CMS-10630 Request for Additional Information (RAI)/PO Response

CMS Request for Additional Information (RAI)/PO Response

Sample Information:

Element:
Sample Number:
Participant/Personnel Name:
Participant ID:

General Instructions:

1. Enter responses for each question regarding potential non-compliance directly into this document.

2. Enter responses for each document request regarding potential non-compliance directly into this document.

3. Please see the ‘Questions’ and ‘Documentation Requests’ sections of this document for specific instructions pertaining to those sections.

4. After responding to the questions and documentation requests, save this completed document along with all documentation in a ZIP file.

5. When naming the ZIP file, use the file name identified in the ‘File Name Requested’ column of the document request log (DRL).

6. Upload the complete ZIP file to the Health Plans Management System (HPMS).

Questions Section:

Instructions:

1. If there are no questions, CMS auditors will enter “No questions” in the first row of this section.

2. Each question in this section is designed to help CMS assess compliance with a specific regulatory requirement. Please keep this in mind as you respond to the questions and answer them completely and clearly.

3. Please respond to each question.

   1. If a question has multiple parts, answer all parts of the question (even if the response is “not applicable”).

   2. Label your responses to match the auditors numbering/lettering for their questions.

      1. Example: If question 2 has 3 sub-questions (2a, 2b, 2c) the PO should label their responses 2a, 2b and 2c to clearly align with the question.

4. Responding to Questions:

When responding to questions please do the following:

1. Provide a “Yes” or “No” response before providing any additional information (unless the question is open-ended).

2. If additional information is available that demonstrates compliance, mitigates non-compliance, or provides additional context, please provide that information after providing a “Yes” or “No” response.

1. Providing Documentation:

PACE organizations MUST provide supporting documentation in the following circumstances:

1. If it is specifically requested by the auditor.

2) If the PO has documentation that demonstrates compliance, mitigates non-compliance, or provides additional context. Please note,

if your organization believes you are compliant with a requirement you must provide documentation that supports your position and

response(s) to the questions. When submitting supporting documentation in response to auditor questions, please do the following:

1. Include each document in the ZIP file uploaded to HPMS.

2. Begin the name of each document with the letter ‘Q’ and the corresponding question number. For example, the name of the document provided in response to question 1a would begin with ‘Q1a.’

3. Identify the name(s) of document(s) for each question in the response column (see example below).

4. If the documentation cannot be provided, enter a statement indicating that the documentation cannot be provided and, if known, why the documentation cannot be provided.

CMS Questions	PO Responses Please carefully review the instructions at the top of this section before responding to the questions. Reviewing the instructions will help to reduce the need for additional questions.
Example Question: The participant was enrolled on 01/01/2026. Initial RN and dietitian assessments could not be located within the medical record. Was an in-person initial RN assessment completed within 30 days of enrollment? If yes, please provide a copy of the initial RN assessment. If no, please explain why an initial RN assessment was not completed. Was an in-person initial dietitian assessment completed within 30 days of enrollment? If yes, please provide a copy of the initial RN assessment. If no, please explain why an initial RN assessment was not completed.	Example Response: 1a. Yes, an in-person initial RN assessment was completed on 01/15/2026. The assessment is saved in the EMR on 1/15 and is called “RN progress note.” 1ai. A copy of the assessment is included in the ZIP file (Q1a Initial RN Assessment). 1aii. NA 1b. No, an initial dietitian was not completed. 1bi. NA 1bii. The dietitian inadvertently forgot to complete the assessment (human error).

Documentation Requests Section:

Instructions:

1. If there are no specific documentation requests, CMS auditors will enter “No documentation requests.”

2. Please provide each document requested by CMS.

3. Include each document in the ZIP file uploaded to HPMS.

4. Begin the name of each document with the letters ‘DR’ and the corresponding request number. For example, the name of the document provided in response to request 1 would begin with ‘DR1.’

5. Identify the full name(s) of document(s) for each question in the response column (see example below).

6. If the documentation cannot be provided, enter a statement indicating that the documentation cannot be provided and, if known, why the documentation cannot be provided (see example below).

CMS Documentation Requests	PO Responses Please carefully review the instructions at the top of this section before responding to the requests. Reviewing the instructions will help to reduce the need for additional documentation requests.
Example Documentation Request 05/01/2026 Dental Consult	DR1. Dental Consult 05012026
Example Documentation Request 06/01/2026 ER discharge summary	The documentation cannot be provided. It was not requested from the hospital.

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.

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