NYS Passes New HIV Testing Bill

NYS Passes New HIV Testing Bill

July 2010

On July 30, Governor Patterson signed into law a new HIV testing bill (S8227 and A.11487, introduced by Senator Tom Duane and Assemblyman Richard Gottfried). The law is scheduled to go into effect on September 1, 2010, pending adoption of rules and regulations by the Commissioner of Health.

The new law dramatically changes the landscape of HIV testing in New York. We have gone from a pure opt-in state to a hybrid schema that involves opt-in testing now in certain situations (under a new required offer of testing provision), and opt-out in other situations (where consent may be included in a general medical consent form unless the individual pots-out). Further, oral consent may now replace written consent when rapid testing, and subsequent confirmatory tests, are given. These changes and others indicate a significant change for the state of testing in New York. HIV Law Project applauds some of the law’s new features, and regrets others.

Key elements of the new law include:

• ORAL CONSENT IS NOW SUFFICIENT FOR RAPID TESTING: Until now, New York has required medical providers to obtain a patient’s written, informed consent before administering an HIV test. Under the new law, a patient’s oral consent is sufficient when a rapid HIV test is being ordered. (Rapid testing is defined as any test that produces results in 60 minutes or less, and also any confirmatory tests-- rapid or otherwise-- if the screening result is positive.) This oral consent is to be documented in the individual’s medical file. (This section does not apply to tests performed in correctional facilities.) Otherwise, written consent remains the standard.

HIV Law Project endorses written informed consent as the surest way to guarantee that testing is non-coercive and undertaken with the full understanding of the patient. While we are relieved that the principle of informed consent has been preserved, we are concerned that other elements of the law erode the purity of the consent (specifically, see the following two bullets).

• HIV TESTING MAY NOW BE INCLUDED IN A GENERAL MEDICAL CONSENT FORM: Under the new law, consent to HIV testing may now be included as part of a general consent to medical care and services. Where a general consent form includes HIV testing, the form must include a clearly marked place adjacent to the signature where the patient can specifically decline in writing HIV-related testing.

This provision establishes for the first time “opt-out” testing in New York State. Previously individuals could not be tested unless they explicitly “opted-in” by signing a HIV-specific consent form. HIV Law Project believes many people – especially when confronted with a barrage of documents to sign before seeing a medical provider – may unknowingly give consent to HIV testing on a general medical consent form that includes HIV testing. We applaud the law’s attempt to reduce the danger of this unknowing consent by including the opt-out option near the signature. However, this measure is insufficient to ensure informed consent.

• CONSENT IS ON-GOING: Written or oral consent for HIV testing is now valid until revoked, or until it expires by its terms. Every time an HIV test is ordered pursuant to the consent, the health care provider must orally notify the patient of the test, and must note the notification in the patient’s record.

These two changes (the inclusion of HIV consent in general medical consent, together with durable consent) mean there is more possibility for confusion or misunderstanding surrounding HIV testing. These provisions also create a greater likelihood that patients whose consent is part of a durable consent to medical services, and particularly those patients with limited English proficiency, will be tested without their knowledge, despite the oral notification requirement.

• NEW PRE-TEST COUNSELING REQUIREMENTS: The new law makes pre-test counseling requirements more specific. Previously, pre-test counseling included an explanation of 1) the nature of AIDS and HIV-related illness; 2) information about discrimination problems and legal protections against HIV-related discrimination; and 3) information about behaviors known to pose risks for HIV transmission. Now pre-test counseling includes an explanation that 1) HIV can be transmitted through sexual activities and needle sharing, from pregnant women to their fetuses and through breast-feeding infants; 2) there is treatment for HIV that can help an individual stay healthy; 3) individuals with HIV can adopt safe practices to protect against onward infection; 4) testing is voluntary and can be done anonymously at a public testing center; 5) the confidentiality of HIV test results is protected by law; 6) the law prohibits discrimination based on HIV-status, and services are available to help with such discrimination; and 7) the law allows an individual’s consent for HIV testing to be valid until revoked or until it expires by its terms.

The additional pre-test counseling requirements provide important information to patients before testing. The new law provides for more specific prevention messages, including discussion of specific modes of transmission and the possibility of safe practices. The reminder that testing is voluntary, and the assurance of confidentiality should help people feel more comfortable about getting tested. An explanation of the durable nature of the consent is important in assuring that people being tested understand the meaning of their consent. Finally, addressing the availability of medication should encourage people that a positive test result is not a death sentence.

• TWO-TIERED POST-TEST COUNSELING: Previously post-test counseling was the same whether an individual tested positive or negative. Counseling was required to touch on the following: 1) coping with the emotional consequences of the test result; 2) discrimination problems resulting from disclosure; 3) behavior change to prevent transmission or contraction of HIV; 4) information about available medical treatments; and 5) the need to notify contacts.

The new law requires differing levels and forms of counseling depending on test results. Post-test counseling for positive test results remains unchanged. In the case of negative results, the patient must now be given information about the risks of participating in high risk sexual or needle-sharing behavior; this “counseling” may take the form of oral or written reference to information previously provided.

HIV Law Project believes that pre- and post- test counseling are critical opportunities for sharing information with patients, and for hearing from patients about circumstances in their lives, such as violence in the home, or pervasive stigma in the community, that are relevant to HIV testing and diagnosis. Admittedly, the post-test counseling requirements under the old law were not all highly relevant in the case of a negative diagnosis. But the current contraction of the post-test counseling of negatives, and the possibility for delivering the information as a mere written reference to information provided previously means the de facto loss of an important intervention opportunity.

• LINKAGE TO CARE: The new law requires the medical provider, with the consent of the patient, to provide an appointment for follow-up medical care for HIV, or arrange for a follow-up appointment with another health care provider.

HIV Law Project applauds this addition to the law. While testing is a critical element of prevention strategies, it can only have an impact if patients who test positive are affirmatively linked to care. This provision takes an important step forward in ensuring that the testing to care continuum is unbroken.

• REQUIRED OFFER OF HIV TESTING: With a couple of minor exception, under the new law, every individual between the ages of 13 and 64 (or younger or older if there is evidence or indication of risk activity) who receives emergency or primary medical care shall be offered an HIV test. The offer of HIV testing shall be culturally and linguistically appropriate.

HIV Law Project strongly endorses this new provision. Despite the fact that the CDC recommended routine HIV screening for everyone between the ages of 13 and 64 in all health care settings, including primary care, in 2006, too many providers failed to integrate the recommendation into their practice. Given that too many people -- an estimated quarter of a million -- are living in the U.S. with undiagnosed HIV[1], the continued use of a risk-based HIV screening practice is unconscionable.

The outdated risk-based HIV screening practice will come to an end with the new law. Risk-based HIV testing typically focus on known risky behavior of the individual or their sexual partner(s). Yet a partner’s infidelity or history of injection drug use, for instance, are often unknown. Risk assessments, therefore, regularly fail to capture true risk, particularly for women with no identified risk factors. Further, populations once considered at low-risk for infection can no longer be considered so, as infection patterns and the demographics of HIV are changing. Women, young people, Blacks and Latinos, and individuals living outside of metropolitan areas all represent an increasing proportion of infected individuals.[2] As a result, many people who are at risk for HIV infection, or may already be living with HIV, have not been offered an HIV test and remain unaware of their status. As the CDC’s 2006 revised screening guidelines recognize, early diagnosis and treatment are central to the fight to slow the HIV epidemic and improve the lives of people living with HIV, and routine testing is an essential element of this approach.

With the passage of the new law, HIV Law Project is committed to working toward the reimbursement of routine testing by both public and private insurers in New York.

HIV Law Project|15 Maiden Lane, 18th Floor |New York, NY 10038| 212.577.3001|

[1] The Kaiser Family Foundation. “Fact Sheet: The HIV/AIDS Epidemic in the United States”. February 2009.

[2] Center for Disease Control and Prevention. “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings”. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/

Rr5514a1.htm (accessed April 6, 2010).