source patients may be unable to give consent as a result of a variety of situations including but not limited to: * patients who are comatose * patients suffering senile dementia * patients still under post-operative sedation. Consent in these situations should be implied, as opposed to assumption of no consent. The American Medical Association, as reported by their Council on Scientific Affairs (2003), notes that exceptions to confidentiality are appropriate when necessary to protect the public health or when necessary to protect individuals, including health care workers, who are endangered by persons infected with HIV. Precedent exists in several states including Connecticut where requirements for informed consent, written or oral, do not apply in several situations including occupational exposure. Requirements for informed consent are waived in cases where a health care provider, or other person, including a volunteer EMS, fire or public safety official, who in the course of his/her duties, has a significant exposure and certain conditions are met. Similarly, in New York State it has become necessary to amend the HIV testing consent requirements in cases of occupational exposure, when an incapacitated person is unable to give consent and when delays associated with the court process to obtain consent may result in injury to the worker whose employment routine presents risky exposure situations. BUDGET IMPLICATIONS: a. None. The existing appropriation will support the broader purpose of providing HIV services to women and children, including adolescents infected or at risk. b. Minimal (cost of testing and treatment are likely to be covered by existing third-party payers).