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Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force

A hand filling out a medical insurance claim form, with a stethoscope and calculator laying nearby.

Access to safe and effective medical devices for many patients can depend on insurance coverage in addition to FDA market authorization for the device. The FDA’s Center for Devices and Radiological Health (CDRH) established the Payor Communication Task Force to facilitate communication between device manufacturers and insurers, also known as payors, to potentially shorten the time between FDA marketing authorization and coverage decisions, which may expedite patient access. The Payor Communication Task Force activities related to medical device coverage include the Early Payor Feedback Program (EPFP), and Parallel Review with the Centers for Medicare & Medicaid Services. For more information on these programs and other helpful information, please see below.


Medical Device Coverage and the FDA

FDA’s principal role in medical device coverage is to evaluate the safety and effectiveness of medical devices for use in the United States. In general, after the FDA’s approval or clearance of a device, other organizations—for example, payors and the professionals who provide health care (providers)—decide whether to cover, pay for, use, or recommend a device. 

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

Data that medical device manufacturers submit to FDA to demonstrate the safety and effectiveness of a medical device may not always overlap with the data needed by payors to make coverage determinations. As a result, there may be a delay or denial in coverage, payment, and use of a device after it has been approved or cleared. Some decisions may ultimately delay patient access to medical devices. By communicating with payors early, manufacturers may be able to design their clinical trials to produce the data required for regulatory authorization and for positive coverage determinations, which may expedite patient access. Not only do patients and manufacturers benefit from this approach, but also payors benefit as it allows them to horizon-scan and be better prepared for novel medical devices in the pipeline. 

For questions or additional information, email CDRHPayorCommunications@fda.hhs.gov.

Opportunities for Manufacturers to Obtain Payor Input

The Early Payor Feedback Program (EPFP) – All Payors

CDRH provides a voluntary opportunity for medical device manufacturers to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support coverage decisions. Coverage organizations willing to join CDRH meetings with medical device manufacturers or meet directly with manufacturers outside of CDRH meetings are listed below. All regulatory discussions occurring at CDRH-led meetings will continue to follow the processes established within the CDRH Q-Submission Program.

CDRH welcomes coverage organizations responsible for evaluating clinical evidence and making coverage recommendations or decisions for medical devices to contact CDRH to participate in this program.

List of Payor Organizations Participating in the Early Payor Feedback Program (EPFP):

NOTE: This is a voluntary opportunity for both medical device manufacturers and coverage organizations. The decision of a medical device manufacturer to participate or not to participate in the Early Payor Feedback Program will not alter the regulatory and evidentiary standards the 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.

Highmark Blue Shield has a Coverage with Evidence Development (CED) medical policy and process that may provide an opportunity to potentially accelerate patient access to innovative, high-quality medical devices.  More information can be found here

How Manufacturers Can Apply to the Early Payor Feedback Program (EPFP)

Medical device manufacturers interested in obtaining payor feedback through the EPFP may email CDRHEarlyPayorFeedbackProgram@fda.hhs.gov. When submitting the request, please complete this document, using only publicly available information. This document will be shared with the payor organizations selected by the manufacturer to gauge their interest. 

After receiving the request, CDRH will work with the selected organizations to confirm their interest and availability. Early inquiries allow time for the participating organizations to consider the request and to prepare for the meeting. 

Manufacturers may request that payor feedback occur in either an independent meeting with the coverage organization or in an FDA Q-Submission meeting attended by the organization. To request feedback in a Q-Submission meeting, the request is best received prior to submitting the Q-Submission to CDRH.1

If needed, CDRH will set up a call to explain the process, timelines, and potential additional requirements (for example, confidentiality agreements) and answer any questions. Any questions about the EPFP should be emailed to CDRHEarlyPayorFeedbackProgram@fda.hhs.gov.

Parallel Review with the Centers for Medicare & Medicaid Services (CMS)

In 2011, the FDA and CMS introduced the Parallel Review Pilot Program (Parallel Review), which established a mechanism for the FDA and CMS to simultaneously review the pivotal clinical data to help decrease the time between the 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 would be fully implemented and extended indefinitely. Please note, Parallel Review does not address questions regarding coding or payment.

Parallel Review has two stages, the first of which should be completed prior to formally applying:

  1. The FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial design within the Early Payor Feedback Program or other mechanism.
  2. The FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the Premarket Approval application (PMA) or De Novo classification request.

The 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 for Parallel Review

Manufacturers interested in requesting Parallel Review should submit an email to Parallel-Review@fda.hhs.gov, indicating interest in the program and including the following:

  • Name of the manufacturer/requester and relevant contact information;
  • Device name, and proposed indications for use/intended use;
  • Device description including stage of development;
  • Regulatory history (if applicable) detailing the previous FDA interactions and submissions, including feedback received and resolution of that feedback, as applicable. All relevant submission numbers should be included; 
  • History of CMS interactions (see stage 1 above), and
  • Brief statement explaining why the device is an appropriate candidate for Parallel Review (be sure to address each of the five criteria outlined below).

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

  1. The manufacturer met jointly with the FDA and CMS using FDA's Early Payor Feedback Program or other mechanism that allowed the manufacturer to receive feedback on the proposed pivotal clinical trial design.  
  2. The manufacturer incorporated CMS feedback regarding the design and analysis of the pivotal clinical trial to support an NCD;
  3. The medical device requires an original or supplemental application for Premarket Approval application (PMA) or the granting of a De Novo classification request;
  4. The medical device is far enough along in its development (for example, indications for use are 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 (for example, Diagnostic Test, Prosthetic Device) into which the manufacturer believes the medical device falls, including a justification*; and
  5. The medical device addresses the public health needs of the Medicare population (and the request for Parallel Review includes an explanation of how).

*For additional information on benefit categories, please see CMS’ final rule issued on December 28, 2021 (86 FR 73860).  

The FDA intends to respond by email to all requests within 30 calendar days and may contact the manufacturer/requestor for additional information.

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

Current Procedural Terminology (CPT) 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 for many devices, and offers clinicians and health care providers a uniform language for coding medical services and procedures.

The CDRH Payor Communication Task Force may be able to help connect medical device manufacturers with the AMA to address coding questions. Please email CDRHPayorCommunications@fda.hhs.gov with your specific question. For more information about the AMA and coding, visit the AMA’s CPT Overview and Code Approval page.

Frequently Asked Questions

General

Q: Why is CDRH encouraging manufacturers to communicate with payors?
A:
We are aware that for patient access to medical devices, devices may need to be a covered benefit by insurance, which is not always the case, especially for new and innovative medical devices. By facilitating manufacturer communication with payors, manufacturers can learn what data may be needed for a positive coverage decision, and make plans to collect that data, potentially while they are collecting the data needed for market authorization. Gathering the data needed for a positive coverage decision earlier may expedite patient access to innovative medical devices.

Q: How does CDRH define payor?
A: CDRH defines payor broadly to include traditional health insurance companies, governmental agencies that pay for health care, and health technology assessment groups, as well as others who provide input into insurance coverage, procurement, and reimbursement decisions.

Early Payor Feedback Program

Q: Which manufacturers are eligible for the Early Payor Feedback Program (EPFP)?
A:
The Early Payor Feedback Program is intended to potentially shorten the time between FDA marketing authorization and coverage decisions by connecting sponsors with payors prior to finalizing their clinical trial/data collection plans. This allows the sponsor the opportunity to incorporate payor feedback in their evidence generation strategy to support both market authorization and positive coverage determinations. As such, sponsors of devices that have not received a required FDA marketing authorization and would like to connect with payors prior to finalizing data collection plans are eligible for the Early Payor Feedback Program. If a legally marketed device is modified and requires a new marketing submission and the generation of new evidence, then that new version of that device may also be eligible to apply.  However, a currently legally marketed device is not eligible to be part of the program, unless, resources permitting, there is an absence or limited coverage for the legally marketed device due to lack of supportive evidence for a positive coverage determination. Devices enrolled in the Total Product Life Cycle Advisory Program (TAP) Pilot are also eligible to apply. If you have questions related to eligibility, please reach out to the Early Payor Feedback Program (EPFP) at CDRHEarlyPayorFeedbackProgram@fda.hhs.gov.

Q: Are manufacturers of Digital Health devices eligible to apply?
A:
Yes, digital health devices are eligible to apply, provided they meet the criteria listed above.  For more information and resources about FDA’s regulation of digital health devices, please visit the Digital Health Center of Excellence page.

Q: When is the best time to utilize the Early Payor Feedback Program (EPFP)?
A:
CDRH recommends manufacturers contact us when they are planning their pivotal clinical trial, or even sooner. It is helpful to have a proposal ready for payor comments.

Q: How is the Early Payor Feedback Program (EPFP) different from Parallel Review?
A:
The EPFP can serve as the first step in Parallel Review. To help clarify for manufacturers the data CMS needs before submitting their file for Parallel Review, manufacturers can meet with CMS to learn what evidence CMS would like to see. This meeting can happen through the EPFP, or by another mechanism such as contacting CMS independently. 

Q: What is the most frequent impact of manufacturer-payor interactions through the Early Payor Feedback Program (EPFP)? 
A:
These interactions have either confirmed the manufacturer’s general approach or led them to modify study designs, include additional endpoints, alter patient inclusion/exclusion criteria, add clinical trial sites, capture health economic data, and capture real-world data, among other changes. 

Q: How many requests have been matched with a payor through the Early Payor Feedback Program (EPFP)?
A:
As of June 2024, 140 requests have been matched with payors under the EPFP.

Q: As a direct result of this program, how many Q-Submission meetings have included payors?
A:
As of June 2024, 13 Q-Submission meetings have included payors that the manufacturer was introduced to through the Early Payor Feedback Program (EPFP). Since not every manufacturer uses the Q-Submission program, many manufacturers meet with payors in meetings without CDRH present. As of June 2024, there have been 399 unique manufacturer -payor interactions as most manufacturers opt to work with more than one payor.

Q: Do you count one-off meetings as successes?
A:
Yes. CDRH considers it beneficial any time a medical device manufacturer learns what data may be needed for a positive coverage decision before they start a clinical trial.

Q: Have any manufacturers not been matched?
A:
As of June 2024, six manufacturers did not solicit an interested payor. Because participation in the program is completely voluntary for payors, there may be occasions when payors may not be able to, or want to, comment on a manufacturer’s data collection plan.

Q: My device has a Breakthrough designation. Can payors join the “sprint” interactions?
A:
Yes, please reach out to the Early Payor Feedback Program at CDRHEarlyPayorFeedbackProgram@fda.hhs.gov for more information.  Additional information on the Breakthrough Program can be found on the FDA website.  

Q: Do I need to reach out to the Early Payor Feedback Program (EPFP) each time I want to talk with a payor?
A:
Once you have the payor’s contact information, you can reach out to them directly to discuss the possibility of ongoing interactions. If you have a new device that you would like payor feedback on, please reach out to the EPFP to start the process again for the new device.

Q: How does the Early Payor Feedback Program (EPFP) differ from the TAP Pilot?
A:
Both programs are intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world. EPFP is an established program that provides the opportunity for manufacturers to meet with payors. The Total Product Life Cycle Program Advisory Program (TAP) Pilot is a new program implemented under the Medical Device User Fee Amendments for FY 2023 – FY 2027 (MDUFA V). The TAP Pilot is intended to facilitate improved strategic decision-making and better align expectations regarding evidence generation during device development, including through facilitating interactions between TAP participants and stakeholders, including payors. TAP also offers additional types of interactions with payors and/or coding, coverage, and payment subject matter experts to inform a TAP sponsor’s reimbursement strategy early in device development. The TAP Pilot launched in January 2023, and a subset of breakthrough designated devices are currently able to participate in TAP. More information on the TAP Pilot can be found on the FDA website. 

Q:  I’m a payor and I want to join. Is this possible?
A:
We have an open call for payors to join the EPFP. Please email us at CDRHPayorCommunications@fda.hhs.gov for more information on how to join.    

Q: How do payors benefit from participating in the Early Payor Feedback Program (EPFP)?
A:
Payors that participate in EPFP learn about new technologies sooner, have the opportunity to improve data they will ultimately review and have greater visibility to the landscape of treatments for a given condition.   

Q: Will participating in the Early Payor Feedback Program (EPFP) impact the FDA’s review timelines?
A:
No, device marketing submissions will continue to follow the Medical Device User Fee Amendments (MDUFA) established review timelines. Participation in EPFP does not lengthen or shorten the applicable review clock.

Parallel Review 

Q: How many requests have been received for Parallel Review?
A:
As of June 2024, there have been 97 formal requests to participate in Parallel Review.

Q: How many devices have completed Parallel Review?
A:
Two devices have completed Parallel Review: Exact Sciences’ Cologuard in 2014, and Foundation Medicine’s FoundationOne CDx in 2017.

Q: How much time did the companies save by using Parallel Review?
A:
It is estimated that the NCD process typically takes 6-9 months. Cologuard received its FDA approval and the proposed NCD opened on August 11, 2014. The NCD was finalized on October 9, 2014, just under 2 months after the proposed NCD opened. FoundationOne CDx received its FDA approval and the proposed NCD opened on November 30, 2017. The NCD was finalized on March 18, 2018, about 3.5 months after the proposed NCD opened.

Related Links


1https://www.fda.gov/media/114034/download

 

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