O&#038;P Policy Developments Accelerate

A flurry of noteworthy O&P policy developments have occurred throughout the past few months. Congress continues to work toward introduction of the bipartisan Medicare Orthotics and Prosthetics Patient-Centered Care Act. This is the successor to the O&P Medicare Improvement Act and has been significantly redrafted since the last Congress. The Limb Loss and Preservation Registry (LLPR), the first of its kind in O&P, continues to make progress as it proceeds to launch phase I of the joint National Institutes of Health (NIH)-U.S. Department of Defense (DOD) project. The durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) proposed rule for calendar year 2020 was finalized with few changes, despite substantial advocacy by the O&P profession to improve the rule. These and other developments are gathering momentum as the second session of the 116th Congress approaches.

O&P Patient-Centered Care Act Nears Completion, Introduction

As has been discussed in past issues of The O&P EDGE , O&P advocates continue to push forward with introduction of the O&P Patient-Centered Care Act. It has taken several months to redraft this new bill from the previous Medicare Orthotics and Prosthetics Improvement Act (S. 1191, H.R. 2599). After enactment of the provision within that bill to recognize the prosthetist's and orthotist's clinical notes as part of the patient's medical record for purposes of determining medical necessity—a significant O&P victory—the bill required revision before reintroduction.

The new bill has been streamlined to make it less complex and easier to understand. It also omits the provision involving implementation of Section 427 of the Benefits Improvement and Protection Act (BIPA) of 2000, a federal law that was never fully implemented. BIPA Section 427 links the ability to be paid by the Medicare program for custom-fabricated orthotics and prosthetics with the qualifications of the provider, including practitioners who are state licensed or certified by the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC), the Board of Certification/Accreditation (BOC), or an equivalent certifying agency. Congress resisted the idea of a bill that instructed the Centers for Medicare & Medicaid Services (CMS) to implement the same law twice. So the National Association for the Advancement of Orthotics and Prosthetics (NAAOP) and its partners in the O&P Alliance will continue working directly with CMS to implement this provision in any manner possible.

The purpose of the new bill is to ensure that Medicare beneficiaries have access to appropriate, safe, effective, patient-centered orthotic and prosthetic care. The bill proposes a number of critical provisions:

Separates durable medical equipment (DME) from O&P care Limits the definition of off-the-shelf (OTS) orthotics to restore congressional intent Prohibits the drop shipment of all non-OTS orthotics Exempts state-licensed and certified O&P practitioners from OTS competitive bidding Defines key terms in prosthetics and orthotics Bipartisan sponsors are expected to introduce the bill soon in the House and Senate, and then it falls to the O&P profession to build support and gather congressional cosponsors. Limb Loss and Preservation Registry Prepares to Launch Phase I

In 2018, the NIH and the DOD announced a partnership to develop the LLPR. The LLPR is the first national registry of people who have lost limbs or are at risk of losing limbs, and promises to collect data that will improve prevention, treatment, and rehabilitation efforts for this population. The National Institute of Child Health and Human Development, which houses the National Center for Medical Rehabilitation Research (NCMRR), selected the Mayo Clinic as the recipient of a five-year contract to develop and launch the registry.

At the most recent American Orthotic & Prosthetic Association (AOPA) National Assembly in San Diego, the principal investigator for the LLPR, Kenton Kaufman, PhD, sought input from the O&P profession on his efforts to design and implement the registry from scratch. Earlier in September, Kaufman and his registry team convened the second meeting of a set of external stakeholders established to provide advice to the registry team.

A wide range of topics was discussed, but the ultimate message was clear: For the LLPR to realize its promise as a quality improvement registry, the entire O&P profession must embrace it, participate in it, and actively use it to help make clinical decisions, advise patients, and improve the quality of patient care. As a profession, the O&P community has been given an incredible opportunity to develop a registry that offers real value to participants, but it must be sustainable once the federal grant money dries up. How, exactly, can O&P clinicians, manufacturers, and patients help the registry succeed?

A quality improvement registry is a longitudinal database of clinical information on certain types of patients, which is primarily used to improve care and patient outcomes. Once developed, the goal is to have healthcare providers (and others) use the database to forecast best practices, pathways of care, and expected outcomes; develop and improve clinical practice guidelines; obtain reliable incidence and prevalence data; and aid patients in making evidence-based decisions about their healthcare choices.

Phase I of the registry involves the selection of three beta sites that will collect a limited set of data, primarily from existing electronic data sources, and begin the process of building the database of clinical information about patients who seek to preserve their limbs after illness or injury, or who have lost their limbs, whether or not they seek prosthetic care. In fact, existing data suggests that between 50 and 70 percent of individuals with limb loss do not use prostheses, a phenomenon the registry should be able to help explain or improve.

There will be only limited opportunities for manufacturers, O&P clinicians, and patients to participate in phase I of the registry, which should last about one year. Phase II will engage the O&P community to a much greater extent. For instance, it will be important to work with manufacturers to better identify specific O&P components to match them with patient-reported O&P outcomes. Practitioners will be key participants in collecting clinical data on limb loss and preservation patients as well as encouraging patients to fill out patient-reported outcome measures.

Demonstrating the value of participating in this endeavor is the real challenge. Most data will be collected through existing sources, such as electronic medical record systems in use throughout the country (O&P electronic records and broader electronic health records as well). The goal is to spare practitioners from inputting specific data on each patient for the purpose of the registry only. Another goal is to facilitate easy patient reporting of outcome data without erecting barriers to doing so. More information will be forthcoming once the registry proceeds to phase II of the project, but everyone in the O&P community has a role to play to make the LLPR a success.

CMS Releases Final DMEPOS Rule for 2020

On October 31, CMS released the final rule updating the fiscal year 2020 regulations for DMEPOS items and related services. The proposed rule included a number of provisions that would impact the O&P field, with significant proposals involving a new process for calculating payment amounts for new items and services (gap-filling) and a new consolidated list of DMEPOS products that are eligible for prior authorization. Despite strong advocacy efforts by the O&P Alliance organizations, including NAAOP, the major provisions in the proposed rule were finalized without major substantive revisions. The final rule continues to regulate O&P the same way that CMS regulates DME, highlighting the need to clearly distinguish O&P from DME through legislation.

HCPCS Pricing and Gap-filling

When determining the reimbursement levels for new Healthcare Common Procedure Coding System (HCPCS) codes, CMS looks to compare new technologies with existing ones and crosswalks the values to establish the payment level for the new code. In the final rule, CMS set an explicit framework and basis for identifying comparable items. This framework includes five main categories upon which new DMEPOS items can be compared to older items: physical components, mechanical components, electrical components (if applicable), function and intended use, and additional attributes and features. (The O&P Alliance submitted comments that the value of clinical services must be factored into the reimbursement levels for new O&P technologies, but CMS disagreed in the final rule.)

This methodology will be applied to new DMEPOS items without a pricing history. If it is determined that the new item is comparable to older existing item(s), CMS will use the fee schedule amounts for the older existing item(s) to establish the fee schedule amounts for the new item. If it is determined that there are no comparable items to use for establishment of a payment level, the gap-filling methodology will be used. This methodology would, among other things, examine other sources of commercial pricing data to establish Medicare payments, such as internet retail prices or information from supplier invoices. The commercial prices will then be deflated to the fee schedule base period (i.e., 1986-1987) and updated by the covered item annual inflation factors (i.e., CPI-U).

When commercial pricing data is not available, unverifiable, or insufficient to determine fee schedule amounts, CMS originally proposed utilizing technology assessments (either internally or by contracting with outside companies) to analyze samples of the product(s) as well as older items to determine relative supplier costs of furnishing the item or service. In response to stakeholder concerns about the application of technology assessments, specifically regarding the complexity of the process and expertise required to understand relative costs, CMS is not finalizing the use of technology assessments at this time. However, CMS reserves the right to include a revised proposal addressing technology assessments in future rulemaking.

CMS finalized its proposed revisions to the gap-filling process, which includes authority for CMS to perform a one-time adjustment (e.g., a second round of gap-filling) when prices drop less than 15 percent within a five-year period. The rationale for this adjustment is that new technologies seldom have competitors and, therefore, the market is not mature when the reimbursement level is initially established. If prices for a product or technology decrease more than 15 percent, CMS has existing authority to implement an inherent reasonableness adjustment to address grossly excessive (or deficient) fees. CMS largely dismissed stakeholder comments opposing the proposed adjustment authority.

Master List

CMS also proposed to adopt a new, singular Master List of DMEPOS items that are potentially subject to prior authorization requirements as well as face-to-face encounter and written order requirements. Currently, CMS maintains separate lists of items that are eligible for each requirement. CMS has not required any O&P L-codes to have a face-to-face encounter, and while there are 82 L-codes eligible for prior authorization requirements, CMS has not imposed this requirement on any O&P codes currently. CMS finalized its proposal to create a standardized Master List. This list dramatically increases the number of DMEPOS items that are potentially eligible to be selected for prior authorization with 60-days' notice, including an astonishing 144 new HCPCS L-codes to be added to the list. There is little evidence to support this dramatic expansion of prior authorization eligibility, and CMS largely dismissed stakeholder concerns in the final rule. However, the agency does state that the expansion is only to the list of items potentially eligible for these new requirements and is "not indicative of any known plans to widely increase prior authorization."

Additional Elements of the Final Rule

The rule also finalizes the creation of a new set of standardized required elements for all DMEPOS orders, including orthotics and prosthetics. Specifically, CMS will require the following elements to be included in all DMEPOS orders/prescriptions in the future:

1. Beneficiary name or Medicare Beneficiary Identifier (MBI)

2. General description of the item

3. Quantity to be dispensed, if applicable

4. Order date

5. Treating practitioner name or National Provider Identifier (NPI)

6. Treating practitioner signature

The final rule directs the DME Medicare Administrative Contractors to consider the totality of the medical record when reviewing for compliance with standardized order/prescription elements, as some required elements may be listed in the medical record but not written on the prescription/order. This is a hidden gem in the final rule and a principle the O&P profession has been advocating for years. This concept should decrease the number of O&P claim denials and make it easier on providers to challenge denials when appealed through the administrative appeals process.

Perspective

The current administration professes an unbending interest in reduction of burdensome regulations and then dramatically expands the list of O&P codes that are potentially subject to prior authorization. CMS continues to defer action on implementation of BIPA Section 427—a 19-year-old federal statute that has never been implemented—but then seemingly tolerates $1.7 billion in OTS orthotics fraud and abuse announced by the U.S. Department of Justice. NAAOP and its Alliance partners spend hours responding to proposed regulations to inform policymakers of the real-life consequences of CMS' gap-filling proposals, only to be essentially ignored on all but the most minor of provisions. The route to successful O&P policy is a long and winding road, but it bends toward justice.

Peter W. Thomas, JD, is a principal with the Powers Law Firm, Washington DC, general counsel for NAAOP, and counsel to the Orthotic and Prosthetic Alliance. Joseph Nahra is manager of government affairs with the Powers Law Firm.

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