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. § 411.406

Criteria for determining that a provider, practitioner, or supplier knew that services were excluded from coverage as custodial care or as not reasonable and necessary

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(a) Basic rule. A provider, practitioner, or supplier that furnished services which 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 any one of the conditions specified in paragraphs (b) through (e) of this section is met.

(b) Notice from the QIO, intermediary or carrier. The QIO, intermediary, or carrier had informed the provider, practitioner, or supplier that the services furnished were not covered, or that similar or reasonably comparable services were not covered.

(c) Notice from the utilization review committee or the beneficiary's attending phyician. The utilization review group or committee for the provider or the beneficiary's attending physician had informed the provider that these services were not covered.

(d) Notice from the provider, practitioner, or supplier to the beneficiary. Before the services were furnished, the provider, practitioner or supplier informed the beneficiary that—

(1) The services were not covered; or

(2) The beneficiary no longer needed covered services.

(e) Knowledge based on experience, actual notice, or constructive notice. It is clear that the provider, practitioner, or supplier could have been expected to have known that the services were excluded from coverage on the basis of the following:

(1) Its receipt of CMS notices, including manual issuances, bulletins, or other written guides or directives from intermediaries, carriers, or QIOs, including notification of QIO screening criteria specific to the condition of the beneficiary for whom the furnished services are at issue and of medical procedures subject to preadmission review by a QIO.

(2) Federal Register publications containing notice of national coverage decisions or of other specifications regarding noncoverage of an item or service.

(3) Its knowledge of what are considered acceptable standards of practice by the local medical community.

[54 FR 41734, Oct. 11, 1989, as amended at 60 FR 48425, Sept. 19, 1995]
Notes of Decisions
Cited in 22 cases (5 in the last 5 years), 1997–2025 · leading case: Livinrite, Inc. v. Azar
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Livinrite, Inc. v. Azar (2019) vaed · cites it 4× “" 42 C.F.R. § 411.406 (e) ; see also Medicare Claims Processing Manual ("MCPM") Ch.”
Horras v. Leavitt (2007) ca8 · cites it 2× “” 42 C.F.R. § 411.406 . The regulations further ex *901 plain: “Knowingly” means that “a person, with respect to information, has actual knowledge of information, acts in deliberate ignorance of the truth or falsity of the information, or acts in reckless disregard of the truth…”
United States v. Bourseau (2008) ca9 “§ 1395cc; 42 C.F.R. §§ 411.406 , 413.24(f), 489.11.”
Caring Hearts Personal Home Services, Inc. v. Burwell (2016) ca10 “Neither, for that matter, does it appear CMS’s position in litigation always followed a straight course: as late as 2009 the agency seems to have endorsed an approach (in at least one case) closer to the one advocated by Caring Hearts and found in the agency’s prior regulations…”
Willowood of Great Barrington, Inc. v. Sebelius (2009) mad · cites it 3× “) In support of this further conclusion, the ALJ noted that, pursuant to 42 C.F.R. § 411.406 (e), a Medicare provider “may be deemed to have constructive notice of non-coverage based on the receipt of CMS notices, including manual issuances, bulletins, or other written guides or…”
Almy v. Sebelius (2010) mdd · cites it 3× “42 C.F.R. § 411.406 (e). Suppliers may provide beneficiaries with written “advance beneficiary notice” (“ABN”) that states that Medicare will probably not cover or pay for a DME item because of a lack of medical necessity.”
Yale-New Haven Hospital, Inc. v. Thompson (2001) ctd · cites it 3× “See 42 C.F.R. § 411.406 (e)(1). Section § 1395pp(a) provides in relevant part that where a determination is made that services furnished to an individual by a provider are not reasonable and necessary within the meaning of 42 U.”
Anghel v. Sebelius (2012) nyed “” See 42 C.F.R. § 411.406 (e). It is obvious to the Court that Dr.”
Edwin R. Banks v. Secretary, Department of Health and Human Services (2022) ca11 “§ 1395pp(a); 42 C.F.R. § 411.406 (d); MCPM ch. 30, § 50.”
Maximum Comfort, Inc. v. Thompson (2004) caed · cites it 2× “According to 42 C.F.R. § 411.406 (e)(1), a supplier will be presumed to know that an item was not reasonable and necessary where the supplier has received relevant CMS notices, including manual issuances or other written guides from the Medicare carrier.”
Maximum Comfort Inc. v. Secretary of Health & Human Services (2007) ca9 “See 42 C.F.R. § 411.406 (e). CIGNA’s Supplier Manual states that physicians are required to maintain documentation of medical necessity beyond the certificate of medical necessity.”
Art of Healing Medicine, P.C. v. Burwell (2015) nyed “42 C.F.R. § 411.406 (e)(1); see also, e.g.”
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— 42 C.F.R. § 411.406(e)(1) — 1 case
Encompass Health Rehabilitation Hospital of Charleston, LLC v. Becerra (2024) scd
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.