Medicare Program; Conditions of Participation (CoPs) for Community Mental Health Centers, 35684-35711 [2011-14673]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35684-35711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14673]



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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 https://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: https://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 https://www.gpoaccess.gov/), 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

[[Page 35688]]

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

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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,

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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