[Federal Register Volume 64, Number 80 (Tuesday, April 27, 1999)]
[Notices]
[Pages 22619-22625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-3432-GN]
RIN 0938-AJ31


Medicare Program; Procedures for Making National Coverage 
Decisions

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: General notice.

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SUMMARY: This notice announces the process we will use to make a 
national coverage decision for a specific item or service under 
sections 1862 and 1871 of the Social Security Act. This notice will 
streamline our decisionmaking process and will increase the 
opportunities for public participation in making national coverage 
decisions.

EFFECTIVE DATES: This notice is effective June 28, 1999.

FOR FURTHER INFORMATION CONTACT: Ron Milhorn, (410) 786-5663; Maria 
Ellis, (410) 786-0309, for a graphical representation of the process.

SUPPLEMENTARY INFORMATION:

Availability of Copies and Electronic Access

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    This Federal Register document is also available from the Federal 
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is http://www.access.gpo.gov/nara__docs/, by

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using local WAIS client software, or by telnet to swais.access.gpo.gov, 
then log in as guest (no password required). Dial-in users should use 
communications software and modem to call 202-512-1661; type swais, 
then log in as guest (no password required).

I. Background

    We published a notice on April 29, 1987 (52 FR 15560), that 
described the process we used to make Medicare coverage decisions, 
including decisions regarding whether new technology and services can 
be covered. We invited the public to comment on the procedures, and 
specifically on procedures for allowing greater public input into the 
coverage decisionmaking process when appropriate.
    In response to the comments we received on that notice, we 
developed a proposed rule. That proposed rule set forth our process and 
criteria for making coverage decisions under the Social Security Act 
(the Act). In addition, the proposed rule described the relationship 
between our coverage decisions and the roles played by the Food and 
Drug Administration (FDA) and other parties, including Medicare 
contractors. We published the proposed rule on January 30, 1989 (54 FR 
4302).
    We have made changes to our internal procedures in response to the 
comments we received following publication of the 1987 notice and the 
January 1989 proposed rule. In addition, over the past year, we have 
received numerous requests to revise our process to make it more open, 
responsive, and understandable to the public. We share the goal of 
increasing public participation in the development of Medicare coverage 
issues. This will assist us in obtaining the information we require to 
make a national coverage decision in a timely manner and ensuring that 
the Medicare program continues to meet the needs of its beneficiaries.

II. Purpose of This Notice

    We have decided not to adopt the January 29, 1989 proposed rule. 
This notice announces the process we will use to make a national 
coverage decision under the Medicare program. It sets forth the steps 
we are taking to make our national coverage decisionmaking process more 
open and understandable to the public. We intend to take the following 
steps:
     Explain why and how we make a national coverage decision 
and how we reconsider a previously-made decision. This notice outlines 
the review process and the steps involved. By offering this 
explanation, we hope to increase public awareness of the process we 
use, and to provide information about when and how the public may most 
effectively contact us to offer information on issues under 
consideration.
     Maintain a current list of issues we are considering for 
national coverage decisions. This list identifies our staff person 
responsible for reviewing each issue, the stage at which an issue is in 
the review process, and the materials we are reviewing to reach a 
decision on the issue.
     Make all of the above public and accessible using our Home 
Page (http://www.hcfa.gov) on the Internet as a primary tool for 
publicizing these matters. We believe use of our Home Page will offer 
quick and easy access that will enable the public to determine the 
status of any issue under review.
     Prepare and maintain a complete and indexed record for all 
issues that we review for national coverage decisions. This record, a 
summary of which will also be available on our Home Page as part of the 
record of the issue, will form the basis for any subsequent requests 
for reconsideration of the issue, as well as the formal record of 
review for any challenge to our coverage decision under section 
1869(b)(3) of the Act.
     Continue to review new medical and scientific information 
in order to modify a national coverage decision when appropriate.
    We are also announcing our intent to work with various sectors of 
the medical community to develop and publish guidance documents 
specific to their needs and interests. These ``sector-specific'' 
guidance documents will offer a more detailed explanation of how we 
would apply the general national coverage criteria to a new item or 
service proposed for coverage eligibility in the particular sector 
involved. Guidance documents will provide a vehicle for us to explain 
how the general criteria apply to the special circumstances unique to a 
particular sector of the health care industry. We will develop the 
guidance documents after we publish the proposed and final rules for 
the criteria we will use to make a national coverage decision.
    This notice is intended to provide clearer information on our 
national coverage decisionmaking process, and to ensure that it is open 
and understandable to the public. We would welcome comments from the 
public on our process. Comments may be submitted to us in writing 
through the traditional mail service, or through our Home Page 
identified in section IV.K. of this notice.

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 benefits available to 
eligible beneficiaries are called ``covered'' services.
    Medicare is a defined benefit program--the services covered are 
broadly defined in the Act, in what we call benefit categories. There 
are currently about 55 benefit categories in the Act, some broadly 
defined, others more narrowly defined. Specific health care services 
must fit into one of these benefit categories to be eligible for 
coverage under Medicare.
    The Act does not list the specific items and services eligible for 
coverage under the Medicare program. Rather, it lists categories of 
items and services, and vests in the Secretary the authority to make 
decisions about which specific items and services within these 
categories can be covered by the Medicare program. That is, the Act 
allows Medicare to cover medical devices, surgical procedures, and 
diagnostic services, but generally does not specify which particular 
medical devices, surgical procedures, or diagnostic services can be 
covered, or, conversely, are excluded from coverage. The Congress 
vested in the Secretary the authority to make these more specific 
decisions regarding the items and services eligible for coverage under 
Medicare. Section 1862(a)(1)(A) of the Act states, in part, that no 
payment may be made for any expenses for services that are not 
``reasonable'' and ``necessary'' for the diagnosis and treatment of 
illness or injury. For over 30 years, the Medicare program has 
exercised this authority to make coverage decisions regarding whether 
specific services that meet one of the broadly-defined benefit 
categories can be covered under the program.
    We previously proposed that we would establish the procedures we 
would follow for making national coverage decisions by issuing 
regulations. The Administrative Procedure Act (APA), however, exempts 
``rules of agency organization, procedure, or practice'' from the 
notice-and-comment rulemaking procedures (5 U.S.C. 553(b)(3)(A)). The 
primary purpose of the procedural rules exemption in the APA is to 
ensure that an agency retains latitude in organizing its internal 
operations. Additional flexibility is particularly important given the 
dynamic changes in the health care industry that may have a profound

[[Page 22621]]

effect on the health of Medicare beneficiaries.
    The Congress has provided that national coverage decisions may be 
issued without requiring us to engage in notice-and-comment rulemaking 
procedures (sections 1871(a)(2) and 1869(b)(3)(B) of the Act). National 
coverage decisions are our national policy statements granting, 
limiting, or excluding Medicare coverage for a specific medical 
service, procedure, or device. A national coverage decision is binding 
on all Medicare carriers, fiscal intermediaries, peer review 
organizations (PROs), health maintenance organizations (HMOs), 
competitive medical plans (CMPs), health care prepayment plans (HCPPs) 
and, in the future, program safeguard contractors (PSCs) when published 
in HCFA program instructions or in the Federal Register. In addition, 
national coverage decisions made under section 1862(a)(1) of the Act 
may not be disregarded, set aside, or otherwise reviewed by an 
administrative law judge during the administrative appeals process (42 
CFR 405.732 and 405.860).
    By establishing the process we will use in making a national 
coverage decision by procedural rules rather than notice-and-comment 
rulemaking, we believe we will better be able to serve Medicare 
beneficiaries. Using a procedural rule does not mean that the process 
that we will use will be changed frequently or in an arbitrary manner. 
Before implementing any changes to the national coverage decision 
process, we will provide advance public notice about those changes. In 
addition, we will separately provide notice and an opportunity for 
public comment on the substantive criteria we would use in making a 
national coverage decision.

B. Medicare Contractors and Coverage Policies

    We contract with private insurance companies, referred to as 
carriers and intermediaries to process Medicare claims (that is, 
claims-payment contractors). Local PROs (and, in the future, PSCs) are 
also involved in claims adjudication processes. We call all of these 
entities ``Medicare contractors.''
    Medicare contractors review and adjudicate claims for services to 
assure that Medicare payments are made only for services that are 
covered under Medicare Part A or Part B. In the absence of a specific 
national coverage decision, coverage decisions are made at the 
discretion of the local contractors.
    Contractors may also publish local medical review policies (LMRPs) 
to provide guidance to the public and medical community within a 
specified geographic area. These LMRPs explain when an item or service 
will be considered ``reasonable and necessary'' and thus eligible for 
coverage under the Medicare statute. If a contractor develops an LMRP, 
its LMRP applies only within the area it serves. While another 
contractor may come to a similar decision, we do not require it to do 
so. An LMRP may not conflict with a national coverage decision once the 
national coverage decision is effective. If a national coverage 
decision conflicts with a previously made LMRP, the contractor must 
change its LMRP to conform it to the national coverage decision. A 
contractor may, however, make an LMRP that supplements a national 
coverage decision.

IV. HCFA's Process for Making National Coverage Decisions

A. Initiation of Coverage Review Process

    We will initiate our review process for making a national coverage 
decision when we identify issues internally that we wish to consider 
for a national coverage decision or when we receive a formal request 
for us to review an issue and make a national coverage decision.
1. Initiation Based on Internal Decisions
    We will initiate our review process if we determine that a service 
requires a national coverage decision. Examples of when we may do this 
include, but are not limited to, the following:
     There are conflicting carrier or intermediary policies.
     The service represents a significant medical advance, and 
no similar service is currently covered under Medicare.
     The service is the subject of substantial controversy 
among medical experts as to its medical effectiveness.
     The service is currently covered, but is widely considered 
ineffective or obsolete.
     There are program integrity issues surrounding significant 
underutilization or overutilization of the service.
2. Initiation Based on External Formal Request
    We will also initiate our review process if we accept an external 
formal request for a national coverage decision. The rules for a formal 
request are outlined in section B.2.

B. Informal Contacts and Formal Requests for HCFA Review

    We will treat any communication we may receive from an individual 
or organization inquiring about a national coverage decision as either 
an informal contact or a formal request.
1. Informal Contacts
    We currently receive public contacts by telephone or in writing 
that raise general questions about the coverage of services. We 
consider these to be informal contacts. These include questions asking 
us to explain the current coverage of a particular service, or to 
assist and advise the requestor about how to formally request that we 
make a national coverage decision.
    If the contact leads to questions about how to request a national 
coverage decision, we will advise the requestor of the information we 
need to have submitted with a formal request. We will offer assistance 
to the requestor to clarify the amount and kind of information 
necessary for us to evaluate whether an item or service meets the 
statutory requirement that the item or service is ``reasonable'' and 
``necessary.''
    In some cases, we will assume the task of gathering and preparing 
the information necessary to proceed to a formal request. This may 
occur when the request is made by a Medicare beneficiary or another 
member of the public who we could not reasonably expect to have access 
to scientific data that may be necessary to support a formal request. 
Because we expect a considerable amount of contact and discussion with 
the requestor and because some flexibility is needed, we do not believe 
that strict timeframes are warranted following this informal contact.
    Although informal contacts are not confidential, we will not 
announce an informal contact that may lead to a request on our Home 
Page. We will not release, to the extent permitted by law, company 
proprietary material, trade secrets, or other information shared with 
us on a confidential basis before the contact makes a formal request.
2. Formal Requests
    We will require a requestor to make a formal request for a national 
coverage decision in the following manner:
     The request must be in writing.
     The requestor must identify the request as a ``formal 
request for a national coverage decision.''
     The requestor must submit supporting documentation that we 
will specify. At a minimum, the requestor must submit the following 
information:
    + A full and complete description of the service in question, 
including the benefit category or categories of the Medicare program to 
which it applies.
    + A compilation of the medical and scientific information currently 
available.
    + A description of any clinical trials or studies currently 
underway, which

[[Page 22622]]

might be relevant to a decision regarding the coverage of the service. 
This description should be as complete as possible without disclosing 
confidential information.
    + In the case of a drug, device, or a service using a drug or 
device subject to regulation by the FDA, the status of current FDA 
administrative proceedings concerning the drug or device involved. In 
the case of any item regulated by the FDA, the FDA labeling for the 
item, together with an indication of whether the service for which a 
review is being requested is covered under the labeled indication(s). 
We recognize that FDA changes the labeling of drugs and 510(k) devices 
and devices with premarket approvals (PMAs). For the purposes of our 
review, we are interested in the labeled indications at the time of the 
submission of the formal request. If, during our review, the labeled 
indications change, we expect the requestor to notify us.
    + In the case of a request for reconsideration, new evidence 
supporting the request or an analysis of our earlier decision 
demonstrating that we materially misinterpreted the evidence submitted 
with the earlier request.
    Upon receipt of a formal request, we will quickly review the 
request to determine if the requestor submitted adequate supporting 
documentation to enable us to review the service. If we determine that 
the request lacks adequate supporting documentation to enable us to 
review the service to make a national coverage decision, we will notify 
the requestor and identify the information that we require to enable us 
to review the service. We will not post the request on our list of 
pending coverage issues on our Home Page until we receive adequate 
supporting documentation.

C. Acceptance of Formal Request, Initiation of Timeframes

    If we determine the request is adequately supported, we will accept 
the request and begin our review process. Acceptance of a formal 
request starts a series of internal timeframes that we are establishing 
for ourselves in this notice to ensure that requests are processed in a 
timely manner. The discussion, negotiations, and other work done before 
that point do not count toward meeting these timeframes. If we initiate 
review of a service for purposes of making a national coverage 
decision, we will follow this same review process, post these issues on 
our Home Page, and generally follow our timeframes and maintain the 
same openness we provide for issues that have been raised by formal 
requests.
    We expect the timeframes we are establishing in this notice for 
ourselves generally will be the timeframes that we believe we will need 
to respond to a complex coverage issue. Generally, we would be likely 
respond in a shorter amount of time if the issue is not as complex, is 
not controversial, or is supported by clear medical and scientific 
evidence that establishes that the item or service is ``reasonable'' 
and ``necessary.'' Likewise, a significantly more complex and 
controversial coverage issue may result in longer processing 
timeframes. We understand the importance of making timely coverage 
decisions and the benefits that may be afforded Medicare beneficiaries. 
Therefore, we will expedite the processing of all formal requests for a 
coverage decision.
    We will post the acceptance of a request by adding the item or 
service to the list of pending coverage issues on our Home Page. We 
will identify all subsequent actions, such as meetings and requests for 
assessments. This will permit interested individuals to track an issue 
through our entire review process. Interested individuals could contact 
us at optimal times to offer comments, furnish information 
(particularly scientific data), or meet to discuss the issue. This 
public tracking system will be a key element in making our national 
coverage decision process more efficient as well as more open and 
accessible to the public.
    We will ordinarily respond in writing to the requestor within 90 
calendar days of receiving the complete request. If the requestor 
submits additional medical and scientific information during this 90-
day period, however, we will ordinarily respond to the requestor within 
90 calendar days of receiving the additional information.
    Because the FDA is charged with regulating whether devices or 
pharmaceuticals are safe and effective for use by consumers, we will 
generally accept a formal request for a device or a pharmaceutical only 
after it is officially approved or cleared for marketing by the FDA. 
One exception is if the FDA has granted a device a Category B 
investigational device exemption (IDE) or it has been approved as a 
nonsignificant risk IDE by an institutional review board. Our process 
for making a national coverage decision for Category B IDE devices is 
described in our regulations at 42 CFR 405.205. Parties interested in 
the coverage of a drug or device (other than a Category B IDE device), 
however, may contact us with an informal request while the drug or 
device is proceeding through the FDA approval process. We are willing 
to meet and discuss these situations. We will monitor the progress of 
the drug or device through the FDA process so that we may make a rapid 
coverage decision if FDA approval or clearance for marketing is 
obtained. The general timeframes we have set for formal requests will 
not begin, however, until we learn that the FDA has approved or cleared 
the device for marketing.
    In general, within 90 days of receiving a formal request, we will 
respond in writing to the requestor and post this information on our 
Home Page. Our formal response to a formal request or an internally-
initiated review will include, at a minimum, one of the following:
     A decision that the request duplicates another pending 
request and we will combine the requests and respond with a single 
decision.
     A decision that the request duplicates an earlier request 
for which we have already made a national coverage decision (and that 
there is insufficient new evidence to begin the process again).
     A referral for a technology assessment.
     A referral to the Medicare Coverage Advisory Committee 
(MCAC) for consideration.
     A national noncoverage decision (which precludes 
contractors from making Medicare payment).
     No national coverage decision (which allows for local 
contractor discretion).
     A national coverage decision with limitations on coverage.
     A national coverage decision without limitations on 
coverage.
    If our decision is a national noncoverage decision or we decide not 
to make a national coverage decision, our response will also identify 
deficiencies in the evidence and the types of information that we will 
require to reach a national coverage decision or evidence we would need 
for us to withdraw a national noncoverage decision.

D. HCFA Processing of a Formal Request

    We may process a formal request in one of the following ways:
    1. Our review requires little or no outside input.
    Issues that fall into this category are usually those for which the 
medical and scientific information submitted by the requestor (as well 
as any additional information available to us) is overwhelmingly in 
favor of, or against, coverage. We will usually complete our

[[Page 22623]]

review and issue our decision within 90 days of receiving the formal 
request.
    2. Our review requires a referral to the MCAC or an outside 
assessment of the service.
    Most national coverage issues fall into this category. These issues 
will generally be complex and controversial and often involve broad 
health policy concerns. Usually these issues also may require extensive 
consultation with specialty societies, medical researchers, and others 
familiar with the service and the evidence presented to support its 
coverage.
    We will notify the requestor, usually well within 90 days from 
receiving the requestor's formal request, that the request will require 
a referral to the MCAC and the anticipated due date for our response. 
We will consider the need and amount of time for receiving a 
recommendation from the MCAC. If applicable, we will consider the need 
for, and amount of time that will be required to perform, a technology 
assessment and to review these findings. We will make every effort to 
assure that we obtain timely assessments.
    We will inform the requestor that, although we will make every 
effort to meet the general timeframes, the use of assessments and/or a 
referral to the MCAC, together with the possibility of emerging new 
medical and scientific information, may sometimes result in revising 
our timeframe for responding to the request. We will post any changes 
for all timeframes on our Home Page to keep the public informed.

E. Additional Factors Affecting Our 90-Day Timeframe for Responding to 
Formal Requests

    It is our intention to respond to a formal request for a national 
coverage decision within 90 days of receiving a request. In general, we 
expect to be able to meet our self-imposed timeframes. There may be 
circumstances, however, that would prevent us from meeting the 
timeframes. For instance, if the requestor subsequently submits 
additional information, or requests that our national coverage review 
be expanded or narrowed, we may decide that we are unable to respond 
until 90 days after receipt of the additional information or request. 
We would post the revised due date for our response on our Home Page. 
Also, if another interested individual submits additional information 
that materially affects our consideration of the issue, we may notify 
the requestor of the need to reset our due date for responding to the 
initial request.
    In addition, if we discover additional information not submitted as 
part of the formal request (for example, reports of clinical trials, 
and assessments either completed or close to completion), we may notify 
the requestor and the public about the newly-discovered information and 
the need to reset our due date for responding to the initial national 
coverage decision request. For example, an assessment related to an 
issue we are considering may be scheduled to be issued shortly after 
our 90-day due date for responding to a formal request. We would 
normally wish to review the assessment because it may contain useful 
scientific and timely data before responding to the request. Also, 
changes or modifications in the FDA approval or clearance for marketing 
of a drug or device used in furnishing a service may affect the timing 
of our response to a formal request.

F. Medicare Coverage Advisory Committee

    On December 14, 1998, we published a notice in the Federal Register 
(63 FR 68780) that announces the establishment of the MCAC. The MCAC 
will make recommendations to us about whether services can be 
considered ``reasonable'' and ``necessary'' under title XVIII of the 
Act. We expect the MCAC will meet approximately twice a year. The 
notice requested, by January 29, 1999, nominations for members for the 
Committee. (We have received more than 400 nominations.) The notice 
also announces the signing by the Secretary on November 24, 1998 of the 
charter establishing the Committee. This charter ends at close of 
business on November 23, 2000 unless renewed by the Secretary. The MCAC 
Charter is available on our Home Page.
    In general, we may refer an issue to the MCAC if the service meets 
any of the following conditions:
     It is the subject of significant scientific or medical 
controversy--Is there a major split in opinion among researchers and 
clinicians regarding the medical effectiveness of the service, the 
appropriateness of staff or setting, or some other significant 
controversy that would affect whether the service is ``reasonable'' and 
``necessary'' under the Act?
     It has the potential to have a major impact on the 
Medicare program.
     It is subject to broad public controversy.
    If we refer a formal request to the MCAC, the discussion of the 
request at the MCAC meeting will be subject to the requirements of the 
Federal Advisory Committee Act. Therefore, we will publish a notice in 
the Federal Register generally 30 days before the meeting. It will 
announce the agenda and the time and place of the meeting so that all 
interested individuals will have the opportunity to attend the meeting 
and present their views. We will request that all evidentiary 
presentations be submitted to us in writing at least 20 days before the 
meeting. At the end of each meeting, there will be an additional period 
for the public to present comments. After considering all presentations 
and comments, the MCAC will create its recommendation to us concerning 
national coverage, which it must adopt by majority vote.
    We expect the MCAC will make its recommendations to us as 
expeditiously as possible. We will provide an estimate of when we 
believe we will receive the MCAC referral; however, we cannot predict 
when the MCAC may decide, during its deliberations, that additional 
information is needed for it to make a recommendation to us.
    Once the MCAC makes a formal recommendation to us, we will post it 
on our Home Page. Within 60 calendar days of receiving the 
recommendation, we will either adopt the MCAC recommendation (or adopt 
it with modifications) or notify the requestor and the public why we 
disagree with the MCAC recommendation. If we choose not to adopt the 
recommendation, our notification will explain the reasons why we have 
decided not to adopt the MCAC recommendation. We will also identify 
further evidence we will require be submitted to us. Again, we will 
post our decision on our Home Page.

G. Technology Assessments

    During our review of a request, we may find that we will require a 
technology assessment to complete our review. Generally, a technology 
assessment provides a systematic analysis of the safety, efficacy, and 
effectiveness of a health care technology.
    Two of the reasons we may request a technology assessment include 
the following:
     There is sufficient medical and scientific literature 
available to provide a basis for an assessment, but the complexity of 
the subject and/or complexity of the issue exceed our staff expertise 
or capability.
     The MCAC requests a technology assessment.
    A key element of the assessment process is the need for the 
assessor to be impartial. If we require an assessment, we will obtain 
it from an impartial third party, such as the Agency for Health Care 
Policy and Research. Under agreement with us, the assessor will conduct 
or arrange for preparation or

[[Page 22624]]

purchase of the assessment, as appropriate.
    If we receive a request for coverage on an item or service for 
which an assessment is already underway, we will immediately inform the 
requestor of the status and estimated timing of the assessment. If we 
initiate an assessment in response to a request, we will, within 45 
days of requesting an assessment, inform the requestor of the estimated 
time for receiving the assessment.
    We anticipate that a few technology assessments will be completed 
within 90 days of their initiation. Complex assessments will, of 
course, require additional time but will not normally take longer than 
12 months from the time the assessment was begun. We will post 
completed technology assessments on our Home Page.

H. HCFA Announcement of National Coverage Decisions

    Before we issue a national coverage decision as a ruling, program 
instruction to our contractors, or Federal Register document, we will 
announce our intention to make the national coverage decision in the 
form of a decision memorandum. The decision memorandum will merely 
announce our intention to make a national coverage decision. It will 
not be binding on our contractors until we publish the national 
coverage decision in the Federal Register or issue it as a program 
instruction or HCFA ruling.
    If we do not refer an issue to the MCAC or for a technology 
assessment, we will forward the decision memorandum to the requestor 
and post it on our Home Page no later than 90 calendar days after we 
accept the formal request (or after we accept additional medical and 
scientific information supporting the request). In situations involving 
a referral to the MCAC or that require a technology assessment, we will 
forward the decision memorandum to the requestor and post it on our 
Home Page generally no later than 60 calendar days after receiving the 
MCAC recommendation or the technology assessment or the technical 
assessment followed by an MCAC recommendation.
    The memorandum may contain remarks regarding the level and content 
of evidence presented and reviewed. Moreover, if significant, we will 
include the conclusions and recommendations of any assessments or the 
MCAC recommendations received. Finally, the memorandum may include any 
other factors that had a major influence on our decision, and will 
contain our rationale for the decision we made.
    If we announce our intention to not cover or to reduce coverage of 
a service, the decision memorandum will include the reasons for 
noncoverage and identify the information we will require for a 
different coverage decision. The memorandum will not be effective 
immediately, but will become effective on the date specified in the 
national coverage decision.

I. Implementation of National Coverage Decisions

    Within 60 calendar days of forwarding the decision memorandum to 
the requestor and posting the memorandum on our Home Page, we will 
issue a national coverage decision. As explained previously, we may 
publish a national coverage decision in a variety of forms such as 
program memorandum, manual instruction, HCFA ruling, or Federal 
Register notice. We will also publish a reference to each national 
coverage decision in the Federal Register as part of our quarterly 
listing of program issuances. We could also choose to publish a general 
notice in the Federal Register. If we withdraw or reduce coverage for a 
service, we will publish a general notice in the Federal Register.
    The program instruction, Federal Register notice, or HCFA ruling 
will include the date on which our claims-payment contractors will 
implement any change in payment that may result from the national 
coverage decision. 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 national coverage 
decision.
    If we make a positive decision to cover an item or service, 
numerous complex and related steps remain before a payment change is 
made. We must determine which codes the providers, suppliers, and our 
contractors will use for submission and payment of claims consistent 
with our coverage decision and issue appropriate instructions. We must 
also determine the appropriate Medicare payment level. Finally, we must 
develop and issue claims processing instructions to our systems 
maintainers and claims-payment contractors to ensure accurate payment 
and to include the necessary program integrity safeguards and edits. 
Our contractors now implement systems changes at the start of a 
calendar quarter, and instructions are required well in advance in 
order to install and test the systems changes.
    As stated previously, a national coverage decision is binding on 
all Medicare carriers, fiscal intermediaries, PSCs, PROs, HMOs, CMPs, 
and HCPPs when issued as a HCFA program instruction or HCFA ruling, or 
published in the Federal Register. Moreover, national coverage 
decisions made under section 1862(a)(1) of the Act are subject to 
limited administrative and judicial review (See 42 CFR 405.860.).

J. Revisiting National Coverage Decisions

    After we implement a decision or if there is an existing national 
coverage decision, we will consider new requests to revise a national 
coverage decision concerning the service at any time. These requests 
should include additional medical and scientific information that we 
have not considered to make our original national coverage decision or 
an analysis of how we materially misinterpreted original information 
submitted by the requestor. We will not accept any new request that 
does not include this additional information.
    If we receive the additional information as part of a request for 
reconsideration, we will consider this a new formal request and start 
our review process. The timeframes for our formal review process will 
apply to a new formal request. Our original national coverage decision 
will remain in effect until we withdraw that decision and make another 
national coverage decision.

K. How To Access HCFA's Home Page

    Our Home Page can be accessed by entering ``http://www.hcfa.gov.'' 
To access information about our coverage process, select ``Development 
of coverage policies'' and then ``Medicare Coverage Process.''

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day 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 the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the

[[Page 22625]]

affected public, including automated collection techniques.
    We are soliciting public comment on each of these issues for 
section IV, HCFA's Process for Making National Coverage Decisions.
    In accordance with that section, HCFA will accept an external 
formal request for a national coverage decision if the information 
collection requirements outlined above in section IV.B.2 are met. These 
requirements include:
     The request must be in writing.
     The requestor must identify the request as a ``formal 
request for a national coverage decision.''
     The requestor must submit supporting documentation that we 
will specify. At a minimum, the requestor must submit the following 
information:
     A full and complete description of the service in 
question, including the benefit category or categories of the Medicare 
program to which it applies.
     A compilation of the medical and scientific information 
currently available.
     A description of any clinical trials or studies currently 
underway, which might be relevant to a decision regarding the coverage 
of the service. This description should be as complete as possible 
without disclosing confidential information.
     In the case of a drug, device, or a service using a drug 
or device subject to regulation by the FDA, the status of current FDA 
administrative proceedings concerning the drug or device involved. In 
the case of any item regulated by the FDA, the FDA labeling for the 
item, together with an indication of whether the service for which a 
review is being requested is covered under the labeled indication(s). 
We recognize that FDA changes the labeling of drugs and 510(k) devices 
and devices with premarket approvals (PMAs). For the purposes of our 
review, we are interested in the labeled indications at the time of the 
submission of the formal request. If, during our review, the labeled 
indications change, we expect the requestor to notify us.
     In the case of a request for reconsideration, new evidence 
supporting the request or an analysis of our earlier decision 
demonstrating that we materially misinterpreted the evidence submitted 
with the earlier request.
    The burden associated with this requirement is the time and effort 
necessary to disclose the materials referenced above to HCFA. We 
estimate that on average it will take each entity 40 hours to provide 
the materials and that there will be 200 requests on an annual basis. 
Therefore, the total annual burden associated with these requirements 
is 8,000 hours. While an estimate of 40 hours may appear low, given 
that entities will most likely have already compiled these data to meet 
the FDA approval process, we believe it to be accurate.
    If you have any comments on any of these information collection and 
record keeping requirements, please mail the original and 3 copies 
directly to the following:
    Health Care Financing Administration, Office of Information 
Services, Standards and Security Group, Division of HCFA Enterprise 
Standards, Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-
1850. Attn: John Burke HCFA-3432-GN

      and

Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Allison Eydt, HCFA Desk Officer.

    In accordance with the provision of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

    Authority: Sections 1862, 1869(b)(3), 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; Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: April 21, 1999.
Nancy-Ann Min DeParle,
Administrator,
Health Care Financing Administration.

    Dated: April 21, 1999.
Donna E. Shalala,
Secretary.
[FR Doc. 99-10460 Filed 4-22-99; 10:36 a.m.]
BILLING CODE 4120-01-P