Issue Paper
Proposed Rule Would Modify Longstanding Definition for
DME – CMS Must Abandon this Misguided Effort
Issue
On July 8, 2011, the Center for Medicare & Medicaid Services (CMS) published a proposed rule
that would revise the definition of “durable” in the term “Durable Medical Equipment” (DME)
by adding a 3-year minimum lifetime criterion that must be met by an item or device in order to
be considered durable for the purpose of classifying the item under the Medicare benefit category
for DME. CMS claims that the proposed change will “clarify the meaning of the term „durable‟
and reflect our current interpretation of the statute.” CMS indicates the definition change would
not apply to items classified as DME before the proposed rule, does not include supplies and
accessories, and does not replace the Reasonable Useful Lifetime (RUL) standard established by
the Social Security Act for payment purposes. The RUL rules are used to determine how often
payment can be made for replacement items and is not a minimum lifetime requirement for
DME.
The American Association for Homecare (AAHomecare) believes that this change is
unnecessary, unfounded, and would negatively impact DME manufactures and patients. The
Association urges CMS to abandon this misguided effort.
Current Definition Provides for Complexity and Future Innovation for DME
42 U.S.C. §1395 x(n) defines the term “durable medical equipment” to include items such as iron
lungs, oxygen tents, hospital beds, and wheelchairs (manual and power) that are used in the
home whether purchased or rented. In regulations, CMS expanded on the definition by
specifying that DME is equipment that-• Can withstand repeated use;
• Is primarily and customarily used to serve a medical purpose;
• Generally is not useful to an individual in the absence of an illness or injury; and
• Is appropriate for use in the home.
The current definition addresses the inherent problem with applying an arbitrary standard across
all DME product categories. This definition takes into account the complexity of durable
1
American Association for Homecare
2011 Crystal Drive, Suite 725
Arlington, VA 22202 ~703-836-6263
www.aahomecare.org ~ 08-26-11
medical equipment, while allowing for future innovation to allow more patients to receive care in
their own homes. DME manufacturers can design new technologies and modify existing
equipment for the benefit of the patients‟ care and not to comply with an arbitrary “one size fits
all” standard.
CMS’ Proposed Change Will Create a Regulatory Nightmare
CMS claims the proposed change (developed without stakeholder input) is intended to clarify the
term “durable.” In reality, CMS‟ proposed rule will create confusion and a regulatory nightmare
by trying to fix a problem that doesn‟t exist. In its proposal, CMS states that it would determine
the device‟s lifetime from various sources, including the HCPCS code applications, Federal Drug
Administration (FDA) pre-market clearance documents, product warranty documents, product
marketing materials and user guides, subject matter expert reviews, industry product standards
data, and other data from clinical studies or standardized test results. For the vast majority of
DME devices, however, these documents contain absolutely no information or statements
regarding the products “lifetime.” FDA rules require medical devices to be safe and efficacious;
they do not require devices to last for any particular period of time.
For the vast majority of DME devices, there is no existing standard of measurement or
documentation regarding a product‟s lifetime as part of the manufacturer‟s process. If this
proposal were to be implemented, CMS would require the development of a significant and new
regulatory hurdle, which has nothing to do with quality. While the FDA requires devices to be
safe, market competition encourages manufacturers to develop warranty and quality. There is no
third party or industry standard regarding “lifetime” for most DME devices.
CMS’ Proposed Rule Will Stifle Innovation
CMS‟ proposed rule would significantly discourage the design of new DME technologies and
would hinder the redesign on existing equipment. The 3-year minimum lifetime requirement
would not apply to items classified as DME before the rule would be implemented. The CMS
proposal would subject new technologies to the arbitrary 3-year lifetime requirement and is
vague about DME that is redesigned or modified to improve functionality for Medicare patients.
This burdensome requirement will force DME manufacturers to limit research and development
of new DME items, as well as hinder redesign of existing equipment because of the risk that the
item will not qualify as DME.
CMS Must Abandon This Proposed Rule
CMS must abandon this misguided effort. AAHomecare believes that this change is
unnecessary, unfounded, and will negatively impact DME manufacturers and patients. The
Association respectfully requests that members of Congress contact CMS and urge the
agency to stop this flawed proposed rule.
2
American Association for Homecare
2011 Crystal Drive, Suite 725
Arlington, VA 22202 ~703-836-6263
www.aahomecare.org ~ 08-26-11