(a) Scope. This subpart establishes that—
(1) CMS uses the FDA categorization of a device as a factor in making Medicare coverage decisions; and
(2) CMS may consider for Medicare coverage certain devices with an FDA-approved investigational device exemption (IDE) that have been categorized as Category B (Nonexperimental/investigational) device.
(3) CMS identifies criteria for coverage of items and services furnished in IDE studies.
(b) Definitions. As used in this subpart—
Category A (Experimental) device refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective.
Category B (Nonexperimental/investigational) device refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type.
ClinicalTrials.gov refers to the National Institutes of Health's National Library of Medicine's online registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Contractors refers to Medicare Administrative Contractors and other entities that contract with CMS to review and adjudicate claims for Medicare payment of items and services.
Investigational device exemption (IDE) refers to an FDA-approved IDE application that permits a device, which would otherwise be subject to marketing approval or clearance, to be shipped lawfully for the purpose of conducting a clinical study in accordance with 21 U.S.C. 360j(g) and 21 CFR part 812.
Routine care items and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benefit category exists, it is not statutorily excluded, and there is no national noncoverage decision) that are furnished during a clinical study and that would be otherwise furnished even if the beneficiary were not enrolled in a clinical study.
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013; 86 FR 3009, Jan. 14, 2021; 86 FR 62958, Nov. 15, 2021]
Notes of Decisions
United States Ex Rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011).
· cites it 2× “Class II” — such as Medtronic’s biliary stents at issue in this case — are Category B, “nonexperimental/investigational” devices, 42 C.F.R. § 405.201 (b), which Medicare contractors “may approve .”
Harris v. Olszewski, 442 F.3d 456 (6th Cir. 2006).
“§ 1395y(m)(2); 42 C.F.R. § 405.201 (b). Having failed to enact a definition of “medical devices” that precludes the phrase from covering “incontinence products,” having used a phrase that has a range of meanings, including one that naturally extends to incontinence products, and…”
Almy v. Sebelius, 749 F. Supp. 2d 315 (D. Maryland 2010).
“See 42 C.F.R. § 405.201 (a)(1) (“CMS uses the FDA categorization of a device as a factor in making Medicare coverage determinations.”
Am. Hosp. Ass'n v. Bowen, 640 F. Supp. 453 (D.D.C. 1986).
“1079 also refers to 42 C.F.R. § 405.201 (c), which governs who may act as a beneficiary’s representative in an appeal from a non-coverage determination.”
Yale-New Haven Hosp., Inc. v. Thompson, 162 F. Supp. 2d 54 (D. Conn. 2001).
“42 C.F.R. §§ 405.201 (b); 405.203. The intermediaries may approve coverage for any non-experimental/investi-gational IDE device in Category B if all other coverage requirements have been met.”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
· cites it 2× “3 42 C.F.R. §§ 405.201 (b), 405.211(b). The FDA classified all other devices in Category A (experimental/investigational), which continued to be excluded from Medicare coverage.”
Int'l Rehabilitative Sciences, Inc. v. Sebelius, 737 F. Supp. 2d 1281 (W.D. Wash. 2010).
“” 42 C.F.R. § 405.201 (a)(1). The Secretary has stated that “CMS adopts FDA determinations of safety and effectiveness”, but that “[ajlthough an FDA-regulated product must receive FDA approval or clearance for at least one indication to be eligible for Medicare coverage, .”
— 42 C.F.R. § 405.201(b) — 2 cases
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
“3 42 C.F.R. §§ 405.201 (b), 405.211(b). The FDA classified all other devices in Category A (experimental/investigational), which continued to be excluded from Medicare coverage.”
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