Title 18, Section 1861(s)(12) of the Social Security Act requires that diabetic footwear be “fitted and furnished by a podiatrist or other qualified individual (such as a pedorthist or orthotist, as established by the Secretary)” who is not the certifying physician (unless the Secretary finds that the physician is the only such qualified individual in the area). (Emphasis added).

Suppliers continue to question who is an “other qualified individual.” Tricenturion LLC, the Program Safeguard Contractor (PSC) for the Region A DMERC, addressed this issue in its December 2002 PSC Bulletin titled “Therapeutic Shoes for Diabetics—Who is a Qualified Provider?” This bulletin stated: “Podiatrists, as defined by Medicare, are practitioners, rendering healthcare services within the scope of their state licensure. Qualified orthotists and prosthetists are practitioners certified by either the American Board of Certification (ABC) or Board of Certification (BOC) in orthotics and/or prosthetics. Qualified pedorthists are practioners [sic] certified by the Board of Certification in Pedorthics. In the absence of instruction from the Secretary expanding the list of qualified individuals, the DMERCs consider podiatrists, pedorthists, orthotists and prosthetists, as defined above, as the only qualified individuals to fit and furnish diabetic shoes under this benefit. Those individuals whose credentials are limited to completion of a manufacturer-sponsored or supplier-sponsored training course are not deemed to be qualified providers.” (Emphasis added).

While this clarification was to be implemented for Region A effective April 1, 2003, this provision of the December 2002 bulletin was withdrawn in January 2003. The published local medical review policy (LMRP) for Region A still states only that a supplier “may be a podiatrist, pedorthist, orthotist, or other qualified individual.” The definitions are similar in the LMRPs for Regions B, C, and D. The Negotiated Rulemaking Committee on Special Payment Provisions for Prosthetics and Certain Custom-Fabricated Orthotics (convened by CMS) met several times last year to address this and several related issues with various supplier representatives.

Their last meeting on June 2-3, 2003, ended with no specific conclusion on this issue. While no standards have come out of this Committee, it is clear that some type of ABC or BOC certification was a generally accepted standard. Individuals whose credentials are limited to completion of a manufacturer-sponsored or supplier-sponsored training course were not considered to be qualified providers. The National Supplier Clearinghouse (NSC) posted a Standards & Compliance article on “Qualifications for Diabetic Footwear Suppliers” on its Web site on May 14, 2004, which was removed shortly thereafter. This article stated that: “[O]ther qualified individuals are defined as having any of the following ABC/BOC certifications: Orthotist, Prosthetist, Orthotist/ Prosthetist, or Certified Fitter. Suppliers must have a qualified individual on their staff to render these services. It is not authorized for a supplier to contract with any individual or business entity to provide this service.”

It is presumed that this posting was premature. The NSC has since published Draft Guidance Concerning the CMS Supplier Standards (“Draft Standards”). These Draft Standards include clarification of Standard 1 that states, in part: “If a specific license is required for certain services (for example, orthotist or prosthetist for diabetic footwear), a supplier cannot contract with an individual or other entity to provide these licensed services. The owner of the supplier, or full-time W-2 employee, must have this license.” Some specific examples of licensing requirements: 1) §1861(s)(12)(C) of the Social Security Act requires that diabetic footwear be fitted by a podiatrist, orthotist, pedorthist, physician, or other qualified individual. The supplier must demonstrate that the individual on staff responsible for fitting the shoes is licensed or certified (National Community Pharmacists Association [NCPA], ABC, or BOC certified) in some way.

The time for comment on these Draft Standards expired on June 28, 2004. These Draft Standards did not receive a wide circulation and were not published on the NSC web site. The June 28, 2004, Federal Register Notice of the CMS Unified Agenda includes (among many other agenda items) that CMS is working on proposed rule Sequence Number 948 Supplier Standards for home oxygen, therapeutic shoes, and home nutrition therapy (CMS6010-P). The timetable for developing this proposed rule is September 2004. Basically, the writing is on the wall.

The days are numbered for suppliers who continue to rely on the general definition of “other qualified individual” in the DMERC’s LMRP language to include individuals who have completed a manufacturer- or supplier-sponsored training course. Suppliers should move toward using only orthotists, prosthetists, pedorthists, or ABC or BOC certified fitters if they expect to stay in the therapeutic shoe business.

Darrel J. Scott, JD, is an attorney in the Health Law Group of Brown & Fortunato PC, Amarillo, Tex. He is board certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6327 or by email: dscott@bf-law.com.