98-4230. Medicare Program; ``Without Fault'' and Waiver of Recovery from an Individual as it Applies to Medicare Overpayment Liability  

  • [Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
    [Proposed Rules]
    [Pages 14506-14526]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-4230]
    
    
    
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    Part II
    
    
    
    
    
    Department of Health and Human Services
    
    
    
    
    
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    Health Care Financing Administration
    
    
    
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    42 CFR Parts 401, 403, et al.
    
    
    
    Medicare Program; ``Without Fault'' and Waiver of Recovery From an 
    Individual as It Applies to Medicare Overpayment Liability; Proposed 
    Rule
    
    Federal Register / Vol. 63, No. 57 / Wednesday, March 25, 1998 / 
    Proposed Rules
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    
    42 CFR Parts 401, 403, 405, 410, 411, 413, 447, 466, 473, and 493
    
    [HCFA-1719-P]
    RIN: 0938-AD95
    
    
    Medicare Program; ``Without Fault'' and Waiver of Recovery from 
    an Individual as it Applies to Medicare Overpayment Liability
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Proposed rule.
    
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    SUMMARY: This rule would amend the Medicare regulations governing 
    liability for overpayments to eliminate application of certain 
    regulations of the Social Security Administration and to replace them 
    with HCFA regulations more specific to circumstances involving Medicare 
    overpayments. The following specific changes are included in this rule.
        Explicit criteria and the circumstances under which a provider or 
    supplier can be relieved of liability for an overpayment on the basis 
    of being ``without fault'' with respect to the overpayment.
        Specific criteria and circumstances of the conditions under which a 
    waiver of recovery for Medicare overpayments would apply to 
    individuals.
        A provision to ordinarily consider it inequitable to recover an 
    overpayment from a without-fault individual when an overpayment is made 
    to a without-fault provider.
        Specific provisions that enable Medicare intermediaries and 
    carriers to determine without fault in Medicare overpayments resulting 
    from Medicare secondary payer conditional payments.
        Provisions that grant Peer Review Organizations the authority to 
    make without-fault determinations.
        Provisions for an administrative appeals process for providers and 
    suppliers with regard to a ``not-without-fault'' determination.
        We expect this rule would prevent some providers and suppliers from 
    claiming without-fault status. This could reduce the number of 
    overpayment liabilities passed on to individuals and result in a slight 
    increase in the amount of money recovered.
    
    DATES: To ensure consideration, comments must be mailed or delivered to 
    the appropriate address, as provided below, and be received by 5 p.m. 
    on May 26, 1998.
    
    ADDRESSES: Mail written comments (1 original and 3 copies) to the 
    following address: Health Care Financing Administration, Department of 
    Health and Human Services, Attention: HCFA-1719-P, P.O. Box 26676, 
    Baltimore, MD 21207.
        If you prefer, you may deliver your written comments (1 original 
    and 3 copies) to one of the following addresses: Room 309-G, Hubert H. 
    Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, 
    or Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
        Because of staffing and resource limitations, we cannot accept 
    comments by facsimile (FAX) transmission. In commenting, please refer 
    to file code HCFA-1719-P. Comments received timely will be available 
    for public inspection as they are received, generally beginning 
    approximately 3 weeks after publication of this document, in Room 309-G 
    of the Department's offices at 200 Independence Avenue, SW., 
    Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 
    5 p.m. (phone: (202) 690-7890).
        Copies: To order copies of the Federal Register containing this 
    document, send your request to: New Orders, Superintendent of 
    Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date 
    of the issue requested and enclose a check or money order payable to 
    the Superintendent of Documents, or enclose your Visa or Master Card 
    number and expiration date. Credit card orders can also be placed by 
    calling the order desk at (202) 512-1800 or by faxing to (202) 512-
    2250. The cost for each copy is $8. As an alternative, you may view and 
    photocopy the Federal Register document at most libraries designated as 
    Federal Depository Libraries and at many other public and academic 
    libraries throughout the country that receive the Federal Register.
    
    FOR FURTHER INFORMATION CONTACT: David Walczak (410) 786-4475.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        In any large organization that makes payments to a substantial 
    number of individuals, providers, and suppliers, excesses in payment 
    amounts may occur. Medicare overpayments are Medicare funds an 
    individual, provider, or supplier has received that exceed amounts due 
    and payable under the Medicare statute and regulations. (The Medicare 
    rules at Sec. 400.202 define a ``supplier'' as ``a physician or other 
    practitioner, or an entity other than a provider, that furnishes health 
    care services under Medicare.'' Therefore, in this preamble, we have 
    used the term ``supplier'' to include a physician.)
        Overpayments generally result when payment is made by Medicare for 
    noncovered items or services, when payment is made that exceeds the 
    amount allowed by Medicare for an item or service, or when payment is 
    made for items or services that should have been paid by another 
    insurer (Medicare secondary payer obligations). Once a determination 
    and any necessary adjustments in the amount of the overpayment have 
    been made, the remaining amount is a debt owed to the United States 
    Government.
        Section 1870 of the Social Security Act (the Act) provides a 
    framework within which liability for Medicare overpayments is 
    determined and recoupment of overpayments is pursued. This framework 
    prescribes a certain flow of events (that is, a decisionmaking process) 
    that must be followed when pursuing the recoupment of Medicare 
    overpayments.
        Specifically, section 1870(a) of the Act provides that a payment to 
    a provider or a supplier is considered to be a payment to the 
    individual who received the items or services. Therefore, all 
    overpayments (with the exception of certain aggregate overpayments 
    described later in this preamble) are considered to be an individual's 
    overpayments. However, under section 1870(b) of the Act, if payment was 
    made to a provider or supplier, Medicare looks first to recover any 
    associated overpayment from the provider or supplier unless: (1) The 
    provider or supplier is ``without fault'' with respect to the 
    overpayment, or (2) the Secretary determines that the overpayment 
    cannot be recouped from the provider or supplier. Section 1870(b) of 
    the Act also specifies that, in the absence of evidence to the 
    contrary, without fault is administratively presumed for a provider or 
    supplier when an overpayment is discovered after the third calendar 
    year following the year in which notice of the payment was sent to the 
    provider or supplier.
        In accordance with section 1870(b) of the Act, if an overpaid 
    provider or supplier is determined to be without fault or the 
    overpayment cannot be recouped from the provider or supplier or the 
    individual was paid directly by the Medicare program, the individual is 
    liable for the overpayment, and Medicare seeks recovery from the 
    individual. In the case of an individual who is liable for an 
    overpayment, section 1870(b) of the Act provides for recovery by 
    adjusting cash benefits by
    
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    decreasing subsequent title II payments (social security retirement, 
    survivors, and disability cash benefits) or railroad retirement 
    benefits to which the individual (or other person if the individual 
    dies before the adjustment has been completed) is entitled.
        Under section 1870(c) of the Act, adjustment (or any other type of 
    recovery of an overpayment against the individual) is waived if the 
    individual is without fault with respect to the overpayment and if the 
    adjustment or recovery would ``defeat the purposes of title II or title 
    XVIII'' (Medicare Part A and Part B benefits) of the Act or would be 
    ``against equity and good conscience.'' Section 1870(c) of the Act also 
    specifies that adjustment or recovery is deemed to be against equity 
    and good conscience if the overpayment resulted from expenses incurred 
    for items or services for which payment may not be made under Medicare 
    by reason of the provisions of section 1862(a)(1) or (a)(9) of the Act 
    (not reasonable and necessary or custodial care), and if the 
    Secretary's determination that the payment was incorrect was made after 
    the third year following the year in which notice of that payment was 
    sent to the individual.
    
    II. Current Regulations and Instructions Dealing with Overpayments
    
        The provisions of section 1870(a) through (d) of the Act are 
    incorporated in our regulations in Secs. 405.350 to 405.359 
    (``Liability for Payments to Providers or Suppliers and Handling of 
    Incorrect Payments''). Specifically, Sec. 405.350 (``Individual's 
    liability for payments made to providers and other persons for services 
    furnished the individual'') provides that an individual is liable for 
    an overpayment if the overpayment cannot be recouped from the provider 
    or supplier or if the provider or supplier is without fault with 
    respect to the overpayment. Section 405.350(c) further specifies that, 
    in the absence of evidence to the contrary, a provider or supplier is 
    deemed to be without fault if the overpayment determination was made 
    after the third year following the year in which a payment notice was 
    sent to the provider or supplier.
        In accordance with Sec. 405.350, we look first to recoup an 
    overpayment from the provider or supplier unless: (1) We determine that 
    the overpayment cannot be recouped from the provider or supplier, or 
    (2) the provider or supplier is without fault with respect to the 
    overpayment. Currently, there are no criteria in our regulations 
    pertaining to when a provider or supplier is without fault, nor do our 
    regulations make reference to Social Security Administration (SSA) 
    regulations with respect to provider or supplier fault. However, 
    criteria are listed in section 3708 of the Medicare Intermediary Manual 
    and in section 7103 of the Medicare Carrier Manual that incorporate the 
    principles employed in the SSA regulations.
        Under these manual instructions, a provider or supplier is without 
    fault if it exercised reasonable care in billing for and accepting 
    payment. Exercising reasonable care means that the provider or supplier 
    disclosed all material facts and, based on available information, 
    including but not limited to, the Medicare regulations and 
    instructions, had a reasonable basis for assuming that the payment was 
    correct. However, if the provider or supplier had reason to question 
    the payment, it must have promptly brought the question to the 
    attention of the appropriate Medicare contractor (intermediary or 
    carrier).
        If the intermediary or carrier, acting on behalf of HCFA, 
    determines that the provider or supplier is liable for the overpayment 
    according to Sec. 405.350 and the applicable manual instructions, we 
    recoup the overpayment from the provider or supplier. If the 
    intermediary or carrier, acting on behalf of HCFA, determines that the 
    provider or supplier is not liable for the overpayment, liability rests 
    with the individual, regardless of whether the individual was without 
    fault. Whether an individual was without fault is not relevant to his 
    or her liability for the overpayment, but is considered in deciding 
    whether to waive adjustment or recovery of the overpayment.
        Under Sec. 405.355 (``Waiver of adjustment or recovery''), 
    adjustment or recovery against the individual is waived if the 
    individual is without fault with respect to the overpayment and if 
    recovery would cause substantial financial hardship so that the 
    purposes of title II or title XVIII of the Act would be defeated or if 
    recovery would be against equity and good conscience. Section 405.356 
    (``Principles applied in waiver of adjustment or recovery'') specifies 
    that the principles applied in determining waiver of adjustment or 
    recovery are the applicable principles found in SSA regulations at 20 
    CFR 404.506 through 404.509, 20 CFR 404.510(a), and 20 CFR 404.512. 
    These regulations, in part, define ``fault'' (as used in without fault) 
    and explain the conditions for waiver of the adjustment or recovery if 
    an incorrect payment has been made under title II or title XVIII of the 
    Act. (Before we were established as a separate agency, SSA was 
    responsible for both the social security cash benefit program and the 
    Medicare program. Consequently, the two programs have many identical 
    regulations that embody SSA's understanding of the terms used in the 
    overpayment recoupment process.)
        Under Sec. 405.356 of our regulations, intermediaries and carriers, 
    acting on behalf of HCFA, currently determine if an individual is 
    without fault, based on SSA regulations at 20 CFR 404.507 (``Fault''). 
    Under 20 CFR 404.507, the following three elements are considered in 
    determining fault:
         Whether the overpayment resulted from an incorrect 
    statement made by the individual that he or she knew or should have 
    known to be incorrect.
         Whether the overpayment resulted from the individual's 
    failure to furnish information that he or she knew or should have known 
    to be material.
         Whether the overpayment resulted from acceptance of a 
    payment that he or she either knew or could have been expected to know 
    was incorrect. These criteria provide the foundation for making 
    individual waiver of adjustment or recovery decisions.
        Under Sec. 405.355, we may waive all or part of a recovery against 
    an individual who is found to be without fault if recovery would defeat 
    the purposes of title II or title XVIII of the Act or would be against 
    equity and good conscience. We currently use as a basis for making 
    these determinations the definitions for these terms found in SSA 
    regulations at 20 CFR 404.508 (``Defeat the purpose of title II'') and 
    20 CFR 404.509 (``Against equity and good conscience; defined'').
        Under 20 CFR 404.508, ``defeat the purpose of title II'' means to 
    deprive a person of income required for ordinary and necessary living 
    expenses. Ordinary and necessary expenses, as specified in 20 CFR 
    404.508, include the following:
         Living expenses, such as food and clothing, rent, mortgage 
    payments, utilities, maintenance, insurance (for example, life, 
    accident, and health insurance including premiums for supplementary 
    medical insurance benefits under title XVIII), taxes, and installment 
    payments.
         Medical, hospitalization, and other similar expenses.
         Expenses for the support of others for whom the individual 
    is legally responsible.
         Other miscellaneous expenses that may reasonably be 
    considered as part of the individual's standard of living.
        Using these criteria, 20 CFR 404.508(b) specifies that adjustment 
    or recovery will defeat the purpose of title II, for example, if the 
    person from whom recovery is sought needs substantially all of his or 
    her current income
    
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    (including social security monthly benefits) to meet current ordinary 
    and necessary living expenses.
        Under 20 CFR 404.509, recovery of an overpayment is against equity 
    and good conscience in the following circumstances:
         Because the individual relied on a notice that payment 
    would be made, or actually received the erroneous payment, the 
    individual--
        * Changed his or her position for the worse; or
        * Relinquished a valuable right.
         The individual was living in a separate household from the 
    overpaid person at the time of the overpayment and did not receive the 
    overpayment. That section further specifies that the individual's 
    financial circumstances are not material to a finding of against equity 
    and good conscience.
        HCFA, through its intermediaries and carriers, currently makes 
    determinations of without fault with regard to providers and suppliers. 
    Intermediaries and carriers also coordinate the waiver process if the 
    individual is liable for the overpayment. When an overpayment consists 
    of both Medicare Part A and Part B claims, the lead intermediary or 
    carrier, that is, the one that has paid the most in benefits, is 
    responsible for coordinating the without-fault determinations and the 
    waiver request process. The lead intermediary or carrier coordinates 
    Medicare's activities with all parties, including the intermediary or 
    carrier, the individual or his or her representative(s), the liability 
    insurer or tort-feasor (in Medicare secondary payer cases), and the 
    HCFA regional office, to ensure that the overpayment situation is 
    resolved in accordance with our guidelines.
    
    III. Problem Areas Within the Framework of the Current Regulations 
    and Our Proposed Revisions to the Regulations
    
    A. Without Fault
    
    1. Differences Between the Social Security and Medicare Programs
        The proposed regulations regarding without fault will clarify 
    circumstances unique to the Medicare context because the social 
    security regulations do not consider the different roles played by the 
    individual within the social security and Medicare programs. These 
    roles that an individual plays in obtaining benefits from each of the 
    programs are significantly diverse. As a social security claimant, the 
    individual (or his or her representative) receives a cash benefit 
    directly from SSA, generally with no third party involved. As a result, 
    the individual has a very proactive role in providing accurate 
    information to obtain this benefit and has a direct degree of 
    responsibility in accepting the SSA payment each month.
        The individual entitled to Medicare, on the other hand, generally 
    receives items or services from a provider or supplier that, in turn, 
    directly bills and accepts payment from the Medicare contractor on 
    behalf of the individual. (There are exceptions to this arrangement, as 
    described later in this preamble.) The information furnished by the 
    individual with respect to the Medicare claim is minimal; most claim-
    related information is furnished by the provider or supplier. 
    Therefore, the individual entitled to Medicare, in obtaining and 
    accepting Medicare benefits, does not have the same role as a social 
    security claimant.
        Because of these role distinctions, the SSA regulations are not 
    always clearly transferable to Medicare overpayment situations. For 
    example, the term ``fault,'' as described in the SSA regulations, 
    focuses on the individual's disclosure of accurate information. This 
    element is emphasized because a social security claimant is in control 
    of all of his or her financial information (for example, receipt of 
    benefit checks and employment information) that often determines the 
    outcome of the claim. SSA relies primarily on the claimant's own self-
    reporting and disclosure. A social security claimant receives a benefit 
    payment directly and is in a position to know if he or she received 
    more than the correct payment due under title II of the Act.
        In contrast, Medicare relies largely on information received from 
    providers and suppliers to determine payment amounts. The individual 
    entitled to Medicare does not have the same control that a social 
    security claimant has in the outcome of a claim. Under most 
    circumstances (with the exception of cases involving unassigned Part B 
    claims and certain Medicare secondary payer situations), the individual 
    entitled to Medicare receives no actual payment and does not know if 
    the payment made under Medicare is correct. Generally, the information 
    generated by a provider or supplier, not information provided by the 
    individual, causes the overpayment to be made. The SSA regulations do 
    not take into account the significant difference between the role an 
    individual plays in receiving social security cash benefits and in 
    receiving Medicare benefits and, therefore, the social security 
    regulations are not always transferable to Medicare overpayment 
    situations.
    2. Differences Resulting From Provider and Supplier Involvement
        In addition, the SSA regulations do not take into consideration the 
    role that a provider or supplier plays in administering Medicare 
    benefits. While 20 CFR 404.507 describes what constitutes fault (as it 
    relates to without fault) on the part of an overpaid individual, it 
    makes no specific reference to without fault as it pertains to a 
    provider or supplier and does not adequately provide for situations 
    when a determination regarding without fault must be made for providers 
    or suppliers.
        While the criteria in 20 CFR 404.507 can generally be applied to 
    all recipients of payments, they do not specifically consider 
    substantive differences between an individual and a provider or 
    supplier billing for and accepting Medicare payment. (Generally, the 
    recipient of a Medicare payment is a provider or supplier. However, in 
    the case of unassigned claims, the recipient is the individual.) 
    Because of Medicare provisions that require all providers and suppliers 
    to submit claims on behalf of individuals, the individual entitled to 
    Medicare does not participate in the actual claim filing process in a 
    significant way. Also, in most instances, it is the provider or 
    supplier, not the individual, that actually receives the Medicare 
    payment. This is because most providers and suppliers agree to bill 
    Medicare directly and to accept the payment amount as determined under 
    the applicable payment system (prospective payment, reasonable cost 
    method, fee schedule, or reasonable charge method) as total payment for 
    covered services. For providers, this is accomplished by entering into 
    a Medicare provider agreement. Suppliers accomplish this either by 
    agreeing to accept assignment on an individual claims basis or by 
    entering into a Medicare participation agreement. Under these 
    circumstances, the individual is responsible for providing the entity 
    with the correct insurance information and authorizing the claim by 
    signing the claim form; however, he or she plays no direct role in the 
    claim filing process and receives no direct payment.
        In the case of a supplier that does not accept Medicare assignment, 
    the individual pays the supplier directly. The claim is submitted to 
    the Medicare contractor by the supplier, and the Medicare contractor 
    pays the individual directly. Although in these situations the 
    individual receives payment directly, he or she normally has no way of 
    knowing if the Medicare payment
    
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    amount for the item or service he or she received is correct.
        These differences raise questions as to whether the same criteria 
    should be applied both to the individual and to the provider or 
    supplier when determining without fault with regard to an overpayment. 
    In particular, determining if the recipient of the payment knew, or 
    could reasonably be expected to know, that the payment amount was 
    incorrect depends on determining the level of information available to 
    the recipient.
        The information available to a provider or supplier is more 
    extensive than that available to an individual. We furnish instruction 
    manuals to providers, and intermediaries and carriers send detailed 
    instructions, such as newsletters, to suppliers. This direct access to 
    Medicare payment information should impart a degree of knowledge and 
    responsibility to both providers and suppliers that does not apply to 
    individuals.
        For example, a provider or supplier that receives an unusual 
    payment amount for a routinely billed service should be in a better 
    position than the individual to question and determine whether the 
    payment amount is correct. This is because of the information available 
    to a provider or a supplier (for example, a physician should know the 
    Medicare physician fee schedule payment amount for a particular 
    service). Although the individual may directly receive a Medicare 
    payment, an Explanation of Medicare Benefits or a Notice of Utilization 
    showing that Medicare payment has been made, the individual normally 
    has no way of knowing if the Medicare payment amount for a particular 
    covered service or item is correct.
        Thus, we propose revisions to the regulations that consider the 
    substantive differences between an individual accepting a Medicare 
    payment and a provider or supplier billing for and accepting a Medicare 
    payment.
    3. Revisions Proposed to Reflect Circumstances Unique to Medicare
        a. Without Fault as it Applies to Individuals Entitled to Medicare. 
    In this rule, we propose to add regulations that are specifically 
    applicable to individuals entitled to Medicare for determining without 
    fault in Medicare overpayment situations. We propose that an individual 
    be considered to be without fault with respect to a Medicare 
    overpayment if he or she exercises reasonable care in requesting 
    Medicare payment and in accepting Medicare payment.
        Under these proposed regulations, an individual exercised 
    reasonable care if he or she accepted a payment that he or she did not 
    know, or could not reasonably have been expected to know, was 
    incorrect; accepted a payment that, on the basis of information 
    available, he or she could reasonably assume was correct; or accepted 
    payment because of reliance on erroneous written information on the 
    interpretation of a pertinent provision of the Act or implementing 
    regulations from an official source within HCFA, SSA, or a Medicare 
    contractor.
        Conversely, we propose that an individual is not without fault when 
    the individual: (1) Receives prior written notice that a particular 
    item or service was not covered by Medicare; (2) makes an incorrect 
    statement or withheld information to obtain benefits that were not due 
    him or her; (3) accepts a payment that he or she knew or should have 
    known was not due; or (4) receives a prior determination of liability 
    under the limitation on liability provisions in section 1879 of the Act 
    for the specific items or services for which a without-fault 
    determination is being made.
        Criteria to be considered in deciding whether an individual was 
    without fault would include the cause of the overpayment, the 
    individual's ability to realize that the payment was incorrect (based 
    on his or her age, education, and physical or mental state), and 
    whether the individual could reasonably be expected to have taken 
    action to prevent the overpayment from occurring.
         b. Without Fault as it Applies to Providers and Suppliers. We 
    propose to incorporate in regulations criteria that currently exist in 
    the Medicare Intermediary Manual, the Medicare Carrier Manual, and 20 
    CFR 404.506.
        Under these proposed regulations, providers or suppliers are ``not 
    without fault'' unless they exercise reasonable care in billing for and 
    accepting Medicare payments and either: (1) Did not know, and could not 
    reasonably have been expected to know, that Medicare payment exceeded 
    amounts payable under the Medicare statute and regulations and, 
    therefore, accepted payment based on a reasonable assumption that the 
    payment was correct; or (2) did know, or could reasonably have been 
    expected to know, that Medicare payment exceeded amounts payable under 
    the Medicare statute and regulations but questioned the appropriate 
    intermediary or carrier in writing, within 60 days of receipt of the 
    excess payment. If, after questioning the appropriate intermediary or 
    carrier, the provider or supplier relied on a written response from the 
    intermediary or carrier that stated that the Medicare payment was 
    correct, or failed to receive a response from the intermediary or 
    carrier within 120 days of the intermediary's or carrier's receipt of 
    the written inquiry, the provider or supplier is without fault.
        We propose that the exercise of reasonable care in billing includes 
    making full disclosure of all material facts and complying with each 
    applicable provision specified in subpart C (``Claims for Payment'') of 
    part 424, including the supplying of all the necessary information on 
    the billing form, to ensure correct payment by the intermediary or 
    carrier. We further propose criteria for determining that a provider or 
    supplier knew, or could reasonably have been expected to know, that 
    Medicare payment exceeded amounts payable under the Medicare statute 
    and regulations. Under these proposed criteria, a provider or supplier 
    is considered to have known that Medicare payment exceeded amounts 
    payable under the Medicare statute and regulations if any one of the 
    following conditions is met:
         It had knowledge that payment exceeded amounts payable 
    under the statute and regulations based on experience, actual notice, 
    or constructive notice, including (except in very limited circumstances 
    described later in this preamble) final publication of payment amounts 
    in official source documents; receipt of HCFA notices including manual 
    issuances, bulletins, or other written guides or directives from 
    intermediaries, carriers, or Peer Review Organizations; or experience 
    with Medicare payment amounts for similar or reasonably comparable 
    items or services. Under this criterion, final publication of payment 
    amounts in official source documents includes correction notices that 
    are published after the initial publication.
         It received prior notice from the peer review 
    organization, intermediary, or carrier of the correct Medicare payment 
    for the items or services furnished or for similar or reasonably 
    comparable items or services.
         It gave the individual prior notice of the correct 
    Medicare payment for the items or services furnished or for similar or 
    reasonably comparable items or services.
        These proposed criteria are similar to those contained in 
    Sec. 411.406 (``Criteria for determining that a provider, practitioner, 
    or supplier knew that services were excluded from coverage as custodial 
    care or as not reasonable and necessary''). Those criteria are used to 
    determine if a provider or supplier is liable for payment of an item or 
    service
    
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    under the limitation on liability provisions in section 1879 of the Act 
    because of knowledge that Medicare payment for the item or service 
    would be denied.
        Because the criteria we propose in the without fault regulations is 
    based, in part, on the limitation on liability provisions, we propose 
    that a provider or supplier that has already been determined liable 
    under the limitation on liability provisions in section 1879 of the Act 
    for a specific item or service cannot be found without fault with 
    regard to the overpayment for that specific item or service.
        c. Without Fault as it Applies to Peer Review Organization 
    Responsibilities. Because this proposed rule would furnish providers 
    and suppliers with appeal rights for determinations that the provider 
    or supplier must repay an overpayment because the provider or supplier 
    is not-without-fault (discussed later), we are considering expanding 
    the responsibility for making without-fault determinations to peer 
    review organizations. Although our final decision may be that 
    intermediaries and carriers make the without-fault determinations for 
    overpayments resulting from peer review organization determinations, we 
    want to provide as much flexibility as possible in exploring this 
    issue. Therefore, we propose revising our regulations to provide peer 
    review organizations with the authority to make without-fault 
    determinations. However, it should be noted that intermediaries, 
    carriers, and peer review organizations that make determinations are 
    acting on behalf of HCFA.
        d. Without Fault as it Applies to the Prospective Payment System. 
    Under section 1886(d) of the Act, effective with hospital cost 
    reporting periods beginning on or after October 1, 1983, we established 
    a system of payment for acute inpatient hospital stays under Medicare 
    Part A (Hospital Insurance), based on prospectively-set rates. Under 
    this prospectively-set rate system (the prospective payment system), 
    Medicare payment is made at a predetermined, specific rate for each 
    hospital discharge. All discharges are classified according to a list 
    of diagnosis-related groups. The regulations governing the inpatient 
    hospital prospective payment system are located at 42 CFR part 412.
        Regarding payments under the prospective payment system, we are 
    required, under section 1886(e)(5)(B) of the Act, to publish by 
    September 1 of each year a list of diagnosis-related group categories 
    and provide instructions on calculating proper Medicare payment 
    amounts. Thus, hospitals paid under the prospective payment system 
    generally have a way to determine whether a payment is correct or 
    incorrect. Accordingly, these hospitals are generally liable for 
    refunding Medicare overpayments they receive under the prospective 
    payment system because, under most circumstances, they cannot be found 
    to be without fault since they have an independent means of 
    conclusively determining whether the prospective payment system payment 
    they accept is correct.
        However, under our proposed rule, a provider may be found to be 
    without fault for payments under the prospective payment system in the 
    event of an error in our prospective payment system publication in the 
    Federal Register, relating to the diagnosis-related group for which the 
    hospital was overpaid. In these circumstances, a hospital that can 
    show, based on criteria specified in these proposed regulations, that 
    it did not know and could not reasonably have been expected to know 
    that a Medicare payment based on an erroneous published schedule of 
    payment amounts exceeded amounts payable under the Medicare statute and 
    regulations is considered to be without fault for the overpayment that 
    resulted from the erroneous published schedule of payment amounts. We 
    note, however, that this rule would not apply if a correction notice 
    containing the correct schedule of payment amounts has been published 
    in the Federal Register after the initial publication of the erroneous 
    schedule of payment amounts. In this instance, the correction notice 
    imputes the same responsibility for knowledge of the overpayment as a 
    correct published schedule of payment amounts.
        If the hospital is without fault, liability shifts to the 
    individual under section 1870(b) of the Act. However, under these 
    circumstances, an individual will also be without fault because there 
    is nothing to indicate that the overpayment resulted from the 
    individual not exercising reasonable care in requesting and accepting 
    Medicare payment, as specified in our regulations. In addition, 
    recovery from the individual may be waived on the basis of ``equity and 
    good conscience'' with respect to Medicare overpayments of this type.
        The same rules would also apply for Medicare payment for inpatient 
    hospital capital-related costs. In a final rule published on August 30, 
    1991 (56 FR 43358), a new subpart M was added to 42 CFR part 412 to 
    provide for a prospective payment system for hospital inpatient 
    capital-related costs. Previously, hospital inpatient operating costs 
    were the only costs covered under the prospective payment system. 
    However, section 1886(g)(1) of the Act now requires that capital-
    related costs be paid under the prospective payment system effective 
    with cost reporting periods beginning after September 30, 1991, for 
    hospitals paid under the prospective payment system. Implementing 
    regulations are found at Sec. 412.300.
        e. Without Fault and Aggregate Overpayment Issues. Under section 
    1870 of the Act, if a provider is found to be without fault for an 
    overpayment, the individual who received the service for which payment 
    was made is liable for the overpayment. Therefore, application of the 
    without fault provision in section 1870 of the Act is limited to 
    overpayments for individual claims for which lability can ultimately be 
    shifted to a specific individual.
        Consequently, the without fault provisions under section 1870 of 
    the Act do not extend to aggregate overpayment issues, such as Medicare 
    cost report errors, because liability for an individual claim cannot be 
    shifted to a specific individual. For certain providers, aggregate 
    overpayments result from payments under a reasonable cost payment 
    methodology in which payment is made on an interim basis throughout the 
    year, with appropriate adjustments made upon settlement of annual cost 
    reports. Because Medicare cost report errors are not directly 
    associated with specific services, liability cannot be shifted from a 
    specific provider to a specific individual.
        Thus, the without fault provisions of this proposed rule would not 
    apply to overpayments resulting from aggregate payment issues, such as 
    cost report errors. These overpayments are addressed in section 1878 of 
    the Act, which contains provisions relating to the Provider 
    Reimbursement Review Board and the circumstances under which a provider 
    may obtain a hearing with the Board.
        f. Without Fault as it Applies to Payment Under the Medicare 
    Physician Fee Schedule. A major change in Medicare physician payment 
    rules was enacted as part of the Omnibus Budget Reconciliation Act of 
    1989, (OBRA 1989), Public Law 101-239. Section 6102 of OBRA 1989 added 
    to the Act a new section 1848, ``Payment for Physicians' Services.'' 
    The new section contains three major elements: (1) A new fee schedule 
    for physicians' services based on a Resource-Based Relative Value Scale 
    to replace the reasonable charge payment mechanism; (2) a Medicare 
    volume performance
    
    [[Page 14511]]
    
    standard for the rates of increase in Medicare expenditures for 
    physicians' services; and (3) limits on the amounts that 
    nonparticipating physicians submitting unassigned claims can charge 
    individuals for covered services.
        We issued a final rule on November 25, 1991, (56 FR 59502) to 
    implement section 1848 of the Act. (The physician fee schedule 
    regulations are set forth at 42 CFR part 414, subpart A.) Section 1848 
    requires that the fee schedule include national uniform relative values 
    for all physicians' services. The fee schedule is being phased in over 
    4 years, beginning in 1992, with the new rules fully effective in 1996. 
    During 1992 through 1995, transition provisions generally blend the old 
    payment amount with the fee schedule amount.
        At the end of each calendar year, we send each physician and other 
    supplier a schedule of the next year's physician fee schedule amounts. 
    In addition, the fee schedule is published in the Federal Register each 
    year. Therefore, all physicians and other suppliers paid under the 
    physician fee schedule are generally in a position to determine whether 
    a payment is correct. Accordingly, physicians and other suppliers are 
    generally liable for refunding Medicare overpayments they receive under 
    this payment system because, under most circumstances, they cannot be 
    found to be without fault since they have an independent way of 
    conclusively determining whether the payment they accept is correct.
        However, under our proposed rule, a physician or other supplier may 
    be found to be without fault if an error in the annual fee schedule for 
    the services for which the physician or supplier was overpaid is 
    published in the Federal Register. In these circumstances, a physician 
    or other supplier is considered to be without fault for an overpayment 
    resulting from the erroneous schedule if the physician or supplier can 
    show, based on criteria specified in these proposed regulations, that 
    he or she did not know and could not reasonably have been expected to 
    know that a Medicare payment based on an erroneous schedule of payment 
    amounts exceeded amounts payable under the Medicare statute and 
    regulations. We note, however, that this would not be the case if a 
    notice correcting the erroneous schedule has been published.
        If the physician or other supplier is found to be without fault, 
    liability shifts to the individual under section 1870(b) of the Act. 
    However, under these circumstances, the individual will also be without 
    fault under our proposed regulations because there is nothing to 
    indicate that the overpayment resulted from the individual not 
    exercising reasonable care in requesting and accepting Medicare 
    payment. In addition, recovery from the individual may be waived on the 
    basis of equity and good conscience with respect to Medicare 
    overpayments of this type.
        g. Without Fault As It Applies to Medicare Secondary Payer 
    Obligations. A large proportion of Medicare overpayments results from 
    Medicare secondary payer situations. Because the nature of Medicare 
    secondary payer obligations is somewhat different from other types of 
    Medicare overpayments, in that Medicare secondary payer situations 
    involve a conditional payment and a third party payer, the current 
    regulations addressing without fault pose particular problems for the 
    recovery of Medicare secondary payer obligations.
        For example, if a conditional Medicare payment becomes a de facto 
    overpayment (that is, a primary payer pays after Medicare payment) as a 
    result of an individual's action that is unrelated to the filing of a 
    Medicare claim, direct application of the SSA regulations can be 
    difficult. The SSA regulations predate the Medicare secondary payer 
    provisions and, therefore, do not provide for them. Under the current 
    regulations, when an Medicare secondary payer obligation results from a 
    conditional Medicare payment for an individual who is injured in an 
    automobile or other accident, and who subsequently receives a 
    settlement or damage award, the individual is generally considered to 
    be without fault. This is because, within the framework of the SSA 
    regulations, the obligation does not result from failure to supply 
    information because even if the individual informs us of a pending suit 
    we frequently make a conditional payment for the claim.
        Thus, when applying the SSA regulations, few circumstances will 
    ever arise when the individual could be found to be at fault in causing 
    an overpayment of this type. This de facto without-fault finding, when 
    coupled with financial or equity considerations, could result in 
    waiving recovery from the individual in the majority of cases, even 
    though the individual may have been instrumental in causing the 
    overpayment.
        We do not believe this to be an appropriate outcome in Medicare 
    secondary payer contexts because, under our current operating 
    procedures, all individuals entitled to Medicare receive a Notice of 
    Utilization or an Explanation of Medicare Benefits showing that 
    Medicare has paid for services. Therefore, individuals are informed 
    that Medicare has made a conditional payment. We believe that, because 
    this information is available, a degree of responsibility should be 
    imputed to the individual or the individual's representative. We 
    believe that the individual who elects to pursue subsequent settlement 
    or damage awards for injuries from liability or no-fault insurers or, 
    in some cases, tort-feasors, should be responsible for notifying us of 
    this intent and protecting the proceeds until the Medicare claim is 
    satisfied. If the individual does not take this responsibility, he or 
    she should be found not without fault once a liability insurance 
    payment is made and we seek to recover our conditional payment.
        All too often, we are not aware of an individual's liability suit 
    until a liability insurance payment is about to be made, or thereafter. 
    At that point, it is more difficult to assert Medicare's interest, 
    despite the fact that under the Medicare secondary payer statute, 
    Medicare has a priority right of recovery. The Congress intended that 
    Medicare payment would be available to individuals to pay for their 
    covered medical expenses to avoid their having to pay for their medical 
    expenses out-of-pocket. Since Medicare conditionally paid for these 
    medical expenses, Medicare is entitled, under the statute, to 
    reimbursement, as opposed to the individual collecting twice for the 
    same loss--first in the form of a benefit payment and then in the form 
    of a cash settlement.
        We propose adding regulations that are specifically applicable to 
    determining without fault for Medicare overpayments resulting from 
    Medicare secondary payer conditional payments. We propose that a 
    provider or supplier will generally be not-without-fault with respect 
    to a Medicare payment in a Medicare secondary payer situation unless 
    the provider or supplier complied with all of the claims filing 
    requirements specified in 42 CFR part 411 and, in the case of 
    providers, the provider agreement provisions in 42 CFR part 489. In 
    addition, we are specifying in these regulations that the without fault 
    provisions do not apply to third party payers or other non-Medicare 
    entities involved in a Medicare secondary payer case.
        With regard to individuals in Medicare secondary payer cases, we 
    propose that an individual would not be considered to be without fault 
    if the facts show that the individual failed to notify Medicare within 
    30 days of the receipt of a payment from an entity that is primary to 
    Medicare or the overpayment resulted because the
    
    [[Page 14512]]
    
    individual failed to file a proper claim, as required in regulations, 
    with an entity that is primary to Medicare; made an incorrect statement 
    or withheld information to obtain benefits that were not due him or 
    her; or accepted a payment that he or she should have known was not 
    due.
        In some cases we seek recovery of Medicare secondary payer 
    obligations from group health plans as a result of the data match in 
    section 1862(B)(5) of the Act and other procedures. In those 
    situations, it would ordinarily be considered inequitable to recover 
    from the individual, and we will not recover the incorrect Medicare 
    payment from the individual unless the Medicare payment was made to the 
    individual.
        In the past, we have required written notification when an 
    individual requests a waiver of recovery of an overpayment. However, on 
    July 10, 1995, we published a proposed rule (60 FR 35544) offering the 
    option of requesting by telephone a review of Part B initial claim 
    determinations. Consequently, we are also proposing in this document 
    that an individual may request to be found without fault and may 
    request waiver by telephoning the contact listed in the notice from the 
    carrier, intermediary, or HCFA.
        We also propose to require that, if the individual or the 
    individual's representative received an Explanation of Medicare 
    Benefits or a Notice of Utilization that Medicare made a payment, and 
    the individual subsequently elects to pursue a liability settlement or 
    damage award for an illness or for injuries sustained in an accident, 
    he or she must notify the Medicare contractor within 60 days of filing 
    a suit or a claim with the insurer. Otherwise, he or she cannot be 
    considered to be without fault. Thus, when Medicare is billed for 
    services furnished to an individual, and the individual (or his or her 
    estate) pursues a liability or damage award or payment from another 
    source, he or she must notify the Medicare contractor both when a suit 
    or claim is filed and when payment is received from any source other 
    than Medicare. This notice requirement does not apply in MSP group 
    health plan situations. Failure to furnish the Medicare contractor with 
    both notices will result in the individual (or his or her estate) being 
    ``at fault'' with respect to any resulting Medicare secondary payer 
    obligation.
        To ensure that beneficiaries realize their obligation to notify the 
    Medicare contractor as proposed above, we would include these 
    requirements in general program information furnished to Medicare 
    beneficiaries, as well as in material (such as, pamphlets) that are 
    targeted to Medicare secondary payer situations. Also, we would include 
    these new requirements in any notice or communication we send to 
    beneficiaries in connection with potential liability situations.
    
    B. Not-Without-Fault Determinations and the Appeals Process
    
        Under current regulations (405.704(b)(14)), determinations 
    concerning the waiver of adjustment or recovery of overpayments are 
    considered initial determinations, for purposes of the Medicare appeals 
    process, under Medicare Part A and Part B with respect to individuals. 
    These determinations are often based on not-without-fault findings. 
    However, we do not have regulations that address not-without-fault 
    determinations made for providers or suppliers. We believe that our 
    regulations need to be revised to afford providers and suppliers an 
    explicit right to appeal determinations made under section 1870(b) of 
    the Act that they are not without fault and, therefore, that they must 
    repay an overpayment.
        Although the Medicare statute does not specifically provide for 
    appeal rights for providers and suppliers regarding a not-without-fault 
    determination, we believe that the administrative appeals process 
    should include that issue. This process will ensure that, when a not-
    without-fault determination is made, the adversely-affected party has a 
    due process right of appeal that is expressly recognized by regulation.
        Therefore, we propose to revise the Medicare appeals regulations to 
    state that, if a provider or supplier that is not without fault 
    receives an initial determination that an overpayment must be refunded, 
    the issue of without fault would also be appealable.
    
    C. Defeats the Purposes of Title II or Title XVIII of the Act and 
    Equity and Good Conscience
    
        If it is determined that an individual entitled to Medicare is 
    without fault, we may waive all or part of a recovery against that 
    individual according to SSA regulations at 20 CFR 404.508 (``Defeat the 
    purpose of title II'') or 20 CFR 404.509 (``Against equity and good 
    conscience; defined''). SSA's definitions of these terms and the 
    examples cited in which they arise reflect SSA's assessment of how this 
    principle applies to recovery from a social security claimant when the 
    claimant has received more than the correct payment due under title II 
    of the Act. There are no illustrations that explain how to apply this 
    principle to a Medicare overpayment situation. As previously noted, an 
    individual entitled to Medicare and a social security claimant are in 
    distinguishable positions with respect to overpayments. For example, 
    the social security claimant is actually receiving a cash benefit. 
    However, the individual entitled to Medicare, in most cases, receives 
    no direct payment. Consequently, the SSA rules are not always directly 
    transferable to a Medicare overpayment situation and provide no clear 
    guidelines for their application to Medicare situations.
        In particular, in the case of a Medicare secondary payer 
    overpayment, transferring the SSA regulations for granting a waiver 
    based on financial hardship or equity and good conscience poses a 
    specific problem. Because the SSA regulations predate the existence of 
    the Medicare secondary payer provisions, they were not written with 
    Medicare secondary payer situations in mind and contain no specific 
    illustrations applying to Medicare secondary payer recoveries. In 
    principle, in the Medicare secondary payer context, there is no basis 
    for the existence of financial hardship because the individual either 
    knows or may reasonably be expected to know from the inception of a 
    claim that Medicare has a priority right of recovery (that is, that we 
    can recover our conditional payments directly from the primary payer or 
    from any entity that received payment, directly or indirectly, from the 
    primary payer).
        The facts of a particular circumstance, however, do not always 
    support this position. For example, suppose an individual entitled to 
    Medicare has received a cash settlement as a result of a liability suit 
    after receiving Medicare payment. Subsequently, the individual spends 
    the settlement proceeds without repaying Medicare. Within the framework 
    of the SSA regulations, the overpayment does not result from failure to 
    supply information since Medicare pays even if the individual makes us 
    aware of a pending suit. Therefore, the individual passes the first 
    test of being without fault.
        The final settlement payment received by the individual as a result 
    of this liability suit could be small enough that an individual could 
    contend that reimbursing Medicare would cause economic hardship or 
    would be inequitable. Thus, it is possible that the individual would 
    not be required to repay Medicare for this type of overpayment because 
    of the application of the SSA regulations addressing without fault 
    coupled with the SSA definitions of ``defeats the purposes of title II 
    or title XVIII'' and ``against equity
    
    [[Page 14513]]
    
    and good conscience.'' We believe that the current Medicare overpayment 
    regulations should be revised to not preclude recovery of an 
    overpayment in Medicare secondary payer situations, but be written in a 
    way that does not unfairly disadvantage the individual or the Medicare 
    program.
        Additionally, a 1990 Court of Appeals decision indicates that SSA's 
    definition of against equity and good conscience may be too narrow for 
    SSA or Medicare issues. In the court case, a social security claimant 
    challenged SSA's waiver denial determination that, although he was 
    without fault in causing the overpayment, recovery would not defeat the 
    purpose of title II or be against equity and good conscience. In an 
    unreported decision, the District Court for the Western District of 
    Washington upheld the waiver denial. However, the Court of Appeals for 
    the Ninth Circuit reversed the decision, holding that requiring the 
    plaintiff to repay the overpayment would be against equity and good 
    conscience. (Quinlivan v. Sullivan, 916 F.2d 524 (9th Cir. 1990)).
        The Court indicated that, although the Act does not define the 
    phrase against equity and good conscience, the Secretary has 
    interpreted it, in 20 CFR 404.509, to be narrowly limited to situations 
    when (1) the claimant changed his or her position for the worse, (2) 
    relinquished a valuable right, or (3) lived in a separate household 
    from the overpaid person at the time of the overpayment and did not 
    receive the overpayment.
        The Court was of the opinion that the Congress intended to broaden 
    the availability of the waiver (id. at 526). Accordingly, the Court 
    concluded that ``the meaning of the phrase, `against equity and good 
    conscience,' cannot be limited to the three narrow definitions set 
    forth in the Secretary's regulations. The Congress intended a broad 
    concept of fairness to apply to waiver requests, one that reflects the 
    ordinary meaning of the statutory language and considers the facts and 
    circumstances of each case'' (id. at 527). The Court favored the 
    against equity and good conscience interpretation used by the 
    Department of Veterans Affairs (VA) in its regulations at 38 CFR 1.965 
    (July 1, 1988 edition), published on July 19, 1974 (39 FR 26400) (id. 
    at 526 and 527, n.2).
        The cited VA regulation indicates that the application of the 
    standard, ``equity and good conscience,'' will be applied when the 
    facts and circumstances in a particular case indicate a need for 
    reasonableness and moderation in the exercise of the Government's 
    rights. Under the VA regulations, equity and good conscience means 
    arriving at a fair decision between the obligor and the Government that 
    is not unduly favorable or adverse to either side.
        In making a determination of equity and good conscience, the VA 
    regulation specified that consideration should be given, but should not 
    be limited, to the following elements: (1) Fault of the debtor; (2) 
    balance of faults; (3) undue hardship; (4) defeats the purpose for 
    which benefits were intended; (5) unjust enrichment; and (6) changed 
    position to one's detriment. In applying this single standard for all 
    areas of indebtedness, the VA regulation further indicates that 
    consideration should be given to the elements of (1) fraud or 
    misrepresentation of a material fact, (2) material fault, and (3) lack 
    of good faith; any one of which, if found, would preclude the granting 
    of a waiver.
        Because the Quinlivan case related to a social security claimant, 
    we are not bound to follow that decision. However, a 1993 District 
    Court decision found that we were not using broad concepts of fairness 
    in reviewing waivers in Medicare secondary payer liability cases, nor 
    had we told our decision makers to ``base the waiver determination on 
    the totality of the circumstances.'' We submitted substantial materials 
    to the court to reflect our actual policies (contrasted with the 
    policies reflected in the SSA regulations) with regard to waiver of 
    recovery in Medicare secondary payer liability cases. However, despite 
    those representations, the court ordered us to formalize these policies 
    by way of written guidelines to ensure their application, instead of 
    the SSA policies, when reviewing whether waiver should be granted under 
    equity and good conscience in Medicare secondary payer liability 
    situations. The court, making reference to the Quinlivan case, further 
    ordered that the guidelines incorporate broad concepts of fairness and 
    not limit waivers to the three factual situations listed in 20 CFR 
    404.509. (Zinman v. Shalala, Civ. No. 90-20674 (N.D. Cal. September 24, 
    1993 and November 29, 1993)). The September ruling is reported at 835 
    F. Supp. 1135 (N.D. Cal. 1993).
        As a result of that court ruling, we issued guidelines to all of 
    our regional offices on November 17, 1994. In those guidelines, we 
    incorporated our longstanding interpretation of against equity and good 
    conscience as that principle relates to Medicare overpayments. While 
    the guidelines were issued to apply to Medicare secondary payer 
    liability overpayment situations, we advised that they could also be 
    used as guidance in overpayment situations other than those involving 
    Medicare secondary payer liability cases.
        We have always taken the broader view of equity and good conscience 
    that the Quinlivan and Zinman Courts endorsed. Not only do we find the 
    Courts' reasoning in those cases to be persuasive, we also find the 
    language of the VA regulation to be a useful guide. Accordingly, in 
    formulating standards for applying equity and good conscience to 
    Medicare situations for the guidelines issued in November 1994, we have 
    not only expressed our long-held expansive view of this concept, we 
    have also incorporated, to the extent possible, the VA approach in 
    expressing that policy.
        We propose to incorporate into our regulations our current policies 
    regarding when recovery of an overpayment may be waived based on 
    financial hardship. Our current policies are in accordance with SSA's 
    definition of defeat the purposes of title II or title XVIII. Under 
    this proposed regulation, recovery of an overpayment would defeat the 
    purposes of title II or title XVIII when the individual needs 
    substantially all current income and assets to meet ordinary and 
    necessary living expenses.
        We propose to consider the individual's current assets and ordinary 
    and necessary living expenses when evaluating requests for waiver based 
    on financial hardship. Ordinary and necessary living expenses would 
    include the following:
         Current living expenses, such as food and clothing, rent, 
    mortgage payments, utilities, maintenance, insurance (for example, 
    life, accident, and health insurance including premiums for Part B 
    Medicare), taxes, and installment payments.
         Current medical, hospitalization, and other related 
    expenses not covered by Medicare or another insurer.
         Expenses for the support of others for whom the individual 
    is legally responsible.
         Other miscellaneous expenses that may reasonably be 
    considered necessary to maintain the individual's current standard of 
    living.
        In addition, we propose to include in the regulations examples that 
    demonstrate how the principles of defeat the purposes of title II or 
    title XVIII would be applied in Medicare overpayment situations.
        We propose to add regulations that incorporate criteria to be used 
    when determining whether recovery of an overpayment may be waived based 
    on equity and good conscience. Our proposed regulations require that 
    the standard of equity and good conscience would be applied to Medicare
    
    [[Page 14514]]
    
    overpayment recoveries using broad concepts of fairness and reviewing 
    the totality of the circumstances in each particular case. We have used 
    as the basis for our proposed regulations both language from the VA 
    regulation on equity and good conscience found at 38 CFR 1.965, which 
    the U.S. Court of Appeals for the Ninth Circuit believes reflects the 
    intent of the Congress, and guidelines that were issued as a result of 
    the Zinman court case (as discussed earlier in this preamble).
        Under the proposed regulations, factors to be considered when 
    applying the standard of equity and good conscience include, but are 
    not limited to, the following:
         The amount of the overpayment.
         The size of a liability settlement and the amount the 
    individual would retain if Medicare recovered.
         The degree to which recovery would cause undue hardship 
    for the individual.
         The degree to which Medicare and/or its contractors 
    contributed to causing the overpayment.
         The degree to which the individual contributed to causing 
    the overpayment (even if determined to be without fault in accordance 
    with Sec. 401.355).
         The impact of an accident on the individual, both 
    physically and financially.
         Whether the individual would be unjustly enriched by a 
    waiver of recovery.
         Whether it would be equitable for us to reduce the 
    recovery if the individual is responsible for noncovered accident-
    related out-of-pocket expenses and/or future accident-related expenses.
         Whether the individual made a personal financial decision 
    based on his or her reliance on erroneous information supplied to the 
    individual by Medicare or SSA, and recovery would change the 
    individual's position to his or her material detriment.
        Also, we would provide several Medicare overpayment examples in 
    which waiver of recovery is being sought based on the concepts involved 
    with equity and good conscience to illustrate how those concepts are to 
    be applied.
        In some cases an overpayment is made to a without-fault provider or 
    supplier on behalf of a without-fault individual who did not receive 
    the payment. In those situations, we ordinarily would consider recovery 
    from the individual to be inequitable, and would, therefore, waive 
    recovery.
        In accordance with section 1870(c) of the Act, we would specify 
    that recovery is deemed to be against equity and good conscience if the 
    overpayment resulted from expenses incurred for items or services for 
    which payment may not be made under Medicare by reason of the 
    provisions of 1862(a)(1) or (a)(9) of the Act (reasonable and necessary 
    or custodial care), and if the Secretary's determination that the 
    payment was incorrect was made after the third year following the year 
    in which notice of that payment was sent to the individual.
        The basic concepts embodied in the principle of waiver based on 
    equity and good conscience assume that an individual did not 
    intentionally cause an overpayment. Therefore, we propose that applying 
    the equity and good conscience standard for waiving recovery does not 
    apply if we determine that the individual committed fraud, 
    misrepresentation, or some other action or omission that indicates the 
    individual's lack of good faith in causing an overpayment.
    
    D. Waiver Policy With Regard to Liability Settlement Agreements and 
    Stipulations
    
        In general, Medicare policy requires recovering payments from 
    liability awards or settlements, whether a settlement arises from a 
    personal injury action or a survivor action, without regard to how a 
    settlement agreement stipulates disbursement should be made. This 
    requirement also applies to situations in which the settlements do not 
    expressly address damages for medical expenses. Since liability 
    payments are usually based on the injured or deceased person's medical 
    expenses, liability payments are considered to have been made ``with 
    respect to'' medical services related to the injury even when the 
    settlement does not expressly include an amount for medical expenses. 
    To the extent that Medicare has paid for these services, the law 
    obligates us to seek recovery of Medicare payments.
        The only situation in which we recognize allocations of liability 
    payments to nonmedical losses is when the payment is based on a court 
    order on the merits, that is, the court makes a substantive decision on 
    the amounts to be awarded. If the court specifically designates amounts 
    that are for the reimbursement of pain and suffering or other amounts 
    not related to medical services, we will accept the court's designation 
    and not seek recovery from portions of court awards that are designated 
    as payment for losses other than medical services.
        Conversely, we do not generally grant waivers if an individual 
    obtains a settlement that is expressly awarded for medical expenses. 
    However, we believe there are circumstances in which waiver could be 
    justified. For example, a situation could arise in which an 
    individual's injury was great but the award of damages was small, or in 
    which the individual incurred bona fide medical expenses (other than 
    deductibles, premiums, and coinsurance) that were not reimbursed by 
    Medicare; that is, out-of-pocket medical expenses. We believe the 
    criteria we propose for equity and good conscience are broad enough 
    that these situations will be taken into consideration when determining 
    whether waiver of recovery should be granted.
    
    E. Waiver Policy With Regard to Estates
    
        Under current law, a deceased individual's estate may request a 
    waiver of adjustment or recovery of an overpayment when the estate (or 
    the now-deceased individual) has effected a liability recovery. 
    Although in these situations an estate (or the now-deceased individual) 
    may be found to have been without fault with respect to notifying us of 
    the third party recovery, it is generally difficult to satisfy the 
    second test for waiver--that recovery from the estate would defeat the 
    purposes of title II or title XVIII or be against equity and good 
    conscience. Because the individual is deceased, he or she does not need 
    the monies to meet ordinary and necessary living expenses or medical 
    expenses. In addition, it is unlikely that the estate would warrant the 
    money based on an argument of detrimental reliance. Therefore, waiver 
    is generally not applied in these situations.
        However, when a title II dependent survives a deceased individual 
    (who is without fault), and Medicare's recovery or adjustment of an 
    overpayment from the estate would be made by decreasing payments to the 
    title II dependent, situations could arise in which waiver of 
    adjustment or recovery of the overpayment would be appropriate. 
    Therefore, we propose adding a provision to the regulations that would 
    permit a waiver for an estate if the estate (and the individual) were 
    without fault and the individual had a surviving title II dependent. A 
    waiver would be granted in these situations if recovery from the estate 
    would be made by decreasing payments to the title II dependent and the 
    recovery would defeat the purposes of title II or title XVIII or would 
    be against equity and good conscience.
    
    IV. Provisions of the Proposed Regulations
    
        The existing regulations at Secs. 405.301 through 405.359 would be 
    removed.
    
    [[Page 14515]]
    
    With the exception of Sec. 405.356, these sections would be replaced by 
    proposed Secs. 401.301 through 401.370. The remaining sections of 
    subpart C of part 405 (Secs. 405.370 through 405.380) would be 
    redesignated and moved into subpart D of part 401 as Secs. 401.375 
    through 401.396.
        These proposed regulations would supersede SSA criteria for 
    Medicare purposes. SSA criteria would no longer have any application to 
    recovering Medicare overpayments.
        Generally, this proposed rule clarifies the explicit criteria and 
    circumstances under which a provider, supplier, or individual will be 
    relieved of liability for a Medicare overpayment. Thus, we are 
    proposing no changes to current carrier and intermediary liability in 
    instances when an overpayment results from a carrier or intermediary 
    error. We are aware, however, of the perception that carriers and 
    intermediaries may not be held accountable in instances when an 
    overpayment results from their error. Therefore, we are requesting 
    comments on proposed changes to our current carrier and intermediary 
    standards that might introduce a higher level of accountability when 
    overpayments are the result of carrier or intermediary errors, 
    regardless of whether a provider or supplier was without fault.
        As part of the proposed changes to the regulations, we would 
    describe ``recovery'' to include ``adjustment'' as one type of 
    recovery, rather than listing it separately, as in section 1870 of the 
    Act. Under Medicare operations, adjustment is one way we can recover an 
    overpayment from an individual who is found liable for that 
    overpayment. However, we have alternative ways of recovering an 
    overpayment that we often use before adjusting title II or railroad 
    retirement benefits. Therefore, we would include adjustment as one of 
    several ways we may recover from an individual (or his or her estate).
        In addition, we would make certain technical changes to the 
    regulations.
        Once these proposed regulations are published as final, conforming 
    changes will be made to the appropriate regulations in 20 CFR part 404 
    to remove references to title XVIII as they relate to without fault.
    
    V. Collection of Information Requirements
    
        Under the Paperwork Reduction Act of 1995, we are required to 
    provide 60-day notice in the Federal Register and solicit public 
    comment before a collection of information requirement is submitted to 
    the Office of Management and Budget (OMB) for review and approval. In 
    order to fairly evaluate whether an information collection should be 
    approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
    of 1995 requires that we solicit comment on the following issues:
         The need for the information collection and its usefulness 
    in carrying out the proper functions of our agency.
         The accuracy of our estimate of the information collection 
    burden.
         The quality, utility, and clarity of the information to be 
    collected.
         Recommendations to minimize the information collection 
    burden on the affected public, including automated collection 
    techniques.
        However, we believe the information collection requirements 
    referenced in this proposed rule, as summarized below, are exempt from 
    the Paperwork Reduction Act of 1995 for the following reasons:
        The requirements in this proposed rule are either facts or opinions 
    obtained or solicited through non-standardized follow-up questions 
    designed to clarify responses to approved collections of information, 
    initiated on an individual basis, and/or are performed in the conduct 
    of an administrative action, investigation, or audit involving an 
    agency against specific individuals or organizations (see title 5 
    Sec. 1320.3(c), 1320.3(h)(9), and/or 1320.4(a)(2)).
    
    Section 401.352  Waiver of Recovery of Overpayment From Individuals
    
        Section 401.352 requires an individual desiring a waiver of 
    recovery of an overpayment to request the waiver within 60 days from 
    the date on the written notification from HCFA that he or she is liable 
    for the overpayment.
    
    Section 401.364  Without Fault and Medicare Secondary Payer (MSP) 
    Obligations
    
        Section 401.364 requires an individual to give notice of receipt of 
    a payment from an entity that is primary to Medicare and requires an 
    individual desiring a waiver of recovery of an MSP obligation to 
    request the waiver within 60 days from receipt of written notification 
    from HCFA that he or she is liable for the obligation.
    
    Section 411.23  Individual's Cooperation
    
        When HCFA makes conditional payments, Sec. 411.23 requires an 
    individual to notify HCFA of the progress and final outcome of the 
    liability claim. The individual must notify the intermediary or carrier 
    within 60 days of filing a claim with an entity that is primary to 
    Medicare and notify HCFA within 30 days of receipt of payment from an 
    entity primary to Medicare.
        Organizations and individuals desiring to submit comments should 
    send them to both the following addresses:
    
    Health Care Financing Administration, Office of Information Services, 
    Information Technology Investment Management Group, Division of HCFA 
    Enterprise Standards, Room C2-26-17, 7500 Security Boulevard, 
    Baltimore, MD 21244-1850, Attn: HCFA-1719-P.
    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.
    
    VI. Regulatory Impact Statement
    
    A. Introduction
    
        This proposed rule clarifies our right and responsibility to 
    recover overpayments, and the conditions under which recovery of 
    overpayments may be waived. Under the Medicare statute, when a Medicare 
    overpayment occurs, and a provider or supplier is found to be without 
    fault, the liability is passed on to the individual. Medicare then 
    seeks recovery from the individual or waives the recovery.
        Our present regulations do not clearly differentiate an 
    individual's responsibilities from provider and supplier 
    responsibilities with regard to overpayment liability and recovery. 
    This proposed rule describes the conditions for determining who is at 
    fault for the overpayment; specifies criteria for determining the 
    liability of providers, suppliers, and individuals; and describes the 
    circumstances under which recoveries from individuals can be waived.
        In addition, this proposed rule would provide for the 
    administrative appeals process to include determinations when a 
    provider or supplier is found to be at fault in causing an overpayment. 
    Also, this proposed rule more specifically defines without fault with 
    respect to Medicare secondary payer situations as well as the 
    conditions for waiver of adjustment or recovery of Medicare 
    overpayments in Medicare secondary payer situations.
        We expect the main effect of this proposal would be to prevent some 
    providers and suppliers from claiming without-fault status. This could 
    reduce the number of overpayment liabilities passed on to individuals 
    and result in a slight increase in the amount of money recovered. We 
    estimate that this proposed rule would result in
    
    [[Page 14516]]
    
    additional overpayment recoveries for 5 fiscal years as follows:
    
     Estimated Additional Recoveries From the Medicare Program Parts A and B
                                  [In Millions]                             
    ------------------------------------------------------------------------
         1996           1997           1998           1999          2000    
    ------------------------------------------------------------------------
    $7...........        $13            $15            $16            $18   
    ------------------------------------------------------------------------
    
    B. Regulatory Flexibility Act
    
        Consistent with the Regulatory Flexibility Act (5 U.S.C. 601 
    through 612) we generally prepare a regulatory flexibility analysis 
    unless the Secretary certifies that a proposed rule would not have a 
    significant economic impact on a substantial number of small entities. 
    For purposes of the Regulatory Flexibility Act, all providers and 
    suppliers are considered to be small entities. Individuals and Medicare 
    contractors are not included in the definition of a small entity.
        In addition, section 1102(b) of the Act requires the Secretary to 
    prepare a regulatory impact analysis if a proposed 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 603 of the Regulatory Flexibility Act. For purposes of section 
    1102(b) of the Act, we define a small rural hospital as a hospital that 
    is located outside of a Metropolitan Statistical Area and has fewer 
    than 50 beds.
        This proposed rule would add regulations that are specifically 
    applicable for determining without fault in general Medicare 
    overpayment situations, as well as for obligations resulting from 
    Medicare secondary payer conditional payments.
        Under this proposed rule, a provider or supplier would be required 
    to notify the Medicare contractor in writing within 60 days if any 
    payment exceeds the usual compensation for an item or service under 
    Medicare. A Medicare contractor would be required to respond to a 
    provider or supplier within 120 days of receipt of a written inquiry 
    from the provider or supplier questioning the correctness of a Medicare 
    payment amount.
        For Medicare secondary payer situations, an individual pursuing a 
    claim for a liability settlement or damage award for illness or 
    injuries sustained in an accident would be required to notify the 
    Medicare contractor within 60 days of filing a suit or a claim with an 
    insurer. In addition, an individual would be required to notify the 
    Medicare contractor within 30 days of receiving a payment from a 
    liability insurer or, in certain circumstances, direct payment for a 
    tort-feasor.
        This proposed rule would not place an unreasonable burden on 
    individuals, providers, suppliers, or Medicare contractors. We believe 
    that the time required for individuals, providers, suppliers, or 
    Medicare contractors to comply with the provisions of this proposed 
    rule would be minimal. As in the past, providers and suppliers would be 
    required to exercise reasonable care in billing for and accepting 
    payment from Medicare.
        For these reasons, we have determined that this proposed rule would 
    not result in a significant economic impact on a substantial number of 
    small entities and would not have a significant economic impact on the 
    operations of a substantial number of small rural hospitals. Therefore, 
    we are not preparing an analysis for either the Regulatory Flexibility 
    Act or section 1102(b) of the Act.
        In accordance with the provisions of Executive Order 12866, this 
    proposed rule was reviewed by the Office of Management and Budget.
    
    VI. Other Information
    
    A. Response to Comments
    
        Because of the large number of items of correspondence we normally 
    receive on Federal Register documents published for comment, we are not 
    able to acknowledge or respond to them individually. However, we will 
    consider all comments that are received by the date and time specified 
    in the DATES section of this preamble, and, if we proceed with a 
    subsequent document, we will respond to the comments in the preamble to 
    that document.
    
    List of Subjects
    
    42 CFR Part 401
    
        Claims, Freedom of information, Health facilities, Medicare, 
    Privacy.
    
    42 CFR Part 403
    
        Health insurance, Hospitals, Intergovernmental relations, Medicare, 
    Reporting and recordkeeping requirements.
    
    42 CFR Part 405
    
        Administrative practice and procedure, Health facilities, Health 
    professions, Kidney diseases, Medicare, Reporting and recordkeeping 
    requirements, Rural areas, X-rays.
    
    42 CFR Part 410
    
        Health facilities, Health professions, Kidney diseases, 
    Laboratories, Medicare, Rural areas, X-rays.
    
    42 CFR Part 411
    
        Kidney diseases, Medicare, Reporting and recordkeeping 
    requirements.
    
    42 CFR Part 413
    
        Health facilities, Kidney diseases, Medicare, Puerto Rico, 
    Reporting and recordkeeping requirements.
    
    42 CFR Part 447
    
        Accounting, Administrative practice and procedure, Drugs, Grant 
    programs-health, Health facilities, Health professions, Medicaid, 
    Reporting and recordkeeping requirements, Rural areas.
    
    42 CFR Part 466
    
        Grant programs-health, Health care, Health facilities, Health 
    professions, Peer Review Organizations (PRO), Reporting and 
    recordkeeping requirements.
    
    42 CFR Part 473
    
        Administrative practice and procedure, Health care, Health 
    professions, Peer Review Organizations (PRO), Reporting and 
    recordkeeping requirements.
    
    42 CFR Part 493
    
        Grant programs-health, Health facilities, Laboratories, Medicaid, 
    Medicare, Reporting and recordkeeping requirements.
    
        42 CFR chapter IV would be amended, under the authority of sections 
    1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), 
    as follows.
    
    PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS
    
        A. Part 401 is amended by adding a new subpart D to read as 
    follows:
    
    Subpart D--Recovery of Overpayments, Suspension of Payment, and 
    Repayment of Scholarships and Loans
    
    General Provisions
    
    401.301  Basis and scope.
    401.303  Definitions.
    
    Liability for Payments to Providers and Suppliers and Handling of 
    Incorrect Payments
    
    401.305  Individual's liability for incorrect payments.
    
    Medicare Debts Arising from an Overpayment to a Provider or to a 
    Supplier that Received Payment on Behalf of an Individual
    
    401.310  Overpayments.
    
    [[Page 14517]]
    
    401.320  Liability of a provider or a supplier.
    401.323  Determining without fault for a provider or a supplier.
    401.326  When a provider or a supplier is relieved of liability.
    401.329  Recovery of overpayment from providers or suppliers: 
    General rule.
    
    Medicare Debts Arising from an Overpayment to an Individual
    
    401.340  Liability of an individual.
    401.343  Overpayment limitation for the individual.
    401.346  Recovery of overpayment from the individual.
    401.349  Adjustment against an individual's title II or railroad 
    retirement benefits.
    401.352  Waiver of recovery of overpayment from individuals.
    401.355  Determining without fault for an individual.
    401.358  Defeat the purposes of title II or title XVIII of the Act.
    401.361  Equity and good conscience.
    401.364  Without fault and Medicare Secondary Payer (MSP) 
    obligations.
    401.367  Initial determination.
    401.370  Liability of certifying or disbursing officer.
    
    Suspension of Payment to Providers and Suppliers and Collection and 
    Compromise of Overpayments
    
    401.375--401.390  [Reserved]
    
    Interest
    
    401.393  [Reserved]
    
    Repayment of Scholarships and Loans
    
    401.396  [Reserved]
    
    Subpart D--Recovery of Overpayments, Suspension of Payment, and 
    Repayment of Scholarships and Loans
    
        Authority: Secs. 1102 and 1871 of the Social Security Act (42 
    U.S.C. 1302 and 1395hh).
    
    General Provisions
    
    
    Sec. 401.301  Basis and scope.
    
        (a) Statutory basis. This subpart is based on the indicated 
    provisions of the following sections of the Act:
        1815--Payment to providers of services (Part A).
        1833--Payment of benefits (Part B).
        1842--Use of carriers for administration of benefits.
        1848--Payment for physicians' services.
        1866--Agreements with providers of services.
        1870--Overpayment on behalf of individuals and settlement of claims 
    for benefits on behalf of deceased individuals.
        1879--Limitation on liability of individual if Medicare claims are 
    disallowed.
        1886--Payment to hospitals for inpatient hospital services.
        1892--Offset of payments to individuals to collect past-due 
    obligations arising from breach of scholarship and loan contracts.
        (b) Scope. (1) This subpart sets forth the policies and procedures 
    for processing incorrect payments and recovering overpayments under the 
    Medicare program and for offsetting payments to collect past-due 
    obligations arising from breach of scholarship and loan contracts.
        (2) When the term ``HCFA'' is used in reference to making 
    determinations, it includes intermediaries, carriers, or PROs, as 
    appropriate.
    
    
    Sec. 401.303  Definitions.
    
        (a) Person (for purposes of this subpart) means an individual, a 
    trust or estate, a partnership, or a corporation.
        (b) Supplier has the meaning given in Sec. 400.202 of this chapter.
    
    Liability for Payments to Providers and Suppliers and Handling of 
    Incorrect Payments
    
    
    Sec. 401.305  Individual's liability for incorrect payments.
    
        (a) In accordance with section 1870(a) of the Act, any payment made 
    under title XVIII of the Act to any provider or supplier with respect 
    to any item or service furnished an individual is regarded as a payment 
    to the individual, and recovery is made in accordance with 
    Secs. 401.346 through 401.352 if any of the following conditions 
    exists:
        (1) More than the correct amount is paid to a provider or supplier 
    and the intermediary, the carrier, or HCFA determines that--
        (i) Within a reasonable period of time, the excess over the correct 
    amount cannot be recouped from the provider or supplier, or
        (ii) The provider or supplier was without fault with respect to the 
    payment of the excess.
        (2) A payment has been made to a provider for inpatient hospital 
    services furnished to a noneligible individual before notification of 
    noneligibility, in accordance with the provisions described in section 
    1814(e) of the Act.
        (b) For purposes of paragraph (a)(1)(ii) of this section, a 
    provider or supplier is, in the absence of evidence to the contrary, 
    deemed to be without fault if the determination by HCFA, that more than 
    the correct amount was paid, was made after the third year following 
    the year in which notice was sent to the individual that the amount had 
    been paid.
    
    Medicare Debts Arising From an Overpayment to a Provider or to a 
    Supplier That Received Payment on Behalf of an Individual
    
    
    Sec. 401.310  Overpayments.
    
        (a) Definition. An overpayment consists of Medicare funds a 
    provider, a supplier, or an individual has received in excess of 
    amounts payable under the Medicare statute and regulations.
        (b) Types of overpayments. Overpayments are of the following types:
        (1) Overpayment to a provider that received payment on behalf of an 
    individual (including an overpayment resulting from payment for 
    inpatient hospital services furnished to a noneligible individual 
    before notification of noneligibility in accordance with section 
    1814(e) of the Act and an overpayment to a provider determined from a 
    cost report under part 413 of this chapter or under the prospective 
    payment systems (PPS) included in part 412 of this chapter).
        (2) Overpayment to a supplier that received payment on behalf of an 
    individual.
        (3) Direct overpayment to an individual or to a person acting on 
    behalf of an individual.
        (c) Examples of causes of Medicare overpayments. Examples of how 
    Medicare overpayments occur include, but are not limited to, the 
    following:
        (1) Payments made by Medicare for noncovered services.
        (2) Medicare payment in excess of the allowable amount for an 
    identified covered service.
        (3) Errors and nonreimbursable expenditures in cost reports.
        (4) Duplicate payments.
        (5) Medicare payment when another entity had the primary 
    responsibility for payment.
        (d) When an overpayment is considered a debt. (1) General 
    Overpayments. Once a determination and any adjustments in the amount of 
    the overpayment have been made, the remaining amount is a debt owed to 
    the United States Government.
        (2) Medicare Secondary Payer (MSP) obligations. Potential debts 
    arise under the MSP provisions when an individual recovers payment from 
    an entity that had the primary responsibility for payment. Obligations 
    to refund Medicare under the MSP provisions are addressed in part 411, 
    subparts B through F of this chapter and Sec. 401.364.
    
    
    Sec. 401.320  Liability of a provider or a supplier.
    
        (a) In accordance with section 1870(b), unless found to be without
    
    [[Page 14518]]
    
    fault, as described in this subpart, a provider or a supplier that 
    receives Medicare payment with respect to items or services furnished 
    to an individual is liable for any overpayment resulting from that 
    payment.
        (b) HCFA makes determinations whether providers or suppliers are 
    without fault with respect to overpayments.
    
    
    Sec. 401.323  Determining without fault for a provider or a supplier.
    
        (a) General rule. In accordance with section 1870(b) of the Act, a 
    provider or a supplier is without fault if--
        (1) Based on the criteria specified in paragraph (b) of this 
    section, the facts show that the provider or the supplier exercised 
    reasonable care in billing for and accepting Medicare payment; and
        (2) Based on the criteria specified in paragraph (c) of this 
    section, the facts show that the provider or the supplier either--
        (i) Did not know, and could not reasonably have been expected to 
    know, that Medicare payment was in excess of amounts payable under the 
    Medicare statute and regulations and, therefore, accepted payment based 
    on a reasonable assumption that the payment was correct; or
        (ii) Did know, or could reasonably have been expected to know, that 
    Medicare payment was in excess of amounts payable under the Medicare 
    statute and regulations but questioned the appropriate intermediary or 
    carrier in writing, at the correct address, within 60 days of receipt 
    of the excess payment, and--
        (A) Relied on a written response from the intermediary or carrier 
    that stated that the Medicare payment was correct; or
        (B) Failed to receive a response from the intermediary or carrier 
    within 120 days of the intermediary's or carrier's receipt of the 
    inquiry.
        (b) Exercising reasonable care in billing. Exercising reasonable 
    care in billing includes--
        (1) Making full disclosure of all material facts; and
        (2) Complying with each applicable provision specified in subpart C 
    of part 424 of this chapter, including supplying all necessary 
    information on the billing form (or through electronic media), to 
    ensure correct payment by the intermediary or carrier.
        (c) Criteria for determining that a provider or a supplier knew 
    that the payment was an excess payment. A provider or a supplier is 
    considered to have known that the Medicare payment was in excess of 
    amounts payable under the Medicare statute and regulations if any one 
    of the conditions specified in paragraphs (c)(1) through (c)(3) of this 
    section is met.
        (1) Knowledge based on experience, actual notice, or constructive 
    notice. It is clear that the provider or the supplier knew, or could 
    have been expected to know, that Medicare payment was in excess of 
    amounts payable under the Medicare statute and regulations on the basis 
    of--
        (i) Final publication (including any published correction notice) 
    of payment amounts in official source documents, for example, the 
    Federal Register (except in very limited circumstances, as provided for 
    in paragraph (h)(1) of this section);
        (ii) Receipt of HCFA notices, either written or electronic, 
    including manual issuances, bulletins or other written guides, or 
    directives from intermediaries, carriers, or PROs; or
        (iii) Experience with Medicare payment amounts for similar or 
    reasonably comparable items or services.
        (2) Notice from the PRO, intermediary, or carrier. Before the items 
    or services were furnished, the PRO, intermediary, or carrier had 
    informed the provider or supplier of the correct Medicare payment for 
    the items or services furnished or for similar or reasonably comparable 
    items or services.
        (3) Notice from the provider or supplier to the individual. Before 
    the items or services were furnished, the provider or the supplier 
    informed the individual of the correct Medicare payment for the items 
    or services furnished, or for similar or reasonably comparable items or 
    services.
        (d) Intermediary or carrier fault. Determination of without fault, 
    as specified in paragraph (a) of this section, pertains solely to the 
    liability of the provider or the supplier. Even when HCFA's or an 
    intermediary's or carrier's actions cause or contribute to the 
    overpayment, that fact does not relieve the provider or the supplier 
    from liability for repayment if the provider or the supplier is not 
    without fault.
        (e) Intermediary and carrier action. (1) The Medicare intermediary 
    or carrier, as appropriate, must provide a written response within 120 
    days of receipt of a correctly addressed written inquiry regarding the 
    correctness of a Medicare payment amount. If the intermediary or 
    carrier informs the provider or the supplier that the payment amount is 
    correct, or fails to reply within 120 days, the provider or the 
    supplier is without fault even if the intermediary or carrier should 
    later discover that the questioned payment amount was an overpayment.
        (2) The 120-day limitation for the response applies only to an 
    evaluation of the correctness of the payment amount. If the evaluation 
    indicates that the payment amount is incorrect, the intermediary or 
    carrier must send a notice to that effect to the provider or supplier 
    within the 120-day period. Once a timely notice has been sent, the 
    intermediary or carrier may determine the precise amount of the 
    overpayment and initiate recovery procedures without regard to the 120-
    day limitation.
        (f) When a provider or a supplier is considered to be not without 
    fault. There are some circumstances when a provider or a supplier will 
    never be without fault. A provider or a supplier is not without fault 
    if any of the following conditions exist:
        (1) It did not exercise reasonable care in billing for and 
    accepting payment, in accordance with criteria specified in paragraph 
    (b) of this section.
        (2) It accepted a Medicare payment that it knew, or could 
    reasonably have been expected to know, was in excess of amounts payable 
    under the Medicare statute and regulations, as determined by criteria 
    specified in paragraph (c) of this section.
        (3) It has already been determined, in accordance with the 
    limitation on liability provisions of section 1879 of the Act and 
    Sec. 411.406 of this chapter, that the provider or the supplier knew, 
    or could reasonably have been expected to know, that the specific items 
    or services (for which a without fault determination is being made) 
    would not be paid for by Medicare.
        (4) The overpayment resulted from a payment that did not conform to 
    the applicable published schedule payment amount, as explained in 
    paragraph (h)(2) of this section.
        (5) The overpayments resulted from payment for noncovered services 
    that were a part of a pattern of billing for similar services that the 
    provider or the supplier knew or should have known were noncovered.
        (6) The overpayment resulted from the failure of the provider or 
    the supplier, in making a claim for payment, to comply with a provision 
    of subpart C of part 424 of this chapter.
        (7) The overpayment resulted from a payment by a workers' 
    compensation plan, a liability or no-fault insurer, or group health 
    plan for the same service paid for by Medicare.
        (8) Fraud or similar fault has been determined. Similar fault 
    includes situations when a provider or supplier obtains a provider 
    number from a carrier
    
    [[Page 14519]]
    
    or intermediary while excluded from the Medicare program and when a 
    provider or supplier hires and seeks reimbursement for services 
    performed by excluded individuals.
        (g) Overpayments that result from Medicare provider cost report 
    errors. The without fault provisions in this section do not apply to 
    overpayments that result from aggregate payment issues, such as 
    Medicare provider cost report errors.
        (h) Special rule for physician fee schedule and prospective payment 
    system (PPS) diagnosis-related group (DRG) schedule and Medicare fee or 
    rate schedule amounts. HCFA publishes fee schedules that establish 
    payment amounts for physician services and rates of payment for 
    services furnished under the hospital PPS as indicated by a specific 
    DRG. Other fee schedules or rates of payment may be established from 
    time to time. Except as provided in paragraph (h)(1) of this section, 
    the final publication of these payment amounts in official source 
    documents is evidence that a provider or a supplier could have been 
    expected to know that the payment amount was in excess of amounts 
    payable under the Medicare statute and regulations, as specified in 
    paragraph (c)(1)(i) of this section.
        (1) In the case of an error in a schedule of payment amounts 
    published in the Federal Register (for which no correction notice has 
    been published), a provider or a supplier that can show, based on 
    criteria specified in paragraphs (c)(1)(ii) or (c)(1)(iii), (c)(2), and 
    (c)(3) of this section, that it did not know, and could not have been 
    expected to know, that a Medicare payment based on the erroneous 
    published schedule of payment amounts was in excess of amounts payable 
    under the Medicare statute and regulations, is without fault with 
    respect to the resulting overpayment.
        (2) When an overpayment occurs because a payment does not conform 
    to the applicable published schedule, a provider or a supplier is not 
    without fault.
        (i) Without fault presumption: Three-year rule. In accordance with 
    section 1870(b) of the Act, if HCFA determines that more than the 
    correct amount was paid to a provider or supplier, and this 
    determination was made after the third calendar year following the year 
    in which the notice was sent to the provider or supplier that payment 
    had been made (or, in the case of Part A benefits, approved), the 
    overpaid provider or supplier is considered without fault unless one of 
    the following conditions exist:
        (1) The overpayment resulted from a payment that did not conform to 
    the applicable published schedule payment amount, as explained in 
    paragraph (h)(2) of this section.
        (2) The overpayment resulted from payment for noncovered services 
    that were a part of a pattern of billing for similar services that the 
    provider or the supplier knew, or should have known, were noncovered.
        (3) The overpayment resulted from the failure of the provider or 
    the supplier, in making a claim for payment, to comply with a provision 
    of subpart C of part 424 of this chapter.
        (4) The overpayment resulted from a payment by a workers' 
    compensation plan, a liability or no-fault insurer, or group health 
    plan for the same service paid for by Medicare.
        (5) The overpayment resulted from fraud or similar fault. Similar 
    fault includes situations when a provider or supplier obtains a 
    provider number from a carrier or intermediary while excluded from the 
    Medicare program and when a provider or supplier hires and seeks 
    reimbursement for services performed by excluded individuals.
    
    
    Sec. 401.326  When a provider or a supplier is relieved of liability.
    
        A provider or a supplier is relieved of liability for refunding an 
    overpayment when it is found to be without fault under the criteria in 
    this subpart. When a provider or a supplier is determined to be without 
    fault, liability for the overpayment shifts to the individual. See 
    Sec. 401.340 (concerning the liability of an individual).
    
    
    Sec. 401.329  Recovery of overpayment from providers or suppliers: 
    General rule.
    
        When it is determined that a provider or a supplier is liable for 
    an overpayment, HCFA uses the following methods to recover the 
    overpayment:
        (a) Direct collection.
        (b) Recoupment or offset against any monies that HCFA owes the 
    provider or supplier.
        (c) Offset against a Federal tax refund under authority of 31 
    U.S.C. 3720A.
    
    Medicare Debts Arising From an Overpayment to an Individual
    
    
    Sec. 401.340  Liability of an individual.
    
        (a) Direct payment imputed. In accordance with section 1870(a) of 
    the Act, a Medicare payment made to a provider or a supplier with 
    respect to any item or service furnished to an individual is considered 
    as if it were a payment to the individual.
        (b) Scope of individual's potential liability. In accordance with 
    section 1870(b) of the Act, subject to the provisions in Secs. 401.346 
    through 401.352, an individual is liable for an overpayment if any of 
    the following situations occur:
        (1) An amount is paid to an individual that is more than the amount 
    payable under the Medicare statute and regulations.
        (2) An amount is paid to a provider or a supplier for items or 
    services furnished to the individual that is more than the amount 
    payable under the Medicare statute and regulations, and HCFA determines 
    that--
        (i) The overpayment cannot be recouped from the provider or the 
    supplier within a reasonable period of time; or
        (ii) The provider or the supplier was without fault, as described 
    in Sec. 401.323, with respect to the overpayment.
        (3) Payment was made to a provider for items and services furnished 
    to an individual under the provisions described in section 1814(e) of 
    the Act (``Payment for Inpatient Hospital Services Prior to 
    Notification of Noneligibility'').
    
    
    Sec. 401.343  Overpayment limitation for the individual.
    
        If an overpayment has been made to a provider or a supplier, the 
    individual is liable only to the extent that he or she has benefited 
    from that payment, for example, when the Medicare payment exceeds the 
    charges for which the individual was legally responsible.
    
    
    Sec. 401.346  Recovery of overpayment from the individual.
    
        If an individual is liable for an overpayment (that is, a payment 
    described in Sec. 401.340(b)), recovery, to the extent of the 
    liability, is made in one of the following ways:
        (a) By direct collection against the individual (or his or her 
    estate if the individual has died).
        (b) By adjustment of title II or railroad retirement benefits, in 
    accordance with section 1870(b)(3) and 1870(b)(4) of the Act, in one of 
    the following ways:
        (1) By decreasing any payment under title II of the Act or under 
    the Railroad Retirement Act of 1974 (45 U.S.C. 231) to which the 
    individual is entitled.
        (2) By decreasing, if the individual has died before recovery is 
    completed, any payment under title II of the Act or under the Railroad 
    Retirement Act of 1974 that is based on the individual's earnings 
    record (or compensation) and payable to the individual's estate or to 
    any other person.
        (c) By offset against a Federal tax refund under authority of 31 
    U.S.C. 3720A.
        (d) By applying the requirements and procedures that implement the 
    Federal
    
    [[Page 14520]]
    
    Claims Collection Act (FCCA) (31 U.S.C. 3711) with respect to Medicare 
    payments and the general FCCA regulations set forth at Sec. 401.387 and 
    subpart F of this part. If HCFA's regulations fail to address a 
    particular issue, refer to 45 CFR part 30.
    
    
    Sec. 401.349  Adjustment against an individual's title II or railroad 
    retirement benefits.
    
        (a) Certification of amount that will be adjusted. In accordance 
    with section 1870(b) of the Act, as soon as practicable after any 
    adjustment against an individual's title II or railroad retirement 
    benefits is determined to be necessary, HCFA certifies to SSA the 
    amount of the overpayment or payment with respect to which the 
    adjustment is to be made. If the adjustment is to be made by decreasing 
    subsequent payments under the railroad retirement benefits, the 
    certification is made to the Railroad Retirement Board.
        (b) Procedures for recovery by adjustment of benefits.
        (1) The procedures applied in making an adjustment to title II 
    benefits are the applicable procedures of 20 CFR 404.502.
        (2) The procedures applied in making an adjustment to railroad 
    retirement benefits are the applicable procedures of 20 CFR part 367.
    
    
    Sec. 401.352  Waiver of recovery of overpayment from individuals.
    
        (a) The provisions of Sec. 401.346 are not applied and there is no 
    recovery of an overpayment made under Sec. 401.340(b) if--
        (1) The overpayment has been made with respect to an individual who 
    is without fault, as specified in Sec. 401.355, or the recovery would 
    be made by decreasing payment to which another person who is without 
    fault is entitled, as provided in section 1870(c) of the Act; and (2) 
    The recovery would either--
        (i) Defeat the purposes of title II or title XVIII of the Act, as 
    specified in Sec. 401.358; or
        (ii) Would be against equity and good conscience, as specified in 
    Sec. 401.361.
        (b) An individual desiring a waiver of recovery of an overpayment 
    must request the waiver within 60 days from the date on the written 
    notification from HCFA that he or she is liable for the overpayment.
        (c) A waiver granted in accordance with Sec. 401.358 or 
    Sec. 401.361 may be granted partially or in full.
        (d) HCFA determines whether waiver of recovery of an overpayment 
    for which an individual is liable under this subpart will be granted.
        (e) A waiver of recovery of an overpayment may be granted to a 
    deceased individual's estate if all of the following conditions exist:
        (1) The estate and the deceased individual are without fault.
        (2) The deceased individual is survived by a title II dependent.
        (3) Recovery of the overpayment from the estate would be made by 
    decreasing payments to the title II-dependent. (4) The recovery would 
    defeat the purposes of title II or title XVIII, as defined in 
    Sec. 401.358, or would be against equity and good conscience, as 
    defined in Sec. 401.361.
    
    
    Sec. 401.355  Determining without fault for an individual.
    
        (a) General. In accordance with section 1870(c) of the Act, a 
    determination of without fault pertains to the liability of the 
    individual. Even when HCFA's actions cause or contribute to the 
    overpayment, that fact does not relieve the individual from liability 
    for repayment if the individual is not without fault. In determining 
    whether a individual is without fault, HCFA considers all pertinent 
    circumstances, including the individual's age, intelligence, education, 
    and physical and mental condition. (See Sec. 401.364(d) for application 
    of without fault for an individual with respect to a Medicare payment 
    in an MSP situation.)
        (b) Reasonable care standard. An individual is considered without 
    fault with respect to an overpayment made to him or her, or to a 
    provider or a supplier on his or her behalf, if the individual has 
    exercised reasonable care in requesting and accepting Medicare payment. 
    The individual, or other person acting on behalf of the individual, has 
    exercised reasonable care when he or she has--
        (1) Accepted a payment that the individual, or other person acting 
    on behalf of the individual, did not know, or could not reasonably have 
    been expected to know, was incorrect;
        (2) Accepted a payment because of reliance on erroneous written 
    information from an official source within HCFA, SSA, or a Medicare 
    intermediary or carrier with respect to the interpretation of a 
    pertinent provision of the Act or implementing regulations; or
        (3) Made a reasonable assumption, based on available information 
    including, but not limited to, Medicare instructions and regulations, 
    that the payment was correct.
        (c) When an individual is considered to be not without fault. There 
    are some circumstances in which an individual will never be without 
    fault. An individual is considered to be not without fault for an 
    overpayment when the individual, or other person acting on behalf of 
    the individual, has--
        (1) Received prior written notice that a particular item or service 
    was not covered or paid for by Medicare;
        (2) Made an incorrect statement or withheld information to obtain 
    benefits that were not due the individual;
        (3) Accepted a payment that he or she knew or should have known was 
    not due; or
        (4) Received a prior determination, in accordance with the 
    limitation on liability provisions in section 1879 of the Act and 
    Sec. 411.404 of this chapter, that he or she knew, or could reasonably 
    have been expected to know, that the specific items or services (for 
    which a without fault determination is being made) would not be paid 
    for by Medicare.
    
    
    Sec. 401.358  Defeat the purposes of title II or title XVIII of the 
    Act.
    
        (a) General. The standard of defeat the purposes of title II or 
    title XVIII, contained in section 1870(c) of the Act, means that 
    recovery of all or part of the overpayment frustrates the purposes of 
    benefits under these titles by depriving an individual (or surviving 
    title II dependent) of income required for ordinary and necessary 
    living expenses.
        (b) Ordinary and necessary living expenses. For purposes of this 
    subpart, an individual's ordinary and necessary living expenses include 
    the following expenses:
        (1) Current living expenses, such as food and clothing, rent, 
    mortgage payments, utilities, maintenance, insurance (for example, 
    life, accident, and health insurance, including premiums for 
    Supplementary Medical Insurance benefits under title XVIII and premiums 
    for Medigap insurance), taxes, and installment payments.
        (2) Current medical, hospitalization, and other related expenses 
    not covered by Medicare or another insurer.
        (3) Expenses for the support of others for whom the individual is 
    legally responsible.
        (4) Other miscellaneous expenses that may reasonably be considered 
    necessary to maintain the individual's current standard of living.
    
        (c) Example. An individual entitled to Medicare, who was also 
    receiving title II benefits, was injured in a slip and fall accident. 
    He pursued a liability suit and received a settlement. However, after a 
    pro rata share of procurement costs were deducted, he was left with an 
    amount that was smaller than, or close to, Medicare's claim amount. As 
    a result of expenses related to the accident, he has a monthly 
    budgetary shortfall and does not have savings. In
    
    [[Page 14521]]
    
    addition, the individual has out-of-pocket medical expenses. If 
    Medicare were to recover the overpayment by adjusting the individual's 
    title II benefit, he would be deprived of income necessary for ordinary 
    and necessary living expenses. Assuming that the individual is without 
    fault, his liability for the overpayment may be waived partially or in 
    full based on financial hardship. (The fact that the individual is left 
    with a settlement amount that is smaller, or close to, what Medicare 
    would recover does not automatically permit waiver of the recovery 
    under this regulation. The final determination would depend on the 
    total amount of the individual's settlement and his other financial 
    circumstances.)
    
    
    Sec. 401.361  Equity and good conscience.
    
        (a) General rule. The standard of equity and good conscience, 
    contained in section 1870(c) of the Act, is applied to title XVIII 
    overpayment recoveries using broad concepts of fairness and reviewing 
    the totality of an individual's circumstances in each particular case.
        (b) Factors to be considered. In applying the standard of equity 
    and good conscience, factors to consider include, but are not limited 
    to, the following:
        (1) The amount of the overpayment.
        (2) The size of a liability settlement and the amount the 
    individual would retain if Medicare recovered.
        (3) The degree to which recovery would cause undue hardship on the 
    individual.
        (4) The degree to which Medicare and/or its contractors contributed 
    to causing the overpayment.
        (5) The degree to which the individual contributed to causing the 
    overpayment (even if determined to be without fault in accordance with 
    Sec. 401.355.
        (6) The impact of an accident on the individual both physically and 
    financially.
        (7) Whether the individual would be unjustly enriched by a waiver 
    of recovery.
        (8) If the individual is responsible for noncovered accident-
    related out-of-pocket expenses and/or future accident-related expenses, 
    whether it would be equitable for Medicare to reduce its recovery.
        (9) Whether the individual made a personal financial decision based 
    on his or her reliance on erroneous information supplied to the 
    individual by Medicare or SSA, and recovery would change the 
    individual's position to his or her material detriment.
        (c) Examples in which waiver of recovery is being sought based on 
    the concepts involved with equity and good conscience. Assuming that 
    the individual is without fault in accordance with Sec. 401.355, the 
    following examples illustrate situations in which waiver of recovery is 
    sought based on the concepts involved with equity and good conscience 
    and how those concepts are to be applied. The purpose of these examples 
    is to illustrate both the application of the basic principles of the 
    equity and good conscience standard and that each individual case must 
    be evaluated on the basis of its particular facts and circumstances.
    
    Example 1
    
        Facts: As a result of an accident, an individual's leg was 
    amputated below the knee, and he was confined to a nursing home. He 
    filed suit for the injuries and damages he suffered as a result of the 
    accident. The settlement he received was just a few hundred dollars 
    more than Medicare's claim amount (after a pro rata share of 
    procurement costs were deducted). The individual has substantial 
    outstanding medical bills that will not be reimbursed by Medicare or 
    another insurer.
        Analysis: In determining whether waiver may be granted on the basis 
    of equity and good conscience, HCFA may take into consideration that 
    the accident has had a significant impact on the individual, both 
    physically and financially, in that he must not only deal with the 
    physical trauma of the leg amputation, but also with being confined to 
    the nursing home with its resultant increased nursing care costs. In 
    addition, the individual will retain only a few hundred dollars of his 
    settlement if Medicare seeks full recovery, and will still have 
    substantial remaining medical bills he will be responsible to pay. This 
    situation could cause undue hardship for the individual.
        Action: Given the significant impact that the accident has had on 
    the individual, both physically and financially, HCFA may find that it 
    is against equity and good conscience to recover and may grant a full 
    waiver.
    
    Example 2
    
        Facts: As a result of an accident, a 26-year-old individual is 
    rendered a ventilator-dependent quadriplegic. (The individual was 
    eligible for Medicare prior to the accident because of a disabling 
    condition that occurred several years ago; however, he had been able to 
    care for himself without outside assistance.) The individual pursued a 
    liability claim after the accident and received a settlement that was 
    twice the amount of Medicare's potential claim (after a pro rata share 
    of procurement costs were deducted). The individual needs all of his 
    income and settlement proceeds to finance 24-hour nursing care, upon 
    which he will be totally dependent for the remainder of his lifetime, 
    and to enable him to live independently (outside of an institution). In 
    addition, the individual will have future unavoidable accident-related 
    expenses that will not be reimbursed by Medicare or another insurer.
        Analysis: In determining whether waiver may be granted on the basis 
    of equity and good conscience, several factors involved in this case 
    should be considered. The individual's young age should be considered 
    as it relates to the expense of being totally dependent on 24-hour 
    nursing care for the remainder of his lifetime. Moreover, he is a 
    ventilator-dependent quadriplegic. Additionally, although he received a 
    settlement that was twice the amount of Medicare's potential recovery, 
    he has substantial accident-related expenses and is likely to have 
    future out-of-pocket expenses that will not be covered by Medicare or 
    another insurer.
        Action: HCFA may find that it is against equity and good conscience 
    to recover, and grant full waiver based on the various factors involved 
    in this case. Although the settlement received by the individual is 
    more than Medicare's potential recovery, consideration must be given to 
    the extent of his disability, his need for lifetime 24-hour nursing 
    care, and the future accident-related expenses he is likely to incur.
    
    Example 3
    
        Facts: After being notified in writing by an SSA official that she 
    was eligible for title II and title XVIII benefits, the individual 
    dropped her existing health insurance based on the prospect of 
    receiving health insurance coverage under Medicare. One year later, it 
    was discovered that, due to an error by SSA, her eligibility status was 
    erroneous because she did not have enough qualifying quarters of 
    covered employment under the Act to obtain the required insured status. 
    During that year, the individual was hospitalized, and a significant 
    amount of Medicare benefits was paid on her behalf. Because the 
    individual dropped her previous health insurance coverage, Medicare was 
    her only source of health care coverage during this time. The 
    individual's financial situation is such that recovery of the 
    overpayment would change her financial position for the worse.
        Analysis: In determining whether waiver may be granted on the basis 
    of equity and good conscience, HCFA may consider several factors. The 
    fact that the individual made a personal financial
    
    [[Page 14522]]
    
    decision based on her reliance on erroneous information supplied by SSA 
    warrants significant consideration. This, in turn, raises the question 
    of whether recovery would change the individual's position to her 
    material detriment, as well as the degree to which she contributed to 
    the overpayment. Since she did not know that she was not entitled to 
    receive the Medicare services (and, in fact, was told otherwise by 
    SSA), it appears that she did nothing to actually contribute to the 
    overpayment other than avail herself of services to which she believed 
    she was entitled.
        Action: In this situation, recovery may be waived as against equity 
    and good conscience because the individual, based on erroneous 
    information provided by SSA, relinquished her right to payment from 
    another source, and recovery would change her position to her material 
    detriment.
    
    Example 4
    
        Facts: An individual sustained injuries in an automobile accident 
    that rendered her incapable of operating a motor vehicle unless the 
    vehicle was modified for use by a handicapped person. Medicare made 
    conditional payments on the individual's behalf. The individual filed 
    suit for the injuries and damages she suffered as a result of the 
    accident and received a settlement that was about equal to the amount 
    of Medicare conditional payments made on her behalf. The individual 
    submitted documentation demonstrating that all of the money she 
    received in the settlement was used to purchase a modified vehicle 
    required as a result of the accident and requested a waiver of recovery 
    of the overpayment.
        Analysis: If Medicare seeks full recovery, the individual will 
    likely have to sell her modified vehicle to repay Medicare. This 
    modified vehicle is necessary because of the injuries she sustained in 
    the accident and, like the car in which she had the accident, is her 
    only means of transportation. Selling the modified vehicle to repay 
    Medicare would cause her to be without transportation and would place 
    her in a worse position than before the accident. Based on this 
    consideration, and the significant physical impact that the accident 
    has had on the individual, recovery of the overpayment may be against 
    equity and good conscience.
        Action: HCFA may grant a waiver in an amount equal to the cost of 
    the vehicle and, based on the various factors involved in this case, 
    including the fact that all of the money she received in the settlement 
    was used to purchase the modified vehicle, could be justified in 
    waiving an additional amount. If the cost of the modified vehicle were 
    less than the settlement amount, HCFA could grant a partial waiver up 
    to the cost of the vehicle.
    
        Note: Using the settlement money to purchase a vehicle was 
    considered appropriate only because the individual required a 
    modified vehicle as a result of her accident. It would be 
    inappropriate to grant waiver simply because the individual chose to 
    purchase another car from the proceeds.
    
    Example 5
    
        Facts: An individual sustained multiple injuries in an automobile 
    accident that caused him to be away from his job (without pay) for 4 
    months. His monthly income just equals his monthly expenses. The 
    individual received a liability settlement that was about equal to 
    Medicare's potential claim (after a pro rata share of procurement costs 
    were deducted). However, he incurred significant accident-related out-
    of-pocket medical expenses.
        Analysis: In determining whether waiver may be granted on the basis 
    of equity and good conscience, HCFA may take into consideration that 
    the accident has caused the individual to lose 4 months of income, and, 
    thus, his ability to absorb the out-of-pocket medical expenses has 
    greatly diminished. If the individual repaid Medicare the total amount 
    owed, he would be left with no funds with which to pay his out-of-
    pocket medical expenses. Because of this, it may be equitable for 
    Medicare to reduce its recovery due to the individual's responsibility 
    for noncovered out-of-pocket expenses. Therefore, it would be against 
    equity and good conscience for Medicare to recoup its entire potential 
    recovery amount.
        Action: HCFA may grant a partial waiver up to the amount of out-of-
    pocket expenses.
    
    Example 6
    
        Facts: An individual was injured in an accident that triggered 
    Medicare conditional payments. Before the accident, he was experiencing 
    monthly financial difficulties due to expenses that were not related to 
    the accident. Medicare's recovery after reduction for procurement costs 
    is significantly less than the total liability settlement received by 
    the individual. The individual has several thousand dollars worth of 
    injury-related out-of-pocket medical expenses.
        Analysis: Although the individual has monthly financial 
    difficulties that appears to constitute a financial hardship, it must 
    be noted that this financial hardship existed before the accident. It 
    is important to remember that repaying Medicare must be the 
    circumstance that causes financial hardship. Pre-existing financial 
    hardship alone is not a sufficient reason to grant waiver. 
    Additionally, after repaying Medicare and reimbursing himself for out-
    of-pocket expenses, the individual will still retain a significant 
    portion of the settlement proceeds. The repayment of Medicare's claim 
    will not cause undue hardship. All of these factors must be taken into 
    consideration when making a waiver decision that is not unduly 
    favorable or adverse to either side, but is fair to both the individual 
    and to HCFA.
        Action: Based on the circumstances presented in this case, the 
    likely outcome is to deny waiver. Although the individual has 
    substantial out-of-pocket expenses, he would not be unduly 
    disadvantaged if Medicare seeks full recovery because he will still 
    retain a significant portion of his settlement after the recovery.
        (d) Special Rule: When recovery of an overpayment from an 
    individual is ordinarily considered inequitable. (1) Except for MSP 
    obligations, recovery of an overpayment from a without-fault individual 
    is ordinarily considered to be inequitable if the individual did not 
    receive the payment.
        (2) For MSP obligations, recovery from a without-fault individual 
    is considered to be inequitable only if the recovery involves a group 
    health plan and the individual did not receive the Medicare payment.
        (e) Deemed to be against equity and good conscience. In accordance 
    with section 1870(c) of the Act, recovery of an overpayment, or of such 
    part of an overpayment as is determined would be inconsistent with the 
    purposes of title XVIII of the Act, is deemed to be against equity and 
    good conscience when either of the following conditions exist:
        (1) The overpayment resulted from expenses incurred for items or 
    services for which payment may not be made under title XVIII by reason 
    of the provisions of section 1862 (a)(1) or (a)(9) of the Act 
    (reasonable and necessary, or custodial care).
        (2) HCFA did not determine that the payment was incorrect until 
    after the third year following the year in which the notice of the 
    payment was sent to the individual.
        (f) Equity and good conscience deemed inapplicable. In considering 
    whether recovery of a Medicare overpayment should be waived, the 
    application of the standard of equity and good conscience is deemed 
    inapplicable in either of the following circumstances:
    
    [[Page 14523]]
    
        (1) The individual committed a fraud or misrepresented a material 
    fact that resulted, directly or indirectly, in the overpayment.
        (2) The individual's actions or omissions indicate a lack of good 
    faith or the absence of an honest intention to abstain from taking an 
    unfair advantage of Medicare.
    
    
    Sec. 401.364  Without fault and Medicare Secondary Payer (MSP) 
    obligations.
    
        (a) MSP debt defined. In general, an MSP debt is an amount owed to 
    the United States Government, once a determination and any recovery 
    adjustments are made to an obligation, that resulted from a payment 
    made by Medicare for an identified item or service and payment for the 
    item or service has been made, can reasonably be expected to be made, 
    or, in certain circumstances, can reasonably be expected to be made 
    promptly, by another entity that is required or responsible under 
    section 1862(b) of the Act to make primary payment. HCFA's rules that 
    govern MSP obligations are located at part 411, subparts B through F of 
    this chapter.
        (b) Application of without-fault provisions to MSP obligations--
    third-party payor or other non-Medicare entity. The without-fault and 
    related provisions specified in Secs. 401.323 and 401.326 (with respect 
    to providers and suppliers) and in Secs. 401.352, 401.355, 401.358, and 
    401.361 (with respect to individuals entitled to Medicare) do not apply 
    to MSP obligations for which a third-party payer or other non-Medicare 
    entity is liable. A provision in a contract to which a third-party 
    payer or other non-Medicare entity is a party, or a State law provision 
    that governs the relations between the third-party payer or other non-
    Medicare entity and an individual entitled to Medicare, that gives or 
    purports to give any right of subrogation to the third-party payer or 
    other non-Medicare entity does not confer a right to without-fault 
    consideration for an obligation for which the third-party payer or 
    other non-Medicare entity is responsible.
        (c) Application of without-fault provisions to MSP obligations--
    providers and suppliers. In general, a provider or a supplier is not 
    without fault with respect to a Medicare payment in an MSP situation 
    unless it complied with all of the requirements specified in part 411 
    of this chapter and, in the case of providers, part 489 of this 
    chapter.
        (d) Application of without-fault provisions to MSP obligations--
    individuals. (1) In general, an individual is without fault with 
    respect to a Medicare payment in an MSP situation except when the 
    individual (or the individual's representative)--
        (i) Fails to give notice as required by Sec. 411.23(a)(1) of this 
    chapter (that is, notice that a claim has been filed with an entity 
    that may be primary to Medicare) to the intermediary or carrier within 
    60 days of filing the claim;
        (ii) Fails to give notice as required by Sec. 411.23(a)(2) of this 
    chapter (that is, notice of receipt of a payment from an entity that is 
    primary to Medicare) to HCFA within 30 days of receipt of a payment;
        (iii) Fails to file a proper claim, as defined in Sec. 411.21 of 
    this chapter, with an entity that is primary to Medicare for the item 
    or service for which no proper claim was filed, subject to the recovery 
    provisions in Secs. 411.24(l) and 411.32(c) of this chapter;
        (iv) Makes an incorrect statement or withholds information to 
    obtain benefits that are not due him or her; or
        (v) Accepts a payment that he or she clearly should have known was 
    not due.
        (2) An individual who is without fault according to paragraph 
    (d)(1) of this section may have recovery of an MSP obligation (either 
    by adjustment of his or her social security benefit or by direct 
    recovery) waived if the recovery would either--
        (i) Defeat the purposes of title II or title XVIII of the Act, as 
    specified in Sec. 401.358; or
        (ii) Would be against equity and good conscience, as specified in 
    Sec. 401.361 (a) through (c), (e), and (f).
        (3) An individual desiring a waiver of recovery of an MSP 
    obligation must request the waiver within 60 days from receipt of 
    written notification from HCFA that he or she is liable for the 
    obligation.
        (4) HCFA may waive recovery, in whole or in part, in accordance 
    with Sec. 401.358 or Sec. 401.361 (a) through (c), (e), and (f) of this 
    subpart.
    
    
    Sec. 401.367  Initial determination.
    
        Each of the following determinations is an initial determination 
    for purposes of Secs. 405.704(b), 405.704(c), and 405.803(b) of this 
    chapter, as applicable, and the entities are parties for purposes of 
    Secs. 405.708 and 405.805 of this chapter:
        (a) A determination that a provider or supplier must repay an 
    overpayment because the provider or supplier is not without fault.
        (b) A determination that an individual (or the estate of an 
    individual), does not qualify for waiver of adjustment or recovery of 
    overpayments because the individual is, or the estate and the 
    individual are, not without fault.
        (c) A determination, with respect to an individual that is (or an 
    estate and individual that are) without fault, that the individual (or 
    estate) does not qualify for waiver of adjustment or recovery of 
    overpayments on the basis that the purposes of title II or of title 
    XVIII of the Act would be defeated, as described in Sec. 401.358.
        (d) A determination, with respect to an individual that is (or an 
    estate and individual that are) without fault, that the individual (or 
    estate) does not qualify for waiver of adjustment or recovery of 
    overpayments on the basis that recovery would be against equity and 
    good conscience, as described in Sec. 401.361.
    
    
    Sec. 401.370  Liability of certifying or disbursing officer.
    
        No certifying or disbursing officer is liable for any amount 
    certified or paid by him or her to a provider or supplier in either of 
    the following situations:
        (a) The amount is waived under the provisions of this subpart.
        (b) Recovery is not completed prior to the death of all persons 
    against whose benefits the recovery is authorized.
    
    Suspension of Payment to Providers and Suppliers and Collection and 
    Compromise of Overpayments
    
    
    Secs. 401.375--401.390  [Reserved]
    
    Interest
    
    
    Sec. 401.393  [Reserved]
    
    Repayment of Scholarships and Loans
    
    
    Sec. 401.396  [Reserved]
    
        B. Part 401, subpart F, is amended as follows:
    
    Subpart F--Claims Collection and Compromise
    
        1. In Sec. 401.601, paragraphs (d)(2)(ii) and (d)(2)(iii) are 
    revised to read as follows:
    
    
    Sec. 401.601  Basis and scope.
    
    * * * * *
        (d) Related regulations. * * *
        (2) HCFA regulations. * * *
        (ii) Adjustments in railroad retirement or social security benefits 
    to recover Medicare overpayments to individuals are covered in 
    Secs. 401.310 through 401.340.
        (iii) Claims against providers and suppliers for overpayments under 
    Medicare and for assessment of interest are covered in Secs. 401.387 
    and 401.393.
    * * * * *
        2. In Sec. 401.607, paragraph (d)(2) is revised to read as follows:
    
    
    Sec. 401.607  Claims collection.
    
    * * * * *
    
    [[Page 14524]]
    
        (d) Collection by offset. * * *
        (2) Under regulations at Secs. 401.310 through 401.340, HCFA may 
    initiate adjustments in program payments to which an individual is 
    entitled under title II (Federal Old-Age, Survivors, and Disability 
    Insurance Benefits) of the Act or under the Railroad Retirement Act of 
    1974 (45 U.S.C. 231) to recover Medicare overpayments.
        C. Part 405 is amended as set forth below:
    
    PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
    
        1. The authority citation for subpart C continues to read as 
    follows:
    
        Authority: Sections 1102, 1815, 1833, 1842, 1866, 1870, 1871, 
    1879, and 1892 of the Social Security Act (42 U.S.C. 1302, 1395g, 
    1395l, 1395u, 1395cc, 1395gg, 1395hh, 1395pp, and 1395ccc) and 31 
    U.S.C. 3711.
    
        2. The following sections are redesignated as part 401, subpart D 
    as shown in the table below:
    
    ------------------------------------------------------------------------
                   Old section--                        New section--       
    ------------------------------------------------------------------------
    405.370...................................  401.375                     
    405.371...................................  401.378                     
    405.372...................................  401.381                     
    405.373...................................  401.384                     
    405.374...................................  401.387                     
    405.375...................................  401.390                     
    405.376...................................  401.393                     
    405.377...................................  401.394                     
    405.378...................................  401.395                     
    405.380...................................  401.396                     
    ------------------------------------------------------------------------
    
        3. Subpart C, is further amended by removing the undesignated 
    centered headings and Secs. 405.301 through 405.359, and subpart C is 
    reserved.
    
    Subpart G--Reconsiderations and Appeals Under Medicare Part A
    
        4. Subpart G is amended as follows:
        a. The authority citation for subpart G continues to read as 
    follows:
    
        Authority: Secs. 1102, 1151, 1154, 1155, 1869(b), 1871, 1872, 
    and 1879 of the Social Security Act (42 U.S.C. 1302, 1320c, 1320c-3, 
    1320c-4, 1395ff(b), 1395hh, 1395ii, and 1395pp).
    
        b. In Sec. 405.704, the section heading and the introductory text 
    of paragraph (c) are revised, and a new paragraph (c)(3) is added, to 
    read as follows:
    
    
    Sec. 405.704  Actions that are initial determinations.
    
    * * * * *
        (c) Initial determination with respect to a provider. An initial 
    determination with respect to a provider is a determination made on the 
    basis of the request for payment filed by the provider under Part A of 
    Medicare on behalf of an individual who was furnished items or services 
    by the provider, but only if the determination involves the following:
    * * * * *
        (3) A determination by HCFA that a provider must repay an 
    overpayment because the provider is not without fault as that term is 
    described in Sec. 401.323 of this chapter.
    
    Subpart H--Appeals Under the Medicare Part B Program
    
        5. Subpart H is amended as follows:
        a. The authority citation for subpart H is revised to read as 
    follows:
    
        Authority: Secs. 1102, 1842(b)(3)(C), and 1869(b) of the Social 
    Security Act (42 U.S.C. 1302, 1395u(b)(3)(C), and 1395ff(b)).
    
        b. In Sec. 405.803, paragraph (b) is revised to read as follows:
    
    
    Sec. 405.803  Initial determination.
    
    * * * * *
        (b) An initial determination for purposes of this subpart includes, 
    among others, the following determinations:
        (1) Whether the items and services furnished are covered.
        (2) Whether an individual deductible has been met.
        (3) Whether a receipted bill or other evidence of payment is 
    acceptable.
        (4) Whether the charges for items or services furnished are 
    reasonable.
        (5) For items or services furnished an individual by a supplier in 
    accordance with an assignment under Sec. 424.55 of this chapter, that 
    are not covered by reason of Sec. 411.15(g) or Sec. 411.15(k) of this 
    chapter, whether the individual or supplier knew, or could reasonably 
    have been expected to know, that the items or services were excluded 
    from coverage.
        (6) A determination that a supplier must repay an overpayment 
    because the supplier is not without fault as that term is described in 
    Sec. 401.323 of this chapter.
        (7) A determination that an individual, or the estate of the 
    individual, does not qualify for waiver of adjustment or recovery of 
    overpayments because the individual is, or the estate and the 
    individual are, not without fault as that term is described in 
    Sec. 401.355 of this chapter.
        (8) A determination, with respect to an individual that is (or an 
    estate and individual that are) without fault, that the individual (or 
    estate) does not qualify for waiver of adjustment or recovery of 
    overpayments on the basis that recovery would defeat the purposes of 
    title II or of title XVIII of the Act, as described in Sec. 401.358 of 
    this chapter.
        (9) A determination, with respect to an individual that is (or an 
    estate and individual that are) without fault, that the individual (or 
    estate) does not qualify for waiver of adjustment or recovery of 
    overpayments on the basis that recovery would be against equity and 
    good conscience, as described in Sec. 401.361 of this chapter.
    * * * * *
        c. Section 405.805 is revised to read as follows:
    
    
    Sec. 405.805  Parties to the initial determination.
    
        The parties to the initial determination (see Sec. 405.803) may be 
    any party described in Sec. 405.802(b). A party may also be any 
    supplier as defined at Sec. 400.202 of this chapter that has been 
    determined to be not without fault as that term is described in 
    Sec. 401.323 of this chapter, with respect to that issue only.
        D. Part 411 is amended as set forth below:
    
    PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
    PAYMENT
    
        1. The authority citation for part 411 continues to read as 
    follows:
    
        Authority: Secs. 1102 and 1871 of the Social Security Act (42 
    U.S.C. 1302 and 1395hh).
    
        2. Section 411.23 is revised to read as follows:
    
    
    Sec. 411.23  Individual's cooperation.
    
        If HCFA makes conditional payments, the individual must do the 
    following:
        (a) Cooperate in notifying HCFA of the progress and final outcome 
    of the liability claim, including, but not limited to--
        (1) Notifying the intermediary or carrier within 60 days of filing 
    a claim with an entity that may be primary to Medicare; and
        (2) Notifying HCFA within 30 days of the receipt of a payment from 
    the entity that is primary to Medicare.
        (b) Cooperate in the recovery action.
        3. Section 411.28 is revised to read as follows:
    
    
    Sec. 411.28  Waiver of recovery and compromise of claims.
    
        (a) HCFA may waive recovery, in whole or in part, if HCFA 
    determines that waiver is in the best interest of the Medicare program.
        (b) General rules applicable to compromise of claims are set forth 
    in subpart F of part 401 of this chapter.
        (c) Other rules pertinent to recovery are contained in subpart D of 
    part 401 of this chapter.
    
    [[Page 14525]]
    
    E. Part 466 is amended as set forth below:
    
    PART 466--UTILIZATION AND QUALITY CONTROL REVIEW
    
        1. The authority citation for part 466 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. 466.86, new paragraph (a)(5) is added to read as 
    follows:
    
    
    Sec. 466.86  Correlation of Title XI functions with Title XVIII 
    functions.
    
        (a) Payment determinations. * * *
        (5) A finding by the PRO that the provider or supplier is not 
    without fault, as that term is described in Sec. 401.323 of this 
    chapter, with respect to an overpayment, is conclusive for payment 
    purposes.
    * * * * *
        3. In Sec. 466.94, paragraph (c)(6) is redesignated as paragraph 
    (c)(7), and a new paragraph (c)(6) is added to read as follows:
    
    
    Sec. 466.94  Notice of PRO initial denial determination and changes as 
    a result of a DRG validation.
    
    * * * * *
        (c) Content of the notice. * * *
        (6) If applicable, a statement about the without fault 
    determination as that term is described in Sec. 401.323 of this 
    chapter.
    * * * * *
        F. Part 473 is amended as set forth below:
    
    PART 473--RECONSIDERATIONS AND APPEALS
    
        1. The authority citation for part 473 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. 473.14, paragraph (c)(2) is revised to read as follows:
    
    
    Sec. 473.14  Applicability.
    
    * * * * *
        (c) Nonapplicability of rules to related determinations. * * *
        (2) Without fault determinations with respect to overpayments are 
    made under section 1870 of the Act, and limitation on liability 
    determinations on excluded coverage of certain services are made under 
    section 1879 of the Act. Initial determinations under sections 1870 and 
    1879 and further appeals are governed by the reconsideration and appeal 
    procedures in part 405, subpart G of this chapter for determinations 
    under Medicare Part A, and part 405, subpart H of this chapter for 
    determinations under Medicare Part B. References in those subparts to 
    initial and reconsidered determinations made by HCFA should be read to 
    mean initial and reconsidered determinations made by a PRO.
        G. Technical Amendments.
    
    
    Sec. 401.378  [Amended]
    
        1. Redesignated Sec. 401.378 is amended as follows:
        a. In paragraph (b), the citations ``Sec. 405.372'' and 
    ``Sec. 405.373'' are removed, and the citations ``Sec. 401.381'' and 
    ``Sec. 401.384'', respectively, are added in their place.
        b. In paragraph (c), the citations ``Sec. 405.372'' and 
    ``Sec. 405.372(a)(2)'' are removed, and the citations ``Sec. 401.381'' 
    and ``Sec. 401.381(a)(2)'', respectively, are added in their place.
    
    
    Sec. 401.381  [Amended]
    
        2. Redesignated Sec. 401.381 is amended as follows:
        a. In paragraph (a)(1), the citation ``Sec. 405.371(a)(1)'' is 
    removed and the citation ``Sec. 401.378(a)(1)'' is added in its place.
        b. In paragraph (a)(2), the citation ``Sec. 405.371(c)'' is removed 
    and the citation ``Sec. 401.378(c)'' is added in its place.
        c. In paragraph (b)(1), the citations ``Sec. 405.374'' and 
    ``Sec. 405.375'' are removed and the citations ``Sec. 401.387'' and 
    ``Sec. 401.390'', respectively, are added in their place.
        d. In paragraph (e), the citations ``Sec. 405.371(b)'' and 
    ``Sec. 405.378'' are removed and the citations ``Sec. 401.378(b)'' and 
    ``Sec. 401.395'', respectively, are added in their place.
        3. Redesignated Sec. 401.384 is amended as follows:
        a. In paragraph (a) introductory text, the citation 
    ``Sec. 405.371(a)(2)'' is removed and the citation 
    ``Sec. 401.378(a)(2)'' is added in its place.
        b. In paragraph (a)(2), the citation ``Sec. 405.374'' is removed 
    and the citation ``Sec. 401.387'' is added in its place.
        c. In paragraph (c), the citations ``Sec. 405.374'' and 
    ``Sec. 405.375'' are removed and the citations ``Sec. 401.387'' and 
    ``Sec. 401.390'', respectively, are added in their place.
    
    
    Sec. 401.387  [Amended]
    
        4. In redesignated Sec. 401.387, paragraph (a), the citations 
    ``Sec. 405.372'' and ``Sec. 405.373'' are removed and the citations 
    ``Sec. 401.381'' and ``Sec. 401.384'', respectively, are added in their 
    place.
    
    
    Sec. 401.390  [Amended]
    
        5. In redesignated Sec. 401.390, paragraph (a), the citations 
    ``Sec. 405.374'' and ``Sec. 405.372(b)(2)'' are removed and the 
    citations ``Sec. 401.387'' and ``Sec. 401.381(b)(2)'', respectively, 
    are added in their place.
    
    
    Sec. 401.394  [Amended]
    
        6. In redesignated Sec. 401.394, paragraph (e) introductory text, 
    the citation ``Sec. 405.374'' is removed and the citation 
    ``Sec. 401.387'' is added in its place.
    
    
    Sec. 401.601  [Amended]
    
        7. In Sec. 401.601, the following changes are made:
        a. In paragraph (d)(2)(ii), the phrase ``Secs. 405.350-405.356 of 
    this chapter'' is removed, and the citation ``Sec. 401.305'' is added 
    in its place.
        b. In paragraph (d)(2)(iii), the phrase ``Secs. 405.374 and 405.376 
    of this chapter'' is removed, and the phrase ``Secs. 401.387 and 
    401.393'' is added in its place.
    
    
    Sec. 401.607  [Amended]
    
        8. In Sec. 401.607, in paragraph (d)(2), the phrase 
    ``Secs. 405.350-405.358 of this chapter'' is removed, and the phrase 
    ``Secs. 401.346 and 401.349'' is added in its place.
    
    PART 403--RECOGNITION OF STATE REIMBURSEMENT CONTROL SYSTEMS
    
        9. The authority citation for part 403 continues to read as 
    follows:
    
        Authority: Secs. 1102 and 1871 of the Social Security Act (42 
    U.S.C. 1302 and 1395hh).
    
    Sec. 403.310  [Amended]
    
        10. In Sec. 403.310, in paragraph (a), the citation 
    ``Sec. 405.378'' is removed, and the citation ``Sec. 401.395'' is added 
    in its place.
    
    
    Sec. 405.705  [Amended]
    
        11. In Sec. 405.705, in paragraph (d), the citation 
    ``Sec. 405.376'' is removed, and the citation ``Sec. 401.393 of this 
    chapter'' is added in its place.
    
    
    Sec. 405.1801  [Amended]
    
        12. In Sec. 405.1801, in paragraph (a), under the definition 
    ``Intermediary determination,'' in paragraph (4), the citation 
    ``Sec. 405.376'' is removed, and the citation ``Sec. 401.393 of this 
    chapter'' is added in its place.
    
    
    Sec. 405.1803  [Amended]
    
        13. In Sec. 405.1803, in paragraph (c), the citation ``405.373'' is 
    removed, and the citation ``Sec. 401.384(a) of this chapter'' is added 
    in its place.
    
    [[Page 14526]]
    
    PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
    
        14. The authority citation for part 410 continues to read as 
    follows:
    
        Authority: Secs. 1102 and 1871 of the Social Security Act (42 
    U.S.C. 1302 and 1395hh).
    
    
    Sec. 410.1  [Amended]
    
        15. In Sec. 410.1, in paragraph (b), the phrase ``subpart C of part 
    405 of this chapter'' is removed, and the phrase ``Subpart D of Part 
    401 of this chapter'' is added in its place.
    
    
    Sec. 411.28  [Amended]
    
        16. In Sec. 411.28, the following changes are made:
        a. In paragraph (b), the citation ``405.376'' is removed, and the 
    citation ``401.393'' is added in its place.
        b. In paragraph (c), the phrase ``in subpart C of part 405 of this 
    chapter'' is removed, and the phrase ``in subpart D of part 401 of this 
    chapter'' is added in its place.
    
    PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR 
    END-STAGE RENAL DISEASE SERVICES
    
        17. The authority citation for part 413 continues to read as 
    follows:
    
        Authority: Secs. 1102, 1861(v)(1)(A), and 1871 of the Social 
    Security Act (42 U.S.C. 1302, 1395x(v)(1)(A), and 1395hh).
    
    
    Sec. 413.20  [Amended]
    
        18. In Sec. 413.20, in paragraph (e), the citation 
    ``Sec. 405.372(a)'' is removed wherever it appears (twice), and the 
    citation ``Sec. 401.381'' is added in its place.
    
    
    Sec. 413.153  [Amended]
    
        19. In Sec. 413.153, the following changes are made:
        a. In paragraph (a)(1)(ii), the citation ``Sec. 405.377'' is 
    removed, and the citation ``Sec. 401.394'' is added in its place.
        b. In paragraph (a)(1)(iii), the citation ``Sec. 405.378'' is 
    removed, and the citation ``Sec. 401.395'' is added in its place.
    
    PART 447--PAYMENTS FOR SERVICES
    
        20. The authority citation for part 447 continues to read as 
    follows:
    
        Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
    1302).
    
    Sec. 447.31  [Amended]
    
        21. In Sec. 447.31, in paragraph (a), the citation ``Section 
    405.377'' is removed, and the citation ``Sec. 401.394'' is added in its 
    place.
    
    PART 493--LABORATORY REQUIREMENTS
    
        22. The authority citation for part 493 continues to read as 
    follows:
    
        Authority: Sec. 353 of the Public Health Service Act, secs. 
    1102, 1861(e), the sentence following 1861(s)(11), 1861(s)(12), 
    1861(s)(13), 1861(s)(14), 1861(s)(15), and 1861(s)(16) of the Social 
    Security Act (42 U.S.C. 1302, 1395x(e), the sentence following 
    1395x(s)(11), 1395x(s)(12), 1395x(s)(13), 1395x(s)(14), 
    1395x(s)(15), and 1395x(s)(16).
    
    
    Sec. 493.1834  [Amended]
    
        23. In Sec. 493.1834, in paragraph (i)(1)(ii), the citation 
    ``Sec. 405.378(d)'' is removed, and the citation ``Sec. 401.395(d)'' is 
    added in its place.
    
    (Catalog of Federal Domestic Assistance Program No. 93.773, 
    Medicare--Hospital Insurance; and Program No. 93,774, Medicare--
    Supplementary Medical Insurance Program)
    
        Dated: January 8, 1998.
    Nancy-Ann Min DeParle,
    Administrator, Health Care Financing Administration.
    
        Dated: January 20, 1998.
    Donna E. Shalala,
    Secretary.
    [FR Doc. 98-4230 Filed 3-24-98; 8:45 am]
    BILLING CODE 4120-01-U
    
    
    

Document Information

Published:
03/25/1998
Department:
Health Care Finance Administration
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
98-4230
Dates:
To ensure consideration, comments must be mailed or delivered to
Pages:
14506-14526 (21 pages)
Docket Numbers:
HCFA-1719-P
PDF File:
98-4230.pdf
CFR: (54)
20 CFR 1320.3(c)
20 CFR 411.406
42 CFR 401.301
42 CFR 401.303
42 CFR 401.305
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