TSD Qualified Providers
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TSD Qualified Providers

The Pedorthic Footcare Association (PFA), recognizing that Medicare's Therapeutic Shoes for Persons with Diabetes (TSD) benefit has unique quality control standards necessary to ensure adequate patient care throughout the dispensing process to prevent the future potential for traumatizing and costly lower extremity amputations (LEA) requests that qualified provider language for the TSD benefit be formalized by Congress or by the Centers for Medicare & Medicaid Services (CMS).  Specifically, PFA's Board of Directors recommends the following language be used by Medicare to clarify who is considered qualified to dispense the TSD benefit:

"The supplier may be a podiatrist, a pedorthist credentialed by a CMS-deemed credentialing agency/state licensed pedorthist, certified/licensed orthotist or certified/licensed prosthetist, or other qualified individual who has a credential recognized by the Secretary as an appropriate supplier of this benefit."

PFA believes this language will clarify the TSD statute's original intention, affirm CMS's interpretation, and meet the U.S. Dept. of Health and Human Services' Office of the Inspector General's (HHS OIG) recommendations as expressed in their August 1998 report ("Medicare Payments for Therapeutic Shoes," [OEI-03-97-00300]).

Background Information:

All TSD devices, including those that are mass-produced/off-the-shelf, are devices where:

  • Patient care is an integral part of the device being dispensed and is a factor in the patient's outcome;
  • The dispenser requires special education and training. Their responsibilities to the patient include evaluation, assessment, fitting and furnishing of device or devices and continued follow-up care after the device or devices have been dispensed; and,
  • The dispenser's responsibility includes selection, fitting and furnishing of the device and follow-up with the patient after the device has been dispensed.

Medicare beneficiaries who are eligible for the TSD benefit are particularly vulnerable because they have insensate feet and/or a history of foot problems, which means they cannot fully participate in the fitting process, and therefore require considerable practitioner knowledge and time for the initial consultation, fitting and follow-up. Additional concerns include:

  • Costs and risks: A goal of Medicare is to prevent foot complications resulting from diabetes, including ulceration and lower extremity amputations. If effectively used, the TSD benefit will decrease the need for more extensive Medicare services, which will in turn lower overall costs.
  • Quality of life issues: Successful outcomes allow the patient to remain mobile, independent, and a contributing member of society for a much longer period of time.
  • Patient care: Allowing only educated, trained and certified providers to fit and dispense inherently increases the likelihood of the patient receiving the quality of care necessary to meet the TSD's goals.
  • Supplier's needs: Most prescribing physicians consider the qualified TSD dispenser an important member of their health care team and rely on the dispenser to determine which modality(ies) best meet the patient's needs.
  • Limited access: TSD-eligible beneficiaries have special needs that cannot be met by all DMEPOS suppliers.

To further support PFA's position on qualified provider language, PFA has collected the following information from various federal government sources:

  • Originating Statute:  The statute creating the benefit was introduced and passed as part of the Omnibus Budget Reconciliation Act (OBRA) of 1987. OBRA's Section 4072 (a)(4) states that the TSD shoes are "fitted and furnished by a podiatrist or other qualified individual (such as a pedorthist or orthotist, as established by the Secretary)…"
  • Demonstration Project:  The statute mandated a demonstration study to test the cost-effectiveness of providing therapeutic shoes to Medicare beneficiaries with severe diabetic foot disease. The study was administered by Mathematica Policy Research, Inc. Mathematica's final report explained that eligible "shoe suppliers" were "podiatrists, certified pedorthists, certified orthotists, and certified prosthetists." Mathematica's suggested changes to the statute included "To help ensure that shoes fitted were of high quality,…require that facilities supplying either type of shoe meet the specifications of the relevant professional body—for example, the Board for Certification in Pedorthics."
  • Start of TSD Benefit:  The TSD benefit became effective on May 1, 1993.
  • OIG Report:  In 1997 and 1998, the HHS OIG conducted a survey to assess the propriety of billings for therapeutic footwear provided to Medicare beneficiaries.
  • From the Findings portion: "‘The footwear must be fitted and furnished by a podiatrist or other qualified (emphasis added by OIG) individual such as (emphasis added by OIG) a pedorthist, orthotist or prosthetist.'"
  • Clarification from DMERC Region D:  In response to PFA's questions, Robert D. Hoover, Jr., MD, the Durable Medical Equipment Regional Carrier (DMERC) Region D's medical director, sent a letter to PFA on August 24, 2000. On behalf of Region D only, Dr. Hoover's response included: "…it is critical that this benefit be administered in a professional manner by persons trained to correctly assess the pedorthic needs of the patient. This assessment, which encompasses the initial fitting and follow-up care, should be accomplished by direct, physical interaction with the patient."
  • TriCenturion Bulletin (partial):  In "the absence of instructions from the Secretary expanding the list of qualified individuals,…" the Region A DMERC PSC (TriCenturion) released a bulletin in December 2002 to address "which provider types were permitted to provide therapeutic shoes for diabetics" and announced that CMS was preparing a regulation addressing this subject. The bulletin, which was withdrawn in January 2003 pending publication of this regulation, included:
  • A reference to the statute as to who is a qualified to fit and furnish shoes under the TSD benefit and noted that the statute also requires all services to be performed by a qualified individual.
  • A reference to the Medicare Carriers Manual (MCM) that added prosthetists as qualified providers.
  • A statement that "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 practitioners certified by the Board for Certification in Pedorthics."

In summary, PFA believes that the inclusion of qualified provider language for providers of the TSD will better serve the patient and the Medicare program, decrease long-term Medicare costs and allow the benefit to achieve its original goals, such as reducing the instances of costly and traumatizing lower extremity amputations.

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