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

Medicare Coverage Policy Change Opens Up Commercial Market Pathway – If Biden Likes It

 
• By Ramsey Baghdadi

Modification to ‘reasonable and necessary’ definition in MCIT final rule offers new avenue for drug manufacturers to get products covered in Part B. The Biden Administration will have to decide whether it will keep the Trump regulation unchanged.

open door with balloons (shutterstock)
CMS is opening the door to different Medicare Part B reimbursement. • Source: Shutterstock

The vast majority of injectable and infused drugs are covered by Medicare for their FDA-approved indications or medically accepted off-label uses laid out in compendia. But there are always exceptions.

Dendreon Corporation’s autologous cell therapy Provenge for prostate cancer is one that comes to mind. In that case, Medicare opened a national coverage analysis for the product with a list price at the time that came in at just under $100,000

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

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.

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

More from Government Payers

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.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

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.