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OMB Control No: 0938-0566	ICR Reference No: 200705-0938-006
Status: Historical Active	Previous ICR Reference No: 200404-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/01/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/25/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	01/31/2008
Responses	40,302,506	0	21,171,480
Time Burden (Hours)	4,701,959	0	1,764,290
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. The notice used to fulfill this requirement was originally referred to as an "Advance Notice." Eventually, the term "Advance Beneficiary Notice" abbreviated as "ABN" became more popular; ABN became standard usage in 1996. The general ABN notice last received OMB approval under the Paperwork Reduction Act of 1995 (PRA) in 2003. In seeking renewal of OMB's approval, CMS is retaining the widely-known ABN acronym, but it is changing the official title to "Advance Beneficiary Notice of Noncoverage" in order to more clearly convey the purpose of the notice, and also to make this title more consistent with other similar notices, such as the Hospital Issued Notice of Noncoverage (HINN). Note that previous OMB approval was for two versions of the ABN, the General Use ABN, form CMS-R-131-G, and CMS-R-131-L, specifically for physician-ordered laboratory tests. These versions have now been combined into a single notice meeting both needs and satisfying all pertinent regulatory requirements. 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): US Code: 42 USC 1395pp Name of Law: Limitation on liability of beneficiary where medicare claims are disallowed
   US Code: 42 USC 1395m Name of Law: Special payment rules for particular items and services
   US Code: 42 USC 1395u Name of Law: Provisions relating to the administration of Part B

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:
	72 FR 8167	02/23/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 1111	05/25/2007
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	40,302,506	21,171,480	19,131,026
Annual Time Burden (Hours)	4,701,959	1,764,290	2,937,669
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:

Annual Cost to Federal Government: $0

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Saleda Perryman

View ICR - OIRA Conclusion