Ryan White CARE Act: Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs
GAO-06-646
Published: Apr 26, 2006. Publicly Released: Apr 26, 2006.
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Highlights
The CARE Act authorized grants to the states and certain territories for AIDS Drug Assistance Programs (ADAP) to purchase and provide HIV/AIDS drugs to eligible individuals. An ADAP's coverage--who and what is covered--is determined by each ADAP's eligibility and other program criteria, and ADAPs may establish waiting lists for eligible individuals. ADAPs may purchase their drugs through the 340B federal drug pricing program, which provides discounts on certain drugs to covered entities. The Health Resources and Services Administration (HRSA) oversees ADAPs and is responsible for monitoring the prices they pay. GAO was asked to examine (1) coverage differences among ADAPs, (2) how the prices ADAPs reported paying for HIV/AIDS drugs compare to 340B prices, (3) how HRSA monitors the drug prices ADAPs pay, and (4) how the 340B prices compare to other selected federal drug pricing programs.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Health Resources and Services Administration | To ensure that ADAPs are obtaining the best prices for drugs they provide, the Administrator of the Health Resources and Services Administration should require that all ADAPs report final prices they paid for drugs, and that those final prices reflect any discounts or rebates received. |
Closed – Not Implemented
In commenting on the report, the Health Resources and Services Administration (HRSA) has continually raised concerns about its ability to implement this recommendation. HRSA stated that it would like to verify final drug prices but this would be labor intensive because reports AIDS Drug Assistance Programs (ADAPs) currently provide do not contain the needed information. Specifically, HRSA noted that ADAPs may receive rebate checks many months after the drugs were purchased, which complicates the task of comparing prices. HRSA further stated that it is taking steps to develop the information it will require to determine whether the prices ADAPs paid for the drugs they purchased are at or below the 340B prices, but that it lacks the resources to conduct manual cost comparisons on a large scale. HRSA noted that it is making efforts to develop systems to allow ADAPs to check drug prices and that the agency has requested that drug manufacturers who participate in the 340B program voluntarily submit quarterly 340B prices on covered drugs to HRSA for comparison with the government computed 340B ceiling prices. HRSA has made improvements to its process, but has not implemented improvements that would meet our recommendation. In more recent work done by GAO, we identified a number of issues with HRSA's compliance with 340B requirements overall, indicating that HRSA has not implemented this recommendation.
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| Health Resources and Services Administration | To ensure that ADAPs are obtaining the best prices for drugs they provide, the Administrator of the Health Resources and Services Administration should routinely determine whether the prices ADAPs paid for the drugs they purchased were at or below the 340B prices. |
Closed – Not Implemented
In commenting on the report, the Health Resources and Services Administration (HRSA) raised concerns about its ability to implement this recommendation. HRSA stated that it would like to verify final drug prices but this would be labor intensive because reports AIDS Drug Assistance Programs (ADAPs) currently provide do not contain the needed information. Specifically, HRSA noted that ADAPs may receive rebate checks many months after the drugs were purchased, which complicates the task of comparing prices. HRSA further stated that it is taking steps to develop the information it will require to determine whether the prices ADAPs paid for the drugs they purchased are at or below the 340B prices, but that it lacks the resources to conduct manual cost comparisons on a large scale. HRSA has made improvements to its process, but has not implemented improvements that would meet our recommendation. In more recent work done by GAO, we identified a number of issues with HRSA's compliance with 340B requirements overall, indicating that HRSA has not implemented this recommendation.
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Topics
AIDSComparative analysisCost analysisEligibility criteriaPrime vendorEligibility determinationsHealth care costsHealth care programsHealth policyMonitoringPrescription drugsPrices and pricingSexually transmitted diseases