Payor Communication Task Force

Background

CDRH established the Payor Communication Task Force to facilitate communication between device manufacturers and payors to potentially shorten the time between FDA approval or clearance and coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for regulatory approval or clearance and positive coverage determinations, which may expedite patient access.

Payors include public payors such as Centers for Medicare & Medicaid Services (CMS), private health plans, health technology assessment groups, and others who provide input into coverage and reimbursement decisions.

FDA's Center for Devices & Radiological Health (CDRH) evaluates the safety and effectiveness of medical devices for use in the U.S. Usually after FDA approval or clearance, other organizations—for example, public and private organizations that pay for health care (payors) and the professionals who provide health care (providers)—decide whether to cover, pay for, or use a device. Often, the data submitted by medical device manufacturers to demonstrate safety and effectiveness to the FDA may not include data needed by payors to make coverage determinations. As a result, after FDA approval or clearance, there may be a delay in coverage, payment and use decisions that may ultimately delay patient access to medical devices.

Opportunities to Obtain Public Payor Input

The opportunities for collaboration with a public payor, CMS, are outlined below. CDRH hopes to further expand the opportunities to include collaborations with other public payors in the future.

Parallel Review

In 2011, FDA and CMS introduced the Parallel Review Pilot Program (Parallel Review), which established a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA's approval of a premarket application and the subsequent CMS national coverage determination (NCD). In October 2016, the FDA and CMS announced the Parallel Review program will be fully implemented and extended indefinitely.

Parallel Review has two stages:

FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the CDRH Pre-Submission Program.
FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the PMA or De Novo request.

FDA and CMS will independently review the data to determine whether it meets their respective Agency's standards and communicate with the manufacturer during their respective reviews.

How to Apply

Manufacturers interested in parallel review should submit an email request for parallel review to Parallel-Review@fda.hhs.gov that indicates their interest in the program and includes the following :

Name of the sponsor/requester and relevant contact information;
Device name, and proposed indications for use/intended use;
Device description including stage of development of the technology;
Submission number (if applicable); and
Brief statement explaining why the device is an appropriate candidate for Parallel Review (be sure to address each of the four criteria outlined below).

Preference for enrollment in Parallel Review is given to devices that meet all the following criteria:

The manufacturer intends to meet jointly with FDA and CMS using FDA's Pre-Submission program or other mechanisms that allow for meetings of the three parties to gather and incorporate feedback about the design and analysis of their pivotal clinical trial to support a marketing application and a National Coverage Determination.
The medical device will require an original or supplemental application for premarket approval (PMA) or the granting of a de novo request;
The medical device is not excluded by statute from Part A and/or Part B Medicare coverage (and the request for parallel review includes a list of Part A and/or Part B Medicare benefit categories, as applicable, into which the manufacturer believes the medical device falls); and
The medical device addresses the public health needs of the Medicare population (and the request for parallel review includes an explanation of how).

FDA intends to respond by email to all requests within 30 calendar days, and may contact the sponsor/requestor to request additional information.

Participation in Parallel Review is voluntary and does not change the existing separate and distinct review standards for FDA device approval or clearance and CMS national coverage determination. For questions or additional information on the Parallel Review, contact Parallel-Review@fda.hhs.gov.

Public Payor Pre-Submission Participation

Manufacturers who may not be eligible for, or interested in Parallel Review, may request CMS' input on clinical trial design and other considerations by asking for CMS' participation in a Pre-Submission meeting. Manufacturers are highly encouraged, but not required, to develop or modify their proposed clinical trial design based on feedback received from CMS. Depending on available resources, CMS hopes to provide some form of feedback to all manufacturers who make the request.

How to Apply

When submitting your Pre-Submission meeting request, please indicate in your cover letter that you would like CMS to participate. Be sure to clearly indicate where in your submission where to find the specific questions for CMS.

All regulatory discussions will continue to follow the processes established within the CDRH Pre-Submission Program.

For questions or additional information about Pre-Submission interactions for coverage and payment decisions and other opportunities, contact CDRHPayorCommunications@fda.hhs.gov.

Opportunities to Obtain Private Payor Input

CDRH has a voluntary opportunity for medical device sponsors to obtain private payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. CDRH has an open request for private coverage organizations that evaluate clinical evidence and make coverage recommendations or decisions for private payors and health plans to express interest in providing input to medical device sponsors during a Pre-Submission meeting.

Organizations that responded to the request are listed below. The FDA will periodically update the table to notify the public when other organizations have responded.

NOTE: This is a voluntary opportunity for both the medical device sponsors and coverage organizations. The decision of a medical device sponsor to participate or not to participate in this opportunity will not alter the regulatory and evidentiary standards FDA uses for decision making. Inclusion on this list does not imply or constitute any endorsement or relationship between these organizations and the FDA. The FDA has not independently verified that these organizations evaluate clinical evidence used to support private payor coverage decisions for medical devices, or make coverage recommendations to or decisions for private payors and health plans regarding medical devices.

List of Current Participants:

Company Name	Company Mailing Address
CareFirst BlueCross BlueShield (Payor Provider Organization)	1501 S. Clinton Street, 17th Floor Baltimore, MD 21224
BlueCross BlueShield Association (Health Technology Assessment)	225 North Michigan Avenue Chicago, IL 60601
Duke Evidence Synthesis Group, Duke Clinical Research Institute, Duke University (Health Technology Assessment)	2400 Pratt Street Duke Clinical Research Institute Durham, NC 27705
ECRI Institute Headquarters (Health Technology Assessment)	5200 Butler Pike Plymouth Meeting, PA 19462-1298
Humana (Payor Provider Organization)	500 West Main Street Louisville, KY 40202
Kaiser Permanente (Payor Provider Organization)	393 East Walnut Street Pasadena, CA 91188
National Institute for Health and Care Excellence (NICE) (Health Technology Assessment)	Level 1A City Tower, Piccadilly Plaza, Manchester, M1 4BT, United Kingdom
United Health Group (Payor Provider Organization)	9900 Bren Road East Minnetonka, MN 55343

How to Apply

Medical device sponsors may contact CDRHPayorCommunications@fda.hhs.gov to request that a listed respondent join their Pre-Submission meeting. This request must be received prior to submitting your Pre-Submission to CDRH for review. Once we receive your request, we will work with those selected to gauge their interest and availability. If you have any questions about this opportunity, please email CDRHPayorCommunications@fda.hhs.gov.

Stakeholder Engagement

CDRH's Payor Communication Task Force co-hosted a Payor Summit for Medical Devices on December 14, 2016. In this meeting, we discussed ways to further improve patient access to safe and effective medical devices. Regulators, payors, patient advocacy groups, professional societies, coding experts, heath technology assessment groups, small and large businesses, and venture capitalist/investors considered barriers and challenges to patient access and brainstormed potential solutions. From this meeting, we collectively decided that CDRH will prioritize these action items:

Create a Medical Device Innovation Hub - We will establish a program/group intended to improve patient access to medical devices through addressing the many different aspects of the evaluation process including FDA clearance/approval, evidence generation, healthcare technology assessment, coding, coverage, and payment.
Match Technologies with Integrated Healthcare Providers - Explore opportunities to identify needs of integrated healthcare payor providers and match those needs with specific technologies, allowing for coverage with evidence development (or similar process) to determine if the technology addresses the needs of the integrated healthcare provider.

If you have any questions about these efforts or would like to help, please email us at CDRHPayorCommunications@fda.hhs.gov.