42 U.S.C. § 1395eee : US Code - Section 1395EEE: Payments to, and coverage of benefits under, programs of all-inclusive care for elderly (PACE)

Search 42 U.S.C. § 1395eee : US Code - Section 1395EEE: Payments to, and coverage of benefits under, programs of all-inclusive care for elderly (PACE)

(a) Receipt of benefits through enrollment in PACE program;
definitions for PACE program related terms
(1) Benefits through enrollment in a PACE program
In accordance with this section, in the case of an individual
who is entitled to benefits under part A of this subchapter or
enrolled under part B of this subchapter and who is a PACE
program eligible individual (as defined in paragraph (5)) with
respect to a PACE program offered by a PACE provider under a PACE
program agreement -
(A) the individual may enroll in the program under this
section; and
(B) so long as the individual is so enrolled and in
accordance with regulations -
(i) the individual shall receive benefits under this
subchapter solely through such program; and
(ii) the PACE provider is entitled to payment under and in
accordance with this section and such agreement for provision
of such benefits.
(2) "PACE program" defined
For purposes of this section, the term "PACE program" means a
program of all-inclusive care for the elderly that meets the
following requirements:
(A) Operation
The entity operating the program is a PACE provider (as
defined in paragraph (3)).
(B) Comprehensive benefits
The program provides comprehensive health care services to
PACE program eligible individuals in accordance with the PACE
program agreement and regulations under this section.
(C) Transition
In the case of an individual who is enrolled under the
program under this section and whose enrollment ceases for any
reason (including that the individual no longer qualifies as a
PACE program eligible individual, the termination of a PACE
program agreement, or otherwise), the program provides
assistance to the individual in obtaining necessary
transitional care through appropriate referrals and making the
individual's medical records available to new providers.
(3) "PACE provider" defined
(A) In general
For purposes of this section, the term "PACE provider" means
an entity that -
(i) subject to subparagraph (B), is (or is a distinct part
of) a public entity or a private, nonprofit entity organized
for charitable purposes under section 501(c)(3) of the
Internal Revenue Code of 1986; and
(ii) has entered into a PACE program agreement with respect
to its operation of a PACE program.
(B) Treatment of private, for-profit providers
Clause (i) of subparagraph (A) shall not apply -
(i) to entities subject to a demonstration project waiver
under subsection (h) of this section; and
(ii) after the date the report under section 4804(b) of the
Balanced Budget Act of 1997 is submitted, unless the
Secretary determines that any of the findings described in
subparagraph (A), (B), (C), or (D) of paragraph (2) of such
section are true.
(4) "PACE program agreement" defined
For purposes of this section, the term "PACE program agreement"
means, with respect to a PACE provider, an agreement, consistent
with this section, section 1396u-4 of this title (if applicable),
and regulations promulgated to carry out such sections, between
the PACE provider and the Secretary, or an agreement between the
PACE provider and a State administering agency for the operation
of a PACE program by the provider under such sections.
(5) "PACE program eligible individual" defined
For purposes of this section, the term "PACE program eligible
individual" means, with respect to a PACE program, an individual
who -
(A) is 55 years of age or older;
(B) subject to subsection (c)(4) of this section, is
determined under subsection (c) of this section to require the
level of care required under the State medicaid plan for
coverage of nursing facility services;
(C) resides in the service area of the PACE program; and
(D) meets such other eligibility conditions as may be imposed
under the PACE program agreement for the program under
subsection (e)(2)(A)(ii) of this section.
(6) "PACE protocol" defined
For purposes of this section, the term "PACE protocol" means
the Protocol for the Program of All-inclusive Care for the
Elderly (PACE), as published by On Lok, Inc., as of April 14,
1995, or any successor protocol that may be agreed upon between
the Secretary and On Lok, Inc.
(7) "PACE demonstration waiver program" defined
For purposes of this section, the term "PACE demonstration
waiver program" means a demonstration program under either of the
following sections (as in effect before the date of their
repeal):
(A) Section 603(c) of the Social Security Amendments of 1983
(Public Law 98-21), as extended by section 9220 of the
Consolidated Omnibus Budget Reconciliation Act of 1985 (Public
Law 99-272).
(B) Section 9412(b) of the Omnibus Budget Reconciliation Act
of 1986 (Public Law 99-509).
(8) "State administering agency" defined
For purposes of this section, the term "State administering
agency" means, with respect to the operation of a PACE program in
a State, the agency of that State (which may be the single agency
responsible for administration of the State plan under subchapter
XIX of this chapter in the State) responsible for administering
PACE program agreements under this section and section 1396u-4 of
this title in the State.
(9) "Trial period" defined
(A) In general
For purposes of this section, the term "trial period" means,
with respect to a PACE program operated by a PACE provider
under a PACE program agreement, the first 3 contract years
under such agreement with respect to such program.
(B) Treatment of entities previously operating PACE
demonstration waiver programs
Each contract year (including a year occurring before the
effective date of this section) during which an entity has
operated a PACE demonstration waiver program shall be counted
under subparagraph (A) as a contract year during which the
entity operated a PACE program as a PACE provider under a PACE
program agreement.
(10) "Regulations" defined
For purposes of this section, the term "regulations" refers to
interim final or final regulations promulgated under subsection
(f) of this section to carry out this section and section 1396u-4
of this title.
(b) Scope of benefits; beneficiary safeguards
(1) In general
Under a PACE program agreement, a PACE provider shall -
(A) provide to PACE program eligible individuals enrolled
with the provider, regardless of source of payment and directly
or under contracts with other entities, at a minimum -
(i) all items and services covered under this subchapter
(for individuals enrolled under this section) and all items
and services covered under subchapter XIX of this chapter,
but without any limitation or condition as to amount,
duration, or scope and without application of deductibles,
copayments, coinsurance, or other cost-sharing that would
otherwise apply under this subchapter or such subchapter,
respectively; and
(ii) all additional items and services specified in
regulations, based upon those required under the PACE
protocol;
(B) provide such enrollees access to necessary covered items
and services 24 hours per day, every day of the year;
(C) provide services to such enrollees through a
comprehensive, multidisciplinary health and social services
delivery system which integrates acute and long-term care
services pursuant to regulations; and
(D) specify the covered items and services that will not be
provided directly by the entity, and to arrange for delivery of
those items and services through contracts meeting the
requirements of regulations.
(2) Quality assurance; patient safeguards
The PACE program agreement shall require the PACE provider to
have in effect at a minimum -
(A) a written plan of quality assurance and improvement, and
procedures implementing such plan, in accordance with
regulations; and
(B) written safeguards of the rights of enrolled participants
(including a patient bill of rights and procedures for
grievances and appeals) in accordance with regulations and with
other requirements of this subchapter and Federal and State law
that are designed for the protection of patients.
(3) Treatment of medicare services furnished by noncontract
physicians and other entities
(A) Application of medicare advantage requirement with respect
to medicare services furnished by noncontract physicians and
other entities
Section 1395w-22(k)(1) of this title (relating to limitations
on balance billing against MA organizations for noncontract
physicians and other entities with respect to services covered
under this subchapter) shall apply to PACE providers, PACE
program eligible individuals enrolled with such PACE providers,
and physicians and other entities that do not have a contract
or other agreement establishing payment amounts for services
furnished to such an individual in the same manner as such
section applies to MA organizations, individuals enrolled with
such organizations, and physicians and other entities referred
to in such section.
(B) Reference to related provision for noncontract providers of
services
For the provision relating to limitations on balance billing
against PACE providers for services covered under this
subchapter furnished by noncontract providers of services, see
section 1395cc(a)(1)(O) of this title.
(4) Reference to related provision for services covered under
subchapter XIX but not under this subchapter
For provisions relating to limitations on payments to providers
participating under the State plan under subchapter XIX of this
chapter that do not have a contract or other agreement with a
PACE provider establishing payment amounts for services covered
under such plan (but not under this subchapter) when such
services are furnished to enrollees of that PACE provider, see
section 1396a(a)(66) of this title.
(c) Eligibility determinations
(1) In general
The determination of whether an individual is a PACE program
eligible individual -
(A) shall be made under and in accordance with the PACE
program agreement; and
(B) who is entitled to medical assistance under subchapter
XIX of this chapter, shall be made (or who is not so entitled,
may be made) by the State administering agency.
(2) Condition
An individual is not a PACE program eligible individual (with
respect to payment under this section) unless the individual's
health status has been determined by the Secretary or the State
administering agency, in accordance with regulations, to be
comparable to the health status of individuals who have
participated in the PACE demonstration waiver programs. Such
determination shall be based upon information on health status
and related indicators (such as medical diagnoses and measures of
activities of daily living, instrumental activities of daily
living, and cognitive impairment) that are part of a uniform
minimum data set collected by PACE providers on potential PACE
program eligible individuals.
(3) Annual eligibility recertifications
(A) In general
Subject to subparagraph (B), the determination described in
subsection (a)(5)(B) of this section for an individual shall be
reevaluated at least annually.
(B) Exception
The requirement of annual reevaluation under subparagraph (A)
may be waived during a period in accordance with regulations in
those cases where the State administering agency determines
that there is no reasonable expectation of improvement or
significant change in an individual's condition during the
period because of the severity of chronic condition, or degree
of impairment of functional capacity of the individual
involved.
(4) Continuation of eligibility
An individual who is a PACE program eligible individual may be
deemed to continue to be such an individual notwithstanding a
determination that the individual no longer meets the requirement
of subsection (a)(5)(B) of this section if, in accordance with
regulations, in the absence of continued coverage under a PACE
program the individual reasonably would be expected to meet such
requirement within the succeeding 6-month period.
(5) Enrollment; disenrollment
(A) Voluntary disenrollment at any time
The enrollment and disenrollment of PACE program eligible
individuals in a PACE program shall be pursuant to regulations
and the PACE program agreement and shall permit enrollees to
voluntarily disenroll without cause at any time.
(B) Limitations on disenrollment
(i) In general
Regulations promulgated by the Secretary under this section
and section 1396u-4 of this title, and the PACE program
agreement, shall provide that the PACE program may not
disenroll a PACE program eligible individual except -
(I) for nonpayment of premiums (if applicable) on a
timely basis; or
(II) for engaging in disruptive or threatening behavior,
as defined in such regulations (developed in close
consultation with State administering agencies).
(ii) No disenrollment for noncompliant behavior
Except as allowed under regulations promulgated to carry
out clause (i)(II), a PACE program may not disenroll a PACE
program eligible individual on the ground that the individual
has engaged in noncompliant behavior if such behavior is
related to a mental or physical condition of the individual.
For purposes of the preceding sentence, the term
"noncompliant behavior" includes repeated noncompliance with
medical advice and repeated failure to appear for
appointments.
(iii) Timely review of proposed nonvoluntary disenrollment
A proposed disenrollment, other than a voluntary
disenrollment, shall be subject to timely review and final
determination by the Secretary or by the State administering
agency (as applicable), prior to the proposed disenrollment
becoming effective.
(d) Payments to PACE providers on capitated basis
(1) In general
In the case of a PACE provider with a PACE program agreement
under this section, except as provided in this subsection or by
regulations, the Secretary shall make prospective monthly
payments of a capitation amount for each PACE program eligible
individual enrolled under the agreement under this section in the
same manner and from the same sources as payments are made to a
Medicare+Choice organization under section 1395w-23 of this
title (or, for periods beginning before January 1, 1999, to an
eligible organization under a risk-sharing contract under section
1395mm of this title). Such payments shall be subject to
adjustment in the manner described in section 1395w-23(a)(2) of
this title or section 1395mm(a)(1)(E) of this title, as the case
may be.
(2) Capitation amount
The capitation amount to be applied under this subsection for a
provider for a contract year shall be an amount specified in the
PACE program agreement for the year. Such amount shall be based
upon payment rates established for purposes of payment under
section 1395w-23 of this title (or, for periods before January 1,
1999, for purposes of risk-sharing contracts under section 1395mm
of this title) and shall be adjusted to take into account the
comparative frailty of PACE enrollees and such other factors as
the Secretary determines to be appropriate. Such amount under
such an agreement shall be computed in a manner so that the total
payment level for all PACE program eligible individuals enrolled
under a program is less than the projected payment under this
subchapter for a comparable population not enrolled under a PACE
program.
(e) PACE program agreement
(1) Requirement
(A) In general
The Secretary, in close cooperation with the State
administering agency, shall establish procedures for entering
into, extending, and terminating PACE program agreements for
the operation of PACE programs by entities that meet the
requirements for a PACE provider under this section, section
1396u-4 of this title, and regulations.
(B) Numerical limitation
(i) In general
The Secretary shall not permit the number of PACE providers
with which agreements are in effect under this section or
under section 9412(b) of the Omnibus Budget Reconciliation
Act of 1986 to exceed -
(I) 40 as of August 5, 1997; or
(II) as of each succeeding anniversary of August 5, 1997,
the numerical limitation under this subparagraph for the
preceding year plus 20.
Subclause (II) shall apply without regard to the actual
number of agreements in effect as of a previous anniversary
date.
(ii) Treatment of certain private, for-profit providers
The numerical limitation in clause (i) shall not apply to a
PACE provider that -
(I) is operating under a demonstration project waiver
under subsection (h) of this section; or
(II) was operating under such a waiver and subsequently
qualifies for PACE provider status pursuant to subsection
(a)(3)(B)(ii) of this section.
(2) Service area and eligibility
(A) In general
A PACE program agreement for a PACE program -
(i) shall designate the service area of the program;
(ii) may provide additional requirements for individuals to
qualify as PACE program eligible individuals with respect to
the program;
(iii) shall be effective for a contract year, but may be
extended for additional contract years in the absence of a
notice by a party to terminate and is subject to termination
by the Secretary and the State administering agency at any
time for cause (as provided under the agreement);
(iv) shall require a PACE provider to meet all applicable
State and local laws and requirements; and
(v) shall contain such additional terms and conditions as
the parties may agree to, so long as such terms and
conditions are consistent with this section and regulations.
(B) Service area overlap
In designating a service area under a PACE program agreement
under subparagraph (A)(i), the Secretary (in consultation with
the State administering agency) may exclude from designation an
area that is already covered under another PACE program
agreement, in order to avoid unnecessary duplication of
services and avoid impairing the financial and service
viability of an existing program.
(3) Data collection; development of outcome measures
(A) Data collection
(i) In general
Under a PACE program agreement, the PACE provider shall -
(I) collect data;
(II) maintain, and afford the Secretary and the State
administering agency access to, the records relating to the
program, including pertinent financial, medical, and
personnel records; and
(III) make available to the Secretary and the State
administering agency reports that the Secretary finds (in
consultation with State administering agencies) necessary
to monitor the operation, cost, and effectiveness of the
PACE program under this section and section 1396u-4 of this
title.
(ii) Requirements during trial period
During the first 3 years of operation of a PACE program
(either under this section or under a PACE demonstration
waiver program), the PACE provider shall provide such
additional data as the Secretary specifies in regulations in
order to perform the oversight required under paragraph
(4)(A).
(B) Development of outcome measures
Under a PACE program agreement, the PACE provider, the
Secretary, and the State administering agency shall jointly
cooperate in the development and implementation of health
status and quality of life outcome measures with respect to
PACE program eligible individuals.
(4) Oversight
(A) Annual, close oversight during trial period
During the trial period (as defined in subsection (a)(9) of
this section) with respect to a PACE program operated by a PACE
provider, the Secretary (in cooperation with the State
administering agency) shall conduct a comprehensive annual
review of the operation of the PACE program by the provider in
order to assure compliance with the requirements of this
section and regulations. Such a review shall include -
(i) an on-site visit to the program site;
(ii) comprehensive assessment of a provider's fiscal
soundness;
(iii) comprehensive assessment of the provider's capacity
to provide all PACE services to all enrolled participants;
(iv) detailed analysis of the entity's substantial
compliance with all significant requirements of this section
and regulations; and
(v) any other elements the Secretary or State administering
agency considers necessary or appropriate.
(B) Continuing oversight
After the trial period, the Secretary (in cooperation with
the State administering agency) shall continue to conduct such
review of the operation of PACE providers and PACE programs as
may be appropriate, taking into account the performance level
of a provider and compliance of a provider with all significant
requirements of this section and regulations.
(C) Disclosure
The results of reviews under this paragraph shall be reported
promptly to the PACE provider, along with any recommendations
for changes to the provider's program, and shall be made
available to the public upon request.
(5) Termination of PACE provider agreements
(A) In general
Under regulations -
(i) the Secretary or a State administering agency may
terminate a PACE program agreement for cause; and
(ii) a PACE provider may terminate an agreement after
appropriate notice to the Secretary, the State agency, and
enrollees.
(B) Causes for termination
In accordance with regulations establishing procedures for
termination of PACE program agreements, the Secretary or a
State administering agency may terminate a PACE program
agreement with a PACE provider for, among other reasons, the
fact that -
(i) the Secretary or State administering agency determines
that -
(I) there are significant deficiencies in the quality of
care provided to enrolled participants; or
(II) the provider has failed to comply substantially with
conditions for a program or provider under this section or
section 1396u-4 of this title; and
(ii) the entity has failed to develop and successfully
initiate, within 30 days of the date of the receipt of
written notice of such a determination, a plan to correct the
deficiencies, or has failed to continue implementation of
such a plan.
(C) Termination and transition procedures
An entity whose PACE provider agreement is terminated under
this paragraph shall implement the transition procedures
required under subsection (a)(2)(C) of this section.
(6) Secretary's oversight; enforcement authority
(A) In general
Under regulations, if the Secretary determines (after
consultation with the State administering agency) that a PACE
provider is failing substantially to comply with the
requirements of this section and regulations, the Secretary
(and the State administering agency) may take any or all of the
following actions:
(i) Condition the continuation of the PACE program
agreement upon timely execution of a corrective action plan.
(ii) Withhold some or all further payments under the PACE
program agreement under this section or section 1396u-4 of
this title with respect to PACE program services furnished by
such provider until the deficiencies have been corrected.
(iii) Terminate such agreement.
(B) Application of intermediate sanctions
Under regulations, the Secretary may provide for the
application against a PACE provider of remedies described in
section 1395w-27(g)(2) (or, for periods before January 1, 1999,
section 1395mm(i)(6)(B) of this title) or 1396b(m)(5)(B) of
this title in the case of violations by the provider of the
type described in section 1395w-27(g)(1) (or section
1395mm(i)(6)(A) of this title for such periods) or
1396b(m)(5)(A) of this title, respectively (in relation to
agreements, enrollees, and requirements under this section or
section 1396u-4 of this title, respectively).
(7) Procedures for termination or imposition of sanctions
Under regulations, the provisions of section 1395w-27(h) of
this title (or for periods before January 1, 1999, section
1395mm(i)(9) of this title) shall apply to termination and
sanctions respecting a PACE program agreement and PACE provider
under this subsection in the same manner as they apply to a
termination and sanctions with respect to a contract and a
Medicare+Choice organization under part C of this subchapter (or
for such periods an eligible organization under section 1395mm of
this title).
(8) Timely consideration of applications for PACE program
provider status
In considering an application for PACE provider program status,
the application shall be deemed approved unless the Secretary,
within 90 days after the date of the submission of the
application to the Secretary, either denies such request in
writing or informs the applicant in writing with respect to any
additional information that is needed in order to make a final
determination with respect to the application. After the date the
Secretary receives such additional information, the application
shall be deemed approved unless the Secretary, within 90 days of
such date, denies such request.
(f) Regulations
(1) In general
The Secretary shall issue interim final or final regulations to
carry out this section and section 1396u-4 of this title.
(2) Use of PACE protocol
(A) In general
In issuing such regulations, the Secretary shall, to the
extent consistent with the provisions of this section,
incorporate the requirements applied to PACE demonstration
waiver programs under the PACE protocol.
(B) Flexibility
In order to provide for reasonable flexibility in adapting
the PACE service delivery model to the needs of particular
organizations (such as those in rural areas or those that may
determine it appropriate to use nonstaff physicians according
to State licensing law requirements) under this section and
section 1396u-4 of this title, the Secretary (in close
consultation with State administering agencies) may modify or
waive provisions of the PACE protocol so long as any such
modification or waiver is not inconsistent with and would not
impair the essential elements, objectives, and requirements of
this section, but may not modify or waive any of the following
provisions:
(i) The focus on frail elderly qualifying individuals who
require the level of care provided in a nursing facility.
(ii) The delivery of comprehensive, integrated acute and
long-term care services.
(iii) The interdisciplinary team approach to care
management and service delivery.
(iv) Capitated, integrated financing that allows the
provider to pool payments received from public and private
programs and individuals.
(v) The assumption by the provider of full financial risk.
(C) Continuation of modifications or waivers of operational
requirements under demonstration status
If a PACE program operating under demonstration authority has
contractual or other operating arrangements which are not
otherwise recognized in regulation and which were in effect on
July 1, 2000, the Secretary (in close consultation with, and
with the concurrence of, the State administering agency) shall
permit any such program to continue such arrangements so long
as such arrangements are found by the Secretary and the State
to be reasonably consistent with the objectives of the PACE
program.
(3) Application of certain additional beneficiary and program
protections
(A) In general
In issuing such regulations and subject to subparagraph (B),
the Secretary may apply with respect to PACE programs,
providers, and agreements such requirements of part C of this
subchapter (or, for periods before January 1, 1999, section
1395mm of this title) and sections 1396b(m) and 1396u-2 of this
title relating to protection of beneficiaries and program
integrity as would apply to Medicare+Choice organizations under
part C of this subchapter (or for such periods eligible
organizations under risk-sharing contracts under section 1395mm
of this title) and to medicaid managed care organizations under
prepaid capitation agreements under section 1396b(m) of this
title.
(B) Considerations
In issuing such regulations, the Secretary shall -
(i) take into account the differences between populations
served and benefits provided under this section and under
part C of this subchapter (or, for periods before January 1,
1999, section 1395mm of this title) and section 1396b(m) of
this title;
(ii) not include any requirement that conflicts with
carrying out PACE programs under this section; and
(iii) not include any requirement restricting the
proportion of enrollees who are eligible for benefits under
this subchapter or subchapter XIX of this chapter.
(4) Construction
Nothing in this subsection shall be construed as preventing the
Secretary from including in regulations provisions to ensure the
health and safety of individuals enrolled in a PACE program under
this section that are in addition to those otherwise provided
under paragraphs (2) and (3).
(g) Waivers of requirements
With respect to carrying out a PACE program under this section,
the following requirements of this subchapter (and regulations
relating to such requirements) are waived and shall not apply:
(1) Section 1395d of this title, insofar as it limits coverage
of institutional services.
(2) Sections 1395e, 1395f, 1395l, and 1395ww of this title,
insofar as such sections relate to rules for payment for
benefits.
(3) Sections 1395f(a)(2)(B), 1395f(a)(2)(C), and 1395n(a)(2)(A)
of this title, insofar as they limit coverage of extended care
services or home health services.
(4) Section 1395x(i) of this title, insofar as it imposes a 3-
day prior hospitalization requirement for coverage of extended
care services.
(5) Paragraphs (1) and (9) of section 1395y(a) of this title,
insofar as they may prevent payment for PACE program services to
individuals enrolled under PACE programs.
(h) Demonstration project for for-profit entities
(1) In general
In order to demonstrate the operation of a PACE program by a
private, for-profit entity, the Secretary (in close consultation
with State administering agencies) shall grant waivers from the
requirement under subsection (a)(3) of this section that a PACE
provider may not be a for-profit, private entity.
(2) Similar terms and conditions
(A) In general
Except as provided under subparagraph (B), and paragraph (1),
the terms and conditions for operation of a PACE program by a
provider under this subsection shall be the same as those for
PACE providers that are nonprofit, private organizations.
(B) Numerical limitation
The number of programs for which waivers are granted under
this subsection shall not exceed 10. Programs with waivers
granted under this subsection shall not be counted against the
numerical limitation specified in subsection (e)(1)(B) of this
section.
(i) Miscellaneous provisions
Nothing in this section or section 1396u-4 of this title shall be
construed as preventing a PACE provider from entering into
contracts with other governmental or nongovernmental payers for the
care of PACE program eligible individuals who are not eligible for
benefits under part A of this subchapter, or enrolled under part B
of this subchapter, or eligible for medical assistance under
subchapter XIX of this title.