[Federal Register Volume 66, Number 155 (Friday, August 10, 2001)]
[Notices]
[Pages 42229-42232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20049]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[CMS-1107-N]


Medicare and Medicaid Programs; Notice for the Solicitation of 
Proposals for the Private, For-Profit Demonstration Project for the 
Program of All-Inclusive Care for the Elderly (PACE)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice for solicitation of proposals.

-----------------------------------------------------------------------

SUMMARY: This notice solicits proposals from private, for-profit 
organizations for a fully capitated joint Medicare and Medicaid 
demonstration program. The purpose of this demonstration is to 
determine whether the risk-based long-term care model employed by the 
nonprofit Programs of All-Inclusive Care for the Elderly (PACE) can be 
replicated successfully by for-profit organizations

[[Page 42230]]

in various communities nationwide with comparable costs, quality, and 
access to services. The PACE model focuses on frail community dwelling 
elderly, most of whom are dually eligible for Medicare and Medicaid, 
and all of whom are assessed as being eligible for nursing home 
placement according to their State's standards. The program of care 
includes as core services the provision of adult day care and case 
management through which a multidisciplinary team coordinates all 
health and long-term care services for a participant. This 
demonstration will include a maximum of 10 for-profit demonstration 
sites.

DATES: Letters of Intent: We will begin accepting letters of intent 
from interested private, for-profit organizations beginning on August 
10, 2001. Proposals: We will accept proposals beginning December 10, 
2001. An unbound original and 10 copies must be submitted.

ADDRESSES: Letters of intent and proposals should be mailed to the 
following address: Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Attention: Michael Henesch, Project 
Officer, Center for Health Plans and Providers, Room C4-17-27, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850.

FOR FURTHER INFORMATION CONTACT: Michael Henesch at (410) 786-6685, or 
by e-mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

A. Legislative History

    On Lok Senior Health Systems, located in San Francisco's Chinatown, 
began operating in 1971. The intent of the program was to enable the 
frail elderly to remain in the community and live at home. Participants 
were transported to an adult day care center a few times a week where 
they visited their physicians, received supportive services, and 
socialized with other elderly community members.
    Under section 9412(b) of the Omnibus Budget Reconciliation Act of 
1986 (Pub. L. 99-509), the Congress authorized a demonstration program 
of all-inclusive care for the frail elderly for nonprofit entities that 
sought to replicate the model developed by On Lok in various 
communities nationwide. The demonstration came to be known as the 
Program of All-Inclusive Care for the Elderly (PACE) demonstration. The 
On Lok protocol was used as the guiding principle for creating new PACE 
sites, and the demonstration eventually grew to 26 sites, including On 
Lok, in 14 States.
    Section 4801 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-
33) authorized coverage of PACE under the Medicare program. It amended 
title XVIII of the Social Security Act (the Act) by adding section 
1894, which addresses Medicare payment to, and coverage of benefits 
under, PACE. Section 4802 of the BBA authorized the establishment of 
PACE as a State option under Medicaid. It amended title XIX of the Act 
by adding section 1934, which directly parallels the provisions of 
section 1894. Section 4803 of the BBA addresses implementation of PACE 
under both Medicare and Medicaid, the effective date, timely issuance 
of regulations, priority and special consideration in processing 
applications, and transition from PACE demonstration project status. On 
November 24, 1999, we published an interim final rule with comment 
period, ``Program of All-Inclusive Care for the Elderly (PACE)'' (64 FR 
66234) that establishes the nonprofit PACE demonstration as a permanent 
provider program under Medicare and Medicaid. These PACE regulations 
appear at 42 CFR Part 460--Programs of All-Inclusive Care for the 
Elderly.

B. Nonprofit Program Versus For-Profit Demonstration

    Section 4804(a)(2) of the BBA requires us to conduct a study to 
compare the costs, quality, and access to services provided by for-
profit entities to those of nonprofit PACE providers. The for-profit 
entities must operate under demonstration project waivers granted under 
sections 1894(h) and 1934(h) of the Act.
    The protocol developed by On Lok contained the program's guiding 
principles and was used to review the proposals for nonprofit PACE 
demonstrations. Section 4801(h)(2)(A) of the BBA states that the terms 
and conditions for the for-profit PACE program must be the same as 
those for PACE providers that are nonprofit, private organizations 
except that only 10 waivers may be granted (section 4801(h)(2)(B) of 
the BBA). Under the demonstration for for-profit entities, the existing 
PACE regulations at part 460 for nonprofit, private entities, will be 
the primary standard against which proposals will be reviewed.

C. Program Regulations for Nonprofit Entities

    The description below summarizes key components of the November 24, 
1999 final rule for the nonprofit organization PACE program.
 State's Role
    An interested organization should contact the State Administering 
Agency in coordination with the State Medicaid Agency about applying to 
participate in the PACE demonstration. The PACE demonstration is 
intended to be a three-way partnership between us, the States, and the 
PACE organizations. The State plays an integral role in not only the 
process for reviewing a proposal, but in the monitoring of an 
organization and the annual certification of a participant's 
eligibility. We will review a proposal after we receive an assurance 
from the State Administering Agency indicating that it considers the 
applicant qualified to be a PACE organization and that the State is 
willing to enter into a PACE Program Agreement with the applicant.
 General
    A PACE participant must meet the State's nursing facility 
eligibility criteria, be 55 years of age or older, be a resident of the 
PACE organization's service area, and be assessed by the PACE 
organization's multidisciplinary team. The multidisciplinary team must 
consist of a primary care physician, registered nurse, social worker, 
physical therapist, occupational therapist, dietitian, home care 
coordinator, PACE center manager, recreational therapist or activity 
coordinator, driver, and personal care attendant. Except for the 
physical therapist, occupational therapist, driver, and dietitian, the 
members of the multidisciplinary team must be employed by the PACE 
organization. A waiver may be granted by the State Administering Agency 
and us as specified in Sec. 460.102(g). The multidisciplinary team 
assesses each participant during the intake process, and develops a 
plan of care tailored to that individual's needs as specified in 
Secs. 460.104 and 460.106. On at least a semi-annual basis, the 
multidisciplinary team must reassess the participant and reevaluate the 
participant's plan of care, including defined outcomes, and make 
changes as necessary.
    A PACE organization must operate at least one PACE center and 
should either own or contract with at least one hospital, nursing home, 
and transportation service. The PACE organization must provide primary 
care, social services, restorative therapies, personal care and 
supportive services, nutritional counseling, and meals at the PACE 
center. A PACE participant must be able to access services 24 hours a 
day, 365 days a year. The PACE organization's responsibility for the 
participant extends beyond the PACE

[[Page 42231]]

center. If the participant requires help cooking, cleaning, bathing, 
etc., a home visit must be arranged by the PACE organization. If the 
center's physicians are unable to treat a participant for a particular 
condition, the organization must pay for treatment by an outside 
specialist or provider. In addition to the provision of all Medicare 
and Medicaid services, without the usual limitations and conditions, 
the PACE service package must include all primary, acute, and long-term 
care necessary to improve or maintain the participant's health status 
with the exceptions specified in Secs. 460.94 and 460.96. Section 
1894(b)(1)(A) of the Act prohibits the use of deductibles, copayments, 
coinsurance, or cost sharing in this program. The capitation rate 
covers all of the costs related to the participant's care.
    The PACE program seeks to enhance the quality of life and autonomy 
of the participant, while maximizing the dignity of, and respect for, 
older adults and elderly persons. A PACE program's success hinges on 
conscientious preventative care to avoid costly hospital and nursing 
home stays. It is the attentiveness of the multidisciplinary team and 
the preventative care and social interaction at the PACE center that 
helps participants to avoid acute and long-term care settings.
 Payment
    The nonprofit entities are currently paid the Medicare+Choice rate 
(Sec. 460.180) multiplied by a frailty adjuster of 2.39 for all PACE 
participants except those diagnosed with end-stage renal disease 
(ESRD). Payments for persons with ESRD are paid the ESRD statewide rate 
book amount multiplied by PACE specific adjustors of 1.46 for part A 
and 1.36 for part B. At the present time, we are developing a specific 
risk adjustment methodology to apply to the PACE program that is 
expected to change the payment methodology in the future.
    States that elect PACE set Medicaid rates subject to Federal 
regulations. Each State develops a payment amount based on the cost of 
comparable services for the State's nursing-facility-eligible 
population. The amount is generally based on a blend of the cost of 
nursing home and community-based care for the frail elderly. The 
monthly capitation payment amount is negotiated between the PACE 
organization and the State Administering Agency and must be less than 
the amount that is paid under the State plan if the participant is not 
enrolled in the PACE program.

II. Provisions of This Notice

A. Purpose

    This notice solicits proposals from for-profit entities to 
demonstrate that they can successfully provide comprehensive 
coordinated care for the frail elderly under a prepaid fully capitated 
payment system.

B. Duration of the Demonstration

    The demonstration will operate for 3 years. There is no authority 
for payment to for-profit entities outside of this demonstration, 
absent a change in the law. Participating programs must be prepared to 
disenroll participating beneficiaries at that time subject to the 
requirements of Secs. 460.166 and 460.168. Under section 4804(b)(2) of 
the BBA, an evaluation of the demonstration comparing the for-profit 
entities to the nonprofit entities must be conducted. A CMS contractor 
will design and conduct an evaluation of the demonstration.

C. Requirements for Proposal Submission

    We will only consider proposals from for-profit organizations. 
Interested applicants must submit a proposal that provides a 
comprehensive array of benefits and must be willing to assume full 
financial risk for all primary, acute, and long-term care. A PACE 
organization must accept both Medicare and Medicaid capitation to 
participate, although individual participants who are not eligible for 
Medicare or Medicaid may enroll in the program. We will consider only 
one site per proposal and define a site as one contiguous service area.

D. Proposal Process

    Proposals will be accepted until we choose 10 sites. After we have 
chosen 10 sites, we will notify the organization that submits a letter 
of intent that the limit of approved sites has been reached. We 
recommend the following steps to expedite a proposal submission:
Step One
    An organization that wishes to apply to participate in the 
demonstration should review the PACE program regulations for nonprofit 
organizations at Part 460 (Programs of All-Inclusive Care for the 
Elderly), which can be accessed from various sources including websites 
www.jcfa.gov/medicare (or Medicaid)/PACE/pacehmpg.htm or 
www.access.gpo.gov/mara/index.html, or by calling 1-888-293-6498. These 
regulations should serve as the organization's guiding principles 
during the development of a demonstration proposal for a PACE program. 
A successful proposal will be one that satisfies the requirements of 
the PACE program regulations.
Step Two
    An applicant interested in pursuing participation should send a 
letter of intent to us and to their State Medicaid Agency. An applicant 
should collaborate with the State in developing its proposal. The for-
profit organization should submit a complete proposal, along with 6 
copies, to its State Medicaid Agency.
Step Three
    Once the State agrees to enter into a PACE program agreement with 
the for-profit organization, the applicant should submit a proposal to 
us. In addition, the applicant should include a letter obtained from 
the State indicating that the State considers the applicant qualified 
to be a PACE organization and that it is willing to participate in the 
demonstration.

III. Final Selection

    A review panel will perform an independent review of proposals and 
will make recommendations based on organizational capabilities, fiscal 
soundness, service delivery, quality improvement plan, and data 
collection and record maintenance capabilities.
    Our Administrator will make a final decision on awards taking into 
consideration proposals that observe the following priority areas:
    1. An applicant should be able to serve the frail elderly in 
geographical areas that are currently not being served. Sections 
1894(e)(2)(B) and 1934(e)(2)(B) of the Act state that we may exclude 
from designation an area that is already covered under another PACE 
program agreement. This is to avoid unnecessary duplication of services 
and avoid impairing the financial and service viability of an existing 
program. The organization's State Administering Agency will also be 
able to provide technical assistance on this issue.
    2. We would prefer to have a rural site participate to determine if 
these sites are viable and how the sites differ from existing nonprofit 
entities.
    3. We would prefer to limit sites to one for-profit organization 
per State.
    4. We encourage for-profit entities of all organizational types to 
apply. We would prefer to have a variety of sites with differing 
organizational structures and backgrounds to participate in the 
demonstration.
    5. Finally, considering that this program grew out of a community's 
interest in enabling its elderly members to age in a community-based 
setting,

[[Page 42232]]

and the program's emphasis on community involvement, we would prefer 
for-profit organizations that have a longstanding relationship with the 
community they serve to participate in the demonstration.
    In reviewing the proposals, we will give greatest consideration to 
an organization's development of policies and procedures. Due to the 
short time frame of this demonstration and the frailty of the 
population, we need to be certain that the organization can anticipate 
potential problems and is prepared to handle the problems efficiently 
and effectively. In addition, these policies and procedures will 
increase quality by providing safeguards to protect the beneficiaries.
    We reserve the right to conduct site visits to the awardee's 
location before making awards. An independent contractor, selected and 
funded by us, will design and conduct an evaluation. The awardee will 
be required to cooperate with the contractor conducting the evaluation.

IV. Collection of Information Requirements

    As referenced in this notice, we will award up to 10 sites. 
However, given that we expect less then 10 proposals on an annual basis 
and the proposals are not standardized, the requirements referenced in 
this notice do not meet the definition of an information collection, as 
defined under 5 CFR 1320.3(c) and as such are not subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

    Authority: Sections 1894(h) and 1934(h) of the Social Security 
Act (42 U.S.C. 1395eee and 1396u-4)


(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare-Hospital Insurance Program; 
and No. 93.774, Medicare-Supplementary Medical Insurance Program)

    Dated: August 6, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-20049 Filed 8-9-01; 8:45 am]
BILLING CODE 4120-01-P