WASHINGTON--CMS is not gathering enough input from stakeholders as it develops documentation guidance for power wheelchairs and scooters, the Restore Access to Mobility Partnership said in a statement issued on Wednesday.

The coalition of power mobility manufacturers and suppliers said CMS did a good job "reaching out" to the industry in drafting the national coverage determination last year, "but since then the regulations related to the new coverage policy, as well as other new rules and regulations, are being finalized without recommendations from suppliers, manufacturers and physicians being seriously considered."

"We felt that there was a healthy working relationship during the NCD process,'' Mal Mixon, chairman and CEO of Elyria, Ohio-based Invacare Corp., said in the statement. "But since then, it has been back to business as usual. Regulations are being drawn up in a vacuum without being shaped by the practical, real-life experiences that the stakeholders can provide. The result is that the regulations are often ambiguous and confusing, and make it more difficult for qualified Medicare beneficiaries to receive mobility equipment.''

RAMP said one of its biggest concerns is that CMS is rushing to implement the new changes to mobility policy. "The latest example is the new documentation requirements for power mobility equipment," according to the statement. RAMP said it recommends a 90-day period to implement the changes outlined by the DME Program Safeguard Contractors in July (see HomeCare Monday, July 17).

"Currently, suppliers and physicians have no way to know if their documentation is sufficient," RAMP said. "They have been attempting to comply with the provisions of the interim final rule and the final rule, but there are now new changes that leave key questions unanswered. There is also an overriding problem: suppliers are attempting to obtain information from the physicians, but have no consistent vehicle to reasonably do this."

According to RAMP, the following issues in the documentation guidance need to be addressed:

• The entire report of the face-to-face physician examination should not be required to be transcribed directly into chart records. "Physician notes in patient records are usually not very detailed," the statement noted, and "the six questions and 16 bullet points of information asked for" are not typically found in chart notes. While questionnaires and forms don't replace the comprehensive medical record, RAMP said, CMS should acknowledge such supporting documentation as long as it is placed in the patient's chart.
• The guidance states that for certain diagnosis codes for COPD, heart failure and arthritis, "the major emphasis will be on symptoms and history of the progression of their condition rather than on the physical examination." But RAMP said that statement conflicts with the rule stating that patient information collected at the face-to-face examination is sufficient. "Is CMS setting up a two-tiered system whereby patients with COPD, heart failure and arthritis have a more difficult time qualifying for mobility equipment?" RAMP questioned.
• As product manufacturer/model changes are made at the time of delivery, will suppliers be able to amend the detailed product description at the time of delivery or have to postpone delivery until they can get a physician to re-sign a description with a new manufacturer/model listed?
• Will CMS or equipment suppliers have to obtain the additional documents required under the new guidance from physicians? If CMS' collection attempts are unsuccessful, will claims be denied?
• If medical documentation states that the equipment will be used outside of the home as well as in the home, will that disqualify the patient?

Commenting in the statement, Dan Meuser, president of Pride USA, Exeter, Pa., said many of the problems could be resolved if CMS "would just have an open ear" before regulations are finalized. "It's unfortunate because we all have the same goal: the stakeholders and CMS want a policy and process that allows qualified beneficiaries to obtain mobility equipment. But by not considering industry recommendations, it is likely to produce the exact opposite result. We will have confusing regulations and delays in equipment deliveries."

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In a transmittal issued Friday, CMS did make one clarification to its new power mobility requirements: The face-to-face physician exam necessary for prescription of a power mobility device is not required when only PMD accessories or PMD replacements are being ordered. However, the agency said, the PMD must be the same device as previously ordered. If a beneficiary currently has a scooter and would like to replace it with a power wheelchair, he or she must have a face-to-face exam.

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