96-33330. Medicare and Medicaid Programs; Requirements for Physician Incentive Plans in Prepaid Health Care Organizations  

  • [Federal Register Volume 61, Number 252 (Tuesday, December 31, 1996)]
    [Rules and Regulations]
    [Pages 69034-69050]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-33330]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    42 CFR Parts 417 and 434
    
    [OMC-010-F]
    RIN 0938-AF74
    
    
    Medicare and Medicaid Programs; Requirements for Physician 
    Incentive Plans in Prepaid Health Care Organizations
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Final rule.
    
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    SUMMARY: This final rule amends the regulations established by a March 
    27, 1996, final rule with comment period. The regulations govern 
    physician incentive plans operated by Federally-qualified health 
    maintenance organizations and competitive medical plans contracting 
    with the Medicare program, and certain health maintenance organizations 
    and health insuring organizations contracting with the Medicaid 
    program.
        As explained in the March 27 rule, the provisions of this final 
    rule will also have an effect on certain entities subject to the 
    physician referral rules in section 1877 of the Social Security Act.
    
    DATES: Effective date. These regulations are effective on January 1, 
    1997.
    
    FOR FURTHER INFORMATION CONTACT: Beth Sullivan, (410) 786-4596.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
    A. Introduction
    
        Prepaid health care organizations, such as health maintenance 
    organizations (HMOs), competitive medical plans (CMPs), and health 
    insuring organizations (HIOs) are entities that provide enrollees with 
    comprehensive, coordinated health care in a cost-efficient manner. The 
    goal of prepaid health care delivery is to control health care costs 
    through preventive care and case management and provide enrollees with 
    affordable, coordinated, quality health care services. Titles XVIII and 
    XIX of the Social Security Act (the Act) authorize contracts with 
    prepaid health care organizations (hereinafter referred to as 
    ``organizations'' or ``prepaid plans'') for the provision of covered 
    health services to Medicare beneficiaries and Medicaid recipients, 
    respectively. Such organizations may contract under either a risk-based 
    or cost-reimbursed contract.
    
    B. Medicare
    
        Section 1876 of the Act authorizes the Secretary to enter into 
    contracts with eligible organizations (HMOs that have been Federally 
    qualified under section
    
    [[Page 69035]]
    
    1310(d) of the Public Health Service Act and CMPs that meet the 
    requirements of section 1876(b)(2) of the Act) to provide Medicare-
    covered services to beneficiaries and specifies the requirements the 
    organizations must meet. Payment under these contracts may either be 
    made on a risk capitation basis, under which a fixed amount is paid per 
    Medicare enrollee per month, or on a reasonable cost basis, under which 
    costs are reimbursed retrospectively. Implementing Federal regulations 
    for the organization and operation of Medicare HMOs and CMPs, contract 
    requirements, and conditions for payment are located at 42 CFR 417.400 
    through 417.694.
        The amount paid to risk HMOs/CMPs is the projected actuarial 
    equivalence of 95 percent of what Medicare would have paid if the 
    beneficiaries had received services from fee-for-service providers or 
    suppliers. Organizations paid on a risk basis are liable for any 
    difference between the Medicare prepaid amounts and the actual costs 
    they incur in furnishing services, and they are therefore ``at risk.''
        Cost-reimbursed organizations are paid monthly interim per capita 
    payments that are based on a budget. Later, a retrospective cost 
    settlement occurs to reflect the reasonable costs actually incurred by 
    the organization for the covered services it furnished to its Medicare 
    enrollees.
    
    C. Medicaid
    
        Section 1903(m) of the Act specifies requirements that must be met 
    for States to receive Federal financial participation (FFP) for 
    contracts with organizations (HMOs, and certain HIOs) to furnish, 
    either directly or through arrangements, specific arrays of services on 
    a risk basis. Federal implementing regulations for these contract 
    requirements and conditions for payment are located at 42 CFR part 434.
        States determine the per capita monthly rates that are to be paid 
    to risk-based organizations. FFP is available for these payments at the 
    matching rate applicable in the State as long as HCFA determines that 
    the contracts comply with detailed requirements in section 
    1903(m)(2)(A) and 42 CFR part 434.
    
    II. Legislative and Regulatory History
    
        Section 9313(c) of the Omnibus Budget Reconciliation Act of 1986 
    (OBRA '86), Public Law 99-509, prohibited, effective April 1, 1989, 
    hospitals and prepaid health care organizations with Medicare or 
    Medicaid risk contracts from knowingly making incentive payments to a 
    physician as an inducement to reduce or limit services to Medicare 
    beneficiaries or Medicaid recipients. Under the OBRA '86 provisions, 
    parties who knowingly made or accepted these payments would have been 
    subject to specified civil money penalties. Additionally, the 
    provisions required that the Secretary report on incentive arrangements 
    in HMOs and CMPs. Section 4016 of the Omnibus Budget Reconciliation Act 
    of 1987 (OBRA '87), Public Law 100-203, extended the original 
    implementation date for the OBRA '86 physician incentive provisions to 
    April 1, 1991. Subsequently, sections 4204(a) and 4731 of the Omnibus 
    Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508, 
    repealed, effective November 5, 1990, the prohibition of physician 
    incentive plans in prepaid health care organizations and enacted 
    requirements, effective January 1, 1992, for regulating these plans.
        Specifically, section 4204(a)(1) of OBRA '90 added paragraph (8) to 
    section 1876(i) of the Act to specify that each Medicare contract with 
    a prepaid health care organization must stipulate that the organization 
    must meet the following requirements if it operates a physician 
    incentive plan:
         That it not operate a physician incentive plan that 
    directly or indirectly makes specific payments to a physician or 
    physician group as an inducement to limit or reduce medically necessary 
    services to a specific individual enrolled with the organization.
         That it disclose to us its physician incentive plan 
    arrangements in detail that is sufficient to allow us to determine 
    whether the arrangements comply with Departmental regulations.
         That, if a physician incentive plan places a physician or 
    physician group at ``substantial financial risk'' (as defined by the 
    Secretary) for services not provided directly, the prepaid health care 
    organization: (1) Provide the physician or physician group with 
    adequate and appropriate stop-loss protections (under standards 
    determined by the Secretary) and (2) conduct surveys of currently and 
    previously enrolled members to assess the degree of access to services 
    and the satisfaction with the quality of services.
        Section 4204(a)(2) of OBRA '90 amended section 1876(i)(6)(A)(vi) of 
    the Act to add violations of the above requirements to the list of 
    violations that could subject a prepaid health care organization to 
    intermediate sanctions and civil money penalties.
        Section 4731 of OBRA '90 enacted similar provisions for the 
    Medicaid program by amending sections 1903(m)(2)(A) and 1903(m)(5)(A) 
    of the Act.
        Section 13562 of OBRA '93 amended section 1877 of the Act, which 
    prohibits physicians from referring Medicare patients to an entity for 
    the furnishing of certain designated health services if the physician 
    (or an immediate family member) has a financial relationship with that 
    entity. A financial relationship can consist of either an ownership or 
    investment interest in the entity or a compensation arrangement with 
    the entity. OBRA '93 provides an exception to the section 1877 
    physician referral prohibition that incorporates the physician 
    incentive plan rules implemented in this final rule. Under this 
    exception, compliance with these physician incentive rules is one of 
    several conditions that must be satisfied if a physician's or family 
    member's personal services compensation arrangement with an entity 
    involves compensation that varies based on the volume or value of 
    referrals. OBRA '93 also extended the provisions in section 1877 to 
    Medicaid.
        In the December 14, 1992 issue of Federal Register, we published, 
    in conjunction with the Office of Inspector General, our proposal for 
    implementing the requirements in sections 4204(a) and 4731 of OBRA '90 
    (57 FR 59024). On March 27, 1996, again in conjunction with the Office 
    of Inspector General, we published, at 61 FR 13430, a final rule with 
    comment period that set forth in regulations incentive plan 
    requirements that govern Federally-qualified HMOs and CMPs contracting 
    with the Medicare program and certain HMOs and HIOs contracting with 
    the Medicaid program. On September 3, 1996, we published, at 61 FR 
    46384, a final rule correction that clarified and changed some of the 
    dates by which prepaid health plans had to comply with the requirements 
    of the March 27 rule. Readers who desire additional background 
    information are referred to the above cited Federal Register documents.
    
    III. Provisions of the March 27, 1996 Rule
    
        This section contains a brief summary of the provisions of the 
    March 27, 1966 rule. If we received public comments on a particular 
    provision, a fuller description of the provision is given in section IV 
    of this preamble (Analysis of and Responses to Public Comments), and we 
    indicate that in this section. Note that we do not describe below those 
    provisions of the March 27, 1996 rule that amended 42 CFR Part 1003 
    (Civil Money Penalties, Assessments
    
    [[Page 69036]]
    
    and Exclusions) since they are not the subject of this revised final 
    rule.
        The requirements for physician incentive plans are set forth in 
    Sec. 417.479. Paragraph (a) of that section specifies that the contract 
    between HCFA and an HMO or CMP must specify that the HMO or CMP may 
    operate a physician incentive plan only if: (1) No specific payment is 
    made directly or indirectly under the plan to a physician or physician 
    group as an inducement to reduce or limit medically necessary services 
    furnished to an individual enrollee, and (2) the stop-loss protection, 
    enrollee survey, and disclosure requirements of Sec. 417.479 are met.
        Section 417.479(b) provides that the physician incentive plan 
    requirements apply to physician incentive plans between HMOs/CMPs and 
    individual physicians or physician groups with whom the HMOs or CMPs 
    contract to provide medical services to enrollees. It further provides 
    that the requirements apply only to physician incentive plans that base 
    compensation (in whole or in part) on the use or cost of services 
    furnished to Medicare beneficiaries or Medicaid recipients.
        Section 417.479(c) defines the following terms for purposes of 
    Sec. 417.479: Bonus, capitation, payment, physician group, physician 
    incentive plan, referral services, risk threshold, and withhold.
        Section 417.479(d) prohibits payment of any kind made directly or 
    indirectly under the incentive plan as an inducement to reduce or limit 
    medically necessary services covered under the HMO's or CMP's contract 
    that are furnished to an individual enrollee.
        Section 417.479(e) sets forth a general rule for determining when 
    substantial financial risk occurs. (See section IV.)
        Section 417.479(g) mandates that, if an HMO or CMP operates an 
    incentive plan that places physicians or physician groups at 
    substantial financial risk, it must conduct enrollee surveys that meet 
    specified requirements and ensure that all physicians and physician 
    groups at substantial financial risk have either aggregate or per-
    patient stop-loss protection that meets specified requirements. (See 
    section IV.)
        Section 417.479(h) requires that organizations with physician 
    incentive plans disclose information about those plans to us and to any 
    Medicare beneficiary who requests it. (See section IV.)
        Section 417.479(i) sets forth requirements related to 
    subcontracting arrangements. (See section IV.)
        Section 417.479(j) specifies that we may apply intermediate 
    sanctions, or the Office of Inspector General may apply civil money 
    penalties, if we determine that an HMO or CMP fails to comply with the 
    physician incentive plan requirements. In addition, failure to comply 
    with the physician incentive plan requirements was added to the list of 
    bases for imposition of sanctions at Sec. 417.500.
        The March 27, 1996 final rule also amended the Medicaid rules at 
    Sec. 434.70 (Conditions for Federal financial participation (FFP)) to 
    specify that FFP is available in expenditures for payments to an HMO or 
    HIO only if it complies with the physician incentive plan requirements. 
    The final rule also incorporated these requirements into Secs. 434.44 
    (Special rules for certain HIOs) and 434.67 (Sanctions against HMOs 
    with risk comprehensive contracts).
    
    IV. Analysis of and Responses to Public Comments
    
        We received 38 timely items of correspondence on the March 27, 1996 
    final rule with comment period. Commenters included prepaid plans, 
    national and local associations of managed care providers, physician 
    associations, a State medical association, and consumer advocacy 
    groups. This section of the preamble contains a summary of the comments 
    and our responses. Note that a national association that indicated that 
    it represents approximately 1,000 health plans and identified below as 
    ``a major association'' submitted comments. Although some of the 
    comments below are attributed only to the major association, individual 
    health plans also made some of these same comments.
    
    Applicability
    
        Comment: A commenter asked whether the regulations apply to 
    enrollees who are enrolled through the prepaid plan's commercial line 
    of business if the enrollees are also Medicare beneficiaries. For 
    example, if an individual who is over 65 but is actively working is 
    covered by the prepaid plan's commercial product through his or her 
    employer, would the physician incentive arrangement between the prepaid 
    plan and the physician(s) treating that individual under the commercial 
    product be subject to the regulations?
        Response: Yes, the regulations apply to these plans. The employer's 
    plan is the first payer, and the Medicare capitation payment is 
    adjusted downward, but the enrollee is still a Medicare beneficiary.
        Comment: One commenter stated that the regulation defines 
    ``physician group'' as a corporation or other group that ``distributes 
    income from the practice among members.'' [Emphasis added by 
    commenter.] The commenter stated that community health centers (CHCs) 
    are clearly not included within this definition. As a result, the 
    commenter is unable to ascertain whether plans contracting with CHCs 
    will be required to provide to CHCs the stop-loss protection described 
    in the regulation. The commenter recommends that the definition of 
    ``physician group'' be changed as regards distribution of income and 
    membership so as to include CHCs. The commenter pointed out the 
    following: CHCs are by definition public or private nonprofit entities. 
    As tax-exempt entities, they cannot ``distribute'' income like a for-
    profit entity does. CHC physicians are not ``members'' of the 
    corporation. Usually they are employees or, in some instances, 
    contractors.
        Response: We disagree that the definition needs to be revised. We 
    believe the commenter has misinterpreted the definition as describing 
    profit sharing among the members of a for-profit entity. The term 
    ``income'' does not equate to ``profits.'' The definition does include 
    CHCs.
    
    Disclosure
    
        We received several comments concerning the disclosure requirements 
    in the March 27 rule. Specifically, Sec. 417.479(h)(1) requires each 
    HMO or CMP with a physician incentive plan to provide us with 
    information concerning its physician incentive plans as required or 
    requested by us. The disclosure must contain the following information 
    in detail sufficient to enable us to determine whether the incentive 
    plan complies with the requirements of Sec. 417.479:
         Whether services not furnished by the physician or 
    physician group are covered by the incentive plan. If only the services 
    furnished by the physician or physician group are covered by the plan, 
    disclosure of other aspects of the plan need not be made.
         The type of incentive arrangement.
         If the incentive plan involves a withhold or bonus, the 
    percent of the withhold or bonus.
         The amount and type of stop-loss protection.
         The panel size, and if patients are pooled, the pooling 
    method used.
         In the case of a capitated physician or physician group, 
    capitation paid to primary care physicians for the most recent year 
    broken down by percent for primary care services, referral services to 
    specialists, and hospital and other types of provider services.
    
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         In the case of an HMO or CMP that is required to conduct 
    beneficiary surveys, the survey results.
        Section 417.479(h)(2) requires an HMO or CMP to provide the above 
    information to us (1) upon application for a contract; (2) upon 
    application for a service area expansion; and (3) within 30 days of a 
    request by us. This section also requires an HMO or CMP to notify us at 
    least 45 days before implementing a change in the type of incentive 
    plan, a change in the amounts of risk or stop-loss protection, or 
    expansion of the risk formula to cover services not furnished by the 
    physician group that the formula had not included previously.
        Section 417.479(h)(3) of the March 27 rule requires an HMO or CMP 
    to provide the following information to any Medicare beneficiary who 
    requests it:
         Whether it uses a physician incentive plan that affects 
    the use of referral services.
         The type of incentive arrangement.
         Whether stop-loss protection is provided.
         If it was required to conduct a beneficiary survey, a 
    summary of the survey results.
        Section 417.479(i) requires a prepaid plan that contracts with a 
    physician group that places the individual physician members at 
    substantial financial risk for services they do not furnish to disclose 
    to us any incentive plan between the physician group and its individual 
    physicians that bases compensation to the physician on the use or cost 
    of services furnished to Medicare beneficiaries or Medicaid recipients. 
    The disclosure must include the information specified in Sec. 417.479 
    (h)(1)(i) through (h)(1)(vii) and be made at the times specified in 
    Sec. 417.479(h)(2).
        Section 434.70(a) provides that Federal financial participation is 
    available in expenditures for payment to HMOs or HIOs only for periods 
    that the HMO or HIO has (1) supplied the information listed in 
    Sec. 417.479(h)(1) to the State Medicaid agency; and (2) supplied the 
    information on physician incentive plans listed in Sec. 417.479(h)(3) 
    to any Medicaid recipient who requests it. The timeframes for 
    disclosure to the State Medicaid agency are the same as those for 
    Medicare.
        Comment: One commenter suggested that health plans be permitted to 
    deem themselves to have transferred substantial financial risk without 
    having to describe to us the specific incentive arrangements and 
    analyses of each arrangement. The commenter also questioned our 
    authority for requiring disclosure of incentive arrangements and 
    believed that disclosure presents an enormous administrative burden. 
    The commenter asked: If an HMO agrees to provide stop-loss and to 
    conduct surveys, must it still disclose the information to HCFA as 
    required by the regulation?
        Response: Yes, under the statute and the regulation, health plans 
    must disclose this information. This information serves many purposes. 
    For example, it will be used to monitor compliance, evaluate the impact 
    of the regulation, and ensure the delivery of high quality health care. 
    In addition, this information will be useful to beneficiaries in 
    ensuring that they get needed care. Section 1876(i)(8) of the Act 
    requires the HMO or CMP provide the Secretary with descriptive 
    information regarding the plan that is sufficient to permit the 
    Secretary to determine whether the plan is in compliance with the 
    physician incentive plan requirements. Congress clearly intended health 
    plans to disclose information about the nature of physician incentive 
    compensation arrangements and the extent to which physicians are being 
    placed at substantial risk by the arrangements.
        In preparing both the March 27 regulation and these amendments and 
    clarifications, we have tried to limit the information being reported 
    to only that which is essential for us to carry out this explicit 
    statutory responsibility to ensure that plans are in compliance. We are 
    not requiring extensive detail about the compensation arrangements 
    being used, but rather are seeking information about the general nature 
    and scope of these arrangements.
        Comment: One commenter believed that the information to be 
    disclosed to us under the regulation is proprietary and should be 
    protected under the Freedom of Information Act (FOIA). The commenter 
    stated that we should adopt the same policy we use for disclosure of a 
    risk contractor's adjusted community rating (ACR). The commenter 
    believed that the physician incentive information merits comparable 
    treatment.
        Response: To the degree that physician incentive information 
    constitutes ``trade secrets or commercial or financial information 
    obtained from a person [that is] privileged or confidential,'' the 
    information will be protected from release under exemption (b)(4) of 
    the FOIA (5 U.S.C. 552(b)(4).) In accordance with 45 CFR 5.65 (c) and 
    (d), the submitter of such information may designate all or part of the 
    information as confidential and exempt from disclosure at the time the 
    information is submitted to the government. Also, the Freedom of 
    Information and Privacy Office, HCFA, upon receipt of a FOIA request 
    for the information, will ask that the involved submitter specify what 
    it believes to be confidential commercial or financial information. In 
    both situations, we will follow procedures set forth at 45 CFR 5.65(d), 
    with the initial disclosure decisions independently made by our Freedom 
    of Information Officer. The information specified as available to a 
    beneficiary upon request will be available under FOIA. For instance, 
    whether or not the incentive plan covers referral services, the type of 
    incentive arrangement (for example, withhold or capitation), and 
    whether adequate stop-loss protection is in place would be available 
    under FOIA.
        Comment: One commenter did not believe that disclosure requirements 
    would pose an undue burden on plans, because ``plans routinely provide 
    information to patients at the time of enrollment.'' The commenter 
    stresses the time that notice is provided as well as the substance of 
    what is provided. The commenter believed that all financial information 
    should be provided at enrollment (and annually thereafter), but also 
    notes that plans should report information regarding the scope of 
    benefits and procedures for review of grievances. The commenter stated 
    that one of its internal publications includes a statement on incentive 
    plans, asserting that these plans ``should be disclosed to the patient 
    upon enrollment and at least annually thereafter.'' The commenter 
    elaborated on that assertion by stating, ``[we] strongly support 
    disclosure to patients of physician incentive plans affecting Medicare 
    and Medicaid patients'' and ``strongly support disclosure by all 
    managed care plans to patients of information regarding the scope of 
    benefits and procedures for review of grievances.''
        The commenter also stated the disclosures are necessary to serve as 
    notice to patients that incentives exist. The commenter went on to 
    state that it believes the information is necessary in place of 
    outcomes measures until such measures are widely accepted and 
    available.
        In contrast, a major association of health plans asked that we give 
    plans broad discretion to decide how this information will be 
    presented.
        Another commenter contended that section 1876(i)(8) of the Act does 
    not give us the authority to require that a prepaid plan release 
    information about its incentive plans to Medicare beneficiaries and 
    Medicaid recipients, and that there is no such grant of authority in 
    parallel medical provisions. The commenter added that, even if it
    
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    were to assume that a general authority conferred upon us allows us to 
    impose this obligation, the regulation goes far beyond what the 
    commenter believes to be reasonable. The commenter noted that, under 
    the regulation, every beneficiary or recipient in the country, 
    regardless of location and regardless of the relationship to the 
    prepaid plan, may obtain information about the incentive plan. The 
    commenter recommended that only enrollees of the prepaid plan or 
    beneficiaries or recipients who file an application to join the plan 
    should be entitled to obtain the information. The commenter also 
    recommended that the information be limited to the following: (1) 
    Whether the physician has an arrangement with the prepaid plan that has 
    the potential to compensate him or her for controlling the services he 
    or she provides; (2) that the amount of risk is limited because of 
    stop-loss protection; and (3) the results of any enrollee survey will 
    be provided, upon request, including information about quality of care.
        Response: Some of the information may be confidential and will be 
    protected by FOIA. Nonetheless, we intend to require plans to publish 
    in the evidence of coverage (EOC) notices that beneficiaries can 
    request summary information on the HMO's physician incentive plans. 
    These EOC notices are available at enrollment. We will provide further 
    guidance on this in the future.
        On the question of our legal authority to require disclosure to 
    beneficiaries, we believe that in requiring disclosure of information 
    on physician incentive plans, Congress intended that this information 
    be used in the best interests of the beneficiary. While the statute 
    refers only to disclosure of this information to the Secretary, this 
    information is clearly of interest to beneficiaries as well. Requiring 
    plan disclosure directly is simply more efficient than having the 
    Secretary provide this information to beneficiaries, which the 
    Secretary clearly has legal authority to do.
        We do not agree that this information should be made available only 
    to an enrollee or applicant for enrollment in a managed care plan. This 
    information is potentially very important and useful to a beneficiary 
    in deciding whether to select managed care rather than fee-for-service 
    care and which of the available managed care plans to select.
        Comment: A major association of health plans stated that we should 
    make available to the public all the information on incentive plans 
    that we and the States receive. The commenter did not explain why the 
    information should be made public, but just noted that there is ``no 
    valid reason to keep this information from the public'' and that 
    publication would allow health policy researchers to better understand 
    the relationship between specific risk arrangements and access and 
    quality of care provided to enrollees.
        Response: We plan to publish aggregate information on physician 
    incentive plans obtained under the regulation; therefore, the 
    information will be public. Publication of additional information, 
    beyond that specified in the regulation, however, would be a 
    substantial administrative task and would not advance the purposes of 
    the law.
        Comment: One commenter stated that requiring the HMO or CMP to 
    collect information about incentive plans operated by physician groups 
    or subcontractors is not the most efficient or effective means of 
    collecting the necessary information. The commenter suggested that we 
    collect the information directly from the physician groups and 
    subcontractors. This commenter believed we should allow a physician 
    group to attest that it has no physician incentive plan or no physician 
    incentive plan related to use of referral services for Medicare or 
    Medicaid enrollees and that HMOs should be allowed to rely upon that 
    attestation.
        Response: The HMO/CMP is responsible for ensuring that the 
    requirements of this regulation are met if a physician group or 
    individual physicians are placed at substantial financial risk by a 
    subcontractor or physician group. Requiring that the HMO or CMP collect 
    the information ensures that it is aware of all arrangements subject to 
    the regulations. In addition, since lines of communication between the 
    physician group or subcontractor and the prepaid plan are already in 
    place, the HMO or CMP is the most efficient conduit for the disclosure 
    of information. We will allow physician groups to make attestations and 
    will provide further guidance on this item. We will also develop a 
    disclosure form that will describe the minimum amount of information 
    that the prepaid plan must obtain from physician groups.
    
    Substantial Financial Risk
    
        We received significant comments on our definition of ``substantial 
    financial risk.'' Section 417.479(e) provides that substantial 
    financial risk occurs when an incentive arrangement places a physician 
    or physician group at risk for amounts beyond the risk threshold (25 
    percent), if the risk is based on the use or costs of referral 
    services. Amounts at risk based solely on factors other than a 
    physician's or physician group's referral levels do not contribute to 
    the determination of substantial financial risk.
        Section 417.479(f) provides that physician incentive plans with any 
    of the following features place physicians at substantial financial 
    risk if the risk is based (in whole or in part) on use or costs of 
    referral services, and the patient panel size is not greater than 
    25,000 patients, or is greater than 25,000 patients only as a result of 
    pooling patients:
         Withholds greater than 25 percent of potential payments.
         Withholds less than 25 percent of potential payments if 
    the physician or physician group is potentially liable for amounts 
    exceeding 25 percent of potential payments.
         Bonuses greater than 33 percent of potential payments 
    minus the bonus.
         Withholds plus bonuses if the withholds plus bonuses equal 
    more than 25 percent of potential payments. The threshold bonus 
    percentage for a particular withhold percentage may be calculated using 
    the formula: Withhold % = -0.75(Bonus %)+25%.
         Capitation arrangements if--
        + The difference between the maximum possible payments and minimum 
    possible payments is more than 25 percent of the maximum possible 
    payments; or
        + The maximum and minimum possible payments are not clearly 
    explained in the physician's or physician group's contract.
         Any other incentive arrangements that have the potential 
    to hold a physician or physician group liable for more than 25 percent 
    of potential payments.
        Section 417.479(f) defines ``potential payments'' as the maximum 
    anticipated total payments (based on the most recent year's utilization 
    and experience and any current or anticipated factors that may affect 
    payment amounts) that could be received if use or costs of referral 
    services were low enough.
        Comment: A major association contended that the methodology for 
    determining substantial financial risk is flawed because a substantial 
    number of affected prepaid plans will be viewed as transferring 
    substantial financial risk and be subject to the stop-loss and enrollee 
    survey requirements. The association pointed out that we stated in the 
    proposed rule that the original choice of a 25 percent threshold for 
    substantial financial risk was based on the assumption that only 
    ``outlier'' risk levels would be considered ``substantial.'' The 
    association contends
    
    [[Page 69039]]
    
    that our methodology in fact covers ``mainstream'' arrangements, and 
    thus implicitly suggests that they are outliers. The association 
    believes that the proportion of outliers in a given population should 
    be quite small (typically in the range of 5 percent) and that a 
    methodology that purports to only identify outliers is invalid to the 
    extent it includes a proportion of the population beyond that 
    represented by the extreme. The association has concluded, based on 
    extensive communications with its membership and its work group, that 
    application of the methodology in the March 27 rule will result in the 
    inclusion of substantial numbers of what it contends to be 
    ``mainstream'' incentive arrangements as involving substantial 
    financial risk. The association stated that, based upon information 
    from its member organizations, a large number of plans combine 
    capitation or withholds with bonuses, and the result is that the risk 
    level exceeds 25 percent.
        The association reminded us that, in the preamble of the proposed 
    rule, we stated that we anticipate most prepaid plans will not incur 
    significant additional costs because most of them already meet the 
    requirements that are specified in this regulation, but that if new 
    information regarding the influence of various elements of physician 
    incentive plans becomes available, we will evaluate it to determine if 
    the approach in our proposed regulations should be reconsidered. The 
    association contended that a reevaluation of this structure is clearly 
    necessary at this time and that the regulations need to be modified to 
    address five areas: (1) The association believes that the risk 
    threshold should be refined to allow for the transfer of a larger 
    portion of risk for referral services; (2) the association believes 
    that the regulation needs a mechanism to estimate the amount of risk 
    transferred if a precise calculation cannot be made; (3) the 
    association recommends that maximum and minimum thresholds be 
    calculated based on standards that are more ``realistic'' in its view; 
    (4) the association would like more latitude in the pooling rules to 
    allow large physician groups that spread risk across large total 
    numbers of health plan patients to be exempt from the requirements; and 
    (5) the association suggests that a good cause exemption be available 
    to allow for the approval of physician incentive plans that, for policy 
    reasons, should not be considered as transferring substantial financial 
    risk, although the circumstances were not envisioned when the 
    regulations were drafted.
        To achieve the above objectives, the association presented a number 
    of recommendations. These recommendations and our response to each of 
    them follow, but first we respond to the above comment that many plans 
    would be identified as outliers.
        Response: At the time we were developing these regulations in 
    proposed form, it was our understanding that most physician incentive 
    plans created financial incentives to reduce unnecessary referrals 
    through the use of bonuses or withholds or some combination of the two. 
    On the assumption that a specific amount of payment was ``at risk'' 
    (whether an amount withheld when referrals are high or a bonus paid if 
    they are low), we had to come up with a threshold beyond which risk 
    would be considered ``substantial.'' As the commenting association 
    correctly notes, we used an outlier approach to determine what level of 
    risk would be considered ``substantial'' under this methodology. This 
    resulted in a figure of 25 percent of potential payments. It is our 
    view that 25 percent represents a significant amount of income to lose. 
    This may be in addition to discounts that physicians may give to 
    various patients or prepaid plans. Many consumer and physician groups, 
    in fact, believe that 25 percent is too high. We now recognize that an 
    increasing number of plans use capitation arrangements under which 
    referral service costs must be covered with capitation amounts, and 
    that these plans will be determined to be at substantial financial risk 
    if the maximum and minimum potential payments are not clearly explained 
    in the physician's or physician group's contract. Raising the risk 
    threshold to a higher level will not affect these plans since they 
    would still be deemed to involve substantial financial risk and trigger 
    stop-loss insurance requirements. However, in most of these cases, the 
    physicians already have stop-loss protection comparable to the 
    requirements of this regulation. With regard to suggestions to lower 
    the threshold, here, again, changing the threshold would not affect 
    these plans. We thus believe that the 25 percent threshold should 
    remain in place.
        Recommendation: The association recommended that an exception to 
    the 25 percent risk threshold be created for certain bonus 
    arrangements. This exception would permit prepaid plans to supplement 
    their incentive programs by offering an opportunity for a bonus, in 
    addition to capitation payments or withholds, or an opportunity for an 
    additional bonus where a bonus is already in place. The supplemental 
    bonus could not exceed 15 percent of the ``payments.''
        Response: Under the March 27, 1996 rule, any combination of 
    incentive arrangements that exceeds the 25 percent threshold, whether 
    labeled a bonus or withhold, puts the physician or physician group at 
    substantial financial risk. We adopted this policy towards bonuses 
    because (1) if the same amount of money is at risk based on referral 
    levels, it should not matter whether this money is labeled a withhold 
    or a bonus, and (2) we did not want plans to avoid these rules merely 
    by ``re-labeling'' withholds or other arrangements as bonuses. The 
    incentive arrangement described in this comment would exceed the 25 
    percent threshold for substantial financial risk as we interpret this 
    term and, accordingly, should not be permitted in our view.
        Recommendation: The association recommended that a prepaid plan 
    that capitates physicians or physician groups be permitted to estimate 
    the portion of the capitation allocated to referral services for 
    purposes of determining whether there is substantial financial risk. 
    This is because it is the association's belief that many large prepaid 
    plans do not have, and cannot obtain, this information. The association 
    believes that the regulatory requirement that contracts specify the 
    allocation between services provided by the physician or physician 
    group and the amount allocated for referral services (provided outside 
    the physician group or the physician's practice) has two objectives: 
    (1) To provide a basis for the calculation of risk transference to 
    determine whether substantial financial risk is transferred; and (2) to 
    apprise the physician or physician group of the portion of its 
    capitation ``at risk.'' The association contends that we could achieve 
    the first of these two objectives by allowing the prepaid plan to 
    estimate the expected portion of referrals through the use of 
    historical data or actuarial tables. The prepaid plan could be required 
    to certify that its decision was made in good faith based on the best 
    available data. In accepting this proposal, the association contends 
    that we would be meeting our responsibilities under E.O. 12866 to find 
    an alternative regulatory approach that imposes the least burden on 
    society while still achieving its objective.
        The association questioned whether the second objective it has 
    presumed, to apprise the physician or physician group of the portion of 
    its capitation ``at
    
    [[Page 69040]]
    
    risk,'' is meaningful today since physicians are far more aware of the 
    implications of risk assumption than they once were.
        As an alternative approach, the association suggested that the 
    physician/physician group put in the contract the estimated portion of 
    services that would not be provided by the physician or physician 
    group. The association stated that, although this amount may change 
    over time, it would not support revisions to the contract to reflect 
    changes made within the discretion of the individual physician or 
    physician group. The association notes that this alternative approach 
    would not be the most desirable because it would require the burdensome 
    step of recontracting with large numbers of physicians.
        Response: As indicated in the March 27, 1996 rule, prepaid plans 
    have the option of specifying in the contract maximum and minimum 
    payment amounts. As long as the difference between these amounts does 
    not exceed 25 percent of the maximum amount, the physician or physician 
    group is not at substantial financial risk. Without specifying these 
    limits, physicians who are capitated for all services are potentially 
    at risk of losing 100 percent of their income. Given this potential 
    loss, they may feel the pressure to reduce necessary services.
        Prepaid plans have the opportunity to include a provision in their 
    contract with a physician group that would require the physician group 
    to specify the level of potential risk for referral services. Relying 
    on historical or actuarial data may not be reflective of risk in 
    current contracts. While it may be true that physicians today are more 
    aware of the implications of risk assumption, there is no evidence that 
    the ability to manage this risk has substantially changed. Further, 
    while physician groups may want the flexibility to change risk sharing 
    arrangements on an ad hoc basis, we have to question the impact of 
    these changes on patient care decisions.
        Recommendation: The association recommends that the regulation be 
    amended to allow for the pooling of the total prepaid enrollment from 
    the prepaid plan and across prepaid plans for purposes of determining 
    substantial financial risk. The regulation exempts from the 
    requirements of the regulations physicians or physician groups who 
    provide services to 25,000 Medicare or Medicaid enrollees of the 
    prepaid plan. The association maintains that this approach, which does 
    not allow for the pooling of patients, is unnecessarily and 
    inappropriately rigid and conservative. The association stated that it 
    believed the 25,000 patient exemption is permitted because physician 
    groups with a patient base this large can assume the risk for referral 
    services greater than the risk threshold without the need for stop-loss 
    coverage. As the number of enrollees under the responsibility of the 
    physician group increases, so does the ability of the physician group 
    to assume that risk. The association believed that this risk is reduced 
    regardless of whether the patients are Medicare, Medicaid, or 
    commercial. Similarly, this risk is reduced regardless of whether the 
    patients are the enrollees of a single prepaid plan or the enrollees of 
    several prepaid plans. Thus, for purposes of qualifying for the 
    substantial financial risk exemption, a prepaid plan should be allowed 
    to consider the total number of prepaid enrollees served by a physician 
    group. These pooled enrollees should, in the association's view, 
    include all enrollees of that prepaid plan and enrollees of other 
    prepaid plans that have selected the physician or physician group, 
    provided that the physician or physician group is at risk for the 
    provision of services to those enrollees.
        Response: In the preamble, we provided evidence from analyses by 
    Rossiter and Adamache (1990) (Health Care Financing Review, vol. 12, 
    prepaid plan. 19-30) that supported the decision that physician groups 
    with more than 25,000 patients are able to adequately spread risk and 
    are so unlikely to lose money that we could determine them to not be at 
    substantial financial risk.
        We have decided to allow pooling of Medicare, Medicaid, and 
    commercial members for purposes of determining substantial financial 
    risk because this kind of pooling is consistent with the rationale for 
    permitting pooling (that is, the spreading of risk). The physician 
    group may also pool patients across more than one managed care plan 
    with which it has a contract. Note, however, that, as revised by this 
    final rule, Sec. 417.479(h)(1)(v) allows for pooling of patients for 
    purposes of determining substantial financial risk and meeting various 
    stop-loss requirements. This section then specifies that pooling is 
    permitted only if: (1) Pooling is otherwise consistent with the 
    relevant contracts governing the compensation arrangements for the 
    physician or physician group; (2) the physician or physician group is 
    at risk for referral services with respect to each of the categories of 
    patients being pooled; (3) the terms of the compensation arrangements 
    permit the physician or physician group to spread the risk across the 
    categories of patients being pooled; (4) the distribution of payments 
    to physicians from the risk pool is not calculated separately by 
    patient category; and (5) the terms of the risk borne by the physician 
    or physician group are comparable for all categories of patients being 
    pooled.
        In general, the purpose of these conditions is to ensure that all 
    patients included in the risk pool are being treated under comparable 
    payment arrangements; that is, the risk or reward to the physician or 
    physician group would be the same for referring services for any 
    individual patient in the pool. The patient categories refer to 
    Medicare, Medicaid, and commercial members. The type of incentive 
    arrangements, such as withholds and capitation would usually be the 
    same throughout the pool to be considered comparable. Pools over the 25 
    percent risk threshold can be combined with those arrangements below 
    the 25 percent risk threshold. The pool represents the total dollars on 
    which the payout is made to the doctor or the stop-loss threshold is 
    assessed.
        This final rule, however, eliminates the arrangement that allows 
    the HMO, CMP, or HIO to pool across physician groups to reduce the 
    stop-loss requirements. We believe physician behavior is influenced by 
    the number of patients using the physician group, rather than total 
    enrollment in the HMO, CMP, or HIO. A physician group that has a small 
    number of patients does not spread its risk throughout the prepaid 
    plan, but only within its group. Allowing pooling across groups does 
    not provide patients enough protection.
        Recommendation: The association recommended that the regulations 
    apply a ``reasonableness test'' in calculating compensation under a 
    physician incentive plan. The association noted that plans often use 
    formulas to calculate the amount of the withhold to be returned or the 
    bonus to be distributed. These formulas allow for distributions of a 
    certain percentage of savings to the physician or physician group when 
    utilization or costs are less than projected. These arrangements often 
    do not cap the upside potential gain from a bonus although natural 
    limits may exist because there is no expectation that the scenario in 
    which no services are provided will occur. The physicians and physician 
    groups understand these de facto limits, and it would be unnecessarily 
    burdensome to require prepaid plans to amend thousands of contracts to 
    insert bonus limits in their contracts. The regulations should be 
    amended to confirm that prepaid plans may use an amount for purposes of 
    determining the maximum
    
    [[Page 69041]]
    
    payment that is realistic rather than the theoretical highest payment 
    level. The same standard should be applied in calculating minimum 
    levels.
        Response: We believe that past behavior is no guarantee of future 
    behavior. Physicians could still feel the pressure if they are placed 
    at substantial financial risk, regardless of past payments. Therefore, 
    the incentive plan contracts must contain these limits explicitly.
        Recommendation: The association recommends that the regulation 
    should allow for a ``good cause'' exemption from the requirements of 
    the regulation in the event that substantial financial risk is 
    transferred. The association argued that in an ever-changing health 
    care delivery system, the regulation should provide for flexibility to 
    adapt to unanticipated circumstances. The association notes that our 
    regulations frequently allow for good cause exemptions from 
    requirements, and it contends that circumstances may arise in the 
    future that merit an exemption from the regulatory requirements. 
    According to the association, inclusion of a good cause exemption would 
    give us the flexibility to approve appropriate physician incentive 
    plans without the need to amend our regulations. An example of one 
    instance in which a good cause exemption may be appropriate is if the 
    prepaid plan can demonstrate that the physician group is assured of 
    receiving compensation on an encounter basis comparable to or at a 
    certain percentage of the resource-based relative value scale fee 
    schedule amount.
        The association stated that it is currently exploring functional 
    ways in which a good cause exemption could be designed and 
    appropriately implemented.
        Response: We have no legal authority to permit plans to fail to 
    comply with the rules in section 1876(i)(8) for ``good cause.'' 
    Moreover, even if we did, we do not know of any systematic basis for 
    providing a good cause exemption to this regulation. The example cited 
    by the commenter can be written into the contract to ensure that the 
    physician receives a certain percentage of the fee schedule amount. 
    However, the issue is not guaranteeing a minimum level of income. 
    Rather it is setting parameters so that decisions are not made because 
    of a concern with unforseen circumstances, such as adverse selection, 
    bad incentive plan design, etc. Our goal is to protect beneficiaries in 
    these circumstances.
        Comment: A group that advocates on behalf of individuals with 
    disabilities recommended that we consider alternative methods to 
    determine the appropriate levels of stop-loss insurance for those 
    involved in the care of persons or communities who are at high risk for 
    unexpected, adverse medical events (For example, urban providers with a 
    high patient load of pregnant women with histories of substance abuse). 
    The group stated that these providers may have difficulties determining 
    an accurate estimate of expected expenditures based on a previous 
    year's per-patient costs. The group suggested that other methods to 
    determine substantial financial risk may include:
        (1) The use of several years of longitudinal data to determine a 
    realistic substantial risk level (in order to adjust for the 
    periodicity of certain illnesses); or
        (2) The use of retrospective analyses to determine the incidence of 
    unexpected events within the provider's pool, with adjustments made to 
    correct for current levels of expected ``substantial risk'' related to 
    the likelihood of these previous events.
        This group further recommended that we examine alternative methods 
    of determining substantial risk for providers who are likely to care 
    for ``medically needy'' eligibles. The association gave the following 
    example, a preferred provider organization (PPO) medical specialist 
    provider may care for a substantial number of persons with life-
    threatening illness, such as cancer, Alzheimer's or AIDS. If patients 
    switch from private to public health insurance while under the care of 
    the medical provider (due to ``spending down'' into poverty), the 
    provider's determination of ``substantial risk'' may be underestimated. 
    In this case, the PPO medical specialist may be subject to various 
    levels of financial incentives (through both private and public funded 
    health plans) without having to demonstrate adequate quality of care or 
    financial liability provisions.
        Response: The goal of the substantial financial risk analysis is to 
    determine whether stop-loss protection is needed. The stop-loss 
    protection is designed to provide protection if the physician group 
    experiences patients with a greater than average risk. Thus, there is 
    no need to set a different substantial financial risk threshold for 
    high risk cases. The stop-loss protection addresses this concern.
        Comment: A commenter recommended that we consider lowering the 
    threshold at which plans are required to provide stop-loss coverage for 
    CHCs. The commenter suggested that we consider whether it is 
    appropriate to compare risks to CHCs with risks to other kinds of 
    primary care providers. The commenter pointed out that CHCs provide 
    services almost exclusively to Medicaid/Medicare beneficiaries and 
    impoverished uninsured patients. Thus, CHCs essentially have no 
    capacity to generate revenues to offset losses sustained on referrals 
    under a capitated rate. In addition, the commenter suggested that the 
    schedule reducing the amount of protection required should be modified 
    so that it decreases more slowly as a CHC's patient panel increases. 
    The commenter said such a change is justified because CHCs may incur 
    even greater risk as their capitated patient enrollment increases 
    because the CHC's patients are likely to be in poorer health than the 
    average patient.
        Response: We are giving additional consideration to the impact of 
    the current risk threshold on physician incentive plans with CHCs. 
    During the implementation of this regulation, we will collect data on 
    the impact of the 25 percent threshold on CHCs, and consider whether 
    some form of relief may be appropriate. We are concerned, however, that 
    lowering the threshold as the commenter suggests would require a 
    substantial number of these centers to provide stop-loss protection to 
    their physicians that they may not be able to afford.
        Comment: A commenter asked whether ancillary services are 
    considered referral services.
        Response: For purposes of Sec. 411.479, if the physician group 
    performs the ancillary services then the services are not referral 
    services. If the physician group refers patients to other providers of 
    services for the ancillary services, then the services are referral 
    services.
        Comment: A commenter pointed out that a response in the March 27 
    final rule at 61 FR 13438, column 2, states that, if the HMO uses a 
    combination of withhold and/or bonus arrangements, these arrangements 
    will be aggregated for purposes of determining whether the physician is 
    placed at substantial financial risk. The commenter adds that, in 
    column 3 of that page, however, the response states that we are not 
    requiring disclosure of every incentive arrangement between a physician 
    group and its physicians, only those under which the physician is 
    placed at substantial financial risk. A prepaid plan wanted to know how 
    it could be expected to know that in the aggregate the arrangements 
    created substantial financial risk if the physician group is not 
    required to disclose the individual arrangements.
        Response: The above comment reflects a misconception. The quote 
    from the third column addresses what
    
    [[Page 69042]]
    
    information must be disclosed by the prepaid plan to us, not what 
    information the physician group must disclose to the prepaid plan. It 
    is incumbent upon the prepaid plan to obtain from the physician group 
    all the information that it needs to determine whether individual 
    physicians are placed at substantial financial risk. This can be a 
    subject addressed as part of the contract negotiations between the 
    prepaid plan and the physician group.
        Comment: A commenter stated that the methodology used to determine 
    substantial financial risk has consequences that they believe we never 
    intended. For example, certain bonus arrangements could be construed as 
    transferring substantial financial risk. The commenter described a 
    program under which bonuses that are added to a base capitation are 
    aimed at rewarding the primary care physician (PCP) for high quality 
    care, full service capacity, long office hours, accepting all new 
    patients, and cost-effectiveness. The commenter offered the following 
    illustration: a PCP might get $10.50 per member/per month (PMPM) as 
    capitation, $1.50 PMPM for scoring well on member surveys and office 
    record reviews, $1.00 PMPM for being open to new patients, and $1.50 
    PMPM for having average utilization. The total compensation would then 
    be $14.50 PMPM. The commenter stated it does not believe that these 
    quality performance and service bonuses are the ``substantial financial 
    risk'' with which we are concerned. The commenter stated that there is 
    no downside risk here, but there is the ability to add to income for 
    good performance. If the intent is to include these bonus arrangements, 
    the commenter wanted to know whether the relevant amount was the 
    maximum attainable bonus or the average bonus paid to all PCPs in the 
    network. The commenter also pointed out that, in applying our 
    methodology to calculate substantial financial risk, a physician who is 
    paid a higher quality office component than a second physician (both 
    with the same utilization), would be found to have assumed a greater 
    financial risk than the second, even though the first physician's 
    revenues were greater.
        Response: While we are supportive of a quality bonus payment, there 
    is very limited experience with its use, and whether a physician will 
    actually receive it is speculative. We will revisit the issue when more 
    information is available on the nature, extent, and experience with 
    quality bonuses.
    
    Subcontracting
    
        A number of commenters, including a major association, made the 
    same comment on the provisions of section 417.479(i), which requires 
    that the disclosure, stop-loss protection, and survey requirements of 
    Sec. 417.479 be satisfied when an HMO or CMP contracts with a physician 
    group that places the individual physician members at substantial 
    financial risk for services they do not furnish. The major 
    association's comment, which was the most comprehensive, is presented 
    below.
        Comment: One major association challenged our legal authority to 
    reach arrangements between a contracting physician group and its 
    individual physicians (or between an ``intermediate entity'' and 
    physicians or a physician group). The association pointed out that 
    section 1876(i)(8)(B) of the Act defines a physician incentive plan 
    as--
    
    any compensation arrangement between an eligible organization and 
    physician or physician group that may directly or indirectly have 
    the effect of reducing or limiting services provided with respect to 
    individuals enrolled with the organization. [Emphasis added by the 
    association.]
    
        The association argued that, regardless of the policy 
    considerations that favor extending the reach of these rules to 
    subcontracts (for example, the possibility that failure to do so could 
    create a ``loophole'' that could be abused), doing so was inconsistent 
    with the ``plain meaning'' of this statute. The association accordingly 
    contended that our interpretation was legally impermissible, regardless 
    of the policy considerations in its favor.
        The association also argued that expanding the scope of the 
    regulation to cover other incentive plans without a new opportunity for 
    notice and comment violated the Administrative Procedure Act (APA). The 
    association pointed out that the APA requires that there be a general 
    notice of proposed rulemaking published in the Federal Register that 
    includes, among other things, the terms or substance of a proposed rule 
    or a description of the subjects and issues involved. The association 
    included the following quotation from a decision by the Court of 
    Appeals for the District of Columbia Circuit discussing a standard that 
    the court applied for determining whether the APA requirement has been 
    met:
    
    Statutory duty to submit proposed rule for comment does not include 
    obligation to provide new opportunities for comments whenever final 
    rule differs from proposed rule; rather, an agency adopting final 
    rules that differ from proposed rules is required to renotice when 
    changes are so major that original notice did not adequately frame 
    subjects for discussion. (Air Transport Association of America v. 
    C.A.B., 732 F.2d 219 (D.C. Cir. 1984))
    
        The association argued that revising the proposed rule to extend 
    its provisions to subcontractor arrangements was a sufficiently 
    ``major'' change that a new notice and opportunity for comment was 
    required under the above standard.
        Finally, the association contended that support for its position 
    could be found in language from earlier legislation directing HHS to 
    study incentive arrangements. This language referred to ``incentive 
    arrangements offered by health maintenance organizations and 
    competitive medical plans to physicians.''
        Response: We believe that in referring both to individual 
    ``physician[s]'' and to ``physician group[s],'' Congress intended to 
    cover all incentive arrangements that could provide incentives for a 
    physician treating an HMO enrollee to reduce or limit services; both 
    those affecting only an individual physician and those affecting a 
    group of physicians as a whole. A letter from the original author of 
    this legislation confirms that this was his intent in drafting this 
    language.
        As noted above, the association attempts to place significance on 
    the use of the word ``between'' in the definition of physician 
    incentive plan in section 1876(i)(8)(B) (quoted above). The association 
    reads this as limiting the scope of the definition of physician 
    incentive plan to arrangements in a contract directly between a prepaid 
    plan and a physician or physician group. In fact, however, an 
    individual physician who serves a prepaid plan's enrollees as a member 
    of a physician group does have a relationship with that prepaid plan, 
    albeit an indirect one. There is an indirect but clear link ``between'' 
    that physician and the prepaid plan whose enrollees the physician 
    treats. The only difference is that instead of a single direct contract 
    between the physician and the prepaid plan, the physician has a 
    contract with the group, and the group in turn contracts with the 
    prepaid plan.
        Even though this is a two or more step arrangement rather than a 
    single direct contract, there nonetheless is a physician incentive plan 
    involving the prepaid plan's enrollees that exists ``between'' the 
    physician providing services to a prepaid plan's enrollees and the 
    prepaid plan that is accountable for these services. There is simply an 
    added layer of organization and legal arrangements ``between'' the 
    physician and the prepaid plan. During our review
    
    [[Page 69043]]
    
    of applications for Medicare contracts, we currently review the plan's 
    contracting arrangements to ensure that subcontracts actually signed by 
    the physician at the ``retail'' end of the prepaid plan's health care 
    delivery network inform physicians of their responsibility to carry out 
    the prepaid plan's obligations under section 1876. This longstanding 
    practice is fully consistent with our view that an individual physician 
    contract with a physician group is part of the total arrangement 
    ``between'' that physician and the prepaid plan that is accountable for 
    the services the physician is providing to the plan's members. For 
    instance, we hold the plan accountable for the quality of care 
    delivered by all components subcontracting with the plan including the 
    care delivered by the physicians.
        For all of the above reasons, we believe that it is fully 
    consistent with the words of the statute to reach all incentive 
    arrangements that exist ``between'' doctors providing the care and a 
    prepaid plan accountable for that care, whether they are contained in a 
    physician's contract with a physician group or other intermediate 
    entity, or in the contract the group or entity has with the prepaid 
    plan. (With respect to the association's reliance on language in past 
    legislation, we do not believe that it has any relevance in 
    interpreting section 1876(i)(8). Indeed, it is inconsistent with the 
    language in section 1876(i)(8), since it references only arrangements 
    with a physician, and not those with a physician group.)
        In addition to being consistent with the words of the statute, we 
    believe that our interpretation is consistent with the purpose of the 
    statute, which is to protect Medicare beneficiaries enrolled in prepaid 
    plans from the possible effects of financial incentives to deny or 
    limit medically necessary care. It is irrelevant to this statutory 
    objective whether incentives are contained in the prepaid plan's 
    contract with a physician group, or in the group's contract with the 
    physician. It is fully consistent with the intent and purpose of 
    section 1876(i)(8) to reach any plan that could contain the incentives 
    Congress wanted to address. As suggested above, it also would make no 
    sense to establish a regulatory scheme that could be circumvented 
    simply by erecting a ``protective shield'' between the prepaid plan and 
    individual physicians in the form of an intermediate entity or 
    physician group structure. The possibility of such a ``loophole'' 
    permitting plans to circumvent these regulations was a major factor in 
    our decision to extend the reach of these regulations to 
    subcontractors.
        We also disagree with the association that the change we made in 
    the final rule violated the APA under the standards of the Air 
    Transport Association case cited by the association. Indeed, we believe 
    that this type of revision is precisely the kind the court had in mind 
    when it wrote that there is no ``obligation to provide new 
    opportunities for comments whenever a final rule differs from a 
    proposed rule.'' We believe that it is clear that this is not a change 
    ``so major that original notice did not adequately frame [the] subject 
    [] for discussion.'' Clearly the ``original notice'' did ``frame'' this 
    as a ``subject [] for discussion,'' since commenters in fact commented 
    on this question. A second notice thus was not required under the Air 
    Transport decision.
        In any event, even if a second opportunity to comment had been 
    required under the Air Transport standard, any such requirement has now 
    been satisfied through the notice and comment process culminating in 
    this revised rule.
    
    Stop-loss
    
        We received several comments on the stop-loss requirements in the 
    March 27 rule. Section 417.479(g)(2) requires that HMOs or CMPs that 
    operate incentive plans that place physicians or physician groups at 
    substantial financial risk ensure that these physicians or physician 
    groups have either aggregate or per-patient stop-loss protection in 
    accordance with the following requirements:
         If aggregate stop-loss protection is provided, it must 
    cover 90 percent of the costs of referral services (beyond allocated 
    amounts) that exceed 25 percent of potential payments.
         If the stop-loss protection provided is based on a per-
    patient limit, the stop-loss limit per patient must be determined based 
    on the size of the patient panel. In determining patient panel size, 
    the patients may be pooled using one of the approved methods (discussed 
    below) if pooling is consistent with the relevant contract between the 
    physician or physician group and the prepaid plan. Stop-loss protection 
    must cover 90 percent of the costs of referral services that exceed the 
    per patient limit. The per-patient stop-loss limit is as follows:
         Less than 1,000 patients--$10,000.
         1,000 to 10,000 patients--$30,000.
         10,000 to 25,001 patients--$200,000.
         Greater than 25,000 patients:
        + Without pooling patients--none; and
        + As a result of pooling patients--$200,000.
        Section 417.479(h)(1)(v) provides that, for purposes of determining 
    panel size, patients may be pooled according to one of the following 
    methods:
         Including commercial, Medicare, and/or Medicaid patients 
    in the calculation of the panel size.
         Pooling together, by the HMO or CMP, of several physician 
    groups into a single panel.
        Section 417.479(g)(2)(iii) provides that the HMO or CMP may provide 
    the stop-loss protection directly or purchase it, or the physician or 
    physician group may purchase the stop-loss protection. This section 
    also provides that, if the physician or physician group purchases the 
    stop-loss protection, the HMO or CMP must pay the portion of the 
    premium that covers its enrollees or reduce the level at which the 
    stop-loss protection applies by the cost of that protection.
        Comment: A major association stated that enormous confusion exists 
    among its membership as to the meaning and application of the stop-loss 
    provisions. The association urged us to reevaluate not only the 
    substantive requirements, but the manner in which we expressed the 
    information and to explain more clearly our intentions. The 
    association's comments on this issue fall into two categories: (1) The 
    obligation for payment of the stop-loss coverage and (2) the 
    substantive requirements for stop-loss. In making its comments, the 
    association also offered recommendations for amendments to the 
    regulations. We summarize the association's comments and 
    recommendations below:
        Comment 1. The association believed that the responsibility of 
    paying for the stop-loss protection should be a negotiable issue 
    between the HMO or CMP and its physician group or physician. The 
    association argued that the language used in section 1876(i)(8) of the 
    Act requiring HMOs or CMPs to provide stop-loss can be reasonably 
    interpreted to impose an obligation that the stop-loss coverage be made 
    available to the physician or physician group.
        The association also maintained that public policy supports 
    allowing the financial responsibility for stop-loss coverage to be 
    determined between the parties and not mandated by us. The association 
    noted that a common element in a capitation arrangement between an 
    organization and a physician group is a requirement that stop-loss be 
    obtained to protect the physician group from undue risk. This stop-loss 
    could be purchased by the prepaid plan or by the physician group.
    
    [[Page 69044]]
    
    The association stated that typically, these arrangements provide that 
    the physician group, and not the prepaid plan, has the responsibility 
    to pay for the stop-loss coverage. Another option the association noted 
    would be to give the physician group the option either of purchasing 
    the stop-loss coverage made available by the prepaid plan or purchasing 
    the stop-loss coverage itself. The association pointed out that in all 
    cases, the cost of the stop-loss coverage is an element of the 
    compensation (the capitation would be reduced if the prepaid plan pays 
    for the stop-loss coverage and would be higher if the physician group 
    does).
        The association stated that stop-loss coverage at the levels 
    required by the regulations is very expensive to obtain and that 
    requiring prepaid plans to bear that cost would result in an enormous 
    financial burden shifted from physician groups to prepaid plans. To 
    avoid this, and consistent with the discussion above, the association 
    recommended that we allow the prepaid plan and the physician group or 
    physician to negotiate the financial responsibility for the stop-loss 
    coverage.
        Response: After further analysis, and for the reasons set forth in 
    the above comment, we are amending the regulation to require only that 
    the HMO or CMP provide us proof that the physician groups have adequate 
    stop-loss protection in place. We believe this is consistent with the 
    primary goal of the regulation of ensuring that if the physicians are 
    at substantial risk, they have adequate stop-loss protection. In 
    addition, we have further information that physician groups may have 
    access to more affordable stop-loss as a result of their participation 
    in a number of HMOs or CMPs.
        Comment 2. The association recommended that we revise the 
    regulations to reflect what it believes to be more appropriate stop-
    loss levels, to account for existing stop-loss arrangements, and to 
    provide an appropriate means of applying the stop-loss requirements to 
    bonus and withhold arrangements. The association believed that the 
    stop-loss limits are inappropriately low. It stated that a $10,000 
    limit might be appropriate for a panel size less than 250 patients, but 
    is not reasonable for a 1,000 patient panel. The association stated 
    that one of its members projects that the cost of stop-loss over 
    $10,000 for hospital services for a Medicare enrollment would be about 
    20 percent of the total medical cost; this could be about $80 to $100 
    per member per month depending on geographic area. Therefore, the 
    association believed that it is incumbent upon us to reevaluate the 
    stop-loss limits and to replace the existing limits with ones that are 
    more appropriate and less costly to obtain.
        In addition, the association maintained that the stop-loss 
    requirements fail to identify how prepaid plans can analyze stop-loss 
    coverage that is already being provided to the physicians or physician 
    groups to determine whether it meets the regulatory standard. The 
    association stated that while it assumes we would allow prepaid plans 
    to obtain ``credit'' for stop-loss coverage that already exists, it may 
    be exceedingly difficult to compare the coverage. For example, existing 
    stop-loss coverage may have a lower attachment point (that is, 
    deductible), but higher coinsurance amounts or vice versa. Some stop-
    loss coverage may vary by disease. Also, some coverage may vary 
    depending on whether the cost is related to inpatient care or specialty 
    care. Some prepaid plans apply individual and aggregate stop-loss 
    simultaneously. Some stop-loss limits are linked to utilization levels 
    and not cost levels. Some physician groups decline the coverage offered 
    by the prepaid plan because it may be less costly to obtain the 
    coverage for all their patients rather than only those who are 
    enrollees of a single prepaid plan. In light of this, the association 
    recommended that we do the following:
         Reevaluate the stop-loss limits in light of actuarial 
    input on the appropriate need for stop-loss coverage and its cost.
         Allow a prepaid plan to retain the services of an actuary 
    who would assign an actuarial value to the stop-loss coverage currently 
    being provided to the physician or physician group. Allow the prepaid 
    plan to meet the stop-loss requirements by providing (that is, making 
    available) the difference between the actuarial value of the 
    requirement and the value of the stop-loss currently being provided to 
    the physician or physician group. The prepaid plan, in consultation 
    with its actuary, could convert this difference into an actuarial 
    equivalent in order that the new coverage be consistent with the nature 
    of the stop-loss coverage already provided to the physician or 
    physician group. The association stated that this recommendation is 
    intended to accomplish two objectives: (1) The prepaid plan would 
    obtain credit for stop-loss coverage already provided to the physician 
    or physician group; (2) the prepaid plan would have more flexibility in 
    determining how the requirement was met; for example, if it wished, the 
    prepaid plan could meet the requirement by building on the structure of 
    its existing stop-loss coverage.
        A second issue raised by the association concerns the applicability 
    of the stop-loss requirements to withhold and bonus arrangements. When 
    physicians or physician groups are at risk for referral services under 
    a capitation arrangement, stop-loss coverage would protect the 
    physician group or physician from excessive costs. In contrast, when an 
    organization uses withholds or bonuses as its incentive arrangements, 
    no large potential economic loss would occur at which the stop-loss 
    would attach. The association recommended that we rethink the 
    application of the stop-loss requirements to withhold and bonus 
    situations. It also argued that we should amend our regulation to allow 
    for adjustments in the stop-loss attachment points to account for 
    inflation; that is, as health care costs increase, the limits need to 
    be raised accordingly. Otherwise, the stop-loss coverage provided by 
    the prepaid plan would become unduly and inappropriately comprehensive.
        Response: Based on actuarial analyses and consultation with experts 
    knowledgeable about current stop-loss insurance practices, this final 
    rule makes a number of changes to the stop-loss provision. Because many 
    of the stop-loss arrangements currently in place differentiate between 
    professional services and hospital or other institutional services, we 
    are revising Sec. 417.478(g)(2)(ii) to permit prepaid plans and 
    physician groups to choose either a single combined limit or separate 
    limits for professional services and institutional services. We are 
    also revising the categories of patient panel size to increase the 
    number of categories and smooth out the gradation of attachment points. 
    This final rule establishes the following limits:
    
    [[Page 69045]]
    
    
    
                                                                            
    ------------------------------------------------------------------------
                                       Single       Separate      Separate  
              Panel Size              Combined   Institutional  Professional
                                       Limit         Limit          Limit   
    ------------------------------------------------------------------------
    1-1000........................     * $6,000     * $10,000       * $3,000
    1,001-5000....................       30,000        40,000         10,000
    5,001-8,000...................       40,000        60,000         15,000
    8,001-10,000..................       75,000       100,000         20,000
    10,001-25,000.................      150,000       200,000         25,000
    > 25,000......................         none          none           none
    ------------------------------------------------------------------------
    
        The asterisks indicate that, at this level, stop-loss insurance is 
    impractical. The premiums would be prohibitively expensive. Plans and 
    physician groups clearly should not be putting physicians at financial 
    risk for panel sizes this small. It is our understanding that doing so 
    is not common. For completeness, however, we do show what the limits 
    would be in these circumstances.
        In regard to the comments on bonuses and withholds, we specifically 
    indicated that when bonuses and withholds put physicians at substantial 
    financial risk, the physicians need to have stop-loss protection. The 
    legislation and regulation require that all forms of incentive 
    arrangements that put physicians at substantial financial risk have 
    stop-loss protection. Even though current stop-loss policies may not 
    cover bonuses and withholds, this is the requirement of this 
    regulation. Thus, if current policies do not cover these arrangements, 
    the prepaid plans, physician groups, and/or the reinsurance companies 
    must arrange for protection against losses that can occur due to 
    withholds or the potential loss of bonus payments.
        With regard to the suggestion that we account for inflation, we 
    will be periodically reviewing the requirements of this regulation in 
    light of new or more complete information about compensation 
    arrangements and their impact on patients. We will consider this and 
    other recommendations again in the future.
        Comment: A commenter asked how frequently panel size can be updated 
    and how soon this increased panel size can be reflected in higher stop-
    loss limits for the group. The commenter also asked whether an HMO that 
    increases enrollment in a physician panel and correspondingly raises 
    its stop-loss limits must refile its physician incentive arrangement 
    with us.
        Response: There is no limitation on the frequency with which panel 
    size can be updated.
        Comment: One commenter noted that the stop-loss protection required 
    by this regulation would cover only 90 percent of the costs of referral 
    services that exceed 25 percent of potential payments. The commenter 
    believed that the financial incentive to reduce or withhold referral 
    services to Medicare patients could, in this situation, be 
    overwhelming. The commenter said this would be particularly true in 
    situations in which the physician treated an atypical mix of patients 
    requiring referrals for specialty care.
        Response: We adopted our position based upon comments on the 
    proposed rule. As indicated in the preamble to the March 27, 1996 final 
    rule, this policy is currently used by many prepaid plans and has 
    worked well to ensure that physicians are sensitive to avoid the 
    furnishing of unnecessary services. Recent information from prepaid 
    plans and actuaries confirms that this 90/10 standard is consistent 
    with actual practices and policies. We set the ratio at the high end of 
    the continuum of ratios used in the industry since they range from 90/
    10 to 75/25. Thus, we have allowed for limited risk sharing beyond the 
    stop-loss limits. Further, as indicated in the preamble to the March 
    1996 rule, we made changes in the stop-loss limits to adjust for the 
    incorporation of this additional risk sharing.
        Comment: A major organization representing physicians believed that 
    we should require a reduced, but still substantial, amount of stop-loss 
    for plans with enrollment in excess of 25,000 patients.
        Response: As stated earlier, evidence from analyses by Rossiter and 
    Adamache supports the decision that physician groups with more than 
    25,000 patients are able to adequately spread risk. Therefore we 
    concluded that they are not at substantial financial risk. The 
    commenter did not provide any data or rationale that would lead us to a 
    different conclusion. Note also that the change made by this final rule 
    discussed earlier that eliminates pooling by the prepaid plan across 
    physician groups to achieve the 25,000 base should alleviate the 
    commenter's concern.
    
    Survey
    
        We received a single comment on the enrollee survey provisions in 
    the rule. Section 417.479(g)(1) requires that HMOs or CMPs that operate 
    incentive plans that place physicians or physician groups at 
    substantial financial risk conduct enrollee surveys. These surveys 
    must--
         Include either all current Medicare/Medicaid enrollees of 
    the HMO or CMP and those who have disenrolled (other than because of 
    loss of eligibility in Medicaid or relocation outside the HMO's or 
    CMP's service area) in the past 12 months, or a sample of these same 
    enrollees and disenrollees.
         Be designed, implemented, and analyzed in accordance with 
    commonly accepted principles of survey design and statistical analysis.
         Address enrollees/disenrollees satisfaction with the 
    quality of the services provided and their degree of access to the 
    services.
         Be conducted no later than 1 year after the effective date 
    of the incentive plan, and at least every 2 years thereafter.
        Comment: A major organization suggested that we require health 
    plans to use a standardized survey questionnaire designed by HCFA; 
    require health plans to oversample disenrollees and persons with 
    chronic conditions or high cost illnesses; provide detailed 
    instructions to plans on survey design; and publish a comparison report 
    card of all survey results.
        Response: The final rule did not specify that the plans conduct a 
    separate survey for this regulation because most plans already 
    administer surveys that meet the requirements of this regulation. We 
    do, however, recognize the value of having a standardized survey 
    instrument and have developed one, as part of our effort to measure and 
    improve quality of care, that can be used to satisfy the requirements 
    of this regulation.
        We have, in concert with the Agency for Health Care Policy and 
    Research through the latter's CAHPS process
    
    [[Page 69046]]
    
    (Consumer Assessments of Health Plans Study), sponsored the development 
    of a Medicare-specific consumer satisfaction instrument, so that the 
    unique health care concerns of the senior population are adequately 
    addressed. CAHPS is a 5-year project whose purpose is to develop a set 
    of standardized consumer satisfaction instruments usable across all 
    populations; subpopulation specific modules are being developed not 
    only for the Medicare population, but also for Medicaid, the 
    chronically ill and disabled, and children.
        We have notified plans of our intention to require all Medicare 
    contracting plans that have had a Medicare contract for at least 1 year 
    as of January 1, 1997 to participate in this CAHPS survey. The CAHPS 
    Medicare survey will be administered by an independent third-party 
    contractor to the Government, secured through an open, competitive 
    bidding process. The primary purpose of the survey is to provide 
    information to consumers that will enable them to make plan-to-plan 
    comparisons and thereby to make better-informed health plan choices. 
    Key results of the survey will be published in a comparability chart 
    that contains cost and benefit information on all Medicare contracting 
    plans.
        We will consider participation by a plan in the CAHPS survey as 
    satisfying the requirements of this regulation, subject to the 
    following two additional considerations. First, the current version of 
    CAHPS does not contain a module addressed to disenrollees. Efforts are 
    underway to develop such a module, which may be available by 1998. For 
    1997, we are preparing guidelines to managed care plans on how to 
    satisfy the requirement to survey disenrollees. That guidance will be 
    available in the spring of 1997.
        Second, as noted above, under the requirements of our quality 
    initiative, plans that received their initial Medicare contract after 
    January 1, 1996, are not required to participate in the CAHPS survey 
    until calendar year 1998. There will likely be plans, however, that 
    received their first contract after January 1, 1996, that will be 
    required to meet the enrollee and disenrollee survey requirements of 
    this regulation in calendar year 1997. Those plans may wish to use the 
    CAHPS survey to meet this requirement.
        We have issued an operational policy letter explaining this 
    requirement in more detail (See OPL number 96.045, December 3, 1996).
        Oversampling for the chronically ill and disabled, dually eligible, 
    and various racial and ethnic groups is a complex issue. Strategies for 
    doing so are being seriously considered. We will be forwarding 
    additional guidance to managed care plans.
        It should also be noted that the CAHPS survey collects information 
    at the level of the managed care plans, without distinguishing among 
    patients of various physician groups within the plan. Ideally, the 
    survey required under this regulation, however, should do so. We will 
    accept the CAHPS survey as satisfying this regulation at this time, 
    while we continue to evaluate additional measures that might be taken 
    to collect information by physician group.
        Finally, we will not require that the Medicaid version of the CAHPS 
    survey be administered by HMOs with Medicaid contracts. However, we are 
    willing to assist States that wish to require administration of the 
    CAHPS Medicaid survey.
    
    Other Comments
    
        We received other comments that were not specifically directed to 
    the provisions of the regulation. Since these comments do not directly 
    address the regulations, we are not responding to them in this 
    preamble.
        We also want to clarify an inconsistency that occurred in the 
    preamble to the March 27, 1996 final rule. While the regulation text 
    was accurate in specifying that subcontracts were covered by the 
    regulations, we were inconsistent in different sections of the 
    preamble. In the first column at 61 FR 13439, we indicated that 
    subcontracts are covered, while in the second and third column of the 
    same page we indicated that they were not covered. The statements in 
    the second and third column were incorrect.
    
    V. Provisions of this Final Rule
    
        This final rule reflects the March 27, 1996 final rule with comment 
    period, with changes. Many of the substantive change listed below have 
    been discussed in section IV of this preamble. Those that have not are 
    explained below.
         Section 417.479(b) is revised to clarify that the 
    physician incentive plan requirements also apply to subcontracting 
    arrangements.
         Section 417.479(f), which describes arrangements that 
    cause substantial financial risk, is revised to permit pooling by 
    physician groups of patients across prepaid plans. A technical change 
    is also made to change ``possible payments'' wherever it appears to 
    ``potential payments''. This latter change reflects the fact that 
    ``potential payments'' is the term defined in the paragraph's 
    introductory text.
         In Sec. 417.479(g), which sets forth the requirements that 
    HMOs and CMPs that place physicians or physician groups at substantial 
    financial risk must meet, the following changes are made:
        + Paragraph (g)(1) is revised to require that the enrollee survey 
    be conducted no later than 1 year after the effective date of the 
    Medicare contract and at least annually thereafter.
        + Paragraph (g)(2)(ii) is revised to establish new stop-loss limits 
    based either on a single combined limit or on separate limits for 
    professional services and institutional services.
        + Paragraph (g)(2)(iii) is removed to eliminate the requirement 
    that the HMO or CMP pay for the stop-loss protection.
         In Sec. 417.479(h), which concerns disclosure 
    requirements, the following changes are made:
        + Paragraph (h)(1)(iv) is revised to specify that the HMO or CMP 
    must provide us with proof that the physician or physician group has 
    adequate stop-loss protection, including the amount and type of stop-
    loss protection.
        + Existing paragraph (h)(1)(v) is removed to eliminate, as an 
    approved method of pooling, pooling together, by the organization, of 
    several physician groups into a single panel. A new paragraph (h)(1)(v) 
    is added to permit pooling, by a physician group, of patients across 
    prepaid plans. New paragraph (h)(1)(v) also specifies the conditions 
    under which pooling is permitted.
        + Paragraph (h)(2) is revised to change when the HMO or CMP must 
    provide the required information. The current regulation requires this 
    to be done upon application for a contract, upon application for a 
    service area expansion, within 30 days of a request by us, and at least 
    45 days before implementing certain changes in the incentive plan. We 
    have changed this to make it an annual requirement. This first 
    submission must be done prior to approval of a new contract, with 
    subsequent submissions prior to each renewal of the contract. This 
    change is intended to simplify the requirement and reduce the reporting 
    burden on the prepaid plans.
        In addition we now specify, in paragraph (h)(2)(ii), that an HMO or 
    CMP must provide the capitation data for the previous calendar year to 
    us by April 1 of each year. This change is being made to eliminate 
    confusion about the reporting period and ensure consistency.
         In Sec. 434.70, which concerns conditions for FFP, 
    paragraph (a)(3) is revised to--
        + Eliminate the requirement that the HMO or HIO must disclose 
    certain
    
    [[Page 69047]]
    
    information within 30 days of a request by the State or HCFA.
        + To specify that an HMO or HIO must provide the capitation data 
    for the previous calendar year to the State Medicaid agency by April 1 
    of each year.
        + Eliminate the requirement that the HMO or HIO submit the required 
    information at least 45 days before implementing certain changes in its 
    incentive plan.
    
    VI. Collection of Information Requirements
    
        Under the Paperwork Reduction Act of 1995, agencies are required to 
    provide 60-day notice in the Federal Register and solicit public 
    comment before a collection of information requirement is submitted to 
    the Office of Management and Budget (OMB) for review and approval. This 
    final rule contains information collections that are subject to review 
    by OMB under the Paperwork Reduction Act of 1995. The title, 
    description, and respondent description of the information collections 
    are shown below with an estimate of the annual reporting and 
    recordkeeping burden. Included in the estimate is the time for 
    reviewing instructions, searching existing data sources, gathering and 
    maintaining the data needed, and collecting and reviewing the 
    collection of information.
        We are, however, requesting an emergency review of these 
    regulations. In compliance with the requirement of section 
    3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted 
    to OMB the following requirement for emergency review. We are 
    requesting an emergency review because the collection of this 
    information is needed prior to the expiration of the normal time limits 
    under OMB's regulations at 5 CFR part 1320, to ensure compliance with 
    the physician incentive regulation necessary to implement congressional 
    intent with respect to incentive arrangements between managed care 
    entities and their contracting providers. We cannot reasonably comply 
    with the normal clearance procedures because public harm is likely to 
    result due to the delay in reporting and monitoring of these 
    incentives. If emergency clearance is not provided, we will be forced 
    to postpone the collection of these data for 12 months due to the 
    timing of contract cycles.
        We are requesting that OMB provide a 5-day public comment period 
    with a 2-day OMB review period and a 180-day approval. During this 180-
    day period, we will publish a separate Federal Register notice 
    announcing the initiation of an extensive 60-day agency review and 
    public comment period on these requirements. Then we will submit the 
    requirements for OMB review and an extension of this emergency 
    approval.
        Type of Information Request: New collection.
        Title of Information Collection: Incentive Arrangement Disclosure 
    Form and Supporting Regulations 42 CFR 417.479 (g)(1), 417.479(h)(1) 
    and (h)(2), 417.479(i), and 434.70(a)(3).
        Form Number: HCFA-R-201.
        Use: Incentive Arrangement Form and supporting regulations will be 
    used to monitor physician incentive plans.
        Frequency: Annually.
        Affected Public: Nonprofit and for profit HMOs, CMPs, and HIOs.
        Number of Respondents: 450.
        Total Annual Responses: 450.
        Total Annual Hours Requested: 45,000.
        To request copies of the proposed paperwork collections referenced 
    above, call the Reports Clearance Office at (410) 786-1326.
        The sections in these final regulations that contain information 
    collection requirements are:. Secs. 417.479 (h)(1) and (h)(2), 
    417.479(i), 434.70(a)(3), and 417.479(g)(1), (and Sec. 434.70(a)(3) for 
    Medicaid) of this document. However, the information collection 
    requirements referenced in Secs. 417.479(g)(1) and 434.70(a)(3) of this 
    final rule, described below, are currently pending approval by OMB 
    (under the title ``HEDIS 3.0 (Health Plan Data and Information Set) and 
    supporting regulations 42 CFR 417.470 and 42 CFR 417.126'').
        The information collection requirements at existing 
    Secs. 417.479(h) (1) and (h)(2), 417.479(i), and 434.70(a)(3) were 
    established by the March 27, 1996 final rule with comment period. These 
    sections of the regulations specify that disclosure concerning 
    physician incentive plans must be made to us or the State, as 
    appropriate. The requirements apply to physician incentive plans 
    between prepaid plans and individual physicians or physician groups 
    with whom they contract to furnish medical services to enrollees. The 
    requirements apply only to physician incentive plans that base 
    compensation on the use or cost of services furnished to Medicare 
    beneficiaries or Medicaid recipients. Under the existing regulations, a 
    prepaid plan must provide the information upon application for a 
    contract; upon application for a service area expansion; at least 45 
    days before implementing certain changes in its incentive plan, and 
    within 30 days of a request by us or the State. This rule would amend 
    the regulations by removing the requirements that disclosure be made 
    upon application for a service area expansion, within 30 days of a 
    request by us or the State, and at least 45 days before implementing 
    certain changes in the incentive plan. It would add that disclosure 
    must be made prior to the approval of a new contract or agreement and 
    annually thereafter. These changes should reduce the reporting burden 
    on prepaid plans. At the time we published the March 1996 rule, we 
    estimated that approximately 600 entities will submit the information. 
    We estimated the burden as 8 hours per response. As discussed in 
    section IV above, we received numerous comments stating that we greatly 
    underestimated the burden associated with complying with the disclosure 
    requirements and suggesting alternative approaches. We now estimate 
    that approximately 450 prepaid plans will disclose information. We 
    estimate that the burden per response will be 100 hours, for an annual 
    total burden of 45,000 hours. This estimate includes time spent by 
    subcontractors in furnishing information to the prepaid plan.
        Existing Sec. 417.479(g)(1) (and Sec. 434.70(a)(3) for Medicaid) 
    concern prepaid plans that operate physician incentive plans that place 
    physicians or physician groups at substantial financial risk and 
    require them to conduct enrollee surveys that include either all 
    current Medicare/Medicaid enrollees in the prepaid plan and those who 
    have disenrolled (other than because of loss of eligibility in Medicaid 
    or relocation outside the prepaid plan's) in the past 12 months, or a 
    sample of these same enrollees and disenrollees. These surveys are 
    required to be conducted annually.
        The information collection and recordkeeping requirements, 
    referenced in Sec. 417.479 (h)(1) and (h)(2), 417.479(g)(1), 
    417.479(i), and 434.70(a)(3) of these regulations are not effective 
    until they have been approved by OMB. The agency has submitted a copy 
    of this final rule with comment period to OMB for its review of these 
    information collections. A notice will be published in the Federal 
    Register when approval is obtained. Interested persons are invited to 
    send comments regarding this burden or any other aspect of these 
    collections of information, including any of the following subjects: 
    (1) The necessity and utility of the information collection for the 
    proper performance of the agency's functions; (2) the accuracy of the 
    estimated burden; (3) ways to enhance the quality, utility, and clarity 
    of the information to be collected; and (4) the use of automated 
    collection
    
    [[Page 69048]]
    
    techniques or other forms of information technology to minimize the 
    information collection burden.
        Comments on these information collections should be mailed directly 
    to the following address:
        Office of Information and Regulatory Affairs, Office of Management 
    and Budget, Room 10235, New Executive Office Building, Washington, DC 
    20503, Attn: Allison Herron Eydt, HCFA Desk Officer.
        In addition, comments may be faxed to: Allison Herron Eydt at (202) 
    395-6974.
        A copy of the comments may be mailed to the following address: 
    Health Care Financing Administration, Office of Financial and Human 
    Resources, Management Analysis and Planning Staff, Room C2-26-17, 7500 
    Security Boulevard, Baltimore, MD 21244-1850.
        We will also be undertaking an overall evaluation of all of the 
    reporting and disclosure requirements in this regulation within the 
    next year, to assess the value of the information compared with the 
    burden of reporting. All of the disclosure and reporting requirements, 
    and any related forms, will continue to be subject to review under the 
    Paperwork Reduction Act.
    
    VII. Regulatory Impact Statement
    
        Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
    through 612), we prepare a regulatory flexibility analysis unless the 
    Secretary certifies that a rule will not have a significant economic 
    impact on a substantial number of small entities. For purposes of the 
    RFA, we consider all HMOs, CMPs, and HIOs to be small entities.
        In addition, section 1102(b) requires the Secretary to prepare a 
    regulatory impact analysis if a rule may have a significant impact on 
    the operations of a substantial number of small rural hospitals. This 
    analysis must conform to the provisions of section 604 of the RFA. For 
    purposes of section 1102(b), we define a small rural hospital as a 
    hospital that is located outside of a Metropolitan Statistical Area and 
    has fewer than 50 beds.
        In the preamble to the March 27, 1996 rule, which provided an 
    opportunity for comments, we stated that we had decided not to prepare 
    a regulatory flexibility analysis because we believed that few 
    incentive plans will require changes to comply with the regulations. A 
    major association of health plans, which submitted comments on behalf 
    of its membership, strongly disagreed with this position.
        The association maintained that the regulations, as adopted, will 
    result in substantial administrative and financial burdens on a large 
    number of organizations. The association requested that, in light of 
    the information it was providing to us in its other comments, we 
    reconsider our decision not to prepare a regulatory impact analysis.
        A number of commenters believed that, in estimating a burden of 8 
    hours per response, we had grossly underestimated the time and 
    financial resources that need to be expended to comply with the 
    disclosure requirements. These commenters stated that this problem may 
    be alleviated to some extent if the prepaid plans were allowed to agree 
    that all or some of their physician incentive programs resulted in 
    substantial financial risk without having to disclose to us the 
    detailed information specified in the Regulations. One commenter added 
    that the regulations, in essence, require prepaid plans to act as 
    information gathering conduits for information related to physician 
    group and/or subcontractor incentive plans. The commenter stated that 
    this is not the most efficient or effective means and that a preferable 
    approach is for us to solicit the information directly from the 
    physician group or subcontractor. The commenter recommended that we 
    adopt a uniform and standardized calculation and attestation form that 
    prepaid plans could use to solicit the information.
        Another commenter stated that the stop-loss limits are 
    inappropriately low and, because of this, the cost of stop-loss 
    coverage is very high. The commenter maintains that this rule results 
    in substantial financial burdens on a large number of prepaid plans.
        The suggestions offered by the commenters have been addressed in 
    section IV above. With regard to our assessment of the impact of the 
    March 27, 1966 rule, we have reviewed our assessment. In this review, 
    we used information developed by a major accounting firm at the request 
    of a major association, which was shared with us.
        Based on survey data from Mathematica (1995), approximately one-
    third of prepaid plans capitate their physicians for all services. This 
    means that, of approximately 300 Medicare prepaid plans, about 100 
    plans will capitate for all services. Of approximately 300 Medicaid 
    HMOs and HIOs, approximately one-half will have Medicare contracts and, 
    thus, do not add to the total. Of the remaining 150 Medicaid plans, 
    many will be relatively new Medicaid plans. Most new Medicaid plans do 
    not capitate their physicians for all services. Therefore, we estimate 
    that there will be a total of 25 Medicaid prepaid plans in addition to 
    the 100 Medicare plans that capitate for all services. These 125 plans 
    will have to provide stop-loss insurance. Very few plans that use 
    bonuses or withholds will exceed the substantial risk threshold.
        Of the 125 plans that will need to provide stop-loss insurance, 
    most of these plans already have such coverage. Taking into account the 
    changes made by this final rule, we estimate that approximately 44 
    prepaid plans (35 percent) will need to increase their stop-loss 
    coverage. The cost of this additional coverage is estimated at 
    approximately $65 million. Since the affected entities are large, $65 
    million represents a very small percentage of their gross annual 
    income. In addition, we expect that some of the $65 million will be 
    offset by monies received from the insurers because of the increased 
    coverage.
        With regard to the financial burden associated with complying with 
    the disclosure requirements, we continue to estimate that approximately 
    450 plans will need to comply with the disclosure requirements. We now 
    estimate the burden to be 100 hours per response, at a cost of $20 per 
    hour. This includes the burden on the physician groups and 
    subcontractors in furnishing information to the prepaid plan. Thus, we 
    estimate the total impact of the disclosure requirements at $900,000 
    per year.
        This rule changes the frequency of the survey requirements (from 
    biennially to annually), we believe that this imposes very little 
    additional burden on prepaid plans since most plans already conduct 
    annual surveys. In addition, as discussed in section V of the preamble, 
    this rule changes when disclosure must be made to HCFA or the State 
    Medicaid agency. While this rule adds that disclosure must be made upon 
    the contract or agreement renewal or anniversary date, it removes other 
    circumstances under which disclosure must be made. We believe the 
    overall effect of these changes as to when disclosure must be made is 
    to reduce the reporting burden on the affected prepaid plans.
        We are not preparing analyses of this final rule for either the RFA 
    or section 1102(b) of the Act because we have determined, and the 
    Secretary certifies, that this rule will not have a significant 
    economic impact on a substantial number of small entities or a 
    significant economic impact on the operations of a substantial number 
    of small rural hospitals.
        In accordance with the provisions of Executive Order 12866, this 
    regulation was reviewed by the Office of Management and Budget.
    
    [[Page 69049]]
    
    VIII. Waiver of Delayed Effective Date
    
        We ordinarily provide for final rules to be effective no sooner 
    than 30 days after the date of publication unless we find good cause to 
    waive the delay.
        This final rule amends existing regulations that set forth the 
    requirements that certain managed care organizations must meet in order 
    to contract with the Medicare and/or Medicaid program. A number of the 
    changes made by this final rule either reduce the burden associated 
    with the regulations or recognize existing industry practices. Since 
    many managed care Medicare and Medicaid contracts renew on January 1, 
    if this final rule does not become effective until after that date, the 
    benefits that result from the changes made by this rule will not be 
    realized until 1998. Therefore, we find that it would be against the 
    public interest to delay the effective date of this final rule.
        Chapter IV of title 42 is amended as set forth below:
    
    PART 417--HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL 
    PLANS, AND HEALTH CARE PREPAYMENT PLANS
    
        A. Part 417 is amended as follows:
        1. The authority citation for part 417 continues to read as 
    follows:
    
        Authority: Secs. 1102 and 1871 of the Social Security Act (42 
    U.S.C. 1302 and 1395hh).
    
        2. In Sec. 417.479, paragraph (g) introductory text and paragraph 
    (g)(1) introductory text are republished; paragraph (g)(2)(iii) is 
    removed; paragraph (b), paragraph (f) introductory text, paragraphs 
    (f)(5), (g)(1)(iv), (g)(2)(ii), (h)(1)(iv), (h)(1)(v), and (h)(2) are 
    revised to read as follows:
    
    
    Sec. 417.479  Requirements for physician incentive plans.
    
    * * * * *
        (b) Applicability. The requirements in this section apply to 
    physician incentive plans between HMOs and CMP and individual 
    physicians or physician groups with which they contract to provide 
    medical services to enrollees. The requirements in this section also 
    apply to subcontracting arrangements as specified in Sec. 417.479(i). 
    These requirements apply only to physician incentive plans that base 
    compensation (in whole or in part) on the use or cost of services 
    furnished to Medicare beneficiaries or Medicaid recipients.
    * * * * *
        (f) Arrangements that cause substantial financial risk. For 
    purposes of this paragraph, potential payments means the maximum 
    anticipated total payments (based on the most recent year's utilization 
    and experience and any current or anticipated factors that may affect 
    payment amounts) that could be received if use or costs of referral 
    services were low enough. The following physician incentive plans cause 
    substantial financial risk if risk is based (in whole or in part) on 
    use or costs of referral services and the patient panel size is not 
    greater than 25,000 patients:
    * * * * *
        (5) Capitation, arrangements, if--
        (i) The difference between the maximum potential payments and the 
    minimum potential payments is more than 25 percent of the maximum 
    potential payments; or
        (ii) The maximum and minimum potential payments are not clearly 
    explained in the physician's or physician group's contract.
    * * * * *
        (g) Requirements for physician incentive plans that place 
    physicians at substantial financial risk. HMOs and CMPs that operate 
    incentive plans that place physicians or physician groups at 
    substantial financial risk must do the following:
        (1) Conduct enrollee surveys. These surveys must--
    * * * * *
        (iv) Be conducted no later than 1 year after the effective date of 
    the Medicare contract and at least annually thereafter.
        (2) * * *
        (ii) If the stop-loss protection provided is based on a per-patient 
    limit, the stop-loss limit per patient must be determined based on the 
    size of the patient panel and may be a single combined limit or consist 
    of separate limits for professional services and institutional 
    services. In determining patient panel size, the patients may be pooled 
    in accordance with paragraph (h)(1)(v) of this section. Stop-loss 
    protection must cover 90 percent of the costs of referral services that 
    exceed the per patient limit. The per-patient stop-loss limit is as 
    follows:
    
                                                                            
    ------------------------------------------------------------------------
                                       Single       Separate      Separate  
              Panel size              combined   institutional  professional
                                       limit         limit          limit   
    ------------------------------------------------------------------------
    1-1000........................       $6,000       $10,000         $3,000
    1,001-5000....................       30,000        40,000         10,000
    5,001-8,000...................       40,000        60,000         15,000
    8,001-10,000..................       75,000       100,000         20,000
    10,001-25,000.................      150,000       200,000         25,000
    > 25,000......................         none          none           none
    ------------------------------------------------------------------------
    
    * * * * *
        (h) * * *
        (1) * * *
        (iv) Proof that the physician or physician group has adequate stop-
    loss protection, including the amount and type of stop-loss protection.
        (v) The panel size and, if patients are pooled, the method used. 
    Pooling is permitted only if: it is otherwise consistent with the 
    relevant contracts governing the compensation arrangements for the 
    physician or physician group; the physician or physician group is at 
    risk for referral services with respect to each of the categories of 
    patients being pooled; the terms of the compensation arrangements 
    permit the physician or physician group to spread the risk across the 
    categories of patients being pooled; the distribution of payments to 
    physicians from the risk pool is not calculated separately by patient 
    category; and the terms of the risk borne by the physician or physician 
    group are comparable for all categories of patients being pooled. If 
    these conditions are met, the physician or physician group may use 
    either or both of the following methods to pool patients:
        (A) Pooling any combination of commercial, Medicare, or Medicaid 
    patients enrolled in a specific HMO or CMP in the calculation of the 
    panel size.
        (B) Pooling together, by a physician group that contracts with more 
    than one HMO, CMP, health insuring organization (as defined in 
    Sec. 434.2 of
    
    [[Page 69050]]
    
    this chapter), or prepaid health plan (as defined in Sec. 434.2 of this 
    chapter) the patients of each of those entities.
    * * * * *
        (2) When disclosure must be made to HCFA. (i) HCFA will not approve 
    an HMO's or CMP's application for a contract unless the HMO or CMP has 
    provided to it the information required by paragraphs (h)(1)(i) through 
    (h)(1)(v) of this section. In addition, an HMO or CMP must provide this 
    information to HCFA upon the effective date of its contract renewal.
        (ii) An HMO or CMP must provide the capitation data required under 
    paragraph (h)(1)(vi) for the previous calendar year to HCFA by April 1 
    of each year.
    * * * * *
    
    PART 434--CONTRACTS
    
        B. Part 434 is amended as follows:
        1. The authority citation for part 434 continues to read as 
    follows:
    
        Authority: Secs. 1102 of the Social Security Act (42 U.S.C. 
    1302).
    
        2. In Sec. 434.44, paragraph (a)(1) is revised to read as follows:
    
    
    Sec. 434.44  Special rules for certain health insuring organizations.
    
        (a) * * *
        (1) Subject to the general requirements set forth in Sec. 434.20(d) 
    concerning services that may be covered; Sec. 434.20(e), which sets 
    forth the requirements for all contracts; the additional requirements 
    set forth in Secs. 434.21 through 434.38; and the Medicaid agency 
    responsibilities specified in subpart E of this part; and
    * * * * *
        3. In Sec. 434.70, paragraph (a) introductory text is republished, 
    and paragraph (a)(3) is revised to read as follows:
    
    
    Sec. 434.70  Condition for FFP.
    
        (a) FFP is available in expenditures for payments to contractors 
    only for the periods that--
    * * * * *
        (3) The HMO, HIO (or, in accordance with Sec. 417.479(i) of this 
    chapter, the subcontracting entity) has supplied the information on its 
    physician incentive plan listed in Sec. 417.479(h)(1) of this chapter 
    to the State Medicaid agency. The information must contain detail 
    sufficient to enable the State to determine whether the plan complies 
    with the requirements of Secs. 417.479 (d) through (g) of this chapter. 
    The HMO or HIO must supply the information required under Secs. 417.479 
    (h)(l)(i) through (h)(1)(v) of this chapter to the State Medicaid 
    agency as follows:
        (i) Prior to approval of its contract or agreement.
        (ii) Upon the contract or agreements anniversary or renewal 
    effective date.
    * * * * *
    (Catalog of Federal Domestic Assistance Program No. 93.773, 
    Medicare--Hospital Insurance; Program No. 93.774, Medicare--
    Supplementary Medical Insurance Program; and Federal Domestic 
    Assistance Program No. 93.778, Medical Assistance Program)
    
        Dated: December 17, 1996.
    Bruce C. Vladeck,
    Administrator, Health Care Financing Administration.
        Dated: December 20, 1996.
    Donna E. Shalala,
    Secretary.
    [FR Doc. 96-33330 Filed 12-30-96; 8:45 am]
    BILLING CODE 4120-01-P
    
    
    

Document Information

Effective Date:
1/1/1997
Published:
12/31/1996
Department:
Health and Human Services Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-33330
Dates:
Effective date. These regulations are effective on January 1, 1997.
Pages:
69034-69050 (17 pages)
Docket Numbers:
OMC-010-F
RINs:
0938-AF74: Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid Health Care Organizations (OMC-010-F)
RIN Links:
https://www.federalregister.gov/regulations/0938-AF74/medicare-and-medicaid-programs-requirements-for-physician-incentive-plans-in-prepaid-health-care-org
PDF File:
96-33330.pdf
CFR: (4)
42 CFR 417.479
42 CFR 434.2
42 CFR 434.44
42 CFR 434.70