Therapeutic Shoe Bill Puts Pedorthics On the Map

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“Very few people knew who we were and what we did,” said Libby McGraw, CPed, immediate past president of the Pedorthic Footwear Association (PFA). That was pre-TSB, the certified pedorthist from Edina, Minn., added.

McGraw means Medicare’s Therapeutic Shoes for Persons with Diabetes Benefit, which took effect in 1993. Its official acronym is TSD. But many pedorthists still call the measure the Therapeutic Shoe Bill, or TSB for short.

By any name, the benefit put pedorthics on the map. It extended Medicare Part B coverage to eligible diabetes patients for footwear and shoe inserts. Probably no other government action, not even state licensure, has had more effect on the practice of pedorthics.

Mixed Reviews

Even so, the TSD plays to mixed reviews among pedorthists. Evidently the majority see the benefit as a boon, but to some certified pedorthists, it is a bane. Still, others say the benefit is both.

“We live by the bill and die by the bill,” said Roger Marzano, CPO, CPed, vice president of clinical services at Yanke Bionics Inc., in Akron, Ohio.

Apparently, many pedorthists favor broadening the benefit to include arthritis patients and others who suffer serious foot problems. Some certified pedorthists want to expand recognized footwear providers under the TSD to include a new category — therapeutic shoe fitter (TSF).

The therapeutic shoe fitter proposal is controversial. The PFA’s board of directors and the directors of the Board for Certification in Pedorthics (BCP), which sets the industry’s provider standards, oppose the TSF category.

Meanwhile, McGraw, who owns Centennial Lakes Pedorthic Center, added that after the TSD was created, “all of a sudden everybody knew what pedorthics was. We are now getting good recognition and respect from other health care professions.”

Congressional Approval

Congress approved the TSD benefit as part of the Omnibus Budget Reconciliation Act of 1987. The benefit was known as the “Therapeutic Shoes for Diabetics Benefit” until earlier this year, when it became the “Therapeutic Shoes for Persons with Diabetes Benefit.”

Pedorthics

Despite the name change, the benefit’s purpose stayed the same. The TSD is designed to help diabetes patients avoid foot and leg amputations through the use of protective footwear and inserts.

The TSD benefit requires that “the footwear … be fitted and furnished by a podiatrist, or other qualified individual such as a pedorthist, orthotist or prosthetist.” The PFA wants Medicare to clarify who it considers qualified to supply shoes and orthotics, suggesting “podiatrist, certified/licensed pedorthist, certified/licensed orthotist or certified/licensed prosthetist, or other qualified individual who has a credential recognized by the secretary [of the Department of Health and Human Services] as an appropriate supplier of this benefit.”

McGraw said that the TSD benefit “put our name out there in front of the doctors and patients and Medicare. When Medicare agreed to reimburse us for our services, it finally validated our profession, although reimbursement could certainly be more generous.”

McGraw also said the benefit “elevated [recognition of] shoes, orthotics and shoe modifications into the realm of medical devices.” Nonetheless, she said there is room for improvement in the benefit, which “helps pay for one pair of therapeutic shoes per calendar year and for inserts,” according to Medicare. “Shoe modifications may be substituted for inserts.”

McGraw added, “I really wish patients didn’t have to sacrifice a pair of orthotics for a shoe modification. For example, if a person needs a rocker sole, that eliminates one pair of foot orthotics.”

Other Patient Groups

Further, she said the TSD should cover more than just diabetes patients.

“I would like to see other patient groups included, such as people with arthritis who have hypersensitive feet, as opposed to insensitive feet with diabetes patients,” McGraw said. “It was argued that the bill would be cost effective because it would save money down the road by helping prevent amputations among diabetic patients. I wish the focus of the bill had been more on human suffering than on saving money.

“People with hypersensitive feet curtail their activities of daily living. They slow down more and miss out on more because their feet hurt. I wish there was some way they could be covered in the same way diabetes patients are.”

Marzano agreed that the TSD “helped pedorthics increase it viability, visibility and [added to the] sheer number of certified pedorthists.” But he said that the benefit also “embroiled the field in the world of lobbyists and political action committees and increased the struggle, energy and expense required to participate in the bill.

“With negotiated rule making taking place [and] … competitive bidding on the table in the budget, the field of pedorthics can lose everything we have striven to achieve since the implementation of the shoe bill. I think the field needs to expand its domain of practice, recognize that retail pedorthics is a more profitable part of our business and try to influence those in the proper places as to the role of pedorthists as key providers of therapeutic footwear and diabetic inserts as well as orthoses and footwear modifications.

“Certainly we have striven, and continue to strive, to have a new code for a custom-made diabetic orthosis … [and to be] reimbursed at a rate commensurate to the pathology being managed … That could be a significant help to all that provide therapeutic footwear and inserts, but also could further substantiate the viability of a certified pedorthist as an integral part of the diabetic foot care team.”

Rheumatoid Arthritis

Like McGraw, Marzano wants to see more than just patients with diabetes included under the TSD benefit. He would welcome the day when “shoes and orthoses would be covered for patients with rheumatoid arthritis who suffer from crippling foot deformities equivalent to the those with diabetes, as well as others who suffer from neuropathies but do not have diabetes.”

Wayne Decker, CPed, a certified pedorthist and an orthopedic shoe technician, said a big reason the TSD was so important to pedorthics was that the word “pedorthist” was used in the definition of providers under the measure. “This is huge when you consider that no one knew what a pedorthist was just a few years ago and now [pedorthics] … is recognized and promoted as a health care profession by the federal government,” said Decker, owner of American Pedorthic Services in Henryetta, Okla., and a member of the PFA board of directors.

He said that diabetes patients covered by the benefit are “a primary source of income for many pedorthists … This makes it incredibly important for pedorthists to constantly improve the quality of services and products that are being fitted. As certified pedorthists improve their knowledge about the diabetic foot and keep current on the best methods used to protect these people, the rate of amputation is bound to go down, thereby suggesting that pedorthics is an integral part of diabetic care.”

Credibility

Mark Grundman, CPed, a Vincennes, Ind., certified pedorthist, said that the TSD benefit lent credibility to pedorthics “because pedorthists are probably the biggest dispensers under the bill.” Grundman, who owns M.G. Grundman and Sons, an accredited pedorthics facility which makes orthopedic shoes and other footwear, added that the benefit boosted the credibility of certified pedorthists “with the public, the medical profession and the insurance industry, because a lot of people didn’t know what pedorthists did before the … bill.”

Michelangelo Scafidi, CPed, a certified pedorthist in Illinois, suggests that the benefit’s new A5511 code be assigned a new reimbursement level.

“It is too bad that a new code for custom orthoses had to be tied by law to the heat molded (A5509) rate,” said Scafidi, who owns Michelangelo’s Foot Comfort and Pedorthic Shoppe, an accredited pedorthics facility in Chicago.

He also said, “It would be great if the three-per-year allowance for A5509 could be combined for one A5511. While many certified pedorthists charge more than $195 for custom orthoses, it is better than what is covered now.”

Scafidi, a director of the BCP, “also would like to see the benefit opened up to all people suffering with arthritis, pulmonary vascular disorder and neuropathy. Not all neuropathics are diabetic.”

In addition, Scafidi thinks the TSD benefit needs better publicity. “Many doctors and the public still do not know about the benefit. Education about the benefit is key.”

Carl Riecken, CPed, an Evansville, Ind. certified pedorthist and orthopedic shoe technician, agrees that some doctors are still in the dark about the TSD benefit.

“The first group that needs more information and education is the primary care physicians,” said Riecken, president of Riecken’s Shoes and Orthothic Laboratory, an accredited pedorthics facility. “They need to know what the bill provides and pass that information along to their patients who are at risk of [foot] ulceration.”

Additionally, Riecken favors “more policing of the abuses of the program. There are businesses dispensing diabetic footwear as if it were free, and they are not even qualified to fit it properly, much less design a proper orthosis for the patient.”

Similarly, Randy Brown, CPed, of Washington, Mo., sees a danger in “those providers who function on the borderline and distribute footwear via non-certified personnel in an effort to save money, lower expenses and increase distribution — all at the expense of the diabetic.” Brown, owner of Brown’s Enterprises, which includes accredited pedorthic facilities in Washington and St. Louis, said such practices skirt “the real intent of the TSD and, in doing so, place the whole program in jeopardy.”

Brown asks, “Who is better qualified to fit and dispense footwear than pedorthists? We have the specific training and related medical education; we have the inventory, and our accredited facilities have the environment. Additionally, our accessibility to the community must also be considered an advantage over alternative providers.”

Medicare Therapeutic Shoe Bill

In May 1993, Medicare’s Therapeutic Shoes for Persons with Diabetes Benefit took effect. Known by most clinicians as the Medicare Therapeutic Shoe Bill, the bill provides partial reimbursement for depth shoes, custom molded shoes and shoe inserts or modifications to qualifying Medicare Part B patients with diabetes. According to the Centers for Disease Control and Prevention, people with diabetes account for 60 percent of all lower limb amputations in the United States, or about 86,000 amputations each year. Over half of all lower limb amputations associated with diabetes could be prevented. The Pedorthic Footwear Association states the majority of experts agree that most diabetes-related amputations are preventable with properly fitting, appropriate footwear.

Eligibility

Medicare covers diabetic shoes, inserts and modifications if beneficiaries meet the following criteria:

(a) The patient has diabetes and one or more of the following conditions:

  • Previous amputation of the other foot, or part of either foot
  • History of previous foot ulceration of either foot
  • History of pre-ulcerative calluses of either foot
  • Peripheral neuropathy with evidence of callus formation of either foot
  • Foot deformity of either foot
  • Poor circulation in either foot

(b) The certifying physician who is managing the patient’s systemic diabetes condition has certified that:

  • One or more of the indications required by (a) above are present
  • He or she is treating the patient under a comprehensive plan of care for his or her diabetes
  • The patient needs diabetic shoes, inserts or modifications

Medicare carriers recommend that suppliers use the Medicare approved “Statement of Certifying Physician for Therapeutic Shoes” form to satisfy this requirement.

A podiatrist or physician experienced in fitting diabetic shoes and inserts must write the prescription. The footwear must be fitted and provided by a podiatrist or other qualified person such as a pedorthist, orthotist or prosthetist.

What is Covered

Within a given calendar year, the patient can receive 80 percent of the allowed amounts for one of the following:

  • One pair of off-the-shelf depth shoes and three additional pairs of multidensity inserts
  • One pair of off-the-shelf depth shoes including modification, and two additional pairs of multidensity inserts
  • One pair of custom-molded shoes and two additional pairs of multidensity inserts

There may be additional requirements. Contact Medicare for more information.

For more information:

Recognition to Field

Karen Lanier, CPed, a certified pedorthist and BCP president, agrees that the TSD benefit “… has brought great recognition to our field. Today, doctors who 10 years ago had never even heard of a certified pedorthist are writing prescriptions, not only for diabetics in the program, but also for many other foot problems.”

Lanier owns the Hollywood, Fla.-based Branier Orthopedic Care Centers, which are accredited pedorthics facilities. She added that the TSD benefit “has created awareness of pedorthics to the general public. Pedorthics has made significant progress with federal and state government and third parties who, again, were unaware of our profession a few years ago.”

Further, she said the benefit has generated more revenue for pedorthists.

“Not only do the patients come in for their yearly footwear, many of them return throughout the year to purchase additional footwear and pedorthic devices.”

Lanier is for expanding the benefit to cover patients with rheumatoid arthritis, Hansen’s disease and neuropathic disorders.

“Although many of them are not in jeopardy of losing a limb, they are still in dire need of proper fitting, quality footwear fitted by a professional such as a certified pedorthist,” she said.

Don Pierson, CPed, BCP director, of Peoria, Ill., said the TSD gave certified pedorthists a big boost in the medical community by “allowing certified pedorthists to exhibit their expertise and knowledge at providing care for what can be a complex condition. I believe the recognition pedorthics receives when certified pedorthists work as a team with physicians and nurses in treating diabetes-related foot problems outweighs the monetary reimbursement Medicare provides. This confidence from other medical professionals leads to more referrals for a variety of pedorthic services.”

Pierson, the staff certified pedorthist at Plattner Pedorthic Services Inc., an accredited pedorthics facility, also favors expanding benefits under the benefit “to those folks who suffer from neuropathy of the feet, yet do not have diabetes. Also, arthritis can be such a stealer of quality of life for many individuals. I wish there were benefits available for those sufferers. This would need to include footwear, footwear modifications and orthoses.”

Vital to Business

Chris Bonsall, CPed, of Palo Alto, Calif., said the TSD benefit “is important in some aspects and vital in others. It is difficult — but not impossible — to succeed just selling diabetic footwear. However, one can add a nice supplemental to their own practice.”

Bonsall, also an orthopedic shoe technician, is vice president of Walk-Rite Shoes, which operates comfort shoe stores in Palo Alto, Calif. and San Jose, Calif., the latter an accredited pedorthics facility. He said that by including a certified pedorthist as a qualified provider under the benefit, the certified pedorthist “gains in stature and respect. Because the pedorthist has unique training in diabetic feet with respect to shoes and inserts, the diabetic patient receives the best possible service.”

Bonsall would like to see the TSD benefit doubled to two pairs of shoes.

“It is not healthy for a diabetic foot to be in the same pair of shoes every day,” he said. “The perspiration does not have time to dry out and will result in increased bacterial buildup. Also, heavier patients will wear the shoes out before a year is up. Plus, what happens if the shoes are damaged or lost and the patient can’t afford to replace them?”

Bonsall also said certified pedorthists merit more reimbursement. “The single orthotic prices need to be increased to match the total amount of the three heat molded footbeds.”

In addition, Bonsall said the TSD benefit should be changed to permit “only companies or professionals who stock shoes to … dispense them. My experience is that those diabetics who get items from companies who only order and have nothing to try on end up with items that are not the best fit, or do not fit at all.”

Further, Bonsall would amend the TSD to require that anyone dispensing shoes and inserts be licensed or certified. He said the minimum standard should be a certified pedorthist.

“A pharmacist at the local drug store should not qualify,” he said.

Therapeutic Shoe Fitter

Dennis Janisse, CPed, of Milwaukee, and others say the therapeutic shoe fitter should be in the new rule. Janisse, who is also an orthopedic shoe technician, owns National Pedorthic Services, which operates nine BCP-accredited pedorthics facilities in four states.

“I believe that the providers for therapeutic footwear … should not be limited to podiatrists, pedorthists, orthotists and prosthetists,” he said. But Janisse added that the therapeutic shoe fitter would only “be allowed to dispense shoes and pre-made foot orthoses for lower risk patients.”

Janisse said therapeutic shoe fitters could be trained in two to three-day courses focusing on shoe fitting and modifying pre-made orthoses. Students also could be taught “to recognize severe foot problems that would require sending the patient to one of the other qualified providers.” He added that the BCP could even “set the standards for the therapeutic shoe fitter and determine which courses would be required.”

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  TSD plays to mixed reviews among pedorthists. Evidently the majority see the benefit as a boon, but to some certified pedorthists it is a bane. Still, others say the benefit is both.

In addition, Janisse said he proposed the therapeutic shoe fitter classification to help solve “the problem of adequate access to therapeutic footwear for the nearly 7 million people in this country age 65 and older with diabetes. Based on my conversations with pedorthists and other medical professionals, diabetes patients and legislators, there is great concern that people with diabetes are not currently being adequately serviced.”

Janisse said medical professionals who treat minority patients have echoed his concerns about limiting TSD benefit suppliers mainly to podiatrists, orthotists, prosthetists and pedorthists.

“They are worried about who would provide therapeutic footwear for those in rural areas, for Native Americans on reservations and for inner city residents — the same populations that have a significantly greater incidence of diabetes,” he said, adding that therapeutic shoe fitters could be the providers.

Janisse also said the therapeutic shoe fitter category would improve patient care. “More specifically, I am concerned about providing shoes for these [diabetes] patients,” he said. “Podiatrists do not have shoe inventories and have essentially no training or experience in fitting shoes.

“The training for orthotists and prosthetists also lacks any formal shoe fitting component. In addition, many of the orthotic and prosthetic facilities are not interested in maintaining shoe inventories or dispensing shoes. The only one of the four groups with the appropriate level of training with regard to shoes is the certified pedorthist.”

Disagreement

Janisse said he is not alone in challenging the PFA board’s stand on suppliers under the TSD benefit.

“The statements made by the PFA board do not necessarily represent the views of PFA’s membership. There are many sustaining members of PFA as well as ordinary practicing pedorthists who disagree with the PFA board’s position on this issue. They share my concerns about access and shoe fitting skills.”

Larry Schwartz, CPed, president of Apex Foot Health Industries, agrees with Janisse.

“I think that it’s important to clarify that this is not an issue between Dennis Janisse and the PFA,” said Schwartz, whose company is in South Hackensack, N.J. “Since the issue became public, we have heard from many customers and colleagues across several professions who believe that there is a serious need for this designation. Apex strongly concurs for many reasons.”

Schwartz also shares Janisse’s concern about patient access under the TSD benefit.

“First and foremost, the access issue is real and is the paramount issue that needs to be addressed if Medicare is going to propose a new TSD benefit rule,” said Schwartz.

He added that opponents of the proposed therapeutic shoe fitter category “seem to dismiss the access issue without much concern. The areas in this country with the highest incidence of diabetes are areas with few certified pedorthists. For example, according to the Mississippi State Health Department, there are approximately 285,000 Mississippians with diabetes.

“We all can agree that the 11 certified pedorthists in the state would have a tough time responding to the needs of this population. Other states with high diabetic populations such as Alabama and Louisiana have similar disproportions.”

Podiatrists

In addition, Schwartz is unconvinced that making podiatrists recognized provider sunder the TSD benefit will improve patient access. “Podiatrists admittedly receive very little training in shoe fitting and most understandably cannot allocate more than 40 hours away from their practice to become certified pedorthists.”

Schwartz said it is ironic that “many of those on the PFA board who oppose the CTSF [Certified Therapeutic Shoe Fitter] became certified pedorthists themselves without taking the 120-hour course. What makes them the best in their profession is their experience with patients and their enthusiasm regarding patient care. Would they really be better pedorthists had they become certified after 1997 and had taken the 120-hour precertification course?”

A recent issue of Current Pedorthics outlined the PFA board’s opposition to the therapeutic shoe fitter category. “The Board for Certification in Pedorthics’ … current eligibility requirements of 120 contact hours of specific pedorthic precertification education represents the minimum level of education and training necessary to dispense pedorthic devices, especially to patients suffering from diabetes,” the magazine reported.

“A basic course on shoe fitting and modification of premade orthotics for diabetic patients would be insufficient to qualify such an individual to recognize foot problems requiring the attention of a physician or other health care professional, or allow such an individual to dispense pedorthic devices independently without direct supervision of a qualified provider as defined by PFA above.”

David L. Stumph, BCP executive director, agrees with the PFA board.

“BCP in no way supports the proposed fitter category,” he said. “We are evaluating ways to improve the educational requirements for certified pedorthists and the possibility of creating additional levels of credentials for pedorthists.

“We see this as a public safety issue. Patients with diabetes have complex medical needs that cannot be understood in two or three days of training. Currently, one only needs 120 hours of formal training to become a certified pedorthist. We believe that a public awareness campaign would be a far greater benefit to the patients by making them aware that pedorthic services exist and can be obtained from certified pedorthists as well as from podiatrists, certified orthotists and certified prosthetists.”

More Education

The PFA and BCP agree on the need for more pedorthic education, according to Current Pedorthics. “Any second layer of certification within the pedorthic industry should be of a higher, not a lower, level of educational mastery … federal and state governments are raising the bar for all allied health professions and are increasingly turning to certification and licensing procedures as protection for the public.”

Current Pedorthics also reported “that the recognition of a shoe fitter designation could negatively affect the credibility accorded to the profession of pedorthics. As government regulations and legislation change, creating a ‘lower level’ designation while simultaneously fighting for recognition of the present designation could create negative perceptions and consequences for all of those who practice our profession.”

PFA president Alan Darby, CPed, LPed, said that Congress and Medicare set the standards for whom the government considers qualified. “For us, it was great that certified pedorthists were included in the original 1987 statute,” said Darby, vice president of Wrymark Inc., a St. Louis firm that includes Resource Pedorthics, an accredited pedorthics facility. “But we’re aware that other qualified provider classifications may exist and may emerge in the future, which is why we’ve been recommending adding the words ‘or other qualified individual who has a credential recognized by the secretary as an appropriate supplier of the benefit.’”

Darby said that as far as he is aware, no certification process for therapeutic shoe fitters currently exists. Thus, Medicare regulations couldn’t recognize such a category, he added.

“Whatever Medicare decides to do regarding the question of access, the bottom line for PFA is that we’re a membership association, not a credentialing group,” Darby said. “Credentials are within BCP’s territory. Generally speaking, greater access to care is normally beneficial to patients, but patient access is not a replacement for patient care.”

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