Application Crosswalk

2019_Summary of Changes_ FINAL_01182018.docx

The PACE Organization Application Process in 42 CFR Part 460 (CMS-10631)

Application Crosswalk

OMB: 0938-1326

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High Level Summary of Change or Crosswalk of Changes for

PRA Package (OMB Control No. 0938-1326 Electronic PACE Application (for Both Initial and Service Area Expansion Applications)









Revision/Clarification







Purpose of the

Revision/Clarification







2018 PACE Application Section

Level of

Applicant

Burden I = Increases burden

D – Decreases burden

N No

Change

  1. Added Section 3.5 (Marketing) to the Table of Contents.

This section was inadvertently excluded from the TOC previously.

Table of Contents

N

  1. 2. Modified the “Note” that is included in the marketing section to emphasize that SAE applicants need only submit new or revised marketing material to the HPMS PACE Marketing Module for review. CMS also added language to clarify the timing of the submission of marketing material following application submission. The complete revised note is as follows (added language in bold italics):

NOTE:  Marketing materials for both initial and SAE applications are captured separately, via the HPMS PACE marketing module. Applicants must submit marketing materials to the HPMS marketing module for CMS/state review and approval within 5 days of the submission of the application. (Note: Initial applicants must first hit the “Final Submit” button for the application itself, at which point the contract will be made available in the HPMS marketing module.  The action of hitting the final submit button for an application submittal does not preclude the PO from submitting marketing materials.)  After the application is submitted, CMS will communicate the name of the CMS and state marketing reviewers to the applicant and the applicant may then submit all marketing materials associated with its marketing plan via the HPMS marketing module.  When submitting the materials, initial and SAE applicants must include the contract number and “Initial Application” or “SAE Application” in the comments field of the marketing submission (e.g., Hxxxx Initial Application). Note that SAE applicants need only submit new or revised marketing material to the HPMS PACE Marketing Module for review. Initial PACE applicants may not begin marketing until they have been approved and have received a copy of their program agreement signed by all parties; SAE applicants may not begin marketing in the expanded geographic area, as applicable, until the SAE has been approved and the PO has received the amended program agreement, accompanied by an approval letter from CMS.”


Added language for clarification purposes, based on external comment. In addition, CMS has added instructions regarding the timing of the marketing material, which is consistent with the guidance detailed in the PACE Marketing Guidelines and some clarifying language to address questions previously raised to CMS by PACE applicants.

Section 3.5 (Marketing)

N (Represents some added information to clarify the instructional note previously included in the application)

  1. Based on internal review, the attestation below (previously the second attestation in Section 3.4.2) was moved to its own unique section (Section 3.0 - Administrative Requirements – Trial Period (SAE applicants only) and the following statement added: “The purpose of this section is to ensure that SAE applicants have successfully completed the first trial period audit in order to be able to proceed with the submission of a SAE application.”


Attestation Language:


(SAE Only) Applicant acknowledges that the first trial period audit has been successfully completed.


(In accordance with Chapter 17 of the PACE manual, if the response is “No,” the applicant may not proceed with the SAE application because CMS will only approve an expansion application after an organization has completed the first trial period audit and achieved an acceptable corrective action plan for the initial PACE center and service area.)”



This attestation


This attestation was not appropriate for inclusion in Section 3.4.2 (the Fiscal Soundness section specific to service area expansion (SAE) applications). In addition, moving it upfront in the application provides an immediate notification that SAE applicants must have successfully completed the first trial period audit in order to be able to proceed with the submission of a SAE application.


Section 3.0


N (The same information was present initially in a different section of the application; the language was simply moved to its own section of the application).

  1. Based on internal review, added the bolded language to the upload description in Part C:


C. In the Documents Section, upload a detailed map, with a scale of the complete geographic service area that includes county, zip code, street boundaries, census tract or block or tribal jurisdiction and main traffic arteries, physical barriers such as mountains and rivers and location of the PACE center (including the address of the PACE center facility), hospital providers, ambulatory and institutional services sites. Depict on the map the mean travel time from the farthest points on the geographic boundaries to the nearest ambulatory and institutional service sites.”


In response to some applicant confusion, language was added to clarify that the PACE center address is to be referenced in the upload.

Section 3.1 (Service Area)

N (minor language added for clarification purposes)

  1. Changed the regulatory citation in Attestation No. 2 from §460.62(b)(2) to §460.62(b).

This is the appropriate citation, as it is all-encompassing.

Section 3.3

N (technical correction only)

  1. Changed the regulatory citation in Attestation No. 3 from §460.62(b)(1) to §460.62(c).

This is the appropriate citation, as it is all-encompassing.

Section 3.3

N (technical correction only)

  1. Based on internal review, the bolded language was added to the Part B upload requirement:


B. In the Documents Section, upload a current list of the governing body members/board of directors and their titles. SAE applicants must indicate which members are PACE participant representative(s). Include the name and phone number of a contact for the governing body and the name and phone number of the PACE Program Director responsible for oversight and administration as described in 42 CFR §460.60(b).”

Section “B” was inadvertently deleted. In addition, per guidance, while the governing body representative need not be an actual PACE participant, the modification was made to acknowledge that only active PACE organizations are in a position to have participants and identify a participant as a governing body representative.

Section 3.3 (Governing Body)

N (minor language added for clarification purposes)

  1. Replaced “is with “our” in the language below:


B. In the Documents Section, upload a copy of your policies and procedures for grievances. Note the policies and procedures should specify whether the timeframes for responding to grievances are calendar days or business days.”



Modification in order to be grammatically correct:


Section 3.7 (Grievances)

N

  1. Modified the language as indicated below:


B. In the Documents Section, upload policies and procedures for eligibility and enrollment, including the State’s criteria used to determine if individuals are able to live in a community setting without jeopardizing their health or safety.


(Deleted the last part: “; and 2) make a determination whether individuals are eligible for “deemed continued eligibility” for the PACE program.” )


Change made because the deemed continued eligibility is now captured as part of Section 3.29 (State Attestations).

Section 3.9 (Enrollment)

N (deleted what would have otherwise been a redundancy)

  1. Modified Attestation No. 2 to reflect that the “Personal care attendant” as part of the IDT should be “Personal care attendant or representative.”

Change made per the regulatory language.

Section 3.17 (IDT)

N (technical change only)

  1. Modified the regulatory citation in Attestation No. 1 as follows: 42 CFR §460.104(a)(4).

Change made to provide correct regulatory citation.

Section 3.18 (Participant Assessment)

N (technical change only)

  1. Based on public comment, it was suggested that the correct regulatory citation referenced in Attestation No. 2 is §460.104(a)(2) and not §460.104(2). Also referenced §460.104(a)(1) and §460.104(a)(3).

Change made per the public comment to provide correct regulatory citation. However, an internal review found that 2 other another regulatory provisions needed to be cited: §460.104(a)(1), to reflect the requirement that the IDT conduct an initial comprehensive assessment upon enrollment and §460.104(a)(3), to reflect that other healthcare disciplines may be included in the comprehensive assessment process as determined by the IDT.

Section 3.18 (Participant Assessment)

N (technical change only)

  1. Based on public comment, the purpose of the Emergency and Disaster Preparedness section was modified to reference CMS’s new emergency preparedness regulatory requirements at §460.84, instead of §460.72.

The change was necessitated by new regulations that address emergency preparedness requirements for PACE organizations. The previous regulatory provision (§460.72) were replaced by the new requirements at 460.84.

Section 3.22 (Emergency and Disaster Preparedness)

N (technical change only)

  1. Added the following attestation (No. 1): “Applicant agrees to comply with all applicable Federal, State and local emergency preparedness requirements. This includes establishing and maintaining an emergency preparedness program that meets all requirements as specified in 42 CFR §460.84.


The change was necessitated by new regulations that address emergency preparedness requirements for PACE organizations. The previous regulatory provision (§460.72) were replaced by the new requirements at 460.84. This represents a global requirement, captured as a single attestation.

Section 3.22 (Emergency and Disaster Preparedness)

D – Perhaps a nominal decrease, as this serves as the replacement for 3 other attestations which were removed (see revisions 14-16, below).

  1. Removed the following attestation previously identified as No. 1:


Applicant ensures availability of emergency equipment at each center as specified in 42 CFR §460.72(c)(4) which includes the following:
• Portable oxygen;
• Airways;
• Suction; and
• Emergency drugs.”

The change was necessitated by new regulations that address emergency preparedness requirements for PACE organizations. The previous regulatory provision (§460.72) were replaced by the new requirements at 460.84.

Section 3.22 (Emergency and Disaster Preparedness)

D (see No. 13 above)

  1. Removed the following attestation previously identified as No. 2:


Applicant ensures that staff who know how to use the emergency equipment are on the premises of every center at all times and are immediately available to use the emergency equipment.”


The change was necessitated by new regulations that address emergency preparedness requirements for PACE organizations. The previous regulatory provision (§460.72) were replaced by the new requirements at 460.84.

Section 3.22 (Emergency and Disaster Preparedness)

D (see No. 13 above)

  1. Removed the following attestation previously identified as No. 3:


Applicant ensures testing, evaluating and documenting of the effectiveness of emergency and disaster plans at least annually as specified in 42 CFR §460.72(c)(5).”

The change was necessitated by new regulations that address emergency preparedness requirements for PACE organizations. The previous regulatory provision (§460.72) were replaced by the new requirements at 460.84.

Section 3.22 (Emergency and Disaster Preparedness)

D (see No. 13 above)

  1. Based on public comment, it was suggested that the correct regulatory citation referenced in Attestation No. 3 is §460.76(b)(2) and not §460.76(b)(1).

Change made per the public comment to provide correct regulatory citation.

Section 3.23 (Transportation)

N (technical change only)

  1. Changed the header in the Chart in Section A to reference “QAPI” instead of “Medical Records.”

Change made to correctly reflect the title of the section.

Section 3.28 (QAPI)

N (technical change only)

  1. Changed “State Attestation” title to “State Attestations.”

To reflect multiple state aspects to the application.

Section 3.29 (State Attestations)

N

  1. Added a line between Parts F and G.

To be grammatically correct.

Section 3.29 State Attestations)

N

  1. Modified the Governing Body document upload template to align with the revisions to the template. The template now includes reference to the individual who serves as the participant representative, as required by regulation at 460.62(c).







Revisions made to align with revisions to the upload template and regulatory requirements.

Section 4.1

N (The upload description has always instructed applicants to indicate who the participant representative(s) is on the governing body. This change to the template is simply to align with the information requested in the upload document.)

  1. Added the following document upload templates:


4.2 (Legal Entity and organizational Structure)

4.4 (Explanation of Rights)

4.5 (Enrollment)

4.6 (Additional Enrollment criteria)

4.7 (Voluntary Enrollment)

4.8 (Involuntary Enrollment)

4.9 (Grievances)

4.10 (Appeals)

4.11 (Additional Appeal Rights)

4.12 (QAPI)

4.13 (Medicare and Medicaid Capitated Payment)

4.14 (State Enrollment/Disenrollment Reconciliation Methodology)

4.15 (Termination)

4.16 (SAA Enrollment Process)

4.17 (SAA Oversight of PO Administration of Safety Criteria

4.18 (Information Provided By State to Participants

4.19 (State Disenrollment Process)

4.20 (State Attestations/Assurances Signature Pages)







Revisions made to reflect the new templates intended to provide consistency with document submissions and facilitate assembly of program agreements upon application approval.

Section 4.2

I (This substantive part of the information is already required as part of the application and that burden is already captured. The templates simply provide a header for applicants to follow when they submit their information, which will be incorporated within the program agreement as required appendices once the application is approved. However, there is a nominal amount of added burden associated with adding the header to the appendices, which includes 2 lines to reference the title and applicable appendix. )

  1. Modified the State Assurances Signature Pages document upload template (now 4.20 due to the addition of new templates) to align with the revisions to the template. Specifically, the title was slightly modified and is now “STATE ATTESTATIONS/ASSURANCES SIGNATURE PAGES.” In addition, some minor edits were made to the template content, including 2 statements specific to a SAE application, as applicable.

To provide greater clarity regarding this SAA-based document and the fact that it serves as the state attestations document.

Section 4.20

Simply adds information to guide applicants in the structure of the information to be provided.

  1. Modified I.E. of the State readiness Review Report to reference the “latest” edition of the LSC instead of the “2000” edition.

Change made to ensure the appropriate edition of the LSC is cited, and not a dated version.

State Readiness Review Report

N (Technical change only)


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