For purposes of this subpart, the following definitions apply:
Complex rehabilitative power-driven wheelchair means a power-driven wheelchair that is classified as—
(1) Group 2 power wheelchair with power options that can accommodate rehabilitative features (for example, tilt in space); or
(2) Group 3 power wheelchair.
Covered item update means the percentage increase in the consumer price index for all urban consumers (U.S. city average) (CPI-U) for the 12-month period ending with June of the previous year.
Durable medical equipment means equipment, furnished by a supplier or a home health agency that meets the following conditions:
(1) Can withstand repeated use.
(2) Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years.
(3) Is primarily and customarily used to serve a medical purpose.
(4) Generally is not useful to an individual in the absence of an illness or injury.
(5) Is appropriate for use in the home.
Prosthetic and orthotic devices means—
(1) Devices that replace all or part of an internal body organ, including ostomy bags and supplies directly related to ostomy care, and replacement of such devices and supplies;
(2) One pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens; and
(3) Leg, arm, back, and neck braces, and artificial legs, arms, and eyes, including replacements if required because of a change in the beneficiary's physical condition.
The following are neither prosthetic nor orthotic devices—
(1) Parenteral and enteral nutrients, supplies, and equipment;
(2) Intraocular lenses;
(3) Medical supplies such as catheters, catheter supplies, ostomy bags, and supplies related to ostomy care that are furnished by an HHA as part of home health services under § 409.40(e) of this chapter;
(4) Dental prostheses.
Region means, for the purpose of implementing § 414.210(g), geographic areas defined by the Bureau of Economic Analysis in the United States Department of Commerce for economic analysis purposes, and, for the purpose of implementing § 414.228, those contractor service areas administered by CMS regional offices.
Rural area means, for the purpose of implementing § 414.210(g), a geographic area represented by a postal zip code if at least 50 percent of the total geographic area of the area included in the zip code is estimated to be outside any metropolitan area (MSA). A rural area also includes a geographic area represented by a postal zip code that is a low population density area excluded from a competitive bidding area in accordance with the authority provided by section 1847(a)(3)(A) of the Act at the time the rules at § 414.210(g) are applied.
[57 FR 57689, Dec. 7, 1992, as amended at 75 FR 73622, Nov. 29, 2010; 76 FR 70314, Nov. 10, 2011; 79 FR 66262, Nov. 6, 2014]
Notes of Decisions
Cited in
25
cases (
6 in the last 5 years), 1998–2023 · leading case:
Warder v. Shalala, 149 F.3d 73 (1st Cir. 1998).
Warder v. Shalala, 149 F.3d 73 (1st Cir. 1998).
· cites it 4× “42 C.F.R. § 414.202 . The manual HCFA prepares for its carriers repeats the regulatory criteria.”
Smith v. Becerra, 44 F.4th 1238 (10th Cir. 2022).
· cites it 2× “42 C.F.R. § 414.202 . In CMS-1682-R, CMS explained that some CGMs require a separate blood glucose test to confirm blood sugar levels before corrective measures can be taken.”
United States ex rel. Phalp v. Lincare Holdings, Inc., 116 F. Supp. 3d 1326 (S.D. Fla. 2015).
· cites it 2× “” 42 C.F.R. § 414.202 (1). Thus, the applicable regulations support a distinction between equipment as reusable implements and supplies as materials that may be used to replenish or augment the equipment.”
Currier v. Thompson, 369 F. Supp. 2d 65 (D. Me. 2005).
· cites it 2× “42 C.F.R. § 414.202 . The statute also fails more fully to define prosthetic device.”
Currier v. Leavitt, 490 F. Supp. 2d 1 (D. Me. 2007).
· cites it 2× “” 42 C.F.R. § 414.202 . Here, the parties agree that the VM can withstand repeated use and that it is appropriate for use in the home.”
DeSario v. Thomas, 139 F.3d 80 (2d Cir. 1998).
“42 C.F.R. § 414.202 (1996). It is true that the Medicare program differs in many respects from Medicaid and that comparisons of benefits offered under the two programs are not always useful.”
Blue v. Bonta, 2002 Cal. Daily Op. Serv. 5821 (Cal. Ct. App. 2002).
“” ( 42 C.F.R. § 414.202 (2001).) California requires by statute that “[djurable medical equipment,” be covered by the California Medi-Cal program.”
United States v. Medica-Rents Co., 285 F. Supp. 2d 742 (N.D. Tex. 2003).
“” 42 C.F.R. § 414.202 (2003). 5 . The SADMERC was also charged with collecting statistical and other information and disseminating it to the four DMERCs.”
Finigan v. Burwell, 189 F. Supp. 3d 201 (D. Mass. 2016).
“42 C.F.R. § 414.202 . In addition to the statutory examples and regulatory definition of “durable medical equipment,” the regulations provide instructions to hearing officers and the Council with regard to certain other documents: (a) [Hearing officers and the Council] are not…”
United States ex rel. Jamison v. McKesson Corp., 900 F. Supp. 2d 683 (N.D. Miss. 2012).
“” Items considered as DMEPOS are "equipment furnished by a supplier or a home health agency that — (1) can withstand repeated use; (2) is primarily and customarily used to serve a medical purpose; (3) generally is not useful to an individual in the absence of an illness or…”
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