[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48164-48169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19060]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3284-N]
Medicare Program; Revised Process for Making National Coverage
Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice updates the process we use for opening, deciding
or reconsidering national coverage determinations (NCDs) under the
Social Security Act (the Act). It addresses external requests and
internal reviews for new NCDs or for reconsideration of existing NCDs.
The notice further outlines an expedited administrative process to
remove certain NCDs, thereby enabling local Medicare contractors to
determine coverage under the Act. This notice does not alter or amend
our regulations that establish rules related to the administrative
review of NCDs.
DATES: This notice is effective on August 7, 2013.
FOR FURTHER INFORMATION CONTACT: Katherine Tillman, (410) 786-9252.
SUPPLEMENTARY INFORMATION:
I. Background
In a September 26, 2003, Federal Register notice (68 FR 55634), we
announced our procedures for considering national coverage
determination (NCD) requests and our procedure for issuing NCDs,
including the role of external public requests to open an NCD and our
procedures for internally-generated NCD reviews. As we strive to
continually improve our processes and in recognition of the changes
made by the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003), we
are superseding the 2003 Federal Register notice with this updated
notice.
II. Provisions of the Notice
This notice establishes the procedures for requesting an NCD or
reconsideration of an existing NCD. We also describe how the public may
participate in the NCD process during the indicated comment period(s).
The topics addressed in the notice include the following:
Informal contacts and inquiries prior to requesting a
national coverage determination.
What constitutes a complete, formal request for an NCD or
formal request for reconsideration of an existing NCD.
External requests for NCDs, including the following:
++ Request by an external party for a new NCD.
++ Request by an external party for reconsideration of an existing
NCD.
++ Request by an aggrieved party (as defined below) to issue an NCD
when no NCD exists.
CMS internally-generated review of NCDs, including the
following:
++ CMS internal review for a new NCD.
++ CMS internal review for reconsideration of an existing NCD.
An expedited process to remove NCDs under certain
circumstances.
Based on our experience since 2003 with the current NCD process, we
are establishing a new procedure to be used in circumstances in which
we have previously issued an NCD, but have now determined that the NCD
is no longer needed. Since we would not be establishing a new NCD, we
would use an expedited process to remove these NCDs. After the
effective date of the removal of the NCD, local Medicare contractors
would determine coverage under section 1862(a)(1) of the Act for those
specific items or services previously addressed through the NCD. We
describe this process and the opportunity for public participation in
this process in section IV.C of this notice.
We are also restating our process for developing an NCD to provide
clarity and transparency for the public pertaining to modifications
made to the coverage process since the MMA. As in the 2003 Federal
Register notice, we will inform the public by addressing the following
in this notice:
The internal and external processes for requesting an NCD
or an NCD reconsideration.
A tracking system that provides public notice of our
acceptance of a complete, formal request and subsequent actions in a
web-based format.
The process we use to afford notice and opportunity for
public comment before issuing a decision memorandum.
How we use public comments to inform the NCD final
decision.
We continue to pursue our efforts to work with various sectors of
the scientific and medical community to develop and publish on our Web
site documents that describe our approach when analyzing scientific and
clinical evidence to develop an NCD. The CMS coverage Web site can be
accessed at
[[Page 48165]]
http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html.
III. Medicare Coverage--General Principles
A. Statutory Authority
The Medicare program was established by Title XVIII of the Act.
Part A is the hospital insurance program and Part B is the voluntary
supplementary medical insurance program. The scope of benefits
available to eligible beneficiaries under Part A and Part B is
prescribed by law in sections 1812 and 1832 of the Act. Part C, known
as the Medicare Advantage Program, includes at a minimum, all of the
items and services available under Part A and Part B to individuals
enrolled in the plan. On January 1, 2006, Medicare began to cover
prescription drugs through a new voluntary and privately-administered
Part D program, established by the MMA. To obtain prescription drug
coverage, Medicare beneficiaries must take the affirmative step of
enrolling in a private Medicare Part D plan that is either a stand-
alone prescription drug plan (PDP) or a Medicare Advantage prescription
drug plan (MA-PD).
In addition, with relatively few exceptions, the statute provides
in section 1862(a)(1) of the Act that no payment may be made under Part
A or Part B for any expenses incurred for items or services which ``are
not reasonable and necessary for the diagnosis or treatment of illness
or injury or to improve the functioning of a malformed body member.''
The Supreme Court has recognized that ``[t]he Secretary's decision as
to whether a particular medical service is `reasonable and necessary'
and the means by which she implements her decision, whether by
promulgating a generally applicable rule or by allowing individual
adjudication, are clearly discretionary decisions.'' Heckler v. Ringer,
466 U.S. 602, 617 (1984).
This notice concerns our procedures for making NCDs for items and
services under Part A or Part B. NCDs serve as generally applicable
rules to ensure that similar claims for items or services are covered
in the same manner. Often an NCD is written in terms of defined
clinical characteristics that identify a population that may or may not
receive Medicare coverage for a particular item or service. The term
``national coverage determination'' is defined by statute and means a
determination by the Secretary of the Department of Health and Human
Services (Secretary) with respect to whether or not a particular item
or service is covered nationally under Title XVIII of the Act. NCDs are
controlling authorities for Medicare contractors and adjudicators as
described more fully in 42 CFR 405.1060.
In the absence of an NCD, Medicare contractors may establish a
local coverage determination (LCD) (defined in section 1869(f)(2)(B) of
the Act) or adjudicate claims on a case-by-case basis. The case-by-case
adjudicatory model permits consideration of a beneficiary's particular
factual circumstances described in the medical record. The case-by-case
model affords more flexibility to consider a particular individual's
medical condition than is possible when the agency establishes a
generally applicable rule.
B. Differences Between Food and Drug Administration (FDA) and CMS
Review
Parties interested in the coverage of a drug or device may contact
us with an inquiry on Medicare coverage while the particular drug or
device is proceeding through the Food and Drug Administration (FDA)
review process. Since the FDA is charged with regulating whether
devices or pharmaceuticals are safe and effective for their intended
use by consumers, generally we will not accept a coverage request for a
device or pharmaceutical that has not been approved or cleared for
marketing by the FDA for at least one indication; one exception is
Category B Investigational Device Exemption (IDE) devices. A Category B
IDE device is a non-experimental/investigational device for which the
incremental risk is the primary risk in question (that is, underlying
questions of safety and effectiveness of that device type have been
resolved), or it is known that the device type can be safe and
effective because, for example, other manufacturers have obtained FDA
approval or clearance for that device type.
Both CMS and FDA review scientific evidence and will likely review
some of the same evidence to meet each agency's mission. Among other
things, FDA reviews evidence to determine that a product is safe and
effective, that is, it conducts a premarket review of products under a
statutory standard and delegated authority (67 FR 66755) different from
that of CMS. We also review clinical evidence to determine, among other
things, whether the item or service is reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member for the affected Medicare
beneficiary population. An FDA-regulated product must receive FDA
approval or clearance (unless exempt from the FDA premarket review
process) for at least one indication to be eligible for consideration
of Medicare coverage (except in specific circumstances). However, FDA
approval or clearance alone does not entitle that technology to
Medicare coverage.
IV. CMS' Process for Making a National Coverage Determination
Section 1862(l) of the Act establishes, among other things, a
timeframe for the NCD process and an opportunity for public comment on
the agency's proposed decisions.
A. Informal Contacts and Inquiries Before Requesting an NCD
We encourage, but do not require, potential requesters to
communicate, via conference call or meeting, with our staff in the
Coverage and Analysis Group (CAG) within the Center for Clinical
Standards and Quality (CCSQ) before submission of a formal request. We
have found that an initial submission of a ``formal request'' without
any conversation with us generally requires additional clarification
and discussion before we can definitively act on the request. A summary
of the item or service and supporting documentation can be presented by
the requester, and our staff can identify additional information that
might be needed or helpful. Preliminary discussions are also the
appropriate time for the requester to identify clinical trial protocols
whose results will be later submitted to support an NCD request, if
relevant. A positive response, however, to a clinical trial protocol is
not an indication of forthcoming Medicare coverage.
A significant proportion of potential requesters have either
withdrawn or substantially amended their initial requests after
informal discussion with us. These instances have generally included
one or more of the following factors:
Existing coverage of the item or service is already
available at the national or local level.
The substance of the request concerns the coding or
payment amount for the item or service and is therefore outside the
scope of an NCD.
The item or service falls outside the scope of the
Medicare Part A and Part B benefits.
The requester learns that the item or service, even if
covered, would not be separately paid under the Medicare program, for
example, the item or service would be included in a bundled payment.
[[Page 48166]]
The requester recognizes the request would not be
supported by a persuasive body of evidence.
Informal communications between us and the requester allow both
parties to clarify the NCD request and discuss potential issues that
would affect our review and implementation of coverage of the item or
service, such as the issues discussed above. These meetings and
conversations expedite consideration and ensure that the requester
understands that all relevant materials must be submitted in a timely
manner and not delay the opening of the NCD review.
B. What Constitutes a Complete, Formal Request for an NCD or a
Complete, Formal Request for Reconsideration
We can initiate an NCD request or one can be initiated by an
individual, (including a beneficiary), or an entity (including a
medical professional society or business interest). We require that any
request for an NCD review be a written ``complete, formal request.''
Acceptance of a complete, formal request indicates that we have
sufficient information to conduct the NCD review. A request is
considered to be a complete, formal request once the following
conditions are met:
The requester has provided a final letter of request that
is not marked as a draft, and is clearly identified as ``A Formal
Request for a National Coverage Determination.'' The requester must
identify and submit the scientific evidence that he or she believes
supports the request for coverage. Our review, however, is not limited
to the materials submitted by the requester.
Supporting documentation must include a full and complete
description of the item or service in the request and scientific
evidence supporting the clinical indications for the item or service.
This includes a specific detailed description of the proposed use of
the item or service, including the target Medicare population and the
medical indication(s) for which it can be used and whether the item or
service is intended for use by health care providers or beneficiaries.
If the requester has submitted an application to the FDA
for premarket approval or 510(k) clearance of the product for which
coverage is sought, a copy of the ``integrated summary of safety data''
and ``integrated summary of effectiveness data'', or the combined
``summary of safety and effectiveness data'' portions of the FDA
application must be included. (Section 510(k) of the Food, Drug, and
Cosmetic Act requires device manufacturers who must register, to notify
FDA of their intent to market a medical device at least 90 days in
advance.)
In the case of items or services that are eligible for a
510(k) clearance by the FDA, the request must include identification of
the predicate devices to which the item or service is claimed to be
substantially equivalent.
The request must include information regarding the use of
an item or service (for example, drug or device) subject to FDA
regulation as well as the status of current FDA regulatory review of
the item or service involved. An FDA regulated item or service would
include the labeling submitted to FDA or approved by the FDA for that
article, together with an indication of whether the article for which
review is being requested is covered under the labeled indication(s).
We recognize that the labeling on FDA-approved products sometimes
changes. For purposes of our review, we are interested in the labeled
indications at the time a requester submits a formal request. If during
our review, the labeled indication or status of pending FDA approval or
clearance changes, the requester must notify us of those changes.
The request must state the Medicare Part A or Part B
benefit category or categories in which the requester believes the item
or service falls. Medicare does not develop NCDs to establish coverage
of items or services that fall outside the scope of the Part A or Part
B benefits.
Requests for NCDs may be submitted electronically via the
Coverage Center Web site using the ``Contact Us'' link at http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html.
Requests may also be submitted to the Centers for Medicare &
Medicaid Services; Director, Coverage and Analysis Group; 7500 Security
Blvd.; Baltimore, MD 21244.
We will consider a request to be a complete, formal request if the
following conditions are met:
The request is in writing.
The request clearly identifies the statutorily-defined
benefit category to which the requester believes the item or service
applies and contains enough information for us to make a benefit
category determination.
The request is accompanied by sufficient, supporting
evidentiary documentation.
The information provided addresses relevance, usefulness,
or the medical benefits of the item or service to the Medicare
population.
The information fully explains the design, purpose, and
method of using the item or service for which the request is made.
C. External Requests for National Coverage Determinations
1. Request by an External Party for a New National Coverage
Determination
Typically, a requester is a Medicare beneficiary, a manufacturer, a
physician or a physician professional association. A request may be to
establish, limit, or entirely remove coverage.
Upon acceptance of a complete, formal request, publication of a
tracking sheet on the CMS Web site enables interested individuals to
participate in and monitor the progress of our review. The tracking
sheet contains a reference number, the name of the issue under
consideration, requests for public comments, and summarizes the
significant actions we have taken. The tracking sheet is a key element
in making our NCD process efficient, open, and accessible to the
public.
A formal evidence review is then undertaken to determine whether or
not an unbiased interpretation of the available evidence base supports
or refutes the requested coverage in whole or in part. A proposed
decision is normally issued for public comment within six months of
opening the NCD review. Consistent with section 1862(l)(3)(B) of the
Act, we provide 30 days for public comment on the proposal. Not later
than 60 days after the close of the 30-day public comment period, we
issue a final NCD. The final NCD decision memorandum includes a summary
of the public comments on the proposed decision as well as responses to
those comments. The proposed and final memoranda also include the
scientific basis for our coverage determination, for example, an
analysis and summary of the evidence considered (including medical,
technical, and scientific evidence). The statutory timeframes, however,
vary depending on whether or not we commission a technology assessment
from an outside entity, or whether we decide to convene the Medicare
Evidence Development and Coverage Advisory Committee (MEDCAC) to
discuss the quality of the evidence, or whether a clinical trial is
requested.
2. Request by an External Party for Reconsideration of an Existing NCD
When an NCD currently exists, any individual or entity may request
that we reconsider any provision of that NCD by filing a complete
formal request for reconsideration. Similar to a request for a new NCD,
the request for reconsideration must be submitted in
[[Page 48167]]
writing and be clearly identified. We consider accepting a request to
revise an existing NCD at any time, but only if the requester presents
documentation that meets one of the following criteria:
Additional scientific evidence that was not considered
during the most recent review along with a sound premise by the
requester that new evidence may change the NCD decision.
Plausible arguments that our conclusion materially
misinterpreted the existing evidence at the time the NCD was decided.
Similar to a request for a new NCD, we consider a reconsideration
request to be a ``complete, formal request'' if the following
conditions are met:
The requester provides a final letter of request (for
example, not marked as a ``draft''), and clearly identifies the request
as a ``Formal Request for NCD Reconsideration.''
The requester identifies the scientific evidence that he
or she believes supports the request for reconsideration (see above).
Our review, however, is not limited to the materials submitted by the
requester.
The written request includes and supports any additional
Medicare Part A or Part B benefit categories in which the requester
believes the item or service falls.
The request includes supporting documentation and is
received electronically (unless there is good cause for only a hardcopy
submission such as inability to scan necessary documents for electronic
submission or lack of access to an electronic method of submission).
Requests for NCDs may be submitted electronically via the Coverage
Center Web site using the ``Contact Us'' link. Requests may also be
submitted to the Centers for Medicare & Medicaid Services; Director,
Coverage and Analysis Group; 7500 Security Blvd.; Baltimore, MD 21244.
We review materials presented in a complete, formal request by the
requester. We also review other related clinical materials before
accepting a request for reconsideration. In a change from the 2003
Federal Register notice and because of the time required for clinical
research, reviews and analysis in a global health arena, we have
determined that 60 days is usually a reasonable time period for us to
make a decision to accept or reject decline an external NCD
reconsideration request. If we accept the request, we post the letter
requesting reconsideration together with a tracking sheet announcing
that a reconsideration of the NCD has begun. If we decline the request,
we will send a letter to the requester, rejecting the reconsideration
request.
3. Request by an Aggrieved Party To Issue a Coverage or Noncoverage NCD
Section 1869(f)(4) of the Act permits certain aggrieved persons to
make a request that the Secretary issue a national coverage or
noncoverage determination with respect to a particular type or class of
items or services, if the Secretary has not made a national coverage or
noncoverage determination. These individuals are described in section
1869(f)(5) of the Act as ``individuals entitled to benefits under Part
A, or enrolled under Part B, or both, who are in need of the item or
service that is the subject of the coverage determination.'' Thus, this
option can be invoked only for an initial request if we have not issued
a coverage or noncoverage NCD. In these rare instances related to
requests made by aggrieved parties, the statute establishes specific
time deadlines for our consideration of such requests and we will
notify the public through the posting of the NCD Tracking sheet when
this occurs.
D. Internally-Generated NCD Review
1. Internally-Generated Review of an NCD
We may internally initiate the NCD process. The following are
examples of circumstances that may prompt us, when supported by our
initial investigation of available evidence for review, to generate an
internal NCD review on new or longstanding items or services:
Practitioners, patients, or other members of the public
have raised significant questions about the health outcomes
attributable to the use of the items or services for the Medicare
beneficiary population.
New evidence or reasonable re-interpretation of previously
available evidence indicates that a national coverage review may be
warranted.
Local coverage policies on a particular item or service
may vary in language or implementation. While this may be manifested by
LCD variations among Medicare Administrative Contractors (MACs), we
note that variability is not a de facto sign of inappropriate local
policy and may be appropriate.
The health technology represents a substantial clinical
advance and is likely to result in a significant improvement in patient
health outcomes or positive impact on the Medicare program.
When rapid diffusion of an item or service is anticipated
the evidence may inadequately address questions regarding impact on the
Medicare population, target subgroup populations, practitioner or
facility qualifications, etc., or on beneficiary health outcomes. Under
these particularly complex circumstances, we may also require a
comprehensive technology assessment, or convene a MEDCAC meeting to
discern and evaluate those complexities and help inform our national
decision.
2. Internally-Generated NCD Reconsideration Review
We may also internally open a reconsideration of any policy or of
an entire NCD. Generally, we internally open an NCD reconsideration
because we have become aware of new evidence that could support a
material change in coverage and we seek public comment on relevant
questions.
E. Expedited Process To Remove an NCD Using Certain Criteria
We recognize the need to periodically review our policies and
processes to ensure that we remain effective and efficient as well as
open and transparent. We are aware that clinical science and technology
evolve and that items and services that were once considered state-of-
the-art or cutting edge may be replaced by more beneficial technologies
or clinical paradigms. Therefore, we are announcing an administrative
procedure to periodically review the inventory of NCDs that are older
than 10 years since their most recent review and evaluate the continued
need for those policies to remain active on a national scale. We are
administratively simplifying the Medicare program by removing NCDs in
circumstances described below. This process of removal would not result
in an NCD as that term is defined in sections 1869(f) and 1862(l) of
the Act because there would be no uniform national decision about
whether or not the particular item or service would be covered under
Title XVIII of the Act. Rather, the initial coverage decision under
section 1862(a)(1)(A) of the Act for the particular item or service
would be made by local contractors. We believe that allowing local
contractor discretion in these cases better serves the needs of the
Medicare program and its beneficiaries since we believe the future
utilization for items and services within these policies will be
limited.
This expedited procedure allows us to regularly identify and remove
NCDs that no longer contain clinically pertinent and current
information or that involve items or services that are used
infrequently by beneficiaries. As the scientific community continues to
pursue research in certain areas, the
[[Page 48168]]
evidence base we previously reviewed may have evolved to support other
policy conclusions. Alternatively, in some circumstances, removing an
NCD has the effect of striking national noncoverage and may permit
access to technologies that may be beneficial for some limited uses.
Under this process, we will periodically publish on our Web site, a
list of NCDs proposed for removal along with our rationale for their
proposed removal. We will solicit public comment for 30 calendar days.
This will invite the public to comment on whether any or all of these
NCDs should be removed or retained. In addition, we will ask the
commenters to include a rationale to support their comments. We use the
public comments to help inform our decision to do one of the following:
Follow the proposal to remove the NCD.
Retain the policy as an NCD.
Formally reconsider the NCD and post a tracking sheet to
that effect on the Coverage Web site.
We consider all the public comments when developing a final NCD
list for removal. When the final NCD list for removal is posted to our
Coverage Web site, we summarize the comments and briefly explain our
rationale as to why a specific NCD remained active, was removed from
active national status, or qualified for reconsideration. The final
list will be effective upon posting it to the Web site.
Currently, an existing NCD must undergo a formal reconsideration
process to be removed or amended and the process generally takes 9 to
12 months. We expect this new administrative procedure to reduce that
time significantly. We believe that this streamlined process is more
efficient and helpful to the public because it instills confidence that
national policies are being monitored to ensure health benefits for
Medicare beneficiaries remain current.
We may consider an older NCD for removal if, among other things,
any of the following circumstances apply:
We believe that allowing local contractor discretion
better serves the needs of the Medicare program and its beneficiaries.
The technology is generally acknowledged to be obsolete
and is no longer marketed.
In the case of a noncoverage NCD based on the experimental
status of an item or service, the item or service in the NCD is no
longer considered experimental.
The NCD has been superseded by subsequent Medicare policy.
The national policy does not meet the definition of an
``NCD'' as defined in sections 1862(l) or 1869(f) of the Act.
The benefit category determination is no longer consistent
with a category in the Act.
V. CMS' Evaluation of Requests for an NCD and Related Tasks
When we receive a request for an NCD, we review the submitted
material to determine if it is a complete, formal written request. If
it is not a complete, formal request it does not trigger the NCD
statutory timeline because we do not have a clear basis upon which to
act on the inquiry. In these instances, we notify the requester and
explain our rationale, so the requester has the opportunity to provide
missing information. As we explain elsewhere in this notice, many of
the incomplete or informal inquiries we have received in the past did
not ultimately result in a formal request.
Upon acceptance of a complete, formal, request, posting of the
tracking sheet on our Web site facilitates the ability of interested
individuals to participate in, and monitor, the progress of our review.
This is a key element in making our NCD process more efficient, open,
and accessible to the public.
We then undertake a formal evidence review to determine whether or
not an unbiased interpretation of the available evidence base supports
or refutes the requested coverage in whole or in part. We may also
consider the need to obtain additional input through technology
assessments from an outside entity and/or deliberation by the Medicare
Evidence Development and Coverage Advisory Committee (MEDCAC). A formal
review may result in an NCD, a noncoverage NCD, or an NCD with
limitations. We also may determine that no NCD is required, permitting
local Medicare contractors to make the initial determination under
section 1862(a)(1) of the Act.
VI. Public Comment
We strive to conduct the NCD process in an open and transparent
manner with thoughtful consideration of public comment. We have found
that public commenters may cite published clinical evidence, contribute
insight, and give us useful information. We are particularly interested
in comments that include new evidence we have not reviewed for the
proposed decision or in past considerations of the NCD. Comments should
be timely and pertinent to the NCD. We respond in detail to the public
comments on a proposed decision in the final decision memorandum.
While the statute affords an opportunity for public comment on the
proposed decisions, we may also solicit public comment upon the initial
opening of an NCD review announced via the tracking sheet. We use the
initial public comments to inform our proposed decision and respond in
detail to the public comments on a proposed decision when issuing the
final decision memorandum.
Also, we may, at our discretion, open a proposed decision
concurrently with the notice of opening an NCD. This occurs rarely when
we determine it is efficient to reduce the time necessary to manage an
unforeseen health related issue or program need that must be resolved
quickly. We may also use our discretion, as we have publicly stated, in
an attempt to expedite a final NCD for requests that are accepted in
the FDA CMS parallel review project (see the notice published on
October 11, 2011 (76 FR 62808 through 62810)).
Public comments providing information on unpublished evidence, such
as the results obtained by individual practitioners or patients, are
less rigorous and therefore less useful for making a coverage
determination.
Public comments that contain personally identifiable health
information are either redacted or not made available to the public.
Comments containing extensive personal health information may leave no
substantive comment after redaction.
We prefer to receive comments electronically; as these are more
efficiently reviewed, catalogued, and redacted for personally
identifiable health information. If a commenter chooses to submit
comments through more than one channel, duplicate submissions are
treated as a single comment.
In general, we avoid opening and closing public comment periods on
federal holidays or weekends. We may have limited ability to
accommodate this goal, however, under tight statutory deadlines.
VII. Prioritizing Requests
In the event that we have a large volume of NCD requests for
simultaneous review, we prioritize these requests based on the
magnitude of the potential impact on the Medicare program and its
beneficiaries and staffing resources.
VIII. Time Frames
We strive to complete NCD-related activities in a timely and
efficient manner, often before statutory deadlines. We prepare an
annual Report to Congress that tracks our performance
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with respect to certain key steps in the process which is also posted
on our Web site. The following steps and time frames are used for new
NCDs and for reconsiderations of existing NCDs:
Upon acceptance of a complete formal request or upon the
opening of a CMS initiated review, we publish on our Web site a
tracking sheet that provides public notice of the opening of the NCD
process. We generally allow a 30-day public comment period on the NCD
review topic announced via the tracking sheet. We use the initial
public comments to inform a proposed decision. As stated above, at our
discretion, we may announce a proposed decision concurrent with the
notice of opening.
A proposed decision is posted no later than 6 months after
the posting of the tracking sheet, unless a technology assessment (TA)
from an outside entity is commissioned, a clinical trial is requested,
or a meeting of the MEDCAC is convened.
In the event that a TA is commissioned from an outside
entity or a MEDCAC meeting is held and a clinical trial is not
requested, the proposed decision is posted no later than 9 months
following the posting of the tracking sheet.
Upon the posting of the proposed decision, there is a 30-
day public comment period during which time the public is invited to
comment on the substance of the proposed decision.
A final NCD is posted on our Web site no later than 60
days following the close of the public comment period on the proposed
decision.
With publication of the final decision memorandum, the NCD
is effective for claims with dates of service beginning with the
effective date of the NCD. The memorandum contains, among other
materials, the analysis and conclusions and also the NCD that becomes a
part of the Medicare National Coverage Determination Manual (Pub. 100-
3) of the CMS Internet Only Manual. After enactment of section 1862(l)
of the Act, the effective date for the NCD is the same date as the
publication date of the final decision memorandum. Therefore, we have
found it expedient and practical to include the NCD that is included in
the Medicare National Coverage Determination manual in the final
decision memoranda and to use that date as the effective date for
Medicare coverage and payment purposes.
IX. Collection of Information Requirements
This document does not impose any new reporting, recordkeeping or
third-party disclosure requirements. This document, however, does make
reference to information associated with an existing information
collection request. The information listed in section IV.B ``What
Constitutes a Complete, Formal Request for a National Coverage
Determination or a Complete, Formal Request for Reconsideration'' of
this notice, was previously approved under OMB control number 0938-
0776. We are currently seeking reinstatement of the OMB control number
and the information collection requirements. We published the required
60-day notice on February 12, 2013 (78 FR 9927). The 60-day comment
period ended April 15, 2013. We will announce the submission of the
information collection request to OMB via the required 30-day notice.
Authority: (Catalog of Federal Domestic Assistance Program No.
93.778, Medical Assistance Program; No. 93.773 Medicare--Hospital
Insurance Program; and No. 93.774, Medicare--Supplementary Medical
Insurance Program)
Dated: May 17, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Approved: May 17, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2013-19060 Filed 8-2-13; 4:15 pm]
BILLING CODE 4120-01-P