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55634 Federal Register / Vol. 68, No.

187 / Friday, September 26, 2003 / Notices

Approved CFR sections in title 42, title 45, and title 20 (note: sections in title 45 are preceded by ‘‘45 CFR,’’ and sections
OMB control Nos. in title 20 are preceded by ‘‘20 CFR’’)

0938–0897 .............
412.22, 412.533.

[FR Doc. 03–24069 Filed 9–25–03; 8:45 am] service of the U.S. Government Printing Historically, we have based our
BILLING CODE 4120–03–P Office. The Web site address is: http:// coverage determinations on descriptive
www.access.gpo.gov/nara/index.html. information, and scientific and clinical
evidence. Under the revised BIPA
I. Background
DEPARTMENT OF HEALTH AND coverage process, we will continue to
HUMAN SERVICES In the April 27, 1999 Federal Register use descriptive information, and
(64 FR 22619), we published a notice scientific and clinical evidence as a
Centers for Medicare & Medicaid that announced changes to our internal basis for our coverage determinations.
Services procedures for developing a national
coverage determination (NCD) and II. Purpose of This Notice
[CMS–3062–N]
making the NCD process more open and This notice outlines the process we
RIN 0938–AK61 understandable to the public. As we will use to make an NCD under the
strive for continuous improvement of Medicare program. It sets forth the steps
Medicare Program; Revised Process our processes, and in recognition of the we are taking to make the NCD process
for Making Medicare National changes that section 522 of the more efficient, while maintaining as
Coverage Determinations Medicare, Medicaid, and SCHIP open and transparent a process as
AGENCY: Centers for Medicare & Benefits Improvement and Protection appropriate. It describes the following:
Medicaid Services (CMS), HHS. Act of 2000 (BIPA) requires, we are • A tracking system that provides
ACTION: Notice. revising our process for developing an public notice of our acceptance of a
NCD in order to make the process more complete, formal request and
SUMMARY: This notice revises the efficient and ensure that we have access subsequent actions in a web-based
process we will use to make a national to all relevant information to make fully format.
coverage determination for a specific informed decisions. (BIPA, Pub. L. 106– • The process we will institute to
item or service under sections 1812, 554, was enacted on December 21, afford notice and opportunity to
1832, 1861, 1862, 1869, and 1871 of the 2000.) The processes described in this comment before implementation of an
Social Security Act, as revised by notice apply to both scope of benefit NCD.
sections of the Medicare, Medicaid, and and section 1862(a)(1) determinations as • Information that does and does not
SCHIP Benefits Improvement and defined in the Social Security Act (the constitute a complete, formal request.
Protection Act of 2000. This notice Act). This notice replaces the April 27, • The process for asking us to
further clarifies our decision-making 1999 notice and will be effective on reconsider an existing NCD based on
process and increases the opportunities October 27, 2003. Improvements new information, including new
for public participation. include the following: medical or scientific evidence.
• Updating and organizing the • The basis and purpose of a decision
EFFECTIVE DATE: This notice is effective
reconsideration process into one memorandum and where it can be
on October 27, 2003.
section, and distinguishing it from an accessed on our Web site.
FOR FURTHER INFORMATION CONTACT:
initial request to make an NCD. • The revisions made to the NCD
Vadim Lubarsky, (410) 786–0840. process under BIPA, including a
• Defining, streamlining, and
SUPPLEMENTARY INFORMATION: organizing the contact/inquiry response to public comments, and how
Availability of Copies and Electronic information into one section. these revisions affect the current NCD
Access Copies: To order hard copies of • Revising, formalizing, and updating process and any subsequent challenges
the Federal Register containing this the elements that constitute a complete, to an NCD.
document, send your request to: New formal request to reflect best practices. In addition, we will continue to
Orders, Superintendent of Documents, • Adding a section on information pursue an ongoing effort to work with
PO Box 371954, Pittsburgh, PA 15250– that does not constitute a complete, various sectors of the scientific and
7954. Specify the date of the issue formal request. medical community to develop and
requested and enclose a check or money • Updating and clarifying the publish on the CMS Web site
order payable to Superintendent of conditions for acceptance of a complete, documents that describe our approach
Documents, or enclose your Visa or formal request. when analyzing scientific and clinical
Master Card number and expiration • Making it clear that all evidence evidence to develop an NCD. Interested
date. Credit card orders can also be currently available must be adequate for parties will be able to offer comments.
placed by calling the order desk at (202) us to conclude that the item or service Accordingly, these documents will
512–1800, or by faxing to (202) 512– is reasonable and necessary. make our coverage process more open
2250. The cost for each copy is $9. As • Establishing two main tracks for the and offer the public a better
an alternative, you can view and initial NCD request. One track is a understanding into our NCD process.
photocopy the Federal Register highly time-structured track only In our April 1999 notice, we
document at most libraries designated available to aggrieved parties (section announced that we anticipated
as Federal Depository Libraries and at IV.E track #2), as defined in section 522 publishing a final coverage criteria rule
many other public and academic of BIPA. The other track is open to that would be followed by sector-
libraries throughout the country that anyone, including aggrieved parties, specific guidance documents (64 FR
receive the Federal Register. beneficiaries, and manufacturers, and 22620). Since then, we published a
This Federal Register document is offers a more collaborative and less notice of intent to engage in rulemaking
also available from the Federal Register time-stringent process (section IV.E for coverage criteria (May 16, 2000, 65
online database through GPO Access, a track #1). FR 31124) and had a subsequent town

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Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Notices 55635

hall meeting. Given that there are categories are defined more broadly could not be reviewed by administrative
substantial competing interests about than others. Specific health care law judges (ALJs). Effective October 1,
the coverage criteria, we believe it best services must fit into one of these 2001, BIPA expanded the definition of
not to pursue rulemaking. In the benefit categories, and not be otherwise NCDs, and provides that all NCDs shall
meantime, as we have done in the past excluded, to be eligible for coverage not be reviewed by ALJs under section
35 years, we would continue to need to under the Medicare program. 1869(f)(1) of the Act.
make coverage decisions and interpret The Act does not contain a It is important to distinguish between
what is ‘‘reasonable and necessary.’’ We comprehensive list of specific items or a decision memorandum and an NCD.
believe that in the interest of expediting services eligible for Medicare coverage. The decision memorandum is the public
NCDs and making the process as Rather, it lists categories of items and document that lays out and describes
predictable as possible that, in the services, and vests in the Secretary the the analytic framework for our decision
interim, nonbinding sector-specific authority to make determinations about on a topic under NCD review. Its
guidance documents would be helpful. which specific items and services purpose is to inform the reader of the
Sector-specific guidance documents within these categories can be covered decision, the reasons for the decision
refer to how our expectations and under the Medicare program. That is, and process followed, and provide a
evaluation of evidence may differ in the Act allows Medicare to cover summary of the evidence considered.
some respects depending on the nature medical devices, surgical procedures, The decision memorandum alerts the
of the topic under review. Evidence can and diagnostic services, but generally public of our intent to implement the
vary greatly, for example, between a does not identify specific covered or decision at some point in the future.
diagnostic and an item of DME or excluded items or services. The NCD itself follows the decision
between a near-term fatal condition and Medicare payment is contingent upon memorandum, sometimes by a number
a life-long chronic condition. a determination that a service meets a of months. It is the formal instruction to
Thus, we are notifying the public that benefit category, is not specifically our claims processing contractors
we may choose to publish sector- excluded from coverage, and the item or regarding how to process claims (when
specific guidance documents even in service is ‘‘reasonable and necessary.’’ to pay, when not to pay, pay only when
the absence of a final rule. We will Section 1862(a)(1)(A) of the Act states certain clinical conditions are met).
consider doing so as the need arises. that, subject to certain limited Those instructions have a specific
This is also notice that we currently do exceptions, no payment may be made effective date dictating when claims will
not plan to develop a proposed rule for any expenses incurred for items or be processed according to the new
based on the May 2000 Notice of Intent. services that are not ‘‘reasonable and criteria.
Section 522(b) of BIPA amends necessary’’ for the diagnosis and Generally, once we receive a complete
section 1862(a) of the Act to require the treatment of illness or injury or to formal request, it takes 90 days to
Secretary ‘‘to make available to the improve the functioning of a malformed develop a decision memorandum. As
public the data (other than proprietary body member. For over 30 years, we noted above, the decision memorandum
data) considered in making the have exercised these authorities to make is not the NCD, but rather is one step
determination.’’ In a notice of proposed a coverage determination regarding towards making an NCD for an item or
rulemaking published on August 22, whether a specific item or service meets service. After the decision
2002 (67 FR 54534), we described the one of the broadly defined benefit memorandum is prepared, we must
process for handling proprietary categories and can be covered under the prepare the actual NCD. The NCD may
information related to NCDs. After Medicare program. be issued as a manual instruction or
As revised by section 522 of BIPA, an other document such as a program
considering public comments, we will
NCD is now defined to be a memorandum, ruling, or Federal
establish and announce a policy that
determination by the Secretary with Register notice. The NCD may be
addresses that issue and defines
respect to whether or not a particular accompanied by additional information
‘‘proprietary’’ data in the final rule. item or service is covered nationally for our contractors that is necessary to
III. Medicare Coverage—General under title XVIII of the Act, but does not ensure that Medicare claims will be
Principles include a determination about which properly processed when the NCD is
code, if any, is assigned to a particular effective. As noted above, except in very
A. Statutory Authority item or service covered under title limited circumstances, preparing the
Administration of the Medicare XVIII, or a determination with respect to NCD will occur after this 90-day review
program is governed by title XVIII of the the amount of payment for a particular process.
Act. Under the Medicare program, the covered item or service. We expect to make any payment
scope of benefits available to eligible In general, an NCD is a national changes or other systems changes
beneficiaries is prescribed by law and policy statement granting, limiting, or dictated by the NCD instructions
divided into several main parts. Part A excluding Medicare coverage for a effective within 180 calendar days of the
is the hospital insurance program, and specific medical item or service. Often, first day of the next full calendar quarter
Part B is the voluntary supplementary an NCD is written in terms of a that follows the date we issue the
medical insurance program. particular patient population that may decision memorandum. Thus, the
The scope of benefits under Part A receive (or not receive) Medicare decision memorandum and payment
and Part B is defined in the Act. See reimbursement for a particular item or change can take up to 270 days from the
sections 1812 (scope of Part A), 1832 service. An NCD is binding on all date a formal request for an NCD is
(scope of Part B); and 1861(s) (definition Medicare carriers, fiscal intermediaries accepted for review by CMS. The date
of medical and other health services). (FIs), quality improvement when a Medicare beneficiary may obtain
Part C, known as the Medicare+Choice organizations (QIOs), health the item or service and receive Medicare
program, includes at a minimum, all of maintenance organizations (HMOs), payment for that item or service under
the items and services (other than competitive medical plans (CMPs), and an NCD that expands coverage will not
hospice care) available under Part A and health care prepayment plans (HCPPs). be known until the NCD is completed
Part B to individuals residing in the area Before October 1, 2001, NCDs made and has been assigned an effective date.
served by the plan. Some benefit under section 1862(a)(1) of the Act The NCD will be implemented by all of

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55636 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Notices

our contractors on the effective date. for use by consumers, generally we will time-structured. The other track is open
Additional details concerning this not accept a request for a device or to anyone, including aggrieved parties,
process, as well as certain limited pharmaceutical that has not been other beneficiaries, and manufacturers,
exceptions, are described later in this approved or cleared for marketing by and offers a more collaborative and less
notice. the FDA for at least one indication; one time-stringent process. The NCD
exception is Category B IDE devices. An development process under BIPA-
B. Medicare Contractors and Coverage
IDE Category B device is a non- legislated time frames will only be
Policies
experimental/investigational device for initiated when we receive a complete,
We contract with private insurance which the incremental risk is the formal request from an aggrieved party.
companies, referred to as carriers and primary risk in question (that is,
FIs, to process Medicare claims; that is, underlying questions of safety and A. Informal Contacts and Inquiries
claims-payment contractors. Local QIOs effectiveness of that device type have The public frequently raises general
are also involved in the claims been resolved), or it is known that the questions about the coverage of items
adjudication process. We refer to all of device type can be safe and effective and services to us by telephone, the
these entities as ‘‘Medicare contractors.’’ because, for example, other postal mail system, electronic means, or
Medicare contractors review and manufacturers have obtained FDA in person. These questions may include,
adjudicate claims to ensure that approval or clearance for that device but are not limited to, asking us to
Medicare payments are made only for type. explain the current coverage of a
those items or services covered under Both CMS and the FDA review particular item or service, or requesting
Medicare Part A or Part B. In the scientific evidence, and may review the assistance with, or advice about, a
absence of a specific NCD, coverage same evidence, to make purchasing and possible submission of a formal request
determinations are made locally by the regulatory decisions, respectively. for an NCD. We consider all of these
Medicare contractors within the However, CMS and its contractors make contacts to be informal. Although
boundaries established by the law. coverage determinations and the FDA informal contacts are not confidential,
Sometimes these determinations are conducts premarket review of products we will not announce the substance of
made on a claim-by-claim basis. under different statutory standards and these contacts on our Web site.
Medicare contractors will also publish different delegated authority (67 FR If the requestor asks for specific
local coverage determinations (LCDs) 66755, November 1, 2002). Whereas the information about how to request an
that will provide guidance to the public FDA must determine that a product is NCD, we will advise them on
and medical community within a safe and effective as a condition of implications of such a request and
specified geographic area. An LCD is approval, CMS must determine that the explain what is required for us to accept
defined in section 522 of BIPA as a product is reasonable and necessary as a submission as a complete, formal
determination made by an FI or a carrier a condition of coverage under section request. We will offer suggestions to the
under Medicare Part A or Part B, as 1862(a)(1)(A) of the Act. CMS adopts requestor to clarify the amount and kind
applicable, for whether or not a FDA determinations of safety and of information necessary for us to
particular item or service is covered on effectiveness, and CMS evaluates evaluate whether an item or service is
an intermediary-wide or carrier-wide whether or not the product is reasonable ‘‘reasonable and necessary’’ under the
basis under those parts, in accordance and necessary for the Medicare Act, and in limited instances, we may
with section 1862(a)(1)(A) of the Act. population. Although an FDA-regulated offer to assist the requestor in meeting
An LCD may not conflict with an NCD, product must receive FDA approval or these requirements.
but the LCD may supplement an NCD. clearance (unless exempt from the FDA
premarket review process) for at least B. What Constitutes a Complete, Formal
C. Procedural one indication to be eligible for Initial Request for a National Coverage
We continue to expect that all Medicare coverage, except for Category Determination or Formal Request for
evidence currently available must be B devices under an IDE clinical trial (see Reconsideration
adequate for us to conclude that the 60 FR 48417, September 19, 1995), FDA We consider a request to be a
item or service is reasonable and approval/clearance alone does not complete, formal request, only if all of
necessary. In the absence of adequate generally entitle that device to coverage. the following conditions are met:
evidence, we may conclude that the • The formal request letter must be in
item or service is not reasonable and IV. CMS’s Process for Making National
writing.
necessary. Coverage Determinations • The formal request letter and
There are several ways an individual supporting documentation must be
D. Differences Between Food and Drug or entity can contact us about NCDs. submitted electronically (unless there is
Administration (FDA) and CMS Review One approach involves informal good cause for only a hardcopy
Parties interested in the coverage of a contacts, discussed in section IV.A of submission).
drug or device (other than a Category B this notice. The other approach involves • The requestor must identify the
investigational device exemption (IDE) ‘‘formal requests.’’ request as a ‘‘formal request for an
device, which is addressed through a If we have not issued an NCD for a NCD’’ or a ‘‘formal request for
separate process as described in 42 CFR particular item or service, an external reconsideration’’ and identify the NCD
405.201 through 405.215) may contact requestor may use one of two formal development track chosen (described in
us with an inquiry on Medicare tracks to submit a request to make an detail in section IV.E of this notice).
coverage while the particular drug or initial NCD. One track, established by • The requestor must state the benefit
device is proceeding through the Food section 522 of BIPA, is available only to category or categories of the Medicare
and Drug Administration (FDA) aggrieved parties, as defined by statute program to which the requestor believes
premarket review process. We are to be ‘‘individuals entitled to benefits the item or service applies. Examples of
willing to meet and discuss issues under Part A, or enrolled under Part B, benefit categories may include durable
within this context. Because the FDA is or both, who are in need of the items or medical equipment, physician services,
charged with regulating whether devices services that are the subject of the inpatient hospital services, and
or pharmaceuticals are safe and effective coverage determination’’ and is highly diagnostic tests. The requestor may

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recommend one or more benefit population. using the equipment for which the
categories for the item or service and ++In the case of an aggrieved party, request is made.
must submit supporting documentation how that party is ‘‘in need’’ of the • Information provided is not
justifying the recommendation. We item or service. supported by scientific or clinically
must have all information, both from the —A description of any clinical trials or relevant data.
requestor and internally, to make a studies currently underway that
• Information provided is not
benefit category determination, before might be relevant to a decision
relevant to the item or service for which
the request can be considered complete. regarding coverage of the item or
the request is made.
If an item or service can fit into more service.
than one benefit category, we have the —Information involving the use of a • Request does not clearly identify
discretion to assign it to the most drug or device subject to FDA the statutorily defined benefit category
appropriate benefit category. regulation as well as the status of to which the requestor believes the item
• The requestor must submit current FDA regulatory review of or service applies and does not contain
adequate supporting documentation the drug or device involved. An enough information for us to make a
along with the formal letter, including FDA regulated article would benefit category determination.
the following: include the labeling submitted to • Request is considered an informal
—A full and complete description of the the FDA or approved by the FDA contact described in section IV.A.
item or service in question. for that article, together with an
D. Acceptance of a Complete, Formal
—A specific, detailed description of the indication of whether the article for
National Coverage Determination or
proposed use of the item or service, which a review is being requested
Reconsideration Request
including the target Medicare is covered under the labeled
population and the medical indication(s). (We recognize that the In the rare event that we have a large
condition(s) for which it can be labeling on FDA-approved products volume of NCD requests to review at
used. sometimes changes. For purposes of once, we retain the flexibility to
—A compilation of the supporting our review, we are interested in the prioritize these requests based on the
medical and scientific information labeled indications at the time a magnitude of the impact on the
currently available that measures requestor submits a formal request. Medicare program and beneficiaries.
the medical benefits of the item or If, during our review, the labeled This flexibility will enable us to ensure
service. This may include portions indication or status of a pending that we can pay priority attention to
of primary study data that have FDA approval or clearance changes, those requests that have potential for
been separately submitted to the we expect the requestor to notify significant impact on our beneficiaries—
FDA as part of its submission us.) a life-saving cancer treatment, a
—In the case of items that are eligible breakthrough in cardiac pacing, etc. In
package and are deemed most
for a 510(k) clearance by the FDA, order to do so, we may have to
relevant for our review.
identification of the predicate temporarily suspend or diminish our
—If the requestor has submitted an
device to which the item is claimed review of other issues that, while
application to the FDA for market
to be substantially equivalent. important, do not have the same
approval of the product for which
coverage is sought, then a copy of C. When a National Coverage profound potential. We expect to use
the ‘‘integrated summary of safety Determination Request or any such authority infrequently.
data’’ and ‘‘integrated summary of Reconsideration Request Is Not For these cases, two lists, an accepted
effectiveness data,’’ or the Considered Complete and Formal list and lower priority list (based on
combined ‘‘summary of safety and impact) will be maintained and
When a requestor submits a request
effectiveness data,’’ portions of the available on our Web site; the lower
for an NCD or reconsideration, we will
FDA application should be priority list will be processed based on
review the materials to determine if it
included in the request for an NCD. the order of acceptance as resources
meets the definition of a complete,
These documents will ensure that become available. Requestors can use
formal request as defined in section IV.B
our review is comprehensive. this public priority list to verify whether
of this notice. If the request lacks
—An explanation of the design, the request has been accepted, the status
adequate supporting documentation to
purpose, and method of using the of the request, and where the requestor
enable us to conduct our review, we
item or equipment, including is in the order of priorities.
will notify the requestor and explain our
whether the item or equipment is rationale. If we accept the request, we Upon acceptance of a request, we will
for use by health care practitioners will notify the requestor of the notify the requestor and post a tracking
or patients. acceptance. We will also post our sheet announcing our review of this
—A statement from the requestor (in acceptance on our Web site under our issue on the list of pending coverage
cases in which there is an aggrieved list of pending coverage issues. issues on the coverage Web site. Posting
party, the statement must be from As we previously stated, we will not of the tracking sheets permits interested
that party) containing the following: consider a request to be a complete, individuals to participate and monitor
++An explanation of the relevance of formal request if any of the following the progress of the NCD process. This is
the evidence selected. occur: a key element in making our NCD
++Rationale for how the evidence • Request is not in writing. process more efficient, open, and
selected demonstrates the medical • Request is not accompanied by accessible to the public. Once a formal
benefits for the target Medicare sufficient, supporting documentation. request is posted, there will be an
population. • Information provided does not opportunity for public participation and
++Information that examines the address relevance, usefulness, or the submission of additional evidence. (If
magnitude of the medical benefit. medical benefits of the item or service after accepting the request, we decide
++Reasoning for how coverage of the to the Medicare population. that the request does not fall under a
item or service will help improve • Information does not fully explain benefit category, we will issue a
the medical benefit to the target the design, purpose, and method of noncoverage NCD.)

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E. Review of a Complete, Formal request that the Secretary issue a considered during the initial review,
Request for a National Coverage national coverage or noncoverage that is, results from new clinical trials,
Determination determination with respect to a new scientific or medical publications,
Development of a complete, formal particular type or class of items or or studies supporting the request.
services, if the Secretary had not • Arguments that our conclusion
request for an NCD can be initiated in
previously made a coverage or materially misinterpreted the existing
one of three ways:
noncoverage determination. Thus, this evidence at the time the NCD was made.
Track #1: Request for New National • If the request is for reconsideration
Coverage Determinations Initiated by track can be invoked only for an initial
request if we have not issued a coverage of the benefit category determination,
Any Party, Including Beneficiaries, the requestor must recommend a benefit
Manufacturers, Providers, or Suppliers. or noncoverage NCD.
As noted in section E, track 1, category and, in support of the
A request to make an NCD can be recommendation, submit either (1) new
generally we expect to make a payment
received from an individual or entity information that was not considered
change effective within 180 calendar
who identifies an item or service as a during the initial benefit category
days of the first day of the next full
potential benefit (or to prevent potential determination, or (2) arguments that our
calendar quarter that follows the date
harm) to the Medicare population; this determination decision materially
we issue a decision memorandum. This
requestor can be either an aggrieved misinterpreted the applicable statutory
time is necessary to identify and make
party as defined by section 522 of BIPA, any necessary coding, payment, and provisions, the applicable regulatory
or a nonaggrieved party. This may systems changes. However, if an provisions, or the existing evidence at
include a manufacturer, provider, aggrieved party initiates a request under the time the benefit category
supplier, or party who requests our track 2, we expect to issue a decision determination was made.
consideration of a particular issue for an memorandum and an NCD (that is, the We will not accept a request for
NCD. All requests must meet the manual instruction or other appropriate reconsideration that is not submitted in
requirements in this notice. An initial document) to our contractors by no later writing, identified as ‘‘A Formal Request
request can only be made if we have not than the end of the 90-day period, in for Reconsideration,’’ and accompanied
previously issued an NCD for a accordance with the statutory by the required, additional, supporting
particular item or service. timeframe. The NCD will include the information as described more fully in
If an individual or other entity effective date of the policy. In cases sections IV.B and IV.C. Upon receipt of
initiates a request, we expect to where we are not able to complete our the additional information as outlined
generally issue a decision memorandum review within this 90-day timeframe, above, we will consider this a formal
within a 90-day period. More complex the law requires that we issue a notice request for an NCD reconsideration and
issues, or issues that require referral to that includes an identification of the initiate the reconsideration process. We
the Medicare Coverage Advisory remaining steps in the review process generally expect to complete the
Committee or for a Technology and a deadline by which we will reconsideration process and issue a
Assessment, would generally take complete that review. decision memorandum within 90
longer than 90 days. Generally, we A decision memorandum will include calendar days. Our current NCD will
expect to make a payment change a clear statement of the basis for the remain in effect during the
effective within 180 calendar days of the determination including our responses reconsideration process until we issue a
next full calendar quarter that follows to comments we receive from the revised NCD, if applicable.
the date we issue the decision public. The actual effective date of the A reconsideration of an NCD must be
memorandum. NCDs will depend on whether we must distinguished from a challenge to an
Though the 90-day clock in this make changes to our claims processing existing NCD. Under section 522 of
option is not as strict as the process systems to allow Medicare payment; BIPA and section 1869(f)(1) of the Act,
used only for aggrieved parties, this this step is not included in the 90-day aggrieved parties may elect to challenge
track offers a more collaborative process clock. However, whether systems an existing NCD. On August 22, 2002,
than track two. The opportunities for changes are needed and how long they we published a proposed rule (67 FR
greater collaboration will flow from the may take to implement will be reflected 54534) that addresses procedures for the
more flexible approach to the 90-day in the effective date contained in the Departmental Appeals Board (Board)
clock. Requestors and other interested NCD. review process under section 522 of
parties will be able to provide Track #3: Internally Generated BIPA.
additional information, clarify issues, Request. A request for review of new clinical
and engage in dialogue as questions We may generate a request to make an and scientific evidence that was
arise. The ability to follow this path is NCD in the interest of the general health published or available only after the
necessarily constrained when we are and safety of Medicare beneficiaries. date the initial NCD was issued may be
under a strict, narrowly-framed 90-day Generally, this process is similar to the submitted as a request for
response timeline. externally generated request process. reconsideration. The reconsideration of
Track #2: Request by an Aggrieved an existing NCD is part of our coverage
Party for New National Coverage F. NCD Reconsideration Process determination process so that our
Determinations Where There Were No When an NCD currently exists, any medical and scientific experts have an
National Coverage or Noncoverage individual or entity may request that we opportunity to examine this new
Determinations. reconsider any provision of that NCD by evidence. Thus, a reconsideration of an
Aggrieved parties are defined in filing an acceptable request for an NCD NCD is separate and distinct from an
section 1869(f)(5) of the Act as reconsideration. We will consider a initial NCD request and separate from
‘‘individuals entitled to benefits under request to revise an existing NCD at any the Board review process under section
Part A, or enrolled under Part B, or both, time, but only if the requestor presents 522 of BIPA.
who are in need of the items or services documentation that meets either of the As noted above, because
that are the subject of the coverage following criteria: reconsiderations are outside of the strict
determination.’’ Section 1869(f)(4) of the • Additional material medical and/or BIPA timeline, they offer several
Act permits these individuals to make a scientific information that was not alternative opportunities for individuals

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and entities that may make the process memorandum and before implementing coverage determination on our Web site.
more advantageous: the NCD for the particular item or The decision memorandum is not
• The reconsideration process does service. binding on our contractors, and no
not involve a formal adjudicatory We will use the remainder of the 90­ change in existing policy is effective
hearing. day timeframe to research and evaluate until we publish the revised NCD in the
• The process may be more the NCD request. This process entails, relevant coverage manual or other
collaborative with the original clinical but is not limited to, the following issuance with a specific effective date.
reviewers at CMS, with greater activities: Generally, by the end of the 270-day
opportunity for clarification and • Review pertinent data and scientific period following formal acceptance of
dialogue. literature a requestor submits. an NCD or reconsideration request, we
• Research relevant sources of will make effective the payment changes
G. Improvements in the National
Coverage Determination Process evidence in addition to evidence a for an NCD on that request.
requestor submits. These may include, We will create and maintain a
Our 90-day clock for considering or but are not limited to, other peer- complete and adequate record of all
reconsidering coverage requests will reviewed medical, technical, and NCDs that are developed. The record
begin once we have accepted the scientific literature, recommendations of will provide an explanation of our
complete, formal request. Acceptance of expert panels, unpublished data used to rationale for an NCD and include the
a complete formal request begins a secure FDA approval, and clinical evidence we considered. This record
series of internal timeframes over the experience. will form the basis for any subsequent
course of 90 days. • Formulate inclusion and exclusion requests for reconsideration of the NCD,
We will post the acceptance of a parameters for literature searches. and will also serve as the formal record
complete, formal request on our Web • Develop analytic questions needed of review for any subsequent challenges
site. This initiates a 30-day comment for subsequent policy formulation. to the NCD under section 1869(f)(1) of
(public input) period, during which • Determine whether the issue the Act. Information contained in the
submission of evidence or other warrants further review either by the record will conform to the proprietary
comments relevant to the request will be MCAC or through a health technology data policy in the 522 BIPA final rule.
accepted in accordance with section assessment (HTA) from an agency such
522(b) of BIPA. During this time, the as the Agency for Healthcare Research H. Health Technology Assessments
public, including the requestor of the and Quality (AHRQ). (HTAs)
NCD or reconsideration, may submit • Evaluate all pertinent evidence. During our review of an NCD request,
comments and additional information or In general, by the end of the 90-day we may require an HTA to complete our
evidence of studies regarding the NCD period following formal acceptance of review. Generally, an HTA provides an
issue under review. We will provide a an NCD or reconsideration request, we independent analysis of all scientific
response to these comments in our will issue a decision memorandum on and clinical evidence available on a
decision memoranda. that request. We will outline, in a particular health care technology. We
There may be times, such as a public decision memorandum, one of the may request an HTA when there is
health emergency, when there is good following three actions: conflicting or complex medical and
cause for developing an NCD more (1) Our intention to issue an NCD, scientific literature available, or when
rapidly, and we may need to reduce the with or without limitations. we believe an independent analysis of
time period for public comment. For (2) Our intention to issue a national all relevant literature will assist us in
instance, in the case of a national noncoverage determination. determining whether an item or service
disaster, it may be necessary to quickly (3) A determination that an NCD or a is reasonable and necessary. We may
modify an NCD to facilitate access to noncoverage determination is not also request an HTA in preparation for
covered services in a particular service appropriate at the present time. an upcoming MCAC meeting.
area. In these emergency situations, we We will provide notice if we We will obtain services from the
may expedite the development of an determine that additional time will be Agency for Healthcare Research and
NCD and reduce the notice and necessary to complete an NCD review. Quality, or a third party with the
comment period, during which We will identify the remaining steps in requisite experience in HTA and
evidence can be submitted. For the review process and the deadline by evidence-based medicine to ensure the
instance, following the flooding in which we will complete the review and technical competence and fairness of
Texas in the summer of 2001, we issued take an action described in (1), (2), or (3) the HTA.
an NCD shortly after a request was made above. This option may include such If we receive a formal request for
in order to permit payments for actions as referring the request to the coverage on an item or service for which
transplant recipients. MCAC or to a third party for an HTA as an HTA is already underway, we will
After the close of the 30-day comment described in section IV.H of this notice. inform the subsequent requestor of the
(public input) period, we will only A decision memorandum is not an status of the pending HTA, as well as an
accept additional information or NCD, but rather a statement announcing estimated time for completion. Any
evidence from the public if we request our intent to issue policy. The decision request for an HTA will be reflected on
information or during subsequent memorandum details the analysis of the our Web site tracking sheet, followed by
Medicare Coverage Advisory Committee scientific and clinical literature, and either the executive summary or the full
(MCAC) proceedings, if applicable. We provides the rationale for the coverage and complete HTA.
must strictly enforce the 30-day determination. The decision
comment (public input) period, in memorandum will include the rationale I. Medicare Coverage Advisory
which evidence can be submitted, to we used in reaching our determination. Committee (MCAC)
ensure that we make timely decisions. If we make a coverage determination to On December 14, 1998, we published
We will consider and incorporate the modify an existing NCD that results in a notice in the Federal Register (63 FR
relevant public input, and any a reduction of coverage, in whole or in 68780) announcing establishment of the
subsequent information received during part, we will also publish a notice in the MCAC, and requesting nominations for
MCAC meetings, in the decision Federal Register and announce our membership. The MCAC has met

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55640 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Notices

periodically since September 1999, to public comment. We ask that all NCD is binding on all Medicare
discuss coverage issues, make requests for presentation and contractors; that is, carriers, FIs, QIOs,
judgments about the adequacy and consideration of evidence to the MCAC, HMOs, CMPs, and HCPPs. NCDs that
conclusions of existing scientific submit a request to us in writing at least expand coverage are binding on
evidence, make recommendations to us 20 days before the meeting. The MCAC Medicare+Choice plans. We will also
about whether particular items or considers all available evidence, publish a reference to each national
services can be considered ‘‘reasonable presentations, and comments. The coverage decision in the Federal
and necessary’’ under title XVIII of the MCAC makes recommendations to us. Register as part of our quarterly listing
Act, and to advise the Secretary on Those recommendations are advisory. of program issuances.
matters relating to the interpretation, We expect the MCAC to make
application, or implementation of recommendations as expeditiously as K. Essential Differences in This Notice
section 1862(a)(1) of the Act. The MCAC possible. We will provide an estimate of In summary, this notice distinguishes
operates under a 2-year charter. The when we believe we will receive the between the two tracks available for an
MCAC charter is available on our Web MCAC recommendation. Once the external party to request a new NCD
site. MCAC makes a formal recommendation, when no NCD currently exists. For an
The primary role of the MCAC is to we will post it on our Web site. initial request, the highly time-
provide independent, expert advice and Generally, within 60 calendar days of structured track is only available to
assistance to us in making sound receiving the formal MCAC aggrieved parties, as defined in section
coverage decisions based upon the recommendation, we will issue a 522 of BIPA. The other track is open to
reasoned application of scientific decision memorandum. In the decision anyone, including aggrieved parties,
evidence. Voting members must possess memorandum, we will explain the beneficiaries, and manufacturers, and
the scientific and technical competence MCAC recommendation, and how it was offers a more collaborative and less
commensurate with this purpose. In considered in our final determination. time-stringent process. We also explain
addition, a consumer and industry the steps that anyone can take to request
J. Implementation of National Coverage
representative serve as nonvoting a reconsideration of an existing NCD.
Determinations
members on each panel. To ensure their
full participation, nonvoting members The general 90-day clock for NCD and L. How To Access CMS’s Home Page
have access to all information and data reconsideration requests described for Our home page can be accessed by
(other than information exempt from individuals who are not aggrieved entering ‘‘http://www.cms.hhs.gov.’’ To
disclosure relating to trade secrets or parties or aggrieved parties who elect access information about our coverage
where the disclosure would present a the collaborative approach includes process, select ‘‘Development of
conflict of interest) made available to time for the analysis, processing, and Coverage Policies’’ and then ‘‘Medicare
voting members. The MCAC meetings development of a decision Coverage Process,’’ or http://
are open to the public, and time is memorandum. Upon making a decision, www.cms.hhs.gov/coverage.
allotted for public comment on the numerous internal, related steps remain
particular coverage issue under before a payment change can take place. V. Collection of Information
consideration. We must determine which codes the Requirements
In general, we may refer a coverage providers, suppliers, and Medicare Under the Paperwork Reduction Act
issue to the MCAC if it meets any of the contractors will use for submission and (PRA) of 1995, we are required to
following conditions: payment of claims consistent with the provide 60 days notice in the Federal
• It is the subject of significant decision and issue corresponding Register and solicit public comment
scientific or medical controversy; that instructions. We must also determine before a collection of information
is, there is a major split in opinion the appropriate Medicare payment level. requirement is submitted to the Office of
among researchers and clinicians As previously mentioned, coding and Management and Budget (OMB) for
regarding the medical benefits of the payment decisions are not included review and approval. In order to fairly
item or service, the appropriateness of within the definition of an NCD for evaluate whether an information
staff or setting, or some other significant purposes of a Board review. Finally, collection should be approved by OMB,
controversy that would affect whether NCDs often require us to develop and section 3506(c)(2)(A) of PRA requires
the item or service is ‘‘reasonable and issue claims processing instructions to that we solicit comment on the
necessary’’ under the Act. our systems maintainers and Medicare following issues:
• It is the subject of controversy contractors to ensure accurate payment. • Need for the information collection
among the general public. Medicare contractors generally and its usefulness in carrying out the
• It has the potential to have a major implement systems changes at the start proper functions of our agency.
impact on a target population of the of a calendar quarter, and instructions • Accuracy of our estimate of the
Medicare program. are required well in advance of the information collection burden.
If we refer a coverage issue to the beginning of each quarter in order to • Quality, utility, and clarity of the
MCAC, we will schedule a public install and test the systems changes. information to be collected.
meeting to discuss the coverage issue The NCD (issued as a program • Recommendations to minimize the
under consideration. All MCAC memorandum, manual instruction, information collection burden on the
meetings are subject to the requirements Federal Register notice, or CMS ruling) affected public, including automated
of the Federal Advisory Committee Act. will include the effective date when our collection techniques.
We will publish a notice in the Federal Medicare contractors will implement However, the collection requirements
Register generally 30 days before any change in payment that may result referenced in section IV.B ‘‘What
holding an MCAC meeting. We will from the NCD. Generally, we expect to Constitutes a Complete, Formal Initial
announce in our notice the draft agenda, make a payment change effective within Request for a National Coverage
time, and place of the meeting so that 180 calendar days of the first day of the Determination or Formal Request for
all interested persons will have ample next full calendar quarter that follows Reconsideration’’ of this notice, are
notification. During the course of each the date we issue the decision currently approved under OMB
meeting, there will be time allotted for memorandum. As stated previously, an approval number 0938–0776.

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Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Notices 55641

VI. Regulatory Impact Statement have a consequential effect on the gene therapies, and human cellular and
We have examined the impacts of this governments mentioned or on the tissue-based products).
notice as required by Executive Order private sector. Date and Time: The workshop will be
12866 (September 1993, Regulatory Executive Order 13132 establishes held on October 23, 2003, from 8:30
Planning and Review) and the certain requirements that an agency a.m. to 5 p.m., and on October 24, 2003,
Regulatory Flexibility Act (RFA) must meet when it promulgates a from 8:30 a.m. to 5 p.m.
(September 19, 1980 Pub. L. 96–354). proposed rule (and subsequent final Location: The workshop will be held
Executive Order 12866 directs agencies rule) that imposes substantial direct at the Hyatt Regency Bethesda, One
to assess all costs and benefits of requirement costs on State, local, or Bethesda Metro Center, Bethesda, MD.
available regulatory alternatives and, if tribal governments, preempts State law, Contact Person: Gloria Blankenship,
regulation is necessary, to select or otherwise has Federalism CBER (HFM–49), Food and Drug
regulatory approaches that maximize implications. We have determined that Administration, 1401 Rockville Pike,
net benefits (including potential this notice does not significantly affect Rockville, MD 20852, 301–827–2000,
economic, environmental, public health the rights, roles, and responsibilities of FAX 301–827–3079, e-mail:
and safety effects, distributive impacts, State, local, or tribal governments. Blankenship@cber.fda.gov.
and equity). A regulatory impact In accordance with the provisions of Registration: Mail, e-mail, or fax your
analysis (RIA) must be prepared for Executive Order 12866, this notice was registration information (including
major rules with economically reviewed by the Office of Management name, professional degree, title, e-mail
significant effects ($100 million or more and Budget. address, firm name, address, telephone,
annually). Since this notice revises the Authority: Sections 1862, 1869(f), and and fax number) to Gloria Blankenship,
process we will use to make an NCD for 1871 of the Social Security Act (42 U.S.C. (see Contact Person) by October 10,
a specific item or service and has no 1395y, 1395ff(b)(3), and 1395hh). 2003. There is no registration fee for the
economic impact on the Medicare (Catalog of Federal Domestic Assistance public workshop. Because seating is
program, we have determined this is not Program No. 93.773, Medicare-Hospital limited, we recommend early
a major notice. Insurance; and Program No. 93774, Medicare- registration. There will be no onsite
The RFA requires agencies to analyze Supplementary Medical Insurance Program). registration.
options for regulatory relief of small If you need special accommodations
businesses. For purposes of the RFA, Dated: September 15, 2003.
due to a disability, please contact Gloria
small entities include small businesses, Thomas A. Scully,
Blankenship (see Contact Person) at
nonprofit organizations, and Administrator, Centers for Medicare & least 7 days in advance.
government agencies. Most hospitals Medicaid Services.
and most other providers and suppliers Dated: September 15, 2003. SUPPLEMENTARY INFORMATION: The
are small entities, either by nonprofit Tommy G. Thompson, purpose of this public workshop is to
status or by having revenues of $5 to provide a forum for sharing information
Secretary.
$25 million or less annually. We have and strategies to assist in the efficient
[FR Doc. 03–24361 Filed 9–25–03; 8:45 am]
determined that this notice will not and successful development of products
BILLING CODE 4120–01–P
have a significant economic impact on regulated by CBER and used for counter
a substantial number of small entities. terrorism efforts. CBER is interested in
We believe that few small entities will promoting a discussion of issues related
DEPARTMENT OF HEALTH AND
submit requests. We estimate that to the development of counter terrorism
HUMAN SERVICES
approximately five beneficiaries or products, including manufacturing and
small entities may submit a request in Food and Drug Administration clinical issues, and other relevant
a year. issues. The workshop is intended to
In addition, section 1102(b) of the Act Counter Terrorism Products Regulated help sponsors address commonly asked
requires us to prepare a regulatory by the Center for Biologics Evaluation questions and avoid common
impact analysis if a rule may have a and Research: Effective Strategies to misunderstandings and to provide
significant impact on the operations of Assist in Product Development; Public practical information on successful
a substantial number of small rural Workshop product development strategies.
hospitals. This analysis must conform to FDA invites participants to submit
the provisions of section 604 of the AGENCY: Food and Drug Administration, issues for discussion prior to the
RFA. For purposes of section 1102(b) of HHS. workshop. There will be an opportunity
the Act, we define a small rural hospital ACTION: Notice of public workshop. to raise additional questions and issues
as a hospital that is located outside of for discussion at the meeting. Mail or
a Metropolitan Statistical Area and has The Food and Drug Administration fax your issues and questions to Gloria
fewer than 100 beds. We have (FDA) is announcing a public workshop Blankenship (see Contact Person) by
determined that this notice will not entitled ‘‘Counter Terrorism Products October 10, 2003.
have a significant impact on the Regulated by the Center for Biologics FDA will post on CBER’s Web site
operations of a substantial number of Evaluation and Research: Effective (http://www.fda.gov/cber/) the agenda
small rural hospitals. Strategies to Assist in Product for this meeting, when finalized.
Section 202 of the Unfunded Development.’’ The purpose of the Transcripts: Please note that
Mandates Reform Act of 1995 also public workshop is to provide a forum transcripts of the meeting will not be
requires that agencies assess anticipated for discussing strategies to assist in the prepared.
costs and benefits before issuing any effective development of products
rule that may result in expenditure in regulated by the Center for Biologics Dated: September 17, 2003.
any 1 year by State, local, or tribal Evaluation and Research (CBER) that Jeffrey Shuren,
governments, in the aggregate, or by the may be used in counter terrorism efforts Assistant Commissioner for Policy.
private sector, of $110 million. We have (e.g., vaccines, blood and blood [FR Doc. 03–24303 Filed 9–25–03; 8:45 am]
determined that this notice will not products including immunoglobulins, BILLING CODE 4160–01–S

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