In the 1990s, there were some brutal and very long-lived lawsuits over when and how Medicare could cover healthcare providing in "clinical trials." (See Yale New Haven v. Thompson, 2001, here.) Manualized agency policy varied from year to year from 1980 forward; and what policies there were, were implemented haphazardly by contractors.
In 1995, CMS and FDA finalized a program under which devices in FDA-approved investigational device clinical trials could be covered by Medicare. One lynchpin was to have the FDA pre-classify investigational device trials as "Category A" ("experimental") and "Category B." The rule is actually a model of clear prose (60 FR 48417, September 19, 1995; here.) The point was not that CMS was to cover "experimental studies" but rather than CMS could cover "medical care:" the patient needed an artificial hip, and got one, and so on, even if it was a modified hip joint that was in a trial.
Local MACs had the authority to decide whether a particular Category B study was covered, and in the 00's (2006, 2008, 2010) there were a lot of debates whether this was done efficiently, consistently, or rationally. A few years ago, CMS finalized rulemaking to make the Category B coverage decisions a centralized function by Baltimore staff. This process went live on January 1, 2015. The home page at CMS is here; as of May 2016, 58 Category B trials are cleared for payment; here.
The corresponding regulations are at 42 CFR 405.201ff as updated in 2013 (here); the CMS manual chapter updated in 2014 is here.
Several additional 2015/2016 updates.
- In December 2015, CMS and FDA published a "revised memorandum of understanding" for the process, which reflects recent updates on the CMS process side. Here.
- In May 2016, FDA published a Federal Register notice that flags the online publication of a new guidance for how the FDA makes Category A and B decisions. That draft guidance is here. Comment period runs 60 days, or until about August 1.
- Coverage at Gray Sheet (subscription; here).
FDA's new document provides guidance that covers some ambiguities that emerged since the 1995 policymaking. In some cases, devices initially classed as Category A can be downclassed to Category B after first-in-man trials.
Medicare Trick Issue
The device guidance, using the Category A, Category B device classifications, is entirely separate from the NCD for other types of clinical trials that can be covered by Medicare. The "Clinical Trials NCD" was last updated in 2007 and is here. At that time, CMS had proposed a very large update of the NCD, but settled on some wordsmithing and small edits.