• Background
• Opportunities to Obtain Payor Input
  • Early Payor Feedback Program – All Payors
  • Parallel Review with Centers for Medicare and Medicaid Services (CMS)
• AMA Coding Questions

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 for 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, procurement, 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.

For questions, additional information, or to request our presence at an event, please email us at [email protected]. Please note, all formal speaking requests will need to follow the procedures outlined here.

Opportunities to Obtain Payor Input

Early Payor Feedback Program – All Payors

CDRH has a voluntary opportunity for medical device sponsors to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. All regulatory discussions will continue to follow the processes established within the CDRH Q-Submission Program. Organizations willing to join CDRH meetings are listed below. CDRH has an open request for additional coverage organizations that evaluate clinical evidence and make coverage recommendations or decisions for payors and health plans to join this opportunity.

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 Early Payor Feedback 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 payor coverage decisions for medical devices or make coverage recommendations to or decisions for payors and health plans regarding medical devices.

List of Current Payor Participants:

How to Apply

Medical device sponsors may contact [email protected] to request that one or more participating organizations join a Pre-Submission meeting. This request must be received prior to submitting your Pre-Submission to CDRH for review, to allow time for the participating organizations to consider the request and to prepare for the meeting. Once we receive your request, we will work with the selected organizations to confirm their interest and availability. We will also explain the process, timelines, potential additional requirements (e.g., confidentiality agreements), and answer any questions you may have. If you have any questions about this opportunity, please email [email protected].

Parallel Review with Centers for Medicare and Medicaid Services (CMS)

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:

1. FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the Early Payor Feedback Program or other mechanism.
2. 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 [email protected] 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;
• Regulatory history (if applicable) detailing the previous FDA interactions and submission, including feedback received and resolution of that feedback, as applicable.  All relevant submission numbers should be included; 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:

1. The manufacturer intends to meet jointly with FDA and CMS using FDA's Q-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.
2. The medical device will require an original or supplemental application for premarket approval (PMA) or the granting of a de novo request;
3. The medical device is far enough along in its development (e.g. indications for use nearly final) to determine if it 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 (e.g. Diagnostic Test, Prosthetic Device) into which the manufacturer believes the medical device falls, including a justification; and
4. 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 [email protected].

AMA Coding Questions

The reimbursement process typically includes three separate elements: coding, coverage, and payment.

The American Medical Association (AMA) is responsible for the Current Procedural Terminology (CPT®), which is part of the coding process and offers doctors and health care providers a uniform language for coding medical services and procedures.

The CDRH Payor Communication Task Force may be able to help sponsors with coding questions. Please email CDRH Payor Communications with your specific question, and if your question falls under the purview of the American Medical Association (AMA), we will put you in contact with them. For more information about the AMA and coding, please visit the AMA website.

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Related Links

• New Program with Payors Aims to Accelerate Patient Access to Medical Devices, FDA Voices by Commissioner Scott Gottlieb, September 5, 2018
• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers Guidance for Industry and Review Staff (June 2018)
• Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care (June 2018)
• FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers (11/30/2017)
• Federal Register: Program for Parallel Review of Medical Devices (10/24/2016)
• Federal Register: Request for Expressions of Interest From Coverage Organizations; Coverage Organizations Interested in Providing Input Regarding Private Payer Coverage to Medical Device Sponsors Who Request Their Participation in a Pre-Submission Meeting With the Food and Drug Administration (2/24/2016)
• FDA approves first non-invasive DNA screening test for colorectal cancer (8/11/2014)