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OMB Control No: 0938-0566	ICR Reference No: 202511-0938-004
Status: Received in OIRA	Previous ICR Reference No: 202211-0938-012
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Advance Beneficiary Notice of Non-Coverage (ABN) (CMS-R-131)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 11/21/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2026
Responses	331,715,277	323,947,630
Time Burden (Hours)	38,701,221	37,794,970
Cost Burden (Dollars)	0	0

Abstract: The use of written notices to inform beneficiaries of their liability under specific conditions has been available since Title XVIII of the Social Security Act (the Act), section 1879, Limitation On Liability, was enacted in 1972 (P.L. 92-603). Similar required notification and liability protections are available under other sections of the Act: section 1834(a)(18) refund requirements for certain items when unsolicited telephone contacts are made, section 1834(j)(4) for the same types of items when there is neither a required advance coverage determination nor required supplier number; 1834(a)(15) also for advance determinations for these items and section 1842(l) applicable to physicians not accepting assignment. Implementing regulations are found at 42 CFR 411.404(b) and (c), and 411.408(d)(2) and (f), on written notice requirements. These statutory requirements apply only to Original Medicare, not Medicare Advantage plans. Under section 1879 of the Act, Medicare beneficiaries may be held financially responsible for items or services usually covered under Medicare, but denied in an individual case under specific statutory exclusions, if the beneficiary is informed prior to furnishing the issues or services that Medicare is likely to deny payment. When required, the ABN is delivered by Part B paid physicians, providers (including institutional providers like outpatient hospitals) practitioners (such as chiropractors), and suppliers, as well as hospice providers and Religious Non-medical Health Care Institutions paid under Part A. Other Medicare institutional providers paid under Part A use other approved notice for this purpose.

Authorizing Statute(s): Statute at Large: 18 Stat. 1879

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 37515	08/05/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52675	11/21/2025
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	331,715,277	323,947,630	7,767,647
Annual Time Burden (Hours)	38,701,221	37,794,970	906,251
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden has increased due to an overall increase in respondents and decrease in Medicare claims filed by the respondents. In terms of Medicare’s general growth, the number of participating providers and suppliers has increased since the last PRA submission from 1,701,558 to1,723,755. The number of claims submitted that might receive an ABN has increased from 981,659,485 to 1,005,197,808 claims; from 323,947,630 to 331,715,277 claims associated with an ABN issuance.

Annual Cost to Federal Government: $1,571

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: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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