Taking Stock of the O&P Policy Agenda, Part Two

Part I of “Taking Stock of the O&P Policy Agenda” discussed a portion of the policy and advocacy history pursued by the O&P profession in the past decade or more to advance O&P and the care clinicians provide to patients with limb loss and limb difference, including the provisions of the Medicare O&P Patient-Centered Care Act, the advances the field has made in O&P coverage and coding, and areas requiring further efforts. Looking back to assess the O&P profession’s track record is highly instructive in determining where we need to focus in the future, which is critical in the wake of the 117th Congress adjourning without passing the Medicare O&P Patient-Centered Care Act. Part II summarizes progress in areas critical to future O&P care and is instructive in determining our policy and advocacy path moving forward. The remainder of this article focuses on additional areas where advocacy efforts have advanced O&P policy to benefit providers and the patients they serve. O&P Reimbursement Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule: The last bill passed in the 117th Congress, the omnibus spending bill, appropriated $1.7 trillion in federal funding to keep the federal government agencies operating, but it also significantly impacted the Medicare O&P fee schedule in a positive way. The fee schedule was slated to be increased by over 8 percent in 2023 due to the statutorily mandated Consumer Price Index increase, less the productivity adjustment. A 4 percent decrease to Medicare fees for all providers would have applied unless Congress acted; however, Congress did, in fact, waive this decrease (known as PAYGO) for two years. This produced one of the highest increases in the Medicare O&P fee schedule in at least 30 years. O&P providers are, therefore, being paid over 8 percent more in 2023 for Medicare patients than they were in the last half of 2022, a welcome development. To the extent this increase impacts fee schedule amounts with private and other payers that tie their fee schedules to Medicare, all the better. This positive outcome follows years of O&P organizations advocating to Congress that they not take the annual O&P fee schedule increases and use them instead to fund other Medicare priorities, such as paying physicians and therapists a reasonable increase each year, as Congress routinely did in the 1990s and early 2000s. In contrast to O&P providers, physicians and therapists typically receive fee schedule decreases each year. In 2023, physicians and therapists received a 2 percent decrease, and in 2024 physicians and therapists are slated to receive a 3.25 percent decrease, unless Congress acts again this year to limit this decrease. Competitive Bidding: From the time Medicare DMEPOS competitive bidding was originally enacted in 2003, the O&P community made the case that custom O&P care should be exempt. Congress agreed, and while competitive bidding has ravaged the DME fee schedule, it has been sparingly applied only to off-the-shelf (OTS) orthoses, defined in statute as orthoses requiring minimal self-adjustment. The Centers for Medicare & Medicaid Services (CMS) implemented regulations that expanded the definition of OTS orthoses to include orthoses that could be adjusted by the patient, the patient’s caretaker, or a supplier. This clearly violated congressional intent to limit the application of competitive bidding to orthoses that patients might find in a drugstore or DME supply store and be able to adjust themselves. Despite strong and prolonged opposition from O&P organizations and the O&P community at large, CMS pressed forward with this definition in the regulations, prompting the O&P organizations to request that Congress restrain CMS through legislative proposals included in the Medicare O&P Improvement Act, and later, the Medicare O&P Patient-Centered Care Act. A necessary step in passing legislation is to have the Congressional Budget Office (CBO) score any legislation up for a vote on the House or Senate floor. CBO is typically overwhelmed, and the score for both iterations of these O&P-supported bills came very late in the legislative process. In the end, the entire Medicare orthotic fee schedule would have had to be cut by over 16 percent to exempt OTS orthoses from competitive bidding. Considering that traditional O&P clinicians provide less than 20 percent of OTS orthoses, the O&P associations decided that a blanket exemption was too costly and not in the best interests of the O&P profession. Even proposals to offset this cost, such as banning drop shipment of prostheses and custom-fitted and custom-fabricated orthoses, which should save the Medicare program money, were not enough to offset the cost and make passage of the OTS exemption attractive. Where the O&P profession goes on the competitive bidding legislative front remains to be seen, but some argue that advocacy resources could be better spent on other priorities. Quality and Qualifications In 1997, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report on Medicare orthotics recommending that CMS impose requirements on practitioners and suppliers providing custom orthotics and prosthetics. This was intended to distinguish DME suppliers who the OIG considered to be overutilizing the Medicare orthotics benefit. Congress responded in 2000 by passing the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Section 427. Section 427 of BIPA provides that “no payment shall be made…for an item of custom-fabricated orthotics…or for an item of prosthetics unless such item is (I) furnished by a qualified practitioner; and (II) fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate.” The statute provides a definition for the terms qualified practitioner and qualified supplier. This section of the federal law, which is still in effect, was never regulated, mainly because physicians and therapists wanted regulatory authority to also provide the full continuum of O&P patient care and the O&P organizations could not agree to that position. In 2017, CMS finally issued a regulation to implement BIPA Section 427, but under the Trump administration, the proposed regulation was withdrawn due to the administration’s interest in reducing regulation. However, CMS has said it remains committed to “exploring options and alternatives with stakeholders.” The O&P organizations continue to wage the battle to implement BIPA Section 427 to ensure that patients are protected by having practitioners and suppliers who are truly qualified to provide custom O&P care. The organizations have consistently kept the pressure on CMS to regulate in this area, meeting repeatedly with senior CMS and HHS officials through the years. In 2021, CMS issued a transmittal that partially implemented BIPA 427 for those states that have O&P licensure, but questions remain as to the enforceability of that guidance document. The O&P organizations have also proposed alternative methods to achieve implementation of BIPA Section 427 without the need for CMS to issue formal regulations, but this “sub-regulatory” approach has not yet gained traction in the agency. Most recently, there have been indications that CMS is again considering issuing regulations to implement this important provision fully and, if they do, the O&P associations will engage the larger O&P provider and patient community in actively supporting enforcement of the O&P qualification requirements. O&P Medicare Claims Following publication in 2011 of the Dear Physician letter issued by the DME Medicare Administrative Contractor (MAC) medical directors, O&P suppliers began receiving numerous audits of their Medicare claims. The letter was interpreted by Administrative Law Judges as nullifying the value of O&P clinicians’ patient notes, despite being required to record detailed patient information to submit Medicare claims. Only the physicians’ notes were deemed relevant to the medical necessity determination, and physicians were notoriously deficient in justifying their prescriptions of O&P care. Several years of extensive government audits created an avalanche of O&P denials, which chilled the provision of advanced technologies to Medicare O&P patients. Orthotist’s and Prosthetist’s Clinical Notes as Part of the Patient’s Medical Record: It took passage of federal legislation to strengthen the relevance of the O&P clinicians’ notes through enactment of a key provision of the Medicare O&P Improvement Act in 2018. All of the O&P associations supported this goal, and it was considered a major legislative achievement. Not only did it clarify that the practitioner’s clinical notes are relevant to the Medicare medical necessity determination, but it elevated O&P clinicians in their professionalism and how Medicare treats O&P clinicians. It also differentiated DME suppliers from O&P providers for purposes of justifying medical necessity of Medicare claims. Member Education: The National Association for the Advancement of Orthotics and Prosthetics (NAAOP), the American Academy of Orthotists and Prosthetists (the Academy), and the American Orthotic and Prosthetic Association (AOPA) routinely conduct webinars and presentations to educate the profession on coding, coverage, and payment, with an emphasis on documenting claims and challenging denials when they occur. Many years ago, NAAOP began making it a priority to try to educate the profession about O&P policy and advocacy through routine articles in The O&P EDGE and monthly video updates. AOPA conducts the annual Policy Forum, hosts a coding committee to advance O&P coding, routinely publishes government relations updates, and hosts a political action committee to assist in Washington. All these efforts support overarching priorities to ensure that practitioners are able to provide quality care and obtain appropriate payment for their services, without the risk of recoupment of those funds in the future. O&P Community Consensus on Key Policy Issues In 2008, the national O&P organizations created a working coalition compelled by the imperative that the O&P profession speak with one voice in Washington and across the country. The O&P Alliance originally included NAAOP, AOPA, the Academy, and the American Board for Certification in Orthotics, Prosthetics & Pedorthics. The Board of Certification/Accreditation joined the Alliance in 2012, which prompted a negotiation between the two accreditors to align their professional standards. The negotiation resulted in a historic agreement on O&P standards, eliminating inconsistent professional standards in the same relatively small, specialized field. The O&P Alliance continues to serve as a platform to align the profession on new and emerging policy issues impacting O&P. For instance, the Alliance recently published a statement supporting additive manufacturing as a tool in the practitioner’s toolbox, but not at the expense of losing access to clinician-led care. When sexual harassment in the profession was exposed, the O&P Alliance’s organizations worked together to issue a call to action to address ways to acknowledge and address these concerns in the field. Osseointegration (OI) is another example of an issue the O&P Alliance has examined in depth, trying to get ahead of the curve to develop policies that will integrate OI into the broader O&P profession. Leadership Development The O&P organizations are strongest when a diverse set of individuals volunteer to help lead the profession forward. Every national organization has a mechanism, formal or informal, to attract new leaders to help advance their organization. NAAOP believes the best advocates are individuals who use prostheses and orthoses. This is why NAAOP launched the George and Dena Breece Fellowship, named after NAAOP’s founding and current Executive Director George W. Breece. The fellowship is a paid ten-week program in Washington, where the fellows learn about and participate in the legislative, regulatory, and advocacy process. To date, all five Breece fellows are actively working on O&P priorities through a number of O&P organizations. Last summer, the Breece fellows helped organize a Capitol Hill Virtual Fly-In to enable NAAOP members to advocate in Congress. The fly-in was designed to augment, not duplicate, congressional efforts led by other O&P organizations. Research and Development NAAOP’s roots are based in its advocacy efforts to help establish the National Center for Medical Rehabilitation Research (NCMRR or the Center) at NIH. The Center’s statutory purpose is to conduct, support, and coordinate medical rehabilitation research, including O&P research and development. The Center has created a consistent funding stream for O&P research, particularly through the Small Business Innovation Research program. Both NAAOP and the Academy leverage their resources by participating in the Disability and Rehabilitation Research Coalition (DRRC), a coalition of national organizations focused on rehabilitation science policy and funding. DRRC focuses on all kinds of rehabilitation science, including O&P research, through agencies such as the National Institute of Disability, Independent Living, and Rehabilitation Research; the Department of Veterans Affairs; the Department of Defense (DOD); and the National Science Foundation, to name a few of the federal agencies that support O&P research and development. NIH and DOD have jointly funded the Limb Loss and Preservation Registry (LLPR), a quality improvement registry that has great potential to establish a robust evidence base in O&P over the next decade and more. Registries are usually funded by trade associations in a given field, but after major advocacy efforts with NCMRR, the O&P organizations were successful in getting the federal government to devote $5 million in government funds to establish it. Mayo Clinic currently houses the registry, but soon the LLPR is expected to be launched as a nonprofit organization. It is incumbent upon every O&P practice to join the registry and begin downloading data that can be aggregated into a usable evidence base for the profession. Many in O&P believe its future success is predicated upon data, and the LLPR affords the profession a once-in-a-generation opportunity to pursue this critically important goal. The O&P profession began investing in O&P research several years ago with the creation of not one, but two, research foundations. While both organizations were active in supporting O&P research, they were viewed as duplicative. Recently the Academy and AOPA announced the merger of these research foundations into one entity, the Orthotics and Prosthetics Foundation for Education and Research. This will allow the profession to focus on advancing O&P science in an efficient and more effective manner. Patient Focus There is growing recognition in the O&P profession that patients are the best advocates to help advance favorable policy where all boats rise together. NAAOP has long been guided by putting the patient first in all of its decision-making under the theory that what is good for the patient is good for the provider. The Breece Fellowship program is a prime example of enabling patients to learn key skills to become effective advocates and future leaders in the field. The O&P provider organizations often collaborate with the Amputee Coalition on policy and advocacy, including the Amputee Coalition’s annual Congressional Lobby Day. In fact, a wide variety of disability organizations, many of whose members use orthoses, such as the Spina Bifida Association, the Brain Injury Association of America, the National Multiple Sclerosis Society, and many other organizations work in collaboration with NAAOP and other O&P groups to leverage efforts to advance O&P priorities. Differentiation Between DME and O&P One of the most enduring goals of the O&P profession is to distinguish the clinical services it provides from DME suppliers. O&P patients often rely heavily on DME, but O&P and DME are distinct and separate, and they should be treated as such by Medicare and other payers. The O&P organizations have worked for years to have CMS regulate O&P differently than DME and specific to the needs of O&P providers and patients. The Medicare statute itself covers O&P separately from DME. Competitive bidding applies widely to DME but only to a sliver of orthoses and no prostheses. O&P has separate quality standards from DME, different surety bond requirements, and the fee schedule over the past three decades has been treated more favorably by Congress and CMS than the DME fee schedule. Yet, despite these clear differences in how Congress and CMS treat O&P and DME, greater differentiation between the two fields remains a priority of the O&P organizations. O&P Care in Context The Americans with Disabilities Act of 1990 (ADA) was landmark legislation that sought to level the playing field by prohibiting discrimination based on disability. Since then, society has fundamentally changed to accommodate (and in some instances, embrace) individuals with disabilities. O&P, particularly prosthetics, is the embodiment of the promise of the ADA. O&P is a prime example of the value of the human-machine interface. People with limb loss and limb difference can live active, successful lives with the assistance of quality O&P care. It is incumbent on the O&P community to promote this message and define our value ourselves, or others will co-opt this very positive story of success. Many O&P practitioners who have practiced for some time clearly feel the pressures of today’s reimbursement environment in trying to run their O&P practices and meet patient needs while making financial ends meet. But compared to many other sectors of healthcare, O&P has fared relatively well over the years. The O&P fee schedule is increased annually and has performed historically better than the DME fee schedule. Only a relatively small portion of orthoses (OTS orthoses) has been exposed to competitive bidding, which has served to lock in substantial DME fee schedule reductions for years to come. The disastrous lower-limb coverage policy proposed in 2015 was beaten back by strong O&P advocacy and was never implemented. Physicians and therapists are envious of the fee schedule treatment O&P receives compared to their annual battles against budget neutrality, which tends to produce significant fee schedule decreases year after year. The home health and skilled nursing facility sectors have had major payment reforms in recent years, necessitating significant changes in care delivery and layoffs of skilled staff. Many other sectors of healthcare have witnessed serious policy reforms that have reigned in spending at one point or another through the past two decades. But O&P has been largely unscathed, despite how practitioners might feel on the front lines. Future O&P Policy Priorities Challenges across the profession remain, of course, and these challenges help define the policy agenda of the future. The O&P profession needs to continue to press for an exemption from OTS competitive bidding for certified and licensed O&P practitioners and alter the current useful lifetime restrictions on orthotics. Additional actions need to be taken to compensate practitioners for the clinical services they provide, not just a global payment for a device. The LLPR must take root and gain widespread provider engagement if the profession is going to continue to make meaningful strides in advancing evidence-based O&P practice. Expansion of coverage of microprocessors and other advanced technologies is long overdue for additional patient populations that can benefit from these innovations and state laws that include coverage of activity-specific prostheses and custom orthoses need to be enacted. Finally, the profession must have a more comprehensive approach to OI so prosthetists remain at the forefront of care using this emerging method of prosthetic design and patients retain access to the care they need. These and other priorities for the O&P community will form the basis of the next round of advocacy in the ongoing pursuit to advance the O&P profession for the benefit of O&P patients. Peter W. Thomas, JD, is managing partner of the Powers Law Firm in Washington DC. He serves as general counsel of the NAAOP and counsel to the O&P Alliance.

Taking Stock of the O&P Policy Agenda, Part Two

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Cross-Cultural Collaboration

Editor’s Note–April 2023

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