99-23515. Medicaid Program; Optional Coverage of Certain Tuberculosis- Related Services to TB-Infected Individuals  

  • [Federal Register Volume 64, Number 175 (Friday, September 10, 1999)]
    [Proposed Rules]
    [Pages 49121-49128]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-23515]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    
    42 CFR Parts 435, 436, and 440
    
    [HCFA-2082-P]
    RIN 0938-AG72
    
    
    Medicaid Program; Optional Coverage of Certain Tuberculosis-
    Related Services to TB-Infected Individuals
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Proposed rule.
    
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    SUMMARY: This proposed rule would amend the existing Medicaid 
    regulations to incorporate statutory provisions that allow States to 
    cover a limited Medicaid service package to an eligibility group of 
    low-income individuals infected with tuberculosis (TB). The services 
    provided under this optional coverage are limited to those related to 
    the treatment of TB. This optional coverage will ensure Medicaid 
    services for the treatment of TB-infected individuals who would 
    otherwise be unlikely to receive coverage under Medicaid. This proposed 
    rule would incorporate and interpret provisions of the Omnibus Budget 
    Reconciliation Act of 1993.
    
    DATES: Comments will be considered if we receive them at the 
    appropriate address, as provided below, no later than 5 p.m. on 
    November 9, 1999.
    
    ADDRESSES: Mail written comments (one original and three copies) to the 
    following address: Health Care Financing Administration, Department of 
    Health and Human Services, Attention: HCFA-2082-P, P.O. Box 9010, 
    Baltimore, MD 21244-9010.
        If you prefer, you may deliver your written comments (one original 
    and three copies) to one of the following addresses: Room 443-G, Hubert 
    H. Humphrey Building, 200 Independence Avenue, SW, Washington, DC, or 
    C5-14-03, Central Building, 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-2082-P.
    
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        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 5:00 p.m. (phone (202) 690-7890).
        For comments that relate to information collection requirements, 
    mail a copy of comments to: Health Care Financing Administration, 
    Office of Information Services, Security and Standards Group, Division 
    of HCFA Enterprise Standards Room N2-14-26, 7500 Security Boulevard, 
    Baltimore, MD 21244-1850, Attn: John Burke, HCFA-2082-P; and Lauren 
    Oliven, HCFA Desk Officer, Office of Information and Regulatory 
    Affairs, Room 3001, New Executive Office Building, Washington, DC 
    20503.
    
    FOR FURTHER INFORMATION CONTACT: Ingrid Osborne (410) 786-4461, Gerald 
    Zelinger (410) 786-5929.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        Because of the emerging recurrence of tuberculosis (TB) in this 
    country, Congress included provisions in its 1993 legislation that 
    allows States, at their option, to extend Medicaid eligibility to low-
    income individuals infected with TB. The Omnibus Budget Reconciliation 
    Act of 1993 (OBRA '93), Public Law 103-66, amended the Social Security 
    Act (the Act) in several ways to provide for this coverage. Prior to 
    OBRA '93, TB-infected individuals who did not qualify as disabled under 
    the disability definition under the Supplemental Security Income (SSI) 
    program would have been unlikely to receive Medicaid coverage. Even 
    though these individuals might have met the income and resource 
    requirements of the cash assistance programs, they could not meet the 
    categorical requirements necessary to qualify for Medicaid.
        Consistent with the addition of the new eligibility group whose 
    eligibility is based on, among other factors, being infected with TB, 
    Congress limited the services available to this new eligibility group. 
    Congress effected this limitation by amending the statutory text 
    following section 1902(a)(10)(F) of the Act to provide for an exception 
    to the comparability rules, which require certain types of eligibility 
    groups to be treated comparably in terms of the services available. The 
    new exception provides that coverage for individuals who are eligible 
    for Medicaid under the optional TB-infected eligibility group is 
    limited to the TB-related services listed in section 1902(z)(2). 
    Congress amended section 1915(g)(1) to permit States to provide 
    targeted case management services to TB-infected individuals. Section 
    13603 of OBRA '93 added a new section 1902(z)(2) that specifies the 
    categories of services that eligible TB-infected individuals may 
    receive. The services listed in section 1902(z)(2) include--
        (1) Prescribed drugs;
        (2) Physicians' services and services described in section 
    1905(a)(2) of the Act (these services include outpatient hospital 
    services, rural health clinic services, and Federally qualified health 
    center services);
        (3) Laboratory and X-ray services (including services to confirm 
    the presence of infection);
        (4) Clinic services and Federally qualified health center services;
        (5) Case management services (as defined in section 1915(g)(2)); 
    and
        (6) Services (other than room and board) designed to encourage 
    completion of regimens of prescribed drugs by outpatients, including 
    services to directly observe the intake of prescribed drugs.
        Since the last of these listed services was not previously within 
    the scope of coverable Medicaid services, section 13603 of OBRA '93 
    amended section 1905(a)(19) of the Act to add to the overall list of 
    coverable Medicaid services the TB-related services described in 
    section 1902(z)(2)(F). Section 1902(z)(2)(F) describes the new services 
    as services (other than room and board) designed to encourage 
    completion of regimens of prescribed drugs by outpatients, including 
    services to directly observe the intake of prescribed drugs.
        The amendments made by section 13603 of OBRA '93 apply to medical 
    assistance furnished on or after January 1, 1994, without regard to 
    whether or not final regulations to carry out the amendments had been 
    promulgated by that date.
    
    II. Provisions of the Proposed Regulations
    
        We propose to incorporate the OBRA '93 provisions relating to 
    optional coverage of TB-infected individuals in the Medicaid 
    regulations and provide the following interpretations:
    
    A. Eligibility Requirements
    
        Section 1902(z)(1) of the Act, as added by OBRA '93, describes the 
    low-income individuals infected with TB who may be eligible for 
    Medicaid. We propose to add new Secs. 435.219 and 436.219 to 
    incorporate this optional group and interpret the eligibility 
    requirements.
    1. Individuals Who Are Infected with TB
        As indicated in the legislative history of section 13603 of OBRA 
    '93, the conference committee intended that eligibility on the basis of 
    the criterion of being infected with TB be interpreted as broadly as 
    possible in order to allow the maximum number of TB-infected persons to 
    receive services. (H. Rept. No. 213, 103rd Cong., 1st Sess. 833 (1993) 
    and H. Rept. No. 111, 103rd Cong., 1st Sess. 219-220 (1993)).
        Therefore, we are proposing that, in determining eligibility under 
    this group, States need not rely on ``positive'' test results for 
    determining who is infected with tuberculosis. The committee recognized 
    that traditional TB tests and diagnostic methods are of questionable 
    value, particularly among persons with low immune function, and may 
    possibly produce both false positive and false negative test results. 
    For purposes of determining eligible individuals infected with TB, we 
    propose to use customary medical criteria that define the symptoms and 
    conditions that differentiate TB from other diseases. We consulted the 
    Centers for Disease Control and Prevention (CDC) regarding the types of 
    medical criteria that physicians use when diagnosing suspected cases of 
    TB. On the basis of the CDC medical advice, we propose to define a TB-
    infected individual for purposes of the section 1902(z)(1) requirement 
    as any individual who has a positive diagnosis as confirmed by certain 
    tests or a suspicion of TB infection in his or her diagnosis. These 
    individuals could include--
         Any individual with a positive tuberculin skin test using 
    the Mantoux method and who receives treatment for latent TB infection 
    or active tuberculosis;
         Any individual with a negative tuberculin skin test but 
    whose sputum culture or culture from another tissue sample is positive 
    for the tuberculosis organism;
         Any individual who never received a tuberculin skin test 
    but whose sputum culture or culture from another tissue sample is 
    positive for the tuberculin organism;
         Any individual whose TB skin test is negative and whose 
    sputum or other tissue culture for tuberculosis is not or cannot be 
    obtained, but who, in the physician's judgment, requires and is given 
    TB-related drug or surgical therapy or both; and
         Any symptomatic individual with a negative TB skin test 
    who is being
    
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    treated with a TB drug regimen while awaiting the TB culture results 
    because the physician suspects the individual may have active TB, and 
    whose cultures turn out to be negative for TB, causing the TB drug 
    regimen to be discontinued.
        2. Individuals Who Are Not Eligible as a Mandatory Categorically 
    Needy Group or Special Group
        According to the statute, the optional eligibility group of TB-
    infected individuals does not include any individuals who would be 
    eligible for mandatory coverage because they are (or are deemed to be) 
    cash assistance recipients or are members of special groups described 
    under section 1902(a)(10)(A)(i) of the Act. The statute includes TB-
    infected persons as an optional categorically needy eligibility group 
    only under the provisions of section 1902(a)(10)(A)(ii).
        In terms of the distinction between mandatory and optional 
    categorically needy groups, we believe that the language describing the 
    new eligibility group as ``not described as mandatory categorically 
    needy'' does not create a problem. This is because if an individual 
    qualifies under a mandatory categorically needy group, the individual 
    would have more services available (including TB-related services that 
    the State elects to provide) than if the individual qualified only 
    under the new TB-infected group. Since the service package available to 
    mandatory categorically needy individuals must include all services 
    otherwise available (under Sec. 1902(a)(10)(b)(i)), these individuals 
    will not lose access to any services.
    3. Financial Eligibility Requirements
        Sections 1902(z)(1)(B) and (z)(1)(C) of the Act specify the income 
    and resource requirements that individuals must meet in order to be 
    eligible for Medicaid as TB-infected individuals. While the individual 
    need not be ``disabled'' as described in section 1902(a)(10)(A)(i) in 
    order to be eligible for the optional TB-infected group, section 
    1902(z)(1)(b) requires that his or her gross income must not exceed the 
    maximum amount a disabled individual may have and remain eligible for 
    Medicaid under the State plan. Disabled individuals are among those 
    eligible for benefits under the SSI program under title XVI of the Act, 
    and among the types of individuals described in section 
    1902(a)(10)(A)(i) who are eligible for Medicaid because they are 
    individuals to whom SSI benefits are being paid. Reading section 
    1902(z)(1) in context, we thus concluded that the reference to 
    ``disabled individual'' in section 1902(z)(1)(B) is properly read to 
    refer to disabled individuals under the SSI program. To develop a 
    uniform standard for eligibility of TB-infected individuals, we thus 
    looked to financial eligibility for disabled individuals under the SSI 
    program. Many of the SSI income exclusions, however, are linked to 
    circumstances related to particular disabilities. These exclusions 
    would not be appropriate for the TB-infected eligibility group, since 
    that group is generally not disabled, and would thus never qualify for 
    these exclusions.
        To give effect to the statutory link between eligibility for TB-
    infected individuals and the standards of the SSI program applicable to 
    disabled individuals, while recognizing that TB-infected individuals 
    are not disabled, we propose to use a method based on the most generous 
    income exclusions under section 1612(b) of the Act that are not 
    dependent on disabled status. Using this method, we calculate the 
    maximum income level a TB-infected individual may have by determining 
    the maximum income level that an individual hypothetically could have 
    if these income exclusions were applied in full. The resulting amount 
    is a national uniform standard for income eligibility for the TB-
    infected eligibility group. The income exclusions that we use in the 
    formula to determine the maximum income for TB-infected individuals are 
    the general earned or unearned income exclusions under section 
    1612(b)(2)(A), the general earned income exclusion under section 
    1612(b)(4)(B)(i), and the additional earned income exclusion under 
    section 1612(b)(4)(B)(iii). Since these are the most generous income 
    disregards that are not related to disabling conditions and connected 
    expenses, using this methodology will result in the most liberal 
    interpretation possible. The general income exclusion is $20, the 
    general earned income exclusion is $65 (for a total of an $85 general 
    exclusion), and the additional earned income exclusion is 50 percent of 
    additional earned income. The formula that we propose to use to 
    determine the maximum monthly income for eligibility as a TB-infected 
    individual is 2 times the SSI Federal Benefit Rate (FBR) plus $85 (2 
    x  FBR + $85). (See section 00810.350 of the Program Operations Manual 
    System (POMS SI).) Income above this level would result in countable 
    income in excess of ordinary SSI eligibility standards. We are 
    proposing to require States to apply this SSI break-even point 
    methodology for the income eligibility calculation of TB-infected 
    individuals.
        We note that this formula does not represent the actual application 
    of SSI methods and standards to any particular individual, or even to 
    any particular hypothetical individual, as he or she would apply under 
    the SSI program. For example, under SSI, an individual with earned 
    income sufficient to demonstrate ``significant gainful activity'' would 
    not be ``disabled,'' and thus the earned income disregard would not 
    ordinarily be applicable to income of a disabled individual above the 
    level to demonstrate significant gainful activity. Since TB-infected 
    individuals are not ordinarily disabled, we did not believe it would be 
    appropriate to limit earned income (and the earned income disregard) to 
    the level showing significant activity in devising an eligibility 
    formula for TB-infected individuals.
        We propose to permit States to use the section 1902(r) authority 
    (which permits States to use more liberal income and resource 
    methodologies than those used under the cash assistance programs) to 
    disregard income when making the eligibility determination for the 
    section 1902(z) group. Use of the section 1902(r) authority will permit 
    States to make eligible, under section 1902(z), persons with gross 
    income in excess of the amount derived from the formula set forth 
    above. Because the income eligibility standards are based on standards 
    for disabled SSI recipients, we propose that the income limits set 
    forth at section 1903(f) that limit Federal financial participation for 
    individuals whose eligibility standards are related to the standards 
    for Aid to Families with Dependent Children (in effect as of July 16, 
    1996) would not apply for TB-infected individuals. Otherwise these 
    limits might render meaningless the financial eligibility standards 
    permitted by section 1902(z)(1)(B).
        In cases where both members of a married couple, or more than one 
    member of a family are TB-infected, we have interpreted section 
    1902(z)(1) to mean that each applicant will be considered as a single 
    individual and thus will be subject to income standards independent 
    from his or her spouse or child. Section 1902(z) specifies that each 
    family member should be considered separately by applying the 
    eligibility standard for ``a disabled individual.''
        When only one spouse is eligible or applies for Medicaid, the other 
    spouse's income should be deemed to be considered as available income 
    as permitted under the State plan. If the members of a couple were 
    legally separated, or if some of the spouse's income was allocated to 
    other individuals (for example, if the spouse had dependent children 
    for whom the applicant was not legally responsible),
    
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    the income would be deemed accordingly.
        We propose that the resource eligibility requirements for the 
    optional TB-related group remain consistent with the SSI resource limit 
    of $2,000 for an individual. However, States would again be permitted 
    under the authority of section 1902(r)(2) to use more liberal resource 
    requirements in making eligibility determinations for TB-infected 
    applicants.
        We propose to require section 1902(f) States that use more 
    restrictive requirements than the SSI program uses to disregard SSI 
    payments and optional State supplementation payments when determining 
    financial eligibility of a TB-infected individual under section 
    1902(z)(1). A section 1902(f) State that includes aged, blind, or 
    disabled individuals as medically needy under its approved plan must 
    allow individuals deemed to be SSI recipients, essential spouses, State 
    supplementation payment recipients, and individuals who are eligible 
    for State supplements but who do not receive them to spend down to the 
    State's more restrictive January 1, 1972 standard or to the SSI income 
    standard. A section 1902(f) State that does not include aged, blind, or 
    disabled individuals as medically needy may allow individuals to spend 
    down only to the income standard that the State would use if there were 
    no optional categorically needy eligibility groups included under its 
    January 1, 1972 approved plan.
        We propose to require that territories base their maximum financial 
    eligibility levels for TB-infected individuals on the standards under 
    their State Medicaid plans for disabled individuals, that is, the Aid 
    to the Aged, Blind, or Disabled (AABD) program. The territories must 
    describe in their State plans the financial eligibility standards and 
    methodologies that are applicable to the TB-infected group. Although we 
    recognize that this policy may restrict eligibility for TB-infected 
    individuals in territories that have limited AABD programs, the 
    statutory language specifically ties eligibility for TB-infected 
    individuals to eligibility of disabled individuals under the State 
    plan.
    
    B. Services
    
    1. New Service Category
        Section 1905(a)(19) was amended by OBRA '93 to add a new TB-related 
    service category to the overall list of coverable services. The new 
    service category described in section 1902(z)(2)(F) of the Act 
    specifies the limited services available to eligible individuals who 
    are infected with TB. In order for a State to make this service 
    available to any categorically needy eligible individual, including the 
    new TB-infected group, the State must elect to cover this service under 
    its State plan and make it available to all categorically needy 
    individuals for whom the service is medically necessary. Like most 
    other optional Medicaid services included in section 1905(a), when a 
    State elects to make the service available under its Medicaid plan, the 
    service must be equally available in amount and scope to all 
    individuals in a covered group who need the service. As such, if a 
    State elects this service it must be equally available to TB-infected 
    categorically needy individuals. Similarly, if a State elects this 
    service for its medically needy eligibility group, the service must be 
    equally available to that population as well. However, because this 
    service is described in the statute as a TB-related service it is 
    available only to those individuals who are under a drug treatment 
    regimen for the treatment of TB. We also propose to add a new 
    Sec. 440.164 to incorporate the services provisions. A further 
    discussion of the scope of this benefit is provided below.
    2. List of Services and Applicable Limitations
        Section 1902(z)(2) lists the following service categories that are 
    available to the group of eligible TB-infected individuals:
         Prescribed drugs;
         Physicians' services, outpatient hospital, rural health 
    clinics, federally qualified health clinic services;
         Laboratory and x-ray services, including services to 
    diagnose and confirm the presence of infection;
         Clinic and federally qualified health center services;
         Targeted case management services; and
         Services, other than room and board, designed to encourage 
    completion of regimens of prescribed drugs by outpatients.
        Even though section 1902(z)(2) lists these above services as 
    available to the new eligibility group, the services (except for case 
    management and services designed to encourage the completion of TB-drug 
    regimens) are available only to the extent they are otherwise available 
    to mandatory categorically needy eligibility groups under the State's 
    Medicaid plan. That is, although the statutory material found in the 
    matter following section 1902(a)(10)(F) (which provides exceptions to 
    the Medicaid comparability rules), specifically limits the services 
    available to the new group to those categories listed above, there is 
    nothing in the exception to the comparability rules that would permit 
    the State to offer the new eligibility groups any more services than 
    are available to all other categorically needy groups.
        Some of the services listed in section 1902(z)(2), specifically, 
    physician, outpatient hospital, rural health center, federally 
    qualified health center, laboratory, and x-ray services, are mandated 
    services. This means that States that elect to extend eligibility to 
    the new group of TB-infected individuals must make these categories of 
    services available to the new group to the same extent the services are 
    available under the plan as long as the services are TB-related.
        With regard to prescribed drugs and clinic services, the State may 
    only make these service categories available if the service category is 
    already available under the approved State Medicaid plan. That is, a 
    State could not make prescribed drugs available to an individual 
    eligible under the new TB-infected group if the State does not make 
    prescribed drugs available to the categorically needy under its State 
    plan. To do so would violate the Medicaid comparability rules which 
    require that services be available in equal amount, duration, and scope 
    to all categorically needy individuals. Conversely, if a State offers 
    prescribed drugs and clinic services under its plan, the comparability 
    requirements dictate that the State must make these categories 
    available to the new group to the same extent the services are 
    available under the plan as long as the services are TB-related. Any 
    limitations on amount, duration, and scope that otherwise apply under 
    the plan also apply to the new group. For example, if a State limits 
    the number of prescriptions an individual may receive in a month, that 
    same limitation applies to individuals eligible under the new TB-
    infected group.
        With regard to case management services, OBRA '93 also provides 
    that a State may limit case management services to TB-infected 
    individuals. In order to make the services available only to the new 
    eligibility group, the State must identify the new eligibility group as 
    a target group under its State plan. If a State chooses to broaden the 
    target group to encompass all TB-infected individuals, including 
    individuals in other categorically needy groups, it may do so.
        As indicated earlier, services designed to encourage completion of 
    drug regimens are not subject to the
    
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    comparability rules that require services to be available in the same 
    amount, duration, and scope to all eligibility groups. However, the 
    comparability rules would apply within the covered TB-infected group.
        With the exception of services designed to encourage completion of 
    drug regimens, each of the outpatient services must meet the 
    requirements and conditions of the existing regulations and statutory 
    provisions applicable to regular Medicaid. That is--
         Prescribed drugs must meet the definition in Sec. 440.120 
    and the FFP conditions of sections 1903(i) and 1927 of the Act relating 
    to drug rebates and drug rebate agreements with manufacturers and the 
    FFP limitations of Secs. 441.25, 447.331, and 447.332.
         Physicians' services must meet the definition in 
    Sec. 440.50; outpatient hospital services and rural health clinic 
    services must meet the definition in Sec. 440.20; and Federally 
    qualified health center services must meet the definition in section 
    1905(l)(2) of the Act. We propose to permit States to claim FFP for 
    costs incurred by physicians who diagnose and treat individuals 
    suspected of being infected with TB. Individuals whom a physician 
    suspects are TB-infected are eligible to receive services. If the 
    individual is later determined to not be TB-infected under the 
    specified criteria, eligibility will end on the last day of the month 
    in which the State takes action to terminate eligibility and sends 
    appropriate advance notice.
         Laboratory and X-ray services, including services to 
    confirm the presence of infection, must meet the definition in 
    Sec. 440.30;
         Clinic services must meet the definition in Sec. 440.90, 
    and Federally qualified health center services must meet the definition 
    in section 1905(l)(2) of the Act;
         Case management services must meet the definition in 
    section 1915(g)(2) of the Act.
        With respect to the services described in section 1902(z)(2)(F) 
    that are designed to encourage completion of regimens of prescribed 
    drugs by outpatients, including services to directly observe the intake 
    of prescribed drugs, we propose to permit States the option to 
    authorize providers broad latitude in furnishing a limited package of 
    TB-related services to individuals who qualify for Medicaid under the 
    provisions of section 1902(z)(1) of the Act. We believe that services 
    designed to encourage completion of drug regimens will vary among 
    States. Permitting a broad interpretation will allow States to design 
    the program most appropriate to their needs. Any service related to the 
    completion of a prescribed drug regimen, except for inpatient services 
    and room and board, may be covered. For example, the types of services 
    may include:
        (1) Transportation to and from necessary treatment services.
        (2) In-home monitoring of the individual's illness and adherence to 
    a prescribed drug regimen.
        (3) Patient education and anticipatory guidance. These services are 
    directly related to ensuring the patient's completion of the prescribed 
    drug regimen.
        (4) Certain other medical services which are not otherwise included 
    under section 1905(a) that will encourage completion of the drug 
    regimen; for example, coverage of pick up and delivery of prescribed 
    drugs as long as this service is not generally provided for free in the 
    community.
        These services may also include other medical services designed to 
    minimize barriers to completion of a prescribed drug regimen. However, 
    nonmedical services would be excluded. For example, nonmedical services 
    would include monetary incentives or gifts used as an incentive to 
    induce recipients to complete drug regimens; these items are not 
    medical nor would they minimize barriers to completion of a drug 
    regimen.
        We propose to require a State to specify in its State plan the 
    services that will be made available under the benefit to encourage 
    outpatients to complete regimens of prescribed drugs.
        Services available to this new group are available only if they 
    relate to the treatment of TB. We propose to allow the State to make 
    the determination of whether any particular service relates to the 
    treatment of TB on the basis of the individual's circumstances. For 
    example, some prescribed drugs for the treatment of TB can cause side 
    effects that may require additional care by specialists, such as 
    ophthalmologists, and the prescription of additional drugs to treat 
    side effects. Also, inpatient services are not covered, whether for 
    acute care hospitalization or for long-term care (H.R. Rep. No. 111, 
    103rd Cong., 1st Sess., 219 (1993)).
    
    C. Conforming Changes
    
        We propose to amend Secs. 435.201 and 436.201 to specify TB-
    infected individuals as a separate optional group. In addition, we 
    propose to amend Sec. 440.250 to specify the limitations on services to 
    TB-infected persons.
    
    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
    
        Section 804(2) of title 5, United Sates Code (as added by section 
    251 of Public Law 104-121), specifies that a ``major rule'' is any rule 
    that the Office of Management and Budget finds is likely to result in--
         An annual effect on the economy of $100 million or more;
         A major increase in costs or prices for consumers, 
    individual industries, Federal, State, or local government agencies, or 
    geographic regions; or
         Significant adverse effects on competition, employment, 
    investment productivity, innovation, or on the ability of United States 
    based enterprises to compete with foreign based enterprises in domestic 
    and export markets.
        We estimate that the federal share of Medicaid program costs 
    associated with this proposed rule, contingent upon 100 percent 
    participation by States, is approximately $100 million in FY 1999. 
    Therefore, this rule is a major rule as defined in Title 5, United 
    States Code, section 804(2).
        HCFA has examined the impact of this proposed rule as required by 
    Executive Order 12866 and the Regulatory Flexibility Act (Public Law 
    96-354). Executive Order 12866 directs agencies to assess all costs and 
    benefits of available regulatory alternatives and, when 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 Regulatory Flexibility 
    Act requires agencies to analyze options for regulatory relief for 
    small businesses. For purposes of the RFA, States and individuals are 
    not considered small entities. However, we do consider most Medicaid-
    participating physicians to be small entities if they have revenues of 
    $5 million or less annually.
        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
    
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    hospitals. Such an 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.
        This proposed rule would incorporate in regulations statutory 
    changes that are already in effect. The statutory provisions are 
    effective on the statutory established date, regardless of whether or 
    not we have issued final regulations. The statutory changes that expand 
    eligibility groups and coverage of services will increase Medicaid 
    program expenditures independently of the promulgation of this rule. 
    Program costs associated with these proposed regulations, which are 
    reflected in the following chart, are the result of legislation or due 
    to the interpretation of statutory changes already in effect.
    
                                 [Dollars in millions rounded to the nearest $5 million]
    ----------------------------------------------------------------------------------------------------------------
                                                                FY 1999    FY 2000    FY 2001    FY 2002    FY 2003
    ----------------------------------------------------------------------------------------------------------------
    Federal..................................................        100        105        115        125        135
    State....................................................         75         85         90         95        105
    ----------------------------------------------------------------------------------------------------------------
    
    These cost estimates are based on Center for Disease Control (CDC) data 
    on active, suspected (where a treatment regimen is begun until 
    infection is ruled out), and inactive (discovered during screenings and 
    are put on a prevention regimen) TB cases. The cost estimates are also 
    based on demographic, coverage, and income data in the Current 
    Population Survey and make assumptions regarding case growth and 
    medical inflation. The details of the cost estimate calculations are 
    available upon request. In addition, Federal administrative costs 
    associated with these proposed regulations are estimated at $5 million 
    annually. State and local administrative costs are also estimated at $5 
    million annually.
        For these reasons, we are not preparing analyses 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.
    
    V. Collection of Information Requirements
    
        Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), 
    agencies are required to provide 60-day notice in the Federal Register 
    and solicit public comment before a collection of information 
    requirement is submitted to the Office of Management and Budget (OMB) 
    for review and approval. In order to fairly evaluate whether an 
    information collection should be approved by OMB, the Paperwork 
    Reduction Act of 1995 requires that we solicit comment on the following 
    issues:
         Whether the information collection is necessary and useful 
    to carry out the proper functions of the agency;
         The accuracy of the agency's estimate of the information 
    collection burden;
         The quality, utility, and clarity of the information to be 
    collected; and
         Recommendations to minimize the information collection 
    burden on the affected public, including automated collection 
    techniques.
        Section 440.164 of this document contains requirements that a State 
    must specify in its State Medicaid plan what services will be provided 
    as TB-related services and describe any services that the State will 
    cover as services designed to encourage completion of regimens of 
    prescribed drugs by outpatients. We estimate that the public reporting 
    burden for this collection of information is approximately 1 hour.
        A notice will be published in the Federal Register when approval is 
    obtained. Organizations and individuals desiring to submit comments on 
    the information collection and recordkeeping requirements should direct 
    them to the officials whose names appear in the ADDRESSES section of 
    this preamble.
    
    List of Subjects
    
    42 CFR Part 435
    
        Aid to Families with Dependent Children, Grant programs-health, 
    Medicaid, Reporting and recordkeeping requirements, Supplemental 
    Security Income (SSI), Wages.
    
    42 CFR Part 436
    
        Aid to Families with Dependent Children, Grant programs-health, 
    Guam, Medicaid, Puerto Rico, Supplemental Security Income (SSI), Virgin 
    Islands.
    
    42 CFR Part 440
    
        Grant programs-health, Medicaid.
    
        42 CFR Chapter IV, Subchapter C, would be amended as follows:
    
    PART 435--ELIGIBILITY IN THE STATES, DISTRICT OF COLUMBIA, THE 
    NORTHERN MARIANA ISLANDS, AND AMERICAN SAMOA
    
        A. Part 435 is amended as follows:
        1. The authority citation for part 435 continues to read as 
    follows:
    
        Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
    1302).
    
        2. In Sec. 435.201, the introductory text of paragraph (a) is 
    republished, paragraphs (a)(7) and (a)(8) are reserved, and a new 
    paragraph (a)(9) is added, to read as follows:
    
    
    Sec. 435.201  Individuals included in optional groups.
    
        (a) The agency may choose to cover as optional categorically needy 
    any group or groups of the following individuals who are not receiving 
    cash assistance and who meet the appropriate eligibility criteria for 
    groups specified in the separate sections of this subpart.
    * * * * *
        (9) Individuals infected with tuberculosis (as defined in 
    Sec. 435.219).
    * * * * *
        3. A new Sec. 435.219 is added under the undesignated center 
    heading ``Options for Coverage of Families and Children and the Aged, 
    Blind, and Disabled'' to read as follows:
    
    
    Sec. 435.219  Individuals infected with tuberculosis (TB).
    
        (a) General rule. The agency may provide certain tuberculosis (TB) 
    related services (as defined in Sec. 440.164 of this subchapter) as 
    Medicaid to individuals who--
        (1) Are not mandatory categorically needy under subpart B of this 
    part;
        (2) Are infected with tuberculosis, as defined in paragraph (b) of 
    this section; and
        (3) Meet the income and resource requirements specified in 
    paragraph (c) of this section.
        (b) Definition of a TB-infected individual. An individual is 
    considered
    
    [[Page 49127]]
    
    to be TB-infected if any of the following conditions exist:
        (1) The individual has a positive tuberculin skin test using the 
    Mantoux method and receives treatment for latent TB infection or active 
    tuberculosis;
        (2) The individual has a negative tuberculin skin test but has 
    sputum culture or culture from another tissue sample that is positive 
    for the tuberculosis organism;
        (3) The individual has never received a tuberculin skin test but 
    has sputum culture or culture from another tissue sample that is 
    positive for the tuberculin organism;
        (4) The individual has a tuberculosis skin test that is negative 
    and whose sputum or other tissue culture for tuberculosis that is not 
    or cannot be obtained, but in the physician's judgment the individual 
    requires and is given TB-related drug or surgical therapy or both; or
        (5) The individual has a negative tuberculosis skin test, is being 
    treated with a tuberculosis drug regimen while awaiting the 
    tuberculosis culture results because the physician suspects that the 
    individual may have active tuberculosis, and has cultures that turn out 
    to be negative for tuberculosis, causing the tuberculosis drug regimen 
    to be discontinued.
        (c) Income and resource eligibility criteria.
        (1) Except as provided under paragraph (c)(2) of this section, the 
    individual must have--
        (i) Gross monthly income that does not exceed an amount equal to 2 
    times the SSI Federal Benefit Rate (as specified in 20 CFR 
    Secs. 416.105 and 416.410) plus $85; and
        (ii) Resources that do not exceed the SSI resource standard.
        (2) The State may use--
        (i) More restrictive Medicaid financial eligibility requirements 
    applicable to disabled individuals as specified in Secs. 435.121 and 
    435.230; and
        (ii) More liberal income and resource methodologies as specified 
    under Sec. 435.601(d).
        B. Part 436 is amended as follows:
    
    PART 436--ELIGIBILITY IN GUAM, PUERTO RICO, AND THE VIRGIN ISLANDS
    
        1. The authority citation for part 436 continues to read as 
    follows:
    
        Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
    1302).
    
        2. In Sec. 436.201, the introductory text of paragraph (a) is 
    republished, paragraphs (a)(8) and (a)(9) are reserved, and a new 
    paragraph (a)(10) is added, to read as follows:
    
    
    Sec. 436.201  Individuals included in optional groups.
    
        (a) The agency may choose to cover as optional categorically needy 
    any group or groups of the following individuals who are not receiving 
    cash assistance and who meet the appropriate eligibility criteria for 
    groups specified in the separate sections of this subpart:
    * * * * *
        (10) Individuals infected with tuberculosis (as defined in 
    Sec. 436.219).
    * * * * *
        3. A new Sec. 436.219 is added to read as follows:
    
    
    Sec. 436.219  Individuals infected with tuberculosis (TB).
    
        (a) General rule. The agency may provide certain tuberculosis (TB) 
    related services (as defined in Sec. 440.164 of this subchapter) as 
    Medicaid to individuals who--
        (1) Are not mandatory categorically needy under subpart B under 
    this part;
        (2) Are infected with tuberculosis, as defined in paragraph (b) of 
    this section; and
        (3) Meet the income and resource requirements specified in 
    paragraph (c) of this section.
        (b) Definition of a TB-infected individual. An individual is 
    considered to be TB-infected if any of the following conditions exist:
        (1) The individual has a positive tuberculin skin test using the 
    Mantoux method and receives treatment for latent TB infection or active 
    tuberculosis;
        (2) The individual has a negative tuberculin skin test but has 
    sputum culture or culture from another tissue sample that is positive 
    for the tuberculosis organism;
        (3) The individual has never received a tuberculin skin test but 
    has sputum culture or culture from another tissue sample that is 
    positive for the tuberculin organism;
        (4) The individual has a tuberculosis skin test that is negative 
    and whose sputum or other tissue culture for tuberculosis that is not 
    or cannot be obtained, but in the physician's judgment the individual 
    requires and is given TB-related drug or surgical therapy or both; or
        (5) The individual has a negative tuberculosis skin test, is being 
    treated with a tuberculosis drug regimen while awaiting the 
    tuberculosis culture results because the physician suspects that the 
    individual may have active tuberculosis, and has cultures that turn out 
    to be negative for tuberculosis, causing the tuberculosis drug regimen 
    to be discontinued.
        (c) Income and resource eligibility criteria.
        (1) Except as provided under paragraph (c)(2) of this section, the 
    individual must have--
        (i) Gross monthly income that does not exceed the AABD income 
    standard for disabled individuals, applying the maximum income 
    exclusion or disregards that are not dependent on disabled status.
        (ii) Resources that do not exceed the AABD resource standard (as 
    applicable to disabled individuals).
        (2) The State may use more liberal income and resource 
    methodologies as specified under Sec. 436.601(d).
        C. Part 440 is amended as follows:
    
    PART 440--SERVICES: GENERAL PROVISIONS
    
        1. The authority citation for part 440 continues to read as 
    follows:
    
        Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
    1302).
    
        2. A new Sec. 440.164 is added to read as follows:
    
    
    Sec. 440.164  Tuberculosis-related services.
    
        Tuberculosis (TB)-related services for individuals described in 
    Secs. 435.219 and 436.219 of this subchapter means the following 
    outpatient services--
        (a) Prescribed drugs (as defined in Sec. 440.120 and subject to the 
    FFP limitations of Secs. 441.25, 447.331 and 447.332 of this 
    subchapter);
        (b) Physicians' services (as defined in Sec. 440.50) and services 
    described in section 1905(a)(2) of the Act.
        (c) Laboratory and X-ray services including services to confirm the 
    presence of infection (as defined in Sec. 440.30);
        (d) Clinic services (as defined in Sec. 440.90) and Federally 
    qualified health center services (as defined in section 1905(l)(2) of 
    the Act).
        (e) Case management services (as defined in section 1915(g)(2) of 
    the Act); and
        (f) Services (other than room and board) designed to encourage 
    completion of regimens of prescribed drugs by outpatients, including 
    services to observe directly the intake of prescribed drugs.
        (1) The agency must specify in its State plan the types of services 
    it will provide under this benefit.
        (2) The services may not include nonmedical services, such as 
    monetary incentives or gifts, inpatient services, or room and board.
        (3) The services may not include a service that is generally 
    provided free in the community.
        3. Section 440.250 is amended by adding a new paragraph (u), to 
    read as follows:
    
    [[Page 49128]]
    
    Sec. 440.250  Limits on comparability of services.
    
    * * * * *
        (u) If the agency elects to cover individuals infected with 
    tuberculosis as specified in Secs. 435.219 and 436.219 of this 
    subchapter, medical assistance to those individuals is limited to TB-
    related services described in Sec. 440.164.
    * * * * *
    (Catalog of Federal Domestic Assistance Program No. 93.778--Medical 
    Assistance Programs)
    
        Dated: September 1, 1998.
    Nancy-Ann Min DeParle,
    Administrator, Health Care Financing Administration.
        Dated: April 28, 1999.
    Donna E. Shalala,
    Secretary.
    [FR Doc. 99-23515 Filed 9-9-99; 8:45 am]
    BILLING CODE 4120-01-P
    
    
    

Document Information

Published:
09/10/1999
Department:
Health Care Finance Administration
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
99-23515
Dates:
Comments will be considered if we receive them at the
Pages:
49121-49128 (8 pages)
Docket Numbers:
HCFA-2082-P
RINs:
0938-AG72: Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With Tuberculosis (HCFA-2082-P)
RIN Links:
https://www.federalregister.gov/regulations/0938-AG72/medicaid-optional-coverage-of-tb-related-services-for-individuals-infected-with-tuberculosis-hcfa-20
PDF File:
99-23515.pdf
CFR: (8)
42 CFR 436.219)
42 CFR 435.219)
42 CFR 435.201
42 CFR 435.219
42 CFR 436.201
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