CMS-10630 PACE Supplemental Questionnaire

The PACE Organization (PO) Monitoring and Audit Process in Part 460 of 42 CFR (CMS-10630)

AttachmentIIPACESupplementalQuestions.xlsx

Trial Year and Routine Audits

OMB: 0938-1327

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Overview

Instructions
PACE Supplemental Questions


Sheet 1: Instructions

Instructions: • Enter responses to each question in the PACE Supplemental Questions tab of this document.

• Responses must reflect practices, policies, and procedures in place during the data collection period. The data collection period begins 6 months prior to the date of the audit engagement letter and ends on the date of the audit engagement letter. For example, an audit engagement letter is issued on March 4, 2026. The audit review period for this audit is September 4, 2025, through March 4, 2026.


Due Date: This document must be completed and submitted to HPMS within 5 business days following the issuance of the audit engagement letter.


According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1327. This information collection will allow CMS to conduct comprehensive reviews of PACE organizations to ensure compliance with regulatory requirements. The time required to complete this information collection is estimated at 780 per response, including the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection. This information collection is mandatory per CMS’s authority under Section 1894 and 1934 of the Social Security Act and implementing regulations at 42 CFR § 460.190 and 460.194, which state that CMS, in conjunction with the State Administering Agency (SAA), audit PACE organizations (POs) annually for the first 3 contract years (during the trial period), and then on an ongoing basis following the trial period. Additionally, per § 460.200(a) PACE organizations are required to collect data, maintain records, and submit reports as required by CMS and the State administering agency. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

Sheet 2: PACE Supplemental Questions

Question # Question Response
1 List the emergency medications (name, dosage and quantity) that your organization keeps readily available on site at all times.

Note: List drug name as written on the product label. Do not include medications that are stored in a cabinet, cart, room, etc. for convenience but are not specifically for emergency situations. This list of emergency drugs may be provided as a separate attachment labeled "emergency medications".

2 Identify the name of each medical record system used by the PACE organization including, but not limited to, systems used to document progress notes, medications orders, orders for all other services, the provision of all services, assessments, care plans, home care, lab and diagnostic test results, hospital and ER records, imported documentation, etc.
3 Can CMS access all of the organization’s medical records systems using a web-based portal or will auditors need to utilize specialized software, a VPN, or other methods to connect remotely to the systems?

4 What information is needed in order to provide auditors with access to your systems?

5 Other than establishing usernames and passwords for each system, is any additional authentication required? For example, will auditors need to complete two-factor authentication using a text message or an authentication application?

6 Does your organization use a committee to advise the IDT on decision making?

7 Does your organization have any policies that place limits on the amount, duration, frequency, or other restrictions to receiving any of the following items or services:

a. Glasses/replacement glasses
b. Hearing aids/replacement hearing aids
c. Home care services (including services at night, on the weekends, or holidays)?
d. Respite care
e. Specialist consultations
f. Nursing facility services
g. Hospital or ER services
h. Dental services
i. DME
j. Personal alert systems
k. Medications

If you answer yes to any of the above items, please explain the policy or restriction. You may submit the policies directly into HPMS in lieu of an explanation (use the "Supplemental" file type to upload).

8 Do you collect/require a copay or coinsurance for any services? If so, please list the services and copay/coinsurance amount.

9 Does your organization utilize a Pharmacy Benefits Manager and, if so, please explain the services they provide?

10 Does your organization have a Pharmacy & Therapeutics (P&T) committee? If yes, please explain the responsibilities of the P&T committee?

11 Can participants obtain prescriptions or orders written from any prescriber including specialists? This includes prescriptions or orders for medications, DME, or any other care/services applicable. If no, explain the process of reviewing recommendations for prescriptions or orders from other prescribers and how the PACE organization determines if the recommendation should be provided.

12 How does your organization identify drugs that are covered under Medicare Part D?

13 Are there any drugs that must undergo prior authorization before dispensing?

Prior authorization means that the participant must meet some form of criteria prior to approval, for example, the participant must have a specific diagnosis or the participant cannot be using illegal substances prior to receiving approval for the requested drug.

14 Are there any drugs that require step therapy?

This includes any program that requires a certain drug to be used first, before a different drug can be dispensed.

15 Are there any drugs with quantity limits?

Quantity limits are often used in cases where FDA-approved prescribing instructions state that only a certain number of doses should be used in a certain time period.

16 Does your organization maintain a list of preferred drugs that your providers refer to when considering which medication to prescribe? What factors go into identifying a drug as preferred for prescribing purposes?

17 What cost containment or utilization management programs do you utilize for Part D drugs?
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