There were two important developments in June that advanced O&P policy, one regulatory and one legislative. On June 30, the Centers for Medicare & Medicaid Services (CMS) released the 2024 Home Health Prospective Payment proposed rule that contained an important orthotics section defining this benefit. The details of the proposal follow, and public comments are being collected by CMS. On June 23, the Medicare Orthotics and Prosthetics Patient-Centered Care Act was introduced as H.R. 4315 in the US House of Representatives. The bipartisan legislation contains three important provisions that will advance O&P care.
Medicare Definition of Orthotics
Medicare definition of a brace
Currently, the term brace is not defined in Medicare statute or in its implementing regulations. Instead, the Medicare Benefit Policy Manual (MBPM) defines braces as: “Rigid and semirigid 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.”
Under this proposed rule, CMS would codify this definition in regulation, which is a positive development for people with limb difference and the providers who serve them. Elevating the definition of orthotics to regulation rather than nonbinding guidance helps settle the definition and protects this benefit from a future administration limiting or restricting the scope of the benefit without going through notice and comment rulemaking. The fact that CMS proposes to adopt in regulation the exact same definition as appears in the MBPM will preserve stability in this benefit and not create uncertainty as to its scope.
However, orthotics practice continues to advance and become more sophisticated. There is potential that locking in a regulatory definition of orthotics may limit Medicare’s ability to adapt to new innovations in the field. The National Association for the Advancement of Orthotics and Prosthetics (NAAOP) and its O&P Alliance partner organizations have commented extensively on this issue, urging CMS to reconsider its outdated and fairly simplistic thinking about orthotics to reflect a more contemporary view of current orthotic practice in future guidance, coverage, and coding policies.
Rigid and semirigid
CMS clarifies that “[r]igid materials are used to eliminate motion but also to support underload,” and “semirigid materials…intentionally allow some amount of motion as compared to materials that completely immobilize a part of the body.” CMS also describes a three-point pressure system that is needed “for a brace to properly function” as follows:
In order for a brace to properly function, it must utilize a three-point pressure system to provide angular control over anatomical joints. A three-point pressure system places a single force at the area of the deformity, while two counter forces act in the opposing direction. This pressure system requires that a brace be rigid or semirigid in structure to apply sufficient relevant force to support, restrict, or eliminate motion of the joint or specific body part. The rigidity level of a brace is dependent on the body part and purpose for which the brace is used. For example, a fully rigid brace is used to eliminate motion and support underload.
Furthermore, CMS also states that “[b]races are typically prescribed to patients during the process of recovery and rehabilitation in order to stop limbs, joints, or specific body segments from moving for a predetermined period.” CMS further says that braces “may also be prescribed for ongoing medical problems that require restriction or limitation of joint movement; removal of weight or pressure from healing or injured joints, muscles, or body parts; or reduction of misalignment and function to reduce pain and facilitate improved mobility.”
While not necessarily inaccurate, this nonbinding language that appears in the proposed rule is fairly simplistic and does not seem to recognize the advances made in orthotic practice over the past several decades. This language is an indication of how CMS officials view the orthotic benefit and indicates a superficial understanding of contemporary orthotic practice. It also creates concern that future developments in the orthotics field will face uphill battles due to CMS’ view of orthoses.
Several years ago, CMS issued guidance stating that devices that added forces to a joint did not meet the definition of an orthosis, which refers to supporting a weak or deformed body member or restricting or eliminating motion. After pushback from the O&P organizations, CMS retired this guidance and, to its credit, has proposed the opposite interpretation in this proposed rule, detailed below. But the concern remains that CMS staff needs additional education about the current state of orthotic practice and should interpret future orthotic innovations with a more contemporary view.
Powered features in orthoses
Marking another significant victory for the O&P community, CMS also confirmed in this proposed rule that devices with power features designed to assist with traditional bracing functions are considered braces for purposes of Medicare coverage. Specifically, under the proposed rule, the following powered upper-limb devices and powered lower-limb exoskeleton device would fall under the definition of orthoses:
MyoPro: L-8701 (Powered upper-extremity range of motion assist device, elbow, wrist, hand with single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated)
MyoPro: L-8702 (Powered upper-extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated)
ReWalk: K-1007 (Bilateral hip, knee, ankle, foot device, powered, includes pelvic component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors)
This is a major, positive decision that illustrates how CMS’ thinking can evolve over time. It sets the stage for coverage of a whole new family of powered orthoses that could be of significant benefit to individuals requiring orthotic bracing in future years. Of course, there are other aspects of powered orthoses that will have to be addressed before patients have meaningful access to these benefits as they come onto the market. For instance, new codes will have to be established with new reimbursement levels so that practitioners can make ends meet.
One additional issue in the proposed rule relates to leg orthoses with shoes that are an integral part of the brace. Section 1862(a)(8) of the Social Security Act generally excludes orthopedic shoes or other supportive devices for the feet from coverage under the Medicare program. However, other than specific coverage of diabetic shoes, longstanding policy at CMS (MBPM Pub 100-02, Chapter 15, §290) indicates that this exclusion does not apply to such a shoe if it is an integral part of a leg brace. If that shoe or other supportive device for the feet is an integral part of a leg brace, then the cost of that shoe or device is included as part of the cost of the brace. CMS is proposing to include this exception in the proposed definition of a brace at §410.2.
House Bill Introduced to Improve Patient-centered Care
The Medicare Orthotics and Prosthetics Patient-Centered Care Act was reintroduced in the House of Representatives on June 23. The bill is similar to the legislation of the same name introduced last year as H.R. 1990, but there are notable changes between the two versions of the bill. This bipartisan legislation was introduced by Rep. Glenn Thompson (R-PA), Rep. Mike Thompson (D-CA), Rep. Brett Guthrie (R-KY), Rep. Angie Craig (D-MN), and Rep. Pete Sessions (R-TX). The bill would protect Medicare beneficiaries who use orthotic braces and prosthetic limbs to be as functional and live as independently as possible while limiting waste, fraud, and abuse in the Medicare O&P benefit. A companion bipartisan bill is being prepared for introduction in the US Senate.
It offers several key benefits to O&P patients and the practitioners dedicated to providing their care.
Exempting appropriately credentialed clinicians from competitive bidding
To ensure that patients have access to the full range of orthotic care from appropriately credentialed practitioners, H.R. 4315 would exempt certified and/or licensed orthotists and prosthetists from the requirement to have a competitive bidding contract to provide off-the-shelf (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 the O&P care they need in a timely and convenient manner. As is the practice with physicians and therapists who CMS treats in this same manner, the competitive bidding rate (not the higher fee schedule amount) would apply to OTS orthoses provided in these circumstances. Therefore, this provision is not expected to add any additional cost to the Medicare program, but the Congressional Budget Office will make that formal determination in the future.
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 all prosthetic limbs and custom-fabricated or custom-fitted orthoses to patients’ homes without being associated with a clinical care pathway. These prohibitions would save the federal government significant dollars by preventing unscrupulous suppliers from shipping orthoses and prostheses to beneficiaries without providing necessary clinical care and, in some instances, without beneficiaries requesting or needing an orthosis or prosthesis. It would also ensure that beneficiaries have appropriate access to a healthcare practitioner to provide the necessary assessment, fitting, training, and follow-up care for proper use of their devices.
The need for Congress to ban drop- shipping was highlighted by “Operation Brace Yourself,” a Department of Justice investigation in 2019 that exposed $1.2 billion in Medicare overpayments for orthoses that were shipped to Medicare beneficiaries across the country by numerous durable medical equipment (DME) suppliers.1 Additionally, the Department of Health and Human Services Office of Inspector General published a series of reports that appear to primarily involve DME suppliers that employ a business model reliant upon shipping OTS orthoses, and in some cases custom-fabricated orthoses, directly to Medicare beneficiaries’ homes without any documented interaction with a certified/licensed orthotist or other trained clinician.2 These reports found high error rates in the claims billed to the Medicare program. The legislation is designed to curtail this practice, which would not only save the program money but would also protect patients from receiving orthotic devices without clinical care.
Ensuring access to replacement orthoses
A new provision in the bill would promote timely access to replacements of custom-fitted and custom-fabricated orthoses in the event that the ordering physician determines that the provision of a replacement is necessary because of any of the following reasons:
- A change in the physiological condition of the patient
- An irreparable change in the condition of the orthosis, or in a part of the orthosis
- The condition of the orthosis, or a part of the orthosis, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement orthosis or the part being replaced
Currently, Medicare does not generally cover the replacement of a custom-fitted or custom-fabricated orthosis within the “reasonable useful lifetime” of the orthosis, which is often five years. This forces beneficiaries to wait long periods of time before being eligible for replacements, ultimately delaying access to medically necessary care. Section 428 of the Benefit Improvement and Protection Act of 2000 provides an exception to the reasonable useful lifetime restriction for prosthetic limbs.3 H.R. 4315 would extend this exception to include custom-fitted and custom-fabricated orthoses.
Changes to H.R. 4315
The new bill omits two sections that proved controversial in the 117th Congress and significantly delayed action on the bill. The first involves differentiation between DME and clinical orthotic and prosthetic services. This provision was lengthy and detailed and, unfortunately, became a sticking point with several other stakeholder organizations in the rehabilitation continuum.
The second provision omitted from this year’s Patient-Centered Care Act involved a redefinition of “off-the-shelf” orthotics and the specific language defining that term, i.e., “minimal self-adjustment.” To limit the scope of competitive bidding to orthoses that are truly OTS, rather than a more expansive definition issued by CMS in the form of regulations, legislators would have had to impose a major reduction in the orthotics fee schedule to offset the cost of limiting the scope of OTS competitive bidding. This proved to be a bridge too far for O&P leaders to even consider. As a result, NAAOP and the O&P Alliance organizations will continue working with CMS on these important issues but agreed to remove them from the legislation to expedite and enhance the likelihood of passage of the bill.
H.R. 4315 includes comprehensive provisions designed to ensure that Medicare beneficiaries receive appropriate, safe, effective, patient-centered O&P care by appropriately credentialed practitioners. The bill is also designed to improve program integrity and limit fraud and abuse in the orthotic benefit. It is bipartisan and endorsed by over 40 national nonprofit organizations including all of the major O&P provider organizations, the Amputee Coalition, the American Physical Therapy Association, the American Occupational Therapy Association, and the American Podiatric Medical Association. All members of the O&P community should communicate with their members of Congress, educate them on the bill, and seek their support by having them cosponsor the legislation.
Peter W. Thomas, JD, is general counsel of the National Association for the Advancement of Orthotics and Prosthetics, counsel to the O&P Alliance, and managing partner of the Powers Law Firm.
Images top to bottom: photograph by Heather Swanson; photograph courtesy MyoPro; photograph courtesy ReWalk; mlphoto/stock.adobe.com.
- DOJ, Federal Indictments & Law Enforcement Actions in One of the Largest Health Care Fraud Schemes Involving Telemedicine and Durable Medical Equipment Marketing Executives Results in Charges Against 24 Individuals Responsible for Over $1.2 Billion in Losses (Apr. 9, 2019), https://www.justice.gov/opa/pr/federal-indictments-and-law-enforcement-actions-one-largest-health-care-fraud-schemes.
- OIG, Freedom Orthotics, Inc.: Audit of Medicare Payments for Orthotic Braces, (A-09-19-03012) (July 6, 2020), https://oig.hhs.gov/oas/reports/region9/91903012.pdf; OIG, Desoto Home Health Care, Inc.: Audit of Medicare Payment for Orthotic Braces, (A-09-19-03021) (Aug. 6, 2020), https://oig.hhs.gov/oas/reports/region9/91903021.pdf; OIG, Visionquest Industries, Inc. Audit of Medicare Payment for Orthotic Braces, (A-09-19-03010) (Aug. 10, 2020), https://oig.hhs.gov/oas/reports/region9/91903010.pdf.
- Benefits Improvement and Protection Act of 2000, Pub. L. No. 106-554, § 428, 114 Stat. 2763A-522 (codified at 42 U.S.C. § 1395m(h)(1)(G)).