99-19115. Medicare Program; Replacement of Reasonable Charge Methodology by Fee Schedules  

  • [Federal Register Volume 64, Number 143 (Tuesday, July 27, 1999)]
    [Proposed Rules]
    [Pages 40534-40539]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-19115]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    
    42 CFR Part 414
    
    [HCFA-1010-P]
    RIN 0938-AJ00
    
    
    Medicare Program; Replacement of Reasonable Charge Methodology by 
    Fee Schedules
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Proposed rule.
    
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    SUMMARY: We are proposing to implement fee schedules to be used for 
    payment of services, excluding ambulance services, still subject to the 
    reasonable charge payment methodology. The authority for establishing 
    these fee schedules is provided by section 4315 of the Balanced Budget 
    Act of 1997 (Public Law 105-33), which adds to the Social Security Act 
    a new section 1842(s). A fee schedule for ambulance services is 
    mandated by a different statutory provision. Section 1842(s) of the 
    Social Security Act specifies that statewide or other areawide fee 
    schedules may be implemented for the following services: medical 
    supplies; home dialysis supplies and equipment; therapeutic shoes; 
    parenteral and enteral nutrients, equipment, and supplies; 
    electromyogram devices; salivation devices; blood products; and 
    transfusion medicine.
    
    DATES: Comments will be considered if we receive them at the 
    appropriate address, as provided below, no later than 5 p.m. on 
    September 27, 1999.
    
    ADDRESSES: Mail an original and 3 copies of written comments to the 
    following address: Health Care Financing Administration, Department of 
    Health and Human Services, Attention: HCFA-1010-P, P.O. Box 26688, 
    Baltimore, MD 21207-0488.
    
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        If you prefer, you may deliver an original and 3 copies of your 
    written comments to one of the following addresses: Room 443-G, Hubert 
    H. Humphrey Building, 200 Independence Avenue, SW., Washington, D.C. 
    20201, or Room C5-09-26, 7500 Security Boulevard, Baltimore, Maryland 
    21244-1850.
        Because of staffing and resource limitations, we cannot accept 
    comments by facsimile (FAX) transmission. In commenting, please refer 
    to file code HCFA-1010-P. Comments received timely will be available 
    for public inspection as they are received, generally beginning 
    approximately 3 weeks after publication of a document, in Room 443-G of 
    the Department's offices at 200 Independence Avenue, SW., Washington, 
    DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
    (phone: (202) 690-7890).
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    FOR FURTHER INFORMATION CONTACT: Joel Kaiser, (410) 786-4499.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
    A. Payment Under Reasonable Charges
    
        Payment for most services, including supplies and equipment, 
    furnished under Part B of the Medicare program (Supplementary Medical 
    Insurance) is made through contractors known as Medicare carriers. At 
    one point, payment for most of these services was made on a reasonable 
    charge basis by these carriers. The methodology for determining 
    reasonable charges is set forth in section 1842(b) of the Social 
    Security Act (the Act) and 42 CFR part 405, subpart E of our 
    regulations. Reasonable charge determinations are generally based on 
    customary and prevailing charges derived from historic charge data. The 
    reasonable charge for service is generally set at the lowest of the 
    following factors:
         The supplier's actual charge for the service.
         The supplier's customary charge for the service.
         The prevailing charge in the locality for similar 
    services. (The prevailing charge may not exceed the 75th percentile of 
    the customary charges of suppliers in the locality.)
         The inflation indexed charge (IIC). The IIC is defined in 
    Sec. 405.509(a) as the lowest of the fee screens used to determine 
    reasonable charges for services, including supplies, and equipment paid 
    on a reasonable charge basis (excluding physicians' services) that is 
    in effect on December 31 of the previous fee screen year, updated by 
    the inflation adjustment factor. Fee screens are those factors 
    identified above, including the IIC and lowest charge level if 
    applicable, used to determine payment under the reasonable charge 
    methodology. The inflation adjustment factor is based on the current 
    change in the consumer price index for all urban consumers (CPI-U) for 
    the 12-month period ending June 30.
        For parenteral and enteral nutrients, equipment, and supplies, an 
    additional factor, the lowest charge level (LCL), is used to determine 
    the reasonable charge. In accordance with Sec. 405.511(c), the LCL is 
    set at the 25th percentile of the charges (incurred or submitted on 
    claims processed by the carrier) for the above services, in the 
    locality designated by the carrier for this purpose, during the 3-month 
    period of July 1 through September 30 preceding the fee screen year 
    (January 1 through December 31) for which the service was furnished.
        Sections 405.502(g) and 405.506 permit exceptions to the general 
    rules for determining reasonable charges. Section 405.502(g) gives the 
    carrier the authority to establish special payment limits for a 
    category of service if it determines that the standard rules for 
    calculating payments result in grossly deficient or grossly excessive 
    payments. Section 405.506 provides that a charge which exceeds the 
    customary charge, the prevailing charge, or the LCL ``may be found to 
    be reasonable, but only where there are unusual circumstances, or 
    medical complications requiring additional time, effort or expense 
    which support an additional charge, and only if it is acceptable 
    medical or medical service practice in the locality to make an extra 
    charge in such cases.''
    
    B. Payment Under Fee Schedules
    
        The law gradually replaced the reasonable charge payment 
    methodology with fee schedule payment methodologies for most services 
    furnished under Part B of the Medicare program. Fee schedules have been 
    established for physicians' services, laboratory services, durable 
    medical equipment (DME), prosthetics and orthotics, surgical dressings, 
    and, beginning in the year 2000, ambulance services. Subject to 
    coinsurance and deductible rules, Medicare payment for these services 
    is equal to the lower of the actual charge for the service or the 
    amount determined under the fee schedule methodology.
        Section 4315 of the Balanced Budget Act of 1997 (BBA) amends the 
    Act at section 1842 by adding a new subsection(s). Section 1842(s) of 
    the Act provides authority for implementing statewide or other areawide 
    fee schedules to be used for payment of the following services that are 
    currently paid on a reasonable charge basis:
         Medical supplies.
         Home dialysis supplies and equipment (as defined in 
    section 1881(b)(8) of the Act).
         Therapeutic shoes.
         Parenteral and enteral nutrients, equipment, and supplies 
    (PEN).
         Electromyogram devices.
         Salivation devices.
         Blood products.
         Transfusion medicine.
        Section 1842(s)(1) of the Act provides that the fee schedules for 
    the services listed above are to be updated on an annual basis by the 
    percentage increase in the CPI-U (United States city average) for the 
    12-month period ending with June of the preceding year. The fee 
    schedules for PEN, however, may not be updated before the year 2003. 
    Finally, total payments for the initial year of the fee schedules must 
    be approximately equal to the estimated total payments that would have 
    been made under the
    
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    reasonable charge payment methodology.
    
    II. Provisions of the Proposed Regulations
    
    A. General
    
        We propose, under section 1842(s) of the Act, to implement fee 
    schedules for those services listed above. Subject to coinsurance and 
    deductible rules, Medicare payment for these services is to be equal to 
    the lower of the actual charge for the service or the amount determined 
    under the applicable fee schedule payment methodology presented below. 
    The fee schedules we propose would apply to services furnished on or 
    after January 1, 1999, and would be calculated using base reasonable 
    charges updated by an inflation update factor.
        Section 4315(d) of the BBA requires that the total payments for the 
    initial year of the fee schedules be approximately equal to the 
    estimated total payments that would have been made under the reasonable 
    charge payment methodology. For this reason, for services other than 
    PEN, we are proposing that the fee schedule amounts be based on average 
    reasonable charges from the period July 1, 1996 through June 30, 1997, 
    the same data period used in calculating the 1998 reasonable charges. 
    Furthermore, for the purposes of calculating the 1999 fee schedule 
    amounts, we are proposing that the base fee schedule amounts be 
    increased by the change in the CPI-U for the 12-month period ending 
    with June of 1998, the inflation adjustment factor that would have 
    otherwise been used in calculating the 1999 IICs. This would update the 
    reasonable charge data to the 1999 level, the initial year of the fee 
    schedules. For PEN, which accounts for approximately 90 percent of the 
    Medicare expenditures for services addressed in this rule, we are 
    proposing that the fee schedule amounts be based on the reasonable 
    charges that would have been used in determining payment for PEN in 
    1999.
        The proposed fee schedules would have a minimal, if any, impact on 
    the efforts of HCFA and its contractors to revise their current systems 
    to be millennium or Y2K compliant, as Y2K compliant fee schedule 
    systems are already in place for other services. The proposed fee 
    schedules would be incorporated into these current systems.
    
    B. National Limits
    
        For medical supplies, electromyogram devices, salivation devices, 
    blood products, and transfusion medicine furnished within the 
    continental United States, we propose national limits on the statewide 
    fee schedule amounts similar to those that were mandated by the 
    Congress for DME and surgical dressings in section 1834 of the Act. The 
    Congress mandated ceilings and floors, equal to 100 percent and 85 
    percent, respectively, of the median of all statewide fee schedule 
    amounts, to limit unreasonably high and low fees resulting from the 
    local fee calculations for DME and surgical dressings. The Congress 
    recognized the unique costs of doing business in areas outside the 
    continental United States and therefore did not apply the national 
    limits for DME and surgical dressings to these areas.
        The national limits for DME and surgical dressings have been 
    effective at eliminating outlying fees that cannot be explained by the 
    differences in the costs of doing business in one part of the country 
    versus another. We are therefore proposing that this methodology be 
    applied to the services identified above. Accordingly, the statewide 
    fee schedule amounts for these services may not exceed 100 percent of 
    the median of all statewide fee schedule amounts for areas within the 
    continental United States and may not be less than 85 percent of the 
    median of all statewide fee schedule amounts for areas within the 
    continental United States. The statewide fee schedule amounts for areas 
    outside the continental United States will not be subject to the 
    national limits. National limits are not proposed for home dialysis 
    supplies and equipment, therapeutic shoes, or PEN because the payment 
    amounts for these services are already subject to national limits or 
    are determined on a national basis in the case of PEN.
    
    C. Medical Supplies
    
        Medical supplies are miscellaneous supplies or devices including, 
    but not limited to, casts, splints, and paraffin that are not already 
    included under an existing fee schedule. In addition, intraocular 
    lenses (IOLs) inserted during or subsequent to cataract surgery in a 
    physician's office are considered medical supplies for payment purposes 
    under this rule. For calendar year 1999, we propose statewide fee 
    schedule amounts equal to the weighted average of allowed charges for 
    the services. For these calculations, we will use reasonable charge 
    data with dates of service from July 1, 1996 through June 30, 1997, 
    increased by the change in the CPI-U for the 12-month period ending 
    with June of 1998. The fee schedule amounts are to be updated on an 
    annual basis in accordance with section 1842(s)(1) of the Act. 
    Beginning with the second year of the fee schedule, the statewide fee 
    schedule amounts for IOLs inserted in a physician's office are not to 
    exceed the Medicare allowed payment amount for IOLs furnished by 
    ambulatory surgical centers (ASCs).
    
    D. Home Dialysis Supplies And Equipment
    
        These are services as defined in Sec. 410.52. For calendar year 
    1999, we propose statewide fee schedule amounts equal to the weighted 
    average of allowed charges for the services. For these calculations, we 
    will use reasonable charge data with dates of service from July 1, 1996 
    through June 30, 1997, increased by the change in the CPI-U for the 12-
    month period ending with June of 1998. However, amount of payment under 
    this methodology may not exceed the limit specified for equipment and 
    supplies in Sec. 414.330(c)(2). The fee schedule amounts are to be 
    updated on an annual basis in accordance with section 1842(s)(1) of the 
    Act.
    
    E. Therapeutic Shoes
    
        These services are defined in section 1861(s)(12) of the Act as 
    ``extra-depth shoes with inserts or custom molded shoes with inserts 
    for an individual with diabetes.'' In addition, section 1833(o)(2)(D) 
    of the Act provides that an individual ``may substitute modification of 
    such shoes instead of obtaining one (or more, as specified by the 
    Secretary) pairs of inserts (other than the original pair of inserts 
    with respect to such shoes).'' Section 1833(o)(2)(A) of the Act 
    establishes national payment limits for these services. These are upper 
    payment limits, or ceilings, applied to the reasonable charges 
    calculated for these services. The initial year, 1988 limits were $300 
    for one pair of custom molded shoes (including any inserts that are 
    provided initially with the shoes), $100 for one pair of extra-depth 
    shoes (not including inserts provided with such shoes), and $50 for any 
    pairs of inserts. In accordance with section 1833(o)(2)(C) of the Act, 
    these national payment limits are increased on an annual basis by the 
    same annual percentage increase provided for DME, rounded to the 
    nearest multiple of $1. We may establish limits lower than these limits 
    if shoes and inserts of appropriate quality are readily available at or 
    below the limits. We have determined that, to the extent that 
    reasonable charges for shoes and inserts are lower than the limitations 
    contained in section 1834(o)(2)(A) of the Act, shoes and inserts are 
    readily available at that level. Therefore, we find it appropriate and 
    consistent with the
    
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    direction of the BBA to apply fee schedule amounts lower than the 
    limits.
        For calendar year 1999, we propose statewide fee schedule amounts 
    equal to the weighted average of allowed charges for the services. For 
    these calculations, we will use reasonable charge data with dates of 
    service from July 1, 1996 through June 30, 1997, increased by the 
    change in the CPI-U for the 12-month period ending with June of 1998. 
    In addition, the statewide fee schedule amounts may not exceed the 
    national payment limits established under section 1833(o)(2) of the 
    Act. The fee schedule amounts are to be updated on an annual basis in 
    accordance with section 1842(s)(1) of the Act.
    
    F. Parenteral and Enteral Nutrients (PEN)
    
        These services are covered by Medicare as prosthetic devices, which 
    are defined in section 1861(s)(8) of the Act. However, PEN is excluded 
    from the prosthetic and orthotic fee schedule payment methodology by 
    section 1834(h)(4)(B) of the Act. In accordance with section 4551(b) of 
    the BBA, the reasonable charges for PEN for the years 1998 through 2002 
    may not exceed the reasonable charges determined for 1995. The 
    prevailing charges for PEN are currently determined on a nationwide 
    basis (that is, the 75th percentile of the customary charges of 
    suppliers in the entire nation).
        As explained above, section 4551(b) of the BBA limits the 
    reasonable charges calculated for 1998 through 2002 for PEN to the 
    reasonable charges calculated in 1995. Therefore, payment under the 
    reasonable charge methodology would be based on the lesser of the 
    charges calculated for the given fee screen year (for example, 1999) or 
    the charges calculated for 1995. For calendar year 1999, we propose 
    nationwide fee schedule amounts equal to the lesser of the charges 
    determined to be reasonable for the services during 1995 or the charges 
    determined to be reasonable for the services during 1998 (using charge 
    data with dates of service from July 1, 1996 through June 30, 1997), 
    increased by the inflation adjustment factor that would have otherwise 
    been used in calculating the 1999 IICs, in effect, the 1999 reasonable 
    charges. Beginning the fee screen year 2003, the fee schedule amounts 
    are to be updated on an annual basis in accordance with section 
    1842(s)(1) of the Act.
    
    G. Electromyogram Devices And Salivation Devices
    
        The decision regarding Medicare coverage of these services is made 
    at the carrier's discretion. In any carrier area in which these 
    services are covered, for calendar year 1999, we propose statewide fee 
    schedule amounts equal to the weighted average of allowed charges for 
    the services. For these calculations, we will use reasonable charge 
    data with dates of service from July 1, 1996 through June 30, 1997, 
    increased by the change in the CPI-U for the 12-month period ending 
    with June of 1998. The fee schedule amounts are to be updated on an 
    annual basis in accordance with section 1842(s)(1) of the Act.
    
    H. Blood Products
    
        For calendar year 1999, we propose statewide fee schedule amounts 
    equal to the weighted average of allowed charges for the blood products 
    services. These services are not included under the definition of drugs 
    and biologicals in section 1861(t)(1) of the Act. For these 
    calculations, we will use reasonable charge data with dates of service 
    from July 1, 1996 through June 30, 1997, increased by the change in the 
    CPI-U for the 12-month period ending with June of 1998. The fee 
    schedule amounts are to be updated on an annual basis in accordance 
    with section 1842(s)(1) of the Act.
    
    I. Transfusion Medicine
    
        For calendar year 1999, we propose statewide fee schedule amounts 
    equal to the weighted average allowed charges for transfusion medicine 
    services. For these calculations, we will use reasonable charge data 
    with dates of service from July 1, 1996 through June 30, 1997, 
    increased by the change in the CPI-U for the 12-month period ending 
    with June of 1998. The fee schedule amounts are to be updated on an 
    annual basis in accordance with section 1842(s)(1) of the Act.
    
    III. 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. We will consider 
    all comments we receive 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.
    
    IV. Regulatory Impact Statement
    
        We have examined the impacts of this proposed rule as required by 
    Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Public 
    Law 96-354). Executive Order 12866 directs agencies to assess all costs 
    and benefits of available regulatory alternatives and, if regulation is 
    necessary, to select regulatory approaches that maximize net benefits 
    (including potential economic, environmental, public health and safety 
    effects, distributive impacts, and equity). The RFA requires agencies 
    to analyze options for regulatory relief of small businesses. For 
    purposes of the RFA, small entities include small businesses, non-
    profit organizations and government agencies. Most hospitals and most 
    other providers and suppliers are small entities, either by non-profit 
    status or by having revenues of $5 million or less annually. For 
    purposes of the RFA, all suppliers of Medicare Part B services are 
    considered to be small entities. Individuals and States are not 
    included in the definition of a small entity.
        In addition, section 1102(b) of the Act requires us to prepare a 
    regulatory impact analysis if a rule may have a significant impact on 
    the operations of a substantial number of small rural hospitals. This 
    analysis must conform to the provisions of section 603 of the RFA. For 
    purposes of section 1102(b) of the Act, we define a small rural 
    hospital as a hospital that is located outside of a Metropolitan 
    Statistical Area and has fewer than 50 beds.
        We expect suppliers of the Part B services listed in this preamble 
    to be affected by this proposed rule. For 1999, the initial year of the 
    fee schedules, we estimate that there will be a decrease of less than 1 
    percent in total expenditures for the services addressed in this 
    proposed rule. Therefore, we expect that the overall impact of this 
    proposed rule will be negligible.
        With regard to IOLs, beginning with the second year of the fee 
    schedules, we are proposing that the fee schedule amounts not exceed 
    the Medicare allowed payment amount for IOLs furnished by ASCs. 
    Therefore, it is likely that the IOL fee schedule amounts will decrease 
    after the first year of the fee schedules. We do not believe, however, 
    that limiting payment for IOLs furnished in a physician's office to the 
    amount paid for IOLs furnished in an ASC will result in a lack of 
    availability of IOLs to Medicare beneficiaries. The IOLs furnished by 
    ASCs are the same devices that are furnished in a physician's office. 
    The Medicare payment amount for IOLs furnished by ASCs is established 
    through separate regulations and is based on the average price paid by 
    ASCs for these devices. This amount should represent adequate payment 
    to physicians for the cost of the IOL device that they insert in their 
    office.
    
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        We expect that total expenditures in the outlying fee schedule 
    years of 2000 and beyond will continue to approximate total 
    expenditures that would have otherwise been made under the reasonable 
    charge methodology in part because the fee schedules are updated using 
    the same factor used in updating the IICs under the reasonable charge 
    methodology.
        For these reasons, we are not preparing an analysis for either the 
    RFA or section 1102(b) of the Act because we have determined, and we 
    certify, that this proposed rule would not have a significant economic 
    impact on a substantial number of small entities or a significant 
    impact on the operations of a substantial number of small rural 
    hospitals.
        In accordance with the provisions of Executive Order 12866, this 
    regulation was reviewed by the Office of Management and Budget.
        42 CFR part 414 would be amended as set forth below:
    
    PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
    
        1. The authority citation for part 414 continues to read as 
    follows:
    
        Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social 
    Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
    
    Subpart A--General Provisions
    
        2. A new Sec. 414.70 is added to read as follows:
    
    
    Sec. 414.70  Fee schedules for certain items and services previously 
    paid on a reasonable charge basis.
    
        (a) General rule. For services defined in Sec. 400.202 of this 
    chapter furnished on or after January 1, 1999, Medicare pays for the 
    services as described in paragraph (b) of this section on the basis of 
    80 percent of the lesser of--
        (1) The actual charge for the service; or
        (2) The fee schedule amount for the service, as determined in 
    accordance with paragraphs (e) through (k) of this section.
        (b) Payment classification. (1) HCFA or the carrier determines fee 
    schedules for the following categories of services:
        (i) Medical supplies, as specified in paragraph (e) of this 
    section.
        (ii) Home dialysis supplies and equipment, as specified in 
    paragraph (f) of this section.
        (iii) Therapeutic shoes, as specified in paragraph (g) of this 
    section.
        (iv) Parenteral and enteral nutrients, equipment, and supplies 
    (PEN), as specified in paragraph (h) of this section.
        (v) Electromyogram devices and salivation devices, as specified in 
    paragraph (i) of this section.
        (vi) Blood products, as specified in paragraph (j) of this section.
        (vii) Transfusion medicine, as specified in paragraph (k) of this 
    section.
        (2) HCFA designates the specific services in each category through 
    program instructions.
        (c) Definition. Local payment amount means the weighted average 
    reasonable charge for the service furnished in a State, the District of 
    Columbia, or a United States territory during the period July 1, 1996 
    through June 30, 1997, as determined by the carrier, increased by the 
    change in the consumer price index for all urban consumers (CPI-U) for 
    the 12-month period ending with June 1998.
        (d) Updating the fee schedule amounts. Except for the fee schedule 
    amounts for services described in paragraph (h) of this section, for 
    each year subsequent to 1999, the fee schedule amounts of the preceding 
    year are updated by the percentage increase in the CPI-U for the 12-
    month period ending with June of the preceding year. For services 
    described in paragraph (h) of this section, for each year subsequent to 
    2002, the fee schedule amounts of the preceding year are updated by the 
    percentage increase in the CPI-U for the 12-month period ending with 
    June of the preceding year.
        (e) Medical supplies. (1) This category includes, but is not 
    limited to, cast supplies, splints, paraffin, and intraocular lenses 
    (IOLs) inserted during or subsequent to cataract surgery in a 
    physician's office.
        (2) Payment for medical supplies is made in a lump sum amount for 
    purchase of the item based on the applicable fee schedule amount.
        (3) The fee schedule amount for an item furnished in 1999 is one of 
    the following:
        (i) Within the continental United States, 100 percent of the local 
    payment amount if the local payment amount is neither greater than the 
    median nor less than 85 percent of the median of all local payment 
    amounts for areas within the continental United States.
        (ii) Within the continental United States, 100 percent of the 
    median of all local payment amounts for areas within the continental 
    United States if the local payment amount exceeds the median of all 
    local payment amounts for areas within the continental United States.
        (iii) Within the continental United States, 85 percent of the 
    median of all local payment amounts for areas within the continental 
    United States if the local payment amount is less than 85 percent of 
    the median of all local payment amounts for areas within the 
    continental United States.
        (iv) 100 percent of the local payment amount for areas outside the 
    continental United States.
        (4) For each year subsequent to 1999, the fee schedule payment 
    amounts for IOLs inserted in a physician's office may not exceed the 
    Medicare allowed payment amount for IOLs furnished by ambulatory 
    surgical centers.
        (f) Home dialysis supplies and equipment. (1) This category 
    includes items and services as defined in Sec. 410.52 of this chapter.
        (2) Payment for home dialysis supplies and equipment is made in a 
    lump sum based on the applicable fee schedule amount, but may not 
    exceed the limit for equipment and supplies in Sec. 414.330(c)(2).
        (3) The fee schedule amount for a service furnished in 1999 is 
    equal to the local payment amount.
        (g) Therapeutic shoes. (1) This category includes extra-depth shoes 
    with inserts or custom molded shoes with inserts for an individual with 
    diabetes, modifications of the shoes, and replacement inserts for the 
    shoes.
        (2) Payment for therapeutic shoes is made in a lump sum based on 
    the applicable fee schedule amount.
        (3) The fee schedule amount for payment for a service furnished in 
    1999 is the lesser of--
        (i) The local payment amount; or
        (ii) The national payment limit specified in section 1833(o)(2) of 
    the Act.
        (h) Parenteral and enteral nutrients, equipment, and supplies 
    (PEN). (1) Payment for PEN is made in a lump sum based on the 
    applicable fee schedule amount.
        (2) The fee schedule amount for payment for a service furnished in 
    1999 is the lesser of--
        (i) The charge determined to be reasonable for the service during 
    1995; or
        (ii) The charge determined to be reasonable for the service during 
    1998, increased by the inflation adjustment factor used in calculating 
    the 1999 IIC.
        (i) Electromyogram and salivation devices.
        (1) Payment for an electromyogram device or a salivation device is 
    made in a lump sum for purchase of the device or on a monthly rental 
    basis based on the applicable fee schedule amount.
        (2) The fee schedule amount for payment for an electromyogram 
    device or a salivation device furnished in 1999 is one of the 
    following:
        (i) Within the continental United States, 100 percent of the local 
    payment
    
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    amount if the local payment amount is neither greater than the median 
    nor less than 85 percent of the median of all local payment amounts for 
    areas within the continental United States.
        (ii) 100 percent of the median of all local payment amounts for 
    areas within the continental United States if the local payment amount 
    within the continental United States exceeds the median of all local 
    payment amounts for areas within the continental United States.
        (iii) 85 percent of the median of all local payment amounts for 
    areas within the continental United States if the local payment amount 
    within the continental United States is less than 85 percent of the 
    median of all local payment amounts for areas within the continental 
    United States.
        (iv) 100 percent of the local payment amount for areas outside the 
    continental United States.
        (j) Blood products. (1) Payment for blood products is made in a 
    lump sum based on the applicable fee schedule amount.
        (2) The fee schedule amount for payment for a blood product 
    furnished in 1999 is one of the following:
        (i) Within the continental United States, 100 percent of the local 
    payment amount if the local payment amount is neither greater than the 
    median nor less than 85 percent of the median of all local payment 
    amounts for areas within the continental United States.
        (ii) 100 percent of the median of all local payment amounts for 
    areas within the continental United States if the local payment amount 
    within the continental United States exceeds the median of all local 
    payment amounts for areas within the continental United States.
        (iii) 85 percent of the median of all local payment amounts for 
    areas within the continental United States if the local payment amount 
    within the continental United States is less than 85 percent of the 
    median of all local payment amounts for areas within the continental 
    United States.
        (iv) 100 percent of the local payment amount for areas outside the 
    continental United States.
        (k) Transfusion medicine. (1) Payment for transfusion medicine is 
    made in a lump sum based on the applicable fee schedule amount.
        (2) The fee schedule amount for payment for transfusion medicine 
    furnished in 1999 is one of the following:
        (i) Within the continental United States, 100 percent of the local 
    payment amount if the local payment amount is neither greater than the 
    median nor less than 85 percent of the median of all local payment 
    amounts for areas within the continental United States.
        (ii) 100 percent of the median of all local payment amounts for 
    areas within the continental United States if the local payment amount 
    within the continental United States exceeds the median of all local 
    payment amounts for areas within the continental United States.
        (iii) 85 percent of the median of all local payment amounts for 
    areas within the continental United States if the local payment amount 
    within the continental United States is less than 85 percent of the 
    median of all local payment amounts for areas within the continental 
    United States.
        (iv) 100 percent of the local payment amount for areas outside the 
    continental United States.
    
    Subpart E--Determination of Reasonable Charges Under the ESRD 
    Program
    
        3. In Sec. 414.330 the introductory text of paragraph (a)(2) is 
    revised to read as follows:
    
    
    Sec. 414.330  Payment for home dialysis equipment, supplies, and 
    support services.
    
        (a) * * *
        (2) Exception. If the conditions in paragraphs (a)(2)(i) through 
    (a)(2)(iv) of this section are met, Medicare pays for home dialysis 
    equipment and supplies on a fee schedule basis in accordance with 
    Sec. 414.70, but the amount of payment may not exceed the limit for 
    equipment and supplies in paragraph (c)(2) of this section.
    * * * * *
    (Catalog of Federal Domestic Assistance Programs No. 93.774, 
    Medicare-Supplementary Medical Insurance Program)
    
        Dated: January 3, 1999.
    Nancy-Ann Min DeParle,
    Administrator, Health Care Financing Administration.
        Dated: February 25, 1999.
    Donna E. Shalala,
    Secretary.
    [FR Doc. 99-19115 Filed 7-26-99; 8:45 am]
    BILLING CODE 4120-01-P
    
    
    

Document Information

Published:
07/27/1999
Department:
Health Care Finance Administration
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
99-19115
Dates:
Comments will be considered if we receive them at the
Pages:
40534-40539 (6 pages)
Docket Numbers:
HCFA-1010-P
RINs:
0938-AJ00
PDF File:
99-19115.pdf
CFR: (3)
42 CFR 405.509(a)
42 CFR 414.70
42 CFR 414.330