C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT › Subpart K—Payment for Certain Excluded Services

42 C.F.R. § 411.404

Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary

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(a) Basic rule. A beneficiary who receives services that constitute custodial care under § 411.15(g) or that are not reasonable and necessary under § 411.15(k), is considered to have known that the services were not covered if the criteria of paragraphs (b) and (c) of this section are met.

(b) Written notice. (1) Written notice is given to the beneficiary, or to someone acting on his or her behalf, that the services were not covered because they did not meet Medicare coverage guidelines.

(2) A notice concerning similar or reasonably comparable services furnished on a previous occasion also meets this criterion.

(3) After a beneficiary is notified that there is no Medicare payment for a service that is not covered by Medicare, he or she is presumed to know that there is no Medicare payment for any form of subsequent treatment for the non-covered condition.

(c) Source of notice. The notice was given by one of the following:

(1) The QIO, intermediary, or carrier.

(2) The group or committee responsible for utilization review for the provider that furnished the services.

(3) The provider, practitioner, or supplier that furnished the service.

[54 FR 41734, Oct. 11, 1989, as amended at 69 FR 66423, Nov. 15, 2004]
Notes of Decisions
Cited in 13 cases (8 in the last 5 years), 2010–2022 · leading case: Anniken Prosser v. Xavier Becerra, 2 F.4th 708 (7th Cir. 2021).
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Anniken Prosser v. Xavier Becerra, 2 F.4th 708 (7th Cir. 2021). · cites it 2× “See 42 C.F.R. § 411.404 (a), (b). Medical device suppli- ers—as opposed to healthcare providers in general—bear an additional burden should they wish to shift the risk that cov- erage may be denied: they must obtain a written agreement by the patient that she will individually…”
Edwin R. Banks v. Sec'y, Dep't of Health & Human Servs., 38 F.4th 86 (11th Cir. 2022). · cites it 2× “1, 50; see also 42 C.F.R. § 411.404 ; Int’l Rehab. Scis., Inc.”
California Clinical Lab'y Ass'n v. Sec'y of Dep't of Health & Human Servs., 104 F. Supp. 3d 66 (D.D.C. 2015). · cites it 2× “2012) (citing 42 C.F.R. § 411.404 ) (explaining that Medicare providers bear the financial risk of coverage denials in absence of written advance beneficiary notices shifting financial responsibility to Medicare recipients).”
Int'l Rehabilitative Sciences Inc. v. Sebelius, 688 F.3d 994 (9th Cir. 2012). “42 C.F.R. § 411.404 . These advance beneficiary notices “allow beneficiaries to make an informed consumer decision about receiving items or services for which they may have to pay out-of-pocket.”
Almy v. Sebelius, 749 F. Supp. 2d 315 (D. Maryland 2010). · cites it 2× “42 C.F.R. § 411.404 (b); MCPM Ch. 30, § 40.”
Mississippi Care Ctr. of Morton, L.L.C. v. Sebelius, 449 F. App'x 341 (5th Cir. 2011). · cites it 4× “It defines the basic rule as requiring that (1) “[w]ritten notice is given to the beneficiary, or to someone acting on his or her behalf, that the services were not covered because they did not meet Medicare coverage guidelines”10 and (2) the notice is given by “[t]he QIO,…”
Int'l Rehabilitative Sciences, Inc. v. Sebelius, 737 F. Supp. 2d 1281 (W.D. Wash. 2010). “§ 1395pp; 42 C.F.R. § 411.404 (b); Medicare Claims Processing Manual, CMS Publication 100-04, § 40.”
Edwin R. Banks v. Sec'y of Health & Human Servs. (11th Cir. 2021). “” See 42 C.F.R. § 411.404 (b)(3) (“After a beneficiary is notified that there is no Medicare payment for a service that is not covered by Medicare, he or she is presumed to know that there is no Medicare payment for any form of subsequent treatment for the non-covered condition.”
Edwin R. Banks v. Sec'y of Health & Human Servs. (11th Cir. 2021). “” See 42 C.F.R. § 411.404 (b)(3) (“After a beneficiary is notified that there is no Medicare payment for a service that is not covered by Medicare, he or she is presumed to know that there is no Medicare payment for any form of subsequent treatment for the non-covered condition.”
Lynn Oxenberg v. Sec'y United States Depart (3rd Cir. 2022). “See 42 C.F.R. § 411.404 (a)– (b). Medical device suppliers are also subject to additional regulation when shifting liability.”
Townsend v. Azar (S.D.N.Y. 2021). “42 C.F.R. § 411.404 (b). Here, there was no evidence that Plaintiff had received an Advance Beneficiary Notice.”
Thumann v. Sec'y, Dep't of Health & Human Servs. (S.D. Ohio 2021). “42 C.F.R. § 411.404 . Instead, the supplier must get the beneficiary to sign a cost-shifting agreement—called an “ABN.”
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