Medicare Seeks Input On Dispute Resolution, Civil Penalties For Rx Pricing Program

Calculating a ‘fair price’ for new versions of already negotiated moiety is also one of several that CMS is requesting input on in its recently released initial guidance on the negotiation program.

Medicare Guidance Explains How Price Negotiation Will Work In First Year • Source: Shutterstock

While one section of the initial Centers for Medicare and Medicaid Services guidance on the drug price negotiation program is final, the agency is actively seeking comment, if quickly, on several other elements.

The 91-page guidance was released 15 March with a narrow 30-day window for public comments, which are due by 14...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from Market Access

CMS Should ‘Clarify’ That Part B Inflation Rebates Do Not Apply In Medicare Advantage, Pharma Urges

The Centers for Medicare and Medicaid Services is considering imposing price inflation rebates on Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.

PS-MarketAccess (Premium-2): Why Financial Scammers Are So Successful Targeting Doctors

 
• By 

Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.

Gene Therapy Hemgenix Gains Ground In Europe With Spanish Reimbursement Deal

 
• By 

Hemgenix has now secured reimbursement in several European markets, and while the path to reimbursement for the high-cost product has not always been easy, innovative access deals have helped to smooth the way.

Senate Hearing On Ozempic, Wegovy Highlights Concerns About PBMs, International Price Disparities

 
• By 

Senate HELP Committee chair Sanders trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices.

More from Pink Sheet

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By 

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
• By 

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.