Study Questions Necessity Of Diabetic Footwear

Podiatrists often turn to therapeutic footwear when trying to prevent re-ulceration in diabetic patients. A recent study in the Journal of the American Medical Association suggests regular shoes may work just as well for some of those patients, although some DPMs question the study.
The randomized study was comprised of 400 men and women who had diabetes and a history of foot ulcers. The first group of 121 patients wore extra-depth therapeutic shoes and customized cork inserts. The second group of 119 patients wore therapeutic shoes and prefabricated, polyurethane inserts. The control group of 160 patients wore their own shoes.
What were the results? After two years, researchers found similar re-ulceration rates in all of the groups: 15 percent in the first group; 14 percent in the second group; and 17 percent in the third group.

“The results were surprising,” noted principal study investigator Gayle E. Reiber, MPH, PhD, to ThatFootSite.com. “The popular notion among foot specialists is that therapeutic shoes and inserts should be prescribed freely to all patients with diabetes and prior foot ulcers. However, this study did not provide evidence to support this practice.”
Yet a couple of podiatrists disagreed with this assertion.
“My experience with diabetic therapeutic shoes has been universally positive,” says Douglas Stoker, DPM, a Fellow of the American College of Foot And Ankle Surgeons. “Many of the diabetic patients that are on Medicare wear shoes far too long and do not necessarily wear the type of shoes that they should. The use of the therapeutic shoes has helped these people tremendously, along with the orthotics that are included in the treatment.”
While Dr. Stoker says he has not gone back and done a statistical analysis of the ulcer rates on his own patients, he does not believe shoe dispensing patterns should change at all as a result of the study. He says the study “does not tell (him) anything except that attention to good foot care does reduce the incidence of foot ulcerations.”
Guy Pupp, DPM, the Clinic Director at the Kern Hospital and Medical Center in Warren, Michigan, also disagrees with the study results and says he wants to recreate the study of diabetic footwear. He does not disagree with the study’s conclusion that routine care is important but says he does rely upon therapeutic shoes for diabetic patients.
“In our clinics, without the proper therapeutic shoes, re-ulceration is predictable,” says Dr. Pupp, who is also the Clinic Director at the Sinai Grace Diabetic Foot Center in Detroit. “This is especially true if the primary etiology has not been addressed, but is also necessary to balance weightbearing pressures after surgical intervention.”
The re-ulceration rates reported in the study were lower than those found in several previous European studies. Citing possible reasons for the lower rates, Dr. Reiber told ThatFootSite.com that all study participants wore specially designed slippers when they were not wearing their shoes.
Dr. Reiber, who practices within the Veterans Affairs (VA) Puget Sound Health Care System and is affiliated with the University Of Washington, also emphasized that all patients had access to good quality health care. Every 17 weeks, the researchers documented patient data, including physical, foot and diabetes characteristics; footwear use; foot lesions and ulcers.
However, Dr. Pupp says it is not realistic for podiatrists to see patients every 17 weeks since many patients blow off or forget about their appointments. He says he recently saw one patient for the first time in several months and the man had “horrendous” ulcers, the size of silver dollars. Even if patients do not keep their appointments, Dr. Pupp says therapeutic shoes are with them all the time, which enables him to have some influence on the patients even if they do not see him regularly.
“I rely on those shoes a hell of a lot more than that patient showing up for an appointment,” claims Dr. Pupp.
Dr. Stoker also pointed out a few things about the study, noting that it doesn’t indicate what type of shoes were worn by those who wore their own shoes. He feels that information is important.
Dr. Stoker also emphasized that the study concentrated only on people with ulceration problems, and he feels therapeutic shoes are also a “great help” to diabetic patients with neuropathy, contracted toes, bunions and painful callus tissue.
According to the report by ThatFootSite.com, study researchers did note that the study excluded the 5 percent of diabetic patients with severe foot deformities or other problems who may benefit from therapeutic footwear.
In the JAMA article, Dr. Reiber and her co-authors didn’t entirely discount the role of special footwear in diabetics, but suggested that careful, attentive foot care from health care professionals plays more of a prominent role.
“I agree with the statement that regular, good diabetic foot care does more to prevent problems than any other modality, including shoes,” notes Dr. Stoker. “Shoes are certainly important but in and of themselves, they will not solve these problems. It would be interesting to see what would happen if this type of regular foot care was not provided to the same group of people. I would guess that the type of shoe would make more of a difference in that case.”

CMS Offers New Codes For Patients With Diabetic Neuropathy
Recent changes to Medicare coverage mean DPMs may have to familiarize themselves with three new HCPCS codes.
Effective July 1, Medicare started covering evaluation and treatment of those who have diabetic sensory neuropathy with new billing codes. According to the Centers for Medicare and Medicaid Services (CMS), the code G0245 covers the initial evaluation of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS).
However, there is a caveat to using the G0245 code, according to Billie Bradford, the Director of the Department of Socioeconomics and Practice Management with the American College of Foot and Ankle Surgeons.
"Each provider or provider group, of which a physician is a member, may only receive reimbursement once for G0245 for each patient,” explains Bradford. “However, should that patient need to see a new provider, that new provider may also be reimbursed once for G0245 for that patient.”
The new code G0246 covers follow-up evaluation of these patients, but it will only be paid once within a six-month period for a given practitioner, notes Bradford.
According to the CMS, both the initial examination and follow-up must include a diagnosis of LOPS, patient history, physical examination that includes an inspection of the forefoot, hindfoot, and toe web spaces, notes Bradford. It also must include evaluation of protective sensation, foot structure and biomechanics, vascular status and skin integrity, evaluation and recommendation of footwear, and providing of patient education.
The 2002 Medicare non-facility physician fee for G0245 is $61.54 and the in-facility physician fee is $45.61. For code G0246, the non-facility physician fee is $36.20, while the in-facility fee is $23.17.
The G0247 code covers routine foot care of a diabetic patient with diabetic sensory neuropathy. Routine care includes local care of superficial wounds, debridement of calluses, and trimming and/or debridement of nails. Bradford says you must bill code G0247 on the same date of service with either G0245 or G0246 in order to be considered for payment.
For this code, Medicare lists the non-facility physician fee as $39.82, with the in-facility fee at $27.87.

— B.M.

In Brief
• Biolitec, Inc. is seeking investigators for a new clinical study to determine the efficacy of laser light at the 980 nm wavelength in healing diabetic foot wounds.
For more information, call Biolitec at (800) 934-2377, e-mail at woundhealstudy@biolitec.com or visit www.biolitec.com.
• Getting reimbursed for using the AmeriGel Wound Dressing just got a little easier. AmeriGel has been assigned the HCPCS code “A6248 Hydrogel dressing, wound filler, gel, per fluid ounce” for Medicare billing, according to the Centers for Medicare and Medicaid Services.
Podiatrists with durable medical equipment licenses can submit form 1500 to DMERC for reimbursement. AmeriGel, made by AmerX Health Care, is indicated for stage I-IV pressure ulcers and other conditions.
• As reported in the June 1 Podiatry Today E-News, Langer, Inc. announced it has acquired the assets of Benefoot, Inc. and Benefoot Professional Products, Inc. Langer provides orthotics and gait-related products and Benefoot distributes Birkenstock products. Both companies are based on Long Island, N.Y.