Proposed Rule Making:
Amendment of Part 63 of Title 10
(HIV/AIDS Testing, Reporting and Confidentiality of HIV Related Information)
Publication Date: 11/02/2011
Effective September 1, 2010, Chapter 308 of the Laws of 2010 authorized significant changes in HIV testing in New York State. This law was enacted to increase HIV testing in the State and promote HIV-positive persons entering into treatment. Implementing this legislation is critical, since approximately 20 percent of HIV-positive New Yorkers are unaware of their infection status and 33 percent of persons newly identified with HIV are diagnosed with AIDS within one year.
Key provisions of the legislation and the proposed regulatory changes include:
- HIV testing must be offered to all persons between the ages of 13 and 64 receiving hospital or primary care services, with limited exceptions noted in the law. The offering must be made to inpatients; persons seeking services in emergency departments; persons receiving primary care as an outpatient at a clinic; or from a physician, physician assistant, nurse practitioner or midwife.
- Standardized model forms for obtaining informed consent and providing for disclosure will be developed by the New York State Department of Health and posted on the Department website.
- Consent for HIV testing can be part of a general durable consent to medical care, though specific opt out language for HIV testing must be included.
- Consent for rapid HIV testing can be oral and noted in the medical record, except within correctional facilities.
- Prior to being asked to consent to HIV testing, patients must be provided the seven points of information about HIV required by the Public Health Law.
- Health care and other HIV test providers authorizing HIV testing must arrange an appointment for medical care for persons confirmed positive.
- HIV test requisition forms submitted to laboratories will be simplified.
- Deceased, comatose or persons otherwise incapable of providing consent, and who are the source of an occupational exposure, may now be tested for HIV in certain circumstances without consent.
- Confidential HIV information may be released without a written statement prohibiting re-disclosure when routine disclosures are made to treating providers or to health insurers to obtain payment.
Required HIV Related Consent and Authorization Form (NYS Department of Health)
Frequently Asked Questions regarding the Amended HIV Testing Law (NYS Department of Health)
Per the New York State Department of Health, to comply with the law, the general medical consent form must have a clearly marked place next to the signature where the person providing consent is given the opportunity to decline the HIV test. Below is model language. Please note: One, single signature is sufficient for the purpose of consenting to all medical care including HIV testing. The model below includes such a signature line to demonstrate proper placement of the opt out language and check box.
- I have received information on HIV testing and I agree to be tested for HIV
Signature:________________________________________ (patient or person authorized to consent)
Check below if you do not wish to consent to an HIV test at this time. You may request HIV testing in the future.
_____ I do not want an HIV test
ACOG COMMITTEE OPINION HIV OPT-OUT
Universal Testing With Patient Notification and Right of Refusal-Opt-Out Testing
Opt-out testing removes the requirement for pretest counseling and detailed, testing-related informed consent. Under the opt-out strategy, physicians must inform patients that routine blood work will include HIV testing and that they have the right to refuse this test. The goal of this strategy is to make HIV testing less cumbersome and more likely to be performed by incorporating it into the routine battery of tests (eg, the first-trimester prenatal panel or blood counts and cholesterol screening for annual examinations). In theory, if testing barriers are reduced, more physicians may offer testing, which may lead to the identification and treatment of more women who are infected with HIV and, if pregnant, to the prevention of mother-to-infant transmission of HIV. This testing strategy aims to balance competing ethical considerations. On the one hand, personal freedom (autonomy) is diminished. On the other hand, there are medical and social benefits for the woman and, if she is pregnant, her newborn from identifying HIV infection. Although many welcome the now widely endorsed opt-out testing policy for the potential benefits it confers, others have raised concerns about the possibility that the requirement for notification before testing will be ignored, particularly in today's busy practice environment. Indeed, the opt-out strategy is an ethically acceptable testing strategy only if the patient is given the option to refuse testing. In the absence of that notification, this approach is merely mandatory testing in disguise. If opt-out testing is elected as a testing strategy, a clinician must notify the patient that HIV testing is to be performed. Refusal of testing should not have an adverse effect on the care the patient receives or lead to denial of health care. This guarantee of a right to refuse testing ensures that respect for a woman's autonomy is not completely abridged in the quest to achieve a difficult-to-reach public health goal.