Response to Comment

Crosswalk/Summary of Change Based on 60-day Comments and CMS Response for

PRA Package (CMS-10631 Electronic PACE Application)

Comment	CMS Response to Comment	PACE Application Section	Level of Applicant Burden I = Increases burden; D – Decreases burden; N – No Change
The commenter recommends that CMS allow an active PACE organization to have more than one Service Area Expansion (SAE) application under CMS review at a time. (CMS does not allow PACE organizations to submit an expansion application if one is currently pending.)	This recommendation is outside the scope of this information collection. However, we note that this recommendation has been made a number of times and CMS has addressed it through other channels.	N/A	N
2. In the absence of being able to have more than one expansion application under review concurrently, the commenter recommends that CM allow a PACE organization (PO) seeking to expand its geographic service area when another application is pending to opt to establish a new contract if such application has the support of its SAA.	The suggestion is outside the scope of this information collection but was addressed as part of a prior information collection. While we are aware of certain entities establishing unique legal entities for purposes of submitting separate applications, as we have indicated previously, a single, PACE organization-specific program agreement, which serves as the binding contract between CMS, the PO and the State Administering Agency (SAA), provides the essential basis for the operations of a PO.  This suggestion would result in multiple program agreements specific to a single PO and, depending on the timing of submission and review of that organization’s expansion applications, would, over time, likely result in varying program agreement information applicable to a single entity, which would be cumbersome and confusing for all parties involved. Furthermore, CMS conducts annual audits in each of the first 3 years of operation after initial approval to ensure an organization is adhering to regulatory requirements and is providing quality services to the population it serves. All initial PACE applicants, once approved, are subject to this “trial period” and may not submit expansion applications during this time.	N/A	N
Remove quarterly restriction on submission of initial and SAE applications. Specifically, the commenter suggests that CMS reconsider the current designated quarterly submission date (i.e., 4 times per year) and allow applications to be submitted on a continuous basis.	The suggestion is outside the scope of this information collection. Similar recommendations to allow more frequent submission of PACE applications have been proposed before. Unlike the Medicare Advantage program, which has one opportunity per year to submit applications, PACE applicants have four opportunities throughout the year. CMS believes this is more than adequate and plans to continue offering four quarterly application submission opportunities per year. We note there are a number of subject matter experts involved with PACE application review and the ability to control when applications are submitted allows CMS to better manage and track application reviews. In addition, the ability for organizations to submit initial applications at 4 points throughout the year affects the timing of bid submission and review and already causes some issues due to varying and unpredictable approval dates, which is not something CMS can control, as final approval of an application is dependent on when an applicant responds to a CMS request for additional information. Allowing organizations to submit applications at any time of the year would further complicate this process.	N/A	N
Page 14 – Commenter noted that §460.62(c) does not include a reference to “community representation.”	Comment accepted; edit to be made to application in HPMS and the current paper copy application available on the PACE website. The modified language will read as follows (language in italics added): Applicant agrees to appoint a participant representative to act as a liaison between the governing body and Participant Advisory Committee, to and present participant issues from the participant advisory committee to the governing body. and to ensure community representation per §460.62(c).	Section 3.3 (Attestation #3)	N (negligible change)
Page 20: Commenter asked if “unsolicited door-to-door marketing” should be expanded to include “or other unsolicited means of direct contact” consistent with §460.82(e)(5).	Comment accepted; edit to be made to application in HPMS and the current paper copy application available on the PACE website. The modified language will read as follows (language in italics added): Unsolicited door-to-door marketing, or other unsolicited means of direct contact.	Section 3.5 (Attestation #6)	N (negligible change)
Page 24: Commenter suggested a small edit to include “to” between “agrees” and “give.”	The language is correct in the Health Plan Management system, but we will make the change to the current paper copy application available on the PACE website.	Section 3.9 (Attestation #3)	N
Page 30: The commenter pointed out that the Note is repetitive of the Note for document upload B.	No change needed. This language is intentional. The note associated with document upload C is referring to any additional program specific eligibility conditions as permitted at 460.150 (b)(4).	Section 3.10 (Document Upload C)	N
Page 46: The commenter questioned whether the language in Section 3.19, Attestation No. 7 is duplicative of information included in Section 3.19, Attestation No. 4.	Comment not accepted. While the 2 attestations are similar, we see them as distinct in that No. 7 more explicitly addresses and emphasizes the face-to-face nature/process for conducting reassessments, a critical component of the participant assessment process.	Section 3.19 (Attestation #7)	N
Page 65: Referring to the reference to information on the HOS-M in Chapter 10 of the PACE manual, the reference to section 10.30 appears to be incorrect. Information on the HOS-M is found in sections 30.7-30.11. In addition, some of the information included in the manual is outdated, e.g., reference to random sampling for POs with 1,400 or more enrollees.	We note this comment is based on a template document that is included in the paper copy application. This boilerplate language is part of the program agreement, not the electronic application itself, which is what this information collection addresses. We will work to make this correction.	Section 4.13 of the paper application (reflects boilerplate language included in all program agreements with PACE organizations and applicable SAA)	N
Page 71: The commenter notes that in the Applicant Attestation (Section 4.21), the banner is blank.	We note this is part of a Notice of Intent to Apply form and is outside the scope of this information collection but is included in the paper copy application. We will add the following language to the banner in the paper copy application: CENTERS FOR MEDICARE AND MEDICAID SERVICES PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY NOTICE OF INTENT TO APPLY (NOIA) DATA COLLECTION FORM	Section 4.21 of the paper application.	N
Page 81: In 4th bullet, “participant’s” should be “participants”.	This comment is based on a template document that serves as a tool for SAAs conducting state readiness reviews. This tool is included in the paper copy application but is not the electronic application itself, which is what this information collection addresses. We will work to make this correction.	State Readiness Review Template	N