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, 9203-9204 [2016-03909]
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9203
Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Outcomes Evaluation Survey for
Graduates of the FDA Commissioner’s
Fellowship Program (OMB Control
Number 0910–NEW)
Collecting outcomes information from
the CFP graduates will allow FDA’s
Office of the Commissioner to easily and
efficiently elicit and review information
from the CFP graduates needed to
collect program feedback. The process
will reduce the time and cost of
submitting written documentation to the
Agency and lessen the likelihood of
surveys being misrouted within the
Agency mail system. It will assist the
Agency in promoting and protecting the
public health by encouraging outside
persons to share their experience with
the FDA while a Commissioner’s
Fellow.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Fellowship Program Survey .....................................
10
1
10
0.50 (30 minutes) ......
5
1 The
capital costs or operating and maintenance costs associated with this collection of information is $300 annually.
FDA based these estimates on the
number of fellows who that have
graduated and left the Agency over the
past 5 years.
Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03791 Filed 2–23–16; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice; request for expressions
of interest.
ACTION:
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 thirdparty commercial health insurance
organizations, payer/provider
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:54 Feb 23, 2016
Jkt 238001
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 CDRHInnovation@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:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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
E:\FR\FM\24FEN1.SGM
24FEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
9204
Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
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
VerDate Sep<11>2014
17:59 Feb 23, 2016
Jkt 238001
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 PreSubmission 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 PreSubmission 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.
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 CDRHInnovation@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
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/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
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 9990
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[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 https://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
