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The Centers for Medicare and Medicaid Services (CMS) have specific
documentation necessary prior to dispensing diabetic footwear.
HIPAA
Patient File
CMS Documentation
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.
• 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
• 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
•Medical History
•Prescription/Order information
•Assessment
•Treatment Plan
•Follow Up
•Progress Notes/Performance
Outcomes
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.
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.
• 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.
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.
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.
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.”
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.
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
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
These inserts are only billable as A5512
when they are molded to a patients foot
using an external heat source and
achieving full contact.
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.
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
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
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:
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:
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)
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.
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.
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
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
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.
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.
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.
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.
• 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.