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Medicare CED Update Targets Study ‘Efficiency,’ But May Not Ease Data Collection Burden

 
• By Cathy Kelly

It's not clear that the proposed revisions and additions to the Centers for Medicare and Medicaid Services’ existing coverage with evidence development study design requirements would address what some experts view as a program failure – the fact that sponsors of the vast majority of technologies subject to CED have not generated the data CMS is looking for. 

Latest Update To 17-Year Old CED Policy Underway • Source: Shutterstock

The Centers for Medicare and Medicaid Services is considering a substantive update of the study design requirements for sponsors of treatments that are subject to a Medicare national coverage determination that conditions coverage on further evidence development.

A revised set of requirements was developed for CMS by the Agency for Healthcare Research and Quality and will...

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More from Medicare

Sticker Shock? Cost Of Orphan Drug Medicare Negotiation Relief May Complicate Future Fixes

 
• By Cathy Kelly

Heavy lobbying produced relief for orphan drugs in President Trump's budget reconciliation law and the cost of the changes to Medicare now is becoming clearer.

Colorado Board Adopts Medicare Maximum Fair Price For Enbrel, Assumes Amgen ‘Amenable’

 
• By Cathy Kelly

The state’s prescription drug affordability board could be the first to recommend an upper payment limit for a prescription drug.

Medicare Part D Plans Turn to Coinsurance, Higher Deductibles Amid IRA Changes

 
• By Tim Casey

Newly implemented IRA provisions may not necessarily lower drug costs for those enrolled in Medicare Part D plans, according to research by the USC Schaeffer Center for Health Policy and Economics.

US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By Cathy Kelly

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

More from Government Payers

UK Drug Pricing Scheme Talks Collapse: Industry Braces For Another Year Of High Rebates

 
• By Eliza Slawther

Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.

Medicare Part D Plans Turn to Coinsurance, Higher Deductibles Amid IRA Changes

 
• By Tim Casey

Newly implemented IRA provisions may not necessarily lower drug costs for those enrolled in Medicare Part D plans, according to research by the USC Schaeffer Center for Health Policy and Economics.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.