Information Collection Request

Advance Beneficiary Notice of Non-Coverage (ABN) (CMS-R-131)

ICR 202511-0938-004 · OMB 0938-0566 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form CMS-R-131 Advanced Beneficiary Notice of Non-coverage (Vietnamese Version) Form Modified Repair queued
Form CMS-R-131 Advanced Beneficiary Notice of Non-coverage (Korean Version) Form Modified Available
Form CMS-R-131 Advanced Beneficiary Notice of Non-coverage (Chinese Version) Form Modified Repair queued
Form CMS-R-131 Advanced Beneficiary Notice of Non-coverage (Spanish Version) Form Modified Repair queued
Form CMS-R-131 Advanced Beneficiary Notice of Non-coverage Instructions Form and Instruction Modified Repair queued
Form CMS-R-131 Advanced Beneficiary Notice of Non-coverage Form Modified Available
Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form Modified Missing upstream
CMS-R-131 - Supporting Statement A .docx Supporting Statement A Uploaded 2025-11-21 Repair queued
CMS-R-131 - Supporting Statement A .docx Supporting Statement A Uploaded 2025-11-21 Missing upstream
CROSSWALK DOCUMENT ABN_.pdf Supplementary Document Uploaded 2025-11-18 Repair queued
CROSSWALK DOCUMENT ABN_.pdf Supplementary Document Uploaded 2025-11-18 Repair queued
CMS Response to 60-day Public Comments - CMS-R-131.docx Supplementary Document Uploaded 2025-11-18 Repair queued
CMS Response to 60-day Public Comments - CMS-R-131.docx Supplementary Document Uploaded 2025-11-18 Missing upstream
Quest Diagnostics.pdf Public Comments Uploaded 2025-10-06 Repair queued
American Clinical Laboratory Association.pdf Public Comments Uploaded 2025-10-06 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form ModifiedAdvanced Beneficiary Notice of Non-coverage (Vietnamese Version)
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form ModifiedAdvanced Beneficiary Notice of Non-coverage (Korean Version)
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form ModifiedAdvanced Beneficiary Notice of Non-coverage (Chinese Version)
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form ModifiedAdvanced Beneficiary Notice of Non-coverage (Spanish Version)
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form and Instruction ModifiedAdvanced Beneficiary Notice of Non-coverage Instructions
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form ModifiedAdvanced Beneficiary Notice of Non-coverage
8163 Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 Form Modified
ICR Details
0938-0566 202511-0938-004
Active 202211-0938-012
HHS/CMS CM-CPC
Advance Beneficiary Notice of Non-Coverage (ABN) (CMS-R-131)
Revision of a currently approved collection   No
Regular
Approved without change 03/10/2026
Retrieve Notice of Action (NOA) 11/21/2025
  Inventory as of this Action Requested Previously Approved
03/31/2029 36 Months From Approved 03/31/2026
331,715,277 0 323,947,630
38,701,221 0 37,794,970
0 0 0

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.

Statute at Large: 18 Stat. 1879
  
None

Not associated with rulemaking

  90 FR 37515 08/05/2025
90 FR 52675 11/21/2025
Yes

  Total Approved 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 331,715,277 323,947,630 0 0 7,767,647 0
Annual Time Burden (Hours) 38,701,221 37,794,970 0 0 906,251 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.

$1,571
No
    No
    No
No
No
No
No
Stephan McKenzie 410 786-1943 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/21/2025