March 2011

The Therapeutic Shoe Bill: Making sure the benefits add up

Taking full advantage of the TSB means jumping through more than a few bureaucratic hoops, as mandated by the federal government. But it also requires that lower extremity experts build better working relationships with each other and with their diabetic patients.

By Shalmali Pal

Nearly 30 million adults in the U.S. have diabetes and another 79 million are considered prediabetic, according to the “2011 National Diabetes Fact Sheet” from the American Diabetes Association. It is a safe bet that the incidence of diabetes-related lower extremity complications will skyrocket as well. The burgeoning diabetes epidemic, paired with an aging population, means that more patients will qualify under Medicare’s Therapeutic Shoes for Persons with Diabetes Benefit, also known as the Therapeutic Shoe Bill (TSB), for financial assistance with their therapeutic footwear.

Taking advantage of the TSB certainly requires some bureaucratic basics as mandated by the Centers for Medicare & Medicaid Services (CMS). But working the TSB to its full advantage also requires that lower extremity experts build better working relationships with each other and with their patients.

TSB eligibility and coverage

The TSB is fairly straightforward on which diabetic patients qualify for diabetic shoes, inserts, and modifications. Table 1 outlines eligibility criteria; Table 2 details which specific combinations of products are covered.

The TSB also requires that the physician who is managing the patient’s diabetic condition produce a Medicare-approved, signed certificate of medical necessity (CMN). Unfortunately, CMS does not offer a standard, downloadable format for the CMN, but examples from various sources are available online (see table). According to the original 1993 TSB, the “Statement of Certifying Physician for Therapeutic Shoes” must contain the following:

  • One or more of the indications required in table 1 are present
  • The patient is being treated under a comprehensive plan for diabetes management
  • The patient requires diabetic shoes, inserts, or shoes with modifications

Getting started

To work with the TSB, a provider must obtain a durable medical equipment (DME) supplier number. The best place to get started is on the CMS web site, which offers a guideline on how to enroll as a DME  Prosthetics, Orthotics, and Supplies (DMEPOS) supplier (

All applications for a DME number must be processed and approved by a National Supplier Clearinghouse (NSC). The applicant must complete the Medicare enrollment form (CMS-855S) and submit all supporting documentation to the NSC. Another form that may be required is CMS-460, which is a participation agreement between the supplier and CMS. Enrollment forms can be found at Find more information on enrollment, as well as form CMS-855S, at the NSC (

Next, look to develop a CMN that is clear, concise, and easy to read. Bear in mind that a diabetic patient’s lower extremity health may not be foremost in the minds of the referring physician. Make sure that the CMN statement enumerates the following:

Clarify that you will be conducting a full examination of the patient’s feet to determine if she needs even needs therapeutic footwear and if she qualifies for the TSB.


There is a misconception in the medical community that all diabetic patients “deserve” shoes through the TSB, but that is not the case, said Jeremy Long, CPed, from the Smoky Mountain Foot & Ankle Clinic in Asheville, NC.

“This program is not intended to provide free shoes for all diabetics,” Long said. “A quality shoe given under the TSB is not a replacement for exercise and better nutrition. It’s one of many tools that can be used to help diabetic patients toward better health.”

Explain the various components that are needed to build therapeutic footwear, including the shoes, insoles, and any modifications.


“These are patients are at risk for losing their limbs; dispensing a shoe or insert that is wrong for the patient or ill-fitting could be a medical disaster,” said Harry Goldsmith, DPM, a coding and reimbursement consultant based in Cerritos, CA, and a healthcare practice and policy consultant for the American Podiatric Medical Association.

“Giving patients a prescription does not guarantee they will fill that prescription at the moment,” he said. When the patient is told to take the prescription to a commercial supplier somewhere in town, there will always be a segment of the population that’s going to put that prescription in a pocket or purse, and forget about it. Part of the intent of the TSB was to make it more convenient for the patient and increase compliance.”

Develop a risk stratification system, or use a pre-existing one.


This will help the primary physician get an idea as to where his patient falls on the scale (table 3). Assigning a value to a patient’s risk level also will clarify whether the patient really needs therapeutic footwear at all.


“The way I stratify risk is that the more deformity, neuropathy, and vascular disease that I see, the more likely that I am to want (therapeutic) devices for those patients,” said Michael S. Pinzur, MD, professor of orthopaedic surgery and rehabilitation at Loyola University Medical Center in Maywood, IL.

“People who have no deformity, good sensation, and good blood flow, they don’t need therapeutic shoes. They need good instruction on the right kinds of shoes to wear,” added Pinzur, a spokesperson for the American Orthopaedic Foot & Ankle Society (AOFAS).

Make sure that the CMN form looks professional.

Examples of CMN formats can be found online (see table 4). Despite the promise of streamlining with electronic health records systems, most medical professionals are still awash in paperwork, Goldsmith said.

“The MD/DO could sign the form and send it back to me, but not put a copy in their own records. They get these kinds of reports all the time,” Goldsmith said. “Talk to your MD/DO colleagues and explain that…you understand that it’s a hassle, but you need them to help you help the patient.”

Know and respect the limits of Medicare reimbursement rates.


Medicare reimburses about $300 for one pair of off-the-shelf, extra-depth therapeutic shoes (A5500) and three sets of heat-molded multilaminar insoles (AA5512) or custom fabricated insoles (A5513). The Healthcare Common Procedure Coding System (HCPCS) is quite specific about what is reimbursable under the benefit (see table 5).

“Unfortunately, there are some professionals out there who use (the TSB) to try to build their income base,” Long said. “In reality, it’s intended to protect the foot and save our social insurance programs money because amputations and ulcer treatments put a strain on the system. If you are able to improve the quality of care for the person wearing the shoes, then it should reduce that financial strain.”

Addressing audit

Ideally, treating the diabetic foot is treated by a team of professionals: A referring physician, a foot and ankle physician, and a shoe/insole specialist. Based on the language in the original TSB, the certifying doctor (MD/DO) must issue the CMN, but in reality the practitioner who writes the prescription for the therapeutic footwear is the one who usually initiates the CMN, Goldsmith said. The prescribing practitioner then sends the CMN form to the certifying physician and asks him to sign and date it, keep a copy in his records, and send the signed paperwork back to the prescriber.

This chain of custody has been in place since the bill was implemented nearly 20 years ago. But in the summer of 2010, the CMS announced that the certifying physician must also keep detailed records of the patient’s lower extremity issues in addition to having a copy of the CMN. In Goldsmith’s estimation, this requirement places an undue burden on the certifying physicians and prescribing practitioners for two reasons: Additional paperwork and the potential for audit.

“We are now getting calls and emails from podiatrists essentially saying that the MD/DOs are starting to balk at the excess paperwork. It is onerous,” he said. “A lot of primary care physicians are overworked and they are just refusing to (generate the records).”

Although the CMS 2010 bulletin ( did not specify if this amended rule would be enforced retroactively, many practitioners are nervous that it could open them up to an audit and, subsequently, a request for refund from Medicare. The APMA has devised what Goldsmith called a “Band-Aid” to address this situation.

“We are essentially telling our members to…make a copy of your medical records detailing the  patient’s work up (for) diabetic shoe/inserts…and then send it to the (certifying) doctor along with the CMN. On the bottom of that medical-record letter, podiatrists should request that the MD/DO review the information, and if they agree with the information, sign and date the letter. They should then be instructed to place the signed document from the prescribing podiatrist in the patient’s medical records,” he said.

While Pinzur said he understands that additional burden of this requirement, he also stressed that practitioners need to look at the intention behind it: reducing fraud and waste. In 1993, after the TSB had been tested out in a two-year pilot program, Pinzur said he received a call from the office of Donna Shalala, the secretary of health and human services at the time.

“They asked me, for what percentage of my patients do I order custom footwear? I said, ‘Five percent at most.’ But in…the pilot program, they were getting billed for 40% custom footwear.”

Long stressed that the TSB procedures have not actually changed since 1993 but the oversight of the TSB has.

“There is now the potential for auditing,” he said. “You can’t skip steps anymore and run the risk of an audit. Do the right steps in the right order and it should be no problem.”

Patient participation

One way for practitioners to contend with a greater demand on their time in terms of meeting the TSB paperwork requirements is to involve their patients.

“The only ‘new’ hoop that people believe they have to jump through is obtaining the signature of the physician who orders the device and the physician treating the condition. But that’s always been the rule; CMS never enforced it before and now they are,” Pinzur said. “Patients have to take some responsibility for their care.”

There are a number of ways in which practitioners can help patients help themselves:

Make sure that patients understand what they do, or does not, quality for under the TSB. Direct patients to resources where they can learn more about the benefit (table 6).


“If the patient is compliant and follows directions (of the diabetes care team), there is a good chance that they will see a reversal in their diabetic symptoms, such as lower blood sugar or improvements in neuropathy. If things go well, the patient should eventually go off the therapeutic shoes,” Long said. “Unfortunately, there are individuals out there who use the TSB to get their patients new shoes every year. But if the patient is doing things well, and their diabetes is improving, the hope is that they won’t need the TSB program anymore.”

Send the CMN with the patient to have the certifying physician sign it.

A request from a patient will garner more attention than a mailed reporting sitting on top of a pile or in an email inbox.

“This is a great benefit, but patients may have to participate and make sure that their physicians sign the paperwork,” Pinzur said. “I sign at least 50 things a day. Is that a burden for me? I view that as my responsibility.”

Make sure the patient understands that the shoes may not appear overnight.


It can take four to six weeks from the time of evaluation to the time of shoe fitting. And some patients may experience additional delays because of insurance requirements. Long said that when patients are enrolled in a Medicare HMO, that sends up a flag in his group’s practice.

“Medicare HMOs, like Blue Options, require pre-authorization before dispensing the shoes,” he said. “So that is adding another step: You need the CMN from the referring physician and you also need certification from the insurance.”

If the patient has private insurance, check to see if that carrier offers coverage.


Some private carriers will pay for some or all of a diabetic shoe or insert. The level of coverage will vary depending on the company; some follow Medicare rules and pay 80%, while others set their own rules. For example, Empire Plan Network Management, an East Coast-based arm of United Healthcare, will pay out a maximum of $500 per calendar year for therapeutic footwear.

Private carriers often have to follow state regulations regarding coverage, particularly for diabetic patients who are not eligible for Medicare. In Rhode Island, Blue Cross Blue Shield must meet a state mandate to pay for 80% of a pair of therapeutic/molded shoes for the prevention of amputation every calendar year, for any qualified diabetic patient.

While financial hardship is common among older diabetic patients, do not discount the possibility that some patients may be able to pay for therapeutic footwear out of pocket. Depending on the patient’s clinical situation, a practitioner can look to some commercially available footwear to meet the patient’s physical needs and financial restrictions, Long said. He cautioned that it may require additional time and effort on the part of the practitioner to find a credibly made, well constructed, reasonably priced shoe, but it should be offered as an option.

“There are no limitations to the number of depth shoes a patient can get on an annual basis,” Long pointed out. “There’s only a limitation to what Medicare will pay for.”



Table 1. TSB eligibility criteria

  • Complete or partial amputation of the foot
  • History of previous foot ulceration
  • History of pre-ulcerative calluses
  • Peripheral neuropathy with evidence of callus formation
  • Foot deformity
  • Poor circulation


Table 2. TSB coverage

In a given calendar year, Medicare will cover 80% of the allowed amounts for one of the following:

  • One pair of off-the-shelf (OTS) depth shoes plus three pairs of multidensity inserts
  • One pair of OTS depth shoes including modification plus two pairs of multidensity inserts
  • One pair of custom-molded shoes plus two pairs of multidensity inserts


Table 3. Diabetic foot risk classification systems


Table 4. Sample CMN forms


Table 6. Patient resources

Sponsored by an educational grant from Dr. Comfort

One Response to The Therapeutic Shoe Bill: Making sure the benefits add up

  1. Annette M. Smith says:

    My mother was diagnosed over 40 yrs ago with Rheumatoid Arthritis. She has had multiple surgeries on both feet, and has had Grade 2 & 3 ulcers on the plantar surface of both feet for the past 8-10 yrs. Over 5 yrs ago, I sent a letter with pictures of her feet showing the ulcers to her insurance company and she was TURNED DOWN for help with buying the special shoes because she is NOT diabetic. This is ridiculous ! An ulcer is an ulcer is an ulcer, no matter what caused it.
    Can anyone tell me who I should contact with current pictures or what specifically has to be said in the letter to the insurance company to get them to help her with the unbelievably high cost of these shoes ?
    Thank You for this great article !!

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