April 2019

Therapeutic Shoes Work for People with Diabetes. Why Doesn’t Every Patient Use Them?

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Patients are unaware or reluctant, and some providers hesitate to engage in what can be a burdensome prescribing and procuring process—helping explain why uptake of this valuable preventative is disappointing.

By Erick Janisse, CO, CPED

As allied healthcare professionals, we are, of course, acutely aware of the ever-growing diabetes epidemic in the United States. As shocking as it is that more than 30 million Americans live with diabetes (90% to 95% of whom have type 2 disease), the situation grows even more disturbing when statistics are divided by age: More than 1 of every 4 Americans older than 65 years has diabetes—accounting for roughly 12 million cases.1 That’s correct: Slightly more than a quarter of Medicare-aged Americans have diabetes and are therefore at risk of diabetes-related foot problems.

As the prevalence of diabetes (and obesity) began to rise sharply in the 1980s, a group of healthcare providers, including leading endocrinologists, orthopedists, and pedorthists, came together with Congress to develop a plan that would lead to having shoes and inserts covered by the Medicare program as a preventive measure for at-risk beneficiaries with diabetes (see Table 12). Congress passed this bill and President Ronald Reagan signed it into law as part of the Omnibus Budget Reconciliation Act of 1987. The benefit went live in 1993 and came to be known as the “Therapeutic Shoes for Persons with Diabetes” benefit.

“Fewer than 20% of eligible Medicare beneficiaries with diabetes use the plan’s therapeutic shoe benefit and receive shoes and inserts.”

Brian Lane, BS Ed, CPed

But Utilization Is (Surprisingly) Low

Although much research has been conducted and published to demonstrate the efficacy of depth shoes and inserts in preventing such diabetic foot complications as ulcers and amputation, it appears that the Medicare benefit is not being utilized as often as one might assume. According to Brian Lane, BS Ed, CPed, education director at Dr. Comfort, manufacturer of shoes and other products for people with diabetes, fewer than 20% of eligible beneficiaries use the benefit and receive shoes and inserts.

“Back in 2015,” Lane says, “Dr. Comfort commissioned a report via the Freedom of Information Act to determine just how many therapeutic shoes and inserts Medicare actually pays for on an annual basis. The findings were as disappointing as they were upsetting. We suspected the number would not be anywhere close to 100% utilization, but we certainly didn’t expect it to be as low as it is.”

When asked why numbers are lower than expected, Lane looks back to his time managing a large podiatric practice in Atlanta, Georgia, and points to a lack of awareness as an explanation.

Table 1. Objectives for Prescribing Therapeutic Shoes for Persons With Diabetes2

  • Protect the foot
  • Relieve areas of excess pressure
  • Reduce shock
  • Reduce shear
  • Accommodate deformities
  • Stabilize and support deformities
  • Accommodate foot orthoses and AFOs.

“A lot of times, patients who might be eligible for therapeutic shoe coverage are not only unaware of the benefit,” he points out, “but they do not even understand that they are at risk for developing foot problems… until they occur. I also believe that the changes Medicare made in 2011 requiring more documentation have made it more difficult for patients to obtain the shoes. As a result, patients—and some providers—have just stopped trying.”

A survey of African Americans with diabetes, conducted by the American Podiatric Medical Association, appears to corroborate what Lane reports: At least 45% of respondents had some type of diabetes-related foot problem (including 7% who had an ulcer), but only 17% have, or have ever had, therapeutic shoes.3

Milwaukee area-based podiatrist Sean E. Wilson, DPM, agrees: Lack of patient awareness and the complexity of required documentation are major obstacles to eligible beneficiaries obtaining therapeutic footwear, even when patients know that the Medicare benefit exists.

“A large portion of our elderly diabetic population, diabetes educators, and primary care physicians just don’t understand what steps must be taken and what documentation is necessary to be able receive shoes,” Wilson says. “Simply being on Medicare and having diabetes isn’t enough.”

To Wilson’s point, medical necessity for eligibility requires that the patient also have any 1 of 6 qualifying conditions (see Table 2). Medicare then requires suppliers to obtain, and verify for accuracy, a physician’s office notes confirming 1) the presence of 1 or more of those qualifying conditions and 2) that the patient is being treated under a comprehensive care plan for their core systemic disease. Here is where the process often gets bogged down.

“The whole process moves along more smoothly when everyone involved understands what is required of them,” Wilson says. “This education needs to be the first step. I make sure my patients are aware that the pedorthist to whom I refer them will need to procure signed documents and notes from their primary care doctors and that it is a multistep process that won’t happen overnight.

“Unfortunately, I have no control over how things are handled on the [primary care physician’s] end. I know there are times it takes weeks to get the necessary paperwork…. Given the dramatic rise in diabetes in our country, the need for and importance of proper shoe gear and accommodative inserts is at an all-time high. They are critical for the prevention of ulcers and amputations.”

“It is up to the whole team—CDEs, doctors, pedorthists—to reach and educate people with diabetes about possible foot complications [and] to convey the message about foot complications as positively as possible.”

Joan McGinnis, MSN, RN,CDE

Education and Teamwork Can Make a Difference

Certified diabetes educators (CDEs) are the boots on the ground in the effort to raise awareness of all things diabetes among people who have the disease. According to the American Association of Diabetes Educators, more than 15,000 CDEs practice in the United States. That might sound like a lot, but it isn’t when you consider that more 30 million people in this country have diabetes: There is 1 practitioner for every 2000 people who would benefit from the services of a CDE. Furthermore, CDEs tend to concentrate in population-dense areas, rather than in rural areas.

Recently retired diabetes educator Joan McGinnis, MSN, RN,CDE, of St. Louis, Missouri, offered her thoughts on this topic, based on decades of helping people with diabetes.

“It is up to the whole team—CDEs, doctors, pedorthists—to reach and educate people with diabetes about possible foot complications. For many of the programs that I coordinated and conducted over the years,” McGinnis explains, “I would bring in a respected certified pedorthist to talk to my patients about the importance of proper footwear and how and where to obtain it. I am not an authority on footwear, so I found it most helpful to utilize the experts.”

McGinnis believes it is important to convey the message about foot complications as positively as possible.

“Anyone can go online, search for and find all sorts of negative, frightening information about diabetes and foot complications. I don’t think that is very constructive,” she contends. “People will tune out; they don’t want to read about the scary things that can happen to them. The information needs to be presented in a proactive, glass-half-full style. We need to let them know that, while these problems are possible, they are preventable—and often easily preventable.”

McGinnis agrees that explaining the steps required for accessing and using Medicare’s therapeutic shoe benefit is important to do early on: “Patients need to have a firm understanding of the insurance process and fully advocate for themselves.”

Need to Overcome Provider and Patient Reluctance

Table 2. General Practitioners Must Certify Patients to Receive the Benefit As Follows:

I certify that all of the following statements are true:

  1. This patient has diabetes mellitus
  2. This patient has one or more of the following conditions (check all that apply)

___ History of partial or complete amputation of the foot

___ History of previous foot ulceration

___ History of pre-ulcerative calli

___ Peripheral neuropathy with evidence of callus formation

___ Foot deformity

___ Poor circulation

  1. I am treating this patient under a comprehensive plan for his/her diabetes.
  2. This patient needs special shoes (depth or custom-molded shoes) because of his/her diabetes.

Source: Therapeutic Shoes Statement of Certifying Physician Template Draft R1.0a 6/08/2018. Available online at www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Electronic-Clinical-Templates/Downloads/Therapeutic-Shoes-for-Persons-with-Diabetes-Statement-of-Certifying-Physician-Template-Draft-R10a-6082018.pdf. Accessed April 15, 2019.

When Pedorthic Footcare Association (PFA) Past President Christopher Costantini, CPed, is asked if he sees any barriers to beneficiaries obtaining therapeutic shoes, he replies that patient perception of the program can be negative.

“There are definitely significant obstacles,” says Costantini, who has been involved with pedorthics and providing diabetic shoes since 1993. “There is a lack of understanding of the benefit, what it entails, and what the beneficiary is responsible to do. Many of the requirements make it appear as though we, the suppliers, are just making things difficult. The beneficiary only knows that there is interaction that occurs with their providers and they often don’t really know what it is all involved—just that it causes delays in them receiving their shoes and inserts.”

Clearly, patient education and elevated awareness are key to increasing use of shoes and inserts and decreasing ulceration and amputation rates.4,5 As Dr. Comfort Educator Director Brian Lane says, however, some providers have, regrettably, just “given up” on providing therapeutic footwear because of the increased burden of documentation.

Notably, and to Lane’s point, the Centers for Medicare & Medicaid Services (CMS) have conducted quarterly Targeted Probe and Educate (TPE) audits of claims for therapeutic shoes over the past few years. That Medicare is even conducting these audits speaks to the fact that documentation requirements are not being understood or adhered to by suppliers. According to CMS, “TPE is intended to increase accuracy in very specific areas [by using] data analysis to identify: providers and suppliers who have high claim error rates or unusual billing practices, and items and services that have high national error rates and are a financial risk to Medicare.”

Some TP audits have shown an improper payment rate as high as 80%, with the top reasons for denial being entirely documentation-related.

Costantini, currently chief of prosthetics and sensory aid services at the Canandaigua Veterans Affairs Medical Center in the Finger Lakes region of New York, says that, during his many years on the Pedorthic Footcare Association’s executive board, he observed an exodus of sorts in recent years among providers looking to get out of the Medicare therapeutic shoe business.

“We have definitely seen movement away from providing footwear for patients with diabetes by both pedorthists and other O & P providers,” Costantini acknowledges. “They feel the economics just aren’t there, especially if they are set up with Medicare to accept assignment in their practice. The consensus among folks leaving therapeutic footwear behind is that there is a ton of work that goes into getting the paperwork in order.”

Costantini says that it is especially difficult getting started with a new physician unfamiliar with the process.

“Until you have worked with a particular primary care physician for a while and gotten them familiar with the process of providing you with the written documentation required, it all seems overly burdensome to the physicians. Remember that they have to take time out to get all the paperwork in place for something they will not be paid for. Once you have your paperwork from the certifying physician, you then have to go through the same exercise with the podiatrist or prescribing physician.”

Among the reasons Costantini hears why people opt out of the program is the labor-to-reimbursement ratio.

“They feel reimbursement is much lower than that of other products, so many pedorthists look at all that is involved and decide their time is better spent elsewhere,” he points out. “Many discover they could see one or more patients for other pedorthic modalities who are paying out of pocket and make the same or more money without having to spend the time and energy to track down the paperwork required to provide shoes for 1 patient with diabetes.”

“There has definitely been movement away from providing footwear for patients with diabetes by both pedorthists and other O & P providers.”

Christopher Costantini, CPed

Not All Doom and Gloom

Many practitioners have demonstrated that providing therapeutic shoes to Medicare beneficiaries can be profitable—as long as the volume is there and the work is done as efficiently as possible.

“It is imperative that suppliers are doing everything they can to avoid sending shoes back and reordering them in a different size,” Lane says. “This only serves to slow down the process and creates additional visits that necessarily cut into the bottom line. You need to get it right the first time.”

Some of the tools Lane recommends that suppliers use are manufacturer-specific Brannock devices for measuring shoe size and a full run of shoe sizes on hand to have patients try on, all to ensure proper sizing and ordering.

Increasing the volume of patients and increasing awareness of the benefits of therapeutic footwear go hand-in-hand with that strategy, says Costantini.

“I have always found health fairs to be a great marketing tool. Often, I have set up, or joined, a community event and done presentations on footwear for patients with diabetes and the requirements to get the shoes. I’ve done presentations to physician groups and partnered with third-party payers to rent a booth in provider meetings to be able to discuss the benefit and requirements directly with providers. Getting the message out there is paramount.”

When asked to compare utilization of therapeutic shoes in the VA system, compared to the Medicare population, Costantini shared valuable insight.

“Providing footwear to veterans with diabetes is certainly a lot easier than it is to provide them to the general population. In the VA system, we only concern ourselves with medical necessity.” He adds that “if a provider establishes and documents that footwear is medically necessary and the veteran qualifies for care in the VA system, the shoes are provided at no cost to the veteran. I think it is quite telling that the VA spends about $88 million annually on footwear, much of which is for patients with diabetes.

“If you remove the roadblocks, patients certainly recognize the value and desire the care,” Costantini concludes. “They just have difficulty getting it in many areas.”

Erick Janisse, CO, CPed, has more than 20 years of experience as a certified orthotist and pedorthist and currently works as a corporate trainer for Dr. Comfort, a division of DJO Global.

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REFERENCES
  1. Division of Diabetes Translation, National Center for Chronic Disease Prevention, Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017: Estimates of diabetes and its burden in the United States. 2017. www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed April 25, 2019.
  2. Janisse D, Janisse E. Pedorthic management of the diabetic foot. Prosthetics Orthotics Intern. 2015;39(1):40–47.
  3. American Podiatric Medical Association; Kelton Research. APMA Diabetes Survey. September 2009. www.apma.org/files/FileDownloads/2009%20Diabetes%20Survey%20Results%20.pdf. Accessed April 25, 2019.
  4. Bus SA, van Deursen RW, Armstrong DG, et al; International Working Group on the Diabetic Foot. Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016;32(Suppl 1):99-118.
  5. Wu SC, Driver VR, Wrobel JS, Armstrong DG. Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manag. 2017;3(1):65-76.
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