Therapeutic Shoes and Inserts for Diabetes (for Kentucky Only) - UHCprovider.com
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UnitedHealthcare® Community Plan
Coverage Determination Guideline
Therapeutic Shoes and Inserts for Diabetes
(for Kentucky Only)
Guideline Number: CS349KY.01
Effective Date: January 1, 2021 Instructions for Use
Table of Contents Page Related Policy
Application ..................................................................................... 1 • Durable Medical Equipment, Orthotics, Medical
Coverage Rationale ....................................................................... 1 Supplies and Repairs/Replacements
Definitions ...................................................................................... 2
Applicable Codes .......................................................................... 3
References ..................................................................................... 5
Guideline History/Revision Information ....................................... 5
Instructions for Use ....................................................................... 6
Application
This Coverage Determination Guideline only applies to the state of Kentucky.
Coverage Rationale
Indications for Coverage
The below criteria are adopted from and can be referenced by accessing the DME MAC.
Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all of the following criteria are met:
1. The member has diabetes mellitus; and
2. The certifying physician has documented in the member's medical record one or more of the following conditions:
a. Previous amputation of the other foot, or part of either foot, or
b. History of previous foot ulceration of either foot, or
c. History of pre-ulcerative calluses of either foot, or
d. Peripheral neuropathy with evidence of callus formation of either foot, or
e. Foot deformity of either foot, or
f. Poor circulation in either foot; and
3. The certifying physician has certified that indications (1) and (2) are met and that he/she is treating the member under a
comprehensive plan of care for his/her diabetes and that the member needs diabetic shoes.
4. Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation
of the member.
5. At the time of in-person delivery to the member of the items selected, the supplier must conduct an objective assessment
of the fit of the shoe and inserts and document the results. A member’s subjective statements regarding fit as the sole
documentation of the in-person delivery does not meet this criterion.
If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied.
In order to meet criterion 2, the certifying physician must either:
Therapeutic Shoes and Inserts for Diabetes (for Kentucky Only) Page 1 of 6
UnitedHealthcare Community Plan Coverage Determination Guideline Effective 01/01/2021
Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.1. Personally, document one or more of criteria a – f in the medical record of an in-person visit within 6 months prior to
delivery of the shoes/inserts and prior to or on the same day as signing the certification statement; or
2. Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical
records of an in-person visit with a podiatrist, other M.D or D.O., physician assistant, nurse practitioner, or clinical nurse
specialist that is within 6 months prior to delivery of the shoes/inserts, and that documents one of more of criteria a – f.
A modification of a custom molded or depth shoe may be covered as a substitute for an insert. Although not intended as a
comprehensive list, the following are the most common shoe modifications:
1. Rigid rocker bottoms (A5503),
2. Roller bottoms (A5503),
3. Wedges (A5504),
4. Metatarsal bars (A5505), or
5. Offset heels (A5506).
Other modifications to diabetic shoes (A5507) include but are not limited to flared heels.
Deluxe features of diabetic shoes (A5508) do not meet the definition of Medically Necessary
Coverage Limitations and Exclusions
The following items shall be excluded from Medicaid coverage through the DME Program:
An item covered for Medicaid payment through another Medicaid program;
Equipment that is not primarily and customarily used for a medical purpose;
Physical fitness equipment;
Equipment used primarily for the convenience of the recipient or caregiver;
A home modification;
Routine maintenance of DME that includes:
o Testing;
o Cleaning;
o Regulating; and
o Assessing the recipient’s equipment;
Backup equipment; or
An item determined not medically necessary, clinically appropriate, or reasonable by The Plan.
Definitions
Check the definitions within the member benefit plan document that supersede the definitions below.
Diabetes: A group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin
action, or both.
Diabetes Self-Management Training and Educational Services: Instruction in an inpatient or outpatient setting which enables
diabetic patients to understand the diabetic management process and daily management of diabetic therapy as a method of
avoiding frequent hospitalizations and complications, when the instruction is provided in accordance with a program in
compliance with the National Standards of Diabetes Self-Management Education Program
as developed by the American Diabetes Association. Diabetes self-management training and educational services includes
coverage for medical nutrition therapy when prescribed by a health care professional and when provided by a certified,
registered or licensed health care professional. Diabetes self-management training and educational services does not include
programs with the primary purpose of weight reduction
Durable Medical Equipment (DME): Medical Equipment that is all of the following:
• Withstands repeated use;
• Is primarily and customarily used to serve a medical purpose;
• Is generally not useful to a person in the absence of an illness or injury; and
• Is appropriate for use in the home. (907 KAR 1:479)
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Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.Medically Necessary: The determination of whether a covered benefit or service is medically necessary shall:
Be based on an individualized assessment of the recipient’s medical needs; and
Comply with the requirements established in this paragraph. To be medically necessary or a medical necessity, a covered
benefit shall be:
o Reasonable and required to identify, diagnose, treat, correct, cure, palliate, or prevent a disease, illness, injury,
disability, or other medical condition, including pregnancy;
o Appropriate in terms of the service, amount, scope, and duration based on generally-accepted standards of good
medical practice;
o Provided for medical reasons rather than primarily for the convenience of the individual, the individual's caregiver, or
the health care provider, or for cosmetic reasons;
o Provided in the most appropriate location, with regard to generally-accepted standards of good medical practice,
where the service may, for practical purposes, be safely and effectively provided;
o Needed, if used in reference to an emergency medical service, to exist using the prudent layperson standard.
o Provided in accordance with early and periodic screening, diagnosis, and treatment (EPSDT) requirements established
in 42 U.S.C. 1396d(r) and 42 C.F.R. Part 441 Subpart B for individuals under twenty-one (21) years of age; and
o Provided in accordance with 42 C.F.R. 440.230. (907 KAR 3:30)
Applicable Codes
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive.
Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service.
Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may
require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim
payment. Other Policies and Guidelines may apply.
Coding Clarifications:
A depth shoe (A5500) is one that:
o Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16" of additional depth used to
accommodate custom-molded or customized inserts; and
o Is made from leather or other suitable material of equal quality; and
o Has some form of shoe closure; and
o Is available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the
upper portions of the shoe according to the American standard last sizing schedule or its equivalent. (The American
last sizing schedule is the numerical shoe sizing system used for shoes in the United States.)
The shoe may or may not have an internally seamless toe.
A custom-molded shoe (A5501) is one that:
o Is constructed over a positive model of the member's foot; and
o Is made from leather or other suitable material of equal quality; and
o Has removable inserts that can be altered or replaced as the member's condition warrants; and
o Has some form of shoe closure.
The shoe may or may not have an internally seamless toe.
Code A5512 describes a total contact, multiple density, prefabricated removable inlay that is directly molded to the
member’s foot. Direct molded means it has been conformed by molding directly to match the plantar surface of the
individual member’s foot. Total contact means it makes and retains actual and continuous physical contact with the weight-
bearing portions of the foot, including the arch throughout the standing and walking phases of gait.
The A5512 insert must retain its shape during use for the life of the insert. The layer responsible for shape retention is
called the “base layer” in the code descriptor. This material usually constitutes the bottom layer of the device and must be
of a sufficient thickness and durometer to maintain its shape during use (i.e., at least ¼ inch of 35 Shore A or higher or at
least 3/16 inch of 40 Shore A or higher). The material responsible for maintaining the shape of the device must be heat
moldable. The specified thickness of the base layer must extend from the heel through the distal metatarsals and may be
absent at the toes.
Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a model of the
member’s foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom
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Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length,
or toe shape.
The A5513 insert must retain its shape during use for the life of the insert. The base layer of the device must be at least
3/16 inch of 35 Shore A or higher material. The base layer is allowed to be thinner in the custom fabricated device because
appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact
and accommodate each member’s specific needs. The central portion of the base layer of the heel may be thinner (but at
least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer
must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be
of a lower durometer and must also be heat moldable. The materials used should be suitable with regards to the member’s
condition.
Code A5514 describes a total contact, custom fabricated, multiple density, removable inlay that is directly milled from a
rectified virtual model of the member's foot so that it conforms to the plantar surface and makes total contact with the foot,
including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup
height, arch height and length, or toe shape.
The A5514 insert must retain its shape during use for the life of the insert. The base layer of the device must be at least
3/16 inch of 35 Shore A or higher material. The base layer is allowed to be thinner in the custom fabricated device because
appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact
and accommodate each member's specific needs. The central portion of the base layer of the heel may be thinner (but at
least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer
must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be
of a lower durometer and must also be heat moldable. The materials used should be suitable with regards to the member's
condition.
Rigid rocker bottoms (A5503) are exterior elevations with apex position for 51 percent to 75 percent distance measured
from the back end of the heel. The apex is a narrowed or pointed end of an anatomical structure. The apex must be
positioned behind the metatarsal heads and tapering off sharply to the front tip of the sole. Apex height helps to eliminate
pressure at the metatarsal heads. Rigidity is ensured by the steel in the shoe. The heel of the shoe tapers off in the back in
order to cause the heel to strike in the middle of the heel.
Roller bottoms (sole or bar) (A5503) are the same as rocker bottoms, but the heel is tapered from the apex to the front tip
of the sole.
Wedges (posting) (A5504) are either of hind foot, fore foot, or both and may be in the middle or to the side. The function is
to shift or transfer weight bearing upon standing or during ambulation to the opposite side for added support, stabilization,
equalized weight distribution, or balance.
Metatarsal bars (A5505) are exterior bars which are placed behind the metatarsal heads in order to remove pressure from
the metatarsal heads. The bars are of various shapes, heights, and construction depending on the exact purpose.
Offset heel (A5506) is a heel flanged at its base either in the middle, to the side, or a combination, that is then extended
upward to the shoe in order to stabilize extreme positions of the hind foot.
A deluxe feature (A5508) does not contribute to the therapeutic function of the shoe. It may include, but is not limited to
style, color, or type of leather.
Code A5507 is only to be used for not otherwise specified therapeutic modifications to the shoe or for repairs to a diabetic
shoe(s).
There are two categories of products that are billed with code A5513:
o Inserts that are custom fabricated by a manufacturer/central fabrication facility and then sent to someone other than
the member. These items may be billed using code A5513 only if they are listed on the PDAC web site.
o Inserts that are custom fabricated from raw materials that are dispensed directly to the member by the entity that
fabricated the insert. These items do not have to be listed on the PDAC web site in order to be billed using code
A5513. However, the supplier must provide a list of the materials that were used and a description of the custom
fabrication process on request.
The only products that may be billed using codes A5514 are those that are specified in the Product Classification List on
the Pricing, Data Analysis, and Coding (PDAC) contractor web site.
The standard exclusion for shoe orthotics & shoe inserts does not apply to the below codes.
HCPCS Code Description
A5500 For diabetics only, fitting (including follow-up), custom preparation and supply of off-the-shelf depth-inlay
shoe manufactured to accommodate multi-density insert(s), per shoe
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Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.HCPCS Code Description
A5501 For diabetics only, fitting (including follow-up), custom preparation and supply of shoe molded from
cast(s) of patient's foot (custom molded shoe), per shoe
A5503 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded
shoe with roller or rigid rocker bottom, per shoe
A5504 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded
shoe with wedge(s), per shoe
A5505 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded
shoe with metatarsal bar, per shoe
A5506 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded
shoe with off-set heel(s), per shoe
A5507 For diabetics only, not otherwise specified modification (including fitting) of off-the-shelf depth-inlay shoe
or custom-molded shoe, per shoe
A5508 For diabetics only, deluxe feature of off-the-shelf depth-inlay shoe or custom-molded shoe, per shoe
A5510 For diabetics only, direct formed, compression molded to patient's foot without external heat source,
multiple-density insert(s) prefabricated, per shoe
A5512 For diabetics only, multiple density insert, direct formed, molded to foot after external heat source of 230
degrees Fahrenheit or higher, total contact with patient's foot, including arch, base layer minimum of 1/4
inch material of Shore A 35 durometer or 3/16 inch material of Shore A 40 durometer (or higher),
prefabricated,
A5513 For diabetics only, multiple density insert, custom molded from model of patient's foot, total contact with
patient's foot, including arch, base layer minimum of 3/16 inch material of Shore A 35 durometer (or
higher), includes arch filler and other shaping material, custom fabricated, each
A5514 For diabetics only, multiple density insert, made by direct carving with CAM technology from a rectified
CAD model created from a digitized scan of the patient, total contact with patient's foot, including arch,
base layer minimum of 3/16 inch material of Shore A 35 durometer (or higher), includes arch filler and
other shaping material, custom fabricated, each
References
Kentucky Administrative Regulations. Cabinet for Health and Family Services - Department for Medicaid Services. 907 KAR
1:479. Durable medical equipment covered benefits and reimbursement.
https://apps.legislature.ky.gov/law/kar/907/001/479.pdf
Kentucky Administrative Regulations. Cabinet for Health and Family Services - Department for Medicaid Services. 907 KAR
3:130. Medical necessity and clinically appropriate determination basis.
https://apps.legislature.ky.gov/law/kar/907/003/130.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3006051/#__sec1title
Noridian Healthcare Solutions:
https://med.noridianmedicare.com/documents/2230703/7218263/Therapeutic+Shoes+for+Persons+with+Diabetes+LCD+and
+PA (article 52501)
Guideline History/Revision Information
Date Summary of Changes
01/01/2021 • New Coverage Determination Guideline
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Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.Instructions for Use
This Coverage Determination Guideline provides assistance in interpreting UnitedHealthcare standard benefit plans. When
deciding coverage, the federal, state, or contractual requirements for benefit plan coverage must be referenced as the terms of
the federal, state, or contractual requirements for benefit plan coverage may differ from the standard benefit plan. In the event
of a conflict, the federal, state, or contractual requirements for benefit plan coverage govern. Before using this guideline, please
check the federal, state, or contractual requirements for benefit plan coverage. UnitedHealthcare reserves the right to modify its
Policies and Guidelines as necessary. This Coverage Determination Guideline is provided for informational purposes. It does
not constitute medical advice.
UnitedHealthcare uses InterQual® or MCG™ (Milliman) for the primary medical/surgical criteria, and the American Society of
Addiction Medicine (ASAM) for substance use, in administering health benefits. If InterQual® or MCG™ do not have applicable
criteria, UnitedHealthcare may also use UnitedHealthcare Medical Policies, Coverage Determination Guidelines, and/or
Utilization Review Guidelines that have been approved by the Kentucky Department for Medicaid Services. The
UnitedHealthcare Medical Policies, Coverage Determination Guidelines, and Utilization Review Guidelines are intended to be
used in connection with the independent professional medical judgment of a qualified health care provider and do not
constitute the practice of medicine or medical advice.
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