How Patients Benefit From O&P Policy Reforms

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By Peter W. Thomas, JD
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In the world of healthcare policy, patients and providers are usually aligned on the majority of issues, while health plans, businesses, and other payers usually take the opposite view. This is a general statement for which there are exceptions, of course, but what benefits patients usually benefits providers. For instance, if a health plan decides to cover vacuum socket technology for people with lower-limb amputations, prosthetists and physicians have another prosthetic tool to use in designing treatment plans. But patients are the ultimate beneficiaries, since they are then able to access the technology to advance their functional goals without paying out of pocket for more than deductibles or co-pays.

This common interest between patients and providers was on full display recently in Washington, when the Amputee Coalition held a Congressional Lobby Day and the American Orthotic & Prosthetic Association (AOPA) hosted Policy Forum. Both events were critical in communicating a number of key O&P policy priorities. This "one-two punch" created a critical mass around these issues that helped the O&P community educate members of Congress and their staff about the relatively small field of O&P. And it signaled to key congressional offices that the main priorities of patients and providers in the O&P community are well aligned.

Amputee Coalition Lobby Day

Because the Amputee Coalition's Lobby Day hadn't been held for several years, this spring's event was new to many. More than 25 people with limb loss made the trip to Washington to educate lawmakers. The two key issues under discussion were the Draft Local Coverage Determination (LCD) for Lower Limb Prostheses and a federal fairness bill to augment state-based efforts toward O&P fairness (formerly known as parity). The fairness bill would require insurance plans to cover O&P care to the same extent as they cover other medical benefits, if they choose to cover O&P at all. Most plans do cover O&P care, so fairness legislation has the effect of prohibiting arbitrary limits or exclusions of care specific to the O&P benefit. Nearly 20 states have O&P fairness laws on the books, but more states need to take this path, and these laws do not apply to health plans organized under the Employee Retirement Income Security Act (ERISA), which allows large businesses to self-insure their employees, thereby making them exempt from state insurance laws.

O&P Policy Forum

One week after the Amputee Coalition's fly-in, nearly 150 practitioners, patients, and others in the O&P profession attended AOPA's Policy Forum. Each of the Orthotic and Prosthetic Alliance organizations participated, including the National Association for the Advancement of Orthotics and Prosthetics; the Board of Certification/Accreditation; the American Board for Certification in Orthotics, Prosthetics and Pedorthics; and the American Academy of Orthotists and Prosthetists. The strong attendance was reflective of the many policy challenges facing the field, from the draft LCD, which is currently on hold, to prior authorization, to the expansion of competitive bidding, to major threats to orthotic coding, coverage, and payment.

This year's Policy Forum included a novel experiment spearheaded by former Senator Bob Kerrey, who uses a lower-limb prosthesis. Kerrey spoke at the O&P Leadership Conference in January and suggested that the profession come together and draft a piece of legislation to address the field's major concerns. The outcome was an O&P congress. The congress comprised all 150 attendees who met for half a day to discuss a two-page bill Kerrey drafted as a starting point. Five breakout groups then discussed this draft bill in depth and prioritized their findings. Each breakout group reported its recommendations when they reconvened as a whole group, and the O&P congress voted on a number of alternative proposals. Some proposals were cut from the final draft, and other provisions were added or modified to accommodate the findings of the subgroups. In the end, this congress produced a one-page bill that listed the key O&P policy priorities in summary format.

Those priorities were as follows:

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Separation of O&P From Durable Medical Equipment: This would separate O&P from durable medical equipment (DME) in federal law and regulations to ensure that the O&P field does not continue to be subjected to DME-based restrictions.

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Provider Qualifications and Recognition of Clinical Notes: This would require implementation of the Medicare, Medicaid, and SCHIP (State Children's Health Insurance Program) Benefits Improvement and Protection Act of 2000 (BIPA) Section 427. BIPA is a federal law enacted in 2000, but Section 427 was never implemented through regulations. The provision prohibits Medicare from paying for custom orthotics and prosthetics unless provided by a qualified practitioner or supplier. In addition, it would ensure that such practitioner's clinical notes are recognized as part of the patient's medical record for purposes of determining medical necessity.

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Expansion of Competitive Bidding: This item opposes efforts to further expand competitive bidding to all prosthetics and orthotics, as the Obama Administration has proposed in its most recent federal budget proposals, and presses for clarification that competitive bidding only applies to off-the-shelf orthotics that are subject to minimal self-adjustment.

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Draft LCD for Lower Limb Prostheses: This would rescind or at least place a moratorium on issuance of the Draft LCD for Lower Limb Prostheses and ensure that any future LCD is developed in a transparent way with robust stakeholder input to ensure it does not restrict access to appropriate patient care.

Each of these policies is reflected in existing federal legislation that the O&P organizations have been promoting in recent years, including the Medicare Orthotic and Prosthetic Improvement Act of 2015 (H.R. 1530 and S. 829), the Medicare Audit Improvement Act of 2015 (H.R. 1526), the Protecting Access Through Competitive-Pricing Transition Act of 2015 (H.R. 4185), and the recently introduced Preserving Access to Modern Prosthetic Limbs Act of 2016 (H.R. 5045). But the value of the new bill designed by the O&P congress lies in the direct engagement and participation from the O&P community that created it. The bill summarizes our most pressing concerns as a field, and it facilitates top-line communication with policymakers on the reform concepts themselves, not the technical language of pending legislation.

An O&P Champion

Not only did Kerrey lead the O&P congress, but he then headed to Capitol Hill and met with eight senators to discuss the newly minted legislation. Direct discussions between senators can be extraordinarily productive, and Kerrey's personal meetings with his former colleagues were no exception. The momentum created by those meetings, followed by hundreds of meetings between Policy Forum attendees and their members of Congress, was apparent in the days following these events. Whether Congress is able to pass any Medicare bill this year is an open question, but if something moves, there is a strong likelihood that O&P provisions will be included.

The Impact of O&P Policy Priorities on Patients

Because Medicare is a federal program that is national in scope, it has always been the focus of healthcare policy reforms that eventually tend to find their way into the policies of other payers, including Medicaid, the Veterans Health Administration, and private payers. Medicare is a massive healthcare program that covers over 40 million seniors and over eight million people with disabilities below the age of 65, so it drives healthcare policy across the United States. This is the principal reason why most of the O&P policy agenda is directed toward reform of the Medicare program.

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The impact of these policies on patients is nearly indistinguishable from the impact on O&P practitioners, again, because patients and providers tend to sink or swim together. For instance, if Congress were to mandate a separation of O&P from DME, that would mean that the Centers for Medicare & Medicaid Services (CMS) would have to issue separate regulations for O&P than for DME. This would permit the O&P community to advocate for the lifting of certain restrictions on O&P that derived from efforts to fight fraud and abuse in the DME sector. It would strengthen the field's argument that the prosthetist/orthotist's clinical notes should be recognized in the patient's medical record-not dismissed as a supplier-generated record-as documentation that is relevant and reliable in terms of demonstrating medical necessity of the prosthetic or orthotic care provided.

Separation would also strengthen the argument that competitive bidding should not be applied to the vast majority of O&P. Competitive bidding of custom orthotics and all prosthetics would interrupt long-standing clinician-patient relationships and cast individuals with limb loss and those who need custom orthoses to the lowest bidder in order to obtain O&P clinical care. Separating O&P from DME would permit O&P-specific solutions to be applied to problems that arise in the administration of O&P benefits, rather than having to endure DME-based solutions imposed upon the very different field of O&P clinical care.

BIPA Section 427 is another critical priority, and it has been for 16 years since enactment of that statute. CMS has failed to implement this important section of the federal law through federal regulations and, instead, has adopted one restriction after another that derives from the DME world and imposed them on O&P benefits. Linking practitioner qualifications to the payment of custom orthotics and prosthetics would not only offer consumers some measure of protection from providers who are not appropriately educated and trained in the provision of that care, but it would also protect the Medicare program's trust funds, limiting fraud and abuse and preventing payment to unqualified providers of custom O&P care.

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Establishing this link has never been more important as all healthcare providers move toward a new world of healthcare reform. CMS is driving physicians and other providers to become involved with alternative payment methods, such as accountable care organizations, bundled payment systems, and other arrangements where providers share savings with the Medicare program if they can save money in the delivery of an episode of care. As alternative payment arrangements begin to take hold, it will be critical for O&P patients to continue to have access to qualified O&P practitioners for care. In an environment where savings is the main goal, O&P patients could be sent to less expensive, less qualified providers to obtain their O&P care, resulting, perhaps, in short-term savings but long-term costs, especially in terms of patient outcomes.

Finally, the Draft LCD for Lower Limb Prostheses was a disaster when the DME Medicare Administrative Contractors proposed the policy last summer and it was put on hold after an outcry from O&P consumers, other patient organizations, O&P providers, and rehabilitation physicians and clinicians alike. Virtually no one found value or credibility in the draft LCD and most agreed that it would have sent people with amputations back to the 1970s in terms of their prosthetic treatment options. The patient voice was instrumental in getting the U.S. Department of Health and Human Services and CMS to place that draft policy on hold while they appointed an Interagency Work Group to ponder the evidence base of contemporary prosthetic care. The draft LCD was indeed a disaster, but it brought O&P patients and providers together like never before. It truly produced a silver lining that will potentially endure for years to come.

Peter W. Thomas, JD, is a principal with Powers, Pyles, Sutter & Verville, P.C., Washington D.C. He is general counsel of the National Association for the Advancement of Orthotics and Prosthetics and counsel to the Orthotic and Prosthetic Alliance.