C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED › Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology

42 C.F.R. § 405.211

Coverage of items and services in FDA-approved IDE studies

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(a) Coverage of routine care items and services for Category A (Experimental) devices. Medicare covers routine care items and services furnished in an FDA-approved Category A (Experimental) IDE study if CMS (or its designated entity) determines that the Medicare coverage IDE study criteria in § 405.212 are met.

(b) Coverage of Category B (Nonexperimental/investigational) IDE devices and routine care items and services. Medicare may make payment for a Category B (Nonexperimental/investigational) IDE device and routine care items and services furnished in an FDA-approved Category B (Nonexperimental/investigational) IDE study if CMS (or its designated entity) determines prior to the submission of the first related claim that the Medicare coverage IDE study criteria in § 405.212 are met.

(c) CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in § 405.212 are met for purposes of coverage of items and services described in paragraphs (a) and (b) of this section:

(1) FDA approval letter of the IDE.

(2) IDE study protocol.

(3) IRB approval letter.

(4) NCT number.

(5) Supporting materials, as needed.

(d) Notification. A listing of all CMS-approved Category A (Experimental) IDE studies and Category B (Nonexperimental/investigational) IDE studies shall be posted on the CMS Web site and published in the Federal Register.

[78 FR 74809, Dec. 10, 2013]
Notes of Decisions
Cited in 3 cases, 2001–2011 · leading case: United States Ex Rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011).
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United States Ex Rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011). · cites it 2× “if all other coverage requirements are met,” 42 C.F.R. § 405.211 (b) (emphasis added).”
US Ex Rel. Bennett v. Medtronic, Inc., 747 F. Supp. 2d 745 (S.D. Tex. 2010). “42 C.F.R. § 405.211 (b). The decision on medical necessity is made by individual physicians exercising independent professional judgment based on the knowledge of their particular patients.”
Yale-New Haven Hosp., Inc. v. Thompson, 162 F. Supp. 2d 54 (D. Conn. 2001). “; 42 C.F.R. § 405.211 (b). According to plaintiffs, over 90% of the inves-tigational medical devices sold to the hospitals for use in clinical trials fall within that category.”
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