SubD

Medicare Plus Choice (M+C): Interim Final Rule

 Subpart D–Quality Assurance

Sec. 422.152 Quality assessment and performance improvement program.

(a) General rule. Each M+C
organization that offers one or more M+C plans must have, for each of
those plans, an ongoing quality assessment and performance
improvement program that meets the applicable requirements of this
section for the services it furnishes to its M+C enrollees.

(b) Requirements for M+C coordinated care
plans and network M+C MSA plans. An organization offering an
M+C coordinated care plan or M+C network MSA plan must do the
following: (1) Meet the requirements in paragraph (c)(1) of this
section concerning performance measurement and reporting. With
respect to an M+C coordinated care plan, an organization must also
meet the requirements of paragraph (c)(2) of this section concerning
the achievement of minimum performance levels. The requirements of
paragraph (c)(2) of this section do not apply with respect to an M+C
MSA plan. (2) Conduct performance improvement projects as described
in paragraph (d) of this section. These projects must achieve,
through ongoing measurement and intervention, demonstrable and
sustained improvement in significant aspects of clinical care and
nonclinical care areas that can be expected to have a favorable
effect on health outcomes and enrollee satisfaction. (3) In
processing requests for initial or continued authorization of
services, follow written policies and procedures that reflect current
standards of medical practice. (4) Have in effect mechanisms to
detect both underutilization and overutilization of services. (5)
Make available to HCFA information on quality and outcomes measures
that will enable beneficiaries to compare health coverage options and
select among them, as provided in Sec. 422.64(c)(10).

(c) Performance measurement and reporting.
The organization offering the plan must do the following: (1)
Measure performance under the plan, using standard measures required
by HCFA, and report its performance to HCFA. The standard measures
may be specified in uniform data collection and reporting instruments
required by HCFA, and will relate to– (i) Clinical areas including
effectiveness of care, enrollee perception of care, and use of
services; and (ii) Nonclinical areas including access to and
availability of services, appeals and grievances, and organizational
characteristics. (2) Achieve any minimum performance levels that HCFA
establishes locally, regionally, or nationally with respect to the
standard measures. (i) In establishing minimum performance levels,
HCFA considers historical plan and original Medicare performance data
and trends. (ii) HCFA establishes the minimum performance levels
prospectively upon contract initiation and renewal. (iii) The
organization must meet the minimum performance levels by the end of
the contract year. (iv) In accordance with Sec. 422.506, HCFA may
decline to renew the organization’s contract in the year that HCFA
determines that it did not meet the minimum performance levels.

(d) Performance improvement projects.
(1) Performance improvement projects are organization initiatives
that focus on specified clinical and nonclinical areas and that
involve the following: (i) Measurement of performance. (ii) System
interventions, including the establishment or alteration of practice
guidelines. (iii) Improving performance. (iv) Systematic follow-up on
the effect of the interventions. (2) Each project must address the
entire population to which the measurement specified in paragraph
(d)(1)(i) of this section is relevant. (3) HCFA establishes M+C
organization and M+C plan-specific obligations for the number and
distribution of projects among the required clinical and nonclinical
areas, in accordance with paragraphs (d)(4) and (d)(5) of this
section, to ensure that the projects are representative of the entire
spectrum of clinical and nonclinical care areas associated with a
plan. [[Page 35083]] (4) The required clinical areas include: (i)
Prevention and care of acute and chronic conditions. (ii) High-volume
services. (iii) High-risk services. (iv) Continuity and coordination
of care. (5) The required nonclinical areas include: (i) Appeals,
grievances, and other complaints. (ii) Access to, and availability
of, services. (6) In addition to requiring that the organization
initiate its own performance improvement projects, HCFA may require
that the organization– (i) Conduct particular performance
improvement projects that are specific to the organization; and (ii)
Participate in national or statewide performance improvement
projects. (7) For each project, the organization must assess
performance under the plan using quality indicators that are– (i)
Objective, clearly and unambiguously defined, and based on current
clinical knowledge or health services research; and (ii) Capable of
measuring outcomes such as changes in health status, functional
status and enrollee satisfaction, or valid proxies of those outcomes.
(8) Performance assessment on the selected indicators must be based
on systematic ongoing collection and analysis of valid and reliable
data. (9) Interventions must achieve improvement that is significant
and sustained over time. (10) The organization must report the status
and results of each project to HCFA as requested.

(e) Requirements for non-network M+C MSA
plans and M+C private fee- for-service plans. An organization
offering an M+C non-network MSA plan or an M+C private
fee-for-service plan must do the following: (1) Measure performance
under the plan using standard measures required by HCFA and report
its performance to HCFA. The standard measures may be specified in
uniform data collection and reporting instruments required by HCFA
and will relate to– (i) Prevention and care of acute and chronic
conditions; (ii) High-volume services; (iii) High-risk services; and
(iv) Enrollee satisfaction. (2) Evaluate the continuity and
coordination of care furnished to enrollees. (3) If the organization
uses written protocols for utilization review, the organization
must– (i) Base those protocols on current standards of medical
practice; and (ii) Have mechanisms to evaluate utilization of
services and to inform enrollees and providers of services of the
results of the evaluation.

(f) Requirements for all types of
plans— (1) Health information. For all types of plans that it
offers, an organization must– (i) Maintain a health information
system that collects, analyzes, and integrates the data necessary to
implement its quality assessment and performance improvement program;
(ii) Ensure that the information it receives from providers of
services is reliable and complete; and (iii) Make all collected
information available to HCFA. (2) Program review. For each plan,
there must be in effect a process for formal evaluation, at least
annually, of the impact and effectiveness of its quality assessment
and performance improvement program.

Sec. 422.154 External review.

(a) Basic rule. Except as provided in
paragraph (c) of this section, each M+C organization must, for each
M+C plan it operates, have an agreement with an independent quality
review and improvement organization (review organization) approved by
HCFA to perform functions of the type described in part 466 of this
chapter.

(b) Terms of the agreement. The
agreement must be consistent with HCFA guidelines and include the
following provisions: (1) Require that the organization– (i)
Allocate adequate space for use of the review organization whenever
it is conducting review activities; and (ii) Provide all pertinent
data, including patient care data, at the time the review
organization needs the data to carry out the reviews and make its
determinations. (2) Except in the case of complaints about quality,
exclude review activities that HCFA determines would duplicate review
activities conducted as part of an accreditation process or as part
of HCFA monitoring.

(c) Exceptions. The requirement of
paragraph (a) of this section does not apply for an M+C private
fee-for-service plan or a non-network M+C MSA plan if the
organization does not carry out utilization review with respect to
the plan.

Sec. 422.156 Compliance deemed on the basis of
accreditation.

(a) General rule. An M+C organization
may be deemed to meet any of the requirements of paragraph (b) of
this section if– (1) The M+C organization is fully accredited (and
periodically reaccredited) by a private, national accreditation
organization approved by HCFA; and (2) The accreditation organization
used the standards approved by HCFA for the purposes of assessing the
M+C organization’s compliance with Medicare requirements.

(b) Deeming requirements. The
following requirements are deemable: (1) The quality assessment and
performance improvement requirements of Sec. 422.152. (2) The
confidentiality and accuracy of enrollee records requirements of Sec.
422.118.

(c) Effective date of deemed status.
The date on which the organization is deemed to meet the
applicable requirements is the later of the following: (1) The date
on which the accreditation organization is approved by HCFA. (2) The
date the M+C organization is accredited by the accreditation
organization.

(d) Obligations of deemed M+C organizations.
An M+C organization deemed to meet Medicare requirements
must– (1) Submit to surveys by HCFA to validate its accreditation
organization’s accreditation process; and (2) Authorize its
accreditation organization to release to HCFA a copy of its most
recent accreditation survey, together with any survey- related
information that HCFA may require (including corrective action plans
and summaries of unmet HCFA requirements).

(e) Removal of deemed status. HCFA
removes part or all of an M+C organization’s deemed status for any of
the following reasons: (1) HCFA determines, on the basis of its own
survey or the results of the accreditation survey, that the M+C
organization does not meet the Medicare requirements for which deemed
status was granted. (2) HCFA withdraws its approval of the
accreditation organization that accredited the M+C organization. (3)
The M+C organization fails to meet the requirements of paragraph (d)
of this section.

(f) Enforcement authority. HCFA
retains the authority to initiate enforcement action against any M+C
[[Page 35084]] organization that it determines, on the basis of its
own survey or the results of an accreditation survey, no longer meets
the Medicare requirements for which deemed status was
granted.

Sec. 422.157 Accreditation organizations.

(a) Conditions for approval. HCFA may
approve an accreditation organization with respect to a given
standard under this part if it meets the following conditions: (1) In
accrediting M+C organizations, it applies and enforces standards that
are at least as stringent as Medicare requirements with respect to
the standard or standards in question. (2) It complies with the
application and reapplication procedures set forth in Sec. 422.158.
(3) It is not controlled, as defined in Sec. 413.17 of this chapter,
by the entities it accredits.

(b) Notice and comment--(1) Proposed
notice. HCFA publishes a proposed notice in the Federal Register
whenever it is considering granting an accreditation organization’s
application for approval. The notice– (i) Specifies the basis for
granting approval; (ii) Describes how the accreditation
organization’s accreditation program meets or exceeds all of the
Medicare requirements for which HCFA would deem compliance on the
basis of the organization’s accreditation; and (iii) Provides
opportunity for public comment. (2) Final notice. (i) After reviewing
public comments, HCFA publishes a final Federal Register notice
indicating whether it has granted the accreditation organization’s
request for approval. (ii) If HCFA grants the request, the final
notice specifies the effective date and the term of the approval,
which may not exceed 6 years.

(c) Ongoing responsibilities of an approved
accreditation organization. An accreditation organization
approved by HCFA must undertake the following activities on an
ongoing basis: (1) Provide to HCFA in written form and on a monthly
basis all of the following: (i) Copies of all accreditation surveys,
together with any survey- related information that HCFA may require
(including corrective action plans and summaries of unmet HCFA
requirements). (ii) Notice of all accreditation decisions. (iii)
Notice of all complaints related to deemed M+C organizations. (iv)
Information about any M+C organization against which the accrediting
organization has taken remedial or adverse action, including
revocation, withdrawal or revision of the M+C organization’s
accreditation. (The accreditation organization must provide this
information within 30 days of taking the remedial or adverse action.)
(v) Notice of any proposed changes in its accreditation standards or
requirements or survey process. If the organization implements the
changes before or without HCFA approval, HCFA may withdraw its
approval of the accreditation organization. (2) Within 30 days of a
change in HCFA requirements, submit to HCFA– (i) An acknowledgment
of HCFA’s notification of the change; (ii) A revised cross-walk
reflecting the new requirements; and (iii) An explanation of how the
accreditation organization plans to alter its standards to conform to
HCFA’s new requirements, within the time-frames specified in the
notification of change it receives from HCFA. (3) Permit its
surveyors to serve as witnesses if HCFA takes an adverse action based
on accreditation findings. (4) Within 3 days of identifying, in an
accredited M+C organization, a deficiency that poses immediate
jeopardy to the organization’s enrollees or to the general public,
give HCFA written notice of the deficiency. (5) Within 10 days of
HCFA’s notice of withdrawal of approval, give written notice of the
withdrawal to all accredited M+C organizations.

(d) Continuing Federal oversight of approved
accreditation organizations. This paragraph establishes
specific criteria and procedures for continuing oversight and for
withdrawing approval of an accreditation organization. (1)
Equivalency review. HCFA compares the accreditation organization’s
standards and its application and enforcement of those standards to
the comparable HCFA requirements and processes when– (i) HCFA
imposes new requirements or changes its survey process; (ii) An
accreditation organization proposes to adopt new standards or changes
in its survey process; or (iii) The term of an accreditation
organization’s approval expires. (2) Validation review. HCFA or its
agent may conduct a survey of an accredited organization, examine the
results of the accreditation organization’s own survey, or attend the
accreditation organization’s survey, in order to validate the
organization’s accreditation process. At the conclusion of the
review, HCFA identifies any accreditation programs for which
validation survey results– (i) Indicate a 20 percent rate of
disparity between certification by the accreditation organization and
certification by HCFA or its agent on standards that do not
constitute immediate jeopardy to patient health and safety if unmet;
(ii) Indicate any disparity between certification by the
accreditation organization and certification by HCFA or its agent on
standards that constitute immediate jeopardy to patient health and
safety if unmet; or (iii) Indicate that, irrespective of the rate of
disparity, there are widespread or systematic problems in an
organization’s accreditation process such that accreditation no
longer provides assurance that the Medicare requirements are met or
exceeded. (3) Onsite observation. HCFA may conduct an onsite
inspection of the accreditation organization’s operations and offices
to verify the organization’s representations and assess the
organization’s compliance with its own policies and procedures. The
onsite inspection may include, but is not limited to, reviewing
documents, auditing meetings concerning the accreditation process,
evaluating survey results or the accreditation status decision making
process, and interviewing the organization’s staff. (4) Notice of
intent to withdraw approval. If an equivalency review, validation
review, onsite observation, or HCFA’s daily experience with the
accreditation organization suggests that the accreditation
organization is not meeting the requirements of this subpart, HCFA
gives the organization written notice of its intent to withdraw
approval. (5) Withdrawal of approval. HCFA may withdraw its approval
of an accreditation organization at any time if HCFA determines
that– (i) Deeming based on accreditation no longer guarantees that
the M+C organization meets the M+C requirements, and failure to meet
those requirements could jeopardize the health or safety of Medicare
enrollees and constitute a significant hazard to the public health;
or (ii) The accreditation organization has failed to meet its
obligations under this section or under Sec. 422.156 or Sec. 422.158.
(6) Reconsideration of withdrawal of approval. An accreditation
organization dissatisfied with a determination to withdraw HCFA
approval may request a reconsideration of that determination in
accordance with subpart D of part 488 of this chapter. [[Page
35085]]

Sec. 422.158 Procedures for approval of accreditation as a
basis for deeming compliance.

(a) Required information and materials.
A private, national accreditation organization applying for
approval must furnish to HCFA all of the following information and
materials. (When reapplying for approval, the organization need
furnish only the particular information and materials requested by
HCFA.) (1) The types of M+C plans that it would review as part of its
accreditation process. (2) A detailed comparison of the
organization’s accreditation requirements and standards with the
Medicare requirements (for example, a crosswalk). (3) Detailed
information about the organization’s survey process, including– (i)
Frequency of surveys and whether surveys are announced or
unannounced. (ii) Copies of survey forms, and guidelines and
instructions to surveyors. (iii) Descriptions of– (A) The survey
review process and the accreditation status decision making process;
(B) The procedures used to notify accredited M+C organizations of
deficiencies and to monitor the correction of those deficiencies; and
(C) The procedures used to enforce compliance with accreditation
requirements. (4) Detailed information about the individuals who
perform surveys for the accreditation organization, including– (i)
The size and composition of accreditation survey teams for each type
of plan reviewed as part of the accreditation process; (ii) The
education and experience requirements surveyors must meet; (iii) The
content and frequency of the in-service training provided to survey
personnel; (iv) The evaluation systems used to monitor the
performance of individual surveyors and survey teams; and (v) The
organization’s policies and practice with respect to the
participation, in surveys or in the accreditation decision process by
an individual who is professionally or financially affiliated with
the entity being surveyed. (5) A description of the organization’s
data management and analysis system with respect to its surveys and
accreditation decisions, including the kinds of reports, tables, and
other displays generated by that system. (6) A description of the
organization’s procedures for responding to and investigating
complaints against accredited organizations, including policies and
procedures regarding coordination of these activities with
appropriate licensing bodies and ombudsmen programs. (7) A
description of the organization’s policies and procedures with
respect to the withholding or removal of accreditation for failure to
meet the accreditation organization’s standards or requirements, and
other actions the organization takes in response to noncompliance
with its standards and requirements. (8) A description of all types
(for example, full, partial) and categories (for example,
provisional, conditional, temporary) of accreditation offered by the
organization, the duration of each type and category of accreditation
and a statement identifying the types and categories that would serve
as a basis for accreditation if HCFA approves the accreditation
organization. (9) A list of all currently accredited M+C
organizations and the type, category, and expiration date of the
accreditation held by each of them. (10) A list of all full and
partial accreditation surveys scheduled to be performed by the
accreditation organization as requested by HCFA. (11) The name and
address of each person with an ownership or control interest in the
accreditation organization.

(b) Required supporting
documentation. A private, national accreditation organization
applying or reapplying for approval must also submit the following
supporting documentation: (1) A written presentation that
demonstrates its ability to furnish HCFA with electronic data in HCFA
compatible format. (2) A resource analysis that demonstrates that its
staffing, funding, and other resources are adequate to perform the
required surveys and related activities. (3) A statement
acknowledging that, as a condition for approval, it agrees to comply
with the ongoing responsibility requirements of Sec. 422.157(c).

(c) Additional information. If HCFA
determines that it needs additional information for a determination
to grant or deny the accreditation organization’s request for
approval, it notifies the organization and allows time for the
organization to provide the additional information.

(d) Onsite visit. HCFA may visit the
accreditation organization’s offices to verify representations made
by the organization in its application, including, but not limited
to, review of documents, and interviews with the organization’s
staff.

(e) Notice of determination. HCFA
gives the accreditation organization a formal notice that– (1)
States whether the request for approval has been granted or denied;
(2) Gives the rationale for any denial; and (3) Describes the
reconsideration and reapplication procedures.

(f) Withdrawal. An accreditation
organization may withdraw its application for approval at any time
before it receives the formal notice specified in paragraph (e) of
this section.

(g) Reconsideration of adverse
determination. An accreditation organization that has received
notice of denial of its request for approval may request
reconsideration in accordance with subpart D of part 488 of this
chapter.

(h) Request for approval following denial.
(1) Except as provided in paragraph (h)(2) of this section, an
accreditation organization that has received notice of denial of its
request for approval may submit a new request if it– (i) Has revised
its accreditation program to correct the deficiencies on which the
denial was based; (ii) Can demonstrate that the M+C organizations
that it has accredited meet or exceed applicable Medicare
requirements; and (iii) Resubmits the application in its entirety.
(2) An accreditation organization that has requested reconsideration
of HCFA’s denial of its request for approval may not submit a new
request until the reconsideration is administratively
final.

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