Three major orthotic and prosthetic organizations have spoken strongly against a draft of a new medical policy for knee orthoses proposed by the four Durable Medical Equipment Regional Carriers (DMERCs).
The organizations asserted that both patients and highly trained health professionals would be hurt by the policy, which is felt to devalue the education and accreditation standards required for trained professionals while it opens the door to "opportunistic" suppliers and "non-professional salespeople." In turn, patient care would suffer, they pointed out.
Besides spelling out overall objections, the organizations also made point-by-point comments, sent to the DMERC medical directors, on the aspects of the draft of "Local Determination and Policy on Knee Orthoses." These detailed comments can be read on their respective websites. Also, comments can be read on the Centers for Medicare & Medicaid Services (CMS) website: www.cms.hhs.gov/regulations/ecomments/
Academy's View
The American Academy of Orthotists & Prosthetists strongly objected to several provisions as detrimental to patient access and quality of care. The Academy faulted the L-Code system itself for not having kept pace with orthotic advances.
"The need for the use of addition codes in knee orthoses is warranted by CMS' failure to create new base codes that reflect the current standard of care," the Academy's response to the DMERC directors stated. The Academy also distinguished between "suppliers" and "providers" within the policy. Its letter identified certified orthotists and prosthetists as the only providers of O&P care; all others are suppliers.
Pointing out that the L-Code system was conceived and largely created in the 1970s, the Academy said that the system often has not maintained accurate descriptions for devices representing the norm in O&P care. The proliferation of prefabricated devices, along with an equal proliferation of DME suppliers for these devices, has changed the nature of providing patient care, the Academy asserted.
"The Academy realizes the need for cost containment, but we strongly oppose efforts that use the proposed narrow medical necessity policy to do so," the response declared, adding, "Constraining the medical necessity guidelines for knee orthoses and adding burdensome prescription requirements to qualified providers adversely affects our profession economically and presents unnecessary barriers to patients seeking appropriate care from qualified individuals. We believe there is a way to provide quality care in an environment of fiscal control."
The Academy then viewed the L-Code system and how "opportunistic" suppliers find it a "limitless economic treasure," saying, "That process [of providing quality care] begins with a realistic look at the L-Code system and how non-qualified suppliers utilize it."
The Academy statement continued, "The distinction between 'suppliers' and 'providers' is inherent in the coding system's descriptions of prefabricated and custom-fabricated devices...To fit a patient with a custom-fabricated device requires a brick-and-mortar facility from which to provide the service essential in the delivery of that item. Orthotic and prosthetic professionals have years of training in biomechanical and technical sciences; they possess knowledge of materials and clinical practice to prepare them for evaluation, measurement, fabrication, fitting, and initial instruction in the use of orthotic and prosthetic devices, as well as the ability to modify and maintain such devices during follow-up care.
"These skills require access to specialized clinical care settings and facilities," the Academy continued. "Other suppliers lack the specific training and education to perform these precise duties, and often work and practice from medical offices and storefronts that lack the specialized machinery to fabricate, adjust, and service these devices.
"These suppliers augment shrinking reimbursements by supplying prefabricated and custom outsourced devices opportunistically to patients that may be served more efficiently and comprehensively with care from orthotists and prosthetists," the Academy pointed out. "The result is often increased utilization by suppliers who view the L-Code system as a limitless economic treasure. The only 'providers' of orthotic and prosthetic care are the certified orthotic and prosthetic practitioners credentialed by the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board of Certification (BOC). The remaining DME vendors should be classified as 'suppliers.'...We feel the DMERCs should explore ways to distinguish certified providers from non-certified providers and regulate them accordingly."
For more information, visit the Academy's website: www.oandp.org
AOPA's Response
"This proposal arbitrarily redefines base codes to include components or features that are not actually listed in the descriptors and which historically have not been considered as part of the base code," stated the American Orthotic & Prosthetic Association (AOPA). "Under the guidance of the Statistical Analysis DME Regional Carrier (SADMERC), we have always operated with the understanding that if a component or addition was not listed in the HCPCS code definition, it was not included in that code. Therefore, if an item or feature is not listed, an additional code is acceptable as long as the item/feature is medically necessary."
AOPA noted that the new policy changes this coding philosophy, resulting in a violation of the original "building block" principle of the L-Code system. "AOPA strongly believes that it is inappropriate to suddenly redefine what items are included in a base code and certainly not appropriate that such a radical change in the tenets of this coding system be done through medical policy development," the association declared, adding, "We therefore ask that you not redefine the base codes in this manner."
AOPA also noted that the new policy states that addition codes that are not designated as "approved" with a certain base code will automatically become "not medically necessary" and will be denied. "Historically, Medicare has covered services as long as they are medically necessary and not specifically excluded in the law," AOPA pointed out, adding, "This across-the-board determination of 'not medically necessary' status, without considering the needs of the patient, is in effect a reduction in coverage through the implementation of a new medical policy. Therefore, the policy should be amended to allow for payment of medically necessary addition codes."
Since the proposed wording of the "qualified provider" section of the draft policy denotes that custom fabricated L-Coded orthoses are covered only if they are made by, or under the direct (i.e. onsite) supervision of an ABC- or BOC-certified orthotist or a registered occupational therapist or a licensed physical therapist, AOPA urges that the definition of qualified providers should be changed from "made by" to "fitted and provided by." Noting that the draft policy only regulates those who actually make the device, AOPA pointed out that the orthosis could be fabricated in a laboratory by someone meeting the policy's criteria, but "fit by someone that lacks the necessary educational background to ensure that an appropriate evaluation has been performed and that the device has been fit appropriately."
Objecting to the inclusion of physical and occupational therapists as qualified providers, the association stated, "AOPA continues to believe that physical therapists and occupational therapists have little training and in a very high percentage of cases, fail to have any equipment or the facilities necessary to either make or modify and adjust a custom device, as is required in being able to provide them."
AOPA's statement examines in detail the aspects of the draft policy. For more information, visit AOPA's website: www.aopanet.org and click on the "Hot Issues in O&P" button near the top of the page.
NAAOP Replies
"This new policy, if finalized in current form, will adversely impact practitioners and the Medicare program, and will deprive patients of necessary options that enhance the comfort, stability, and, most-importantly, function of knee orthoses," said NAAOP President Michael J. Allen, CPO, FAAOP, in a letter to the DMERC medical directors. He added, "As we witnessed with the policy clarification in December 2003, this new policy is contrary to the history and fundamental nature of the L-Code system and, we believe, should not be implemented without substantial revision."
NAAOP noted what it regards as detrimental trends, including devaluing the education and skills of certified orthotic practitioners: "First, The SADMERC and DMERC medical directors appear to be willing to grant orthotic practitioners less and less deference and recognition as healthcare professionals. Instead, they are more likely to view those who provide orthoses to Medicare beneficiaries as suppliers akin to salesmen of off-the-shelf items, despite the complexity and wide range of orthoses provided to Medicare patients today.
"This approach devalues the high accreditation standards in the orthotic profession and undermines the importance of the thorough education and residency requirements necessary to become certified," Allen continued. "This, in turn, opens the practice up to opportunistic behavior from other providers and suppliers, as well as non-professional 'salespeople,' who boldly assert that they are just as qualified to provide comprehensive orthotic care as the orthotists who have devoted their lives and livelihoods to the orthotic profession. The ultimate result is a diminution in the quality of patient care."
Although NAAOP noted that this first trend seems to "emanate almost entirely from often legitimate concerns about overutilization and fraud and abuse generally," it pointed out that much of the problem may lie in separating quality orthotic care from DME. "But as we have just suggested, the lack of recognition for professional orthotic care is, in part, responsible for the increasing number of providers and supplierswho lack sufficient training and experience in orthotic carebilling an ever-increasing number of orthoses to patients," Allen said.
"In our view, the answer to many of the controversial issues raised by the draft knee orthosis medical policy lies in treating orthotics as truly separate and distinct from durable medical equipment and developing medical policy that recognizes that quality orthotic care is as much a professional, clinical service as it is the provision of an orthosis," Allen declared.
Allen pointed out that this recognition is most effectively accomplished through certification of orthotists and accreditation of orthotic facilities. In his letter to the DMERC medical directors, he noted, "There are professional orthotic and prosthetic credentialing organizations and educational accreditation programs in place to provide guidance to CMS and the DMERCs as to whom should be considered a qualified supplier of orthotic and prosthetic care. CMS should accept the education and training criteria embraced by the American Medical Association in 1992 to be declarative of orthotics and prosthetics being allied health professions."
In addition, standards have been established by the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Orthotist/Prosthetist Certification (BOC), "which currently administer psychometrically sound credentialing examinations for both orthotics and prosthetics," Allen said.
"... the Medicare program must also recognize the demographics of the Medicare population and the increased prevalence of conditions such as diabetes, obesity, and other chronic diseases and disabilities that will continue to build demand for orthotic intervention," Allen pointed out. "Pursuing the laudable goal of decreasing inappropriate utilization should not translate into the implementation of medical policy that fundamentally changes the quality of orthotic care available to Medicare beneficiaries. The risk of overutilization of orthoses can clearly be addressed without sacrificing access to, and the safety of, professional orthotic clinical care and related orthotic technology."
NAAOP expressed concern that, instead of simply focusing on the problem of overutilization, the draft policy proposes sweeping changes to the entire L-Code system "that, in our view, are inappropriate and potentially harmful to patients."
Allen pointed out what NAAOP sees as a weakness in the draft: "The current draft seems to be less a medical policy based on clinical studies and sound medical practice and more a rationing policy that employs a 'least common denominator' approach, all with the intention of limiting Medicare expenditures for orthoses with little recognition of the impact on patient care."
For more information, visit NAAOP's website: www.oandp.com/naaop
