Medicare Urged To Create Clear Path For Ending Coverage With Evidence Development Restrictions

As CMS faces a possible decision on what further study it will require for an Alzheimer’s drug if granted a traditional FDA approval, work on updating Medicare’s underlying CED policies continues. Stakeholders press their case ahead of December meeting.

Should Update Consider Whether CMS Is A Gatekeeper For FDA Approved Drugs? • Source: Shutterstock

The Centers for Medicare and Medicaid Services should develop a transparent process for lifting coverage with evidence development restrictions as part of its planned update of the Medicare CED policy, a coalition of 20 patient groups, providers and researchers told the Agency for Healthcare Research and Quality in recent comments.

The comments respond to a recent draft report released by AHRQ that is intended to inform an update of the specifications around studies required as a condition of Medicare coverage in a CED decision (Also see "Medicare CED

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