§ 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 or enrolled under part B 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:
(B)
Comprehensive benefits
(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); 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
(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), is determined under subsection (c) 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).
(6)
“PACE protocol” defined
(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
(9)
“Trial period” defined
(B)
Treatment of entities previously operating PACE demonstration waiver programs
(10)
“Regulations” defined
(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, 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
(B)
Reference to related provision for noncontract providers of services
(4)
Reference to related provision for services covered under subchapter XIX but not under this subchapter
(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, shall be made (or who is not so entitled, may be made) by the State administering agency.
(3)
Annual eligibility recertifications
(4)
Continuation of eligibility
(5)
Enrollment; disenrollment
(A)
Voluntary disenrollment 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
(iii)
Timely review of proposed nonvoluntary disenrollment
(e)
PACE program agreement
(1)
Requirement
(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); or
(II)
was operating under such a waiver and subsequently qualifies for PACE provider status pursuant to subsection (a)(3)(B)(ii).
(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.
(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
(B)
Development of outcome measures
(4)
Oversight
(A)
Annual, close oversight during trial period
During the trial period (as defined in subsection (a)(9)) 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.
(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
(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
(7)
Procedures for termination or imposition of sanctions
(8)
Timely consideration of applications for PACE program provider status
(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:
(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.
(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.
([Aug. 14, 1935, ch. 531], title XVIII, § 1894, as added [Pub. L. 105–33, title IV, § 4801], Aug. 5, 1997, [111 Stat. 528]; amended [Pub. L. 106–554, § 1(a)(6) [title IX, § 902(a)]], Dec. 21, 2000, [114 Stat. 2763], 2763A–582; [Pub. L. 108–173, title II, § 236(a)(2)], Dec. 8, 2003, [117 Stat. 2210]; [Pub. L. 110–275, title I, § 161(c)], July 15, 2008, [122 Stat. 2569]; [Pub. L. 111–148, title III, § 3201(i)(1)], Mar. 23, 2010, [124 Stat. 453]; [Pub. L. 111–152, title I, § 1102(a)], Mar. 30, 2010, [124 Stat. 1040].)