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Insights on Remote Monitoring for Diabetic Foot Ulcers

With the isolation caused by the pandemic, remote monitoring for patients with diabetes is more critical than ever to get information on patients’ adherence. This author takes a closer look at several remote monitoring technologies, offering guidance for use and coding.

Most of us are familiar with devices worn by people every day such as Fitbit telling us our heart rate and how many steps taken throughout the day. Patients can even buy an “ECG” device on Amazon with the tracing they can send to the doctor.

Health care is gearing up for remote patient monitoring (RPM) and with our current isolation measures during COVID-19, the Food and Drug Administration (FDA) and Department of Health and Human Services/Centers for Medicare and Medicaid Services (HHS/CMS) are providing guidance on more devices and artificial intelligence software and hardware to help physicians provide care and monitor their patients more closely without getting too close.

CMS defines remote or wearable patient monitoring devices as devices that must measure or detect common physiological parameters and must wirelessly transmit patient information to their health care provider or a monitoring entity. The 21st Century Cures Act, signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances faster and more efficiently to patients who need them.

With the Cures Act, new devices on the market need to be FDA approved and the RPM must be monitoring a physiologic factor. We have seen these in medicine, such as the glucometers that patients wear externally so they longer need to prick their fingers and take a reading; blood sugar can now be monitored 24/7. Devices include blood pressure cuffs or wrist bands worn all day long and pulse oximeters. There are also pacemakers/defibrillators that can send information to the manufacturer’s data collection center every time the patients wearing the device walk by the transmitter in their homes. This then alerts the doctor if there is a pivotal event, or the doctor downloads the information when the patient returns to the monitoring clinic. A newer implantable device created by the Georgia Institute of Technology is a stretchable sensor that could be combined with the flow diverter to monitor flow and pressure in a blood vessel to alert physicians of an impending aneurysm.

These are but a few remote monitoring devices. There are new players in the world of diabetic foot care that are of most interest and may be of potential use within the wound care arena.

The  21st Century Cures Act was initiated to aid providers, patients and caregivers to reduce inefficiencies, improve access, reduce costs, increase quality, and allow medicine to be more personalized for patients. Patients or consumers of health care can use digital health technologies to better manage and track their health and wellness and participate at a higher level, a more integrated position within the healthcare team, in maintaining their own health status. Now with COVID-19, the desire for decreased contact but maintaining and improving care delivery is needed even more.

A Closer Look At Remote Monitoring Devices

Let’s look at a few of the devices that I have come across over the past 6 months. Some are available on the open market (such as through the company’s website). These offerings often start in the sports arena, for those sports enthusiasts who want to monitor everything as they are working out; and as such are not reimbursed by insurance plans (just like Fitbit).   

We will look at several devices that require a physician’s prescription and the monitoring services. As of January 1, 2020 there are CPT codes that can be billed for potential reimbursement when monitoring using these covered devices.  

The Smart Bath Mat (Mateo) looks at temperature measures. For those with diabetes and neuropathy, a difference of 2.22°C could provide early signs of skin breakdown and ulceration. However, the mat is not currently covered under the Medicare program for remote monitoring; it does not meet the requirement for constant monitoring, just due to the nature of the product.

The Orpyx SI insole (Orpyx Medical Technologies) measures temperature changes continuously and can alert the wearer on their smart phone of the subtle differences in temperature. This would warn patients with diabetes that they may be developing an ulcer. While there are other similar devices like the one from Orpyx, this device monitors both temperature and pressure. The clinical trial completed by Orpyx shows that wearing the insole even for half of the walking hours, ulceration reduction is significantly reduced.1

One factor with the Orpyx device that is of some concern to me is that measuring direct pressure is not the issue at hand. In all of the research that has been published regarding pressure as causative agent with the formation of diabetic foot ulcers is that of shearing, and this is not addressed in this device or with any other pressure measuring device. If this device is to be billed to Medicare, the patient will also need the depth shoe that Medicare covers for at-risk patients. The insoles will need to be moved from shoe to shoe if the patient wears more than one pair of shoes, which is highly likely. Adherence with this program may be more difficult as the device has to be recharged every night.

Siren Socks (Siren) measure foot temperature in real time and again, like the insole that measures foot temperature changes, can assist in alerting the doctor through a dashboard that the physician’s office would monitor. When alerted, the doctor would contact the patient to educate him or her to reduce the amount of weightbearing and shearing that may be causing increased skin temperature in the foot, or to cool the foot to reduce tissue damage. I can see patients wearing this device daily, as most of us wear socks with our shoes on a daily basis. Socks can assist in reduction of friction and shearing, and thus socks with sensors to look at skin temperature changes may be more readily accepted by patients.  

If you participated in the Symposium on Advanced Wound Care Virtual in July 2020, there were lectures talking about offloading diabetic foot ulcers. My lecture on “Pearls for Best Practice in Treating DFUs” included the International Working Group for the Diabetic Foot Guidelines for offloading.2 During the same session, James McGuire, DPM, gave a lecture with a comprehensive review of the guidelines and types of offloading recommended.  

A 2007 Diabetes Care study discusses the use of an instant total contact cast (TCC).3 It has been instilled in us as wound care providers that offloading the plantar foot ulcer for a patient with diabetes is the gold standard. There is more research showing that a removable cast walker (either made nonremovable or applied to a cooperative patient) can benefit almost equally as having a TCC applied.

Motus Smart (Sensoria) cast walker boots are aesthetically pleasing and highly functional. There is a rocker plate that can be removed so patients can keep the boot on, and sleep with it on. It is made of light material and the entire boot weighs 2.2 lbs., as noted in the company’s advertising. The boot can be locked so the patient cannot remove it, and it can be adjusted to fit for swelling in legs. Of more interest is that an inner sole with sensors can measure the pressure in the boot from the foot when you fit the patient with it, and it provides continuous monitoring of the patient’s level of activity. If the patient is not wearing the boot, we would know about this, and if the patient is walking around too much on it, we know more immediately. When patients return to the clinic or office, we often know they are on their feet excessively as the boot is covered in dirt or dog hair, etc.

This system can be monitored by staff who can alert the patient to “get off your feet.” I don’t know the company too well, but I would like them to add a siren that says “GET OFF YOUR FEET.” It does alert the patient’s smart phone, but we can turn off the volume on these, can’t we?   

Even though I like the whole idea of this product, there is some understanding that needs to be reached when using this device. Remote monitoring of activity level is not a physiological parameter that is required by the Centers for Medicare and Medicaid Services (CMS) rules under which remote monitoring services are covered. Even though there is a code for the walking boot, unless you are treating a mechanical condition of the foot and ankle, and not just the wound, the boot is not covered for treatment of an ulcer.

Also, if you dispense this boot has a HCPCS code, the one recommended by the company to bill is for a prefabricated boot (L4386), which requires some adjusting or heat molding to the patient. This is something that is not done in a wound center; podiatrists or orthopedists with a heat gun would likely be adjusting if needed and can bill the code if this was actually performed. Adjusting a strap or two is not adequate to qualify for the higher paying code of L4386. Code L4387, in my work as a certified coder, would be a better fit for the description of the device as often in the wound center I would just be taking it off the shelf based on leg and foot measurements and putting it on the patient, even if one or two of the straps had to be moved or adjusted. Unless the wound center has a durable medical equipment (DME) license, then the boot would not be billable to Medicare. I don’t see that the prosthetic companies that often provide products for outpatient wound center would carry this product, as the cost of this boot is 5 times the cost of the standard non-pneumatic walker boot.

The last concern with the boot itself is that under the Medicare rules of “like or similar.” That is, if a patient received a walking boot like this within the time frame that Medicare deems that a DME is supposed to last, which is usually 3–5 years, then the newest item dispensed would not be covered. However, I do love the design of this boot way better and I love the idea of monitoring the activity of the patient.  

Rules for Monitoring Patients

If you want to start monitoring your patients, how do you do this so your time and cost of the products are covered (and your credit card is not maxed out)? To qualify for Medicare reimbursement, there are some rules you need to follow.     

  • You need to get the patient’s consent to be monitored.
  • The ordering provider must be a qualified healthcare professional (QHP) who is under the supervision of the prescribing physician.
  • The device must be an FDA approved item (you can’t as of now use a Fitbit-like item).
  • The remote patient monitoring data has to be synched wirelessly, and the patient has to be monitored for 30 days. (During the COVID-19 emergency use authorization, you have to have at least 16 days of use and monitoring per month. This may or may not return to 30 days once the public health emergency is over.)
  • Monitoring can be by a physician, QHP, or trained office staff.
  • Just as with anything that CMS pays for, the patient will be responsible for 20% of the fees.

What Are the Relevant Codes?

The next question I often get is what are the codes for remote patient monitoring. Just a word of caution: just because there is a code, it does not mean that every payor will pay you. It is up to you to check with your carrier, their policies on coverage, and make sure your documentation supports medical necessity for whatever it is you are doing.

Currently, the set up and equipment codes are to be billed once, during the episode of care, and you must monitor for at least 16 days or more during the month. I have not included how much each code pays, as it may vary in different areas or regions of the country based on the carrier’s published fee schedule.  

Final Thoughts

There is also, in my opinion, a glitch in the system: the codes for monitoring are paid only once, regardless of how many devices you are monitoring. The codes are not attached to a specific device, just the action of monitoring. You may be able to bill for the set up of each device, however, and the total time you spend on monitoring more than one device is likely to take you over the 20-minute timeframe that you can use the add-on code listed above.

In this exciting new world, the technology has certainly surpassed the payment model that we currently live under. If I have questions regarding DME coding and CMS regulation, even though I am considered a coding and billing expert in wound care and in the podiatric word. I called upon Paul Kesselman, DPM, to discuss my thoughts and concerns to make sure I am on the right track. More knowledgeable people like Dr. Kesselman, who is considered a DME guru, are working to help educate CMS on these types of issues we face as caregivers.   

Now we must boldly go seeking out new technologies and new methods of gathering health status data. The future is here, but I want to tread lightly and to remember that touchless healthcare is not something that could or should work well from a remote site. I always remember the words “healing touch,” which physicians are often attributed with (this holds true for all health care givers). Often the soft gentle touch is what patients are wanting—to be reassured, to give them hope. As digital care options become more accepted, there is nothing the electronic world has on sitting in front of the patient and making an assessment by feel, smell and watching the patient, and listening when patients tell us their story of their conditions, so we may come to know and understand them.

Dr. Aung is Chief of the Podiatry Section of the Tenet Health System/St. Joseph’s Hospital and a panel physician at Tenet Health System/St. Mary’s Hospital Outpatient Wound and Hyperbaric Center in Tucson, Ariz. She is a member of the American Podiatric Medical Association (APMA) Coding Committee, the APMA MACRA/MIPS Task Force and is on the Exam Committee of the American Board of Wound Management. Dr. Aung is also on the Editorial Review Board for Wound Management and Prevention and a Fellow of the Academy of Physicians in Wound Healing. Her website is www.healthy-feet.com.


 

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Barbara Aung, DPM, CWS, DABPM, FAPWHc
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References

1. Abbott CA, Chatwin KE, Foden P, et al. Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Lancet Digital Health. 2019; 1:e308–18.
2. Aung B, McGuire J. Pearls for Best Practice in Treating DFUs. Symposium on Advanced Wound Care Virtual 2020. Available at https://www.sawcvirtual.com/live-stream/15340854/Pearls-for-Best-Practice-in-Treating-DFUs .
3. Piaggesi A, Macchiarini S, Rizzo L, et al. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes Care. 2007; 30(3):586–90.

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