SummaryEffective September 2010, New York became the first state to require that hospitals and primary care providers offer an HIV test to all patients between the ages of 13 and 64 years. The law also streamlines the consent process, including allowing oral consent for rapid HIV testing. If the test is positive, providers must arrange an appointment for followup care, with the patient’s permission. The law also includes special provisions that make it easier to test in cases of potential occupational exposure and that clarify restrictions on information sharing. To encourage compliance with the law, the New York State Department of Health offered technical assistance to providers and other stakeholders through webinars, online educational materials, and direct advice. A mandatory evaluation of the law's impact found that it increased testing significantly throughout the state. The proportion of HIV-positive patients linked to followup care remained stable.Moderate: The evidence consists of pre- and post-implementation comparisons of testing rates and the proportion of HIV-positive patients that access followup care. These comparisons may underestimate the law's impact because of the short time frame between the effective date of the law and the release of the mandated evaluation, as many of the data points began to show improvement in the latter part of the evaluation period.
Developing OrganizationsNew York State Department of Health AIDS Institute
Use By Other OrganizationsSeveral states have contacted New York officials to discuss enacting similar legislation.
Date First Implemented2010
The law went into effect in September 2010, with associated regulations developed and released after this time.
Problem AddressedDespite great progress in the diagnosis and treatment of HIV and AIDS, many people do not know they are infected until late in the disease's progression. Increased testing would speed diagnosis, get patients treated sooner, increase the patient’s chance of long-term survival, and reduce spread of the disease. However, many clinicians do not routinely offer the test to sexually active patients.
- Many undiagnosed until late in disease process: The Centers for Disease Control and Prevention (CDC) estimates that 20 percent of the 1.2 million HIV-positive people in the United States do not know they are infected.1 Many will not find out until late in the disease process; roughly one-third of newly diagnosed HIV cases progress to AIDS within 1 year, indicating that those patients carried the infection for a while before being diagnosed.1
- Undiagnosed patients place themselves and others at risk: Late diagnosis increases the risk of serious medical conditions and early death.1 It also exacerbates spread of the disease, with 50,000 new individuals becoming infected with HIV each year. People who do not know their HIV status are less likely to practice safe sex and therefore may spread the disease without knowing it.2 In addition, those with undiagnosed or poorly controlled HIV are more likely to have high viral load counts, which increase the chance of transmitting the disease.1
- Missed opportunity to offer routine HIV testing: Although CDC recommends the inclusion of HIV testing as part of routine care for patients ages 13 to 64 years, many providers offer testing only to patients with a known risk factor for HIV/AIDS. Only 60 percent of providers report offering HIV screening on a routine basis.2
Description of the Innovative ActivityEffective September 2010, New York became the first state to require that hospitals and primary care providers offer an HIV test to all patients between the ages of 13 and 64 years. The law also streamlines the consent process, including allowing oral consent for rapid HIV testing. If the test is positive, providers must arrange an appointment for followup care (with the patient’s permission). The law also includes special provisions that make it easier to test in cases of potential occupational exposure and that clarify restrictions on information sharing. To encourage compliance with the law, the New York State Department of Health offered technical assistance to providers and other stakeholders through webinars, online educational materials, and direct advice. Key provisions of the policy are detailed below:
- Required offer of HIV testing: The law requires primary care providers and hospitals to offer an HIV test to all patients between the ages of 13 and 64 years. The law applies to emergency departments; inpatient facilities; and physicians, physician assistants, nurse practitioners, and midwives who provide primary care, including those at urgent care and in-pharmacy clinics. For patients who would like to have the test but cannot afford it, providers make referrals to free testing programs available from public health clinics in the state.
- Streamlined consent process: Previous legislation required inperson counseling before the test and again in the event of a positive diagnosis. The 2010 law makes the consent process more efficient in several ways, as outlined below:
- No one-on-one counseling requirement before test: Under the law, providers no longer have to provide one-on-one counseling before the test. Instead, they give the patient a New York State Department of Health brochure or similar material that includes seven key points about HIV, HIV testing, and the testing law, including the patient's right to confidentiality and to ask for an anonymous test. The requirement for inperson counseling after a positive diagnosis remains unchanged. (Negative results may be delivered electronically or verbally.)
- Consent for HIV testing as part of general consent: Providers may integrate consent for HIV testing into a general consent to medical care, as long as the form includes a specific “opt-out” box in which patients can indicate that they do not want HIV testing. Providers may use forms developed by the New York State Department of Health or their own forms, as long as they use language consistent with the State-provided forms. The patient may specify a time frame in which the consent remains in effect. The patient can also revoke consent at any time orally or in writing.
- Oral consent for rapid HIV testing: Patients can give their consent orally for testing in which results will be available within 24 hours, as long as such consent is noted in the medical record.
- Required linkage to care: In the event that a patient tests positive, the clinician who authorized the HIV test must, with the patient’s permission, arrange an appointment for followup care.
- Provisions for occupational exposure and information sharing: The law also addresses concerns providers had about testing patients who may have exposed a health care worker to HIV and about sharing information among providers.
- Anonymous testing in case of potential occupational exposure: Under previous legislation, if a health care worker was potentially exposed to infected body fluids from an unconscious or anesthetized patient, postexposure prophylaxis was sometimes postponed until the patient could consent to the test. The new law allows anonymous testing without the patient’s permission at no cost to the patient. In these situations, the patient is not informed of the test or its results, and the results do not get entered into the patient’s medical record. However, the patient may be offered a test when he or she is conscious.
- Information sharing: Another provision of the law clarifies when and how medical providers involved in a patient’s care can share information about that person’s HIV status. In the event of death, for example, the patient’s complete medical record—including HIV status, if known—will be released to the executor of the person’s will. This provision is intended to avoid misunderstandings that could lead to malpractice accusations.
- Technical assistance: The AIDS Institute of the New York State Department of Health developed toolkits, webinars, and other materials, and offered technical assistance to help providers understand and comply with the legislation. The Institute set up a dedicated e-mail address and telephone number to receive questions from providers and made all materials available on the Department of Health Web site. The Institute is developing a provider packet that includes a variety of information about how to implement the law in various settings.
Context of the InnovationEstablished in 1983 (the early years of the AIDS crisis) as part of the New York State Department of Health, the AIDS Institute has a history of working closely with advocates and communities most affected by HIV/AIDS to build trust and promote practices that increase the diagnosis and treatment of HIV/AIDS while reducing its spread. The impetus for this New York State law came from a 2006 recommendation of CDC that HIV testing become part of routine care for all people between the ages of 13 and 64 years.
ResultsA mandatory evaluation of the law's impact found that it increased testing significantly throughout the State. There are also early indications that the law contributed to an increase in the proportion of HIV-positive patients linked to followup care, particularly in upstate New York.
Moderate: The evidence consists of pre- and post-implementation comparisons of testing rates and the proportion of HIV-positive patients that access followup care. These comparisons may underestimate the law's impact because of the short time frame between the effective date of the law and the release of the mandated evaluation, as many of the data points began to show improvement in the latter part of the evaluation period.
- More tests performed: Nearly 5.5 million New Yorkers have been tested for HIV, with more than 1 million residents ages 18 to 64 years having been tested in 2011, the first full year after the law’s enactment. Depending on the data source used (e.g., laboratories, telephone-based interviews, provider surveys), evaluators found that testing increased by between 9 percent and 30 percent in the first year after implementation.
- More HIV-positive patients linked to followup care: Before the law’s enactment, more than three-quarters of newly diagnosed cases entered care within 3 months of diagnosis. Although that figure did not change in the first full year after the law took effect, by the second half of 2011 more than 90 percent of newly diagnosed people had an appointment for followup care.
- Greater impact seen in upstate New York: The increase in testing and linkages to followup care was greater in upstate New York, where rates of testing and linkage to care are lower than in New York City, which for many years has used aggressive strategies to encourage testing and to link HIV-positive patients to followup care.
Planning and Development ProcessKey steps included the following:
- Release of CDC recommendation: As noted, in 2006 CDC released the recommendation for routine HIV testing for people ages 13 to 64 years. Soon thereafter, New York State representatives and Department of Health staff began discussing a law that would help ensure the “routinization” of HIV testing throughout New York state.
- Drafting and passing legislation: After several years of negotiations among legislators, advocacy groups, and health care providers, compromise legislation was drafted. One of the most contentious areas related to making the consent process more efficient and less onerous for health care providers, without compromising patients’ right to privacy.
- Stakeholder meetings and webcasts: After enactment of the legislation but before drafting regulations, Department of Health staff held stakeholder meetings in each region of the state to take questions and get feedback about the law and related implementation challenges. They also conducted webcasts and special meetings with members of the Healthcare Association of New York State and the Greater New York Hospital Association. At these meetings, Department of Health staff fielded questions, which then became the basis for the frequently asked questions (FAQ) documents developed for providers (see below).
- Drafting regulations and releasing them for public comment: Based on the stakeholder meetings, the Department of Health developed draft regulations that provided more specifics about implementation. These regulations were released for public comment in November 2011 and went into full effect in February 2012.
- Development of clinical education materials: To supplement the regulations, AIDS Institute staff developed fact sheets, FAQs, toolkits, and other materials that answer common questions from providers and patients. These materials were intended to help make the implementation process easier.
Resources Used and Skills Needed
- Staffing: Several AIDS Institute and other Department of Health staff worked on development and implementation of this legislation as part of their regular duties. Implementation workload has decreased from approximately 1 full-time equivalent (FTE) to approximately .3 FTE. Evaluation efforts have similarly decreased from approximately 4 FTEs to approximately .5 FTE.
- Costs: The law provided no additional funding to implement and enforce the law. Evaluation and implementation costs were approximately $1 million, which were redirected to these efforts. Ongoing costs are fairly minimal and have been absorbed into the normal operations of the AIDS Institute.
Funding SourcesNew York State Department of Health
The New York State Department of Health pays for legislation-related costs out of its operating budget of State funds and grant dollars from its CDC HIV prevention cooperative agreement.
Tools and Other ResourcesInformation about the law and resources developed by the AIDS Institute to support its implementation are available at http://www.health.ny.gov/diseases/aids/testing/.
Getting Started with This Innovation
- Keep lines of communication open: Throughout the drafting and implementation of the law and associated regulations, the Department of Health kept lines of communication open with providers who would be affected, primarily though the Healthcare Association of New York State and the Greater New York Hospital Association.
- Take time to get it right: Although it took 4 years to enact the law after CDC released its recommendation and another year to draft the associated regulations, the time was well spent. It allowed for all issues to surface and be dealt with in the final legislation and regulations. No stakeholder got everything it wanted; however, all stakeholders got legislation they could live with that would benefit New Yorkers. After the regulations were released, only a handful of comments surfaced, a testimony to the ability of the upfront stakeholder meetings to surface and resolve many issues.
- Find common ground: When providers complained that the law was an “unfunded mandate,” leaders of the Department of Health pointed out that they too had received no additional funds to implement the law. Once everyone realized they were in the same boat, they cooperated to “make the law work" and found mutual respect and a common goal that helped them succeed.
Sustaining This Innovation
- Be realistic: In developing the regulations and guidance contained in the FAQs, Department of Health staff tried to remain realistic about what could reasonably be expected from providers and patients.
- Anticipate challenges: The law clearly presents challenges to providers facing certain situations, such as offering the test to a 13-year-old child or knowing what to do if an anonymous test comes back positive. The Department of Health has formulated guidance to help providers respond in these situations, which in turn has helped encourage cooperation with the law.
- Keep working to improve compliance: Although the law seems to have increased testing rates throughout the state, most adults continue to report in telephone surveys that their doctor did not offer an HIV test at their last visit. Likewise, surveys of clinicians show that at least one-third remain unaware of the law. The Department of Health continues to work to raise awareness of and compliance with the law.
- Consider going back to legislature on controversial issues: The requirement not to share positive results of anonymous tests performed after occupational exposure with the source patient or to include that information in the medical record has proven somewhat controversial and may need to be revisited in future legislation. In the meantime, the Department of Health recommends that providers explain to source patients that a test was done while he or she was unconscious that showed a positive result and to urge the patient to consent to having a non-anonymous test done.
Use By Other OrganizationsSeveral states have contacted New York officials to discuss enacting similar legislation.
Contact the InnovatorDan O'Connell
New York State Department of Health
Innovator DisclosuresMr. O’Connell reported having no professional and/or financial relationships relevant to the work described in this profile.
References/Related ArticlesNew York State Department of Health. HIV Testing Law Mandated Report. 2012 Aug. Available at: http://www.health.ny.gov/diseases/aids/testing/law/docs/chapter_308.pdf (If you don't have the software to open this PDF, download free Adobe Acrobat Reader® software .).
McNaghten AD, Valverde EE, Blair JM, et al. Routine HIV testing among providers of HIV care in the United States, 2009. PLoS One. 2013;8(1):e51231. [PubMed]
McNaghten AD, Valverde EE, Blair JM, et al. Routine HIV testing among providers of HIV care in the United States, 2009. PLoS One. 2013;8:e51231. [PubMed]
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Original publication: April 10, 2013.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: April 09, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: March 18, 2014.
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