Form CMS-R-305 Attachment C final BBAC

ATTACHMENT C
Sample Documentation and Reporting Tool
for Recording MCO/PIHP Compliance with
Medicaid Managed Care Regulatory Provisions

This sample documentation and reporting tool illustrates how results of monitoring activities
could be recorded. Entities conducting compliance reviews may find it helpful to use this tool,
modify this tool, or use a tool of their own design. Whatever tool is used, all entities conducting
compliance reviews must use some approach that documents, in writing, their findings with
respect to MCO/PIHP compliance with individual regulatory provisions. Reviewers will use their
personal notes recorded during or immediately following data gathering activities to complete
this data reporting tool.
This tool contains three components:
1) First, it presents each of the applicable regulatory provisions of subparts C, D and F (Enrollee
Rights, Quality Assessment and Performance Improvement, and the Grievance System,
respectively) as well as supporting notes and definitions. Regulatory provisions have been
divided into distinct parts to facilitate compliance determination. For ease of use, whenever
subparts C, D or F contain a cross-reference to a regulatory provision that is not in subparts C,
D, or F, these provisions are included with the regulatory provision that contains the cross
reference.
2) Next to each regulatory provision is space for indicating the extent to which an MCO/PIHP is
in compliance with the provision. Three possible compliance designations are presented: Met,
Partially Met, and Not Met. These designations should be amended to reflect whatever
compliance categories are specified by the State (See Protocol Activity 6, pp. 62-64).
3) Below each grouping of regulatory provisions, space is provided to allow reviewers to
reference documentation or other evidence supporting the compliance designations.

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Subpart C Regulations: Enrollee Rights and Protections

§438.100

Met

Partially
Met

Not
Met

Enrollee rights.

(a) General rule. The State must ensure that-(1) Each MCO and each PIHP has written policies regarding the
enrollee rights specified in this section; and
(2) Each MCO, PIHP, . . . complies with any applicable
Federal and State laws that pertain to enrollee rights, and ensures
that its staff and affiliated providers take those rights into account
when furnishing services to enrollees.
Documentation for 438.100(a)

§438.100 Enrollee rights.
(b) Specific rights.
(1) Basic requirement. The State must ensure that . . .
(2) An enrollee of an MCO, PIHP, . . . has . . .;
The right to-(i) Receive information in accordance with §438.10. [Section
438.10 is stated below.]

§438.10 Information requirements.
(b) Basic rule. Each . . . MCO, PIHP, . . . must provide all
enrollment notices, informational materials, and instructional
materials relating to enrollees and potential enrollees in a manner
and format that may be easily understood.
Documentation for 438.10(b)

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Partially
Met

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§438.10 Information requirements.
(c) Language. The State must…:
(3) Require each MCO, PIHP, . . . to make its written information
available in the prevalent, non-English languages in its particular
service area.
Documentation for 438.10(c)(3)

§438.10 Information requirements.
(c) Language. The State must…:
(4) . . . require each MCO, PIHP, . . . to make those services [i.e.,
oral interpretation services] available free of charge to the each
potential enrollee and enrollee. This applies to all non-English
languages, not just those the State identifies as prevalent.
(5) . . . require each MCO, PIHP, . . . to notify its enrollees-(i) That oral interpretation is available for any language and
written information is available in prevalent languages; and
(ii) How to access those services.
Documentation for 438.10(c)(4) and (5)

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Met

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§438.10 Information requirements.
(d) Format.
(1) Written material must-(i) Use easily understood language and format;
Documentation for 438.10(d)(1)(i)

§438.10 Information requirements.
(d) Format.
(1) Written material must-(ii) Be available in alternative formats and in an appropriate manner
that takes into consideration the special needs of those who, for
example, are visually limited or have limited reading proficiency.
(2) All enrollees and potential enrollees must be informed that
information is available in alternative formats and how to access
those formats.
Documentation for 438.10(d)(1)(ii) and (2)

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§438.10 Information requirements.
(f) General information for all enrollees of MCOs, PIHPs, . . .
Information must be made available to MCO, PIHP, . . . enrollees
as follows:
(2) The State, its contracted representative, or the MCO, PIHP, . . .
must notify all enrollees of their right to request and obtain the
information listed in paragraph (f)(6) of this section, and if
applicable, paragraphs (g)…of this section, at least once a year.
(3) The State, its contracted representative, or the MCO, PIHP, . . .
must furnish to each of its enrollees the information listed in
paragraph (f)(6) of this section, and, if applicable, paragraphs (g)…
of this section, within a reasonable time after the MCO, PIHP, . . .
receives, from the State or its contracted representative, notice of
the recipient’s enrollment.
(4) … the MCO, PIHP, . . . must give each enrollee written notice
of any change (that the State defines as “significant”) in the
information specified in paragraph (f)(6) of this section, and, if
applicable, paragraphs (g)… of this section, at least 30 days before
the intended effective date of the change.
(5) The MCO, PIHP, . . . must make a good faith effort to give
written notice of termination of a contracted provider, within 15
days after receipt or issuance of the termination notice, to each
enrollee who received his or her primary care from, or was seen on
a regular basis by, the terminated provider.
(6) … the MCO, or PIHP,… must provide the following
information to all enrollees:
(i) Names, locations, telephone numbers of, and non-English
languages spoken by current contracted providers in the enrollee’s
service area, including identification of providers that are not
accepting new patients. For MCOs, PIHPs,… this includes, at a
minimum, information on primary care physicians, specialists, and
hospitals.
(ii) Any restrictions on the enrollee’s freedom of choice among
network providers. [Related provisions addressing the free choice
of providers for family planning services are included herein:]
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431.51 Free choice of providers
(a) Statutory basis. ***
(4) Section 1902(a)(23) of the Act provides that a recipient
enrolled in a … Medicaid managed care organization
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(MCO) may not be denied freedom of choice of
qualified providers of family planning services.
(5) Section 1902(e)(2) of the Act provides that an
enrollee who, while completing a minimum
enrollment period, is deemed eligible only for
services furnished by or through the MCO… may
as an exception to the deemed limitation, seek
family planning services from any qualified
provider.
(6) Section 1932(a) of the Act permits a State to restrict
the freedom of choice required by section
1902(a)(23), under specified circumstances, for all
services except family planning services.
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(iii) Enrollee rights and responsibilities, as specified in §438.100
(iv) Information on grievance and fair hearing procedures, and the
information specified in §438.10(g)(i)…
(v) The amount, duration, and scope of benefits available under the
contract in sufficient detail to ensure that enrollees understand the
benefits to which they are entitled.
(vi) Procedures for obtaining benefits, including authorization
requirements.
(vii) The extent to which, and how, enrollees may obtain benefits,
including family planning services, from out-of-network providers.
(viii) The extent to which, and how, after-hours and emergency
coverage are provided, including:
(A) What constitutes emergency medical condition, emergency
services, and post-stabilization services, with reference to the
definitions in §438.114 (a). [Section 438.114 definitions listed
below:]
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438.114 Emergency and post-stabilization services
(a) Definitions. As used in this section-Emergency medical condition means a medical condition
manifesting itself by acute symptoms of sufficient severity
(including severe pain) such that a prudent layperson, who
possess an average knowledge of health and medicine, could
reasonably expect the absence of immediate medical
attention to result in the following:
(1) Placing the health of the individual (or with respect to a
pregnant woman, the health of the woman or her unborn
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child) in serious jeopardy.
(2) Serious impairment to bodily functions; or
(3) Serious dysfunction of any bodily organ or part.
Emergency services means covered inpatient or outpatient
services that are as follows:
(1) Furnished by a provider qualified to furnish
these services under this title.
(2) Needed to evaluate or stabilize an emergency
medical condition.
Post-stabilization care services means covered services,
related to an emergency medical condition that are provided
after an enrollee is stabilized in order to maintain the
stabilized condition, or, under the circumstances described in
paragraph (e) of this section, to improve or resolve the
enrollee’s condition.”
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(B) The fact that prior authorization is not required for
emergency services.
(C) The process and procedures for obtaining emergency
services, including use of the 911-telephone system or its
local equivalent.
(D)The locations of any emergency settings and other
locations at which providers and hospitals furnish emergency
services and post-stabilization services covered under the
contract.
(E) The fact that, subject to the provisions of this section, the
enrollee has the right to use any hospital or other setting for
emergency care.
(ix) The post-stabilization care service rules set forth at 422.113(c)
of this chapter. [Section 422.113(c) is stated below.]
******************************************
422.113(c) Maintenance care and post-stabilization care
services.
(1) Definition. [This is the same as shown above.]
(2) M+C organization financial responsibility. The
M+C organization—
(i) Is financially responsible (consistent with § 422.214)
for post-stabilization care services obtained within or
outside the M+C organization that re pre-approved by a
plan provider or other M+C organization representative;
(ii) Is financially responsible for post-stabilization care
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services obtained within or outside the M+C
organization that are not pre-approved by a plan
provider or other M+C organization representative, but
administered to maintain the enrollee’s stabilized
condition within 1 hour of a request to the M+C
organization for pre-approval of further poststabilization care services;
(iii) Is financially responsible for post-stabilization care
services obtained within or outside the M+C
organization that are not pre-approved by a plan
provider or other M+C organization representative, but
administered to maintain, improve, or resolve the
enrollee’s stabilized condition if—
(A) The M+C organization does not respond to a request
for pre-approval within 1hour;
(B) The M+C organization cannot be contacted; or
(C) The M+C organization representative and the
treating physician cannot reach an agreement concerning
the enrollee’s care and a plan physician is not available
for consultation. In this situation, the M+C organization
must give the treating physician the opportunity to
consult with a plan physician and the treating physician
may continue care of the patient until a plan physician is
reached or one of the criteria in § 422.113(c)(3) is met;
and
(iv) Must limit charges to enrollees for post-stabilization
care services to an amount no greater than what the
organization would charge the enrollee if he or she had
obtained the services through the M+C organization.
(3) End of M+C organization’s financial responsibility.
The M+C organization’s financial responsibility for
post-stabilization care services it has not approved ends
when—
(i) A plan physician with privileges at the treating
hospital assumes responsibility for the enrollee’s care;
(ii) A plan physician assumes responsibility for the
enrollee’s care through transfer;
(iii) An M+C organization representative and the
treating physician reach an agreement concerning the
enrollee’s care; or

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(iv) The enrollee is discharged.
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(x)Policy on referrals for specialty care and for other benefits not
furnished by the enrollee’s primary care provider.
(xi) Cost sharing, if any.
(xii) How and where to access any benefits that are available under
the State plan but are not covered under the contract, including any
cost-sharing, and how transportation is provided. For a counseling
or referral service that the MCO, PIHP… does not cover because of
moral or religious objections, the MCO, PIHP… need not furnish
information on how and where to obtain the service. The State must
furnish information about how and where to obtain the service.
Documentation for 438.10(f)

(g) Specific information requirements for enrollees of MCOs and
PIHPs. In addition to the requirements in §438.10(f),… the MCO
and PIHP must provide the following information to their enrollees:
(1) Grievance, appeal, and fair hearing procedures and timeframes,
as provided in §§438.400 through 438.424, in a State-developed or
State-approved description, that must include the following:
(i) For State fair hearing-(A) The right to hearing;
(B) The method for obtaining a hearing; and
(C) The rules that govern representation at the hearing.
(ii) The right to file grievances and appeals.
(iii)The requirements and timeframes for filing a grievance or
appeal.
(iv) The availability of assistance in the filing process.
(v) The toll-free numbers that the enrollee can use to file a
grievance or an appeal by phone.
(vi) The fact that, when requested by the enrollee-197

Subpart C Regulations: Enrollee Rights and Protections

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(A) Benefits will continue if the enrollee files an appeal or a
request for State fair hearing within the timeframes
specified for filing; and
(B) The enrollee may be required to pay the cost of services
furnished while the appeal is pending, if the final decision is
adverse to the enrollee.
(vii) Any appeal rights that the State chooses to make available to
providers to challenge the failure of the organization to cover a
service.
(2) Advance directives, as set forth in §438.6(i)(2). [Compliance
with requirements for advance directives are addressed as part of
the provisions of §438.100(b)(2)(iv) pertaining to enroll
participation in treatment decisions.]
(3) Physician incentive plans as set forth in §438.6(h) of this
chapter. [Section 438.6(h) is stated below].
*****************************************************
438.6(h) Physician incentive plans
(1) MCO, PIHP,… contracts must provide for compliance with
the requirements set forth in §§ 422.208 and 422.210 of this
chapter.
(2) In applying the provision of §§ 422.208 and 422.210 of this
chapter, references to “M+C organization”, “CMS’, and
“Medicare beneficiaries” must be read as references to
“MCO, PIHP,…”, “State agency” and “Medicaid
recipients”, respectively.
*****************************************************
Documentation for 438.10(g)

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(i) Special rules: States with mandatory enrollment under state
plan authority.-(1) Basic rule. If the State plan provides for mandatory enrollment
under §438.50, the State or its contracted representative must
provide information on MCOs,… (as specified in paragraph (i)(3)
of this section), either directly or through the MCO….
(2) When and how the information must be furnished. The
information must be furnished as follows:
(i) For potential enrollees, within the timeframe specified in
§438.10(e)(1).
(ii) For enrollees, annually and upon request.
(iii) In a comparative, chart-like format.
(3) Required information. Some of the information is the same as
the information required for potential enrollees under paragraph (e)
of this section and for enrollees under paragraph (f) of this section.
However, all of the information in this paragraph is subject to the
timeframe and format requirements of paragraph (i)(2) of this
section, and includes the following for each contracting MCO… in
the potential enrollee and enrollee’s service area:
(i) The MCO’s. . . service area.
(ii) The benefits covered under the contract.
(iii) Any cost sharing imposed by the MCO…[Related
provisions addressing cost sharing are included below.]
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438.106 Liability for payment
Each MCO, PHIP… must provide that its Medicaid enrollees are
not held liable for any of the following:
(a) The MCO’s, PIHP’s… debts, in the event of the entity’s
insolvency.
(b) Covered services provided to the enrollee, for which –
(1) The State does not pay the MCO, PIHP,…; or
(2) The State, or the MCO, PIHP,… does not pay the
individual or health care provider that furnishes the
services under a contractual, referral, or other
arrangement.
(c) Payments for covered services furnished under a contract,
referral, or other arrangement, to the extent that those
payments are in excess of the amount that the enrollee
would owe if the MCO, PIHP … provided the services
directly.

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438.108 Cost sharing
The contract must provide that any cost sharing imposed on
Medicaid enrollees is in accordance with 447.50 through 447.60 of
this chapter.
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(iv) To the extent available, quality and performance
indicators, including but not limited to, disenrollment rates as
defined by the State, and enrollee satisfaction.
Documentation for 438.10(h)

§438.100 Enrollee rights (cont.)
(b) Specific rights.
(1) Basic requirement. The State must ensure that each managed
care enrollee is guaranteed the rights as specified in paragraph
(b)(2) and (b)(3) of this section.
(2) An enrollee of an MCO, PIHP,… has the following rights: The
right to-(ii) Be treated with respect and with due consideration for his
or her dignity and privacy;

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§438.100 Enrollee rights (cont.)
(b) Specific rights.
(1) Basic requirement. The State must ensure that each managed
care enrollee . . .
(2) . . . has . . . The right to-(iii) Receive information on available treatment options and
alternatives, presented in a manner appropriate to the enrollee’s
condition and ability to understand. (The information requirements
for services that are not covered under the contract because of
moral or religious objections are set forth in §438.10(f)(6)(xii).
Note to reviewers: See related §438.102 and its exception
clause, below:
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§438.102 Provider-enrollee communications
(a) General rules.
(1) An MCO, PIHP. . . may not prohibit, or otherwise restrict, a
health care professional acting within the lawful scope of
practice, from advising or advocating on behalf of an enrollee
who is his or her patient, for the following:
(i) The enrollee’s health status, medical care or treatment
options, including any alternative treatment that may be
self-administered.
(ii) Any information the enrollee needs in order to decide
among all relevant treatment options.
(iii) The risks, benefits, and consequences of treatment or
nontreatment.
(iv) The enrollee’s right to participate in decisions regarding
his or her health care, including the right to refuse
treatment, and to express preferences about future
treatment decisions.
(2) Subject to the information requirements of paragraph (b) of
this section, an MCO, PIHP… that would otherwise be
required to provide, reimburse for, or provide coverage of,
a counseling or referral service because of the requirement
in paragraph (a)(1) of this section is not required to do so
if the MCO, PIHP, . . . objects to the service on moral or
religious grounds.
(b) Information requirements: MCO, PIHP. . . responsibility.
(1) An MCO, PIHP…that elects the option provided in
paragraph (a)(2) of this section must furnish information
about the services it does not cover as follows:
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(i) To the State-(A) With its application for a Medicaid contract; and
(B) Whenever it adopts the policy during the term of the
contract.
(ii) Consistent with the provisions of §438.10—
(A) To potential enrollees, before and during enrollment; and
(B) To enrollees, within 90 days after adopting the policy with
respect to any particular service. (Although this timeframe
would be sufficient to entitle the MCO, PIHP . . . to the
option provided in paragraph (a)(2) of this section, the
overriding rule in § 438.10(f)(4) requires the MCO, PIHP,.
. . to furnish the information at least 30 days before the
effective date of the policy.)
(3) As specified in § 438.10(f), the information that MCOs,
PIHPs, . . must furnish to enrollees does not include how
and where to obtain the service excluded under paragraph
(a)(2) of this section.
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Documentation for 438.100(b)(2)(iii)

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§438.100 Enrollee rights (cont.)
(b) Specific rights.
(1) Basic requirement. The State must ensure that. . .
(2) An enrollee of an MCO, PIHP, . . . has the . . . right to-(iv) Participate in decisions regarding his or her health
care, including the right to refuse treatment.
(v) Be free from any form of restraint or seclusion used as
a means of coercion, discipline, convenience, or
retaliation, as specified in other Federal regulations on the
use of restraints and seclusion.
Note: Section 438.10(g)(2) requires that MCO and PIHP
enrollees receive information on advance directives. Because of
the relationship of advance directives to decisions regarding
health care, these provisions are discussed in this section.
438.10(g) states that, “. . .MCOs and PIHPs must provide to their
enrollees, information on
2) Advance Directives, as set forth in §438.6(i)(2). [ Section
438.6(i)(2) is stated below.]
************************************************
438.6(i)Advance Directives
(1) All MCO and PIHP contracts must provide for compliance
with the requirements of §422.128 of this chapter for
maintaining written policies and procedures with respect to
advance directives. (Note: Section 422.128(a) requires that
each organization must maintain written policies and
procedures that meet the requirements for advance
directives, as set forth in subpart I of part 489 of this
chapter. Section 489.102(d) requires adherence to §417.436
requirements which are stated below.)
(2) The MCO or PIHP must provide adult enrollees with
written information on advance directives policies, and
include a description of applicable State law.
(3) The information must reflect changes in State law as soon
as possible, but no later than 90 days after the effective date of
the change.
------------------------------------------------------------------417.436(d) Advance directives. (1) An HMO or CMP must
maintain written policies and procedures concerning advance
directives, as defined in §489.100 of this chapter 1 ,

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with respect to all adult individuals receiving medical care by
or through the HMO or CMP and are required to:
(i) Provide written information to those individuals concerning(A) Their rights under the law of the State in which the
organization furnishes services (whether statutory or recognized
by the courts of the State) to make decisions concerning such
medical care, including the right to accept or refuse medical or
surgical treatment and the right to formulate, at the individuals
option, advance directives. Providers are permitted to contract
with other entities to furnish this information but are still legally
responsible for ensuring that the requirements of this section are
met. Such information must reflect changes in State law as soon
as possible, but no later than 90 days after the effective date of
the State law; and
(B) The HMO’s or CMP’s written policies respecting the
implementation of those rights, including a clear and precise
statement of limitation if the HMO or CMP cannot implement
an advance directive as a matter of conscience. At a minimum,
this statement should:
(1) Clarify any differences between institution-wide conscience
objections and those that may be raised by individual
physicians;
(2) Identify the state legal authority permitting such objection;
and
(3) Describe the range of medical conditions or procedures
affected by the conscience objection.
(ii) Provide the information specified in paragraphs (d)(1)(i) of
this section to each enrollee at the time of initial enrollment. If
an enrollee is incapacitated at the time of initial enrollment and
is unable to receive information (due to the incapacitating
condition or a mental disorder) or articulate whether or not he or
she has executed an advance directive, the HMO or CMP may
give advance directive information to the enrollee’s family or
surrogate in the same manner that it issues other materials about
policies and procedures to the family of the incapacitated
enrollee or to a surrogate or other concerned persons in
accordance with State law.
1

Section 489.100 states, “Advance directive means a written instruction, such as a living will or durable power of
attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State),
relating to the provision of health care when the individual is incapacitated.”

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The HMO or CMP is not relieved of its obligation to provide
this information to the enrollee once he or she is no longer
incapacitated or unable to receive such information. Follow-up
procedures must be in place to ensure that the information is
given to the individual directly at the appropriate time.
(iii) Document in the individual’s medical record whether or
not the individual has executed an advance directive;
(iv) Not condition the provision of care or otherwise
discriminate against an individual based on whether or not the
individual has executed an advance directive;
(v) Ensure compliance with requirements of State law (whether
statutory or recognized by the courts of the State) regarding
advance directives;
(vi) Provide for the education of staff concerning its policies
and procedures on advance directives; and
(vii) Provide for community education regarding advance
directives that may include material required in paragraph
(d)(1)(i)(A) of this section, either directly or in concert with
other providers or entities. Separate community education
materials may be developed and used, at the discretion of the
HMO or CMP. The same written materials are not required for
all settings, but the material should define what constitutes an
advance directive, emphasizing that an advance directive is
designed to enhance an incapacitated individual’s control over
medical treatment, and describe applicable State law
concerning advance directives. An HMO or CMP must be able
to document its community education efforts.
(2) The HMO or CMP - (i) Is not required to provide care that
conflicts with an advance directive.
(ii) Is not required to implement an advance directive if, as a
matter of conscience, the HMO or CMP cannot implement an
advance directive and State law allows any health care
provider or any agent of such provider to conscientiously
object.
(3) The HMO or CMP must inform individuals that complaints
concerning non-compliance with the advance directive may be
filed with the State survey and certification agency.

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Documentation for 438.100(b)(2)(iv) and (v)

§438.100 Enrollee rights (cont.)
(b) Specific rights.
(3) An enrollee of an MCO, PIHP,… has the right to be
furnished health care services in accordance with
§§438.206 through 438.210.
Documentation for 438.100(b)(3)

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§438.100 Enrollee rights (cont.)
(d) Compliance with other Federal and State laws. The State
must ensure that each MCO, PIHP,. . . complies with any other
applicable Federal or State laws (such as the Title VI of the Civil
Rights Act of 1964 as implemented by regulations at 45 CFR part
80; the Age Discrimination Act of 1975 as implemented by
regulations at 45 CFR part 91; the Rehabilitation Act of 1973; and
titles II and III of the Americans with Disabilities Act; and other
laws regarding privacy and confidentiality).
Documentation for 438.100(d)

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Subpart D Regulations: Quality Assessment
and Performance Improvement
438.206 Availability of services
(b) Delivery network. The State must ensure, through its
contracts, that each MCO, and each PIHP… consistent with the
scope of the PIHP’s… contracted services, meets the following
requirements:
(1) Maintains and monitors a network of appropriate
providers that is supported by written agreements and is
sufficient to provide adequate access to all services covered
under the contract.
In establishing and maintaining the network, the MCO must
consider the following:
(i) The anticipated Medicaid enrollment.

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(ii) The expected utilization of services, taking into
consideration the characteristics and health care needs of
specific Medicaid populations represented in the particular
MCO, PIHP,…
(iii) The numbers and types (in terms of training,
experience, and specialization) of providers required to
furnish the contracted Medicaid services.
(iv) The number of network providers who are not
accepting new Medicaid patients.
(v)The geographic location of providers and Medicaid
enrollees, considering distance, travel time, the means of
transportation ordinarily used by Medicaid enrollees, and
whether the location provides physical access for Medicaid
enrollees with disabilities.
Documentation for 438.206(b)(1)(i-v) Availability of services:

208

Subpart D Regulations: Quality Assessment
and Performance Improvement
438.206(b). . . Each MCO, and each PIHP… consistent with the
scope of the PIHP’s… contracted services, meets the following
requirements:
(2) Provides female enrollees with direct access to a women’s
health specialist within the network for covered care necessary
to provide women’s routine and preventive health care
services. This is in addition to the enrollee’s designated source
of primary care if that source is not a women’s health
specialist.
Documentation for 438.206(b)(2):

Met

Partially
met

Not
met

438.206(b). . . Each MCO, and each PIHP… consistent with the
scope of the PIHP’s… contracted services, meets the following
requirement:
(3) Provides for a second opinion from a qualified health care
professional within the network, or arranges for the enrollee to
obtain one outside the network, at no cost to the enrollee.
Documentation for 438.206(b)(3):

209

Subpart D Regulations: Quality Assessment
and Performance Improvement
438.206(b). . . Each MCO, and each PIHP… consistent with the
scope of the PIHP’s… contracted services, meets the following
requirements:
(4) If the network is unable to provide necessary services, covered
under the contract, to a particular enrollee, the MCO, PIHP,…
must adequately and timely cover these services out of network
for the enrollee, for as long as the MCO, PIHP,… is unable to
provide them.
Documentation for 438.206(b)(4):

Met

Partially
met

Not
met

438.206(b). . . Each MCO, and each PIHP… consistent with the
scope of the PIHP’s… contracted services, meets the following
requirements:
(5) Requires out-of-network providers to coordinate with the
MCO, PIHP,… with respect to payment and ensures that cost
to the enrollee is no greater than it would be if the services
were furnished within the network.
Documentation for 438.206(b)(5):

210

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.206(c) Furnishing of services.
(1) Timely access. Each MCO, PIHP,… must-(i) Meet and require its providers to meet State
standards for timely access to care and services,
taking into account the urgency of need for
services;
(ii) Ensure that the network providers offer hours of
operation that are no less than the hours of
operation offered to commercial enrollees or
comparable to Medicaid fee-for-service, if the
provider serves only Medicaid enrollees.
(iii) Make services included in the contract available 24
hours a day, 7 days a week, when medically
necessary.
(iv)Establish mechanisms to ensure compliance by
providers.
(v) Monitor providers regularly to determine
compliance.
(vi)Take corrective action if there is failure to comply.
Documentation for 438.206(c)(1)(i) through (vi): Timely access

211

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.206(c)(2) Cultural considerations.
Each MCO, PIHP,… participates in the State’s efforts to promote
the delivery of services in a culturally competent manner to all
enrollees, including those with limited English proficiency and
diverse cultural and ethnic backgrounds.
Documentation for 438.206(c)(2) Cultural considerations:

438.208 Coordination and continuity of care.
(b) Primary care and coordination of health care services for
all MCO, PIHP,… enrollees. Each MCO, PIHP, … must
implement procedures to deliver primary care to and coordinate
health care services for all MCO, PIHP, … enrollees. These
procedures must meet State requirements and must do the
following:
(1) Ensure that each enrollee has an ongoing source of primary
care appropriate to his or her needs and a person or entity
formally designated as primarily responsible for
coordinating the health care services furnished to the
enrollee.
(2) Coordinate the services the MCO, PIHP,… furnishes to the
enrollee with the services the enrollee receives from any
other MCO, PIHP, or PAHP.
(3) Share with other MCOs, PIHPs, and PAHPs serving the
enrollee the results of its identification and assessment of
that enrollee’s needs to prevent duplication of those
activities.
(4) Ensure that in the process of coordinating care, each
enrollee’s privacy is protected in accordance with the
privacy requirements in 45 CFR parts 160 and 164
subparts A and E, to extent that they are applicable.
212

Met
Partially Not
Subpart D Regulations: Quality Assessment
met
met
and Performance Improvement
Documentation for 438.208(b) Primary care and coordination of health care services:

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.208 Coordination and continuity of care.
(c) Additional services for enrollees with special health care
needs.
(1) Identification. The State must implement mechanisms
to identify persons with special health care needs to
MCOs, PIHPs,… as those persons are defined by the
State. These identification mechanisms—
(ii) May use State staff, the State’s enrollment broker,
or the State’s MCOs, PIHPs,…
Documentation for 438.208(c)(1) Identification:

438.208 Coordination and continuity of care.
(c) Additional services for enrollees with special health care
needs.
(2) Assessment. Each MCO, PIHP,… must implement
mechanisms to assess each Medicaid enrollee
identified by the State (through the mechanisms
specified in paragraph (c)(1) of this section) and
identified to the MCO, PIHP,… by the State as having
special health care needs in order to identify any
ongoing special conditions of the enrollee that require
a course of treatment or regular care monitoring. The
assessment mechanisms must use appropriate health
213

care professionals.
Subpart D Regulations: Quality Assessment
and Performance Improvement
Documentation for 438.208(c)(2) Assessment:

Met

Partially
met

Not
met

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.208 Coordination and continuity of care.
(c) Additional services for enrollees with special health care
needs.
(3) Treatment plans. If the State requires MCOs,
PIHPs,… to produce a treatment plan for enrollees with
special health care needs who are determined through
assessment to need a course of treatment or regular care
monitoring, the treatment plan must be—
(i) Developed by the enrollee’s primary care provider
with enrollee participation, and in consultation with
any specialists caring for the enrollee;
(ii) Approved by the MCO, PIHP,… in a timely
manner, if this approval is required by the MCO,
PIHP,… and
(iii) In accord with any applicable State quality
assurance and utilization review standards.
Documentation for 438.208(c)(3) Treatment plans:

214

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.208 Coordination and continuity of care.
(c) Additional services for enrollees with special health care
needs.
(4) Direct access to specialists. For enrollees with special
health care needs determined through an assessment by
appropriate health care professionals (consistent with
§438.208(c)(2)) to need a course of treatment or regular
care monitoring, each MCO, PIHP,… must have a
mechanism in place to allow enrollees to directly access a
specialist (for example, through a standing referral or an
approved number of visits) as appropriate for the enrollee’s
condition and identified needs.
Documentation for 438.208(c)(3) Treatment plans:

438.210 Coverage and authorization of services.
(b) Authorization of services. For the processing of requests for
initial and continuing authorizations of services, each contract
must require—
(1)That the MCO, PIHP,… and its subcontractors have in
place and follow, written policies and procedures.
(2)That the MCO, PIHP,… -(i) Have in effect mechanisms to ensure consistent
application of review criteria for authorization
decisions; and
(ii) Consult with the requesting provider when
appropriate.
(3) That any decision to deny a service authorization request
or to authorize a service in an amount, duration or scope
that is less than requested, be made by a health care
professional who has appropriate clinical expertise in
215

treating the enrollee’s condition or disease.
Subpart D Regulations: Quality Assessment
and Performance Improvement
Documentation for 438.210(b) Authorization of services:

438.210

Met

Partially
met

Not
met

Coverage and authorization of services.

(c) Notice of adverse action. Each contract must provide for the
MCO,PIHP,… to notify the requesting provider, and give the
enrollee written notice of any decision by the MCO, PIHP,…
to deny a service authorization request, or to authorize a
service in an amount, duration or scope that is less than
requested. The notice must meet the requirements of §
438.404, except that the notice to the provider need not be in
writing.
Documentation for 438.210(c) Notice of adverse action:

438.210

Coverage and authorization of services.

(d) Timeframe for decisions. Each MCO, PIHP,… contract must
provide for the following decisions and notices:
(1) Standard authorization decisions. For standard
authorization decisions, provide notice as expeditiously
as the enrollee’s health condition requires and within
State-established timeframes that may not exceed 14
calendar days following receipt of the request for service,
with a possible extension of up to 14 additional calendar
days, if—
(i) The enrollee, or the provider, requests extension; or
(ii) The MCO, PIHP,… justifies (to the State agency
upon request) a need for additional information and
how the extension is in the enrollee’s interest.
216

Subpart D Regulations: Quality Assessment
and Performance Improvement
(2) Expedited authorization decisions.
(i) For cases in which a provider indicates, or the MCO,
PIHP,… determines, that following the standard
timeframe could seriously jeopardize the enrollee’s
life or health or ability attain, maintain, or regain
maximum function, the MCO, PIHP,… must make an
expedited authorization decision and provide notice as
expeditiously as the enrollee’s health condition
requires and no later than 3 working days after receipt
of the request for service.
(ii) The MCO, PIHP,… may extend the 3 working days
time period by up to 14 calendar days if the enrollee
requests an extension, or if the MCO, PIHP,…
justifies (to the State agency upon request) a need for
additional information and how the extension is in the
enrollee’s interest.
Documentation for 438.210(d) Timeframe for decisions:

438.210

Met

Partially
met

Not
met

Coverage and authorization of services.

(e)

Compensation for utilization management activities. Each
contract must provide that, consistent with §438.6(h), and
§422.208 of this chapter, compensation to individuals or
entities that conduct utilization management activities is not
structured so as to provide incentives for the individual or
entity to deny, limit, or discontinue medically necessary
services to any enrollee.
Documentation for 438.210(e) Compensation for utilization management decisions:

217

Subpart D Regulations: Quality Assessment
and Performance Improvement
438.114 Emergency and post-stabilization services
(a) Definitions. As used in this section-Emergency medical condition means a medical condition
manifesting itself by acute symptoms of sufficient severity
(including severe pain) that a prudent layperson, who possess an
average knowledge of health and medicine, could reasonably
expect the absence of immediate medical attention to result in(1) Placing the health of the individual (or, with respect to a
pregnant woman, the health of the woman or her unborn
child) in serious jeopardy.
(2) Serious impairment to bodily functions.
(3) Serious dysfunction of any bodily organ or part.
Emergency services means covered inpatient or outpatient services
that are—
(1) Furnished by a provider that is qualified to furnish these
services under this title.
(2) Needed to evaluate or stabilize an emergency medical
condition.
Poststabilization care services means covered services, related to
an emergency medical condition, that are provided after an
enrollee is stabilized in order to maintain the stabilized condition
or, under the circumstances described in paragraph (e) of this
section, to improve or resolve the enrollee’s condition.
(b) Coverage and payment: General rule. The following entities
are responsible for coverage and payment of emergency
services and post-stabilization care services.
(1) The MCO, PIHP,…
(c) Coverage and payment: Emergency services.
(1) The entities identified in paragraph (b) of this section-(i) Must cover and pay for emergency services regardless
of whether the entity that furnishes the services has a
contract with the MCO, PIHP,… and
(ii) May not deny payment for treatment obtained under
either of the following circumstances: (cont.)

Met

Partially
met

Not
met

218

Subpart D Regulations: Quality Assessment
and Performance Improvement
(A) An enrollee had an emergency medical condition,
including cases in which the absence of immediate medical
attention would not have had the outcomes specified in
paragraphs (1), (2), and (3) of the definition of emergency
medical condition in paragraph (a) of this section.
(B) A representative of the MCO, PIHP,. . . instructs the
enrollee to seek emergency services.
(d) Additional rules for emergency services.
(1) The entities specified in paragraph (b) of this section may
not-(i) Limit what constitutes an emergency medical condition
with reference to paragraph (a) of this section, on the basis
of lists of diagnoses or symptoms; and
(ii) Refuse to cover emergency services based on the
emergency room provider, hospital, or fiscal agent not
notifying the enrollee’s primary care provider, MCO,
PIHP,… or applicable State entity of the enrollee’s
screening and treatment within 10 calendar days of
presentation for emergency services.
(2) An enrollee who has an emergency medical condition may
not be held liable for payment of subsequent screening and
treatment needed to diagnose the specific condition or
stabilize the patient.
(3) The attending emergency physician, or the provider
actually treating the enrollee, is responsible for
determining when the enrollee is sufficiently stabilized for
transfer or discharge, and that determination is binding on
the entities identified in paragraph (b) of this section as
responsible for coverage and payment.
(e) Coverage and payment: Poststabilization care services.
Poststabilization care services are covered and paid for in
accordance with provisions set forth at §422.113(c) of this
chapter. In applying those provisions, reference to “M+C
organization” must be read as reference to the entities
responsible for Medicaid payment, as specified in paragraph
(b) of this section.
(f) Applicability to PIHPs . . . To the extent that services required
to treat an emergency medical condition fall within the scope
of the services for which the PIHP. . . is responsible, the rules
under this section apply.

Met

Partially
met

Not
met

219

Met
Subpart D Regulations: Quality Assessment
and Performance Improvement
Documentation for 438.114 Emergency and pos-stabilization services:

Partially
met

Not
met

438.214 Provider selection
(a) General rules. The State must ensure, through its contracts,
that each MCO, PIHP,… implements written policies and
procedures for selection and retention of providers and that those
written policies and procedures include, at a minimum the
requirements of this section.
(b) Credentialing and recredentialing requirements.
(1) Each State must establish a uniform credentialing and
recredentialing policy that each MCO, PIHP,… must follow.
(2) Each MCO, PIHP,… must follow a documented process for
credentialing and recredentialing of providers who have signed
contracts or participation agreements with the MCO, PIHP,...
Documentation for 438.214(a) and (b) General rules and Credentialing and recredentialing
requirements:

220

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.214 Provider selection.
(c) Nondiscrimination. MCO, PIHP,… provider selection policies
and procedures, consistent with §438.12 (below) do not
discriminate against particular practitioners that serve high risk
populations, or specialize in conditions that require costly
treatment.

438.12

Provider discrimination prohibited.

(a) General rules.
(1) An MCO, PIHP,… may not discriminate for the
participation, reimbursement, or indemnification of any
provider who is acting within the scope of his or her
license or certification under applicable State law, solely
on the basis of that license or certification. If the MCO,
PIHP,… declines to include individual or groups of
providers in its network, it must give the affected
providers written notice of the reason for its decision.
(2) In all contracts with health care professionals, an MCO,
PIHP,… must comply with the requirements specified in
§438.214.
(b) Construction. Paragraph (a) of this section may not be
construed to-(1) Require the MCO, PIHP,… to contract with providers
beyond the number necessary to meet the needs of its
enrollees;
(2) Preclude the MCO, PIHP,… from using different
reimbursement amounts for different specialties or for
different practitioners in the same specialty; or
(3) Preclude the MCO, PIHP,… from establishing measures
that are designed to maintain quality of services and
control costs and are consistent with its responsibilities
to enrollees.
Documentation for 438.214(c) and 438.12 Nondiscrimination and Provider discrimination
prohibited:

221

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.214: Provider selection
(d) Excluded providers. MCOs, PIHPs,… may not employ or
contract with providers excluded from participation in Ffederal
health care programs under either section 1128 or section 1128A
of the Act.
Documentation for 438.214(d) Excluded providers:

438.214: Provider selection
(e) State requirements. Each MCO, PIHP,… must comply with
any additional requirements established by the State.
Documentation for 438.214(e) State requirements:

222

Subpart D Regulations: Quality Assessment
and Performance Improvement

438.226

Met

Partially
met

Not
met

Enrollment and disenrollment:

The State must ensure that each MCO, PIHP,… contract complies
with the enrollment and disenrollment requirements and
limitations set forth in 438.56. (relevant sections of 438.56
included below).
438.56 Disenrollment: Requirements and limitations.
(b) Disenrollment requested by the MCO, PIHP,. . . All
MCO, PIHP,… contracts must-(1) Specify the reasons for which the MCO, PIHP,…
may request disenrollment of an enrollee;
(2) Provide that the MCO, PIHP, . . .may not request
disenrollment because of an adverse change in the
enrollee’s health status, or because of the enrollee’s
utilization of medical services, diminished mental
capacity, or uncooperative or disruptive behavior
resulting from his or her special needs (except when
his or her continued enrollment in the MCO, PIHP,. .
. seriously impairs the entity’s ability to furnish
services to either this particular enrollee or other
enrollees); and
(3) Specify the methods by which the MCO, PIHP,…
assures the agency that it does not request
disenrollment for reasons other than those permitted
under the contract.
Documentation for 438.226 and 438.56(b)(1) - (3) Disenrollment requested by the MCO,
PIHP:

223

Met
Subpart D Regulations: Quality Assessment
and Performance Improvement
438.56 Disenrollment: Requirements and limitations.
(c) Disenrollment requested by the enrollee. If the State chooses
to limit disenrollment, MCO, PIHP,… contracts must
provide that a recipient may request disenrollment as
follows:
(1) For cause, at any time.
(2) Without cause, at the following times:
(i) During the 90 days following the date of the
recipient’s initial enrollment with the MCO, PIHP,…
or the date the State sends the recipient notice of the
enrollment, whichever is later.
(ii) At least once every 12 months thereafter.
(iii) Upon automatic reenrollment under paragraph (g) of
this section, if the temporary loss of Medicaid
eligibility has caused the recipient to miss the
annual disenrollment opportunity.
(iv) When the State imposes the intermediate sanction
specified in §438.702(a)(3).
Documentation for 438.56(c) Disenrollment requested by the enrollee:

Partially
met

Not
met

224

Subpart D Regulations: Quality Assessment
and Performance Improvement
438.56 Disenrollment: Requirements & limitations.
(d) Procedures for disenrollment.
(1) Request for disenrollment. The recipient (or his or her
representative) must submit an oral or written request-(i) To the State agency (or its agent); or
(ii) To the MCO, PIHP,… if the State permits MCOs, PIHPs,.
. . to process disenrollment requests.
(2) Cause for disenrollment. The following are cause for
disenrollment:
(i) The enrollee moves out of the MCO, PIHP,… service area.
(ii)The plan does not, because of moral or religious
objections, cover the service the enrollee seeks.
(iii)The enrollee needs related services (for example a
cesarean section and a tubal ligation) to be performed at
the same time; not all related services are available within
the network; and the enrollee’s primary care provider or
another provider determines that receiving the services
separately would subject the enrollee to unnecessary risk.
(iv) Other reasons, including but not limited to, poor quality
of care, lack of access to services covered under the
contract, or lack of access to providers experienced in
dealing with the enrollee’s health care needs.
(3) MCO, PIHP,. . . action on request.
(i) An MCO, PIHP,… may either approve a request for
disenrollment or refer the request to the State.
(ii)If the MCO, PIHP, . . . or State agency (whichever is
responsible) fails to make a disenrollment determination
so that the recipient can be disenrolled within the
timeframes specified in paragraph (e)(1) of this section,
the disenrollment is considered approved.
(4) State agency action on request. For a request received directly
from the recipient, or one referred by the MCO, PIHP,… the
State agency must take action to approve or disapprove the
request based on the following:
(i) Reasons cited in the request.
(ii) Information provided by the MCO, PIHP,… at the
agency’s request.
(iii) Any of the reasons specified in paragraph (d)(2) of this
section.

Met

Partially
met

Not
met

225

Subpart D Regulations: Quality Assessment
and Performance Improvement
(5) Use of the MCO, PIHP,. . . grievance procedures.
(i) The State agency may require that the enrollee seek
redress through the MCO, PIHP,… grievance system
before making a determination on the enrollee’s
request.
(ii) The grievance process, if used, must be completed in
time to permit the disenrollment (if approved) to be
effective in accordance with the timeframe specified in
§438.56(e)(1).
(iii) If, as a result of the grievance process, the MCO,
PIHP,… approves the disenrollment, the State agency
is not required to make a determination.
Documentation 438.56(d) Procedures for disenrollment:

Met

Partially
met

Not
met

438.56 Disenrollment: Requirements and limitations.
(e) Timeframe for disenrollment determinations.
(1) Regardless of the procedures followed, the effective date
of an approved disenrollment must be no later than the
first day of the second month following the month in
which the enrollee or the MCO, PIHP,. . . files the
request.
(2) If the MCO, PIHP, . . . or the State agency (whichever is
responsible) fails to make the determination within the
timeframes specified in paragraphs(e)(1) of this section,
the disenrollment is considered approved.
Documentation 438.56(e) Timeframe for disenrollment determinations:

226

Subpart D Regulations: Quality Assessment
and Performance Improvement
438.228 Grievance systems.
(a) The State must ensure, through its contracts, that each MCO
and PIHP has in effect a grievance system that meets the
requirements of subpart F of this part.
(b) If the State delegates to the MCO or PIHP responsibility for
notice of action under subpart E of part 431 of this chapter,
the State must conduct random reviews of each delegated
MCO and PIHP and its providers and subcontractors to ensure
that they are notifying enrollees in a timely manner.
Documentation for 438.228 Grievance systems:

Met

Partially
met

Not
met

227

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

§438.230 Subcontractual relationships and
delegation.
(a) General rule. The State must ensure, through its contracts, that
each MCO, PIHP,… -(1) Oversees and is accountable for any functions and
responsibilities that it delegates to any subcontractor, and
(2) Meets the conditions of paragraph (b) of this section.
(b) Specific conditions.
(1) Before any delegation, each MCO, PIHP,… evaluates the
prospective subcontractor’s ability to perform the activities
to be delegated.
(2) There is a written agreement that -(i) Specifies the activities and report responsibilities
designated to the subcontractor; and
(ii) Provides for revoking delegation or imposing other
sanctions if the subcontractor’s performance is
inadequate.
(3) The MCO, PIHP,… monitors the subcontractor’s
performance on an ongoing basis and subjects it to formal
review according to a periodic schedule established by the
State, consistent with industry standards or State MCO
laws and regulations.
(4) If any MCO, PIHP,… identifies deficiencies or areas for
improvement, the MCO, PIHP,… and the subcontractor
take corrective action.
Documentation for 438.230 (a) and (b) Subcontractual relationships and delegation:

228

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.236 Practice guidelines.
(a) Basic rule. The State must ensure, through its contracts,
that each MCO and, when applicable, each PIHP… meets
the requirements of this section.
(b) Adoption of practice guidelines. Each MCO and, when
applicable, each PIHP,… adopts practice guidelines that meet
the following requirements:
(1) Are based on valid and reliable clinical evidence or a
consensus of health care professionals in the particular
field.
(2) Consider the needs of the MCO’s, PIHP’s,… enrollees.
(3) Are adopted in consultation with contracting health care
professionals.
(4) Are reviewed and updated periodically, as appropriate.
Documentation for 438.236(b)(1-4) Adoption of practice guidelines:

438.236 Practice guidelines.
(c) Dissemination of guidelines.
Each MCO, PIHP,… disseminates the guidelines to all affected
providers and, upon request, to enrollees and potential enrollees.
Documentation for 438.236(c) Dissemination of [practice] guidelines:

229

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.236 Practice guidelines.
(d) Application of guidelines.
Decisions for utilization management, enrollee education,
coverage of services, and other areas to which the guidelines apply
are consistent with the guidelines.
Documentation for 438.236(d) Application of [practice] guidelines.

438.240 Quality assessment and performance
improvement program.
(a) General rules.
(1) The State must require, through its contracts, that each
MCO and PIHP has an ongoing quality assessment and
performance improvement program for the services it
furnishes to its enrollees.
Documentation for 438.240(a)(1) Quality assessment and performance improvement
program - General rules:

230

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.240 Quality assessment and performance
improvement program.
(b) Basic elements of MCO and PIHP quality assessment and
performance improvement programs.
At a minimum, the State must require that each MCO and PIHP
comply with the following requirements-(1) Conduct performance improvement projects as described
in paragraph (d) of this section [Note: Paragraph (d) is
included below]. These projects must achieve, through
ongoing measurements and intervention, significant
improvement, sustained over time, in clinical care and
nonclinical care areas that are expected to have a
favorable effect on health outcomes and enrollee
satisfaction.
******************************************
(d) Performance improvement projects.
(1) MCOs and PIHPs must have an ongoing program of
performance improvement projects that focus on clinical
and nonclinical areas, and that involve the following:
(i) Measurement of performance using objective quality
indicators.
(ii) Implementation of system interventions to achieve
improvement in quality.
(iii) Evaluation of the effectiveness of the interventions.
(iv) Planning and initiation of activities for increasing or
sustaining improvement.
(2) Each MCO and PIHP must report the status and results of
each project to the State as requested, including those that
incorporate the requirements of §438.240(a)(2). Each
performance improvement project must be completed in a
reasonable time period so as to generally allow
information on the success of performance improvement
projects in the aggregate to produce new information on
quality of care every year.

231

Met
Partially Not
Subpart D Regulations: Quality Assessment
met
met
and Performance Improvement
Documentation for 438.240(b)(1) Basic elements of MCO and PIHP quality assessment and
performance improvement programs, and 438.240(d) Performance improvement projects:

438.240 Quality assessment and performance
improvement program.
(b) Basic elements of MCO and PIHP quality assessment and
performance improvement programs.
At a minimum, the State must require that each MCO and PIHP
comply with the following requirements-(2) Submit performance measurement data as described in
paragraph (c) of this section. [Note: Paragraph (c) is
included below.]
******************************************
438.240(c) Performance measurement.
Annually, each MCO and PIHP must—
(1) Measure and report to the State its performance, using
standard measures required by the State, including those
that incorporate the requirements of §438.204(c) [included
below] and §438.240(a)(2);
(2) Submit to the State, data specified by the State, that enables
the State to measure the MCO’s or PIHP’s performance; or
(3) Perform a combination of the activities described in
paragraphs (c)(1) and (c)(2) of this section.
***********************************************
438.204(c) Performance measures and levels identified and
developed by CMS in consultation with States and other relevant
stakeholders.
***********************************************
232

Met
Partially Not
Subpart D Regulations: Quality Assessment
met
met
and Performance Improvement
Documentation for 438.240(b)(2) and (c), and 438.204(c) Performance measurement:

438.240 Quality assessment and performance
improvement program.
(b) Basic elements of MCO and PIHP quality assessment and
performance improvement programs.
At a minimum, the State must require that each MCO and PIHP
comply with the following requirements-(3) Have in effect mechanisms to detect both underutilization
and overutilization of services;
Documentation for 438.240(b)(3) Basic elements of MCO and PIHP quality assessment and
performance improvement:

233

Subpart D Regulations: Quality Assessment
and Performance Improvement

Met

Partially
met

Not
met

438.240 Quality assessment and performance
improvement program.
(b) Basic elements of MCO and PIHP quality assessment and
performance improvement programs.
At a minimum, the State must require that each MCO and PIHP
comply with the following requirements-(4) Have in effect mechanisms to assess the quality and
appropriateness of care furnished to enrollees with special
health care needs.
Documentation for 438.240(b)(4) Basic elements of MCO and PIHP quality assessment and
performance improvement:

438.240 Quality assessment and performance
improvement program.
(e) Program review by the State.
(1) The State must review, at least annually, the impact and
effectiveness of each MCO’s and PIHP’s quality assessment
and performance improvement program. The review must
include-(i) The MCO’s PIHP’s performance on standard measures on
which it is required to report; and
(ii) The results of each MCO’s and PIHP’s perfroamnce
improvement projects.
(2) The State may require that an MCO or PIHP have in effect a
process for its own evaluation of its quality assessment and
performance improvement program.
234

Met
Partially Not
Subpart D Regulations: Quality Assessment
met
met
and Performance Improvement
Documentation for 438.240(e) Basic elements of MCO and PIHP quality assessment and
performance improvement- Program review by the State:

438.242

Health information systems.

(a) General rule. The State must ensure through its contracts, that
each MCO and PIHP maintains a health information system
that collects, analyzes, integrates, and reports sata and can
achieve the objectives of this subpart. The system must
provide information on areas including, but not limited to,
utilization, grievances, and disenrollments for other than loss
of Medicaid eligibility.
Documentation for 438.242(a) Health information systems- General rule:

235

Subpart D Regulations: Quality Assessment
and Performance Improvement

438.242

Met

Partially
met

Not
met

Health information systems.

(j)

Basic elements of a health information system. The State
must require, at a minimum, that each MCO and PIHP comply
with the following:
(1) Collect data on enrollee and provider characteristics as
specified by the State, and on services furnished to enrollees
through an encounter data system or such other methods as
may be specified by the State.
(2) Ensure that data received from providers is accurate and
complete by-(i) Verifying the accuracy and timeliness of reported
data;
(ii) Screening the data for completeness, logic, and
consistency; and
(iii) Collecting service information in standardized
formats to the extent feasible and appropriate.
Documentation for 438.242(b)(1) and (2) Basic elements of a health information system:

438.242

Health information systems.

(b) Basic elements of a health information system. The State
must require, at a minimum, that each MCO and PIHP comply
with the following:
(3) Make all collected data available to the State and upon
request to CMS, as required in this subpart.
Documentation for 438.242(b)(3) Basic elements of a health
information system:

236

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

438.402 General requirements.
(a)

The grievance system. Each MCO and PIHP must have a
system in place for enrollees that includes a grievance
process, an appeal process, and access to the State’s fair
hearing system.
Documentation for 438.402(a) The grievance system:

438.402

General requirements

(b) Filing requirements.
(1) Authority to file.
(i) An enrollee may file a grievance and an MCO or
PIHP level appeal, and may request a State fair
hearing.
(ii) A provider, acting on behalf of the enrollee and with
the enrollee’s written consent, may file an appeal. A
provider may file a grievance or request a State fair
hearing on behalf of an enrollee, if the State permits
the provider to act as the enrollee’s authorized
representative in doing so.
Documentation for 438.402(b)(1) Filing requirements - Authority to file:

237

Subpart F Regulations --Grievance System

438.402

Met

Partially
Met

Not
met

General requirements

(b)

Filing requirements.
(2) Timing. The State specifies a reasonable timeframe that
may be no less than 20 days and not to exceed 90 days
from the date on the MCO’s or PIHP’s notice of action.
Within that timeframe-(i) The enrollee or the provider may file an appeal; and
(ii) In a State that does not require exhaustion of MCO and
PIHP level appeals, the enrollee may request a State fair
hearing.
Documentation for 438.402(b)(2) Filing requirements – Timing:

438.402

General requirements

(b)

Filing requirements.
(3) Procedures.
(i) The enrollee may file a grievance either orally or in
writing and, as determined by the State, either with the
State or with the MCO or the PIHP.
(ii) The enrollee or the provider may file an appeal either
orally or in writing, and unless he or she requests
expedited resolution, must follow an oral filing with a
written, signed, appeal.
Documentation for 438.402(b)(3). Filing requirements – Procedures:

238

Subpart F Regulations --Grievance System

438.404

Met

Partially
Met

Not
met

Notice of action

(a) Language and format requirements. The notice must be in
writing and must meet the language and format requirements
of §438.10(c) and (d) to ensure ease of understanding.
[Sections §438.10(c) and (d) are restated below.]
*********************************************
§438.10 Information requirements.
(c) Language. The State must:
(1) Establish a methodology for identifying the prevalent
non-English languages spoken by enrollees and
potential enrollees throughout the State. “Prevalent”
means a non-English language spoken by a significant
number or percentage of potential enrollees and
enrollees in the State.
(2) [This paragraph contains a requirement for the State; not
the MCO or PIHP.]
(3) Require each MCO, PIHP, . . . to make its written
information available in the prevalent, non-English
languages in its particular service area.
(cont.)
(4) … require each MCO, PIHP, . . . to make those services
[i.e., oral interpretation services] available free of
charge to the each potential enrollee and enrollee. This
applies to all non-English languages, not just those that
the State identifies as prevalent.
(5) … require each MCO, PIHP,… to notify its enrollees(i) That oral interpretation is available for any
language and written information is available in
prevalent languages; and
(ii) How to access those services.
(d) Format.
(1) Written material must-(i) Use easily understood language and format; and
(ii) Be available in alternative formats and in an
appropriate manner that takes into consideration
the special needs of those who, for example, are
visually impaired or have limited reading
proficiency.
(2) All enrollees and potential enrollees must be informed
that information is available in alternative formats and
how to access those formats.
239

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

Documentation for 438.404(a) Notice of action - Language and format:

438.404 Notice of action
(b) Content of notice. The notice must explain the following:
(1) The action the MCO or PIHP or its contractor has taken or
intends to take.
(2) The reasons for the action.
(3) The enrollee’s or the provider’s right to file an MCO or
PIHP appeal.
(4) If the State does not require the enrollee to exhaust the
MCO or PIHP level appeal procedures, the enrollee’s right
to request a State fair hearing.
(5) The procedures for exercising the rights specified in this
paragraph.
(6) The circumstances under which expedited resolution is
available and how to request it.
(7) The enrollee’s right to have benefits continue pending
resolution of the appeal, how to request that benefits be
continued and, the circumstances under which the enrollee
may be required to pay the costs of these services.
Documentation for 438.404(b) Notice of action - Content of notice:

240

438.404

Notice of action

(c) Timing of notice. The MCO or PIHP must mail the notice
within the following timeframes:
(1) For termination, suspension, or reduction of previously
authorized Medicaid-covered service, within the time
frames specified in §§431.211, 431.213, and 431.214 of
this chapter.
[Note: Sections 431.211, 431.213, and 431.214 are restated,
below.]
*************************************************
431.211 Advance notice. The State or local agency must mail a
notice at least 10 days before the date of action, except as
permitted under §§431.213 and 431.214 of this subpart.
431.213 Exceptions from advance notice. The agency may mail a
notice no later than the date of action if-(a) The agency has factual information confirming the death
of a recipient;
(b) The agency receives a clear written statement signed by
the recipient that-(1) He no longer wishes services; or
(2) Gives information that requires termination or reduction
of services and indicates that he understands that this
must be the result of supplying that information;
(c) The recipient has been admitted to an institution where he
is ineligible under the plan for further services;
(d) The recipient’s whereabouts are unknown and the post
office returns agency mail directed to him indicating no
forwarding address (See §431.231(d) of this subpart
[restated below] for procedure if the recipient’s
whereabouts become known);
[Section 431.231 Reinstatement of services.
(d) If a recipient’s whereabouts are unknown, as indicated by
the return of unforwardable agency mail directed to him, any
discontinued service must be reinstated if his whereabouts
become known during the time he is eligible for services.]

241

(e) The agency establishes the fact that the recipient has been
accepted for Medicaid services by another local
jurisdiction, State, territory, or commonwealth;
(f) A change in the level of medical care is prescribed by the
recipient’s physician;
(g) The notice involves an adverse determination made with
regard to the preadmission screening requirements of
section 1919(e)(r) of the Act; or;
(h) The date of action will occur in less than 10 days, in
accordance with §483.12(a)(5)(ii), which provides
exceptions to the 30 days notice requirements of
§483.12(a)(5)(i).
431.214 Notice in the case of probable fraud. The agency may
shorten the period of advance notice to 5 days before the date of
action if-(a) The agency has facts indicating that action should be
taken because of probable fraud by the recipient; and
(b) The facts have been verified, if possible, through
secondary sources.
********************************************
(2) For denial of payment, at the time of any action affecting the
claim.
(3) For standard service authorization decisions that deny or limit
services, within the time frame specified in §438.210(d)(1)
[Section 438.210(d)(1) is restated, below.]
**************************************************
438.210(d) Timeframe for decisions. Each MCO, PIHP,…
contract must provide for the following decisions and notices:
(1) Standard authorization decisions. For standard
authorization decisions, provide notice as expeditiously as
the enrollee’s health condition requires and within Stateestablished timeframes that may not exceed 14 calendar
days following receipt of the request for service, with a
possible extension of up to 14 additional calendar days,
if—
(i) The enrollee, or the provider, requests an extension; or
(ii) The MCO, PIHP,… justifies (to the State agency upon
request) a need for additional information and how the
extension is in the enrollee’s interest.
****************************************

242

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

(4) If the MCO or PIHP extends the timeframe in accordance
with §438.210(d)(1), it must-(i) Give the enrollee written notice of the reason for the
decision to extend the timeframe and inform the enrollee
of the right to file a grievance if he or she disagrees with
that decision; and
(ii) Issue and carry out its determination as expeditiously as
the enrollee’s health condition requires and no later than
the date the extension expires.
(5) For service authorization decisions not reached within the
timeframes specified in §438.210(d) (which constitutes a
denial and is thus an adverse action), on the date that the
timeframes expire.
(6) For expedited service authorization decisions, within the
timeframes specified in §438.210(d). [Section 438.210(d)(2)
provisions pertaining to expedited authorizations are restated
below.]
********************************************
438.210(d) Timeframe for decisions. Each MCO, PIHP,…
contract must provide for the following decisions and notices:
(2) Expedited authorization decisions.
(i) For cases in which a provider indicates, or the MCO,
PIHP,… determines, that following the standard timeframe
could seriously jeopardize the enrollee’s life or health or
ability to attain, maintain, or regain maximum function, the
MCO, PIHP,… must make an expedited authorization
decision and provide notice as expeditiously as the
enrollee’s health condition requires and no later than 3
working days after receipt of the request for service.
(ii) The MCO, PIHP,… may extend the 3 working days
time period by up to 14 calendar days if the enrollee
requests an extension, or if the MCO or PIHP justifies (to
the State agency upon request) a need for additional
information and how the extension is in the enrollee’s
interest.

243

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

Documentation for §438.404(c): Notice of action - timing of notice:

438.406

Handling of grievances and appeals.

(a) General requirements. In handling grievances and appeals,
each MCO and each PIHP must meet the following
requirements;
(1) Give enrollees any reasonable assistance in completing
forms and taking other procedural steps. This includes, but
is not limited to, providing interpreter services and toll-free
numbers that have adequate TTY/TTD and interpreter
capability.
(2) Acknowledge receipt of each grievance and appeal.
(3) Ensure that the individuals who make decisions on
grievances and appeals are individuals-(i) Who were not involved in any previous level of review
or decision-making; and
(ii) Who, if deciding any of the following, are health care
professionals who have the appropriate clinical
expertise in treating the enrollee’s condition or
disease.
(A) An appeal of a denial that is based on lack of
medical necessity.
(B) A grievance regarding denial of expedited
resolution of an appeal.
(C) A grievance or appeal that involves clinical issues.
244

Partially
Met
Documentation for 438.406(a) Handling of grievances and appeals -General
requirements:

Subpart F Regulations --Grievance System

Met

Not
met

438.406 Handling of grievances and appeals.
(b) Special requirements for appeals. The process for appeals
must:
(1) Provide that oral inquiries seeking to appeal an action are
treated as appeals (to establish the earliest possible filing
date for the appeal) and must be confirmed in writing,
unless the enrollee or provider requests expedited
resolution.
(2) Provide the enrollee a reasonable opportunity to present
evidence, and allegations of fact or law, in person as well
as in writing. (The MCO or PIHP must inform the enrollee
of the limited time available for this in the case of
expedited resolution.)
(3) Provide the enrollee and his or her representative
opportunity, before and during the appeals process, to
examine the enrollee’s case file, including medical records,
and any other documents and records considered during the
appeals process.
(4) Include, as parties to the appeal-(i) The enrollee and his or her representative; or
(ii) The legal representative of a deceased enrollee’s estate.
245

Partially Not
Met
met
Documentation for 438.406(b) Handling of grievances and appeals -Special requirements
for appeals:

Subpart F Regulations --Grievance System

Met

438.408 Resolution and notification:
Grievances and appeals.
(a) Basic rule. The MCO or PIHP must dispose of each grievance
and resolve each appeal, and provide notice, as expeditiously
as the enrollee’s health condition requires, within Stateestablished timeframes that may not exceed the timeframes
specified in this section.
Documentation for 438.408(a) Resolution and notification: Grievances and appeals- Basic
rule:

246

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

438.408 Resolution and notification:
Grievances and appeals.
(b) Specific timeframes.
(1) Standard disposition of grievances. For standard
disposition of a grievance and notice to the affected
parties, the timeframe is established by the State, but may
not exceed 90 days from the day the MCO or PIHP
receives the grievance.
(2) Standard resolution of appeals. For standard resolution
of an appeal and notice to the affected parties, the State
must establish a timeframe that is no longer than 45 days
from the day the MCO or PIHP receives the appeal. This
timeframe may be extended under paragraph (c) of this
section.
(3) Expedited resolution of appeals. For expedited
resolution of an appeal and notice to the affected parties,
the State must establish a timeframe that is no longer than
3 working days after the MCO or PIHP receives the
appeal. This timeframe may be extended under paragraph
(c) of this section.
(c) Extension of timeframes.
(1) The MCO or PIHP may extend the timeframes from
paragraph (b) of this section by up to 14 calendar days if-(i) The enrollee requests the extension; or
(ii) The MCO or PIHP shows (to the satisfaction of the
State agency, upon its request) that there is a need for
additional information and how the delay is in the
enrollee’s interest.
(2) Requirements following extension. If the MCO or PIHP
extends the timeframes, it must--for any extension not
requested by the enrollee, give the enrollee written notice
of the reason for the delay.
Documentation for 438.408(b) and (c) Resolution and notification: Grievances and
appeals - specific timeframes and extension of timeframes

247

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

438.408 Resolution and notification:
Grievances and appeals.
(d) Format of notice.
(1) Grievances. The State must establish the method the
MCOs and PIHPs will use to notify an enrollee of the
disposition of a grievance.
(2) Appeals.
(i) For all appeals, the MCO or PIHP must provide written
notice of disposition.
(ii) For notice of expedited resolution, the MCO or PIHP
must also make reasonable efforts to provide oral
notice.
(e) Content of notice of appeal resolution. The written notice of
the resolution must include the following:
(1) The results of the resolution process and the date it was
completed.
(2) For appeals not resolved wholly in favor of the enrollees(i) The right to request a State fair hearing, and how to do
so;
(ii)The right to request to receive benefits while the hearing
is pending, and how to make the request; and
(iii)That the enrollee may be held liable for the cost of
those benefits if the hearing decision upholds the
MCO’s or PIHP’s action.
Documentation for 438.408 (d) and (e) Resolution and notification: Grievances and
appeals- Format of notice and Content of notice of appeal resolution:

248

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

438.408 Resolution and notification:
Grievances and appeals:
(f) Requirements for State fair hearings.-(1) Availability. The State must permit the enrollee to request a
State fair hearing within a reasonable time period specified by
the State, but not less than 20 or in excess of 90 days from
whichever of the following dates applies-(i) If the State requires exhaustion of the MCO or PIHP level
appeal procedures, from the date of the MCO’s or PIHP’s
notice of resolution; or
(ii) If the State does not require exhaustion of the MCO or
PIHP level appeal procedures and the enrollee appeals
directly to the State for a fair hearing, from the date on the
MCO’s or PIHP’s notice of action.
(2) Parties. The parties to the State fair hearing include the MCO
or PIHP as well as the enrollee and his or her representative or
the representative of a deceased enrollee’s estate.
Documentation for 438.408(f) Resolution and notification: Grievances and appealsRequirements for State fair hearings:

438.410 Expedited resolution of appeals.
(a) General rule. Each MCO and PIHP must establish and
maintain an expedited review process for appeals, when the MCO
or PIHP determines (for a request from the enrollee) or the
provider indicates (in making the request on the enrollee’s behalf
or supporting the enrollee’s request) that taking the time for a
standard resolution could seriously jeopardize the enrollee’s life or
health or ability to attain, maintain or regain maximum function.
249

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

(b) Punitive Action. The MCO or PIHP must ensure that punitive
action is neither taken against a provider who requests an
expedited resolution or supports an enrollee’s appeal.
(c) Action following denial of a request for expedited resolution.
If the MCO or PIHP denies a request for expedited resolution
of an appeal, it must-(1) Transfer the appeal to the timeframe for standard
resolution in accordance with §438.408(b)(2);
(2) Make reasonable effort to give the enrollee prompt oral
notice of the denial, and follow up within 2 calendar days
with a written notice.
Documentation for 438.410 Expedited resolution of appeals:

438.414 Information about the grievance
system to providers and subcontractors.
The MCO or PIHP must provide the information specified at
§438.10(g)(1) [restated below] about the grievance system to all
providers and subcontractors at the time they enter into a contract.
*****************************************************
§438.10(g)(1) Grievance , appeal … procedures, and
timeframes, as provided in §§438.400 through 438.424, in a
State-developed or State-approved description, that must
include:
(i) . . . (Requirement applies only to the State.)
(ii) The right to file grievances and appeals.
(iii)The requirements and time frames for filing a
grievance or appeal.
(iv)The availability of assistance in the filing process.
(v) The toll-free numbers that the enrollee can use to file
a grievance or an appeal by phone.
250

Partially Not
Met
met
Documentation for 438.414 Information about the grievance system to providers and
subcontractors:

Subpart F Regulations --Grievance System

Met

438.416 Recordkeeping and reporting
requirements.
The State must require MCOs and PIHPs to maintain records of
grievances and appeals and must review the information as part of
the State quality strategy.
Documentation for 438.416 Recordkeeping and reporting requirements:

438.420 Continuation of benefits while the
MCO or PIHP appeal and the State fair
hearing are pending.
(a) Terminology. As used in this section, “timely” filing means
filing on or before the later of the following:
(1) Within 10 days of the MCO or PIHP mailing the notice of
action.
(2) The intended effective date of the MCO’s or PIHP’s
proposed action.
251

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

(b) Continuation of benefits. The MCO or PIHP must continue
the enrollee’s benefits if-(1) The enrollee or the provider files the appeal timely;
(2) The appeal involves the termination, suspension, or
reduction of a previously authorized course of treatment;
(3) The services were ordered by an authorized provider;
(4) The original period covered by the original authorization
has not expired; and
(5) The enrollee requests extension of benefits.
(c) Duration of continued or reinstated benefits. If, at the
enrollee’s request, the MCO or PIHP continues or reinstates
the enrollee’s benefits while the appeal is pending, the
benefits must be continued until one of the following occurs:
(1) The enrollee withdraws the appeal.
(2) Ten days pass after the MCO or PIHP mails the notice,
providing the resolution of the appeal against the
enrollee, unless the enrollee, within the 10-day
timeframe, has requested a State fair hearing with
continuation of benefits until a State fair hearing decision
is reached.
(3) A State fair hearing Office issues a hearing decision
adverse to the enrollee.
(4) The time period or service limits of a previously
authorized service has been met.
(d) Enrollee responsibility for services furnished while the
appeal is pending. If the final resolution of the appeal is
adverse to the enrollee, that is, upholds the MCO’s or PIHP’s
action, the MCO or PIHP may recover the cost of the services
furnished to the enrollee while the appeal is pending, to the
extent that they were furnished solely because of the
requirements of this section, and in accordance with the policy
set forth in §431.230(b) of this chapter. [Section 431.230(b) is
restated below.]
************************************************
§431.230 Maintaining services.
(b) If the agency’s action is sustained by the hearing
decision, the agency may institute recovery procedures
against the applicant or recipient to recoup the cost of any
services furnished the recipient, to the extent they were
furnished solely by reason of this section.
****************************************
252

Partially Not
Met
met
Documentation for 438.420 Continuation of benefits while the MCO or PIHP appeal and
the State fair hearing are pending:

Subpart F Regulations --Grievance System

Met

438.424 Effectuation of reversed appeal
resolutions.
(a) Services not furnished while the appeal is pending. If the
MCO or PIHP, or the State fair hearing officer reverses a
decision to deny, limit, or delay services that were not
furnished while the appeal was pending, the MCO or PIHP
must authorize or provide the disputed services promptly, and
as expeditiously as the enrollee’s health condition requires.
(b) Services furnished while the appeal is pending. If the
MCO or PIHP, or the State fair hearing officer reverses a
decision to deny authorization of services, and the enrollee
received the disputed services while the appeal was pending,
the MCO or the PIHP or the State must pay for those services,
in accordance with State policy and regulations.

253

Subpart F Regulations --Grievance System

Met

Partially
Met

Not
met

Documentation for 438.424 Effectuation of reversed appeal resolutions:

END OF APPENDIX C

254