1. The Centers for Medicare and Medicaid Services (CMS) have specific documentation necessary prior to dispensing diabetic footwear. HIPAA Patient File CMS Documentation

2. HIPAA- health insurance portability and accountability act of 1996, mandates the use of standards for the exchange of health care data. What is it? It is protection for the privacy and security of Protected Health Information (PHI). It is also the standardization of electronic data interchange in health care transactions. Covered entities may use PHI for the purposes of Treatment, Payment and health care Operations (TPO) without any special permission from the patient. Special permission, called an authorization, must be obtained for uses and disclosures other than for TPO.

3. Right to a notice of the covered entity privacy practices Right to request restrictions and confidential communications concerning PHI Right to obtain access to protected health information for inspection and copying Right to obtain an accounting of certain disclosures Right to request amendment of PHI

4. Limit the unauthorized use and disclosure of PHI Give patients new rights to access their medical records and to know who else has accessed them Restrict most disclosure of health information to the minimum needed for the intended purpose Establish new criminal and civil sanctions for proper use or disclosure Establish new requirements for access to records by researchers and others

5. Medical History Prescription/Order information Assessment Treatment Plan Follow Up Progress Notes/Performance Outcomes

6. The patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician's office records, hospital records, home health care records, records from other healthcare professional and test reports. All documentation must be available to the DMERC upon request.

7. For an item to be covered by Medicare a written signed and dated order must be on file with the following criteria: 1)The patient has diabetes mellitus (ICD-9 code 250.00-250.93); AND 2)The patient has one or more of the following conditions: a) Previous amputation of the foot or part of either foot, or b) History of previous foot ulceration, or c) History of pre-ulcerative calluses of either foot, or d) Peripheral neuropathy with evidence of callous formation, or e) Foot deformity, or f) Poor circulation, AND 3)The certifying physician who is managing the patient’s systematic diabetes has certified that indications 1) and 2) are met and that he/she is treating the patient under a comprehensive plan of care for his/her diabetes and that the patient needs diabetic shoes. See “Statement of Certifying Physician for Therapeutic Shoes” in binder. A new form is required annually.

8. The order must be signed and dated by the prescribing physician and kept on file by the supplier. **Physician should also have dictated notes regarding the status of the patient’s deformity and need for footwear.** Therapeutic Shoes billed to the DMERC before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

9. Prescription: Following certification by the physician managing the patient’s systemic diabetic condition, a podiatrist or other qualified physician who is knowledgeable in the fitting of diabetic shoes and inserts may prescribe the particular type of footwear necessary. The prescription should contain: Patient Information (Name, DOB, Chart #...) Current Diagnosis (Diabetes, Neuropathy, Previous amputations…) Devices being prescribed (Custom/Non-custom Shoes and inserts, and/or toe filler) Physician information (name and contact info, signature and date) See “Prescription for Therapeutic Footwear” in binder. A new prescription is required annually.

10. Medicare may elect to perform an audit of the supplier’s documentation to support payments received. The documentation must demonstrate both medical necessity and the level of the service provided. The documentation for diabetic footwear is straightforward.

11. For patients meeting these criteria, coverage is limited to one of the following within one calendar year (January-December). 1)One pair of custom molded shoes (a5501) and a total of 3 pairs of inserts (either A5512 or A5513); or 2)One pair of depth shoes (a5500) and 3 pairs of inserts (either a5512 or a5513). A modification of a custom molded or depth shoe will be covered as a substitute for an insert. Such as, rigid rocker bottoms (a5503), roller bottoms (a5503), wedges (a5504), metatarsal bars (a5505). When codes are billed without a KX modifier, they will be denied as non covered. KX means “specific required documentation on file.”

12. In the case of selling the diabetic footwear and not filing the shoes through an insurance company, including Medicare, the cash paying price of the shoes must be at or above the price Medicare reimburses. In the event of an audit, Medicare also will examine those without insurance benefits and if it was lower than what they reimburse, Medicare could potentially reduce the reimbursed amount and demand a repayment on all previous payments. The same care and level of service should be provided for each patient or cash paying customer.

13. The vendor, Dr. Comfort, should have an invoice for the depth shoes which meet Medicare guidelines. These forms can be found on the website at: http://www.drcomfortdpm.com/SADM ERC.htm http://www.drcomfortdpm.com/SADM ERC.htm

14. The vendor, Dr. Comfort, must have an invoice for the inserts which meet Medicare guidelines. These forms can also be found at: www.drcomfortdpm.com/SADMERC.htm www.drcomfortdpm.com/SADMERC.htm These inserts are only billable as A5512 when they are molded to a patients foot using an external heat source and achieving full contact.

15. Necessary footwear, modifications and inserts must be prescribed by a podiatrist or other qualified physician, knowledgeable in the fitting of diabetic shoes and inserts. The footwear must be fitted and furnished by a podiatrist, or other qualified individual, such as a pedorthist, orthotist or prosthetist. The certifying physician (who manages the diabetes) may not furnish the footwear unless he/she practices in a defined rural area or health professional shortage area. There is no separate payment for the fitting of the shoes.

16. Provided in this binder is a list of the 26 Medicare Supplier Standards. Any supplier of durable medical equipment should disclose these standards to the patient at the time of dispensing of shoes. Also, a form stating the patient received the standards should be completed. Make copies of this form or it can also be found at the Centers for Medicare &Medicaid Services website at: http://www.cms.hhs.gov/cmsforms/downloads/cms855s.pdf

17. In addition to the Supplier Standards, the following is also required to occur upon providing the patient with the shoes: How to use, maintain and clean the shoes (includes wearing instructions and replacement of inserts) How to properly don and doff the shoes (includes how to adjust closures for proper fit) How to inspect the skin ( identify pressure areas, redness, irritation, skin breakdown, pain, edema…) How to report any problems related to the shoes or inserts to the supplier or prescribing physician How to schedule follow-up appointments

18. I have received pair of Dr. Comfort (style: ) extra depth shoes and total of Dr. Comfort full contact inserts. The inserts were made from a cast/bio-foam impression of my feet. Or, the inserts were heat molded to my feet. I am satisfied with the fit and authorize Medicare and any supplemental insurance carrier to pay fill in the blank directly. I understand I am responsible for any deductible and unpaid balance. I have not received any other shoes or inserts under this plan from any other supplier in this calendar year. I have also received the CMS DMEPOS Supplier Standards and have been educated on proper break-in procedures and care for my Dr. Comfort shoes. Signature: Date:

19. Dr. Comfort will accept returns of any Dr. Comfort shoes, for any reason, within 30 days of the shoes being dispensed. If, within 30 days, the shoes have been determined that they do not properly fit, Dr. Comfort will properly replace them, at no charge, with a properly fitted shoe. Dr. Comfort shoes that have been dispensed for a period of over thirty days will only be exchanged or credited at the sole discretion of Dr. Comfort. Any shoe that is returned must be returned in the original shoe box for proper credit. Signature: Date:

20. Care of the Shoes (Leather) 1. Clean your shoes regularly – saddle soap works great 2. Use a leather crème for the leather shoes. 3. Simply apply the crème with a clean dry cloth and work it into the leather. 4. Never use shoe polish, as the shoes are hand-tanned. Shoe polish will ruin the finish. Care of the Shoes (Nubuck) 1. This material can be cleaned by the using a small stiff brush to brush-away the dirt. 2. There are sprays on the market designed to refurbish suede or nubuck materials. 3. Do not immerse the nubuck shoes in water and do not use a shoe polish Care of the Shoes (Lycra) 1 Never put this shoe in the washing machine. 2 We suggest using any fabric protector on this material to help retard the dirt. 3 Spray the shoes after the appropriate break in period and before you wear them regularly. 4 If they do get soiled, use a small amount of soap and water – Woolite works well. 5 Try a baby wipe! (works great if the shoe has first been sprayed with a fabric protector)

21. Break-In Period for Shoes with Heat Molded or Custom Inserts In order to ensure that your shoes become a functioning extension of your pedorthic medical care, please follow these instructions. 1. When you arrive home, place your new shoes (with the inserts in them) on your feet (with socks) and wear them for 30 to 60 minutes – only on carpeting at first 2. Remove your shoes and look for any areas of redness (ask a family member for assistance, if necessary) 3. Once you have verified that the shoes do not rub your skin (absence of redness), wear your shoes around your home for a day or two; check again for areas of redness 4. Once you (or your family member) have verified that you are not having problems with these new shoes, you are ready to wear them outside the home 5. Remember, even after this break-in period, you should always check your shoes and feet each day - looking for anything out of the ordinary The therapeutic shoe bill provides for a pair of shoes and three pairs of inserts in one calendar year. The maximum lifespan of these inserts is about 4 months. Please remove each insert as instructed every 4 months (mark your calendar now) and replace it with the other inserts provided. If used properly, 3 pairs of inserts should last one year.

22. The patient has the right to freely voice grievances and recommend changes in care or services without fear or reprisal or unreasonable interruption of services. Complaints need to be documented in the Medicare Beneficiaries Complaint Log. The log must contain the patient’s name, address, telephone number, and health claim number, a summary of the complaint, the date it was received, the name of the person receiving the complaint, and summary of the actions taken to resolve the complaint. A sample form can be found in the Dr. Comfort manual or at the back of this presentation.

23. A provider of DMEPOS products must possess the following liability coverage: Professional Liability—this is liability insurance for the services which are rendered Product Liability-the liability for the devices or products dispensed from the office/clinic Property/Casualty—the protection of the storefront

24. The progress notes for each patient are used to keep record of the status, progress and plan of care. They also provide legal protection should any problems arise with the patient. Standard components may be in the following form, known as, SOAP notes: S: Subjective O: Objective A: Assessment P: Plan

25. This would include anything the patient tells you regarding the reason for the visit. It also may be on the initial patient paperwork you may have had patient fill out. Chief complaint Activity level Employment status Health Status Social/Health Habits Family History Medical History Medications Goals Sample: Patient complains of burning and tingling in both feet. Denies any recent changes in medical history. She said that when she checked her blood sugar last week it was “over 290” during the day. Patient is currently not working and states that she does very little during the day. Patient would like to be able to work more without the burning.

26. This would include the problem, diagnosis and reason for the visit with you today. Also, add things that you find during the examination using only four senses: What do you see? What do you smell? What do you feel? What do you hear? No tasting Example: 68 year old female with history of DM since 2004, non-insulin dependant, was referred in today by her endocrinologist— Dr. Smith. Patient indicated that she smokes 1 pack of cigarettes a day and denies use of alcohol. Observed an unstable gait and a callus under the first met head. Upon examination, patient had no sensation on the plantar aspect of both feet using the monofilament test. No digital hair growth. Patient’s feet were hot to the touch.

27. This would include any measurable data during the examination: Results of testing Temperature ROM Pulses Measurements of wounds Shoe measurements Example: Patient’s loss of sensation, tingling and burning as well as callus formation indicates she is a good candidate for diabetic shoe gear.. She was also advised to revisit her podiatrist or PCP for further testing.

28. This would include any anticipated goals and progress that you would like seen. Also, any referrals that are necessary to obtain these outcomes. Also, be sure to include what was given or ordered today and any upcoming follow-up visits. Example: Measured for shoes and custom inserts to properly off load the area of callus formation. We decided on the Betty Black 8 ½ wide and she will be seen in 2 weeks to check proper fit. Along with her physician, we would like to see the callus debrided and no longer present.

29. Sign and date the note. Do not leave any empty space between your final notation and signature. Note should have your full name and title. Write legibly or dictate/type. If a mistake is made when writing the note, draw a single line through the error, write the word “error” and initial the mistake. Do NOT scribble out or attempt to erase it. Every word of a progress note must be readable or it may be suspect to alteration.