CMS and FDA’s Regulatory Review & Coverage Coordination Rochelle Fink, M.D., J.D.– FDA-CMS Liaison Center for Devices & Radiological Health U.S. Food and Drug Administration

Parallel Review Program Purpose: Reduce the time between FDA marketing approval and a CMS national coverage determination (NCD) First announced: 75 Fed. Reg. 57045 (Sept. 17, 2010) Described: 76 Fed. Reg. 62808 (Oct. 11, 2011) Extended: 78 Fed. Reg. 76628 (Dec. 18, 2013)

Before Parallel Review Steps in series Coverage considered after FDA regulatory decision Payment Regulatory Concept Patients FDA decision CMS decision Now – Series. Reimbursement considered late. Long gap between FDA decision and patient access. Future – Parallel. Reimbursement considered early. Shorter (or no) gap between FDA decision and patient access. Manufacturers are encouraged to engage FDA early in the development process, sometimes well before a regulatory submission is filed.

Concept of Parallel Review Steps in parallel or simultaneous Coverage considered earlier Payment Regulatory Concept Patients Payer decision FDA decision Now – Series. Reimbursement considered late. Long gap between FDA decision and patient access. Future – Parallel. Reimbursement considered early. Shorter (or no) gap between FDA decision and patient access. Manufacturers are encouraged to engage FDA early in the development process, sometimes well before a regulatory submission is filed.

What are we talking about? FDA is not talking about coverage or payment but rather about communication of the evidentiary requirements from 3rd party payers to sponsors

Program Candidates Sponsor candidate has had sufficient pre-IDE interaction with FDA or approved IDE application Technology for which an original or supplemental application for PMA or petition for de novo review would be required Technologies that fall within a defined benefit category—Sec. 1861 of the Social Security Act

Pilot Success Cologuard August 11, 2014: FDA approves Cologuard CMS issues its proposed NCD October 9, 2014: CMS issued its final NCD

Program’s Future Payer Provide a process to enable manufacturers to include and engage payers during meetings with FDA using the Pre-Submission program FDA Review Team Manufacturer Like an advisory panel meeting.

What is FDA not doing? Being coverage or payment experts Promoting specific devices or manufacturers Promoting specific payers or specific codes Considering payment or costs for approvals Modifying FDA review or decision processes Suggesting that payers use FDA’s evidentiary requirements or alter anyone’s standards

Important Clarifications FDA evaluates safety and effectiveness in the same way using the same methods FDA’s communication facilitation will be done through FDA’s established Pre-Submission process Manufacturers will opt-in Manufacturers will invite payers/providers

Value to Stakeholders Patient Earlier access to innovative technologies Payers Learn more about new technologies beyond current horizon scanning Provide suggestions about what data and analyses would be useful for evaluation Learn more about FDA review process

Value to Stakeholders Manufacturer Engage payers earlier in discussion about evidentiary needs Potential for earlier payment due to earlier engagement FDA Improve public health by shortening the time for patients to access innovative medical devices

More Information E-mail: Parallel-Review@fda.hhs.gov Internet Information: 1) Payer Communication Task Force http://www.fda.gov/aboutfda/centersoffices/officeofmedica lproductsandtobacco/cdrh/cdrhinnovation/ucm456149.htm 2) Pre-Submission Program Guidance http://www.fda.gov/downloads/medicaldevices/deviceregul ationandguidance/guidancedocuments/ucm311176.pdf

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