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Each manufacturer must pay the rebate within thirty (30) days of receiving the invoice and failure to pay will result in civil monetary penalties (“CMPs”), which CMS will establish through regulations, including a penalty equal to at least one hundred twenty-five percent (125%) of the rebate amount. 9, 2023). [2]
Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation. A safe harbor applicable to flat fee arrangements paid by pharmaceutical manufacturers directly to PBMs for PBM services.
Pressure from Senator Bernie Sanders, Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee seems to have catalyzed the administration to make this move. pharmaceutical market. Federal support by BARDA and the CDC have de-risked the development of medical products for the pharmaceutical industry.
I argue that Biden’s advisors chose a narrow path of pharmaceutical intervention (i.e., a “vaccine-only” approach) because they saw the politics of a comprehensive publichealth response as a losing proposition. There were no occupational healthregulations in the bill. The cost is too high.
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