94-3609. Medicare Program; Health Maintenance Organization and Competitive Medical Plan National Coverage Decisions  

  • [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]
    
    
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    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.
    
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    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
    
    
    

Document Information

Published:
02/22/1994
Department:
Health Care Finance Administration
Entry Type:
Uncategorized Document
Action:
Proposed rule.
Document Number:
94-3609
Dates:
Comments will be considered if we receive them at the
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: February 22, 1994, BPD-732-P
RINs:
0938-AF76
CFR: (10)
42 CFR 417.414(b)(4)
42 CFR 417.440(b)(4)(i)
42 CFR Sec
42 CFR 417.440
42 CFR 417.401
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