[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Rules and Regulations]
[Pages 64604-64636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24056]
[[Page 64603]]
Vol. 78
Tuesday,
No. 209
October 29, 2013
Part II
Department of Health and Human Services
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Center for Medicare & Medicaid Services
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42 CFR Part 485
Medicare Program: Conditions of Participation (CoPs) for Community
Mental Health Centers; Final Rule
Federal Register / Vol. 78 , No. 209 / Tuesday, October 29, 2013 /
Rules and Regulations
[[Page 64604]]
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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.
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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 Medicare-certified 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, outcome-
oriented 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 Sec. 410.2 and
provides partial hospitalization program (PHP) services that are in
accordance with regulations at Sec. 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 Medicare-enrolled 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/oei-04-11-00100.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
[[Page 64605]]
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 person-centered 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
person-centered 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 (Sec. 485.900)
At Sec. 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 (Sec. 485.902)
At Sec. 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 Sec. 485.918(d). The commenters believe it is unreasonable to
require CMHCs to provide the specific training and competency
assessments required under Sec. 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, de-escalation 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
[[Page 64606]]
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 (Sec. 485.904)
We proposed to add a new CoP at Sec. 485.904 to establish staff
qualifications for CMHCs. The proposed CoP was divided into two
standards.
At Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
[[Page 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 Sec. 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
non-profit 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 Sec.
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 Sec. 485.914, ``Admission, initial assessment,
comprehensive assessment and discharge or transfer of the client'' and
Sec. 485.916, ``Treatment team, person-centered 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 Sec. 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 Sec. 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 board-certified 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 board-
certified. 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 board-certified
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
[[Page 64608]]
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 Sec. 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 Sec. 410.73.
If the CMHC chooses to also employ a social worker that does not meet
Sec. 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 Sec. 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 Sec.
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 Sec.
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 Sec.
485.904(b)(5), Mental health counselor, to include ``assessments.'' We
have also modified the language at Sec. 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 Sec. 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 Sec. 485.904(b)(2) is vague and lacks
quality assurance
[[Page 64609]]
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 Sec.
485.904(b)(2) reference the clinical psychologist qualification
requirements at Sec. 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 non-
accredited 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
Sec. 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 Sec. 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 Sec. 485.904(b)(8) to set requirements for
PAs, and have re-designated 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 (Sec. 485.910)
We proposed to add a new CoP at Sec. 485.910. The proposed CoP was
divided into six standards.
At Sec. 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 Sec. 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 Sec. 485.914(b).
At Sec. 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 Sec. 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 Sec. 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 Sec. 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
[[Page 64610]]
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 Sec. 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 Sec. 482.13. The hospital restraint and seclusion
CoP is the basis for the proposed CMHC restraint and seclusion CoP,
with modifications to the regulatory requirements to accommodate this
outpatient setting.
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 Sec. 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. Sec. 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
[[Page 64611]]
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 Sec.
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 Sec.
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 de-escalation 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 Sec.
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 in-service
training requirements at Sec. 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
[[Page 64612]]
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 Sec. 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 (Sec. 485.914)
We proposed to add a new CoP at Sec. 485.914 to establish
requirements for admission, initial evaluation, comprehensive
assessment, and discharge or transfer of the client. The proposed CoP
at Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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).
[[Page 64613]]
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 Sec. 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 Sec. 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 Sec. 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 Sec. 485.14(b)(4)(v) to include environmental factors and at Sec.
485.16(e)(5) to include coordination of services with other healthcare
and non-medical 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-the-counter 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-the-counter
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 Sec. 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.
[[Page 64614]]
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 Sec.
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 Sec. 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 Sec. 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 Sec. 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, Sec.
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 non-compliant 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 Sec. 485.914(e).
CMHC CoP: Treatment Team, Person-Centered Active Treatment Plan, and
Coordination of Services (Sec. 485.916)
We proposed to add a new CoP at Sec. 485.916 to establish
requirements for an active treatment plan and coordination of services.
At Sec. 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 Sec. 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
[[Page 64615]]
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 Sec. 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 Sec. 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 Sec. 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-to-day 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 Sec. 485.916(b),
``Standard: Active treatment plan'' to add ``primary caregiver.''
Comment: Many commenters believe that the proposed CoPs were over-
reaching 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
Sec. 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
short-term 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 Sec.
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
[[Page 64616]]
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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
[[Page 64617]]
have amended the language in Sec. 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 recovery-focused 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 Sec. 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 Sec.
485.917)
We proposed to add a new CoP at Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
[[Page 64618]]
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 Sec. 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, Sec. 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, Sec. 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 data-driven 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 CMHC-wide 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 (Sec. 485.918)
We proposed to add a new CoP at Sec. 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 Sec. 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 Sec. 485.918(b), ``Provision of services,'' we proposed to
specify a comprehensive list of services that a CMHC would be required
to provide. At Sec. 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 Sec. 410.2 set out in
the November 24, 2010 Outpatient Prospective Payment System (OPPS)
[[Page 64619]]
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, Sec. 410.110,
and Sec. 424.24(e)). It is essential for CMHCs to have sufficient
numbers of appropriately educated and trained staff to meet these
service expectations. For example, CMHCs that provide partial
hospitalization services could provide the services of ``other staff
trained to work with psychiatric clients'' (42 CFR 410.43(a)(3)(iii)).
Non-specified staff might be responsible for supervising clients and
ensuring a safe environment. CMHCs would be expected to have a
sufficient number of appropriately-trained staff to meet these
responsibilities at all times.
At Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
[[Page 64620]]
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 Sec. 488.6 to grant deeming authority for CMHCs to
accrediting organizations. CMS's regulation at Sec. 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 patient-centric 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 Sec. 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 Sec. 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 Sec. 424.530(a)(1))
or revoked for non-compliance (see Sec. 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 Sec. 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.
[[Page 64621]]
Comment: Several commenters stated that volunteers should not be
included in the staff education component described by Sec.
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
person-centered 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 Sec. 485.918(d)(3) requires
that CMHCs ``assess the skills and competence of all individuals
furnishing care[hellip].'' 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 Sec. 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 Sec. 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.
[[Page 64622]]
Table 1--Assumptions and Estimates Used Throughout the Collection of
Information and Impact Analysis Sections
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of Medicare CMHCs nationwide (Based on CY 2012 100
CMS data)............................................
Number of CMHC clients nationwide * (Estimate based on 22,700
CY 2010 data)........................................
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 (Sec.
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 x 22,700 clients).
The estimated cost associated with these requirements is $44,509, based
on a psychiatric nurse performing this function (947 hours x $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 Sec. 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, Sec. 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
[[Page 64623]]
fewer than 10 entities in a 12-month period.
B. ICRs Related to Condition of Participation: Admission, Initial
Evaluation, Comprehensive Assessment, and Discharge or Transfer of the
Client (Sec. 485.914)
Section 485.914(b) through (e) requires each CMHC to conduct and
document in writing an initial evaluation and a comprehensive client-
specific assessment; maintain documentation of the assessment and any
updates; and coordinate the discharge or transfer of the client. The
burden associated with these 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 (Sec. 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 Sec. 485.916(c) specify the minimum elements
that the active treatment plan must include. In addition, in Sec.
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 x $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 Sec. 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 (Sec. 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 (Sec. 485.918)
Section 485.918(b) lists care and services a Medicare CMHC must be
primarily engaged in regardless of payer type. Specifically, Sec.
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, Sec. 485.918(d)(2) requires a CMHC to
[[Page 64624]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly Total
OMB Burden per Total labor cost labor cost Total
Regulation section(s) Control Respondents Responses response annual of of capital/ Total cost
No. (hours) burden reporting reporting maintenance ($)
(hours) ($) ($) costs ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 485.910(a)(1)...................... 0938-New 100 100 8 800 66 52,800 0 52,800
Sec. 485.910(a)(3)...................... 0938-New 100 22,700 .0417 947 47 44,509 0 44,509
Sec. 485.910(d)(2)...................... 0938-New 100 5,200 .0833 433 66 28,578 0 28,578
Sec. 485.910(d)(4)...................... 0938-New 100 5,200 .0833 433 66 28,578 0 28,578
Sec. 485.910(e)(4)(v)................... 0938-New 100 100 .75 75 47 3,525 0 3,525
Sec. 485.910(f)(4)...................... 0938-New 100 700 .0833 58 47 2,726 0 2,726
Sec. 485.916(c)......................... 0938-New 100 22,700 .1667 3784 47 177,848 ........... 177,848
Sec. 485.916(d)......................... 0938-New 100 22,700 .0833 1891 47 88,877 0 88,877
Sec. 485.917............................ 0938-New 100 100 4 400 66 26,400 0 26,400
Sec. 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: [email protected].
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 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 Total industry time Total cost per average
average CMHC (hours) 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 265 26,500 $11,568 $1,156,800
Coordination of Services...........................
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 (Sec. 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 x 22,700 clients). The estimated cost associated with these
requirements is $44,509, based on a psychiatric registered nurse
performing this function (947 hours x $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
[[Page 64626]]
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
Sec. 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 Sec. 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 train-the-trainer programs can be found on
CPI, Inc.'s Web site at http://www.crisisprevention.com.
We estimate, on average, that the cost to train one nurse 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
[[Page 64627]]
estimated total annual cost for all CMHCs.
4 hours x $47/hr = $188 per CMHC
$188 per CMHC x 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
----------------------------------------------------------------------------------------------------------------
Total time Cost per
Standard Time per average CMHC (in hours) 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 (Sec. 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 (Sec. 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
(Sec. 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 Sec. 485.916(c) requires a licensed
professional member of the
[[Page 64628]]
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 Sec. 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 7,600 to 11,400 $3,572 to $5,358 $357,200 to $535,800
Average: 95 Average: 9,500 Average: $4,465 Average: $446,500
Mental Health Counselor......................... 76 to 114 7,600 to 11,400 $2,356 to $3,534 $235,600 to $353,400
Average: 95 Average: 9,500 Average: $2,945 Average: $294,500
Clinical Social Worker.......................... 76 to 114 7,600 to 11,400 $2,660 to $3,990 $266,000 to $399,000
Average: 95 Average: 9,500 Average: $3,325 Average: $332,500
**Total Average (for all disciplines)........... 76 to 114 Total Average Range: Total Average Range: Total Average Range:
Total Average: 95 7,600-11,400 $2,862-$4,294 $286,200-$429,400
Total Average: 9,500 Total Average: $3,578 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 (Sec. 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 x 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
----------------------------------------------------------------------------------------------------------------
Time per CMHC Total time
Standard (hours) (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 (Sec. 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
[[Page 64629]]
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
in-service training program. This standard does not prescribe the
content or format of the CMHC's assessment and in-service 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 in-servicing 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 Total time (in Cost per Total cost
(in hours) hours) average CMHC
----------------------------------------------------------------------------------------------------------------
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 on-site 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.
[[Page 64630]]
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
0
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)).
0
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)
Sec. 485.900 Basis and scope.
(a) Basis. This subpart is based on the following sections of the
Social Security Act:
(1) Section 1832(a)(2)(J) of the Act specifies that payments may be
made under Medicare Part B for 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.
Sec. 485.902 Definitions.
As used in this subpart, unless the context indicates otherwise--
Active treatment plan means an individualized client plan that
focuses on the provision of care and treatment services that address
the client's physical, psychological, psychosocial, emotional, and
therapeutic needs and goals as identified in the comprehensive
assessment.
Community mental health center (CMHC) means an entity as defined in
Sec. 410.2 of this chapter.
Comprehensive assessment means a thorough evaluation of the
client's physical, psychological, psychosocial, emotional, and
therapeutic needs related to the diagnosis under which care is being
furnished by the CMHC.
Employee of a CMHC means an individual--
(1) Who works for the CMHC and for whom the CMHC is required to
issue a W-2 form on his or her behalf; or
(2) For whom an agency or organization issues a W-2 form, and who
is assigned to such CMHC if the CMHC is a subdivision of an agency or
organization.
Initial evaluation means an immediate care and support assessment
of the client's physical, psychosocial (including a screen for harm to
self or others), and therapeutic needs related to the psychiatric
illness and related conditions for which care is being furnished by the
CMHC.
Representative means an individual who has the authority under
State law to authorize or terminate medical care on behalf of a client
who is mentally or physically incapacitated. This includes a legal
guardian.
Restraint means--
(1) Any manual method, physical or mechanical device, material, or
equipment that immobilizes or reduces
[[Page 64631]]
the ability of a client to move his or her arms, legs, body, or head
freely, not including devices, such as orthopedically prescribed
devices, surgical dressings or bandages, protective helmets, or other
methods that involve the physical holding of a client for the purpose
of conducting routine physical examinations or tests, or to protect the
client from falling out of bed, or to permit the client to participate
in activities without the risk of physical harm (this does not include
a client being physically escorted); or
(2) A drug or medication when it is used as a restriction to manage
the client's behavior or restrict the client's freedom of movement, and
which is not a standard treatment or dosage for the client's condition.
Seclusion means the involuntary confinement of a client alone in a
room or an area from which the client is physically prevented from
leaving.
Volunteer means an individual who is an unpaid worker of the CMHC;
or if the CMHC is a subdivision of an agency or organization, is an
unpaid worker of the agency or organization and is assigned to the
CMHC. All volunteers must meet the standard training requirements under
Sec. 485.918(d).
Sec. 485.904 Condition of participation: Personnel qualifications.
(a) Standard: General qualification requirements. All professionals
who furnish services directly, under an individual contract, or under
arrangements with a CMHC, must be legally authorized (licensed,
certified or registered) in accordance with applicable Federal, State
and local laws, and must act only within the scope of their State
licenses, certifications, or registrations. All personnel
qualifications must be kept current at all times.
(b) Standard: Personnel qualifications for certain disciplines. The
following qualifications must be met:
(1) Administrator of a CMHC. A CMHC employee who meets the
education and experience requirements established by the CMHC's
governing body for that position and who is responsible for the day-to-
day operation of the CMHC.
(2) Clinical psychologist. An individual who meets the
qualifications at Sec. 410.71(d) of this chapter.
(3) Clinical Social worker. An individual who meets the
qualifications at Sec. 410.73 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 Sec. 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 Sec. 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 Sec. 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 Sec.
410.75 of this chapter; or
(ii) Is a clinical nurse specialist who meets the qualifications at
Sec. 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.
Sec. 485.910 Condition of participation: Client rights.
The client has the right to be informed of his or her rights. The
CMHC must protect and promote the exercise of these client rights.
(a) Standard: Notice of rights and responsibilities. (1) During the
initial evaluation, the CMHC must provide the client, the client's
representative (if appropriate) or surrogate with verbal and written
notice of the client's rights and responsibilities. The verbal notice
must be in a language and manner that the client or client's
representative or surrogate understands. Written notice must be
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.
[[Page 64632]]
(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 Sec. 485.902, may only be imposed to ensure the immediate physical
safety of the client, staff, or other individuals.
(2) The use of restraint or seclusion must be in accordance with
the written order of a physician or other licensed independent
practitioner who is authorized to order restraint or seclusion in
accordance with State law and must not exceed 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
[[Page 64633]]
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.
Sec. 485.914 Condition of participation: Admission, initial
evaluation, comprehensive assessment, and discharge or transfer of the
client.
The CMHC must ensure that all clients admitted into its program are
appropriate for the services the CMHC furnishes in its facility.
(a) Standard: Admission. (1) The CMHC must determine that each
client is appropriate for the services it provides as specified in
Sec. 410.2 of this chapter.
(2) For clients assessed and admitted to receive partial
hospitalization services, the CMHC must also meet separate requirements
as specified in Sec. 485.918(f).
(b) Standard: Initial evaluation. (1) 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, non-
physician 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.
Sec. 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.
[[Page 64634]]
(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 person-centered 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 person-centered active treatment plan.
The CMHC interdisciplinary treatment team must review, revise, and
document the individualized active treatment plan as frequently as the
client's condition requires, but no less frequently than every 30
calendar days. A revised active treatment plan must include information
from the client's initial evaluation and comprehensive assessments, the
client's progress toward outcomes and goals specified in the active
treatment plan, and changes in the client's goals. The CMHC must also
meet partial hospitalization program requirements specified under Sec.
424.24(e) of this chapter 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.
Sec. 485.917 Condition of participation: Quality assessment and
performance improvement.
The CMHC must develop, implement, and maintain an effective,
ongoing, CMHC-wide data-driven quality assessment and performance
improvement program (QAPI). The CMHC's governing body must ensure that
the program reflects the complexity of its organization and services,
involves all CMHC services (including those services furnished under
contract or arrangement), focuses on indicators related to improved
behavioral health or other healthcare outcomes, and takes actions to
demonstrate improvement in CMHC performance. The CMHC must maintain
documentary evidence of its quality assessment and performance
improvement program and be able to demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The CMHC program must be able to
demonstrate measurable improvement in indicators related to improving
behavioral health outcomes and CMHC services.
(2) The CMHC must measure, analyze, and track quality indicators;
adverse client events, including the use of restraint and seclusion;
and other aspects of performance that enable the CMHC to assess
processes of care, CMHC services, and operations.
(b) Standard: Program data. (1) The program must use quality
indicator data, including client care, and other relevant data, in the
design of its program.
(2) The CMHC must use the data collected to do the following:
(i) Monitor the effectiveness and safety of services and quality of
care.
(ii) Identify opportunities and priorities for improvement.
(3) The frequency and detail of the data collection must be
approved by the CMHC's governing body.
(c) Standard: Program activities. (1) The CMHC's performance
improvement activities must:
(i) Focus on high risk, high volume, or problem-prone areas.
(ii) Consider incidence, prevalence, and severity of problems.
(iii) Give priority to improvements that affect behavioral
outcomes, client safety, and 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.
[[Page 64635]]
(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.
Sec. 485.918 Condition of participation: Organization, governance,
administration of services, and partial hospitalization services.
The CMHC must organize, manage, and administer its resources to
provide CMHC services, including specialized services for children,
elderly individuals, individuals with serious mental illness, and
residents of its mental health 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 Sec. 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 person-centered 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)
[[Page 64636]]
of assessing competency and must maintain a written description of the
in-service training provided during the previous 12 months.
(e) Standard: Physical environment. (1) Environmental conditions.
The CMHC must provide a safe, functional, sanitary, and comfortable
environment for clients and staff that is conducive to the provision of
services that are identified in paragraph (b) of this section.
(2) Building. The CMHC services must be provided in a location that
meets Federal, State, and local health and safety standards and State
health care occupancy regulations.
(3) Infection control. There must be policies, procedures, and
monitoring for the prevention, control, and investigation of infection
and communicable diseases with the goal of avoiding sources and
transmission of infection.
(4) Therapy sessions. The CMHC must ensure that individual or group
therapy sessions are conducted in a manner that maintains client
privacy and ensures client dignity.
(f) Standard: Partial hospitalization services. A CMHC providing
partial hospitalization services must--
(1) Provide services as defined in Sec. 410.2 of this chapter.
(2) Provide the services and meet the requirements specified in
Sec. 410.43 of this chapter.
(3) Meet the requirements for coverage as described in Sec.
410.110 of this chapter.
(4) Meet the content of certification and plan of treatment
requirements as described in Sec. 424.24(e) of this chapter.
(g) Standard: Compliance with Federal, State, and local laws and
regulations related to the health and safety of clients. The CMHC and
its staff must operate and furnish services in compliance with all
applicable Federal, State, and local laws and regulations related to
the health and safety of clients. If State or local law provides for
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