1. CMS and FDA The History and Horizon of Regulatory Coordination
Louis Jacques MD, Director
Coverage and Analysis Group
CMS

2. History
FDA and CMS have separate authorities and standards under statute
Safe and Effective v. Reasonable and Necessary
Both depend on access to robust data of clinical outcomes
Coordination before 2010 has been ad hoc
Product specific MOUs
Sponsor-specific invitations to have joint meetings
Attendance at each other’s symposia etc.
CMS rep on FDA Council for Medical Device Innovation

3. Things we hear… FDA approved it so CMS must cover it.
Just because FDA didn’t approve it…CMS should cover it anyway.
We don’t think the Boxed Warning is really relevant to this indication.
FDA won’t allow us to include clinical outcomes in our trial.
We can’t share (our own) data with you without getting FDA approval.
These post approval requirements are nothing special.

4. CMS and FDA: Parallel Review
Parallel review is a voluntary process that allows overlapping review and evaluation of certain FDA-regulated medical products by both CMS and FDA prior to products entering the market.
Purpose:
Help speed consumer access to those new medical products and services that demonstrate benefit.
Both agencies seek a process that allows them to share data and information collaboratively in a way that protects the confidentiality of proprietary information and safeguards patients’ privacy.
Enhance administrative and regulatory efficiency.

5. Parallel Review How it works
To occur only if a product sponsor and both agencies agree to use this process
CMS action will depend on the stage of the FDA review timeline.
When parallel review is utilized, CMS may launch a national coverage analysis (NCA) to determine whether the product is reasonable and necessary for the Medicare population while FDA completes its pre-market review to determine whether the product meets applicable safety and effectiveness standards.
Alternatively, compelling clinical trial evidence may obviate the need for an NCA if local Medicare contractors cover it under their own authority.

6. Parallel Review Potential effects: Standard of review
Could save time and resources as both agencies work together to review medical technologies
Standard of review
Proposal does not change any substantive element of FDA’s legal responsibility to ensure that technologies marketed in the United States meet applicable safety and effectiveness requirements
Proposal does not change CMS’ legal responsibility to assure that technologies covered by Medicare are “reasonable and necessary” for beneficiaries

7. Horizon Review public comments on the FR Notice
Develop and disseminate a roadmap for parallel review participants
Parallel review pilot(s)
Support collaboration on single manufacturer-sponsored clinical trial to meet both FDA's and CMS's evidentiary requirements

8. FDA CMS MOU

9. FDA-CMS Parallel Review FR Notice