article thumbnail

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.

Insurance 130
article thumbnail

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. covered insulin product or vaccine). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.

IT 52
article thumbnail

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.

article thumbnail

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.

article thumbnail

Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

The Part B rebate would exclude vaccines as well. Excluded from both the Part B and the Part D rebates would be drugs in shortage, drugs subject to an MFP (see Part 1, above), and drugs for which the average total annual allowed charges (Part B) or cost (Part D) for an individual are less than $100 (adjusted for inflation after 2023).