Mostly Clear Path Through States for CDC
HIV Testing Guidelines for Routine Testing
from Jules: in reality there are many barriers to implementation including doctors & providers who are not fully on board for various reasons like not being fully aware of why routine testing should be performed, or they still have biases about who might have HIV, or their clinic is too busy to bother, or local advocates construct political barriers.|
Published: February 16, 2009
* Explain to interested patients that state laws have been seen as barriers to new CDC recommendations intended to increase the number of people getting tested for HIV.
* Note that this study suggests that only a minority of states have legal barriers to implementation of the new guidelines.
LOS ANGELES, Feb. 16 -- Despite fears that state laws could hamper new HIV testing recommendations, most states offer no barriers to the proposals, researchers here said.
Indeed, since the CDC proposed so-called "opt-out testing" in 2006, several states have amended their laws so that they do not impede implementation of the recommendations, according to Anish Mahajan, M.D., of the University of California Los Angeles, and colleagues.
As of Nov. 1, 2008, that leaves only 16 states that have one or more laws that form a barrier to the CDC recommendations, Dr. Mahajan and colleagues said in the Feb. 17 issue of Annals of Internal Medicine.
The remaining 34 states and the District of Columbia have laws that are either consistent with or neutral to the CDC recommendations, the researchers said.
The 2006 recommendations eliminated previous requirements for pretest counseling, for a separate written consent for HIV testing, and for a specific request for an HIV test. (See: CDC Urges HIV Tests as Routine in Health Care)
Under the new scheme, the CDC said:
* HIV screening should be routine in all medical settings on an "opt-out" basis for patients from 13 through 64. The recommendation includes pregnant women during prenatal care and at labor and delivery, who do not have a documented negative test result.
* The physician should offer the patient the opportunity to ask questions and to decline testing, but the general consent for medical care would include consent for HIV testing.
* Oral or written pretest information should be provided to explain the risks and benefits of the testing and to explain the meaning of test results. Only positive results require personal follow-up, along with attempts to ensure care and counseling.
The new guidelines effectively altered three things: the need for separate consent, the kinds of pre- and post-test counseling needed, and the need to ask for testing, rather than having it as part of routine care.
The guidelines are intended to increase the number of people tested for HIV, but there is a widespread perception that state laws and regulations may prevent healthcare providers from putting them into practice, Dr. Mahajan and colleagues said.
To see how accurate that perception is, the researchers looked at state laws six, 12 and 24 months after the recommendations were made.
States were regarded as "consistent" with the guidelines if they had at least one law consistent with any of the three changes and no laws inconsistent with them.
They were regarded as "neutral" if their laws were either consistent with any of the three or were silent. Finally, they were regarded as "inconsistent" if there was any law that formed a barrier to any of the three changes.
Dr. Mahajan and colleagues said:
* nine states required specific written consent for HIV testing.
* 10 states required post-test counseling, regardless of whether the result was negative or positive.
* two states required pregnant women either to specifically ask for HIV testing or to provide a separate written consent in an opt-out process.
Because of overlap, 16 states were regarded as inconsistent with the CDC guidelines.
The guidelines had also come under fire from patient advocates who feared they would compromise patient autonomy, Dr. Mahajan said. (See: Proposed HIV Testing Guidelines Draw Fire)
"We found that the CDC guidelines' definition of 'opt-out' does require specific protection of patient autonomy, which in many cases is not required by state laws," Dr. Mahajan said in a statement.
He and his colleagues noted that -- unlike the case with many other tests -- the CDC calls on providers to offer pretest information, ask if there are questions, and inform patients of the right to decline.
The authors noted that "it is important not to lose sight of patient perspectives on and satisfaction with an opt-out HIV screening process, particularly for vulnerable populations that may have limited access to healthcare services and are disproportionately at risk for HIV stigma and discrimination."
They also pointed out that "providers should receive adequate information about the HIV opt-out screening and consent process and about the importance of establishing referral mechanisms with HIV prevention and care providers." Data on an ED-based opt-out screening program showed that half of patients with positive test results were lost to follow-up, which illustrates the challenge, they said.
"For settings without immediate access to infectious disease specialists, establishing formal collaborations with community-based HIV/AIDS organizations and clinical HIV/AIDS care providers may be necessary to ensure linkage to care," they concluded.
The study was supported by the Robert Wood Johnson Clinical Scholars Program and the NIH.
The researchers reported no potential conflicts.
Centers for Disease Control and Prevention 2006 Human Immunodeficiency Virus Testing Recommendations and State Testing Laws - pdf attached (table)
JAMA. 2011;305(17):1767-1768. doi: 10.1001/jama.2011.564
Sarah Neff, MPH firstname.lastname@example.org Ronald Goldschmidt, MD Department of Family and Community Medicine University of California, San Francisco
"Nearly all states' HIV testing laws and administrative codes were compatible with the current CDC HIV testing recommendations1 on consent and counseling as of January 2011. Although 5 states still had incompatible laws, 24 states actively changed their laws toward compatibility with CDC recommendations. This study is limited to state HIV testing statutes and administrative code available online and does not include case law or policies issued by other regulatory agencies (eg, health departments). State HIV testing laws are often complicated; can be contradictory or subject to interpretation; and can vary across populations, settings, scenarios, or providers. When assessed for overall compatibility, however, HIV testing laws in nearly all states no longer present obstacles to routine HIV testing. "
To the Editor: In 2006, the Centers for Disease Control and Prevention (CDC) issued recommendations for routine human immunodeficiency virus (HIV) testing in health care settings with HIV prevalence of 0.1% or greater for all persons aged 13 to 64 years, regardless of risk.1 Central elements address consent and counseling. CDC recommendations promote written or oral informed consent through an opt-out process (ie, patient is told the test will be obtained unless declined), in which general consent for medical care is sufficient for HIV testing, and advocate against mandatory prevention counseling and in-person notification of negative test results.
Although national recommendations exert influence over state laws, HIV testing laws are ultimately under state jurisdiction. At the time of these recommendations, however, many state HIV testing laws presented barriers to implementation. For state laws to be compatible with CDC recommendations, they need to either conform or, at a minimum, not conflict. To assess current compatibility of laws with CDC recommendations, we reviewed all state HIV testing laws and administrative codes related to consent and counseling.
We compared consent and counseling HIV testing laws from the Compendium of State HIV Testing Laws,2 updated January 2011, with the 2006 CDC recommendations. The compendium contains detailed profiles of HIV testing laws drawn from state statutes and administrative codes, excluding case law and policies issued by other regulatory agencies. The database is updated regularly; accuracy and validity are maintained by review and feedback. We also tracked consent and counseling legislation introduced since the recommendations' issuance. Consent and counseling laws were further evaluated by subparameters (Table).
Key terms such as opt-out and HIV-prevention counseling were interpreted as defined in the CDC recommendations. We defined specific consent as a separate HIV testing consent form distinct from the general consent for medical care; test counseling as HIV test counseling, information, or education provided verbally or with written materials or videos; and discretionary notification as delivery of results through a mode deemed appropriate by the clinician (eg, telephone, mail, electronic means, or in person). Laws and policies were considered compatible if they were not in conflict with CDC recommendations and incompatible if they would preclude implementation of CDC recommended routine testing. When laws were ambiguous or open to interpretation (14% of states), we consulted state and national experts to help resolve differences.
As of January 2011, 46 states and jurisdictions (including Washington, DC) (90.2%) were coded as compatible with the 2006 CDC recommendations for consent and counseling; 5 states were incompatible on at least 1 measured subparameter. For some states, compatibility varied by health care provider, setting, scenario, or type of law (Table). Although 21 states were already compatible in 2006 and had no legislative action since, 24 states (including Washington, DC) subsequently changed their statutes, administrative code, or both, making them more compatible (Figure). State laws remained in flux. In 2009-2010, 9 states (Connecticut, Hawaii, Michigan, Montana, New York, Ohio, Rhode Island, Washington, and Wisconsin) made their laws more compatible with CDC recommendations.
Figure. Legislative Changes Toward Compatibility of State Laws Regarding Human Immunodeficiency Virus Consent and Counseling Since 2006 CDC Recommendations (as of January 2011)
States designated as having introduced legislation include 5 states (Massachusetts, Nebraska, New York, Pennsylvania, and Rhode Island) with laws incompatible as of January 2011. Washington changed its administrative code to be more compatible with the Centers for Disease Control and Prevention (CDC) recommendations and has no conflicting statutory law. New York and Rhode Island remain incompatible but have passed some legislation more compatible with the CDC recommendations. New York passed legislation on 2 subparameters of consent, allowing use of a general consent form and opt-out testing. Rhode Island passed legislation on all subparameters of consent and 1 subparameter of counseling (in-person vs discretionary notification). Delaware, Florida, and Texas were compatible in 2006 and have introduced additional legislation more explicitly consistent with the CDC recommendations for opt-out consent. Washington, DC, was compatible in 2006 but passed laws more explicitly consistent with the CDC recommendations for opt-out consent in emergency departments.
Nearly all states' HIV testing laws and administrative codes were compatible with the current CDC HIV testing recommendations1 on consent and counseling as of January 2011. Although 5 states still had incompatible laws, 24 states actively changed their laws toward compatibility with CDC recommendations. This study is limited to state HIV testing statutes and administrative code available online and does not include case law or policies issued by other regulatory agencies (eg, health departments). State HIV testing laws are often complicated; can be contradictory or subject to interpretation; and can vary across populations, settings, scenarios, or providers. When assessed for overall compatibility, however, HIV testing laws in nearly all states no longer present obstacles to routine HIV testing.
1. BransonBM,HandsfieldHH,LampeMA,etal;CentersforDiseaseControland Prevention (CDC). Revised recommendations for HIV testing of adults, adoles- cents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006; 55(RR-14):1-17.
2. 2011 Compendium of state HIV testing laws. National HIV/AIDS Clinicians' Consultation Center. http://www.nccc.ucsf.edu/consultation_library /state_hiv_testing_laws/. Accessed January 10, 2011.