Dispensing Therapeutic Shoes and Inserts

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By Christine Duprey

Compliance Just Got a Little More Complicated

Since Medicare's Therapeutic Shoes Policy Article (PA) has been revised, the stage is now set for stricter compliance practices in the fitting and dispensing of therapeutic shoes and inserts.

Pedorthists have built relationships with physicians, internal medicine specialists, podiatrists, and orthopedic surgeons as the core referral sources for their Medicare beneficiaries who have diabetes. In the past, these beneficiaries presented prescriptions for therapeutic shoes and/or inserts, or signed and dated written orders to the pedorthist for the fitting, fabrication, and dispensing of therapeutic shoes and inserts they needed for proper foot care. For the device to be covered by Medicare, the pedorthist was required to ensure the patient had met all coverage conditions prior to dispensing therapeutic shoes and inserts, including the receipt of a written order/prescription for the items, as well as a certification statement from the physician who is managing the patient's diabetes. (Editor's note: The Statement of Certifying Physician for Therapeutic Shoes form is available for download at coverage.cms.fu.com/lcd_area/lcd_uploads/11535_19/~ as a PDF )

New Requirements

After January 1, 2011, the responsibility to ensure the coverage criteria have been met will increase exponentially. Not only will the criteria for the written order and certifying statement be necessary, but pedorthists will also need to verify that the individual was seen face-to-face by the prescribing and certifying physician within six months prior to the delivery of the shoes and inserts.

Statement of Certifying Physician for Therapeutic Shoes

Coverage Criteria

  1. Document in the patient's medical record that the patient has diabetes.
  2. Document in the patient's medical record the presence of one or more of the following conditions:
    1. Previous amputation of the other foot, or part of either foot, or
    2. History of previous foot ulceration of either foot, or
    3. History of pre-ulcerative calluses of either foot, or
    4. Peripheral neuropathy and evidence of callus formation of either foot, or
    5. Foot deformity of either foot, or
    6. Poor circulation (i.e., small or large vessel arterial insufficiency) in either foot.
  3. I am treating this patient under a comprehensive plan of care for his/her diabetes.
  4. This patient needs special shoes (depth or custom-molded shoes) because of his/her diabetes.

The certifying physician, who must be a medical doctor (MD) or doctor of osteopathy (DO), is the one who indicates on the certification form that both coverage criteria 1 and 2 have been met, and that the patient has at least one of the conditions listed in 2(a)-2(f); that they are treating the patient under a comprehensive care plan for his or her diabetes; and that the patient requires diabetic shoes (see Coverage Criteria, left). This documentation must be dated within six months of the date the shoes were dispensed and within three months prior to or on the date the certification statement is signed.

The certifying physician may also obtain, initial/sign, date (prior to or on the same date the certification statement is signed), and indicate agreement with information from the medical records of an in-person visit with a podiatrist (DPM), other medical doctor or doctor of osteopathy, physician assistant, nurse practitioner, or clinical nurse specialist that is within six months prior to the delivery of the shoes/inserts, and that documents one or more of the criteria indicated in 2(a)-2(f).

In order for a claim to meet the billing criteria, there must be an in-person visit with the prescribing physician within six months prior to the date that therapeutic shoes and/or inserts are dispensed as well as the in-person documentation of the certifying physician. The pedorthist must also have two face-to-face visits with the patient—one to evaluate the patient for the selection of the appropriate footwear and another for the fitting and dispensing of the footwear and/or inserts.

Impact on Pedorthists

Pedorthists across the country are concerned with their ability to enforce or ensure that the new requirements for the in-person visit and documentation are met by the prescribing medical professionals and certifying physicians. The concern is not that these requirements are not necessary to ensure proper care and management of the patient's condition, the concern is the amount of additional work it will take to "prove" and educate the providers about the documentation that is necessary prior to writing the prescription or completing the certification statement.

Pedorthists are concerned about jeopardizing their relationships with their referral sources and also about whether or not all pedorthists will enforce the new requirements or "take their chances" that the required documentation is in place at the physician's practice to make it easier on the certifying or prescribing physician.

Since the industry has experienced a history of prescriptions that have been renewed or written without the now-required in-person visit, it is clear why the requirement was put into place. Medicare holds the supplier responsible for ensuring the coverage criteria and conditions for dispensing therapeutic shoes and inserts are met in order for the services to be eligible for payment. Lack of documentation to meet these new requirements will result in payment issues for the supplier.

The "Right Road" Is Not Always the "Easy Road"

Managing the compliance of this new documentation requirement will take more time and effort on the referring source's staff as well as the pedorthist's staff. Because the supplier will now be held financially responsible to ensure the proper documentation and in-person visits have occurred prior to dispensing the shoes and inserts, a new level of communication with the referral sources will be needed.

As with any compliance requirements, some pedorthists will require all of the criteria to be met and in hand prior to billing to ensure they are not at risk for non-payment, a refund of payments, potential fines, or sanctions by Medicare, etc. At the same time, there will be pedorthists who will not order the required documentation, will be billing with the KX modifier, and will be depending on the physician to have the required documentation in the event they are audited for the documented information.

We recommend using this new requirement as an opportunity to circle back to your referral sources and build stronger relationships. Conduct the following steps with your physicians:

  1. Confirm your commitment to serving them and the patients they have been referring to you.
  2. Educate physicians and staff members on the new documentation requirements in order for the beneficiaries to receive coverage for the items.
  3. Provide the requirements to the physicians and their staff for additional support.
  4. Discuss a process for obtaining the medical records along with the prescription and/or certifying statement for all services after January 1, 2011, that will work for their office and yours.
  5. Begin the process this fall as it takes everyone time to adopt new practices, and some patients that physicians see this fall may be coming for fitting and dispense after January 1, 2011.

Communication with your referral sources can be accomplished via a brochure, lunch-and-learn, or face-to-face conversation. Whichever communication method you choose, ensure that your physicians and your practice have a process in place to handle all of the patients you will see on or after January 1, 2011.

Christine Duprey is the co-founder of CARIS Innovation, Abrams, Wisconsin. She can be reached at 920.826.5300 or at