[Federal Register: August 13, 2007 (Volume 72, Number 155)]
[Proposed Rules]
[Page 45201-45213]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au07-23]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 440 and 441
[CMS 2261-P]
RIN 0938-A081
Medicaid Program; Coverage for Rehabilitative Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would amend the definition of Medicaid
rehabilitative services in order to provide for important beneficiary
protections such as a person-centered written rehabilitation plan and
maintenance of case records. The proposed rule would also ensure the
fiscal integrity of claimed Medicaid expenditures by clarifying the
service definition and providing that Medicaid rehabilitative services
must be coordinated with but do not include services furnished by other
programs that are focused on social or educational development goals
and available as part of other services or programs. These services and
programs include, but are not limited to, foster care, child welfare,
education, child care, prevocational and vocational services, housing,
parole and probation, juvenile justice, public guardianship, and any
other non-Medicaid services from Federal, State, or local programs.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on October 12, 2007.
ADDRESSES: In commenting, please refer to file code CMS-2261-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic
[[Page 45202]]
comments on CMS regulations with an open comment period.'' (Attachments
should be in Microsoft Word, WordPerfect, or Excel; however, we prefer
Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-2261-P, P.O. Box 8018, Baltimore, MD 21244-8018.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-2261-P, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-3685 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201; or
7500 Security Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Maria Reed, (410) 786-2255 or Shawn
Terrell, (410) 786-0672.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-2261-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable (for example, names, addresses,
social security numbers, and medical diagnoses) or confidential
business information (including proprietary information) that is
included in a comment. We post all comments received before the close
of the comment period on the following Web site as soon as possible
after they have been received: http://www.cms.hhs.gov/eRulemaking.
Click on the link ``Electronic Comments on CMS Regulations'' on that
Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
A. Overview
Section 1905(a)(13) of the Social Security Act (the Act) includes
rehabilitative services as an optional Medicaid State plan benefit.
Current Medicaid regulations at 42 CFR 440.130(d) provide a broad
definition of rehabilitative services. Rehabilitative services are
defined as ``any medical or remedial services recommended by a
physician or other licensed practitioner of the healing arts, within
the scope of his or her practice under State law, for maximum reduction
of physical or mental disability and restoration of a recipient to his
best possible functional level.'' The broad general language in this
regulatory definition has afforded States considerable flexibility
under their State plans to meet the needs of their State's Medicaid
population.
Over the years the scope of services States have provided under the
rehabilitation benefit has expanded from physical rehabilitative
services to also include mental health and substance abuse treatment
rehabilitative services. For example, services currently provided by
States under the rehabilitative benefit include services aimed at
improving physical disabilities, including physical, occupational, and
speech therapies; mental health services, such as individual and group
therapy, psychosocial therapy services; and services for substance-
related disorders (for example, substance use disorders and substance
induced disorders). These Medicaid services may be delivered through
various models of care and in a variety of settings.
The broad language of the current statutory and regulatory
definition has, however, had some unintended consequences. It has also
led to some confusion over whether otherwise applicable statutory or
regulatory provider standards would apply under the rehabilitative
services benefit.
As the number of States providing rehabilitative services has
increased, some States have viewed the rehabilitation benefit as a
``catch-all'' category to cover services included in other Federal,
State and local programs. For example, it appears some States have used
Medicaid to fund services that are included in the provision of foster
care and in the Individuals with Disabilities Education Improvement Act
(IDEA). Our audit reviews have recently revealed that Medicaid funds
have also been used to pay for behavioral treatment services in
``wilderness camps,'' juvenile detention, and similar facilities where
youth are involuntarily confined. These facilities are under the domain
of the juvenile justice or youth systems in the State, rather than
Medicaid, and there is no assurance that the claimed services reflect
an independent evaluation of individual rehabilitative needs.
This proposed regulation is designed to clarify the broad general
language of the current regulation to ensure that rehabilitative
services are provided in a coordinated manner that is in the best
interest of the individuals, are limited to rehabilitative purposes and
are furnished by qualified providers. This proposed regulation would
rectify the improper reliance on the Medicaid rehabilitation benefit
for services furnished by other programs that are focused on social or
educational development goals in programs other than Medicaid.
This proposed regulation would provide guidance to ensure that
services claimed under the optional Medicaid rehabilitative benefit are
in fact rehabilitative out-patient services, are furnished by qualified
providers, are
[[Page 45203]]
provided to Medicaid eligible individuals according to a goal-oriented
rehabilitation plan, and are not for services that are included in
programs with a focus other than that of Medicaid.
B. Habilitation Services
Section 6411(g) of the Omnibus Budget Reconciliation Act of 1989
(OBRA 89) prohibits us from taking adverse action against States with
approved habilitation provisions pending the issuance of a regulation
that ``specifies types of day habilitation services that a State may
cover under paragraphs (9) (clinic services) or (13) (rehabilitative
services) of section 1905(a) of the Act on behalf of persons with
mental retardation or with related conditions.'' We believe that
issuance of a final rule based on this proposed rule will satisfy this
condition. We intend to work with those States that have habilitation
programs under the clinic services or rehabilitative services benefits
in their State plans to transition to appropriate Medicaid coverage
authorities, such as section 1915(c) waivers or the Home and Community-
Based Services State plan option under section 1915 (i) of the Deficit
Reduction Act (DRA) of 2005 (Pub. L. 107-171), enacted on February 8,
2006.
II. Provisions of the Proposed Rule
[If you choose to comment on issues in this section, please include
the caption ``PROVISIONS OF THE PROPOSED REGULATIONS'' at the beginning
of your comments.]
A. Definitions
In 440.130(d)(1), we propose to define the terms used in this rule,
as listed below:
Recommended by a physician or other licensed practitioner
of the healing arts.
Other licensed practitioner of the healing arts.
Qualified providers of rehabilitative services.
Under the direction of.
Written rehabilitation plan.
Restorative services.
Medical services.
Remedial services.
In Sec. 440.130(d)(1)(iii), we would define ``qualified providers
of rehabilitative services'' to require that individuals providing
rehabilitative services meet the provider qualification requirements
applicable to the same service when it is furnished under other benefit
categories. Further, the provider qualifications must be set forth in
the Medicaid State plan. These qualifications may include education,
work experience, training, credentialing, supervision and licensing,
that are applied uniformly. Provider qualifications must be reasonable
given the nature of the service provided and the population being
served. We require uniform application of these qualifications to
ensure the individual free choice of qualified providers, consistent
with section 1902(a)(23) of the Act.
Under this proposed definition, if specific provider qualifications
are set forth elsewhere in subpart A of part 440, those provider
qualifications take precedence when those services are provided under
the rehabilitation option. Thus, if a State chooses to provide the
various therapies discussed at Sec. 440.110 (physical therapy,
occupational therapy, speech, language and hearing services) under
Sec. 440.130(d), the requirements of Sec. 440.110 applicable to those
services would apply. For example, speech therapy is addressed in
regulation at Sec. 440.110(c) with specific provider requirements for
speech pathologists and audiologists that must be met. If a State
offers speech therapy as a rehabilitative service, the specific
provider requirements at Sec. 440.110(c) must be met. It should be
noted that the definition of Occupational Therapy in Sec. 440.110 is
not correct insofar as the following--Occupational Therapists must be
certified through the National Board of Certification for Occupational
Therapy, not the American Occupational Therapy Association.
We are proposing a definition of the term ``under the direction
of'' because it is a key issue in the provision of therapy services
through the rehabilitative services benefit. Therapy services may be
furnished by or ``under the direction of'' a qualified provider under
the provisions of Sec. 440.110. We are proposing to clarify that the
term means that the therapist providing direction is supervising the
individual's care which, at a minimum, includes seeing the individual
initially, prescribing the type of care to be provided, reviewing the
need for continued services throughout treatment, assuming professional
responsibility for services provided, and ensuring that all services
are medically necessary. The term ``under the direction of'' requires
each of these elements; in particular, professional responsibility
requires face-to-face contact by the therapist at least at the
beginning of treatment and periodically thereafter. Note that this
definition applies specifically to providers of physical therapy,
occupational therapy, and services for individuals with speech, hearing
and language disorders. This language is not meant to exclude
appropriate supervision arrangements for other rehabilitative services.
B. Scope of Services
Consistent with the provision of section 1905(a)(13) of the Act, we
have retained the current definition of rehabilitative services in
Sec. 440.130(d)(2) as including ``medical or remedial services
recommended by a physician or other licensed practitioner of the
healing arts, within the scope of his practice under State law, for
maximum reduction of physical or mental disability and restoration of a
recipient to his best possible functional level.'' We would, however,
clarify that rehabilitative services do not include room and board in
an institution, consistent with the longstanding CMS interpretation
that section 1905(a) of the Act has specifically identified
circumstances in which Medicaid would pay for coverage of room and
board in an inpatient setting. This interpretation was upheld in Texas
v. U.S. Dep't Health and Human Servs., 61 F.3d 438 (5th Cir. 1995).
C. Written Rehabilitation Plan
We propose to add a new requirement, at Sec. 440.130(d)(3), that
covered rehabilitative services for each individual must be identified
under a written rehabilitation plan. This rehabilitation plan would
ensure that the services are designed and coordinated to lead to the
goals set forth in statute and regulation (maximum reduction of
physical or mental disability and restoration to the best possible
functional level). It would ensure transparency of coverage and medical
necessity determinations, so that the beneficiary, and family or other
responsible individuals, would have a clear understanding of the
services that are being made available to the beneficiary. In all
situations, the ultimate goal is to reduce the duration and intensity
of medical care to the least intrusive level possible which sustains
health. The Medicaid goal is to deliver and pay for the clinically-
appropriate, Medicaid-covered services that would contribute to the
treatment goal. It is our expectation that, for persons with mental
illnesses and substance-related disorders, the rehabilitation plan
would include recovery goals. The rehabilitation plan would establish a
basis for evaluating the effectiveness of the care offered in meeting
the stated goals. It would provide for a process to involve the
beneficiary, and family or other responsible individuals, in the
overall management of rehabilitative care. The rehabilitation plan
would also
[[Page 45204]]
document that the services have been determined to be rehabilitative
services consistent with the regulatory definition, and will have a
timeline, based on the individual's assessed needs and anticipated
progress, for reevaluation of the plan, not longer than one year. It is
our expectation that the reevaluation of the plan would involve the
beneficiary, family, or other responsible individuals and would include
a review of whether the goals set forth in the plan are being met and
whether each of the services described in the plan has contributed to
meeting the stated goals. If it is determined that there has been no
measurable reduction of disability and restoration of functional level,
any new plan would need to pursue a different rehabilitation strategy
including revision of the rehabilitative goals, services and/or
methods. It is important to note that this benefit is not a custodial
care benefit for individuals with chronic conditions but should result
in a change in status. The rehabilitation plan should identify the
rehabilitation objectives that would be achieved under the plan in
terms of measurable reductions in a diagnosed physical or mental
disability and in terms of restored functional abilities. We recognize,
however, that rehabilitation goals are often contingent on the
individual's maintenance of a current level of functioning. In these
instances, services that provide assistance in maintaining functioning
may be considered rehabilitative only when necessary to help an
individual achieve a rehabilitation goal as defined in the
rehabilitation plan. Services provided primarily in order to maintain a
level of functioning in the absence of a rehabilitation goal are not
rehabilitation services.
It is our further expectation that the rehabilitation plan be
reasonable and based on the individual's diagnosed condition(s) and on
the standards of practice for provisions of rehabilitative services to
an individual with the individual's condition(s). The rehabilitation
plan is not intended to limit or restrict the State's ability to
require prior authorization for services. The proposed requirements
state that the written rehabilitation plan must:
Be based on a comprehensive assessment of an individual's
rehabilitation needs including diagnoses and presence of a functional
impairment in daily living;
Be developed by qualified provider(s) working within the
State scope of practice acts with input from the individual,
individual's family, the individual's authorized health care decision
maker and/or persons of the individual's choosing;
Ensure the active participation of the individual,
individual's family, the individual's authorized health care decision
maker and/or persons of the individual's choosing in the development,
review and modification of these goals and services;
Specify the individual's rehabilitation goals to be
achieved, including recovery goals for persons with mental health and/
or substance related disorders;
Specify the physical impairment, mental health and/or
substance related disorder that is being addressed;
Identify the medical and remedial services intended to
reduce the identified physical impairment, mental health and/or
substance related disorder;
Identify the methods that would be used to deliver
services;
Specify the anticipated outcomes;
Indicate the frequency, amount and duration of the
services;
Be signed by the individual responsible for developing the
rehabilitation plan;
Indicate the anticipated provider(s) of the service(s) and
the extent to which the services may be available from alternate
provider(s) of the same service;
Specify a timeline for reevaluation of the plan, based on
the individual's assessed needs and anticipated progress, but not
longer than one year;
Document that the individual or representative
participated in the development of the plan, signed the plan, and
received a copy of the rehabilitation plan; and
Document that the services have been determined to be
rehabilitative services consistent with the regulatory definition.
We believe that a written rehabilitation plan would ensure that
services are provided within the scope of the rehabilitative services
and would increase the likelihood that an individual's disability would
be reduced and functional level restored. In order to determine whether
a specific service is a covered rehabilitative benefit, it is helpful
to scrutinize the purpose of the service as defined in the care plan.
For example, an activity that may appear to be a recreational
activity may be rehabilitative if it is furnished with a focus on
medical or remedial outcomes to address a particular impairment and
functional loss. Such an activity, if provided by a Medicaid qualified
provider, could address a physical or mental impairment that would help
to increase motor skills in an individual who has suffered a stroke, or
help to restore social functioning and personal interaction skills for
a person with a mental illness.
We are proposing to require in Sec. 440.130(d)(3)(iii) that the
written rehabilitation plan include the active participation of the
individual (or the individual's authorized health care decision maker)
in the development, review, and reevaluation of the rehabilitation
goals and services. We recommend the use of a person-centered planning
process. Since the rehabilitation plan identifies recovery-oriented
goals, the individual must be at the center of the planning process.
D. Impairments to be Addressed
We propose in Sec. 440.130(d)(4) that rehabilitative services
include services provided to an eligible individual to address the
individual's physical needs, mental health needs, and/or substance-
related disorder treatment needs. Because rehabilitative services are
an optional service for adults, a State has flexibility to determine
whether rehabilitative services would be limited to certain
rehabilitative services (for example, only physical rehabilitative
services) or will include rehabilitative treatment for mental health or
substance-related disorders as well.
Provision of rehabilitative services to individuals with mental
health or substance-related disorders is consistent with the
recommendations of the New Freedom Commission on Mental Health. The
Commission challenged States, among others, to expand access to quality
mental health care and noted that States are at the very center of
mental health system transformation. Thus, while States are not
required to provide rehabilitative services for treatment of mental
health and substance-related disorders, they are encouraged to do so.
The Commission noted in its report that, ``[m]ore individuals would
recover from even the most serious mental illnesses and emotional
disturbances if they had earlier access in their communities to
treatment and supports that are evidence-based and tailored to their
needs.''
Under existing provisions at Sec. 440.230(a), States are required
to provide in the State plan a detailed description of the services to
be provided. In reviewing a State plan amendment that proposes
rehabilitative services, we would consider whether the proposed
services are consistent with the requirements in Sec. 440.130(d) and
section 1905(a)(13) of the Act. We would also consider whether the
proposed scope of rehabilitative services
[[Page 45205]]
is ``sufficient in amount, duration and scope to reasonably achieve its
purpose'' as required at Sec. 440.230(b). For that analysis, we will
review whether any assistive devices, supplies, and equipment necessary
to the provision of those services are covered either under the
rehabilitative services benefit or elsewhere under the plan.
E. Settings
In Sec. 440.130(d)(5), consistent with the provisions of section
1905(a)(13) of the Act, we propose that rehabilitative services may be
provided in a facility, home, or other setting. For example,
rehabilitative services may be furnished in freestanding outpatient
clinics and to supplement services otherwise available as an integral
part of the services of facilities such as schools, community mental
health centers, or substance abuse treatment centers. Other settings
may include the office of qualified independent practitioners, mobile
crisis vehicles, and appropriate community settings. The State has the
authority to determine in which settings a particular service may be
provided. While services may be provided in a variety of settings, the
rehabilitative services benefit is not an inpatient benefit.
Rehabilitative services do not include room and board in an
institutional, community or home setting.
F. Requirements and Limitations for Rehabilitative Services
1. Requirements for Rehabilitative Services
In Sec. 441.45(a), we set forth the assurances required in a State
plan amendment that provides for rehabilitative services in this
proposed rule. In Sec. 441.45(b) we set forth the expenditures for
which Federal financial participation (FFP) would not be available.
As with most Medicaid services, rehabilitative services are subject
to the requirements of section 1902(a) of the Act. These include
statewideness at section 1902(a)(1) of the Act, comparability at
section 1902(a)(10)(B), and freedom of choice of qualified providers at
section 1902(a)(23) of the Act. Accordingly, at Sec. 441.45(a)(1), we
propose to require that States comport with the listed requirements.
At Sec. 441.45(a)(2), we propose to require that the State ensure
that rehabilitative services claimed for Medicaid payment are only
those provided for the maximum reduction of physical or mental
disability and restoration of the individual to the best possible
functional level.
In Sec. 441.45(a)(3) and (a)(4), we propose to require that
providers of the rehabilitative services maintain case records that
contain a copy of the rehabilitation plan. We also propose to require
that the provider document the following for all individuals receiving
rehabilitative services:
The name of the individual;
The date of the rehabilitative service or services
provided;
The nature, content, and units of rehabilitative services
provided; and
The progress made toward functional improvement and
attainment of the individual's goals.
We believe this information is necessary to establish an audit
trail for rehabilitative services provided, and to establish whether or
not the services have achieved the maximum reduction of physical or
mental disability, and to restore the individual to his or her best
possible functional level.
A State that opts to provide rehabilitative services must do so by
amending its State plan in accordance with proposed Sec. 441.45(a)(5).
The amendment must (1) describe the rehabilitative services proposed to
be furnished, (2) specify the provider type and provider qualifications
that are reasonably related to each of the rehabilitative services, and
(3) specify the methodology under which rehabilitation providers would
be paid.
2. Limitations for Rehabilitative Services
In Sec. 441.45(b)(1) through (b)(8) we set forth limitations on
coverage of rehabilitative services in this proposed rule.
We propose in Sec. 441.45(b)(1) that coverage of rehabilitative
services would not include services that are furnished through a non-
medical program as either a benefit or administrative activity,
including programs other than Medicaid, such as foster care, child
welfare, education, child care, vocational and prevocational training,
housing, parole and probation, juvenile justice, or public
guardianship. We also propose in Sec. 441.45(b)(1) that coverage of
rehabilitative services would not include services that are intrinsic
elements of programs other than Medicaid.
It should be noted however, that enrollment in these non-medical
programs does not affect eligibility for Title XIX services.
Rehabilitation services may be covered by Medicaid if they are not the
responsibility of other programs and if all applicable requirements of
the Medicaid program are met. Medicaid rehabilitative services must be
coordinated with, but do not include, services furnished by other
programs that are focused on social or educational development goals
and are available as part of other services or programs. Further,
Medicaid rehabilitation services must be available for all participants
based on an identified medical need and otherwise would have been
provided to the individual outside of the foster care, juvenile
justice, parole and probation systems and other non-Medicaid systems.
Individuals must have free choice of providers and all willing and
qualified providers must be permitted to enroll in Medicaid.
For instance, therapeutic foster care is a model of care, not a
medically necessary service defined under Title XIX of the Act. States
have used it as an umbrella to package an array of services, some of
which may be medically necessary services, some of which are not. In
order for a service to be reimbursable by Medicaid, states must
specifically define all of the services that are to be provided,
provider qualifications, and payment methodology. It is important to
note that provider qualifications for those who furnish care to
children in foster care must be the same as provider qualifications for
those who furnish the same care to children not in foster care.
Examples of therapeutic foster care components that would not be
Medicaid coverable services include provider recruitment, foster parent
training and other such services that are the responsibility of the
foster care system.
In Sec. 441.45(b)(2), we propose to exclude FFP for expenditures
for habilitation services including those provided to individuals with
mental retardation or ``related conditions'' as defined in the State
Medicaid Manual Sec. 4398. Physical impairments and mental health and/
or substance related disorder are not considered ``related conditions''
and are therefore medical conditions for which rehabilitation services
may be appropriately provided. As a matter of general usage in the
medical community, there is a distinction between the terms
``habilitation'' and ``rehabilitation.'' Rehabilitation refers to
measures used to restore individuals to their best functional levels.
The emphasis in covering rehabilitation services is the restoration of
a functional ability. Individuals receiving rehabilitation services
must have had the capability to perform an activity in the past rather
than to actually have performed the activity. For example, a person may
not have needed to drive a car in the past, but may have had the
capability to do so prior to having the disability.
[[Page 45206]]
Habilitation typically refers to services that are for the purpose of
helping persons acquire new functional abilities. Current Medicaid
policy explicitly covers habilitation services in two ways: (1) When
provided in an intermediate care facility for persons with mental
retardation (ICF/MR); or (2) when covered under sections 1915(c), (d),
or (i) of the Act as a home and community-based service. Habilitation
services may also be provided under some 1905(a) service authorities
such as Physician services defined at 42 CFR 440.50, Therapy services
defined at 42 CFR 440.110 (such as, Physical Therapy, Occupational
Therapy, and Speech/Language/Audiology Therapy), and Medical or other
remedial care provided by licensed practitioners, defined at 42 CFR
440.60. Habilitative services can also be provided under the 1915(i)
State Plan Home and Community Based Services pursuant to the Deficit
Reduction Act of 2005. In the late 1980s, the Congress responded to
State concerns about disallowances for habilitation services provided
under the State's rehabilitative services benefit by passing section
6411(g) of the OBRA 89. This provision prohibited us from taking
adverse actions against States with approved habilitation provisions
pending the issuance of a regulation that ``specifies types of day
habilitation services that a State may cover under paragraphs (9)
[clinic services] or (13) [rehabilitative services] of section 1905(a)
of the Act on behalf of persons with mental retardation or with related
conditions.'' Accordingly, this regulation would specify that all such
habilitation services would not be covered under sections 1905(a)(9) or
1905(a)(13) of the Act. If this regulation is issued in final form, the
protections provided to certain States by section 6411(g) of OBRA 89
for day habilitation services will no longer be in force. We intend to
provide for a delayed compliance date so that States will have a
transition period of the lesser of 2 years or 1 year after the close of
the first regular session of the State legislature that begins after
this regulation becomes final before we will take enforcement action.
This transition period will permit States an opportunity to transfer
coverage of habilitation services from the rehabilitation option into
another appropriate Medicaid authority. We are available to States as
needed for technical assistance during this transition period.
In Sec. 441.45(b)(3), we propose to provide that rehabilitative
services would not include recreational and social activities that are
not specifically focused on the improvement of physical or mental
health impairment and achievement of a specific rehabilitative goal
specified in the rehabilitation plan, and provided by a Medicaid
qualified provider recognized under State law. We would also specify in
this provision that rehabilitative services would not include personal
care services; transportation; vocational and prevocational services;
or patient education not related to the improvement of physical or
mental health impairment and achievement of a specific rehabilitative
goal specified in the rehabilitation plan. The first two of these
services may be otherwise covered under the State plan. But these
services are not primarily focused on rehabilitation, and thus do not
meet the definition of medical or remedial services for rehabilitative
purposes that would be contained in Sec. 440.130(d)(1).
It is possible that some recreational or social activities are
reimbursable as rehabilitative services if they are provided for the
purpose allowed under the benefit and meet all the requirements
governing rehabilitative services. For example, in one instance the
activity of throwing a ball to an individual and having her/him throw
it back, may be a recreational activity. In another instance, the
activity may be part of a program of physical therapy that is provided
by, or under the direction of, a qualified therapist for the purpose of
restoring motor skills and balance in an individual who has suffered a
stroke. Likewise, for an individual suffering from mental illness, what
may appear to be a social activity may in fact be addressing the
rehabilitation goal of social skills development as identified in the
rehabilitation plan. The service would need to be specifically related
to an identified rehabilitative goal as documented in the
rehabilitation plan with specific time-limited treatment goals and
outcomes. The rehabilitative service would further need to be provided
by a qualified provider, be documented in the case record, and meet all
requirements of this proposed regulation.
When personal care services are provided during the course of the
provision of a rehabilitative service, they are an incidental activity
and separate payment may not be made for the performance of the
incidental activity. For example, an individual recovering from the
effects of a stroke may receive occupational therapy services from a
qualified occupational therapy provider under the rehabilitation option
to regain the capacity to feed himself or herself. If during the course
of those services the individual's clothing becomes soiled and the
therapist assists the individual with changing his or her clothing, no
separate payment may be made for assisting the individual with dressing
under the rehabilitation option. However, FFP may be available for
optional State plan personal care services under Sec. 440.167 if
provided by an enrolled, qualified personal care services provider.
Similarly, transportation is not within the scope of the definition
of rehabilitative services proposed by this regulation since the
transportation service itself does not result in the maximum reduction
of a physical or mental disability and restoration of the individual to
the best possible functional level. However, transportation is a
Medicaid covered service and may be billed separately as a medical
assistance service under Sec. 440.170, if provided by an enrolled,
qualified provider, or may be provided under the Medicaid program as an
administrative activity necessary for the proper and efficient
administration of the State's Medicaid program.
Generally, vocational services are those that teach specific skills
required by an individual to perform tasks associated with performing a
job. Prevocational services address underlying habilitative goals that
are associated with performing compensated work. To the extent that the
primary purpose of these services is to help individuals acquire a
specific job skill, and are not provided for the purpose of reducing
disability and restoring a person to a previous functional level, they
would not be construed as covered rehabilitative services. For example,
teaching an individual to cook a meal to train for a job as a chef
would not be covered, whereas, teaching an individual to cook in order
to re-establish the use of her or his hands or to restore living skills
may be coverable. While it may be possible for Medicaid to cover
prevocational services when provided under the section 1915(c) of the
Act, home and community based services waiver programs, funding for
vocational services rests with other, non-Medicaid Federal and State
funding sources.
Similarly, the purpose of patient education is one important
determinant to whether the activity is a rehabilitative activity
covered under Sec. 440.130(d). While taking classes in an academic
setting may increase an individual's integration into the community and
enable the individual to learn social skills, the primary purpose of
this activity is academic enhancement.
[[Page 45207]]
Thus, patient education in an academic setting is not covered under the
Medicaid rehabilitation option. On the other hand, some patient
education directed towards a specific rehabilitative therapy service
may be provided for the purpose of equipping the individual with
specific skills that will decrease disability and restore the
individual to a previous functioning level. For example, an individual
with a mental disorder that manifests with behavioral difficulties may
need anger management training to restore his or her ability to
interact appropriately with others. These services may be covered under
the rehabilitation option if all of the requirements of this regulation
are met.
In Sec. 441.45(b)(4), we propose to exclude payment for services,
including services that are rehabilitative services that are provided
to inmates living in the secure custody of law enforcement and residing
in a public institution. An individual is considered to be living in
secure custody if serving time for a criminal offense in, or confined
involuntarily to, State or Federal prisons, local jails, detention
facilities, or other penal facilities. A facility is a public
institution when it is under the responsibility of a governmental unit
or over which a governmental unit exercises administrative control.
Rehabilitative services could be reimbursed on behalf of Medicaid-
eligible individuals paroled, on probation, on home release, in foster
care, in a group home, or other community placement, that are not part
of the public institution system, when the services are identified due
to a medical condition targeted under the State's Plan, are not used in
the administration of other non-medical programs.
We also propose to exclude payment for services that are provided
to residents of an institution for mental disease (IMD), including
residents of a community residential treatment facility of over 16
beds, that is primarily engaged in providing diagnosis, treatment, or
care of persons with mental illness, and that does not meet the
requirements at Sec. 440.160. It appears that in the past, certain
States may have provided services under the rehabilitation option to
these individuals. Our proposed exclusion of FFP for rehabilitative
services provided to these populations is consistent with the statutory
requirements in paragraphs (A) and (B) following section 1905(a)(28) of
the Act. The statute indicates that ``except as otherwise provided in
paragraph (16), such term [medical assistance] does not include--(A)
Any such payments with respect to care or services for any individual
who is an inmate of a public institution; or (B) any such payments with
respect to care or services for any individual who has not attained 65
years and who is a patient in an IMD.'' Section 1905(a)(16) of the Act
defines as ``medical assistance'' ``* * * inpatient psychiatric
hospital services for individuals under age 21 * * *''. The Secretary
has defined the term ``inpatient psychiatric hospital services for
individuals under age 21'' in regulations at Sec. 440.160 to include
``a psychiatric facility which is accredited by the Joint Commission on
Accreditation of Healthcare Organizations, the Council on Accreditation
of Services for Families and Children, the Commission on Accreditation
of Rehabilitation Facilities, or by any other accrediting organization,
with comparable standards, that is recognized by the State.'' Thus, the
term ``inpatient psychiatric hospital services for individuals under
age 21'' includes services furnished in accredited children's
psychiatric residential treatment facilities that are not hospitals.
The rehabilitative services that are provided by the psychiatric
hospital or accredited psychiatric residential treatment facility
(PRTF) providing inpatient psychiatric services for individuals under
age 21 to its residents would be reimbursed under the benefit for
inpatient psychiatric services for individuals under age 21 (often
referred to as the ``psych under 21'' benefit), rather than under the
rehabilitative services benefit.
In Sec. 441.45(b)(6), we propose to exclude expenditures for room
and board from payment under the rehabilitative services option. While
rehabilitative services may be furnished in a residential setting that
is not an IMD, the benefit provided by section 1905(a)(13) of the Act
is primarily intended for community based services. Thus, when
rehabilitative services are provided in a residential setting, such as
in a residential substance abuse treatment facility of less than 17
beds, delivered by qualified providers, only the costs of the specific
rehabilitative services will be covered.
In Sec. 441.45(b)(7), we propose to preclude payment for services
furnished for the rehabilitation of an individual who is not Medicaid
eligible. This provision reinforces basic program requirements found in
section 1905(a) of the Act that require medical assistance to be
furnished only to eligible individuals. An ``eligible individual'' is a
person who is eligible for Medicaid and requires rehabilitative
services as defined in the Medicaid State plan at the time the services
are furnished.
The provision of rehabilitative services to non-Medicaid eligible
individuals cannot be covered if it relates directly to the non-
eligible individual's care and treatment. However, effective
rehabilitation of eligible individuals may require some contact with
non-eligible individuals. For instance, in developing the
rehabilitation plan for a child with a mental illness, it may be
appropriate to include the child's parents, who are not eligible for
Medicaid, in the process. In addition, counseling sessions for the
treatment of the child might include the parents and other non-eligible
family members. In all cases, in order for a service to be a Medicaid
coverable service, it must be provided to, or directed exclusively
toward, the treatment of the Medicaid eligible individual.
Thus, contacts with family members for the purpose of treating the
Medicaid eligible individual may be covered by Medicaid. If these other
family members or other individuals also are Medicaid eligible and in
need of the services covered under the State's rehabilitation plan,
Medicaid could pay for the services furnished to them.
In Sec. 441.45(b)(8), we propose that FFP would only be available
for claims for services provided to a specific individual that are
documented in an individual's case record.
We will work with States to implement this rule in a timely fashion
using existing monitoring and compliance authority.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
[[Page 45208]]
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:
Section 440.130 Diagnostic, Screening, Preventative, and Rehabilitative
Services
This section outlines the scope of service for rehabilitative
services provided by States. The services discussed in this section
must be provided under a written rehabilitation plan as defined in
Sec. 440.130(d)(1)(v). Specifically, Sec. 440.130(d)(3) states that
the written rehabilitation plan must meet the following requirements:
(i) Be based on a comprehensive assessment of an individual's
rehabilitation needs including diagnoses and presence of a functional
impairment in daily living.
(ii) Be developed by a qualified provider(s) working within the
State scope of practice act with input from the individual,
individual's family, the individual's authorized health care decision
maker and/or persons of the individual's choosing.
(iii) Ensure the active participation of the individual,
individual's family, the individual's authorized health care decision
maker and/or persons of the individual's choosing in the development,
review, and modification of these goals and services.
(iv) Specify the individual's rehabilitation goals to be achieved
including recovery goals for persons with mental illnesses or substance
related disorders.
(v) Specify the physical impairment, mental health and/or substance
related disorder that is being addressed.
(vi) Identify the medical and remedial services intended to reduce
the identified physical impairment, mental health and/or substance
related disorder.
(vii) Identify the methods that will be used to deliver services.
(viii)Specify the anticipated outcomes.
(ix) Indicate the frequency and duration of the services.
(x) Be signed by the individual responsible for developing the
rehabilitation plan.
(xi) Indicate the anticipated provider(s) of the service(s) and the
extent to which the services may be available from alternate
provider(s) of the same service.
(xii) Specify a timeline for reevaluation of the plan, based on the
individual's assessed needs and anticipated progress, but not longer
than one year.
(xiii) Be reevaluated with the involvement of the beneficiary,
family or other responsible individuals.
(xiv) Be reevaluated including a review of whether the goals set
forth in the plan are being met and whether each of the services
described in the plan has contributed to meeting the stated goals. If
it is determined that there has been no measurable reduction of
disability and restoration of functional level, any new plan would need
to pursue a different rehabilitation strategy including revision of the
rehabilitative goals, services and/or methods.
(xv) Document that the individual or representative participated in
the development of the plan, signed the plan, and received a copy of
the rehabilitation plan.
(xvi) Document that the services have been determined to be
rehabilitative services consistent with the regulatory definition.
The burden associated with the requirements in this section is the
time and effort put forth by the provider to gather the information and
develop a specific written rehabilitation plan. While these
requirements are subject to the PRA, we believe they meet the exemption
requirements for the PRA found at 5 CFR 1320.3(b)(2), and as such, the
burden associated with these requirements is exempt.
Section 441.45 Rehabilitative Services
Section 441.45(a)(3) requires that providers maintain case records
that contain a copy of the rehabilitation plan for all individuals.
The burden associated with these requirements is the time and
effort put forth by the provider to maintain the case records. While
these requirements are subject to the PRA, we believe they meet the
exemption requirements for the PRA found at 5 CFR 1320.3(b)(2), and as
such, the burden associated with these requirements is exempt.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Regulations Development Group, Attn:
Melissa Musotto [CMS-2261-P], Room C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Katherine Astrich, CMS Desk Officer, [CMS-1321-P],
katherine_astrich@omb.eop.gov. Fax (202) 395-6974.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a final document, we will respond to the
comments in that document.
V. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This is a major rule because of the size of the anticipated reduction
in Federal financial participation that is estimated to have an
economically significant effect of more than $100 million in each of
the Federal fiscal years 2008 through 2012.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$6.5 million to $31.5 million in any 1 year. The Secretary certifies
that this major rule would not have a direct impact on providers of
rehabilitative services that furnish services pursuant to section
1905(a)(13) of the Act. The rule would directly affect states and we do
not know nor can we predict the manner in which states would adjust or
respond to the provisions of this rule. CMS is unable to determine the
[[Page 45209]]
percentage of providers of rehabilitative services that are considered
small businesses according to the Small Business Administration's size
standards with total revenues of $6.5 million to $31.5 million or less
in any 1 year. Individuals and States are not included in the
definition of a small entity. In addition, section 1102(b) of the Act
requires us to prepare a regulatory impact analysis if a rule may have
a significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 603 (proposed documents) of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicaid
payment regulations and has fewer than 100 beds. The Secretary
certifies that this major rule would not have a direct impact on small
rural hospitals. The rule would directly affect states and we do not
know nor can we predict the manner in which states would adjust or
respond to the provisions of this rule.
Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. Since this rule would
not mandate spending in any 1 year of $120 million or more, the
requirements of the UMRA are not applicable.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this rule would not impose any costs on State or
local governments, preempt State law, or otherwise have Federalism
implications, the requirements of E.O. 13132 are not applicable.
B. Anticipated Effects
FFP will be available for rehabilitative services for treatment of
physical, mental health, or substance-related disorder rehabilitation
treatment if the State elects to provide those services through the
approved State plan. Individuals retain the right to select among
qualified providers of rehabilitative services. However, because FFP
will be excluded for rehabilitative services that are included in other
Federal, State and local programs, it is estimated that Federal
Medicaid spending on rehabilitative services would be reduced by
approximately $180 million in FY 2008 and would be reduced by $2.2
billion between FY 2008 and FY 2012. This reduction in spending is
expected to occur because FFP for rehabilitative services would no
longer be paid to inappropriate other third parties or other Federal,
State, or local programs.
The estimated impact on Federal Medicaid spending was calculated
starting with an estimate of rehabilitative service spending that may
be subject to this rule. This estimate was developed after consulting
with several experts, as data for rehabilitative services, particularly
as it would apply to this rule, is limited. Given this estimate, the
actuaries discounted this amount to account for four factors: (1) The
ability of CMS to effectively identify the rehabilitative services
spending that would be subject to this proposal; (2) the effectiveness
of CMS's efforts to implement this rule and the potential that some
identified rehabilitative services spending may still be permissible
under the rule; (3) the change in States' plans that may regain some of
the lost Federal funding; and (4) the length of time for CMS to fully
implement the rule and review all States' plans.
The actual impact to the Federal Medicaid program may be different
than the estimate to the extent that the estimate of the amount of
rehabilitative services spending subject to this rule is different than
the actual amount and to the extent that the effectiveness of the rule
is greater than or less than assumed. Because a comprehensive review of
these rehabilitative services had not been conducted at the time of
this estimate and because we do not routinely collect data on spending
for rehabilitative services, particularly as it relates to this rule,
there is a significantly wide range of possible impacts.
Thus, we are unable to determine what fiscal impact the publication
of this rule would have on consumers, individual industries, Federal,
State, or local government agencies or geographic regions under
Executive Order 12866. We invite public comment on the potential impact
of the rule.
C. Alternatives Considered
This proposed rule would amend the definition of rehabilitative
services to provide for important individual protections and to clarify
that Medicaid rehabilitative services must be coordinated with but do
not include services furnished by other programs that are focused on
social or educational development goals and available as part of other
services or programs. We believe this proposed rule is the best
approach to clarifying the covered rehabilitative services, and also
because all stakeholders will have the opportunity to comment on the
proposed rule. These comments will then be considered before the final
document is published.
In considering regulatory options, we considered requiring States
to license all providers as an alternative to only requiring that
providers to be qualified as defined by the State. However we believe
that giving States the flexibility to determine how providers are
credentialed allows for necessary flexibility to States to consider a
wide range of provider types necessary to cover a variety of
rehabilitation services. We believe this flexibility will result in
decreases in administrative and service costs.
We also considered restricting the rule to only include participant
protections but not explicitly prohibiting FFP for services that are
intrinsic elements of other non-Medicaid programs. Had we not
prohibited FFP for services that are intrinsic elements of other
programs, States would continue to provide non-Medicaid services to
participants, the result would have been a less efficient use of
Medicaid funding because increased Medicaid spending would not result
in any increase in services to beneficiaries. Instead, increased
Medicaid funding would have simply replaced other sources of funding.
D. Accounting Statement and Table
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf
), in the table below, we
have prepared an accounting statement showing the classification of the
savings associated with the provisions of this proposed rule. This
table provides our best estimate of the savings to the Federal
Government as a result of the changes presented in this proposed rule
that Federal Medicaid spending on rehabilitative services would be
reduced by approximately $180 million in FY 2008 and would be reduced
by $2.24 billion between FY 2008 and FY 2012. All savings are
classified as transfers from the Federal Government to State
Government. These transfers represent a reduction in the federal share
of Medicaid spending once the rule goes into effect, as it would limit
States from claiming Medicaid reimbursement for
[[Page 45210]]
rehabilitation services that could be covered through other programs.
Accounting Statement: Classification of Estimated Savings, From FY 2008 to FY 2012
[In millions]
----------------------------------------------------------------------------------------------------------------
Primary Units discount
Category estimates Year dollar rate Period covered
----------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized ($millions/year)... 443.4 2008 7% 2008-2012
.............. .............. .............. ..............
441.6 2008 3% 2008-2012
.............. .............. .............. ..............
448 2008 0% 2008-2012
---------------------------------------------------------------
From Whom to Whom?.............................. Federal Government to State Government
----------------------------------------------------------------------------------------------------------------
Column 1: Category--Contains the description of the different
impacts of the rule; it could include monetized, quantitative but not
monetized, or qualitative but not quantitative or monetized impacts; it
also may contain unit of measurement (such as, dollars). In this case,
the only impact is the Federal annualized monetized impact of the rule.
Column 2: Primary Estimate--Contains the quantitative or
qualitative impact of the rule for the respective category of impact.
Monetized amounts are generally shown in real dollar terms. In this
case, the federalized annualized monetized primary estimate represents
the equivalent amount that, if paid (saved) each year over the period
covered, would result in the same net present value of the stream of
costs (savings) estimated over the period covered.
Column 3: Year Dollar--Contains the year to which dollars are
normalized; that is, the first year that dollars are discounted in the
estimate.
Column 4: Unit Discount Rate--Contains the discount rate or rates
used to estimate the annualized monetized impacts. In this case, three
rates are used: 7 percent; 3 percent; 0 percent.
Column 5: Period Covered--Contains the years for which the estimate
was made.
Rows: The rows contain the estimates associated with each specific
impact and each discount rate used.
``From Whom to Whom?''--In the case of a transfer (as opposed to a
change in aggregate social welfare as described in the OMB Circular),
this section describes the parties involved in the transfer of costs.
In this case, costs previously paid for by the Federal Government would
be transferred to the State Governments. The table may also contain
minimum and maximum estimates and sources cited. In this case, there is
only a primary estimate and there are no additional sources for the
estimate.
Estimated Savings--The following table shows the discounted costs
(savings) for each discount rate and for each year over the period
covered. ``Total'' represents the net present value of the impact in
the year the rule takes effect. These numbers represent the anticipated
annual reduction in Federal Medicaid spending under this rule.
Estimated Savings, From FY 2008 to FY 2012
[In millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Discount rate (percent) 2008 2009 2010 2011 2012 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
0....................................................... 180 360 520 570 610 2,288
3....................................................... 175 339 476 506 526 2,069
7....................................................... 168 314 424 435 435 1,822
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. Conclusion
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because a comprehensive review of these
rehabilitative services had not been conducted at the time of this
estimate and because we do not routinely collect data on spending for
rehabilitative services. Accordingly, there is a significantly wide
range of possible impacts due to this rule. As indicated in the
Estimated Savings table above, we project an estimated savings of $180
million in FY 2008, $360 million in FY 2009, $520 million in FY 2010,
$570 million in FY 2011, and $610 million in FY 2012. This reflects a
total estimated savings of $2.240 billion dollars for FY 2008 through
FY 2012. We invite public comment on the potential impact of this rule.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
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.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 440--SERVICES: GENERAL PROVISIONS
1. The authority citation for part 440 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
2. Section 440.130 is amended by revising paragraph (d) to read as
follows:
Sec. 440.130 Diagnostic, screening, preventative, and rehabilitative
services.
* * * * *
[[Page 45211]]
(d) Rehabilitative Services--(1) Definitions. For purposes of this
subpart, the following definitions apply:
(i) Recommended by a physician or other licensed practitioner of
the healing arts means that a physician or other licensed practitioner
of the healing arts, based on a comprehensive assessment of the
individual, has--
(A) Determined that receipt of rehabilitative services would result
in reduction of the individual's physical or mental disability and
restoration to the best possible functional level of the individual;
and
(B) Recommended the rehabilitative services to achieve specific
individualized goals.
(ii) Other licensed practitioner of the healing arts means any
health practitioner or practitioner of the healing arts who is licensed
in the State to diagnose and treat individuals with the physical or
mental disability or functional limitations at issue, and operating
within the scope of practice defined in State law.
(iii) Qualified providers of rehabilitative services means
individuals who meet any applicable provider qualifications under
Federal law that would be applicable to the same service when it is
furnished under other Medicaid benefit categories, qualifications under
applicable State scope of practice laws, and any additional
qualifications set forth in the Medicaid State plan. These
qualifications may include minimum age requirements, education, work
experience, training, credentialing, supervision and licensing
requirements that are applied uniformly. Provider qualifications must
be documented in the State plan and be reasonable given the nature of
the service provided and the population served. Individuals must have
free choice of providers and all willing and qualified providers must
be permitted to enroll in Medicaid.
(iv) Under the direction of means that for physical therapy,
occupational therapy, and services for individuals with speech, hearing
and language disorders (see Sec. 440.110, ``Inpatient hospital
services, other than services in an institution for mental diseases'')
the Medicaid qualified therapist providing direction is a licensed
practitioner of the healing arts qualified under State law to diagnose
and treat individuals with the disability or functional limitations at
issue, is working within the scope of practice defined in State law and
is supervising each individual's care. The supervision must include, at
a minimum, face-to-face contact with the individual initially and
periodically as needed, prescribing the services to be provided, and
reviewing the need for continued services throughout the course of
treatment. The qualified therapist must also assume professional
responsibility for the services provided and ensure that the services
are medically necessary. Therapists must spend as much time as
necessary directly supervising services to ensure beneficiaries are
receiving services in a safe and efficient manner in accordance with
accepted standards of practice. Moreover, documentation must be kept
supporting the supervision of services and ongoing involvement in the
treatment. Note that this definition applies specifically to providers
of physical therapy, occupational therapy, and services for individuals
with speech, hearing and language disorders. This language is not meant
to exclude appropriate supervision arrangements for other
rehabilitative services.
(v) Rehabilitation plan means a written plan that specifies the
physical impairment, mental health and/or substance related disorder to
be addressed, the individualized rehabilitation goals and the medical
and remedial services to achieve those goals. The plan is developed by
a qualified provider(s) working within the State scope of practice act,
with input from the individual, individual's family, the individual's
authorized decision maker and/or of the individual's choosing and also
ensures the active participation of the individual, individual's
family, individual's authorized decision maker and/or of the
individual's choosing in the development, review, and modification of
the goals and services. The plan must document that the services have
been determined to be rehabilitative services consistent with the
regulatory definition. The plan must have a timeline, based on the
individual's assessed needs and anticipated progress, for reevaluation
of the plan, not longer than one year. The plan must be reasonable and
based on the individual's condition(s) and on general standards of
practice for provision of rehabilitative services to an individual with
the individual's condition(s).
(vi) Restorative services means services that are provided to an
individual who has had a functional loss and has a specific
rehabilitative goal toward regaining that function. The emphasis in
covering rehabilitation services is on the ability to perform a
function rather than to actually have performed the function in the
past. For example, a person may not have needed to take public
transportation in the past, but may have had the ability to do so prior
to having the disability. Rehabilitation goals are often contingent on
the individual's maintenance of a current level of functioning. In
these instances services that provide assistance in maintaining
functioning may be considered rehabilitative only when necessary to
help an individual achieve a rehabilitation goal defined in the
rehabilitation plan. Services provided primarily in order to maintain a
level of functioning in the absence of a rehabilitation goal are not
within the scope of rehabilitation services.
(vii) Medical services means services specified in the
rehabilitation plan that are required for the diagnosis, treatment, or
care of a physical or mental disorder and are recommended by a
physician or other licensed practitioner of the healing arts within the
scope of his or her practice under State law. Medical services may
include physical therapy, occupational therapy, speech therapy, and
mental health and substance-related disorder rehabilitative services.
(viii) Remedial services means services that are intended to
correct a physical or mental disorder and are necessary to achieve a
specific rehabilitative goal specified in the individual's
rehabilitation plan.
(2) Scope of services. Except as otherwise provided under this
subpart, rehabilitative services include medical or remedial services
recommended by a physician or other licensed practitioner of the
healing arts, within the scope of his practice under State law, for
maximum reduction of physical or mental disability and restoration of a
individual to the best possible functional level. Rehabilitative
services may include assistive devices, medical equipment and supplies,
not otherwise covered under the plan, which are determined necessary to
the achievement of the individual's rehabilitation goals.
Rehabilitative services do not include room and board in an institution
or community setting.
(3) Written rehabilitation plan. The written rehabilitation plan
shall be reasonable and based on the individual's condition(s) and on
the standards of practice for provision of rehabilitative services to
an individual with the individual's condition(s). In addition, the
written rehabilitation plan must meet the following requirements:
(i) Be based on a comprehensive assessment of an individual's
rehabilitation needs including diagnoses and presence of a functional
impairment in daily living.
(ii) Be developed by a qualified provider(s) working within the
State scope of practice act with input from the individual,
individual's family, the individual's authorized health care
[[Page 45212]]
decision maker and/or persons of the individual's choosing.
(iii) Follow guidance obtained through the active participation of
the individual, and/or persons of the individual's choosing (which may
include the individual's family and the individual's authorized health
care decision maker), in the development, review, and modification of
plan goals and services.
(iv) Specify the individual's rehabilitation goals to be achieved,
including recovery goals for persons with mental health and/or
substance related disorders.
(v) Specify the physical impairment, mental health and/or substance
related disorder that is being addressed.
(vi) Identify the medical and remedial services intended to reduce
the identified physical impairment, mental health and/or substance
related disorder.
(vii) Identify the methods that will be used to deliver services.
(viii) Specify the anticipated outcomes.
(ix) Indicate the frequency, amount and duration of the services.
(x) Be signed by the individual responsible for developing the
rehabilitation plan.
(xi) Indicate the anticipated provider(s) of the service(s) and the
extent to which the services may be available from alternate
provider(s) of the same service.
(xii) Specify a timeline for reevaluation of the plan, based on the
individual's assessed needs and anticipated progress, but not longer
than one year.
(xiii) Be reevaluated with the involvement of the individual,
family or other responsible individuals.
(xiv) Be reevaluated including a review of whether the goals set
forth in the plan are being met and whether each of the services
described in the plan has contributed to meeting the stated goals. If
it is determined that there has been no measurable reduction of
disability and restoration of functional level, any new plan would need
to pursue a different rehabilitation strategy including revision of the
rehabilitative goals, services and/or methods.
(xv) Document that the individual or representative participated in
the development of the plan, signed the plan, and received a copy of
the rehabilitation plan.
(xvi) Document that the services have been determined to be
rehabilitative services consistent with the regulatory definition.
(xvii) Include the individual's relevant history, current medical
findings, contraindications and identify the individual's care
coordination needs, if any, as needed to achieve the rehabilitation
goals.
(4) Impairments to be addressed. For purposes of this section,
rehabilitative services include services provided to the Medicaid
eligible individual to address the individual's physical impairments,
mental health impairments, and/or substance-related disorder treatment
needs.
(5) Settings. Rehabilitative services may be provided in a
facility, home, or other setting.
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).
Subpart A--General Provisions
2. A new Sec. 441.45 is added to subpart A to read as follows:
Sec. 441.45 Rehabilitative services.
(a) If a State covers rehabilitative services, as defined in Sec.
440.130(d) of this chapter, the State must meet the following
requirements:
(1) Ensure that services are provided in accordance with Sec.
431.50, Sec. 431.51, Sec. 440.230, and Sec. 440.240 of this chapter.
(2) Ensure that rehabilitative services are limited to services
furnished for the maximum reduction of physical or mental disability
and restoration of the individual to their best possible functional
level.
(3) Require that providers maintain case records that contain a
copy of the rehabilitation plan for all individuals.
(4) For all individuals receiving rehabilitative services, require
that providers maintain case records that include the following:
(i) A copy of the rehabilitative plan.
(ii) The name of the individual.
(iii) The date of the rehabilitative services provided.
(iv) The nature, content, and units of the rehabilitative services.
(v) The progress made toward functional improvement and attainment
of the individual's goals as identified in the rehabilitation plan and
case record.
(5) Ensure the State plan for rehabilitative services includes the
following requirements:
(i) Describes the rehabilitative services furnished.
(ii) Specifies provider qualifications that are reasonably related
to the rehabilitative services proposed to be furnished.
(iii) Specifies the methodology under which rehabilitation
providers are paid.
(b) Rehabilitation does not include, and FFP is not available in
expenditures for, services defined in Sec. 440.130(d) of this chapter
if the following conditions exist:
(1) The services are furnished through a non-medical program as
either a benefit or administrative activity, including services that
are intrinsic elements of programs other than Medicaid, such as foster
care, child welfare, education, child care, vocational and
prevocational training, housing, parole and probation, juvenile
justice, or public guardianship. Examples of services that are
intrinsic elements of other programs and that would not be paid under
Medicaid include, but are not limited to, the following:
(i) Therapeutic foster care services furnished by foster care
providers to children, except for medically necessary rehabilitation
services for an eligible child that are clearly distinct from packaged
therapeutic foster care services and that are provided by qualified
Medicaid providers.
(ii) Packaged services furnished by foster care or child care
institutions for a foster child except for medically necessary
rehabilitation services for an eligible child that are clearly distinct
from packaged therapeutic foster care services and that are provided by
qualified Medicaid providers.
(iii) Adoption services, family preservation, and family
reunification services furnished by public or private social services
agencies.
(iv) Routine supervision and non-medical support services provided
by teacher aides in school settings (sometimes referred to as
``classroom aides'' and ``recess aides'').
(2) Habilitation services, including services for which FFP was
formerly permitted under the Omnibus Budget Reconciliation Act of 1989.
Habilitation services include ``services provided to individuals'' with
mental retardation or related conditions. (Most physical impairments,
and mental health and/or substance related disorders, are not included
in the scope of related conditions, so rehabilitation services may be
appropriately provided.)
(3) Recreational or social activities that are not focused on
rehabilitation and not provided by a Medicaid qualified provider;
personal care services; transportation; vocational and prevocational
services; or patient education not related to reduction of physical or
mental disability and the restoration of an individual to his or her
best possible functional level.
[[Page 45213]]
(4) Services that are provided to inmates living in the secure
custody of law enforcement and residing in a public institution. An
individual is considered to be living in secure custody if serving time
for a criminal offence in, or confined involuntarily to, public
institutions such as State or Federal prisons, local jails, detention
facilities, or other penal facilities. A facility is a public
institution when it is under the responsibility of a governmental unit;
or over which a governmental unit exercises administrative control.
Rehabilitative services could be reimbursed on behalf of Medicaid-
eligible individuals paroled, on probation, on home release, in foster
care, in a group home, or other community placement, that are not part
of the public institution system, when the services are identified due
to a medical condition targeted under the State's Plan, are not used in
the administration of other non-medical programs.
(5) Services provided to residents of an institution for mental
disease (IMD) who are under the age of 65, including residents of
community residential treatment facilities with more than 16 beds that
do not meet the requirements at Sec. 440.160 of this chapter.
(6) Room and board.
(7) Services furnished for the treatment of an individual who is
not Medicaid eligible.
(8) Services that are not provided to a specific individual as
documented in an individual's case record.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
Dated: March 22, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: July 12, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07-3925 Filed 8-8-07; 4:00 pm]
BILLING CODE 4120-01-P