Question:

Medicare allows coverage of some Investigational Device Exemption (IDE) studies.  The Centers for Medicare and Medicaid (CMS) checklist for reimbursement, line requires a statement of compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CFR parts 50, 56, and 812, and 45 CFR part 46. Most IDE studies are regulated by FDA regulations and not by the Department of Health and Human Services’ (HHS) 45 CFR 46 (“the Common Rule”).

Before the revised Common Rule, the FDA and 45 CFR 46 (HHS) regulations aligned.  Now there is a gap between the two. What are the regulatory requirements for compliance for Medicare-covered medical device studies?
– Associate Director, Quality and Regulatory, Device Company

Response: 

The requirement for compliance that you reference comes directly from the Medicare regulations on coverage decisions, 42 CFR § 405.201(6) Subpart B:

“The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CFR parts 50, 56, and 812 and 45 CFR part 46.”

The key here is that only the applicable regulations apply. The HHS regs would only apply when the study is funded or supported by HHS.  

In addressing your concern about the revised Common Rule, you may find it helpful to read the FDA’s October 2018 guidance on the impact of the revised common rule on FDA-Regulated Clinical Investigations.  This guidance document addresses the differences between the FDA regulations the Common Rule and clarifies that when FDA-regulated clinical investigations are also conducted or supported by HHS, then both sets of regulations apply.