Public Policy Solutions Co-Founder Joe Grogan authored an op-ed, “Agency Overreach Leaves Patients Untreated,” in the Wall Street Journal. He argues that the Centers for Medicare and Medicaid Services’ (CMS) program “Coverage with Evidence Development” creates barriers to treatment. Intended to expedite Medicare coverage for FDA-approved innovations, the program now delays access to life-saving therapies, undermining the FDA’s role, and he urges the Trump administration to end it.
In his op-ed, Grogan writes
CMS established the program two decades ago to speed Medicare coverage of new treatments that had been approved by the Food and Drug Administration. Instead, CED has slowed it down. In 2005 advances in medical devices were solving major medical problems, but CMS bureaucrats worried about taxpayer costs and demanded more data before covering them
CMS Administrator Mark McClellan understood the value of these breakthroughs. He created CED to provide a fast pathway for Medicare coverage that would allow patients access through clinical trials while additional data was collected to meet CMS’s coverage standard. He understood that interagency power struggles and bureaucratic risk aversion could choke off innovation, so he gave CMS a role in driving it. He hoped CED would generate better, more personalized evidence, which could improve treatments.
The program took a turn for the worse under the Obama administration. CMS abused CED to stifle access to FDA-approved products, from heart valve replacements to PET scans diagnosing Alzheimer’s disease, restricting Medicare coverage. Under the Biden administration, CMS applied CED for the first time to medications, which restricted coverage for an entire class of new Alzheimer’s therapies.
Medical innovations remain stuck between FDA approval and full Medicare coverage. Of 27 medical devices covered under CED since 2005, four have “graduated” to unrestricted coverage. Two product decisions were ceded to Medicare’s regional administrative contractors. The other 21 remain in limbo. Implantable cardioverter defibrillators languished under CED for 18 years. How much data does CMS need?