NAAOP’S Formal Letter to CMS Administrator on Section 302(a)

Mark McClellan, M.D., PhD
c/o Ms. Karen Daily
Center for Medicare and Medicaid Services

Department of Health and Human Services
Attention: CMS-1429-P
P.O. Box 8012
Baltimore, MD 21244-8012

Dear Dr. McClellan:

This letter constitutes formal comments from the National Association for the Advancement of Orthotics and Prosthetics (“NAAOP”) to the Centers for Medicare and Medicaid Services (“CMS”) on Section 302(a)(2) of the Medicare Program Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 (69 Fed. Reg. 47488, August 5, 2004) addressing clinical conditions for coverage of Durable Medical Equipment (“DME”).

NAAOP is a national non-profit association representing the collective interests of certain specialized clinicians-as well as the rehabilitation and disability communities they serve-who are engaged in the provision of quality orthotic and prosthetic (“O&P”) healthcare. Specifically, NAAOP represents highly trained and educated clinicians who carefully evaluate both limb loss and limb or trunk dysfunction for the purpose of providing appropriate, custom-designed orthoses (orthopedic braces) and prostheses (artificial limbs). Quality O&P care assures a custom body interface to each patient’s unique shape and activity level in order to maximize function and minimize an individual’s disability. These clinical services often mean the difference between functional independence and long term disability for people with amputations, musculoskeletal conditions, neurological disorders, stroke, and large numbers of congenital and acquired physically disabling conditions.

NAAOP is responding to this proposed rule because CMS has proposed to extend Section 302(a)(2) of the Medicare Modernization Act from DME to all orthotics, prosthetics and supplies (commonly referred to as “DMEPOS”), without regard to the limits set forth in the statute as to the application of Section 302(a)(2).

The Expansion of Section 302(a)(2) of the MMA from DME to all DMEPOS is Inconsistent with the Statute and Fails to Recognize Significant Distinctions Between the Provision of DME Items and Professional Orthotic and Prosthetic Clinical Care and Related Custom Technology

Section 302(a)(2) of the MMA requires the Secretary of Health and Human Services to establish clinical conditions for payment of covered items of durable medical equipment. The law requires the Secretary to establish types or classes of covered items that require a face-to-face examination of the individual by a physician or practitioner and also requires a prescription for items of DME. However, the proposed rule seeks to expand this face-to-face physician visit requirement to orthotics, prosthetics and supplies. CMS reasons that this expansion is appropriate because it believes that orthotics, prosthetics and supplies require “the same level of medical intervention and skill as DME.” NAAOP strongly disagrees with this reasoning since professional O&P clinical care requires clinical judgment while DME is often drop shipped or supplied by lay sales representatives. Consequently, NAAOP objects to the expansion of the face-to-face physician visit requirement to orthotics and prosthetics. We have no position with respect to expansion of this requirement to “supplies” as NAAOP’s members do not generally supply these items.

Expanding the Face-to-Face Physician Requirement to Professional O&P Clinical Care is Inconsistent with the Statute:

The statutory language of the MMA is very clear with regard to which Medicare benefits CMS should apply the face-to-face physician visit requirement. The statute specifically states that “motorized or power wheelchairs” require a face-to-face examination of the individual by a physician or other practitioner as well as a written prescription for the item. MMA, Section 302(a)(2). The statute then directs the HHS Secretary to establish similar standards on a priority basis for which the Secretary determines there has been “a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation to provide for payment” of covered items.

There is very little evidence that the proliferation of use witnessed with some items of DME is present in the orthotic and prosthetic benefit. In the one report where the Office of Inspector General examined a spike in billings under a small number of orthotic billing codes, the principal reason for the problem was identified to be non-certified suppliers (e.g., DME suppliers) inappropriately utilizing the orthotic billing codes. See, Medicare Payments for Orthotics – Inappropriate Payments (OEI-02-99-00120), Office of Inspector General, (March 2000). To address this concern, the OIG recommended, and Congress later enacted in BIPA 2000, special payment provisions for the provision of orthotics and prosthetics.

NAAOP asserts that the rather stringent standard of demonstrable and repeated fraudulent and abusive conduct established by Section 302(a)(2) of the MMA statute has not been met in the case of orthotics and prosthetics and, therefore, the face-to-face physician requirement should not be expanded to these professions.

Expanding Section 302(a)(2) Fails to Recognize the Distinction Between the Provision of DME Items and Professional Orthotic and Prosthetic Clinical Care and Related Custom Technology:

Contrary to the proposed rule’s statement that “items of [prosthetics, orthotics and supplies] require the same level of medical intervention and skill as DME,” DME and orthotics and prosthetics are completely separate and distinct. While it is true that DME and O&P are both reimbursed under a fee schedule by the Durable Medical Equipment Regional Carriers (“DMERCs”), they each have separate statutory authority for coverage under the Medicare program. 42 U.S.C. 1395x(s)(6) and 42 U.S.C. 1395x(s)(9), respectively. Providing professional orthotic and prosthetic clinical care and related custom technology to Medicare patients is vastly different from the provision of DME items and supplies.

Certified orthotists and prosthetists must undergo specialty instruction, skills training, clinical residency and extensive testing specific to the care and management of the O&P patient. Such specialty education and training is unique to O&P, encompassing bodies of knowledge and skills not embraced by any other health care specialty. The provision of professional orthotic and prosthetic care is a unique mix of hands-on clinical practice and biomechanical and technical skill. In order to provide quality orthotic and prosthetic care, O&P practitioners must have access to clinical care settings and technical laboratories designed to provide customized clinical care and technical services.

The provision of DME, in contrast, has little in common with the provision of orthotic and prosthetic patient care. DME suppliers have not been certified for many years and are only now, as a result of the MMA, being required to obtain certification. Clinical patient settings and laboratories are not needed to provide DME, which is usually sold in storefronts and in pharmacies across the country. Indeed, the field of DME requires far less “medical intervention and skill” than the provision of professional O&P clinical care and related custom technology.

As such, the safeguard of requiring a face-to-face physician visit in order for orthotic and prosthetic care to be reimbursed is completely unnecessary and burdensome to Medicare beneficiaries, the practitioners who provide these services, and physicians who prescribe these services. The education, training, and skill level that O&P practitioners have should accord them some degree of deference from CMS to act as partners with physicians in recommending an appropriate course of treatment to O&P patients. As such, the risk of inappropriate proliferation of use of professional O&P clinical care and related custom technology is far less likely than in the field of DME.

CMS Should Remain Consistent with Its Prior Treatment of DME and O&P

There are at least two recent examples where CMS has separately treated DME from orthotics and prosthetics that should serve as strong evidence that CMS should continue to treat these two distinct fields separately. First, in Section 531 of the Beneficiary Improvement and Protection Act of 2000 (“BIPA 2000”), Congress included a provision that permitted DME billing code applications to receive an in-person meeting between the manufacturer requesting a new billing code and the CMS coding panel. In response to the proposed rule implementing this provision of BIPA 2000 (66 Fed. Reg. 58743 (Nov. 23, 2001)), NAAOP requested that orthotic and prosthetic billing code applications receive the same treatment under this new law and submitted comments to that effect.

CMS did not publish a final rule but in telephone conversations with CMS staff, CMS confirmed that they declined to extend this statutory provision impacting DME to orthotics and prosthetics based on the premise that to do so would be an unauthorized expansion of Congressional authority. If this reasoning was valid in the year 2002-when NAAOP confirmed CMS’ position-this same interpretation should apply in 2004.

Similarly, in Section 302(b) of the MMA, Congress created a competitive acquisition program under Medicare for DME but specifically exempted all custom orthotics and all prosthetics. This constitutes that vast bulk of professional orthotic and prosthetic clinical care and related technology except for what the MMA defined as “off the shelf” orthotics. Congress’ reasoning behind this exclusion was that customized devices and services do not lend themselves well to a competitive bidding framework and that professional orthotic and prosthetic services were significantly different (as well as separate and distinct legally) from the provision of DME. This separate treatment of DME and O&P should not be inconsistently applied absent a clear directive from Congress, which clearly does not exist in this instance.

As a practical matter, it should be noted that virtually every orthosis and prosthesis that is reimbursed by the Medicare program must be accompanied by a written physician’s order detailing the O&P treatment required. Therefore, application of this face-to-face physician visit requirement to orthotics and prosthetics will provide CMS with little, if any, additional control over utilization of these services. However, application to orthotics and prosthetics of a number of provisions in the proposed rule could cause delays in treatment of O&P patients, potential compromising the functional outcomes and medical status of beneficiaries with amputations and other orthopedic impairments. Application of Section 302(a)(2) to professional O&P clinical care and related custom technology could erect unnecessary barriers to care, without any significant corresponding benefit to the Medicare program.

If the Secretary Chooses to Expand Section 302(a)(2) to Orthotics and Prosthetics, Medical Necessity Should be the Guiding Principal for Application of the Regulations to Professional O&P Clinical Care and Related Custom Technology

If the HHS Secretary insists on expanding Section 302(a)(2) beyond what the statute clearly seems to authorize, then NAAOP suggests that the final regulations should rely on the concept of “medical necessity” as the guiding principal when determining how the provisions of the rule will apply to professional O&P care.

The Physician’s Order Should Depend on the Medical Necessity of the Professional O&P Care Needed, Not Whether the Physician Designed an Overall Treatment Plan

The proposed rule 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.” The proposed rule continues by stating that the physician is expected to “conduct a sufficient examination of the patient’s medical condition to ascertain the appropriate overall treatment plan and to order the DMEPOS as only one aspect of that treatment plan.” NAAOP believes that for initial orders of orthotics and prosthetics, this proposal is not unreasonable, 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, this proposed rule seems misplaced and out-of-step with current medical practice.

NAAOP believes that CMS should make a distinction in the final rule between one-time, temporary users of orthoses (i.e., those who have a need for support of an injured body part following an acute episode until such time as routine healing and rehabilitation restore function to that body part) and permanent, long term users of orthoses. Many people with orthopedic impairments who require orthotic treatment are permanent users of orthotic devices and, therefore, have a long term need.

Similarly, all amputations are permanent and, therefore, all prosthesis (i.e., artificial limb) users have a long term need for prosthetic care. Except for a new amputee’s first prosthesis in which the physician has significant involvement, long term prosthesis users do not require, and routinely do not have, a close relationship with their physician for their prosthetic needs (absent ongoing medical complications). In these instances, the 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.

Other than chronic or progressive conditions and instances where medical complications are at issue, most individuals who have long term orthotic and/or prosthetic needs do not have an active “medical condition,” but rather, have long term impairments or disabilities. These individuals usually become very familiar with their O&P needs and establish close working relationships with their O&P practitioners. These practitioners are highly trained to provide ongoing professional services to O&P patients with limited involvement from the physician, in most instances.

Again, other than chronic or progressive disorders, it would be rare that an individual who has lived with an amputation or orthopedic impairment for a significant period of time would require an ongoing plan of treatment designed by a physician, unless other complications are in play. To subject these individuals to a requirement for a face-to-face physician examination that specifically prohibits such a visit for “the sole purpose” of obtaining the physician’s order-when this is exactly what is needed from the physician-appears to be an unnecessary barrier that is out-of-step with current medical practice and will lead to nothing more than a delay in treatment, additional barriers to care, and unnecessary costs to the program.

In these instances, the physician’s role should be to assess and, if appropriate, approve themedical necessity of the recommended orthotic or prosthetic treatment, whether or not a face-to-face examination with the physician has occurred and whether or not a plan of treatment has been developed by the physician. Indeed, for long term O&P users, there is usually no other treatment that would be appropriately prescribed other than the professional O&P clinical care and related custom technology itself. To require physicians to develop a plan of treatment for these patients where the O&P care is “only one aspect of that treatment plan” could prompt physicians to unnecessarily prescribe other services such as physical or occupational therapy or other services, just to ensure the physician is in compliance with this rule and is ultimately reimbursed for the face-to-face visit. This has the potential to add unnecessary costs to the Medicare program without any corresponding benefit.

The Physician’s Prescription Should be Effective for the Life of the O&P Device, including Repairs, Maintenance, Minor Revisions and Replacement of Component Parts

The proposed rule suggests that CMS would “promulgate through contractor instructions othercriteria 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 these types of services. To impose such a requirement every time an orthotic or prosthetic user needed 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.

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.

Thank you for your consideration of our comments to this very important issue. If you have any questions or need additional information, please do not hesitate to contact me or our Washington counsel, Peter W. Thomas, Esq., at 202-466-6550.

Sincerely,
Michael J. Allen, CPO, FAAOP President
cc: NAAOP Board of Directors

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