CMS proposal covers qualified practitioners and providers of prosthetics and custom-fabricated orthotics
On Jan. 12, 2017, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom Fabricated Orthotics [CMS-6012-P]) to establish qualifications that providers and suppliers must meet to furnish, fabricate, or bill for custom-fabricated orthotics under Medicare. In addition, this rule proposes to remove the current exemption from accreditation and quality standards for certain practitioners and suppliers.

Although the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 directed CMS to establish standards for such items, the CMS proposal goes beyond the statutory mandate. This rule, if finalized, is likely to disrupt the provision of prosthetics and custom-fabricated orthotics by orthopaedic surgeons and their assisting providers.

The AAOS and partner organizations have grave concerns about many of the provisions in the proposed rule, as outlined in this article. The AAOS raised these concerns in its comments to CMS on the proposal. In its comments, AAOS incorporated concerns raised by the Board of Specialty Societies (BOS), state societies, and other stakeholder organizations and asked these organizations to sign on to the letter.

The comment period on the proposed rule is now closed. The next step will be for CMS to review and consider the comments before issuing a final rule. The AAOS Office of Government Relations has prepared a detailed action strategy involving legislative advocacy, regulatory rule-making listening sessions, and coalition building with other professional organizations that are similarly affected.

Qualified practitioner
The proposed rule would require a qualified practitioner to be licensed by the state or be certified by the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) or by the Board for Orthotist/Prosthetist Certification International (BOPC). Alternatively, the provider may be credentialed and approved by a program that the Secretary of Health and Human Services (HHS) determines has appropriate credentialing requirements. CMS sought comments on applying these requirements to physicians.

In its comments, the AAOS stressed the importance of effective safeguards and protections to ensure that Medicare patients have access to the best, safest, and most reliable prosthetic and orthotic care. AAOS noted that orthopaedic surgeons are trained and expected to be able to skillfully fabricate, apply, and monitor prosthetics and orthotics as part of their licensing and continuing education. The AAOS has worked closely with medical schools as well as with residency and fellowship programs to incorporate prosthetic and orthotic management as part of orthopaedic training. In addition to affecting orthopaedic surgeons, the proposed rule also obstructs the ability of occupational and physical therapists to properly use orthoses as a component of upper and lower extremity rehabilitation across the continuum of care.

The proposed rule, if implemented, would also allow states to implement eligible professional exemptions as they now do for all Medicare providers. This would increase variation across state lines and increase disparities in costs and patient quality. Therefore, maintaining the current exemptions for physicians and therapists will ensure both high-quality standards and coordinated patient management. The AAOS recommended that CMS make significant changes on these requirements in advance of release of the final rule.

Fabrication Facility
The statute does not define a "fabrication facility." However, CMS is proposing criteria for facilities that construct prosthetics and custom-fabricated orthotics because the statute provides that Medicare will pay for these if they are made at a facility that meets criteria determined as appropriate by the HHS Secretary.

In its comments, the AAOS noted that CMS rightly wants to maintain the highest quality standards for patients requiring orthotics and prosthetics. However, continued the AAOS, this proposal would actually compel patients who often have significant mobility issues to use facilities with licensed prosthetists and orthotists who would be providing just one part of the patient care and would be doing so without coordination with the patient or therapists providing the face-to-face patient care. Thus, this proposal, if finalized, would fragment care for Medicare beneficiaries.

Requirements for accrediting organizations
The statute requires that qualified suppliers must be accredited by the ABC or the BOPC or by an equivalent accrediting program as deemed by the HHS Secretary.

The AAOS comments noted that physicians and therapists who are fully trained and licensed to fabricate, fit, apply, and shape prosthetics and orthotics through their current training should not be subject to another regulatory requirement for licensing. For example, orthopaedic surgeons who specialize in hand and upper extremity surgeries regularly rely on physical and occupational therapists to fabricate custom orthoses for their patients. These therapists have training in evaluation, skills in fabricating orthotics, and knowledge of anatomy, soft-tissue healing, and postoperative protocols.

Many of these therapists not only have graduate degrees that include instruction in orthosis fabrication but also are certified hand therapists (CHTs) who are already credentialed through the Hand Therapy Certification Commission. The body of knowledge of appropriate orthotic intervention specific to upper extremity injury and rehabilitation is a substantial component of the credentialing examination and included in the requirements for recertification. No evidence in the existing literature finds that the orthotist and prosthetist accreditation meets the level of rigor specific to upper extremity rehabilitation. However, evidence indicates that these professionals provide superior quality outcomes.

Conclusion
In conclusion, the AAOS noted that orthopaedic surgeons are best able to evaluate the patient's limb alignment, deformity, and biomechanics. Proper evaluation by surgeons enables patient-specific customization of orthotic inserts to address each individual patient's biomechanical needs—either to help avoid surgery or to address residual deficits.

For example, osteointegration plays an important role in prosthetic rehabilitation and is uniquely in the realm of orthopaedic surgeons specializing in trauma care, military medicine, joint replacements, spine surgery, and pediatric care. Osteointegration has greatly advanced the science of bone and joint replacement techniques and prosthetics for amputees.

This proposal is likely to limit innovations such as the 3D-printed produced products currently used in Veterans Administration hospitals. Thus, AAOS urged CMS to maintain the current exemptions for physicians and therapists as well as the definition of qualified professionals and appropriate facilities. This would ensure high-quality standards as well as coordinated, integrated and one-stop patient management, resulting in greater patient satisfaction and higher overall quality of care.

Shreyasi Deb, PhD, MBA, is senior manager, health policy, in the AAOS office of government relations. The author acknowledges the contributions made by Matthew J. Twetten, MA, and Kyle Shah, MHA, to this article and thanks them for their work on this issue.