O&P Policy Priorities Advance at the National Level

In recent weeks, the O&P profession has successfully advanced its policy agenda for the 117th Congress. In the midst of Congress' continued response to the COVID-19 public health emergency, key O&P legislation has been introduced with support from important leaders in the House and Senate. This article provides an overview of recent activity on the Hill with the introduction of O&P legislation and important stakeholder meetings to ensure successful passage of the legislation. Medicare Orthotics and Prosthetics Patient-Centered Care Act On July 29, Senators Mark Warner (D-VA) and Steve Daines (R-MT) introduced S. 2556, the Medicare Orthotics and Prosthetics Patient-Centered Care Act, also known as the Patient-Centered Care Act. Senators Tammy Duckworth (D-IL), John Cornyn (R-TX), Bill Cassidy (R-LA), and Charles Grassley (R-IA) are original cosponsors of the legislation. Duckworth is a champion of issues that impact people with limb loss and uses prosthetic limbs herself. Cornyn was in Republican leadership until he was term limited out of his leadership position, Cassidy is a former physician, and Grassley is the former chairman of the Senate Finance Committee. Except for Duckworth, all of the cosponsors sit on the Senate Finance Committee, the committee with jurisdiction over Medicare bills. The bill is a companion to House bill H.R. 1990, which was introduced in March by Representatives Mike Thompson (D-CA), G. T. Thompson (R-PA), G. K. Butterfield (D-NC), and Brett Guthrie (R-KY). Since introduction, Representatives Dutch Ruppersberger (D-MD) and Blaine Luetkemeyer (R-MO) have also joined as cosponsors. The Ways and Means Committee and the Energy and Commerce Committee have shared jurisdiction over this bill in the House. The Patient-Centered Care Act is a significantly revised version of the Medicare Orthotic and Prosthetic Improvement Act (S. 4503) introduced in prior Congresses. The new bill is aptly named, reflecting its focus on the key policy proposals designed to improve patient care and protect patients against poor quality care, as well as fraud, waste, and abuse. The bill is streamlined to focus on four major provisions to benefit Medicare beneficiaries in need of O&P care as follows: Differentiating O&P care from durable medical equipment (DME): The legislation would distinguish in statute the clinical, service-oriented nature in which O&P care is provided from delivery of DME items. DME is an important benefit for Medicare beneficiaries with injuries and disabilities, but it is totally different than O&P care and should be treated separately in statute and regulations. By creating a new section of the Medicare law to address O&P alone, the Centers for Medicare & Medicaid Services (CMS) would be able to better tailor its regulations to the provision of O&P care so it does not continue to regulate the O&P profession through a DME lens. Revising the definition of off-the-shelf (OTS) orthotics for competitive bidding: The Patient-Centered Care Act would limit the definition of OTS orthotics for competitive bidding to clarify that CMS may only competitively bid orthoses that require "minimal self-adjustment" by patients themselves, and not by a patient's caregiver or a supplier. By limiting competitive bidding in this way, the bill would protect beneficiaries and preserve access to clinical services associated with the prescribed orthosis (i.e., assessment, determination of the most appropriate device, fitting, and instruction) that are necessary to achieve the therapeutic value of the orthotic intervention. Current regulations allow CMS to be overinclusive when determining which orthoses to competitively bid. In fact, earlier this year, CMS began competitive bidding of 22 OTS orthotic Healthcare Common Procedure Coding System codes but included orthoses that the profession believes are custom fitted or prefabricated. This means that patients are at risk of losing the clinical services needed to provide custom-fitted and prefabricated orthoses safely and effectively. Prohibiting drop shipping to patients' homes: The bill would reduce the likelihood of waste, fraud, and abuse in the Medicare program by prohibiting the practice of drop shipping of all prosthetic limbs and orthotic braces that are not truly OTS (i.e., subject to minimal self-adjustment by the patient him- or herself). These prohibitions would ensure that beneficiaries have appropriate access to a healthcare practitioner to provide the necessary assessment, fitting, training, and follow-up care for the proper use of their orthosis or prosthesis. Truly OTS orthoses—defined by this legislation—would continue to be drop shipped under this proposal, recognizing that OTS orthoses that do not require clinical care can be delivered to the patient without any clinical involvement. Exempting appropriately credentialed clinicians from competitive bidding: To ensure patients have access to the full range of orthotic care from appropriately credentialed practitioners, S. 2556 would exempt certified and/or licensed orthotists and prosthetists from the requirement to have a competitive bidding contract to provide OTS orthoses to their patients. This would allow O&P professionals to meet patients' needs efficiently and conveniently in the course of the practitioner's clinical practice, increasing patients' ability to easily access all the O&P care they need in a timely manner and at one convenient location. Given the pandemic and the preference to reduce human contact, this provision is highly patient-centric. It would treat appropriately credentialled orthotists and prosthetists in a similar manner to physicians and therapists under the competitive bidding program. These professionals and practitioners would not be required to have a separate contract with CMS to provide OTS orthoses but would only be reimbursed at the competitive bidding rate, not the full fee schedule amount. As already noted, this new bill is a streamlined version of S. 4503, which gained significant attention but did not pass in Congress after several attempts. One provision was pulled out of S. 4503 and did become law, namely the recognition of the clinical notes of the prosthetist or orthotist to demonstrate medical necessity. This was a big victory for the O&P community, but it was just one provision out of several priorities. With a streamlined approach and a patient-centric focus, there is a strong chance of advancing this version of the bill through this Congress, which lasts through 2022, in particular because of the bipartisan make-up of the cosponsors of the bill. What Will the Bill Cost? One of the frequently asked questions about the bill from members of Congress and staff relates to the forecasted cost of the bill. Congressional rules require Medicare bills to be scored by the Congressional Budget Office (CBO) to pass the House or Senate. These scores are usually forecasted over a five-year or, more often, a ten-year period, and several arcane rules often result in unexpectedly high estimates. This makes it more difficult to achieve passage of legislation. The O&P organizations, particularly the American Orthotic & Prosthetic Association (AOPA), which is spearheading this legislative initiative, believe this bill is budget neutral or, in other words, should not cost the federal government anything to implement. The differentiation of O&P from DME is a statutory exercise and is not expected to change the benefit in any way. This means it should cost nothing. Similarly, the exemption for appropriately credentialled orthotists and prosthetists from OTS competitive bidding should not be a "coster" because the O&P codes used must be reimbursed at the competitively bid rate. So CMS will not be paying more for OTS orthoses provided by O&P clinics that do not have a competitive bidding contract. Refining the definition of OTS orthotics will limit the number of orthotic codes that CMS can subject to competitive bidding in the future and, therefore, will cost the federal government more compared to what it would have paid for orthoses over the next ten-year period. However, the ban on drop shipping of all O&P codes other than truly OTS orthoses should save the federal government money, potentially a significant sum over ten years. This provision, therefore, should offset the cost of the limitation of OTS competitive bidding, potentially rendering the bill budget neutral, or without cost. It is conceivable, of course, that a CBO analysis will indicate that this bill will actually save the federal government over ten years due to the reduction of waste, fraud, and abuse in the orthotic benefit. This would provide Congress with a significant incentive to enact the bill into law. CBO usually estimates the cost of legislation once a bill is poised to be considered in committee. One major goal of the O&P profession, therefore, is to secure a CBO score at the earliest opportunity, thereby increasing the chances of an early mark-up of the legislation coupled with a committee vote. O&P Alliance Meets With MedPAC To help increase the likelihood of S. 2556 and H.R. 1990 advancing in Congress, the Orthotic and Prosthetic Alliance met with the Medicare Payment Advisory Commission (MedPAC) on July 26 to discuss the bill in depth. MedPAC is an independent legislative branch agency that provides analysis and policy advice on the Medicare program to Congress. In the past, MedPAC has identified concerns with the orthotic benefit, concerns that the Patient-Centered Care Act will help to address. Most recently, in a July 2018 report to Congress, MedPAC highlighted increased spending on OTS back braces following a 2014 OTS coding change that split many orthotic codes into two separate codes—one for OTS orthoses and another for custom-fitted orthoses. CMS maintained the same reimbursement rates for these so-called split codes, which incentivized drop shipment of OTS versions of orthoses at rates that included compensation for clinical services associated with these orthoses. Following this change in coding, MedPAC found that Medicare spending for OTS back braces increased rapidly, but that "physicians, hospitals, physical therapists, and orthotists furnished a minority of the off-the-shelf back brace product [MedPAC] studied and are not driving the increase in utilization and expenditures for such products."1 During the presentation and conversation with MedPAC, the O&P Alliance highlighted how the drop-shipment provision of the Patient-Centered Care Act will help reduce Medicare waste, fraud, and abuse in the O&P benefit by addressing the growing use of lead generators that operate under a model based on late-night advertisements, internet marketing, and telemedicine where a clinician never sees the patient. The drop-shipment provision in S. 2556 and H.R. 1990 is designed to ensure that patients have access to a healthcare practitioner to help assess, adjust, and train the beneficiary in the proper use of the orthosis or prosthesis and should reduce waste, fraud, and abuse to a significant extent. The longer the acute phase of COVID-19 lasts, the longer attention in Washington will focus on the pandemic and its aftermath. But as Congress continues to respond to COVID-19, there are signs that Medicare policies and other priorities cannot be ignored indefinitely. There will be opportunities to include this bill in relevant hearings, secure a mark-up of the bill, and get CBO to score the legislation. At that point, a legislative vehicle will be needed on which the Patient-Centered Care Act can hitch a ride. The quickest way of achieving these goals is to demonstrate support for this legislation in both the House and Senate through the addition of cosponsors of the bills. Every member of the O&P community needs to do his or her part to help build the lists of cosponsors. With strong support for the Patient-Centered Care Act and ongoing advocacy at the federal level, there is a real chance of advancing this legislation in the months to come. O&P EDGE Peter W. Thomas, JD, is general counsel for the National Association for the Advancement of Orthotics & Prosthetics, O&P Alliance counsel, and managing partner, Powers Law Firm. Taryn Couture, MPA, is director of Government Relations, Powers Law Firm. Authors' note: To contact your member of Congress and two senators, visit naaop.org and open the Congressional Action Center to urge co-sponsorship of the Medicare O&P Patient-Centered Care Act (H.R. 1990 in the House and S. 2556 in the Senate).

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