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U.S. Code as of:
01/19/04
Section 1395b-8. Chronic care improvement
(a) Implementation of chronic care improvement programs
(1) In general
The Secretary shall provide for the phased-in development,
testing, evaluation, and implementation of chronic care
improvement programs in accordance with this section. Each such
program shall be designed to improve clinical quality and
beneficiary satisfaction and achieve spending targets with
respect to expenditures under this subchapter for targeted
beneficiaries with one or more threshold conditions.
(2) Definitions
For purposes of this section:
(A) Chronic care improvement program
The term "chronic care improvement program" means a program
described in paragraph (1) that is offered under an agreement
under subsection (b) or (c) of this section.
(B) Chronic care improvement organization
The term "chronic care improvement organization" means an
entity that has entered into an agreement under subsection (b)
or (c) of this section to provide, directly or through
contracts with subcontractors, a chronic care improvement
program under this section. Such an entity may be a disease
management organization, health insurer, integrated delivery
system, physician group practice, a consortium of such
entities, or any other legal entity that the Secretary
determines appropriate to carry out a chronic care improvement
program under this section.
(C) Care management plan
The term "care management plan" means a plan established
under subsection (d) of this section for a participant in a
chronic care improvement program.
(D) Threshold condition
The term "threshold condition" means a chronic condition,
such as congestive heart failure, diabetes, chronic obstructive
pulmonary disease (COPD), or other diseases or conditions, as
selected by the Secretary as appropriate for the establishment
of a chronic care improvement program.
(E) Targeted beneficiary
The term "targeted beneficiary" means, with respect to a
chronic care improvement program, an individual who -
(i) is entitled to benefits under part A of this subchapter
and enrolled under part B of this subchapter, but not
enrolled in a plan under part C of this subchapter;
(ii) has one or more threshold conditions covered under
such program; and
(iii) has been identified under subsection (d)(1) of this
section as a potential participant in such program.
(3) Construction
Nothing in this section shall be construed as -
(A) expanding the amount, duration, or scope of benefits
under this subchapter;
(B) providing an entitlement to participate in a chronic care
improvement program under this section;
(C) providing for any hearing or appeal rights under section
1395ff, 1395oo of this title, or otherwise, with respect to a
chronic care improvement program under this section; or
(D) providing benefits under a chronic care improvement
program for which a claim may be submitted to the Secretary by
any provider of services or supplier (as defined in section
1395x(d) of this title).
(b) Developmental phase (Phase I)
(1) In general
In carrying out this section, the Secretary shall enter into
agreements consistent with subsection (f) of this section with
chronic care improvement organizations for the development,
testing, and evaluation of chronic care improvement programs
using randomized controlled trials. The first such agreement
shall be entered into not later than 12 months after December 8,
2003.
(2) Agreement period
The period of an agreement under this subsection shall be for 3
years.
(3) Minimum participation
(A) In general
The Secretary shall enter into agreements under this
subsection in a manner so that chronic care improvement
programs offered under this section are offered in geographic
areas that, in the aggregate, consist of areas in which at
least 10 percent of the aggregate number of medicare
beneficiaries reside.
(B) Medicare beneficiary defined
In this paragraph, the term "medicare beneficiary" means an
individual who is entitled to benefits under part A of this
subchapter, enrolled under part B of this subchapter, or both,
and who resides in the United States.
(4) Site selection
In selecting geographic areas in which agreements are entered
into under this subsection, the Secretary shall ensure that each
chronic care improvement program is conducted in a geographic
area in which at least 10,000 targeted beneficiaries reside among
other individuals entitled to benefits under part A of this
subchapter, enrolled under part B of this subchapter, or both to
serve as a control population.
(5) Independent evaluations of Phase I programs
The Secretary shall contract for an independent evaluation of
the programs conducted under this subsection. Such evaluation
shall be done by a contractor with knowledge of chronic care
management programs and demonstrated experience in the evaluation
of such programs. Each evaluation shall include an assessment of
the following factors of the programs:
(A) Quality improvement measures, such as adherence to
evidence-based guidelines and rehospitalization rates.
(B) Beneficiary and provider satisfaction.
(C) Health outcomes.
(D) Financial outcomes, including any cost savings to the
program under this subchapter.
(c) Expanded implementation phase (Phase II)
(1) In general
With respect to chronic care improvement programs conducted
under subsection (b) of this section, if the Secretary finds that
the results of the independent evaluation conducted under
subsection (b)(6) of this section indicate that the conditions
specified in paragraph (2) have been met by a program (or
components of such program), the Secretary shall enter into
agreements consistent with subsection (f) of this section to
expand the implementation of the program (or components) to
additional geographic areas not covered under the program as
conducted under subsection (b) of this section, which may include
the implementation of the program on a national basis. Such
expansion shall begin not earlier than 2 years after the program
is implemented under subsection (b) of this section and not later
than 6 months after the date of completion of such program.
(2) Conditions for expansion of programs
The conditions specified in this paragraph are, with respect to
a chronic care improvement program conducted under subsection (b)
of this section for a threshold condition, that the program is
expected to -
(A) improve the clinical quality of care;
(B) improve beneficiary satisfaction; and
(C) achieve targets for savings to the program under this
subchapter specified by the Secretary in the agreement within a
range determined to be appropriate by the Secretary, subject to
the application of budget neutrality with respect to the
program and not taking into account any payments by the
organization under the agreement under the program for risk
under subsection (f)(3)(B) of this section.
(3) Independent evaluations of Phase II programs
The Secretary shall carry out evaluations of programs expanded
under this subsection as the Secretary determines appropriate.
Such evaluations shall be carried out in the similar manner as is
provided under subsection (b)(5) of this section.
(d) Identification and enrollment of prospective program
participants
(1) Identification of prospective program participants
The Secretary shall establish a method for identifying targeted
beneficiaries who may benefit from participation in a chronic
care improvement program.
(2) Initial contact by Secretary
The Secretary shall communicate with each targeted beneficiary
concerning participation in a chronic care improvement program.
Such communication may be made by the Secretary and shall include
information on the following:
(A) A description of the advantages to the beneficiary in
participating in a program.
(B) Notification that the organization offering a program may
contact the beneficiary directly concerning such participation.
(C) Notification that participation in a program is
voluntary.
(D) A description of the method for the beneficiary to
participate or for declining to participate and the method for
obtaining additional information concerning such participation.
(3) Voluntary participation
A targeted beneficiary may participate in a chronic care
improvement program on a voluntary basis and may terminate
participation at any time.
(e) Chronic care improvement programs
(1) In general
Each chronic care improvement program shall -
(A) have a process to screen each targeted beneficiary for
conditions other than threshold conditions, such as impaired
cognitive ability and co-morbidities, for the purposes of
developing an individualized, goal-oriented care management
plan under paragraph (2);
(B) provide each targeted beneficiary participating in the
program with such plan; and
(C) carry out such plan and other chronic care improvement
activities in accordance with paragraph (3).
(2) Elements of care management plans
A care management plan for a targeted beneficiary shall be
developed with the beneficiary and shall, to the extent
appropriate, include the following:
(A) A designated point of contact responsible for
communications with the beneficiary and for facilitating
communications with other health care providers under the plan.
(B) Self-care education for the beneficiary (through
approaches such as disease management or medical nutrition
therapy) and education for primary caregivers and family
members.
(C) Education for physicians and other providers and
collaboration to enhance communication of relevant clinical
information.
(D) The use of monitoring technologies that enable patient
guidance through the exchange of pertinent clinical
information, such as vital signs, symptomatic information, and
health self-assessment.
(E) The provision of information about hospice care, pain and
palliative care, and end-of-life care.
(3) Conduct of programs
In carrying out paragraph (1)(C) with respect to a participant,
the chronic care improvement organization shall -
(A) guide the participant in managing the participant's
health (including all co-morbidities, relevant health care
services, and pharmaceutical needs) and in performing
activities as specified under the elements of the care
management plan of the participant;
(B) use decision-support tools such as evidence-based
practice guidelines or other criteria as determined by the
Secretary; and
(C) develop a clinical information database to track and
monitor each participant across settings and to evaluate
outcomes.
(4) Additional responsibilities
(A) Outcomes report
Each chronic care improvement organization offering a chronic
care improvement program shall monitor and report to the
Secretary, in a manner specified by the Secretary, on health
care quality, cost, and outcomes.
(B) Additional requirements
Each such organization and program shall comply with such
additional requirements as the Secretary may specify.
(5) Accreditation
The Secretary may provide that chronic care improvement
programs and chronic care improvement organizations that are
accredited by qualified organizations (as defined by the
Secretary) may be deemed to meet such requirements under this
section as the Secretary may specify.
(f) Terms of agreements
(1) Terms and conditions
(A) In general
An agreement under this section with a chronic care
improvement organization shall contain such terms and
conditions as the Secretary may specify consistent with this
section.
(B) Clinical, quality improvement, and financial requirements
The Secretary may not enter into an agreement with such an
organization under this section for the operation of a chronic
care improvement program unless -
(i) the program and organization meet the requirements of
subsection (e) of this section and such clinical, quality
improvement, financial, and other requirements as the
Secretary deems to be appropriate for the targeted
beneficiaries to be served; and
(ii) the organization demonstrates to the satisfaction of
the Secretary that the organization is able to assume
financial risk for performance under the agreement (as
applied under paragraph (3)(B)) with respect to payments made
to the organization under such agreement through available
reserves, reinsurance, withholds, or such other means as the
Secretary determines appropriate.
(2) Manner of payment
Subject to paragraph (3)(B), the payment under an agreement
under -
(A) subsection (b) of this section shall be computed on a
per-member per-month basis; or
(B) subsection (c) of this section may be on a per-member
per-month basis or such other basis as the Secretary and
organization may agree.
(3) Application of performance standards
(A) Specification of performance standards
Each agreement under this section with a chronic care
improvement organization shall specify performance standards
for each of the factors specified in subsection (c)(2) of this
section, including clinical quality and spending targets under
this subchapter, against which the performance of the chronic
care improvement organization under the agreement is measured.
(B) Adjustment of payment based on performance
(i) In general
Each such agreement shall provide for adjustments in
payment rates to an organization under the agreement insofar
as the Secretary determines that the organization failed to
meet the performance standards specified in the agreement
under subparagraph (A).
(ii) Financial risk for performance
In the case of an agreement under subsection (b) or (c) of
this section, the agreement shall provide for a full recovery
for any amount by which the fees paid to the organization
under the agreement exceed the estimated savings to the
programs under this subchapter attributable to implementation
of such agreement.
(4) Budget neutral payment condition
Under this section, the Secretary shall ensure that the
aggregate sum of medicare program benefit expenditures for
beneficiaries participating in chronic care improvement programs
and funds paid to chronic care improvement organizations under
this section, shall not exceed the medicare program benefit
expenditures that the Secretary estimates would have been made
for such targeted beneficiaries in the absence of such programs.
(g) Funding
(1) Subject to paragraph (2), there are appropriated to the
Secretary, in appropriate part from the Federal Hospital Insurance
Trust Fund and the Federal Supplementary Medical Insurance Trust
Fund, such sums as may be necessary to provide for agreements with
chronic care improvement programs under this section.
(2) In no case shall the funding under this section exceed
$100,000,000 in aggregate increased expenditures under this
subchapter (after taking into account any savings attributable to
the operation of this section) over the 3-fiscal-year period
beginning on October 1, 2003.
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