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In Elections’ Wake, New Senate Leadership and a New GAO Study on 340B

Report is due to be issued in mid-2015
 

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November 5, 2014—U.S. Senate committees with responsibility for the 340B drug discount program will have new leaders starting early next year following the GOP’s strong showing in yesterday’s midterm elections. [ms-protect-content id=”2799″]

Even before the elections, the current top Republicans on the Senate health, finance, and judiciary panels (plus a fourth GOP senator and a Republican representative, both influential on 340B matters), asked the Government Accountability Office for a second major report on 340B. It is slated for release in mid-2015. The GAO’s first congressionally mandated report on 340B came in September 2011.

The GOP lawmakers who asked for the new GAO study are: Sens. Lamar Alexander (Tenn.), Orrin Hatch (Utah), Charles Grassley (Iowa), Michael Enzi (Wyo.), and Rep. Joe Pitts (Pa.).

Republican committee chairmanships and assignments for the next session of Congress will not be settled for several weeks. At this time, either Senator Alexander or Enzi is likely to be the next chairman of the Health, Education, Labor, and Pensions Committee, which has primary jurisdiction over 340B. Senator Hatch is in line to chair the Finance Committee and Senator Grassley to chair the Judiciary Committee. The Finance Committee has primary jurisdiction over Medicare and Medicaid. Senator Grassley has conducted inquiries of 340B manufacturer and provider stakeholders. Senator Hatch is also a member of the HELP panel.

Rep. Pitts currently chairs the Energy and Commerce Subcommittee on Health. The full committee has primary jurisdiction over 340B in the House, and Rep. Fred Upton (Mich.) is expected to remain its chairman.

The GAO’s 2011 report on 340B found that while hospitals and other providers were using 340B discounts as Congress intended, oversight was inadequate. It recommended covered entity audits, a new 340B definition of patient, more specific eligibility criteria for private nonprofit hospitals, reviews of manufacturers’ plans to restrict distribution of drugs at 340B prices, and more specific guidance governing nondiscrimination in 340B drug sale for cases in which distribution of drugs is restricted.

The forthcoming report is expected to have two objectives: (1) to examine 340B and non-340B hospitals’ sources of revenues and margins and how they have changed over time, and (2) to compare 340B and non-340B hospitals’ Medicare Part B drug reimbursements and how those have changed over time. The GAO has already begun interviews for its study.

On a separate track, the Department of Health and Human Services Office of Inspector General is working on a study to determine how much Medicare Part B spending could be reduced if Medicare were able to share in the savings for 340B-purchased drugs. That report is also scheduled for release next year. [/ms-protect-content]

 

 

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