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Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division
IN THE CASE OF  


SUBJECT: NCD Complaint - Durable Medical Equipment
Reference List (Air
Cleaners) � 280.1

DATE: September 29, 2005
   


 

Docket No. A-04-145
Decision No. 1999
DECISION
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DECISION

On May 20, 2005, the Board accepted a complaint from the aggrieved party (whose name is not used in this decision for privacy reasons). The aggrieved party challenged Medicare's policy that air cleaners are not covered as durable medical equipment (DME) for Medicare beneficiaries. That policy is embodied in a DME reference list in the Medicare National Coverage Determination (NCD) Manual, section 280.1. (1) The Board has jurisdiction to review NCDs under section 1869 of the Social Security Act (Act) (2) and implementing regulations at 42 C.F.R. Part 426. Consistent with the regulations, the Board ordered the Centers for Medicare & Medicaid Services (CMS) to produce the NCD record for the aggrieved party to review. The aggrieved party had an opportunity to submit a statement explaining "why the NCD record is not complete, or not adequate to support the validity of the NCD under the reasonableness standard." Board Notice of Acceptable Complaint, dated May 20, 2005, at 2. CMS responded to the statement and materials submitted by the aggrieved party.

[Page 2] Under the regulations, the initial stage in the review of an NCD is to determine whether the existing NCD record is complete and adequate to support the validity of the NCD or whether, instead, the aggrieved party has shown that the Board should go forward to permit discovery and take evidence to determine the validity of the NCD under the reasonableness standard. 42 C.F.R. �� 426.525(c), 426.531. The reasonableness standard requires the Board to uphold an NCD "if the findings of fact, interpretations of law, and applications of fact to law" by CMS are reasonable based on the NCD record and the relevant record developed before the Board. 42 C.F.R. � 426.110.

In the present matter, the aggrieved party has shown no basis for the Board to conduct further proceedings. For reasons explained below, we conclude that the NCD record is complete and adequate to support the validity of the NCD under the reasonableness standard. The review therefore ends with this final decision, and the case is now closed. 42 C.F.R. � 426.525(c)(2).

The aggrieved party purchased an air cleaner described as an ultraviolet air purification filter system in 2002 on the recommendation of her allergist (3) and sought payment for the purchase under Medicare. Her claim was denied on the ground that air cleaners are not covered under the DME reference list. The denial was upheld by an ALJ and by the Medicare Appeals Council. She also sought review of this policy on the basis that coverage of air cleaners would benefit many Medicare beneficiaries. The benefits proposed include possible prevention of illness by reducing "exposure to bacteria, mold, and other types of living organisms that cause illness." Aggrieved Party Letter, dated August 9, 2004, at 1. She requested that Medicare consider expanding coverage to air cleaners as a cost effective item to help people with breathing problems avoid hospital visits. Id.

The materials submitted by the aggrieved party address ways in which air cleaners may be useful and beneficial. The materials include manufacturers' brochures for several air purifiers or cleaners, which contain references to web sites of government agencies and health-related organizations.

Medicare law provides for limited coverage of durable medical equipment. The term "durable medical equipment" as used for Medicare purposes "includes iron lungs, oxygen tents, hospital [Page 3] beds, and wheelchairs" when these are "used in the patient's home," whether rented or purchased, and also "includes blood-testing strips and glucose monitors for diabetics" and seat lift mechanisms for chairs (but not the chairs themselves). Section 1861(n) of the Act. CMS interpreted the use of the word "includes" in the DME definition to imply that CMS has discretion to recognize additional items as DME beyond those specifically listed in the statute. CMS Response to Aggrieved Party Statement (CMS Response) at 3. To facilitate that end, CMS issued regulations explaining the elements required to treat equipment as covered DME. Specifically, DME means equipment, furnished by a supplier or 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 injury; and
(4) Is appropriate for use in the home.

42 C.F.R. � 414.202. The NCD record provided by CMS contains a published notice of NCD decisions dated August 21, 1989, which includes these four factors, and explains that air cleaners are not considered to meet these standards because they are "environmental control equipment; not primarily medical in nature." NCD Record at 8-9; 54 Fed. Reg. 34,555 (August 21, 1989).

In its response, CMS recognizes the aggrieved party's concern with providing policy makers with "information as to the benefits and cost savings" which might result from coverage of air cleaners. CMS Response at 5. The CMS policy does not imply that air cleaners are not useful or appropriate items. Nor does the policy constitute a finding that beneficiaries do not receive any health benefit from their use. CMS has not disputed the aggrieved party's report that the air cleaner she obtained assisted her in improving her health.

CMS's position is that the aggrieved party has not shown that its interpretation of the statute to require equipment to be primarily medical in nature and not useful for general purposes (such as environmental control) is an unreasonable or impermissible interpretation of the meaning of "durable medical equipment." Id. at 5-7, 9. We agree. The aggrieved party simply did not address this basis for the non-coverage decision.

Furthermore, CMS argues that the aggrieved party's submissions do not challenge CMS's factual finding that air cleaners are not [Page 4] primarily medical and are intended to serve "a useful purpose for all residents of a home regardless of the presence of an illness or injury," even if the reduction of micro-organisms may particularly benefit individuals with allergies or other problems. Id. at 8. CMS analogizes the air cleaner systems at issue to air conditioners, which may also be particularly beneficial to persons with certain medical conditions but which are generally useful to persons without illness as well. Again, we agree. The brochures assert, for example, that the air purifiers will "reduce the amount of odors and certain off-gasses in the building" and that the "family will enjoy the benefits of whole house or portable air purification." Second Wind brochure at 2.

We conclude that CMS's interpretation of the definition of DME to preclude coverage of air cleaners as primarily non-medical in nature, even if beneficial for persons with certain illnesses, is not unreasonable on this record. Based on her statements and submissions, the aggrieved party has failed to show that the NCD record is incomplete or inadequate to support the validity of the NCD under the reasonableness standard.

Under the regulations, this decision ends the NCD review, and therefore constitutes the final decision of the agency for purposes of judicial review. 42 C.F.R. � 426.566.

 

JUDGE
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Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

FOOTNOTES
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1. This and other NCDs and additional information on NCD policies are available from the CMS website at http://www.cms.gov/coverage/default.asp.

2. The current version of the Social Security Act can be found at www.ssa.gov/OP_Home/ssact/comp-ssa.htm. Each section of the Act on that website contains a reference to the corresponding United States Code chapter and section. Also, a cross reference table for the Act and the United States Code can be found at 42 U.S.C.A. Ch. 7, Disp Table.

3. The aggrieved party supplied the recommendation by her allergist that she use an air cleaner "to help protect" her health. Aggrieved Party Letter, dated August 9, 2004, at 2.

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