81 FR 9203 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 36 (February 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 36 (February 24, 2016)
| Page Range | 9203-9204 | |
| FR Document | 2016-03909 |
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)] [Notices] [Pages 9203-9204] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices 9203
assumptions used; (3) ways to enhance Outcomes Evaluation Survey for submitting written documentation to the
the quality, utility, and clarity of the Graduates of the FDA Commissioner’s Agency and lessen the likelihood of
information to be collected; and (4) Fellowship Program (OMB Control surveys being misrouted within the
ways to minimize the burden of the Number 0910–NEW) Agency mail system. It will assist the
collection of information on Collecting outcomes information from Agency in promoting and protecting the
respondents, including through the use the CFP graduates will allow FDA’s public health by encouraging outside
of automated collection techniques, Office of the Commissioner to easily and persons to share their experience with
when appropriate, and other forms of efficiently elicit and review information the FDA while a Commissioner’s
information technology. from the CFP graduates needed to Fellow.
collect program feedback. The process FDA estimates the burden of this
will reduce the time and cost of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
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 organizations, health technology I. Background
number of fellows who that have assessment groups and various
The mission of CDRH is to protect and
graduated and left the Agency over the organizations that evaluate clinical
promote public health. This is
past 5 years. evidence and make coverage
accomplished in part by fulfilling its
Dated: February 18, 2016. recommendations to and decisions for
vision that patients in the U.S. have
Leslie Kux, private payers and health plans. The
access to safe and effective high quality
Associate Commissioner for Policy.
Center for Devices and Radiological
medical devices of public health
Health (CDRH) is taking this step to
[FR Doc. 2016–03791 Filed 2–23–16; 8:45 am] importance first in the world.
assist sponsors in identifying such
BILLING CODE 4164–01–P
organizations and soliciting clinical trial In the September 17, 2010, Federal
design or other evidence-gathering input Register notice (75 FR 57045), the
from them. Centers for Medicare and Medicaid
DEPARTMENT OF HEALTH AND Services (CMS) and FDA introduced
HUMAN SERVICES If coverage organizations express Parallel Review, which is intended to
interest, FDA intends to provide a reduce the time between FDA marketing
Food and Drug Administration mechanism for such organizations to approval or clearance and CMS’s
identify themselves so that medical National Coverage Determinations
[Docket No. FDA–2012–D–0530]
device sponsors who would like to (NCDs). As part of that program,
Request for Expressions of Interest obtain coverage input can voluntarily sponsors met with FDA and CMS at
From Coverage Organizations; contact them to participate in a FDA various times, to discuss the type of
Coverage Organizations Interested in Pre-Submission meeting. Early input clinical evidence that would support
Providing Input Regarding Private from payers regarding their evidentiary positive decisions by each agency. The
Payer Coverage to Medical Device needs can streamline the process from Parallel Review process improves the
Sponsors Who Request Their FDA approval or clearance to payer public health and quality of patient care
Participation in a Pre-Submission coverage and improve public health by by facilitating earlier access to
Meeting With the Food and Drug facilitating earlier access to innovative, innovative medical devices for Medicare
Administration safe, and effective medical devices. beneficiaries. Based in part on the
DATES: This notice will be effective lessons learned from the Parallel Review
AGENCY: Food and Drug Administration,
HHS. February 24, 2016. program and from Pre-Submission
ADDRESSES: Expressions of interest meetings involving CMS, FDA found
ACTION: Notice; request for expressions
should be emailed to CDRH- that early input from payers regarding
of interest.
Innovation@fda.hhs.gov and contain the their evidentiary needs can streamline
SUMMARY: The Food and Drug subject line ‘‘Expression of Interest in the process from FDA approval or
Administration (FDA) is requesting Providing Input Regarding Private Payer clearance to payer coverage.
expressions of interest from Coverage to Medical Device Sponsors.’’ CDRH wishes to facilitate the
organizations that evaluate clinical The body of the email should contain voluntary inclusion, by sponsors in
evidence used to support private payer your organization’s name, email, and their Pre-Submission meetings, of those
coverage decisions for medical devices mailing address. organizations that evaluate clinical
(coverage organizations) that wish to evidence used to support private payer
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with NOTICES
provide input to medical device coverage determinations for medical
CDRH Innovation, Center for Devices
developers (sponsors) on clinical trial devices (coverage organizations), so that
and Radiological Health, Food and Drug
design or other plans for gathering sponsors can obtain early input from
Administration, 10903 New Hampshire
clinical evidence needed to support both FDA and private payers, and plan
Ave., Bldg. 66, Rm. 5410, Silver Spring,
positive coverage decisions. These accordingly. The communications
MD 20993–0002, CDRH-Innovation@
coverage organizations include third- within the scope of this notice consist
fda.hhs.gov.
party commercial health insurance of input from coverage organizations to
organizations, payer/provider SUPPLEMENTARY INFORMATION: sponsors on clinical trial design or other
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![9204 Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
plans for gathering clinical evidence therapies and the associated costs of facilitate sponsor communication with
needed to support positive coverage those therapies, are often not fully coverage organizations that make
decisions. It is not intended to include collected. If the sponsor subsequently private coverage determinations in a
sponsors’ communications of clinical learns that these data are needed for manner that would promote the public
evidence to coverage organizations. coverage determinations, even if the health (Ref. 1). FDA is requesting that
These coverage organizations include data exist, it may be difficult to collect organizations that evaluate clinical
third-party commercial health insurance and analyze retrospectively, years after evidence used to support private payer
organizations, payer/provider the pivotal clinical study was initiated. decisions for medical devices, and that
organizations, health technology It is similarly challenging to conduct an may be interested in communicating to
assessment groups and various other additional clinical trial after FDA device sponsors about the evidence
organizations that evaluate clinical approval or clearance designed only to
needed to support positive coverage
evidence and make coverage meet a payer’s needs. Either situation
recommendations to and decisions for can result in delays to coverage and determinations, send an email to CDRH-
private payers and health plans. broad patient access, with negative Innovation@fda.hhs.gov to express
Timely access to innovative medical implications for the public health. interest. The subject line of the email
devices has been a significant issue in Further, it may be difficult for should state: ‘‘Expression of Interest in
the delivery of high quality health care. sponsors to identify and engage with Providing Input Regarding Private Payer
Generally, access to medical devices coverage organizations, and as a result, Coverage to Medical Device Sponsors.’’
first requires FDA approval or clearance sponsors may not consider the The body of the email should contain
for marketing, and, for broad patient evidentiary needs of coverage the organization’s name, email, and
access to innovative devices, coverage organizations when planning their mailing address. If necessary, we may
by payers. In this context, a ‘‘payer’’ pivotal clinical study. follow up with organizations that
refers to those organizations that may If coverage organizations express respond solely to clarify their
provide both coverage and interest, CDRH intends to create a identifying information.
reimbursement for the use of a medical mechanism for such organizations to
identify themselves so medical device Additional information may also be
device within a variety of clinical
settings. They are generally third-party sponsors who would like to obtain posted on the CDRH Payer
commercial health insurance coverage input can voluntarily contact Communication Task Force Web site.
companies, health plans, payer-provider them to participate in an FDA Pre- For general questions or concerns,
organizations, and others. Submission meeting. CDRH intends to contact CDRH Innovation at the email
Without proper planning, medical list interested coverage organizations on listed in the FOR FURTHER INFORMATION
device sponsors developing innovating its Web site. Sponsors who voluntarily CONTACT section of this document.
devices might encounter delays or meet with coverage organizations early
III. Reference
barriers to payer coverage. Development in the device development process may
of medical devices often occurs in a obtain the information to initially The following reference has been
sequential manner, whereby the sponsor design a clinical trial that can capture placed on display in the Division of
initially interacts with FDA to both the data necessary for FDA Dockets Management (see ADDRESSES),
determine whether or not clinical marketing clearance or approval and and may be seen by interested persons
evidence would be required in a that necessary to support a positive between 9 a.m. and 4 p.m., Monday
subsequent marketing application for payer coverage decision, to modify their
through Friday. (FDA has verified the
FDA approval or clearance. If clinical pivotal study to satisfy both sets of
Web site address, but we are not
data are required, the sponsor may requirements, or to develop other plans
further interact with FDA to develop the responsible for any subsequent changes
to collect the necessary data. This may
study protocol for the pivotal clinical help avoid delays to patient access that to the Web site address after this
trial. Next, the sponsor initiates and may result if clinical trials are document publishes in the Federal
conducts the clinical trial and then conducted, or data are collected, Register.)
submits that clinical evidence to FDA in sequentially when it could have been 1. FDA Guidance, ‘‘Requests for
a premarket submission. Lastly, the FDA done concurrently. Feedback on Medical Device
reviews the submission and issues a Sponsors are not required to include Submissions: The Pre-Submission
regulatory decision. It is after these a coverage organization in any Pre- Program and Meetings with Food and
steps have been completed that the Submission meeting. Coverage Drug Administration Staff.’’ Available at
sponsor may begin marketing the organizations are not required to submit http://www.fda.gov/downloads/
device; however, the clinical evidence expressions of interest in order to be MedicalDevices/DeviceRegulationand
sufficient for marketing the device is not included in a Pre-Submission meeting. Guidance/GuidanceDocuments/
always the same as that needed to The regulatory and evidentiary UCM311176.pdf.
support payer coverage decisions. standards FDA uses for decisionmaking
Payer evidentiary requirements for would not change; under any review Dated: February 18, 2016.
coverage depend on the payer. In some scenario, FDA would continue to make Leslie Kux,
cases, payers may make their own its decisions under its authority and Associate Commissioner for Policy.
independent coverage decisions. In with its own standards, independent of [FR Doc. 2016–03909 Filed 2–23–16; 8:45 am]
other cases, payers may rely on Health the coverage organization’s input. BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Technology Assessments (HTAs)
conducted by others, including CMS. II. Expression of Interest by Coverage
While some clinical evidence Organizations
developed in a pivotal clinical trial CDRH’s Pre-Submission program, by
undertaken to support FDA approval or providing a forum to support
clearance could support payer coverage communication with sponsors prior to
decisions, outcome endpoints needed the finalization of their clinical trial
by payers, such as comparison to other design, serves as a potential tool to
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Document Created: 2016-02-23 23:55:35
Document Modified: 2016-02-23 23:55:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for expressions of interest. | |
| Dates | This notice will be effective February 24, 2016. | |
| 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- [email protected] | |
| FR Citation | 81 FR 9203 |
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