Medicare Program; Procedures for Making National Coverage Decisions

Federal RegisterApr 27, 1999

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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

Copies: To order copies of the Federal Register containing this

document, send your request to: New Orders, Superintendent of

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This Federal Register document is also available from the Federal

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the World Wide Web; the Superintendent of Documents home page address

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

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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

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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

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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

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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

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

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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