Vol. 78 Tuesday, 

No. 209 October 29, 2013 

Part II 

Department of Health and Human Services 

Center for Medicare & Medicaid Services 

42 CFR Part 485 

Medicare Program: Conditions of Participation (CoPs) for Community 

Mental Health Centers; Final Rule 

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64604 Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 485 

[CMS–3202–F] 

RIN 0938–AP51 

Medicare Program: Conditions of 

Participation (CoPs) for Community 

Mental Health Centers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule establishes, for 

the first time, conditions of 

participation (CoPs) that community 

mental health centers (CMHCs) must 

meet in order to participate in the 

Medicare program. These CoPs 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 enable CMS to 

survey CMHCs for compliance with 

health and safety requirements. 

DATES: These regulations are effective 

on October 29, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Mary Rossi-Coajou, (410) 786–6051. 

Maria Hammel, (410) 786–1775. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Introduction 

In 2012, 100 certified Community 

Mental Health Centers (CMHCs) billed 

Medicare for partial hospitalization 

services. Currently, there are no 

Conditions of Participation (CoPs) in 

place for Medicare-certified CMHCs. As 

such, an insufficient regulatory basis 

exists to ensure quality and safety for 

CMHC care. Sections 1102 and 1871 of 

the Social Security Act (the Act) give 

CMS the general authority to establish 

CoPs for Medicare providers. Therefore, 

we are establishing for the first time a 

set of requirements that Medicarecertified CMHCs must meet in order to 

participate in the Medicare program. 

These CoPs will help to ensure the 

quality and safety of CMHC care for all 

clients served by the CMHC, regardless 

of payment source. 

These requirements focus on a short 

term, person-centered, outcomeoriented process that promotes quality 

client care. Requirements for CMHC 

services 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. 

Bridging these CMHC requirements are 

quality assessment and performance 

improvement program requirements that 

build on a provider’s own quality 

management system to improve client 

care performance. We expect CMHCs to 

furnish health care that meets the 

essential health and quality standards 

that are established by this rule; 

therefore, a CMHC will be expected to 

use its own quality management system 

to monitor and improve its own 

performance and compliance. 

B. Current Requirements for CMHCs 

Section 1832(a)(2)(J) of the Act 

established coverage of partial 

hospitalization services for Medicare 

beneficiaries in CMHCs. 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, apart from limited 

telehealth services, 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 requirements that apply 

only to CMHCs that receive Medicaid or 

other direct state funding. 

A CMHC may receive Medicare 

payment for partial hospitalization 

services only if it meets the core 

requirements at § 410.2 and provides 

partial hospitalization program (PHP) 

services that are in accordance with 

regulations at § 424.24(e). 

When the partial hospitalization 

program benefit in CMHCs was first 

enacted, CMHCs were certified based on 

self-attestation. 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) of the Act and 

provides the core services described in 

section 1913(c)(1) of the PHS Act. CMS 

has received complaints regarding some 

CMHCs, such as their 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 CMHC 

from Medicare participation based on 

the result of a complaint investigation. 

Without such health and safety 

standards in place, CMS’s oversight of 

CMHCs is severely limited. 

C. Rationale for Establishing 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 clients and their families. 

Establishing CMHC CoPs will enable 

CMS to survey providers, through State 

survey and certification agencies, to 

ensure that the care being furnished 

meets the standards. 

On August 20, 2012, the U.S. 

Department of Health and Human 

Services Office of the Inspector General 

(OIG) published a report entitled 

Questionable Billing by Community 

Mental Health Centers, OEI–04–11– 

00100 http://oig.hhs.gov/oei/reports/oei04-11-00100.asp. In this report it was 

found that in 2010 approximately half of 

the CMHCs met or exceeded thresholds 

that indicated unusually high billing for 

at least one out of nine questionable 

billing characteristics. Approximately 

one-third of these CMHCs had at least 

two of the characteristics. Additionally, 

approximately two-thirds of the CMHCs 

with questionable billing were located 

in eight metropolitan areas. Finally, 90 

percent of the CMHCs with questionable 

billing were located in States that do not 

require CMHCs to be licensed or 

certified. The OIG had four specific 

recommendations including the 

finalization of the proposed conditions 

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of participation for CMHCs. Due to the 

possibility of significant gaps in State 

requirements to ensure the health and 

safety of CMHC clients, we chose to 

propose and are finalizing a core set of 

health and safety requirements that will 

apply to all CMHCs receiving Medicare 

funds, regardless of the State in which 

the CMHC is located. These 

requirements will ensure a basic level of 

services provided by qualified staff, and 

will be consistent with the 

recommendations of the OIG. As with 

CoPs applied to other provider types, 

these requirements will apply for all 

clients served by the CMHC, not just 

Medicare beneficiaries. 

D. Principles Applied in Developing the 

CMHC CoPs 

We developed the 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 person-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 

proposed and are finalizing 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. 

The ‘‘Personnel qualifications’’ CoP 

establishes staff qualifications for the 

CMHC. 

The ‘‘Client rights’’ CoP emphasizes 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 

reflects 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 incorporates a personcentered interdisciplinary team 

approach, in consultation with the 

client’s primary health care provider (if 

any). 

The ‘‘Quality assessment and 

performance improvement’’ CoP 

challenges 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 charges 

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 CoPs, ‘‘Admission, initial 

evaluation, comprehensive assessment, 

and discharge or transfer of the client’’ 

and ‘‘Treatment team, active treatment 

plan, and coordination of services,’’ 

establish a cycle of individualized client 

care. The client’s care needs will be 

comprehensively assessed, enabling the 

interdisciplinary team, with the client, 

to establish an active treatment plan. 

The active treatment plan will be 

implemented, and the results of the care 

will be evaluated by updating the 

comprehensive assessment and active 

treatment plan. 

These CoPs present an opportunity for 

CMHCs, States, and CMS to join in a 

partnership for improvement. CMHC 

programming will reflect a personcentered approach that will affect how 

State survey and certification agencies 

and CMS manage the survey process. 

This approach provides opportunities 

for improvement in client care. 

II. Provisions of the Proposed Rule and 

Analysis and Response to Public 

Comments 

We published a proposed rule in the 

Federal Register (76 FR 35684) on June 

17, 2011. In that rule, we proposed to 

establish a new subpart J under the 

regulations at part 485 to incorporate 

the proposed CoPs for CMHCs. 

We specified that the new subpart J 

would include the basis and scope of 

the subpart, definitions, and the six 

CoPs and requirements. 

We provided a 60-day public 

comment period in which we received 

a total of 203 timely comments from 

accrediting bodies, consumer advocacy 

organizations, CMHCs, individuals, 

national health care provider 

organizations, State agencies, and State 

health care provider organizations. 

Overall, the majority of commenters 

were supportive of the proposed 

changes. Summaries of the major issues 

and our responses are set forth below. 

A. Basis and Scope (§ 485.900) 

At § 485.900, we proposed to cite the 

statutory authority for CMHCs to 

provide services that are payable under 

Medicare Part B. In addition, we 

proposed to describe the scope of 

provisions in proposed subpart J. 

B. Definitions (§ 485.902) 

At § 485.902, we proposed to define 

the following terms to be used in the 

CoPs for CMHCs under the proposed 

subpart J: ‘‘active treatment plan,’’ 

‘‘community mental health center 

(CMHC),’’ ‘‘comprehensive assessment,’’ 

‘‘employee of a CMHC,’’ ‘‘initial 

evaluation,’’ ‘‘representative,’’ 

‘‘restraint,’’ ‘‘seclusion,’’ and 

‘‘volunteer’’. 

Comment: Some commenters 

expressed concern related to the 

requirement that all volunteers meet the 

standard training requirements under 

§ 485.918(d). The commenters believe it 

is unreasonable to require CMHCs to 

provide the specific training and 

competency assessments required under 

§ 485.918(d)(1) and (d)(3) for volunteers. 

Other commenters believe an initial 

orientation tailored to the actual work a 

volunteer will be doing ensures that 

volunteers will receive the information 

and guidelines they need from CMHCs 

without imposing an unnecessary and 

impractical barrier to using volunteers. 

Response: We appreciate the feedback 

related to the definition of a volunteer 

and associated training requirements. 

We agree with the commenters that 

orientation should be tailored to the 

actual work the volunteer will be doing. 

However, the volunteer would need 

additional training in areas such as 

CMHC care and services, as well as 

specific in-service training and 

education, depending on the role of the 

volunteer. For example, if a volunteer 

role is to work in the CMHC client 

waiting area, we would expect the 

CMHC to educate the volunteer in areas 

such as the CMHC privacy policy, deescalation techniques, and other 

pertinent training that may affect the 

role of that volunteer. Therefore, we are 

finalizing the definition of volunteer 

and their training requirements as 

proposed. 

Comment: One commenter stated that 

it is difficult to imagine a situation 

where a client’s representative would be 

terminating medical care on the client’s 

behalf. The commenter stated that the 

definition should reflect the principles 

of client involvement and the protection 

of client rights, including emphasizing 

the right of a client to make decisions 

regarding treatment. The commenter 

stated that one possibility would be to 

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change the definition to state that a 

representative is ‘‘an individual legally 

authorized to make decisions on behalf 

of a client who is mentally and 

physically incapacitated,’’ and eliminate 

any reference to terminating medical 

care. 

Response: We appreciate the feedback 

and suggestions related to the definition 

of ‘‘representative’’. We agree that it 

would be more common for a client to 

have a representative who would be 

authorizing care, not terminating care. 

However, CMS uses the term 

‘‘representative’’ across many different 

provider types. Therefore, we are 

finalizing the definition of 

‘‘representative’’ as proposed. 

CMHC CoP: Personnel Qualifications 

(§ 485.904) 

We proposed to add a new CoP at 

§ 485.904 to establish staff qualifications 

for CMHCs. The proposed CoP was 

divided into two standards. 

At § 485.904(a), ‘‘Standard: General 

qualification requirements,’’ we 

proposed 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. We also 

proposed that all personnel 

qualifications would have to be kept 

current at all times. 

At § 485.904(b), ‘‘Standard: Personnel 

qualifications for certain disciplines,’’ 

we proposed to require staff 

qualifications to be consistent with, or 

similar to, those set forth in CoPs for 

other provider types in the Medicare 

regulations. Specifically, we proposed 

personnel requirements for the 

following disciplines: Administrator of 

a CMHC, Clinical Psychologist, Clinical 

Social Worker, Mental Health 

Counselor, Occupational Therapist, 

Physician, Psychiatric Registered Nurse, 

and Psychiatrist. 

Comment: Several commenters agreed 

with requiring that ‘‘all professionals 

who furnish services directly 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.’’ They also stated 

that most states allow individuals with 

Master’s level degrees, such as social 

work and psychology, to provide 

services under the supervision of a 

licensed professional. Commenters 

stated that a period of supervision is 

required for these professionals to 

receive licenses. In addition, 

commenters stated that many peer 

educators and Bachelor’s level 

professionals do not have a process for 

becoming licensed, or must work in a 

supervised position for a certain number 

of hours to obtain certification. 

Response: We thank the commenters 

for the information regarding 

professionals who furnish services in a 

CMHC. We believe that the regulations 

at § 485.904 allow for professionals with 

a Master’s degree in psychology or 

social work to provide services under a 

licensed professional as long as it is 

within their scope of practice and 

allowed by the State. If a State decides 

that Baccalaureate level professionals 

need to be supervised for a certain 

number of hours to meet State licensure 

requirements to obtain their license, we 

defer to that State’s decision. Our 

proposed language did not impose 

additional restrictions or require that 

States establish additional licensing 

programs or requirements. Therefore, 

we are finalizing § 485.904(a) as 

proposed. 

Comment: A few commenters agreed 

that it is important that personnel 

qualifications be defined by CMS. 

However, they believe that the facility 

should qualify their staff and make sure 

their staff is competent to perform their 

job responsibilities. Commenters stated 

that this could be achieved by using the 

education, experience, and services the 

individual is able to perform under the 

scope of his or her license and based on 

the laws of his or her state. Commenters 

also believe it is important that CMS 

recognize that there are many different 

types of mental health professionals 

who are qualified to perform the clinical 

responsibilities within the CMHC, 

regardless of the ‘‘title of their degree.’’ 

According to the commenters, it is 

imperative that CMS not limit the 

CMHC provider to one specific degree 

and or license (that is, clinical social 

worker vs. mental health counselor) to 

perform ‘‘certain’’ roles in the CMHC, as 

this would be an impossible task to 

adhere to and an administrative and 

financial burden that is unnecessary to 

the CMHC. 

Commenters also stated that CMS is 

required to accept the scope of state 

licensure of various mental health care 

professionals in the context of 

Medicare’s partial hospitalization 

program benefit. Congress explicitly 

stated in the Social Security Act that 

individual and group therapy services 

provided within a partial 

hospitalization program at a CMHC can 

be conducted by physicians, 

psychologists or ‘‘other mental health 

professionals to the extent authorized 

under State law’’, as noted in Section 

1861(ff)(2)(A) of the Act. 

Response: We thank the commenters 

for the comments regarding licensure, 

education, and experience as they relate 

to the personnel requirements. Our goal 

in requiring specific personnel 

requirements is to protect the health and 

safety of the clients served by the 

CMHC. That said, we agree that 

practitioners should not be restricted by 

our rules from acting within the scope 

of practice authorized under State law 

and any applicable licensing 

requirements. We have amended the 

language in this final rule to assist in 

ensuring that practitioners can practice 

to the full extent of their State licensure. 

Comment: A few commenters are 

concerned that, in their view, CMHCs 

may have inadequate boards of 

directors, and that the board and 

administrator of the CMHC are 

permitted to be one and the same. 

Commenters stated that anyone with 

limited investment capital and no 

knowledge of psychiatric care can open 

and operate a CMHC, and that this is 

one of the system’s greatest weaknesses. 

Commenters requested that, in cases 

where the administrator has a financial 

(that is, controlling) interest in the 

CMHC, minimum professional 

standards should apply. 

Response: We thank the commenters 

for the information regarding the 

administrator and board of directors. We 

agree that in some cases there is 

potential for the administrator and the 

governing body to be one and the same. 

However, we do not believe that 

modifying the language under personnel 

requirements for the administrator is the 

best place to address this issue. 

Therefore, we are finalizing the 

administrator personnel requirements as 

proposed. We have also modified the 

language at § 485.918(a)(1) related to the 

governing body to require two or more 

persons to serve on the governing body, 

one of whom must possess knowledge 

and experience as a mental health 

clinician. The administrator will be able 

to serve as a member of the governing 

body, but we will require at least one (or 

more) additional person(s) to be part of 

the governing body. For example, if the 

administrator has no psychiatric health 

background, either one of the CMHC’s 

clinicians or another qualified 

professional should be appointed to 

serve as a member of the governing 

body. 

Comment: At proposed 

§ 485.904(b)(6), a few commenters noted 

that CMS used the definition of 

physician found in section 1861(r) of 

the Act. The commenters requested that 

CMS further limit the statutory 

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Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Rules and Regulations 64607 

definition of physician by limiting it to 

section 1861(r)(1), which lists a doctor 

of medicine or osteopathy. The 

commenter believes that this will help 

ensure that clients in a CMHC receive 

quality care from appropriately trained 

doctors of medicine or osteopathy 

legally authorized to practice medicine 

and surgery by the State. 

Response: We thank the commenters 

for the comment regarding the 

definition of a physician, now located at 

§ 485.904(b)(7). We understand the 

commenters’ concerns with the 

broadness of the definition, and believe 

that requiring the physician to have 

experience in providing mental health 

services to clients will assure that these 

physicians are qualified to provide 

CMHC services. Therefore, the 

requirements will remain as proposed. 

Comment: Some commenters 

expressed concern with the psychiatric 

registered nurse personnel 

requirements. Specifically, the 

commenters expressed concern about 

the requirement of 2 years of education 

and training in psychiatric nursing. 

Some commenters believe the training 

requirement should be reduced to 1 

year. Other commenters stated that nonprofit CMHCs face competition for 

professional staff and cannot always 

offer salaries as high as those offered by 

other providers, such as hospitals. 

CMHCs in rural areas have an added 

hurdle to recruiting and retaining 

clinicians. One way CMHCs can attract 

staff at the salaries they are able to pay 

is by offering recent graduates the 

opportunity to gain more experience 

working in community behavioral 

health. The commenters stated that it is 

unclear whether the two-year education 

and/or training requirement would 

disqualify recent nursing school 

graduates from working at non-profit 

CMHCs. The commenters are requesting 

clarification of this requirement to 

include approved nursing school 

graduates who have ‘‘education and/or 

training in psychiatric nursing,’’ 

without specifying a length of time. 

Other commenters stated that 

psychiatric registered nursing is 

specialized nursing care and an integral 

component in the provision of services 

at CMHCs. As a result, those 

commenters recommended that CMS 

remove the word ‘‘registered’’ and 

broaden the definition of ‘‘psychiatric 

nurse’’ so that it includes all licensed 

nurses who possess the requisite 

education and experience as outlined in 

the CoP. Furthermore, the commenters 

requested that the personnel 

requirement for psychiatric registered 

nurses remain in accordance with 

§ 410.43(a)(4)(iii), ‘‘trained psychiatric 

nurses,’’ and eliminate the word 

‘‘Registered.’’ Commenters also 

requested that psychiatric nurses be 

permitted to facilitate education groups 

and to perform mental health 

assessments in the CMHC setting, as 

allowed by state law. 

Response: We appreciate the 

comments regarding personnel 

requirements of the psychiatric 

registered nurse. We understand that 

some CMHCs may have more difficulty 

than others hiring a psychiatric 

registered nurse, due to location, 

salaries and competition. However, we 

believe that the role of the psychiatric 

registered nurse is specialized and 

essential to the care of a CMHC client. 

Therefore the requirements will remain 

as proposed. We note that, in addition 

to the psychiatric registered nurse, the 

CMHC may hire nurses such as licensed 

practical nurses (LPNs) or licensed 

vocational nurse (LVNs), as long as they 

meet the personnel requirements at 

485.904(a). In response to commenters’ 

concerns about the proposed work 

experience requirements, we have 

modified the time to 1 year in this final 

rule, and will allow the time spent in a 

psychiatric nursing rotation during 

nursing education to count towards the 

1-year training requirement. We will 

provide further sub-regulatory guidance 

regarding the work experience 

requirements in the State operations 

manual, which will include interpretive 

guidelines for this section. 

Comment: Several commenters 

requested that CMS add definitions for 

‘‘Advanced Practice Registered Nurse,’’ 

‘‘Nurse Practitioner,’’ or ‘‘NP’’ to the 

personnel requirements. Commenters 

also requested that CMS require the 

Advanced Practice Registered Nurse to 

be educated specifically in psychiatric 

and mental health nursing with a 

minimum of a Master’s degree, to have 

experience which includes both 

didactic and clinical components, 

advanced knowledge in nursing theory, 

physical and psychosocial assessment, 

nursing interventions, and management 

of health care. They also stated that the 

NP should be practicing under a 

collaborative practice agreement with a 

board eligible psychiatrist and may 

perform services to the extent 

established by the governing bylaws, but 

not beyond the scope of license, 

certificate or other legal credentials as 

defined by the State in which he/she is 

licensed or certified. Additionally, 

commenters stated that advanced 

practice nurses—both psychiatric 

mental health nurse practitioners 

(PMHNPs) and psychiatric mental 

health clinical nurse specialists 

(PMHCNSs) need to be included in the 

mix of health care providers who are 

authorized as gatekeepers to mental 

health services. 

Response: We appreciate the 

comments regarding the utilization of 

advanced practice nurses (APNs) in a 

CMHC. We agree that non-physician 

practitioners, such as the APN, are 

essential to the care of clients served in 

a CMHC. To address the comments 

related to the use of an APN for 

assessment and as a member of the 

treatment team, we modified language 

in both § 485.914, ‘‘Admission, initial 

assessment, comprehensive assessment 

and discharge or transfer of the client’’ 

and § 485.916, ‘‘Treatment team, personcentered active treatment plan and 

coordination of services.’’ These 

changes allow for APNs to serve in these 

roles, as permitted by State licensure. 

We also added a new element at 

§ 485.904(b)(9), ‘‘Advanced practice 

nurse,’’ which covers the personnel 

requirements for both the nurse 

practitioner and the clinical nurse 

specialist. 

Comment: A few commenters 

requested that CMS include language in 

the definition of ‘‘psychiatrist’’ for the 

purpose of CMHC oversight, as set out 

at § 482.62(b)(1): ‘‘A physician is 

qualified to take the examinations for 

board certification upon successful 

completion of a psychiatric residency 

program approved by the American 

Board of Psychiatry and Neurology and/ 

or the American Osteopathic Board of 

Psychiatry and Neurology.’’ 

Commenters agreed that qualified 

physician oversight of CMHC programs 

is of paramount importance. However, 

they stated that it is important that CMS 

clarify the personnel requirements to 

include psychiatrists who are boardcertified or eligible to be board-certified. 

This clarification mirrors the CoP 

definition currently applied to inpatient 

psychiatric hospitals. 

Response: We appreciate the 

comments regarding the personnel 

requirements for a psychiatrist or 

psychiatrist eligible to be boardcertified. We believe the comment 

partially misquoted the regulation text. 

However, we agree with the commenters 

that it is of utmost importance to hire a 

board-certified psychiatrist. We also 

understand that it may not always be 

possible for a rural CMHC to employ a 

board-certified psychiatrist. In the rare 

cases that the CMHC has demonstrated 

that it is unable to employ a boardcertified psychiatrist, we would expect 

the CMHC to hire a highly qualified 

psychiatrist who has documented 

equivalent education, training or 

experience, and is fully licensed to 

practice medicine in the State in which 

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he or she practices. Therefore, in 

response to comments, we have 

modified that language by adding 

‘‘board certified or is eligible to be board 

certified’’. Additional information and 

guidance regarding this requirement 

will be available in State operations 

manual, which includes the interpretive 

guidelines. 

Comment: A few commenters 

requested that we add ‘‘activity 

therapist’’ to the personnel definitions. 

The commenters stated that an activity 

therapist is an individual who possesses 

a Bachelor’s-level education in 

behavioral science or a related field, and 

who is certified or licensed by the state 

to facilitate activity groups. 

Response: We appreciate the 

comments related to activity therapists. 

An activity therapist falls under the 

general qualifications requirement at 

§ 485.904. CMHCs that employ activity 

therapists will be expected to employ 

individuals who are legally authorized 

(licensed, certified or registered) in 

accordance with applicable Federal, 

State and local laws, and they must act 

within the scope of any State licenses, 

certifications, or registrations that apply 

to these employees. We also expect 

CMHCs to have defined personnel 

requirements for these individuals. 

Comment: Several commenters 

suggested CMS avoid the use of specific 

licensure requirements in the definition 

of ‘‘Clinical Social Worker’’(CSW) and 

instead reflect the clinician’s education 

and experience level. The commenters 

recommended that CMS consider and 

adopt the following alternative: 

‘‘CMHCs must employ a full time 

Director of Social Services who is a 

Master’s degree level clinician with a 

minimum of 2 years experience in 

providing care to the mentally ill and is 

licensed or certified to perform 

psychotherapy by the laws of the State 

in which the services are performed. 

Other clinicians may be utilized to 

provide psychotherapy provided they 

are licensed or certified to perform 

psychotherapy in the state in which the 

services are performed.’’ The 

commenters’ suggested language 

eliminates the use of licensing titles 

which are not uniform in all states and 

may potentially eliminate clinicians 

who are licensed and certified to 

provide services. Another commenter 

stated that unlike other health care 

settings, CSWs in CMHCs do not operate 

independently, but rather operate as 

part of a clinical team of personnel/staff 

rendering treatment services. They 

recommended that CMS’ definition 

require that CSWs providing care in 

CMHCs possess a Master’s degree and 

have a minimum of at least 2 years’ 

experience in providing treatments to 

clients with mental disorders or severe 

disabilities. Commenters also stated that 

CSWs working in the CMHC setting 

should be licensed or certified to 

perform psychotherapy by the laws of 

the state in which the services are 

performed. According to the 

commenters, CMS should specify that 

additional types of clinicians may 

provide psychotherapy in the CMHC 

setting, provided these professionals are 

licensed or certified to perform 

psychotherapy in the state in which the 

services are performed. 

Some commenters believe that the 

clinical social worker definition should 

be expanded to reflect the services that 

they perform. The definition 

recommended by the commenters was 

‘‘Clinical social work services include 

the assessment, diagnosis, treatment, 

and prevention of mental illness, 

emotional, and other behavioral 

disturbances.’’ 

Response: We appreciate the 

comments regarding the personnel 

requirements of the clinical social 

worker. We agree that addressing the 

education and experience level of the 

CSW may be a more appropriate means 

to ensure quality treatment and to meet 

the needs of the different types of 

clients served in a CMHC. This will 

ensure that appropriate personnel will 

work with each client to meet 

individual needs. We agree that 

eliminating the use of licensing titles, 

which are not uniform in all states and 

may potentially eliminate clinicians 

who are licensed and certified to 

provide services, is appropriate in these 

circumstances. We believe that all 

CMHCs must strive to employ qualified 

individuals to provide social work 

services to clients and their families. To 

ensure CMHCs employ a qualified 

individual as a clinical social worker, 

we are requiring that at least one of the 

CMHC clinical social worker(s) must 

meet the qualifications at § 410.73. If the 

CMHC chooses to also employ a social 

worker that does not meet § 410.73, 

then, at a minimum, the social worker 

must meet one of the following 

requirements: 

• Have a Bachelor’s degree in social 

work (BSW) from an institution 

accredited by the Council on Social 

Work Education; or a Bachelor’s degree 

in psychology or sociology, and be 

supervised by an MSW who meets the 

qualifications set out at § 410.73 of this 

chapter. 

If a CMHC chooses to employ a social 

worker with a Bachelor’s degree in 

social work, psychology or sociology, 

the services of the social worker must be 

provided under the supervision of a 

clinical social worker with an MSW or 

a doctoral degree in social work from a 

school of social work accredited by the 

Council on Social Work Education. 

Such BSW must also meet the 

qualifications set out at § 410.73 of this 

chapter. We believe that requiring MSW 

supervision of BSW services will help 

ensure that client needs are met. The 

MSW supervisor role is that of an active 

advisor, consulting with the BSW on 

assessing the needs of clients, 

developing and updating the social 

work portion of the active treatment 

plan, and delivering care to clients. The 

supervision may occur over the 

telephone, through electronic 

communication, or any combination 

thereof. 

Comment: A few commenters 

recommended that CMS add additional 

language to the definition of mental 

health counselors. Commenters also 

stated that CMS should allow for the 

mental health counselors to provide 

mental health assessments, as permitted 

by state law, in addition to the other 

service areas included in the proposed 

rule. Commenters clarified that under 

the Joint Commission’s standards, 

mental health counselors are qualified 

to perform assessments. They stated that 

since providing mental health 

assessments for state mental health 

entities is a core service area required of 

CMHCs by Federal law, it is important 

that the assessments be listed among the 

services provided by mental health 

counselors as outlined in the proposed 

rule. 

Response: We appreciate the 

comments related to mental health 

counselors. The role of the mental 

health counselor is located at 

§ 485.904(b)(5) under the personnel 

requirements. We agree the mental 

health counselors can provide mental 

health assessments, as defined by State 

law. Therefore, we modified the 

regulation text at § 485.904(b)(5), Mental 

health counselor, to include 

‘‘assessments.’’ We have also modified 

the language at § 485.914, ‘‘Admission, 

initial evaluation, comprehensive 

assessment and discharge or transfer of 

the client,’’ to allow for mental health 

counselors to provide the assessment of 

the client. Specifically, we have 

modified the language at § 485.904(b)(5) 

by broadening the requirement to allow 

for a licensed mental health professional 

(acting within his or her state scope of 

practice requirements) to complete the 

initial evaluation and the 

comprehensive assessment. 

Comment: Some commenters stated 

that the personnel requirement for 

clinical psychologists at § 485.904(b)(2) 

is vague and lacks quality assurance 

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needed to protect Medicare 

beneficiaries. Commenters requested 

that CMS consider specifying that the 

clinical psychologist must have 

graduated from a doctoral program that 

is accredited by the American 

Psychological Association or designated 

by the Association of State and 

Provincial Psychology Boards/National 

Register of Health Service Providers in 

Psychology. 

Some commenters raised concern that 

the standard contains no verification 

that the psychologists are trained in 

health service provisions and that only 

requiring a generic license to authorize 

the individual to engage in a variety of 

psychological services does not 

distinguish between individuals who 

are trained and experienced in health 

service provision and those who are 

trained in research, teaching, or 

industrial/organizational fields. 

Response: We appreciate the 

comments related to the psychologist 

personnel requirements. We agree that 

properly educated and trained health 

service psychologists will be strong 

CMHC team leaders. These standards 

will help improve client treatment, and 

hold CMHCs accountable for their care. 

We also agree that protecting the 

clients served by the CMHC is of great 

importance. The personnel 

requirements for psychologists at 

§ 485.904(b)(2) reference the clinical 

psychologist qualification requirements 

at § 410.71(d). We understand the 

importance of requiring the schools to 

be accredited. However, we do not have 

any data indicating that clinical 

psychologists graduating from nonaccredited programs reduces the level of 

quality care provided to clients served. 

Without formal evidence, modifying the 

psychologist personnel requirement in 

the CoPs would create a discrepancy 

between the conditions of participation 

and the payment policy requirements at 

§ 410.71(d). 

Comment: A few commenters 

recommended the inclusion of 

physician assistants (PAs) in the 

proposed community mental health 

center conditions of participation to 

enable CMHCs to utilize this group of 

practitioners as legally authorized in 

accordance with applicable federal, 

State and local laws. Commenters 

believe that the lack of specific 

inclusion of PAs in a standard can 

imply to surveyors that PAs are not 

authorized to deliver certain medical 

services. Other commenters stated that 

PAs in psychiatry expand access to 

mental health services. They often work 

in behavioral health facilities and 

psychiatric units of rural and public 

hospitals, where psychiatrists are in 

short supply. The commenters defined a 

physician assistant as ‘‘an individual 

who meets the qualifications and 

conditions as defined in section 

1861(s)(2)(K)(i) of the Act and provides 

services, in accordance with State law, 

at § 410.74.’’ 

Response: We appreciate the 

comments regarding PAs. We agree that 

PAs play an important role in 

behavioral health. Therefore we have 

modified the language at § 485.904(b)(8) 

to set requirements for PAs, and have redesignated the remaining elements 

accordingly. 

Comment: One commenter requested 

that CMS recognize psychiatric 

technicians. The commenter stated that 

in California, and elsewhere in the 

United States, these direct-care staff are 

used by providers. 

Other commenters requested that 

CMS add requirements for mental 

health technicians and drivers. The 

commenters also expressed concern 

regarding the level of supervision of 

these employees. Furthermore, the 

commenters stated that many CMHCs 

employ drivers who also work as 

‘‘Mental Health Techs’’. It is unclear if 

these medically unlicensed individuals 

have direct contact with clients and if 

so, what level of supervision should be 

expected. 

Response: We appreciate the 

comments and suggestions regarding 

psychiatric technicians, mental health 

technicians and drivers. Psychiatric 

technicians, mental health technicians, 

and CMHC drivers all play important 

roles in the care of clients. However, we 

do not believe that we need to add 

personnel requirements for these 

positions at this time. We expect the 

CMHCs that utilize psychiatric 

technicians, mental health technicians, 

and drivers to clearly define their roles 

and functions (utilizing accepted 

standards of practice) within the 

CMHC’s own policies, procedures and 

personnel requirements. We would also 

expect the CMHC to educate and train 

these staff members, just as they educate 

and train their other staff, related to the 

functions of the CMHC and care of the 

CMHC clients, confidentiality, safety, 

and any other areas the CMHC assesses 

as needed. For states that have licensing 

and regulatory requirements for the 

psychiatric technician, mental health 

technician, and driver we would expect 

the psychiatric technician, mental 

health technician, and driver to provide 

services in accordance with State law. 

CMHC CoP: Client Rights (§ 485.910) 

We proposed to add a new CoP at 

§ 485.910. The proposed CoP was 

divided into six standards. 

At § 485.910(a), ‘‘Standard: Notice of 

rights and responsibilities,’’ we 

proposed 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. 

We also proposed to require that the 

client be provided a written copy of 

client rights information. This 

information would have to be accessible 

to persons who have limited English 

proficiency (LEP). 

At § 485.910(a)(1), we proposed that 

the notice of rights and responsibilities, 

including information concerning how 

to file a grievance, 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). 

At § 485.910(b), ‘‘Standard: Exercise 

of rights and respect for property and 

person,’’ we proposed that a client 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, at § 485.910(b)(2), we 

proposed procedures if the client has 

been adjudged incompetent under State 

law. At (b)(3), the proposed rule 

addressed the appointment of a legal 

representative. We also proposed at 

§ 485.910, ‘‘Standard: Rights of the 

client,’’ that 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. 

At § 485.910(d), ‘‘Standard: 

Addressing violations of client rights,’’ 

we proposed that CMHC personnel be 

required to report all complaints of 

alleged violations of clients’ rights to the 

CMHC administrator. We also proposed 

that the CMHC 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 proposed 

that the CMHC report the violations to 

appropriate authorities having 

jurisdiction within 5 working days of 

the CMHC becoming aware of the 

verified violations of client rights. 

We proposed the client rights CoP to 

act as a safeguard of client health and 

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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. We also proposed to require all 

CMHCs to comply with Federal rules 

concerning the privacy of individually 

identifiable health information set out at 

45 CFR parts 160 and 164. 

At § 485.910(e), ‘‘Standard: Restraint 

and seclusion,’’ we addressed the use of 

restraints and seclusion in a CMHC. We 

proposed that all clients 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 

want to 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 for 

evaluation and treatment when 

exhibiting behavior that threatens 

immediate harm to the client or others. 

In response to accidental injuries and 

deaths, we published 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. 

The proposed restraint and seclusion 

standard was divided into five elements. 

These elements focused on the proper 

use of seclusion and restraints and the 

need for CMHC personnel to receive 

training and education on the proper 

use of seclusion and restraint 

application and techniques, as well as 

the use of alternative methods for 

handling situations that arise. The 

standard proposed specific 

requirements for physician orders for 

seclusion or restraint, along with a 

corresponding order for the client’s 

immediate transfer to a hospital when 

restraint or seclusion is ordered. The 

standard also included a requirement 

that there must be specific 

documentation in the client’s clinical 

record regarding the use of restraints. 

At § 485.910(f), ‘‘Standard: Restraint 

or seclusion: Staff training 

requirements,’’ we address the training 

of the CMHC staff. The training consists 

of specific intervals, content and trainer 

requirements. § 485.910(g), ‘‘Standard: 

Death reporting requirements’’ states 

that a CMHC would have to report to its 

CMS regional office no later than close 

of business the next business day, any 

death that occurs while a client is 

restrained or in seclusion while 

awaiting transfer to the hospital. 

Comment: A few commenters stated 

that all CMHCs should establish written 

policies and procedures regarding 

clients’ rights. 

Response: We appreciate the feedback 

on establishing policies and procedures 

for clients’ rights. We believe it is 

already current standard of practice and 

the responsibility of each CMHC to 

establish written policies and 

procedures regarding clients’ rights and 

the rights of the client’s representative 

(if appropriate) or surrogate. We have 

provided requirements for clients’ rights 

that facilitate the development of these 

policies and procedures. We are 

clarifying that the client’s representative 

or surrogate must be able to exercise the 

rights of the client if the client is unable 

to represent himself or herself. 

Comment: Commenters stated that the 

CMHC should be required to attempt to 

communicate with the client, and 

should be required to accommodate the 

client’s communication needs, before 

opting to rely on a representative or 

surrogate. 

Additionally, commenters also stated 

that there should also be additional 

emphasis on the provision of sign 

language interpretation for individuals 

who are deaf, and alternative written 

formats such as Braille and large print 

for individuals who are visually 

impaired. 

Response: We agree that all CMHCs 

should attempt to communicate with 

the client first, and accommodate the 

client’s communication needs. CMHCs 

must take appropriate steps to ensure 

effective communication with their 

clients and provide auxiliary aids and 

services to accommodate the client’s 

communication needs. There are 

specific civil rights statutes that address 

the obligation of covered entities to 

provide appropriate auxiliary aids and 

services, such as Braille and large print 

to individuals with disabilities. 

Section 504 of the Rehabilitation Act 

of 1973 prohibits discrimination on the 

basis of disability in programs or 

activities that receive Federal financial 

assistance. Therefore, as recipients of 

Federal financial assistance (that is, 

loans, grants, or Medicare or Medicaid 

reimbursements), CMHCs must comply 

with the nondiscrimination 

requirements. Furthermore, there are 

also several sections of the Americans 

with Disabilities Act (ADA) that require 

facilities, such as CMHC providers, to 

provide appropriate accommodations 

for their clients. Since section 504 and 

the ADA provisions are applicable to 

CMHCs, we are not addressing the 

specifics of these requirements in the 

CoPs. 

Comment: One commenter suggested 

that CMS should require a CMHC with 

a clientele that is more than 25 percent 

non-English speaking to provide written 

translations of clients’ rights 

information in the relevant language(s). 

Response: We appreciate the feedback 

that if the CMHC clientele is over 25 

percent non-English speaking, the 

CMHC must provide written 

translations of clients’ rights 

information in the relevant languages. 

We recognize that this is an area of 

concern for CMHCs, as it may be 

challenging for CMHCs to communicate 

with clients who speak languages other 

than English. The HHS guidance on 

Title VI (August 8, 2003, 68 FR 47311) 

applies to those entities that receive 

Federal financial assistance from HHS, 

including CMHCs. CMHCs are already 

expected to comply with the HHS 

guidance, which requires the CMHC to 

take reasonable steps to provide 

meaningful access to its programs or 

activities. CMHCs should take 

reasonable steps to provide meaningful 

access to persons with LEP. This may 

involve securing a qualified interpreter 

for CMHC-client communications, 

including those involving the notice of 

clients’ rights. Providing meaningful 

access may also involve the CMHC 

translating written copies of the notice 

of rights available in the language(s) that 

are commonly spoken in the CMHC 

service area. As explained in the HHS 

LEP guidance at http://www.gpo.gov/

fdsys/pkg/FR-2003-08-08/pdf/03- 

20179.pdf (section VI B), use of an oral 

interpreter presents a set of complex 

issues. For example, use of family 

members or friends as interpreters may 

be actively sought by some patients but 

may present a danger to the patient in 

other cases. What is required of CMHCs 

in particular communities will depend 

on what HHS terms a ‘‘four factor 

analysis,’’ taking into account 

availability of interpreters, how many 

languages are commonly or rarely 

encountered among CMHC clients, and 

other situational factors. For additional 

information related to LEP, the 

Department of Health and Human 

Services recently released a new 

document highlighting the departments 

commitment to LEP, which is located at 

the following Web site: http://

www.hhs.gov/open/execorders/13166/

index.html. 

Comment: Some commenters stated 

that a 5-day timeframe for violation 

reporting is too long. Other commenters 

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stated that the reliance on internal 

procedures and self-regulation may 

cause CMHCs to determine that most 

violations do not require any type of 

corrective action or reporting because of 

the fear of repercussions from State 

regulatory agencies or CMS. 

Response: We understand that the 5 

working days timeframe may seem too 

long. However, the CMHC may require 

a shorter timeframe through its policies 

and procedures. The CMHC is required 

to immediately report an incident to the 

administrator, who must immediately 

investigate all alleged violations. The 

CMHC must take action to prevent 

further potential violations while the 

alleged violation is being verified. This 

process begins as soon as the alleged 

violation is discovered and will likely 

be resolved sooner than 5 days. 

Additionally, because CMHCs are not 

residential facilities, it is unlikely that 

the involved client will be in the facility 

during the entire 5-day period. 

We also understand the commenters’ 

concern with the CMHC internal 

investigation procedures. We believe 

requiring CMHCs to investigate 

potential violations of client rights by 

CMHC staff (including contracted or 

arranged services) may represent a 

conflict of interest, or insufficient to 

protect clients and their families. 

For this reason, we are amending the 

requirement at § 485.910(d)(4) to require 

that all violations be reported to State 

survey and certification agencies, and 

verified by the appropriate investigator, 

violations also be reported to State and 

local entities having jurisdiction. While 

we understand the commenters’ concern 

with the CMHC internal investigation 

procedures, we believe requiring 

CMHCs to investigate potential 

violations of client rights by CMHC staff 

(including contracted or arranged 

services) will protect clients and their 

families. Reporting violations, when 

verified in accordance with CMHC 

policies and procedures and any 

applicable State and local laws and 

regulations related to client health and 

safety, is an integral part of improving 

the quality of CMHC care provided to 

Medicare beneficiaries. Ultimately the 

CMHC must follow Federal and State 

laws related to client health and safety, 

as well as follow its own internal 

policies and procedures. We expect 

significant violations, such as illegal 

actions by CMHC staff, to be reported to 

State and local authorities. We believe 

that the framework in this regulation, 

coupled with a CMHC’s own policies 

and procedures and State and local 

requirements related to client health 

and safety, will allow CMHCs to adapt 

the requirements to the particular needs 

and concerns of their client populations 

now and in the future. 

If State requirements for reporting 

violations are stricter than our Federal 

requirements, the stricter State 

requirements would take precedence. 

Stricter State requirements may be those 

that require violations to be reported 

regardless of whether they are verified, 

or requirements that verified violations 

be reported in less than five days. 

However, if State requirements are less 

stringent than Federal requirements, 

then the Federal requirements will take 

precedence. 

Comment: One commenter stated that 

there should be a limit to the number of 

clients attending a group session. 

Specifically, the commenter requested 

that CMS add an additional requirement 

at § 485.910(c), ‘‘Standard: Rights of the 

client,’’ limiting a PHP group maximum 

size to 12–15 clients. The commenter 

stated that this would help to ensure all 

clients receive full benefit from PHP 

sessions. 

Response: We appreciate the 

commenter’s concern regarding the 

number of clients attending a group 

session. We believe that the CMHC 

would need to determine, through its 

policies, procedures, and guidelines 

related to group therapy sessions, what 

is appropriate for each client. There are 

many different acuity levels and needs 

for CMHC clients which may require 

larger or smaller group sizes. All the 

participants within a given group 

should have the same acuity level and 

group session treatment goal. A group’s 

size should be based on the needs and 

abilities of its participants. A group 

should not be too small to prevent the 

benefit of learning and sharing from 

other participants that occurs in a 

‘‘group,’’ nor too large as to prevent all 

members from the benefit of actively 

participating. We expect the CMHC and 

the client’s therapist or team will 

exhibit sound clinical judgment and 

clinical practice when assigning a client 

to a particular group or group 

psychotherapy and when developing 

the actual group. Therefore, we will 

leave it up to the clinical expertise and 

sound professional judgment of the 

CMHC trained staff to determine what 

works best for each client. For each 

client there is a periodic reassessment 

and review of the client’s progress. This 

review will allow adjustments for such 

treatments, including the size of the 

group to which the client belongs or the 

need for individualized therapy. 

Comment: Several commenters stated 

that restraint and seclusion are not used 

in CMHCs. Therefore, they believe 

training of staff should focus on deescalation techniques. Commenters 

stated that following established 

procedures for involuntary 

hospitalization should minimize or 

completely eliminate the need to use 

restraint and/or seclusion. Likewise, 

other commenters stated that State law 

prohibits CMHCs from using seclusion 

and restraint in any program. As a 

result, CMHCs no longer train staff on 

these prohibited practices. Instead, 

CMHCs train staff in de-escalation 

techniques and crisis management. 

Furthermore, some commenters stated 

that there is no evidence that CMHCs’ 

use of seclusion or restraint is a 

concern, and the training and reporting 

requirements would create 

administrative and financial burdens. 

Response: We appreciate the feedback 

from the commenters on restraint and 

seclusion. We agree that if State law is 

more stringent than Federal law, State 

law takes precedence. That is, if the use 

of seclusion and restraint is prohibited 

by the State, then the CMHC is not 

allowed to use seclusion and restraint 

techniques in the process of providing 

services to CMHC clients. The 

requirements at § 485.910(f)(1) and (f)(2) 

state that training of CMHC staff focuses 

on techniques to identify staff and client 

behaviors, events and environmental 

factors that may trigger circumstances 

that require the use of restraint or 

seclusion, as well as the use of 

nonphysical intervention skills. We 

believe that training CMHC staff to 

identify potential triggers and to use 

positive behavioral intervention 

supports and nonphysical intervention 

skills, also known as de-escalation 

techniques, is compatible with State law 

even in states that expressly prohibit the 

use of seclusion and restraint 

techniques. While the concepts are 

related, identifying triggers and using 

nonphysical interventions are not the 

same as using seclusion and restraint 

techniques. Therefore, all CMHCs, even 

those located in states that prohibit the 

use of seclusion and restraint 

techniques, are required to train their 

staff in the use of nonphysical 

interventions in order to assure the 

safety of all clients and staff. Training 

on nonphysical interventions could be 

incorporated into the CMHC staff inservice training requirements at 

§ 485.918(d)(3). This type of training 

meets the requirements of the 

regulation. 

We emphasize that in states where the 

use of seclusion and restraint 

techniques are permitted, they may only 

be used to protect the client or others 

from immediate harm, and their use 

would trigger immediate transportation 

to a hospital. In the rare occurrence that 

a restraint and seclusion order is 

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needed, the duration of the order is for 

1 hour. If there is a delay in the arrival 

of client transport extending past the 1 

hour order duration, a second order 

would need to be obtained. We believe 

that if this delay occurs, it is in the best 

interest of the health and safety of the 

client that a re-assessment of the client’s 

condition be made to determine if 

restraints remain necessary, before the 

second order is obtained. 

Comment: A few commenters stated 

that restraint and seclusion death 

reporting should be expanded to 

include the reporting of deaths that 

occur as the result of abuse or neglect. 

Other commenters requested an 

additional requirement, such as 

reporting the incident to the relevant 

protection and advocacy agency. One 

commenter recommended that CMS be 

very specific in defining what it means 

by ‘‘attributed to.’’ Commenters 

recommended that reporting should be 

required only when restraint and 

seclusion was determined to be a direct 

cause of death. Additionally, 

commenters stated that CMS should 

investigate the death as part of the 

complaint survey investigation process. 

Response: We agree with the 

commenters on reporting deaths that 

occur as a result of abuse or neglect. We 

expect that a health care provider or 

agency that believes a CMHC client is 

the subject of abuse or neglect will 

report the concern to the proper State 

authorities. This requirement falls under 

§ 485.910(d)(1), to ensure that all alleged 

violations involving abuse or neglect are 

reported immediately to the CMHC 

administrator. An investigation should 

immediately occur and procedures 

should be put in place to prevent further 

potential violations while the alleged 

violation is investigated. The CMHC is 

then required to take appropriate 

corrective action in accordance with 

State law (which may include 

contacting appropriate advocacy 

agencies), if the alleged violation is 

verified by the CMHC administration or 

verified by an outside entity having 

jurisdiction. 

Should a seclusion or restraint-related 

death occur, our intent is to ensure that 

the CMHC immediately notify CMS and 

begin to fully investigate the death. 

Waiting to determine if the death was 

directly caused by the use of restraint or 

seclusion could potentially have 

negative impact on other clients being 

served by the CMHC. We acknowledge 

that seclusion and restraint are rarely, if 

ever, used and that the likelihood of 

death ever having to be reported is 

extremely low. However, it is 

imperative that the CMHC report any 

instance where a death of a client is 

associated with the use of seclusion or 

restraint. Should a seclusion or 

restraint-related death occur, we would 

initiate an onsite complaint survey of 

the CMHC in accordance with the 

existing complaint investigation 

process. 

CMHC CoP: Admission, Initial 

Evaluation, Comprehensive Assessment 

and Discharge or Transfer of the Client 

(§ 485.914) 

We proposed to add a new CoP at 

§ 485.914 to establish requirements for 

admission, initial evaluation, 

comprehensive assessment, and 

discharge or transfer of the client. The 

proposed CoP at § 485.914 identified 

general areas that would be included in 

a client assessment and the timeframes 

for completing the assessments to help 

the CMHC ensure it was identifying the 

needs in all areas in a timely fashion. 

The proposed CoP was divided into five 

standards. 

At § 485.914(a), ‘‘Standard: 

Admission,’’ we proposed to require the 

CMHC to determine whether a client is 

appropriate for the services the CMHC 

provides. At § 485.914(b), ‘‘Standard: 

Initial evaluation,’’ we proposed to 

require the CMHC psychiatric registered 

nurse or clinical psychologist to 

complete the initial evaluation. We 

stated that 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. We also specified 

that the initial assessment would be 

completed within 24 hours of the client 

admission to the CMHC. 

At § 485.914(c), ‘‘Standard: 

Comprehensive assessment,’’ we 

proposed that a physician-led 

interdisciplinary team, in consultation 

with the client’s primary health care 

provider (if any), complete the 

comprehensive assessment. We stated 

that the comprehensive assessment 

would build from the initial evaluation 

and identify the client’s physical, 

psychological, psychosocial, emotional 

and therapeutic needs. The 

interdisciplinary team would be 

composed of a doctor of medicine, 

osteopathy or psychiatry; a psychiatric 

registered nurse, a clinical psychologist, 

a clinical social worker, an occupational 

therapist, and other licensed mental 

health counselors, as necessary. Each 

member of the team would provide 

input within the scope of that 

individual’s practice. As proposed, the 

comprehensive assessment would 

include information about the client’s 

psychiatric illness and history, 

complications and risk factors, drug 

profile review, and the need for referrals 

and further evaluations by appropriate 

health care professionals. The 

comprehensive assessment would be 

completed within 3 working days after 

the admission to the CMHC. 

At § 485.914(d), ‘‘Standard: Update of 

the comprehensive assessment,’’ we 

proposed that the CMHC would 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 

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. 

At § 485.914(e), ‘‘Standard: Discharge 

or transfer of the client,’’ we proposed 

that the CMHC 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 

this standard we proposed that 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 was smooth, 

and that the appropriate care continued 

without being compromised (where 

applicable). 

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Comment: Several commenters stated 

that under Medicaid and State law, 

CMHCs are allowed a wide range of staff 

to provide initial evaluations, from 

unlicensed, Master’s level practitioners 

(under supervision of a licensed 

professional) to licensed Master’s level 

clinicians, including social workers and 

counselors. Commenters also stated that 

State laws allow for licensed clinical 

social workers (LCSWs) or other mental 

health counselors to conduct initial 

evaluations. Other commenters stated 

that use of a psychiatric RN or clinical 

psychologist to conduct the initial 

evaluation should only apply to PHP 

programs. 

Response: We appreciate the 

comments regarding the appropriate 

staff to conduct an initial evaluation. 

We understand currently that there may 

be several different staff the CMHC uses 

to conduct an initial evaluation, and 

that the types of staff used may vary 

from State to State. While it may be 

appropriate for a psychiatric RN or 

psychologist to conduct an initial 

evaluation on a client, we understand 

that this may not be appropriate for all 

clients and is not necessarily a standard 

of practice in the CMHC setting. We 

would expect the CMHC to assign the 

most appropriate mental health 

professionals to conduct the initial 

evaluation. Therefore, the CMHC may 

add additional requirements under their 

policy and procedures to require the 

initial evaluation on all PHP clients to 

be conducted by a psychiatric RN, 

acting within his or her State’s scope of 

practice, or by a clinical psychologist, 

who meets the qualifications in 

§ 410.71(d), acting within his or her 

State’s scope of practice. We have 

removed the requirement that a 

psychiatric RN or clinical psychologist 

conduct the initial evaluation. 

We also understand that there may be 

unlicensed staff (completing their 

education or licensure requirements) 

conducting initial evaluations under the 

supervision of a licensed professional. 

We believe that the initial evaluation is 

paramount in meeting the immediate 

needs of the client and beginning the 

active treatment plan. Therefore, we 

have amended the language at 

§ 485.914(b)(1) to allow a licensed 

mental health professional acting within 

his or her State scope of practice to 

conduct the initial evaluation. We will 

allow staff working towards completing 

their education or licensure 

requirements to complete the initial 

evaluation under the direct supervision 

of a licensed mental health professional 

(as required by all State law and 

regulations related to the supervision of 

unlicensed professionals and students) 

employed by the CMHC. 

Comment: One commenter stated the 

CMHC should be required to notify a 

client’s primary care provider, if any, in 

lieu of a formal consultation. The 

commenter stated that such notification 

would be contingent upon a client’s 

understanding and consent. 

Response: This comment was 

somewhat unclear. We believe it is 

referring to communication between the 

CMHC and the client’s primary care 

provider during the comprehensive 

assessment. We agree with the 

commenter that the CMHC should 

obtain consent from the client when 

sharing information between the CMHC 

and the PCP. Therefore, we have 

amended the language at 

§ 485.914(c)(4)(ii) regarding the CMHC 

receiving the client’s consent before 

client information is obtained or shared 

with the client’s primary care provider. 

Comment: Commenters asked to add 

additional assessment criteria such as 

environmental factors. Commenters 

stated that strengths and barriers related 

to a client’s home, work, or social 

environments can play a critical role in 

the success or failure of key 

interventions. 

Response: We agree that it is 

important to assess environmental 

factors related to the home and work 

environments in the overall 

development and coordination of the 

active treatment plan. Furthermore, we 

believe the assessment and coordination 

of information related to environmental 

factors such as housing and 

employment services, as well as the 

client’s preferences and personal goals, 

are essential in developing a recovery 

focused active treatment plan and to 

meeting the client’s recovery goals. 

Therefore we amended the assessment 

language at § 485.14(b)(4)(v) to include 

environmental factors and at 

§ 485.16(e)(5) to include coordination of 

services with other healthcare and nonmedical providers. 

We would like to stress the 

importance of client privacy and 

confidentiality and remind CMHCs that 

HIPAA applies to release of protected 

health information by CMHCs; it is 

generally prohibited to release client 

information to non-health care entities 

without the express consent of the 

client. If CMHCs do release such 

information to state or local agencies, 

they must generally obtain consent from 

the client before such release. 

Comment: Some commenters believe 

that the medication review should be 

limited to requiring that the partial 

hospitalization program maintain only a 

current list of the individual’s 

medications, prescriptions and over-thecounter medications, as well as contact 

information for the treating practitioner 

of the individual served. 

Response: We appreciate the 

comments on medication review. We 

believe that listing the current 

medications (both prescription and 

over-the-counter) is extremely important 

for all clients during the initial 

evaluation. The information 

documented will be reviewed during 

the comprehensive assessment and may 

impact the development of the active 

treatment plan. Therefore, we believe 

that the documentation of current 

medications is essential to the start of 

care for the CMHC clients. 

Comment: Commenters stated that a 

psychiatrist should be required to 

address medication management. 

Response: We appreciate the 

comments regarding a psychiatrist 

addressing medication management. 

The initial evaluation requires 

documentation of both prescription and 

over-the-counter medications. The 

comprehensive assessment requires a 

drug profile that includes a review of all 

of the client’s prescription and over-thecounter medications; herbal remedies; 

and other alternative treatments or 

substances that could affect drug 

therapy. We expect the drug profile 

section of the comprehensive 

assessment to be completed by a CMHC 

licensed mental health professional 

(such as the psychiatrist, MD or nurse 

practitioner) with the appropriate 

knowledge, skills, and certification or 

licensure, and acting within his or her 

State’s scope of practice, to assess drug 

therapy. 

Comment: Commenters stated that a 

CMHC should be assessing the social 

service needs of pediatric clients. They 

also stated that, when appropriate, a 

referral should be made to social 

services, child welfare, and/or the 

juvenile justice system for pediatric 

clients. 

Response: We agree that assessing for 

the social service needs of pediatric 

clients is very important. We expect that 

the assessment of a pediatric client 

would include social service and child 

welfare questions. We also expect that a 

referral be made to social services and/ 

or child welfare services, if appropriate. 

Therefore, we have added language at 

§ 485.914(c)(4)(xiv) to address the 

pediatric assessment. 

Comment: Some commenters stated 

that additional assessment criteria 

should be added to the comprehensive 

assessment. Commenters stated that 

CMHCs should assess for client 

strengths and goals, as well as a history 

of trauma. 

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Response: We agree that it is 

important to assess the client for 

strengths, goals and a history of trauma. 

We believe that a history of trauma is 

already incorporated into the regulation 

language at § 485.914(c)(4)(ii) and (iii). 

These sections outline the assessment 

expectation of the psychiatric 

evaluation, which would review 

medical history and severity of 

symptoms, as well as assessment 

information concerning previous and 

current medical status, including but 

not limited to, previous therapeutic 

interventions and hospitalizations. 

Section § 485.915(c)(4)(viii) addresses 

clients’ goals and requires the client to 

be assessed for functional status, 

including the client’s ability to 

understand and participate in his or her 

own care, and the client’s strengths and 

goals. 

Comment: Some commenters stated 

that CMS should change the 

comprehensive assessment timeframe 

from 3 working days to 7 program days. 

Other commenters stated the assessment 

time-frames should be extended from 3 

working days to 5 working days. 

Response: We appreciate the 

comments related to the assessment 

timeframe. However, we are unclear on 

what the commenters meant by 

‘‘program days’’. The commenters did 

not clarify or give examples regarding 

the term ‘‘program days’’. We use the 

term ‘‘working days’’, which allows the 

CMHC to not count the days that the 

CMHC is closed. Other commenters 

asked that we extend the time-frame for 

completion of the assessment. We 

understand that the clients a CMHC may 

see vary greatly in their treatment needs 

and that assessing a complex client may 

take longer than 3 working days. 

However, we believe that all clients 

should be assessed in a timely manner 

regardless of their diagnosis. Therefore, 

we have amended the timeframe for the 

assessment at § 485.914(c)(2) from 3 

working days to 4 working days, with 

day 1 starting the day after admission. 

For example, if a client is admitted on 

a Friday, the CMHC would need to have 

the comprehensive assessment 

completed within 4 working days, 

which would be by Thursday. 

Comment: A few commenters 

requested that we extend the 

permissible timeframe for a CMHC to 

prepare and forward a discharge 

summary to a receiving facility or 

provider, if any, to 30 days from the 

date of discharge. The commenters 

stated that the proposed 48-hour 

requirement is inconsistent with the 

existing requirement for inpatient 

psychiatric providers and unnecessarily 

places an administrative burden upon 

CMHCs. 

Response: We appreciate the 

comments related to forwarding the 

discharge summary. We acknowledge 

that there is a 30-day discharge 

paperwork requirement for discharge 

from an inpatient psychiatric facility. 

However, the inpatient discharge 

expectation is that the client summary 

information is sent at the time of 

discharge to the receiving entity. Best 

practices would suggest that at 

discharge there would be no break in 

service and that the receiving entity 

receive the appropriate information to 

continue to meet the needs of the client. 

However, we understand that a CMHC 

is open during regular business hours 

and requiring a 48-hour timeframe may 

be unreasonable. Therefore, we 

modified the language at § 485.914(e)(1) 

to require the CMHC to forward the 

discharge summary to the receiving 

entity or practitioner within 2 working 

days after the discharge. For example, if 

a client discharges from the CMHC on 

Friday the discharge summary should 

be sent to the receiving provider by 

close of business on Tuesday. 

Comment: A few commenters asked 

who should be responsible for ensuring 

the discharge plan is complete. 

Response: The discharge process is 

part of the client’s active treatment plan 

and should be discussed and 

incorporated in the plan from the initial 

evaluation. The interdisciplinary team 

is responsible for the care and services 

for each client. Moreover, 

§ 485.916(a)(2) requires the CMHC to 

determine the appropriate licensed 

mental health professional, who is a 

member of the client’s interdisciplinary 

treatment 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. Best practices would suggest 

that this coordinator would also manage 

the discharge process of the client. 

However, the CMHC has the flexibility 

to have any licensed professional who 

serves on the client’s interdisciplinary 

treatment team coordinate the discharge 

plan. 

Comment: One commenter asked that 

we eliminate the requirements regarding 

discharge for non-compliance. 

Response: While we understand the 

commenter’s concern regarding 

discharge for non-compliance, and 

believe that this rarely happens, we 

believe the CMHC wants to serve its 

clients to the best of its ability. 

Unfortunately, when a client is noncompliant with his or her active 

treatment plan, it may be in the best 

interest for both the client and the 

CMHC to discharge the client to a care 

level that meets the client’s needs. If 

non-compliance became an issue for a 

client, the client’s interdisciplinary 

team would need to document that it 

addressed the issue and tried repeatedly 

to work with the client and family, and 

that discharge was the last option. The 

CMHC must ensure that the client’s 

discharge information is forwarded to 

the appropriate practitioner as required 

in § 485.914(e). 

CMHC CoP: Treatment Team, PersonCentered Active Treatment Plan, and 

Coordination of Services (§ 485.916) 

We proposed to add a new CoP at 

§ 485.916 to establish requirements for 

an active treatment plan and 

coordination of services. 

At § 485.916(a), ‘‘Standard: Delivery 

of services,’’ we proposed that the 

CMHC designate a physician-led 

interdisciplinary team for each client. 

We proposed that the interdisciplinary 

team include a psychiatric registered 

nurse, clinical psychologist, or a 

Master’s level prepared or Doctoral level 

prepared social worker, 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 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 one treatment team 

responsible for establishing policies and 

procedures governing the day-to-day 

operations of the CMHC, and the care 

and services provided to clients. 

At § 485.916(b), ‘‘Standard: Active 

treatment plan,’’ we proposed to require 

that all CMHC services furnished to 

clients follow a written active treatment 

plan established 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 within 3 working days after the 

client’s admission to the CMHC. The 

CMHC would have to ensure that each 

client and, if relevant, primary 

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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. 

At § 485.916(c), ‘‘Standard: Content of 

the active treatment plan,’’ we proposed 

to require that each client’s active 

treatment plan reflects 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. 

We would also require a detailed 

statement of the type, duration and 

frequency of services, including social 

work, counseling, psychiatric nursing 

and therapy services. Services furnished 

by other staff trained to work with 

psychiatric clients necessary to meet the 

specific client’s needs should also be 

documented. The interdisciplinary 

treatment team should document 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. 

At § 485.916(d), ‘‘Standard: Review of 

the active treatment plan,’’ we proposed 

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. 

At § 485.916(e) ‘‘Standard: 

Coordination of services,’’ we proposed 

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 and procedures. This 

proposed standard would also make it 

easier for the CMHC to ensure that the 

care and services are provided in 

accordance with the active treatment 

plan, and that all care and services 

provided are based on the 

comprehensive and updated 

assessments of the client’s needs. An 

effective communication system also 

enables the CMHC to ensure the ongoing 

sharing of information among all 

disciplines providing care and services, 

whether the care and services are being 

provided by employees or by 

individuals under contract with the 

CMHC. 

Comment: Several commenters stated 

that the family and/or significant other 

should be included in the active 

treatment planning process. 

Response: We appreciate the 

suggestion to add family and/or 

significant other involvement in the 

active treatment plan. We agree with the 

commenters, but prefer to use the term 

‘‘primary caregiver’’ instead of family 

and/or significant other. The term 

‘‘primary caregiver’’ is a broader term 

that encompasses family and significant 

others but also represents caregivers 

such as friends or significant others. 

Therefore, we have amended the 

language at § 485.916(b), ‘‘Standard: 

Active treatment plan’’ to add ‘‘primary 

caregiver.’’ 

Comment: Many commenters believe 

that the proposed CoPs were overreaching in requiring an 

interdisciplinary team (IDT) which 

‘‘would include’’ many disciplines. 

Commenters stated that CMS should 

replace ‘‘would include’’ with ‘‘may 

include’’ in order to allow for the 

individualization of the treatment 

planning for each client. Other 

commenters disagreed with CMS 

regarding the staff requirements for the 

IDT being standard medical practice. 

Response: We agree with the 

comments related to the members of the 

IDT. We understand that CMHC clients 

vary from clients receiving PHP to 

clients receiving short term counseling 

or medication management. We believe 

there may be clients who, based on their 

diagnosis and assessment, may only 

need a one-person IDT to meet their care 

needs. For example, a client who is 

being treated for medication 

management may be required to be seen 

by a practitioner a couple of times a 

year. Therefore, the proposed ‘‘one size 

fits all’’ approach to the IDT 

membership may not serve the client’s 

interests and potentially takes away 

from the CMHC’s flexibility to serve the 

client’s needs, and the needs of other 

clients. Therefore, we have amended the 

language at § 985.916(a)(2) to allow the 

CMHC to determine (based on the 

findings of the client’s comprehensive 

assessment), the appropriate licensed 

mental health professionals and other 

CMHC staff to serve on the client’s 

interdisciplinary team. The amended 

language now states that the 

interdisciplinary team may include: A 

doctor of medicine, osteopathy or 

psychiatry (who is an employee of or 

under contract with the CMHC), a 

psychiatric registered nurse, a clinical 

social worker, a clinical psychologist, an 

occupational therapist, other licensed 

mental health professionals, and other 

CMHC staff, as necessary. We note that 

the interdisciplinary team membership 

must be based on the client’s assessed 

needs. CMHCs will be expected to 

demonstrate a correlation between the 

client’s comprehensive assessment, 

assessed needs, members serving on the 

interdisciplinary team, and the active 

treatment plan. Therefore a PHP client’s 

interdisciplinary team members are 

likely to be different than the client who 

is being treated by the CMHC for shortterm counseling or medication 

management. 

Comment: A few commenters stated 

that CMHCs often do not have the 

resources to engage a physician in 

leading team care, treatment, and 

services planning. According to 

commenters, there is no recognized data 

to demonstrate improved outcomes in 

PHPs by having a physician leading the 

care team. Other commenters stated that 

the concept of a collaborative healthcare 

team should not be restricted to a 

‘‘physician-led interdisciplinary team’’ 

as it may be more achievable if viewed 

as an interdisciplinary team that 

includes a physician. The commenters 

also believe that a physician-led 

interdisciplinary team limits the 

capacity of advanced practice registered 

nurses, nurse practitioners and clinical 

psychologists, who are qualified and 

licensed to lead interdisciplinary teams. 

Response: We appreciate the 

comments regarding the physician 

leading the interdisciplinary team. We 

proposed this standard to ensure 

physician involvement in the 

interdisciplinary team process. 

However, we agree that there is no 

documented research that demonstrates 

improved outcomes in PHPs by having 

a physician leading the team, and such 

a requirement may limit collaboration 

and the role of the other qualified 

practitioners. Therefore, based on the 

client’s needs, in addition to a 

physician, we have amended the 

language at § 485.916(a)(1), to now 

allow for a nurse practitioner, a clinical 

nurse specialist, a clinical psychologist, 

a physician assistant, or clinical social 

worker to serve as the leader of the 

team, if permitted by State law and 

within his or her scope of practice. This 

allows the CMHC greater flexibility to 

meet the client’s needs. We stress that 

while this change allows additional 

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advanced practice practitioners to lead 

the team, it in no way minimizes the 

physician’s involvement in managing 

the medical component of the client’s 

care and/or serving on the 

interdisciplinary group. 

In the instance of partial 

hospitalization, clients need acute 

services and must be under the care of 

a physician. According to the statutory 

requirements, which are implemented 

in CMS regulations at 42 CFR 424.24(e), 

PHP services must be prescribed by a 

physician and under the supervision of 

a physician pursuant to an 

individualized, written plan of 

treatment established and periodically 

reviewed by a physician (in 

consultation with appropriate staff 

participating in such program). 

Furthermore, upon admission, a 

physician must certify that in absence of 

PHP services, the person would 

otherwise require inpatient psychiatric 

treatment. If continued PHP treatment is 

necessary, a physician must recertify as 

of the 18th day of treatment and no less 

than every 30 days after that 

documenting the need for this level of 

service. Therefore, a physician is 

inextricably involved in a PHP client’s 

treatment team. 

Comment: Several commenters stated 

that advanced practice nurses, including 

both psychiatric mental health nurse 

practitioners (PMHNPs) and psychiatric 

mental health clinical nurse specialists 

(PMHCNSs), need to be included in the 

list of professionals who can lead 

multidisciplinary teams. Other 

commenters stated that occupational 

therapists, social workers and other 

licensed mental health counselors 

should be added to the list of 

professionals who can serve as 

coordinators. 

Response: We appreciate the 

comments regarding leading the 

interdisciplinary team. There are two 

different requirements in the proposed 

CoPs where we discuss leadership of the 

interdisciplinary team. In 

§ 485.916(a)(1), we proposed that the 

interdisciplinary team be led by a 

physician. We proposed this standard to 

ensure physician involvement in the 

interdisciplinary team process. 

However, we agree that allowing a nurse 

practitioner, a clinical nurse specialist, 

a physician assistant, or a psychologist 

would allow the CMHC greater 

flexibility to meet the client’s needs. 

While we allow for additional advanced 

practice practitioners to lead the team, 

that in no way minimizes the physician 

involvement in managing the medical 

component of the client’s care. 

At § 485.916(a)(2), we proposed a 

psychiatric registered nurse, a clinical 

psychologist, or a 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 

were assessed and to ensure the active 

treatment plan was implemented as 

indicated. We understand that there 

may be other licensed mental health 

professionals serving on the 

interdisciplinary team that could be 

appropriate to coordinate the client’s 

care. Therefore, we have amended the 

language at § 485.916(a)(2) to allow the 

CMHC to determine (based on the 

findings of the client’s comprehensive 

assessment) which appropriate licensed 

mental health professional(s) on the 

client’s interdisciplinary team should 

coordinate care and treatment decisions 

with each client. This coordinator role 

would work to ensure that each client’s 

needs are assessed and to ensure that 

the active treatment plan is 

implemented as indicated. 

Comment: A few commenters stated 

that social workers and occupational 

therapists are not needed for every 

client, but should be available. 

Response: Services offered to a client 

should be based on the client’s assessed 

needs. If a client is assessed to need the 

services of a social worker and/or an 

occupational therapist, we would expect 

those disciplines to be part of the 

interdisciplinary team. We note that the 

needs of CMHC clients vary from clients 

receiving PHP to clients receiving short 

term counseling. Therefore, the 

proposed approach to the 

interdisciplinary team membership may 

not serve the client’s interests and 

potentially takes away from the CMHC’s 

flexibility to serve the client’s needs. 

Therefore, we have amended the 

language at § 485.916(a)(2) to allow for 

the CMHC to determine (based on the 

findings of the client’s comprehensive 

assessment) the appropriate licensed 

mental health professional(s) and other 

CMHC staff that will serve on the 

client’s interdisciplinary team. 

Comment: One commenter stated that 

a Licensed Professional Counselor (LPC) 

can fulfill the clinical, psychological, 

and social work needs of clients. 

Response: We appreciate the 

comment regarding LPCs fulfilling 

multiple client needs. We agree there 

are times when an LPC may be able to 

meet several different assessed needs of 

the client, as long as the State licensure 

permits them to do so. We would expect 

to see documentation by the LPC of the 

progress toward the client’s goals. The 

expectation is that if goals are not being 

met and additional needs are assessed, 

the interdisciplinary team will bring in 

additional team members to address the 

client’s needs. 

Comment: One commenter stated that 

a peer specialist or family peer advocate 

should be added to the IDT. Another 

commenter stated that CMS should 

require support of the recovery model 

by allowing for peers (persons with 

lived experience of mental illness, or 

peer specialists) to be part of the 

treatment team. 

Response: We appreciate the 

comments regarding peer specialists and 

family peer advocates. We agree that, 

depending on the CMHC’s client needs 

and programs, peer specialists or family 

peer advocates may be appropriate to 

meet individual client needs. Therefore, 

we have amended the language at 

§ 485.916(a)(2)(vii) to permit other 

CMHC staff or volunteers to serve on the 

interdisciplinary team, as necessary. 

Comment: A few commenters stated 

that the timeframe for developing the 

active treatment plan should be 

extended from 3 working days to 5 

working days. 

Response: We appreciate the 

commenters’ request for extension of the 

active treatment plan timeframe. We 

believe that completing the assessment 

in a timely manner is very important. In 

this final rule, we have amended the 

timeframe of the comprehensive 

assessment to be completed within 4 

working days. Therefore, we also 

amended the language at § 485.916(b) to 

extend the timeframe for completion of 

the active treatment plan to 7 working 

days. 

In the instances of partial 

hospitalization, due to the acuity level 

of the clients served, we expect the 

partial hospitalization program to meet 

the requirement at § 424.24. 

Comment: A few commenters 

recommended amending the treatment 

plan language to allow organizations to 

document the understanding of either 

the individual served or, if the 

individual served is unable to 

acknowledge his or her understanding 

and/or agreement, the representative’s 

understanding of, and agreement with, 

the treatment plan. 

Response: We appreciate the 

commenters’ suggestion. We agree that 

having the CMHC document the client’s 

and/or the client representative’s 

understanding of the active treatment 

plan is necessary. We would expect the 

CMHC to document the client’s 

understanding and involvement in his 

or her active treatment plan. If the client 

is unable to understand the active 

treatment plan, the CMHC would 

document the client’s representative’s 

understanding and involvement in the 

active treatment plan. Therefore, we 

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have amended the language in 

§ 485.916(c)(7). 

Comment: A few commenters stated 

that we should include the individual’s 

preferences and personal goals in the 

active treatment plan. Another 

commenter recommended that we revise 

the standards to reflect current recoveryfocused care planning to better align 

with the recommendations previously 

set forth by the Substance Abuse and 

Mental Health Services Administration. 

Response: We appreciate both 

commenters’ suggestions to include the 

client’s preferences and personal goals 

in the active treatment plan and to have 

a recovery focused active treatment 

plan. We agree with both of the 

commenters, and have amended 

§ 485.916(b) accordingly. We expect that 

the interdisciplinary team will work 

together to establish the client’s 

individual active treatment plan in 

accordance with the client’s recovery 

goals and preferences. 

Comment: One commenter 

recommended that we require the 

development of a crisis plan for each 

client. 

Response: We agree with the 

commenter that crisis planning is 

important for the health and safety of 

clients. However, the individual client’s 

risk factors are assessed during the 

comprehensive assessment and the 

information gathered in the assessment 

and active treatment plan would be 

used to guide the care of the client if an 

emergency should occur. Therefore, we 

do not believe it is necessary to add an 

additional regulatory requirement 

addressing crisis planning. 

CoP: Quality Assessment and 

Performance Improvement (Proposed 

§ 485.917) 

We proposed to add a new CoP at 

§ 485.917 to specify the requirements for 

a quality assessment and performance 

improvement program (QAPI). The 

proposed QAPI CoP was divided into 

five standards. 

At § 485.917(a), ‘‘Standard: Program 

scope,’’ we proposed that a CMHC QAPI 

would 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 such as an unexpected 

occurrence involving death or serious 

injury. The use of restraint or seclusion 

is contrary to targeted client outcomes; 

therefore, we would consider the use of 

restraint or seclusion to be an adverse 

client event that would be tracked and 

analyzed as part of the QAPI program. 

At § 485.917(b), ‘‘Standard: Program 

data,’’ we proposed to require the 

CMHC 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 did not propose to require CMHCs 

to use any particular process, tools or 

quality measures. However, a CMHC 

that uses available quality measures 

could expect an enhanced degree of 

insight into the quality of its services 

and client satisfaction. 

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 

meets 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. We expect the CMHC to 

develop and implement a 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. 

At § 485.917(b), we proposed to 

require that data collected by the 

CMHC, regardless of the source of the 

data elements, would be collected in 

accordance with the detail and 

frequency specifications established by 

the CMHC’s governing body. Once 

collected, the CMHC would use the data 

to monitor the effectiveness and safety 

of 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. 

At § 485.917(c), ‘‘Standard: Program 

activities,’’ we proposed to require the 

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 also proposed 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. 

At § 485.917(d), ‘‘Standard: 

Performance improvement projects,’’ we 

proposed to require that the number and 

scope of improvement projects 

conducted annually would reflect the 

scope, complexity and past performance 

of the CMHC’s services and operations. 

The CMHC would document what 

improvement projects were being 

conducted, the reasons for conducting 

them and the measurable progress 

achieved by them. 

At § 485.917(e), ‘‘Standard: Executive 

responsibilities,’’ we proposed to 

require that the CMHC’s governing body 

would be responsible and accountable 

for ensuring that the ongoing quality 

improvement program is defined, 

implemented, maintained, and 

evaluated annually. The governing body 

would ensure that the program 

addressed priorities for improved 

quality of 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, 

safe, effective, quality care. Therefore, it 

would be incumbent on the governing 

body to lend its full support to agency 

quality improvement and performance 

improvement efforts. 

Comment: One commenter suggested 

that as an alternative to the requirement 

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that CMHCs develop their own QAPI 

programs, CMS could point CMHCs to 

specific, existing programs, such as 

NCQA’s Managed Behavioral Health 

Organization (MBHO) Certification 

program, to ensure consistency among 

facilities in delivering high quality care. 

Response: We acknowledge that there 

are existing programs that may be used 

by CMHCs in their efforts to meet the 

QAPI standards. We would caution, 

however, that participation in such 

programs does not guarantee that the 

CMHCs are in compliance with this 

requirement. As required in 

§ 485.917(b)(2)(ii), CMHCs must use the 

quality indicator data that they have 

gathered to identify and prioritize 

opportunities for improvement. In 

addition, § 485.917(a)(1) requires the 

CMHC QAPI program to show 

measurable improvement in the areas 

related to improved behavioral health 

outcomes and CMHC services specific to 

the individual facility. Furthermore, 

§ 485.917(d)(1) requires that the scope 

and number of a CMHC’s performance 

improvement projects are to be based on 

the unique needs of the CMHC and its 

client population. These requirements 

require the CMHC to develop, 

implement, and assess performance 

improvement projects that reflect the 

areas of weakness, as identified through 

the data they have collected, and the 

needs of their organization. If a CMHC 

participates in a certification program 

that does not address one more of the 

areas of weakness, or if that 

performance improvement project will 

not enable the CMHC to demonstrate 

measurable improvement in areas 

identified as needing to be addressed, 

then participation in a certification 

program alone would not meet the QAPI 

requirements in this rule. 

CMHCs utilizing resources from a 

quality improvement organization will 

still be expected to provide separate 

documentation evidencing their QAPI 

program. 

Comment: Several commenters stated 

their strong support for the proposed 

rule regarding QAPI. According to the 

commenters, the existence of a QAPI 

program ensures the provision of quality 

services, identifies weaknesses in the 

care process, and encourages the 

provider to make changes in order to 

improve their current practices. A few 

commenters stated that they were 

committed to supporting CMHCs in 

developing better data systems and 

using that data to improve service 

quality and efficiency. 

Response: We appreciate the overall 

support for the data collection and QAPI 

requirements, as this support will help 

ensure that CMHCs develop a datadriven program for continuous quality 

improvement that reflects the needs of 

the clients and CMHCs alike. 

Comment: Several commenters 

supported CMS’ decision to work with 

the NCQA and Mathematica to develop 

measures for use in inpatient 

psychiatric facilities, and requested that 

CMS facilitate the development and 

adoption of robust, harmonized, tested, 

and validated measures around 

schizophrenia that could also be used in 

other settings, such as CMHCs. In 

addition, the commenters encouraged 

further development of functional 

measures, such as the ability to return 

to work, that could be used as important 

indicators of successful treatment, 

especially for those clients with 

negative symptoms such as delusional 

behavior. The commenters stated that 

such measures would provide CMHCs 

with an important tool for use in 

evaluating their own quality programs. 

Response: We appreciate the support 

for CMS’ work with the NCQA. At this 

time there are no plans for CMS to 

develop measures specific to CMHCs. 

However as CMS works with NCQA and 

the Substance Abuse and Mental Health 

Services Administration (SAMHSA), we 

will continue to pursue measures 

appropriate for the CMHC setting. 

CMHCs can use the search term ‘‘mental 

health’’ on the National Quality Forum 

Web site at http://

www.qualityforum.org/Qps/

QpsTool.aspx to find additional 

measures-related resources. 

Comment: Several commenters 

strongly agree that CMHCs should track 

‘‘adverse client events’’ and 

immediately ‘‘correct any identified 

problems that would directly or 

potentially threaten the care and safety 

of clients.’’ Commenters stated that all 

existing CMHCs should not have any 

issues complying with this requirement. 

Response: We appreciate the support 

for tracking adverse events. We believe 

it is essential to the CMHC QAPI 

program to begin tracking and analyzing 

adverse events at the same time it begins 

collecting client level outcomes 

measures data elements and CMHCwide measures that are available. 

Adverse events generally result in harm 

to a client; they serve as important 

indicators for areas of potential 

improvement. If CMHCs do not collect 

adverse event information, they may be 

missing important data from which to 

assess their performance. 

CMHC CoP: Organization, Governance, 

Administration of Services, and Partial 

Hospitalization Services (§ 485.918) 

We proposed to add a new CoP at 

§ 485.918, to set out the CMHC’s 

administrative and governance structure 

and to clarify performance expectations 

for the governing body. As explained in 

the proposed rule, the overall goal of 

this CoP is to ensure that the 

management structure is organized and 

accountable. The proposed CoP was 

divided into seven standards. 

In the proposed organization and 

administration of services CoP, we 

proposed to list the services that the 

statute (section 1861(ff)(3) of the Act) 

requires CMHCs to furnish. We also 

proposed 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 was 

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. 

At § 485.918(a), ‘‘Standard: Governing 

body and administrator,’’ we proposed 

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. 

At § 485.918(b), ‘‘Provision of 

services,’’ we proposed to specify a 

comprehensive list of services that a 

CMHC would be required to provide. At 

§ 485.918(b)(1)(v), we proposed 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 § 410.2 set out in the 

November 24, 2010 Outpatient 

Prospective Payment System (OPPS) 

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final rule (75 FR 71800, 72259). Both the 

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) (HCERA). 

Enactment of section 1301(a) of 

HCERA 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 began at least 12 

months after the date of enactment (that 

is, April 1, 2011). As of that date, a 

Medicare-participating CMHC must 

provide at least 40 percent of its services 

to individuals who are not eligible for 

benefits under Medicare. 

We proposed to measure whether a 

CMHC is providing at least 40 percent 

of its services to individuals who are not 

eligible for Medicare benefits by the 

amount of reimbursement for all 

services furnished. Additionally, we 

proposed to measure the 40 percent of 

its services on an annual basis. We 

solicited public comments on whether 

we should determine if a CMHC meets 

the 40 percent requirement annually or 

at some other interval. We also solicited 

comments 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 was total reimbursement from 

all payers, for all services provided, we 

were interested in comments on how we 

should define reimbursement. 

We also requested feedback on 

whether the proposed calculation 

should include uncompensated care or 

any other aspect of reimbursement, and 

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 stated our interest in 

receiving comments on any other 

approaches that could constitute a 

measure of the 40 percent threshold. We 

stressed that we were concerned that the 

implementation of this provision not 

negatively impact access to care. 

Medicare-certified CMHCs are already 

required to provide most of the services 

set out in the proposed provision of 

services standard 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)). Nonspecified staff might be responsible for 

supervising clients and ensuring a safe 

environment. CMHCs would be 

expected to have a sufficient number of 

appropriately-trained staff to meet these 

responsibilities at all times. 

At § 485.918(c), ‘‘Standard: 

Professional management 

responsibility,’’ we proposed 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. 

At § 485.918(d), ‘‘Standard: Staff 

training,’’ which would apply to all 

employees, staff under contract, and 

volunteers, we proposed 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 deliver 

the training, assess competence levels, 

determine training content, determine 

the duration and frequency of training 

for all employees, and track the training 

on a yearly basis. 

At § 485.918(e)(1), ‘‘Standard: 

Environmental conditions,’’ and (e)(2), 

‘‘Building,’’ we proposed to require the 

CMHC to provide services in an 

environment that is 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. We indicated that these 

proposed requirements would help to 

ensure that CMHC services are provided 

in a physical location that is both safe 

and conducive to meeting the needs of 

CMHC clients. 

At § 485.918(e)(3), ’’Infection 

control,’’ we proposed 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 

actions be taken to protect all the clients 

and staff. 

At § 485.918(e)(4), ‘‘Therapy 

sessions,’’ we proposed 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. 

At § 485.918(f), ‘‘Standard: Partial 

hospitalization services,’’ we proposed 

that all partial hospitalization services 

would be required to meet all applicable 

requirements of 42 CFR parts 410 and 

424. 

At § 485.918(g), ‘‘Standard: 

Compliance with Federal, State, and 

local laws and regulations related to the 

health and safety of clients,’’ we 

proposed that the CMHC and its staff 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. 

Comment: Many commenters strongly 

agree with the overall goal of the 

administrative standard at § 485.918(a). 

They believe it would ensure that the 

management structure is organized and 

accountable. 

Response: We appreciate the overall 

support for the administrative standard. 

This support would help ensure 

efficient operation of the CMHC and 

that the CMHC meets the needs of the 

clients and CMHCs alike. 

Comment: Some commenters strongly 

support the option of allowing the 

CMHCs to receive oversight from the 

Joint Commission, or other accrediting 

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bodies. Other commenters encouraged 

CMS to defer to the states regarding 

deemed status, by recognizing deeming 

authority for CMHCs in those states that 

allow deeming. However, some 

commenters stated that CMS should not 

adopt deeming authority for CMHCs. 

Response: We appreciate the wide 

array of comments related to deeming. 

As stated in the proposed rule, we are 

not proposing to amend our regulations 

at § 488.6 to grant deeming authority for 

CMHCs to accrediting organizations. 

CMS’s regulation at § 488.6 does not 

permit deeming for CMHCs. To allow 

for deeming authority to occur for 

CMHCs, there would need to be a 

regulatory change. We will take this 

under advisement for future rulemaking. 

Comment: Many commenters stated 

that CMS should use the language in 

Section 1301 of HCERA to calculate the 

40 percent threshold. Specifically, they 

noted that the Congress used the phrase 

‘‘40 percent of its services to 

individuals’’ without making any 

reference at all to reimbursement or 

payment in the statute. Commenters 

also stated that to be consistent with the 

major themes of the Affordable Care Act 

(which incorporates HCERA), the 

legislative language in Section 1301 of 

HCERA indicates the need for a patientcentric approach rather than a 

reimbursement-based approach. 

Additionally, many commenters stated 

that using an independent auditing 

agency to review CMHC financial 

statements to certify compliance with 

the 40 percent threshold would be 

overly burdensome and confusing for 

the CMHC. 

Response: We agree with the 

commenters on the 40 percent 

calculation. We proposed several 

different potential ideas for calculating 

the 40 percent. After carefully 

considering all the comments received, 

we are adopting a patient-centric 

approach and will require that the 

calculation of 40 percent be based on 

CMHC services to individuals. 

Comment: Commenters offered very 

detailed recommendations on how to 

calculate the 40 percent threshold, the 

implementation process, the 

timeframes, and the consequences if the 

CMHC does not meet the 40 percent 

threshold. Also, commenters stated that 

the calculation to determine the 40 

percent threshold should be based on a 

patient-centric methodology, including 

the following elements: 

• Numerator: The numerator would 

include an unduplicated census of 

individuals who rely solely on health 

care coverage provided through private 

sector insurance or public health 

programs other than Medicare, indigent 

individuals and any other uninsured or 

inadequately insured individuals who 

receive behavioral health services from 

the CMHC. 

• Denominator: The denominator 

would include an unduplicated census 

for all clients who receive services from 

the CMHC. 

• Validation: For each reporting 

period, the CMHC could attest to the 

accuracy of the numbers reported to 

CMS for the patient-centric numerator 

and denominator identified above. 

Medicare providers are required to 

prepare attestations in other contexts 

involving eligibility to receive Medicare 

reimbursement, including, but not 

limited to, the attestations used in the 

calculation of bad debt. 

• Annual Reporting Period: Adopt an 

annual reporting period based on a 

facility’s cost reporting year. 

• Failure to Meet Performance Level: 

Providers that fail to meet the 40 

percent threshold by more than five 

percent during a particular year should 

be placed on probation for 12 months 

and required to develop and implement 

a corrective action plan to bring the 

facility into compliance with the 40 

percent requirement. If a facility fails to 

meet the threshold for a second 

consecutive year, that CMHC should be 

rendered ineligible for Medicare 

reimbursement during the subsequent 

year. 

Response: We agree with the 

commenters’ recommendations for 

calculating the 40 percent threshold. 

Therefore, we amended the proposed 

§ 485.918 (b)(1)(v) to read ‘‘provides at 

least 40 percent of its items and services 

to individuals who are not eligible for 

benefits under title XVIII of the Act.’’ 

We have removed the subsequent 

phrase, which read ‘‘as measured by the 

total revenues received by the CMHC 

that are payments from Medicare versus 

payers other than Medicare.’’ We agree 

that the numerator should include an 

unduplicated census of individuals who 

receive services not paid for in whole or 

in part by Medicare. This may include 

individuals who rely solely on health 

care coverage provided through private 

sector insurance or public health 

programs other than Medicare, or whose 

insurance doesn’t cover the behavioral 

health services they receive from the 

CMHC. The denominator would consist 

of an unduplicated census of all clients 

who receive services from the CMHC, 

including Medicare beneficiaries. The 

calculation will determine the total 

percentage of individuals who are not 

eligible for benefits under title XVIII of 

the Act. The CMHC needs to assure 

continued compliance with the 40 

percent threshold on an annual basis— 

that is, 40 percent of the clients served 

by the CMHC during each intervening 

12 month period must be individuals for 

whom services are not paid for by 

Medicare. 

We will not be using the proposed 

language on reimbursement or cost 

report information to calculate the 40 

percent. Rather, we will require all 

CMHCs to verify their compliance with 

the 40 percent requirement by sending 

documentation to the appropriate Part 

A/Part B Medicare Administrative 

Contractor (A/B MAC) from an 

independent entity such as an 

accounting technician, which will 

certify that it has reviewed the client 

care data for the CMHC. The 

documentation must be sent upon 

initial application for Medicare provider 

status, and upon revalidation, including 

off cycle revalidation, thereafter to the 

relevant A/B MAC (see revalidation 

requirements at § 424.515). The 

documentation must state whether the 

CMHC met or did not meet the 40 

percent requirement for the prior 3 

months (in the case of the initial 

application) or for each of the 

intervening 12 month periods between 

initial enrollment and revalidation. If 

the CMHC did not meet the 40 percent 

threshold, the A/B MAC will notify the 

CMHC that they have 30 days to correct 

the issue or their Medicare enrollment 

and billing privileges will be denied for 

non-compliance (see § 424.530(a)(1)) or 

revoked for non-compliance (see 

§ 424.535(a)(1)). 

If an A/B MAC denies or revokes a 

CMHC’s Medicare billing privileges, the 

CMHC is afforded provider enrollment 

appeal rights, and may reapply or seek 

reinstatement into the Medicare 

program subject to the provisions found 

in § 424.535. 

We appreciate the commenters’ 

suggestions related to failure to meet the 

40 percent threshold. However, we 

disagree with the proposed probationary 

period and the suggestion of a 5 percent 

margin. The law does not allow for a 

probationary period or margins. This 

final rule becomes effective one year 

after publication of this rule in the 

Federal Register. This means all CMHCs 

will have one year to implement the 

provisions of this rule before the 

independent entity audit or a survey 

would occur. 

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Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Rules and Regulations 64621 

Comment: Several commenters stated 

that volunteers should not be included 

in the staff education component 

described by § 485.918(d)(1) and 

recommended that any reference to 

volunteers in this section be removed. 

Response: We appreciate the 

commenters’ opinions. However, we 

believe that educating volunteers about 

CMHC care and services and personcentered planning is just as important 

for the volunteer as it is for the staff 

member. Volunteers are asked to 

interact with clients in many different 

situations, such as the waiting room and 

reception area. For the safety of the 

client and the volunteer, volunteers 

should have a basic understanding of 

the types of clients served and the 

workings within the CMHC. 

Comment: A few commenters stated 

that § 485.918(d)(3) requires that 

CMHCs ‘‘assess the skills and 

competence of all individuals 

furnishing care....’’ They stated that it is 

not clear what such a skills and 

competency assessment would contain, 

and how much time it would take to 

develop and administer such 

assessments for each position within 

every CMHC. Commenters suggested 

that this requirement would be met by 

QAPI. Other commenters suggested that 

the requirement for CMHC staff to 

receive consistent and ongoing 

continuing education is best enforced 

through the personnel requirements. 

Commenters stated that licensure and 

credentialing laws typically include 

requirements for ongoing continuing 

education. Other commenters stated that 

while in-service training may be 

appropriate in some circumstances, 

CMS should recognize and support 

existing continuing education practices 

required for practitioner licensure and 

certification. 

Response: To clarify, we are requiring 

the CMHC to create policies and 

procedures by which to evaluate their 

employees relevant to the duties 

assigned to each employee, which can 

be tied to the CMHC policies related to 

personnel requirements. The specifics of 

these policies and procedures would be 

up to each individual CMHC. The 

commenters are correct that this could 

also be part of the QAPI program. If an 

area of concern is recognized by staff 

administering the QAPI program, or the 

CMHC administration, then it is 

expected that the CMHC would conduct 

in-service training related to the area of 

concern. We understand that there may 

be specific individual provider 

licensure requirements based on State 

laws and regulations; however, this 

would be specific to the provider type, 

such as nurse or therapist to maintain 

his or her license or certification. 

Section 485.918(d)(3) is specifically 

related to overall training of the CMHC 

staff, whether it is specific to issues 

brought up through the QAPI program 

or new or edited policies and/or 

procedures within the CMHC. In-service 

training can also be used to meet other 

State and/or Federal requirements, such 

as infection control. 

Comment: A few commenters stated 

that assessing for self-harm is not 

enough. Commenters stated that CMHCs 

need to educate and train staff on 

suicide prevention. Commenters believe 

that these regulations could help 

address a well-established training 

deficit among service providers and 

their organizations and could reduce 

consumer suicide-related morbidity and 

mortality. Commenters also stated that if 

staff are untrained and cannot 

demonstrate competency in the clinical 

assessment of suicide risk, clients may 

be at risk. 

Response: We agree with the 

commenter that the importance of 

suicide prevention education is critical 

to all staff within the CMHC. Therefore, 

we have modified the language at 

§ 485.914(b)(4)(ix) to read: ‘‘Factors 

affecting client safety or the safety of 

others, including behavioral and 

physical factors as well as suicide risk 

factors.’’ This is an example of where 

the use of in-service training in 

§ 485.918(c)(3) would benefit the entire 

CMHC staff and meet the in-service 

training requirements. It is very 

important that CMHCs follow current 

standards of practice and continually 

monitor and educate their staff as it 

relates to current standards of practice 

such as suicide prevention. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

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 published a proposed rule in the 

Federal Register (76 FR 35684) on June 

17, 2011. The comment period closed 

on August 16, 2011. We did not receive 

any comments related to the PRA 

section of this rule. 

We have made several assumptions 

and estimates in order to assess the time 

that it will take for a CMHC to comply 

with the 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 1 below. We have 

also detailed many of the standards 

within each 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 

CoPs are already standard medical or 

business practices and, as a result, do 

not pose an additional burden on 

CMHCs. 

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64622 Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Rules and Regulations 

TABLE 1—ASSUMPTIONS AND ESTIMATES USED THROUGHOUT THE COLLECTION OF INFORMATION AND IMPACT ANALYSIS

SECTIONS

Number of Medicare CMHCs nationwide (Based on CY 2012 CMS data) .................................................................................... 100 

Number of CMHC clients nationwide * (Estimate based on CY 2010 data) ................................................................................... 22,700 

Number of clients per average CMHC ............................................................................................................................................ 227 

Hourly rate of psychiatric nurse ....................................................................................................................................................... $47 

Hourly rate of clinical psychologist .................................................................................................................................................. $54 

Hourly rate of administrator ............................................................................................................................................................. $66 

Hourly rate of clinical social worker ................................................................................................................................................. $35 

Hourly rate of mental health counselor ........................................................................................................................................... $31 

Hourly rate of auditing or accounting clerk ..................................................................................................................................... $24 

* Reflects 13,600 Medicare clients and 9,100 non-Medicare clients. 

Note: All salary estimates include benefits and overhead package worth 48 percent of the base salary. Salary estimates were obtained from 

http://www.bls.gov/. 

A. ICRs Related to Condition of 

Participation: Client Rights (§ 485.910) 

Section 485.910(a) requires that the 

CMHC develop a notice of rights 

statement to be provided to each client. 

We estimate that it will 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 $528 per CMHC and $52,800 for 

all CMHCs nationwide. In addition, this 

standard requires that the CMHC 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 will 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 that the time it will take for the 

CMHC to document the information will 

be 2.5 minutes per client or 

approximately 9.47 hours per CMHC. At 

an average of 2.5 minutes (.0417 hours) 

per client to complete both tasks, we 

estimate that all CMHCs will use 947 

hours to comply with this requirement 

(.0417 hours per client × 22,700 clients). 

The estimated cost associated with these 

requirements is $44,509, based on a 

psychiatric nurse performing this 

function (947 hours × $47 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 previous discussion of 

Office for Civil Rights guidance issued 

in 2003). Because we impose no new 

requirements not already fully 

encompassed in that regulation and 

guidance, we have estimated no 

paperwork burden. 

Section 485.910(d)(2) requires a 

CMHC to document a client’s or client 

representative’s complaint of an alleged 

violation and the steps taken by the 

CMHC to resolve it. The burden 

associated with this requirement is the 

time it will 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 will take the 

administrator 5 minutes per complaint 

at the rate of $66/hr to document the 

complaint and resolution activities, for 

an annual total of 4.33 hours per CMHC 

or 433 hours for all CMHCs. The 

estimated cost associated with this 

requirement is $28,578. 

Section 485.910(d)(4) requires the 

CMHC to report within 5 working days 

of becoming aware of the violation, all 

confirmed violations to the state and 

local bodies having jurisdiction. We 

anticipate that it will take the 

administrator 5 minutes per complaint 

to report, for an annual total of 4.33 

hours per CMHC or 433 hours for all 

CMHCs. The estimated cost associated 

with this requirement is $28,578. 

Section 485.910(e)(2) requires written 

orders for a physical restraint or 

seclusion, and § 485.910(e)(4)(v) 

requires physical restraint or seclusion 

be supported by a documentation in the 

client’s clinical record of the client’s 

response or outcome. The burden 

associated with this requirement is the 

time and effort necessary to document 

the use of physical restraint or seclusion 

in the client’s clinical record. We 

estimate that it will 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 

physical restraint or seclusion per 

CMHC annually. The estimated annual 

burden associated with this requirement 

for all CMHCs is 75 hours. The 

estimated cost associated with this 

burden for all CMHCs is $3,525. 

Section 485.910(f) specifies restraint 

or seclusion staff training requirements. 

Specifically, § 485.910(f)(1) requires that 

all client care staff working in the 

CMHC be trained and able to 

demonstrate competency in the 

application of restraints and 

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. Section 

485.910(f)(4) requires that a CMHC 

document in the personnel records that 

each employee successfully completed 

the restraint and seclusion training and 

demonstrated competency in the skill. 

We estimate that it will take 35 minutes 

per CMHC to comply with these 

requirements. The estimated total 

annual burden associated with these 

requirements is 58 hours. The estimated 

cost associated with this requirement is 

$2,726. 

Section 485.910(g) requires 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 (for example, 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 or seclusion in a 

CMHC. Several commenters stated that 

the majority of CMHCs have a restraint 

or seclusion free policy. Therefore, 

restraint or seclusion is not permitted in 

these agencies. Hence, we believe the 

number of deaths associated with this 

requirement is estimated at zero. Under 

5 CFR 1320.3(c)(4), this requirement is 

not subject to the PRA as it would affect 

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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) 

Section 485.914(b) through (e) 

requires 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 

requirements is 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. 

Section 485.914(e) requires that, if the 

client were transferred to another 

facility, the CMHC is 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 is required to provide a copy 

of the client’s discharge summary and 

clinical record, if requested, to the 

client’s primary health care provider. 

The burden associated with this 

requirement is the time it takes to 

forward the discharge summary and 

clinical record, if requested. This 

requirement is considered to be 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. 

C. ICRs Related to Condition of 

Participation: Treatment Team, Active 

Treatment Plan, and Coordination of 

Services (§ 485.916) 

Section 485.916(b) requires all CMHC 

care and services furnished to clients 

and their families to follow a written 

active treatment plan established by the 

interdisciplinary treatment team. The 

CMHC is required to ensure that each 

client and representative receives 

education provided by the CMHC, as 

appropriate, for the care and services 

identified in the active treatment plan. 

The provisions at § 485.916(c) specify 

the minimum elements that the active 

treatment plan must include. In 

addition, in § 485.916(d), the 

interdisciplinary team is 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 must 

include information from the client’s 

updated comprehensive assessment, 

and must document the client’s progress 

toward the outcomes specified in the 

active treatment plan. The burden 

associated with these requirements is 

the time it takes to document the active 

treatment plan (.1667 hours per client or 

approximately 3,784 hours nationally) 

estimated to be a total of $1,778 per 

CMHC or $177,848 nationally. 

Additionally, we estimate any revisions 

to the active treatment plan 

(approximately 5 minutes) will cost 

$525 per CMHC or $88,877 nationally 

(1891 hours × $47/hour). 

Section 485.916(e) requires a CMHC 

to develop and maintain a 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 requirement 

will be the time and effort required to 

develop and maintain the system of 

communication in accordance with the 

CMHC’s policies and procedures. We 

believe that the requirement is 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. 

D. ICRs Related to Condition of 

Participation: Quality Assessment and 

Performance Improvement (§ 485.917) 

Section 485.917 requires a CMHC to 

develop, implement, and maintain an 

effective ongoing CMHC-wide data 

driven quality assessment and 

performance improvement (QAPI) 

program. The CMHC is 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 is 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 is required to document what 

quality improvement projects were 

conducted, the reasons for conducting 

these projects, and the measurable 

progress achieved on these projects. 

The burden associated with these 

requirements is the time it takes to 

document the development of the 

quality assessment and performance 

improvement and associated activities. 

We estimate that it will take each CMHC 

administrator an average of 4 hours per 

year at the rate of $66/hr to comply with 

these requirements for a total of 400 

hours annually. The estimated cost 

associated with this requirement is 

$26,400. 

E. ICRs Related to Condition of 

Participation: Organization, 

Governance, Administration of Services, 

and Partial Hospitalization Services 

(§ 485.918) 

Section 485.918(b) lists care and 

services a Medicare CMHC must be 

primarily engaged in regardless of payer 

type. Specifically, § 485.918(b)(1)(v) 

requires the CMHC to provide 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 number of CMHC 

clients treated by the CMHC and not 

paid for by Medicare, divided by the 

total number of clients treated by the 

CMHC. The burden associated with this 

requirement is the time it takes for an 

independent entity contracted by the 

CMHC to calculate compliance with the 

40 percent requirement and create a 

letter for the CMHC to submit to CMS. 

We estimate it will take the independent 

entity an average of 5 hours per new 

CMHC applicant and 5 hours for each 

CMHC that is due for its every 5 year 

revalidation to calculate compliance 

with the 40 percent requirement and 

create a letter to CMS. We estimate there 

will be 10 new CMHC applicants per 

year for a total of 50 hours annually and 

an estimated cost of $1,200. We estimate 

there will be 20 CMHCs up for 

revalidation each year for a total of 100 

hours for all CMHCs, with an estimated 

cost of $2,400. Therefore, the annual 

reporting for new CMHC applicants and 

CMHC revalidation is estimated at 150 

hours with a total cost of $3,600. 

Section 485.918(c) lists 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 is 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 requirement 

is the time and effort necessary to 

develop, draft, execute, and maintain 

the written agreements. We believe 

these 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. 

Section 485.918(d) describes the 

standard for training. In particular, 

§ 485.918(d)(2) requires a CMHC to 

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1 In order to develop this estimate we divided the 

total number of Medicare beneficiaries who 

received partial hospitalization services in 2010 by 

the total number of Medicare-participating CMHCs 

in 2010 to establish the average number of Medicare 

beneficiaries per CMHC. This resulted in 136 

beneficiaries per CMHC. We then assumed that, in 

order to comply with the 40 percent requirement, 

those 136 beneficiaries only accounted for 60 

percent of an average CMHC’s total patient 

population. This meant that an average CMHC also 

treated another 91 clients who did not have 

Medicare as a payer source, for a total of 227 clients 

(Medicare + non-Medicare) in an average CMHC. 

provide an initial orientation for each 

employee, contracted staff member, and 

volunteer that addresses the employee’s 

or volunteer’s specific job duties. 

Section 485.918(d)(3) requires a CMHC 

to have written policies and procedures 

describing its method(s) of assessing 

competency. In addition, the CMHC is 

required to maintain a written 

description of the in-service training 

provided during the previous 12 

months. These requirements are 

considered to be usual and customary 

business practices under 5 CFR 

1320.3(b)(2) and, as such, the burden 

associated with them are exempt from 

the PRA. 

Section 485.918(e)(3) requires 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 requirement is the 

time it takes to develop and maintain 

policies and procedures and document 

the monitoring of the infection control 

program. We believe this 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 2 below summarizes the 

estimated reporting and recordkeeping 

burden for this final rule. 

TABLE 2—ESTIMATED 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 100 100 8 800 66 52,800 0 52,800 

§ 485.910(a)(3) ............................................ 0938–New 100 22,700 .0417 947 47 44,509 0 44,509 

§ 485.910(d)(2) ............................................ 0938–New 100 5,200 .0833 433 66 28,578 0 28,578 

§ 485.910(d)(4) ............................................ 0938–New 100 5,200 .0833 433 66 28,578 0 28,578 

§ 485.910(e)(4)(v) ........................................ 0938–New 100 100 .75 75 47 3,525 0 3,525 

§ 485.910(f)(4) ............................................. 0938–New 100 700 .0833 58 47 2,726 0 2,726 

§ 485.916(c) ................................................. 0938–New 100 22,700 .1667 3784 47 177,848 .................. 177,848

§ 485.916(d) ................................................ 0938–New 100 22,700 .0833 1891 47 88,877 0 88,877 

§ 485.917 ..................................................... 0938–New 100 100 4 400 66 26,400 0 26,400 

§ 485.918(b) ................................................ 0938–New 30 30 5 150 24 3,600 0 3,600 

Total ..................................................... .................. 100 79,530 18.7083 .................. .................. 457,441 .................. 457,441 

If you comment on these information 

collection and recordkeeping 

requirements, please submit your 

comments to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget, Attention: 

CMS Desk Officer, [CMS–3202–F]; Fax: 

(202) 395–6974; or Email: OIRA_

submission@omb.eop.gov. 

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 new 

CoPs in this final rule is estimated to be 

$3 million in the first year of 

implementation and $2.2 million 

annually thereafter. Therefore, this is 

not an economically significant or major 

final 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://www.sba.gov/sites/default/ 

files/Size_Standards_Table.pdf). We 

estimate there are approximately 100 

CMHCs with average admissions of 

approximately 227 clients per CMHC.1

We estimate that implementation of 

this rule will cost CMHCs 

approximately $3 million, or 

approximately $30,000 per average 

CMHC, in the first year of 

implementation and $2.2 million, or 

approximately $22,000 per average 

CMHC, after the first year of 

implementation and annually thereafter. 

Therefore, the Secretary has determined 

that this final rule will 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 (approximately $218 million 

per year, as shown by CY 2010 claims 

data). 

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 

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Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Rules and Regulations 64625 

of small rural hospitals. This analysis 

must conform to the provisions of 

section 604 of the RFA. For purposes of 

section 1102(b) of the Act, we define a 

small rural hospital as a hospital that is 

located outside of a metropolitan 

statistical area and has fewer than 100 

beds. We believe that this final rule will 

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 final 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 2013, that 

threshold is approximately $141 

million. This final rule will not have an 

impact on the expenditures of State, 

local, or tribal governments in the 

aggregate, or on the private sector of 

$141 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 final rule has no Federalism 

implications. 

B. Anticipated Effects on CMHCs 

We are establishing a new subpart J 

under the regulations at 42 CFR part 485 

to incorporate the CoPs for CMHCs 

(which will be effective 12 months after 

the publication of this final rule). The 

new subpart J includes the basis and 

scope of the subpart, definitions, and six 

conditions. 

Section III of this rule, Collection of 

Information Requirements, provides a 

detailed analysis of the burden hours 

and associated costs for all burdens 

related to the collection of information 

by CMHCs that are required by this rule. 

That section, in tandem with this 

regulatory impact analysis section, 

presents a full account of the burdens 

that are imposed by this rule. As shown 

above in table 2 the total cost of all 

information collection requirements in 

the first year is estimated to be 

$457,441. In addition, table 3 below 

presents the total first year cost of 

$2,596,809 for all other requirements. 

Therefore, the total cost for 

implementing all CoP requirements, 

including information collection and 

other costs that CMHCs must meet in 

order to participate in the Medicare 

program, is estimated to be $3 million 

in the first year of implementation and 

2.2 million annually thereafter. 

TABLE 3—TOTAL ESTIMATES FOR ALL REQUIREMENTS DESCRIBED IN THIS SECTION

Total time (hours) per 

average CMHC 

Total industry time 

(hours) 

Total cost per average 

CMHC Total industry cost 

Client rights ...................................... 1st year: 167.47 1st year: 16,747 1st year: $10,968 1st year: $1,096,809 

Annual: 67.47 Annual: 6,747 Annual: $3,449 Annual: $344,909 

Treatment team. Active Treatment 

Plan, and Coordination of Services ............................................... 265 26,500 $11,568 $1,156,800 

Quality Assessment and Performance Improvement ....................... 20 2,000 $1,320 $132,000 

Organization, Governance, Administration of Services ........................ 1st year: 32 1st year: 3,200 1st year: $2,112 1st year: $211,200 

Annual: 24 Annual: 2,400 Annual: $1,584 Annual: $158,400 

Totals ........................................ 1st year: 484.47 1st year: 48,447 1st year: $25,968 1st year: $2,596,809 

Annual: 376.47 Annual: 37,647 Annual: $17,921 Annual: $1,792,109 

Note: Costs presented in this table do not include those accounted for in Section III. Collection of Information Requirements. 

We have detailed, below, many of the 

standards within each CoP, and have 

noted whether or not there is an impact 

for each. However, the requirements 

contained in many of the provisions are 

already standard medical or business 

practices. These requirements will, 

therefore, not pose additional burden to 

CMHCs because they are already 

standards of practice. Client Rights 

(§ 485.910) 

Section 485.910(a), ‘‘Standard: Notice 

of rights and responsibilities,’’ requires 

that during the initial evaluation, the 

CMHC must provide the client and the 

client’s representative or surrogate (if 

appropriate) with verbal and written 

notice of the client’s rights and 

responsibilities in a language and 

manner that the individual understands. 

Communicating with clients, and their 

representatives or surrogates, in a 

manner that meets their communication 

needs is a standard practice in the 

health care industry. Because we are 

implementing a requirement that is fully 

compatible with existing civil rights 

requirements and guidance, we believe 

that the requirement to communicate 

with clients in a manner that meets their 

communication needs will impose no 

additional costs. 

In addition, this standard requires a 

CMHC to provide each CMHC client and 

representative verbal and written 

notification of the CMHC client’s rights. 

We estimate the burden for the time 

associated with providing the verbal 

notice will be 2.5 minutes (0.0417 

hours) per client or approximately 9.47 

hours per CMHC. We note that the 

burden associated with providing the 

written notice is discussed in the 

Collection of Information section of this 

rule. We estimate that all CMHCs will 

use 947 hours to comply with this 

requirement (0.0417 hours per client × 

22,700 clients). The estimated cost 

associated with these requirements is 

$44,509, based on a psychiatric 

registered nurse performing this 

function (947 hours × $47 per hour). 

With respect to the CoP for client 

rights, the standard addressing 

violations of client rights requires a 

CMHC to investigate alleged client 

rights violations, and take corrective 

actions when necessary and 

appropriate. We estimate that the CMHC 

administrator will spend, on average, 25 

minutes investigating each alleged 

client rights violation. For purposes of 

our analysis, we assume that an average 

CMHC will investigate 1 alleged 

violation per week, for a total of 22 

hours annually, at a cost of $1,452 

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annually per CMHC. All CMHCs 

nationwide require 2,200 hours, with an 

average labor cost of $66 per hour for 

the administrator, the estimated 

nationwide cost of $145,200. 

In addition, we are implementing 

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 standards 

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 

the client’s transport to a hospital. They 

are adapted from 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. 

We anticipate that CMHCs will be 

minimally impacted by these standards. 

Several public commenters stated that 

restraints and seclusion are never used 

in CMHCs and therefore are not needed 

in CMHCs. However, we are still 

estimating the burden to facilities for 

restraint and seclusion use. We do not 

have access to several key pieces of 

information to estimate the burden. For 

example, we do not have data on the 

volume of staff in CMHCs, or the 

varying levels and qualifications of 

CMHC staff that may use restraint and 

seclusion. Factors such as size of 

facility, services rendered, staffing, and 

client populations vary as well. We are 

hesitant to make impact estimates in 

this rule that may not account for these 

and other unforeseen variations. Below 

we discuss the anticipated effects on 

providers of the standards related to 

restraints and seclusion. 

The restraint and seclusion standards 

set forth the client’s rights in the event 

that he or she is restrained or secluded, 

and sets limits on when and by whom 

restraint or seclusion can be 

implemented. We recognize that there 

will be some impact associated with 

performing client assessment and 

monitoring to ensure that seclusion or 

restraint is only used in a safe and 

effective manner, when necessary, to 

protect the client and others from 

immediate harm, pending transport to 

the hospital. However, client assessment 

and monitoring are standard 

components of client care, and this 

requirement does not pose a burden to 

a CMHC. 

The standards on staff training for 

restraint or seclusion that we are 

codifying at § 485.910(f) set out the staff 

training requirements for all appropriate 

client care involving the use of 

seclusion and restraint in the CMHC. 

Training is important for the provision 

of safe and effective restraint or 

seclusion use. We 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 staff 

training requirements will address the 

following broad areas: Training 

intervals, training content, trainer 

requirements, and training 

documentation. 

To reduce regulatory burden and 

create a reasonable requirement while 

assuring client safety, we are mandating 

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. 

In this final rule, we are finalizing 

broad topics to be covered in training, 

and are not requiring 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 

will 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, 

the Crisis Prevention Institute) to 

provide such training. We believe that 

most CMHCs then will 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 will be a 

psychiatric registered 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 $1,999 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 will 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 

is approximately $2,959 plus the nurse’s 

total salary of $1,504 for 4 days (at $376 

per day). The total estimated training 

cost for all CMHCs is approximately 

$446,300. 

We believe that CMHCs will add 

seclusion and restraint training onto 

their in-service training programs. The 

train-the-trainer program described 

above provides 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 requires 40 hours of the 

trainer’s time on a one-time basis for all 

affected CMHCs, at a cost of $1,880 per 

CMHC. 

We are requiring that each individual 

who could potentially be involved in 

restraint and seclusion of a client have 

training in the proper techniques. 

According to the National Association 

of Psychiatric Health Systems (NAPHS), 

initial training in de-escalation 

techniques, restraint and seclusion 

policies and procedures, and restraint 

and seclusion techniques range from 7 

to 16 hours of staff and instructor time. 

Due to a lack of data on the average 

number of employees in a CMHC, for 

purposes of this analysis only, we 

assume that an average CMHC will need 

to train seven employees in seclusion 

and restraint techniques. Based on one 

psychiatric registered nurse trainer 

conducting an 8-hour training course for 

seven CMHC staff members, we estimate 

that this requirement will cost $2,728 as 

calculated below. 

• 8 trainer hours at $47/hr = $376 

• 56 trainee hours at $42/hr = $2352 

• $376 trainer cost + $2,352 trainee 

costs = $2,728 

We are also requiring that each 

individual receive documented, 

updated training. Again, according to 

National Association of Psychiatric 

Health Systems (NAPHS), annual 

updates involve about four hours of staff 

and instructor time per employee who 

has direct client contact. We assume an 

average size CMHC has seven 

employees with direct client contact 

who must be trained in de-escalation 

techniques. Therefore, we estimate that 

it will cost $1,364 annually to update 

each person’s training as shown below. 

• 4 trainer hours at $47/hr = $188 

• 28 trainee hours at $42/hr = $1,176 

• $188 trainer costs + $1,176 trainee 

costs = $1,364 

We require that each CMHC revise its 

training program annually as needed. 

We estimate this task, which must be 

completed by the trainer, to take 

approximately 4 hours annually per 

CMHC and have calculated below the 

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estimated total annual cost for all 

CMHCs. 

• 4 hours × $47/hr = $188 per CMHC 

• $188 per CMHC × 100 CMHCs = 

$18,800 nationwide 

Table 4 below shows the initial year 

(one-time) and annual estimated CMHC 

burden, respectively, associated with 

the standards for the client rights CoP. 

TABLE 4—CLIENT RIGHTS BURDEN ASSESSMENT

Standard Time per average CMHC Total time 

(in hours) 

Cost per 

average 

CMHC 

Total cost 

Client rights notification ................................... 9.47 hours ...................................................... 947 $445 $44,509 

Addressing violations ...................................... 22 hours ......................................................... 2,200 1,452 145,200 

4 day trainer training * ..................................... 32 hours ......................................................... 3,200 4,463 446,300 

Staff training program development * ............. 40 hours ......................................................... 4,000 1,880 188,000 

Staff training * .................................................. 64 hours ......................................................... 6,400 2,728 272,800 

Staff training update ........................................ 32 hours ......................................................... 3,200 1,364 136,400 

Staff training program update ......................... 4 hours ........................................................... 400 188 18,800 

Totals 1st year ......................................... 167.47 ............................................................ 16,747 10,968 1,096,809 

Totals Annually ........................................ 67.47 .............................................................. 6,747 3, 449 344,909 

* Initial year (one-time) burden items. 

Admission, Initial Evaluation, 

Comprehensive Assessment and 

Discharge or Transfer of the Client 

(§ 485.914) 

With respect to the CoP for admission, 

initial evaluation, comprehensive 

assessment and discharge or transfer of 

the client, we believe that several of the 

standards associated with the CoP are 

unlikely to impose a burden on CMHCs. 

Specifically, the requirements for 

admitting a client, initially evaluating a 

client, and completing a comprehensive 

assessment of each client’s needs are 

standard medical practice; therefore, 

they do not impose a burden upon a 

CMHC. 

Moreover, the requirement to update 

the comprehensive assessment does not 

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 13,600 Medicare 

beneficiaries who received partial 

hospitalization services 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 does not impose a 

burden upon a CMHC. 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 standard for the 

discharge or transfer of the client is part 

of a CMHC’s standard practice and does 

not pose additional burden to CMHCs. 

Treatment Team, Active Treatment 

Plan, and Coordination of Services 

(§ 485.916) 

Under the CoP for treatment team, 

active treatment plan, and coordination 

of services, we assessed the potential 

impact of the following standards on 

CMHCs: Delivery of services, active 

treatment plan, content of the active 

treatment plan, review of the active 

treatment plan, and coordination of 

services. First, the standard for delivery 

of services sets forth the required 

members of each CMHC’s client’s active 

treatment team and requires 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 does 

not pose a burden. 

Furthermore, this standard requires 

the CMHC to determine the appropriate 

licensed mental health processional, 

who is a member of the client’s 

interdisciplinary treatment team, to be 

designated for each client as a care 

coordinator. The designated individual 

will 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 

will spend 20 to 30 minutes per client 

per week (76 to 114 hours annually) 

overall to fulfill this requirement. The 

annual cost per CMHC associated with 

this requirement is $3,572 to $5,358 for 

a psychiatric registered nurse, $2,356 to 

$3,534 for a mental health counselor, or 

$2,660 to $3,990 for a clinical social 

worker. The aggregate annual cost for all 

CMHCs is $357,200 to $535,800 if a 

psychiatric registered nurse is used; 

$235,600 to $353,400 if a mental health 

counselor is used, or $266,000 to 

$399,000, if a clinical social worker is 

used. This estimated burden is shown in 

Table 5 below. 

Finally, paragraph (a)(4) of this 

standard requires 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 active treatment plan standard 

and its content sets forth the 

requirements for each client’s active 

treatment plan. The written active 

treatment plan will be established by 

the client and interdisciplinary 

treatment team. It will address the 

client’s needs as they were identified in 

the initial evaluation and subsequent 

comprehensive assessment. We estimate 

that establishing the first comprehensive 

active treatment plan requires 35 

minutes of the interdisciplinary 

treatment team’s time. We estimate that 

compliance with the requirements at 

§ 485.916(c) requires a licensed 

professional member of the 

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interdisciplinary team (for this burden 

estimate, we used the nurse) a total of 

35 minutes per client, for a total of 132 

hours per CMHC. Based on the nurses’ 

hourly rate, the total cost will be $6,204 

per CMHC. 

The standard for review of the active 

treatment plan requires the 

interdisciplinary treatment team to 

review and revise the active treatment 

plan as necessary, but no less frequently 

than every 30 calendar days. We 

estimate that updating the content of the 

active treatment plan requires 10 

minutes of the interdisciplinary 

treatment team’s time. Therefore, we 

estimate that compliance with the 

requirements at § 485.916(d) requires a 

licensed professional member of the 

interdisciplinary team (for this burden 

estimate we used the nurse) a total of 10 

minutes per client, for a total of 38 

hours per CMHC. Based on the nurse’s 

hourly rate, the total cost will be $1,786 

per CMHC. 

In addition, the coordination of 

services standard requires 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. We believe that active 

communication within health care 

providers, including CMHCs, is 

standard practice; therefore, this 

requirement does not impose a burden. 

Table 5 below shows the annual 

estimated CMHC burden associated 

with the 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 .. 76 to 114 

Average: 95 

7,600 to 11,400 

Average: 9,500 

$3,572 to $5,358 

Average: $4,465 

$357,200 to $535,800 

Average: $446,500 

Mental Health Counselor ......... 76 to 114 

Average: 95 

7,600 to 11,400 

Average: 9,500 

$2,356 to $3,534 

Average: $2,945 

$235,600 to $353,400 

Average: $294,500 

Clinical Social Worker .............. 76 to 114 

Average: 95 

7,600 to 11,400 

Average: 9,500 

$2,660 to $3,990 

Average: $3,325 

$266,000 to $399,000 

Average: $332,500 

**Total Average (for all disciplines) ................................ 76 to 114 

Total Average: 95 

Total Average Range: 

7,600–11,400 

Total Average: 9,500 

Total Average Range: 

$2,862–$4,294 

Total Average: $3,578 

Total Average Range: 

$286,200–$429,400 

Total Average: $357,800 

Development of the Active 

Treatment Plan ..................... 132 13,200 $6,204 $620,400 

Review and Update of the Active Treatment Plan .............. 38 3,800 $1,786 $178,600 

Total .................................. 265 26,500 $11,568 $1,156,800 

* 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 provided guidance 

to the CMHC on how to establish a 

quality assessment and performance 

improvement program. It is estimated 

that a CMHC will spend approximately 

20 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 will take 9 hours to 

create a program. We also estimate that 

CMHCs will spend 4 hours a year 

collecting and analyzing data. In 

addition, we estimate that a CMHC will 

spend 3 hours a year training their staff 

and 4 hours a year implementing 

performance improvement activities. 

Both the program development and 

implementation will 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 is $1,320 per CMHC. 

$66 per hour × 20 hours = $1,320 

Table 6 below shows the annual 

estimated CMHC burden associated 

with the 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 ........................................................................................... 9 900 $594 $59,400 

QAPI implementation ....................................................................................... 11 1,100 726 72,600 

Total annually ........................................................................................... 20 2,000 1,320 132,000

Organization, Governance, 

Administration of Services, and Partial 

Hospitalization Services (§ 485.918) 

Under the CoP for organization, 

governance, administration of services, 

and partial hospitalization services, we 

assessed the potential impact of the 

following standards on CMHCs: 

Governing body and administration, 

provision of services, professional 

management responsibility, staff 

training, and physical environment. The 

governing body and administration 

standard requires a CMHC to have a 

designated governing body that assumes 

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full legal responsibility for management 

of the CMHC. This standard will 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 does not impose a burden. 

The provision of services standard 

sets forth a comprehensive list of 

services that CMHCs are currently 

required by statute and regulation to 

furnish, requires the CMHC and all 

individuals furnishing services on its 

behalf to meet applicable State licensing 

and certification requirements, and 

requires the CMHC to provide at least 40 

percent of its items and services to 

individuals who are not eligible for 

benefits under title XVIII of the Act. 

In addition, the professional 

management responsibility standard 

requires that, if a CMHC chooses to 

provide certain services under 

agreement, it must ensure that the 

agreement is written. This standard will 

also require the CMHC to retain full 

professional management responsibility 

for the services provided under 

arrangement on its behalf. Full 

professional management responsibility 

will 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 

does not impose a burden. 

Further, the staff training standard 

requires a CMHC to educate all staff 

who have contact with clients and 

families about CMHC care and services. 

It also requires 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 requires 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 requires a 

CMHC to provide and document its inservice training program. This standard 

does not prescribe the content or format 

of the CMHC’s assessment and inservice training programs. Rather, it 

allows CMHCs to establish their own 

policies and procedures to meet their 

individual needs and goals. For 

example, this can be done by inservicing on a need recognized through 

the QAPI program. We believe these 

requirements reflect standard practice in 

the industry and present no additional 

burden. 

The physical environment standard 

requires 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 requirement does 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 standard also requires 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 will 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 provision is $528 to develop 

the infection control program and 

$1,584 annually to follow-up on 

infection control issues in the CMHC. 

We believe that staff education 

regarding infection control will be 

incorporated into the CMHC’s in-service 

training program, described above and 

therefore doesn’t impose additional 

burden. 

Table 7 below shows the initial year 

(one-time) and annual estimated CMHC 

burden, respectively, associated with 

the 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 * ...................................................... 8 800 $528 $52,800 

Infection control follow-up ................................................................................ 24 2,400 1,584 158,400 

Total 1st Year ............................................................................................... 32 3,200 2,112 211,200 

Total Annually .............................................................................................. 24 2,400 1,584 158,400 

* Initial year (one-time) burden items. 

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 CoPs for CMHCs 

on Other Providers 

We do not expect the CoPs for CMHCs 

included in this rule to affect any other 

providers. 

2. Estimated Effects of CoPs for CMHCs 

on the Medicare and Medicaid Programs 

The budget impacts to the Medicare 

and Medicaid programs resulting from 

implementation of the CoPs for CMHCs 

included in this rule are negligible. 

Even though there is likely to be an 

increase in CMS activities, such as onsite surveys, as a result of this final rule, 

CMS will likely be compelled by 

budgetary constraints to accommodate 

these activities into its existing budget. 

We note, however, that the rule-induced 

activities have an opportunity cost equal 

to the value of activities that would 

have been done in the rule’s absence. 

C. Alternatives Considered 

CMHC providers have been operating 

without federally-issued health and 

safety requirements since the 1990 

inception of Medicare coverage of 

partial hospitalization 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. 

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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 possibility of 

significant gaps in State requirements, 

to ensure the health and safety of CMHC 

clients, we chose to propose and are 

finalizing a core set of health and safety 

requirements that will apply to all 

CMHCs receiving Medicare funds, 

regardless of the State in which the 

CMHC is located. These requirements 

ensure a basic level of services provided 

by qualified staff. 

We also considered proposing a more 

comprehensive set of CoPs for CMHCs. 

Such a comprehensive set of CoPs 

would go beyond the requirements in 

this rule to address other areas of CMHC 

services and operations, such as a 

clinical records requirement that would 

outline the specific contents of a clinical 

record. 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 at this time. Furthermore, 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. As a result, we 

chose to focus on a core set of 

requirements and allow for the option of 

additional CoPs in the future. 

Additionally, we considered 

proposing fewer CoPs. However, all of 

the CoPs included in this regulation are 

intended to act as a cohesive system. 

For example eliminating the assessment 

requirement would most likely cause 

issues with the formation of the 

interdisciplinary team and the client’s 

active treatment plan. We believe that 

the CoPs build on each other, and that 

eliminating one or more would 

introduce vulnerabilities in patient 

safety. 

D. Conclusion 

We estimate that this final rule will 

cost CMHCs approximately $3 million 

in the first year of implementation and 

approximately $2.2 million annually 

thereafter. We believe that the burden 

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. 

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 amends 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 and reserve subpart I, and add 

a new subpart J to part 485 to read as 

follows: 

Subpart I—[Reserved] 

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, person-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 partial 

hospitalization services furnished by a 

community mental health center 

(CMHC) as described in section 

1861(ff)(3)(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 

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 

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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 of this chapter. 

(4) Social worker. An individual 

who— 

(i) Has a baccalaureate degree in 

social work from an institution 

accredited by the Council on Social 

Work Education, or a baccalaureate 

degree in psychology or sociology, and 

is supervised by a clinical social worker, 

as described in paragraph (b)(3) of this 

section; and 

(ii) Has 1 year of social work 

experience in a psychiatric healthcare 

setting. 

(5) 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 conducts 

assessments and provides services in 

areas such as psychotherapy, substance 

abuse, crisis management, 

psychoeducation, and prevention 

programs. 

(6) Occupational therapist. A person 

who meets the requirements for the 

definition of ‘‘occupational therapist’’ at 

§ 484.4 of this chapter. 

(7) 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. 

(8) Physician assistant. An individual 

who meets the qualifications and 

conditions as defined in section 

1861(s)(2)(K)(i) of the Act and provides 

the services, in accordance with State 

law, at § 410.74 of this chapter. 

(9) Advanced practice nurse. An 

individual who meets the following 

qualifications: 

(i) Is a nurse practitioner who meets 

the qualifications at § 410.75 of this 

chapter; or 

(ii) Is a clinical nurse specialist who 

meets the qualifications at § 410.76 of 

this chapter. 

(10) 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 1 year of 

education and/or training in psychiatric 

nursing. 

(11) Psychiatrist. An individual who 

specializes in assessing and treating 

persons having psychiatric disorders; is 

board certified, or is eligible to be board 

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 understandable to persons who 

have limited English proficiency. 

(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. (1) 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 

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. 

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(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 to the 

CMHC’s administrator by CMHC 

employees, volunteers and contracted 

staff. 

(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 investigated 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, all 

violations are reported to the State 

survey and certification agency, and 

verified violations are reported to State 

and local entities having jurisdiction. 

(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 one 1-hour 

duration per order. 

(3) The CMHC must obtain a 

corresponding order for the client’s 

immediate transfer to a 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 himself or herself, 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 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 himself or herself, staff or other 

individuals and only in facilities where 

restraint and seclusion are permitted. 

(1) Training intervals. In facilities 

where restraint and seclusion are 

permitted, 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. In facilities 

where restraint and seclusion are not 

permitted, appropriate client care staff 

working in CMHC must be trained in 

the use of alternative methods to 

restraint and seclusion. Training will 

occur 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 could require the use 

of restraint or seclusion. 

(ii) The use of nonphysical 

intervention skills. 

(iii) In facilities where restraint and 

seclusion are permitted, 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 that are 

permitted in the CMHC, including 

training in how to recognize and 

respond to signs of physical and 

psychological distress. 

(v) In facilities where restraint and 

seclusion are permitted, clinical 

identification of specific behavioral 

changes that indicate that restraint or 

seclusion is no longer necessary. 

(vi) In facilities where restraint and 

seclusion are permitted, 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 

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reported to the CMS Regional Office by 

telephone no later than the close of 

business the next business day 

following knowledge of the client’s 

death. 

(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) A 

licensed mental health professional 

employed by the CMHC and acting 

within his or her state scope of practice 

requirements 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 

who 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. 

(3) Based on the findings of the initial 

evaluation, the CMHC must determine 

the appropriate members of each client’s 

interdisciplinary treatment team. 

(c) Standard: Comprehensive 

assessment. (1) The comprehensive 

assessment must be completed by 

licensed mental health professionals 

who are members of the 

interdisciplinary treatment team, 

performing within their State’s scope of 

practice. 

(2) The comprehensive assessment 

must be completed in a timely manner, 

consistent with the client’s immediate 

needs, but no later than 4 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’s interdisciplinary treatment 

team 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, nonphysician practitioner or psychologist 

practicing within the scope of State 

licensure that includes the medical 

history and severity of symptoms. 

Information may be gathered from the 

client’s primary health care provider (if 

any), contingent upon the client’s 

consent. 

(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 

behaviors, including cultural and 

environmental 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, as well 

as suicide risk 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. 

(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. 

(xiv) For pediatric clients, the CMHC 

must assess the social service needs of 

the client, and make referrals to social 

services and child welfare agencies as 

appropriate. 

(d) Standard: Update of the 

comprehensive assessment. (1) The 

CMHC must update the comprehensive 

assessment via the CMHC 

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 goal achievement 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 entity, the CMHC must, 

within 2 working days, forward to the 

entity, 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, person-centered active 

treatment plan, and coordination of 

services. 

The CMHC must designate an 

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. 

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(a) Standard: Delivery of services. (1) 

An interdisciplinary treatment team, led 

by a physician, NP, PA, CNS, clinical 

psychologist, or clinical social worker, 

must provide the care and services 

offered by the CMHC. 

(2) Based on the findings of the 

comprehensive assessment, the CMHC 

must determine the appropriate licensed 

mental health professional, who is a 

member of the client’s interdisciplinary 

treatment 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. 

(3) The interdisciplinary treatment 

team may include: 

(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. 

(vii) Other CMHC staff or volunteers, 

as necessary. 

(4) 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: Person-centered 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 

interdisciplinary treatment team, the 

client, and the client’s primary 

caregiver(s), in accordance with the 

client’s recovery goals and preferences, 

within 7 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 personcentered active treatment plan. The 

CMHC must develop a person-centered 

individualized active treatment plan for 

each client. The active treatment plan 

must take into consideration client 

recovery 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 or 

representative’s and primary caregiver’s 

(if any) understanding, involvement, 

and agreement with the plan of care, in 

accordance with the CMHC’s policies. 

(d) Standard: Review of the personcentered 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 if such 

services are included in the active 

treatment plan. 

(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 and 

non-medical 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, 

and non-medical supports addressing 

environmental factors such as housing 

and employment. 

§ 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 person-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. 

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(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. 

(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 service 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 made up of 

two or more designated persons, one of 

which may be the administrator, that 

assumes full legal authority and 

responsibility for the management of the 

CMHC, the services it furnishes, its 

fiscal operations, and continuous 

quality improvement. One member of 

the governing body must possess 

knowledge and experience as a mental 

health clinician. 

(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 serious 

mental illness, and residents of its 

mental health service 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 number of CMHC clients treated by 

the CMHC for whom services are not 

paid for by Medicare, divided by the 

total number of clients treated by the 

CMHC for each 12-month period of 

enrollment. 

(A) A CMHC is required to submit to 

CMS a certification statement provided 

by an independent entity that certifies 

that the CMHC’s client population 

meets the 40 percent requirement 

specified at this paragraph (b)(1)(v). 

(B) The certification statement 

described in paragraph (b)(1)(v)(A) of 

this section is required upon initial 

application to enroll in Medicare, and as 

a part of revalidation, including any off 

cycle revalidation, thereafter carried out 

pursuant to § 424.530 of this chapter. 

Medicare enrollment will be denied or 

revoked in instances where the CMHC 

fails to provide the certification 

statement as required. Medicare 

enrollment will also be denied or 

revoked if the 40 percent requirement as 

specified in this paragraph (b)(1)(v) is 

not met. 

(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 personcentered care 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) 

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64636 Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Rules and Regulations 

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 

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: September 19, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: September 24, 2013. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2013–24056 Filed 10–28–13; 8:45 am] 

BILLING CODE 4120–01–P 

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