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. § 405.205

Coverage of a Category B (Nonexperimental/investigational) device

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(a) For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:

(1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational).

(2) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.

(b) If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at § 411.15(o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013
Notes of Decisions
Cited in 3 cases, 1982–2001 · leading case: Plyler v. Doe, 457 U.S. 202 (1982).
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Plyler v. Doe, 457 U.S. 202 (1982). · cites it 2× “§ 1395i-2 and 42 CFR § 405.205 (b) (1981), and the Medicaid hospital insurance benefits for the aged and disabled program, 42 U.”
Yale-New Haven Hosp., Inc. v. Thompson, 162 F. Supp. 2d 54 (D. Conn. 2001). “42 C.F.R. §§ 405.205 , 405.209, 405.211. Under the new regulations, the FDA assigns devices that have received IDE’s to one of two categories: Category A (experimental/investigational) or Category B (non-experimental/investigational) depending on whether initial questions as to…”
Local 512, Warehouse & Off. Workers' Union v. Nat'l Labor Relations Bd., 795 F.2d 705 (9th Cir. 1986). “…Security Act, payment of certain federal welfare benefits is restricted to citizens and lawfully admitted aliens. 42 C.F.R. § 405.205 (1985).”
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