[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.

[[Page 49122]]

    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

[[Page 49123]]

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),

[[Page 49124]]

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

[[Page 49125]]

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

[[Page 49126]]

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