HC3 - Discrepancies Between Fda Approval And Cms Coverage For Drugs And Devices

Abstract

Following FDA approval, medical technology must still gain Centers for Medicare and Medicaid Services (CMS) coverage before Medicare reimbursement. However, the two agencies use approval processes based on different evidentiary standards. We identified the type and nature of discrepancies between FDA approval and CMS national coverage determinations (NCDs) for drugs and devices. We used the Tufts Medical Center NCD database, which contains detailed information on 165 NCDs since 1999. For each device or Part B drug considered in an NCD (1999-2011) (n=69), we searched the FDA website to identify the approved indication. We classified CMS coverage as: more restrictive than FDA approval, i.e., conditions were placed on coverage beyond the FDA-approved label; equivalent to FDA approval; or less restrictive than FDA approval, i.e., CMS covers off-label indications. Further, we categorized conditions placed on CMS coverage as: “patient-related”, e.g., restricted to patients with certain comorbidities or characteristics; “place in therapy”, e.g., tied to use as second-line therapy; or “technology-related”, e.g., restricted to a particular application of the drug or device. CMS has covered FDA-approved drugs or devices taken through the Medicare NCD process in 80% of cases (55/69). For CMS covered drugs and devices (n=55), coverage was more restrictive in 32 cases (58%), equivalent to FDA approval/clearance in 16 (29%), and less restrictive in seven (13%). Most common coverage restrictions were patient-related (78%), e.g., laparoscopic gastric banding to treat obesity is covered for patients suffering from an obesity-related comorbidity, and place in therapy (38%), e.g., coverage for extracorporeal immunoadsorption is covered for rheumatoid arthritis patients who have failed three disease-modifying antirheumatic drugs (DMARDs). In roughly one third of cases, CMS placed multiple restrictions on coverage. CMS coverage determinations are generally more restrictive than corresponding FDA approval. CMS often restricts coverage to patients with the most severe disease.