Washington Welcomes New Faces and New Opportunities for O&P Priorities

The new year has ushered in a wave of change in Washington DC, including a new Congress, a change in Senate control, and a new administration. The changes on Capitol Hill come with new policy priorities and new challenges. However, it gives the O&P community an opportunity to review, update, and revive legislative and regulatory targets and priorities. This article provides an overview of the implications of the election results and congressional changes, an update on the priorities of President Joe Biden's administration, and any potential O&P changes and implications. Election Implications Following the 2020 election, Democrats retained control of the House, although their margin of control was reduced by ten seats. In a surprise to many, Democrats also gained control of the Senate, following special elections for both Georgia Senate seats, in which Jon Ossoff (D-GA) and Raphael Warnock (D-GA) won. With the result of the Georgia elections, Democratic control is tight, with a 50-50 split and Vice President Kamala Harris breaking the Senate tie. The sweep of the presidency, House, and Senate opens new options for the Democrats' healthcare policy agenda, but some of the most progressive changes—such as Medicare for All and a public insurance option under the Affordable Care Act—remain unlikely with the close margins of control in the House and Senate. With the 50-50 Senate split, Sen. Chuck Schumer (D-NY) becomes the Majority Leader. Following negotiations between Schumer and Sen. Mitch McConnell (R-KY), the former Majority Leader, the Senate reached an agreement about how the split chamber will operate, with Democrats chairing the Senate committees, but each committee having an equal number of Democrats and Republicans. This model follows the agreement reached in 2001, the last time the Senate had a 50-50 split. Currently, the legislative filibuster remains in place, requiring 60 votes in the Senate to pass most legislation; however, Democrats may choose to use the budget reconciliation process to advance difficult-to-pass legislation. This legislative procedure allows legislation to be passed with a simple majority (51 votes) if it is deemed germane to certain tax, spending, and debt-limit legislation. Because reconciliation has to be tied to a budget resolution, the process cannot be used an unlimited number of times. Biden Administration Transition and Healthcare Agenda Biden indicated during his campaign that healthcare, and in particular fighting COVID-19, would be a top priority for his administration. So far, among his key focus areas are how to mitigate the spread of COVID-19, identify a vaccine, and ensure there are enough resources available to treat the expected rise in cases. In particular, Biden has pledged to: Make testing more widely available to every American Implement mask requirements (he has already signed one order that requires a mask in federal buildings and on federal lands) Implement targeted rolling lockdowns as required Increase the contract tracing workforce to 100,000 Increase the availability of personal protective equipment and ventilators by using the Defense Production Act to heighten production Ramp up the rapid distribution of the COVID-19 vaccine, with a goal of vaccinating 100 million people in his first 100 days of presidency Safely reopen schools Biden has also made it a priority to shore up the Patient Protection and Affordable Care Act (ACA). Large-scale legislative expansions of the ACA are unlikely because of the tight majority in the Senate; however, Biden has outlined specific areas where he believes he can significantly improve the ACA. Some actions he has already taken have been by executive order, in particular reopening ACA health plan enrollment during COVID-19 through a special enrollment period. He is also expected to provide greater funding to the ACA Navigator program to boost outreach and enrollment assistance. Finally, he is expected to reverse President Trump's regulatory changes to the ACA, including changes to short-term, limited-duration health plans and the so-called "public charge" rule, which impacts residency eligibility for low-income immigrants utilizing public benefits such as Medicaid. Biden's Healthcare Team To lead his healthcare agenda, the president nominated California Attorney General and former Congressman Xavier Becerra to be the Secretary of the Department of Health and Human Services (HHS). As attorney general, Becerra led legal efforts to protect the ACA from efforts to dismantle it. Becerra has also expressed interest in adding to the ACA to make it more available and affordable. Becerra's nomination is emerging as one of the most controversial and is not expected to get through the Senate without a fight. Biden has not yet picked an administrator for the Centers for Medicare & Medicaid Services (CMS), but Chiquita Brooks-LaSure has emerged as the most likely candidate. She served at CMS during the Obama administration and helped launch the ACA. Many additional nominees for healthcare leadership positions are expected in the weeks to come. Implications for O&P Policy Priorities As the new Congress begins, the O&P community looks to advance its priorities. In particular, the Medicare Orthotics and Prosthetics Patient-Centered Care Act (formerly H.R. 5262) is expected to be reintroduced early in the new Congress. The Patient-Centered Care Act distinguishes in statute durable medical equipment (DME) from the clinical, service-oriented nature in which O&P care is provided; revises the interpretation of "minimal self-adjustment" for purposes of competitive bidding of off-the-shelf (OTS) orthotics; exempts certified and/or licensed orthotists and prosthetists from the requirement to have a competitive-bidding contract to provide OTS orthoses at the competitive-bidding rate; and prohibits the practice of drop shipping of all prosthetic limbs and orthotic braces that are not truly OTS. While the bill attracted significant congressional attention throughout the 116th Congress, it was eclipsed by the attention appropriately given to COVID-19 and was not enacted before Congress adjourned. Following the 2020 elections, the sponsors of the Patient-Centered Care Act, Sen. Mark Warner (D-VA), Sen. Tammy Duckworth (D-IL), Sen. Steve Daines (R-MT), Sen. John Cornyn (R-TX), Sen. Bill Cassidy (R-LA), Rep. Mike Thompson (D-CA), Rep. Glenn Thompson (R-PA), Rep. G.K. Butterfield (D-NC), and Rep. Brett Guthrie (R-KY) all retained their seats, ensuring prompt reintroduction. Reintroduction of the Access to Assistive Technology and Devices for Americans Study Act (the Triple A Study Act), which the Amputee Coalition has been leading, is also expected early in the new Congress. The Triple A Study Act directs the Government Accountability Office to develop a report evaluating appropriate coverage and provision of healthcare services, particularly prostheses and orthoses. The report would examine timely access to care, assessment and guidelines for O&P determinations, policies for matching O&P technology to individual needs, affordability of O&P care and assistive technologies, and would compare data on practices and outcomes for orthoses and prostheses across payers. Similar to the Patient-Centered Care Act, all the House and Senate sponsors maintained their seats, which includes Duckworth, Butterfield, and Guthrie, and Sen. Marsha Blackburn (R-TN). The VA Issues a Final Rule on Prosthetics In the closing days of the Trump Administration, the Department of Veterans Affairs (VA) issued a final rule governing the provision of prosthetic and rehabilitative items and services—which includes orthoses and prostheses. The corresponding proposed rule, published in 2017, had originally proposed that the VA—not the veteran—would determine whether the VA or a VA-authorized provider would provide prosthetic care to eligible veterans. This proposal sparked significant concerns among veterans, O&P providers with private contracts with the VA, and the entire O&P community. The proposed rule would have significantly impeded the right of veterans to determine whether they could access a private, VA-authorized O&P provider. In fact, in July 2018, the House Veterans Affairs Health Subcommittee held a roundtable discussion where congressional leaders, veterans service organizations, and prosthetic provider and consumer representatives expressed directly to VA personnel significant concerns with the language and intent of the proposed rule. After facing considerable backlash, the VA published a supplemental notice of proposed rulemaking (SNPRM) in 2018, proposing that "VA providers will prescribe items and services based on the veteran's clinical needs and will do so in consultation with the veteran." The SNPRM also clarified that the "VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services…based on, but not limited to, such factors as the veteran's clinical needs, VA capacity and availability, geographic availability, and cost." While this language did address some of the worst aspects of the proposed rule, it still left plenty of discretion with the VA to select a veteran's O&P provider, despite the preferences of the veteran. Under the final rule, VA providers, or healthcare entities and providers that meet certain requirements under the Veterans Community Care Program, will prescribe items and services and will do so in consultation with the veteran. After the item or service is prescribed, the VA will determine whether the item or service will be provided by the VA or a VA-authorized provider. This determination will still be based on, but not limited to, "the veteran's clinical needs, VA capacity and availability, geographic availability, and cost." Subject to certain exceptions, prior authorization of items and services is required for the VA to reimburse VA-authorized providers for providing such items or services to veterans. The final rule addresses some of the O&P community's concerns around ensuring that veterans have a voice in deciding which provider to use, but ultimately does retain decision-making authority with the VA rather than with the veteran. The final rule also falls short of providing sufficient details concerning the mechanisms the VA will use to determine whether the VA will directly provide care or whether it will use an authorized contract provider. Some of the veterans service organizations are cautiously optimistic that the language in the final rule will permit veterans the choice of O&P practitioner they have always enjoyed, but the O&P community is expected to monitor this situation closely to identify problems and address them expeditiously. The final rule also codifies new definitions of prosthetic devices and orthotic devices. Under the final rule, a prosthetic device is defined as an "item that replaces a missing or defective body part. Prosthetic devices include but are not limited to artificial limbs and artificial eyes." Prior to the codification of the new rule, the Veterans Health Administration (VHA) Handbook defined orthosis as follows: A device fitted externally to an anatomical portion of the body to influence motion by assisting, resisting, blocking, or unloading part of the body weight. An orthosis may be used to correct deformity, compensate for weakness, or protect a body segment. It includes, but is not limited to, custom and non-custom devices, corsets, trusses, and belts. This definition has been in effect since at least 2008. The new, regulatory definition of orthotic device states: Orthotic device means an item fitted externally to the body that is used to support, align, prevent, or correct deformities or to improve the function of movable parts of the body. Orthotic devices include, but are not limited to, leg braces, upper extremity splints and braces, and functional stimulation devices.

This broad definition of orthotic device arguably includes a wide range of devices that may not be considered an orthosis under the Medicare program that defines orthotics as "rigid and semi-rigid devices which are used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body." The contrast in orthotic definitions between the VA and Medicare may complicate the coding of such devices, given that CMS—the agency in charge of administering the Medicare program—is also responsible for making decisions about additions, revisions, and deletions to the Healthcare Common Procedure Coding System Level II coding system. On January 28, the Biden administration paused the implementation of the final rule by 30 days, until February 26, to assess the impact of the rule, pursuant to a memorandum issued by the Assistant to the President and Chief of Staff directing agencies to review all rules, guidelines, or other agency actions that have been issued but have not yet taken effect. The O&P community is working to continue to address concerns about this rule and what it will mean regarding veteran choice of O&P practitioner and coding of orthotics and prosthetics. O&P EDGE Peter W. Thomas, JD, is the general counsel for the National Association for the Advancement of Orthotics and Prosthetics (NAAOP), and counsel to the Orthotic and Prosthetic Alliance. Leela Baggett, JD, is an associate with the Powers Law Firm, and Taryn Couture, MPA, is director of government relations at the firm.

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Human-device Integration: Introducing the Biotensegrity Bridge

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