[Federal Register Volume 65, Number 95 (Tuesday, May 16, 2000)]
[Proposed Rules]
[Pages 31124-31129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12237]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 405

[HCFA-3432-NOI]
RIN 0938-AJ31


Medicare Program; Criteria for Making Coverage Decisions

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

ACTION: Notice of intent to publish a proposed rule.

-----------------------------------------------------------------------

SUMMARY: On April 27, 1999, we published a notice in the Federal 
Register that announced the process we

[[Page 31125]]

use to make national coverage decisions under the Medicare program. We 
also announced that we would not be adopting, as final, a 1989 proposed 
rule that set forth the criteria we would have used to make coverage 
decisions under Medicare. This notice announces our intention to 
publish a proposed rule and solicits advance public comments on the 
criteria we would use to make certain national coverage decisions and 
our contractors would use to make local coverage decisions.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on June 15, 2000.

ADDRESSES: Mail written comments (one original and three copies) to the 
following address ONLY: Health Care Financing Administration, 
Department of Health and Human Services, Attention: HCFA-3432-NOI, P.O. 
Box 8016, Baltimore, MD 21244-8016.
    If you prefer, you may deliver, by courier, your written comments 
(one original and three copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
C5-14-03, Central Building, 7500 Security Boulevard, Baltimore, MD 
21244-1850.

    Comments mailed to those addresses may be delayed and received too 
late for us to consider them.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-3432-NOI.
    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, in Room 443-G of the Department's offices at 
200 Independence Avenue, SW., Washington, DC, on Monday through Friday 
of each week from 8:30 a.m. to 5 p.m. (Phone (202) 690-7890).

FOR FURTHER INFORMATION CONTACT: Susan Gleeson, (410) 786-0542.

SUPPLEMENTARY INFORMATION:  

Comments, Procedures, Availability of Copies, and Electronic Access

    Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-3432-NOI. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room 443-G of 
the Department's office at 200 Independence Avenue, SW., Washington, 
DC, on Monday through Friday of each week from 8:30 to 5 p.m. (phone: 
(202) 690-7890).
    Copies: To order copies of the Federal Register containing this 
document, send your request to: New Orders, Superintendent of 
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date 
of the issue requested and enclose a check or money order payable to 
the Superintendent of Documents, or enclose your Visa or Master Card 
number and expiration date. Credit card orders can also be placed by 
calling the order desk at (202) 512-1800 or by faxing to (202) 512-
2250. The cost for each copy is $8. As an alternative, you can view and 
photocopy the Federal Register document at most libraries designated as 
Federal Depository Libraries and at many other public and academic 
libraries throughout the country that receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. Free public access is available on a Wide 
Area Information Server (WAIS) through the Internet and via 
asynchronous dial-in. Internet users can access the database by using 
the World Wide Web; the Superintendent of Documents home page address 
is http://www.access.gpo.gov/nara__docs/, by using local WAIS client 
software, or by telnet to swais.access.gpo.gov, then login as guest (no 
password required). Dial-in users should use communications software 
and modem to call 202-512-1661; type swais, then login as guest (no 
password required).

Overview

    We are issuing this notice to announce our intention to publish a 
proposed rule and solicit public comments on the criteria we would use 
to make a national coverage decision (NCD) and our contractors would 
use to make a local coverage decision (LCD) under section 1862(a)(1) of 
the Social Security Act (the Act). These coverage decisions are 
prospective, population-based policies that apply to a clinical subset 
or class of Medicare beneficiaries and describe the clinical 
circumstances and setting under which an item or service is available 
(or not available). We are setting out in this notice the information 
and approaches we are considering at this time for making coverage 
decisions. We are interested in receiving public comments on this 
information and we will consider them when we develop the subsequent 
proposed rule.
    This notice is narrower in scope than the January 30, 1989 proposed 
rule announcing the coverage criteria we would have used (54 FR 4302). 
We have already announced our process for making an NCD in an April 27, 
1999 general notice (64 FR 22619). Also, rulemaking is not necessary 
for us to establish or modify the procedures our contractors will use 
to make LCDs. This notice only deals with the criteria for making 
national and local coverage decisions under the reasonable and 
necessary provisions of section 1862(a)(1) of the Act. This notice does 
not, and we do not anticipate that the proposed rule will, address 
individual medical necessity determinations and claims adjudication by 
our contractors and other adjudicators. Finally, this notice does not 
address Medicare payment policies and we do not anticipate that the 
proposed rule would include changes to our current rules on Medicare 
payment.

I. Background

A. Need for Timely and Expanded Medicare Coverage of Items and Services

    Given the dynamic nature of the health care system, it is important 
that the Medicare program be responsive to the rapid advances in health 
care. Regulations describing our criteria for coverage under the 
Medicare program would facilitate timely and expanded access for 
Medicare beneficiaries to appropriate new technologies. Within the 
scope of the statutory benefit categories, these criteria would expand 
access for Medicare beneficiaries by covering the following:
    1. A breakthrough technology without consideration of cost.
    2. A medically beneficial item or service if no other medically 
beneficial alternative is available.
    3. A medically beneficial item or service if it is a different 
clinical modality compared to an existing covered beneficial 
alternative, without consideration of cost or magnitude of benefit.
    4. A medically beneficial item or service, even if a less expensive 
alternative, which is not a Medicare benefit, exists.
    We anticipate that these criteria would also make the Medicare 
coverage process, both national and local, more transparent, timely, 
and predictable to manufacturers or other requestors seeking Medicare 
coverage of an item or service.

B. Framework of the Medicare Program

    From the beginning of the Medicare program, one of the goals has 
been to

[[Page 31126]]

provide a health insurance system that would make ``the best of modern 
medicine'' available to Medicare beneficiaries. Over the last 35 years, 
there have been significant advances in medical science that have 
changed the Medicare program and improved the health of beneficiaries 
and others. Some of these changes have been mandated by the Congress in 
title XVIII of the Act, which authorizes coverage of, and payment for, 
items and services under the Medicare program. Other changes have 
occurred as a result of administrative actions. We have adapted the 
Medicare program to meet these changes.
    While the Congress has demonstrated a strong interest in providing 
access to necessary medical care for Medicare beneficiaries, the 
Congress has been equally concerned with ensuring that the Medicare 
program operates on a sound financial basis. The Congress has 
established the specific scope of benefits that are included in the 
program and has defined many of the key terms in section 1861 of the 
Act. In addition, section 1862(a)(1)(A) of the Act requires that ``no 
payment'' may be made under Part A (hospital insurance) or Part B 
(supplementary medical insurance) for any expenses incurred for items 
or services that ``are not reasonable and necessary for the diagnosis 
or treatment of illness or injury or to improve the functioning of a 
malformed body member.'' If we do not cover the expenses incurred for a 
particular item or service under this provision, either the Medicare 
beneficiary or the health care provider or supplier may be financially 
liable for all of the incurred costs.
    The main purpose of our proposed rule will be to explain how the 
term ``reasonable and necessary'' applies in making coverage decisions. 
A Medicare coverage decision, whether made nationally or locally, is a 
prospective, population-based, policy that applies to a clinical subset 
or class of Medicare beneficiaries and describes the clinical 
circumstances and setting under which an item or service is available 
(or is not available).
    We have the authority to determine whether an item or service is 
reasonable and necessary by several distinct approaches. One approach 
is to make a national coverage decision (NCD). Under 42 CFR 405.732 and 
405.860, an NCD either grants, limits, or excludes Medicare coverage 
for a specific medical service, procedure, or device. An NCD is binding 
on all carriers, fiscal intermediaries, Peer Review Organizations, and 
other contractors. Under Sec. 422.256(b), an NCD that expands coverage 
is also binding on a Medicare + Choice Organization. Moreover, under 
Secs. 405.732(b) and 405.860(b), an NCD made under section 1862(a)(1) 
of the Act is binding on an administrative law judge (ALJ) (``An ALJ 
may not disregard, set aside, or otherwise review an NCD.''). While an 
NCD is subject to judicial review, there are limitations on judicial 
review. This framework ensures that an NCD is consistently applied 
throughout the nation and enables a beneficiary to make an informed 
decision about whether to receive an item or service based on the 
knowledge that an item or service will be covered (or not covered) by 
the program.
    Due to regional, local, or institutional differences in the 
practice of medicine, it is not always prudent to issue a prescriptive 
NCD. Sometimes there is not sufficient information for us to determine 
whether an item or service is an effective treatment on a national 
basis. In other circumstances, there are legitimate regional 
differences in the practice of medicine that would make a preemptive 
national rule inappropriate.
    In the absence of an NCD, a decision concerning Medicare coverage 
for an individual could be resolved on a case-by-case basis after a 
claim is submitted. Our regulations separately provide broad appeal 
rights for certain individuals to administratively challenge our 
decision to deny payment for a claim before a neutral ALJ and, in some 
cases, Federal court (42 CFR part 405, subparts G and H). This case-by-
case approach ensures that a beneficiary can present all relevant 
information concerning a particular need for payment for an item or 
service. This review only applies to claims that have been denied and 
is not a mechanism for attaining prior authorization for a specific 
item or service for an individual.
    In order to provide some guidance to beneficiaries and health care 
providers and suppliers regarding which items and services will (or 
will not) be covered in a particular area in the absence of an NCD, our 
contractors may make an LCD. An LCD would provide guidance, in the 
absence of, or as an adjunct to, an NCD by describing the clinical 
circumstances and settings under which an item or service is available 
(or is not available) to a beneficiary under section 1862(a)(1)(A) of 
the Act. This notice seeks only to define the criteria for how we would 
make an NCD and our contractors would make an LCD.
    An LCD is not binding on a contractor in another area of the 
country or on an ALJ who decides cases at higher stages of the appeal 
process. Still, an LCD provides a service to the public by giving some 
advance notice about an item or service a contractor is likely to cover 
or not cover. If a local contractor makes an affirmative finding 
through a published LCD that an item or service is reasonable and 
necessary under the statute, beneficiaries and providers could 
reasonably expect that the service is available to the beneficiaries in 
that jurisdiction for the circumstances described in the LCD.

C. Federal Register Publications

1. 1989 Proposed Rule
    On January 30, 1989, we published a proposed rule (54 FR 4302), 
that identified four generally applicable criteria that we would use to 
make coverage decisions as to whether, and under what circumstances, 
specific health care technologies could be considered reasonable and 
necessary (and thus, covered under Medicare). The four proposed 
criteria were: (1) Safety and effectiveness, (2) experimental or 
investigational, (3) appropriateness, and (4) cost-effectiveness. At 
the time, we explained that each of the four criteria would not 
necessarily apply in all instances because of the complexity and 
variety of issues involved in making coverage decisions under Medicare. 
As explained earlier, we withdrew this proposed rule.
2. 1999 General Notice
    On April 27, 1999, we published a general notice that announced the 
process we use to make an NCD (64 FR 22619). This notice formally 
withdrew the 1989 proposed rule. This procedural notice has been well-
received by Medicare beneficiaries, the health care industry, and 
others who wanted our process to be open, responsive, and 
understandable to the public.

II. Intentions of This Notice

    We are issuing this notice to announce our intention to publish a 
proposed rule and solicit public comments on the criteria we would use 
to make an NCD and our contractors would use to make an LCD under 
section 1862(a)(1) of the Act. We are setting out in this notice the 
information and approaches we are considering at this time. We are 
interested in receiving public comments on this information and we will 
consider them when we develop the subsequent proposed rule.
    Before we can make an NCD or LCD, the item or service must fall 
within a statutory Medicare benefit category and not be otherwise 
statutorily excluded. Moreover, if regulated by the Food and

[[Page 31127]]

Drug Administration, the item or service must be lawfully marketed.
    We would apply an NCD or LCD prospectively to all items and 
services furnished under identical circumstances within the respective 
jurisdiction after the effective date of the NCD or LCD. We anticipate 
the number of criteria we would apply could be reduced and simplified 
based on our experience. We intend that the criteria would make the 
Medicare coverage process more open, responsive, and understandable to 
the public. Finally, as mentioned above, we anticipate that the 
criteria would result in covering more items and services under 
Medicare. The criteria could also result in us beginning a new NCD to 
withdraw coverage of a currently covered item or service. In 
particular, if a new item or service is equivalent in benefit, is in 
the same clinical modality, is thus substitutable for the existing 
service, and is lower in costs, we would consider withdrawing coverage 
for the more expensive currently covered alternative service.

A. Criteria for Medicare Coverage Decisions

    We anticipate applying two criteria when we make an NCD or one of 
our contractors makes an LCD. First, the item or service must 
demonstrate medical benefit, and, second, the item or service must 
demonstrate added value to the Medicare population. In order to ensure 
that we and our contractors consistently interpret and apply these 
criteria, we would use the following sequential steps:
    Step 1--Medical Benefit: Is there sufficient evidence that 
demonstrates that the item or service is medically beneficial for a 
defined population?
    If no, the item or service is not covered under Medicare.
    If yes, proceed to Step 2.
    Step 2--Added Value: For the defined patient population, is there a 
medically beneficial alternative item or service(s) that is the same 
clinical modality and is currently covered by Medicare?
    <bullet> If no, the item or service is covered under Medicare for 
the defined population.
    <bullet> If yes, proceed to Step 3.
    Step 3--Added Value: Is the item or service substantially more or 
substantially less beneficial than the Medicare-covered alternative?
    <bullet> If the item or service is substantially more beneficial 
(that is, a breakthrough), it is covered under Medicare for the defined 
population.
    <bullet> If the item or service is substantially less beneficial, 
it is not covered under Medicare for the defined population.
    <bullet> If the item or service is neither substantially more nor 
substantially less beneficial (that is, it is equivalent in benefit), 
proceed to Step 4.
    Step 4--Added Value: Will the item or service result in equivalent 
or lower total costs for the Medicare population than the Medicare-
covered alternative?
    <bullet> If yes, the item or service is covered under Medicare for 
the defined population.
    <bullet> If no, the item or service is not covered under Medicare.
    When we (or our contractors) compare the medical benefit of two or 
more items or services, we would ensure that the comparisons involve 
both the same patient population, the same clinical circumstances, and 
the same clinical modality. We believe that the sequential steps would 
be administratively feasible and would produce results that are 
consistent with the statute. We invite public comments on this approach 
and suggestions as to feasible alternatives.
    A requestor may use the coverage reconsideration process to modify 
a request that resulted in a denial of coverage for an item or service. 
For example, a requestor could seek a more limited coverage decision 
targeting a narrower population for which there is no Medicare-covered 
alternative. Alternatively, a requestor could submit new evidence that 
demonstrates that the item or service is substantially more beneficial 
than the Medicare-covered alternative.

B. Definitions, Discussion, and Questions

1. Medical Benefit
    We believe an item or service is medically beneficial if it 
produces a health outcome better than the natural course of illness or 
disease with customary medical management of symptoms. We would require 
the requestor to demonstrate that an item or service is medically 
beneficial by objective clinical scientific evidence.
    Given the importance of Medicare coverage decisions for our 39 
million current beneficiaries (as well as future beneficiaries), we do 
not believe we should cover an item or service without adequate 
information that shows the item or service improves the diagnosis or 
treatment of an injury or illness, or improves the functioning of a 
malformed body member. It would be unreasonable and unnecessary to pay 
for expenses incurred for an item or service that are not proven to be 
effective for a defined population.
    Although mortality and life-expectancy are quantifiable and, thus, 
``hard'' health outcomes, we believe we should move towards ``quality 
of life'' as an acceptable health outcome. To help us (and our 
contractors) make coverage decisions, however, especially assessing 
comparative benefits, an acceptable health outcome should be 
quantifiable along a standard scale or metric. We seek suggestions on a 
standard metric system for measuring quality of life outcomes. Examples 
of nationally recognized scales are: QALY--Quality Adjusted Life Years, 
DALY--Disability Adjusted Life Years, or self-described health status 
as measured by the SF-36 (Short Form 36).
    We believe a beneficiary's preference, compliance, and well-being 
are also meaningful outcomes. Similarly, we invite comments on the 
standardized metric systems or methodologies we should employ so that 
we can quantify and compare medical benefits that recognize these 
outcomes.
    Another important consideration is how we would measure the 
magnitude of the improved health outcome. Also, if the treatment 
includes risks of adverse side-effects, how should we determine that 
the benefits outweigh the risks?
2. Added Value
    We believe that an item or service adds value to the existing mix 
of covered items or services if it substantially improves health 
outcomes; provides access to a medically beneficial, different clinical 
modality; or if it can ``substitute'' for an existing item or service 
and lower costs for the Medicare population. There are several 
situations when a new item or service would add value compared to the 
current mix of services.
    One situation is when a new item or service that falls within a 
Medicare benefit category would be medically beneficial for a 
beneficiary with a given clinical circumstance and there is no 
Medicare-covered medically beneficial alternative. We believe this item 
or service would add value to the program and we should cover it 
without consideration of costs during the coverage process.
    Another situation is when a new item or service would be medically 
beneficial and it is a different clinical modality than a Medicare-
covered medically beneficial alternative(s) (for example, a covered 
medication versus surgery). Giving Medicare beneficiaries and providers 
access to competing items or services of different clinical modalities 
adds value to the program and we believe we should also cover the items 
or services without consideration of costs during the coverage process. 
In particular, this adds value to the program because we recognize that 
there

[[Page 31128]]

are legitimate differences between beneficiaries, medical practices by 
region, and delivery systems' capabilities. We believe access to 
different modalities for a similar medical benefit is warranted.
    In making Medicare coverage decisions under these new criteria, we 
would not compare an item or service that falls within a statutory 
benefit category to an item or service that is outside the scope of the 
Medicare program. We do not believe we should compare the effectiveness 
of an item or service that falls within a statutory benefit category to 
the effectiveness of a medically, beneficial alternative that is not 
included in a Medicare benefit category. Due to financial 
circumstances, a beneficiary may not have meaningful access to that 
alternative. We believe that by only comparing two items or services 
that are included in a Medicare benefit category, we increase 
beneficiary access and add value to the program.
    Value also would be added when the magnitude of the benefit of an 
item or service is substantially more than a Medicare-covered 
alternative of similar clinical modality. We refer to this item or 
service as a ``breakthrough''. Even if two services are of the same 
clinical modality, we believe we should cover the substantially 
superior service without any consideration of cost during the coverage 
process.
    We believe value would also be added when a new item or service is 
equivalent in benefit, and is in the same clinical modality (that is, 
substitutable) for a Medicare-covered alternative, and has equal or 
lower total costs for the Medicare population. It is possible that a 
beneficiary would not notice any difference in health outcomes, when an 
item or service is substituted for a Medicare-covered alternative. We 
would cover a substitutable item or service only if the total costs are 
equal or lower than the total costs of the Medicare-covered 
alternative. For clinically substitutable services, it is not 
reasonable or necessary to pay for incurred costs that exceed the cost 
of a Medicare-covered alternative that produces the same health 
outcome. Thus, only by assuring equal or lower costs for the 
substitutable service could we assure adding value to the program. When 
a service (that is, it has equivalent health outcomes and the same 
clinical modality) is substantially more expensive than a Medicare-
covered alternative would cost considerations lead us to deny coverage 
for the service. Since we anticipate limiting the application of costs 
to a narrow situation when two services have equivalent health outcomes 
and are of the same clinical modality, we need to do only a simple 
cost-analysis.
    We would like to receive input on the proposed added value criteria 
before developing a proposed rule. In particular, we would like 
suggestions on how broadly or narrowly we should define ``same clinical 
modality.'' Clearly surgery and prescription medications are not the 
same. But is an open surgical procedure the same clinical modality as a 
closed invasive procedure? What if they both require general 
anesthesia? What if they do not? Perhaps another way of defining ``same 
clinical modality'' would be to simply use the existing Medicare 
statutory benefit categories.
    We would like the public's views on the scope of a ``Medicare-
covered alternative.'' Recognizing that most Medicare coverage 
decisions have been made locally, and not nationally, we would have to 
create a standard for determining which services are currently covered. 
One alternative for the purposes of an NCD or an LCD is to define 
``Medicare-covered alternative'' when a threshold percentage of the 
Medicare population nationally, or in the contractor's jurisdiction, 
has access to an item or service. What threshold percentage should we 
use for either alternative? Are there other alternative definitions?
    Similarly, we encourage suggestions on how to best define 
``substantially more beneficial.'' One way to define this term is that 
the benefit is so large that most clinicians would believe that the 
item or service should be the new standard of care and, thus, 
completely replace the Medicare-covered alternative. Another is that 
the benefit is so large that the clinical experts in the relevant 
clinical discipline believe that the item or service should be the new 
standard of care and, thus, we should cover the new item or service and 
withdraw coverage of the Medicare-covered alternative. A third way 
would be to try to establish a quantifiable statistical ``effect-size'' 
of the new item or service compared with the Medicare-covered 
alternative.
    We are soliciting input on the definition of ``equivalent 
benefit.'' We anticipate defining ``equivalent benefit'' as neither 
substantially more, nor substantially less, beneficial than the 
Medicare-covered alternative. This leaves a range of medical benefit 
between marginally less beneficial, to equally beneficial, to 
marginally more beneficial. Is there an alternative definition of 
``equivalent benefit?'' Is there a common metric system that could be 
used to measure the medical benefit and capture other meaningful health 
outcomes including beneficiary preference, compliance, and well-being?
    We are also specifically requesting comments on the alternative of 
covering a new item or service that is ``substitutable'' for a 
Medicare-covered alternative. At a minimum, a substitutable item or 
service would seem to be one that is the same clinical modality and 
produces an equivalent health outcome. If the substitutable item or 
service has greater total costs to the Medicare program, should we deny 
coverage for the item or service and allow the requestor through the 
reconsideration process to alter the request to seek a positive 
coverage decision? Should we simply cover the new item or service but 
reduce the Medicare payment rate for the incurred expenses to the same 
rate as the Medicare-covered alternative? This principle has been 
called the ``least costly alternative'' adjustment and has been used 
for many years primarily for coverage of durable medical equipment.
    Coverage of new items and services under new regulatory 
requirements may lead to the reexamination of current coverage 
policies. For example, if the new item or service is ``substitutable'' 
for a Medicare-covered alternative and has lower costs for the Medicare 
program, should we deny coverage for the Medicare-covered alternative 
or lower the payment for the Medicare-covered alternative so that the 
total costs for the Medicare program are, at a minimum, equal?
    We are interested in suggestions on the type and extent of 
information that parties seeking coverage decisions should be required 
to provide in relation to the associated costs or savings to the 
program in addition to the direct costs of the item or service.
    We are soliciting comments on the implications for private sector 
insurers of the proposed approach.
3. Demonstration Through Scientific Evidence
    As previously mentioned, we would measure both the medical benefit 
and the added value criteria by clinical scientific evidence. We are 
interested in comments on the proper evidentiary standard. Should there 
be one standard for all services or should there be different standards 
for different health care sectors (for example, surgical procedures, 
diagnostic tests, and biologics)? Finally, recognizing that clinical 
evidence and trials are frequently imperfect, what is the best way to 
deal with bias and external validity when we consider applying the 
findings of clinical trials to coverage

[[Page 31129]]

decisions in the real world. More specifically, under what 
circumstances can clinical trial findings be generalized from the study 
population to the Medicare population? In addition, under what 
circumstances can the controlled delivery setting of the clinical trial 
be generalized and reproduced in the current health care delivery 
setting or to a different health care delivery setting?
    Section 202 of the Unfunded Mandates Reform Act of 1995 requires 
that agencies assess anticipated costs and benefits before issuing any 
rule that may result in an expenditure in any year by State, local, or 
tribal governments, in the aggregate, or by the private sector, of $100 
million. The notice would not have any unfunded mandates.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a notice that imposes substantial 
direct compliance costs on State and local governments, preempts State 
law, or otherwise has Federalism implications. The notice would not 
impose compliance costs on the governments mentioned.
    In accordance with the provisions of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)


    Dated: April 5, 2000.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
    Approved: April 20, 2000.
Donna E. Shalala,
Secretary.
[FR Doc. 00-12237 Filed 5-11-00; 12:00 pm]
BILLING CODE 4120-01-P