[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]
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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.
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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 [email protected] 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, [email protected].
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 [email protected] 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