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OMB Control No: 0938-0334	ICR Reference No: 202408-0938-016
Status: Historical Inactive	Previous ICR Reference No: 202406-0938-005
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
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 09/27/2024
	Date Received in OIRA: 08/16/2024
Terms of Clearance: The agency has reported that this package was improperly submitted.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	07/31/2027
Responses	35,326	0	35,326
Time Burden (Hours)	104,245	0	104,245
Cost Burden (Dollars)	0	0	0

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.

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

Citations for New Statutory Requirements: None

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

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 52261	08/07/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78817	11/16/2023
Did the Agency receive public comments on this ICR? No

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). This final 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.

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

Agency Contact: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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