42 C.F.R. § 405.1060

Applicability of national coverage determinations (NCDs)

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(a) General rule. (1) An NCD is a determination by the Secretary of whether a particular item or service is covered nationally under Medicare.

(2) An NCD does not include a determination of what code, if any, is assigned to a particular item or service covered under Medicare or a determination of the amount of payment made for a particular item or service.

(3) NCDs are made under section 1862(a)(1) of the Act as well as under other applicable provisions of the Act.

(4) An NCD is binding on fiscal intermediaries, carriers, QIOs, QICs, ALJs and attorney adjudicators, and the Council.

(b) Review by an ALJ or attorney adjudicator. (1) An ALJ or attorney adjudicator may not disregard, set aside, or otherwise review an NCD.

(2) An ALJ or attorney adjudicator may review the facts of a particular case to determine whether an NCD applies to a specific claim for benefits and, if so, whether the NCD was applied correctly to the claim.

(c) Review by the Council. (1) The Council may not disregard, set aside, or otherwise review an NCD for purposes of a section 1869 claim appeal, except that the DAB may review NCDs as provided under part 426 of this title.

(2) The Council may review the facts of a particular case to determine whether an NCD applies to a specific claim for benefits and, if so, whether the NCD was applied correctly to the claim.

[70 FR 11472, Mar. 8, 2005, as amended at 70 FR 37704, June 30, 2005; 82 FR 5121, Jan. 17, 2017]
Notes of Decisions
Cited in 23 cases (10 in the last 5 years), 2008–2026 · leading case: United States ex rel. Modglin v. DJO Global Inc., 114 F. Supp. 3d 993 (C.D. Cal. 2015).
United States ex rel. Modglin v. DJO Global Inc., 114 F. Supp. 3d 993 (C.D. Cal. 2015). · cites it 4× “” 42 C.F.R. § 405.1060 (a)(1). NCDs are compiled in the Medicare Manual.”
United States ex rel. Modglin v. DJO Global Inc., 48 F. Supp. 3d 1362 (C.D. Cal. 2014). · cites it 3× “” 42 C.F.R. § 405.1060 (a)(1). NCDs are compiled in the Medicare Manual.”
United States Ex Rel. Groat v. Boston Heart Diagnostics Corp., 255 F. Supp. 3d 13 (D.D.C. 2017). · cites it 2× “§ 1395ff(l); 42 C.F.R. § 405.1060 (a). National coverage determinations are binding on both Medicare contractors and administrative law judges, who preside over Medicare coverage appeals.”
Sensory Neurostimulation, Inc. v. Alex Azar, II, 977 F.3d 969 (9th Cir. 2020). “§ 1395ff(c)(3)(B)(ii)(I); 42 C.F.R. § 405.1060 (a)(4). In the absence of an NCD, MACs may also issue “local” coverage determinations that apply to their own subsequent decisions.”
Smith v. Burwell, 209 F. Supp. 3d 98 (D.D.C. 2016). · cites it 2× “”); 42 C.F.R. § 405.1060 (a)(1) (“An NCD is a determination by the Secretary of whether a particular item or service is covered nationally under Medicare.”
United States v. Adams, 371 F. Supp. 3d 1195 (N.D. Ga. 2019). “" 42 C.F.R. § 405.1060 . The United States Court of Appeals for the Third Circuit explained: The Secretary of Health and Human Services decides "whether a particular medical service is 'reasonable and necessary' .”
United States ex rel. Dildine v. Pandya, 389 F. Supp. 3d 1214 (N.D. Ga. 2019). “" 42 C.F.R. § 405.1060 . The United States Court of Appeals for the Third Circuit explained: The Secretary of Health and Human Services decides "whether a particular medical service is 'reasonable and necessary' .”
Bailey v. Mut. of Omaha Ins., 534 F. Supp. 2d 43 (D.D.C. 2008). “See 42 C.F.R. § 405.1060 (a)(4). In contrast, LCDs are determinations by fiscal intermediaries — such as Mutual — or carriers respecting whether a particular item or service is covered on an intermediary or carrier-wide basis.”
Woodfill v. Sec'y of Health & Human Servs., 557 F. App'x 473 (6th Cir. 2014). “42 C.F.R. § 405.1060 (a). The Secretary has issued a national coverage determination with respect to infusion pumps.”
United States of Am. v. Univ. of Cincinnati Med. Ctr., LLC (S.D. Ohio 2020). · cites it 3× “See also Woodfill, 2013 WL 2153247 , at *2 (“An NCD is binding during administrative adjudication” pursuant to 42 C.F.R. § 405.1060 (a)(4)). In the absence of an NCD, MACs may issue a “local coverage determination” (LCD), which announces “whether or not a particular item or…”
I & R Med., P.C. v. Hargan (E.D.N.Y 2021). · cites it 2× “§ 1395ff(f)(1)(B); 42 C.F.R § 405.1060(a)(1). NCDs are binding on fiscal intermediaries, carriers, Quality Improvement Organizations (“QIOs”), Qualified Independent Contractors (“QICs”), Administrative Law Judges (“ALJs”) and attorney adjudicators, and the Medicare Appeals…”
Greenwald v. Price (D.D.C. 2022). “§§ 1395hh, 1395ff(a)(1). He may also issue binding national coverage determinations, or “NCDs,” that reflect his determination that an item or service is covered under designated medical circumstances on a nationwide basis.”
— 42 C.F.R. § 405.1060(a) — 1 case
United States Ex Rel. Groat v. Boston Heart Diagnostics Corp., 255 F. Supp. 3d 13 (D.D.C. 2017). “§ 1395ff(l); 42 C.F.R. § 405.1060 (a). National coverage determinations are binding on both Medicare contractors and administrative law judges, who preside over Medicare coverage appeals.”
— 42 C.F.R. § 405.1060(a)(1) — 2 cases
I & R Med., P.C. v. Hargan (E.D.N.Y 2021). “§ 1395ff(f)(1)(B); 42 C.F.R § 405.1060(a)(1). NCDs are binding on fiscal intermediaries, carriers, Quality Improvement Organizations (“QIOs”), Qualified Independent Contractors (“QICs”), Administrative Law Judges (“ALJs”) and attorney adjudicators, and the Medicare Appeals…”
USA v. Legacy Heart Care LLC (N.D. Tex. 2019).
— 42 C.F.R. § 405.1060(a)(4) — 2 cases
I & R Med., P.C. v. Hargan (E.D.N.Y 2021). “§ 1395ff(f)(1)(B); 42 C.F.R § 405.1060(a)(1). NCDs are binding on fiscal intermediaries, carriers, Quality Improvement Organizations (“QIOs”), Qualified Independent Contractors (“QICs”), Administrative Law Judges (“ALJs”) and attorney adjudicators, and the Medicare Appeals…”
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