On Friday, September 24, 2004, NAAOP hand delivered public comments to Mark McClellan, M.D., Ph.D., Administrator of the Centers for Medicare and Medicaid Services, regarding the face-to-face physician visit requirement of the Medicare Modernization Act. CMS proposed to expand Section 302(a)(2)-which currently regulates clinical conditions for coverage of only Durable Medical Equipment (“DME”)-to cover all orthotics, prosthetics and supplies (commonly referred to as “DMEPOS”), thereby disregarding the limits set forth in the statute. If Section 302(a)(2) is expanded to include orthotics and prosthetics (“O&P”), a face-to-face examination of the patient by a physician or other practitioner would be required in order for Medicare to cover and reimburse the O&P treatment.
NAAOP stated in its formal comments that the proposed expansion of Section 302(a)(2) is inconsistent with the statute. Based on the law, a face-to-face physician visit is required when the Secretary has determined that significant and continuous cases of fraud and abuse have occurred in a particular benefit category. There is very little evidence, if any, that this is the case with O&P.
In the few instances where fraud and abuse has been examined by the Office of Inspector General, the reason for the fraudulent activity involved non-certified suppliers who inappropriately used the O&P billing codes. The high standard of demonstrating repeated fraud and abuse established in the MMA has simply not been met in the case of O&P, NAAOP asserted.
NAAOP’s comments also noted that there is a clear and distinct difference between O&P and DME. The hands-on training of orthotists and prosthetists requires years of clinical practice and biomechanical and technical skill. O&P practitioners require access to clinical care settings and technical laboratories, unlike DME suppliers who, until recently, were not required to be certified and often sell DME out of storefronts and pharmacies.
In the past, CMS has noted the differences between O&P and DME as separate and distinct and treated them as such. NAAOP encouraged CMS to remain consistent with the policy it set forth in 2002 when CMS declined to extend a statutory DME provision in BIPA 2000 to O&P because doing so would constitute an unauthorized expansion of Congressional authority. In addition, the MMA’s competitive bidding program exempts custom orthoses and all prostheses but DME is impacted by this statute. Clearly, there is precedent for treating DME and O&P as separate and distinct.
Should CMS not follow this precedent, however, NAAOP asked CMS to use “medical necessity” as the guiding principal for the application of the new regulatory rules. Under the proposed rule, CMS states that the “face-to-face examination should be for the purpose of evaluating and treating the patient’s medical condition and not for the sole purpose of obtaining the prescribing physician’s or practitioner’s order for the DMEPOS.” NAAOP does not believe that this proposal is unreasonable for initial orders of orthotics and prosthetics, as the patient has invariably had an acute episode of illness or injury that requires, as part of a treatment plan, orthotic or prosthetic intervention. However, for long term users of orthoses and prostheses, the proposed rule seems misplaced and out-of-step with current medical practice.
NAAOP stressed that CMS should make a distinction in the final rule between one-time, temporary users of orthoses and permanent, long term users of orthoses. NAAOP noted with respect to prosthesis users that all amputations are permanent and, therefore, all prosthesis (i.e., artificial limb) users have a long term need for prosthetic care. In these instances, a trained, professional orthotist and/or prosthetist, working with the seasoned patient, are in the best position to assess the continued orthotic and/or prosthetic needs of the individual, and make a recommendation to the physician for approval of the plan of care.
NAAOP explained to CMS in its comments that individuals with long term impairments or disabilities usually become very familiar with their O&P needs and establish close working relationships with their O&P practitioners. By subjecting these individuals to a requirement for a face-to-face physician examination that specifically prohibits a visit for “the sole purpose” of obtaining the physician’s order-when this is exactly what is needed from the physician-the proposed rule would do nothing more than cause delay in treatment, additional barriers to care, and unnecessary costs to the program.
The proposed rule suggests that CMS will “promulgate through contractor instructions other criteria required for payment, such as for prescription renewal requirements, repair, minor revisions and replacement.” [Emphasis added]. NAAOP strongly supports an exemption from the face-to-face physician requirement for those types of services. To impose such a requirement every time an orthotic or prosthetic user needs an adjustment, revision, repair, or component replacement would create a significant burden on physicians, raise significant barriers for patients and O&P practitioners to provide timely and appropriate care, and would yield no corresponding benefit to the Medicare program in terms of proliferation of use or quality of care.
NAAOP stressed that O&P practitioners clearly have the training and skills necessary to assess for themselves, in consultation with the O&P patient, whether that patient’s orthosis or prosthesis is in need of maintenance, repair or revision. The physician’s original prescription signifying the medical necessity of the orthosis or prosthesis in need of maintenance or repair should extend to the life of the device, as is currently the case under the Medicare O&P benefit. Absent medical complications involving the use of the orthosis or prosthesis, there is no reason for continued physician involvement during the course of routine use necessitating repair or maintenance of the orthosis or prosthesis.
These comments were hand delivered to the Centers of Medicare and Medicaid Services’ Washington, D.C. office. A decision on the final rule on Section 302(a)(2) should be released in the near future.
Peter W. Thomas, NAAOP General Counsel, and Nicole M. Yost drafted this article. For more information, please contact us at 800-662-6740 or by email atinfo@naaop.org.
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