Taking Stock of the O&P Policy Agenda: Part One

Another Congress adjourned without O&P legislation to advance the profession? What happened? And more to the point, what has the O&P profession, with its organizations in Washington DC, accomplished over the past ten or 15 years? It’s a legitimate and important question that needs to be answered to move forward. So let’s take stock of the O&P community’s policy and advocacy track record so we can formulate a proactive strategy to advance everyone’s interests: patients, providers, clinicians, manufacturers, and suppliers. The O&P profession has had its share of policy victories over the years and this two-part article will explore those areas in detail. Chief among them are statutory recognition of the practitioner’s clinical notes for purposes of demonstrating medical necessity of Medicare claims, defeating the proposed Local Coverage Determination for Lower Limb Prostheses that would have set back prosthetic coverage by decades, significant advances in federal O&P research funding capacity, and bolstering coverage of O&P care in private insurance. These and other policy victories require years of advocacy to achieve, building relationships in Washington that develop over time, and raising awareness of the importance of quality O&P care. The key is to link the needs of the profession to policy discussions taking place in Washington DC, and distinguish the relatively small O&P profession in a world of major healthcare and rehabilitation players. The Medicare O&P Patient-Centered Care Act (H.R. 1990 and S. 2556) was the main legislative focal point of the O&P community over the past two Congresses. After an analysis of previous legislative efforts, the contents of this bill emerged from numerous discussions by O&P leaders. At the time, competitive bidding and distinguishing durable medical equipment (DME) from O&P clinical care were major priorities of the O&P profession. The bill sought to achieve four specific objectives, including a reduction in the number of off-the-shelf (OTS) orthoses that the Medicare program could subject to competitive bidding. This would have restored what Congress intended when it defined OTS orthotics as being limited only to those orthoses that require “minimal self-adjustment.” To reduce fraud and abuse, the bill also proposed to ban drop-shipment of custom-fitted and fabricated orthoses and prostheses to patients’ homes without any clinical involvement, as well as an exemption for licensed and certified orthotists and prosthetists to provide OTS orthoses to their patients without a competitive bidding contract, as long as the clinicians accepted the competitive bidding payment rate in that geographic area. This would have treated most O&P clinicians the same way that physicians and therapists are currently treated under the program. Finally, the bill called for greater differentiation between DME and clinical O&P care, a long-standing goal of the O&P community. The legislation was spearheaded by the American Orthotic and Prosthetic Association (AOPA) and strongly supported by the O&P Alliance organizations, including the American Academy of Orthotists and Prosthetists (the Academy), the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC), the Board of Certification/Accreditation (BOC), and the National Association for the Advancement of Orthotics and Prosthetics (NAAOP). In addition, the Amputee Coalition supported the bill, as did over 20 national disability and patient organizations including the Spina Bifida Association, the National Multiple Sclerosis Society, and many others whose members routinely require orthotic care. The physical and occupational therapy associations were not quite as cooperative. At first, the therapy groups raised concerns about being included in the bill and sought a total exemption from its provisions. Then they reversed course and wanted to be included in the bill, mainly to codify in statute how they are currently treated under the competitive bidding program. Negotiations with these groups delayed meaningful progress on the bill for months. In the end, they supported the legislation, but the damage was already done. There was simply not enough time to get the key components of the bill in the end-of-the-year legislative package, which funded the federal government through Fiscal Year 2023. Despite this result, there was significant progress on the bill, including bipartisan support by key committee leaders in the House and Senate. The Congressional Budget Office (CBO), which estimates how much bills save or cost the federal government, was engaged through the bill’s Senate and House champions, but they could not figure out how to accurately estimate how much the ban on drop shipping would save the Medicare program. The Department of Justice’s “Operation Brace Yourself” uncovered significant use of drop shipping to patients’ homes of many orthoses, but quantifying the government’s savings from a ban on O&P drop shipping proved difficult to estimate. In the end, the last train left the station in 2022 without the O&P policy priorities included, along with numerous bills advanced by other healthcare constituencies that also landed on the cutting room floor. Taking Stock Simply reintroducing this same bill in the 118th Congress is not necessarily the right answer. More importantly, it would ignore the passage of time and the need to refresh our priorities as a profession. For instance, the first round of competitive bidding of OTS orthoses is nearing an end, and to date, the Centers for Medicare & Medicaid (CMS) hasn’t announced plans to continue competitive bidding for other orthoses not included in Round I (comprised of a total of 22 orthotic codes). While it is possible that CMS will not increase the number of orthotic codes to which competitive bidding applies, the price of offsetting the cost of reducing the number of orthoses subject to competitive bidding is just too high, and that was confirmed by CBO. The proposed ban on drop shipping is an important protection for patients to ensure they receive clinical care with their orthoses or prostheses and would help limit fraud and abuse, but scoring the savings of this provision is difficult and requires further analysis. Finally, differentiation of O&P from DME is critical, but that issue at the congressional level creates significant risk that other professions that currently dabble in O&P care will try to expand their role in O&P and capitalize if given the chance. In short, the O&P profession needs a reset from a policy and advocacy perspective. But before consensus on a new path can emerge, a review of our progress to date as a field is in order, and in fact, may be necessary. Without assessing where we have come from, it is difficult to determine where we need to go. Therefore, the remainder of this article will focus on a review of the profession’s policy and advocacy milestones over the past decade or more, organized by key topics impacting the field. O&P Coverage Private Insurance Reform: The 2010 Affordable Care Act (ACA) was a milestone achievement for the O&P community. The original draft of the ACA included rehabilitation services in the definition of the essential health benefits (EHB) package, the minimum standard for coverage for all private insurance. But the concern was that this would not be interpreted to cover prosthetics, orthotics, and all kinds of DME that might not be considered “services.” Working in coalition with multiple groups, the O&P community advocated in the Senate to include the words “and devices” in the EHB package. This was bolstered by legislative history and Congressional Record statements from legislators that O&P was specifically meant to be included in this landmark law. As a result, all private insurance plans subject to the ACA cover O&P care. This federal standard allowed NAAOP and others to convince New York legislators, for instance, to eliminate the state’s coverage limitation of one prosthesis per limb per lifetime, an absurd insurance limit that no longer exists. TRICARE: Even before the ACA, NAAOP worked with the Senate Armed Services Committee to secure a total rewrite of the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) benefit under the TRICARE program, the Department of Defense’s healthcare program for the military and their families. The program now includes, in statute, a robust benefit package for orthotics and prosthetics that largely mirrors the Medicare program. The Department of Veterans Affairs (VA) has always prided itself in adopting new O&P technologies and providing ample access to veterans. A few years ago, the VA issued regulations redefining the terms orthotics and prosthetics, and the O&P organizations provided comments throughout that process. The revised definitions appear not to have had an impact on access to care. Lower-limb Prostheses: Perhaps the biggest threat to the Medicare O&P benefit came in the 2015 draft Local Coverage Determination for Lower Limb Prostheses. The policy would have set prosthetic coverage back decades and was a genuine threat to modern prosthetic care. In a show of force opposing this proposal, the O&P community banded together like never before, achieving over 100,000 signatures through a White House petition, picketing the Department of Health and Human Services (HHS), meeting with senior HHS leaders, and overwhelming a public hearing on the policy that required CMS to move the hearing to a larger facility to accommodate scores of individuals with limb loss and their practitioners. The draft policy was rescinded, and National Institutes of Health (NIH) was tasked with drafting a report on the prosthetic care evidence base. The report not only validated that the draft policy was fatally flawed, but actually recommended that CMS consider expanding coverage of microprocessor technology to K2 ambulators, an issue that has some significant support in the clinical literature. This goal needs to be addressed in future prosthetic coverage efforts. Upper-limb Prostheses: More recently, the Durable Medical Equipment Medicare Administrative Contractors (DME MAC) medical directors published correct coding guidance on upper-limb prosthetic care that has the effect of significantly limiting access to care for Medicare beneficiaries with upper-limb loss. This is a prime example of a policy that is described as a clarification of coding that has the effect of limiting coverage. In response to the publication of the guidance, the O&P organizations drafted a comprehensive analysis of the new policy and met with CMS officials to discuss the problems with the policy and lack of public input before the policy was announced. A meeting with the DME MAC medical directors is pending and should enable the profession to make a case for significant changes to this guidance document. Orthotics: Threats to orthotic coverage are also on the horizon. For years, CMS has taken a very narrow view of the definition of orthotics that has delayed access to a new generation of orthotic technologies that use power across a joint to produce therapeutic benefits to patients. CMS recently announced its intention to regulate in this area, and it is widely expected that a proposed regulation will be published this summer that formally limits the definition of orthotics. This may foreclose Medicare coverage, coding, and payment for a wide variety of new orthotic technologies that may not qualify for coverage under any other benefit category. This would be a huge disservice to patients but would also greatly impact the development of the orthotic field. Depending on how this proposed rule reads, a strong, coordinated effort to oppose this regulation will be necessary. Emerging Technologies: Medicare routinely covers new drug breakthroughs that come to market, but its track record in covering breakthrough technologies is much less impressive. The O&P organizations have actively participated in the debate involving coverage of breakthrough technologies, submitting comments, and meeting with CMS to ensure that O&P is included in this new coverage pathway. The original regulation to expand Medicare coverage for new technologies was withdrawn, but a new proposed rule on “emerging technologies” is expected to be published later this spring. It is important that the O&P community remains an active participant in this debate and strives to include O&P breakthroughs in this new coverage regulation. O&P Telehealth: When the COVID-19 public health emergency was announced, telehealth became a major new focus of the Medicare program. The O&P organizations pursued CMS, requesting authority to bill certain O&P services through telehealth. Many O&P services do not lend themselves to telehealth, but clearly some do. CMS did not extend the temporary telehealth authorities to O&P services, mainly due to statutory barriers that prohibit O&P clinicians from using the telehealth billing codes and confine O&P reimbursement to the Healthcare Common Procedure Coding System (HCPCS) code set. If telehealth is to be applied to O&P care in the future, a congressional effort will be necessary, but some question whether achieving this goal would be worth the investment that would be necessary. Expanding Medical Necessity: Finally, NAAOP, AOPA, and the Academy have partnered over the past year in a campaign named “So Kids Can Move.” Nicole Ver Kuilen, a former NAAOP Breece Fellow who now works with AOPA, is helping to lead this effort. The campaign is designed to redefine and expand the concept of medical necessity in private insurance to include activity-specific prostheses and orthoses, especially for children. Model state legislation has been drafted and several states are pursuing this legislative goal with assistance from the national O&P organizations. Maine has already enacted legislation setting the standard for coverage and additional states, New Hampshire, New Mexico, Illinois, and Washington, have introduced, or are preparing to introduce, similar legislation. The campaign is designed to enable individuals with limb loss and limb difference to have access to appropriate O&P technology to participate in physical activities to remain fit and healthy, accomplishing this goal by expanding the concept of O&P medical necessity. O&P Coding HCPCS Work Group: The HCPCS coding process at CMS has been challenging and frustrating for years, but the O&P organizations have been consistently pressing for reforms with some significant progress being made. A well-functioning coding system at Medicare is critical because it forms the Uniform Code Set that applies to all healthcare payers and plans. Working in conjunction with the O&P Alliance for HCPCS Coding Reform, there have been several changes to the HCPCS process to make it more transparent and accountable. For instance, CMS now accepts applications for new or revised billing codes twice per year rather than annually, accelerating consideration of new O&P coding applications. The public hearings were once only available to DME applicants but now the HCPCS Work Group hears from O&P coding applicants as well. While no separate appeals process was established by CMS, there are opportunities to reapply if a coding application is rejected or the applicant believes the coding decision is not correct. But more work needs to be done in this area, including CMS’ disclosure of the participants who comprise the HCPCS Work Group, which CMS has refused to do. Benefit Category and Pricing: Establishing a benefit category and determining the fee schedule amount for new O&P technologies has always been a black-box process at CMS. The benefit category determination process has increased in importance in recent years as new technologies seek Medicare coverage under the DMEPOS benefit. After prolonged advocacy to reform these processes to make them more transparent and predictable, last year CMS finally incorporated them into the HCPCS process, assigning the Work Group the authority to make these determinations in a publicly accountable manner. It is not yet clear whether this new process will materially improve the benefit category and pricing determination processes. However, the recent regulation on establishing fee schedule amounts for DMEPOS could be highly problematic. Despite strong advocacy from the O&P organizations in 2018 when the regulation was adopted, CMS proceeded with a final rule that grants it wide discretion to determine reimbursement levels of new DMEPOS technologies. VA Coding: The VA also plays a role in O&P coding that has changed in the recent past. An Office of the Inspector General (OIG) report in 2018 prompted reforms to how the VA codes and prices new O&P technologies, especially innovations that have not yet been coded by the CMS HCPCS Work Group. The national O&P organizations commented on the OIG report and met with the VA about this issue to help ensure a separate pathway for O&P coding. While VA retains this authority, they appear to issue VA-specific codes for O&P new technologies infrequently. The OIG report also placed added downward pressure on VA reimbursement for new O&P technologies. VA Choice of Practitioner: Related to these coding reforms, the VA also clarified through regulation in 2018 a veteran’s right to choose his or her practitioner. The Injured and Amputee Veterans Bill of Rights, federal legislation championed by NAAOP, was passed by the House of Representatives but was not ultimately enacted into law. Nonetheless, that legislation kept the focus on VA to ensure that veterans could choose their practitioners, whether they are VA employees or contract prosthetists in the private sector. Regulations clarifying this choice were finalized in 2019. Part II of this article will summarize historical milestones in O&P reimbursement, including fee schedule adjustments, competitive bidding, and legislative efforts to limit the scope of OTS orthotic competitive bidding. Other topics include quality and qualifications of providers to furnish O&P care, audits and appeals, patient-centric issues, O&P research and development policy and funding, and the importance of distinguishing durable medical equipment from clinical orthotic and prosthetic care. 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.

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Taking Stock of the O&P Policy Agenda: Part One

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