Medicare coverage with evidence development

United States, agency guidance under the Social Security Act. Coverage with evidence development (CED) lets the Centers for Medicare and Medicaid Services issue a national coverage determination that pays for an item only when the patient is in an approved study or registry, under section 1862(a)(1)(E) of the Social Security Act. CMS set out the policy in 2006 guidance, revised in 2014 and again in 2024. Primary text: the CMS CED page and the Medicare Coverage Database.

Oncology examples: FDG-PET for most cancers was covered from 2006 through the National Oncologic PET Registry, which then generated the evidence that led to unrestricted coverage in 2009 and 2013. National coverage determination 90.2 (March 2018, widened in 2020) covers FDA-approved next-generation sequencing companion diagnostics for patients with advanced cancer, and germline testing for hereditary cancer. CAR-T therapy received a national coverage determination in August 2019 after an initial proposal to impose CED was dropped. More broadly, Medicare Part B must cover anti-cancer drugs for uses supported by the statutory compendia, and Part D treats antineoplastics as a protected class, so unlike Europe there is no national decision on whether a cancer drug is worth its price.

The arguments: CED is praised for turning coverage into evidence and criticised for slow registries that never end; the compendia rule and protected classes are why the United States pays for nearly every approved cancer drug at list price, which the Inflation Reduction Act's negotiation programme begins to change.