[Federal Register Volume 59, Number 35 (Tuesday, February 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3609]


[[Page Unknown]]

[Federal Register: February 22, 1994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 417

[BPD-732-P]
RIN 0938-AF76

 

Medicare Program; Health Maintenance Organization and Competitive 
Medical Plan National Coverage Decisions

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

ACTION: Proposed rule.

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

SUMMARY: This proposed rule would affect health maintenance 
organizations (HMOs) and competitive medical plans (CMPs) that contract 
with HCFA to furnish health care services to Medicare beneficiaries and 
to receive payment on a risk basis. These HMOs and CMPs would no longer 
be required to absorb the expense of furnishing a new or additional 
benefit if all the following conditions apply:
    The benefit was established by a national coverage decision (NCD);
    The cost of furnishing the service would be significant and was not 
taken into account in calculating the per capita rate to be paid by 
HCFA during the current calendar year;
    The NCD was not published until on or after the date of the 
announcement of the current calendar year's per capita rate of payment.
    This rule is necessary to implement section 4204(c) of the Omnibus 
Budget Reconciliation Act of 1990, commonly referred to as ``OBRA 
'90,'' which is effective for calendar years beginning on or after 
January 1, 1991.
    The purpose of the amendment is to encourage HMOs and CMPs to 
contract on a risk basis by ensuring that the actual scope of services 
covered under the contract would not change significantly during the 
year.

DATES: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on April 
25, 1994.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: BPD-732-P, P.O. Box 26688, 
Baltimore, MD 21207.
    If you prefer, you may deliver your written comments to one of the 
following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore, 
MD 21207.

    Due to staffing and resource limitations, we cannot accept comments 
by facsimile (FAX) transmission. In commenting, please refer to file 
code BPD-732-P. 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 309-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: Joanne Sinsheimer, (410) 966-4620.

SUPPLEMENTARY INFORMATION:

I. Background

A. National Coverage Decisions

     The intention of the Congress, at the time the Medicare law was 
enacted in 1965, was that Medicare would provide health insurance to 
protect the elderly (and later, the disabled) from the substantial 
costs of acute health care services, principally hospital care. The law 
was designed generally to cover services ordinarily furnished by 
hospitals, skilled nursing facilities (SNFs), and physicians licensed 
to practice medicine. The Congress understood that questions as to 
coverage of specific services would invariably arise and would require 
a specific decision by those administering the program. Thus, it vested 
in the Secretary the authority to make those decisions (section 
1862(a)(1)(A) of the Act). Section 1862(a)(1)(A) of the Act authorizes 
Medicare payment for items or services that are determined to be 
reasonable and necessary for the diagnosis or treatment of illness or 
injury or to improve the functioning of a malformed body member. While 
the Congress provided for the coverage of services such as inpatient 
hospital care and physicians' services, coverage for these services is 
prohibited unless they are ``reasonable'' and ``necessary.''
    We have interpreted section 1862(a)(1)(A) of the Act to exclude 
from Medicare coverage those medical and health care services that are 
not demonstrated to be safe and effective. Medicare contractors (that 
is, fiscal intermediaries, carriers, and Utilization and Quality 
Control Peer Review Organizations (PROs)) are charged with the 
responsibility of ensuring that payments are made only for services 
that are covered under Medicare Part A or Part B. Therefore, in 
adjudicating a Medicare claim or conducting utilization and quality 
review, they must determine whether a service that has been furnished 
to a Medicare beneficiary is included in the scope of Medicare benefits 
and, if it is, whether it is ``reasonable'' and ``necessary'' for the 
particular medical condition of this particular patient.
    The term ``national coverage decision'' (NCD) refers to a coverage 
decision that we make and issue as national policy under section 
1862(a)(1)(A) of the Act. We have issued over 200 NCDs on specific 
services. We publish NCDs in the Medicare Coverage Issues Manual (HCFA-
Pub. 6), and in other HCFA program manuals or as notices or HCFA 
Rulings in the Federal Register. Under section 1871(a)(2) of the Act, 
NCDs are exempt from the general requirement that no rule, requirement, 
or other statement of policy that establishes or changes a substantive 
legal standard governing the scope of benefits, the payment for 
services, or the eligibility of individuals, entities, or organizations 
to furnish or receive benefits under title XVIII will take effect 
unless it is promulgated by the Secretary through regulations.

B. HMOs and CMPs

    HMOs and CMPs enter into contracts with HCFA to furnish Medicare 
covered services to Medicare beneficiaries who enroll in them in 
accordance with section 1876 of the Act. The contracts provide for 
payment to the HMOs and CMPs on either a risk or a reasonable cost 
basis. The provisions in this proposed rule apply only to HMOs and CMPs 
that contract on a risk basis.
    Risk HMOs and CMPs are paid a predetermined, per capita rate for 
each enrolled Medicare beneficiary. Under section 1876(a)(1)(A) of the 
Act, we annually determine and announce by September 7 for the 
following calendar year, a per capita rate of payment for each class of 
Medicare beneficiaries enrolled in a risk HMO or CMP. The per capita 
rate is set at 95 percent of the adjusted average per capita cost 
(AAPCC). (The AAPCC is an actuarial estimate that we make in advance of 
an HMO's or CMP's contract period and that represents an estimate of 
what the average per capita cost would be to the Medicare program for 
each class of Medicare enrollees if the enrollees had received covered 
services in the same geographic area or a similar area, from sources 
other than the HMO or CMP.)
    We define the classes on the basis of county of residence (State of 
residence, for end-stage renal disease beneficiaries), age, sex, 
disability, institutional status, and welfare status. Within each 
class, we establish two rates, one for beneficiaries entitled to 
Medicare Part A and Part B, and one for those entitled only to Medicare 
Part B.

C. Statutory Provisions

    Under section 1876(c)(2)(A) of the Act, an HMO or CMP is required 
to furnish to Medicare enrollees the Medicare covered services to which 
they are entitled, but only to the extent that those services are 
available to beneficiaries who reside in the geographic area served by 
the HMO or CMP but are not enrolled in the organization. The only 
exceptions to this general rule are: (1) That risk contracting HMOs and 
CMPs are not required to provide hospice care services, or to assume 
financial responsibility for inpatient care furnished to an enrollee 
who, on the effective date of enrollment, was an inpatient in a 
hospital paid under the prospective payment system; and (2) risk 
contractors are not required to enroll Medicare beneficiaries who have 
end-stage renal disease (whether aged, disabled, or entitled to 
Medicare solely because of having end-stage renal disease).
    In summary, before enactment of the Omnibus Budget Reconciliation 
Act of 1990 (OBRA '90), under sections 1876(c)(2)(A), 1876(a)(6), 
1876(a)(1)(D), and 1876(a)(3) of the Act, respectively--
     Risk HMOs and CMPs were responsible for furnishing NCD 
services of significant cost even though that cost had not been taken 
into account in determining the per capita rate that HCFA paid the HMO 
or CMP during that year;
     Payment for services furnished to Medicare enrollees of a 
risk HMO or CMP could be made only to the HMO or CMP, and only in the 
form of advance monthly per capita payments; and
     Those per capita payments were made instead of the amounts 
that would have been made on a fee-for-service basis.

II. Changes Made by OBRA '90

    Section 4204(c)(1) of OBRA '90 added section 1876(c)(2)(B) of the 
Act, applicable to contract periods beginning on or after January 1, 
1991. Under section 1876(c)(2)(B), if HCFA projects that the cost of 
furnishing the NCD service will be significant, and the cost of the 
service was not taken into account in calculating the most recently 
announced per capita payment rates, then, unless otherwise required by 
law--
     The risk HMO or CMP is not required to furnish the new or 
expanded benefit established by the NCD until the first contract year 
that begins after the next payment rate announcement (that takes into 
account the cost of the NCD service); and
     If the risk HMO or CMP does furnish the new or expanded 
benefit during the current contract period, the prohibition of section 
1876(a)(3) does not apply, and HCFA's intermediary or carrier would pay 
the risk HMO or CMP for the NCD service (under the usual Medicare 
payment rules and methods) in addition to the monthly capitation 
payment. (Usual Medicare payment methods require that payment for 
services furnished by a participating provider such as a hospital be 
made only to the provider.)
    Section 4204(c) of OBRA '90 also amended section 1876(a)(6) of the 
Act (the general prohibition against paying any entity other than the 
risk HMO or CMP for services furnished to a Medicare enrollee) by 
providing an exception for NCD services in section 1876(c)(2)(B)(ii) of 
the Act. Under that exception, if a Medicare enrollee chooses to obtain 
an NCD service from a source other than the risk HMO or CMP, HCFA may 
make payment under the usual Medicare payment methods and rules to the 
beneficiary, or to the qualified provider, physician, or supplier, as 
appropriate.

III. Provisions of the Proposed Rule

    To implement the provisions of section 4204(c) of OBRA '90, we 
propose to make the following revisions to 42 CFR part 417 (``Health 
Maintenance Organizations, Competitive Medical Plans, and Health Care 
Prepayment Plans''). We also plan to make various technical changes.

A. Definitions

    In Sec. 417.401 we would add definitions of ``National coverage 
decision'' and ``significant cost.''
    National coverage decision (NCD) means--a statement of national 
policy regarding the Medicare coverage status of a service that we make 
under section 1862(a)(1) of the Act and publish in the Federal Register 
as a notice or HCFA Ruling, issue as a manual instruction, or announce 
by other formal notice. The term does not include coverage changes 
mandated by statute.
    Significant cost, as it relates to a particular NCD, means either 
of the following:
    (1) The average cost of furnishing a single service exceeds a cost 
threshold that--
    (i) For calendar years 1991 and 1992, is $100,000; and
    (ii) For 1993 and subsequent calendar years, is the preceding 
year's dollar threshold, adjusted to reflect the increase or decrease 
in the United States per capita cost (USPCC) for the preceding year.
    (2) The cost of all of the services furnished nationwide as a 
result of the particular NCD represents at least 0.1 percent of the 
USPCC multiplied by the total number of Medicare beneficiaries 
nationwide for the applicable calendar year.
    (We would actuarially determine the significant cost of an NCD and 
include that information in the formal notice of the decison). In 
section IV, below, we discuss our reasoning for proposing these 
thresholds for significant cost.

B. Range of Services Furnished by HMOs and CMPs

    In Sec. 417.414 Qualifying condition: Range of services, we would 
redesignate paragraph (b)(4), concerning selection of practitioners, as 
paragraph (b)(3) of Sec. 417.416 (which deals with furnishing of 
services and is thus a more appropriate location than ``Range of 
services''), and add to Sec. 417.414 a new paragraph (b)(4) to specify 
that a risk HMO or CMP is not required to furnish an NCD service until 
the contract year beginning after the next per capita rate announcement 
if all of the following conditions apply:
     HCFA has determined and announced that the NCD service 
meets the definition of ``significant cost.''
     The cost of that service was not included in the 
determination of the per capita rate of payment that HCFA pays the HMO 
or CMP.
     The NCD that established coverage of the service was 
issued on or after the date of the announcement of the per capita rate 
of payment for that contract year.
    Starting with the beginning of the next contract year, the HMO or 
CMP would be responsible for furnishing or paying for the NCD service.
    We considered that these proposed revisions could have an adverse 
effect on the ability of the risk HMO or CMP to manage the enrollee's 
health care, but believe the changes are required by the wording of the 
statute.

C. Deductible and Coinsurance Amounts

    We would amend Sec. 417.452, which deals with Medicare enrollees' 
liability for Medicare deductible and coinsurance amounts--
     To clarify that the HMO or CMP may reduce these charges 
under the ``additional benefits'' provision in Sec. 417.440(b)(4)(i); 
and
     To provide exemption from deductibles for ``significant 
cost'' NCD services that the risk HMO or CMP is not required to 
furnish, regardless of whether the service is furnished by the HMO or 
CMP or obtained by the enrollee from another source.
    We considered also waiving coinsurance for these services because 
we believe that beneficiaries enroll in an HMO or CMP, in part, to 
protect themselves from significant unanticipated costs. (In HMOs and 
CMPs, the actuarial equivalent of deductible and coinsurance amounts is 
spread among all enrollees and enrollees know in advance what the 
charge will be for particular services.) We believe that imposition of 
such costs for enrollees who need a significant cost NCD service could 
discourage beneficiaries from enrolling or remaining enrolled in an HMO 
or CMP.
    We would prefer to encourage beneficiaries to enroll and remain 
enrolled in Medicare risk contracting HMOs and CMPs, by relieving 
beneficiaries' liability for coinsurance amount. However, we believe 
the law requires that beneficiaries be liable for coinsurance amounts 
because, unlike deductibles, these amounts are attributable to 
particular services received. We are especially interested in comments 
on this issue, including other legal interpretations of beneficiary 
liability for coinsurance amounts.

D. Payment for NCD Services

    We would remove current Sec. 417.586 because it provides an option 
(electing to have Medicare intermediaries process and pay hospital and 
nursing facility bills for services furnished to Medicare enrollees of 
a risk HMO or CMP) that was repealed by section 4012(b) of the Omnibus 
Budget Reconciliation Act of 1987 (OBRA '87).
    We would add a new Sec. 417.586 (Special rules: Payment for 
significant cost national coverage decision (NCD) services). Under this 
new section, for significant cost NCD services whose cost was not 
included in calculating the per capita payment rate for a risk HMO or 
CMP, payment would be made under the usual Medicare payment rules and 
methods. Usual Medicare payment methods require that payments for 
services furnished by a participating provider, for example, a 
hospital, be made only to that provider. The carrier may make payment 
for Part B services of physicians and other suppliers such as other 
practitioners and entities that are not providers, under usual carrier 
procedures, directly to any of the following:
     The beneficiary who obtained the service from a qualified 
source other than the risk HMO or CMP.
     The qualified provider, physician, or supplier that 
furnished the service.
     The risk HMO or CMP that chose to furnish the service even 
though not required to do so.
    We would specify, in Sec. 417.586(c), that HCFA does not make an 
additional payment for a significant cost NCD service furnished by the 
HMO or CMP (even though it is excepted during the current calendar 
year) if the HMO or CMP furnishes the NCD service as an optional or 
required supplemental service under Sec. 417.440(b)(2), or as an 
additional benefit under Sec. 417.592. The reason for the exclusion is 
that the costs of both of these types of services are already provided 
for under the contract, and the statute specifies that the NCD ``shall 
not apply'' to the contract. Optional or required supplemental services 
are paid for by the enrollees. The HMO or CMP may provide ``additional 
benefits'' as one way to compensate the beneficiary if the per capita 
payments it receives from HCFA are higher than the HMO's or CMP's 
adjusted community rate (ACR), which is what the HMO or CMP would 
charge its non-Medicare enrollees for a package of benefits limited to 
Medicare-covered services. We note that, if the NCD services are 
already provided under the contract as additional benefits or 
supplemental services, the beneficiary would not be required to pay any 
additional Medicare coinsurance due to the NCD.

E. Other Clarifying Changes

    1. Throughout the affected sections, we would use the more precise 
term ``HMO'' or ``CMP'' in preference to the generic term 
``organization''.
    2. In Sec. 417.440, we would amend paragraph (a) to update a cross-
reference, and paragraph (b)(1) to break down a too-long sentence.

IV. Significant Cost

    For 1991 and 1992, we propose that the cost of an NCD service be 
considered ``significant'' if the average cost of furnishing that 
service exceeds $100,000 or represents a change of at least 0.1 percent 
in the United States per capita cost (USPCC) determined for the nation 
as a whole. The USPCC is defined in Sec. 417.582 as the average per 
capita cost, including intermediary or carrier administrative costs, 
incurred by Medicare, as determined on an accrual basis, for services 
furnished to Medicare beneficiaries nationwide during the most recent 
period for which HCFA has complete data. AAPCCs derived from the USPCC 
are the basis for Medicare payments to HMOs and CMPs. We also propose 
that beginning with calendar year 1993 the preceding year's threshold 
be adjusted to reflect any increase or decrease in the USPCC. The 
purpose of the annual adjustment is to keep pace with inflation. The 
average annual increase or decrease in the USPCC represents the change 
in the average per capita cost of furnishing services to Medicare 
beneficiaries.
    We would actuarially determine the average cost of an individual 
NCD service and include it at the time the NCD is issued in manuals, 
published in the Federal Register, or announced by other formal notice.
    The $100,000 threshold is proposed because it approximates the 1991 
Medicare Part A cost of a liver transplant, a recent and important 
national coverage decision that was included in the adjusted average 
per capita cost (AAPCC) for 1991. The AAPCC is defined in Sec. 417.401 
as an actuarial estimate made by HCFA in advance of an organization's 
contract period that represents what the average per capita cost to the 
Medicare program would be for each class (that is, Medicare beneficiary 
designated by age, sex, disability, institutional, and welfare status) 
of the organization's Medicare enrollees if they had received covered 
services other than through the organization in the same geographic 
area or in a similar area. We are especially interested in receiving 
public comments concerning the thresholds we are proposing.
    A 0.1 percent annual change in the 1993 USPCC would represent an 
annual increase of approximately $4.30 or about $156 million in 
additional annual outlays for the Medicare program as a whole. We 
believe these figures represent the minimum threshold of significant 
financial outlay for the average risk contracting HMO or CMP that has a 
mean enrollment of nearly 15,800 Medicare beneficiaries and an average 
monthly payment from Medicare of approximately $339 per Medicare 
beneficiary or $5.37 million. We also believe it would protect small 
organizations from unanticipated financial outlays sufficiently to 
induce their continued participation in the Medicare program under 
section 1876 of the Act.
    The section that follows describes the NCDs announced in calendar 
years 1991 and 1992. During that period, HCFA announced the addition of 
six new services and the removal of one service. By combining Medicare 
payment data for physician services with facility costs data, we were 
able to estimate the relative costs associated with providing these 
services. The coverage of liver transplantation for adults was 
estimated to cost over $100,000 per procedure, which meets the 
threshold to be considered ``of significant cost'' under this proposed 
rule. Adult liver transplantation is covered for specific conditions 
when performed in a facility approved by HCFA as meeting certain 
institutional coverage criteria.
    The remaining services were estimated to have average costs that 
are well below the $100,000 threshold. These services are described 
below.

Extracorporeal Immunoadsorption (ECI)

    This procedure, which uses Protein A columns, is covered only for 
the treatment of patients with Idiopathic Thrombocytopenia Purpura 
(ITP) failing other treatments.

Implantation of Automatic Defibrillators

    Patient selection criteria were changed to remove requirements that 
patients had to have inducible tachyrhythmia before implantation or 
that this technology be used as a treatment of last resort. Although 
additional patients may be covered, we believe that the savings in 
diagnostic costs offset additional costs.

Percutaneous Transluminal Angioplasty (PTA)

    This procedure is used in the treatment of obstructive lesions of 
arteriovenous dialysis fistulas.

Laparoscopic Cholecystectomy

    This surgical procedure is covered for the removal of the gall 
bladder.

Apheresis (Therapeutic Pheresis)

    This autologous medical procedure is covered for specific 
conditions. Medicare coverage criteria have been updated to include 
coverage for procedures performed in a hospital setting (inpatient or 
outpatient) or in a nonhospital setting if the patient is under the 
care of a physician and a physician is also present to direct and 
supervise the nonphysician services.

Extracranial-intracranial (EC-IC) Arterial Bypass

    In 1991 this surgical procedure was removed from the list of 
Medicare covered procedures.
    The only ``significant cost'' NCD service among those listed above 
is the liver transplant for adults. That NCD was published in the 
Federal Register as a final notice on April 12, 1991, at 56 FR 15006. 
The decision to cover liver transplants for adults was based on our 
determination that liver transplants are medically reasonable and 
necessary services if furnished to adult patients with certain 
conditions and if furnished by participating facilities that meet 
specific criteria including patient selection criteria. Under certain 
circumstances, coverage of these liver transplants could be effective 
as early as March 8, 1990, which was the publication date of the 
proposed notice in the Federal Register. However, Medicare payment for 
liver transplants for beneficiaries enrolled in risk HMOs and CMPs was 
not included in the per capita rates of payment until January 1991. 
Consequently, risk HMOs and CMPs were forced to absorb any liver 
transplant costs (approximately $100,000 per transplant) from March 8, 
1990, through December 31, 1990.
    Items and services necessary to diagnose a condition for which the 
recommended therapy is a noncovered service, and most services 
furnished as followup care to the noncovered service, are not 
considered part of that service and are not included in the payment for 
that service. Medicare already covers certain diagnostic services, 
which may lead to a recommendation that a beneficiary receive therapy 
that is not covered. In addition, Medicare covers certain medically 
necessary services that relate to follow-up care to a noncovered 
service. For example, for patients who received liver transplants 
before March 8, 1990, outpatient diagnostic services preceding the 
transplant procedure were covered, as was medically necessary follow-up 
care after discharge from the hospital for the noncovered transplant 
procedure.
    The hospitalization for the transplant procedure would not have 
been covered, nor would other services received directly related to the 
noncovered procedure, such as the surgeon's fee for the transplant 
surgery itself. We consider services that would not have been covered 
as part of the NCD occurrence. An occurrence includes the actual 
provision of a discrete item or service that is the subject of an NCD.
    Any item or service that is already covered, such as diagnostic 
services followed by a noncovered therapy, as discussed above, would 
not be considered as part of the NCD service and thus would not be 
eligible for payment outside the HMO's or CMP's monthly rate. An item 
or service that would not have been covered if furnished as part of a 
noncovered procedure, such as the surgeon's fee for a noncovered liver 
transplant, would qualify for payment outside the HMO's or CMP's 
monthly rate, even though it is not itself the subject of the NCD.
    Section 1861(s)(2)(J) of the Act provides for coverage of 
prescription drugs used in immunosuppressive therapy for 1 year 
following a transplant, only if the organ transplant procedure is a 
covered service. Therefore, if future NCDs provide for coverage of 
transplantation of organs other than the presently covered kidney, 
liver, and heart, and are announced after publication of AAPCC rates 
for the contract period, immunosuppressive therapy following those 
organ transplants would also qualify for payment outside the HMO's or 
CMP's monthly rates.

V. Collection of Information Requirements

    This rule contains no information collection requirements subject 
to review by the Office of Management and Budget under the Paperwork 
Reduction Act of 1980 (44 U.S.C. 3501 et seq.).

VI. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on a proposed rule, we are not able to acknowledge or respond 
to them individually. However, we will consider all comments that we 
receive by the date and time specified in the ``Dates'' section of this 
preamble, and if we proceed with the final rule, we will respond to the 
comments in the preamble to the final rule.

VII. Regulatory Impact Statement

A. Introduction

    This proposed rule would affect those HMOs and CMPs (90 as of 
January 1993) that contract with HCFA to furnish health care services 
to Medicare enrollees that are paid on a risk basis. Four demonstration 
projects are also subject to the risk contract rules. As of January 
1993, there were 21,908 Medicare enrollees in the four demonstration 
projects. As a result of the OBRA '90 amendments discussed under 
section II of this preamble, for NCD services that the risk HMO or CMP 
is not required to furnish (because the cost of furnishing the service 
is significant and was not taken into account in determining the per 
capita rate that HCFA pays the HMO or CMP), additional payments may be 
made as explained in section III.D. of the preamble.
    It is clear that these additional payments constitute additional 
program expenditures. However, estimation of the amount is difficult 
because we cannot accurately predict--
     How many of the services added or expanded through NCDs in 
any year will be of ``significant cost''; and
     How many of the Medicare enrollees of risk HMOs and CMPs 
(approximately 1.5 million as of January 1993) will need a 
``significant cost'' NCD service.
    We do know that only six NCD services were added by HCFA during 
1991 and 1992, and that only one of those six services (liver 
transplants for adults) would have met a ``significant cost'' criterion 
(average cost in excess of $100,000). We do not anticipate a 
significant increase in the number of liver transplants performed on 
Medicare beneficiaries because livers for transplantation purposes are 
not readily available. We believe this surgery will continue to be 
performed relatively infrequently.
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the Office of Management and Budget.

B. Regulatory Flexibility Analysis

    We generally prepare a regulatory flexibility analysis that is 
consistent with the Regulatory Flexibility Act (RFA, 5 U.S.C. 601 
through 612) unless the Secretary certifies that a proposed rule would 
not have a significant economic impact on a substantial number of small 
entities. For purposes of the RFA, all HMOs and CMPs that have entered 
into risk contracts with HCFA are considered to be small entities.
    In addition, section 1102(b) of the Act requires the Secretary to 
prepare a regulatory impact analysis if a proposed rule would have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area and has fewer than 50 beds.
    As noted earlier in this preamble, we believe that, by ensuring 
that the cost of furnishing required Medicare services would not 
increase substantially during a contract period, the new rules might 
encourage HMOs and CMPs to contract on a risk basis. We anticipate an 
increase in the number of risk-contracting organizations, but recognize 
that this proposed rule would not constitute a significant economic 
impact on a substantial number of HMOs and CMPs. These rules would not 
affect the operations of small rural hospitals.
    We are not preparing analyses under either the RFA or section 
1102(b) of the Act because we have determined, and the Secretary 
certifies, that this proposed rule would not result in a significant 
economic impact on a substantial number of small entities or a 
significant impact on the operations of a substantial number of small 
rural hospitals.

List of Subjects in 42 CFR Part 417

    Administrative practice and procedure, Grant programs--health, 
Health care, Health facilities, Health insurance, Health maintenance 
organizations (HMO), Loan programs--health, Medicare, Reporting and 
recordkeeping requirements.

    42 CFR part 417 would be amended as set forth below:

PART 417--HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL 
PLANS, AND HEALTH CARE PREPAYMENT PLANS

    1. The authority citation continues to read as follows:

    Authority: Secs. 1102, 1833(a)(1)(A), 1861(s)(2)(H), 1866(a), 
1871, 1874, and 1876 of the Social Security Act (42 U.S.C. 1302, 
1395l(a)(1)(A), 1395x(s)(2)(H), 1395cc(a), 1395hh, 1395kk, and 
1395mm); sec. 114(c) of Pub. L. 97-248 (42 U.S.C. 1395mm note); 31 
U.S.C. 9701; and secs. 215 and 1301 through 1318 of the Public 
Health Service Act (42 U.S.C. 216 and 300e through 300e-17), unless 
otherwise noted.

    2. In Sec. 417.401, the introductory text is republished, and the 
following definitions are added in alphabetical order:


Sec. 417.401  Definitions.

    As used in this subpart, and in subparts K through R of this part, 
unless the context indicates otherwise--
* * * * *
    National coverage decision (NCD) means a national policy statement 
regarding the coverage status of a specified service, that HCFA makes 
under section 1862(a)(1) of the Act, publishes in the Federal Register 
as a notice or HCFA Ruling, or announces by other formal notice. (The 
term does not include coverage changes mandated by statute.)
    Significant cost, as it relates to a particular NCD, means either 
of the following:
    (1) The average cost of furnishing a single service exceeds a cost 
threshold that--
    (i) For calendar years 1991 and 1992, is $100,000; and
    (ii) For 1993 and subsequent calendar years, is the preceding 
year's dollar threshold, adjusted to reflect the increase or decrease 
in the United States per capita cost (USPCC) for the preceding year.
    (2) The cost of all of the services furnished nationwide as a 
result of the particular NCD represents at least 0.1 percent of the 
USPCC multiplied by the total number of Medicare beneficiaries 
nationwide for the applicable calendar year.
* * * * *
    3. In Sec. 417.414, the section heading and paragraphs (a) and (b) 
are revised to read as follows:


Sec. 417.414  Qualifying condition: Range of services furnished by an 
HMO or CMP.

    (a) Condition. The HMO or CMP must demonstrate that it is capable 
of delivering to Medicare enrollees the range of services required in 
accordance with this section.
    (b) Standard: Range of services--(1) Basic requirement. Except as 
specified in paragraphs (b)(3) and (b)(4) of this section, an HMO or 
CMP must furnish to its Medicare enrollees (directly or through 
arrangements with others) all Medicare services to which those 
enrollees are entitled, to the extent that those services are available 
to Medicare beneficiaries who reside in the HMO's or CMP's geographic 
area but are not enrolled in the HMO or CMP.
    (2) Availability. The services are considered available if either 
of the following criteria is met:
    (i) The sources are located within the geographic area of the HMO 
or CMP.
    (ii) It is common practice to refer patients to sources outside 
that geographic area.
    (3) Exception and requirement for hospice care. An HMO or CMP is 
not required to furnish hospice care as described under part 418 of 
this chapter. However, HMOs and CMPs must inform their Medicare 
enrollees concerning the availability of hospice care if either of the 
following criteria is met:
    (i) A hospice that participates in Medicare is located within the 
geographic area of the HMO or CMP.
    (ii) It is common practice to refer patients to hospices outside 
that geographic area.
    (4) Exception for national coverage decision (NCD) services: Risk 
HMOs and CMPs. A risk HMO or CMP is not required to furnish or pay for 
an NCD service until the contract year beginning after the next per 
capita rate announcement if all of the following conditions are met:
    (i) HCFA has determined and announced that the NCD service meets 
the definition of ``significant cost'' in Sec. 417.401.
    (ii) The cost of that service was not included in the determination 
of the per capita rate of payment that HCFA pays the HMO or CMP.
    (iii) The NCD that established coverage of the service was issued 
on or after the date of the announcement of the per capita rate of 
payment for that contract year.
    (5) Examples. The following examples apply to NCD services of 
significant cost and show how the NCD announcement date (which 
determines whether the cost of that service is taken into account in 
calculating the per capita rate of payment) in turn determines when the 
HMO or CMP becomes responsible for furnishing or paying for the NCD 
service.

    Example A: An NCD is announced on September 1, 1993, effective 
on the date of announcement. Because this NCD was announced before 
September 7, 1993, the announcement date of the per capita rate of 
payment for calendar year 1994, a risk HMO or CMP is responsible for 
furnishing or paying for the NCD service beginning with calendar 
year 1994.

    Example B: An NCD is announced on December 1, 1993, effective on 
date of announcement. Because this NCD was announced after September 
7, 1993, the announcement date of the per capita rate of payment for 
calendar year 1994, the risk HMO or CMP is not responsible for 
furnishing or paying for the NCD service until the beginning of 
calendar year 1995.
* * * * *
    4. In Sec. 417.416, a new paragraph (b)(3) is added to read as 
follows:


Sec. 417.416  Qualifying condition: Furnishing of services.

* * * * *
    (b) * * *
    (3) If more than one type of practitioner is qualified to furnish a 
particular service, the organization may select the type of 
practitioner to be used.
* * * * *
    5. In Sec. 417.440, the section heading and paragraphs (a) and 
(b)(1) are revised to read as follows:


Sec. 417.440  Entitlement to health care services from an HMO or CMP.

    (a) Basic rules. (1) Subject to the conditions and limitations set 
forth in this part, a Medicare enrollee of an HMO or CMP is entitled to 
receive health care services directly from, or through arrangements 
made by, the HMO or CMP, as specified in this section and 
Sec. Sec. 417.442 and 417.444.
     (2) A Medicare enrollee is also entitled to receive timely and 
reasonable payment directly (or have payment made on his or her behalf) 
for services he or she obtained from a provider or supplier outside the 
HMO or CMP if those services meet either of the following conditions:
    (i) They are emergency services or urgently needed unforeseen 
services as defined in Sec. 417.401.
    (ii) They are services denied by the HMO or CMP and found (upon 
appeal under subpart Q of this part) to be services the enrollee was 
entitled to have furnished by the HMO or CMP.
    (b) Scope of services. (1) Part A and Part B services. Except as 
specified in paragraphs (c) through (e) of this section, a Medicare 
enrollee is entitled to receive from the HMO or CMP all the Medicare-
covered services that are available to individuals residing in the 
HMO's or CMP's geographic area, as follows:
    (i) Medicare Part A and Part B services if the enrollee is entitled 
to benefits under both programs.
    (ii) Medicare Part B services if the enrollee is entitled only 
under that program.
* * * * *
    6. In Sec. 417.452, paragraph (a) is revised to read as follows:


Sec. 417.452  Liability of Medicare enrollees.

    (a) Deductibles and coinsurance--(1) General rules.
    (i) A Medicare enrollee of an HMO or CMP is responsible for HMO or 
CMP charges that represent applicable Medicare deductible and 
coinsurance amounts.
    (ii) The amounts that the HMO or CMP charges its Medicare enrollees 
under paragraph (a)(1)(i) of this section may not exceed, on the 
average, the actuarial value of the deductibles and coinsurance for 
which the Medicare enrollees would be responsible if they were not 
enrolled in an HMO or CMP.
    (2) Special rules: Medicare enrollees of risk HMOs and CMPs. (i) If 
a risk HMO or CMP reduces the deductible and coinsurance charges in 
accordance with the ``additional benefits'' option provided in 
Sec. 417.440(b)(4)(i), the enrollee pays less than would otherwise be 
required under paragraph (a)(1) of this section.
    (ii) A Medicare enrollee of a risk HMO or CMP is not responsible 
for deductibles applicable to national coverage decision (NCD) services 
that the HMO or CMP is not required to furnish because they are 
excepted under Sec. 417.414(b)(4). The exemption applies regardless of 
whether the HMO or CMP furnishes the services or the enrollee obtains 
them from other sources.
    (3) Type of charge and source of payment. (i) The deductible and 
coinsurance charges imposed by an HMO or CMP may be in the form of 
premiums, membership fees, or per-unit or similar charges.
    (ii) The deductible and coinsurance charges may be paid by the 
enrollee or on his or her behalf by another individual, organization, 
or entity.
* * * * *
    7. Section 417.586 is revised to read as follows:


Sec. 417.586  Special rules: Payment for significant cost national 
coverage decision (NCD) services.

    (a) Applicability. This section applies to NCD services that a risk 
HMO or CMP is not required to furnish because they are excepted under 
Sec. 417.414(b)(4).
     (b) Method of payment. If a Medicare enrollee of a risk HMO or CMP 
receives an NCD service specified in paragraph (a) of this section, 
payment for that service--
    (1) Is in addition to the per capita payments to the HMO or CMP; 
and
    (2) Is made by the fiscal intermediary or carrier under the usual 
Medicare rules and methods set forth in part 405; part 410, subpart E; 
part 412, 413, or 415, as appropriate; and subject to the requirements 
of part 424 of this chapter.
    (c) Exceptions. HCFA does not make additional payments under 
paragraph (b) of this section if the HMO or CMP--
    (1) Is obligated to furnish the NCD service as an ``additional 
benefit'' under Sec. 417.592; or
    (2) Furnishes the NCD service as an optional or required 
supplemental service paid for by the Medicare enrollee under 
Sec. 417.440 (b)(2) or (b)(3).

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

    Dated: July 28, 1993.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
    Dated: November 3, 1993.
Donna E. Shalala,
Secretary.
[FR Doc. 94-3609 Filed 2-18-94; 8:45 am]
BILLING CODE 4120-01-P