Makes provisions relating to HIV testing, including consent for such testing, required offering for such testing, confidentiality and disclosure

Summary of provisions

Section 1 of this bill amends Public Health Law (PHL) § 2781 to author- ize HIV related testing to be part of a signed general consent to medical care, or documented oral consent when the test being ordered is a rapid HIV test. Such consent would be durable and remain in effect until it is revoked or expires. Patients will be provided an opportunity to decline HIV testing, and testing will only be done with full patient consent after the patient is provided with pre-test counseling informa- tion. In all instances, a physician will be required to provide oral notification to the patient whenever an HIV test is performed and this shall be noted on the patient's medical record. The provisions of this section regarding oral informed consent for a rapid HIV test shall not apply to tests performed in a facility operated under the correction law.

Section 1 also provides that HIV counseling messages shall be tailored based on whether the HIV test indicates infection. Counseling with respect to positive tests will remain consistent with existing law. In the case of negative results, counseling will emphasize risks associated with participating in high risk behavior and may be accomplished by oral or written reference to information previously provided. The bill also provides that in the case of a positive test for HIV infection, the person ordering the test must provide or arrange for follow-up medical care if the patient consents.

Section 1 further provides that in situations involving occupational exposures that create a significant risk of contracting or transmitting HIV infection, HIV testing will be allowed in cases where: (1) the source person is deceased, comatose or unable to provide consent, and his or her health care provider determines that mental capacity to consent is not expected to be regained in time for the exposed person to receive appropriate medical care, as determined by the exposed person's health care provider; (2) an authorized representative for the source person is not available or expected to become available in time for the exposed person to provide appropriate medical care; and (3) the exposed

person would benefit medically by knowing the Source person's HIV test results. In these limited cases, a provider shall order an anonymous HIV test of the source person and the results of the anonymous test, but not the identity of the source person would be disclosed to the exposed person's provider, solely for the purpose of making appropriate deci- sions regarding post-exposure medical treatment. The results of the HIV test of the source person would not be disclosed to the Source person or placed in the source person's medical record.

Section 1 also eliminates the requirement that a physician certify that informed consent has been obtained before ordering HIV related testing by a laboratory or other facility.

Section 2 of the bill adds a new PHL § 2781-a to require that an HIV related test be offered to every individual between the ages of 13 and 64 years of age (or younger or older if there is evidence of risk activ- ity) receiving health services as an inpatient or in the emergency department of a hospital or receiving primary care services in the outpatient department of a hospital or in a freestanding diagnostic and treatment center or from a physician, physician assistant, nurse practi- tioner, or midwife providing primary care. The HIV related testing must be offered unless the health care provider believes: (1) the person is being treated for a life threatening emergency; (2) the individual has been previously offered or been the subject of an HIV related test (except that a test shall be offered if otherwise indicated); and (3) the patient lacks capacity to consent to such testing. Such offering shall be culturally and linguistically appropriate.

Section 3 of the bill amends PHL § 2135 to authorize the Department of Health (DOH) to use HIV testing information (in the aggregate without identifying patient information) for programs approved by the Commis- sioner of Health (Commissioner) for the improvement of the quality of medical care provided to individuals with HIV/AIDS. This bill also permits DOH to share this information with public health disease programs within DOH or local health departments to access co-morbidity or completeness of reporting and to direct program needs. Information will not be shared outside of DOH or the local health departments.

Section 4 of the bill amends PHL § 2780(4) to update the definition of "HIV related testing" to mean tests approved for the diagnosis of HIV, and to establish the definition of "Rapid HIV test or testing" to means any laboratory screening test or tests approved for detecting antibodies to HIV, that produce results in sixty minutes or less, and encompasses a confirmatory HIV related test if the screening test is reactive.

Section 5 of the bill amends PHL § 2130(1) to require that data obtained "upon periodic monitoring of HIV infection" be reported to the Commis- sioner.

Section 6 of the bill amends PHL § 2782( 1) to provide limited access to confidential HIV information to the executor or administrator of an estate when needed to fulfill the responsibilities of such a position.

Section 7 of the bill amends PHL § 2782(5)(a) to clarify instances under which disclosure need not be accompanied by a written statement regard- ing confidentiality and redisclosure requirements and prohibitions. In particular, the written statement would no longer have to be provided for routine disclosures to providers assisting in rendering care or for disclosures made to health insurers in the day to day course of the billing process.

Section 8 of the bill amends PHL § 2786(1) to designate the informed consent forms for HIV related testing and disclosure that must be devel- oped by the Commissioner as "standardized model" forms and removes the requirement that providers obtain prior authorization for the use of alternative consent and release forms, provided that the forms contain information consistent with the standardized model forms.

Section 9 of the bill provides that on or before September 1, 2012, the Commissioner must evaluate the impact of the bill with respect to the number of persons who are tested for HIV infection and the number of persons who access care and treatment. Such report shall be submitted to the Governor and to the chairs of the Assembly and Senate Health Commit- tees.

Section 10 of the bill provides that the bill will be effective on September 1, 2010, but authorizes the Commissioner to adopt regulations necessary to implement the bill prior to that date.

Existing law

PHL § 2130 requires health care practitioners and laboratories that determine that a person is infected with HIV or AIDS to report the case to DOH.

PHL § 2135 requires that any HIV information obtained by DOH or any municipal health officer must be maintained as confidential, except as otherwise required by law.

PHL § 2780 defines a number of terms and in particular defines "HIV related test" as "any laboratory test or series of tests for any virus, antibody, antigen or etiologic agent whatsoever thought to cause or to indicate the presence of AIDS."

PHL § 2781 requires written, informed consent before any HIV related test may be ordered, and a physician or other practitioner must certify that consent was received before ordering that such test be performed. The written, informed consent consists of a statement signed by the subject of the test which explains, among other things, the purpose of the test and the applicable confidentiality protections. PHL § 2781 further requires that before execution of the written consent, the prac- titioner or his or her representative must provide an explanation of the nature of AIDS and HIV related illness; information about discrimination problems that could arise from disclosure of test results, and informa- tion about the transmission risks associated with HIV infection. When

test results are communicated, the patient must be provided with coun- seling or referrals for counseling about matters such as the emotional consequences of learning the results and the need to change behavior to prevent transmission of HIV infection. The informed consent require- ments do not apply in certain circumstances, such as when a researcher does not know the test subject's identity.

PHL § 2782 prohibits persons who obtain confidential HIV related infor- mation from disclosing such information, with certain exceptions. In those circumstances when disclosure is authorized, it must be accompa- nied by a statement advising that further disclosure without consent is prohibited.

PHL § 2786 requires the Commissioner to develop forms for informed consent for HIV related testing and disclosure of confidential related information.

Justification

Significant advances in the medical treatment of and testing for HIV/ AIDS have been made in the last two decades. In the early days of the epidemic (in the 1980s), an HIV/AIDS diagnosis was tantamount to a death sentence. Today, people with HIV/AIDS are living longer with the help of new and improved treatments and testing/monitoring. It is vital to increase HIV/AIDS testing rates so that people with HIV can seek treat- ment, earlier and reduce transmission to others, and so that people without HIV can learn to stay that way. This bill updates New York's laws to encourage such testing and reflect new medical technologies and advances.

Recommendations issued by the federal Centers for Disease Control and Prevention (CDC) in 2006 include a recommendation for routine HIV screening for patients between the ages of 13 and 64 in all health care settings, in addition to regular testing for high-risk groups. The bill incorporates this recommendation, with routine screening - meaning that the patient will be offered the opportunity to undergo HIV testing - required for patients between 13 and 64, or for younger or older patients if there is evidence of behavior that increases the risk of infection. Expanded screening will increase the number of individuals who are tested for HIV/AIDS.

The CDC also recommends that states eliminate the requirement of a sepa- rate written informed consent for each HIV test, and instead assume that a general consent to medical treatment encompasses consent for HIV test- ing. This bill relaxes current written consent requirements by providing an option for a durable written general consent that would specifically include HIV testing, or a documented oral consent when the test being ordered is a rapid HIV test. The bill also makes a corresponding techni- cal change to the law requiring that the Commissioner develop forms to be used for informed consent purposes. Specifically, the bill designates such forms as "standardized model" forms, and providers would no longer need to obtain prior authorization for the use of alternative forms that

contain information consistent with the standardized model forms. Simi- larly, the bill removes the requirement that physicians confirm that informed consent has been obtained before ordering HIV related testing.

Currently, the law requires post-test counseling which is the same regardless of the test's results. This legislation will require that counseling be tailored based on whether the HIV test indicates infection. Counseling will remain consistent with existing law with respect to positive tests. For negative results, counseling will empha- size risks associated with participating in high risk behavior and may be accomplished by oral or written reference to information previously provided.

The bill also requires physicians to report HIV data obtained through laboratory tests conducted in conjunction with periodic monitoring of HIV infection, which will enable DOH to monitor the spread of HIV/AIDS and to target program initiatives. This provision reflects the avail- ability of data from HIV tests which was not available when the statute was originally enacted. The bill makes similar technical changes to various provisions of law to update references to testing in accordance with newer testing technologies. In addition, the bill protects individ- uals who are at risk of acquiring HIV infection due to an occupational event by permitting HIV testing if consent is not available.

Finally, the bill makes certain appropriate changes to existing confi- dentiality provisions, first by allowing limited access to confidential HIV information to the executor or administrator of an estate when need- ed by such persons to fulfill their responsibilities. Second, under current law, disclosure of HIV related information must be accompanied by a written statement regarding confidentiality and redisclosure. It is appropriate to exempt from these requirements routine disclosures of information which are made to providers for purposes of treatment and to third party payers for reimbursement purposes.

Legislative history

An earlier version of this bill, A.1146l/S.8722, was introduced in 2008 but did not pass. A.9195/S.6326, which addressed some of the issues raised in this bill, was introduced in 2007-08 and was passed by the Assembly in 2007.

Fiscal implications

This bill will not have a measurable fiscal impact to the State, HIV testing and counseling is already a covered benefit in Medicaid managed care, Family Health Plus and Medicaid fee-for-service. Any additional administrative demands can be accommodated within existing DOH resources.

Effective date

This bill takes effect on September 1, 2010. The Commissioner is author- ized to adopt regulations prior to that date as necessary to implement the bill.