Federal Medicare O&P Legislation Gets a Reboot

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By Peter W. Thomas, JD, and Leela Baggett, JD

With the 116th Congress comes the need to reintroduce federal legislation that was not enacted into law in the previous Congress, including legislation to address the ongoing needs of Medicare beneficiaries who rely on O&P care. One legislative measure, the Medicare Orthotics and Prosthetics Improvement Act (H.R. 2599/S. 1191), attracted significant congressional attention throughout the 115th Congress but, other than one important provision, was not enacted when Congress adjourned. This provides O&P leaders the opportunity to reassess the legislation, take stock of congressional reaction to each provision in the bill, and modify it accordingly before reintroduction in the 116th Congress.

The Medicare O&P Improvement Act sought to advance orthotic and prosthetic care under the Medicare program by addressing the definition of "minimal self-adjustment," which determines the breadth of off-the-shelf (OTS) orthotics exposed to competitive bidding. The bill also called for statutory separation of O&P from durable medical equipment (DME) by making a clear distinction between orthotists/prosthetists and suppliers of commodity-based DME. The bill sought to implement Section 427 of the Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Benefits Improvement and Protections Act of 2000 (BIPA), the provision that links practitioner credentials with the ability to be reimbursed by Medicare for custom-fabricated orthoses and prostheses. These provisions of the bill advanced in Congress but ultimately were not enacted into law.

However, a section of the bill recognizing prosthetists' and orthotists' clinical notes as part of the Medicare patient's medical record for purposes of determining the medical necessity of orthotic and prosthetic care was signed into law—a significant improvement in Medicare policy and a victory for the O&P community.

More work must be done, however, to ensure that Medicare beneficiaries have access to appropriate, safe, effective, patient-centered O&P care. To that end, the Medicare O&P Improvement Act has been updated and streamlined to focus on access to and the quality of O&P care Medicare beneficiaries receive. Additional provisions have been added to address serious gaps in Medicare policy that have contributed to fraud and abuse in the O&P benefit. This article provides an overview of the key provisions of this updated bill, which is likely to be renamed and introduced as the Medicare Orthotics and Prosthetics Patient-Centered Care Act. The new name of the bill reflects the new focus of the legislation, which seeks to convey the importance of patient-centered O&P care.

Restoring the Original Meaning of OTS Orthoses

When Congress authorized competitive bidding of orthoses, it limited the scope of competitive bidding to OTS orthoses that "require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual." This describes a very limited portion of the orthotic benefit, akin to the types of orthoses one would typically find in a retail pharmacy. Congress excluded custom-fitted and custom-fabricated orthoses and limb prostheses from competitive bidding because of the clinical, service-oriented, and customized nature of most orthoses and all prostheses. The Centers for Medicare & Medicaid Services (CMS), however, subsequently expanded the scope of orthoses subject to competitive bidding by defining minimal self-adjustment to mean "an adjustment that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and does not require the services of a certified orthotist...or an individual who has specialized training." This definition essentially wrote the word "self" out of "minimal self-adjustment" and dramatically expanded the scope of orthoses exposed to competitive bidding. Because Medicare currently allows OTS orthoses to be drop-shipped to a beneficiary's home without the clinical involvement of an orthotist, CMS' definition permits any supplier providing OTS orthoses to eliminate clinical care services needed for the proper use of the device.

The Medicare O&P Patient-Centered Care Act would restore congressional intent and effectively reject CMS' overly expansive interpretation of minimal self-adjustment. The bill would achieve this by clarifying that competitive bidding may only apply to orthoses that require minimal self-adjustment by that patient—and not by any other personfor appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to that patient. By limiting competitive bidding to orthoses that truly require only minimal self-adjustment performed by the patient alone, the bill seeks to protect beneficiaries by preserving access to the clinical assessment, fitting, and instruction necessary to achieve the therapeutic value of pre-fabricated or custom-fit orthoses that should not be defined as OTS orthoses, as well as to prevent potential patient harm.

Based on an analysis conducted by the Congressional Budget Office in late 2018, this provision would produce less savings than current law, thereby costing the Medicare program a fair amount of money. It would need to be offset by other provisions in the bill that counter-balance the cost of the provision. The bill seeks to achieve this through a new prohibition on drop-shipment of all limb prostheses and most orthoses to patients' homes.

Prohibiting Drop-shipment to Patients

Over the past several years, there has been an alarming increase in Medicare outlays for certain orthoses. Much of this rise has been attributed to waste, fraud, and abuse in the Medicare orthotic benefit, particularly by lead generators that operate under a model based on late-night advertisements and telemedicine companies. This trend was exposed in an April 7 announcement by the U. S. Department of Justice alleging widespread fraud and abuse in the orthotic benefit by telemedicine companies, corrupt physicians, and approximately 130 DME suppliers.

To preserve the link between clinical care and orthoses and prostheses, and to reduce the likelihood of fraud, waste, and abuse in the Medicare program, the Medicare O&P Patient-Centered Care Act would prohibit the practice of drop-shipping custom-fabricated and custom-fit orthoses as well as limb prostheses to a Medicare beneficiary, with the exception of supply items that effectuate the use of such orthoses and prostheses. The Medicare O&P Patient-Centered Care Act would also prohibit the drop-shipment of OTS orthoses to a Medicare beneficiary, except under limited circumstances determined by CMS. These prohibitions would 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. This provision is expected to save the federal government significant dollars that are currently being expended by the program.

Preserving Patient Access to OTS Orthoses

Under competitive bidding, when a patient needed a custom-fabricated orthosis or prosthesis from a licensed and/or certified orthotist for a limb and an OTS orthosis subject to competitive bidding for the contralateral limb, the patient would be forced to visit two providers should the treating orthotist or prosthetist not have a competitive bidding contract. This creates continuum of care inefficiencies and inconveniences for the patient, instead of being able to receive all the care they need at one O&P clinic.

To ensure that patients have access to the full range of orthotic care from one appropriately credentialed orthotic/prosthetic practitioner, the Medicare O&P Patient-Centered Care Act would exempt certified and/or licensed orthotists and prosthetists from the requirement to have a competitive bidding contract in order to provide OTS orthoses. This would allow orthotists and prosthetists to meet the patient's needs efficiently and conveniently in the course of the practitioner's clinical practice. It would apply the same treatment that physicians receive to certified and/or licensed orthotists and prosthetists under competitive bidding. These providers would still be reimbursed by the Medicare program at the lower, competitively bid rate that applies in that particular competitive bidding area, but patient access would not be limited by the number of competitive bidding contracts with providers in that particular geographic area of the country. In this manner, this provision is expected to cost little or nothing to implement.

Distinguishing Orthotists and Prosthetists From DME Suppliers

The Medicare O&P Patient-Centered Care Act would seek to protect patients by differentiating the clinical, service-oriented manner in which orthoses and limb prostheses are provided in contrast to the commodity-based nature of DME. The provision of O&P care consists of a set of clinical services provided by highly trained practitioners that include the orthosis or prosthesis itself. The majority of orthoses and prostheses are custom fabricated or custom fitted and require the expertise of an orthotist and/or prosthetist who must earn a master of science degree and complete clinical residency training before becoming certified and/or licensed practitioners.

Despite this contrast, current DME statutory provisions apply to the provision of O&P care as well, and this skews the regulation of O&P clinical care through a DME lens. The bill would codify separate statutory requirements for O&P practitioners and suppliers similar to the current DME statutory provisions, but tailor them to the provision of O&P care. This separation of O&P from DME would more specifically regulate orthotics and prosthetics with the patient in mind and lead to improvements in care. It is not expected to cost the federal government anything to implement.

Omissions From the Medicare O&P Improvement Act

The bill seeks to streamline the contents of the Medicare O&P Improvement Act by refocusing the bill on patient care and removing extraneous provisions that were unnecessarily complex or not well understood. Specifically, the new bill is not expected to contain the provision that called for regulations on Section 427 of BIPA to be promulgated. BIPA Section 427 links the credentials of the practitioner with the ability of that practitioner to bill the Medicare program for custom-fabricated orthoses and prostheses. It is a critical provision that CMS has inexplicably failed to regulate for 19 years since its enactment.

The Medicare O&P Improvement Act contained a directive for the U.S. Secretary of Health and Human Services to issue regulations implementing Section 427, but Congress does not like to pass the same legislation twice just to underscore the fact that the federal agencies have not done their part to implement the law. Although CMS has failed to promulgate regulations implementing BIPA Section 427 since its enactment in 2000, there are potential strategies to encourage CMS to protect the quality of O&P care by enforcing the statute through the claims processing systems and the National Supplier Clearinghouse, rather than by seeking to legislate or even regulate this provision again. Thus, while the new legislation will likely omit any reference to BIPA Section 427, it remains a high priority of the O&P community and will be the subject of an alternative subregulatory strategy in the coming year.

Closing Thoughts

By updating and streamlining the Medicare O&P Improvement Act, the soon-to-be-introduced Medicare O&P Patient-Centered Care Act includes comprehensive provisions designed to ensure that Medicare beneficiaries receive appropriate, safe, effective, patient-centered orthotic and prosthetic care by appropriately credentialed practitioners, as prescribed by their physician.

Peter W. Thomas, JD, is a principal with the Powers Law Firm, Washington DC, 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 in the Powers Law Firm's Health Care Practice Group.