Medicare and Medicaid Programs: Conditions for Certification for Rural Health Clinics and Conditions for Coverage for FQHCs in 42 CFR Part 491 (CMS-R-38)

Forms and Documents

Document Name	Status
CMS-R-38 - Supporting Statement A (CMS-1784-F version 8).docx Supporting Statement A	2024-10-07

IC Document Collections

IC ID	Document Title	Status
7968	491.9(b) Patient Care Policies - New RHCs	Removed
45407	491.9(b) Patient Care Policies - Existing RHCs	Removed
270174	Conduct biennial program evaluation (§ 491.11)	Unchanged
270173	Initial development of program evaluation (§ 491.11)	Unchanged
270172	Permitting MFT and MHCs to Furnish Services in RHC/FQHCs (§ 491.9(b))	Unchanged
270171	Biennial review of existing policies for every Medicare-certified clinic/center (§ 491.9(b))	Unchanged
270170	Initial policy development for a new clinic or center (§ 491.9(b))	Unchanged
233902	491.11 - Program Evaluation - Existing FHQCs	Removed
233900	491.11 - Program Evaluation - New FQHCs	Removed
233897	491.9(b) - Patient Care Policies - Existing FQHCs	Removed
233896	491.9(b) Patient Care Policies - New FQHCs	Removed
190717	491.11 Program Evaluation - Existing RHCs	Removed
190716	491.11 - Program Evaluation - New RHCs	Removed

ICR Details

OMB Control No: 0938-0334	ICR Reference No: 202410-0938-009
Status: Received in OIRA	Previous ICR Reference No: 202408-0938-016
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Medicare and Medicaid Programs: Conditions for Certification for Rural Health Clinics and Conditions for Coverage for FQHCs in 42 CFR Part 491 (CMS-R-38)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/07/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2027
Responses	45,655	35,326
Time Burden (Hours)	113,113	104,245
Cost Burden (Dollars)	0	0

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Abstract: This information is needed to determine if rural health clinics and federally qualified health centers meet the requirements to participate in the Medicare Program.

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Authorizing Statute(s): US Code: 42 USC 1395 Name of Law: Social Security Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV07	Final or interim final rulemaking	88 FR 78817	11/16/2023

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 52261	08/27/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78817	11/16/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
491.11 - Program Evaluation - Existing FHQCs
491.11 - Program Evaluation - New FQHCs
491.11 - Program Evaluation - New RHCs
491.11 Program Evaluation - Existing RHCs
491.9(b) - Patient Care Policies - Existing FQHCs
491.9(b) Patient Care Policies - Existing RHCs
491.9(b) Patient Care Policies - New FQHCs
491.9(b) Patient Care Policies - New RHCs
Biennial review of existing policies for every Medicare-certified clinic/center (§ 491.9(b))
Conduct biennial program evaluation (§ 491.11)
Initial development of program evaluation (§ 491.11)
Initial policy development for a new clinic or center (§ 491.9(b))
Permitting MFT and MHCs to Furnish Services in RHC/FQHCs (§ 491.9(b))

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	45,655	35,326	0	10,329	0	0
Annual Time Burden (Hours)	113,113	104,245	0	8,868	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This request for revision was precipitated by the November 16, 2023 (88 FR 78817) final rule (CMS-1784-F, RIN 0938-AV07). The rule implements section 4121 of the CAA by making conforming changes at §491.8(a)(3) and (6), which added MFT and MHCs to the list of staff who may be the owner or an employee of the clinic or center or may furnish services under contract to the clinic or center as well as included as staff available to furnish patient care services at all times the clinic or center operates. If an RHC or FQHC provides services furnished by an MFT or MHC, they will be required to update their patient care policy, as set out in § 491.9(b)(2) of the CfCs. The final rule’s inclusion of MFTs and MHCs as professionals who can provide services in an RHC and FQHC adds an additional burden associated with the existing requirement at § 491.9(b)(3)(i). This requirement states that policies include “A description of the services they provide directly or through agreement or arrangement.” Therefore, if an RHC or FQHC provides services furnished by an MFT or MHC they must update their policies to include a description of the services provided. This would result in a one-time burden of 4,348 hours. While keeping our active response time estimates as is, we have also adjusted our number of responses by plus 1,634 and time by plus 4,520‬ hours. Overall, we estimate an increase of 10,329 responses and 8,868 hours.

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Annual Cost to Federal Government: $10,180

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/07/2024

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