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Joseph Grogan: Agency Overreach Leaves Patients Untreated
Medicare coverage for new treatments takes years. Thanks, CMS.
President Trump is pursuing deregulation to boost economic growth, but he could also use it to encourage medical innovation. As a first step, he could end the Coverage and Evidence Development program at the Centers for Medicare and Medicaid Services.
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 McClellanunderstood 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?
The program’s fatal flaw stems from confusion about agency roles. The FDA evaluates safety and efficacy. CMS’s mandate is to determine whether a product or service is reasonable and necessary to diagnose or treat an illness or injury. CED gave CMS free range to infringe on the FDA’s authority with predictable results: slowing access and blocking patients and doctors from making informed treatment decisions.
The program is also outdated. Unlike in 2005, digital health data is ubiquitous. The FDA can employ real-world evidence and artificial intelligence to analyze millions of patients’ treatments. CED’s clinical trial constructs are obsolete.
CED also restricts access by location, favoring urbanites who live near large academic medical centers over rural Americans. CMS should dramatically reform its process for making coverage decisions, with an eye toward speeding up access for patients. After decades of disappointing results, CED has earned its place in the regulatory graveyard.
Joseph Grogan is a leading healthcare policy expert and former Director of the White House Domestic Policy Council. With more than 20 years of public and private sector experience, he has shaped some of the most impactful health policy debates of the past decade. Grogan brings a pragmatic, bipartisan perspective to issues of innovation, patient access, and healthcare reform. To book WWSG exclusive speaker Joseph Grogan, contact WWSG.
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