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GAO-20-42R 1 (2019-10-10)

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G                      U.S. GOVERNMENT ACCOUNTABILITY OFFICE
441 G St. N.W.
Washington, DC 20548



October 10, 2019


The Honorable Chuck Grassley
Chairman
The Honorable Ron Wyden
Ranking Member
Committee on Finance
United States Senate

The Honorable Frank Pallone, Jr.
Chairman
The Honorable Greg Walden
Ranking Member
Committee on Energy and Commerce
House of Representatives

The Honorable Richard Neal
Chairman
The Honorable Kevin Brady
Ranking Member
Committee on Ways and Means
House of Representatives

Medicare: Spending on Certain Disposable Wound Care Devices in Home Health
Medicare fee-for-service's durable medical equipment (DME) benefit covers medical devices
that are appropriate for use in the home and have an expected lifetime of at least 3 years,
among other criteria. While new medical technology that is disposable may potentially substitute
for DME in certain circumstances, disposable devices generally have not been covered by
Medicare as DME because they are not considered durable.1 The Consolidated Appropriations
Act, 2016, provided for a separate payment for disposable negative pressure wound therapy
(NPWT) devices under Medicare's home health benefit as of January 1, 2017.2
Under the Medicare home health benefit, home health agencies provide services to Medicare
beneficiaries that are homebound and need skilled nursing or therapy services, with all services

1The Centers for Medicare & Medicaid Services has defined DME as equipment that (1) can withstand repeated use;
(2) has an expected lifetime of at least 3 years; (3) is used primarily to serve a medical purpose; (4) is not generally
useful in the absence of an illness or injury; and (5) is appropriate for use in the home. See 42 C.F.R. § 414.202
(2018). The 3-year minimum lifetime requirement is effective for items classified as DME after January 1, 2012. We
previously reported on issues for consideration related to the potential Medicare coverage of disposable medical
devices. See GAO, Medicare: CMS Should Evaluate Providing Coverage for Disposable Medical Devices That Could
Substitute for Durable Medical Equipment, GAO-1 7-600 (Washington, D.C.; Jul 17, 2017).
2pub. L. No. 114-113 § 504(a), (b), 129 Stat. 2242, 3021 (2015)(codified at 42 U.S.C. §§ 13951(a)(1), 1395m(s) and
1395x(m)(5). The act covers disposable negative pressure wound therapy devices only for beneficiaries who are
receiving home health services.


GAO-20-42R Medicare Spending for Disposable Devices


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