The Centers for Medicare and Medicaid Services
(CMS)
Medicare Policy Initiative
Creating a New National Coverage Decision Governing
Funding of Power Wheelchairs and Scooters
Bridges to Better Advocacy Conference
Austin, Texas
April 21-22, 2005
James R. Sheldon, Jr., Supervising Attorney
National Assistive Technology Advocacy Project
Neighborhood Legal Services, Inc.
295 Main Street, Room 495
Buffalo, New York 14203
716-847-0655 ext. 262, 0227 (fax), 1322 (tdd)
jsheldon@nls.org * www.nls.org
Beginning in early 2004, the Centers for Medicare and Medicaid Services (CMS) has been engaged in activity, through an interagency working group, to review the existing criteria used to approve what they now describe as "mobility assistive equipment" (MAE). Originally, the process was to culminate in a new policy being issued by the end of 2004. Following a June 2004 "Open Door Forum" and invitation to submit comments through September 1, 2004, CMS halted that process and, in December 2004, switched to a more formal process for development of a National Coverage Decision (NCD).
On December 15, 2004, CMS announced that it had started the process to develop a new NCD that would provide criteria for all MAE, including power wheelchairs and scooters. A proposed policy was issued at that time (see below) and interested parties were provided a 30-day period for submitting comments. Thereafter, a revised proposal was issued on February 3, 2005 as a "Decision Memorandum," another Open Door Forum was held on February 24, 2005, and a new opportunity was provided to submit comments by March 7, 2005. As this handout was completed on April 15, 2005, no new NCD had been published by CMS on its website.
This handout provides background on Medicare's historical coverage of power wheelchairs and scooters, including the longstanding concerns about its existing policy (now withdrawn in the proposed NCD) requiring that an individual be "bed or chair confined" in order to qualify for a wheelchair or scooter of any kind. We then discuss some of the events that lead CMS to engage in activities to review its existing criteria governing wheelchairs and scooters and revise the criteria. Finally, we provide an update of the process to date in development of the new NCD.
I. Background: Medicare Coverage of Durable
Medical Equipment
A. Medicare has traditionally covered wheelchairs and scooters as durable medical equipment (DME) through its Part B benefit.
B. DME includes, among other things, "iron lungs, oxygen tents, hospital beds and wheelchairs ... used in the patient's home ..." 42 U.S.C. § 1395x(n)(emphasis added).
1. The regulations define DME as equipment that
a. can withstand repeated use;
b. is primarily and customarily used to serve a medical purpose;
c. generally is not useful to an individual in the absence of an illness or injury; and
d. is appropriate for use in the home. 42 C.F.R. §§ 410.38(a), 414.202 (emphasis added).
2. It is a very restrictive (and, the author contends, inappropriate) interpretation of the statutory "used in the patient's home" and regulatory "is appropriate for use in the home" language that has lead CMS to develop an existing policy and a proposed new policy that focus only on the need for power wheelchairs and scooters (i.e., mobility assistive equipment) in the home.
C. Medicare's Medical Necessity Test
1. Medicare coverage is limited to services that are "reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." 42 U.S.C. § 1395y(a)(1)(A).
2. The quoted language is the basis for Medicare's so-called "medical necessity" test.
3. Interpreting this language, a wheelchair or other item of MAE will only be covered if it is necessary to "improve the functioning" of the legs or lower extremities (i.e., the "malformed body member").
a. Recognizing that a wheelchair or scooter does not really contribute to better functioning of the legs (unlike a walker or crutches), it is fair to say that CMS has always approved wheelchairs and scooters, as DME, under a theory that the DME is actually replacing the functioning of the non-functioning (or poorly functioning) legs to enable the individual to achieve a degree of "functional mobility."
b. In this sense, the treatment of wheelchairs and scooters under the DME coverage category is very much like the way Medicare approaches "prosthetic devices":
(1) Prosthetic devices are devices "that replace all or part of an internal body organ." 42 U.S.C. § 1395x(s)(8); 42 C.F.R. § 410.36(a)(2).
(2) The Medicare Carriers Manual, at § 2130, expands on this definition to include devices that "replace all or part of the function of a permanently inoperative or malfunctioning external body member or internal body organ." See CCH Medicare & Medicaid Guide ¶3152 (emphasis added).
D. National Coverage Decisions
1. CMS, the agency which administers Medicare, periodically issues National Coverage Decisions (NCDs) which specify treatments and procedures that are approved or excluded by Medicare. See Medicare Coverage Issues Manual (HCFA-Pub. 6), reprinted as updated in 5 CCH Medicare & Medicaid Guide, ¶27,201, ¶27,211 and ¶27,221.
2. The Coverage Issues Manual is broken down into sections. For example, section 60 addresses durable medical equipment (DME); section 65 addresses prosthetic devices. These manuals are now on the CMS website (see, e.g., www.cms.hhs.gov/manuals/06_cim/ci60.asp, a link to section 60).
3. Some NCDs allow for coverage of specific items [e.g., a power wheelchair is covered under § 60-5 if it is medically necessary and the person cannot operate a manual wheelchair].
4. Other rules specifically exclude coverage [e.g., a white cane for the blind is excluded under § 60-3; coverage of an augmentative communication device was, prior to January 2001, excluded under § 60-9, but is now specifically covered as a "speech generating device" under § 60-23)].
5. NCDs will often be referenced by Medicare decision makers when they approve or deny coverage.
6. The binding effect of NCDs on various Medicare decision makers is spelled out in 42 U.S.C. §§ 1395ff(c)(3)(B)(1) and 1395ff(f).
a. An NCD is binding on all Medicare Durable Medical Equipment Regional Carriers (DMERCs) and HMOs when it is published in CMS program manuals or the Federal Register.
b. In the past, an NCD was only binding on administrative law judges (ALJs) when it has been promulgated under section 1862(a)(1) of the Social Security Act, 42 U.S.C. § 1395ff(b)(3)(A).
(1) Under the recent statutory amendments, all NCDs are now considered binding on ALJs.
(2) Accordingly, many of the old hearing decisions in which ALJs were able to ignore NCDs (e.g., when there was an NCD that forbid funding of augmentative communication, i.e., speech generating devices) are probably no longer valid statements of the current law.
7. A new process for obtaining review of the validity of NCDs and local coverage decisions (LCDs)#1 without going to court has recently been established. 42 U.S.C. § 1395ff(f); 42 C.F.R. §§ 426.100 - 426.587. This is in addition to the ability of an individual to challenge an NCD or LCD in the course of the regular appeal process.
a. The review process begins by the filing of a written "complaint" by an aggrieved party with the Departmental Appeals Board (DAB) for NCDs, and with the office designated by CMS on its website, www.medicare.gov/coverage/static/appeals.asp, for LCDs.
(1) If filed before the requested service has been received, it must be accompanied by a written statement from the aggrieved party's treating practitioner.
(2) If filed after the requested service has been received, must be within 120 days of the initial denial notice.
b. NCDs will be reviewed by the Departmental Appeals Board, while LCDs will be reviewed by Administrative Law Judges.
(1) The aggrieved party may submit additional evidence to show that the particular NCD or LCD at issue should be modified.
(2) The decision-maker may independently consult scientific and clinical experts, and may order discovery.
(3) The standard of review is whether the NCD or LCD is "reasonable" based on the record.
c. If the decision maker concludes that a coverage rule is not "reasonable" the rule at issue can no longer be applied to the aggrieved party's claim and to the claims of other beneficiaries. The decision maker cannot order that any language be added to a coverage rule.
d. Decisions in these review processes are appealable by the aggrieved party, the Medicare contractor, and CMS.
E. The Durable Medical Equipment Regional Carriers (DMERCs) and the DMERC manuals
1. CMS has vested the four regional DMERCs with the authority for oversight of the day-to-day operations of the DME program for individuals enrolled in "traditional Medicare."#2
2. Each of the DMERCs will have their own manuals which are used in their operations.
3. The DMERC manuals for the four regional DMERCs can be accessed through their websites:
a. HealthNow (Region A): www.umd.nycpic.com/dmerc.html (then select publications).
b. Associated Insurance Companies, Inc. - AdminaStar (Region B): www.adminastar.com (see specifically, www.adminastar.com/Providers/DMERC/DMERC.html)
c. Palmetto GBA (Region C): www.palmettogba.com (then select manuals)
d. CIGNA Health Care (Region D): www.cignamedicare.com (then select publications)
II. Medicare's Historical Approach to Coverage of Power Wheelchairs and Scooters
A. Under the CMS Coverage Issues Manual for DME, part 60-9 (also referred to as NCD 60-9), a power wheelchair is covered "if a patient's condition is such . . . that a wheelchair is medically necessary and the patient is unable to operate the wheelchair manually."
B. This policy is further clarified in a policy document, dated February 2004, which is available on the CMS website (http://www.cms.hhs.gov/medlearn/PowerWheelchair.pdf). Under that clarification, the following criteria must be met to qualify for coverage of a power wheelchair:
1. "The patient is bed or chair-bound without the use of a wheelchair (Note: An individual may qualify for a wheelchair and still be considered bed-confined);
[Author's comment: As noted below, the proposed NCD governing approval of mobility assistive equipment eliminates the bed or chair-confined criteria as part of what CMS describes as a functionally-based criteria. As this handout is prepared, it appears that the existing policy may remain operational until the new NCD is adopted.]
2. The patient's condition makes a wheelchair medically necessary, and they are unable to manually operate a wheelchair; and
3. The patient is capable of safely operating the controls of a power wheelchair."
C. The same policy document also provides criteria for "Power Operated Vehicles" or POVs, or what we commonly think of as power scooters:
"These vehicles have been appropriately used in the home setting for vocational rehabilitation and to improve the ability of chronically disabled persons to cope with normal domestic, vocational, and social activities. The may be covered if a wheelchair is medically necessary and the patient is unable to operate a wheelchair manually. Slightly different criteria must be met for Medicare coverage of these ‘scooter' devices. They are:
1. The patient's condition is such that without the use of a wheelchair, the patient would not be able to move about the residence;
2. The patient is unable to operate a manual wheelchair;
3. The patient is capable of safely operating the controls of a POV;
4. The patient can transfer safely in and out of the POV; and
5. The POV is ordered by one of the following specialists: Physical Medicine; Orthopedic Surgery; Neurology; or Rheumatology.
a. Exceptions: When a specialist is not reasonably accessible (e.g., more than a day's round trip travel from the patient's home or the patient's condition precludes travel to a specialist), an order from the patient's physician may be acceptable."
III. The "Operation Wheeler Dealer" Investigation
This initiative was launched in September 2003
A. It has been well-documented that in recent years the Medicare program has paid millions of dollars in fraudulent claims for power wheelchairs and scooters (i.e., POVs).
B. These fraudulent claims have been directly linked to the unscrupulous practices of some Medicare-enrolled suppliers.
C. As part of Operation Wheeler Dealer, CMS identified the following fraudulent practices:
1. Suppliers have charged Medicare for power wheelchairs costing $5,000 or more while providing much cheaper motorized scooters.
2. Suppliers have secretly obtained beneficiaries' Medicare identification numbers and submitted claims for power wheelchairs that are never provided to the beneficiaries.
3. Suppliers have staged fake deliveries, complete with pictures of patients who pose with their power chairs for a fee.
4. Suppliers have persuaded elderly patients to purchase power wheelchairs they didn't need and then billed Medicare for the wheelchairs.
5. Doctors have signed blank wheelchair Certificates of Medical Necessity (CMNs) for suppliers to fill out and submit to Medicare for payment.
6. Doctors have taken kickbacks for writing prescriptions for power wheelchairs.
D. A significant portion of the fraud discovered during Operation Wheeler Dealer was isolated in Harris County, Texas which includes the City of Houston.
1. In a joint September 2003 press release, the Office of Inspector General and the General Accounting Office stated, "in Harris County, Texas alone, Medicare paid for more than 31,000 power wheelchairs in 2002, compared to just over 3,000 power wheelchairs in 2001."
2. Nationwide, Medicare paid for 97,818 power wheelchair units in 2001 and 153,636 power wheelchair units in 2002. About half of the total national increase in power wheelchairs was directly attributed to fraud isolated in Harris County, Texas.
E. In response to the fraud discovered during this investigation, CMS and other federal authorities launched a comprehensive effort to combat fraud in the Medicare power wheelchair benefit. This effort included:
1. CMS aggressively scrutinizing all new applications for supplier numbers to prevent fraudulent suppliers from enrolling with Medicare for the sole purpose of receiving inappropriate payments#3 ;
2. To quickly identify and punish fraudulent suppliers, CMS, Durable Medical Equipment Regional Carriers (DMERCs), and law enforcement agencies collaborated to process fraud cases and assure aggressive, timely application of sanctions, and civil or criminal prosecutions; and
3. To put physicians and beneficiaries back in charge of their mobility equipment decisions, CMS is working with physicians to clarify their prescribing responsibilities, and with beneficiaries, explaining their role and Medicare coverage criteria.
IV. Activity by CMS in 2003 and 2004 That Related to Medicare's Coverage Criteria for Power Wheelchairs and Scooters
A. Interagency Working Group on Assistive Technology Mobility Devices (May 2003 meeting to receive public testimony)
1. The Interagency Working Group on Assistive Technology Mobility Devices held a public meeting on May 21, 2003 to obtain comments concerning, among other things, the barriers that interfere with an individual's ability to obtain funding for wheelchairs, power wheelchairs, and power scooters.#4
2. While the 2003 interagency group looked at issues that go well beyond the current interagency group's mandate (i.e., creation of a new NCD), including issues of the pooling of funds between and among agencies, there is a clear overlap as related to Medicare and the funding criteria it uses for wheelchairs, power wheelchairs, and power operated vehicles (generally understood to include power scooters).
3. Following public testimony and the receipt of written comments, the interagency group issued a final report. See Report on Assistive Technology Mobility Devices (August 2003), issued by last year's Interagency Work Group, http://67.98.119.214/ATMD_Report/index.htm. Unfortunately, the report is little more than a recitation of some current practices with no recommendations for overcoming funding barriers.
B. The Open Door Forum (June 2004) and initial comment period (through September 1, 2004)
1. During the first part of 2004, CMS provided notice of a public meeting on June 14, 2004, known as an "Open Door Forum." The stated purpose of the Open Door Forum was, in part, to introduce an Interagency Wheelchair Work Group and introduce the CMS initiative to "produce clinical guidance for [Medicare's] coverage of wheelchairs, power wheelchairs, and power-operated vehicles."
2. The CMS also offered the public an opportunity to provide both oral comments during the June 14th meeting and written comments thereafter through September 1, 2004.
3. During the June 14, 2004 meeting, CMS announced that the Interagency Work Group's goals were to issue an initial draft policy on October 15, 2004, hold a second Open Door Forum in mid-November 2004, and issue a final policy by December 31, 2004.
4. CMS indicated, in its written invitation, that it was specifically interested in public input on the following broad areas related to Medicare's coverage of these items:
a. how it should structure its clinical guidance; and
b. which clinical or diagnostic elements to incorporate into the guidance.
c. Beyond those broad areas, the written invitation for comments did not specify what areas those providing comments should address.
5. Following the June 2004 Open Door Forum and the receipt of comments through September 1, 2004, it appears that CMS did nothing further on this initiative prior to it December 15, 2004 announcement that the agency was beginning the process to issue an NCD governing mobility assistive equipment.
C. CMS received very critical commentary on its longstanding coverage criteria for power wheelchairs and scooters
1. At both the May 2003 opportunity to present testimony and the June 2004 Open Door Forum (and follow-up comment period), many of those commenting took CMS to task for a national policy that is out of step with the way individuals with disabilities use wheelchairs and scooters in the 21st century.
2. The focus of this criticism was on the very restrictive interpretation of the statutory "used in the patient's home" criteria and the requirement that the individual be bed or chair confined. (See above.)
V. The Post-December 15, 2004 Activity to Develop a National Coverage Decision on Mobility Assistive Equipment
A. With no prior hint of its intention to do so, on December 15, 2004, CMS issued an announcement that it was initiating the formal process to develop an NCD to provide coverage criteria for "mobility assistive equipment."
1. A explanatory memo was issued which included proposed "Clinical Criteria for Wheelchair Prescribing."
2. Despite the pre-holiday period timing of this announcement, CMS received many comments within the 30-day comment period.
B. Thereafter, on February 3, 2005, CMS issued a proposed "decision memorandum" pursuant to section 731 of the Medicare Modernization Act.
1. See NCA Tracking Sheet for Wheelchairs (CAG-00274N), available at http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=151.
2. See Proposed Decision Memo of February 3, 2005, available at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=151 or http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=143.
C. A summary of the CMS proposed criteria:
"CMS proposes that the evidence is adequate to determine that mobility assistive equipment (MAE) is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their performance of mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing. Determination of the presence of a mobility deficit will use an algorithmic process, as outlined in Appendix A: Clinical Criteria for MAE Coverage, to provide the appropriate MAE to correct the mobility deficit With this decision, CMS also proposes to delete the ‘bed or chair confined' criterion currently used to determine if a wheelchair is reasonable and necessary."
D. To our knowledge, this is the first time any health insurance program has suggested that the need for a wheelchair or scooter can be determined by looking at the ability to accomplish activities such as "toileting, feeding, dressing, grooming, and bathing" without the device.
E. Once again, the comments that CMS received, both in writing and at the most recent, February 24, 2005 Open Door meeting, have been nearly universally negative.
1. The public comments, in their entirety, for both the December 15, 2004 and February 3, 2005 postings can be viewed at: http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=143
2. Once again, a significant number of comments have challenged the agency's very restrictive interpretation of the statutory "used in the patient's home" language.
3. One theme of the most recent set of comments is that mobility itself should be viewed as a medical need, with the wheelchair or scooter provided to ensure that mobility needs are met in all environments, within and outside the home, that one encounters during a typical day, week, or month.
4. One comment suggested that the proposed coverage criteria was so out of line with existing practices for prescribing the need for wheelchairs and scooters, there was reason to question the qualifications of the group of "experts" that CMS has convened to develop this policy.
If you would like a copy of the comments submitted through the National AT Advocacy Project, contact Jim Sheldon at 716-847-0650 ext. 262 or jsheldon@nls.org.
1 A local coverage determination, as relevant to DME, is a policy adopted by a\ DMERC to be applied in the geographic area they administer. Sometimes called local\ medical review policies, these LCDs are based on 42 U.S.C. § 1395y(a)(1)(A) which\ prohibits coverage of items that are not "reasonable and necessary." 42 U.S.C. §\ 1395ff(f)(2)(B).
2 For individuals enrolled in the managed care option, now known as the\ Medicare Advantage Program (formerly the Medicare+Choice program), the oversight\ for DME coverage would go through the health maintenance organization that is serving\ the individual.
3 The Operation Wheeler Dealer investigation revealed, among other things, that\ CMS and its Durable Medical Equipment Regional Carriers ("DMERCs") were not\ thoroughly screening the applications of vendors seeking to be Medicare-enrolled\ providers. Specifically, the DMERCs often were not independently verifying the\ information contained in the vendors' applications.
4 See, notice of public meeting and invitation to comment, posted in the Federal\ Register on April 25, 2003, 68 Fed. Reg. 20384-20385.
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