CMS Pub. 100-11, ch. 17, § 20.8

The purpose of the waivers is to provide for reasonable flexibility in adapting the PACE

model to the needs of particular organizations (such as those in rural areas). Sections

1894(f)(2)(B) and 1934(f)(2)(B) of the Act provide for reasonable flexibility in adapting

the PACE service delivery model to the needs of particular organizations and permit the

Secretary, in close consultation with State Administering Agencies, to modify or waive

provisions of the PACE regulations so long as any such modification or waiver is not

inconsistent with and would not impair the essential elements, objections, and

requirements of these sections. These sections state that the following provisions may not

be modified or waived:

• The focus on frail elderly qualifying individuals who require the level of care

provided in a nursing facility;

• The delivery of comprehensive, integrated acute and long-term care services;

• The IDT approach to care management and service delivery;

• Capitated, integrated financing that allows the provider to pool payments

received from public and private programs and individuals; and

• The assumption by the provider of full financial risk.

The CMS advises PACE organizations to engage in dialogue with their State

Administering Agency regarding considerations for waiver requests prior to preparing

formal requests. This will help to ensure mutual understanding and agreement among

parties involved, preventing unnecessary work on the part of the PACE organization.

The following CMS link provides instructions for both PACE organizations and State

administering agencies in submitting BIPA 903 waivers to CMS:

http://www.cms.hhs.gov/PACE/08_BIPA903WaiverRequests.asp#TopOfPage.

Instructions to PACE organizations for preparing and submitting waiver requests to State

Administering Agencies under the authority of Section 903 of the BIPA are as follows:

• Any PACE organization that identifies the need for a BIPA 903 waiver should

include the following information in their waiver submission package:

ο Identification that the submitted document is a waiver request;

ο Identification of the regulatory section the PACE organization is

requesting to have waived;

ο Rationale behind the waiver request;

ο If applicable, process that will be followed to ensure participant care is not

compromised; and

ο Identification as to whether the issue was previously submitted as a BIPA

902 grandfathering request or if it is a new request under Section 903 of

BIPA;

• Waiver requests may be submitted to the State under either of the following

situations:

ο Waiver request as a document separate from an application but

accompanying an application; or

ο Waiver request independent of an application.

Waiver requests submitted in conjunction with provider applications must be marked as

separate documents by placing them in an independent envelope labeled "waiver

request." Waiver requests submitted independent of an application, as stand-alone

documents, must also be clearly labeled "waiver request".

Waiver requests must be submitted to the State Administering Agency. The request will

be reviewed by the State and then forwarded to CMS along with any concerns or

conditions. CMS evaluates a waiver request from a PACE organization or PACE

applicant on the basis of the following information: (1) the adequacy of the description

and rationale for the waiver provided by the PACE organization or PACE applicant,

including any additional information requested by CMS; and (2) information obtained by

CMS and the State Administering Agency in on-site reviews and monitoring of the

PACE organization. Within 90 days after receipt of a waiver request, CMS either

approves the request or denies the request and notifies the PACE organization or PACE

applicant in writing of the basis of the denial. For purposes of the 90-day time limit, the

date that a waiver request is received by CMS from the State Administering Agency is

the date on which the request is delivered to the address designated by CMS. A waiver

request is deemed approved if CMS fails to act on the request within 90 days after the

date the waiver request is received by CMS. CMS may withdraw approval of a waiver for

good cause.

[42 CFR §§ 460.10, 460.26, 460.28]