Pressure mounts against HHS’ 340B pilot: 5 notes

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A group of House lawmakers is urging HHS to scrap or revise its proposed 340B rebate model pilot program, warning the model could dismantle the original intent of the program and harm safety-net providers. 

Here are five things to know: 

  1. In a Sept. 8 letter to HHS Secretary Robert F. Kennedy Jr., a group of 162 bipartisan legislators expressed concerns about the 340B pilot program’s design, implementation timeline and potential consequences for community health centers, rural hospitals and other 340B-covered safety-net hospitals.

  2. The lawmakers criticized HHS for proposing a major structural change to the program while allowing only a 30-day public comment period, questioning the legal authority of the timeline and warning that a rushed implementation could disregard input from affected providers.

  3. The Health Resources and Services Administration announced the rebate model pilot in August, offering drug manufacturers the opportunity to propose alternative 340B discounts, with applications due Sept. 15.

  4. Hospital groups have opposed the 340B pilot program, saying it will take away from the original intent of the program. The American Hospital Association criticized the pilot program, issuing a letter Aug. 27 to HRSA Administrator Thomas Engels. In the letter, the hospital group outlined concerns over the agency’s decision to shift from up-front discounts to a rebate model for select Medicare Part D drugs.

    In a letter adressed to the Federal Trade Commission, the AHA also urged federal investigators to launch an investigation into drugmakers actions when it comes to 340B rebate models.

  5. One of the main concerns raised by the AHA was that hospitals could face increased costs under the new model. The group requested that the HRSA require drugmakers to cover all administrative and operational costs associated with the rebate model. 

    The American Medical Association also opposed the pilot program, stating in a Sept. 8 letter, “Safety-net providers operate on razor-thin margins. The rebate pilot would destabilize these institutions, directly threatening access to affordable medications for patients.” 

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