Ryan White CARE Act:

AIDS Drug Assistance Programs, Perinatal HIV Transmission, and Partner Notification

GAO-06-681T: Published: Apr 26, 2006. Publicly Released: Apr 26, 2006.

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Despite progress in HIV/AIDS drug treatments and the reduction of AIDS mortality in the United States, challenges remain concerning the availability of these drugs for individuals with HIV/AIDS and the prevention of new cases. The CARE Act authorizes grants to the states and certain territories specifically for AIDS Drug Assistance Programs (ADAP) to purchase and provide HIV/AIDS drugs to eligible individuals. In its report issued today, Ryan White CARE Act: Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs (GAO-06-646), GAO examines the program design of ADAPs in the 50 states, the District of Columbia, and Puerto Rico, their funding sources, and drug purchasing. GAO also reports on state approaches to reducing perinatal HIV transmissions and identifying and notifying partners of HIV-infected individuals.

Variation in ADAPs' program design and funding amounts from CARE Act grants and other funding sources contribute to differences in coverage--who is eligible and what drugs are covered by an ADAP--among the 52 ADAPs GAO reviewed. In order to make maximum use of the funding they receive, ADAPs are expected to secure the best price available for the drugs on their formularies. ADAPs may, but are not required to, purchase their drugs through the 340B federal drug pricing program, under which drug manufacturers provide discounts on certain drugs to covered entities. The Health Resources and Services Administration (HRSA) has identified the 340B prices as a measure of ADAPs' economical use of grant funds, but the Department of Health and Human Services does not disclose 340B prices to the ADAPs. GAO found that some ADAPs reported prices that were higher than the 340B prices for selected HIV/AIDS drugs. However, these reported prices may not have reflected any rebates ADAPs eventually received. While HRSA is responsible for monitoring whether ADAPs obtain the best prices available for drugs, it does not routinely compare the drug prices ADAPs report to 340B prices. All 50 states, the District of Columbia, and Puerto Rico have policies or have enacted laws regarding HIV testing of pregnant women to help reduce perinatal HIV transmission. The majority of states have adopted a policy of voluntary prenatal HIV testing of pregnant women that is consistent with guidelines issued by the Centers for Disease Control and Prevention (CDC). GAO contacted 8 states to discuss the approach they use to test pregnant women for HIV, and these states use one of two approaches. Consistent with additional CDC recommendations on testing, three states routinely include HIV tests in standard prenatal testing, but a woman can refuse to be tested for HIV. In the other 5 states, a woman must consent to an HIV test, usually in writing, before the test can be performed. Six of the 8 states GAO contacted report that the number of HIV-positive newborns has declined. However, only 3 states GAO contacted collect the data needed to determine statewide perinatal HIV transmission rates. GAO contacted 12 states regarding their approaches to identifying partners of HIV-infected individuals and notifying them of their possible exposure to the virus. These states used various approaches in conducting HIV partner notification activities as part of their partner counseling and referral services. These activities include eliciting partner information from HIV-infected individuals, but the participation of these individuals varies and not all partners can be reached to be notified. Of the 12 states contacted, 10 have statutory or regulatory provisions that require or permit certain health care entities or workers to notify partners, including spouses, without the consent of the known HIV-infected individual. In the remaining two states, public health officials or the health department may notify partners only with the consent of the HIV-infected individual.

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