
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Pages 9203-9204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03909]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for expressions of interest.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
expressions of interest from organizations that evaluate clinical 
evidence used to support private payer coverage decisions for medical 
devices (coverage organizations) that wish to provide input to medical 
device developers (sponsors) on clinical trial design or other plans 
for gathering clinical evidence needed to support positive coverage 
decisions. These coverage organizations include third-party commercial 
health insurance organizations, payer/provider organizations, health 
technology assessment groups and various organizations that evaluate 
clinical evidence and make coverage recommendations to and decisions 
for private payers and health plans. The Center for Devices and 
Radiological Health (CDRH) is taking this step to assist sponsors in 
identifying such organizations and soliciting clinical trial design or 
other evidence-gathering input from them.
    If coverage organizations express interest, FDA intends to provide 
a mechanism for such organizations to identify themselves so that 
medical device sponsors who would like to obtain coverage input can 
voluntarily contact them to participate in a FDA Pre-Submission 
meeting. Early input from payers regarding their evidentiary needs can 
streamline the process from FDA approval or clearance to payer coverage 
and improve public health by facilitating earlier access to innovative, 
safe, and effective medical devices.

DATES: This notice will be effective February 24, 2016.

ADDRESSES: Expressions of interest should be emailed to CDRH-Innovation@fda.hhs.gov and contain the subject line ``Expression of 
Interest in Providing Input Regarding Private Payer Coverage to Medical 
Device Sponsors.'' The body of the email should contain your 
organization's name, email, and mailing address.

FOR FURTHER INFORMATION CONTACT: CDRH Innovation, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5410, Silver Spring, MD 20993-0002, CDRH-Innovation@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The mission of CDRH is to protect and promote public health. This 
is accomplished in part by fulfilling its vision that patients in the 
U.S. have access to safe and effective high quality medical devices of 
public health importance first in the world.
    In the September 17, 2010, Federal Register notice (75 FR 57045), 
the Centers for Medicare and Medicaid Services (CMS) and FDA introduced 
Parallel Review, which is intended to reduce the time between FDA 
marketing approval or clearance and CMS's National Coverage 
Determinations (NCDs). As part of that program, sponsors met with FDA 
and CMS at various times, to discuss the type of clinical evidence that 
would support positive decisions by each agency. The Parallel Review 
process improves the public health and quality of patient care by 
facilitating earlier access to innovative medical devices for Medicare 
beneficiaries. Based in part on the lessons learned from the Parallel 
Review program and from Pre-Submission meetings involving CMS, FDA 
found that early input from payers regarding their evidentiary needs 
can streamline the process from FDA approval or clearance to payer 
coverage.
    CDRH wishes to facilitate the voluntary inclusion, by sponsors in 
their Pre-Submission meetings, of those organizations that evaluate 
clinical evidence used to support private payer coverage determinations 
for medical devices (coverage organizations), so that sponsors can 
obtain early input from both FDA and private payers, and plan 
accordingly. The communications within the scope of this notice consist 
of input from coverage organizations to sponsors on clinical trial 
design or other

[[Page 9204]]

plans for gathering clinical evidence needed to support positive 
coverage decisions. It is not intended to include sponsors' 
communications of clinical evidence to coverage organizations. These 
coverage organizations include third-party commercial health insurance 
organizations, payer/provider organizations, health technology 
assessment groups and various other organizations that evaluate 
clinical evidence and make coverage recommendations to and decisions 
for private payers and health plans.
    Timely access to innovative medical devices has been a significant 
issue in the delivery of high quality health care. Generally, access to 
medical devices first requires FDA approval or clearance for marketing, 
and, for broad patient access to innovative devices, coverage by 
payers. In this context, a ``payer'' refers to those organizations that 
may provide both coverage and reimbursement for the use of a medical 
device within a variety of clinical settings. They are generally third-
party commercial health insurance companies, health plans, payer-
provider organizations, and others.
    Without proper planning, medical device sponsors developing 
innovating devices might encounter delays or barriers to payer 
coverage. Development of medical devices often occurs in a sequential 
manner, whereby the sponsor initially interacts with FDA to determine 
whether or not clinical evidence would be required in a subsequent 
marketing application for FDA approval or clearance. If clinical data 
are required, the sponsor may further interact with FDA to develop the 
study protocol for the pivotal clinical trial. Next, the sponsor 
initiates and conducts the clinical trial and then submits that 
clinical evidence to FDA in a premarket submission. Lastly, the FDA 
reviews the submission and issues a regulatory decision. It is after 
these steps have been completed that the sponsor may begin marketing 
the device; however, the clinical evidence sufficient for marketing the 
device is not always the same as that needed to support payer coverage 
decisions.
    Payer evidentiary requirements for coverage depend on the payer. In 
some cases, payers may make their own independent coverage decisions. 
In other cases, payers may rely on Health Technology Assessments (HTAs) 
conducted by others, including CMS.
    While some clinical evidence developed in a pivotal clinical trial 
undertaken to support FDA approval or clearance could support payer 
coverage decisions, outcome endpoints needed by payers, such as 
comparison to other therapies and the associated costs of those 
therapies, are often not fully collected. If the sponsor subsequently 
learns that these data are needed for coverage determinations, even if 
the data exist, it may be difficult to collect and analyze 
retrospectively, years after the pivotal clinical study was initiated. 
It is similarly challenging to conduct an additional clinical trial 
after FDA approval or clearance designed only to meet a payer's needs. 
Either situation can result in delays to coverage and broad patient 
access, with negative implications for the public health.
    Further, it may be difficult for sponsors to identify and engage 
with coverage organizations, and as a result, sponsors may not consider 
the evidentiary needs of coverage organizations when planning their 
pivotal clinical study.
    If coverage organizations express interest, CDRH intends to create 
a mechanism for such organizations to identify themselves so medical 
device sponsors who would like to obtain coverage input can voluntarily 
contact them to participate in an FDA Pre-Submission meeting. CDRH 
intends to list interested coverage organizations on its Web site. 
Sponsors who voluntarily meet with coverage organizations early in the 
device development process may obtain the information to initially 
design a clinical trial that can capture both the data necessary for 
FDA marketing clearance or approval and that necessary to support a 
positive payer coverage decision, to modify their pivotal study to 
satisfy both sets of requirements, or to develop other plans to collect 
the necessary data. This may help avoid delays to patient access that 
may result if clinical trials are conducted, or data are collected, 
sequentially when it could have been done concurrently.
    Sponsors are not required to include a coverage organization in any 
Pre-Submission meeting. Coverage organizations are not required to 
submit expressions of interest in order to be included in a Pre-
Submission meeting. The regulatory and evidentiary standards FDA uses 
for decisionmaking would not change; under any review scenario, FDA 
would continue to make its decisions under its authority and with its 
own standards, independent of the coverage organization's input.

II. Expression of Interest by Coverage Organizations

    CDRH's Pre-Submission program, by providing a forum to support 
communication with sponsors prior to the finalization of their clinical 
trial design, serves as a potential tool to facilitate sponsor 
communication with coverage organizations that make private coverage 
determinations in a manner that would promote the public health (Ref. 
1). FDA is requesting that organizations that evaluate clinical 
evidence used to support private payer decisions for medical devices, 
and that may be interested in communicating to device sponsors about 
the evidence needed to support positive coverage determinations, send 
an email to CDRH-Innovation@fda.hhs.gov to express interest. The 
subject line of the email should state: ``Expression of Interest in 
Providing Input Regarding Private Payer Coverage to Medical Device 
Sponsors.'' The body of the email should contain the organization's 
name, email, and mailing address. If necessary, we may follow up with 
organizations that respond solely to clarify their identifying 
information.
    Additional information may also be posted on the CDRH Payer 
Communication Task Force Web site. For general questions or concerns, 
contact CDRH Innovation at the email listed in the FOR FURTHER 
INFORMATION CONTACT section of this document.

III. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES), and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has 
verified the Web site address, but we are not responsible for any 
subsequent changes to the Web site address after this document 
publishes in the Federal Register.)
    1. FDA Guidance, ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff.'' Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.

    Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03909 Filed 2-23-16; 8:45 am]
BILLING CODE 4164-01-P


