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Reimbursement Page
Closing Out 2022
Review rules for holiday gift giving and Medicare participation status
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IT’S THE END OF the calendar year— the season for holiday gift giving, and time to review your facility’s Medicare participation status. This month’s Reimbursement Page provides a quick refresher on the rules for providing acceptable gifts and for updating Medicare participation.
Gift Giving
The giving of gifts to Medicare patients and referral sources is acceptable and allowed; however, some restrictions must be followed. These restrictions prevent your facility from providing a gift as an inducement to encourage patients to choose you, or to encourage referral sources to provide you with business. If these provisions are not followed, your gifts could be considered noncompliant and could land you in serious trouble.
What should you keep in mind when shopping for gifts to patients? In 2002, the Office of Inspector General (OIG) for the Department of Health and Human Services published a special advisory bulletin, “Offering Gifts and Other Inducements to Beneficiaries.” This bulletin outlined three guidelines, still in effect, that must be followed in providing gifts to Medicare beneficiaries: • Gifts cannot be cash or eligible for cash equivalents. • Gifts must be inexpensive or of nominal value. • You may not give gifts with the purpose of securing your services to a patient.
While gifts to patients of cash, or cash equivalents of any kind—including gift certificates or gift cards—are strictly prohibited, the use of nonmonetary gifts is acceptable as long as the gifts are of nominal value. OIG had originally stated that the value of gifts should not exceed $10 per gift, with a $50 aggregate per calendar year. However, these values have been increased over time to $15 per gift, with a $75 aggregate per calendar year. You may offer patients a maximum of five gifts valued up to $15 each in any calendar year. In addition, there may not be terms or strings associated with a gift, according to the OIG report. For example, you cannot require that a patient come in for an evaluation to receive their gift, or that they only receive the gift if they choose to receive a particular service or item.
Some of the same rules apply for gifts to referral sources. Gifts of cash or cash equivalents of any kind—gift certificates, gift cards, and free samples of products— are prohibited to referral sources, but nonmonetary gifts are allowed under very limited circumstances.
First, the value of the gift may not be tied to the volume of referrals received from a physician’s office. For example, you cannot provide a gift of higher value to your regular referral sources than you do to practices that only refer patients periodically. While you are not required to offer the same gift to all of your referral sources, you cannot base your decision on the number of referrals you receive.
Second, gifts may not be directly solicited by referral sources. If a referral requests a specific gift and you provide it, this could be construed as an inducement and a violation of federal antikickback statutes.
Third, there is a limit to the amount of money that may be spent on gifts to referral sources. This gift limit fluctuates from year to year and is adjusted according to the increase in the Consumer Pricing Index. For 2022, the aggregate limit is $452, so any gift or gifts provided to a referral source in 2022 may not exceed $452. Remember that the annual $452 aggregate is a limit, not an entitlement.
When dealing with gifts for patients and referral sources, consider consulting with an attorney, or OIG, if you have any doubts, as it can be very easy to go from an acceptable gift to a nonacceptable gift.
Participation Status
Before changing your participation status, make sure you understand what it means. The term “participating supplier” does not relate to whether you wish to be enrolled in the Medicare program or not—by the act of completing a Medicare enrollment application and obtaining a Medicare supplier number, you are part of the Medicare program.
Participation status instead relates to your agreement with Medicare to either automatically accept assignment for all Medicare claims or not to accept assignment on claims; your decision to be a participating or a nonparticipating supplier hinges primarily on how you wish to handle the assignment of Medicare claims, and the choice to accept assignment only relates to the amount of money you may collect from the patient and where Medicare will send its check.
When you elect to be a participating supplier, you agree to accept assignment on all Medicare claims; and by accepting assignment, you agree to accept the Medicare allowable for any given item or service as payment in full and you don’t have the ability to balance bill a patient. This means that Medicare will forward its payment, 80% of the approved allowed amount, directly to you, and you may then collect the remaining 20% coinsurance directly from the patient.
A nonparticipating supplier, on the other hand, is not automatically tied to accepting assignment and will have the ability to make a claim-byclaim decision on whether to accept assignment. The decision to accept or not accept assignment, however, must be on a claim-by-claim basis; you cannot accept assignment on one claim line and then not accept assignment on another claim line.
Also note that when a nonparticipating supplier elects not to accept assignment, the supplier has the ability to collect its usual and customary Not accepting assignment, or becoming a nonparticipating supplier, does not relieve you from meeting Medicare policy criteria.
charge from the patient, or balance bill the patient, and is not required to accept Medicare’s allowable as payment in full at the time of service.
When not accepting assignment, remember you must still submit the claim on the patient’s behalf, but Medicare will make its payment directly to the patient, and the patient is not obligated to use the Medicare payment to pay you.
Also remember that not accepting assignment, or becoming a nonparticipating supplier, does not relieve you from meeting Medicare policy criteria, including documentation requirements, or eliminate your financial liability should the claim be denied.
Your elected participation status with Medicare is valid for one year and may only be changed during the open enrollment period, typically in mid-November. The contractors in charge of supplier enrollment and revalidations will send all Medicare-enrolled suppliers a letter reminding them of their current participation status. The letter also informs each supplier that if they wish to change their current participation status, they must do so before December 31, the closing of the open enrollment period.
Prior to Nov. 6, 2022, there was only one contractor handling all enrollments and revalidations for suppliers of durable, medical equipment, prosthetic, orthotic and supplies: Palmetto GBA or the National Supplier Clearinghouse. There are now two contractors, and each contractor will handle a different region.
Novitas Solutions will handle all suppliers in the eastern part of the United States, including Alabama, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, District of Columbia, Puerto Rico, and U.S. Virgin Islands, and will be referred to as National Provider Enrollment (NPE) East. The Novitas Solutions website for NPE East is novitas-solutions.com/ webcenter/portal/DMEPOS.
Palmetto GBA will continue to handle all suppliers in the western part of the United States, including Alaska, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Iowa, Kansas, Louisiana, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wyoming, American Samoa, Guam, and Northern Mariana Islands, and will be referred to as NPE West. You may still use the old National Supplier Clearinghouse website for Palmetto GBA to access information about NPE West, or you may use the new site, palmettogba.com/palmetto/npewest.nsf.
If your organization has a current participation agreement in effect for 2022 and you wish to be nonparticipating for 2023, you must submit written notice to Palmetto or Novitas informing them that you no longer wish to be a participating provider. There is not a standard form to be used for this written notice; it is simply a letter from you to Palmetto/Novitas informing them of your desire to change your participation status. The letter must be on your official letterhead and signed by one of your company’s authorized
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representatives. The authorized representative must be the same person who is on file as an authorized individual— most likely a CEO, chief financial officer, president, or board member. If you are unsure who is on file as the authorized individual for your company review, your most recent Medicare enrollment application and the authorized officials are listed in Section 15.
The letter must be received no later than Dec. 31, 2022; the letter may not be postmarked by December 31 and arrive at a later date.
If your company is currently enrolled as a nonparticipating provider and you wish to change your company’s status to participating, the process is a little bit more formal than simply mailing a request letter to the appropriate contractor. Your company must complete an official Medicare Participation Agreement for 2023, or the CMS-460 form. The CMS-460 is only one page in length and may be filled out by anyone; however, it must be signed by an authorized individual. The completed form must be received by Dec. 31, 2022, or your participation status will remain nonparticipating for 2023. Visit cms.gov/Medicare/ CMS-Forms/CMS-Forms/downloads/ cms460.pdf to download the form.
If you are happy with your current Medicare participation status and you do not wish to make any changes for 2023, simply do nothing and your status will remain the same.
One last thing to keep in mind: Your participation status is tied to your tax ID and not to the physical location of your facility, and any changes you make will not take effect until the start of the next calendar year. So, if you have several locations operating under the same tax ID, you may not have some locations be nonparticipating and other locations be participating; it is all or nothing. If you plan to make a change for 2023, be sure you understand how it may impact your front-office operations, and be sure all of your staff is aware of the change.
Devon Bernard is AOPA’s assistant director of coding and reimbursement services, education, and programming. Reach him at dbernard@AOPAnet.org.
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Emergency RESPONSE
American O&P professionals answer calls for help in war-torn Ukraine
By MICHAEL COLEMAN
NEED TO KNOW
• Between 8,000 and 10,000 individuals in Ukraine—both soldiers and civilians—have lost limbs since February, when Russia first invaded the sovereign nation.
• Many O&P professionals and organizations have donated their time, services, and devices to help treat both new amputees and Ukrainians with preexisting amputation who are struggling to access care and componentry.
• Some U.S. clinicians and volunteers travel to Ukraine to treat patients at facilities or makeshift clinics using donated equipment and componentry; other groups arrange for Ukrainians to travel to the United
States for prosthetic care and rehabilitation.
• Humanitarian groups, charitable organizations, and independent volunteers have been working collaboratively to provide aid, equipment, and care—complementing each other in a common purpose.
EARLY ON THE morning of November 15, Vira Hrabchuk, project manager at the newly launched Unbroken National Rehabilitation Center (Unbroken) in Lviv, Ukraine, sent an email via cellphone to O&P Almanac apologizing that she was unable to join a scheduled Zoom interview.
“Hello! Ukraine is currently under attack,” Hrabchuk wrote. An estimated 100 missiles rained down on Ukraine, including Lviv, as Russia’s brutal invasion of the sovereign nation stretched into its 10th month. “I am sorry, we are currently without good Wi-Fi and electricity. We don’t know when it will be back, but we will reach out to you ASAP. Thank u!”
Fortunately, Hrabchuk, her colleagues, and their patients at Unbroken escaped injury and destruction that frightening day. Four days later, Hrabchuk and her boss, Mariana Svirchuk, executive director of the Lviv Emergency Hospital and chief of Unbroken, explained how they are scrambling to provide prostheses and rehabilitation services to some of the estimated 8,000 to 10,000 Ukrainians who have lost limbs since the war began, and another 400,000 preexisting amputees who no longer can access routine care, because O&P clinics have been destroyed by bombing, according to estimates from the Limbs for Life Foundation. “Right now, the Ministry of Health says that we still have 5,000 people— civilian and military—who need prostheses,” Svirchuk says. “We need money and equipment, but the main thing we need is technicians who can come to Ukraine for a month, or even two or three weeks, to help us.”
PHOTOS: Limbs for Life Foundation, Getty Images Limbs for Life Foundation collecting thousands of donated prosthetic devices and componentry, assembling them into limbs, and shipping them to Poland
First group of soldiers who received care at the Protez Foundation before departure back to Ukraine at Minneapolis-St. Paul airport
Called to Action
O&P professionals across the United States are answering the call, helping to provide equipment, training, and care across the sprawling nation of 43 million people that is roughly the size of Texas. American O&P clinicians and leaders of nonprofit relief agencies are taking part in a coordinated effort to assist Ukrainians with new amputations, including soldiers injured in battle as well as civilians whose limbs have been destroyed by land mines, crushed in bombed buildings, or irreparably damaged by frostbite and sepsis.
Jeff Erenstone, CPO, founder of nonprofit Operation Namaste, traveled to Ukraine with his mobile limb lab and a group of clinicians in September to train Ukrainian O&P clinicians. U.S. nonprofit organizations Limbs for Life Foundation and Penta Medical Recycling are collecting thousands of donated prosthetic devices and componentry, assembling them into limbs, and shipping them to Poland, where they are being transported across the border into Ukraine. Yakov Gradinar, CPO, a Ukrainian-born orthopedic surgeon based in Minneapolis, helped launch the Protez Foundation, a nonprofit that is arranging for war-wounded Ukrainians to travel the U.S. to be fitted with prostheses, rehabilitated, and, in some cases, returned to Ukraine at their request to rejoin the battle against Russia. Hanger Clinic sent several employees to Ukraine this year to help restore mobility to about 50 people who lost their limbs as a result of the ongoing war.
Seth Mischo, a former airborne infantryman and biomedical engineering student at Wake Forest University School of Medicine, helped coordinate relief efforts after traveling to the Ukrainian-Polish border on a medical aid mission early in the war. While there, Mischo connected with key logistical officials and witnessed firsthand the country’s urgent need for O&P care. After returning home to North Carolina, Mischo connected the aforementioned O&P industry professionals in hopes of getting urgently needed prosthetic and orthotic help to Ukrainians. Since then, the ad hoc relief team members have kept in touch and continue to coordinate their relief work.
“We slowly got the ball rolling on helping to get everyone who needed to be together, together to start the effort,” Mischo recalls, adding that an associate put him in touch with AOPA, which connected him with other players in the U.S. O&P industry. The challenge of providing adequate O&P care to the massive number of new limb-loss patients in Ukraine is immense—not only due to the onslaught of new amputees into the state-run healthcare system, but also because the former Soviet nation’s O&P infrastructure is lacking, and professionally trained prosthetists are in short supply. The lack of clinicians is particularly glaring in eastern Ukraine, which has been plagued by strife in Russian separatist-controlled areas since 2014. Making matters worse, O&P care is not categorized as a healthcare profession by Ukraine’s Ministry of Health, meaning it receives less governmental funding than other healthcare disciplines. Instead, it is categorized as a social service under the umbrella of the Ministry of Social Policy, which oversees efforts as disparate as adoptions and labor relations.
Limited Capacity
As of 2018, there were just 216 technician-prosthetists in Ukraine—and no national strategy for upgrading the existing O&P workforce, according to a 2021 World Health Organization report. Some O&P clinicians in Ukraine have limited capabilities; many are quite adept at lower-extremity but less skilled in upper-extremity care, according to individuals with experience in Ukraine. Meanwhile, O&P clinics that are well stocked with plaster, thermoplastics, ovens, grinding tools, and other modern equipment are few and far between. In August, Ukraine’s Ministry of Health reported that 906 healthcare facilities of all kinds had been damaged by Russian attacks—and 123 completely destroyed.
“There is a lot of disruption to existing O&P facilities in the eastern part of Ukraine, or even the middle part of Ukraine,” Erenstone says. One facility centrally located in Kharkiv was bombed, “and they had to dismantle it and kind of move it around.” To help provide equipment, Erenstone traveled to the Unbroken Rehabilitation Center in Lviv with his Limbkit, a compact mobile lab that folds up into a box and can be transported in a small truck or van to provide comprehensive transtibial prosthetic care. “The front part of it comes off and turns into a table that goes next to it, and you add them together and it becomes a sort of workbench and tool storage,” Erenstone explains. “That’s what we deployed in Ukraine.”
Erenstone’s team fitted about 10 patients with prostheses during the trip—mostly soldiers and civilians with lower-extremity injuries sustained in bomb blasts, as well as a couple of civilians who had pre-existing limb loss resulting from diabetes. But their primary goal was to educate local prosthetic practitioners on how to use modern technologies, including 3D printing, to improve the care they provide. The group introduced and trained local clinicians on five types of technology: the Xtremity Socket, the Össur Direct Socket, the Operation Namaste Limbkit, 3D-printed sockets, and 3D-printed prosthetic covers. These technologies were chosen for their ability to provide care in less than one day. The team saw a variety of patients, including soldiers in the rehabilitation hospital and civilians at Arol Plus, an orthopedic shoe retailer in Lviv. Some patients had traveled great distances to receive care and the normal multiweek process for receiving a device wasn’t feasible for them. During the trip, Todd Stone, CPO, Robert Gavin, and Jay Tew, CP, from the Hanger Foundation fit most of the patients and provided general prosthetic education while Erenstone focused on education for 3D printing prostheses.
Working with a Ukrainian technician, Erenstone designed and printed a cosmetic prosthetic leg cover with the now-famous image of a Ukrainian soldier “flipping the bird” at an imposing Russian warship in the waters off Snake Island. The design proved popular among Ukrainian soldiers.
“We took that image and put that on a cosmetic cover and showed it to the soldiers, and they [said], ‘Yeah, that’s what we want!’” Erenstone recalls. “Putin is trying to run a war of attrition where he breaks the will of the population, and he is failing miserably. Their will is strong—nowhere near breaking.”
(Far right) Jeff Erenstone, CPO, traveled to the Unbroken Rehabilitation Center in Lviv with his Limbkit, a compact mobile lab that folds up into a box and can be transported in a small truck or van to provide comprehensive transtibial prosthetic care.
Continuing Challenges
Shelley Dutton, director of development at Limbs for Life Foundation, says her organization has been helping to provide orthoses and prostheses to underdeveloped countries for 28 years, but the challenge in Ukraine is unique. “The volume [of new amputations] is exceptional, and it’s continuing,” she says. “It's not like it happened, and it stopped. We’re seeing more and more coming on a daily basis.”
The fact that so many O&P clinics are underequipped, are understaffed, or have been damaged by Russia’s bombing campaign increases the difficulty of providing care. “A rehabilitation clinic and physical therapy clinic we spoke to last week in southern Ukraine is right at the edge of the fighting, but they don’t have an in-house prosthetic lab there, so we aren’t able to send them anything because they don’t have the people
Yakov Gradinar, CPO, fitting Ukrainian soldier Taranovets Vadym, who lost both limbs below the knee and spent 2.5 months in Russian captivity
and the tools to do anything with it,” Dutton says. She notes there is a massive demand for high-quality prosthetic devices, and she encourages the U.S. O&P community to donate whatever they can.
“We get request lists from some of the clinic locations with general sizes for feet and preferred items,” Dutton says. “There is not much of a pattern as they are seeing individuals of all ages, sizes, and activity levels with varied levels of limb loss,” including individuals with above-knee, belowknee, and upper-extremity loss. “Our best approach is to ask for donations of new and gently used limbs, prosthetic parts, and accessories [liners or socks that are not used], thus increasing our inventory availability when the requests come in.”
Another big hurdle to providing assistance to Ukrainians is the astronomical cost of shipping into a war zone. Currently, Limbs for Life is coordinating with a folkloric dance group in Poland that has a large warehouse on the border. The warehouse is now being utilized not only for colorful costumes and props, but also for prosthetic devices and componentry. Because the organization cannot ship directly to Ukraine, it is sending items to the warehouse, where they are picked up and taken by ground transportation across the border.
“They have become the destination site in Poland to ship to, because they have the capacity to accept it,” Dutton explains. “They have a great relationship with the border patrol and everybody else, and they can get it on track to go to the next [portion] of the journey. From there, it gets picked up again. And so, the shipping costs are exorbitant.”
Henry Iseman, co-founder and executive director of New York City-based Penta Medical Recycling, says his three-person organization— spawned in a dorm room at Yale University before the war began—has now shipped about 200 pieces of prosthetic and orthotic equipment to Ukraine. Mijamin Strong, Penta’s director of operations, says in the early days of the invasion, Penta sent a half-dozen boxes of orthotics, including ankle-foot orthoses and other types of braces, to assist with immediate trauma care. As the war dragged on, amputations became more common, and requests for prosthetic components started flooding in. In September, Penta sent 10 boxes of prosthetic equipment to a major O&P clinic in Odessa.
The shipment included “every major component that makes up a prosthesis, except for the sockets,” Strong explains. “They have a nice clinic, and they are able to do the sockets and fitting, so we shipped them liners, adapters, pylons, clamps, feet, and lots and lots of socks.” Another shipment is bound for clinics in Lviv and Ternopil in mid-December.
Iseman says the components are being donated from sources across the United States. “We have our existing collection network of clinics, and there has been increased interest in donating this year,” he says. “We’ve had the opportunity to collect different equipment than we usually do. There’s been a bigger demand for more advanced equipment that we don’t usually repurpose as much because in [less advanced countries], that technology hasn’t been used before. You can’t use a C-Leg if you don’t have a smartphone or electricity in your home to keep it charged.”
Iseman says shipping into a war zone is a new experience for Penta. “It’s been an interesting trial for us, but also made us realize that we can work in places where there is a more urgent need. It’s just a matter of getting around those barriers.” Iseman has been gratified to see competing O&P aid groups that might normally be jockeying for space or credit, working together to help Ukraine. “It’s been really nice to see more collaboration across the industry and space, where previously there might have been some competition across organizations that are kind of mission adjacent,” Iseman says. “We’ve seen a lot of groups coming together and complementing each other and using each other’s networks to advance each other’s missions. We’re hoping to come out of this with a more organized collective of groups working in the space that can work together outside of Ukraine and in other parts of the world where there’s obviously need, as well.”
Meaningful Work
In late October, Gradinar, the Ukrainian-born orthopedic surgeon and prosthetist who launched the Protez Foundation in Minneapolis, was overseeing the rehabilitation of soldiers who lost limbs in the war. One of the Ukrainians he treated lost his leg at the knee—but continues to work out on a weight machine in a “determined way,” according to Gradinar. The soldier “is not sitting around,” he emphasizes. “He’s trying to get a strong back and trying to walk. Most of [the injured soldiers] want to go back to the front line.”
Gradinar, who previously worked with Limbs for Life, launched Protez and its current project, Prosthetics for Ukrainians, with another Ukrainian, Yury Aroshidze, to help provide Ukrainian children, soldiers, and civilians who have lost their limbs with free, high-quality prosthetic devices in the United States. In late October, Gradinar was working with 19 soldiers, two children, and one civilian adult. One of the children is 9-year-old Artem Fedorenko whose home was struck by a Russian bomb. During the attack, the child’s father gathered him and his 12-year-old brother and began running to a nearby shelter when another bomb struck. Fedorenko’s father and brother were killed—but because the boy was shielded by his father, he lived but lost an arm, according to Gradinar.
In addition to the 22 Ukrainians receiving care at Protez in October, approximately 590 were registered for assistance with the Minnesota nonprofit as of mid-November. The group coordinates with volunteers who help get the amputees out of Ukraine and into Poland, where more volunteers escort them to an airport, through customs, and onto an airplane. Then airport workers in the United States, also coordinated by Protez, greet the visitors and ferry them to Minnesota and the Protez offices. Minnesotans have provided free lodging and meals for the patients while they spend two or three months being fitted with prostheses and rehabilitated in the United States.
Gradinar, who also designs and builds prostheses, says it’s more effective for him to bring Ukrainians to the U.S., where he has appropriate tools and rehabilitation equipment, than for him to travel to Ukraine to help. Bringing injured Ukrainians to see a prosperous and functioning democracy has another unexpected benefit. “The thing that touched us a lot is that [they] say, ‘This is what we’re fighting for—we want Ukraine to look like the United States,’” Gradinar says.
The experience inspires him, as well. “This makes me feel that I’m contributing to the country that educated me and helping my own people,” he says.
Svirchuk, who runs the new Unbroken rehab center in Lviv, notes that Ukrainians who have experienced limb loss are deeply grateful to the U.S. for its assistance during the war, and that much more assistance is needed. She vows that the work of her organization will not be in vain.
“We want to say that we are very strong, and we continue to fight for our independence and our land,” Svirchuk says. “We are very unbroken in our spirit. They can break our physical things, but not our state of mind.”
First group of amputees who defended Ukraine and came to the Protez Foundation for prosthetic care with Artem Fedorenko After receiving care at the Protez Foundation, Mykola Kobilnyk returned to Ukraine and went into training before rejoining the front line. Michael Coleman is a contributing writer to O&P Almanac. EDITOR’S NOTE: The war in Ukraine has resulted in an immense need for O&P supplies, money, and clinical assistance. Reports from within the war-torn country suggest as many as 10,000 people have lost limbs since the invasion, and many of the country's 400,000 existing amputees cannot access care. AOPA thanks members and others in the O&P community who have donated supplies and their expertise to help those in need. Please contact the following organizations if you would like to help: Limbs for Life: www.limbsforlife.org/ukraine Operation Namaste: www.operationnamaste.org Penta Medical Recycling: www.pentaprosthetics.org Protez Foundation: www.protezfoundation.com Unbroken National Rehabilitation Center: https://unbroken.org.ua
Diabetes and Future Foot Health
How trends in technologies, patient education, and access to care will affect treatment
NEED TO KNOW
• Pedorthists, along with orthotists and prosthetists, can play a key role in educating individuals with diabetes about the need for professional foot care, the benefits of properly fitting therapeutic shoes and insoles, signs of neuropathy and ulcers, and the importance of mobility.
• Many pedorthic practices already leverage digital technologies such as scanning, and some are considering how other innovations—including 3D printing and sensor-embedded socks and insoles—may improve patient care in the future.
• With a growing need among people who would benefit from diabetic shoes and inserts, O&P practices should consider adding pedorthic products and services to their offerings.
AS THE U.S. POPULATION continues to age, caring for the 37.3 million Americans—11.3% of the populace— who have diabetes will become increasingly important. Studies have shown that up to 34% of people with diabetes will develop diabetic foot ulcers, and up to 20% of people with moderate or severe diabetic foot infections will experience amputation.
Those numbers are expected to grow. “Many baby boomers are aging into the profile of people who develop full-blown diabetes,” says Seamus Kennedy, CPed, FAAOP(A), co-owner of Hersco Ortho Labs. “Among seniors—those 65 and older—the rate of diabetes is 29.2%. That’s almost one-third of seniors who are diabetic, and it continues to trend upward. This is an epidemic, and it will be a crisis for the healthcare system.” Studies have found the healthcare costs of treating people who have diabetes are 2.3 times higher than of those without diabetes, says Kennedy.
Pedorthists—the clinicians responsible for fitting foot orthoses
Preventative Care and Education
Seamus Kennedy, CPed, FAAOP(A)
and therapeutic shoes, oftentimes for patients with diabetes—are an essential part of the healthcare team, says Dennis Janisse, CPed, founder of National Pedorthic Services and a longtime advocate for pedorthic care. “Pedorthic education is the only education specifically focused on the foot and ankle,” he explains. Pedorthists not only fit the proper shoes, but make the necessary modifications—for example, adding rocker soles or flares, or adapting shoes for foot deformities. “The right shoe and shoe modification can enable people to improve mobility,” and, in some cases, dramatically improve walking distances and comfort, he says. With diabetes predicted to be a significant healthcare burden in the coming years, patient education is essential, and pedorthists—along with orthotists and prosthetists—can play an important role.
“The best practice for individuals with diabetes is to see a podiatrist at least every three months to check for any issues that could be developing, and to wear appropriate footwear,” says John Gurrieri, CPed, CFo, a pedorthist at Hanger Clinic. “Certain conditions within the foot may result in the podiatrist recommending and prescribing extra-depth diabetic shoes with accommodative insoles.”
Individuals with diabetes often experience some form of diabetic neuropathy, or poor sensation, “which is usually the start of problems in the feet,” explains Gurrieri. “When this compromised sensation is paired with poor blood circulation, patients can develop diabetic ulcers. Once these sores develop, these patients are at high risk of infection and face the possibility of serious complications such as amputation. If they are managed appropriately, these wounds can often heal, but patients who have developed diabetic ulcers have a higher chance for them to recur.”
For this population to maintain a healthy lifestyle, preventative pedorthic care is extremely important, according to Gurrieri. “This care is the most effective way to stop ulcerations from occurring the first time, or reduce the likelihood of recurrence. Wearing properly fitted extra-depth diabetic shoes with the appropriate accommodative insole and seeing a podiatrist every three months is a great way to ensure proper foot health throughout
Dennis Janisse, CPed
an individual’s life.” He also recommends updating diabetic footwear every six to 12 months, depending on the patient’s activity level.
Optimal patient care also requires an educational component—particularly in the early stages of the disease, because many patients don’t access the health benefits available to them, according to Erick Janisse, CO, CPed, sales training manager for Enovis. Only 20% of individuals who are eligible for diabetic shoes through Medicare are actually getting these shoes, he says. “Even if they know about the shoes, many don’t realize how their feet problems relate to their diabetes.
“Patients need to understand what an ulcer is, and that there is a risk,” Erick Janisse adds. Pedorthists, orthotists, and prosthetists should consider sharing the message by attending health fairs and other events to educate consumers that patients with diabetes can use Medicare’s therapeutic shoe benefit when ordering special shoes.
For patients who do follow through with purchasing diabetic shoes, education should continue, says Kennedy. “Many people don’t appreciate some of the problems associated with diabetes, like neuropathy, and don’t realize how serious it can be.” Pedorthists and other healthcare professionals can explain to patients why they should take their condition seriously and reconsider some of their exercise and nutrition behaviors, he says.
“If patients are educated, and get proper-fitting shoes and insoles, they will have less opportunities for ulcers to develop,” says Kennedy. The shoes can help prevent areas of pressure and shear from developing. But good foot hygiene also matters, according to Kennedy. To prevent fungal infections, patients shouldn’t wear the same pair of shoes two days in a row—they should purchase at least two pairs and alternate wear. They also should have at least two pairs of insoles to switch out, to help prevent buildup of fungus and microbes. Paying attention to these details—and self-examining their feet on a regular basis to watch for red spots or signs of breakdown—can help prevent a cascade of events that can lead to amputation, he says.
Patients also benefit from understanding how mobility affects overall health. “Some studies show that people have a better quality of life when they walk,” says Kennedy. “If diabetes progresses and the patient ends up with an amputation, mobility may become limited. Less walking equates to a lower quality of life.”
Kennedy encourages patients with diabetes to use smartwatches and apps to measure step counts and distance walked. “The number of steps taken, regardless of intensity, can impact long-term health,” he says. “As pedorthists, we’re here to dispense the shoes and insoles prescribed,” he adds, “but I also think it’s our job to try to change the course of the disease by educating patients.”
Erick Janisse, CO, CPed
New Technologies, Future Options
Just as other healthcare specialties, pedorthic practices are looking to new innovations for improving current and future patient care protocols and options.
Many pedorthic practices already have embraced digital technologies, for example. “Directly scanning a patient’s feet with a 3D scanner can greatly reduce the turnaround time for individuals receiving footwear,” says Gurrieri. “Today, most manufacturers accept digital scans, which eliminates the need to ship casts and final products—resulting in a quicker delivery. Oftentimes there is a critical window to treat a diabetic ulcer, so a quick turnaround is very important.”
Others cite advancements with integrated sensors that can monitor temperature and/or pressure and identify “hot spots” on the foot as potential revolutionary products. “Detecting temperature and pressure can help prevent diabetic foot ulcers,” says Brian Lane, CPed, director of education for Enovis. This is particularly important because many patients with diabetes lose the ability to feel pain due to nerve damage, so small injuries can go unnoticed and develop into an ulcer that could lead to infection and amputation.
Lane says some of these sensorembedded products are designed to alert the patient, and even a medical care provider, about a potential ulcer or infection. Meanwhile, sensors that measure temperature will make a difference because some studies have shown that a 4- to 5-degree temperature difference helps identify future ulceration sites or the beginning of Charcot, according to Dennis Janisse.
Some of the sensor-embedded technologies also provide vibratory sensation, according to Lane, which can be used to improve blood flow as well as aid in fall management. “There are some studies that show it’s beneficial for neuropathy as well,” he adds.
For now, physicians and podiatrists are leveraging these technologies with their patients—but in the future, pedorthic and orthotic providers could be involved as well, according to Lane. While the costs of these technologies can be daunting, podiatrists can get reimbursed for CPT codes for remote monitoring of up to $150 per month, he says.
Brian Lane, CPed
When sensor-embedded insoles come down in cost and rise in availability, then pedorthists may embrace the technologies, says Dennis Janisse. “Right now, the diagnostic billing is for physicians,” he says. “Down the road, there could be a cooperative effort between pedorthists and physicians.” This could be advantageous for patients, many of whom visit their pedorthists more frequently than their physicians.
These technologies will be a “gamechanger” for patient care, predicts Lane. Pedorthists and orthotists will receive feedback confirming how often their patients actually wear the shoes and insoles they are fitting. “From a pedorthic standpoint, this will reinforce if we are prescribing correctly, and if the patient is wearing them,” he says. “We can then aggregate data to show how helpful they are—which will get more patients on board” with wearing shoes and insoles.
Of course, some clinicians have expressed concern about the liability potential related to alerts for patients who experience hot spots while wearing new technologies and subsequently develop ulcers; these issues will need to be addressed as the technology takes hold. “Are you responsible if a patient gets an ulcer?” asks Lane. “There is some risk” in embracing these new technologies—“but the reward is worth the risk,” he says.
Another technology that is predicted to impact the pedorthic space is additive manufacturing. For now, “it’s a waiting game,” says Lane. “We’re waiting for costs to go down and printers to get faster.” But he believes these changes are imminent, and that most O&P and pedorthic facilities will integrate some form of 3D printing in the next few years. This will open the door to datadriven designs, of potentially lighter weight, made with greater accuracy and efficiency, according to Lane.
Erick Janisse is excited for a future where some orthotic insoles are 3D-printed because the process allows for unique geometric structures and areas of different thicknesses. “Right now, it’s costprohibitive for pedorthists to print in-house,” he says, but he predicts it will become more economical. “I haven’t seen many 3D-printed orthotics that I haven’t liked.”
Other innovations that will play a part in modernizing pedorthic care include “different materials, such as newer resins,” which are being used in new designs for diabetic footwear and inserts, according to Lane. And even virtual reality (VR) may play a role. Lane says he recently discovered “a large potential for the reduction of pain” using VR in patients with many types of health problems. In the future, he foresees an opportunity to leverage VR in pedorthics to distract from pain, in rehabilitation, and even in facilitating walking for patients who might not otherwise.
—Erick Janisse, CO, CPed
Access to Care
As we look to the future of pedorthic care, one important uncertainty involves the availability of pedorthic care givers to meet the needs of a growing patient population. Erick Janisse suggests that more O&P practices should add pedorthic products and services to their offerings. Unfortunately, “O&P facilities are increasingly leaving the Medicare diabetic shoe program,” he says. “The number of people who access diabetic shoe services will decrease even further if there are no facilities that offer them.”
Diabetic shoes and insoles can be a revenue booster at O&P facilities, notes Erick Janisse, as long as companies prioritize fitting patients correctly, understanding how shoes from different manufacturers fit, and learning proper documentation techniques. “I would love to see all O&P facilities offering pedorthic services,” he says. Adding a pedorthist to staff to meet the footwear needs of diabetic patients can enhance an O&P practice, “and pedorthists can be privileged for AFOs” under the supervision of an orthotist, he adds.
Facilities may consider offering pedorthic products as self-pay, rather than via insurance, says Dennis Janisse. “There’s such a future for pedorthics,” he says. “Our numbers are going down due to retirements,” and insurance margins aren’t high, but “there’s a value in patients paying out of pocket” for all types of pedorthic services, he says. “Patients appreciate what pedorthists do, if you can show them how you can help them.”
Of course, expanding access to pedorthic care means more certified pedorthists will be needed—which may be a challenge going forward as there are currently no schools offering CAAHEP-approved pedorthic educational programs. Despite the lack of current programming, the need for skilled pedorthic services will continue.
“I don’t think the diabetes epidemic has crested yet,” says Kennedy, who fears that other healthcare practitioners—who don’t have the same skill and training—may step into the pedorthist’s role. “We need more pedorthic practitioners coming into the field.”
Christine Umbrell is a contributing writer to O&P Almanac. Reach her at cumbrell@contentcommunicators.com.
