1. Pink Sheet
  2. >>Market Access
  3. >>Government Payers
  4. >>Medicare

Medicare Payment Caps For Part B Drugs With Accelerated Approvals Endorsed By MedPAC

 
• By Cathy Kelly

Recommendation meant to drive completion of confirmatory trials for accelerated approvals will be forwarded to Congress. Medicare Payment Advisory Commission also recommends allowing Part B to use reference pricing and to adjust ASP payment add-ons for providers.

dollar part B
MedPAC Picking Up Where The IRA Left Off • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

After months of deliberations, the Medicare Payment Advisory Commission unanimously approved a recommendation enabling differential Medicare reimbursement for Part B drugs cleared by the US Food and Drug and Administration through the accelerated approval pathway at its 13 April meeting.

The recommendation and two others covering Part B drugs will be included in the commissioner’s June report to Congress

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Medicare

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
• By Derrick Gingery

US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

If CMS Takes Over 340B, Will Government Allow Rebate Model Changes?

 
• By Cathy Kelly

Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.

More from Government Payers

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
• By Cathy Kelly

Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.