[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Notices]
[Pages 57045-57048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

Food and Drug Administration

[Docket No. FDA-2010-N-0308]


Parallel Review of Medical Products

AGENCIES: Centers for Medicare and Medicaid Services; Food and Drug 
Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) and the Centers for 
Medicare and Medicaid Services (CMS) are considering establishing a 
process for overlapping evaluations of premarket, FDA-regulated medical 
products when the product sponsor and both agencies agree to such 
parallel review. This process will serve the public interest by 
reducing the time between FDA marketing approval or clearance decisions 
and CMS national coverage determinations (NCDs). The agencies are 
establishing a docket to receive information and comment from the 
public on what products would be appropriate for parallel review by the 
two agencies, what procedures should be developed, how a parallel 
review process should be implemented, and other issues related to the 
effective operation of the process. The agencies are also announcing 
their intent to create a pilot program for parallel review of medical 
devices. The pilot program will begin after both agencies have reviewed 
the public comments on this notice. A memorandum of understanding (MOU) 
concerning the exchange of data and information has been completed 
between the two agencies. See http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm217585.htm.

DATES: Submit either electronic or written comments by December 16, 
2010.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    General questions about parallel review: Peter Beckerman, Office of 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-4830, e-mail: 
peter.beckerman@fda.hhs.gov, or Tamara Syrek Jensen, Centers for 
Medicare and Medicaid Services, 7500 Security Blvd., Baltimore, MD 
21244, e-mail: Tamara.Syrekjensen@cms.hhs.gov.
    For device sponsors interested in requesting voluntary parallel 
review: Markham C. Luke, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-5550, e-mail: markham.luke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA and CMS share a common interest in improving the health of 
patients through the availability of safe, effective, and affordable 
medical products and fostering medical product innovations.
    The mission of the FDA is to protect and promote the public health. 
It accomplishes this task, in part, by the following:
     Assuring the safety, efficacy, and quality of human drugs, 
biological products, and medical devices;
     Fostering innovations to make medical products safer and 
more effective; and
     Helping health care providers and the public get the 
accurate, science-based information they need to use medical products 
to improve public health.
    The mission of CMS is to ensure effective, up-to-date Medicare 
coverage and to promote the continual improvement of the quality care 
for its beneficiaries. CMS accomplishes this mission by continuing to 
transform and modernize America's health care system, in part, by the 
following:
     Fostering accurate and predictable payments,
     Ensuring high-value health care,
     Promoting understanding of CMS programs among 
beneficiaries, the health care community, and the public.
    Through coordinated decisions regarding medical products, FDA and 
CMS can affect public health in critical ways: FDA in determining the 
safety and effectiveness of those products and CMS in providing 
beneficial coverage and appropriate payment for covered items and 
services involving those products. Both agencies believe they should 
address the growing need to improve public health by speeding consumer 
access to and spurring the development of new, affordable, reliable, 
safer, and more effective medical products and services. FDA and

[[Page 57046]]

CMS are working together to identify areas in which they can 
collaborate to achieve these goals and parallel review provides one 
such opportunity.

A. Innovative Medical Products are Difficult to Develop

    The recent boom in new basic science discoveries has generated hope 
for the development of new treatments and diagnostics for serious 
illnesses. However, there is concern as to whether there are adequate 
resources available for bringing the most innovative medical devices to 
market. The number of new drug and biologic applications submitted to 
FDA has been declining for several years for reasons not wholly clear. 
Inefficiencies and rising costs appear to account for only part of the 
reluctance to embark on new medical product development. The limited 
predictability of market access may also hinder investment in the 
development of innovative therapies and diagnostics. Reducing the time 
between marketing approval or clearance and obtaining third party 
payment (``approval-to-payment'' time) can produce savings for sponsors 
and improve public health through overlapping medical review of data/
evidence leading to more timely patient access to those new products.
    Currently, medical product development and coverage and payment of 
new therapies and diagnostics generally occur in a serial manner. 
First, a new medical product is submitted to FDA, which determines 
whether it meets applicable safety and effectiveness standards for 
commercial marketing. Next, the company seeks coverage from the payer 
who in turn determines the payment rate for the product.
    Timely access to innovative medical technologies has been 
identified as a significant issue in the delivery of high quality 
health care. Manufacturers of innovative medical products have said 
that after undergoing the FDA approval process the availability of 
their products to consumers is often slow because, in order to obtain 
coverage and payment from third-party payers, the manufacturers must go 
through a second review process by such payers. This is in part because 
the materials submitted by manufacturers for FDA review are, for 
various reasons, not generally made available to third-party payers 
prior to FDA approval or clearance. In addition, the materials 
submitted by manufacturers to FDA may not adequately address the issues 
of importance to payers, such as community or home based use outside of 
clinical trial protocols, generalizability of the results to target 
populations that may have not been studied, and the incremental 
clinical utility of these products compared to currently available 
technologies.
    Although CMS is only one of many third-party payers and provides 
insurance benefits to select populations, the agency plays a leading 
role in healthcare through its coverage and payment decisions. Because 
many third-party payers tend to follow CMS' lead, a positive national 
coverage or payment decision by CMS often promotes rapid adoption of a 
new therapy by the medical community. However, a positive coverage 
decision after a long time lag following FDA approval or clearance can 
delay consumer access to new medical products.

B. Differences in FDA and CMS Review

    FDA premarket review and CMS national coverage determinations 
differ significantly. Each process operates under different statutory 
standards and each asks different questions to meet its respective 
mandates. The FDA premarket review generally assesses the safety and 
effectiveness of these medical products. Even within FDA's review 
processes, there are differences in types of evaluation depending upon 
the application under consideration (for example, premarket approval 
applications (PMAs) must meet standards different from premarket 
notifications (510(k)s)).
    CMS serves a different function by providing health insurance to 
protect the nation's aged and disabled persons from the substantial 
burdens of illness. Under section 1862(a)(1) of the Social Security Act 
(the Act), CMS makes determinations regarding the coverage of specific 
items and services. In short, CMS must make multiple decisions: It must 
decide what items and services it can and should pay for; how it should 
accomplish the payment; and how much to pay.
    CMS' evaluation of medical products depends on the type of request. 
For most NCDs, CMS evaluates whether a medical product or service is 
reasonable and necessary to diagnose or treat an illness or injury 
affecting the Medicare population. This evaluation includes review of 
appropriate outcomes data, such as whether the product provides 
improved, equivalent, or complementary health outcomes in the Medicare 
population as compared to alternative treatments or diagnostics already 
covered by the program. CMS may also evaluate medical product 
indications that have not been approved or cleared by FDA, so-called 
unapproved or off-label uses.

C. Parallel Review--Opportunity To Speed Patient Access To Beneficial 
Medical Products

    Under current practice, CMS does not routinely undertake an NCD 
unless it receives a complete formal external request. At times, CMS 
may also internally generate a request. Because local fiscal 
intermediaries, carriers, or Medicare Administrative Contractors are 
able to make decisions within their own jurisdictions, Medicare 
coverage and payment can occur in the absence of a NCD, such as from 
the initial market availability of a new technology.
    CMS usually begins its national coverage decision making process 
for FDA-regulated medical products after they have been approved or 
cleared by FDA. Because FDA does not approve or clear all the marketing 
applications it reviews, such serial processing ensures that CMS does 
not expend its limited resources assessing medical products that never 
reach the U.S. market. In addition, the CMS NCD process is subject to 
strict statutory time limits (9 to 12 months from the opening to 
publication of the final decision) that cannot be extended if a 
manufacturer should encounter an unexpected delay in obtaining FDA 
approval or clearance. However, this serial review process has been 
subject to criticism because it potentially causes delay in consumer 
access to beneficial medical products. Overlapping evaluations by FDA 
and CMS for innovative products could speed consumer access to those 
new products by reducing the time span between marketing approval or 
clearance decisions and national coverage/payment determinations.
    From time to time CMS finds that developers of new technology fail 
to recognize the differences between the regulatory requirements of FDA 
and CMS. They may undertake clinical studies that are designed to 
address FDA questions but do not adequately address CMS questions 
concerning the impact of the technology on Medicare beneficiary health 
outcomes. This omission can slow the developer's quest for Medicare 
coverage. We believe that a parallel review process can furnish an 
opportunity to educate developers regarding clinical study designs that 
are more likely to simultaneously address both FDA and CMS questions.
    To potentially accelerate consumer access to new, particularly 
innovative, safe and effective medical products, FDA and CMS intend to 
establish a process for parallel review. Parallel review could also 
create incentives for venture capitalists and companies to increase 
their investment in innovative

[[Page 57047]]

medical products by reducing the time to return on investment for those 
products eligible for parallel review.
    The agencies envision parallel review as a collaborative effort in 
which CMS will begin its NCD-related review process to determine 
whether the product is reasonable and necessary for the Medicare 
population while FDA is completing its premarket review. However, 
before developing and implementing such a process, the agencies believe 
that important issues must be resolved. For example, to avoid CMS 
reaching a coverage determination deadline before FDA has completed its 
review process and to minimize the possibility that CMS will begin its 
coverage process for a product that is subsequently not approved or 
cleared by FDA, the CMS process and FDA process should be carefully 
staged. FDA and CMS also seek comment on whether they should establish 
a voluntary process to allow companies to meet with both agencies to 
develop clinical trial protocols that would meet each agency's 
respective statutory standard rather than potentially conducting 
separate clinical studies.
    This notice provides the first opportunity for the public to 
comment on these issues. The public will have a second opportunity to 
provide input should the agencies subsequently issue, as they currently 
intend, a joint draft guidance or other appropriate documents, 
describing the proposed process. The agencies envision that the 
decision to undertake the parallel review process with respect to a 
specific product will be at the request of the manufacturer and with 
the agreement of both agencies, thus making the process voluntary for 
all parties involved. FDA would make its approval or clearance 
determination first because CMS would not ordinarily provide coverage 
to a product not approved or cleared by FDA for marketing in the United 
States. In addition, CMS has statutory requirements (for example, CMS 
must issue a proposed coverage decision memorandum for comment) that 
make it impossible for the issuance of an NCD simultaneous with an FDA 
approval or clearance.
    Parallel review would be a variation of the usual serial review 
process. Sponsors would be able to request use of this process in 
seeking an NCD. The regulatory standards and evidentiary standards used 
by FDA and CMS for decision-making would not change; under any review 
scenario, each agency would continue to make its decision under its 
respective authority and with its own standards, independent of the 
other. The sponsor requesting parallel review would be expected to meet 
the legal requirements, including data submission requirements, for 
both FDA premarket review or clearance and of an NCD request by CMS. 
Once formal procedures are developed, the agencies will work on making 
the data submissions efficient and nonduplicative with the intent of 
making parallel review less burdensome than if the sponsor went to each 
agency in serial fashion. Parallel review between the FDA and CMS would 
include only CMS coverage determination reviews and not any reviews of 
payment mechanisms.
    By means of this notice, we are opening a public comment docket to 
solicit comment from the public on the parallel review process. We are 
interested in comments on all aspects of the process as we have 
explained it, including what categories of products are most 
appropriate for such review, the timing of parallel review, what 
procedures should be developed, how such a review process should be 
implemented, and what efficiencies could be achieved. After reviewing 
the public comments, FDA and CMS intend to issue a joint draft guidance 
describing the parallel review process and the procedures each agency 
would use for its implementation.
    After review of the public comments on this notice, both agencies 
will consider a small number of requests from sponsors of innovative 
medical devices for parallel review on a pilot basis. (No new statutory 
authorities would be required to pursue such a pilot because FDA and 
CMS are continuing to comply with all aspects of current law.) The 
agencies will announce procedures for participating in the pilot at 
that time as well as criteria for participation. For general questions 
about parallel review, contact the persons listed in the ``FOR FURTHER 
INFORMATION CONTACT'' section of this document. Device sponsors 
interested in requesting voluntary parallel review should contact the 
person noted as the contact listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section of this notice.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    To assist interested parties, we are asking for public comment on 
the following issues:
    1. Should anyone other than the product sponsor be able to initiate 
a request for parallel review (for example, the FDA, CMS, an interested 
third party)?
    2. For which classes of products would consumers, payers, or 
sponsors benefit most from parallel review? Why?
    3. FDA and CMS may propose to limit the number of products 
concurrently under parallel review. How should limits be placed on the 
number and/or type of products concurrently under parallel review? 
Should CMS be permitted to review indications for which the sponsor is 
not seeking FDA clearance or approval under parallel review?
    4. Are there disadvantages to parallel review?
    5. Are there any barriers (for example, regulatory, legal, 
scientific) to parallel review and if so, how might they be overcome?
    6. Should a voluntary process be put in place to encourage the 
conduct of clinical trials that are appropriately designed to support 
both FDA approval/clearance and CMS national coverage decisions? If so, 
what process should be established?
    7. What criteria should the FDA and CMS use to decide whether to 
grant a request for parallel review?
    8. At what point during FDA premarket review for prescription 
drugs, biologics, and medical devices, should parallel review begin in 
order to reduce the time between FDA marketing approval or clearance 
decisions and CMS national coverage decisions while avoiding the risk 
that CMS would initiate an NCD for a product whose premarket 
application the FDA subsequently does not approve or clear?
    9. How should parallel review be implemented? Should the agencies 
use means in addition to a guidance document, such as designating 
agency liaisons, to educate sponsors about parallel review?
    10. When, if at all, should the agencies offer joint meetings to 
interested sponsors during parallel review? Before parallel review 
begins? Before a premarket application is submitted to the FDA?
    11. Should FDA and CMS have access to the same data and information 
about the product during parallel review? (Note: Both agencies will 
protect the confidentiality of proprietary information used in the 
parallel review process, as they currently do under their

[[Page 57048]]

respective approval/clearance and coverage processes.)
    12. It is CMS' policy to inform the public when it begins an NCD 
process for a particular product. However, under applicable statutes 
and FDA's regulations, the existence of a premarket application is 
considered confidential commercial information prior to approval or 
clearance unless the sponsor has publicly acknowledged the application. 
With the consent of the sponsor, should CMS make public that it has 
begun the NCD process, as part of parallel review, for a product still 
undergoing FDA premarket review? As a condition of the agencies' 
agreement to initiate parallel review, should a sponsor have to inform 
the public, or consent to the agencies informing the public, that the 
product will be evaluated under parallel review? If the sponsor 
declines to consent to disclosure, should it be permitted to request 
parallel review anyway, which would prevent CMS from disclosing the NCD 
process until after the product is approved by the FDA? How can the 
transparency of CMS' NCD process be reconciled with the need to retain 
confidentiality of certain commercial information?
    13. At present, sponsors whose medical products will undergo both 
FDA premarket review and CMS national coverage review submit separate 
application packages to FDA and CMS that, in part, contain the same 
data, and, in part, contain different data. Keeping in mind the limited 
resources available to the agencies, what steps can the agencies take 
to minimize duplication of data submissions? Would the use of 
electronic submissions reduce submission burdens and facilitate data 
transfers? Are there other steps the agencies can take to streamline a 
parallel review process without modifying the regulatory standards and 
evidentiary requirements of both agencies? Would the transparency of 
CMS' NCD process subject the FDA to additional public pressure 
regarding marketing authorization?
    14. Should the agencies convene a joint advisory committee to 
consider common issues needing public discussion and advice during the 
parallel review process?
    15. What other concerns or considerations should the agencies take 
into account when developing a process for parallel review?
    16. Once FDA and CMS have opened a parallel review should a sponsor 
be able to terminate or withdraw the request for parallel review? If 
this happens, should that information be made public?
    17. Sponsors who submit a PMA or 510(k) to the FDA generally must 
pay a user fee. One key advantage of parallel review is to streamline 
the current process by allowing engagement by a sponsor with both FDA 
and CMS concurrently. Earlier engagement could shorten the time between 
FDA approval or clearance of the PMA or 510(k) and a coverage decision 
from CMS. Parallel review could, however, entail additional costs for 
the agencies (for example, if the product ultimately does not receive 
FDA approval or clearance). Changes to a user fee would also require 
legislative changes. Given these factors, should the current Medical 
Device User Fee be restructured to support the FDA and CMS costs of 
this parallel review and if so, how?

    Dated: September 10, 2010.
Margaret A. Hamburg,
Commissioner of Food and Drugs.

    Dated: July 29, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-23252 Filed 9-16-10; 8:45 am]
BILLING CODE 4160-01-S