PHARMACY COMPLIANCE GUIDE (5)
Diabetic Shoes – Do It Right the First Time
Why would I ever consider doing Diabetic Shoes, Audits, insurance companies, and stinky feet? Is it not worth the hassle?
- Diabetic shoes is the only preventive medicine Medicare and Medicaid pay for. If done correctly, the process is just that, a process. Just like filling any other prescription.
But it takes so much time
- Yes, it does take time. But whose time does it take? This is not a requirement for the pharmacist to accomplish. Depending on the type of shoe and the state, a manufacturer trained individual may see and fit a patient for their shoes and inserts.
Then there is always the audits
- Yes, there is a lot of fraud with shoes. But understanding the audit documentation process and the details the auditors are looking for before you see the patient makes all the difference.
OK, you make it sound simple. Then why are folks dropping diabetic shoes?
It all in the documentation, that is why you must do it right the first time.
Then let’s start at the beginning by asking, who is eligible?
We are talking about Medicare patients billing through their Part B coverage because this is the most restrictive and most audited process.
- The patient must be diabetic
- The patient must have at least one of the following conditions documented by their physician
- History of partial or complete amputation of the foot
- History of previous foot ulceration
- Peripheral Neuropathy with evidence of callus formation
- Foot deformity
- Poor circulation
Who can sign the prescription for diabetic shoes and inserts?
The patient must see a MD, DO, PA, CNPT or Podiatrist for a face-2-face visit and receive a prescription for diabetic shoes and inserts. Once the prescription is received from the patient, a Detailed Written Order is completed and faxed to the individual writing the prescription requesting their signature and their clinical notes. If the prescription was signed by a PA, CNPT or Podiatrist, then the patient must be seen by a MD or DO for another face-2-face visit and a Physician Certification of Therapeutic Footwear is needed along with their clinical notes.
If the initial visit was with a MD or a DO, then the Physician Certification of Therapeutic Footwear can be faxed with the Detailed Written Order.
You mention clinical notes, pharmacists normally don’t deal with physician’s clinical notes. Why is importation for shoes?
Clinical notes are a Medicare Part B, DMEPOS requirement. Almost all audits are lost on the clinical notes. The pharmacist, fitter or billing clerk do not need to be a medical expert to identify what is needed or the problem in the notes. The notes must state:
- The patient is diabetic
- Has an approved medical condition that requires the need for diabetic shoes
- The patient must have at least one of the following conditions documented by their physician
- History of partial or complete amputation of the foot
- History of previous foot ulceration
- Peripheral Neuropathy with evidence of callus formation
- Foot deformity
- Poor circulation
- Prescription was written for both shoes and inserts.
You mentioned fitter, can all pharmacists fit diabetic shoes and insert?
The fitter is designated by state law, licensure and CMS rules. In every state except Illinois, a Pharmacist Scope of Practice covers the dispensing of a medical device with a legal prescription. All that is needed is manufacturer’s training and a training certificate. Pharmacy technician and other staff also require manufacturer’s training and can fit diabetic shoes under the supervision of the trained pharmacist. DME facilities must follow state licensure requirements when applicable and an in most instances will only dispense heat moldable inserts.
When can the initial fitting occur?
The initial fitting can occur at any time after receipt of the initial prescription. The initial fitting is an assessment of the patient to ensure the patient meets the requirements for diabetic shoes and can be safely fitted. The assessment includes the entire foot and every aspect is document. Once the assessment is completed, the fitter and patient pick the best style of shoe and complete the order forms.
Where can the fitting occur?
At your pharmacy, DME facility, assisted living facility, senior center or the patient’s residence. You are not limited to stay within your facility. This is a wonderful way to get into your community.
When is the final assessment / fitting completed?
This is a scheduled appointment. When you have received the diabetic shoes from the manufacturer and have received all of correct documentation:
- Detailed Written Order
- Physician Certification of Therapeutic Footwear
- Clinical notes from all healthcare providers indicating
- Face-2-Face visits
- Needs for Diabetic Shoes
- Orders for Diabetic shoes and type of inserts
- One of the conditions that authorize diabetic shoes
What happens if you don’t or can’t get the documentation?
You use your biggest resource, contact the patient and ask for assistance. Explain what you need from the specific physician or licensed practitioner and ask if they can call. If it is a document that needs completed, you can give the patient the document and ask them to take it to the physician for signatures. The patients are motivated to get their shoes so they are motivated to their paperwork.
There seems to be a lot of diabetic shoe manufactures and they all have their own documentation and they are all different. Which documents should be used?
Shoe manufacturers are experts in manufacturering diabetic shoes and inserts. They market shoes to suppliers and provide a quality product to be dispensed to the patient. They provide documentation from what they feel is appropriate that meets the CMS guidelines but how up to date is it? There are a lot of regulations that must be followed for all Medicare Part B dispensing. If the claim is rejected, the manufacturer really doesn’t have any skin in the game. They have already been paid. It is always the responsibility of the supplier to follow all of the LCD requirements and CMS regulations.
Jeff, you sound very confident on these processes. Why?
Over the years, I have worked with the shoe manufacturers, CMS, DME MAC auditors, inspectors, accreditation organizations and many other groups. We have developed a deep understanding of what is required to dispense diabetic shoes and more importantly how to win audits. It is always about the documentation. If you know what everyone wants before you start, it is easy to meet the requirements. The problem is all the requirements are not written down. You have to talk to all the people involved. Once you do and the process developed, our process done the right way the first time never has an issue with DME MAC or insurance audits.
So does R.J. Hedges have a solution?
Yes, we actually have several solutions.
First, if the pharmacy is exempt, you can still add diabetic shoes to you CMS 855S application. All you need is manufacturer training and an amended CMS 855S application. There is NO fee
Second, we have a Diabetic Shoe program that focus’ just on the dispensing of diabetic shoes. It comes with all of the documentation, DWOs, Physician Certification of Therapeutic Footwear, Assessments, delivery receipts and compliance training. The cost is $500.00 for the first year and $100.00 for every year thereafter.
Our final option for DMEPOS products is a full DMEPOS compliance program that comes fully customized for the facility. Our sales team will work with the facility to set up the best solution for the program and then one of our Project Managers will be assigned and will create the program and become the facility’s Go To Person or what I like to say, your Assistance Compliance Officer.
