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OMB Control No: 0938-0566	ICR Reference No: 202211-0938-012
Status: Active	Previous ICR Reference No: 201912-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 (CMS-R-131)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/17/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/28/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2026	36 Months From Approved	06/30/2023
Responses	323,947,630	0	382,216,385
Time Burden (Hours)	37,794,970	0	44,593,186
Cost Burden (Dollars)	0	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:
	87 FR 54696	09/07/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 72485	11/25/2022
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	323,947,630	382,216,385	-58,268,755
Annual Time Burden (Hours)	37,794,970	44,593,186	-6,798,216
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 estimates has decreased to due to the estimated number of annual responses, which has decreased by 58,268,755 (from 382,216,385 to 323,947,630 claims associated with an ABN issuance). This has resulted in a a corresponding annual hour burden decrease of 6,798,216 hours.

Annual Cost to Federal Government: $1,392

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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