Washington Insider
Early last month the Centers for Medicare and Medicaid Services (CMS) announced the new national coverage determination (NCD) for mobility assistance equipment including power wheelchairs and scooters. The new NCD, which according to CMS was effective immediately, modernizes the coverage policy by moving away from the archaic "bed or chair confined" coverage standard and replacing it with a functional standard based on a Medicare beneficiaries ability to participate in their "mobility related activities of daily living" (MRADLs). While this is a good step forward, it is important to note that the NCD is only one piece to the new coverage puzzle and additional regulations and guidance are necessary to ensure appropriate access to these products for Medicare beneficiaries.
CMS has indicated in various venues that they are working to get the companion regulations Final Face to Face Examination Rule, Revised CMN and Revised POV/scooter policy published soon. In addition, the DMERC Medical Directors have also been working together on an article which should provide assistance to providers on how to implement the coverage policy in the interim period. The DMERCs are also working on a draft LMRP that should be released for comment the end of this month that will tie the new coverage policy to the new codes, effective Jan. 1, 2006.
In announcing the new coverage criteria CMS states 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 participation in mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home.
The foundation for the new coverage policy is based on sequential consideration of the following nine questions that were designed to provide clinical guidance for coverage of the appropriate type and complexity of MAE to restore the beneficiary's ability to participate in mobility-related activities of daily living. The questions also correspond to the number on the algorithm, which CMS included in the NCD.
1. Does the beneficiary have a mobility limitation that significantly impairs his or her ability to participate in one or more mobility-related activities of daily living in the home? A mobility limitation is one that:
a. Prevents the beneficiary from accomplishing the mobility-related activities of daily living entirely, or
b. Places the beneficiary at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to participate in mobility-related activities of daily living, or
c. Prevents the beneficiary from completing the mobility-related activities of daily living within a reasonable time frame.
2. Are there other conditions that limit the beneficiary's ability to participate in mobility-related activities of daily living at home?
a. Some examples are significant impairment of cognition or judgment and/or vision.
b. For these beneficiaries, the provision of MAE might not enable them to participate in mobility-related activities of daily living if the comorbidity prevents effective use of the wheelchair or reasonable completion of the tasks even with MAE.
3. If these other limitations exist, can they be ameliorated or compensated sufficiently such that the additional provision of mobility equipment will be reasonably expected to significantly improve the beneficiary's ability to perform or obtain assistance to participate in mobility-related activities of daily living in the home?
a. A caregiver, for example a family member, may be compensatory, if consistently available in the beneficiary's home and willing and able to safely operate and transfer the beneficiary to and from the wheelchair and to transport the beneficiary using the wheelchair. The caregiver's need to use a wheelchair to assist the beneficiary in the mobility-related activity of daily living is to be considered in this determination.
b. If the amelioration or compensation requires the beneficiary's compliance with treatment, for example medications or therapy, substantive non-compliance, whether willing or involuntary, can be grounds for denial of wheelchair coverage if it results in the beneficiary continuing to have a significant limitation. It may be determined that partial compliance results in adequate amelioration or compensation for the appropriate use of mobility assistive equipment.
4. Does the beneficiary or caregiver demonstrate the capability and the willingness to consistently operate the MAE safely?
a. Safety considerations include personal risk to the beneficiary as well as risk to others. The determination of safety may need to occur several times during the process as the consideration focuses on a specific device.
b. A history of unsafe behavior in other venues may be considered.
5. Can the functional mobility deficit be sufficiently resolved by the prescription of a cane or walker?
a. The cane or walker should be appropriately fitted to the beneficiary for this evaluation.
b. Assess the beneficiary's ability to safely use a cane or walker.
6. Does the beneficiary's typical environment support the use of wheelchairs including scooters/POVs?
a. Determine whether the beneficiary's environment will support the use of these types of mobility equipment.
b. Keep in mind such factors as, physical layout, surfaces, and obstacles, which may render mobility equipment unusable in the beneficiary's home.
7. Does the beneficiary have sufficient upper extremity function to propel a manual wheelchair in the home to participate in mobility-related activities of daily living during a typical day? The manual wheelchair should be optimally configured (seating options, wheelbase, device weight and other appropriate accessories) for this determination.
a. Limitations of strength, endurance, range of motion, coordination and absence or deformity in one or both upper extremities are relevant.
b. A beneficiary with sufficient upper extremity function may qualify for a manual wheelchair. The appropriate type of manual wheelchair, i.e. lightweight, etc. should be determined based on the beneficiary's physical characteristics and anticipated intensity of use.
c. The beneficiary's home should provide adequate access, maneuvering space and surfaces for the operation of a manual wheelchair.
d. Assess the beneficiary's ability to safely use a manual wheelchair.
8. Does the beneficiary have sufficient strength and postural stability to operate a POV/scooter?
a. A POV is a 3 or 4-wheeled device with tiller steering and limited seat modification capabilities. The beneficiary must be able to maintain stability and position for adequate operation.
b. The beneficiary's home should provide adequate access, maneuvering space and surfaces for the operation of a POV.
c. Assess the beneficiary's ability to safely use a POV/scooter.
9. Are the additional features provided by a power wheelchair needed to allow the beneficiary to participate in one or more mobility-related activities of daily living?
a. The pertinent features of a power wheelchair compared to a POV are typically control by a joystick or alternative input device, lower seat height for slide transfers, and the ability to accommodate a variety of seating needs.
b. The type of wheelchair and options provided should be appropriate for the degree of the beneficiary's functional impairments.
c. The beneficiary's home should provide adequate access, maneuvering space and surfaces for the operation of a power wheelchair.
d. Assess the beneficiary's ability to safely use a power wheelchair.
The questions above essentially outline the new coverage policy. As stated earlier this is only one piece to the puzzle and in order for providers to have a clear and consistent coverage requirements, additional regulations and guidance must be published. Clinicians, consumers, providers, manufacturers and other advocates continue to urge CMS for additional guidance to complete the coverage puzzle, and CMS has signaled that the additional regulations will be released soon.
Additional clarity should be provided when CMS issues the new regulations bringing the MAE coverage policy into a clearer focus. One regulation will require physicians to conduct face-to-face examinations of beneficiaries prior to prescribing power wheelchairs. This is a requirement that came out of the Medicare Prescription Drug and Modernization Act (MMA) requiring beneficiaries to have an in-office visit with the prescribing physician prior to receiving the equipment. This requirement should help establish the medical need for the mobility equipment. In addition, CMS plans to issue a revised (POV)/scooter policy, to officially eliminate the four specialist requirement to prescribe a POV. They are also planning to issue a revised wheelchair certificate of medical necessity (CMN) shortly.
Stakeholders continue to press CMS for a consistent set of directives regarding the documentation that will be required to substantiate medical need for Medicare coverage of a mobility device such as a power wheelchair. While the new coverage policy represents a significant step forward, clear and consistent documentation requirements are needed in order for CMS to succeed in its goal of making MAE available to the elderly and disabled beneficiaries with a medical need for such equipment.
The establishment of clear and consistent documentation requirements is paramount for the industry largely because the requirements for determining medical necessity under the previous coverage policy were vague, ineffective and open to interpretation by the Durable Medical Equipment Regional Carriers (DMERCs). This resulted in thousands of claims being disputed in recent years, widespread confusion over the coverage guidelines, and access being denied to beneficiaries with disabilities and mobility impairments. Currently, no clear documentation requirements have been established for the new policy, although CMS has stated publicly that they are working to address this.
The DMERCs are planning to release interim coverage guidance on the new NCD shortly. This interim guidance should provide instruction to providers on how to clearly document medical necessity in order to ensure payment once the equipment has been provided to the beneficiary. In addition, the DMERC Medical Directors are also in the process of drafting a proposed local coverage determination (LCD) which will tie the new coverage policy to the new power wheelchair codes effective Jan. 1, 2006. The proposal should be released for comment in late June with a 45-day comment period. I am hopeful that CMS and the DMERCs understand that in order for the new, clearer policy to be implemented appropriately, documentation requirements need to have a high degree of clarity reflective of the new policy.
RAMP has developed some broad guidelines on documentation, as well as some specific recommendations. RAMP believes that:
Given the complexity of the algorithm determining medical necessity under the new coverage policy, CMS should acknowledge it is unlikely that physicians will, as a matter of practice, document a beneficiary's medical condition in the medical record with the level of specificity that may be envisioned. This was a serious problem with the old policy, which was not nearly as complex.
The documentation requirements must be tied directly to the coverage policy and (A) clearly outline the required information to substantiate medical need, (B) clearly identify who is responsible for providing that information, and (C) clearly state how the information must be documented.
Currently the RAMP organization is advocating for CMS to include the following recommendations related to documentation requirements:
CMS draft a new certificate of medical necessity (CMN) that addresses the detailed coverage rules of the new national Medicare coverage policy. The CMN should be the main document used to determine medical necessity.
CMS should require prescribing physicians, who have the capability, to electronically send the completed CMN and the relevant portions of the beneficiary's medical record to the supplier, at the time of prescription.
In lieu of physician progress notes, a licensed clinician (e.g., the prescribing physician, a physical or occupational therapist) should be able to evaluate the beneficiary's need and document the beneficiary's condition/needs as they relate to the coverage policy. This information need not be in a required form, rather CMS and/or the DMERCs can provide a suggested series of questions to be addressed. Those questions should be based on the coverage policy. This information should be sufficient upon medical review to substantiate medical need.
These guidelines and recommendations are necessary in order to help CMS establish a firm foundation for Medicare coverage of mobility equipment. CMS has continued to have an open door policy for discussion of the need to provide further guidance to providers, and appears to understand the significance of getting a clear set of documentation requirements established so the coverage policy can be appropriately implemented.
RAMP is advocating that by following these basic principles, a workable policy can be established. The overarching goal is to have a documentation policy that works for all the stakeholders, including CMS, the industry and the beneficiaries. It is in everyone's best interest that the documentation rules are written in a way that they can be clearly understood by everyone, and are not left open to interpretation.
In addition to the documentation issue, consumer groups, clinicians and the industry are also concerned that CMS decided not to address the "In the Home" issue in the NCD. The ITEM Coalition has been instrumental in raising this important issue on Capitol Hill through a Dear Colleague letter circulated for signature in the House of Representatives by Congressman Charlie Bass (R-NH) and Jim Langevin (D-RI). The letter provides a good overview of the issue and requests they sign a letter to Secretary of Health and Human Services Mike Leavitt asking him to clarify the government's position as to whether CMS/HHS have the ability to address this from a regulatory perspective or if a change in the law is required.
Overall, the new coverage policy is a good first step, and throughout the next few weeks the overall coverage picture should come into better focus as the additional guidance and regulations are issued. CMS has demonstrated their willingness to work with the industry and other stakeholders to ensure all comments are heard on this important issue. The industry should remain vigilant in continuing to advocate for clear and consistent documentation requirements.
This article originally appeared in the June 2005 issue of HME Business.