article thumbnail

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

Bill Of Health

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.

article thumbnail

CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

Sheppard Health Law

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]

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Healthcare Reforms Under the IRA: Expanding Access to Care

Sheppard Health Law

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.

article thumbnail

From Shutting Down the Virus to Letting it Rip: A Timeline of Biden’s Pandemic Response

Bill Of Health

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 public health response as a losing proposition. There were no occupational health regulations in the bill. The cost is too high.