35684 Federal Register / Vol. 76, No. 117 / Friday June 17, 2011 / Proposed Rules 

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. 

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, outcomeoriented 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 selfattestation. Currently, CMHCs are 

Medicare-certified and Medicareenrolled 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 § 485.900) 

In proposed § 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 § 485.902) 

In proposed § 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 § 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 § 485.904) 

We are proposing to add a new CoP 

at § 485.904 to establish staff 

qualifications for CMHCs. In proposed 

§ 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 § 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 § 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 

§ 485.910) 

We are proposing to add a new CoP 

at § 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 § 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 

§ 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 485.914) 

We are proposing to add a new CoP 

at § 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 § 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 § 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 § 410.2. If the client was 

admitted to receive partial 

hospitalization services, the CMHC 

would also have to meet separate 

requirements specified at proposed 

§ 485.918(f). 

In proposed § 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-thecounter 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 § 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 § 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 

§ 485.914(c)(4)(i) through (xiii): 

In proposed § 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 

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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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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, ClientCentered Active Treatment Plan, and 

Coordination of Services (Proposed 

§ 485.916) 

We are proposing to add a new CoP 

at § 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 § 485.916(a), ‘‘Standard: 

Delivery of services,’’ we are proposing 

that the CMHC designate a physicianled 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 § 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 § 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 § 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 § 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-today 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 

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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 

§ 485.917) 

We are proposing to add a new CoP 

at § 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 § 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 § 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 § 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 § 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 CMHCwide 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 § 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 

§ 485.918) 

We are proposing to add a new CoP 

at § 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 § 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 § 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 § 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 

§ 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 

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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/coinsurance 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 subregulatory 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 appropriatelytrained staff to meet these 

responsibilities at all times. 

In proposed § 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 § 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 § 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 § 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 

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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 § 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 § 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 § 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 (§ 485.910) 

Proposed § 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 × 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 × $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 

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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 § 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 § 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 § 485.910(e)(2)(v) would 

require written orders for a physical 

restraint or seclusion, and proposed 

§ 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 § 485.910(f) would specify 

restraint or seclusion staff training 

requirements. Specifically, 

§ 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 

§ 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 § 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 

(§ 485.914) 

Proposed § 485.914(b) through (d) 

would require each CMHC to conduct 

and document in writing an initial 

evaluation and a comprehensive clientspecific 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 § 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 § 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 (§ 485.916) 

Proposed § 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 

§ 485.916(c) specify the minimum 

elements that the active treatment plan 

would include. In addition, in proposed 

§ 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 § 485.916(e) would require a 

CMHC to develop and maintain a 

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system of communication and 

integration to ensure compliance with 

the requirements contained in 

§ 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 (§ 485.917) 

Proposed § 485.917 would require a 

CMHC to develop, implement, and 

maintain an effective ongoing CMHCwide 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 

(§ 485.918) 

Proposed § 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 § 485.918(d) describes the 

proposed standard for training. In 

particular, § 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 § 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 § 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

Regulation section(s) OMB Control No. Respondents Responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of reporting 

($) 

Total labor 

cost of reporting 

($) 

Total capital/maintenance 

Costs ($) 

Total cost 

($) 

§ 485.910(a)(1) .......... 0938–New ................. 224 224 8 1,792 53 94,976 0 94,976 

§ 485.910(a)(3) .......... 0938–New ................. 224 25,087 .0833 2,090 36 75,240 0 75,240 

§ 485.910(d)(2) .......... 0938–New ................. 224 11,648 .5 5,824 53 308,672 0 308,672 

§ 485.910(d)(4) .......... 0938–New ................. 224 11,648 .0833 971 53 51,463 0 51,463 

§ 485.910(e)(4)(v) ...... 0938–New ................. 224 224 .75 168 36 6,048 0 6,048 

§ 485.910(f)(4) ........... 0938–New ................. 224 224 .583 131 36 4,704 0 4,704 

§ 485.916(c) ............... 0938–New ................. 224 25,087 .75 18,815 36 677,340 .................... 677,340 

§ 485.916(d) ............... 0938–New ................. 224 25,087 .25 6,272 36 225,792 0 225,792 

§ 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: 

OIRA_submission@omb.eop.gov. 

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35698 Federal Register / Vol. 76, No. 117 / Friday June 17, 2011 / Proposed Rules 

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=2465b064ba

6965cc1fbd2eae60854b11&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 

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TABLE 2—ASSUMPTIONS AND ESTIMATES USED THROUGHOUT THE IMPACT ANALYSIS SECTION ON CMHCS—Continued 

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 § 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 × 25,087 clients). The 

estimated cost associated with these 

requirements would be $75,240, based 

on a psychiatric nurse performing this 

function (2090 hours × $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 § 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 § 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 

§ 485.910(f) would set out the training 

requirements for all appropriate client 

care staff involved in the use of 

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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 trainthe-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 deescalation 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 × 7 trainees = 

35 minutes annually 

• 35 minutes × $36/hr = $21 annually 

• 35 minutes per CMHC × 224 

CMHCs = 130.6 hours nationwide 

• 130.6 hours industry wide × $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 × $36/hr = $144 per CMHC 

• $144 per CMHC × 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 

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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) 

Standard 

Time per 

average 

CMHC 

(hours) 

Total time 

(in hours) 

Cost per 

average 

CMHC 

Total cost 

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) 

Standard Time per average CMHC Total time 

(in hours) 

Cost per 

average 

CMHC 

Total cost 

Client rights notification, signature, and documentation ............... 9.3 hours ................................... 1090 $336 $75,240 

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 (§ 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 

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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 § 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 § 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 CMHC 

(in hours) 

Total time 

(in hours) Cost per average CMHC Total cost 

Psychiatric Registered 

Nurse Coordinator.

37 to 56 .............................

Average: 47 .......................

8,288 to 12,544 .................

Average: 10,416 ................

$1,332 to $2,016 ...............

Average: $1,674 ................

$298,368 to $451,584 

Average: $374,976 

Clinical Psychologist .......... 37 to 56 .............................

Average: 47 .......................

8,288 to 12,544 .................

Average: 10,416 ................

$1,776 to $2,688 ...............

Average: $2,232 ................

$397,824 to $602,112 

Average: $499,968 

Clinical Social Worker ....... 37 to 56 .............................

Average: 47 .......................

8,288 to 12,544 .................

Average: 10,416 ................

$1,036 to $1,568 ...............

Average: $1,302 ................

$232,064 to $351,232 

Average: $291,648 

** Total Average (for all 

disciplines).

Total Average: 47 ............. Total Average Range: 

8,288–10,416.

Total Average: 9,352 ........

Total Average Range: 

$1,381–$2,613.

Total Average: $1,736 ......

Total Average Range: 

$309,418–$468,309 

Total Average: $388,864 

Development of the Active 

Treatment Plan.

84 hours ............................ 18,816 hours ..................... $3,024 ............................... $677,376 

Review and Update of the 

Active treatment Plan.

28 hours ............................ 6,272 hours ....................... $1008 ................................ $225,792 

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TABLE 5—TREATMENT TEAM, ACTIVE TREATMENT PLAN, AND COORDINATION OF SERVICES BURDEN ASSESSMENT— 

Continued 

Time per average CMHC 

(in hours) 

Total time 

(in hours) Cost per average CMHC Total cost 

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 (§ 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 × 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

Standard 

Time per 

CMHC 

(hours) 

Total time 

(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 

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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 followup 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 

(in hours) 

Total time 

(in hours) 

Cost per average CMHC Total cost 

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) per 

average CMHC Total industry time Total cost per average CMHC Total industry cost 

Client rights .................................................. 1st year: 184.93 ........

Annual: 76.85 ...........

1st year: 41,439.6 ....

Annual: 17,247.6 ......

1st year: $9,743 .......

Annual: $3,258 .........

1st year: $2,182,797 

Annual: $730,159 

Treatment team. Active Treatment Plan, 

and Coordination of Services.

Range: 37–56 ...........

Average: 47 ..............

Total: 159 ..................

Range: 8,288–12,544 

Average: 10,416 .......

Total: 34,440 ............

Range: $1,381– 

$2,613.

Average: $1,736 .......

$5,768 .......................

Range: $309,418– 

$468,309 

Average: $388,864 

Total: 1,292,032 

Quality Assessment and Performance Improvement.24 .............................. 5,376 ......................... $1,272 ....................... $284,928 

Organization, Governance, Administration 

of Services.

1st year: 32 ...............

Annual: 24 ................

1st year: 7,168 .........

Annual: 5,376 ...........

1st year: $1,696 .......

Annual: $1,272 .........

1st year: $379,904 

Annual: $284,928 

Totals ..................................................... 1st year: 399.93 ........

Annual: 283.93 .........

1st year: 88,423.6 ....

Annual: 62,439.6 ......

1st year: $18,479 .....

Annual: $11,570 .......

1st year: $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. 

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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) 

§ 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. 

§ 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 

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goals as identified in the comprehensive 

assessment. 

Community mental health center 

(CMHC) means an entity as defined in 

§ 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 § 485.918(d). 

§ 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 § 410.71(d) of this chapter. 

(3) Clinical social worker. An 

individual who meets the qualifications 

at § 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 

§ 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 § 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. 

§ 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 

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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 

§ 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. 

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(3) Staff must document in the client’s 

clinical record the date and time the 

death was reported to CMS. 

§ 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 

§ 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 

§ 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. 

§ 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 

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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 

§ 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. 

§ 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. 

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(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. 

§ 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 inservice 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 

§ 410.2 of this chapter. 

(2) Provide the services and meet the 

requirements specified in § 410.43 of 

this chapter. 

(3) Meet the requirements for coverage 

as described in § 410.110 of this chapter. 

(4) Meet the content of certification 

and plan of treatment requirements as 

described in § 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 

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Federal Register / Vol. 76, No. 117 / Friday June 17, 2011 / Proposed Rules 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 

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