Introduction:

These comments are being submitted on behalf of a national, consumer-led coalition known as the “ITEM” Coalition, an acronym for Independence Through Enhancement of Medicare and Medicaid. The ITEM Coalition was formed in 2003, and its 74 member organizations include a diverse set of disability groups, aging organizations, other consumer groups, labor organizations, voluntary health associations, and non-profit provider associations.

The ITEM Coalition’s purpose is to raise awareness and build support for policies that will improve access to assistive devices, technologies, and related services for people of all ages with disabilities and chronic conditions. From coverage for hearing aids to augmentative communications devices (AACs) to advanced artificial limbs to screen readers for people with vision impairments, the Coalition’s mission is a broad one with implications for virtually every person with a disability who relies on assistive devices to be healthy, functional, and independent.

These comments will focus on many provisions in the August 26th Interim Final Rule on Power Mobility Devices (PMDs). The ITEM Coalition recognizes the value associated with the face-to-face examination requirement. Additionally, the ITEM Coalition applauds the Centers for Medicare and Medicaid Services (CMS) for attempting to decrease provider and supplier reliance on the Certificate of Medical Necessity. However, ITEM Coalition members are concerned that several provisions in this regulation may threaten access to PMDs for people with disabilities. Generally, we find that the Interim Final Rule fails to recognize the complexity of the PMD prescription and acquisition process. The ITEM Coalition encourages CMS to take into greater consideration the Medicare beneficiaries impacted by this rule who depend on Mobility Assistance Equipment (MAE) to live healthy and independent lives.

Additionally, members of the ITEM Coalition continue to oppose CMS’ current interpretation of the “used in the patient’s home” language. Although this regulation attempts to improve the prescription and acquisition processes for PMDs, the ITEM Coalition feels that by confining any assessment to beneficiary needs only within the home, CMS is restricting itself from making any true improvements to the benefit. There continues to be no clinical basis for the “in the home” restriction and by asking treating practitioners to document medical need only within the home setting, CMS is severely restricting patients from receiving the most appropriate devices to meet their mobility needs.

I. Background

Specialist’s Assessment for POV Prescription

The August 26th regulation states that a specialist is no longer required by Medicare to assess an individual for a power operated vehicle (POV) as previously required by regulation 57 FR 57688. The ITEM Coalition does not oppose this change for the prescription of POVs and, in fact, recognizes that this change may improve access for beneficiaries to this type of device. However, ITEM Coalition members encourage CMS to invest in education and outreach to those physicians who have not historically been prescribing POVs. Even for those physicians who have been prescribing POVs for many years, the new requirements and regulations issued over the last several months are at a minimum overwhelming, and we are concerned that without proper outreach, providers who are unfamiliar with the process will refrain from prescribing POVs to beneficiaries or improperly do so.

Development of New G Code

The ITEM Coalition commends CMS for recognizing the additional burden associated with the preparation of a written prescription and pertinent parts of the medical record for submission to the supplier in order to establish medical need for the PMD. As stated in the regulation, CMS finds that in prescribing a mobility device, there is an increased burden on physicians above and beyond the evaluation and management (E&M) code corresponding to the history and physical examination of the patient. Thus, creates a new G code for such reimbursement purposes.

However, members of the ITEM Coalition are concerned that the proposed G code value of $21.60 will not provide sufficient incentive for physicians to participate in the prescription of PMDs, which, under the new requirements, will be more complex and time-consuming than under the old rules. ITEM Coalition members believe that the PMD assessment/prescription process is much more complex than laid out in this regulation and commonly includes other professionals such as physical therapists and other clinicians. A G code of $21.60 not only fails to take into account the additional burden that physicians will face under the new regulations, but completely ignores the important role of clinicians in the assessment process.

If physicians and clinicians are not provided an incentive to participate in the Medicare process established for the prescription of a PMD, members of the ITEM Coalition fear that Medicare beneficiaries with disabilities may have difficulty finding a physician and clinician willing to assess them for these important devices. Therefore, the ITEM Coalition encourages CMS to create a payment structure that will provide an incentive not only to physicians but also to clinicians involved in this complex and time consuming process.

II. Provisions of the Interim Final Rule

30-Day Face-to-Face Examination Requirement

Members of the ITEM Coalition recognize that the Medicare Modernization Act of 2003 (MMA) requires CMS to implement a face-to-face examination requirement for the prescription of PMDs. The ITEM Coalition recognizes the value of this requirement and believes that for the prescription of most devices, this is already standard practice. However, members of the ITEM Coalition are concerned by this regulation’s requirement that the “PMD prescription must be in writing and signed and dated by the physician or treating practitioner who performed the face-to-face examination and received by the supplier within 30 days after the face-to-face examination.”

We recognize that additional documents have subsequently been released further clarifying the 30-day face-to-face examination requirement. However, the Interim Final Rule on which we are commenting, the only regulation that addresses this requirement, clearly states that a supplier must receive the written prescription 30 days after the face-to-face examination.

As written, members of the ITEM Coalition believe the 30-day requirement for the face-to-face examination does not take into account the complex process of prescribing a PMD. To obtain an appointment with a physician, attend a session or a series of sessions with a therapist and have complete and accurate medical records to the supplier within a 30-day timeframe can be a difficult task for the average consumer, especially those in more rural settings. However, the individuals to whom this requirement is applicable have severe mobility impairments, low incomes, and likely few resources. Many of these individuals face the difficult task of arranging suitable transportation to coincide with the appointments. Additionally, some of these beneficiaries may face literacy issues or have conditions that impair their motor skills, making it necessary for them to rely on others to assist them with handling, reading, and signing of any documentation. Taking these additional factors into account, the 30-day requirement seems simply impracticable.

The timeframe laid out in the August 26th regulation would create a significant barrier to access to PMDs. Therefore, the ITEM Coalition encourages CMS to recognize through regulations the complex process associated with the acquisition of a PMD for a Medicare beneficiary and issue more appropriate regulations.

Additionally, the ITEM Coalition encourages CMS to review current requirements that prevent billing for multiple codes associated with PMD assessment in a single day. Such restrictions may hinder access by creating an unnecessary delay in the assessment process as patients are required to return to the clinician’s office on several occasions.

Documentation Requirements

With the removal of the Certificate of Medical Necessity (CMN), CMS is now requiring an extensive amount of readily available documentation from the physician via the supplier in order to establish medical necessity for a PMD. Although the regulation explains by example the type of documentation to be used in the prescription process (patient history, physical examination, diagnostic tests, summary of findings, diagnoses, and treatment plans) it does not provide the level of specificity or clarity that physicians, clinicians and suppliers need as they transition from the CMN. Members of the ITEM Coalition are concerned that an increased level of confusion and a subsequent reluctance to participate on the part of the treating practitioners, including the clinicians, and suppliers will create a barrier to access to PMDs for individuals with disabilities.

Additionally, the removal of the CMN and new documentation requirements laid out in this regulation place a new burden of proof on the suppliers. Suppliers are now required to make the final decision as to whether medical necessity has been established by the physician’s and clinician’s documentation or whether additional information is needed before a PMD can be granted. In the current environment, this is a daunting responsibility for a supplier and creates a disincentive to participate in the Medicare program. Without clear guidelines and requirements for establishment of medical necessity, we believe that suppliers, especially smaller suppliers or those with less experience in the Medicare program, will be reluctant to provide PMDs to Medicare recipients, thereby reducing access to PMDs for people with disabilities.

Assessment Process

In an attempt to illustrate the type of information that might justify medical need, the Interim Final Rule provides two examples of what CMS considers appropriate and comprehensive evaluations. The ITEM Coalition is extremely concerned that in both examples CMS fails to include a clinical evaluation by a therapist, a common and integral part of the prescription process. ITEM Coalition members feel that this omission again illustrates a disconnect between CMS’ view of the prescription process for PMDs and what really occurs in the field.

One of the provided examples includes a home visit by the physician to assess the home environment of the patient. Members of the ITEM Coalition find this scenario unrealistic and far from standard practice. Additionally, both examples repeatedly refer to the physicians’ knowledge of the recent National Coverage Determination (NCD) for Mobility Assistance Equipment (MAE). We find it very unlikely that the average physician will be familiar with the coverage standards established by the new NCD, especially without a final Local Coverage Determination (LCD) in existence.

Therefore, ITEM Coalition members encourage CMS to reconsider it vague requirements for the establishment of medical necessity and create a process in which physicians, clinicians, suppliers and, of course, consumers, will be well-served. We believe such a system is essential to ensure access to PMDs for people with disabilities.

III. Response to Comments

Implementation/Timing

Members of the ITEM Coalition are extremely disappointed by CMS’ decision to waive the Notice of Proposed Rule Making and implement the new requirements established by this regulation prior to the end of the comment period.

Over the last several months, stakeholders have been inundated with new regulations and requirements on the prescription, coding, payment, and coverage of wheelchairs and POVs under Medicare. This series of events began with CMS’ interest in reducing waste, fraud and abuse in the system while improving access to the most appropriate devices for people with disabilities. However, the ITEM Coalition believes that the new regulations have only served to complicate further the MAE Medicare benefit and, in fact, stand to hinder access to MAE for beneficiaries.

By implementing these new regulations without first considering the input of all stakeholders, ITEM Coalition members believe that CMS is missing an important chance to create a truly appropriate and comprehensive prescription process. We believe that the established processes for public comment are not simply formalities but rather opportunities for CMS to learn from experts in the field and the consumers on which such regulations have real-life implications. The changes outlined in the Interim Final Rule are significant yet underdeveloped, representing a superficial view of the assessment process for PMDs. We regret that CMS did not find it necessary to consider the public’s comments before implementation of this important rule and we encourage the agency to revise this rule in proposed form.

Sincerely,

The ITEM Coalition Steering Committee:

Kim Ruff-Wilbert
United Spinal Association

Peter W. Thomas
Consortium for Citizens with Disabilities Health Task Force

Mark Richert
American Foundation for the Blind

Lee Page
Paralyzed Veterans of America

Eva DuGoff
Medicare Rights Center