aamc.org does not support this web browser.
  • Washington Highlights

    Energy and Commerce Releases Report on 340B Program

    Jason Kleinman, Senior Legislative Analyst, Govt. Relations

    The House Energy and Commerce Committee Jan. 10 released a report on the 340B Drug Pricing Program. The report is the culmination of the Oversight and Investigations Subcommittee’s examination into the program, which has included several hearings and a request for information from 19 hospitals that participate in the program [see Washington Highlights, Oct. 13, 2017 and July 21, 2017].

    The report, Review of the 340B Drug Pricing Program, notes that the “340B program is an important program that enjoys strong bipartisan support in Congress.” It includes a variety of findings and a list of recommendations to address these concerns.

    Some of the report’s findings include:

    • The Health Resources and Services Administration (HRSA) lacks sufficient authority to adequately oversee the program and its audit process still needs
    • Since covered entities do not have access to ceiling prices, they do not know if they are getting an accurate price from drug manufacturers;
    • Congress did not clearly identify the program’s intent or establish any mechanisms to calculate program savings; and
    • The 340B statute does not require covered entities to report the level of charity care provided and the current eligibility metric does not reflect the level of charity care provided.

    The report provides a list of 12 recommendations to address these findings. Some of the recommendations include:

    • HRSA should finalize and enforce regulations in the areas that it currently has regulatory authority, including the 340B Alternative Dispute Resolution process, the imposition of civil monetary penalties against manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug, and the calculation of ceiling prices;
    • Congress should give HRSA sufficient regulatory authority to adequately administer and oversee the program;
    • Congress should equip HRSA with more resources and staff to conduct more rigorous oversight and more effective management of the program;
    • HRSA should work toward ensuring that it audits covered entities and manufacturers at the same rate
    • Congress should clarify the intent of the program;
    • Congress should promote transparency in the 340B program for both covered entities and manufacturers;
    • Congress should establish a mechanism to monitor the level of charity care provided by covered entities; and
    • Congress should reassess whether DSH is an appropriate measure for program eligibility.