Medicaid Program; Home and Community-Based Services and Respiratory Care for Ventilator-Dependent Individuals

Federal RegisterJul 25, 1994

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 435, 440, and 441

[MB-008-FC]

RIN 0938-AC55

Medicaid Program; Home and Community-Based Services and

Respiratory Care for Ventilator-Dependent Individuals

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule with comment period expands coverage of

Medicaid home and community-based services under the waiver provisions

of section 1915(c) of the Social Security Act. This final rule also

adds coverage of respiratory care services as an optional benefit under

State Medicaid plans.

These revisions and additions incorporate changes made by the

Consolidated Omnibus Budget Reconciliation Act of 1985 and the Omnibus

Budget Reconciliation Act of 1986 and respond to the public comments

that we received as a result of the June 1, 1988, publication of a

proposed rule. This final rule with comment period also incorporates

self-implementing provisions of the Omnibus Budget Reconciliation Act

of 1987, the Medicare Catastrophic Coverage Act of 1988, the Technical

and Miscellaneous Revenue Act of 1988, and the Omnibus Budget

Reconciliation Act of 1990 concerning home and community-based

services, and makes other technical changes not specifically related to

these statutes.

DATES: Effective Date: This final rule with comment period is effective

on August 24, 1994.

Comment Date: Written comments will be accepted on changes as noted

in sections II.C.2., II.G.2.b., II.G.3.b., II.G.4.b., II.G.5.b.,

II.G.6.b., and II.I.2. The comments will be considered if we receive

them at the appropriate address, as provided below, no later than 5:00

p.m. on September 23, 1994.

ADDRESSES: Mail written comments (original and two copies) to the

following address: Health Care Financing Administration, Department of

Health and Human Services, Attention: MB-008-FC, P.O. Box 7518,

Baltimore, Maryland 21207.

If you prefer, you may deliver your written comments (original and

two copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Ave., SW,

Washington, DC.

Room 132, East High Rise Building, 6325 Security Boulevard,

Baltimore, Maryland.

Due to staffing and resource limitations, we cannot accept comments

by facsimile (FAX) transmission.

If comments concern information collection or recordkeeping

requirements, please address a copy of comments to: Office of

Management and Budget, Office of Information and Regulatory Affairs,

Room 10235, New Executive Office Building, Washington, DC 20503,

Attention: Laura Oliven.

In commenting, please refer to file code MB-008-FC. Comments will

be available for public inspection as they are received, beginning

approximately three weeks after publication of this document, in Room

309-G of the Department's offices at 200 Independence Avenue, SW.,

Washington DC on Monday through Friday of each week from 8:30 a.m. to

5:00 p.m. (phone (690) 245-7890).

FOR FURTHER INFORMATION CONTACT: Robert C. Wardwell, (410) 966-5659,

for Payment and Coverage Policy.

Marinos T. Svolos, (410) 966-4451, for Post-Eligibility Treatment

of Income and Resources.

SUPPLEMENTARY INFORMATION:

I. General Background

This final rule with comment period contains final regulations for

the provision of Medicaid home and community-based services under

waivers granted under section 1915(c) of the Social Security Act (the

Act), and for the provision of respiratory care services as an optional

benefit under the Medicaid program.

Home and community-based services are those medical assistance

services provided under a State waiver that are not otherwise available

under a State's Medicaid plan. These services: (1) must be furnished in

accordance with an individually written plan of care that is subject to

approval by the State Medicaid agency; and (2) may be furnished only to

persons who, but for the provision of such services, would otherwise

require the level of care provided in a hospital, nursing facility (NF)

(formerly referred to as a skilled nursing facility (SNF) or

intermediate care facility (ICF)), or intermediate care facility for

the mentally retarded (ICF/MR). (Under section 4211(a)(3) of the

Omnibus Budget Reconciliation Act of 1987 (OBRA '87), Public Law 100-

203, the distinction between SNFs and ICFs under the Medicaid program

ended, effective October 1, 1990. Both of these facilities are now

categorized as NFs, as defined in section 1919(a) of the Act, effective

October 1, 1990. We generally use the acronym ``NF'' throughout this

rule unless we are quoting directly from a statute or providing an

historical reference. Medicaid recognizes two types of long-term care

facilities--NFs and ICFs/MR.)

Respiratory care services as medical assistance may be provided as

an option under the Medicaid program, as authorized and described in

sections 1902(e)(9) and 1905(a)(20) of the Act.

On June 1, 1988, we published a proposed rule in the Federal

Register (53 FR 19950) proposing to revise the Medicaid regulations

governing the provision of home and community-based services under

waivers and respiratory care services. This rule proposed to codify in

regulations section 9502 of the Consolidated Omnibus Budget

Reconciliation Act of 1985 (COBRA), Public Law 99-272, enacted on April

7, 1986, and sections 9408, 9411, and 9435(a) of the Omnibus Budget

Reconciliation Act of 1986 (OBRA '86), Public Law 99-509, enacted on

October 21, 1986.

Four additional public laws have been passed that contain

provisions that impact on the proposed rule. These laws were enacted

either immediately preceding or subsequent to the publication of the

proposed rule. The public laws are:

The Omnibus Budget Reconciliation Act of 1987 (OBRA '87),

Public Law 100-203, enacted on December 22, 1987 (sections 4102 (b) and

(c), 4118, and 4211);

The Medicare Catastrophic Coverage Act of 1988 (MCCA),

Public Law 100-360, enacted on July 1, 1988 (sections 411(k)(10)(A) and

411(k)(10)(H));

The Technical and Miscellaneous Revenue Act of 1988

(TMRA), Public Law 100-647, enacted on November 10, 1988 (section

8437); and

The Omnibus Budget Reconciliation Act of 1990 (OBRA '90),

Public Law 101-508, enacted on November 5, 1990 (sections 4741 and

4742).

In this final rule with comment period, we are incorporating

provisions of these public laws that relate to many of the regulatory

provisions in the June 1, 1988, proposed rule. We are inviting public

comments on the revisions that we have made to this proposed rule in

response to these legislative changes.

We have also revised the proposed regulations in response to public

comments. We received, on a timely basis, 16 letters from individuals,

associations, State agencies, and providers of services (primarily home

health agencies). While most commenters supported the provisions in the

proposed rule, the majority also expressed interest in expanding the

waiver program. Some commenters correctly noted that the proposed rule

did not include statutory changes made by OBRA '87, MCCA, and TMRA.

Because we have made a substantial number of revisions to the

proposed rule in response to legislative changes, we have organized our

discussion in this preamble by specific subject areas. We are using

this organization to group all of the additions and revisions to each

subject in one place. We are presenting the legislative basis for the

proposed rule and any subsequent legislative provisions that changed or

added to the provisions of the proposed rule. We are following the

legislative foundation with a discussion of the proposed regulations

for that area, any public comments we received, and our responses to

the public comments. We conclude each topic with a description of the

applicable provisions contained in this final rule.

II. Home and Community-Based Services Waivers

Section 1915(c) of the Social Security Act authorizes the Secretary

to waive certain Medicaid statutory requirements to enable a State to

cover a broad array of home and community-based services. Coverage of

these services enables elderly, disabled, and chronically ill persons,

who would otherwise be institutionalized, to live in the community.

Section 1915(c) specifies the services that may be covered, the

conditions for granting waivers, and the provisions governing the scope

of services under waivers. Section 1915(c) was added to title XIX of

the Act by the Omnibus Budget Reconciliation Act of 1981 (OBRA '81),

Public Law 97-35, to encourage the provision of services to Medicaid

recipients in noninstitutional settings. Prior to the enactment of OBRA

'81, the Medicaid program provided limited coverage for long-term care

services in noninstitutional settings.

A State may request approval by HCFA of waivers under section

1915(c) to provide home and community-based services that are not

otherwise available to certain recipients under the State's Medicaid

plan. These services must be furnished in accordance with an individual

written plan of care subject to approval by the State's Medicaid agency

and may be furnished only if the individual would otherwise require the

level of care provided in a hospital, NF, or ICF/MR and if the costs

are reimbursable under the State's plan. (The original statute

specified SNF or ICF. OBRA '87 struck out SNF or ICF and substituted NF

or ICF/MR.)

Existing regulations governing home and community based services

under waivers under section 1915(c) appear in various sections of 42

CFR parts 435, 440, and 441. This final rule with comment period

contains regulations which amend each of these three parts.

A. Expanded Habilitation Services

1. Background

Prior to the enactment of COBRA, a waiver granted under section

1915(c) of the Act allowed a State to receive Federal financial

participation (FFP) for the following services as home and community-

based services: case management services, homemaker/home health aide

services, personal care services, adult day health services,

habilitation services, respite care, and ``other'' services as

requested by the State and approved by the Secretary. Section 9502(a)

of COBRA revised section 1915(c) of the Act to explicitly include

certain prevocational, supported employment, and educational services

as habilitation services under home and community-based services.

Habilitation services are authorized by section 1915(b)(4) of the

Act and defined in section 1915(c)(5)(A) of the Act, as amended by

section 9502 of COBRA, as services designed to assist individuals in

acquiring, retaining, and improving the self-help, socialization, and

adaptive skills necessary to reside successfully in home and community-

based settings. Section 9502(a) of COBRA also added new sections

1915(c)(5) (B) and (C) to the Act that allow a State to request HCFA's

approval to include certain additional services previously excluded

from coverage in its definition of ``habilitation services'' for

individuals who receive waiver services after discharge from a NF or

ICF/MR. Sections 1915(c)(5) (B) and (C) provide that habilitation

services include prevocational, educational, and supported employment

services, but do not include--

Special education and related services, as defined in

section 602 (16) and (17) of the 1975 Amendments to the Education of

the Handicapped Act (Public Law 94-142, now located at 20 U.S.C. 1401

(16) and (17)), that are otherwise available to the individual through

a local educational agency; and

Vocational rehabilitation services that are otherwise

available to the individual through a program funded under section 110

of the Rehabilitation Act of 1973 (29 U.S.C. 730).

Section 9502(j)(1) of COBRA provides that section 9502(a) is

effective for services furnished on or after April 7, 1986. Section

4118(j) of OBRA '87 amended section 9502(j)(1) of COBRA to provide that

eligibility of previously institutionalized individuals for the

expanded habilitation services under a section 1915(c) waiver is

determined without regard to whether the individuals were receiving

institutional services before their eligibility under the waiver.

Section 1915(c)(5) as added by section 9502(a) of COBRA refers to

habilitation services, ``* * * with respect to individuals who receive

such services after discharge from a nursing facility or intermediate

care facility for the mentally retarded * * *''. In our proposed rule,

we interpreted ``after discharge'' as meaning that an individual is

discharged directly into a home and community-based services waiver.

(Individuals who have never been institutionalized, however, are not

eligible for the expanded habilitation services.) This provision was

effective as if it were included in the enactment of section 9502(j)(1)

of COBRA. As indicated in the Report of the Committee on the Budget to

accompany H.R. 3545 (OBRA '87) (H. Rept. No. 391, 100th Cong., 1st

Sess. 537 (1987)), the Congress included this amendment to section

9502(j) because it believed HCFA had misread COBRA in the proposed rule

by stating that expanded habilitation services would be provided only

to recipients discharged directly from a NF or ICF/MR into a home and

community-based services waiver program.

In the proposed rule, we included in regulations the provisions of

section 9502(a) by--

Revising Sec. 440.180 to provide for the expanded

definition of habilitation services under paragraphs (b)(6) and (c);

Adding Secs. 440.180(c)(2) and (3) to provide for the

inclusion of prevocational, educational, and supported employment

services under a home and community-based waiver and for the exclusion

of certain services; and adding Sec. 441.302(i) and Sec. 441.303(h) to

require documentation to support State health and welfare assurances

for the provision of these expanded services.

Revising Sec. 441.310(a)(3) to provide for limits on FFP

for prevocational, educational, and supported employment services.

We received the following comments on this proposal:

Comment: Five commenters raised issues concerning the expanded

definition of habilitation to include educational, prevocational, and

supported employment services. Some commenters suggested that HCFA was

imposing an age minimum of 22 for the expanded habilitation services.

Others stated that our definition of prevocational services was too

strict and should be more consistent with section 4442.3(B)(3)(a) of

the State Medicaid Manual, which distinguishes prevocational services

from noncovered vocational services. (This definition was added in HCFA

Transmittal No. 37, issued in September 1988.)

Response: We are not imposing a minimum age for the expanded

habilitation services. Our discussion of this subject in the preamble

of the proposed rule pertained only to the fact that most educational

and prevocational services for individuals under 22 years of age

ordinarily would be provided under State and Federal programs other

than Medicaid. We agree with the commenters concerning the need for

more consistency between the regulations defining prevocational

services and the related HCFA instructions, and have revised

Sec. 440.180(c)(2)(i) of the proposed regulations to make the policy

consistent.

2. Provisions of the Final Rule

We are adopting the proposed regulations as final rules, with the

following changes:

We have revised Sec. 440.180(c)(1) to provide that a State

may provide expanded habilitation services under a new or amended

waiver to recipients who have been discharged from a Medicaid-certified

NF or ICF/MR, regardless of when the discharge occurred. We have made a

conforming change to Sec. 441.302(i)(2).

We have revised Sec. 440.180(c)(2)(i) to incorporate a

provision to distinguish covered prevocational services from noncovered

vocational services.

We have revised Sec. 441.310(a)(3)(iii) to clarify that

FFP is not available for prevocational, educational, or supported

employment services, or any combination of these services, as part of

habilitation services provided to recipients who were never

institutionalized in Medicaid-certified NFs or ICFs/MR.

B. Services to Patients with Chronic Mental Illness

1. Background

Section 9411(d) of OBRA '86 amended section 1915(c)(4)(B) of the

Act by adding day treatment or other partial hospitalization services,

psychosocial rehabilitation services, and clinic services (whether or

not furnished in a facility) for individuals with chronic mental

illness to the list of services specifically enumerated as home and

community-based services. Therefore, effective October 21, 1986 (the

date OBRA '86 was enacted), States may request that any of the above

services be provided under a waiver or renewal of a waiver for persons

diagnosed as chronically mentally ill.

In the proposed rule, we--

Revised Sec. 440.180 to add a new paragraph (b)(8) to

provide for the inclusion of day treatment or other partial

hospitalization services, psychosocial rehabilitation services, and

clinic services for individuals with chronic mental illness as home and

community-based waiver services;

Added new Secs. 441.302(i) and 441.303(i) to specify

requirements for written State health and welfare assurances for the

provision of these services and for supporting documentation of these

assurances;

Added a new Sec. 441.310(a)(4) to specify limits on FFP

for the provision of these services.

We received the following public comment on these proposed

regulations:

Comment: One commenter noted that States may provide the specified

services to the mentally retarded as well as to the chronically

mentally ill.

Response: Section 1915(c)(4)(B) of the Act authorizes the provision

of day treatment or other partial hospitalization services,

psychosocial rehabilitation services, and clinic services (whether or

not furnished in a facility) for individuals with chronic mental

illness. Neither the statute nor the conference committee report

mentions individuals diagnosed as mentally retarded. However, States

may request the authority to provide these services to the mentally

retarded under the broader waiver authority of section 1915(c)(4)(B) of

the Act as ``other'' services. The ``other'' services category has been

in existence since the home and community-based services waiver program

was established, and HCFA has approved a variety of services under this

category that States establish as cost-effective and necessary to avoid

institutionalization.

2. Provisions of the Final Rule

We are adopting the proposed provisions, with minor editorial

changes, as final rules. We have also redesignated Sec. 441.302(i) as

Sec. 441.302(j) to accommodate other revisions.

C. Scope of Respite Care

1. Background

Under section 1915(c)(4)(B) of the Act, a State may provide respite

care under its home and community-based waiver services program.

Respite care may be provided in institutional and noninstitutional

settings. However, under existing regulations at Sec. 441.310, FFP is

not available for the cost of room and board, except when provided as

part of respite care in a State-approved facility that is not a private

residence. Because respite care generally should be a short-term

service, we have required States to fully document the need for more

than 30 days of care.

In the proposed Sec. 440.180(b)(7), in accordance with section

1915(c)(4) of the Act, we imposed a 30-day limitation on the duration

of institutional respite care services provided during a waiver year to

any individual under a waiver program. We indicated in the proposed

rule that we were not placing a limit on noninstitutional respite care

but that we would closely review all waiver applications that requested

noninstitutional respite care in excess of 30 days per waiver year.

(Note: We have traditionally used the term ``waiver year'' for

any 12-month period for which a waiver applies. While we recognize

that the statute uses the term ``fiscal year'', we have not had a

problem with our use of ``waiver year'' for ``fiscal year''. Since

the term ``waiver year'' is generally understood and accepted by

those involved in the waiver process, we are continuing to use it in

the Medicaid regulations. We believe that a switch from the term

``waiver year'' to ``fiscal year'' would cause unnecessary

confusion.)

Subsequent to the publication of the proposed rule, section

4742(d)(l) of OBRA '90 amended section 1915(c)(4) of the Act to

eliminate restrictions on the number of hours or days of respite care

that a State may provide in any period under a waiver as long as the

State continues to show cost-neutrality in its waiver program. (``Cost-

neutrality'' means that the average per capita expenditures for

individuals under waivers does not exceed what the average per capita

expenditures for these individuals would have been if the waiver had

not been granted.) Section 4742(d)(2) of OBRA '90 specifies that the

changes under section 4742(d)(1) apply as if included under OBRA '81,

the original legislation for the waiver program, enacted August 13,

1981.

We received the following public comments on this proposal:

Comment: Six commenters expressed concerns about the proposed 30-

day limit on institutional respite care. Two commenters indicated that

room and board should be included under noninstitutional respite care.

Three commenters indicated that the 30-day limit is too strict; two

recommended a 60-day limit and one a 90-day limit. One of the

commenters who recommended a 60-day limit also recommended a 2-week

limit on consecutive weeks of institutional respite care.

Response: Section 1915(c)(4) of the Act prohibits the Secretary

from placing durational limits on respite care as long as the waiver

retains cost-neutrality as required under section 1915(c)(2)(D). The

issues raised by the commenters regarding our formerly proposed limits

on institutional respite care are now moot.

Section 1915(c)(1) of the Act specifically excludes room and board

as a covered waiver service. However, an exception with regard to

respite care was included under regulations based on the text of

section 1915(c)(4)(B) of the Act, the legislative history of OBRA '81

that amended the Act to include the home and community-based waiver

program, and the fundamental nature of respite care services. In

discussing the services that could be included under section 1915(c)

waiver programs, the Congress explained in H. Rept. No. 208, 97th

Cong., 1st Sess. 966 (1981) that respite care services were provided on

a short-term basis to individuals unable to care for themselves and

designed to fill-in for the absence of care or the ``need for relief

for those persons normally providing such care.'' The Congress

indicated that such services can be offered in ``the home of an

individual or an approved facility such as a hospital, nursing home,

foster home, or community-residential facility.''

Because of the Congress' discussion of certain institutional

facilities as locations for the provision of respite care, and the fact

that room and board costs are a core aspect of the costs of respite

care services offered in these facilities, we believe that the Congress

intended to allow for payment of room and board costs as part of the

costs of respite care services. Based in part on the cited language

from the Conference Report, we have decided to limit institutional

respite care to States which limit the facilities authorized to provide

such care to (1) Medicaid-certified hospitals and nursing homes, and

(2) foster homes and community-residential facilities that meet State

standards as specified in an approved waiver. Payment for room and

board costs as part of the costs of respite care services can be

authorized only for care provided in these facilities.

Section 1915(c)(2)(D) of the Act requires that a State maintain the

overall cost-neutrality of its waiver program. Significant increases in

respite care, particularly institutional respite care because it is

generally costly, could jeopardize the cost-neutrality of a waiver

program. A State that wishes to revise its limit on the number of hours

or days of respite care in a previously approved waiver program must

submit an amendment to its currently operating waiver. The amendment

must specify the revised limits and revise the cost-neutrality formula

to allow for the increased costs attributable to the revised respite

care limits.

2. Provisions of the Final Rule

We are not including in these final regulations any limits on the

duration of respite care. However, the State must continue to show

cost-neutrality in its waiver program. Because of the changes in the

law, the proposed revision to Sec. 440.180(b)(7) that contained limits

on respite care has been deleted. We will consider timely comments on

this deletion.

D. Permitting Hospital Level of Care for Certain Ventilator-Dependent

Recipients

1. Background

Section 9502(b) of COBRA amended sections 1915(c)(1) and (c)(2)(C)

of the Act. These amendments allowed States to provide home and

community-based services to individuals who are ventilator-dependent

and who, but for the provision of home and community-based services,

would continue to receive inpatient hospital, NF, or ICF/MR services

under a State's Medicaid plan. (The original statute specified SNF or

ICF. OBRA '87 struck out ``SNF'' or ``ICF'' and substituted ``NF'' or

``ICF/MR''.) Thus, sections 1915(c)(1) and (c)(2) of the Act authorized

waiver payments for individuals who require an inpatient hospital level

of care, if they enter the waiver program directly from a hospital and

are ventilator-dependent. Prior to this legislation, only persons

requiring NF or ICF/MR levels of care could be covered under a home and

community-based waiver program.

Section 9411(a)(1) of OBRA '86 subsequently amended section

1915(c)(1) of the Act to remove the amendments made by section 9502(b)

of COBRA and added a broader authority to permit States to extend home

and community-based services to individuals who, but for the provision

of these services, would require the inpatient hospital level of care.

Section 9411(a)(2) of COBRA amended section 1915(c)(2)(B) of the Act to

also require the State to provide for an evaluation of the individual's

need for inpatient hospital services prior to permitting the use of

home and community-based services as an alternative to inpatient

hospital services.

In the proposed rule, we revised or added provisions under

Secs. 441.301(a)(3)(i), (b)(1)(ii), and (b)(1)(iii)(A),

Secs. 441.302(c)(1), (c)(2)(i), (e), and (f), and Secs. 441.303(f)(1),

(3), and (5), to incorporate the provisions of section 1915(c)(2).

These provisions extended home and community-based services coverage to

individuals who would otherwise need inpatient hospital care and

required States to provide for an evaluation of the need for inpatient

hospital services. In addition, we included a proposed expansion of

Sec. 441.303(c)(2) to require States that use a level of care

evaluation form other than that used for nursing home placements to

assure us that the outcome of that evaluation form is reliable, valid,

and fully comparable to the form used for nursing home placement.

2. Provisions of the Final Rule

We did not receive any comments on these provisions. We have,

however, made the following clarifying changes in the final rule:

We substituted ``NF'' or ``ICF/MR'' for ``SNF'' or ``ICF''

to conform the regulations to OBRA '87.

We have revised Sec. 441.303(c)(2) by substituting

``hospital, nursing facility, or ICF/MR'' for ``nursing home.'' Level

of care evaluation forms from any of these facilities will not need

State assurances for reliability and validity.

E. Bundling of Services

1. Background

We proposed to revise Sec. 441.301(b)(4) to require States to

describe the services to be furnished under home and community-based

services waivers under section 1915(c) so that each service is

separately defined. Multiple services that are generally considered to

be separate services cannot be consolidated under a single definition.

Commonly accepted terms must be used to describe the service and

definitions may not be open-ended in scope.

We received the following comments on the proposed rule:

Comment: Two commenters recommended that States be allowed to

combine (bundle) certain services under a single definition under home

and community based services waivers under section 1915(c) for ease of

reporting.

Response: We believe that services enumerated in the statute

(section 1915(c)(4)(B)), such as personal care or adult day health

services, must stand alone and not be included in a bundled service. In

addition, bundling of these services would not ease the waiver process

because the cost of each component of the combined service would need

to be computed separately to show how the single service cost was

derived. The bundling of several waiver services into a single service

definition may also unnecessarily restrict an individual's freedom of

choice of providers (section 1902(a)(23) of the Act) by limiting the

pool of qualified providers. Bundling would limit the pool of providers

able to furnish the bundled service because fewer providers would be

capable of furnishing the broader array of services that result when

various services are combined into bundles. Under a bundling

arrangement, a provider must be able to furnish all of the component

services in a bundle to qualify for a provider agreement. We will

consider a combined service definition if the State establishes that

the bundling of services will permit more efficient delivery of

services and not compromise either the availability of services or an

individual's free choice of providers. If HCFA authorizes the bundling

of services, however, States must continue to compute separately the

costs of the component services to support the final cost of the

bundled waiver service for the cost-neutrality formula.

2. Provisions of the Final Rule

We have adopted the proposed regulations as final rules with two

modifications:

We have revised proposed Sec. 441.301(b)(4) to specify

that HCFA will approve combined service definitions (bundling) if the

definitions will permit more efficient delivery of services and not

compromise an individual's access to or free choice of providers.

We have added a new paragraph Sec. 441.303(f)(10) to

require States to continue to compute separately the costs and

utilization of the component services that compose a HCFA-approved

bundled service.

F. Waiver of Comparability Requirement and Certain Income and Resource

Eligibility Requirements

1. Waiver of Comparability Requirement

Section 9411(c) of OBRA '86 amended section 1915(c)(3) of the Act

to limit the Medicaid State plan requirements under section 1902(a)(10)

of the Act that may be waived under section 1915(c) to

``comparability'' of covered services under section 1902(a)(10)(B);

that is, that covered services be equal in amount, duration, and scope

for certain Medicaid recipients. Previously, all of section 1902(a)(10)

of the Act could be waived by the Secretary if requested by States. By

indicating that only section 1902(a)(10)(B) of the Act may be waived,

the Congress narrowed the scope of this particular waiver option.

Specifically, section 1902(a)(10)(B) of the Act requires that the

medical assistance made available to any eligible categorically needy

individual may not be less in amount, duration, or scope than the

medical assistance made available to any other categorically needy

individual, and may not be less in amount, duration, or scope than the

medical assistance made available to medically needy individuals.

Consequently, a waiver of comparability affords the State an

opportunity to target waivers to certain specific groups without

providing those services to other groups. The amendment made by section

9411(c) is effective for waivers and renewals of waivers approved on or

after October 21, 1986.

Regulations implementing section 1902(a)(10)(B) are located at

Sec. 440.240.

In the proposed rule, we revised Sec. 441.301(a)(2) to provide

that, when applicable, a request for waiver of Medicaid requirements

could include a waiver of sections 1902(a)(1) and (a)(10)(B) of the Act

which concern ``statewide'' application of Medicaid and ``comparability

of services.'' Prior to enactment of section 9411 of OBRA '86, a State

could request and receive waivers of section 1902(a)(1) and 1902(a)(10)

of the Act. A waiver of 1902(a)(10) included waiver of comparability as

well as all other subsections in that section of the statute. Section

9411(c) of OBRA '86 limited the waiver authority to section

1902(a)(10)(B) or ``comparability of services''. Because of this

limitation, a State could no longer apply rules for deeming of income

and resources for institutionalized medically needy recipients to

determine Medicaid eligibility of the waiver population.

2. Medicaid Eligibility Rules

Section 4118(a)(1) of OBRA '87 amended section 1915(c)(3) of the

Act to allow States to waive section 1902(a)(10)(C)(i)(III) which

contains rules for determining income and resource eligibility for the

medically needy. This option allows States to use income and resource

methods and standards, other than those that would ordinarily be used

for medically needy individuals living in the community, provided that

such rules do not conflict with other provisions of the Medicaid

statute which States may not waive. That is, the option permits waiver

of rules, such as deeming of income and resources, that are applied

differently in the community than in an institution and are barriers to

participation in a waiver program.

When this provision was enacted, deeming was the primary barrier.

Over time, this has changed. There are now other eligibility policies

applied in an institutional setting that a State may wish to use

instead of policies that would normally be used in the community. For

example, under its waiver, a State may wish to apply to a home and

community-based waiver recipient living with a spouse, the spousal

impoverishment protection rules of section 1924 of the Act which would

have applied to this recipient had the recipient been living in a

medical institution. As a second example, for its home and community-

based recipients, a State might use more liberal income or resource

methods that the State has approved under section 1902(r)(2) of the Act

for institutionalized individuals who are eligible under a special

income level under Sec. 435.231.

If a State elects to use more liberal income rules under this

waiver authority, it is still subject to the FFP limits on Medicaid

expenditures for the medically needy under section 1903(f) of the Act,

as interpreted under Sec. 435.1007. These limits may not be waived. The

FFP limit for the medically needy is 133 and 1/3 percent of the highest

State's Aid to Families with Dependent Children (AFDC) money payment

for a family of the same size which has no income or resources. Because

the legislative history explicitly states that the Congress intended

that this waiver option permit States to use institutional deeming

rules, we are interpreting the FFP limits at Sec. 435.1007 to mean that

the income used for purposes of determining if the FFP limits are met

is income that would be used in the institutional setting. That is,

only the waiver recipient's income would be used in calculating the FFP

limits since spousal and parental income is not deemed to be available

in an institution. This interpretation will be reflected in a revision

to Sec. 435.1007 in a separate rule.

Prior to this amendment to section 1915(c)(3) and the amendment

under section 9411(c) of OBRA '86 limiting waivers under section

1902(a)(10) to ``comparability'' of covered services under section

1902(a)(10)(B), States had been permitted to waive eligibility

requirements for the categorically needy, but not the medically needy.

Generally, States used the waiver authority to use institutional income

and resource deeming rules. The result of these two amendments to

section 1915(c) is that this waiver authority no longer extends to the

categorically needy, but extends only to the medically needy. However,

a State may continue to use the institutional eligibility rules for

categorically needy waiver recipients, if the individuals are members

of an eligibility group that the State may elect to cover under section

1902(a)(10)(A)(ii)(VI) of the Act and Sec. 435.217.

3. Post-Eligibility Treatment of Income

In the proposed rule, we revised the post-eligibility rules at

Sec. 435.726(c)(1) and Sec. 435.735(c)(1) to include the provisions of

section 9502(e) of COBRA and section 9435(a) of OBRA '86. Post-

eligibility calculations for individuals who are found eligible under

Sec. 435.217 determine how much of eligible waiver recipients' income

is applied to the cost of home and community-based waiver services. One

of the deductions from waiver recipients' income included in these

calculations is a deduction for the maintenance needs of the waiver

recipient.

Section 9502(e) of COBRA amended section 1915(c) of the Act to

reflect a change in the amount States may protect for the maintenance

needs of waiver recipients in the post-eligibility calculations. The

amendment in COBRA specifically allows States to use a higher

maintenance needs standard for home and community-based recipients than

permitted under Secs. 435.726 and 435.735(c)(1) for waivers approved or

renewed on or after April 7, 1986. The amendment in OBRA '86 further

amended section 1915(c) to also permit use of the higher maintenance

need standards for waivers approved or renewed before April 7, 1986. In

the proposed rule, we provided that the maintenance amount be based on

a reasonable assessment of need and that States set an upper limit

which cannot be exceeded for any one individual. Should a State choose

to use maintenance need standards that vary by individual, it must

assure that all individuals in like circumstances are treated

comparably.

The proposed rule did not address how the rules used to determine

income in the post-eligibility income and resource process for an

institutionalized individual who has a spouse who lives in the

community would affect home and community-based waiver recipients whose

eligibility is based on section 1924 of the Act. We are addressing this

issue in a separate rule that will propose further revisions to the

post-eligibility regulations. These revisions will address application

of the section 1924 rules and other matters. They will include our

interpretation of ``institutionalized spouse'' at section 1924(h)(1) as

allowing, on a waiver-by-waiver basis, use of the post-eligibility

rules at section 1924(d) to determine Medicaid benefits payable for

individuals who are eligible for home and community-based waiver

services under Sec. 435.217. That is, an individual would be subject to

the section 1924 post-eligibility rules if (1) the individual's State

elected the section 1924(h)(1) post-eligibility option, (2) the

individual meets the criteria of Sec. 435.217, and (3) the individual

has a spouse who is neither institutionalized in a medical institution

or nursing facility nor receiving home and community-based waiver

services.

We caution States to carefully evaluate how section 1924(d) post-

eligibility rules will affect the waiver population. Generally, the

election of the section 1924(d) post-eligibility rules would not

adversely affect the waiver recipient. However, there is at least one

exception with respect to individuals who are not living with their

community spouses. If the section 1924(d) post-eligibility rules are

used for such individuals, the waiver recipient is not likely to have

enough protected income to pay for his or her maintenance needs. This

situation can occur because only the personal needs allowance for

institutionalized individuals is protected in the section 1924 post-

eligibility calculation. Income above the personal needs allowance

would go either to the community spouse in the form of a monthly income

allowance, or for medical and remedial care expenses (including waiver

services). Thus, the waiver recipient is not likely to have income to

pay for his or her food, clothing, and shelter in the community.

4. Provisions of the Final Rule

We are adopting the proposed Sec. 441.301(a)(2) to allow a State to

request a waiver of section 1902(a)(1) or section 1902(a)(10)(B) as

final. We are also adding a provision to that section to allow for

waiver of the requirements of section 1902(a)(10)(C)(i)(III) of the Act

concerning income and resource rules applicable to institutionalized

individuals with spouses living in the community, as added by section

4118(a)(1) of OBRA '87.

We are adopting the proposed revisions to Sec. 435.726(c)(l) and

Sec. 435.735(c)(l) as final, without further modification.

G. Expenditure for Waiver Services

1. Prohibition on Imposition of Certain Regulatory Limits on

Expenditures

a. Background. Section 9502(c) of COBRA amended section

1915(c)(2)(D) of the Act and added a new section 1915(c)(6). Section

9502(c)(1) of COBRA clarified section 1915(c)(2)(D) to specify that,

under a home and community-based services waiver, a State's estimated

average per capita expenditure for individuals under the waiver must

not exceed the estimated average per capita expenditure for services

without the waiver. We refer to this as ``a cost-neutrality test for

section 1915(c) waivers.'' (We have always interpreted section

1915(c)(2)(D) of the Act in this manner and previously implemented the

applicable standards accordingly.) The cost estimate formula is located

in regulations at Sec. 441.303(f)(l).

Section 1915(c)(6) of the Act, as enacted by section 9502(c)(2) of

COBRA, directs the Secretary to abolish the regulatory limitation

concerning home and community-based services waiver expenditures. This

expenditure limitation appears in existing regulations at

Secs. 441.302(e)(2) and 441.310(a)(2) and requires a State to provide

satisfactory assurance that actual total expenditures for home and

community-based services and the State's claim for FFP for the services

will not exceed the State's approved estimates for waiver services.

Under the existing regulations, expenditures that exceed the State's

approved estimates would not have been eligible for FFP.

In the proposed rule, we revised Sec. 441.302 (e) and (f) that deal

with a State's assurances on the cost-neutrality of its waiver

programs. Section 441.302(e) deals with a State's estimates as

contained in its waiver proposals and Sec. 441.302(f) deals with a

State's actual expenditures as reported on the State's annual

expenditure reports as required under section 1915(c)(2)(E) of the Act.

We inserted ``100 percent'' in each section to clearly indicate the

intention of section 9502(c) of COBRA that a waiver be cost-neutral

(formerly referred to as ``cost-effective''). The Congress intended

that expenditures made under a State waiver not exceed 100 percent of

the average per capita expenditure that the State reasonably estimates

would have been made if the waiver had not been granted.

We also proposed revisions to Sec. 441.304(d) to indicate that we

will review all estimates very closely to determine if they are

reasonable and based on statistically supportable assumptions. For

waivers that are approved and operational, we will compare the data the

State must furnish annually on its actual experience (HCFA form 372)

with the approved expenditures the State estimated would occur absent

the waiver. If we find that actual expenditures exceed the State's

approved estimates for expenditures absent the waiver, we will require

the State to amend its estimates for the subsequent waiver year(s). We

will compare the revised estimates with the State's actual experience

to determine if these estimates are reasonable. We may terminate a

waiver if we find that, based on the revised estimates in the amendment

request, the waiver is not cost-neutral or that the revised estimates

are unreasonable. For waiver renewal requests, we will compare the

estimated expenditures for the renewal period against the State's

actual experience as shown in its annual reports. Based on this

comparison, we will not approve a waiver renewal request if we find

that the renewal request is not cost-neutral or that the estimates are

not reasonable based on the annual reports.

These revisions were required by section 9502(c)(2) of COBRA.

We received the following public comments on these proposed

provisions.

Comment: A State agency suggested that a single recipient's cost

not be used to determine the waiver's cost effectiveness.

Response: In virtually all cases, we determine the cost-neutrality

of a waiver request by comparing the average costs for all recipients

under the waiver to the estimated average costs absent the waiver. The

only time we would review a single recipient's cost under a home and

community-based services waiver would be when a waiver serves only one

person. If the recipient's costs exceeded the appropriate institutional

costs, the waiver would not be cost-neutral. However, section

1915(c)(4)(A) of the Act authorizes a State, at its option, to limit

home and community-based services waivers to those recipients for whom

the State has a reasonable expectation that the cost of medical

assistance under the waiver for those individuals will not exceed the

cost of medical assistance for those same recipients absent the waiver.

Thus, this section of the Act permits States to include (1) only

recipients whose costs under a waiver are reasonably expected to be

less than or the same as the appropriate institutional costs under

medical assistance and (2) individual recipients whose waiver costs are

reasonably expected to exceed institutional costs under medical

assistance (if the waiver did not apply), as long as the estimated

average per capita cost with the waiver does not exceed the estimated

average per capita cost absent the waiver.

Comment: Two commenters asserted that a State should not be

required to submit an amendment to its waiver proposal if the State

exceeds its approved cost and utilization estimates.

Response: Section 1915(c)(2)(D) of the Act requires that we assess

the reasonableness of a State's estimates of the cost-neutrality of its

program. The amendment must be submitted prior to the expiration of the

waiver year in question and must include cost and utilization changes

for the current waiver year and all waiver years that follow through

the term of the approved waiver request. If a State anticipates

substantive changes in its cost and utilization estimates, we believe

that the State should be required to submit amendments to explain the

basis and extent of the changes. The State's recomputed cost-

effectiveness formula, based on the revised cost and utilization, must

substantiate continued cost-neutrality.

Comment: One commenter requested that we simplify the waiver

application process which includes estimations of expenditures based on

an equation specified in the regulations.

Response: We agree with the commenter's request. We are making a

significant change in the formula values proposed at Sec. 441.303(f)(1)

to simplify the waiver cost-neutrality formula and thus reduce the

overall complexity of the waiver application procedure. We are reducing

the formula by retaining only those formula values which are critical

in assessing the cost-neutrality of the program: D, D', G, and G'.

Section 1915(c)(2)(D) requires that States make assurances,

satisfactory to the Secretary, that waiver programs will be cost-

neutral to the Medicaid program. Cost-neutrality is defined in terms

which require that the average per capita annual Medicaid expenditure

with the waiver in place not exceed the average per capita annual

Medicaid expenditure without the waiver. The waiver formula is intended

to provide a uniform method of providing data to the Secretary,

sufficient to allow a determination of whether the State's estimate of

per capita cost-neutrality is reasonable. We believe that, based on

many years of program experience, the formula can be simplified to its

key elements. Specifically, we would retain the two factors which

represent average per-capita costs for waiver and other Medicaid

services under the waiver (D and D'). These would be compared to the

average per capita cost for alternative institutional care and other

related Medicaid expenditures without the waiver (G and G'). To ensure

these factors are inclusive of all relevant Medicaid expenditures, we

have redefined D' and G' to include all other medical assistance

expenditures and expanded services not under a State plan for early and

periodic screening, diagnostic and treatment (EPSDT) services

recipients. The meanings of D and G remain unchanged, but the

definitions have been revised for clarity. We are also deleting the

requirement at proposed Sec. 441.303(f)(3) that States must submit data

on the estimated number of beneficiaries and expenditures for those who

would receive hospital, NF, or ICF/MR services. With our simplification

and redefinition of formula values, there is no longer a need for these

data. We are renumbering the remaining paragraphs in section (f)

accordingly.

The following are our new definitions:

D = the estimated annual average per capita Medicaid cost for home

and community-based services for individuals in the waiver program.

D' = the estimated annual average per capita Medicaid cost for all

other services provided to individuals in the waiver program.

G = the estimated annual average per capita Medicaid cost for

hospital, NF, or ICF/MR care that would be incurred for individuals

served in the waiver, were the waiver not granted.

G' = the estimated annual average per capita Medicaid costs for all

services other than those included in factor G for individuals

served in the waiver, were the waiver not granted.

Even though we have eliminated the ``C'' value (number of

unduplicated waiver individuals a State intends to serve for each year

of the waiver) from the equation, we will continue to require each

State to report this information to us as part of a waiver request.

This number may be revised when a State determines that it needs to

increase or decrease the number of individuals it estimates it would

serve under the waiver. We will include this number in our approval

notices.

b. Provisions of the final rule. We are revising Sec. 441.303(f) to

include the changes noted above. We are simplifying the formula at

Sec. 441.303(f)(1). We are providing in Sec. 441.303(f)(2) that, for

purposes of the formula, the prime factors include the average per

capita cost for all services provided under the State plan that are not

accounted for in other formula values and include expanded EPSDT

services.

To further simplify the waiver application process, we are also

revising Sec. 441.304 by deleting paragraph (a)(2), renumbering

paragraphs (a)(1)(i) and (a)(1)(ii) as paragraphs (a)(1) and (a)(2),

and revising paragraph (b). Section 441.304(b) will now read: HCFA will

determine whether a request for extension of an existing waiver is

actually an extension request or a request for a new waiver. If a State

submits an extension request that would add a new group to the existing

group of recipients covered under the waiver (as defined under

Sec. 441.301(b)(6)), HCFA will consider it to be two requests: one as

an extension request for the existing group, and the other as a new

waiver request for the new group. Waivers may be extended for

additional 5-year periods.

2. Computation of Estimated Expenditures Under Waivers for Individuals

With a Particular Illness or Condition

a. Background. Section 9502(d) of COBRA added a new section

1915(c)(7) of the Act that authorized States that have established or

wish to establish separate waivers for institutionalized, physically

disabled individuals to estimate the average per capita expenditure for

such individuals separately from the expenditures for all other

individuals in NFs and ICFs/MR. Section 9411(a)(3) of OBRA '86

subsequently changed section 1915(c)(7) to allow such separate

demonstrations of cost-neutrality to be applied in any waiver targeted

to inpatients with particular illnesses or conditions. In both cases,

the specific group of eligible individuals must have been inpatients in

hospitals, NFs, or ICFs/MR prior to being deinstitutionalized into the

waiver program. Prior to the enactment of COBRA, States were not

authorized to compute expenditures differently for a specific group of

individuals by comparing costs to those in that group only, rather than

total inpatient populations.

Section 9411(a)(3) of OBRA '86 amended section 1915(c)(7) of the

Act to allow States the option of using an alternative method for

estimating costs under section 1915(c)(2)(D) of the Act. This

alternative method applies to waivers for individuals with a particular

illness or condition, who are inpatients in hospitals, NFs, or ICFs/MR.

The State may determine the average per capita expenditure that would

have been made in a fiscal year for those individuals under the State

plan separately from the expenditures for other individuals who are

inpatients of those respective facilities. Alternatively, States may

continue to use the usual method of estimating average per capita

expenditures; that is, include the utilization and cost of all Medicaid

recipients otherwise using a hospital, NF, or ICF/MR.

In the Conference Committee report for OBRA '86 (H. Rept. No. 1012,

99th Cong., 2d Sess. 400 (1986)), the Congress indicated its intention

by stating that ``illness or diagnosis'' meant, for example, acquired

immune deficiency syndrome (AIDS), or AIDS-related condition (ARC) and

that ``condition'' meant, for example, chronic mental illness or

ventilator dependency. Thus, for waivers directed to any specified

group, States may make expenditure estimates specific to that group of

patients who are inpatients of hospitals, NFs, or ICFs/MR,

distinguished by illness or condition.

As with all home and community-based waivers, States must furnish

reasonable and verifiable cost estimates for waivers dealing with

individuals with a specific illness or condition.

The provisions of section 1915(c)(7) of the Act, as amended by OBRA

'86, apply to applications for waivers (or renewals) approved on or

after October 21, 1986.

Section 8437(a) of TMRA made a further amendment to section

1915(c)(7)(A) of the Act to extend the principle of specific illness or

condition cost estimates to individuals ``who would require the level

of care provided in hospitals, NFs or ICFs/MR.'' As amended by TMRA,

section 1915(c)(7)(A) specifies that, for a home and community-based

services waiver that applies to individuals with a particular illness

or condition, who are inpatients in, or who would require the level of

care provided in, hospitals, NFs, or ICFs/MR, the Secretary must allow

the State to determine the average per capita expenditure that would

have been made in a fiscal year for those individuals under the State

plan separately from the expenditures for other individuals who are

inpatients in, or who would require the level of care provided in,

those respective facilities. This provision applies to eligible

individuals whether or not those individuals are institutionalized

prior to entering the waiver.

Section 8437(b) of TMRA made the amendments to section

1915(c)(7)(A) effective for waiver applications submitted before, on,

or after November 10, 1988, the date TMRA was enacted.

In the proposed rule, we revised Sec. 441.303(f)(3) to provide

that, for waivers that apply only to individuals with a particular

illness or condition (formerly referred to as physically disabled in

section 9502(d) of COBRA) who are inpatients in hospitals, NFs, or

ICFs/MR, the State may determine the average per capita expenditures

that would have been made in each waiver year for those individuals

under the State plan separately from the expenditures for other

inpatients of the respective certified facilities.

We did not receive public comments on this specific provision.

b. Provisions of the final rule. We are adopting this proposed

provision as final with the change described below. We will consider

timely comments submitted on this change.

We have revised proposed Sec. 441.303(f)(4) (and renumbered it as

Sec. 441.303(f)(3) to accommodate other revisions) to include reference

to individuals who would require the level of care provided in

hospitals, NFs, or ICFs/MR. In addition, we have revised this section

to allow an agency to (1) exclude expenditures for other individuals in

the affected hospitals, NFs, or ICFs/MR when estimating average per

capita expenditures for a waiver for individuals with a particular

illness or condition who would otherwise require hospital, NF, or ICF/

MR level of care, as provided for in section 8437(a) of TMRA; and (2)

support the accompanying data with documentation to verify that the

cost-effectiveness estimates for these illness or condition specific

waivers are reasonable as required under section 1915(c)(2)(D) of the

Act.

3. Computation of Estimated Expenditures Under Waiver for

Institutionalized Developmentally Disabled Individuals

a. Background. Section 4118(k) of OBRA '87 added a new paragraph

(B) to section 1915(c)(7) of the Act concerning computation of the

average per capita expenditure estimates made by a State under section

1915(c)(2)(B) of the Act for a waiver that applies only to individuals

with developmental disabilities who are inpatients in a nursing

facility. (The original wording of the statute specified SNFs and

ICFs.) The new provision states that, if the State has determined, on

the basis of an evaluation under section 1915(c)(2)(B) of the Act, that

individuals need the level of care provided in an ICF/MR, the State may

determine the average per capita expenditures that would have been made

in a fiscal year for those individuals under the State plan based on

the average per capita expenditures under the State plan for services

to individuals who are inpatients of ICFs/MR (rather than NFs).

We have determined that the evaluation required under section

1915(c)(2)(B) of the Act should be completed as part of the

preadmission screening annual resident review (PASARR) required under

section 1919(e)(7)(B) of the Act entitled ``State Requirements for

Annual Resident Review.'' Section 1919(e)(7)(B)(ii) requires that, as

of April 1, 1990, in the case of each resident of a nursing facility

who is mentally retarded, the State mental retardation or developmental

disability authority must review and determine--

(1) Whether or not the resident, because of the resident's physical

and mental condition, requires the level of services of an intermediate

care facility described under section 1905(d) (ICF/MR); and

(2) Whether or not the resident requires specialized services for

mental retardation.

We assume that the evaluation of need noted above would be

accomplished during the annual resident review. (The requirement that

the States use the PASARR process in conducting these evaluations was

established by HCFA and is not contained in section 1915(c)(2)(B) of

the Act.)

Section 411(k)(10)(H) of MCCA amended section 1915(c)(7)(B) of the

Act to clarify that, in making estimates as to cost-neutrality in a

waiver that applies exclusively to developmentally disabled individuals

under section 1915(c)(7)(B) of the Act, who have been identified as

inappropriately placed in NFs, yet requiring the level of services

provided by an ICF/MR, the State may estimate utilization without

regard to the availability of ICF/MR beds for such inpatients.

Therefore, section 1915(c)(7)(B) exempts States from the requirement to

demonstrate ICF/MR bed capacity for recipients served by waivers

proposed under section 1915(c)(7)(B) of the Act.

b. Provisions of the final rule. We have added a new

Sec. 441.303(f)(4) to provide that, in making estimates for a separate

waiver program that applies only to individuals (1) who are

developmentally disabled, (2) who are inpatients of a NF, and (3) who

have been determined by the State through the PASARR process (section

1919(e)(7)(B) of the Act) to require the level of care provided in an

ICF/MR, the State may determine the average per capita expenditures

that would have been made in a fiscal year for those individuals based

on the average per capita expenditures for inpatients in an ICF/MR.

When submitting estimates of institutional costs without the waiver,

the State may use the average per capita costs of ICF/MR care even

though the deinstitutionalized developmentally disabled individuals

were inpatients of NFs. We will consider timely comments submitted on

this addition.

4. Computation of Expenditure Estimates for Persons With Mental

Retardation or a Related Condition in a Decertified Facility

a. Background. Section 4742(c)(1) of OBRA '90 added a new section

1915(c)(7)(C) to the Act relating to waivers for individuals with

mental retardation or a related condition who are residents in an ICF/

MR that has had its participation under the State's Medicaid plan

terminated. This added provision allows a State, when making estimates

under section 1915(c)(2)(D) of the Act, to determine the average per

capita expenditures under a waiver that would have been made in a

fiscal year for those individuals without regard to the termination and

as if Medicaid institutional payment continued. Termination of an ICF/

MR's participation under a State plan does not affect estimates made

under section 1915(c)(2)(D).

Section 4742(c)(2) provides that this provision applies as if

included in the enactment of OBRA '81, but only applies to facilities

terminated on or after November 5, 1990, the enactment date of OBRA

'90.

b. Provisions of the final rule. We are adding a new

Sec. 441.303(f)(7) to state that in making estimates for waivers that

apply to persons with mental retardation or related conditions, States

may include costs and utilization of Medicaid residents in ICFs/MR that

have been terminated on or after November 5, 1990, when determining the

average per capita expenditure that would have been made in a waiver

year. We will consider timely comments submitted on this addition.

5. Adjustments in Estimates To Include Preadmission Screening

Requirements

a. Background. Section 4742(e) of OBRA '90 provides that, under

section 1915(c) of the Act, a State may adjust its waiver estimates,

submitted under section 1915(c)(2)(D) of the Act, of average per capita

expenditures for individuals with mental retardation or a related

condition to include expenditures made on or after January 1, 1989,

that result from the preadmission screening program required under

section 1919(e)(7)(B) of the Act. The State may include increases in

expenditures for, or utilization of, ICFs/MR resulting from its

preadmission screening program for making determinations for

individuals with mental retardation admitted to NFs on or after January

1, 1989.

b. Provisions of the final rule. We are adding a new section

441.303(f)(9) to incorporate the provisions of section 4742(e) of OBRA

'90. We will consider timely comments submitted on this addition.

6. Treatment of Room and Board in Submitting Estimates of Expenditures

for Personal Caregivers

a. Background. Section 1915(c)(1) of the Act provides for payment,

as medical assistance, of part or all of the cost of home and

community-based services under an approved waiver (other than room and

board). Except for respite care furnished in a State-approved facility

that is not a private residence, FFP is not available for room and

board as part of a home and community-based service.

Section 4741(a)(1) of OBRA '90 amended section 1915(c)(1) to

specify that, for purposes of this section of the Act, ``the term `room

and board' shall not include an amount established under a method

determined by the State to reflect the portion of costs of rent and

food attributable to an unrelated personal caregiver who is residing in

the same household with an individual who, but for the assistance of

such caregiver, would require admission to a hospital, nursing

facility, or intermediate care facility for the mentally retarded.''

b. Provisions of the final rule. We are adding a new

Sec. 441.303(f)(8) to provide that, in submitting estimates for waivers

that include personal caregivers as a waiver service, the State may

include a portion of the rent and food attributed to the unrelated

personal caregiver who resides in the waiver recipient's home or

residence. The method of apportioning the costs of rent and food is

determined by the State, subject to review and approval by HCFA. The

method used must be explained fully to receive HCFA's approval. A

personal caregiver provides a waiver service to meet the recipient's

physical, social, or emotional needs (as opposed to services not

directly related to the care of the recipient; that is, housekeeping or

chore services). FFP for live-in caregivers is not available if the

recipient lives in the caregiver's home or in a residence that is owned

or leased by the caregiver. We have interpreted language in the statute

that rent and food costs attributable to the live-in caregiver may now

be included in the State's estimates of cost-neutrality to include

situations in which the live-in caregiver resides in the recipient's

home and the recipient would incur additional costs for such a

caregiver. When the recipient lives with the caregiver, the caregiver

incurs the additional costs for the recipient. We believe the payment

to the caregiver for the recipient's rent and food would violate the

room and board exclusion under section 1915(c)(1) of the Act. We will

consider timely comments on this addition.

H. Coordinated Services Between Maternal and Child Health Programs and

Home and Community-Based Service Programs

1. Background

Section 9502(h) of COBRA added a new section 1915(c)(8) to the Act.

This section allows the State agency that administers the Medicaid plan

to make cooperative arrangements, whenever appropriate, with the State

agency that administers the program for children with special health

care needs under the Maternal and Child Health Program (Title V of the

Act), to improve access to coordinated services to meet the children's

needs. The amendment made by section 9502(h) was effective April 7,

1986.

In the proposed rule, we redesignated the existing Sec. 441.306 as

Sec. 441.308 and added a new Sec. 441.306 to incorporate the provisions

of section 1915(c)(8) of the Act, as added by section 9502(h) of COBRA.

We did not receive any public comments on this provision.

2. Provisions of the Final Rule

We are adopting the proposed regulations, without modification, as

final rules.

I. Limitation on Participants in Waiver Programs

1. Background

Section 9502(i) of COBRA added a new section 1915(c)(9) to the Act.

This addition provides that when a waiver contains a limit on the

number of individuals who can receive home and community-based

services, the State may substitute additional individuals to replace

any recipients who die or become ineligible for Medicaid services under

the State plan. This provision was effective on April 7, 1986.

In the proposed rule, we redesignated existing Sec. 441.305 as

Sec. 441.307 and added a new Sec. 441.305 to provide that a State may

substitute additional individuals to replace those under a home and

community-based services waiver who die or become ineligible for waiver

services, when the waiver contains a federally imposed limit on the

number of individuals receiving waiver services, as specified in

section 1915(c)(9) of the Act, as added by section 9502(i) of COBRA.

Section 4118(b) (entitled ``Increase in Number of Individuals Who

May Be Served Under Model Home and Community-Based Services Waiver) of

OBRA '87 amended section 1915(c) of the Act by adding a new paragraph

(10) that states that ``No waiver under this subsection shall limit by

an amount less than 200 the number of individuals in the State who may

receive home and community-based services under such waiver.'' We

interpreted this provision as restricting the Secretary's ability to

limit the number of recipients a State could serve in a model waiver

program. That is, the Secretary may not place a limit below 200 on the

number of persons a State may serve. While the provision could,

arguably, be read to limit the actual number of individuals who may

receive model waiver services to no less than 200, based on the

legislative history, and the history of the section 1915(c) program, we

believe that this reading is unsupportable. First, model waiver

programs have historically had a Federally established limit of 50

individuals who could receive services. Second, the limited size of the

program is specifically noted in the OBRA '87 Conference Report (H.

Rept. No. 495, 100th Cong., 1st Sess. 755 (1987)), in the section

describing the current state of the law. Finally, section 4118 of MCCA

is entitled ``Increase in Number of Individuals Who May Be Served Under

Model Home and Community-Based Services Waiver.'' On these bases, we

believe that the Congress intended to enable States to serve a greater

number of persons while maintaining the Secretary's authority to impose

a limit on programs which she believes are of excessive size.

Section 411(k)(10)(A) of MCCA further amended section 1915(c)(10)

of the Act in an attempt to clarify the language in section 4118(b) of

OBRA '87, and confirmed our interpretation of the Congress' intent in

enacting that provision. This amendment restricts the Secretary's power

to limit the number of persons who can receive home and community-based

waivers to no lower than 200. Again, in light of the history of the

waiver program and the legislative history of this provision, we

interpret this amendment to restrict the Secretary's power to limit the

number of participants in the model waiver program only. Historically,

there has been no limit on the number of participants in the regular

home and community-based waiver programs, whereas there has been a 50-

person Federally imposed limit on the number of persons who can

participate in a model waiver. Also, section 411(k)(10)(A) was

specifically enacted to remedy the ambiguity in section 4118(b), which

itself was aimed only at model waivers. We believe, therefore, that

this provision enables the Secretary to limit the number of

participants in a model home and community-based program to 200

persons, or any amount above 200. Through these regulations, the

Secretary has opted to impose a maximum limit of 200 persons for any

State waiver program. On an individual State basis, an approved State

plan may contain a maximum limit that is lower than 200. Thus, no State

may serve any more than 200 persons, but any State may be limited to a

lower number as approved in its waiver program. There is no comparable

limit on regular waiver programs. Thus, the 200-person limit represents

the maximum number of individuals that a State may serve under a

``model'' home and community-based services waiver at any one time.

A State may, in accordance with section 1915(c)(9) of the Act,

replace individuals who die or lose Medicaid eligibility for State plan

services. However, the State is still limited to serving no more than

the number approved in its model waiver request, or 200 individuals, at

any time.

Section 411(k)(10)(A) is effective as if included in the enactment

of OBRA `87, that is, December 22, 1987. Thus, States may continue to

serve less than 200 recipients under approved model waivers and renew

these requests by any number of recipients up to the new 200-person

limit. States with model waivers approved prior to December 21, 1987,

may submit an amendment to obtain approval to serve clients in excess

of those originally approved, up to the new 200-person limit.

We received the following comments on the proposed rule:

Comment: Two commenters recommended that States be allowed to

substitute recipients in a home and community-based services waiver

program under section 1915(c) of the Act, as is permitted under a model

waiver program.

Response: The model waiver program derives its legal base from the

same statutory authority as the section 1915(c) waiver program but

administratively it has been limited in the total number of recipients

that could be served. The original limit was 50 individuals. As we

stated above, the amendment made by section 4118(b) of OBRA `87

increased the limit on model waivers to 200 individuals and the

amendment made by section 9502(i) of COBRA authorized substitution for

recipients who die or lose Medicaid eligibility. Although States may

replace recipients, there is no authorization for exceeding (at any

point in time) the 200-person limit on the model waiver request.

In contrast, HCFA has never prohibited the substitution of

recipients under the section 1915(c) waiver program. In fact, we

require that the utilization estimates submitted prior to approval must

be based on unduplicated recipient counts, not ``slots'' or full-time

equivalents. ``Unduplicated'' means that once a recipient is counted in

a particular setting (in a NF, for example), that recipient cannot be

recounted in that setting if readmitted during the reporting period

(waiver year). This is the same reporting principle used in HCFA Forms

64 and 2082. State waiver utilization estimates must include an

adjustment for Medicaid recipients who die, lose eligibility, or leave

the program for any reason (institutionalization, for example).

Therefore, substitutions are expected, and all persons replaced should

already be incorporated into the waiver utilization estimates approved

for each year of every waiver program. Because the unduplicated

recipient count includes reasonable estimates of substitution and the

statute requires reasonableness of estimates and cost-neutrality, we

are requiring waiver amendments if the State expects to exceed its

approved cost and utilization estimates, regardless of the reason for

the change.

Comment: Two commenters stated that HCFA is narrowing the

legislative intent by requiring institutional bed capacity to offset

increases in waiver recipients, especially since section 9502(c)(2) of

COBRA eliminated HCFA's proposed cap on total waiver costs as

established under Sec. 441.304(d)(1). The proposed cap was the product

of the State's estimate of waiver participants times the estimated

average per capita cost.

Response: We agree. The regulatory cap on total waiver costs has

already been eliminated by legislative action (section 1915(c)(6) of

the Act). Moreover, we believe the requirement that States establish

that there would be sufficient institutional bed capacity for their

waiver population in the event there was no waiver should be rescinded.

While this requirement served a sound analytical purpose as part of the

cost-neutrality test in the early days of the program, our experience

over the last several years has shown it to be of diminishing value.

The requirement placed an unreasonable burden on States by requiring

them to project the estimated development of additional institutional

capacity. That additional burden was never the requirement's intent and

its development was contrary to the interests of the States and the

Federal Government. Moreover, States have generally been successful in

documenting additional bed capacity sufficient to allow the expansion

of their waiver programs. Because the bed capacity test has become an

unnecessary and nonproductive exercise, we are deleting this

requirement. In lieu of this test, and in the absence of information to

the contrary, we will accept a State's assurance that, absent the

waiver, recipients in the waiver would receive the appropriate level of

Medicaid funded institutional care. Also, because the elimination of

the bed capacity test recognizes that data regarding program

utilization will no longer be relevant to the waiver application

process, we have simplified the waiver formula to eliminate those

formula values that relate to utilization. Instead, the formula now

deals exclusively with program costs, with and without the waiver. As

noted above, we will continue to require States to submit estimates of

the number of unduplicated waiver recipients it will serve in each year

of the waiver term. This figure will be indicated as ``C'' value and

may be revised as a State deems necessary.

2. Provisions of the Final Rule

We have adopted, as final, the revised Sec. 441.303(f) and the

proposed new Sec. 441.305 that incorporated the provision of section

1915(c)(9) of the Act as added by section 9502(i) of COBRA, with one

change: We have revised paragraph Sec. 441.305(b) to specify that there

is a 200-person limit (instead of 50) for model waivers under section

1915(c)(10) as amended by section 411(k)(10)(A) of MCCA. The revised

Sec. 441.303(f) reads, ``An explanation with supporting documentation

satisfactory to HCFA of how the agency estimated the average per capita

expenditures for services.'' We will consider timely comments on these

revisions.

We are also redesignating proposed Sec. 441.302(g) as (h) and

adding a new Sec. 441.302(g) to require that a State provide assurance

that, absent a waiver, recipients in the waiver would receive the

appropriate type of Medicaid-funded institutional care (hospital, NF,

or ICF/MR) that they require. We will consider timely comments on this

addition.

J. Waiver Extensions and Renewals

1. Background

Initially, section 1915(c) of the Act provided that approved home

and community-based services waivers could be granted for an initial

term of 3 years and could be extended for additional 3-year periods if

a State requests an extension. The Secretary could approve a request

for a waiver extension if the extension request met the waiver

requirements for the extended period and HCFA determined that the State

met all of the required assurances for the term of the initial waiver.

Section 9502(f) of COBRA provided that the Secretary, upon a

State's request, may extend any home and community-based services

waiver that expired on or after September 30, 1985, and before

September 30, 1986, subject to the State's meeting all requirements for

the waiver. The extension granted must be for a period of not less than

1 year and no more than 5 years.

Section 9502(g) of COBRA amended section 1915(c)(3) of the Act to

revise the periods of time for which a waiver may be renewed from

additional 3-year periods to additional 5-year periods under section

9502(j)(6) of COBRA. This amendment is effective for waiver renewals

approved on or after September 30, 1986.

In our proposed rule, we revised Sec. 441.304(a) to change waiver

extension or renewal periods to reflect the statutory requirements. We

did not receive any public comments on this provision.

Section 4102(c) of OBRA `87 provided that the Secretary extend

approval of a State's section 1915(c) waiver for the elderly on the

same terms and conditions through September 30, 1988, when (l) the

State as of December 1, 1987, had a waiver approved for elderly

individuals under section 1915(c) of the Act; (2) the waiver was

scheduled to expire before July 1, 1988; and (3) the State notified the

Secretary of its intention to file an application for a waiver under

section 1915(d) of the Act.

2. Provisions of the Final Rule

We have adopted, as a final rule, the proposed Sec. 441.304(a) to

change the waiver extension and renewal periods to conform to section

1915(c)(3), as amended by section 9502(g) of COBRA. We have not

included in the final rule changes to paragraph (a)(2) that were

included in the proposed rule because those changes are no longer

necessary.

K. Technical/Administrative Changes

1. Terminology Change

We have revised proposed Sec. 440.185 and amended Sec. 441.301

through Sec. 441.304 and Sec. 441.310 by changing references to ``SNF''

and ``ICF'' to ``NF'' to conform them to nomenclature changes made to

section 1915(c) by section 4211(a)(3) of OBRA `87.

2. Independent Assessment

Although not specifically addressed in the proposed rule, a State

agency asserted that our requirement in Sec. 441.303(g) for an

independent assessment of a State's waiver program that evaluates the

quality of care, the access to care, and the cost effectiveness is

costly and duplicates HCFA's regional office (RO) reviews.

Since the publication of this requirement (50 FR 10028, March 13,

1985), various State agencies have asserted that the requirement is

costly, unproductive, and duplicative of RO assessments. We agree with

the commenter and are making the independent assessment voluntary. If a

State determines it will contract for an independent assessment, FFP is

available for the costs attributable to the assessment. The results

should be forwarded to HCFA by the 90th day prior to expiration of the

approved waiver and cover at least the first 24 or 48 months of the

waiver.

3. Provision of Final Rule

We are revising 441.303(g) to read as follows: ``The agency, at it

option, may provide for an independent assessment of its waiver that

evaluates the quality of care provided, access to care, and the cost-

neutrality. The results of the assessment should be submitted to HCFA

at least 90 days prior to the expiration of the waiver and cover the

first 24 or 48 months of the waiver. If a State chooses to provide for

an independent assessment, FFP is available for the costs attributable

to the independent assessment.''

III. Respiratory Care Services

A. Background

Until the enactment of OBRA '86, the Medicaid statute did not

permit payment for respiratory therapy services in a patient's home as

a separate and distinct State plan service. Previously, such services

could only be provided as a component of other State plan services or

as a home and community-based service under a section 1915(c) waiver.

For example, certain types of respiratory therapy services in the home

were available when provided as a medically necessary component of

covered home health nursing services. States also had the option of

providing respiratory therapy services as an element of three other

optional Medicaid benefits: medical or remedial care provided by a

licensed practitioner, private duty nursing, and rehabilitative

services. Thus, when respiratory care was available previously under

the Medicaid State plan, it was provided as a part of a broader

coverage authority. Because these authorities did not allow respiratory

care services to be directed only to a specific population but required

that such services be available to all recipients, very few States

provided coverage for respiratory care services. Moreover, while

respiratory care services could be provided to a specific population

under a home and community-based services waiver, States' use of this

waiver process to provide coverage was limited.

Section 9408(a) of OBRA '86 amended section 1902(e) of the Act to

provide, under paragraph (9), that, at the option of the State, a State

Medicaid plan may be amended to include respiratory care services as

medical assistance for an individual who:

Is medically dependent on a ventilator for life support at

least 6 hours per day;

Has been so dependent on ventilator support for at least

30 consecutive days as an inpatient (or the maximum number of days of

inpatient care authorized under the State plan, if less than 30 days)

as demonstrated by a continuous stay in one or more hospitals, NFs, or

ICFs/MR;

But for the availability of respiratory care services,

would require respiratory care as an inpatient in a hospital, NF, or

ICF/MR and would be eligible to have payment made for inpatient care

under the State plan;

Has adequate social support services to be cared for at

home; and

Wishes to be cared for at home.

Under this provision, respiratory care services are services

provided on a part-time basis in the home of the individual by a

respiratory therapist or other health care professional who is trained

in respiratory therapy (as determined by the State). The services under

this benefit may not be included within other items and services

furnished to these individuals as medical assistance under the State

Medicaid plan.

Section 9408(b) of OBRA '86 amended section 1902(a)(10) of the Act

by adding item (IX) in the matter following section 1902(a)(10)(E), to

provide that a State is not required to make respiratory care services

(as defined in section 1902(e)(9)(C) of the Act) available, or

available in the same amount, duration, and scope, to individuals who

do not meet the criteria in section 1902(e)(9)(A) of the Act. However,

if the State provides this benefit, it is required to make respiratory

care services available in the same amount, duration, and scope to all

Medicaid recipients who do meet the criteria in section 1902(e)(9)(A)

of the Act.

Section 9408(c) of OBRA '86 includes respiratory care services

under the definition of medical assistance in section 1905(a)(20) of

the Act and makes technical conforming amendments to sections

1902(a)(10)(C)(iv) and 1902(j) of the Act.

In our proposed rule, we added--

A new Sec. 440.185 to allow a State the option to amend

State Medicaid plan coverage of respiratory therapy services for

ventilator-dependent individuals under the specific conditions of

coverage that were enumerated by section 9408(a) of OBRA '86;

A new Sec. 440.250(o) to the list of exceptions to the

comparability of service requirement. In following the statutory

language in section 9408(a) of OBRA '86, we also indicated that

respiratory care services for ventilator-dependent individuals are

exempt from the general comparability requirement that services be

provided in equal amount, duration, and scope to any eligible group

under the State plan. We have, however, required comparability of

services among those Medicaid-eligible persons under the State plan

satisfying the explicit conditions of coverage for these services.

Six entities submitted comments concerning respiratory care

services as a new optional Medicaid benefit.

Comment: One commenter asked whether respiratory care equipment,

particularly ventilators, would be covered as equipment under the new

benefit.

Response: Ventilators will not be covered under this benefit.

Section 1902(e)(9) of the Act, as added by section 9408 of OBRA '86,

provides for respiratory therapy services, not equipment, to be

provided to ventilator-dependent individuals as an optional service.

The statute and accompanying conference committee report (H. Rept. No.

1012, 99th Cong., 2d Sess. 413-414 (1986)) do not suggest that

equipment required in the home (such as ventilators, needed to sustain

the recipient's health and welfare) would be included. Such equipment

is supplied by the State as a home health benefit under

Sec. 440.70(b)(3), that mandates the provision of medical supplies,

equipment, and appliances suitable for use in the home. In addition,

States that pay for the optional prosthetic devices benefit may cover

ventilators as a prosthetic device that supports a weak or deformed

portion of the body under Sec. 440.120(c)(3).

Comment: Another commenter asked us to define a recipient's home.

Response: A recipient's home is a place of residence other than a

hospital, NF, ICF/MR, or other institution as defined at Sec. 435.1009.

We have revised Sec. 440.185 to specify that a recipient's home does

not include these facilities.

Comment: Two commenters suggested that more medical direction be

required in decisions regarding the provision of respiratory therapy at

home. One commenter proposed the use of medically sound criteria to

determine eligibility and the other commenter recommended that more

physician oversight and involvement in the direction of care be

required.

Response: We agree with the commenters concerning the need for

greater medical direction for individuals in need of respiratory care

services. We have added Sec. 440.185(a)(6) to require the direction of

a physician who is familiar with the technical and medical components

of home ventilator support and who has determined that in-home care is

safe and feasible.

Comment: One commenter stated that the regulations implementing the

option to provide respiratory care services are too restrictive and

limited as a Medicaid State plan option because respiratory care

services would be limited to individuals who (1) need at least 6 hours

of ventilator support for life support, (2) depend on ventilator

support for at least 30 consecutive days and (3) require respiratory

care as an inpatient.

Response: Our proposed regulations closely followed the statutory

language and the only restrictions we imposed were those contained in

the statute. In response to comments, we are now adding the requirement

that a recipient receive respiratory care services under the direction

of a physician who is familiar with the technical and medical

components of home ventilator support and who has determined that in-

home care is safe and feasible.

Comment: One commenter was concerned that the payment rate for in-

home respiratory therapy would not be adequate.

Response: Under the Medicaid program, the State establishes the

payment rate within broad Federal guidelines. We believe it would be

inappropriate to dictate a special payment procedure for this service.

Comment: One commenter requested that HCFA specifically refer to

``respiratory therapy technician'' as approved provider of respiratory

care services to effectively recognize another level of skilled

respiratory care practitioner.

Response: Section 9408(a) of OBRA '86 does not anticipate or

require that we specify which practitioners or technicians are accepted

by the States as providers. In the proposed rule (53 FR 19957 and

19960), we designated a broad and inclusive category ``other health

care professional trained in respiratory therapy (as determined by the

State)'' in the preamble and in Sec. 440.185 of the regulation text.

This ``other'' category could include the respiratory therapy

technician as well as other types of skilled practitioners to the

degree that they are recognized under State law.

B. Provisions of the Final Rule

We are adopting the proposed regulations under Sec. 440.185 and

Sec. 440.250(o) as final rules with the following modifications:

We have added Sec. 440.185(a)(6) to require that (1) an

individual who receives home respiratory care must receive these

services under the care of a physician who is familiar with the

technical and medical components of home ventilator support, and (2)

that this physician must determine medically that in-home care is safe

and feasible for the recipient.

We have revised Sec. 440.185(b) to specify the facilities

that are not considered to be a recipient's home.

IV. Regulatory Impact Analysis

A. Introduction

Any impact of this final rule with comment period upon providers

will be the result of individual State decisions as developed in waiver

requests and including coverage of respiratory care for ventilator-

dependent individuals. Due to the positive reception of the home and

community-based waiver program, we believe that this rule will be well-

received by those concerned with such programs. This rule generally

benefits States and providers. The revisions to regulations covering

home and community-based waivers offer broader service coverage than

current rules and may result in new waiver applications and expansion

of existing waivers. Thus, there may be more funds flowing through

waivers. Because of the appeal of the program to States, the proportion

of Medicaid expenditures flowing through home and community-based

waivers is growing. The broader coverage made possible under this final

rule with comment period is one factor that offers opportunity for

further growth. Waivers would also be approved for longer periods,

which may increase the aggregate magnitude of granted waivers.

Thus, although this final rule with comment period should

contribute to the growth of expenditures under waivers, we are unable

to isolate the effects of this final rule from other factors affecting

the growth of waivers.

If this final rule with comment period results in a substantial

increase in the growth of waivers, it could affect small entities. Most

entities would benefit--contingent upon State decisions that cannot be

predicted. Although the changes being implemented in this final rule

will facilitate the approval of an increased volume of waivers, we do

not expect the rule in itself to increase waivers to the extent that a

demonstrable significant economic impact would result. With the

exception of the revision to Sec. 441.303(f)(1) that eliminates the bed

capacity (also called the ``cold bed test'') factor from the annual

average per capita expenditures estimate, regulations establishing

terms or conditions of Federal grants, contracts, or financial

assistance call for a different form of regulatory analysis than do

other types of regulations. In some instances, an extensive benefit-

cost analysis may be appropriate to inform the Congress and the

President more fully about the desirability of the program, but this

would not ordinarily be required in a regulatory impact analysis. The

primary function of an RIA for this type of regulation should be to

verify that the terms and conditions are the minimum necessary to

achieve the purpose for which the funds were appropriated. Beyond

controls to prevent abuse and to ensure that funds appropriated to

achieve a specific purpose are channeled efficiently toward that end,

maximum discretion should be allowed in the use of Federal funds

particularly when the recipient is a State or local government.

B. Regulatory Flexibility Act

We generally prepare a regulatory flexibility analysis that is

consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612) unless the Secretary certifies that a final rule does not

have a significant economic impact on a substantial number of small

entities. For purposes of the RFA, we consider all providers to be

small entities. Thus, both those providers that lose patients

deinstitutionalized into the home or community and the home and

community-based providers of services that receive these patients/

recipients are small entities. This final rule will also affect States

and Medicaid recipients, but they are not considered small entities

under the RFA.

C. Effect on Medicaid Program Costs

We anticipate that the discretionary provision to eliminate the bed

capacity test may result in the following costs:

Medicaid Costs

[In millions rounded to the nearest $5 million]

------------------------------------------------------------------------

Federal State

Fiscal year costs costs

------------------------------------------------------------------------

1994................................................ $85 $65

1995................................................ 110 85

1996................................................ 135 100

1997................................................ 160 120

1998................................................ 190 145

1999................................................ 225 170

------------------------------------------------------------------------

These cost increases are due to the expectation that more

individuals will be eligible for home and community-based waiver

services under Medicaid as a result of the elimination of the bed

capacity test. However, it should be noted that the State costs

reflected in the above chart may include costs that are currently

being, or will be in the future, spent by States to provide medical

assistance under programs other than Medicaid. Additionally, we believe

that costs for waiver growth may be limited as a result of the fiscal

capacities of the States.

Under section 1915(c)(2)(D) of the Act, the estimated average per

capita expenditure under a home and community-based waiver may not

exceed 100 percent of the estimated average per capita expenditure that

the State reasonably estimates would have been made if the waiver had

not been granted. All States have assured HCFA of this as a condition

of waiver approval. Thus, under the law, this final rule is expected to

be technically budget neutral with the exception of the costs

associated with the elimination of the bed capacity test. However,

section 9502 of COBRA and sections 9408 and 9411 of OBRA '86 have

negligible costs associated with them overall. It is difficult to

determine and may be impossible to assess precisely whether these

changes would substantially affect the rate of growth in Medicaid

expenditures.

We expect coverage of home respiratory care for ventilator-

dependent individuals to have a similar impact. This new program also

allows home care as an alternative to institutionalization. New

programs may be added as alternatives to institutionalization as a

result of this final rule with comment period.

We do not expect that the adoption of this final rule with comment

period will result in a major increase in costs or prices for

consumers, individual industries, or local government agencies in any

geographic region. Employment in institutional care is more capital

intensive; home and community services are more labor intensive.

Increased costs or revenue losses may be experienced by providers (both

their owners and employees) that formerly served institutionalized

recipients. Although an institutional provider of services may be

adversely affected by the existence of a waiver in its area, it may

choose to provide services covered under a home and community-based

waiver, and the adverse impact probably will be offset by increased

business.

In conclusion, home and community-based waivers and respiratory

care for ventilator-dependent individuals generally may result in

services being furnished in different settings, often by different

providers, with possibly some losses in revenue by some providers

offset by increases to other providers. We do not consider this

redistributive effect to be significant. We do expect recipients to

benefit from a deinstitutionalized life and from the services that may

be provided under these provisions.

D. Rural Hospital Impact Statement

Section 1102(b) of the Social Security Act (the Act) requires the

Secretary to prepare a regulatory impact analysis for any final rule

that may have a significant impact on the operations of a substantial

number of small rural hospitals. Such an analysis must conform to the

provisions of section 604 of the RFA. For purposes of section 1102(b)

of the Act, we define a small rural hospital as a hospital with fewer

than 50 beds located outside a metropolitan statistical area. We have

determined and the Secretary certifies that this final rule with

comment period will not have a significant impact on the operations of

a substantial number of small rural hospitals.

E. Executive Order 12866

In accordance with the provisions of Executive Order 12866, this

notice was reviewed by the Office of Management and Budget.

V. Recordkeeping and Reporting Requirements

Sections 440.180, 441.301 and 441.303 of this final rule with

comment period contain information collection requirements that are

subject to Office of Management and Budget (OMB) approval under the

Paperwork Reduction Act of 1980. The public is not required to comply

with the information collection requirements until OMB approves these

requirements under section 3507 of the Paperwork Reduction Act (44

U.S.C. 3507). A notice will be published in the Federal Register when

approval is obtained.

List of Subjects

42 CFR Part 435

Aid to families with dependent children, Grant programs-health,

Medicaid, Supplemental security income (SSI).

42 CFR Part 440

Grant programs-health, Medicaid.

42 CFR Part 441

Family planning, Grant programs-health, Infants and children,

Medicaid, Penalties, Prescription drugs, Reporting and recordkeeping

requirements.

42 CFR chapter IV, subchapter C is amended as set forth below:

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. 435.726, the section heading is revised; the

introductory text of paragraph (c) is republished; and paragraph (c)(1)

is revised to read as follows:

Sec. 435.726 Post-eligibility treatment of income of individuals

receiving home and community-based services furnished under a waiver:

Application of patient income to the cost of care.

* * * * *

(c) In reducing its payment for home and community-based services,

the agency must deduct the following amounts, in the following order,

from the individual's total income (including amounts disregarded in

determining eligibility):

(1) An amount for the maintenance needs of the individual that the

State may set at any level, as long as the following conditions are

met:

(i) The deduction amount is based on a reasonable assessment of

need.

(ii) The State establishes a maximum deduction amount that will not

be exceeded for any individual under the waiver.

* * * * *

3. In Sec. 435.735, the introductory text of paragraph (c) is

republished; and paragraph (c)(1) is revised to read as follows:

Sec. 435.735 Post-eligibility treatment of income and resources of

individuals receiving home and community-based services furnished under

a waiver: Application of patient income to the cost of care.

* * * * *

(c) In reducing its payment for home and community-based services,

the agency must deduct the following amounts, in the following order,

from the individual's total income (including amounts disregarded in

determining eligibility):

(1) An amount for the maintenance needs of the individual that the

State may set at any level, as long as the following conditions are

met:

(i) The deduction amount is based on a reasonable assessment of

need.

(ii) The State establishes a maximum deduction amount that will not

be exceeded for any individual under the waiver.

* * * * *

PART 440--SERVICES: GENERAL PROVISIONS

B. Part 440 is amended as follows:

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. Section 440.180 is revised to read as follows:

Sec. 440.180 Home or community-based services.

(a) Description and requirements for services. ``Home or community-

based services'' means services, not otherwise furnished under the

State's Medicaid plan, that are furnished under a waiver granted under

the provisions of Part 441, subpart G of this chapter.

(1) These services may consist of any or all of the services listed

in paragraph (b) of this section, as those services are defined by the

agency and approved by HCFA.

(2) The services must meet the standards specified in

Sec. 441.302(a) of this chapter concerning health and welfare

assurances.

(3) The services are subject to the limits on FFP described in

Sec. 441.310 of this chapter.

(b) Included services. Home or community-based services may include

the following services, as they are defined by the agency and approved

by HCFA:

(1) Case management services.

(2) Homemaker services.

(3) Home health aide services.

(4) Personal care services.

(5) Adult day health services.

(6) Habilitation services.

(7) Respite care services.

(8) Day treatment or other partial hospitalization services,

psychosocial rehabilitation services and clinic services (whether or

not furnished in a facility) for individuals with chronic mental

illness, subject to the conditions specified in paragraph (d) of this

section.

(9) Other services requested by the agency and approved by HCFA as

cost effective and necessary to avoid institutionalization.

(c) Expanded habilitation services, effective April 7, 1986--(1)

General rule. Expanded habilitation services are those services

specified in paragraph (c)(2) of this section, that are provided to

recipients who have been discharged from a Medicaid-certified NF or

ICF/MR, regardless of when the discharge occurred.

(2) Services included. The agency may include as expanded

habilitation services the following services:

(i) Prevocational services, which means services that prepare an

individual for paid or unpaid employment and that are not job-task

oriented but are, instead, aimed at a generalized result. These

services may include, for example, teaching an individual such concepts

as compliance, attendance, task completion, problem solving and safety.

Prevocational services are distinguishable from noncovered vocational

services by the following criteria:

(A) The services are provided to persons who are not expected to be

able to join the general work force or participate in a transitional

sheltered workshop within one year (excluding supported employment

programs).

(B) If the recipients are compensated, they are compensated at less

than 50 percent of the minimum wage;

(C) The services include activities which are not primarily

directed at teaching specific job skills but at underlying habilitative

goals (for example, attention span, motor skills); and

(D) The services are reflected in a plan of care directed to

habilitative rather than explicit employment objectives.

(ii) Educational services, which means special education and

related services (as defined in sections 602(16) and (17) of the

Education of the Handicapped Act) (20 U.S.C. 1401 (16 and 17)) to the

extent they are not prohibited under paragraph (c)(3)(i) of this

section.

(iii) Supported employment services, which facilitate paid

employment, that are--

(A) Provided to persons for whom competitive employment at or above

the minimum wage is unlikely and who, because of their disabilities,

need intensive ongoing support to perform in a work setting;

(B) Conducted in a variety of settings, particularly worksites in

which persons without disabilities are employed; and

(C) Defined as any combination of special supervisory services,

training, transportation, and adaptive equipment that the State

demonstrates are essential for persons to engage in paid employment and

that are not normally required for nondisabled persons engaged in

competitive employment.

(3) Services not included. The following services may not be

included as habilitation services:

(i) Special education and related services (as defined in sections

602(16) and (17) of the Education of the Handicapped Act) (20 U.S.C.

1401 (16) and (17)) that are otherwise available to the individual

through a local educational agency.

(ii) Vocational rehabilitation services that are otherwise

available to the individual through a program funded under section 110

of the Rehabilitation Act of 1973 (29 U.S.C. 730).

(d) Services for the chronically mentally ill--(1) Services

included. Services listed in paragraph (b)(8) of this section include

those provided to individuals who have been diagnosed as being

chronically mentally ill, for which the agency has requested approval

as part of either a new waiver request or a renewal and which have been

approved by HCFA on or after October 21, 1986.

(2) Services not included. Any home and community-based service,

including those indicated in paragraph (b)(8) of this section, may not

be included in home and community-based service waivers for the

following individuals:

(i) For individuals aged 22 through 64 who, absent the waiver,

would be institutionalized in an institution for mental diseases (IMD);

and, therefore, subject to the limitation on IMDs specified in

Sec. 435.1008(a)(2) of this subchapter.

(ii) For individuals, not meeting the age requirements described in

paragraph (d)(2)(i) of this section, who, absent the waiver, would be

placed in an IMD in those States that have not opted to include the

benefits defined in Sec. 440.140 or Sec. 440.160.

3. Section 440.185 is added to read as follows:

Sec. 440.185 Respiratory care for ventilator-dependent individuals.

(a) ``Respiratory care for ventilator-dependent individuals'' means

services that are not otherwise available under the State's Medicaid

plan, provided on a part-time basis in the recipient's home by a

respiratory therapist or other health care professional trained in

respiratory therapy (as determined by the State) to an individual who--

(1) Is medically dependent on a ventilator for life support at

least 6 hours per day;

(2) Has been so dependent for at least 30 consecutive days (or the

maximum number of days authorized under the State plan, whichever is

less) as an inpatient in one or more hospitals, NFs, or ICFs/MR;

(3) Except for the availability of respiratory care services, would

require respiratory care as an inpatient in a hospital, NF, or ICF/MR

and would be eligible to have payment made for inpatient care under the

State plan;

(4) Has adequate social support services to be cared for at home;

(5) Wishes to be cared for at home; and

(6) Receives services under the direction of a physician who is

familiar with the technical and medical components of home ventilator

support, and who has medically determined that in-home care is safe and

feasible for the individual.

(b) For purposes of paragraphs (a)(4) and (5) of this section, a

recipient's home does not include a hospital, NF, ICF/MR or other

institution as defined in Sec. 435.1009.

4. In Sec. 440.250, a new paragraph (o) is added to read as

follows:

Sec. 440.250 Limits on comparability of services.

* * * * *

(o) If the agency makes respiratory care services available under

Sec. 440.185, the services need not be made available in equal amount,

duration, and scope to any individual not eligible for coverage under

that section. However, the services must be made available in equal

amount, duration, and scope to all individuals eligible for coverage

under that section.

* * * * *

C. Part 441 is amended as follows:

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC

SERVICES

1. The authority citation for Part 441 continues to read as

follows:

Authority: Sec. 1102 of the Social Security Act (42 U.S.C.

1302).

2. In Sec. 441.301, paragraph (a) is revised; the introductory text

of paragraph (b) is revised; the introductory text of paragraph (b)(1)

is republished; paragraph (b)(1)(ii) is revised; a new paragraph

(b)(1)(iii) is added; and paragraph (b)(4) is revised to read as

follows:

Sec. 441.301 Contents of request for a waiver.

(a) A request for a waiver under this section must consist of the

following:

(1) The assurances required by Sec. 441.302 and the supporting

documentation required by Sec. 441.303.

(2) When applicable, requests for waivers of the requirements of

section 1902(a)(1), section 1902(a)(10)(B), or section

1902(a)(10)(C)(i)(III) of the Act, which concern respectively,

statewide application of Medicaid, comparability of services, and

income and resource rules applicable to individuals with spouses living

in the community.

(3) A statement explaining whether the agency will refuse to offer

home or community-based services to any recipient if the agency can

reasonably expect that the cost of the services would exceed the cost

of an equivalent level of care provided in--

(i) A hospital (as defined in Sec. 440.10 of this chapter);

(ii) A NF (as defined in section 1919(a) of the Act); or

(iii) An ICF/MR (as defined in Sec. 440.150 of this chapter), if

applicable.

(b) If the agency furnishes home and community-based services, as

defined in Sec. 440.180 of this subchapter, under a waiver granted

under this subpart, the waiver request must--

(1) Provide that the services are furnished--

* * * * *

(ii) Only to recipients who are not inpatients of a hospital, NF,

or ICF/MR; and

(iii) Only to recipients who the agency determines would, in the

absence of these services, require the Medicaid covered level of care

provided in--

(A) A hospital (as defined in Sec. 440.10 of this chapter);

(B) A NF (as defined in section 1919(a) of the Act); or

(C) An ICF/MR (as defined in Sec. 440.150 of this chapter);

* * * * *

(4) Describe the services to be furnished so that each service is

separately defined. Multiple services that are generally considered to

be separate services may not be consolidated under a single definition.

Commonly accepted terms must be used to describe the service and

definitions may not be open ended in scope. HCFA will, however, allow

combined service definitions (bundling) when this will permit more

efficient delivery of services and not compromise either a recipient's

access to or free choice of providers.

* * * * *

3. In Sec. 441.302, the introductory paragraph is revised;

paragraphs (c) and (e) are revised; paragraph (f) is redesignated as

paragraph (h) and republished; and new paragraphs (f), (g), (i), and

(j) are added to read as follows:

Sec. 441.302 State assurances.

Unless the Medicaid agency provides the following satisfactory

assurances to HCFA, HCFA will not grant a waiver under this subpart and

may terminate a waiver already granted:

* * * * *

(c) Evaluation of need.--Assurance that the agency will provide for

the following:

(1) Initial evaluation.--An evaluation of the need for the level of

care provided in a hospital, a NF, or an ICF/MR when there is a

reasonable indication that a recipient might need the services in the

near future (that is, a month or less) unless he or she receives home

or community-based services. For purposes of this section,

``evaluation'' means a review of an individual recipient's condition to

determine--

(i) If the recipient requires the level of care provided in a

hospital as defined in Sec. 440.40 of this subchapter, a NF as defined

in section 1919(a) of the Act, or an ICF/MR as defined by Sec. 440.150

of this subchapter; and

(ii) That the recipient, but for the provision of waiver services,

would otherwise be institutionalized in such a facility.

(2) Periodic reevaluations.--Reevaluations, at least annually, of

each recipient receiving home or community-based services to determine

if the recipient continues to need the level of care provided and

would, but for the provision of waiver services, otherwise be

institutionalized in one of the following institutions:

(i) A hospital;

(ii) A NF; or

(iii) An ICF/MR.

* * * * *

(e) Average per capita expenditures.--Assurance that the average

per capita fiscal year expenditures under the waiver will not exceed

100 percent of the average per capita expenditures that would have been

made in the fiscal year for the level of care provided in a hospital,

NF, or ICF/MR under the State plan had the waiver not been granted.

(1) These expenditures must be reasonably estimated and documented

by the agency.

(2) The estimate must be on an annual basis and must cover each

year of the waiver period.

(f) Actual total expenditures.--Assurance that the agency's actual

total expenditures for home and community-based and other Medicaid

services under the waiver and its claim for FFP in expenditures for the

services provided to recipients under the waiver will not, in any year

of the waiver period, exceed 100 percent of the amount that would be

incurred by the State's Medicaid program for these individuals, absent

the waiver, in--

(1) A hospital;

(2) A NF; or

(3) An ICF/MR.

(g) Institutionalization absent waiver.--Assurance that, absent the

waiver, recipients in the waiver would receive the appropriate type of

Medicaid-funded institutional care (hospital, NF, or ICF/MR) that they

require.

(h) Reporting.--Assurance that annually, the agency will provide

HCFA with information on the waiver's impact. That information must be

consistent with a data collection plan designed by HCFA and must

address the waiver's impact on--

(1) The type, amount, and cost of services provided under the State

plan; and

(2) The health and welfare of recipients.

(i) Habilitation services.--Assurance that prevocational,

educational, or supported employment services, or a combination of

these services, if provided as habilitation services under the waiver,

are--

(1) Not otherwise available to the individual through a local

educational agency under section 602 (16) and (17) of the Education of

the Handicapped Act (20 U.S.C. 1401 (16 and 17)) or as services under

section 110 of the Rehabilitation Act of 1973 (29 U.S.C. 730); and

(2) Furnished only to individuals who have been

deinstitutionalized, regardless of discharge date from a Medicaid-

certified NF or ICF/MR.

(3) Furnished as part of expanded habilitation services on or after

April 7, 1986, if the State has requested and received HCFA's approval

under a waiver or an amendment to a waiver.

(j) Day treatment or partial hospitalization, psychosocial

rehabilitation services, and clinic services for individuals with

chronic mental illness. Assurance that FFP will not be claimed in

expenditures for waiver services including, but not limited to, day

treatment or partial hospitalization, psychosocial rehabilitation

services, and clinic services provided as home and community-based

services to individuals with chronic mental illnesses if these

individuals, in the absence of a waiver, would be placed in an IMD and

are--

(1) Age 22 to 64;

(2) Age 65 and older and the State has not included the optional

Medicaid benefit cited in Sec. 440.140; or

(3) Age 21 and under and the State has not included the optional

Medicaid benefit cited in Sec. 440.160.

4. In Sec. 441.303, the introductory paragraph is revised; the

introductory text of paragraph (c) is republished; paragraph (c)(2) is

revised; the introductory text of paragraph (f) is revised; paragraphs

(f)(1) and (f)(2) are revised; (f)(3) is removed; paragraph (f)(4) is

redesignated as paragraph (f)(3) and revised; new paragraphs (f)(4),

(5), (6), (7), (8), (9), and (10) are added; paragraph (g) is revised;

and new paragraphs (h) and (i) are added to read as follows:

Sec. 441.303 Supporting documentation required.

The agency must furnish HCFA with sufficient information to support

the assurances required by Sec. 441.302. Except as HCFA may otherwise

specify for particular waivers, the information must consist of the

following:

* * * * *

(c) A description of the agency's plan for the evaluation and

reevaluation of recipients, including--

* * * * *

(2) A copy of the evaluation form to be used; and if it differs

from the form used in placing recipients in hospitals, NFs, or ICFs/MR,

a description of how and why it differs and an assurance that the

outcome of the new evaluation form is reliable, valid, and fully

comparable to the form used for hospital, NF, or ICF/MR placement;

* * * * *

(f) An explanation with supporting documentation satisfactory to

HCFA of how the agency estimated the average per capita expenditures

for services.

(1) The annual average per capita expenditure estimate of the cost

of home and community-based and other Medicaid services under the

waiver must not exceed the estimated annual average per capita

expenditures of the cost of services in the absence of a waiver. The

estimates are to be based on the following equation:

D+D' G+G'.

The symbol ``'' means that the result of the left side of

the equation must be less than or equal to the result of the right

side of the equation.

D = the estimated annual average per capita Medicaid cost for home

and community-based services for individuals in the waiver program.

D' = the estimated annual average per capita Medicaid cost for all

other services provided to individuals in the waiver program.

G = the estimated annual average per capita Medicaid cost for

hospital, NF, or ICF/MR care that would be incurred for individuals

served in the waiver, were the waiver not granted.

G' = the estimated annual average per capita Medicaid costs for all

services other than those included in factor G for individuals

served in the waiver, were the waiver not granted.

(2) For purposes of the equation, the prime factors include the

average per capita cost for all State plan services and expanded EPSDT

services provided that are not accounted for in other formula values.

(3) In making estimates of average per capita expenditures for a

waiver that applies only to individuals with a particular illness (for

example, acquired immune deficiency syndrome) or condition (for

example, chronic mental illness) who are inpatients in or who would

require the level of care provided in hospitals as defined by

Sec. 440.10, NFs as defined in section 1919(a) of the Act, or ICFs/MR,

the agency may determine the average per capita expenditures for these

individuals absent the waiver without including expenditures for other

individuals in the affected hospitals, NFs, or ICFs/MR.

(4) In making estimates of average per capita expenditures for a

separate waiver program that applies only to individuals identified

through the preadmission screening annual resident review (PASARR)

process who are developmentally disabled, inpatients of a NF, and

require the level of care provided in an ICF/MR as determined by the

State on the basis of an evaluation under Sec. 441.303(c), the agency

may determine the average per capita expenditures that would have been

made in a fiscal year for those individuals based on the average per

capita expenditures for inpatients in an ICF/MR. When submitting

estimates of institutional costs without the waiver, the agency may use

the average per capita costs of ICF/MR care even though the

deinstitutionalized developmentally disabled were inpatients of NFs.

(5) For persons diverted rather than deinstitutionalized, the

State's evaluation process required by Sec. 441.303(c) must provide for

a more detailed description of their evaluation and screening

procedures for recipients to ensure that waiver services will be

limited to persons who would otherwise receive the level of care

provided in a hospital, NF, or ICF/MR, as applicable.

(6) The State must indicate the number of unduplicated

beneficiaries to which it intends to provide waiver services in each

year of its program. This number will constitute a limit on the size of

the waiver program unless the State requests and the Secretary approves

a greater number of waiver participants in a waiver amendment.

(7) In determining the average per capita expenditures that would

have been made in a waiver year, for waiver estimates that apply to

persons with mental retardation or related conditions, the agency may

include costs of Medicaid residents in ICFs/MR that have been

terminated on or after November 5, 1990.

(8) In submitting estimates for waivers that include personal

caregivers as a waiver service, the agency may include a portion of the

rent and food attributed to the unrelated personal caregiver who

resides in the home or residence of the recipient covered under the

waiver. The agency must submit to HCFA for review and approval the

method it uses to apportion the costs of rent and food. The method must

be explained fully to HCFA. A personal caregiver provides a waiver

service to meet the recipient's physical, social, or emotional needs

(as opposed to services not directly related to the care of the

recipient; that is, housekeeping or chore services). FFP for live-in

caregivers is not available if the recipient lives in the caregiver's

home or in a residence that is owned or leased by the caregiver.

(9) In submitting estimates for waivers that apply to individuals

with mental retardation or a related condition, the agency may adjust

its estimate of average per capita expenditures to include increases in

expenditures for ICF/MR care resulting from implementation of a PASARR

program for making determinations for individuals with mental

retardation or related conditions on or after January 1, 1989.

(10) For a State that has HCFA approval to bundle waiver services,

the State must continue to compute separately the costs and utilization

of the component services that make up the bundled service to support

the final cost and utilization of the bundled service that will be used

in the cost-neutrality formula.

(g) The State, at its option, may provide for an independent

assessment of its waiver that evaluates the quality of care provided,

access to care, and cost-neutrality. The results of the assessment

should be submitted to HCFA at least 90 days prior to the expiration

date of the approved waiver-period and cover the first 24 or 48 months

of the waiver. If a State chooses to provide for an independent

assessment, FFP is available for the costs attributable to the

independent assessment.

(h) For States offering habilitation services that include

prevocational, educational, or supported employment services, or a

combination of these services, consistent with the provisions of

Sec. 440.180(c) of this chapter, an explanation of why these services

are not available as special education and related services under

sections 602 (16) and (17) of the Education of the Handicapped Act (20

U.S.C. 1401 (16 and 17)) or as services under section 110 of the

Rehabilitation Act of 1973 (29 U.S.C. section 730);

(i) For States offering home and community-based services for

individuals diagnosed as chronically mentally ill, an explanation of

why these individuals would not be placed in an institution for mental

diseases (IMD) absent the waiver, and the age group of these

individuals.

5. In Sec. 441.304, paragraphs (a), (b), and (d) are revised to

read as follows:

Sec. 441.304 Duration of a waiver.

(a) The effective date for a new waiver of Medicaid requirements to

provide home and community-based services approved under this subpart

is established by HCFA prospectively on or after the date of approval

and after consultation with the State agency. The initial approved

waiver continues for a 3-year period from the effective date. If the

agency requests it, the waiver may be extended for additional periods

unless--

(1) HCFA's review of the prior waiver period shows that the

assurances required by Sec. 441.302 were not met; and

(2) HCFA is not satisfied with the assurances and documentation

provided by the State in regard to the extension period.

(b) HCFA will determine whether a request for extension of an

existing waiver is actually an extension request or a request for a new

waiver. If a State submits an extension request that would add a new

group to the existing group of recipients covered under the waiver (as

defined under Sec. 441.301(b)(6)), HCFA will consider it to be two

requests: One as an extension request for the existing group, and the

other as a new waiver request for the new group. Waivers may be

extended for additional 5-year periods.

* * * * *

(d) If HCFA finds that an agency is not meeting one or more of the

requirements for a waiver contained in this subpart, the agency is

given a notice of HCFA's findings and an opportunity for a hearing to

rebut the findings. If HCFA determines that the agency is not in

compliance with this subpart after the notice and any hearing, HCFA may

terminate the waiver. For example, a State submits to HCFA a waiver

request for home and community-based services that includes an estimate

of the expenditures that would be incurred if the services were

provided to the covered individuals in a hospital, NF, or ICF/MR in the

absence of the waiver. HCFA approves the waiver. At the end of the

waiver year, the State submits to HCFA a report of its actual

expenditures under the waiver. HCFA finds that the actual expenditures

under the waiver exceed 100 percent of the State's approved estimate of

expenditures for these individuals in a hospital, NF, or ICF/MR in the

absence of the waiver. HCFA next requires the State to amend its

estimates for subsequent waiver year(s). HCFA then compares the revised

estimates with the State's actual experience to determine if the

revised estimates are reasonable. HCFA may terminate the waiver if the

revised estimates indicate that the waiver is not cost-neutral or that

the revised estimates are unreasonable.

Sec. 441.305 [Redesignated as Sec. 441.307]

6. Section 441.305 is redesignated as Sec. 441.307.

7. A new Sec. 441.305 is added to read as follows:

Sec. 441.305 Replacement of recipients in approved waiver programs.

(a) Regular waivers. A State's estimate of the number of

individuals who may receive home and community-based services must

include those who will replace recipients who leave the program for any

reason. A State may replace recipients who leave the program due to

death or loss of eligibility under the State plan without regard to any

federally-imposed limit on utilization, but must maintain a record of

recipients replaced on this basis.

(b) Model waivers.

(1) The number of individuals who may receive home and community-

based services under a model waiver may not exceed 200 recipients at

any one time.

(2) The agency may replace any individuals who die or become

ineligible for State plan services to maintain a count up to the number

specified by the State and approved by HCFA within the 200-maximum

limit.

Sec. 441.306 [Redesignated as Sec. 441.308]

8. Section 441.306 is redesignated as Sec. 441.308.

9. A new Sec. 441.306 is added to read as follows:

Sec. 441.306 Cooperative arrangements with the Maternal and Child

Health program.

Whenever appropriate, the State agency administering the plan under

Medicaid may enter into cooperative arrangements with the State agency

responsible for administering a program for children with special

health care needs under the Maternal and Child Health program (Title V

of the Act) in order to ensure improved access to coordinated services

to meet the children's needs.

10. Section 441.310 is revised to read as follows:

Sec. 441.310 Limits on Federal financial participation (FFP).

(a) FFP for home and community-based services listed in

Sec. 440.180 of this chapter is not available in expenditures for the

following:

(1) Services provided in a facility subject to the health and

welfare requirements described in Sec. 441.302(a) during any period in

which the facility is found not to be in compliance with the applicable

State standards described in that section.

(2) The cost of room and board except when provided as--

(i) Part of respite care services in a facility approved by the

State that is not a private residence; or

(ii) For waivers that allow personal caregivers as providers of

approved waiver services, a portion of the rent and food that may be

reasonably attributed to the unrelated caregiver who resides in the

same household with the waiver recipient. FFP for a live-in caregiver

is not available if the recipient lives in the caregiver's home or in a

residence that is owned or leased by the provider of Medicaid services

(the caregiver). For purposes of this provision, ``board'' means 3

meals a day or any other full nutritional regimen and does not include

meals provided as part of a program of adult day health services as

long as the meals provided do not constitute a ``full'' nutritional

regimen.

(3) Prevocational, educational, or supported employment services,

or any combination of these services, as part of habilitation services

that are--

(i) Provided prior to April 7, 1986;

(ii) Provided in approved waivers that include a definition of

``habilitation services'' but which have not included prevocational,

educational and supported employment services in that definition;

(iii) Provided to recipients who were never institutionalized in a

Medicaid certified NF,or ICF/MR; or

(iv) Otherwise available to the recipient under either special

education and related services as defined in section 602(16) and (17)

of the Education of the Handicapped Act (20 U.S.C. 1401 (16) and (17))

or vocational rehabilitation services available to the individual

through a program funded under section 110 of the Rehabilitation Act of

1973 (29 U.S.C. 730).

(4) For waiver applications and renewals approved on or after

October 21, 1986, home and community-based services provided to

individuals aged 22 through 64 diagnosed as chronically mentally ill

who would be placed in an institution for mental diseases. FFP is also

not available for such services provided to individuals aged 65 and

over and 21 and under as an alternative to institutionalization in an

IMD if the State does not include the appropriate optional Medicaid

benefits specified at Secs. 440.140 and 440.160 of this chapter in its

State plan.

(b) FFP is available for expenditures for expanded habilitation

services, as described in Sec. 440.180, if the services are included

under a waiver or waiver amendment approved by HCFA on or after April

7, 1986.

(Catalog of Federal Assistance Program No. 93.778, Medical

Assistance Program)

Dated: May 11, 1994.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: June 21, 1994.

Donna E. Shalala,

Secretary.

[FR Doc. 94-17816 Filed 7-22-94; 8:45 am]

BILLING CODE 4120-01-P

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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