[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35684-35711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14673]
[[Page 35683]]
Vol. 76
Friday
No. 117
June 17, 2011
Part V
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 485
Medicare Program; Conditions of Participation (CoPs) for Community
Mental Health Centers; Proposed Rule
Federal Register / Vol. 76 , No. 117 / Friday June 17, 2011 /
Proposed Rules
[[Page 35684]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 485
[CMS-3202-P]
RIN 0938-AP51
Medicare Program; Conditions of Participation (CoPs) for
Community Mental Health Centers
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would establish, for the first time,
conditions of participation (CoPs) that community mental health centers
(CMHCs) would have to meet in order to participate in the Medicare
program. These proposed CoPs would focus on the care provided to the
client, establish requirements for staff and provider operations, and
encourage clients to participate in their care plan and treatment. The
new CoPs would enable CMS to survey CMHCs for compliance with health
and safety requirements.
DATES: To be assured consideration, comments must be received at one of
the addresses provided in the ADDRESSES section no later than 5 p.m. on
August 16, 2011.
ADDRESSES: In commenting, please refer to file code CMS-3202-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (Fax) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3202-P, P.O. Box 8010, Baltimore, MD
21244-1850.
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 to
the following address only:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3202-P, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments only to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey 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.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Mary Rossi-Coajou, (410) 786-6051.
Maria Hammel, (410) 786-1775.
SUPPLEMENTARY INFORMATION:
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 or confidential business
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.regulations.gov. Follow the search instructions 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, MD 21244, on Monday through Friday of each week from 8:30
a.m. to 4 p.m. E.S.T. To schedule an appointment to view public
comments, phone 1-800-743-3951.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. Free public access is available on a Wide
Area Information Server (WAIS) through the Internet and via
asynchronous dial-in. Internet users can access the database by using
the World Wide Web (the Superintendent of Documents' home page address
is http://www.gpoaccess.gov/index.html), by using local WAIS client
software, or by telnet to swais.access.gpo.gov, then login as guest (no
password required). Dial-in users should use communications software
and modem to call (202) 512-1661; type swais, then login as a guest (no
password required).
I. Background
A. Introduction
In 2007, 224 certified Community Mental Health Centers (CMHCs)
billed Medicare for partial hospitalization services for 25,087
Medicare beneficiaries. Currently, there are no Conditions of
Participation (CoPs) in place for Medicare-certified CMHCs. As such, no
regulatory basis exists to ensure basic levels of quality and safety
for CMHC care. The Federal government, as the single largest payer of
health care services in the United States, administers many statutory
and regulatory requirements on the delivery and quality of health care
furnished under its programs. Therefore, we are proposing for the first
time a set of requirements that Medicare-certified CMHCs must meet in
order to participate in the Medicare program. The CoPs that we are
proposing would help to ensure the quality and safety of CMHC care for
all clients served by the CMHC, regardless of payment source.
These requirements would focus on a short term, client-centered,
outcome-oriented process that promotes quality client care.
Requirements for CMHC services would encompass--(1) Personnel
qualifications; (2) client rights; (3) admission, initial evaluation,
comprehensive assessment, and discharge or transfer of the client; (4)
treatment team, active treatment plan, and coordination of services;
(5) quality assessment and performance improvement; and (6)
organization, governance, administration of services, and partial
hospitalization services. Overarching the proposed CMHC
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requirements would be a quality assessment and performance improvement
program that would build on a provider's own quality management system
to improve client care performance. We would expect CMHCs to furnish
health care that met the essential health and quality standards that
would be established by this rule; therefore, a CMHC would use its own
quality management system to monitor and improve its own performance
and compliance. To achieve this objective, we are proposing new CMHC
requirements.
B. Current Requirements for CMHCs
Section 1832(a)(2)(J) of the Social Security Act (the Act)
established coverage of partial hospitalization services for Medicare
beneficiaries. Section 1861(ff)(2) of the Act defines partial
hospitalization services as a broad range of mental health services
``that are reasonable and necessary for the diagnosis or active
treatment of the individual's condition, reasonably expected to improve
or maintain the individual's condition and functional level and to
prevent relapse or hospitalization, and furnished pursuant to such
guidelines relating to frequency and duration of services as the
Secretary shall by regulation establish''.
Section 4162 of the Omnibus Budget Reconciliation Act of 1990 (OBRA
1990) (Pub. L. 101-508) amended sections 1832(a)(2) and 1861(ff)(3) of
the Act to allow CMHCs to provide partial hospitalization services.
Under the Medicare program, CMHCs are recognized as Medicare providers
only for partial hospitalization services (see 42 CFR 410.110).
A CMHC, in accordance with section 1861(ff)(3)(B) of the Act, is an
entity that meets applicable licensing or certification requirements
for CMHCs in the State in which it is located and provides the set of
services specified in section 1913(c)(1) of the Public Health Service
Act (PHS Act). However, CMS has learned that most States either do not
have a certification or licensure program for these types of
facilities, or have regulatory regimens that apply only to CMHCs that
receive state funding.
A CMHC may receive Medicare payment for partial hospitalization
services only if it demonstrates two key components:
(1) The CMHC meets each of the following core requirements
identified at 42 CFR 410.2:
Provides outpatient services, including specialized
outpatient services for children, elderly individuals, individuals with
chronic mental illness, and residents of the CMHC's mental health
service area that have been discharged from inpatient treatment at a
mental health facility.
Provides 24 hour-a-day emergency care services.
Provides day treatment, partial hospitalization services,
or psychosocial rehabilitation services.
Provides screening for clients being considered for
admission to State mental health facilities to determine the
appropriateness of such admission. (Section 1861(ff)(3)(B)(i)(II) of
the Act allows CMHCs to provide these services by contract if State law
precludes the entity from directly providing the screening services.)
Provides at least 40 percent of its services to
individuals who are not eligible for benefits under Medicare.
(2) The CMHC, in accordance with regulations at 42 CFR 424.24(e),
provides partial hospitalization program (PHP) services that are:
Furnished under the general supervision of a physician;
Subject to certification or recertification by a physician
that the individual would require inpatient psychiatric care if partial
hospitalization services were not provided; and
Furnished under an individualized plan of treatment that
is periodically reviewed and meets the requirements of 42 CFR
424.24(e)(2).
When the partial hospitalization program benefit was first enacted,
CMHCs were certified based on self-attestation. Currently, CMHCs are
Medicare-certified and Medicare-enrolled based on a CMS Regional Office
determination that the provider meets the definition of a CMHC at
section 1861(ff)(3)(B)(i) of the Act and provides the core services
described in section 1913(c)(1) of the PHS Act. CMS has received
complaints regarding CMHCs such as: ceasing to provide services once
the CMHC has been certified, physically mistreating clients, and
providing fragmented care. As there are no CoPs in place for CMHCs,
many participating CMHCs have never had an onsite survey visit by CMS
after their initial certification. Furthermore, there are currently
only limited circumstances in which CMS can terminate a facility based
on the result of a complaint investigation. Without such health and
safety standards in place, CMS' oversight of CMHCs is severely limited.
C. Rationale for Proposing CMHC CoPs
Medicare is responsible for establishing requirements to promote
the health and safety of care provided to its beneficiaries. We believe
that basic health and safety standards should be established for CMHCs
in order to protect patients and their families. Once our rules have
been established, CMS will be able to survey providers, through State
survey and certification agencies, to ensure that the care being
furnished meets the standards. These CoPs would enable CMS to establish
a survey process to promote the safety and quality of client care
provided by Medicare-certified CMHCs. At this time, we are not
proposing to amend our regulations at 42 CFR 488.6 to grant deeming
authority for CMHCs to accrediting organizations. We are specifically
soliciting public comment regarding this issue.
These proposed CoPs are part of CMS' overall effort to improve the
safety and quality of all care provided to Medicare beneficiaries,
regardless of the setting in which the care is provided. To that end,
CMS has issued new and revised regulations for end-stage renal disease
facilities, hospices, hospitals, nursing homes, transplant hospitals,
organ procurement organizations, ambulatory surgery centers, and other
providers. The proposed CMHC CoPs would adopt relevant provisions (for
example, those related to client rights) from these other provider
types to ensure that clients receive consistent protections as they
move from one type of care to another.
D. Principles Applied in Developing the Proposed CMHC CoPs
We developed the proposed CMHC requirements based on the following
principles:
A focus on the continuous, integrated, mental health care
process that a client experiences across all CMHC services.
Activities that center around client assessment, the
active treatment plan, and service delivery.
Use of a client-centered, interdisciplinary approach that
recognizes the contributions of various skilled professionals and other
support personnel and their interaction with each other to meet the
client's needs.
Promotion and protection of client rights.
Based on these principles, we are proposing the following six CoPs:
(1) Personnel qualifications; (2) client rights; (3) admission, initial
evaluation, comprehensive assessment, and discharge or transfer of the
client; (4) treatment team, active treatment plan, and coordination of
services; (5) quality assessment and performance improvement; and (6)
organization, governance, administration of services, and partial
hospitalization services.
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The ``Personnel qualifications'' CoP would establish staff
qualifications for the CMHC.
The ``Client rights'' CoP would emphasize a CMHC's responsibility
to respect and promote the rights of each CMHC client.
The ``Admission, initial evaluation, comprehensive assessment, and
discharge or transfer of the client'' CoP would reflect the critical
nature of a comprehensive assessment in determining appropriate
treatments and accomplishing desired health outcomes.
The ``Treatment team, active treatment plan, and coordination of
services'' CoP would incorporate a client-centered interdisciplinary
team approach, in consultation with the client's primary health care
provider (if any).
The ``Quality assessment and performance improvement'' CoP would
challenge each CMHC to build and monitor its own quality management
system to monitor and improve client care performance.
The ``Organization, governance, administration of services, and
partial hospitalization services'' CoP would charge each CMHC with the
responsibility for creating and implementing a governance structure
that focuses on and enhances its coordination of services to better
serve its clients.
Two of the proposed CoPs, ``Admission, initial evaluation,
comprehensive assessment, and discharge or transfer of the client'' and
``Treatment team, active treatment plan, coordination of services,''
would establish a cycle of individualized client care. The client's
care needs would be comprehensively assessed, enabling the
interdisciplinary team, with the client, to establish an active
treatment plan. The active treatment plan would be implemented, and the
results of the care would be evaluated by updating the comprehensive
assessment and active treatment plan.
These proposed CoPs present an opportunity for CMHCs, States, and
CMS to join in a partnership for improvement. When implemented, CMHC
programming will reflect a client-centered approach that will affect
how State survey and certification agencies and CMS manage the survey
process. We believe that this approach will provide opportunities for
improvement in client care.
II. Provisions of the Proposed Regulations
A. Proposed Requirements
We are proposing to establish a new subpart J under the regulations
at 42 CFR part 485 to incorporate the proposed CoPs for CMHCs. We are
proposing that the effective date of these provisions would be 12
months after the publication of the final rule. Delaying the effective
date for 12 months after the date of publication of the final rule
would allow CMHCs time to educate staff, initiate their quality
assessment and performance improvement (QAPI) program, and implement
the new set of CoPs. The new subpart J would include the basis and
scope of the subpart, definitions, and the six CoPs and standards.
Below we discuss each proposed section in detail.
Basis and Scope (Proposed Sec. 485.900)
In proposed Sec. 485.900, we are proposing to cite the statutory
authority for CMHCs to provide services that are payable under Medicare
Part B. In addition, we would describe the scope of provisions in the
proposed subpart J.
Definitions (Proposed Sec. 485.902)
In proposed Sec. 485.902, we are proposing to include the
following definitions for terms used in the CoPs for CMHCs under the
proposed subpart J:
``Active treatment plan'' would mean an individualized client plan
that focuses on the provision of care and treatment services that
address the client's physical, psychological, psychosocial, emotional,
and therapeutic needs and goals as identified in the comprehensive
assessment. This proposed definition was established by reviewing 42
CFR 424.24(e)(2) and The Joint Commission Accreditation Manual for
Behavioral Health Care definition of ``planning of care.''
``Community mental health center (CMHC)'' would mean the entity
type defined at 42 CFR 410.2.
``Comprehensive assessment'' would mean a thorough evaluation of
the client's physical, psychological, psychosocial, emotional, and
therapeutic needs related to the diagnosis under which care is being
furnished by the CMHC. This proposed definition was derived from the
home health and hospice assessment CoPs under 42 CFR parts 484 and 418,
respectively. Clients served by home health and hospice agencies have
comprehensive and complex needs, and the comprehensive assessment
requirements for these providers capture the key elements we believe
are also essential for assessing a CMHC client.
``Employee of a CMHC'' would mean an individual--(a) Who works for
the CMHC and with respect to whom the CMHC is required to issue a W-2
form; or (b) for whom an agency or organization issues a W-2 form, and
who is assigned to the CMHC if the CMHC is a subdivision of such agency
or organization.
``Initial evaluation'' would mean an immediate care and support
assessment of the client's physical, psychosocial, and therapeutic
needs (including a screen for harm to self or others), related to the
client's psychiatric illness and related conditions for which care is
being furnished by the CMHC. This proposed definition is derived from
the hospice CoPs at part 418, but with the addition of the term
``psychiatric illness.'' We added the term ``psychiatric illness'' to
the definition to ensure that the client's needs relate to the care and
services provided by the CMHC. Similar to hospice clients, we believe
that the CMHC client's immediate care needs should be assessed and
addressed as soon as possible. The initial evaluation is the vehicle
that identifies a client's immediate needs and initiates the care
planning process.
``Representative'' would mean an individual who has the authority
under State law to authorize or terminate medical care on behalf of a
client who is mentally or physically incapacitated. This would include
a legal guardian. This proposed definition is consistent with the
definition of this term found in the CoPs for hospices at 42 CFR 418.3.
We do not propose to regulate the relationship between a client and his
or her authorized representative. However, we believe reference to such
representatives is necessary due to the potential instability of some
CMHC clients, and the need to ensure that decisions related to the
client's care and active treatment plan are made appropriately. We
recognize that clients may refuse to participate in their care and
active treatment or, in documented circumstances, be unable to be
present. There is no implication that clients will or will not have
representatives.
``Restraint'' would mean--(a) Any manual method, physical or
mechanical device, material, or equipment that immobilizes or reduces
the ability of a client to move his or her arms, legs, body, or head
freely, not including devices, such as orthopedically prescribed
devices, surgical dressings or bandages, protective helmets, or other
methods that involve the physical holding of a client for the purpose
of conducting routine physical examinations or tests, or to protect the
client from falling out of bed, or to permit the client to participate
in activities without the risk of physical harm (this does not include
a client
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being physically escorted); or (b) a drug or medication when it is used
as a restriction to manage the client's behavior or restrict the
client's freedom of movement, and which is not a standard treatment or
dosage for the client's condition.
``Seclusion'' would mean the involuntary confinement of a client
alone in a room or an area from which the client is physically
prevented from leaving.
The proposed definitions for ``restraint'' and ``seclusion'' are
used in other Medicare-certified provider CoPs such as those for
hospices at Sec. 418.3 and hospitals at 42 CFR 482.13(e)(1), and are
in accordance with section 3207 of the Children's Health Act (Pub. L.
106-310).
``Volunteer'' would mean an individual who--(a) Is an unpaid worker
of the CMHC; or (b) if the CMHC is a subdivision of an agency or
organization, is an unpaid worker of the agency or organization and is
assigned to the CMHC. All volunteers would have to meet the standard
training requirements under 42 CFR 485.918(d).
CMHC CoP: Personnel Qualifications (Proposed Sec. 485.904)
We are proposing to add a new CoP at Sec. 485.904 to establish
staff qualifications for CMHCs. In proposed Sec. 485.904(a),
``Standard: General qualification requirements,'' we are proposing to
require that all professionals who furnish services directly, under an
individual contract, or under arrangements with a CMHC, be legally
authorized (licensed, certified or registered) in accordance with
applicable Federal, State and local laws, and be required to act only
within the scope of their State licenses, certifications, or
registrations. All personnel qualifications would have to be kept
current at all times.
In proposed Sec. 485.904(b), ``Standard: Personnel qualifications
for certain disciplines,'' we are proposing to require staff
qualifications to be consistent with, or similar to, those set forth in
CoPs for other provider types in the Medicare regulations.
``Administrator of a CMHC'' would mean a CMHC employee that meets
the education and experience requirements established by the CMHC
governing body for that position and who is responsible for the day-to-
day operation of the CMHC. This proposed definition is similar to the
definition used in the hospice CoPs at part 418. We believe this
proposed qualification would allow for provider flexibility to
establish requirements based on the services provided by individual
CMHCs.
``Clinical psychologist'' would mean an individual who meets the
qualifications at 42 CFR 410.71(d). This proposed definition by CMS is
used as a basis for payment for services.
``Clinical social worker'' would mean an individual who meets the
qualifications at 42 CFR 410.73(a). This proposed definition also is
currently in use for CMHC services paid by Medicare.
``Mental health counselor'' would mean a professional counselor who
is certified and/or licensed by the State (as applicable) and has the
skills and knowledge to provide mental health services to clients. The
mental health counselor would provide services in areas such as
psychotherapy, substance abuse, crisis management, psychoeducation and
prevention programs. Information contained in The Joint Commission
Accreditation Behavioral Health Care Manual contributed to the
development of these proposed qualifications. These counselors have an
essential role in the care of CMHC clients, and we believe that it is
necessary to define this role to ensure that CMHCs use a variety of
appropriate personnel to care for CMHC clients.
``Occupational therapist'' would mean an individual who meets the
requirements for ``occupational therapist'' set forth at 42 CFR 484.4.
This proposed definition was established in the November 27, 2007,
``Revision to Payment Policies Under the Physician Fee Schedule, and
Other part B Payment Policies for 2008'' final rule (72 FR 66222) that
applied the same requirements for occupational therapists to a variety
of provider types; we believe that this definition is appropriate for
the CMHC environment.
``Physician'' would mean an individual who meets the qualifications
and conditions as defined in section 1861(r) of the Act and provides
the services as specified at Sec. 410.20 of this chapter and would
have experience providing mental health services to clients. This
proposed definition is consistent with the definition of the term
``physician'' in the requirements for other providers such as hospices
and hospitals, with the addition of having experience with clients
receiving mental health services. While we believe experience is
important, we are proposing that through the CMHC's policies and
procedures, the CMHC would determine the level and range of experience
appropriate to care for CMHC clients.
``Psychiatric registered nurse'' would mean a registered nurse that
is a graduate of an approved school of professional nursing, who is
licensed as a registered nurse by the State in which he or she is
practicing, and has at least 2 years of education and/or training in
psychiatric nursing. This proposed definition is similar to that used
for other Medicare-certified providers. We are proposing to add the
additional requirement of 2 years of education and/or training in
psychiatric nursing due to the sensitive and complex needs of the CMHC
client.
``Psychiatrist'' would mean an individual who specializes in
assessing and treating persons having psychiatric disorders, is
certified by the American Board of Psychiatry and Neurology or has
documented equivalent education, training or experience, and is fully
licensed to practice medicine in the State in which he or she
practices. Information contained in The Joint Commission Accreditation
Behavioral Health Care Manual contributed to the development of these
proposed qualifications.
CMHC CoP: Client Rights (Proposed Sec. 485.910)
We are proposing to add a new CoP at Sec. 485.910 to set forth
certain rights to which CMHC clients would be entitled, and to require
that CMHCs inform each client verbally of these rights in a language
and manner that the client or client's representative (if appropriate)
or surrogate understands. The client's representative or surrogate, who
could be a family member or friend that accompanies the client, may act
as a liaison between the client and the CMHC to help the client
communicate, understand, remember, and cope with the interactions that
take place during the visit, and explain any instructions to the client
that are delivered by the CMHC staff. If a client is unable to fully
communicate directly with CMHC staff, then the CMHC may give client
rights information to the client's representative or surrogate. The
client also has the choice of using an interpreter of his or her own or
one supplied by the CMHC. A professional interpreter is not considered
to be a client's representative or surrogate. Rather, it is the
professional interpreter's role to pass information from the CMHC to
the client.
We also propose to require that the client be provided a written
copy of client rights information. This must be provided in English,
for present or future reference or translation by the client's
representative or surrogate. We recommend, but do not propose
requiring, that a written translation be provided in languages that
non-English speaking clients can read, particularly
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for languages that are most commonly used by non-English-speaking
clients of the CMHC.
In proposed Sec. 485.910(a)(1), the notice of rights and
responsibilities would be given to the client, the client's
representative or surrogate, as appropriate, during the initial
evaluation, as described at proposed Sec. 485.914(b). Ensuring that
clients are aware of their rights and how to exercise them are vital
components of improving overall CMHC quality and client satisfaction.
While we propose this standard under the authority of section
1832(a)(2)(F)(i) of the Act, we are also guided by Title VI of the
Civil Rights Act of 1964. Our proposed requirement has been designed to
be compatible with guidance on Title VI. The Department of Health and
Human Services (HHS) guidance related to Title VI of the Civil Rights
Act of 1964, ``Guidance to Federal Financial Assistance Recipients
Regarding Title VI Prohibition Against National Origin Discrimination
Affecting Limited English Proficient Persons'' (August 8, 2003, 68 FR
47311) applies to those entities that receive Federal financial
assistance from HHS, including CMHCs. This guidance may assist CMHCs in
ensuring that client rights information is provided in a language and
manner the client understands.
At proposed Sec. 485.910(b), ``Standard: Exercise of rights and
respect for property and person,'' we are proposing that a client would
be able to exercise his or her rights, have his or her property and
person respected, voice grievances, and not be subjected to
discrimination or reprisal for exercising his or her rights.
Furthermore, in proposed Sec. 485.910(c), the client would have the
right to--(1) Participate in the active treatment planning process; (2)
refuse care or treatment; (3) have his or her records kept
confidential; (4) be free from mistreatment, neglect, abuse, and
misappropriation of his or her personal property; (5) receive
information about limitations on CMHC services; and (6) not be
compelled to perform services for the CMHC. If services are performed
by clients for the CMHC, the wages received by the clients would have
to be commensurate with prevailing wages for the nature of services
performed and the clients' abilities.
In proposed Sec. 485.910(d), ``Standard: Addressing violations of
client rights,'' we are proposing that CMHCs report all complaints of
alleged violations of clients' rights to the CMHC administrator. We are
also proposing that the CMHC would immediately investigate all alleged
violations, take intermediate actions to prevent further potential
client rights violations during the investigation period, and take
appropriate corrective action where necessary. Furthermore, we are
proposing that the CMHC report verified violations of client rights to
appropriate authorities having jurisdiction within five working days of
the CMHC becoming aware of the violation.
The proposed client rights CoP would act as a safeguard of client
health and safety. Open communication between CMHC staff and the
client, and client access to information are vital to enhancing the
client's participation in his or her coordinated active treatment plan.
All CMHCs also would be required to comply with Federal rules
concerning the privacy of individually identifiable health information
set out at 45 CFR parts 160 and 164.
In proposed Sec. 485.910(e), ``Standard: Restraint and
seclusion,'' we are proposing that all clients would have the right to
be free from physical or mental abuse, and corporal punishment. Since
accidental injuries and deaths have been documented in medical
facilities due to the use of restraint and seclusion, we strongly
discourage the use of restraints or seclusion in a CMHC environment
where the clients are receiving services on an outpatient basis.
However, we are aware that under extremely rare instances their
application may be warranted for brief periods of time, and only while
awaiting transport of the client to a hospital. In response to
accidental injuries and deaths, we published new hospital restraint and
seclusion requirements on December 8, 2006 (71 FR 71378) that included
a new standard at Sec. 482.13. The hospital restraint and seclusion
CoP is the basis for the proposed CMHC restraint and seclusion CoP,
with modifications to the regulatory requirements to accommodate this
outpatient setting.
We are proposing that a CMHC restraint and/or seclusion could only
be imposed to ensure the immediate physical safety of the client,
staff, or other individuals while awaiting transfer of the client to a
hospital. A transfer to a hospital immediately is necessary because the
CMHC has limited staff and resources available to safely monitor a
restrained or secluded client. Additionally, the safety of the patient,
other clients and the staff may be in jeopardy. The hospital would be
able to safely monitor the client and assess the cause of the client's
behavior. We are proposing this in order to implement the restraint and
seclusion language in section 3207 of the Children's Health Act (CHA),
Public Law 106-310, codified at section 591 of the Public Health
Service Act (42 U.S.C. 290ii). The CHA provisions apply to any health
care facility that receives support in any form from any program
supported in whole or in part with funds appropriated from any Federal
agency, which clearly includes all providers that participate in
Medicare or Medicaid. The CHA was enacted to protect and promote every
client's right to be free from ``any restraints or involuntary
seclusions imposed for purposes of discipline or convenience.'' The CHA
clearly describes the circumstances in which restraints or seclusion
may be appropriate.
Based on discussions with the CMHC industry and The Joint
Commission, we believe restraints or seclusion are rarely, if ever,
used in a CMHC setting and that there are very few deaths (if any) that
occur due to restraints or seclusion in CMHCs. However, there are no
data available regarding this issue. The use of restraint or seclusion
would be considered contrary to targeted client outcomes and therefore
we would consider the use of restraint or seclusion an adverse client
event that would be tracked as part of the QAPI program (Quality
assessment and performance improvement: proposed Sec. 485.917). During
the survey process the surveyors would review all reports on adverse
client events and the actions taken as part of the QAPI review. We
believe that including these proposed requirements in the CMHC CoPs
would promote the safe use of restraint or seclusion in the rare
occurrence that clients posed an immediate physical threat to
themselves or others. Providing for safe use of restraints would, we
believe, prevent accidental injury or death.
In order to ensure the safety of the CMHC client during the rare
event of the need for restraint or seclusion pending transport to the
hospital, the CMHC would be required to continuously monitor the
restrained or secluded client using trained staff that met the
requirements at paragraph (f) of this section. Continuously monitoring
the client would include, but would not be limited to, respiratory and
circulatory status, skin integrity, vital signs, and any other elements
as specified by CMHC policy.
In proposed Sec. 485.910(e)(2) through (e)(4), we are proposing
that a physician or other licensed practitioner authorized by State law
would be required to order the use of restraint or seclusion. A single
order for seclusion or restraint would not be permitted to exceed 1
hour in duration. In the exceptionally rare circumstance that transport
to the hospital did not occur within the
[[Page 35689]]
original 1 hour timeframe, the CMHC would obtain another order, if
clinically warranted. At the time of the restraint or seclusion order,
the CMHC would be required to obtain a separate order for transfer of
the client to the hospital. Finally, we would require that orders for
restraint or seclusion could never be written as standing orders or on
an as needed (PRN) basis.
In proposed Sec. 485.910(f), ``Standard: Restraint or seclusion:
Staff training requirements,'' we have focused on the proper use of
restraint and seclusion, the need for appropriate CMHC personnel to
receive training and education in the proper use of restraint and
seclusion applications and techniques, and the need for CMHC personnel
to receive training and education in alternative methods for handling
emergency situations that may arise. We emphasize that restraint or
seclusion may only be used to protect the client or others from
immediate harm, and would trigger immediate transportation to a
hospital. We believe restraints or seclusion are rarely, if ever, used
in a CMHC setting; therefore, the use of restraint or seclusion is an
adverse event for a CMHC and should be used as part of the CMHC's
quality assessment and performance improvement program, as outlined in
485.917(a). We also emphasize that staff training requirements on
restraint and seclusion would focus on training and education on
alternative methods for handling behavior, symptoms, and interventions
in emergency situations. Restraint or seclusion would be used only when
less restrictive interventions were determined to be ineffective.
In proposed Sec. 485.910(g), ``Standard: Death reporting
requirements,'' we are proposing a death reporting requirement in the
unlikely circumstance that a death would occur at a CMHC due to
restraint and seclusion. If a client's death was attributed to
restraint or seclusion while the client was awaiting transfer to a
hospital, the CMHC would be required to report the death to CMS
promptly. CMS could initiate an onsite investigation and complaint
survey of the CMHC in accordance with the existing complaint
investigation processes and would inform the federally-mandated
Protection and Advocacy Organizations for its state or territory. We
encourage the public to comment on this proposed standard.
CMHC CoP: Admission, Initial Evaluation, Comprehensive Assessment and
Discharge or Transfer of the Client (Proposed Sec. 485.914)
We are proposing to add a new CoP at Sec. 485.914 to establish
requirements for admission, initial evaluation, comprehensive
assessment, and discharge or transfer of the client. These requirements
reflect our view that a client-centered, interdisciplinary, and
systematic client assessment is essential to quality client care. A
client-specific, comprehensive assessment identifies the client's
physical, psychological, psychosocial, emotional and therapeutic needs.
The care needs identified in the initial evaluation would include, but
would not be limited to, those necessary for treatment and management
of the psychiatric illness. The initial assessment would be completed
within 24 hours of the client admission to the CMHC. The comprehensive
assessment would build from the initial evaluation and be completed by
the physician-led interdisciplinary team in consultation with the
client's primary health care provider, if any. The interdisciplinary
team would be composed of a doctor of medicine, osteopathy or
psychiatry, a psychiatric registered nurse, clinical psychologist, a
clinical social worker, an occupational therapist, and other licensed
mental health counselors, as necessary, pursuant to Sec.
485.916(a)(2). Each member of the team would provide input within the
scope of that individual's practice. The comprehensive assessment would
be completed within 3 working days after the admission to the CMHC. We
believe the current practices of the mental health industry support a
client-specific assessment. This requirement would, therefore, support
standards currently in place at other facilities serving mental health
clients.
The information generated from an interdisciplinary, comprehensive
assessment is critical in determining the individual care and support
needs of each client. This information is used to develop each CMHC
client's active treatment plan. As a result of updates of the
comprehensive assessment, a CMHC would be able to track a client's
progress towards achieving the desired care outcomes. Where progress
did not occur, the interdisciplinary treatment team would consider
appropriate changes to the client's active treatment plan.
The proposed comprehensive assessment requirements would guide CMHC
staff in thoroughly assessing their clients by identifying the general
areas that would be included in each assessment and by identifying
timeframes for the completion of each assessment.
We believe that the broad assessment outline we are proposing would
encourage CMHCs to exercise flexibility in determining how best to
achieve positive outcomes. We believe that this approach is consistent
with currently accepted practices in CMHCs.
In proposed Sec. 485.914(a), ``Standard: Admission,'' we are
proposing that each CMHC would have to determine whether a client was
appropriate for its services as specified in the definition of a CMHC
at Sec. 410.2. If the client was admitted to receive partial
hospitalization services, the CMHC would also have to meet separate
requirements specified at proposed Sec. 485.918(f).
In proposed Sec. 485.914(b), ``Standard: Initial evaluation,'' we
are proposing that a CMHC psychiatric registered nurse or clinical
psychologist would be required to complete an initial evaluation to
determine the client's immediate clinical care and support needs,
including an admitting diagnosis and other diagnoses; the source of the
referral; the reason for admission as stated by the client or others
significantly involved; identification of the client's immediate care
needs; a list of current prescriptions and over-the-counter
medications, as well as other substances that the client may be taking;
and for partial hospitalization services only, an explanation as to why
the client would be at risk for hospitalization if the partial
hospitalization services were not provided. We would require that the
initial evaluation be completed within 24 hours after admission to the
CMHC.
In proposed Sec. 485.914(c), ``Standard: Comprehensive
assessment,'' we are proposing that the CMHC physician-led
interdisciplinary treatment team, in consultation with the client's
primary care provider (if any), be required to complete the
comprehensive assessment in a timely manner consistent with the
client's immediate needs, but no later than 3 working days after
admission to the CMHC. In proposed Sec. 485.914(c)(3) and (c)(4), we
are proposing the requirements for the content of the comprehensive
assessment that we believe are critical to quality CMHC care. These
content requirements are at the core of CMHC care and are needed to
evaluate the client's physical, psychological, psychosocial, medical,
emotional, therapeutic and other needs related to psychiatric illness
and the reason for admission. Therefore, we are proposing that the
comprehensive assessment take into consideration the following factors
outlined in proposed Sec. 485.914(c)(4)(i) through (xiii):
In proposed Sec. 485.914(c)(4)(i), we are proposing to require the
CMHC to identify the reason for the client's admission to the CMHC.
This identification would include the reason
[[Page 35690]]
for admission and the admitting diagnosis as stated by the referral
source, the client, and the CMHC. We believe that this information is
necessary to ensure that the CMHC and client are clear about the reason
for the client's treatment at the CHMC.
In proposed Sec. 485.914(c)(4)(ii) through (c)(4)(ix), we are
proposing to require the comprehensive assessment to address client
preferences regarding what is important to, and important for the
client. The comprehensive assessment would also include a psychiatric
evaluation; information concerning previous and current mental status,
including but not limited to, previous therapeutic interventions and
hospitalizations; information regarding the onset of symptoms of the
illness and circumstances leading to the admission; a description of
attitudes and behavior, such as the client's non-verbal presentation;
cultural factors that may affect care planning; an assessment of
intellectual functions, memory and orientation; complications and risk
factors that may affect care planning; functional status, including the
client's ability to understand and participate in his or her own care,
and the client's strengths and goals; and factors affecting client
safety or the safety of others, including behavioral and physical
factors.
In proposed Sec. 485.914(c)(4)(x), we are proposing that the
client's comprehensive assessment include a review of the client's
current medications, including prescription and over-the-counter
medications, herbal remedies, and other alternative treatments or
substances that could affect drug therapy. The review and accompanying
documentation would include identification of the following items:
Effectiveness of drug therapy.
Drug side effects.
Actual or potential drug interactions.
Duplicate drug therapy.
Drug therapy requiring laboratory monitoring.
As part of the update of the comprehensive assessment, as proposed
in Sec. 485.914(d), this review would have to be repeated as often as
necessary to ensure that the client continued to receive drug therapy
that was effective and appropriate for his or her needs. A review of a
client's drug therapy would be included in the comprehensive assessment
and in the development of the active treatment plan. This review could
occur at any time, as well as at the time of the comprehensive
assessment. We believe it would be most appropriate when a client was
prescribed or began to take any new drug and/or when use of a drug was
discontinued.
In proposed Sec. 485.914(c)(4)(xi), we are proposing that CMHCs
would be required to assess each client's need for referrals to
appropriate health professionals unrelated to the client's mental
illness and beyond the scope of the CMHC, such as care related to
additional medical conditions and/or co-morbidities. This would include
consultation of the CMHC with the client's primary health care
provider, if any.
In proposed Sec. 485.914(c)(4)(xii), we are proposing to require
the CMHC to consider discharge planning options at the time of the
comprehensive assessment. We believe that it is important for
continuity of care that the discharge planning process begin as the
CMHC assesses the client's current health care needs, living
environment, support systems, and therapy goals.
In proposed Sec. 485.914(c)(4)(xiii), we are proposing that the
CMHC be required to identify the client's current support system. We
believe that a smooth transition between care settings would be more
likely to occur if the discharge planning process were initiated early
to determine the availability of resources to assist the client after
discharge from the CMHC.
In proposed Sec. 485.914(d), ``Standard: Update of the
comprehensive assessment,'' we are proposing that the CMHC update the
comprehensive assessment via the physician-led interdisciplinary
treatment team, in consultation with the client's primary health care
provider (if any), no less frequently than every 30 days, and when
changes in the client's status, response to treatment, or goals have
occurred. The update would have to include information on the client's
progress toward desired outcomes, a reassessment of the client's
response to care and therapies, and the client's goals. We believe that
these frequent reviews are necessary since clients with ongoing mental
illness may be subject to frequent and/or rapid changes in status,
needs, acuity, and circumstances, and the client's treatment goals may
change, thereby affecting the type and frequency of services that
should be furnished. The physician-led interdisciplinary treatment team
would use assessment information to guide necessary reviews and/or
changes to the client's active treatment plan.
In proposed Sec. 485.914(e), ``Standard: Discharge or transfer of
the client,'' we are proposing to require the CMHC to complete a
discharge summary and forward it to the receiving facility/provider, if
any, within 48 hours of discharge or transfer from the CMHC. If the
client is being discharged due to non-compliance with the treatment
plan, the CMHC would forward the discharge summary and, if requested,
other pertinent clinical record information to the client's primary
health care provider (if any). The discharge summary would be required
to include--(1) A summary of the services provided while a client of
the CMHC, including the client's symptoms, treatment and recovery goals
and preferences, treatments, and therapies; (2) the client's current
active treatment plan at the time of discharge; (3) the client's most
recent physician orders; and (4) any other documentation that would
assist in post-discharge continuity of care. Furthermore, under the
discharge or transfer standard, the CMHC would have to adhere to all
Federal and State-related requirements pertaining to medical privacy
and the release of client information. We believe this standard would
help ensure that the information flow between the CMHC and the
receiving entity is smooth, and that the appropriate care continues
without being compromised (where applicable).
We welcome public comments on our proposed timeframes and content
for the initial assessment, comprehensive assessment, updated
comprehensive assessment, and discharge or transfer requirements.
CMHC CoP: Treatment Team, Client-Centered Active Treatment Plan, and
Coordination of Services (Proposed Sec. 485.916)
We are proposing to add a new CoP at Sec. 485.916 to establish
requirements for the treatment team, active treatment plan, and
coordination of services. This proposed CoP would contain five
standards that reflect an interdisciplinary team approach to CMHC care
delivery.
As proposed, each client would have a written active treatment plan
developed by the CMHC physician-led interdisciplinary team that would
specify the CMHC care and services necessary to meet the client-
specific needs identified in the initial, comprehensive, and updated
assessments. All CMHC services furnished to clients would have to
follow each client-specific written active treatment plan.
In proposed Sec. 485.916(a), ``Standard: Delivery of services,''
we are proposing that the CMHC designate a physician-led
interdisciplinary team for each client, which would include either a
psychiatric registered nurse, clinical psychologist, or clinical social
worker,
[[Page 35691]]
who would be a coordinator responsible, with the client, for directing,
coordinating and managing the care and services provided to the client.
The team would be composed of individuals who would work together to
meet the physical, medical, psychosocial, emotional, and therapeutic
needs of CMHC clients. The interdisciplinary team would include, but
would not be limited to the following:
A doctor of medicine, osteopathy or psychiatry.
A psychiatric registered nurse.
A clinical social worker.
A clinical psychologist.
An occupational therapist.
Other licensed mental health professionals, as necessary.
We believe that the role of the interdisciplinary treatment team is
paramount in directing and monitoring client care. Each discipline
brings forth a unique perspective, that together creates a well
thought-out and thorough active treatment plan. We understand that
there are instances where two of the interdisciplinary team member's
roles could be covered by one person. For example, a nurse who also
holds a qualifying degree in social work, could represent both the
nurse and social worker interdisciplinary treatment team. This team of
medical professionals works in unison to provide comprehensive care for
the client. For example, the physician/psychiatrist (depending on his
or her licenses) would, at a minimum, address medication management.
The psychiatric nurse would bring forth issues related to care and
implementation of the active treatment plan, and the social worker
would bring forth issues related to the social aspects of the client
and family care. The CMHC would designate a psychiatric registered
nurse, clinical psychologist or clinical social worker who was a member
of the interdisciplinary treatment team to coordinate care, ensure the
continuous assessment of each client's needs, and ensure the
implementation and revision of the active treatment plan. Depending on
the number and/or type of clients served by the CMHC, the CMHC may have
more than one interdisciplinary team. If so, the CMHC is required to
designate a treatment team responsible for establishing policies
governing the day-to-day provision of CMHC care and services.
In proposed Sec. 485.916(b), ``Standard: Active treatment plan,''
we are proposing to require that all CMHC services furnished to clients
follow a written active treatment plan established within 3 working
days after the client's admission to the CMHC by the CMHC physician-led
interdisciplinary treatment team and the client (and representative, if
any), in accordance with the client's psychiatric needs and goals. The
CMHC would have to ensure that each client and, if relevant, primary
caregiver(s) received education and training that was consistent with
the client's and caregiver's responsibilities, as identified in the
client-specific active treatment plan. Education is necessary to ensure
that the client and caregiver understand the services and treatments
contained in the active treatment plan and their roles in actively
participating in and following the plan.
In proposed Sec. 485.914(c), ``Standard: Content of the active
treatment plan,'' we are proposing to require that each client's active
treatment plan reflect client goals and interventions for problems
identified in the comprehensive and updated assessments. This proposed
requirement would ensure that care and services were appropriate to the
level of each client's specific needs. The active treatment plan would
include all of the services necessary for the care and management of
the psychiatric illness, including the following:
Client diagnoses;
Treatment goals, based on what is important to and
appropriate for the client, and the client's recovery goals;
Interventions;
A detailed statement of the type, duration and frequency
of services, including social work, counseling, psychiatric nursing and
therapy services, as well as services furnished by other staff trained
to work with psychiatric clients, necessary to meet the specific client
needs;
Drugs, treatments, and individual and/or group therapies;
Family psychotherapy with the primary focus on the
treatment of the client's conditions (or if no family was available for
such psychotherapy, we would expect the CMHC to document this in the
client's clinical record); and
The interdisciplinary treatment team's documentation of
the client's and representative's (if any) understanding, involvement,
and agreement with the active treatment plan, in accordance with the
CMHC's own policies. This would include information about the client's
need for services and supports, and treatment goals and preferences.
The client and/or representative would need to understand the
importance of their roles in implementing elements of the active
treatment plan. We believe that the client's participation and
agreement regarding care is essential in developing an effective
relationship with the CMHC. Some clients would require supports to
participate effectively in the planning process. While it remains
important to actively engage client representatives, representative
participation could not substitute for client participation, unless
there was a documented reason, such as a safety risk. We would expect a
CMHC to document the client's and the representative's understanding
of, and agreement with, the active treatment plan in accordance with
its own policies. This could include an attestation signed by the
client and representative, a note in the clinical record, and/or
another form of documentation decided upon by the CMHC governing body.
In proposed Sec. 485.916(d), ``Standard: Review of the active
treatment plan,'' we are proposing to require that a revised active
treatment plan be updated with current information from the client's
comprehensive assessment and information concerning the client's
progress toward achieving outcomes and goals specified in the active
treatment plan. The active treatment plan would have to be reviewed at
intervals specified in the plan, but no less frequently than every 30
calendar days. We believe that it is essential to include this
requirement because it would establish the linkage between assessment
information, evaluation of treatment results, and active treatment plan
modification.
In proposed Sec. 485.916(e), ``Standard: Coordination of
services,'' we are proposing to require that the CMHC maintain a system
of communication and integration to enable the interdisciplinary
treatment team to ensure the overall provision of care and the
efficient implementation of day-to-day policies. This proposed standard
would also make it easier for the CMHC to ensure that the care and
services were provided in accordance with the active treatment plan,
and that all care and services provided were based on the comprehensive
and updated assessments of the client's needs. An effective
communication system would also enable the CMHC to ensure the ongoing
sharing of information among all disciplines providing care and
services, whether the care and services were being provided by
employees or by individuals under contract with the CMHC.
We believe that this proposed standard is appropriate because a
CMHC client typically encounters many services delivered at different
times by a variety of individuals with different
[[Page 35692]]
skills. Communication and integration of services and observations
among members of the interdisciplinary treatment team and others
providing care is essential to meet and respond to the client's needs
in a timely manner. Additionally, this would ensure that the CMHC
actively coordinated the care that they were providing with the care
being furnished by other providers, including a client's primary health
care provider (if any).
We recognize the value of an interdisciplinary approach to the
delivery of CMHC services. This approach reflects actual industry
practice, and as a result, we believe the proposed requirement is in
step with accepted standards of practice.
We are specifically soliciting public comment on the proposed
requirements for delivery of services, content of the active treatment
plan, the time frames for review of the active treatment plan, and the
coordination of services standard.
CMHC CoP: Quality Assessment and Performance Improvement (Proposed
Sec. 485.917)
We are proposing to add a new CoP at Sec. 485.917 to specify the
requirements for a quality assessment and performance improvement
program. During the last decade, the health care industry has begun to
address quality issues preemptively. In this proposed rule, we have
outlined the scope of the proposed quality assessment and performance
improvement (QAPI) requirement, the guidelines for identifying
performance improvement activities, and the individuals responsible for
ensuring that a CMHC has a QAPI program. In this rule, we are proposing
that each CMHC develop, implement, and maintain an effective,
continuous QAPI program that stimulates the CMHC to constantly monitor
and improve its own performance, and to be responsive to the needs and
satisfaction levels of the clients it serves.
The desired overall outcome of the proposed QAPI CoP is that the
CMHC would drive its own quality improvement activities and improve its
provision of services. With an effective QAPI program in place and
operating properly, the CMHC could better identify the activities that
led to poor client outcomes, and take actions to improve performance.
This proposed condition would require the CMHC to develop,
implement and maintain an effective data-driven QAPI program. The
program would establish a planned approach to quality improvement and
would take into account the complexity of the CMHC's organization and
services, including those provided directly or under contract. The CMHC
would have to take all actions necessary to implement improvements in
its performance as identified by its QAPI program. The CMHC would also
be responsible for ensuring that the professional services it offered
were carried out within current clinical practice guidelines as well as
professional practice standards applicable to CMHC care.
In proposed Sec. 485.917(a), ``Standard: Program scope,'' we are
proposing that the CMHC's QAPI program include, but not be limited to,
an ongoing program that is able to show measureable improvement in
indicators linked to improving client care outcomes and behavioral
health support services. We expect that a CMHC would use standards of
care and the findings made available in current literature to select
indicators to monitor its program. The CMHC would have to measure,
analyze, and track quality indicators, including areas such as adverse
client events and other aspects of performance that assess processes of
care, CMHC services and operations. The term ``adverse client events,''
as used in the field, refers to occurrences that are harmful or
contrary to the targeted client outcomes, including sentinel events.
The use of restraint and seclusion is contrary to targeted client
outcomes; therefore, we would consider the use of restraint and
seclusion to be an adverse client event that would be tracked and
analyzed as part of the QAPI program.
In proposed Sec. 485.917(b), ``Standard: Program data,'' we are
proposing to require the CMHC QAPI program to incorporate quality
indicator data, including client care data and other relevant data,
into its QAPI program. A fundamental barrier in identifying quality
care is lack of measurement tools. Measurement tools can identify
opportunities for improving medical care and examining the impact of
interventions.
We are not proposing to require that CMHCs use any particular
process, tools or quality measures. However, a CMHC that used available
quality measures could expect an enhanced degree of insight into the
quality of its services and client satisfaction than if it began the
quality measure development process anew.
The CMHC could also develop its own data elements and measurement
process as part of its program. A CMHC would be free to develop a
program that met its needs. We recognize the diversity of provider
needs and concerns with respect to QAPI programs. As such, a provider's
QAPI program would not be judged against a specific model.
The proposed program data standard would require the CMHC to
monitor the effectiveness of its services and target areas for
improvement. The main goal of the proposed standard would be to
identify and correct ineffective and/or unsafe care. We expect CMHCs to
assess their potential client load and identify circumstances that
could lead to significant client care issues, and concentrate their
energies in these areas.
In proposed Sec. 485.917(c), ``Standard: Program activities,'' we
are proposing to require a CMHC to set priorities for its performance
improvement activities that focus on high risk, high volume or problem-
prone areas; consider the prevalence and severity of identified
problems; and give priority to improvement activities that affect
client safety, and quality of client outcomes. We expect that a CMHC
would take immediate action to correct any identified problems that
would directly or potentially threaten the care and safety of clients.
Prioritizing areas of improvement is essential for the CMHC to gain a
strategic view of its operating environment and to ensure consistent
quality of care over time.
We are also proposing to require the CMHC to track adverse client
events, analyze their causes, and implement preventive actions that
include feedback and learning throughout the CMHC. In implementing its
QAPI program, a CMHC is expected to treat staff and clients/
representatives as full partners in quality improvement. Staff members
and clients/representatives are in a unique position to provide the
CMHC with structured feedback on, and suggestions for, improving the
CMHC's performance. We expect the CMHC to demonstrate how the staff and
clients have contributed to its quality improvement program.
In proposed Sec. 485.917(d), ``Standard: Performance improvement
projects,'' we are proposing to require that the number and scope of
improvement projects conducted annually reflect the scope, complexity,
and past performance of the CMHC's services and operations. The CMHC
would have to document what improvement projects were being conducted,
the reasons for conducting them, and the measurable progress achieved
on these projects.
As part of its QAPI program, a CMHC could use an IT performance
improvement project that allowed the CMHC to invest in information
technology; that is, we would allow CMHCs to undertake a program of
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investment and development of an IT system that was geared to
improvements in patient safety and quality, as a QAPI project. In
recognition of the time required to develop and implement this type of
system, we would not require that such activities have a demonstrable
benefit in their initial stages, but we would expect that quality
improvement goals and their achievement would be incorporated in the
plan for the program. Initial stages of development would include
activities such as installation of hardware and software, testing of an
installed system, training of staff, piloting the system, and CMHC-wide
implementation of the system. Upon implementation of the system,
monitoring would begin and data would be collected over time as part of
the process to evaluate the impact of the new system on patient safety
and quality. We believe that recognizing an investment in IT as part of
QAPI demonstrates this Administration's deep commitment to patients,
high quality care, and flexibility. This approach would allow CMHCs the
flexibility to invest appropriate efforts in their quality program and
the freedom to make decisions about the best way to improve the quality
of care. We believe that giving CMHCs the flexibility to review their
own organizations and QAPI programs would improve the effectiveness and
efficiency of their services, the outcomes of care they provided, and
client satisfaction with their services.
In proposed Sec. 485.917(e), ``Standard: Executive
responsibilities,'' we are proposing to require that the CMHC's
governing body be responsible and accountable for ensuring that the
ongoing quality improvement program is defined, implemented and
maintained, and evaluated annually. The governing body would be
required to appoint one or more individuals responsible for operating
the QAPI program, and would have to ensure that the program addressed
priorities for improved quality of client-centered care and client
safety. The governing body would also have to specify the frequency and
level of detail of the data collection and ensure that all quality
improvement actions were evaluated for effectiveness. The governing
body's most important role would be to ensure that staff was
furnishing, and clients were receiving, the most appropriate level of
care. Therefore, it would be incumbent on the governing body to lend
its full support to agency quality improvement and performance
improvement efforts.
CMHC CoP: Organization, Governance, Administration of Services, and
Partial Hospitalization Services. (Proposed Sec. 485.918)
We are proposing to add a new CoP at Sec. 485.918 that would
require the CMHC to set out the CMHC's administrative and governance
structure and would clarify performance expectations for the governing
body. The overall goal of this CoP would be to ensure that the
management structure was organized and accountable.
In this proposed organization and administration of services CoP,
we would list the services that the statute (section 1861(ff)(3) of the
Act) requires CMHCs to furnish. We are also proposing a standard that
would require a CMHC to provide in-service training to all employees
and staff, including those under contract or under arrangements, who
have client contact. This requirement would assist in ensuring that all
staff serving CMHC clients were up to date on current standards of
practice. The CMHC would be required to have written policies and
procedures describing its methods for assessing staff skills and
competency, and to maintain a written description of in-service
training offered during the previous 12 months.
In proposed Sec. 485.918(a), ``Standard: Governing body and
administrator,'' we are proposing to emphasize the responsibility of
the CMHC governing body (or designated persons so functioning) for
managing all CMHC facilities and services, including fiscal operations,
quality improvement, and the appointment of the administrator. The
administrator would be responsible for the day-to-day operation of the
CMHC and would report to the governing body. The administrator would
have to be a CMHC employee and meet the education and experience
requirements established by the CMHC's governing body. The specifics of
the administration of the CMHC would be left to the discretion of the
governing body, thereby affording the CMHC's management with
organizational flexibility. The proposed governing body standard
reflects our goal of promoting the effective management and
administration of the CMHC as an organizational entity without
dictating prescriptive requirements for how a CMHC must meet that goal.
In proposed Sec. 485.918(b), ``Standard: Provision of services,''
we are proposing to specify a comprehensive list of services that a
CMHC would be required to provide. At Sec. 485.918(b)(1)(v), we are
proposing to require the CMHC to provide at least 40 percent of its
services to individuals who are not eligible for benefits under title
XVIII of the Act (Medicare). This proposed requirement would track the
changes to 42 CFR Sec. 410.2 set out in the November 24, 2010
Outpatient Prospective Payment System final rule (OPPS) (75 FR 71800,
72259). Both this CMHC proposed rule and the OPPS final rule changes
implement the statutory changes made by section 1301(a) of the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152).
Enactment of section 1301(a) of the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) (HCERA 2010) revised the
definition of a CMHC set forth at section 1861(ff)(3)(B) of the Act by
adding a provision to the existing requirements for CMHCs, effective on
the first day of the first calendar quarter that begins at least 12
months after the date of enactment (that is, April 1, 2011). As of that
date, a CMHC must provide at least 40 percent of its services to
individuals who are not eligible for benefits under Title XVIII of the
Act (Medicare).
We are proposing to measure whether a CMHC is providing ``at least
40 percent of its services'' by the amount of reimbursement for all
services furnished. This is only one of several possible approaches to
implementing this measurement, and we are seeking public comment on
this approach. Alternatives we considered included calculating whether
at least 40 percent of the CMHC's units of service were furnished to
non-Medicare patients, the number of non-Medicare patients served by
the CMHC, or the dollar amount of services billed overall by the CMHC.
We believe that the percentage of total revenues received by the CMHC
that are payments from Medicare versus other payers is an approach that
can be measured efficiently.
Accordingly, the CMHC would be required to demonstrate to the
Medicare program that it is receiving no less than 40 percent of its
reimbursement from payers other than Medicare, including but not
limited to commercial entities, Medicaid and CHIP. Additionally, we
propose to measure the 40 percent of its services on an annual basis.
We are seeking public comment on whether we should determine if a CMHC
meets the 40 percent requirement annually or at some other interval. We
are seeking comment on both the definition of terms used in any
approach to measuring the 40 percent threshold and the data sources for
that measurement. Specifically, since the measure proposed to determine
the 40 percent threshold is total reimbursement from Medicare, we are
interested in
[[Page 35694]]
comments on how we should define reimbursement.
We are interested in comments addressing whether such a calculation
should include uncompensated care or any other aspect of reimbursement.
For example, the denominator would include total reimbursement
received, including co-payments/co-insurance paid by Medicare
beneficiaries and private patients and reimbursement received by
Medicare for bad-debt. The numerator would include reimbursement by
non-Medicare payers, which would include co-pays/co-insurance from
privately insured individuals, reimbursement from Medicaid, other
reimbursement from States, private pay and charity/uncompensated care.
If instead we choose to measure based on service increment, we are
interested in receiving comments on the specific definition for the
services to be included in the calculation and how they would be
counted. We are also interested in receiving comments regarding data
sources for the metrics that comprise the components of a measure of
the 40 percent threshold. In addition, we are interested in seeking
comment on whether CMS should require the CMHCs to attest to whether
they meet the 40 percent requirement, or whether we should subject them
to verification auditing.
Furthermore, we are interested in receiving comments on any other
definitions of what constitutes a measure of the 40 percent threshold.
For example, if there is a way to use a combined metric relying in part
on reimbursement and in part on beneficiary/patient counts, and in part
on service use. Finally, we are interested in seeking comments on how
this measurement would be accomplished; for example, we would be
interested in hearing commenters' ideas on how each of these measures
would be included in the metric calculation and the best data sources
for the calculation. We stress that we are concerned that the
implementation of this provision not negatively impact access to care,
and are seeking additional comment on strategies that would correctly
balance the implementation of this new requirement with access
concerns.
We will carefully consider all public comments received on this
provision, and would respond to public comments in the final rule. We
intend to issue sub-regulatory guidance implementing this requirement
after the publication of the final rule.
We want to clarify that although we have proposed an approach to
calculating the 40 percent threshold, we are broadly seeking comments
on the proposed approach as well as any other approaches that
commenters think might be appropriate as a basis for determining
whether a CMHC meets the requirement of providing at least 40 percent
of its services to non-Medicare patients. We are also seeking comment
on any aspect of how this requirement would be implemented at the
provider level, what operational changes might be needed and whether
there is a need for any additional financial/management document(s) to
enable assessment of whether a CMHC meets the 40 percent threshold. For
example, we would be interested in hearing commenters' views about
whether or not a CMHC should use an independent auditing agency to
review its financial statements and certify whether the CMHC meets the
40 percent threshold. We expect to draw on the comments received and
make a final decision about the definition of what constitutes 40
percent in the final regulation.
Medicare-certified CMHCs are already required to provide most of
the services set out in this proposed provision through the existing
CMS payment rules (42 CFR 410.2, 410.110, and 424.24(e)). It is
essential for CMHCs to have sufficient numbers of appropriately
educated and trained staff to meet these service expectations. For
example, CMHCs that provide partial hospitalization services could
provide the services of ``other staff trained to work with psychiatric
clients'' (42 CFR 410.43(a)(3)(iii)). Non-specified staff might be
responsible for supervising clients and ensuring a safe environment.
CMHCs would be expected to have a sufficient number of appropriately-
trained staff to meet these responsibilities at all times.
In proposed Sec. 485.918(c), ``Standard: Professional management
responsibility,'' we are proposing to require that where services are
furnished by other than CMHC staff, a CMHC would have to have a written
agreement with another agency, individual, or organization that
furnishes the services. Under this agreement, the CMHC would retain
administrative and financial management and oversight of staff and
services for all arranged services. The CMHC would have to have a
written agreement that specified that all services would have to be
authorized by the CMHC, be furnished in a safe and effective manner,
and be delivered in accordance with established professional standards,
the policies of the CMHC and the client's active treatment plan. As
part of retaining financial management responsibility, the CMHC would
retain all payment responsibility for services furnished under
arrangement on its behalf.
In proposed Sec. 485.918(d), ``Standard: Staff training,'' which
would apply to all employees, staff under contract, and volunteers, we
are proposing to require a CMHC to take steps to develop appropriate
in-service programs, including initial orientation for each new
employee or volunteer furnishing services. The new employee orientation
would address specific job duties. The CMHC could also provide staff
training under arrangement.
We would not require a specific staff in-service training program;
rather, we would expect each CMHC to determine the scope of its own
program, including the manner in which it chose to assess competence
levels, determine training content, determine the duration and
frequency of training for all employees, and track the training on a
yearly basis.
In proposed Sec. 485.918(e)(1), ``Environmental conditions,'' and
(e)(2), ``Building,'' would require the CMHC to provide services in an
environment that was safe, functional, sanitary, comfortable, and in
compliance with all Federal, State, and local health and safety
standards, as well as State health care occupancy regulations. These
proposed requirements would help to ensure that CMHC services were
provided in a physical location that was both safe and conducive to
meeting the needs of CMHC clients.
In proposed Sec. 485.918(e)(3), ''Infection control,'' we are
proposing to address the seriousness and potential hazards of
infectious and communicable diseases. We would require a CMHC to
develop policies, procedures, and monitoring, as well as take specific
actions to address the prevention and control of infections and
disease.
We believe that a CMHC should follow nationally accepted infection
control standards of practice and ensure that all staff know and use
current best preventive practices. Periodic training is one way to
assure staff understanding, and we would expect the CMHC to establish a
method to ensure that all staff receives appropriate training. Where
infection and/or communicable diseases are identified, we would expect
aggressive actions be taken to protect all the clients and staff.
This proposed CoP would allow the CMHC to have flexibility in
meeting its infection control, prevention and education objectives. For
example, the extent of training in infection control that would be
necessary for the CMHC's personnel would depend on the client mix and
experience of the staff. One
[[Page 35695]]
example of ``current best practices'' is the standard precautionary use
of gloves when handling blood or blood products. While we would expect
that established best practices be followed, we are not proposing any
specific approaches to meeting this requirement. We would expect to see
clear evidence that the CMHC sought to minimize the spread of disease
and infection through the use of effective techniques by its staff and
through its efforts to help clients understand what can and should be
done for infection control purposes.
In proposed Sec. 485.918(e)(4), ``Therapy sessions,'' we are
proposing that the CMHCs ensure that all individual and group therapy
sessions be conducted in a manner that maintains client privacy and
dignity. We believe that a safe, private environment would enhance the
effectiveness of the therapy sessions.
In proposed Sec. 485.918(f), ``Standard: Partial hospitalization
services,'' we are proposing that all partial hospitalization services
would be required to meet all applicable requirements of 42 CFR parts
410 and 424.
In proposed Sec. 485.918(g), ``Standard: Compliance with Federal,
State, and local laws and regulations related to the health and safety
of clients,'' we are proposing that the CMHC and its staff would be
required to operate and furnish services in compliance with all
applicable Federal, State, and local laws and regulations related to
the health and safety of clients. If State or local law provided for
licensing of CMHCs, the CMHC would have to be licensed. In addition,
the CMHC staff would have to follow the CMHC's policies and procedures.
B. Health Disparities
In 1985, the Secretary of the Department of Health and Human
Services (HHS) issued a landmark report which revealed large and
persistent gaps in health status among Americans of different racial
and ethnic groups and served as an impetus for addressing health
inequalities for racial and ethnic minorities in the U.S. This report
led to the establishment of the Office of Minority Health (OMH) within
HHS, with a mission to address these disparities within the Nation.
National concerns for these differences, termed health disparities, and
the associated excess mortality and morbidity have been expressed as a
high priority in national health status reviews, including Healthy
People 2000 and 2010.
Since that time, research has extensively documented the
pervasiveness of racial and ethnic disparities in health care and has
led to the acknowledgement of racial and ethnic disparities as a
national problem. As a result, more populations have been identified as
vulnerable, which necessitated the development of programs and
strategies to reduce disparities for vulnerable populations, and the
emergence of new leadership to address such disparities. Currently,
vulnerable populations can be defined by race/ethnicity, socio-economic
status, geography, gender, age, disability status, risk status related
to sex and gender, and other populations identified to be at-risk for
health disparities. Other populations at risk may include persons with
visual or hearing problems, cognitive perceptual problems, language
barriers, pregnant women, infants, and persons with disabilities or
special health care needs.
Although there has been much attention at the national level to
ideas for reducing health disparities in vulnerable populations, we
remain vigilant in our efforts to improve health care quality for all
persons by improving health care access and by eliminating real and
perceived barriers to care that may contribute to less than optimal
health outcomes for vulnerable populations. For example, we are aware
that immunization rates remain low among some minorities. Despite the
long-term implementation of some strategies like the use of language
translators in hospitals, health literacy and its impact on health care
outcomes continues to be in the forefront.
We are always seeking better ways to address the needs of
vulnerable populations; therefore, we are specifically requesting
comments in regard to how our proposed requirements could be used to
address disparities.
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 (PRA) 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.
We are soliciting public comment on each of the issues for the
information collection requirements (ICRs) discussed below.
A. ICRs Related to Condition of Participation: Client Rights (Sec.
485.910)
Proposed Sec. 485.910(a) would require that the CMHC develop a
notice of rights statement to be provided to each client. We estimate
that it would require 8 hours on a one-time basis to develop this
notice, and the CMHC administrator would be responsible for this task,
at a cost of $424 per CMHC and $94,976 for all CMHCs nationwide. In
addition, this standard would require that the CMHC provide each client
and client's representative or surrogate with a verbal and written
notice of the client's rights and responsibilities during the initial
evaluation visit, in advance of furnishing care. The CMHC would also be
required to obtain the client's and client representative's (if
appropriate) signature confirming that he or she has received a copy of
the notice of rights and responsibilities. The CMHC would have to
retain the signed documentation showing that it complied with the
requirements and that the client and the client's representative
demonstrated an understanding of these rights. We estimate the burden
for the time associated with disclosing the information would be 2.5
minutes per client or approximately 4.67 hours per CMHC. Similarly, we
estimate that the burden for the CMHC to document the information would
take 2.5 minutes per client or approximately 4.67 hours per CMHC. At an
average of 5 minutes (.0833 hours) per client to complete both tasks,
we estimate that all CMHCs would use 2,090 hours to comply with this
proposed requirement (.0833 hours per client x 25,087 clients). The
estimated cost associated with these requirements would be $75,240,
based on a psychiatric nurse performing this function (2,090 hours x
$36 per hour).
We note that we do not impose any new language translation or
interpretation requirements. Under Title VI of the Civil Rights Act of
1964, recipients of Federal financial assistance, such as CMHCs, have
long been prohibited from discriminating on the basis of race, color,
or national origin. Language interpretation is required under some
circumstances under that statute and the HHS regulations at 45 CFR part
80 (see
[[Page 35696]]
previous discussion of Office for Civil Rights guidance issued in
2003). Because we impose no new requirements not fully encompassed in
that regulation and guidance, we have estimated no paperwork burden.
Proposed Sec. 485.910(d)(2) would require a CMHC to document a
client's or client representative's complaint of the alleged violation
and the steps taken by the CMHC to resolve it. The burden associated
with this proposed requirement is the time it would take to document
the necessary aspects of the issues. In late 2007, the American
Association of Behavioral Health and The Joint Commission informed us
that we could anticipate 52 complaints per year per CMHC and that it
would take the administrator 30 minutes per complaint at the rate of
$53/hr to document the complaint and resolution activities, for an
annual total of 26 hours per CMHC or 5,824 hours for all CMHCs. The
estimated cost associated with this requirement is $308,672.
Proposed Sec. 485.910(d)(4) would require the CMHC to report all
confirmed violations to the State and local bodies having jurisdiction
within 5 working days of becoming aware of the violation. We anticipate
that it would take the administrator 5 minutes per complaint to report,
for an annual total of 4.3 hours per CMHC or 971 hours for all CMHCs.
The estimated cost associated with this requirement is $51,463.
Proposed Sec. 485.910(e)(2)(v) would require written orders for a
physical restraint or seclusion, and proposed Sec. 485.910(e)(5)(v)
would require physical restraint or seclusion be supported by a
documentation of the client's response or outcome in the client's
clinical record. The burden associated with this requirement would be
the time and effort necessary to document the use of physical restraint
or seclusion in the client's clinical record. We estimate that it would
take 45 minutes per event to document this information. Similarly, we
estimate that there will be 1 occurrence of the use of physical
restraint or seclusion per CMHC. The estimated annual burden associated
with this requirement for all CMHCs would be 168 hours. The estimated
cost associated with this burden for all CMHCs is $6,048.
Proposed Sec. 485.910(f) would specify restraint or seclusion
staff training requirements. Specifically, Sec. 485.910(f)(1) would
require that all client care staff working in the CMHC be trained and
able to demonstrate competency in the application of restraints,
implementation of seclusion, monitoring, assessment, and providing care
for a client in restraint or seclusion and on the use of alternative
methods to restraint and seclusion. Proposed Sec. 485.910(f)(4) would
require that a CMHC document in the personnel records that each
employee successfully completed the restraint and seclusion training
and demonstrated competency. We estimate that it would take 35 minutes
per CMHC to comply with these requirements. The estimated total annual
burden associated with these requirements would be 131 hours. The
estimated cost associated with this requirement would be $4,704.
Proposed Sec. 485.910(g) would require the CMHC to report any
death that occurred while a CMHC client was in restraint or seclusion
in the CMHC while awaiting transfer to a hospital. We have a parallel
requirement in all other CMS rules dealing with programs and providers
where restraint or seclusion may be used (e.g., in our hospital
conditions of participation). Based on informal discussions with the
CMHC industry and The Joint Commission, we believe restraints and
seclusion are rarely if ever used in CMHCs and that there are very few
deaths (if any) that occur due to restraint and seclusion in a CMHC.
For purposes of the PRA, we estimate the annual number of deaths to be
zero. However, there are no data available regarding this issue. We are
soliciting public comment, thus allowing the CMHC provider community
the opportunity to provide feedback on this issue. With the number of
deaths estimated at zero, under 5 CFR 1320.3(c)(4), this proposed
requirement is not subject to the PRA as it would affect fewer than 10
entities in a 12-month period.
B. ICRs Related to Condition of Participation: Admission, Initial
Evaluation, Comprehensive Assessment, and Discharge or Transfer of the
Client (Sec. 485.914)
Proposed Sec. 485.914(b) through (d) would require each CMHC to
conduct and document in writing an initial evaluation and a
comprehensive client-specific assessment; maintain documentation of the
assessment and any updates; and coordinate the discharge or transfer of
the client. The burden associated with these proposed requirements
would be the time required to record the initial evaluation and
comprehensive assessment, including changes and updates. We believe
that documenting a client's initial evaluation and comprehensive
assessment is a usual and customary business practice under 5 CFR
1320.3(b)(2) and, as such, the burden associated with it is exempt from
the PRA.
Proposed Sec. 485.914(e) would require that, if the client were
transferred to another facility, the CMHC would be required to forward
a copy of the client's CMHC discharge summary and clinical record, if
requested, to that facility. If a client is discharged from the CMHC
because of noncompliance with the treatment plan or refusal of services
from the CMHC, the CMHC would be required to provide a copy of the
client's discharge summary and clinical record, if requested, to the
client's attending physician. The burden associated with this proposed
requirement would be the time it takes to forward the discharge summary
and clinical record, if requested. This proposed requirement is
considered to be a usual and customary business practice under Sec.
1320.3(b)(2) and, as such, the burden associated with it is exempt from
the PRA.
C. ICRs Related to Condition of Participation: Treatment Team, Active
Treatment Plan, and Coordination of Services (Sec. 485.916)
Proposed Sec. 485.916(b) would require all CMHC care and services
furnished to clients and their families to follow a written active
treatment plan established by the CMHC physician-led interdisciplinary
treatment team. The CMHC would be required to ensure that each client
and representative receives education provided by the CMHC as
appropriate to the care and services identified in the active treatment
plan.
The proposed provisions at Sec. 485.916(c) specify the minimum
elements that the active treatment plan would include. In addition, in
proposed Sec. 485.916(d), the physician-led interdisciplinary team
would be required to review, revise, and document the active treatment
plan as frequently as the client's condition requires, but no less
frequently than every 30 calendar days. A revised active treatment plan
would include information from the client's updated comprehensive
assessment, and would document the client's progress toward the
outcomes specified in the active treatment plan. The burden associated
with these proposed requirements would be the time it would take to
document the active treatment plan (approximately 45 minutes) estimated
to be a total $3,024 per CMHC or $677,376 nationally. Additionally, we
estimate any revisions to the active treatment plan (approximately 15
minutes) would cost $1008 per CMHC or $225,792 nationally.
Proposed Sec. 485.916(e) would require a CMHC to develop and
maintain a
[[Page 35697]]
system of communication and integration to ensure compliance with the
requirements contained in Sec. 485.916(e)(1) through (e)(5). The
burden associated with this proposed requirement would be the time and
effort required to develop and maintain the system of communication in
accordance with the CMHC's policies and procedures. While this proposed
requirement is subject to the PRA, the associated burden would be
considered to be usual and customary business practice as stated in 5
CFR 1320.3(b)(2).
D. ICRs Related to Condition of Participation: Quality Assessment and
Performance Improvement (Sec. 485.917)
Proposed Sec. 485.917 would require a CMHC to develop, implement,
and maintain an effective ongoing CMHC-wide data-driven quality
assessment and performance improvement (QAPI) program. The CMHC's
governing body would have to ensure that the program reflected the
complexity of its organization and services; involved all CMHC
services, including those services furnished under contract or
arrangement; focused on indicators related to improved behavioral
health outcomes and support services provided; and demonstrated
improvement in the CMHC's performance. The CMHC would be required to
maintain and demonstrate evidence of its quality assessment and
performance improvement program and be able to demonstrate its
operation to CMS.
The CMHC would be required to take actions aimed at performance
improvement and, after implementing those actions, must measure its
success and track its performance to ensure that improvements were
sustained.
The CMHC would be required to document what quality improvement
projects were being conducted, the reasons for conducting these
projects, and the measurable progress achieved on these projects.
The burden associated with these requirements would be the time it
would take to document the development of the quality assessment and
performance improvement and associated activities. We estimate that it
would take each CMHC administrator an average of 24 hours per year at
the rate of $53/hr to comply with these requirements for a total of
5,376 hours annually. The estimated cost associated with this
requirement is $284,928.
E. ICRs Related to Condition of Participation: Organization,
Governance, Administration of Services, and Partial Hospitalization
Services (Sec. 485.918)
Proposed Sec. 485.918(c) would list the CMHC's professional
management responsibilities. A CMHC could enter into a written
agreement with another agency, individual, or organization to furnish
any services under arrangement. The CMHC would be required to retain
administrative and financial management, and oversight of staff and
services for all arranged services, to ensure the provision of quality
care. The burden associated with this proposed requirement is the time
and effort necessary to develop, draft, execute, and maintain the
written agreements. We believe these proposed written agreements are
part of the usual and customary business practices of CMHCs under 5 CFR
1320.3(b)(2) and, as such, the burden associated with them is exempt
from the PRA.
Proposed Sec. 485.918(d) describes the proposed standard for
training. In particular, Sec. 485.918(d)(2) would require a CMHC to
provide an initial orientation for each employee, contracted staff
member, and volunteer who addresses the employee's or volunteer's
specific job duties. Proposed Sec. 485.918(d)(3) would require a CMHC
to have written policies and procedures describing its method(s) of
assessing competency. In addition, the CMHC would be required to
maintain a written description of the in-service training provided
during the previous 12 months. These proposed requirements are
considered to be usual and customary business practices under 5 CFR
1320.3(b)(2) and, as such, the burdens associated with them are exempt
from the PRA.
Proposed Sec. 485.918(e)(3) would require the CMHC to maintain
policies, procedures, and monitoring of an infection control program
for the prevention, control and investigation of infection and
communicable diseases. The burden associated with this proposed
requirement would be the time it would take to develop and maintain
policies and procedures and document the monitoring of the infection
control program. We believe this proposed documentation is part of the
usual and customary medical and business practices of CMHCs and, as
such, is exempt from the PRA under 5 CFR 1320.3(b)(2).
Table 1 below summarizes the estimated annual reporting and
recordkeeping burdens for this proposed rule.
TABLE 1--Estimated Annual Reporting and Recordkeeping Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly
Burden per Total labor cost Total labor Total
Regulation section(s) OMB Control No. Respondents Responses response annual of cost of capital/ Total cost
(hours) burden reporting reporting maintenance ($)
(hours) ($) ($) Costs ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 485.910(a)(1).......... 0938-New........ 224 224 8 1,792 53 94,976 0 94,976
Sec. 485.910(a)(3).......... 0938-New........ 224 25,087 .0833 2,090 36 75,240 0 75,240
Sec. 485.910(d)(2).......... 0938-New........ 224 11,648 .5 5,824 53 308,672 0 308,672
Sec. 485.910(d)(4).......... 0938-New........ 224 11,648 .0833 971 53 51,463 0 51,463
Sec. 485.910(e)(4)(v)....... 0938-New........ 224 224 .75 168 36 6,048 0 6,048
Sec. 485.910(f)(4).......... 0938-New........ 224 224 .583 131 36 4,704 0 4,704
Sec. 485.916(c)............. 0938-New........ 224 25,087 .75 18,815 36 677,340 ........... 677,340
Sec. 485.916(d)............. 0938-New........ 224 25,087 .25 6,272 36 225,792 0 225,792
Sec. 485.917................ 0938-New........ 224 224 24 5,376 53 284,928 0 284,928
-------------------------------------------------------------------------------------------------------------------------
Total..................... ................ 224 99,453 ........... 41,439 ........... ........... ........... 1,729,163
--------------------------------------------------------------------------------------------------------------------------------------------------------
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget,
Attention: CMS Desk Officer, CMS-3202-P.
Fax: (202) 395-6974; or
E-mail: [email protected].
[[Page 35698]]
IV. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct 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). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. A regulatory impact analysis (RIA) must be prepared for
major rules with economically significant effects ($100 million or more
in any 1 year). The overall economic impact for all proposed new
Conditions of Participation in this rule is estimated to be $4.1
million in the first year of implementation and $2.6 million after the
first year of implementation and annually thereafter. Therefore, this
is not an economically significant or major rule.
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and government
agencies. Individuals and States are not included in the definition of
a small entity. For purposes of the RFA, most CMHCs are considered to
be small entities, either by virtue of their nonprofit or government
status or by having revenues of less than $10 million in any one year
(for details, see the Small Business Administration's Web site at
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=2465b064ba6965cc1fbd2eae60854b11&rgn=div8&view=text&node=13:1.0.1.1.16.1.266.9&idno=13). We estimate there are approximately 224
CMHCs with average admissions of approximately 112 clients per CMHC
(based on the number of Medicare clients in 2007 divided by the number
of CMHCs in 2007). However, we cannot estimate the full impact of this
rule because we do not know the total number of non-Medicare patients
served by CMHCs. Therefore, we are requesting information on the total
number of non-Medicare clients served. We are also soliciting data on
the potential effect of this rule on patients' access to services, as
well as comments regarding whether specific data exists measuring
availability of necessary services to this patient population.
We estimate that implementation of this proposed rule would cost
CMHCs approximately $4.1 million, or $18,475 per average CMHC, in the
first year of implementation and $2.6 million, or $11,566 per average
CMHC, after the first year of implementation and annually thereafter.
Therefore, the Secretary has determined that this rule would not have a
significant impact on a substantial number of small entities, because
the cost impact of this rule is less than 1 percent of total CMHC
Medicare revenue.
In addition, section 1102(b) of the Social Security Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 603 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a metropolitan statistical area and has fewer than 100 beds. We believe
that this rule would not have a significant impact on the operations of
a substantial number of small rural hospitals since there are few CMHC
programs in those facilities. Therefore, the Secretary has determined
that this proposed rule will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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. In 2011, that
threshold is approximately $136 million. This rule would not have an
impact on the expenditures of State, local, or tribal governments in
the aggregate, or on the private sector of $136 million.
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. This rule has no Federalism implications.
B. Anticipated Effects on CMHCs
We are proposing to establish a new subpart J under the regulations
at 42 CFR part 485 to incorporate the proposed CoPs for CMHCs (which
would be effective 12 months after the publication of the final rule).
The new subpart J would include sections on the basis and scope of the
subpart, definitions, and six conditions. For purposes of this section
of this proposed rule, we have assessed the impact of all proposed CoPs
that may present a burden to a CMHC.
We have made several assumptions and estimates in order to assess
the time that it would take for a CMHC to comply with the proposed
provisions and the associated costs of compliance. CMHC client data
from outside sources are limited; therefore, our estimates are based on
available Medicare data. We have detailed these assumptions and
estimates in Table 2 below. We have also detailed many, but not all, of
the proposed standards within each proposed CoP, and have noted whether
or not there is an impact for each in the section below. However, the
requirements contained in many of the proposed CoPs are already
standard medical or business practices and as a result do not pose an
additional burden on CMHCs.
Table 2--Assumptions and Estimates Used Throughout the Impact Analysis
Section on CMHCs
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of Medicare CMHCs nationwide.......................... 224
Number of Medicare CMHC clients nationwide................... 25,087
Number of Medicare clients per average CMHC.................. 112
Hourly rate of psychiatric nurse............................. $36
Hourly rate of clinical psychologist......................... $48
Hourly rate of administrator................................. $53
[[Page 35699]]
Hourly rate of clinical social worker........................ $28
------------------------------------------------------------------------
Note: All salary estimates include benefits package worth 30 percent of
the fringe base salary. Salary estimates were obtained from http://www.bls.gov/.
As stated earlier, we estimate that implementation of the six CoPs
that we are proposing would not significantly impact CMHCs. We estimate
that implementation of this proposal would cost CMHCs approximately
$4.1 million, or $18,475 per average CMHC, in the first year of
implementation and $2.6 million, or $11,566 per average CMHC, annually
thereafter. We have detailed below many, but not all, of the proposed
standards within each proposed CoP, and have noted whether or not there
is an impact for each. However, the requirements contained in many of
the proposed provisions are already standard medical or business
practices. These proposed requirements would, therefore, not pose
additional burden to CMHCs because they are already standards of
practice. The CoP that we are proposing for client rights would set
forth the rights of CMHC clients, ensure that client and client's
representative or surrogate are educated about their rights, establish
a process for the investigation and reporting of client rights
violations, and establish requirements governing the use of restraint
and seclusion methods in CMHCs.
In proposed Sec. 485.910(a), ``Standard: Notice of rights and
responsibilities,'' we are proposing that during the initial
evaluation, the CMHC would have to provide the client and the client's
representative (if appropriate) or surrogate with verbal and written
notice of the client's rights and responsibilities in a language and
manner that the individual understands. Communicating with the clients,
and their representative or surrogate, including the provision of a
written notice of rights, in a manner that meets their communication
needs is a standard practice in the health care industry. Similar
requirements already exist for many other health care provider types,
including hospice providers, long term care facilities, ambulatory care
surgery centers, and end-stage renal disease facilities. Because we are
proposing a requirement that is fully compatible with existing civil
rights requirements and guidance, we believe that this proposed
standard will impose no additional costs.
This standard would require a CMHC to develop a notice of rights
statement to be provided to each CMHC client. We estimate that it would
require 8 hours on a one-time basis to develop this notice, and that
the CMHC administrator would be responsible for this task, at a cost of
$424 per CMHC and $94,976 for all CMHCs nationwide. In addition, this
standard would require a CMHC to provide each CMHC client and
representative verbal and written notification of the CMHC client's
rights, and obtain a signature certifying that they received such
notification at the time of the initial evaluation. We estimate the
burden for the time associated with disclosing the information would be
2.5 minutes per client or approximately 4.67 hours per CMHC. Similarly,
we estimate that the burden for the CMHC to document the information
would take 2.5 minutes per client or approximately 4.67 hours per CMHC.
At an average of 5 minutes (.0833 hours) per client to complete both
tasks, we estimate that all CMHCs would use 2090 hours to comply with
this proposed requirement (.0833 hours per client x 25,087 clients).
The estimated cost associated with these requirements would be $75,240,
based on a psychiatric nurse performing this function (2090 hours x $36
per hour).
With respect to the proposed CoP for client rights, the proposed
standard addressing violations of client rights would require a CMHC to
investigate alleged client rights violations, take corrective actions
when necessary and appropriate, and report verified violations to State
and local bodies having jurisdiction. We estimate that the CMHC
administrator would spend, on average, 30 minutes investigating each
alleged client rights violation. For purposes of our analysis, we
assume that an average CMHC would investigate 1 alleged violation per
week, for a total of 26 hours annually, at a cost of $1,378 annually
per CMHC. All CMHCs nationwide would require 5,824 hours at an
estimated cost of $308,672.
In addition, we are proposing three standards under the CoP for
client rights pertaining to restraint and seclusion, staff training
requirements for restraints and seclusion, and death reporting
requirements. These proposed standards would include requirements that
guide the appropriate use of seclusion and restraint interventions in
CMHCs when necessary to ensure the physical safety of the client and
others while awaiting transport to a hospital. They are adapted to
reflect the clients' rights CoP for hospitals published as a final rule
in the Federal Register on December 8, 2006 (71 FR 71378), and codified
at Sec. 482.13.
While we anticipate that CMHCs would be impacted by these proposed
standards, we do not have access to several key pieces of information
to estimate the burden. For example, we do not have reliable data on
the prevalence of restraint and seclusion use, the volume of staff in
CMHCs, or the varying levels and qualifications of CMHC staff who may
use restraint seclusion. Factors such as size, services rendered,
staffing, and client populations vary as well. We are hesitant to make
impact estimates in this proposed rule that may not account for these
and other unforeseen variations. Therefore, we reserve the right to
provide estimates when feasible. Below we discuss the anticipated
effects on providers of the standards related to restraints and
seclusion.
The proposed restraint and seclusion standards would set forth the
client's rights in the event he or she is restrained or secluded, and
would limit when and by whom restraint or seclusion could be
implemented. We recognize that there would be some impact associated
with performing client assessment and monitoring to ensure that
seclusion or restraint are only used when necessary to protect the
client and others from immediate harm, pending transport to the
hospital and are implemented in a safe and effective manner. However,
client assessment and monitoring are standard components of client
care, and this requirement does not pose a burden to a CMHC.
We are proposing to specify elements at Sec. 485.910(e)(4)(v)
regarding the documentation that must be included in the client's
clinical record when the client is restrained or secluded. We estimate
on average that it would take 45 minutes per event for a nurse to
document this information. Similarly, we estimate that there will be 1
occurrence of the use of restraint and seclusion per CMHC per year.
Based on the nurses hourly rate the total cost for documenting
restraint and seclusion would be $27 per CMHC.
The proposed standard on staff training for restraint or seclusion
that we are proposing to codify in Sec. 485.910(f) would set out the
training requirements for all appropriate client care staff involved in
the use of
[[Page 35700]]
seclusion and restraint in the CMHC. Training is important for the
provision of safe and effective restraint or seclusion use. We would
require that, before staff apply restraints, implement seclusion,
perform associated monitoring and assessment of the restrained or
secluded client, or provide care for a restrained or secluded client,
the staff be trained and able to demonstrate competency in the
performance of these actions. The proposed staff training requirements
would address the following broad areas: training intervals; training
contents; trainer requirements; and training documentation.
To reduce regulatory burden and create a reasonable requirement
while assuring client safety, we would mandate that only those staff
who would be involved in the application of restraint or seclusion or
performing associated monitoring and assessment of, or providing care
for, restrained or secluded clients would be required to have this
training. While we would expect physicians to be trained in the proper
use of restraint or seclusion, we do not expect that they would be
trained with the other CMHC staff. Therefore, we have not included
physicians in the burden associated with these requirements. Instead,
we would require that the appropriate CMHC staff who have direct
contact with clients must be trained in restraint or seclusion use.
In this proposed rule, we are proposing broad topics to be covered
in training, and would not require that staff be trained by an outside
organization. We believe that in-house training could be more
economical than sending staff off site for instruction. However, CMHCs
would have the option of sending either selected or all staff to
outside training if they believe this is warranted.
Therefore, we have based our burden estimate on a CMHC nurse being
trained by an outside organization (for example, we refer readers to
http://www.crisisprevention.com, below) to provide such training. We
believe that most CMHCs then would have this nurse function as a
program developer and as a trainer of the appropriate CMHC staff. In
addition, we believe in most instances this professional would be a
psychiatric nurse.
Train-the-trainer programs are the way many CMHCs provide staff
instruction. For example, the 4-day instructor certification program
given by the Crisis Prevention Institute (CPI, Inc.) costs $1,529 for
tuition plus travel, lodging, and participant salary. More detailed
information regarding the train-the-trainer programs can be found on
CPI, Inc.'s Web site at http://www.crisisprevention.com.
We estimate, on average, that the cost to train one nurse would
include the following expenses: (1) Round trip travel at approximately
$400 to cover the need for either local or distant travel; (2) lodging
for 3 nights (at $120 per night) for approximately $360; and (3) meals
and incidental expenses for 4 days (at $50 per day) for approximately
$200, depending upon the location within the particular State.
Therefore, we anticipate the cost to train one nurse would be
approximately $2,489 plus the nurse's total salary of $1,152 for 4 days
(at $288 per day). The total estimated training cost for all CMHCs
would be approximately $815,584.
We believe that CMHCs would add seclusion and restraint training
onto their existing in-service training programs. The train-the-trainer
program described above would provide CMHCs with the necessary
personnel and materials to implement a staff-wide seclusion and
restraint training program. We estimate that developing this staff-wide
training program would require 40 hours of the trainer's time on a one-
time basis for all affected CMHCs, at a cost of $1,440 per CMHC.
We would require that each individual who could potentially be
involved in restraint and seclusion of a client have training in the
proper techniques. According to the National Association of Psychiatric
Health Systems (NAPHS), initial training in de-escalation techniques,
restraint and seclusion policies and procedures, and restraint and
seclusion techniques range from 7 to 16 hours of staff and instructor
time.
Due to a lack of data on the average number of employees in a CMHC,
for purposes of this analysis only, we assume that an average CMHC
would need to train 7 employees in seclusion and restraint techniques.
Based on 1 nurse trainer conducting an 8-hour training course for 7
CMHC staff members, we estimate that this requirement would cost $2,248
as calculated below.
8 trainer hours at $36/hr = $288
56 trainee hours at $35/hr = $1,960
$288 trainer cost + $1,960 trainee costs = $2,248
We are also proposing to require that each individual receive
documented, updated training. Again, according to National Association
of Psychiatric Health Systems (NAPHS), annual updates involve about 4
hours of staff and instructor time per employee who has direct client
contact. We assume an average size CMHC has 7 employees with direct
client contact who must be trained in de-escalation techniques.
Therefore, we estimate that it would cost $1,124 annually to update
each person's training as shown below.
4 trainer hours at $36/hr = $144
28 trainee hours at $35/hr = $980
$144 trainer costs + $980 trainee costs = $1,124
Additionally, we are proposing to require recordkeeping for
documenting in each trained individual's personnel record that he or
she successfully completed training. We estimate that it would take the
trainer 5 minutes per trainee to document each participant's completion
of the training. As described above, we estimate that 7 CMHC staff
members would require such documentation and have calculated below the
estimated total annual cost for this proposed requirement for all
CMHCs.
5 minutes per trainee x 7 trainees = 35 minutes annually
35 minutes x $36/hr = $21 annually
35 minutes per CMHC x 224 CMHCs = 130.6 hours nationwide
130.6 hours industry wide x $36/hr = $4,701.60 nationwide
We would require that each CMHC revise its training program
annually as needed. We estimate this task, which would be completed by
the trainer, to take approximately 4 hours annually per CMHC and have
calculated below the estimated total annual cost for all CMHCs.
4 hours x $36/hr = $144 per CMHC
$144 per CMHC x 224 CMHCs = $32,256 nationwide
Finally, the proposed standard for reporting client deaths applies
to all deaths associated with the use of restraint or seclusion
throughout the CMHC. A CMHC would be required to report to CMS each
death that occurs while a client is in restraint or seclusion at the
CMHC.
Each death would require reporting to CMS by telephone no later
than the close of business the next business day following the
facility's learning of the client's death. We have no data on which to
base an estimate of the number of deaths in CMHCs that may be related
to the use of seclusion and restraint. However, based on a lack of
complaints to State agencies and CMS, we believe such deaths to be rare
occurrences. Although our goals are to ensure the safe and appropriate
use of seclusion and restraint and to reduce associated deaths, we are
aware that the actual number of reported deaths from seclusion and
restraint may increase due to these reporting requirements. Therefore,
we anticipate there would be a burden associated with this proposed
requirement due to the increased
[[Page 35701]]
number of deaths that would be reported by CMHCs. Given the lack of
historical data, we assume the number of reports certainly should
average less than one per CMHC per year. We believe the impact
associated with this proposed provision (that is, making a telephone
call and filling in a written report) to be negligible.
Tables 3 and 4 below show the initial year (one-time) and annual
estimated CMHC burden, respectively, associated with the proposed
standards for the client rights CoP.
Table 3--Client Rights Burden Assessment (First Year)
----------------------------------------------------------------------------------------------------------------
Time per Cost per
Standard average Total time average Total cost
CMHC (hours) (in hours) CMHC
----------------------------------------------------------------------------------------------------------------
Client rights form development........................... 8 1,792 $424 $94,976
Client rights notification, signature, and documentation. 9.3 2,090 336 75,240
Addressing violations.................................... 26 5,824 1,378 308,672
Reporting violations..................................... 4.3 971 228 51,463
Documenting Restraint and Seclusion...................... 0.75 168 27 6,048
4 day trainer training................................... 32 7,168 3,641 815,584
Staff training program development....................... 40 8,960 1,440 322,560
Staff training........................................... 64 14,336 2,248 503,552
Staff training records................................... 0.58 130.6 21 4,702
------------------------------------------------------
Totals 1st year...................................... 184.93 41,439.6 9,743 2,182,797
----------------------------------------------------------------------------------------------------------------
Table 4--Client Rights Burden Assessment (Annual)
----------------------------------------------------------------------------------------------------------------
Cost per
Standard Time per average CMHC Total time average Total cost
(in hours) CMHC
----------------------------------------------------------------------------------------------------------------
Client rights notification, signature, and 9.3 hours................... 1090 $336 $75,240
documentation.
Addressing violations..................... 26 hours.................... 5,824 1,378 308,672
Reporting violations...................... 4.3 hours................... 971 228 51,463
Documenting Restraint and Seclusion....... 0.75 hours.................. 168 27 6,048
Staff training update..................... 32 hours.................... 7,168 1,124 251,776
Staff training records.................... 35 minutes.................. 130.6 21 4,704
Staff training program update............. 4 hours..................... 896 144 32,256
---------------------------------------------------------------------
Totals Annually....................... 76.85 hours................. 17,247.6 3,258 730,159
----------------------------------------------------------------------------------------------------------------
With respect to the proposed CoP for admission, initial
evaluation, comprehensive assessment and discharge or transfer of the
client, we believe that several of the proposed standards associated
with the CoP are unlikely to impose a burden on CMHCs. Specifically,
the proposed requirement for admitting a client is standard medical
practice; therefore, this requirement would not impose a burden upon a
CMHC.
Similarly, the proposed requirement to initially evaluate a client
to collect basic information (for example, the admitting diagnosis and
referral source) and to determine his or her immediate care and support
needs is standard medical practice. Therefore, this requirement would
not impose an additional burden upon a CMHC. We believe that this
evaluation, conducted by a psychiatric nurse or clinical psychologist,
would take 30 to 45 minutes per client.
While we are also proposing to require a comprehensive assessment
of each client's needs, this is standard medical practice; therefore,
this requirement would not impose a burden upon a CMHC. We believe that
each discipline involved in the CMHC interdisciplinary treatment team
(physician, psychiatric nurse, clinical social worker, clinical
psychologist, occupational therapist, and any other licensed mental
health counselors), in coordination with the client's primary care
provider (if any), would complete their respective portions of the
comprehensive assessment. We estimate that each discipline would spend
20 to 30 minutes completing its portion of the comprehensive
assessment, for a total of 2 to 3 hours per client.
Moreover, we do not believe that the proposed requirement to update
the comprehensive assessment would impose a burden upon CMHCs.
Currently, all CMHCs are required by CMS payment rules (Sec.
424.24(e)(3)) to recertify a Medicare client's eligibility for partial
hospitalization services. Therefore, the 25,087 Medicare beneficiaries
who received partial hospitalization services in 2007 have already
received an updated assessment in order for the CMHC to recertify their
eligibility. In addition, updating client assessments is part of
standard medical practice to ensure that care is furnished to meet
current client needs and treatment goals. Therefore, we believe that
this requirement would not impose a burden upon a CMHC. We estimate
that updating the comprehensive assessment would require 30 minutes per
client.
Further, as part of the CMHC care model, it is assumed that clients
will eventually be discharged or transferred from the CMHC's care. As
such, CMHCs routinely plan for and implement client discharges and
transfers. Therefore, we believe that the proposed standard for the
discharge or transfer of the client is part of a CMHC's standard
practice and would not pose additional burden to CMHCs.
Under the CoP for treatment team, active treatment plan, and
coordination of services, we assessed the potential impact of the
following proposed standards on CMHCs: Delivery of services, active
treatment plan, content of the active treatment plan, review of the
active treatment plan, and
[[Page 35702]]
coordination of services. First, the standard for delivery of services
would set forth the required members of each CMHC's active treatment
team and would require these members to work together to meet the needs
of each CMHC client. We believe it is standard practice within the CMHC
industry to include these identified members in an active treatment
team and, therefore, this requirement would not pose a burden.
Furthermore, this standard would require a psychiatric nurse,
clinical psychologist, or clinical social worker who is a member of the
interdisciplinary treatment team to be designated for each client as a
care coordinator. The designated individual would be responsible for
coordinating an individual client's care, including ensuring that the
client's needs are fully assessed and reassessed in a timely manner and
that the client's active treatment plan is fully implemented. CMHCs may
choose to assign a single individual to perform this function for all
clients of the CMHC or it may divide this duty between several
individuals, assigning specific clients to specific individuals. While
we believe that CMHCs already actively work to coordinate client
assessment, care planning, and care implementation, we also believe
that designating specific individuals to perform this function may be
new to CMHCs. We estimate that, on average, designated CMHC staff would
spend 20 to 30 minutes per week (37 to 56 hours annually) overall to
fulfill this requirement. The annual cost per CMHC associated with this
requirement would be $1,332 to $2,016 for a psychiatric registered
nurse, $1,776 to $2,688 for a clinical psychologist, or $1,036 to
$1,568 for a clinical social worker. The aggregate annual cost for all
CMHCs would be $298,368 to $451,584 if a psychiatric registered nurse
is used; $397,824 to $602,112 if a clinical psychologist is used, or
$232,064 to $351,232, if a clinical social worker is used. This
estimated burden is shown in Table 5 below.
Finally, subsection (a)(3) of this standard would require a CMHC
that has more than one interdisciplinary treatment team to designate a
single team that is responsible for establishing policies and
procedures governing the day-to-day provision of CMHC care and
services. We believe that using multiple disciplines to establish
client care policies and procedures is standard practice and does not
pose a burden.
The proposed active treatment plan standard and its content would
set forth the requirements for each client's active treatment plan. The
written active treatment plan would be established by the client and
interdisciplinary treatment team. It would address the client's needs
as they were identified in the initial evaluation and subsequent
comprehensive assessment. The treatment plan would include several
required elements (for example, an identification of a client's
treatment goals and his or her prescribed drugs), all of which are
considered to be standard practice in the mental health care industry.
We estimate that establishing the first comprehensive active treatment
plan would require 45 minutes of the interdisciplinary treatment team's
time. The burden associated with this proposed requirements would be
the time it would take to document the active treatment plan in the
clinical record. We estimate that compliance with the requirements at
Sec. 485.916(c) would require a nurse a total of 45 minutes per
client, for a total of 84 hours per CMHC. Based on the nurses' hourly
rate, the total cost would be $3,024 per CMHC.
The proposed standard for review of the active treatment plan would
require the interdisciplinary treatment team to review and revise the
active treatment plan as necessary, but no less frequently than every
30 calendar days. The revised treatment plan would include several
required elements, such as the client's progress toward the treatment
goals identified in the previous treatment plan. We estimate that
updating the active treatment plan would require 15 minutes of the
interdisciplinary treatment team's time. The burden associated with
this proposed requirement would be the time it would take to update the
active treatment plan as a client's care progresses (estimated to be 15
minutes). Therefore, we estimate that compliance with the requirements
at Sec. 485.916(d) would require a nurse a total of 15 minutes per
client, for a total of 28 hours per CMHC. Based on the nurses' hourly
rate, the total cost would be $1,008 per CMHC.
In addition, the proposed coordination of services standard would
require a CMHC to have and maintain a system of communication, in
accordance with its own policies and procedures, to ensure the
integration of its services and systems. This communication would be
required to, among other things, ensure that information is shared
among all disciplines providing care and services for each client and
ensure that information is shared with other health care providers,
including the client's primary care provider (if any) that care for
CMHC clients as necessary and appropriate. We believe that active
communication within health care providers, including CMHCs, is
standard practice; therefore, this requirement would not impose a
burden.
Table 5 below shows the annual estimated CMHC burden associated
with the proposed standards for the treatment team, active treatment
plan, and coordination of services CoP.
Table 5--Treatment Team, Active Treatment Plan, and Coordination of Services Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time per average Total time (in Cost per average
CMHC (in hours) hours) CMHC Total cost
----------------------------------------------------------------------------------------------------------------
Psychiatric Registered Nurse 37 to 56.......... 8,288 to 12,544... $1,332 to $2,016.. $298,368 to
Coordinator. Average: 47....... Average: 10,416... Average: $1,674... $451,584
Average: $374,976
Clinical Psychologist........... 37 to 56.......... 8,288 to 12,544... $1,776 to $2,688.. $397,824 to
Average: 47....... Average: 10,416... Average: $2,232... $602,112
Average: $499,968
Clinical Social Worker.......... 37 to 56.......... 8,288 to 12,544... $1,036 to $1,568.. $232,064 to
Average: 47....... Average: 10,416... Average: $1,302... $351,232
Average: $291,648
** Total Average (for all Total Average: 47. Total Average Total Average Total Average
disciplines). Range: 8,288- Range: $1,381- Range: $309,418-
10,416. $2,613. $468,309
Total Average: Total Average: Total Average:
9,352. $1,736. $388,864
Development of the Active 84 hours.......... 18,816 hours...... $3,024............ $677,376
Treatment Plan.
Review and Update of the Active 28 hours.......... 6,272 hours....... $1008............. $225,792
treatment Plan.
[[Page 35703]]
Total....................... 159 hours......... 34,440 hours...... $5,768............ $1,292,032
----------------------------------------------------------------------------------------------------------------
* Note: CMHC will choose one of the providers in table 5 to coordinate each client care.
** Note: The Total columns represent an average of all 3 provider type.
Quality Assessment and Performance Improvement (Sec. 485.917)
The proposed rule would provide guidance to the CMHC on how to
establish a quality assessment and performance improvement program.
Based on an annual census of 112 Medicare beneficiaries per CMHC, it is
estimated that a CMHC would spend approximately 24 hours a year to
implement a quality assessment and performance improvement program.
Many providers are already using comprehensive quality assessment and
performance improvement programs for accreditation or independent
improvement purposes. For those providers who choose to develop their
own quality assessment and performance improvement program, we estimate
that it would take 12 hours to create a program. We also estimate that
CMHCs would spend 4 hours a year collecting and analyzing data. In
addition, we estimate that CMHC would spend 3 hours a year training
their staff and 5 hours a year implementing performance improvement
activities. Both the program development and implementation would most
likely be managed by that CMHC's administration. Based on an
administrator's hourly rate, the total cost of the quality assessment
and performance improvement condition of participation would be $1,272
per CMHC.
$53 per hour x 24 hours = $1,272
We believe that these estimates may not be a complete reflection of
the impact that this CoP may have on CMHCs, because we do not know the
total number of clients served by CMHCs. Therefore, we are requesting
public comment regarding the total number of all clients served by
CMHCs annually and the length of time on service.
(a) Standard: Program scope. This standard would require that the
CMHC assess its organization and develop a formal quality assessment
and performance improvement program that is capable of showing
measurable improvement through the use of quality indicator data.
(b) Standard: Program data. The proposed rule would require the use
of quality indicator data in a quality assessment and performance
improvement program, but would not require any specific data collection
or utilization, nor would it require CMHCs to report the collected
data. CMHCs would, therefore, be provided flexibility with minimal
burden. The CMHC must use the data to monitor the effectiveness and
safety of services and quality of care. As part of the monitoring
process, the data must be used to assist in the prioritization of the
aforementioned opportunities for improvement.
(c) Standard: Program activities. This standard would identify
certain areas that would be required to be covered in a CMHC's
customized quality assessment and performance improvement program. The
categories would be sufficiently broad to allow for a vast range of
acceptable compliance methods. This would minimize burden.
Table 6 below shows the annual estimated CMHC burden associated
with the proposed standards for the quality assessment and performance
improvement CoP.
Table 6--Quality Assessment and Performance Improvement Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time per CMHC Total time
Standard (hours) (hours) Cost per CMHC Total cost
----------------------------------------------------------------------------------------------------------------
QAPI development................................ 12 2688 $636 $142,464
QAPI implementation............................. 12 2688 636 142,464
---------------------------------------------------------------
Total annually.............................. 24 5376 1272 284,928
----------------------------------------------------------------------------------------------------------------
Under the proposed CoP for organization, governance, administration
of services, and partial hospitalization services, we assessed the
potential impact of the following proposed standards on CMHCs:
governing body and administration, provision of services, professional
management responsibility, staff training, and physical environment.
The proposed governing body and administration standard would require a
CMHC to have a designated governing body that assumes full legal
responsibility for management of the CMHC. This standard would also
require the CMHC governing body to appoint an administrator, in
accordance with its own education and experience requirements, who is
responsible for the day-to-day operations of the CMHC. Having a
governing body and a designated administrator are standard business
practices; therefore, this requirement would not impose a burden.
The proposed provision of services standard would set forth a
comprehensive list of services that CMHCs are currently required by
statute and regulation to furnish. This standard would also require the
CMHC and all individuals furnishing services on its behalf to meet
applicable State licensing and certification requirements. As this
standard is a compilation of requirements that CMHCs must already meet,
it would not impose a burden.
In addition, the proposed professional management responsibility
standard would require that, if a CMHC chooses to provide certain
services under agreement, it must ensure that the agreement is written.
This standard would also require the CMHC to retain full professional
management responsibility for the services provided under arrangement
on its behalf. Full
[[Page 35704]]
professional management responsibility would include paying for the
arranged services and ensuring that the services are furnished in a
safe and effective manner. Having a written agreement and retaining
professional management of all care and services provided is standard
practice in the health care industry. Therefore, this requirement would
not impose a burden.
Further, the proposed staff training standard would require a CMHC
to educate all staff who have contact with clients and families about
CMHC care and services. It would also require a CMHC to provide an
initial orientation for each staff member that addresses his or her
specific job duties. Educating staff about the nature of CMHC care and
their particular job duties are standard practices that would not
impose a burden upon CMHCs.
This standard also would require a CMHC to assess the skills and
competency of all individuals furnishing client and family care in
accordance with its own written policies and procedures. Finally, this
standard would require a CMHC to provide and document its in-service
training program. This proposed standard does not prescribe the content
or format of the CMHC's skills assessment and in-service training
programs. Rather, it would allow CMHCs to establish their own policies
and procedures to meet their individual needs and goals. Due to this
inherent flexibility, we cannot estimate the impact of this proposed
provision at this time; therefore, we specifically invite comments on
this issue.
The proposed physical environment standard would require CMHCs to
furnish services in a safe, comfortable, and private environment that
meets all Federal, State, and local health and safety requirements and
occupancy rules. We believe that this proposed requirement would not
impose a burden on CMHCs as it is considered standard practice to
provide services in a physical location that is both safe and conducive
to meeting the needs of CMHC clients.
This proposed standard would also require a CMHC to have an
infection control program. While basic precautions such as thorough
hand washing and proper disposal of medical waste are standard
practice, developing a comprehensive infection control program may
impose a burden on CMHCs. We estimate that an administrator would spend
8 hours on a one-time basis developing infection control policies and
procedures and 2 hours per month conducting follow up efforts. The
estimated cost associated with this proposed provision would be $424 to
develop the infection control program and $1,272 annually to follow-up
on infection control issues in the CMHC. We believe that staff
education regarding infection control will be incorporated into the
CMHC's in-service training program, described above.
Table 7 below shows the initial year (one-time) and annual
estimated CMHC burden, respectively, associated with the proposed
standards for the organization, governance, administration of services,
and partial hospitalization services CoP.
Table 7--Organization, Governance, Administration of Services, and Partial Hospitalization Services Burden
Assessment
----------------------------------------------------------------------------------------------------------------
Time per
average CMHC Total time Cost per Total cost
(in hours) (in hours) average CMHC
----------------------------------------------------------------------------------------------------------------
Infection control policies and procedures....... 8 1,792 $424 $94,976
Infection control follow-up..................... 24 5,376 1,272 284,928
---------------------------------------------------------------
Total 1st year.............................. 32 7,168 1,696 379,904
---------------------------------------------------------------
Total annually.......................... 24 5,376 1,272 284,928
----------------------------------------------------------------------------------------------------------------
Table 8 below shows the initial year (one-time) and annual
estimated CMHC burden, respectively, associated with all requirements
in this proposed CMHC rule.
Table 8--Total Burden Assessment for All Requirements in the First Year CoP
----------------------------------------------------------------------------------------------------------------
Total time (hours) Total industry Total cost per Total industry
per average CMHC time average CMHC cost
----------------------------------------------------------------------------------------------------------------
Client rights................... 1st year: 184.93.. 1st year: 41,439.6 1st year: $9,743.. 1st year:
Annual: 76.85..... Annual: 17,247.6.. Annual: $3,258.... $2,182,797
Annual: $730,159
Treatment team. Active Treatment Range: 37-56...... Range: 8,288- Range: $1,381- Range: $309,418-
Plan, and Coordination of Average: 47....... 12,544. $2,613. $468,309
Services. Total: 159........ Average: 10,416... Average: $1,736... Average: $388,864
Total: 34,440..... $5,768............ Total: 1,292,032
Quality Assessment and 24................ 5,376............. $1,272............ $284,928
Performance Improvement.
Organization, Governance, 1st year: 32...... 1st year: 7,168... 1st year: $1,696.. 1st year: $379,904
Administration of Services. Annual: 24........ Annual: 5,376..... Annual: $1,272.... Annual: $284,928
-------------------------------------------------------------------------------
Totals...................... 1st year: 399.93.. 1st year: 88,423.6 1st year: $18,479. 1st year:
Annual: 283.93.... Annual: 62,439.6.. Annual: $11,570... $4,139,661
Annual:
$2,592,047
----------------------------------------------------------------------------------------------------------------
All first year costs include the annual burden for Treatment team, Active Treatment Plan, and Coordination of
Services and Quality Assessment and Performance Improvement CoPs.
[[Page 35705]]
We believe that the burden associated with this rule is reasonable
and necessary to ensure the health and safety of all CMHC clients.
1. Estimated Effects of Proposed CoPs for CMHCs on Other Providers
We do not expect the proposed CoPs for CMHCs included in this
proposed rule to affect any other providers.
2. Estimated Effects of Proposed CoPs for CMHCs on the Medicare and
Medicaid Programs
The costs to the Medicare and Medicaid programs resulting from
implementation of the proposed CoPs for CMHCs included in this proposed
rule would be negligible.
C. Alternatives Considered
We considered not proposing CoPs for CMHCs. These providers have
been operating without federally-issued health and safety requirements
since the 1990 inception of Medicare coverage of partial
hospitalizations services in CMHCs. In place of Federal standards, we
have relied upon State certification and licensure requirements to
ensure the health and safety of CMHC clients. However, CMS has learned
that most States either do not have certification or licensure
requirements for CMHCs or that States do not apply such certification
or licensure requirements to CMHCs that are for-profit, privately
owned, and/or not receiving State funds. Due to the significant gaps in
State requirements to ensure the health and safety of CMHC clients, we
chose to propose a core set of health and safety requirements that
would apply to all CMHCs receiving Medicare funds, regardless of the
State in which the CMHC is located. These requirements would ensure a
basic level of services provided by qualified staff.
We also considered proposing a comprehensive set of CoPs for CMHCs.
Such a comprehensive set of CoPs would go beyond the requirements in
this proposed rule to address other areas of CMHC services and
operations, such as the specific contents of a CMHC's quality
assessment and performance improvement program, and its specific
clinical record content and procedures. While we believe that these
areas are important and may warrant additional consideration in future
rulemaking, we do not believe that it is appropriate to begin with an
expansive set of CoPs. A comprehensive set of CoPs may be difficult for
CMHCs to manage, considering that many CMHCs are not currently required
to meet any health and safety standards. Rather than potentially
overwhelming CMHCs with a substantial number of new requirements at one
time, we chose to focus on a set of requirements and allow for the
option of additional CoPs in the future.
D. Conclusion
As stated earlier, we estimate that the changes that we are
proposing in this proposed rule to implement CoPs for CMHCs will not
have a significant economic effect on Medicare payments to CMHCs. We
estimate that this proposal would cost CMHCs approximately $4.1
million, or $18,475 per average CMHC, in the first year of
implementation and approximately $2.6 million, or $11,566 per average
CMHC, annually. We believe that the burden that would be associated
with this rule is reasonable and necessary to ensure the health and
safety of all CMHC clients.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
V. 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 subsequent document, we will respond to the
comments in the preamble to that document.
List of Subjects in 42 CFR Part 485
Grant programs--Health, Health facilities, Medicaid, Privacy,
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 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
1. The authority citation for part 485 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395 (hh)).
2. Add a new subpart J to part 485 to read as follows:
Subpart J--Conditions of Participation: Community Mental Health Centers
(CMHCs)
Sec.
485.900 Basis and scope.
485.902 Definitions.
485.904 Condition of participation: Personnel qualifications.
485.910 Condition of participation: Client rights.
485.914 Condition of participation: Admission, initial evaluation,
comprehensive assessment, and discharge or transfer of the client.
485.916 Condition of participation: Treatment team, client-centered
active treatment plan, and coordination of services.
485.917 Condition of participation: Quality assessment and
performance improvement.
485.918 Condition of participation: Organization, governance,
administration of services, and partial hospitalization services.
Subpart J--Conditions of Participation: Community Mental Health
Centers (CMHCs)
Sec. 485.900 Basis and scope.
(a) Basis. This subpart is based on the following sections of the
Social Security Act:
(1) Section 1832(a)(2)(J) of the Act specifies that payments may be
made under Medicare Part B for those partial hospitalization services
furnished by a community mental health center (CMHC) that are defined
in section 1861(ff)(2)(B) of the Act.
(2) Section 1861(ff) of the Act describes the items and services
that are covered under Medicare Part B as ``partial hospitalization
services'' and the conditions under which the items and services must
be provided. In addition, section 1861(ff) of the Act specifies that
the entities authorized to provide partial hospitalization services
under Medicare Part B include CMHCs and defines that term.
(3) Section 1866(e)(2) of the Act specifies that a provider of
services for purposes of provider agreement requirements includes a
CMHC as defined in section 1861(ff)(3)(B) of the Act, but only with
respect to providing partial hospitalization services.
(b) Scope. The provisions of this subpart serve as the basis of
survey activities for the purpose of determining whether a CMHC meets
the specified requirements that are considered necessary to ensure the
health and safety of clients; and for the purpose of determining
whether a CMHC qualifies for a provider agreement under Medicare.
Sec. 485.902 Definitions.
As used in this subpart, unless the context indicates otherwise--
Active treatment plan means an individualized client plan that
focuses on the provision of care and treatment services that address
the client's physical, psychological, psychosocial, emotional, and
therapeutic needs and
[[Page 35706]]
goals as identified in the comprehensive assessment.
Community mental health center (CMHC) means an entity as defined in
Sec. 410.2 of this chapter.
Comprehensive assessment means a thorough evaluation of the
client's physical, psychological, psychosocial, emotional, and
therapeutic needs related to the diagnosis under which care is being
furnished by the CMHC.
Employee of a CMHC means an individual--
(1) Who works for the CMHC and for whom the CMHC is required to
issue a W-2 form on his or her behalf; or
(2) For whom an agency or organization issues a W-2 form, and who
is assigned to such CMHC if the CMHC is a subdivision of an agency or
organization.
Initial evaluation means an immediate care and support assessment
of the client's physical, psychosocial (including a screen for harm to
self or others), and therapeutic needs related to the psychiatric
illness and related conditions for which care is being furnished by the
CMHC.
Representative means an individual who has the authority under
State law to authorize or terminate medical care on behalf of a client
who is mentally or physically incapacitated. This includes a legal
guardian.
Restraint means--
(1) Any manual method, physical or mechanical device, material, or
equipment that immobilizes or reduces the ability of a client to move
his or her arms, legs, body, or head freely, not including devices,
such as orthopedically prescribed devices, surgical dressings or
bandages, protective helmets, or other methods that involve the
physical holding of a client for the purpose of conducting routine
physical examinations or tests, or to protect the client from falling
out of bed, or to permit the client to participate in activities
without the risk of physical harm (this does not include a client being
physically escorted); or
(2) A drug or medication when it is used as a restriction to manage
the client's behavior or restrict the client's freedom of movement, and
which is not a standard treatment or dosage for the client's condition.
Seclusion means the involuntary confinement of a client alone in a
room or an area from which the client is physically prevented from
leaving.
Volunteer means an individual who is an unpaid worker of the CMHC;
or if the CMHC is a subdivision of an agency or organization, is an
unpaid worker of the agency or organization and is assigned to the
CMHC. All volunteers must meet the standard training requirements under
Sec. 485.918(d).
Sec. 485.904 Condition of participation: Personnel qualifications.
(a) Standard: General qualification requirements. All professionals
who furnish services directly, under an individual contract, or under
arrangements with a CMHC, must be legally authorized (licensed,
certified or registered) in accordance with applicable Federal, State
and local laws, and must act only within the scope of their State
licenses, certifications, or registrations. All personnel
qualifications must be kept current at all times.
(b) Standard: Personnel qualifications for certain disciplines. The
following qualifications must be met:
(1) Administrator of a CMHC. A CMHC employee who meets the
education and experience requirements established by the CMHC's
governing body for that position and who is responsible for the day-to-
day operation of the CMHC.
(2) Clinical psychologist. An individual who meets the
qualifications at Sec. 410.71(d) of this chapter.
(3) Clinical social worker. An individual who meets the
qualifications at Sec. 410.73(a) of this chapter.
(4) Mental health counselor. A professional counselor who is
certified and/or licensed by the State in which he or she practices and
has the skills and knowledge to provide a range of behavioral health
services to clients. The mental health counselor provides services in
areas such as psychotherapy, substance abuse, crisis management,
psychoeducation, and prevention programs.
(5) Occupational therapist. A person who meets the requirements for
the definition of ``occupational therapist'' at Sec. 484.4 of this
chapter.
(6) Physician. An individual who meets the qualifications and
conditions as defined in section 1861(r) of the Act and provides the
services at Sec. 410.20 of this chapter and has experience providing
mental health services to clients.
(7) Psychiatric registered nurse. A registered nurse, who is a
graduate of an approved school of professional nursing, is licensed as
a registered nurse by the State in which he or she is practicing, and
has at least 2 years of education and/or training in psychiatric
nursing.
(8) Psychiatrist. An individual who specializes in assessing and
treating persons having psychiatric disorders; is certified by the
American Board of Psychiatry and Neurology or has documented equivalent
education, training or experience, and is fully licensed to practice
medicine in the State in which he or she practices.
Sec. 485.910 Condition of participation: Client rights.
The client has the right to be informed of his or her rights. The
CMHC must protect and promote the exercise of these client rights.
(a) Standard: Notice of rights and responsibilities.
(1) During the initial evaluation, the CMHC must provide the
client, the client's representative (if appropriate) or surrogate with
verbal and written notice of the client's rights and responsibilities.
The verbal notice must be in a language and manner that the client or
client's representative or surrogate understands. Written notice must
be provided, at a minimum, in English.
(2) During the initial evaluation, the CMHC must inform and
distribute written information to the client concerning its policies on
filing a grievance.
(3) The CMHC must obtain the client's and/or the client
representative's signature confirming that he or she has received a
copy of the notice of rights and responsibilities.
(b) Standard: Exercise of rights and respect for property and
person.
(l) The client has the right to--
(i) Exercise his or her rights as a client of the CMHC.
(ii) Have his or her property and person treated with respect.
(iii) Voice grievances and understand the CMHC grievance process;
including but not limited to grievances regarding mistreatment and
treatment or care that is (or fails to be) furnished.
(iv) Not be subjected to discrimination or reprisal for exercising
his or her rights.
(2) If a client has been adjudged incompetent under State law by a
court of proper jurisdiction, the rights of the client are exercised by
the person appointed in accordance with State law to act on the
client's behalf.
(3) If a State court has not adjudged a client incompetent, any
legal representative designated by the client in accordance with State
law may exercise the client's rights to the extent allowed under State
law.
(c) Standard: Rights of the client. The client has a right to--
(1) Be involved in developing his or her active treatment plan.
(2) Refuse care or treatment.
(3) Have a confidential clinical record. Access to or release of
client information and the clinical record
[[Page 35707]]
client information is permitted only in accordance with 45 CFR parts
160 and 164.
(4) Be free from mistreatment, neglect, or verbal, mental, sexual,
and physical abuse, including injuries of unknown source, and
misappropriation of client property.
(5) Receive information about specific limitations on services that
he or she will be furnished.
(6) Not be compelled to perform services for the CMHC, and to be
compensated by the CMHC for any work performed for the CMHC at
prevailing wages and commensurate with the client's abilities.
(d) Standard: Addressing violations of client rights. The CMHC must
adhere to the following requirements:
(1) Ensure that all alleged violations involving mistreatment,
neglect, or verbal, mental, sexual, and physical abuse, including
injuries of unknown source, and misappropriation of client property by
anyone, including those furnishing services on behalf of the CMHC, are
reported immediately by CMHC employees and contracted staff to the
CMHC's administrator.
(2) Immediately investigate all alleged violations involving anyone
furnishing services on behalf of the CMHC and immediately take action
to prevent further potential violations while the alleged violation is
being verified. Investigations, and documentation, of all alleged
violations must be conducted in accordance with procedures established
by the CMHC.
(3) Take appropriate corrective action in accordance with State law
if the alleged violation is verified by the CMHC's administration or
verified by an outside entity having jurisdiction, such as the State
survey and certification agency or the local law enforcement agency;
and
(4) Ensure that, within 5 working days of becoming aware of the
violation, verified violations are reported to State and local entities
having jurisdiction (including the State survey and certification
agency).
(e) Standard: Restraint and seclusion.
(1) All clients have the right to be free from physical or mental
abuse, and corporal punishment. All clients have the right to be free
from restraint or seclusion, of any form, imposed as a means of
coercion, discipline, convenience, or retaliation by staff. Restraint
or seclusion, defined in Sec. 485.902, may only be imposed to ensure
the immediate physical safety of the client, staff, or other
individuals.
(2) The use of restraint or seclusion must be in accordance with
the written order of a physician or other licensed independent
practitioner who is authorized to order restraint or seclusion in
accordance with State law and must not exceed a duration of 1 hour per
order.
(3) The CMHC must obtain a corresponding order for the client's
immediate transfer to the hospital when restraint or seclusion is
ordered.
(4) Orders for the use of restraint or seclusion must never be
written as a standing order or on an as-needed basis.
(5) When a client becomes an immediate threat to the physical
safety of themselves, staff or other individuals, the CMHC must adhere
to the following requirements:
(i) Restraint or seclusion may only be used when less restrictive
interventions have been determined to be ineffective to protect the
client or other individuals from harm.
(ii) The type or technique of restraint or seclusion used must be
the least restrictive intervention that will be effective to protect
the client or other individuals from harm.
(iii) The use of restraint or seclusion must be implemented in
accordance with safe and appropriate restraint and seclusion techniques
as determined by State law.
(iv) The condition of the client who is restrained or secluded must
be continuously monitored by a physician or by trained staff who have
completed the training criteria specified in paragraph (f) of this
section.
(v) When a restraint or seclusion is used, there must be
documentation in the client's clinical record of the following:
(A) A description of the client's behavior and the intervention
used.
(B) Alternatives or other less restrictive interventions attempted
(as applicable).
(C) The client's condition or symptom(s) that warranted the use of
the restraint or seclusion.
(D) The client's response to the intervention(s) used, including
the rationale for continued use of the intervention.
(E) The name of the hospital to which the client was transferred.
(f) Standard: Restraint or seclusion: Staff training requirements.
The client has the right to safe implementation of restraint or
seclusion by trained staff. Application of restraint or seclusion in a
CMHC must only be imposed when a client becomes an immediate physical
threat to themselves, staff or other individuals.
(1) Training intervals. All appropriate client care staff working
in the CMHC must be trained and able to demonstrate competency in the
application of restraints, implementation of seclusion, monitoring,
assessment, and providing care for a client in restraint or seclusion
and use of alternative methods to restraint and seclusion as follows:
(i) Before performing any of the actions specified in this
paragraph (f).
(ii) As part of orientation.
(iii) Subsequently on a periodic basis, consistent with the CMHC's
policy.
(2) Training content. The CMHC must require all appropriate staff
caring for clients to have appropriate education, training, and
demonstrated knowledge based on the specific needs of the client
population in at least the following:
(i) Techniques to identify staff and client behaviors, events, and
environmental factors that may trigger circumstances that require the
use of a restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) Choosing the least restrictive intervention based on an
individualized assessment of the client's medical and behavioral status
or condition.
(iv) The safe application and use of all types of restraint or
seclusion used in the CMHC, including training in how to recognize and
respond to signs of physical and psychological distress.
(v) Clinical identification of specific behavioral changes that
indicate that restraint or seclusion is no longer necessary.
(vi) Monitoring the physical and psychological well-being of the
client who is restrained or secluded, including, but not limited to,
respiratory and circulatory status, skin integrity, vital signs, and
any special requirements specified by the CMHC's policy.
(3) Trainer requirements. Individuals providing staff training must
be qualified as evidenced by education, training, and experience in
techniques used to address clients' behaviors.
(4) Training documentation. The CMHC must document in the staff
personnel records that the training and demonstration of competency
were successfully completed.
(g) Standard: Death reporting requirements. The CMHC must report
deaths associated with the use of seclusion or restraint.
(1) The CMHC must report to CMS each death that occurs while a
client is in restraint or seclusion awaiting transfer to a hospital.
(2) Each death referenced in paragraph (g)(1) of this section must
be reported to CMS Regional Office by telephone no later than the close
of business the next business day following knowledge of the client's
death.
[[Page 35708]]
(3) Staff must document in the client's clinical record the date
and time the death was reported to CMS.
Sec. 485.914 Condition of participation: Admission, initial
evaluation, comprehensive assessment, and discharge or transfer of the
client.
The CMHC must ensure that all clients admitted into its program are
appropriate for the services the CMHC furnishes in its facility.
(a) Standard: Admission.
(1) The CMHC must determine that each client is appropriate for the
services it provides as specified in Sec. 410.2 of this chapter.
(2) For clients assessed and admitted to receive partial
hospitalization services, the CMHC must also meet separate requirements
as specified in Sec. 485.918(f).
(b) Standard: Initial evaluation.
(1) The CMHC's psychiatric registered nurse or clinical
psychologist must complete the initial evaluation within 24 hours of
the client's admission to the CMHC.
(2) The initial evaluation, at a minimum, must include the
following:
(i) The admitting diagnosis as well as other diagnoses.
(ii) The source of referral.
(iii) The reason for admission as stated by the client or other
individuals that are significantly involved.
(iv) Identification of the client's immediate clinical care needs
related to the psychiatric diagnosis.
(v) A list of current prescriptions and over-the-counter
medications, as well as other substances that the client may be taking.
(vi) For partial hospitalization services only, include an
explanation as to why the client would be at risk for hospitalization
if the partial hospitalization services were not provided.
(c) Standard: Comprehensive assessment.
(1) The comprehensive assessment must be completed by a CMHC
physician-led interdisciplinary treatment team, in consultation with
the client's primary health care provider (if any).
(2) The comprehensive assessment must be completed in a timely
manner, consistent with the client's immediate needs, but no later than
3 working days after admission to the CMHC.
(3) The comprehensive assessment must identify the physical,
psychological, psychosocial, emotional, therapeutic, and other needs
related to the client's psychiatric illness. The CMHC must ensure that
the active treatment plan is consistent with the findings of the
comprehensive assessment.
(4) The comprehensive assessment, at a minimum, must include the
following:
(i) The reasons for the admission.
(ii) A psychiatric evaluation, completed by a psychiatrist or
psychologist with physician counter signature, that includes the
medical history and severity of symptoms.
(iii) Information concerning previous and current mental status,
including but not limited to, previous therapeutic interventions and
hospitalizations.
(iv) Information regarding the onset of symptoms of the illness and
circumstances leading to the admission.
(v) A description of attitudes and behavior, including cultural
factors that may affect the client's treatment plan.
(vi) An assessment of intellectual functioning, memory functioning,
and orientation.
(vii) Complications and risk factors that may affect the care
planning.
(viii) Functional status, including the client's ability to
understand and participate in his or her own care, and the client's
strengths and goals.
(ix) Factors affecting client safety or the safety of others,
including behavioral and physical factors.
(x) A drug profile that includes a review of all of the client's
prescription and over-the-counter medications; herbal remedies; and
other alternative treatments or substances that could affect drug
therapy. The profile must provide documentation that includes, but is
not limited to, the effectiveness of drug therapy; drug side effects;
actual or potential drug interactions; duplicate drug therapy; and drug
therapy requiring laboratory monitoring.
(xi) The need for referrals and further evaluation by appropriate
health care professionals, including the client's primary health care
provider (if any), when warranted.
(xii) Factors to be considered in discharge planning.
(xiii) Identification of the client's current social and health
care support systems.
(d) Standard: Update of the comprehensive assessment.
(1) The CMHC must update the comprehensive assessment via the CMHC
physician-led interdisciplinary treatment team in consultation with the
client's primary health care provider (if any), when changes in the
client's status, responses to treatment, or goals have occurred.
(2) The assessment must be updated no less frequently than every 30
days.
(3) The update must include information on the client's progress
toward desired outcomes, a reassessment of the client's response to
care and therapies, and the client's goals.
(e) Standard: Discharge or transfer of the client.
(1) If the client is transferred to another facility, the CMHC
must, within 48 hours, forward to the facility, a copy of--
(i) The CMHC discharge summary.
(ii) The client's clinical record, if requested.
(2) If a client refuses the services of a CMHC, or is discharged
from a CMHC due to noncompliance with the treatment plan, the CMHC must
forward to the primary health care provider (if any) a copy of--
(i) The CMHC discharge summary.
(ii) The client's clinical record, if requested.
(3) The CMHC discharge summary must include--
(i) A summary of the services provided, including the client's
symptoms, treatment and recovery goals and preferences, treatments, and
therapies.
(ii) The client's current active treatment plan at time of
discharge.
(iii) The client's most recent physician orders.
(iv) Any other documentation that will assist in post-discharge
continuity of care.
(4) The CMHC must adhere to all Federal and State-related
requirements pertaining to the medical privacy and the release of
client information.
Sec. 485.916 Condition of participation: Treatment team, client-
centered active treatment plan, and coordination of services.
The CMHC must designate a physician-led interdisciplinary treatment
team that is responsible, with the client, for directing, coordinating,
and managing the care and services furnished for each client. The
interdisciplinary treatment team is composed of individuals who work
together to meet the physical, medical, psychosocial, emotional, and
therapeutic needs of CMHC clients.
(a) Standard: Delivery of services.
(1) A physician-led interdisciplinary treatment team must provide
the care and services offered by the CMHC.
(2) The CMHC must designate a psychiatric registered nurse,
clinical psychologist, or clinical social worker, who is a member of
the interdisciplinary team, to coordinate care and treatment decisions
with each client, to ensure that each client's needs are assessed and
to ensure that the active treatment plan is implemented as indicated.
The interdisciplinary
[[Page 35709]]
treatment team must include, but is not limited to, individuals who are
licensed, and in compliance with State law, to practice in the
following professional roles:
(i) A doctor of medicine, osteopathy or psychiatry (who is an
employee of or under contract with the CMHC).
(ii) A psychiatric registered nurse.
(iii) A clinical social worker.
(iv) A clinical psychologist.
(v) An occupational therapist.
(vi) Other licensed mental health professionals, as necessary.
(3) If the CMHC has more than one interdisciplinary team, it must
designate the treatment team responsible for establishing policies and
procedures governing the coordination of services and the day-to-day
provision of CMHC care and services.
(b) Standard: Active treatment plan. All CMHC care and services
furnished to clients must be consistent with an individualized,
written, active treatment plan that is established by the CMHC
physician-led interdisciplinary treatment team and the client, in
accordance with the client's psychiatric needs and goals, within 3
working days of admission to the CMHC. The CMHC must ensure that each
client and the client's primary caregiver(s), as applicable, receive
education and training provided by the CMHC that are consistent with
the client's and caregiver's responsibilities as identified in the
active treatment plan.
(c) Standard: Content of the active treatment plan. The CMHC must
develop an individualized active treatment plan for each client. The
active treatment plan must take into consideration client goals and the
issues identified in the comprehensive assessment. The active treatment
plan must include all services necessary to assist the client in
meeting his or her recovery goals, including the following:
(1) Client diagnoses.
(2) Treatment goals.
(3) Interventions.
(4) A detailed statement of the type, duration, and frequency of
services, including social work, psychiatric nursing, counseling, and
therapy services, necessary to meet the client's specific needs.
(5) Drugs, treatments, and individual and/or group therapies.
(6) Family psychotherapy with the primary focus on treatment of the
client's conditions.
(7) The interdisciplinary treatment team's documentation of the
client's and representative's (if any) understanding, involvement, and
agreement with the plan of care, in accordance with the CMHC's
policies.
(d) Standard: Review of the active treatment plan. The CMHC
interdisciplinary treatment team must review, revise, and document the
individualized active treatment plan as frequently as the client's
condition requires, but no less frequently than every 30 calendar days.
A revised active treatment plan must include information from the
client's initial evaluation and comprehensive assessments, the client's
progress toward outcomes and goals specified in the active treatment
plan, and changes in the client's goals. The CMHC must also meet
partial hospitalization program requirements specified under Sec.
424.24(e) of this chapter.
(e) Standard: Coordination of services. The CMHC must develop and
maintain a system of communication that assures the integration of
services in accordance with its policies and procedures and, at a
minimum, would do the following:
(1) Ensure that the interdisciplinary treatment team maintains
responsibility for directing, coordinating, and supervising the care
and services provided.
(2) Ensure that care and services are provided in accordance with
the active treatment plan.
(3) Ensure that the care and services provided are based on all
assessments of the client.
(4) Provide for and ensure the ongoing sharing of information among
all disciplines providing care and services, whether the care and
services are provided by employees or those under contract with the
CMHC.
(5) Provide for ongoing sharing of information with other health
care providers, including the primary health care provider, furnishing
services to a client for conditions unrelated to the psychiatric
condition for which the client has been admitted.
Sec. 485.917 Condition of participation: Quality assessment and
performance improvement.
The CMHC must develop, implement, and maintain an effective,
ongoing, CMHC-wide data-driven quality assessment and performance
improvement program (QAPI). The CMHC's governing body must ensure that
the program: reflects the complexity of its organization and services;
involves all CMHC services (including those services furnished under
contract or arrangement); focuses on indicators related to improved
behavioral health or other healthcare outcomes; and takes actions to
demonstrate improvement in CMHC performance. The CMHC must maintain
documentary evidence of its quality assessment and performance
improvement program and be able to demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The CMHC program must be able to
demonstrate measurable improvement in indicators related to improving
behavioral health outcomes and CMHC services.
(2) The CMHC must measure, analyze, and track quality indicators,
adverse client events, including the use of restraint and seclusion,
and other aspects of performance that enable the CMHC to assess
processes of care, CMHC services, and operations.
(b) Standard: Program data. (1) The program must use quality
indicator data, including client care, and other relevant data, in the
design of its program.
(2) The CMHC must use the data collected to do the following:
(i) Monitor the effectiveness and safety of services and quality of
care.
(ii) Identify opportunities and priorities for improvement.
(3) The frequency and detail of the data collection must be
approved by the CMHC's governing body.
(c) Standard: Program activities. (1) The CMHC's performance
improvement activities must:
(i) Focus on high risk, high volume, or problem-prone areas.
(ii) Consider incidence, prevalence, and severity of problems.
(iii) Give priority to improvements that affect behavioral
outcomes, client safety, and client-centered quality of care.
(2) Performance improvement activities must track adverse client
events, analyze their causes, and implement preventive actions and
mechanisms that include feedback and learning throughout the CMHC.
(3) The CMHC must take actions aimed at performance improvement
and, after implementing those actions, the CMHC must measure its
success and track performance to ensure that improvements are
sustained.
(d) Standard: Performance improvement projects. CMHCs must develop,
implement and evaluate performance improvement projects.
(1) The number and scope of distinct performance improvement
projects conducted annually, based on the needs of the CMHC's
population and internal organizational needs, must reflect the scope,
complexity, and past performance of the CMHC's services and operations.
(2) The CMHC must document what performance improvement projects
are being conducted, the reasons for conducting these projects, and the
measurable progress achieved on these projects.
[[Page 35710]]
(e) Standard: Executive responsibilities. The CMHC's governing body
is responsible for ensuring the following:
(1) That an ongoing QAPI program for quality improvement and client
safety is defined, implemented, maintained, and evaluated annually.
(2) That the CMHC-wide quality assessment and performance
improvement efforts address priorities for improved quality of care and
client safety, and that all improvement actions are evaluated for
effectiveness.
(3) That one or more individual(s) who are responsible for
operating the QAPI program are designated.
Sec. 485.918 Condition of participation: Organization, governance,
administration of services, and partial hospitalization services.
The CMHC must organize, manage, and administer its resources to
provide CMHC services, including specialized services for children,
elderly individuals, individuals with serious mental illness, and
residents of its mental health services area who have been discharged
from an inpatient mental health facility.
(a) Standard: Governing body and administrator.
(1) A CMHC must have a designated governing body (or designated
person(s)) that assumes full legal authority and responsibility for the
management of the CMHC, the services it furnishes, its fiscal
operations, and continuous quality improvement.
(2) The CMHC's governing body must appoint an administrator who
reports to the governing body and is responsible for the day-to-day
operation of the CMHC. The administrator must be a CMHC employee and
meet the education and experience requirements established by the
CMHC's governing body.
(b) Standard: Provision of services.
(1) A CMHC must be primarily engaged in providing the following
care and services to all clients served by the CMHC regardless of payer
type, and must do so in a manner that is consistent with the following
accepted standards of practice:
(i) Provides outpatient services, including specialized outpatient
services for children, elderly individuals, individuals with chronic
mental illness, and residents of its mental health services area who
have been discharged from inpatient mental health facilities.
(ii) Provides 24-hour-a-day emergency care services.
(iii) Provides day treatment, partial hospitalization services
other than in an individual's home or in an inpatient or residential
setting, or psychosocial rehabilitation services.
(iv) Provides screening for clients being considered for admission
to State mental health facilities to determine the appropriateness of
such services, unless otherwise directed by State law.
(v) Provides at least 40 percent of its items and services to
individuals who are not eligible for benefits under title XVIII of the
Act, as measured by the total revenues received by the CMHC that are
payments from Medicare versus payers other than Medicare.
(vi) Provides individual and group psychotherapy utilizing a
psychiatrist, psychologist, or other licensed mental health counselor,
to the extent authorized under State law.
(vii) Provides physician services.
(viii) Provides psychiatric nursing services.
(ix) Provides clinical social work services.
(x) Provides family counseling services, with the primary purpose
of treating the individual's condition.
(xi) Provides occupational therapy services.
(xii) Provides services of other staff trained to work with
psychiatric clients.
(xiii) Provides drugs and biologicals furnished for therapeutic
purposes that cannot be self-administered.
(xiv) Provides client training and education as related to the
individual's care and active treatment.
(xv) Provides individualized therapeutic activity services that are
not primarily recreational or diversionary.
(xvi) Provides diagnostic services.
(2) The CMHC and individuals furnishing services on its behalf must
meet applicable State licensing and certification requirements.
(c) Standard: Professional management responsibility. A CMHC that
has a written agreement with another agency, individual, or
organization to furnish any services under arrangement must retain
administrative and financial management and oversight of staff and
services for all arranged services. As part of retaining financial
management responsibility, the CMHC must retain all payment
responsibility for services furnished under arrangement on its behalf.
Arranged services must be supported by a written agreement which
requires that all services be as follows:
(1) Authorized by the CMHC.
(2) Furnished in a safe and effective manner.
(3) Delivered in accordance with established professional
standards, the policies of the CMHC, and the client's active treatment
plan.
(d) Standard: Staff training.
(1) A CMHC must provide education about CMHC care and services, and
client-centered planning to all employees, volunteers, and staff under
contract who have contact with clients and their families.
(2) A CMHC must provide an initial orientation for each individual
furnishing services that addresses the specific duties of his or her
job.
(3) A CMHC must assess the skills and competence of all individuals
furnishing care and, as necessary, provide in-service training and
education programs where indicated. The CMHC must have written policies
and procedures describing its method(s) of assessing competency and
must maintain a written description of the in-service training provided
during the previous 12 months.
(e) Standard: Physical environment.
(1) Environmental conditions. The CMHC must provide a safe,
functional, sanitary, and comfortable environment for clients and staff
that is conducive to the provision of services that are identified in
paragraph (b) of this section.
(2) Building. The CMHC services must be provided in a location that
meets Federal, State, and local health and safety standards and State
health care occupancy regulations.
(3) Infection control. There must be policies, procedures, and
monitoring for the prevention, control, and investigation of infection
and communicable diseases with the goal of avoiding sources and
transmission of infection.
(4) Therapy sessions. The CMHC must ensure that individual or group
therapy sessions are conducted in a manner that maintains client
privacy and ensures client dignity.
(f) Standard: Partial hospitalization services. A CMHC providing
partial hospitalization services must--
(1) Provide services as defined in Sec. 410.2 of this chapter.
(2) Provide the services and meet the requirements specified in
Sec. 410.43 of this chapter.
(3) Meet the requirements for coverage as described in Sec.
410.110 of this chapter.
(4) Meet the content of certification and plan of treatment
requirements as described in Sec. 424.24(e) of this chapter.
(g) Standard: Compliance with Federal, State, and local laws and
regulations related to the health and safety of clients. The CMHC and
its staff must operate and furnish services in compliance with all
applicable Federal, State, and local laws and regulations related to
the health and safety of clients. If State or local law provides for
[[Page 35711]]
licensing of CMHCs, the CMHC must be licensed. The CMHC staff must
follow the CMHC's policies and procedures.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 26, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 3, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-14673 Filed 6-16-11; 8:45 am]
BILLING CODE 4120-01-P