Testimony: NYS Department of Health Hearing on HIV Testing, Counseling and Informed Consent

Testimony Of Elisabeth Ryden Benjamin on behalf of The New York Civil Liberties Union before The New York State Assembly Committee On Health Hearing On: HIV Testing, Counseling & Informed Consent

My name is Elisabeth Benjamin and I am the Director of the Reproductive Rights Project at the New York Civil Liberties Union (“NYCLU”). The NYCLU, the state affiliate of the American Civil Liberties Union, has approximately 48,000 members. The NYCLU is devoted to the protection and enhancement of those fundamental rights and constitutional values embodied in the Bill of Rights of the U.S. Constitution and the Constitution of the State of New York.

The NYCLU thanks the Assembly Health Committee for the opportunity to present testimony today regarding proposals to relax the informed consent and counseling requirements for HIV testing in New York State. Our testimony will address civil liberties concerns raised by three new initiatives: (1) the 2005 New York State Department of Health regulations; (2) New York City Health and Mental Hygiene Commissioner Thomas Frieden’s proposals to revise Article 27-f of the State Public Health Law; and (3) the Center for Disease Control and Prevention’s (“CDC”) recommendations concerning “routine” testing of patients for HIV.

The NYCLU supports efforts to increase voluntary testing for HIV. But each of the three initiatives — to varying degrees — abridge patients’ ability to provide consent for HIV testing in a way that implicates their fundamental rights and liberties. The NYCLU believes that efforts to increase testing at the expense of patients’ rights are misguided. As described in detail below, we believe that patients should be: (a) given an opportunity to provide written informed consent for testing; (b) provided pre-test and post-test counseling; and (c) offered enhanced access to quality health care.

I. Background: Public Health, HIV and New York

HIV/AIDS is a significant national and local public health issue. According to the CDC, as of December 2004, nearly 1 million Americans had been diagnosed with AIDS. Nearly 56% of those diagnosed with AIDS had died from the disease. Each year, 16-22 million people between the ages of 18-64 are tested for HIV. Accordingly, roughly 40% of the population of the United States has been tested for HIV.

Despite these large numbers, the CDC found that by the end of 2003, nearly 25% of the roughly 1 million people who are living with HIV in the United States remain unaware of their HIV status. Public health experts remain concerned that some of these individuals may unwittingly transmit HIV to others. The CDC has also noted that life-saving and life-sustaining antiretroviral drugs fail to reach many patients who need them.

The rate of new HIV infections has stabilized. But unfortunately, among those newly diagnosed cases, there is a disproportionate percentage amongst African Americans and women. The incidence of new infections is also rising amongst other racial and ethnic minorities and women through heterosexual transmissions.

In New York City, 100,000 residents have HIV/AIDS. This number represents more cases than the number of cases in San Francisco, Los Angeles, Miami and Washington, D.C., combined. The City Department of Health further estimates that there are 20,000 New York City residents who are HIV positive, but are unaware of their status.

Therefore, the NYCLU recognizes that HIV presents a serious public health concern. We believe that the government should take effective measures to prevent its transmission and provide adequate care to those living with HIV. However, these goals can be accomplished, and are more likely to be achieved, if civil liberties concerns are taken into account.

A. New York Laws Governing HIV Testing

In 1988, New York State passed Article 27-f of the Public Health Law — a statute widely considered model HIV legislation. At the time the law was passed, HIV discrimination and stigmatization was rampant in the workplace, in housing and at other public accommodations. Moreover, people who were HIV positive had difficulty receiving health care and getting health insurance coverage for the care they did receive.

In order to address these concerns, the law zealously protects the privacy of individuals who are HIV positive. It bars the administration of an HIV test without pre-test counseling and requires the written informed consent of the patient to whom the test is to be administered. It also ensures that all patients are provided information and an opportunity to choose anonymous testing. Finally, the law strictly governs the confidentiality of HIV information and the circumstances under which HIV information may be disclosed. The law is enforced through a series of criminal, civil and financial penalties.

New York’s Public Health Law also provides that medical providers and laboratories report any HIV test to the State Department of Health when there is:

• An initial determination that someone is HIV positive;
• An initial determination that someone has AIDS; or
• An initial diagnosis that a person has an HIV-related illness.

The public health benefits of counseling are self-evident. Counseling provides an important opportunity to connect people who are HIV positive or at high risk for becoming HIV positive to vital health care and support. The benefits of written informed consent will be described in greater detail below.

In 1999, New York amended its public health laws to allow for the testing of newborns for HIV. Since this law was implemented, the rate of newborn HIV incidence has declined by 98%.17 This decrease, however, cannot be attributed solely to mandatory testing. In New York, all low-income New York women have access to prenatal and 60 days of post-partum care through the State’s Prenatal Care Assistance Program and their newborns have full Medicaid coverage for the first year of life. This ensures that all newly diagnosed cases of HIV in newborns are provided proper treatment and care.

B. New Testing Proposals

Three proposals seek to relax the strict HIV testing regime set forth in New York State law: (1) New York State’s HIV lab test regulations, first adopted as “emergency regulations” in 2005; (2) legislative proposals sought by Commissioner Frieden in 2005-2006, which were substantially adopted in Assemblymembers Towns’ and Mayersohn’s bills; and (3) the federal CDC proposals on “routine” testing for HIV, issued in September 2006.

1. The State’s HIV Lab Test Regulation

Starting on April 25, 2005, the State Department of Health filed a series of emergency regulations that amended 10 N.Y.C.R.R. Part 63. The regulations directed laboratories to report an expanded set of HIV-related data, which extended beyond the limited data set that the law indicates should be reported to the State.18 The NYCLU, as well as several other organizations, believes that these regulations exceeded the statutory provisions for what data the laboratories should report.19 State law does not authorize mandatory reporting of HIV-related tests beyond the initial determination or diagnosis, nor does it authorize the reporting of HIV subtype data or antiviral resistance testing data.

The emergency regulations also provided for the repeal of the regulatory promulgation of the prior HIV written informed consent form, which had complied with requirements set forth in State law. Although the Department of Health has authority to re-write the form, the new informed consent form fails to comply with State law.

On May 15, 2006, the NYCLU, along with the HIV Law Project and South Brooklyn Legal Services, sent a demand letter to the State Department of Health alerting it to these concerns. The State has since promulgated permanent regulations on October 11, 2006, which essentially adopts its initial proposals. The NYCLU and their partner organizations are continuing to meet with the State to address the remaining concerns.

2. Commissioner Frieden’s Proposal to Rewrite the State HIV Law

Commissioner Frieden’s proposals were introduced in the 2006 session in several bills sponsored by Assemblypersons Mayersohn and Towns. These proposals seek to eliminate written informed consent, revise the pre-test and post-test counseling requirements, and permit disclosure of a person’s HIV status to a public health officer for the purpose of linking the patient to care and case management services.

3. The September 2006 CDC Guidelines

In September 2006, the CDC issued Guidelines that endorse the concept of “routine” testing of all patients between the ages of 13 and 64 and annual screening of all high-risk patients. The Guidelines emphasize that all HIV testing must be voluntary. The Guidelines encourage providers to inform a patient “orally or in writing” that HIV testing will be performed unless the patient “opts out.” Accordingly, the CDC does not recommend administering HIV tests without any sort of conversation between the provider and the patient. However, the Guidelines clearly state that “a separate consent form for HIV testing is not recommended.” Finally, the CDC recommends that “[p]revention counseling should not be required as a part of HIV screening programs in health-care settings.”

II. Civil Liberties Concerns

For the reasons described below, the NYCLU believes that written informed consent serves the public health agenda because it ensures that patients are informed of the limits to their medical privacy and shores up the integrity of the public health delivery system.

A. HIV Stigma Persists

Getting an HIV test is not the same as getting a cholesterol test. For a patient to find out that he or she is HIV positive is a singularly life-altering event. In essence, a patient will be finding out that he or she has a permanent medical condition that generally requires the patient to commit to a life-long and complicated treatment regime. Unfortunately, families and friends may sometimes be unsupportive when a patient learns that he or she is HIV positive.

Proponents of “routine” HIV testing without specific written consent and counseling requirements commonly argue that the current HIV testing regime is obsolete because it was developed when HIV was untreatable. The general thrust of these editorials is that social and medical developments no longer warrant treating the policies surrounding HIV diagnosis differently from diagnosing other serious illnesses.

But these arguments underestimate the stigma and harms that continue to afflict the HIV-positive population. A 2005 study of HIV screening in the Annals of Internal Medicine describe the persistence of stigma and discrimination experienced by people who are HIV positive:

True-positive HIV test results are associated with important harms, including fears of rejection, abandonment, verbal abuse, and physical assault. A substantial proportion (20% to 25%) of Americans continue to agree with stigmatizing statements about HIV. Four percent of 142 patients with recently diagnosed HIV infection reported losing a job because of their status, 1% had been asked to move, and 1% had been assaulted.29 Moreover, a profound stigma about HIV persists today. Recent polls indicate that: 37% of Americans believe that HIV is transmissible through a kiss; 22% of Americans believe that HIV is transmissible by sharing a drinking glass; and 16% of Americans believe that HIV is transmissible by touching a toilet seat.

Pre-test and post-test counseling provide important “public health moments” to communicate basic information about the nature of HIV and how it is transmitted. Studies have demonstrated that pre-test counseling increases consent rates to HIV testing. It also allows health providers to deter patients from engaging in high-risk behavior, which leads to an increase in drug-resistant strains of HIV. Finally, studies show that patients’ adherence to prescribed treatment regimes correlate positively with increased physician disclosure.

B. Written Informed Consent Is Important

The development of written informed consent represents the zenith of the 20th Century struggle for patient autonomy and medical privacy. This struggle was famously initiated by Justice Cardozo in 1914 when he held that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body.”

Over the past century, patients reasonably have developed an expectation of privacy about intimate health matters. And this expectation is supported by the law — especially in New York. As a Constitutional matter, the United States Supreme Court has recognized two types of privacy interests: “One is the individual interest in avoiding disclosure of personal matters, and another is the interest in independence in making certain kinds of decisions.” The United States Court of Appeals for the Second Circuit has explicitly held that the constitutionally derived right to medical privacy covers a person’s HIV status. Finally, New York has long been a leader in the realm of medical privacy as set forth in a rich statutory and common law scheme that extends well beyond the HIV context.

As described above, getting the news that a patient has HIV is not the same as getting a diagnosis of high cholesterol. The medical professionals — including the CDC Guidelines and Commissioner Frieden — all agree that routine testing for HIV must be consensual.

Given that there is universal consensus that routine testing must be informed and consensual, the NCYLU believes that providing patients an opportunity to give written consent to testing is the only method that actually guarantees this goal. Without a signed informed consent form, there is no way for practitioners in busy health care settings to prove that a patient’s consent to HIV testing was acquired.

In addition, written informed consent serves several other important goals. First, the written informed consent process is an ideal public health moment that encourages a patient to ask questions and have a dialogue with his or her health provider about the nature of HIV/AIDS, how the disease is transmitted, and how to effectively avoid acquiring the disease. Second, use of a written consent form gives patients a chance to consent to the broader scope of testing that has already been implemented through the State’s regulatory process that extends well beyond what the law authorizes. Third, the consent form gives patients information about — and a chance to seek — anonymous testing.

Any effort to eliminate written informed consent fails to address the heart of the problem, which is two-fold.

First, these are admittedly difficult conversations to have. But our current public health laws governing HIV testing respect patient autonomy and privacy. They represent an evolutionary step in public health thinking away from the paternalistic 19th Century models of surveillance, monitoring and detention of putative “Typhoid Marys.” Moreover, HHC, a sister agency of the NYC DOHMH, has shown us that it is possible to successfully implement “routine” testing while simultaneously respecting patients’ rights as currently set forth in the State Public Health law. According to HHC, using rapid tests within the current written consent legal regime, it was able to test 92,000 patients for HIV during the 2006 fiscal year, a 63% increase over the prior year.

Second, to the extent the problem is really about getting people who need HIV care into treatment, the real solution lies elsewhere. One out of every four New York City residents, and one out of every five New York State residents, do not have health insurance. Proposals like Commissioner Frieden’s do nothing to address the real barriers that prevent people from receiving health care and getting tested for HIV, including the lack of high quality, culturally sensitive medical services in their communities and the difficulty in getting over the hurdles in signing up for insurance. For example, more than 600,000 New Yorkers are eligible, but not enrolled in, government-funded health insurance programs.

Conclusion

The NYCLU does not oppose the concept of routine testing in the sense that we believe that more people should be offered access to HIV testing. But “routine” testing can be implemented successfully while still respecting patients’ rights to receive information about the medical testing and procedures they are about to undergo and, when such testing and procedures are significant, to provide written informed consent.

HHC’s experience this year proves that “routine” testing and respecting patient autonomy and privacy through written consent are not mutually exclusive propositions. Accordingly, any legislative change to the HIV testing regime must maintain the important patient protections — including counseling and written consent — that safeguard individual liberty and autonomy.