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.

PHARMACY COMPLIANCE GUIDE (5)
Diabetic Shoes &ndash; Do It Right the First Time&nbsp;
Why would I ever consider doing Diabetic Shoes, Audits, insurance companies, and stinky feet? Is it not worth the hassle?
<ul>
<li>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.</li>
</ul>
But it takes so much time
<ul>
<li>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.</li>
</ul>
Then there is always the audits
<ul>
<li>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.</li>
</ul>
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&rsquo;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.
<ul>
<li>The patient must be diabetic</li>
<li>The patient must have at least one of the following conditions documented by their physician
<ul>
<li>History of partial or complete amputation of the foot</li>
<li>History of previous foot ulceration</li>
<li>Peripheral Neuropathy with evidence of callus formation</li>
<li>Foot deformity</li>
<li>Poor circulation</li>
</ul>
</li>
</ul>
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&rsquo;t deal with physician&rsquo;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:
<ul>
<li>The patient is diabetic</li>
<li>Has an approved medical condition that requires the need for diabetic shoes</li>
<li>The patient must have at least one of the following conditions documented by their physician
<ul>
<li>History of partial or complete amputation of the foot</li>
<li>History of previous foot ulceration</li>
<li>Peripheral Neuropathy with evidence of callus formation</li>
<li>Foot deformity</li>
<li>Poor circulation</li>
</ul>
</li>
<li>Prescription was written for both shoes and inserts.</li>
</ul>
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&rsquo;s training and a training certificate. Pharmacy technician and other staff also require manufacturer&rsquo;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&rsquo;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:
<ul>
<li>Detailed Written Order</li>
<li>Physician Certification of Therapeutic Footwear</li>
<li>Clinical notes from all healthcare providers indicating
<ul>
<li>Face-2-Face visits</li>
<li>Needs for Diabetic Shoes</li>
</ul>
</li>
</ul>
<ul>
<li>Orders for Diabetic shoes and type of inserts</li>
<li>One of the conditions that authorize diabetic shoes</li>
</ul>
What happens if you don&rsquo;t or can&rsquo;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&rsquo;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&rsquo; 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&rsquo;s Go To Person or what I like to say, your Assistance Compliance Officer.

In March of 2009, Todd S. Eury, launched the Pharmacy Podcast Show. Over the years, the Pharmacy Podcast has accumulated over 75,000+ listeners and subscribers and is the most popular and downloaded podcast about the Pharmacy Industry.

The Pharmacy Podcast Show transformed into the Pharmacy Podcast Network (PPN) in 2014 and will continue to collect the thought leading interviews with some of the most brilliant minds in Pharmacy with over 30 co-hosts. The PPN is a Digital Health Publication and Content Developing partner to the Pharmaceutical industry focusing on Specialty medications, pharmacy business supportive technologies, and industry trends.

The PPN is the world's largest network of podcasts dedicated to the pharmacy professional and industry insiders leading with our hosts interviewing dynamic people in the pharmacy industry making a difference for our profession, customers, and patients.

The definition of “Innovation” is: A new method, idea, product, or process. Processing, implementing, operating, or designing beyond the status-quo. Pharmacists are the HUB of Healthcare & the PPN is the Pharmacist's biggest fan. 

In March of 2009, Todd S. Eury, launched the Pharmacy Podcast Show. Over the years, the Pharmacy Podcast has accumulated over 75,000+ listeners and subscribers and is the most popular and downloaded podcast about the Pharmacy Industry.
The Pharmacy Podcast Show transformed into the Pharmacy Podcast Network (PPN) in 2014 and will continue to collect the thought leading interviews with some of the most brilliant minds in Pharmacy with over 30 co-hosts. The PPN is a Digital Health Publication and Content Developing partner to the Pharmaceutical industry focusing on Specialty medications, pharmacy business supportive technologies, and industry trends.
The PPN is the world's largest network of podcasts dedicated to the pharmacy professional and industry insiders leading with our hosts interviewing dynamic people in the pharmacy industry making a difference for our profession, customers, and patients.
The definition of &ldquo;Innovation&rdquo; is: A new method, idea, product, or process. Processing, implementing, operating, or designing beyond the status-quo. Pharmacists are the HUB of Healthcare &amp; the PPN is the Pharmacist's biggest fan.&nbsp;

Pharmacy Podcast Network

The Pharmacy Podcast Network is ranked as the number one podcast in healthcare dedicated to the Business of Pharmacy and TOP 25 Podcasts in U.S. Business News. The most influential voices in the pharmacy industry are published on the Pharmacy Podcast Network (PPN). The PPN is the leading audio authority of the pharmaceutical & pharmacy industry with more than 30 hosts, 1,200+ episodes, supporting more than 25+ pharmacy industry associations, with more than 80,000 listeners world wide. 

The PPN is an Audio Branding & Public Relations Communications company dedicated to the Pharmaceutical industry focusing on Community, Long-term care, Health System, Specialty, pharmacy business supportive technologies, and industry trends. 

Pharmacy Podcast™ is a registered trademark

The Pharmacy Podcast Network is ranked as the number one podcast in healthcare dedicated to the Business of Pharmacy and TOP 25 Podcasts in U.S. Business News. The most influential voices in the pharmacy industry are published on the Pharmacy Podcast Network (PPN). The PPN is the leading audio authority of the pharmaceutical &amp; pharmacy industry with more than 30 hosts, 1,200+ episodes, supporting more than 25+ pharmacy industry associations, with more than 80,000 listeners world wide.&nbsp;
The PPN is an Audio Branding &amp; Public Relations Communications company dedicated to the Pharmaceutical industry focusing on Community, Long-term care, Health System, Specialty, pharmacy business supportive technologies, and industry trends.&nbsp;
Pharmacy Podcast&trade; is a registered trademark

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...

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