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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

HB 2 – Vaccine Consent What’s in the Bill: Sponsored by Rep. Under current law, minors aged 14 or older are permitted to consent to vaccines (excluding the Covid Vaccine) for themselves without parental consent. Here’s a brief overview of the key pieces of legislation that AAFP is diligently monitoring.

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Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide Deck

FDA Law Blog

The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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What RFK Jr. Isn’t Talking About: How To Make Vaccines Safer

Physician's Weekly

Within an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. The Part B rebate would exclude vaccines as well. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.