[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Notices]
[Page 55634-55641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3062-N]
RIN 0938-AK61
Medicare Program; Revised Process for Making Medicare National
Coverage Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice revises the process we will use to make a national
coverage determination for a specific item or service under sections
1812, 1832, 1861, 1862, 1869, and 1871 of the Social Security Act, as
revised by sections of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000. This notice further clarifies
our decision-making process and increases the opportunities for public
participation.
EFFECTIVE DATE: This notice is effective on October 27, 2003.
FOR FURTHER INFORMATION CONTACT: Vadim Lubarsky, (410) 786-0840.
SUPPLEMENTARY INFORMATION: Availability of Copies and Electronic Access
Copies: To order hard copies of the Federal Register containing this
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.
I. Background
In the April 27, 1999 Federal Register (64 FR 22619), we published
a notice that announced changes to our internal procedures for
developing a national coverage determination (NCD) and making the NCD
process more open and understandable to the public. As we strive for
continuous improvement of our processes, and in recognition of the
changes that section 522 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) requires, we are revising
our process for developing an NCD in order to make the process more
efficient and ensure that we have access to all relevant information to
make fully informed decisions. (BIPA, Pub. L. 106-554, was enacted on
December 21, 2000.) The processes described in this notice apply to
both scope of benefit and section 1862(a)(1) determinations as defined
in the Social Security Act (the Act). This notice replaces the April
27, 1999 notice and will be effective on October 27, 2003. Improvements
include the following:
[sbull] Updating and organizing the reconsideration process into
one section, and distinguishing it from an initial request to make an
NCD.
[sbull] Defining, streamlining, and organizing the contact/inquiry
information into one section.
[sbull] Revising, formalizing, and updating the elements that
constitute a complete, formal request to reflect best practices.
[sbull] Adding a section on information that does not constitute a
complete, formal request.
[sbull] Updating and clarifying the conditions for acceptance of a
complete, formal request.
[sbull] Making it clear that all evidence currently available must
be adequate for us to conclude that the item or service is reasonable
and necessary.
[sbull] Establishing two main tracks for the initial NCD request.
One track is a highly time-structured track only available to aggrieved
parties (section IV.E track 2), as defined in section 522 of
BIPA. The other track is open to anyone, including aggrieved parties,
beneficiaries, and manufacturers, and offers a more collaborative and
less time-stringent process (section IV.E track 1).
Historically, we have based our coverage determinations on
descriptive information, and scientific and clinical evidence. Under
the revised BIPA coverage process, we will continue to use descriptive
information, and scientific and clinical evidence as a basis for our
coverage determinations.
II. Purpose of This Notice
This notice outlines the process we will use to make an NCD under
the Medicare program. It sets forth the steps we are taking to make the
NCD process more efficient, while maintaining as open and transparent a
process as appropriate. It describes the following:
[sbull] A tracking system that provides public notice of our
acceptance of a complete, formal request and subsequent actions in a
web-based format.
[sbull] The process we will institute to afford notice and
opportunity to comment before implementation of an NCD.
[sbull] Information that does and does not constitute a complete,
formal request.
[sbull] The process for asking us to reconsider an existing NCD
based on new information, including new medical or scientific evidence.
[sbull] The basis and purpose of a decision memorandum and where it
can be accessed on our Web site.
[sbull] The revisions made to the NCD process under BIPA, including
a response to public comments, and how these revisions affect the
current NCD process and any subsequent challenges to an NCD.
In addition, we will continue to pursue an ongoing effort to work
with various sectors of the scientific and medical community to develop
and publish on the CMS Web site documents that describe our approach
when analyzing scientific and clinical evidence to develop an NCD.
Interested parties will be able to offer comments. Accordingly, these
documents will make our coverage process more open and offer the public
a better understanding into our NCD process.
In our April 1999 notice, we announced that we anticipated
publishing a final coverage criteria rule that would be followed by
sector-specific guidance documents (64 FR 22620). Since then, we
published a notice of intent to engage in rulemaking for coverage
criteria (May 16, 2000, 65 FR 31124) and had a subsequent town
[[Page 55635]]
hall meeting. Given that there are substantial competing interests
about the coverage criteria, we believe it best not to pursue
rulemaking. In the meantime, as we have done in the past 35 years, we
would continue to need to make coverage decisions and interpret what is
``reasonable and necessary.'' We believe that in the interest of
expediting NCDs and making the process as predictable as possible that,
in the interim, nonbinding sector-specific guidance documents would be
helpful. Sector-specific guidance documents refer to how our
expectations and evaluation of evidence may differ in some respects
depending on the nature of the topic under review. Evidence can vary
greatly, for example, between a diagnostic and an item of DME or
between a near-term fatal condition and a life-long chronic condition.
Thus, we are notifying the public that we may choose to publish
sector-specific guidance documents even in the absence of a final rule.
We will consider doing so as the need arises. This is also notice that
we currently do not plan to develop a proposed rule based on the May
2000 Notice of Intent.
Section 522(b) of BIPA amends section 1862(a) of the Act to require
the Secretary ``to make available to the public the data (other than
proprietary data) considered in making the determination.'' In a notice
of proposed rulemaking published on August 22, 2002 (67 FR 54534), we
described the process for handling proprietary information related to
NCDs. After considering public comments, we will establish and announce
a policy that addresses that issue and defines ``proprietary'' data in
the final rule.
III. Medicare Coverage--General Principles
A. Statutory Authority
Administration of the Medicare program is governed by title XVIII
of the Act. Under the Medicare program, the scope of benefits available
to eligible beneficiaries is prescribed by law and divided into several
main parts. Part A is the hospital insurance program, and Part B is the
voluntary supplementary medical insurance program.
The scope of benefits under Part A and Part B is defined in the
Act. See sections 1812 (scope of Part A), 1832 (scope of Part B); and
1861(s) (definition of medical and other health services). Part C,
known as the Medicare+Choice program, includes at a minimum, all of the
items and services (other than hospice care) available under Part A and
Part B to individuals residing in the area served by the plan. Some
benefit categories are defined more broadly than others. Specific
health care services must fit into one of these benefit categories, and
not be otherwise excluded, to be eligible for coverage under the
Medicare program.
The Act does not contain a comprehensive list of specific items or
services eligible for Medicare coverage. Rather, it lists categories of
items and services, and vests in the Secretary the authority to make
determinations about which specific items and services within these
categories can be covered under the Medicare program. That is, the Act
allows Medicare to cover medical devices, surgical procedures, and
diagnostic services, but generally does not identify specific covered
or excluded items or services.
Medicare payment is contingent upon a determination that a service
meets a benefit category, is not specifically excluded from coverage,
and the item or service is ``reasonable and necessary.'' Section
1862(a)(1)(A) of the Act states that, subject to certain limited
exceptions, no payment may be made for any expenses incurred for items
or services that are not ``reasonable and necessary'' for the diagnosis
and treatment of illness or injury or to improve the functioning of a
malformed body member. For over 30 years, we have exercised these
authorities to make a coverage determination regarding whether a
specific item or service meets one of the broadly defined benefit
categories and can be covered under the Medicare program.
As revised by section 522 of BIPA, an NCD is now defined to be a
determination by the Secretary with respect to whether or not a
particular item or service is covered nationally under title XVIII of
the Act, but does not include a determination about which code, if any,
is assigned to a particular item or service covered under title XVIII,
or a determination with respect to the amount of payment for a
particular covered item or service.
In general, an NCD is a national policy statement granting,
limiting, or excluding Medicare coverage for a specific medical item or
service. Often, an NCD is written in terms of a particular patient
population that may receive (or not receive) Medicare reimbursement for
a particular item or service. An NCD is binding on all Medicare
carriers, fiscal intermediaries (FIs), quality improvement
organizations (QIOs), health maintenance organizations (HMOs),
competitive medical plans (CMPs), and health care prepayment plans
(HCPPs). Before October 1, 2001, NCDs made under section 1862(a)(1) of
the Act could not be reviewed by administrative law judges (ALJs).
Effective October 1, 2001, BIPA expanded the definition of NCDs, and
provides that all NCDs shall not be reviewed by ALJs under section
1869(f)(1) of the Act.
It is important to distinguish between a decision memorandum and an
NCD. The decision memorandum is the public document that lays out and
describes the analytic framework for our decision on a topic under NCD
review. Its purpose is to inform the reader of the decision, the
reasons for the decision and process followed, and provide a summary of
the evidence considered. The decision memorandum alerts the public of
our intent to implement the decision at some point in the future. The
NCD itself follows the decision memorandum, sometimes by a number of
months. It is the formal instruction to our claims processing
contractors regarding how to process claims (when to pay, when not to
pay, pay only when certain clinical conditions are met). Those
instructions have a specific effective date dictating when claims will
be processed according to the new criteria.
Generally, once we receive a complete formal request, it takes 90
days to develop a decision memorandum. As noted above, the decision
memorandum is not the NCD, but rather is one step towards making an NCD
for an item or service. After the decision memorandum is prepared, we
must prepare the actual NCD. The NCD may be issued as a manual
instruction or other document such as a program memorandum, ruling, or
Federal Register notice. The NCD may be accompanied by additional
information for our contractors that is necessary to ensure that
Medicare claims will be properly processed when the NCD is effective.
As noted above, except in very limited circumstances, preparing the NCD
will occur after this 90-day review process.
We expect to make any payment changes or other systems changes
dictated by the NCD instructions effective within 180 calendar days of
the first day of the next full calendar quarter that follows the date
we issue the decision memorandum. Thus, the decision memorandum and
payment change can take up to 270 days from the date a formal request
for an NCD is accepted for review by CMS. The date when a Medicare
beneficiary may obtain the item or service and receive Medicare payment
for that item or service under an NCD that expands coverage will not be
known until the NCD is completed and has been assigned an effective
date. The NCD will be implemented by all of
[[Page 55636]]
our contractors on the effective date. Additional details concerning
this process, as well as certain limited exceptions, are described
later in this notice.
B. Medicare Contractors and Coverage Policies
We contract with private insurance companies, referred to as
carriers and FIs, to process Medicare claims; that is, claims-payment
contractors. Local QIOs are also involved in the claims adjudication
process. We refer to all of these entities as ``Medicare contractors.''
Medicare contractors review and adjudicate claims to ensure that
Medicare payments are made only for those items or services covered
under Medicare Part A or Part B. In the absence of a specific NCD,
coverage determinations are made locally by the Medicare contractors
within the boundaries established by the law. Sometimes these
determinations are made on a claim-by-claim basis.
Medicare contractors will also publish local coverage
determinations (LCDs) that will provide guidance to the public and
medical community within a specified geographic area. An LCD is defined
in section 522 of BIPA as a determination made by an FI or a carrier
under Medicare Part A or Part B, as applicable, for whether or not a
particular item or service is covered on an intermediary-wide or
carrier-wide basis under those parts, in accordance with section
1862(a)(1)(A) of the Act. An LCD may not conflict with an NCD, but the
LCD may supplement an NCD.
C. Procedural
We continue to expect that all evidence currently available must be
adequate for us to conclude that the item or service is reasonable and
necessary. In the absence of adequate evidence, we may conclude that
the item or service is not reasonable and necessary.
D. Differences Between Food and Drug Administration (FDA) and CMS
Review
Parties interested in the coverage of a drug or device (other than
a Category B investigational device exemption (IDE) device, which is
addressed through a separate process as described in 42 CFR 405.201
through 405.215) may contact us with an inquiry on Medicare coverage
while the particular drug or device is proceeding through the Food and
Drug Administration (FDA) premarket review process. We are willing to
meet and discuss issues within this context. Because the FDA is charged
with regulating whether devices or pharmaceuticals are safe and
effective for use by consumers, generally we will not accept a 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 IDE devices. An IDE Category B 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 the FDA review scientific evidence, and may review the
same evidence, to make purchasing and regulatory decisions,
respectively. However, CMS and its contractors make coverage
determinations and the FDA conducts premarket review of products under
different statutory standards and different delegated authority (67 FR
66755, November 1, 2002). Whereas the FDA must determine that a product
is safe and effective as a condition of approval, CMS must determine
that the product is reasonable and necessary as a condition of coverage
under section 1862(a)(1)(A) of the Act. CMS adopts FDA determinations
of safety and effectiveness, and CMS evaluates whether or not the
product is reasonable and necessary for the Medicare population.
Although 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 Medicare coverage, except for
Category B devices under an IDE clinical trial (see 60 FR 48417,
September 19, 1995), FDA approval/clearance alone does not generally
entitle that device to coverage.
IV. CMS's Process for Making National Coverage Determinations
There are several ways an individual or entity can contact us about
NCDs. One approach involves informal contacts, discussed in section
IV.A of this notice. The other approach involves ``formal requests.''
If we have not issued an NCD for a particular item or service, an
external requestor may use one of two formal tracks to submit a request
to make an initial NCD. One track, established by section 522 of BIPA,
is available only to aggrieved parties, as defined by statute to be
``individuals entitled to benefits under Part A, or enrolled under Part
B, or both, who are in need of the items or services that are the
subject of the coverage determination'' and is highly time-structured.
The other track is open to anyone, including aggrieved parties, other
beneficiaries, and manufacturers, and offers a more collaborative and
less time-stringent process. The NCD development process under BIPA-
legislated time frames will only be initiated when we receive a
complete, formal request from an aggrieved party.
A. Informal Contacts and Inquiries
The public frequently raises general questions about the coverage
of items and services to us by telephone, the postal mail system,
electronic means, or in person. These questions may include, but are
not limited to, asking us to explain the current coverage of a
particular item or service, or requesting assistance with, or advice
about, a possible submission of a formal request for an NCD. We
consider all of these contacts to be informal. Although informal
contacts are not confidential, we will not announce the substance of
these contacts on our Web site.
If the requestor asks for specific information about how to request
an NCD, we will advise them on implications of such a request and
explain what is required for us to accept a submission as a complete,
formal request. We will offer suggestions to the requestor to clarify
the amount and kind of information necessary for us to evaluate whether
an item or service is ``reasonable and necessary'' under the Act, and
in limited instances, we may offer to assist the requestor in meeting
these requirements.
B. What Constitutes a Complete, Formal Initial Request for a National
Coverage Determination or Formal Request for Reconsideration
We consider a request to be a complete, formal request, only if all
of the following conditions are met:
[sbull] The formal request letter must be in writing.
[sbull] The formal request letter and supporting documentation must
be submitted electronically (unless there is good cause for only a
hardcopy submission).
[sbull] The requestor must identify the request as a ``formal
request for an NCD'' or a ``formal request for reconsideration'' and
identify the NCD development track chosen (described in detail in
section IV.E of this notice).
[sbull] The requestor must state the benefit category or categories
of the Medicare program to which the requestor believes the item or
service applies. Examples of benefit categories may include durable
medical equipment, physician services, inpatient hospital services, and
diagnostic tests. The requestor may
[[Page 55637]]
recommend one or more benefit categories for the item or service and
must submit supporting documentation justifying the recommendation. We
must have all information, both from the requestor and internally, to
make a benefit category determination, before the request can be
considered complete. If an item or service can fit into more than one
benefit category, we have the discretion to assign it to the most
appropriate benefit category.
[sbull] The requestor must submit adequate supporting documentation
along with the formal letter, including the following:
--A full and complete description of the item or service in question.
--A specific, detailed description of the proposed use of the item or
service, including the target Medicare population and the medical
condition(s) for which it can be used.
--A compilation of the supporting medical and scientific information
currently available that measures the medical benefits of the item or
service. This may include portions of primary study data that have been
separately submitted to the FDA as part of its submission package and
are deemed most relevant for our review.
--If the requestor has submitted an application to the FDA for market
approval of the product for which coverage is sought, then 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 should be
included in the request for an NCD. These documents will ensure that
our review is comprehensive.
--An explanation of the design, purpose, and method of using the item
or equipment, including whether the item or equipment is for use by
health care practitioners or patients.
--A statement from the requestor (in cases in which there is an
aggrieved party, the statement must be from that party) containing the
following:
++An explanation of the relevance of the evidence selected.
++Rationale for how the evidence selected demonstrates the medical
benefits for the target Medicare population.
++Information that examines the magnitude of the medical benefit.
++Reasoning for how coverage of the item or service will help
improve the medical benefit to the target population.
++In the case of an aggrieved party, how that party is ``in need''
of the item or service.
--A description of any clinical trials or studies currently underway
that might be relevant to a decision regarding coverage of the item or
service.
--Information involving the use of a drug or device subject to FDA
regulation as well as the status of current FDA regulatory review of
the drug or device involved. An FDA regulated article would include the
labeling submitted to the FDA or approved by the FDA for that article,
together with an indication of whether the article for which a 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 requestor submits a formal request. If,
during our review, the labeled indication or status of a pending FDA
approval or clearance changes, we expect the requestor to notify us.)
--In the case of items that are eligible for a 510(k) clearance by the
FDA, identification of the predicate device to which the item is
claimed to be substantially equivalent.
C. When a National Coverage Determination Request or Reconsideration
Request Is Not Considered Complete and Formal
When a requestor submits a request for an NCD or reconsideration,
we will review the materials to determine if it meets the definition of
a complete, formal request as defined in section IV.B of this notice.
If the request lacks adequate supporting documentation to enable us to
conduct our review, we will notify the requestor and explain our
rationale. If we accept the request, we will notify the requestor of
the acceptance. We will also post our acceptance on our Web site under
our list of pending coverage issues.
As we previously stated, we will not consider a request to be a
complete, formal request if any of the following occur:
[sbull] Request is not in writing.
[sbull] Request is not accompanied by sufficient, supporting
documentation.
[sbull] Information provided does not address relevance,
usefulness, or the medical benefits of the item or service to the
Medicare population.
[sbull] Information does not fully explain the design, purpose, and
method of using the equipment for which the request is made.
[sbull] Information provided is not supported by scientific or
clinically relevant data.
[sbull] Information provided is not relevant to the item or service
for which the request is made.
[sbull] Request does not clearly identify the statutorily defined
benefit category to which the requestor believes the item or service
applies and does not contain enough information for us to make a
benefit category determination.
[sbull] Request is considered an informal contact described in
section IV.A.
D. Acceptance of a Complete, Formal National Coverage Determination or
Reconsideration Request
In the rare event that we have a large volume of NCD requests to
review at once, we retain the flexibility to prioritize these requests
based on the magnitude of the impact on the Medicare program and
beneficiaries. This flexibility will enable us to ensure that we can
pay priority attention to those requests that have potential for
significant impact on our beneficiaries--a life-saving cancer
treatment, a breakthrough in cardiac pacing, etc. In order to do so, we
may have to temporarily suspend or diminish our review of other issues
that, while important, do not have the same profound potential. We
expect to use any such authority infrequently.
For these cases, two lists, an accepted list and lower priority
list (based on impact) will be maintained and available on our Web
site; the lower priority list will be processed based on the order of
acceptance as resources become available. Requestors can use this
public priority list to verify whether the request has been accepted,
the status of the request, and where the requestor is in the order of
priorities.
Upon acceptance of a request, we will notify the requestor and post
a tracking sheet announcing our review of this issue on the list of
pending coverage issues on the coverage Web site. Posting of the
tracking sheets permits interested individuals to participate and
monitor the progress of the NCD process. This is a key element in
making our NCD process more efficient, open, and accessible to the
public. Once a formal request is posted, there will be an opportunity
for public participation and submission of additional evidence. (If
after accepting the request, we decide that the request does not fall
under a benefit category, we will issue a noncoverage NCD.)
[[Page 55638]]
E. Review of a Complete, Formal Request for a National Coverage
Determination
Development of a complete, formal request for an NCD can be
initiated in one of three ways:
Track #1: Request for New National Coverage Determinations
Initiated by Any Party, Including Beneficiaries, Manufacturers,
Providers, or Suppliers.
A request to make an NCD can be received from an individual or
entity who identifies an item or service as a potential benefit (or to
prevent potential harm) to the Medicare population; this requestor can
be either an aggrieved party as defined by section 522 of BIPA, or a
nonaggrieved party. This may include a manufacturer, provider,
supplier, or party who requests our consideration of a particular issue
for an NCD. All requests must meet the requirements in this notice. An
initial request can only be made if we have not previously issued an
NCD for a particular item or service.
If an individual or other entity initiates a request, we expect to
generally issue a decision memorandum within a 90-day period. More
complex issues, or issues that require referral to the Medicare
Coverage Advisory Committee or for a Technology Assessment, would
generally take longer than 90 days. Generally, we expect to make a
payment change effective within 180 calendar days of the next full
calendar quarter that follows the date we issue the decision
memorandum.
Though the 90-day clock in this option is not as strict as the
process used only for aggrieved parties, this track offers a more
collaborative process than track two. The opportunities for greater
collaboration will flow from the more flexible approach to the 90-day
clock. Requestors and other interested parties will be able to provide
additional information, clarify issues, and engage in dialogue as
questions arise. The ability to follow this path is necessarily
constrained when we are under a strict, narrowly-framed 90-day response
timeline.
Track #2: Request by an Aggrieved Party for New National Coverage
Determinations Where There Were No National Coverage or Noncoverage
Determinations.
Aggrieved parties are defined 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 items or services that are the
subject of the coverage determination.'' Section 1869(f)(4) of the Act
permits these individuals 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 had not
previously made a coverage or noncoverage determination. Thus, this
track can be invoked only for an initial request if we have not issued
a coverage or noncoverage NCD.
As noted in section E, track 1, generally we expect to make a
payment change effective within 180 calendar days of the first day of
the next full calendar quarter that follows the date we issue a
decision memorandum. This time is necessary to identify and make any
necessary coding, payment, and systems changes. However, if an
aggrieved party initiates a request under track 2, we expect to issue a
decision memorandum and an NCD (that is, the manual instruction or
other appropriate document) to our contractors by no later than the end
of the 90-day period, in accordance with the statutory timeframe. The
NCD will include the effective date of the policy. In cases where we
are not able to complete our review within this 90-day timeframe, the
law requires that we issue a notice that includes an identification of
the remaining steps in the review process and a deadline by which we
will complete that review.
A decision memorandum will include a clear statement of the basis
for the determination including our responses to comments we receive
from the public. The actual effective date of the NCDs will depend on
whether we must make changes to our claims processing systems to allow
Medicare payment; this step is not included in the 90-day clock.
However, whether systems changes are needed and how long they may take
to implement will be reflected in the effective date contained in the
NCD.
Track #3: Internally Generated Request.
We may generate a request to make an NCD in the interest of the
general health and safety of Medicare beneficiaries. Generally, this
process is similar to the externally generated request process.
F. NCD Reconsideration Process
When an NCD currently exists, any individual or entity may request
that we reconsider any provision of that NCD by filing an acceptable
request for an NCD reconsideration. We will consider a request to
revise an existing NCD at any time, but only if the requestor presents
documentation that meets either of the following criteria:
[sbull] Additional material medical and/or scientific information
that was not considered during the initial review, that is, results
from new clinical trials, new scientific or medical publications, or
studies supporting the request.
[sbull] Arguments that our conclusion materially misinterpreted the
existing evidence at the time the NCD was made.
[sbull] If the request is for reconsideration of the benefit
category determination, the requestor must recommend a benefit category
and, in support of the recommendation, submit either (1) new
information that was not considered during the initial benefit category
determination, or (2) arguments that our determination decision
materially misinterpreted the applicable statutory provisions, the
applicable regulatory provisions, or the existing evidence at the time
the benefit category determination was made.
We will not accept a request for reconsideration that is not
submitted in writing, identified as ``A Formal Request for
Reconsideration,'' and accompanied by the required, additional,
supporting information as described more fully in sections IV.B and
IV.C. Upon receipt of the additional information as outlined above, we
will consider this a formal request for an NCD reconsideration and
initiate the reconsideration process. We generally expect to complete
the reconsideration process and issue a decision memorandum within 90
calendar days. Our current NCD will remain in effect during the
reconsideration process until we issue a revised NCD, if applicable.
A reconsideration of an NCD must be distinguished from a challenge
to an existing NCD. Under section 522 of BIPA and section 1869(f)(1) of
the Act, aggrieved parties may elect to challenge an existing NCD. On
August 22, 2002, we published a proposed rule (67 FR 54534) that
addresses procedures for the Departmental Appeals Board (Board) review
process under section 522 of BIPA.
A request for review of new clinical and scientific evidence that
was published or available only after the date the initial NCD was
issued may be submitted as a request for reconsideration. The
reconsideration of an existing NCD is part of our coverage
determination process so that our medical and scientific experts have
an opportunity to examine this new evidence. Thus, a reconsideration of
an NCD is separate and distinct from an initial NCD request and
separate from the Board review process under section 522 of BIPA.
As noted above, because reconsiderations are outside of the strict
BIPA timeline, they offer several alternative opportunities for
individuals
[[Page 55639]]
and entities that may make the process more advantageous:
[sbull] The reconsideration process does not involve a formal
adjudicatory hearing.
[sbull] The process may be more collaborative with the original
clinical reviewers at CMS, with greater opportunity for clarification
and dialogue.
G. Improvements in the National Coverage Determination Process
Our 90-day clock for considering or reconsidering coverage requests
will begin once we have accepted the complete, formal request.
Acceptance of a complete formal request begins a series of internal
timeframes over the course of 90 days.
We will post the acceptance of a complete, formal request on our
Web site. This initiates a 30-day comment (public input) period, during
which submission of evidence or other comments relevant to the request
will be accepted in accordance with section 522(b) of BIPA. During this
time, the public, including the requestor of the NCD or
reconsideration, may submit comments and additional information or
evidence of studies regarding the NCD issue under review. We will
provide a response to these comments in our decision memoranda.
There may be times, such as a public health emergency, when there
is good cause for developing an NCD more rapidly, and we may need to
reduce the time period for public comment. For instance, in the case of
a national disaster, it may be necessary to quickly modify an NCD to
facilitate access to covered services in a particular service area. In
these emergency situations, we may expedite the development of an NCD
and reduce the notice and comment period, during which evidence can be
submitted. For instance, following the flooding in Texas in the summer
of 2001, we issued an NCD shortly after a request was made in order to
permit payments for transplant recipients.
After the close of the 30-day comment (public input) period, we
will only accept additional information or evidence from the public if
we request information or during subsequent Medicare Coverage Advisory
Committee (MCAC) proceedings, if applicable. We must strictly enforce
the 30-day comment (public input) period, in which evidence can be
submitted, to ensure that we make timely decisions. We will consider
and incorporate the relevant public input, and any subsequent
information received during MCAC meetings, in the decision memorandum
and before implementing the NCD for the particular item or service.
We will use the remainder of the 90-day timeframe to research and
evaluate the NCD request. This process entails, but is not limited to,
the following activities:
[sbull] Review pertinent data and scientific literature a requestor
submits.
[sbull] Research relevant sources of evidence in addition to
evidence a requestor submits. These may include, but are not limited
to, other peer-reviewed medical, technical, and scientific literature,
recommendations of expert panels, unpublished data used to secure FDA
approval, and clinical experience.
[sbull] Formulate inclusion and exclusion parameters for literature
searches.
[sbull] Develop analytic questions needed for subsequent policy
formulation.
[sbull] Determine whether the issue warrants further review either
by the MCAC or through a health technology assessment (HTA) from an
agency such as the Agency for Healthcare Research and Quality (AHRQ).
[sbull] Evaluate all pertinent evidence.
In general, by the end of the 90-day period following formal
acceptance of an NCD or reconsideration request, we will issue a
decision memorandum on that request. We will outline, in a decision
memorandum, one of the following three actions:
(1) Our intention to issue an NCD, with or without limitations.
(2) Our intention to issue a national noncoverage determination.
(3) A determination that an NCD or a noncoverage determination is
not appropriate at the present time.
We will provide notice if we determine that additional time will be
necessary to complete an NCD review. We will identify the remaining
steps in the review process and the deadline by which we will complete
the review and take an action described in (1), (2), or (3) above. This
option may include such actions as referring the request to the MCAC or
to a third party for an HTA as described in section IV.H of this
notice.
A decision memorandum is not an NCD, but rather a statement
announcing our intent to issue policy. The decision memorandum details
the analysis of the scientific and clinical literature, and provides
the rationale for the coverage determination. The decision memorandum
will include the rationale we used in reaching our determination. If we
make a coverage determination to modify an existing NCD that results in
a reduction of coverage, in whole or in part, we will also publish a
notice in the Federal Register and announce our coverage determination
on our Web site. The decision memorandum is not binding on our
contractors, and no change in existing policy is effective until we
publish the revised NCD in the relevant coverage manual or other
issuance with a specific effective date. Generally, by the end of the
270-day period following formal acceptance of an NCD or reconsideration
request, we will make effective the payment changes for an NCD on that
request.
We will create and maintain a complete and adequate record of all
NCDs that are developed. The record will provide an explanation of our
rationale for an NCD and include the evidence we considered. This
record will form the basis for any subsequent requests for
reconsideration of the NCD, and will also serve as the formal record of
review for any subsequent challenges to the NCD under section
1869(f)(1) of the Act. Information contained in the record will conform
to the proprietary data policy in the 522 BIPA final rule.
H. Health Technology Assessments (HTAs)
During our review of an NCD request, we may require an HTA to
complete our review. Generally, an HTA provides an independent analysis
of all scientific and clinical evidence available on a particular
health care technology. We may request an HTA when there is conflicting
or complex medical and scientific literature available, or when we
believe an independent analysis of all relevant literature will assist
us in determining whether an item or service is reasonable and
necessary. We may also request an HTA in preparation for an upcoming
MCAC meeting.
We will obtain services from the Agency for Healthcare Research and
Quality, or a third party with the requisite experience in HTA and
evidence-based medicine to ensure the technical competence and fairness
of the HTA.
If we receive a formal request for coverage on an item or service
for which an HTA is already underway, we will inform the subsequent
requestor of the status of the pending HTA, as well as an estimated
time for completion. Any request for an HTA will be reflected on our
Web site tracking sheet, followed by either the executive summary or
the full and complete HTA.
I. Medicare Coverage Advisory Committee (MCAC)
On December 14, 1998, we published a notice in the Federal Register
(63 FR 68780) announcing establishment of the MCAC, and requesting
nominations for membership. The MCAC has met
[[Page 55640]]
periodically since September 1999, to discuss coverage issues, make
judgments about the adequacy and conclusions of existing scientific
evidence, make recommendations to us about whether particular items or
services can be considered ``reasonable and necessary'' under title
XVIII of the Act, and to advise the Secretary on matters relating to
the interpretation, application, or implementation of section
1862(a)(1) of the Act. The MCAC operates under a 2-year charter. The
MCAC charter is available on our Web site.
The primary role of the MCAC is to provide independent, expert
advice and assistance to us in making sound coverage decisions based
upon the reasoned application of scientific evidence. Voting members
must possess the scientific and technical competence commensurate with
this purpose. In addition, a consumer and industry representative serve
as nonvoting members on each panel. To ensure their full participation,
nonvoting members have access to all information and data (other than
information exempt from disclosure relating to trade secrets or where
the disclosure would present a conflict of interest) made available to
voting members. The MCAC meetings are open to the public, and time is
allotted for public comment on the particular coverage issue under
consideration.
In general, we may refer a coverage issue to the MCAC if it meets
any of the following conditions:
[sbull] It is the subject of significant scientific or medical
controversy; that is, there is a major split in opinion among
researchers and clinicians regarding the medical benefits of the item
or service, the appropriateness of staff or setting, or some other
significant controversy that would affect whether the item or service
is ``reasonable and necessary'' under the Act.
[sbull] It is the subject of controversy among the general public.
[sbull] It has the potential to have a major impact on a target
population of the Medicare program.
If we refer a coverage issue to the MCAC, we will schedule a public
meeting to discuss the coverage issue under consideration. All MCAC
meetings are subject to the requirements of the Federal Advisory
Committee Act. We will publish a notice in the Federal Register
generally 30 days before holding an MCAC meeting. We will announce in
our notice the draft agenda, time, and place of the meeting so that all
interested persons will have ample notification. During the course of
each meeting, there will be time allotted for public comment. We ask
that all requests for presentation and consideration of evidence to the
MCAC, submit a request to us in writing at least 20 days before the
meeting. The MCAC considers all available evidence, presentations, and
comments. The MCAC makes recommendations to us. Those recommendations
are advisory.
We expect the MCAC to make recommendations as expeditiously as
possible. We will provide an estimate of when we believe we will
receive the MCAC recommendation. Once the MCAC makes a formal
recommendation, we will post it on our Web site. Generally, within 60
calendar days of receiving the formal MCAC recommendation, we will
issue a decision memorandum. In the decision memorandum, we will
explain the MCAC recommendation, and how it was considered in our final
determination.
J. Implementation of National Coverage Determinations
The general 90-day clock for NCD and reconsideration requests
described for individuals who are not aggrieved parties or aggrieved
parties who elect the collaborative approach includes time for the
analysis, processing, and development of a decision memorandum. Upon
making a decision, numerous internal, related steps remain before a
payment change can take place. We must determine which codes the
providers, suppliers, and Medicare contractors will use for submission
and payment of claims consistent with the decision and issue
corresponding instructions. We must also determine the appropriate
Medicare payment level. As previously mentioned, coding and payment
decisions are not included within the definition of an NCD for purposes
of a Board review. Finally, NCDs often require us to develop and issue
claims processing instructions to our systems maintainers and Medicare
contractors to ensure accurate payment. Medicare contractors generally
implement systems changes at the start of a calendar quarter, and
instructions are required well in advance of the beginning of each
quarter in order to install and test the systems changes.
The NCD (issued as a program memorandum, manual instruction,
Federal Register notice, or CMS ruling) will include the effective date
when our Medicare contractors will implement any change in payment that
may result from the NCD. Generally, we expect to make a payment change
effective within 180 calendar days of the first day of the next full
calendar quarter that follows the date we issue the decision
memorandum. As stated previously, an NCD is binding on all Medicare
contractors; that is, carriers, FIs, QIOs, HMOs, CMPs, and HCPPs. NCDs
that expand coverage are binding on Medicare+Choice plans. We will also
publish a reference to each national coverage decision in the Federal
Register as part of our quarterly listing of program issuances.
K. Essential Differences in This Notice
In summary, this notice distinguishes between the two tracks
available for an external party to request a new NCD when no NCD
currently exists. For an initial request, the highly time-structured
track is only available to aggrieved parties, as defined in section 522
of BIPA. The other track is open to anyone, including aggrieved
parties, beneficiaries, and manufacturers, and offers a more
collaborative and less time-stringent process. We also explain the
steps that anyone can take to request a reconsideration of an existing
NCD.
L. How To Access CMS's Home Page
Our home page can be accessed by entering ``http://www.cms.hhs.gov.
'' To access information about our coverage process,
select ``Development of Coverage Policies'' and then ``Medicare
Coverage Process,'' or http://www.cms.hhs.gov/coverage.
V. Collection of Information Requirements
Under the Paperwork Reduction Act (PRA) of 1995, we are required to
provide 60 days notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of PRA requires that we solicit
comment on the following issues:
[sbull] Need for the information collection and its usefulness in
carrying out the proper functions of our agency. ?
[sbull] Accuracy of our estimate of the information collection
burden.
[sbull] Quality, utility, and clarity of the information to be
collected.
[sbull] Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
However, the collection requirements referenced in section IV.B
``What Constitutes a Complete, Formal Initial Request for a National
Coverage Determination or Formal Request for Reconsideration'' of this
notice, are currently approved under OMB approval number 0938-0776.
[[Page 55641]]
VI. Regulatory Impact Statement
We have examined the impacts of this notice as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review)
and the Regulatory Flexibility Act (RFA) (September 19, 1980 Pub. L.
96-354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more annually). Since this notice
revises the process we will use to make an NCD for a specific item or
service and has no economic impact on the Medicare program, we have
determined this is not a major notice.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $5 to $25
million or less annually. We have determined that this notice will not
have a significant economic impact on a substantial number of small
entities. We believe that few small entities will submit requests. We
estimate that approximately five beneficiaries or small entities may
submit a request in a year.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We have determined that
this notice will not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. We have determined that this notice will not
have a consequential effect on the governments mentioned or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State,
local, or tribal governments, preempts State law, or otherwise has
Federalism implications. We have determined that this notice does not
significantly affect the rights, roles, and responsibilities of State,
local, or tribal governments.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
Authority: Sections 1862, 1869(f), and 1871 of the Social
Security Act (42 U.S.C. 1395y, 1395ff(b)(3), and 1395hh).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare-Hospital Insurance; and Program No. 93774, Medicare-
Supplementary Medical Insurance Program).
Dated: September 15, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
Dated: September 15, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-24361 Filed 9-25-03; 8:45 am]
BILLING CODE 4120-01-P