SECTION C: A5500 - A5513 SERIES OF CODES · reassessed by the health care team, the person with diabetes, and his/her family. Patient and family education are important parts of the

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SECTION C: A5500 - A5513 SERIES OF CODES

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CHAPTER CA: OVERVIEW OF DIABETIC/NEUROPATHIC FOOTWEAR CODES

DIABETES—WHY WE HAVE A TSDIn 1993 Congress created the Therapeutic Shoes for Diabetics Medical Policy (TSD)1 benefit in order to providequality care for millions of beneficiaries in a low cost manner—by preventing amputations and the costs and problemsthat stem from amputations. In 2011 there were 20.9 million Americans with diabetes (7 percent of the population),and the number is rising. While an estimated 14.6 million have been diagnosed, 6.2 million people are not awarethat they have the disease.2 There are 54 million Americans with pre-Diabetes, in addition to the 20.8 million whohave it.3 Diabetes is a chronic disease that has no cure. Diabetes is a disease in which the body does not produceor properly use insulin, a hormone that is needed to convert sugar, starches and other food into energy needed fordaily life.4 The Center for Disease Control (CDC) predicts that one in three Americans born in 2000 will developdiabetes during his or her lifetime.5

The total annual economic cost of diabetes in 2002 was estimated to be $132 billion. 6 Some studies have estimatedthat up to 20% of total expenditures on diabetes are estimated to be attributable to the diabetic foot.7 Direct medicalcosts for diabetes is estimated at $92 billion. Indirect costs (disability, work loss, premature mortality) are estimatedat $40.8 billion.8 Diabetes is more prevalent in women than men, and more prevalent in the old than the young.Treatment of diabetes emphasizes control of blood glucose through blood glucose monitoring, regular physicalactivity, meal planning, and attention to relevant medical and psychosocial factors. Many patients must take oralmedications and/or insulin injections. Treatment of diabetes is an ongoing process that is planned and regularlyreassessed by the health care team, the person with diabetes, and his/her family. Patient and family education areimportant parts of the process. Complications from diabetes include increased levels of heart disease, stroke, highblood pressure, blindness, kidney disease, nerve disease, dental disease and foot amputations from non-healingdiabetic foot ulcers.9

About 60-70 percent of people with diabetes have mild to severe forms of diabetic nerve damage, which, in severeforms, can lead to the need for lower limb amputations. This nerve damage is called “neuropathy” and is the trueproblem for diabetic foot management. The diabetic patient can get a blister or cut on their foot. This could be froma foreign object in the shoe or from a tight fitting shoe or from ground reactive forces on the bottom of the foot thatare not being properly managed. For people with peripheral limb protective sensation—this problem will causepain and the patient will “know” about the issues and can investigate the issue and address it. However, in a personwith peripheral neuropathy, there is no sensation of pain. The small problem will go unaddressed and can becomea bigger problem—a full blown diabetic foot ulcer. Since the diabetic patient’s circulation is impaired, the blood flowto the ulcer is diminished, and thus the fresh blood that would aid in healing. If the problem continues unaddressed,the ulcer will get worse. If an infection, such as gangrene, sets in, the foot may need to be amputated.In the United States, diabetes is the most frequent cause of non-traumatic lower limb amputations.10 More than halfof lower limb amputations in the United States occur among people with diabetes.11 The risk of a leg amputation is15-40 times greater for a person with diabetes than a person without diabetes.12

Needing a first amputation is a poor prognostic sign in diabetic patients; 28% to 51% of these patients require asecond amputation within 5 years. The presence of peripheral diabetic complications leading to amputation is alsoassociated with systemic complications. The 5-year mortality rate after lower extremity amputation ranges from 39%to 68% .13

Some important statistics include:14

• 85% of diabetes-related amputations are preceded by a foot ulcer.• 50% to 70% of all lower extremity amputations are related to diabetes.• 3% to 8% of people with diabetes have a foot ulcer.


• The recurrence rate of new ulcers through five-year follow-up is 50% to 70%.• It takes on average 11 to 14 weeks for a diabetes foot ulcer to heal.• There is a 15% amputation rate in people with a diabetic foot ulcer.

The costs per patient of diabetic foot ulcers is staggering. The direct costs for primary healing of an ulcer (withoutamputation) is $8,500 per patient. Direct costs for foot amputation and healing jump to $43,000. Leg amputation andhealing costs an incredible $65,000. The cost to society of amputations was high due to the need for prolongedhospitalization, rehabilitation and home care, and social services for the people with a resulting disability. More than70% of the economic cost of the diabetic foot is incurred after amputation.15

A study in Sweden followed people with diabetes and a previous foot ulcer. This study concluded that the highestcosts were for inpatient care, social-service support and home care, especially for people with a previous majoramputation (above the ankle). The approximate costs (in 1990 prices) during three years from healing were:

$16,500 USD for people whose wounds were healed without severely impaired circulation (ischemia) $27,000 USD for those with ischemia $44,000 USD for people who had to undergo a minor amputation $63,000 USD for those who had to undergo a major amputation.16

The TSD was created because it is a fantastic return on investment for CMS and a lifesaver for the beneficiary. TheTSD and flu shots are the only two preventative portions of the Medicare program. Annual preventative pedorthiccare ranges from only $300-$600 a year under the TSD. In other words, an annual treatment of $300-$600 a year, inthe hands of a qualified practitioner, can reduce/eliminate ulcers and thus reduce/eliminate the need for an amputationand the $8,500 healing cost or the $43,000 foot amputation cost. Even at $600 a year (the maximum), it representsa breakeven of 71.66 years of shoe care ($43,000 / $600 = 71.66 years breakeven—ignoring the time value ofmoney—which if considered, would improve the return on investment to CMS).

NEUROPATHY VERSUS DIABETESDiabetes is the number one cause of neuropathy, but it is not the only cause of neuropathy. Neuropathy can becaused by alcoholism, by Hansen’s Disease, and by idiopathic (unknown) causes. It is neuropathy that is the trueproblem with diabetic foot ulcers—and as such, the PCC suggests expanding the benefit to non-diabetics that haveneuropathy, while limiting the benefit for diabetics without neuropathy.

INTRODUCTION TO THIS SECTIONThis section is designed to give practical and fair advice to today’s practitioners dispensing devices in the A5500series, commonly known as the Therapeutic Shoes for Diabetics Medical Policy codes, or TSD codes. It has beendeveloped by the PCC (PFA Coding Committee), a group formed to provide thoughtful and consistent guidance forpractitioners. PCC encourages all practitioners dispensing these codes to follow this guidance (C.Ped; L.Ped;BOCPD; CO; CP; CPO; BOC (O); BOC (P); and DPMs). This document fills an important void in the marketplace.CMS has provided some guidance in this area. However, this program continues to be plagued with confusion,fraud and abuse. Some of this is driven by logical inconsistencies in the current law, others are driven simply byignorance.

The PCC is advisory in nature, and its findings have not specifically been authorized by any third-party payor,including CMS. The practitioner is ALWAYS responsible for their own coding—including documentation andcompliance with individual requirements of specific insurance companies. The PCC does publish its work andsends it to insurance companies and CMS, with the hope that it will influence the medical policy of all third-party


payors. The PCC encourages practitioners to engage in thoughtful dialogue with their payors about the issuessurrounding the fair use of codes and fair reimbursement.IN THIS DOCUMENT, THE PCC CLEARLY DIFFERENTIATES BETWEEN ACTUAL MEDICARE POLICY, ASUNDERSTOOD BY THE PCC, AND THE SUGGESTED MEDICARE POLICY ESPOUSED BY THE PCC. Again, untilCMS actually adopts the PCC’s suggestions, the PCC’s suggestions cannot be relied upon by practitioners. ThePCC desires to be a change agent in the law in order to help start and encourage a constructive dialogue on theweaknesses of the program. For the actual Medicare policy, see chapter CB.

A logical robust coding system would be ME-CE (pronounced “mee-see”) (mutually exclusive, and collectivelyexhaustive). “Mutually exclusive” means that no two codes could be used for the same device. “Collectivelyexhaustive” means that the codes that exist will cover all work that is currently done in modern Pedorthics.

Sadly, the current code sets are NOT ME-CE. This document tries to work within the guidelines of the currentcodes—providing reasoned decision rules to differentiate between codes. This document also provides suggestionsfor new code opportunities or new code descriptions to create a system that is up-to-date and ME-CE.17

All rule making is a form of “line drawing”. The line has to be drawn somewhere and certainly bright lines can beboth over and under inclusive (include items that should not have been and exclude items that should not havebeen). The PCC has attempted to draw lines in such a way as to limit over and under inclusion, but acknowledgesthat such a task is not entirely possible.

This document is designed to expound on the most common Pedorthic devices and to provide coding guidelinesto be used by practitioners. The suggestions within are designed to be ME-CE for the most common devices usedtoday.

The PCC has several guiding principles underlying its work:1. Code sets need to be ME-CE2. Code sets need to be internally consistent3. Third party payors want to fairly compensate practitioners for their time and materials, plus overhead and a

modest profit.a. The current coding environment does not always reflect this—due primarily to the fact that no industry-

wide body has attempted to bring clarity to these coding issues. The PCC believes that its work willspark the necessary scrutiny and conversations to, over time, allow the L3000-L3649 series code setsto be logical and fair for all parties, and therefore for the A5500-A5513 series to also be logical and fairfor all parties.

4. The coding is an additive coding system—so separate steps or materials should have separate codes—especially where multiple combinations are available above and beyond the “base” code. Deviations from thisshould only be where absolutely necessary.

5. Differences between devices will consist of differences in materials and labor, but the labor component isusually a much bigger driver to differences than material components. Therefore, distinctions between codesshould have this in mind.

THE EIGHT FLAWS OF THE CURRENT TSD MEDICAL POLICYThe current TSD program has eight key flaws in its current formulation. The PCC believes that these flaws should beaddressed by CMS in order to improve patient care and make the program more rational.


FLAW 1: LACK OF QUALIFIED PROVIDER LANGUAGE:

To properly fit a diabetic/neuropathic shoe and to properly manage the diabetic/neuropathic foot, a practitioner musthave relevant training and hands-on experience in shoe fitting and management of plantar pressures. These areskills that CANNOT be picked up solely by reading a book or watching a PowerPoint presentation.

The PCC suggests that there should be qualified provider language for these codes. In other words, the providersof these codes should have had some level of relevant initial training, have passed some sort of national exam,receive some level of relevant continuing education, and be subject to some code of ethics from a certifying boardthat is approved by the National Organization for Competency Assurance (NOCA—www.noca.org).

The PCC suggests the following practitioners are qualified to dispense some or all of the A5500 series: C.Ped;L.Ped; BOCPD; CO; CP; CPO; BOCO (O); BOCO (P); and DPMs. The PCC suggests non-coverage for non-qualified providers.

Personal certification and/or licensure also provides accountability. If a practitioner were to engage in negligence,fraud or abuse, their personal certification/license will be at risk and their ability to participate in the program (at anylevel) in the future can be at risk. The PCC believes that the individual practitioner must have his/her own personalNPI listed on the CMS-1500 form to provide personal traceability and accountability for the program. The use ofcorporate-level NPIs (i.e. for a practice entity, rather than for the individual practitioners) allows for behavior to hide.For instance, an entity could bill for 50 diabetic/neuropathic shoes a day if it contained a large number of practitioners.This would be reasonable. However, if an individual were to do so—that would indicate some sort of fraud andabuse and could be investigated as it would be nearly impossible for one person to properly fit that many diabetic/neuropathic patients in one day. Entities without a valid practitioner would lose their ability to bill for the devices.The PCC believes that this is the most important and fundamental way to reduce fraud and abuse, and provides avery cost-effective way to do it.

Previously, strict qualified provider language has been delayed under the argument that it would unnecessarilyrestrict access to the program. The PCC believes at this point that there is sufficient access, and/or that it would beeasy enough for individuals to become credentialed pedorthists in order to fit diabetic/neuropathic footwear. ThePCC recognizes that an allowance may be necessary for defined rural areas, but believes that for 1) the best interestof the patients, and 2) the best interest of the program (i.e. to reduce negligence, fraud and abuse), that it is time torequire strict qualified provider language and personal (not just corporate) accountability.

In addition, the PCC applauds the intent behind the Facility Accreditation requirements proposed, then partiallyrescinded by CMS. However, the PCC believes that Facility Accreditation will be less effective than the personalaccountability provided by strict qualified provider language. The PCC believes that if any qualified provider musthave their facility accredited, that all qualified providers should have to as well (i.e. all or nothing). This provideshorizontal equity between providers. The PCC does not believe that it is either fair or appropriate for CertifiedPedorthists to be required to have Facility Accreditation to dispense TSD benefits when other practitioners are notrequired to have their facilities accredited. Certified Pedorthists have been dispensing diabetic footwear longbefore other practitioners were dispensing diabetic footwear and long before there was a TSD benefit. If anything,Certified Pedorthists should be the last group of practitioners required to show their competence to bill for the TSD.The PCC applauds mandatory Facility Accreditation for non-qualified providers in an effort to help institute controlsthat are present for qualified providers, but otherwise lacking for non-qualified providers.


FLAW 2: THE LACK OF A REQUIREMENT FOR A FITTING STOCK:

The PCC recognizes that as part of the Facility Accreditation Quality Standards, CMS did not require a fitting stock forthe fitting of diabetic/neuropathic footwear. This shows a fundamental lack of understanding about properly fittingshoes.

Shoes are built over a last. The last is the wooden or plastic form that gives the shoe its fitting characteristics. Thereare no uniform standards for the sizing of shoes—meaning that shoes marked the same size from two differentmanufacturers will usually fit differently. Even within one manufacturer, if there are two styles made over two differentlasts, there is a high probability that the shoes will fit differently, even if marked with the same size.

Diagram: Important Last Measurements That Affect Fit:

The Brannock Device is the most popular device used to measure feet, yet it provides only two of several importantmeasurements needed to fit a shoe—length and width. The Brannock Device attempts to be a uniform standard, yetas mentioned above, there is no uniformity followed between shoe manufacturers—so almost all shoes will fitdifferently.

In addition, virtually no one has two identical feet, i.e. where the left is a perfect mirror image of the right. In addition,the foot is a dynamic structure—it changes size and shape during gait. It is virtually impossible to properly fit atherapeutic or medical-grade shoe on a routine basis using only a Brannock device and a catalogue, no matter howfamiliar one is with the last. Until a more robust sizing system is developed, the only way to properly fit a shoe on agiven person is to try it on and compare it to other nearby sizes and choose the best option.

There are few experienced individuals who fit diabetic/neuropathic shoes (especially those who were fitting diabetic/neuropathic shoes before there was a TSD) who would claim that they could fit shoes as well without a fitting stockas with one. Most practitioners who rely on routine special ordering will confide that they often have concerns aboutthe fit of some of their shoes but fear the delay and expense to both themselves and the patient for a return visit tocompare to another size.


The PCC does not think it necessary that all diabetic/neuropathic shoes must be stocked, but the PCC does thinkthat it is necessary that there be a fitting stock of shoes and that all patients have at least two different sizes or widthstried on them (both feet) in order to confirm that the best fit was accomplished. The PCC believes that this will havea significant impact on improving the quality of patient care.

FLAW 3: SUBSTITUTION OF SHOE MODIFICATIONS FOR INSERTSCMS covers three pair of diabetic/neuropathic inserts per year for one simple reason: these inserts, given theprotective materials they are made from (i.e. plastazote) have an average life of 4 months given normal wear andtear. This assumes an “average” weight of diabetic/neuropathic patients. However, Type II diabetes is highlycorrelated with obesity, and it is not uncommon to have very obese diabetic/neuropathic patients. These obesepatients, who are putting far greater stress on their feet given their extra weight, are receiving the same number ofinserts as “average” or “below average” weight diabetic/neuropathic patients.

The current TSD provides that if a patient needs a shoe modification (i.e. a pair of rocker soles) that they maysubstitute the pair of rocker soles for a pair of inserts. This is intended to control the costs to Medicare.

However, this policy is completely backwards from a medical necessity standpoint. If there is a patient with thepotential to ulcerate on their forefoot so great that the doctor prescribes rocker soles to unload the forefoot ulcerationsite, that is the last patient who should be denied 12 months of insert protection. This patient is the one who needsall three sets of inserts the most. In all cases, actual medical necessity should be the sole determining factor for thenumber of units of service, not an arbitrary artificial “substitution” process.

The PCC favors incremental coverage for shoe modifications—not as a substitution for inserts. The PCC suggestsdeveloping a list of ICD-9 codes that would need to be billed in addition to the diabetes code for each shoemodification covered. Again, the PCC recognizes that CMS is budget constrained and is not looking to increase thecosts of the TSD program. However, with the additional scrutiny of qualified providers and the additional requirementof ICD-9 codes, the PCC does not believe that the shoe modification benefit will be over-consumed. In addition,few patients desire shoe modifications (even though prescribed by their doctor) because many patients perceiveshoe modifications as unsightly. In addition, because incremental coverage could mean an incremental out ofpocket co-pay for the patient, patients are not going to over-consume unnecessary shoe modifications. Thesemarket forces will keep downward pressure on the consumption of shoe modifications and keep them used onlywhere really needed.

Again, the earlier statistics show what a fantastic return on investment the TSD program is for CMS. The incrementalcoverage of shoe modifications would ensure that those patients who are most at risk receive the modalities thatthey need and the full 12 months of insert coverage.

FLAW 4: THE LACK OF GENDER SPECIFIC REIMBURSEMENTS FOR OTS SHOES.In 2005 (the last year for which comprehensive data is available) there were over 2 billion pairs of shoes sold in theUnited States.18 In the same year, approximately 729,000 pair of A5500 were dispensed (0.04% of the entirenumber of pairs of shoes sold).

In virtually no corner of the footwear business do comparable men’s and women’s shoes have the same wholesaleor retail price. For instance, if a manufacturer has a style number that is available for both men and women (i.e. theNew Balance 992), the man’s shoe will cost more than the comparable woman’s shoe. This is due to the fact thatthey require more materials, and also to the fact that all else being equal, more women’s shoes are sold than men’s


shoes, and therefore the fixed costs for manufacturing a man’s shoe is spread over fewer pairs, yielding a higherprice per pair.

The only corner of the shoe business where men’s and women’s shoe prices have been routinely averaged is thediabetic/neuropathic shoe vendors that have sprung up after the passage of the TSD. For these vendors, theiractual costs are not proportionate—they are paying more per pair for their men’s shoes than they are for theirwomen’s shoes. These companies have merely decided to average the prices when they sell them to doctors andother suppliers selling TSD footwear.

It is a fallacy for CMS to provide the same reimbursement for men’s and women’s shoes. Even the L-code systemrecognizes the difference. Doing this is a form of discrimination against men—because it puts economic pressureon suppliers to either avoid helping men or to help them on a non-assigned basis rather than an assigned basis.

Since these costs are not average by the majority of the market, it is bad for CMS, patients, and suppliers toaverage the allowables for men’s and women’s OTS shoes that are part of the TSD.

FLAW 5: LOW REIMBURSEMENT LEVELS—BOTH CMS AND PRIVATE PAYOR

The unique aspect of the TSD reimbursement levels for Medicare is that they are not part of the Fee Schedule, theyare independently and uniquely set by Congress. This means that it literately takes an act of Congress to make achange—even a change that keeps pace with inflation. This creates an unhelpful impediment to the maintenance ofthe program and the PCC strongly supports a move to make the entire TSD part of the fee schedule system to putit on parity with the non-diabetic/neuropathic codes.

The economic importance of these codes and the money saved to Medicare have been previously described inthis chapter. That being said, the reimbursement levels are highly scrutinized by Medicare and some of thereimbursements have been historically low. They have been frozen and reduced in the past. Any increases havebeen modest. Most practitioners agree that the Medicare reimbursements are set at a minimum level. This isevidenced by the fact that many full-service pedorthic practices do not take assignment on TSD codes.

An insult was added to injury in the past few years as private insurances began to offer limited coverage of TSDcodes. However, many insurances have been discounting their reimbursement below Medicare’s already lowlevels. The key difference is that most private insurance contracts have no option for non-assigned work. Thus, thepractitioner has to decide whether to cut quality or cut profits. Some contracts have allowables below the actualdirect costs of the items.

These private insurance A5500 series allowables have another fallacy—they are often set below the L-code allowablesfor the exact same items. Even though the diabetic/neuropathic foot is the riskier foot, it has the lower allowable forthe exact same device.

It is a well-accepted notion in both law and economics that riskier activity requires a risk premium to compensate forthe higher risk. For instance, private bonds must pay investors higher interest rates than government bonds ofequal duration because they carry a higher risk of default. Fireworks manufacturers pay higher fire insurancepremiums than bubble gum manufacturers since fireworks have a higher inherent level of fire risk than bubble gum.Underwater welders make more money than regular welders because there is a risk to doing the work under waterand the underwater welder must be compensated for that risk. In law, the “public policy” argument is that producers


of riskier goods can and should charge a risk premium, and then use part of that risk premium to buy liabilityinsurance to help compensate any parties who might become injured by that risk.

The diabetic/neuropathic foot is the riskiest foot to work on because it has all of the biomechanical challenges of theregular foot combined with the very serious soft-tissue challenges from diabetes. As the riskier foot, it takes ahigher level of knowledge and time on the practitioner’s part. As such, it should be compensated at a level HIGHERthan the corresponding L-code, not lower.

The PCC strongly suggests that all private payor A5500 reimbursement levels be set no lower than Medicare’slevels. The PCC believes that given the public health importance for diabetic/neuropathic footwear, there should berequired parity between private insurance and Medicare on fee schedules. In addition, should CMS implementunfunded mandates on providers (i.e. facility accreditation), then the reimbursements for these devices should beincreased to help pay for the additional administrative requirements. The payors are already getting a fantasticreturn on their investment and they can only reap this return if the products are made and dispensed correctly. It isshort-sighted and immoral to 1) under-compensate for this work, and 2) to do so on a forced assigned basis.

The PCC encourages insurance companies to use the PCC Acid Test: either compensate a code fairly or excludecoverage and let the marketplace decide the fair price. It is not in anyone’s long term interest to artificially under-reimburse a code. All this does is 1) unduly financially penalize practitioners who are tying to provide goodproducts and services, 2) unduly pressure practitioners to try to cut corners, or 3) force practitioners out of theinsurance market. Pedorthists are not alchemists; they cannot stay in business if they are being compensatedbelow their costs plus a reasonable profit.

Included near the end of this document is a list of allowables set by Region A DME MAC, for January 2009 for theWashington, DC area (where the PCC is based). The PCC encourages all third-party payors to at least follow theseallowables.

The PCC recommends all third party payors to adopt its findings, coverages, etc. The PCC recommends thatpractitioners notify their third party payors, in writing, that they are complying with the PCC coding recommendations.

FLAW 6: NO ONE-TO-ONE MATCH BETWEEN THE PEDORTHIC L-CODES AND THE PEDORTHIC A CODES.The L-code system for pedorthics should be ME-CE for the work done by pedorthists. It should include all workdone by pedorthists and it should have each code be logically independent of every other code. The PCC hasdone this in its proposed revision of the L-code system listed in Section A.

In the same way, the A-code system should be ME-CE, and should therefore have a one-to-one match with underlyingpedorthic L-codes. The current system is not this way. The PCC has undertaken this proposed revision of the A-code system in order to make the codes ME-CE and to make sure the codes have a one-to-one match versus theunderlying pedorthic L-codes. To do this, the PCC has had to recommend the elimination of some A-codes and thecreation of several others.

FLAW 7: LOW REIMBURSEMENT FOR A5513.

When the TSD was first enacted, it provided no distinction between allowable amounts for custom and OTS inserts.This was, admittedly, a mistake/oversight on the part of CMS. This policy woefully under compensated custominserts. Several years ago, a distinction was made and custom inserts were given a slightly higher reimbursementthan OTS inserts. However, the reimbursement level is only fair for two types of custom inserts: 1) the custom inlays


in a molded shoe, and 2) a direct milled custom inlay (milled by a CAD/CAM system from a block of EVA orPlastazote foam). The current allowable does not fairly compensate a traditional, hand made custom diabetic/neuropathic foot orthosis that is vacuum formed over a positive model of a foot and that contains multiple layers ofmaterials (i.e. a diabetic/neuropathic trilam topcover (plastazote over PPT over EVA) over cork base orthosis—thegold standard in custom diabetic/neuropathic foot orthoses).

However, the most challenged feet usually require traditional hand-made custom orthoses. It is impractical to use aCAD/CAM system to make this type of orthosis because it cannot achieve the total contact necessary.

FLAW 8: LOW AND EVEN REIMBURSEMENTS FOR SHOE MODIFICATIONS

Shoe modifications are extremely time-consuming and difficult to do. All of the work must be done by hand. Theallowables today do not come close to fairly compensating the work required for most shoe modifications. Inaddition, it is a fallacy to compensate all modifications at the same rate. They have different levels of complexityand should be compensated according to their level of complexity.

(Chapter Footnotes)1 Many people within the industry erroneously refer to this program as the Therapeutic Shoe Bill. A Bill is a proposed law. Once a law has beenpassed, it is no longer appropriate to call it a Bill. This moniker was used by people within the industry prior to the Bill’s passing, and the old habits have proven to die hard. It is more appropriate to call it the TSD “benefit” or TSD “program”, or simply “TSD.”2 http://www.diabetes.org/diabetes-statistics.jsp3 http://www.diabetes.org/about-diabetes.jsp4 http://www.diabetes.org/diabetes-statistics.jsp.5 http://www.andovermedical.com/page_about.html6 http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp7 http://www.diabetesvoice.org/issues/2005-11/Counting_the_costs_of_the_diabetic_foot.pdf8 http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp9 Diabetes Statistics, http://www.pharminfo.com/disease/diabetes/diabstat.html.10 Diabetes Facts and Figures, The American Diabetes Association, http://www.diabetes.org/ada/c20f.html.11 Diabetes Statistics, http://www.pharminfo.com/disease/diabetes/diabstat.html.12 Diabetes Facts and Figures, The American Diabetes Association, http://www.diabetes.org/ada/c20f.html.13 http://www.postgradmed.com/issues/1999/07_99/culleton.htm Quoting National Diabetes Data Group. Diabetes in America. 2d ed. Bethesda: National Institutes of Health, 199514 http://www.diabetesvoice.org/issues/2005-11/Counting_the_costs_of_the_diabetic_foot.pdf15 http://www.diabetesvoice.org/issues/2005-11/Counting_the_costs_of_the_diabetic_foot.pdf quoting Ragnarson Tennvall G, Apelqvist J. Health-economic consequences of diabetic foot Lesions. Clin Infect Dis 2004; 39: 132-9.16 http://www.diabetesvoice.org/issues/2005-11/Counting_the_costs_of_the_diabetic_foot.pdf Quoting A pelqvist J, Ragnarson Tennvall G, LarssonJ, Persson U. Long-term costs for foot ulcers in diabetic patients in a multidisciplinary setting. Foot Ankle Int 1995; 16: 388-94.17 The world is far too complex and ever-changing for code descriptions to be absolutely ME-CE. The PCC’s goal is to account for the vast majorityof what exists in the pedorthic field during the 21st century. New innovative and hybrid items will require judgment. The practitioner should makehis/her own determination of the “best” coding for innovative and/or hybrid items. The goal should be to find the most closely related code, or touse the L3649 /A5507 code, and document the reasons why. The PCC has a program whereby it will review situations and/or devices andprovide written guidance on coding.18 https://www.apparelandfootwear.org/pressreleases/12306PR.pdf




CHAPTER CB: OFFICIAL MEDICARE LCD AND PA FOR THERAPEUTIC SHOES FOR PERSONS WITH DIABETES(L11525) Effective January 1, 2011:

Indications and Limitations of Coverage and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) bereasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of amalformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For theitems addressed in this local coverage determination, the criteria for “reasonable and necessary”, based on SocialSecurity Act § 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/ormedical necessity.

The statutory coverage criteria for therapeutic shoes including the requirement for an order are specified in therelated Policy Article.

Separate inserts may be covered and dispensed independently of diabetic shoes if the supplier of the shoesverifies in writing that the patient has appropriate footwear into which the insert can be placed. This footwear mustmeet the definitions found in this policy for depth shoes or custom-molded shoes.

A custom molded shoe (A5501) is covered when the patient has a foot deformity that cannot be accommodated bya depth shoe. The nature and severity of the deformity must be well documented in the supplier’s records andavailable upon request. If a custom molded shoe is provided but the medical record does not document why thatitem is medically necessary, it will be denied as not reasonable and necessary.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of allBill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equallyto all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to reportthis service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reportedunder other Revenue Codes are equally subject to this coverage determination. Complete absence of all RevenueCodes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to applyequally to all Revenue Codes.

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:EY - No physician or other licensed health care provider order for this item or serviceGY - Item or service statutorily excluded or does not meet the definition of any Medicare benefitKX - Requirements specified in the medical policy have been metLT - Left SideRT - Right Side


HCPCS CODES:

A5500 FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OFOFF-THE-SHELF DEPTH-INLAY SHOE MANUFACTURED TO ACCOMMODATE MULTI- DENSITY INSERT(S), PERSHOE

A5501 FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OFSHOE 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 ORCUSTOM-MOLDED SHOE WITH ROLLER OR RIGID ROCKER BOTTOM, PER SHOE

A5504 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE ORCUSTOM-MOLDED SHOE WITH WEDGE(S), PER SHOE

A5505 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE ORCUSTOM-MOLDED SHOE WITH METATARSAL BAR, PER SHOE

A5506 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE ORCUSTOM-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-MOLDEDSHOE, PER SHOE

A5510 FOR DIABETICS ONLY, DIRECT FORMED, COMPRESSION MOLDED TO PATIENT’S FOOT WITHOUTEXTERNAL HEAT SOURCE, MULTIPLE-DENSITY INSERT(S) PREFABRICATED, PER SHOE

A5512 FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, DIRECT FORMED, MOLDED TO FOOT AFTEREXTERNAL HEAT SOURCE OF 230 DEGREES FAHRENHEIT OR HIGHER, TOTAL CONTACT WITH PATIENT’SFOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 1/4 INCH MATERIAL OF SHORE A 35 DUROMETER OR 3/16INCH MATERIAL OF SHORE A 40 DUROMETER (OR HIGHER), PREFABRICATED, EACH

A5513 FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, CUSTOM MOLDED FROM MODEL OF PATIENT’SFOOT, TOTAL CONTACT WITH PATIENT’S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 3/16 INCH MATERIALOF SHORE A 35 DUROMETER OR HIGHER), INCLUDES ARCH FILLER AND OTHER SHAPING MATERIAL, CUSTOMFABRICATED, EACH

ICD-9 Codes that Support Medical Necessity

For ICD-9 codes relating to statutory coverage, see Policy Article.

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity


General Information

Documentation Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless “there has beenfurnished such information as may be necessary in order to determine the amounts due such provider.” It is expectedthat the patient’s medical records will reflect the need for the care provided. The patient’s medical records includethe physician’s office records, hospital records, nursing home records, home health agency records, records fromother healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the prescribing physician, kept on file by the supplier,and made available upon request. Items billed before a signed and dated order has been received by the suppliermust be submitted with an EY modifier added to each affected HCPCS code.

If the prescribing physician is the supplier, a separate order is not required, but the item provided must be clearlynoted in the patient’s record.

A new order is not required for the replacement of an insert or modification within one year of the order on file.However, the supplier’s records should document the reason for the replacement. A new order is required for thereplacement of any shoe. A new order is also required for the replacement of an insert or modification more thanone year from the most recent order on file. The detailed written order must be signed on or after the date of the visitwith the Prescribing Physician (see related Policy Article for information about the visit with the Prescribing Physician).

The supplier must obtain a signed statement from the physician who is managing the patient’s systemicdiabetes condition (i.e., the certifying physician) specifying that the patient has diabetes mellitus, has one of conditions2a-2f listed in the related Policy Article, is being treated under a comprehensive plan of care for his/her diabetes,and needs diabetic shoes. The certifying physician must be an M.D. or D.O and may not be a podiatrist, physicianassistant, nurse practitioner, or clinical nurse specialist. The “Statement of Certifying Physician for Therapeutic Shoes”form (see LCD Attachments section below) is recommended. Whatever form is used must contain all of the elementscontained on the recommended form attached to this LCD. This statement must be completed, signed, and datedby the certifying physician. A new Certification Statement is required for a shoe, insert or modification provided morethan one year from the most recent Certification Statement on file.

There must be information in the medical records of the certifying physician that:

a. Documents management of the patient’s diabetes; andb. Documents detailed information about the condition (2a-2f listed in the related Policy Article) that qualifies thepatient for coverage.

The Certification Statement by itself does not meet this requirement for documentation in the medical records.

The in-person evaluation of the patient by the supplier at the time of selecting the items that will be provided (referto related Policy Article, Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include at least thefollowing:

1. An examination of the patient’s feet with a description of the abnormalities that will need to be accommodated bythe shoes/inserts/modifications.

2. For all shoes, taking measurements of the patient’s feet.


3. For custom molded shoes (A5501) and inserts (A5513), taking impressions, making casts, or obtaining CAD-CAM images of the patient’s fee that will be used in creating positive models of the feet.

The in-person evaluation of the patient by the supplier at the time of delivery (refer to related Policy Article, Non-Medical Necessity Coverage and Payment Rules, criterion 5) must be conducted with the patient wearing the shoesand inserts and must document that the shoes/inserts/modifications fit properly. The ICD-9 code that justifies theneed for these items must be included on the claim.

KX AND GY MODIFIERS:

Suppliers must add a KX modifier to codes for shoes, inserts, and modification only if criteria 1-5 in the Non- MedicalNecessity Coverage and Payment Rules section of the related Policy Article have been met. This documentationmust be available upon request. The Statement of Certifying Physician form is not sufficient to meet this requirement.

If criteria 1-5 in the Non-Medical Necessity Coverage and Payment Rules section of the related Policy Article havenot been met, the GY modifier must be added to each code.

If a KX or GY modifier is not included on the claim line, it will be rejected as missing information.

Refer to the Supplier Manual for more information on documentation requirements.

Policy Article

Article Text

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For an item addressed in this policy to be covered by Medicare, a written signed and dated order must be receivedby the supplier prior to claim submission. If the supplier bills for an item without first receiving the completed order,the item will be denied as noncovered.

The Certifying Physician is defined as a doctor of medicine (M.D.) or a doctor of osteopathy (D.O.) who is responsiblefor diagnosing and treating the patient’s diabetic systemic condition through a comprehensive plan of care. Thecertifying physician may not be a podiatrist, physician assistant, nurse practitioner, or clinical nurse specialist.

The Prescribing Physician is the person who actually writes the order for the therapeutic shoe, modifications andinserts. This physician must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing physicianmay be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribingphysician may be the supplier (i.e., the one who furnishes the footwear).

The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary andthat bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual.The Prescribing Physician may be the supplier. The Certifying Physician may only be the supplier if the certifyingphysician is practicing in a defined rural area or a defined health professional shortage area.

Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all of the following criteria aremet:

1. The patient has diabetes mellitus (ICD-9 diagnosis codes 249.00-250.93); and


2. The certifying physician has documented in the patient’s medical record one or more of the following conditions:

a. Previous amputation of the other foot, or part of either foot, orb. History of previous foot ulceration of either foot, orc. History of pre-ulcerative calluses of either foot, ord. Peripheral neuropathy with evidence of callus formation of either foot, ore. Foot deformity of either foot, orf. 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 patientunder a comprehensive plan of care for his/her diabetes and that the patient needs diabetic shoes.

For claims with dates of service on or after 1/1/2011, the certifying physician must:

Have an in-person visit with the patient during which diabetes management is addressed within 6 monthsprior to delivery of the shoes/inserts; and

Sign the certification statement (refer to the Documentation Requirements section of the related Local CoverageDetermination) on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.

4. Prior to selecting the specific items that will be provided, the supplier must conduct and document an in -personevaluation of the patient. (Refer to the related Local Coverage Determination, Documentation Requirements section,for additional information.)

5. At the time of delivery of the items selected, the supplier must conduct and document an in-person visit with thepatient.

If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied as noncovered. Whencodes are billed without a KX modifier (see Documentation Requirements section of accompanying Local CoverageDetermination), they will be denied as noncovered.

In order to meet criterion 2, the certifying physician must either:

i. Personally document one or more of criteria a – f in the medical record of an in-person visit within 6 months priorto delivery of the shoes/inserts and prior to or on the same day as signing the certification statement; or

ii. Obtain, initial/sign, date (prior to or on the same day as signing the certification statement), and indicate agreementwith 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 thatdocuments one of more of criteria a – f.

The requirement that the in-person visit(s) be within 6 months prior to delivery of the shoes/inserts is effective forclaims with dates of service on or after 1/1/2011.

Note: The certification statement is not sufficient to meet the requirement for documentation in the medical record.

Depending on the items ordered, both the evaluation and delivery could occur on the same day if the supplier hadboth a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the items thatmeet the beneficiary’s needs. Both components of the visit (criteria 4 and 5 above) must be clearly documented.


For claims with dates of service on or after 1/1/2011, there must be an in-person visit with the prescribing physicianwithin 6 months prior to delivery of the shoes/inserts.

For patients meeting the coverage criteria, coverage is limited to one of the following within one calendar year(January – December):

One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2additional pairs of inserts (A5512 or A5513); or

One pair of depth shoes (A5500) and 3 pairs of inserts (A5512 or A5513) (not including the noncustomizedremovable inserts provided with such shoes).

A modification of a custom molded or depth shoe may be covered as a substitute for an insert. Although notintended as a comprehensive list, the following are the most common shoe modifications: rigid rocker bottoms(A5503), roller bottoms (A5503), wedges (A5504), metatarsal bars (A5505), or offset heels (A5506). Other modificationsto diabetic shoes (A5507) include, but are not limited to flared heels.

Quantities of shoes, inserts, and/or modifications greater than those listed above will be denied as noncovered.

Items represented by code A5510 reflect compression molding to the patient’s foot over time through the heat andpressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contactat the time of dispensing, they do not meet the requirements of the benefit category and will be denied as noncovered.

Inserts used in noncovered shoes are noncovered.

Deluxe features of diabetic shoes (A5508) will be denied as noncovered.

There is no separate payment for the fitting of the shoes, inserts or modifications or for the certification of need orprescription of the footwear. Claims for unrelated evaluation and management services provided by the physicianare processed by the local carrier.

Shoes are also covered if they are an integral part of a covered leg brace. However, different codes are used forfootwear provided under this benefit. See the medical policy on Orthopedic Footwear for details.

CODING GUIDELINES

A depth shoe (A5500) is one that:

1. Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16" of additional depth used toaccommodate custom-molded or customized inserts; and

2. Is made from leather or other suitable material of equal quality; and

3. Has some form of shoe closure; and

4. Is available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width ofthe upper portions of the shoe according to the American standard last sizing schedule or its equivalent. (TheAmerican 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:

1. Is constructed over a positive model of the patient’s foot; and

2. Is made from leather or other suitable material of equal quality; and

3. Has removable inserts that can be altered or replaced as the patient’s condition warrants; and

4. 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 thepatient’s foot. Direct molded means it has been conformed by molding directly to match the plantar surface of theindividual patient’s foot. Total contact means it makes and retains actual and continuous physical contact with theweight-bearing portions of the foot, including the arch throughout the standing and walking phases of gait.

The insert must retain its shape during use for the life of the insert. The layer responsible for shape retention is calledthe “base layer” in the code descriptor. This material usually constitutes the bottom layer of the device and must beof a sufficient thickness and durometer to maintain its shape during use (i.e., at least ¼ inch of 35 Shore A or higheror at least 3/16 inch of 40 Shore A or higher). The material responsible for maintaining the shape of the device mustbe heat moldable. The specified thickness of the base layer must extend from the heel through the distal metatarsalsand may be absent at the toes.

Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to amodel of the patient’s foot so that it conforms to the plantar surface and makes total contact with the foot, includingthe arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cupheight, arch height and length, or toe shape.

The 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 devicebecause appropriate arch fill or other additional material will be layered up individually to maintain shape andachieve total contact and accommodate each patient’s specific needs. The central portion of the base layer of theheel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction. The specified thickness of thelateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at thetoes. The top layer of the device may be of a lower durometer and must also be heat moldable. The materials usedshould be suitable with regards to the patient’s condition.

Rigid rocker bottoms (A5503) are exterior elevations with apex position for 51 percent to 75 percent distancemeasured from the back end of the heel. The apex is a narrowed or pointed end of an anatomical structure. Theapex must be positioned behind the metatarsal heads and tapering off sharply to the front tip of the sole. Apexheight helps to eliminate pressure at the metatarsal heads. Rigidity is ensured by the steel in the shoe. The heel ofthe 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 thefront 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. Thefunction is to shift or transfer weight bearing upon standing or during ambulation to the opposite side for addedsupport, stabilization, equalized weight distribution, or balance.


Metatarsal bars (A5505) are exterior bars which are placed behind the metatarsal heads in order to remove pressurefrom the metatarsal heads. The bars are of various shapes, heights, and construction depending on the exactpurpose.

Offset heel (A5506) is a heel flanged at its base either in the middle, to the side, or a combination, that is thenextended 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 limitedto 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 adiabetic shoe(s).

Deluxe features must be coded using code A5508.

Codes for inserts or modifications (A5503 – A5508, A5510, A5512, A5513) may only be used for items related todiabetic shoes (A5500, A5501). They must not be used for items related to footwear coded with codes L3215 -L3253. Inserts and modifications used with L coded footwear must be coded using L codes (L3000 - L3649).

The right (RT) and/or left (LT) modifiers must be used when billing shoes, inserts, or modifications. If bilateral itemsare provided on the same date of service, bill for both items on the same claim line using the RTLT modifiers and 2units of service. Claims billed without modifiers RT and/or LT will be rejected as incorrect coding.

Inserts for missing toes or partial foot amputation should be coded L5000 or L5999, whichever is applicable.

The only products that may be billed using codes A5512 are those that are specified in the ProductClassification List on the Pricing, Data Analysis, and Coding (PDAC) contractor web site.

There are two categories of products that are billed with code A5513:

Inserts that are custom fabricated by a manufacturer/central fabrication facility and then sent to someoneother than the patient. These items may be billed using code A5513 only if they are listed on the PDAC website.

Inserts that are custom fabricated from raw materials that are dispensed directly to the patient by the entitythat fabricated the insert. These items do not have to be listed on the PDAC web site in order to be billedusing code A5513. However, the supplier must provide a list of the materials that were used and a descriptionof the custom fabrication process on request.

If an insert is not included in one of these categories of items, it must be billed with code A5510 or A9270 (noncovereditem).

Information concerning the documentation that must be submitted to the PDAC for a Coding Verification Review canbe found on the PDAC web site or by contacting the PDAC.


CHAPTER CC: PCC INTERPRETATIONS, SUGGESTIONS AND GUIDANCE FOR TSD(Cannot be relied upon until adopted by CMS)

DATE OF SERVICEFor CMS, the date of service is when the beneficiary receives the device. That works for CMS, because Medicarebeneficiaries tend to maintain their coverage permanently.. The PCC recommends a different rule for privateinsurance, where people often do change between private insurance companies. The PCC believes that CMSshould move to this method for uniformity.

For private third-party payors, the PCC recommends negotiating the Date of Service (DOS) to be the date the itemwas ordered from the practitioner, so long as the practitioner has delivered the device within the required number ofweeks of the date the beneficiary ordered it (six weeks for custom items and three weeks for OTS items), or canprove that he/she has notified the beneficiary that the device is ready to be picked up. If the practitioner cannotmeet that standard, then the DOS should be the date the item is delivered. If the practitioner can prove that thebeneficiary has been notified three times in a two month period that the device is ready, and the beneficiary won’tcome in to pick up the device, the practitioner can ship the device to the beneficiary’s last known address. Withproof of shipment, the practitioner can bill the device using a DOS of the date the device was ordered. The PCC iscommitted to the importance of face-to-face fitting. However, if a beneficiary is being non-responsive and thesupplier has shown their good faith in trying to contact the beneficiary, the options are 1) to have the pedorthicdevice sit unused—prohibiting the beneficiary from getting any value and forcing the supplier to lose money, or 2)put the pedorthic device in the beneficiary’s hands so that the beneficiary now has the incentive to be responsiveand to encourage the beneficiary to get the use of the device. The PCC believes that the latter is in the best interestof public policy.

Medicare does have provision for billing a code when the practitioner has done the work as ordered by a beneficiary,but the beneficiary dies before the items can be picked up. Private insurances should have the same rule,assuming that the time between ordering of the device and the beneficiary’s death is a reasonable amount of time(i.e. six weeks for custom or three weeks for OTS).

COVERAGE TESTCurrently, the coverage test for miscellaneous items related to a covered shoe is whether the item is “related to thediabetes.” For instance, some practitioners argue that an elevation added to a diabetic/neuropathic shoe is not“related to the diabetes” and therefore it is not covered. Their argument is that an elevation is related to a limb lengthdifferential, not the diabetes. Others argue that the elevation is critical to properly managing the plantar pressuresrelated to that diabetic/neuropathic shoe. In other words, if the elevation were not done, the foot would loadimproperly and the patient could develop an ulcer. The PCC agrees with this latter argument, and feels that elevationsapplied to a diabetic/neuropathic shoe should be covered.

Likewise, converting laces to hook-and-loop (i.e. Velcro™) to help patients with easier donning and doffing issometimes cited for not being “related to the diabetes.” This is either for some other medical reason (i.e. rheumatoidarthritis in the hands) or patient convenience. Some argue that it can be for fluctuating edema—a byproduct ofdiabetes. However, laces can be adjusted for fluctuating edema, too, so there is unclear argument for necessity. Atthis time, the PCC does not agree that incremental expense for converting laces to Velcro should be coveredbecause the arguments for necessity are not as strong.

The PCC would like to clarify and refine the “related to diabetes” test as follows:


When fitting an diabetic/neuropathic foot, is the item: Attached to a covered item, AND Necessary for proper fit (dorsal, medial, lateral, posterior, anterior); OR Necessary for proper balancing/redistribution of plantar pressures (plantar).

The dual functionality tests are important for establishing that the diabetic/neuropathic shoe will function properly tomanage the diabetic/neuropathic foot in a safe manner. These dual tests will help to clarify when an L-coded itemcan be properly coded as an A5507 (other covered item) rather than a deluxe upgrade/non-covered item—A5508(or be billed as an L-code). Some lines are still hard to draw with this test, but it is a better test than the “related tothe diabetes” test.

DEFINITION OF FITTING AND DISPENSING AND FOLLOW UPFitting includes face to face evaluation of both feet including range of motion; trial and error fitting of Medical Gradeshoes (i.e. from a fitting inventory), inserts and modifications. Dispensing includes final delivery of the finishedproducts (to include Medical Grade shoes, inserts, and modifications) in a face to face delivery of items to bedispensed. Follow up includes checking on the status of the patient’s foot over time and the necessary adjustmentto devices to ensure their continued efficacy over their normal/expected life. For diabetic inserts, this usuallymeans managing the changes in plantar pressures by either building up unloads in certain portions of the insert and/or grinding/sanding off other portions of the insert (i.e. adding materials and/or taking materials away).

Face-to-face fitting is essential. Many diabetic patients are neuropathic. They cannot give accurate feedback aboutthe fit of their shoes. Indeed, most will “prefer” a size that is two to three sizes too small (so that they can sense thecompressive force of the tight shoe). This is very risky, because shoes this tight can cause the very blisters andulcers they were originally supposed to prevent. The vast majority will initially report that the proper size “feels toobig.” When the patient is reminded by the practitioner that the patient has impaired sensation, most tend to complywith the practitioner. See the discussion above under Date of Service.

SHOE MODIFICATIONSAs indicated above, the PCC believes that shoe modifications should be incrementally covered based on medicalnecessity as deemed by the prescriber, not as a substitution of inserts.

QUALIFIED PROVIDERSAs indicated above, the PCC believes that the supplier must be a qualified individual. The supplier may be apodiatrist, pedorthist, orthotist, prosthetist or other qualified individual receiving their credential from a CMS-deemedcredentialing organization or a state licensing authority, and practicing in an appropriate physical facility with at leasta fitting inventory. The Prescribing Physician may be the supplier. The Certifying Physician may only be the supplierif the certifying physician is practicing in a defined rural area or a defined health professional shortage area.

REUSING POSITIVE FOOT MOLDS AS A STARTING POINT FOR TREATMENTThe PCC would like to point out that many times a qualified provider, when making a second set of custom insertsor shoes for a diabetic patient, will start with a clone of the “old” cast and make modifications rather than take a newcast. This is a valid treatment method so long as this is being done for the right reasons and being done by aprovider who is qualified to make such judgments. The existing cast can provide an appropriate “baseline” positionfrom which to modify. If a patient is doing well from an existing cast, the practitioner and the patient can expect toget a similar response if the cast is reused with necessary modifications. The “wrong” reason to do it is to skip stepsor costs. Again, a qualified provider is capable of making this decision.


THE NUMBER OF UNITS OF INSERTS PER SERVICE DATEIn a perfect world, the PCC would like for diabetic/neuropathic patients to return to their supplier every four monthsfor their replacement inserts as prescribed. In this perfect world, the supplier would have the opportunity to checkon the status of the patient and adjust the inserts accordingly.

The PCC recognizes that in most circumstances, there is just one date of service and the patient is sent home withsix units of inserts. Generally, the patient has been instructed to replace the inserts with new ones every fourmonths. Many practitioners will write on the bottom of the inserts with the date that they are to be replaced.

The PCC recognizes that several problems can arise from either scenario (upfront dispensing versus over timedispensing). They are as follows:

Potential Problems with Upfront Dispensing Potential Problems with Over-Time Dispensing Patient forgets/neglects to swap out inserts. Patient loses/destroys inserts. Patient must do own foot inspection and be

counted on to report issues to the practitioner. The Patient’s foot might undergo changes

significant enough to invalidate the other insert pairs (rare absent surgery—most changes can be accommodated with adjustments within a one-year time span).

Patients never come back for additional inserts and end up wearing one insert for a year or longer.

The additional trips cause extra cost for the patient, and would place an extra burden on patients who rely on others for transportation.

The PCC believes that all else being equal, it is better to err on the side of putting the inserts in the hands of thepatient and then trying to manage patient compliance—rather than putting the patient in the situation of being able toeasily forgo care that is needed. Presumably, the presence of the inserts in the patient’s home and the patient’sunderstanding that the inserts belong to the patient and that the patient and/or patient’s insurance “paid” for themgives the patient the incentive to get the value for the insert. This puts the most pressure on the patient to actuallyuse the additional inserts and get the foot-protecting benefit.

In a “dispensing over time” system—the patient has the erroneous incentive to try to “save money” by not returningfor the additional inserts. With insensate feet, the patient might convince himself that “everything will be fine with hisfeet.” The net effect of this will be patients wearing insufficient inserts under the erroneous belief that everything willbe fine. However, this will rarely be the case. The error costs of this decision are ulcers and amputations, which willcost the patient and the health care system far more money than the inserts (hence the whole point of the TSDprogram). The PCC believes that the average insensate patient is not capable of accurately making these trade-offdecisions, and it is not in anyone’s best interest to tempt the patient with an opportunity to skimp on their footprotection. Therefore, the PCC supports the “dispense upfront” system, with all of its potential shortcomings. ThePCC applauds practitioners who send out reminder notices to their patients to remind them to switch their inserts.

GRADING OF BENEFITS ACCORDING TO RISK CATEGORYThe PCC believes that the current one-tier structure of the TSD can provide excess benefits to those diabetics/neuropathics who do not really need them and/or are at a low risk of complication, and often provides inadequatebenefits to those diabetics/neuropathics who have a more severe level of risk/complication and who need a better-grade shoe. In addition, the current program focuses exclusively on the presence or not of diabetes, but that is


really a proxy for neuropathy which should be the primary focus of the medical benefit. The proposed systemwould provide care to other forms of neuropathy, in addition to diabetic neuropathy.

The PCC would like to see the Statement of Certifying Physician (SCP) revised to include the assignment of a “riskcategory” for each patient. The certifying physician would assign the patient to a risk category as developed by theGillis W. Long Hansen’s Disease Center and adopted by the Bureau of Primary Health Care of the Health Resourcesand Services Administration. The patient’s risk category corresponds to the benefit allowed:

Risk Category 0• Has a disease that leads to insensitivity; and• Has protective sensation; and• Does not have a foot deformity; and• Has not had a plantar foot ulcer.

Benefit: No benefit

Risk Category 1• Does not have protective sensation; and• Does not have a significant foot deformity; and• Has not had a plantar foot ulcer.

Benefit: A5500 (see PCC revisions: A5CDA & A5CDB); Off the shelf inserts (i.e. A5512) (6 units) (see PCC revisions);Shoe modifications (A5503-A5507 and newly suggested).

Risk Category 2• Does not have protective sensation; and• Does not have a significant foot deformity; and• Has not had a plantar foot ulcer; but• Has history of pre-ulcerative calluses.

Benefit: See PCC revisions: A5CDC & A5CDD, Custom Inserts (i.e. A5513) (4 units) (see PCC revisions); Shoemodifications (A5503-A5507 and newly suggested).

Risk Category 3• Does not have protective sensation; and• Has history of foot deformity; and• Has a history of plantar foot ulcer or neuropathic fracture (Charcot); or• Has previous foot amputation.

Benefit: A5501 (see PCC revisions to definition); Custom Inserts (i.e. A5513) (6 units total-see definition of A5501)(see PCC revisions); Shoe modifications (A5503-A5507 and newly suggested).

Many beneficiaries that are Risk Category 0 are today receiving benefits. The introduction of this system will betterassociate health care dollars to the patients with the greatest need who need the more complicated (and expensive)devices.


CHAPTER CD: OFF THE SHELF SHOES-ADULT

OverviewFor a complete description of Off The Shelf Shoe codes and their proper use in pedorthics, please see chapter BA.

Use In Treating the Diabetic/Neuropathic FootThere are four primary concerns when choosing a shoe to treat/protect the diabetic/neuropathic foot: 1) the upper ofthe shoe has to be of an accommodative shape so as to not rub the foot. Such rubbing can create an ulcer; 2) theupper of the shoe has to provide enough support and integrity to manage the foot within the shoe during gait; 3) theinsole of the shoe has to be removable and thick enough to allow replacement with an insert that is capable of a)protecting the diabetic/neuropathic’s skin/soft tissue, b) providing for total contact (to spread ground reaction forcesover the largest possible surface area—thus reducing peak pressure in any one spot), c) accommodating unloads,and d) overall managing the plantar pressures; 4) the base/sole of the shoe has to be supportive enough to supportthe diabetic/neuropathic insert and provide sufficient medial and lateral control of the foot. This helps to control/manage plantar pressures, and to support the orthotic device within the shoe.

Not all diabetic/Medical Grade shoes are created equally. Some shoes are more supportive than others. Diabetics/neuropathics with larger feet, a higher body mass index (BMI), or with higher risk, need a sturdier and morecontrolling shoe to manage their plantar pressures. The PCC has suggested the creation of Level One and LevelTwo shoes in order to differentiate the differences and allocate benefits appropriately. The current one-tier systemis adequate for the Risk Category 1/Level One diabetics/neuropathics, but is inadequate for the Risk Category 2/Level Two diabetics/neuropathics.

The PCC assembled a panel of pedorthic shoe manufacturers to help create definitions or distinctions that wouldallow CMS, practitioners, and manufacturers to distinguish between the current level of support and this “moresupportive” Level Two Medical Grade shoe. A clear, definitive, reliable standard was difficult to settle on, since mostsuggestions had many exceptions provided. The consensus of the group was to settle on the distinction of threewidths versus five widths for the shoes, and for the five-width shoe to have a one-quarter inch removable inlay, ratherthan three-sixteenths of an inch.

Though not perfect, the manufacturers and the practitioners on the PCC agreed that these distinctions were 1) clear,2) manufacturable, and 3) sufficient to distinguish the differences of “better-grade” Medical Grade shoes from “standard”Medical Grade shoes.

Other Shoe Definition ChangesThe PCC suggests several other clarifications to the therapeutic shoe definition. The PCC feels that there areseveral shoes that are currently dispensed as A5500 that may meet the technical definition of A5500, but violate thespirit of the A5500 and are, in fact, of inferior quality to handle most diabetic/neuropathic patients. As such, the PCChas clarified certain portions of the definition.

For instance, as it relates to width: width is a measure of circumference of the ball of a shoe. However, in a qualityshoe, the manufacturer will, for every other width, not just add more upper material, but also use a wider midsole/outsole base. A lower quality manufacturer will attempt to put three different sized uppers (or individually markedshoe sizes) on one sized base. The PCC has clarified that for Medical Grade footwear, a maximum of two individualmarked shoe sizes may be used per unit bottom so that the sole width is graded to the size and width of the upperportions of the shoe. This will provide better fitting qualities and better support. For wider widths, it will alsoincrease plantar surface area, thus reducing peak pressures.


The midsole/outsole, by their 1) materials, 2) shape, 3) components, or 4) design must provide additional medial/lateral support over “regular” shoes. “Regular” shoes are shoes that only serve as foot coverings. The PCCacknowledges that this is a requirement that would be easier to enforce if it had objective, verifiable, and measurementstandards. The PCC will continue to work with the pedorthic community to develop such objective standards. In themean time, this will remain a subjective test.

As it relates to the upper material, the PCC suggests that the shoe be made from leather or other suitableaccommodative material of equal quality that 1) is strong enough to provide control, 2) maintains the shape andconforms to the deformity of the foot, but 3) does not include any stretchable man-made material that will retain theoriginal shape of the shoe when the foot is removed. This is to ensure an upper that is controlling enough, but willincrease the risk of rubbing and ulceration. In addition, the PCC has suggested that the Medical Grade shoes haveheel counters to ensure that the shoe will be able to control the foot during gait. Finally, the PCC clarifies the internalseam issue by clarifying that the shoe must have a soft, non-abrasive lining, without any exposed overlappinginternal forefoot or tongue attachment seam. By way of suggestion, not necessarily requirement, the PCC believesthat the shoe should be designed to allow the foot to “breathe,” either through the use of breathable materials suchas leather, or through the introduction of air holes. Moisture/perspiration management is an important component inproviding a healthy in-shoe environment for the at-risk foot.

As it relates to closures, the PCC required L-code pedorthic shoes to have “some form of closure.” (See chapterBA). However, for diabetic/neuropathic Medical Grade footwear, the PCC believes that the closures should belimited to either lace or hook-and-loop closure systems because for the vast majority of patients—these closuresystems will provide the proper amount of adjustability and control of the foot. The PCC recognizes that some otherclosure systems will work on some patients some of the time, but feel that it is important to restrict A-code status toshoes which will provide the maximum amount of benefit to the maximum number of patients—and this wouldrequire the closures to be either lace or hook-and-loop.

The main codes currently in existence are:

OTS DIABETIC SHOESA5500 FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OFOFF-THE-SHELF DEPTH-INLAY SHOE MANUFACTURED TO ACCOMMODATE MULTI- DENSITY INSERT(S), PERSHOE

This code is inadequate in and of itself to handle the issues surrounding the proper fitting of diabetic/neuropathicshoes for men and women.

As such, the PCC recommends the following:


A5CDA For Beneficiariesin Risk Category 1 Only,Including Face to FaceFitting, Dispensing andFollow Up- Pedorthic OTSLevel One Medical GradeShoe, Ladies’ low top,uppers of leather or otheraccommodative yetformable material, withadjustable lace or hook-and-loop closure, avail-able in at least three

This code is based onthe PCC definition ofL3216, but has beenmore narrowlyrestricted to be: For Beneficiaries in

Risk Category 1only.

Uppers of leatheror otheraccommodativeyet formable

Old ExplanationOld Description PCC/New Description PCC/New Explanation

OTS SHOES

A5500 FOR DIABETICSONLY, FITTING(INCLUDING FOLLOW-UP), CUSTOMPREPARATION ANDSUPPLY OF OFF-THE-SHELF DEPTH-INLAYSHOEMANUFACTURED TOACCOMMODATEMULTI- DENSITYINSERT(S), PER SHOE

A depth shoe (A5500) isone that 1) has a full length,heel-to-toe filler that whenremoved provides aminimum of 3/16" ofadditional depth used toaccommodate custom-molded or customizedinserts; 2) is made fromleather or other suitablematerial of equal quality; 3)has some form of shoeclosure; and 4) is availablein full and half sizes with aminimum of three widths sothat the sole is graded tothe size and width of theupper portions of the shoeaccording to the Americanstandard last sizing sched-ule or its equivalent. (TheAmerican last sizingschedule is the numericalshoe sizing system usedfor shoes in the UnitedStates.) This includes ashoe with or without aninternally seamless toe.

See Below—the PCCrecommends separatecodes for Men’s andLadies’ shoes and alsoseparate codes for LevelOne and Level Two shoes.

See Below—the PCCrecommends sepa-rate codes for Men’sand Ladies’ shoesand also separatecodes for Level Oneand Level Two shoes.



OTS SHOES continued

graded widths, closed toe,heel counters, wedge orunit bottom construction,any material bottomproviding medial/lateralsupport, full length depthinlay at least 3/16" thick,each foot.

material, asdefined

Closure must belace or hook-and-loop

With heelcounters

Midsole/outsoleprovidesadditionalmedial/lateralsupport.

Clarifying a fulldepth inlay of atleast 3/16"

This device isavailable to thosebeneficiaries who areclassified as RiskCategory 1.

Other Data:A ladies’ depth LevelOne Medical GradeShoe (A5CDA) is onethat 1) has a fulllength, heel-to-toeinsole that whenremoved provides aminimum of 3/16" ofadditional depthused toaccommodatecustom-molded orcustomized inserts;2) is made fromleather or othersuitableaccommodativematerial of equalquality that maintains



OTS SHOES continued

the shape andconforms to thedeformity of the foot,but does not includeany stretchable man-made material that willretain the originalshape of the shoewhen the foot isremoved; 3) has alace or hook-and-loopshoe closure; and 4) isavailable in full and halfsizes with a minimumof three widths and amaximum of twoindividual markedshoe sizes per unitbottom so that the solewidth is graded to thesize and width of theupper portions of theshoe according to theAmerican standard lastsizing schedule or itsequivalent. (TheAmerican last sizingschedule is thenumerical shoe sizingsystem used for shoesin the United States.)This shoe has a soft,non-abrasive lining,without any exposedoverlapping internalforefoot or tongueattachment seam.



OTS SHOES continued

A5CDB For Beneficiariesin Risk Category 1 Only,Including Face to FaceFitting, Dispensing andFollow Up- Pedorthic OTSLevel One Medical GradeShoe, Men’s low top,uppers of leather or otheraccommodative yetformable material, withadjustable lace or hook-and-loop closure, avail-able in at least threegraded widths, closed toe,heel counters, wedge orunit bottom construction,any material bottomproviding medial/lateralsupport, full length depthinlay at least 3/16" thick,each foot.



Uppers of leather orotheraccommodativeyet formablematerial, asdefined


With heel counters Midsole/outsole

provides additionalmedial/lateralsupport.


This device is availableto those beneficiarieswho are classified asRisk Category 1.

Other Data:A men’s depth LevelOne Medical GradeShoe (A5CDB) is onethat 1) has a full length,heel-to-toe insole thatwhen removedprovides a minimum of3/16" of additionaldepth used toaccommodate custom-



OTS SHOES continued

molded or customizedinserts; 2) is madefrom leather or othersuitableaccommodativematerial of equalquality that maintainsthe shape andconforms to thedeformity of the foot,but does not includeany stretchable man-made material that willretain the originalshape of the shoewhen the foot isremoved; 3) has alace or hook-and-loopshoe closure; and 4)is available in full andhalf sizes with aminimum of threewidths and a maximumof two individualmarked shoe sizesper unit bottom so thatthe sole width isgraded to the size andwidth of the upperportions of the shoeaccording to theAmerican standard lastsizing schedule or itsequivalent. (TheAmerican last sizingschedule is thenumerical shoe sizingsystem used forshoes in the UnitedStates.) This shoehas a soft, non-abrasive lining, without



OTS SHOES continued

any exposedoverlapping internalforefoot or tongueattachment seam.

A5CDC For Beneficiaries inRisk Category 2 Only,Including Face to FaceFitting, Dispensing andFollow Up- Pedorthic OTSLevel Two Medical GradeShoe, Ladies’ low top,uppers of leather or otheraccommodative yet form-able material, with adjust-able lace or hook-and-loopclosure, available in at leastfive graded widths, closedtoe, heel counters, wedgeor unit bottom construction,any material bottom provid-ing medial/lateral support,full length depth inlay atleast 1/4" thick, each foot.



Uppers of leatheror otheraccommodativeyet formablematerial, asdefined



providesadditional medial/lateral support.


5 graded widths

This device isavailable to thosebeneficiaries who areclassified as RiskCategory 2.

Other Data:A ladies’ depth LevelTwo Medical GradeShoe (A5CDC) is one



OTS SHOES continued

that 1) has a full length,heel-to-toe insole thatwhen removedprovides a minimumof 1/4" of additionaldepth used toaccommodatecustom-molded orcustomized inserts; 2)is made from leatheror other suitableaccommodativematerial of equalquality that maintainsthe shape andconforms to thedeformity of the foot,but does not includeany stretchable man-made material that willretain the originalshape of the shoewhen the foot isremoved; 3) has alace or hook-and-loopshoe closure; and 4)is available in full andhalf sizes with aminimum of five widthsand a maximum of twoindividual markedshoe sizes per unitbottom so that thesole width is gradedto the size and widthof the upper portionsof the shoe accordingto the Americanstandard last sizingschedule or itsequivalent. (TheAmerican last sizing



OTS SHOES continued

schedule is thenumerical shoe sizingsystem used for shoesin the United States.)This shoe has a soft,non-abrasive lining,without any exposedoverlapping internalforefoot or tongueattachment seam.

A5CDD For Beneficiaries inRisk Category 2 Only,Including Face to FaceFitting, Dispensing andFollow Up- Pedorthic OTSLevel Two Medical GradeShoe, Men’s low top,uppers of leather or otheraccommodative yetformable material, withadjustable lace or hook-and-loop closure, availablein at least five gradedwidths, closed toe, heelcounters, wedge or unitbottom construction, anymaterial bottom providingmedial/lateral support, fulllength depth inlay at least1/4" thick, each foot.

This code is based onthe PCC definition ofL3221, but has beenmore narrowlyrestricted to be: For Beneficiaries

in Risk Category 2only.

Uppers of leatheror otheraccommodativeyet formablematerial, asdefined



providesadditional medial/lateral support.


5 graded widths

This device isavailable to thosebeneficiaries who are



OTS SHOES continued

classified as RiskCategory 2.

Other Data:A men’s depth LevelTwo Medical GradeShoe (A5CDD) is onethat 1) has a full length,heel-to-toe insole thatwhen removedprovides a minimumof 1/4" of additionaldepth used toaccommodatecustom-molded orcustomized inserts; 2)is made from leatheror other suitableaccommodativematerial of equalquality that maintainsthe shape andconforms to thedeformity of the foot,but does not includeany stretchable man-made material that willretain the originalshape of the shoewhen the foot isremoved; 3) has alace or hook-and-loopshoe closure; and 4)is available in full andhalf sizes with aminimum of five widthsand a maximum of twoindividual markedshoe sizes per unitbottom so that thesole width is gradedto the size and width



OTS SHOES continued

of the upper portions ofthe shoe according tothe American standardlast sizing schedule orits equivalent. (TheAmerican last sizingschedule is thenumerical shoe sizingsystem used for shoesin the United States.)This shoe has a soft,non-abrasive lining,without any exposedoverlapping internalforefoot or tongueattachment seam.

OTHER SHOE CHARGES

CMS does not currentlycover this code.Currently, there is noprecedent for filing thiscode as an A5507because it is notcurrently clear that thecode is “related to thediabetes.” The PCCwould like to change thatperception.

The proper fit of thediabetic/neuropathic footis paramount. Forpatients with non-standard sized feet whomust go to extra financiallengths to get the propersize—there should be amechanism to pay forthis additional work. ThePCC believes that it is acritical step to proper

A5CDE Pedorthic OTSMedical Grade Shoe,unisex, charge for non-standard shoe width and/orlength, each foot.

Compare to L3254Pedorthic OTS Shoe,unisex, charge fornon-standard shoewidth and/or length,each foot.

This code can only beused if themanufacturer of anOTS shoe charges thepractitioner anincremental chargerelating to a size orwidth that is outside ofa normal size run. Thecharge must be 1)actually paid, and 2)incremental to astandard size. ThePCC recommendscurrent non-coverageof this code, butbelieves that it should



OTHER SHOE CHARGES continued

diabetic/neuropathic fit,and therefore should bebillable as A5507 prior toa new code beingcreated.

be tracked by PDAC/SADMERC for futureLevel 1 or Level 2coverageconsideration.

CMS does not currentlycover this code.Currently, there is noprecedent for filing thiscode as an A5507because it is notcurrently clear that thecode is “related to thediabetes.” The PCCwould like to change thatperception.

The proper fit of thediabetic/neuropathic footis paramount. Forpatients with non-standard sized feet whomust go to extra financiallengths to get the propersize—there should be amechanism to pay forthis additional work. ThePCC believes that it is acritical step to properdiabetic/neuropathic fit,and therefore should bebillable as A5507 prior toa new code beingcreated.

A5CDF Pedorthic OTSMedical Grade Shoe,unisex, additional charge forsplit size, each.

Compare to L3257Pedorthic OTS Shoe,unisex, additionalcharge for split size,each.

Split sizes usuallyhappen one of twoways: 1) themanufacturer of anOTS shoe has aprogram wherebythey will split the sizeat the manufacturerlevel for an additionalcharge, 2) themanufacturer has nosuch program and thepractitioner must selltwo pairs of shoes tothe patient. Mostpractitioners will givethe patient a discounton the second pair,while requiring thesurrender of thecontralateral shoes to1) prevent abuse, 2)use as samples, and/or 3) donate to charity.This code may beused to bill theincrement charged tothe beneficiary that isa) incremental overthe price of a normal


FAQ:Q: What is the difference between an L3216 and the new PCC version of A5500 for ladies (A5CDA)?A: All ladies A5500’s are L3216, but not all L3216’s are ladies A5500’s. The definition for L3216 does not restrict torisk category. In addition, the L3216 requires a full-length removable insert, but does not specify the requiredthickness. The upper on the A-code version has restrictions on the type of material it can be. Likewise, A5CDA isspecific in requiring reinforced counters, a midsole with a layer of 45 Shore A durometer material or higher, and abottom that provides medial/lateral stability.


OTHER SHOE CHARGES continued

pair of shoes, and b)actually paid. The PCCrecommends currentnon-coverage of thiscode, but believesthat it should betracked by PDAC/SADMERC for futureLevel 1 or Level 2coverageconsideration.


CHAPTER CE: ROCKER SOLES

OverviewFor a complete discussion of Rocker Soles, Rocker Bars, etc. and their proper use in pedorthics, please seechapter BB.

Use In Treating the Diabetic/Neuropathic FootModifications are important in treating the diabetic/neuropathic foot because they help to manage plantar pressureson the foot. This can be critical in the healing and prevention of ulcers.

The main codes currently in existence are:A5503 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOEOR CUSTOM-MOLDED SHOE WITH ROLLER OR RIGID ROCKER BOTTOM, PER SHOE

A5505 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOEOR CUSTOM-MOLDED SHOE WITH METATARSAL BAR, PER SHOE

Other important codes:L2360 ADDITION TO LOWER EXTREMITY, EXTENDED STEEL SHANK

The PCC defines four different codes for Rocker Soles and Met Bars compared to the two that are defined by theTSD. As such, the PCC recommends the following:


A5505 FOR DIABETICSONLY, MODIFICATION(INCLUDING FITTING) OFOFF-THE-SHELFDEPTH-INLAY SHOE ORCUSTOM-MOLDEDSHOE WITHMETATARSAL BAR, PERSHOE

Similar to L3400 Shoemodification/ addition:outsole, rocker bar ormetatarsal bar addedto forefoot of shoe,attached to bottom ofoutsole, each foot.

To be used when abar is added. Thisbar is added to theoutside of the sole.This is generally doneto separate heelshoes. For customshoes, see FootnoteX.

In addition: Thesebars are added to the

A5505 For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole, rocker bar ormetatarsal bar added toforefoot of shoe, attached tobottom of outsole, eachfoot.

Compare this code to thenext code.

Metatarsal bars (A5505) areexterior bars which areplaced behind themetatarsal heads in order toremove pressure from themetatarsal heads. The barsare of various shapes,heights, and constructiondepending on the exactpurpose.



exterior of the outsole.They are placed suchthat their apex isproximal to themetatarsal heads inorder to transferpressure away fromthe metatarsal headsand onto the bar. Thebars can be of variousshapes, heights, andconstructiondepending on theexact purpose.

The PCC recommendsthe addition of this codein order to keepparallelism between theA-codes and the PCC’srevision of the L-codes.

A5CEA For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole, rocker bar ormetatarsal bar added toforefoot of shoe, insertedbetween midsole andoutsole, each foot.

Similar to L3410 Shoemodification/ addition:outsole, rocker bar ormetatarsal bar addedto forefoot of shoe,inserted betweenmidsole and outsole,each foot.

To be used when abar is added. This baris inserted betweenthe outsole andmidsole. This isgenerally done toseparate heel shoes.For custom shoes,see Footnote X.

A5503 FOR DIABETICSONLY, MODIFICATION(INCLUDING FITTING) OFOFF-THE-SHELFDEPTH-INLAY SHOE ORCUSTOM-MOLDEDSHOE WITH ROLLER ORRIGID ROCKER BOT-TOM, PER SHOE

Rigid rocker bottoms(A5503) are exteriorelevations with apex positionfor 51 percent to 75 percentdistance measured from theback end of the heel. Theapex is a narrowed orpointed end of an anatomicalstructure. The apex must bepositioned behind the

A5CEB For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole, rocker soleadded to wedge bottomshoe, attached to bottomof outsole, each foot.

Similar to L3BBA Shoemodification/addition:outsole, rocker soleadded to wedgebottom shoe, added tobottom of outsole,each foot.

To be used when therocker sole is attached



metatarsal heads andtapering off sharply to thefront tip of the sole. Apexheight helps to eliminatepressure at the metatarsalheads. Rigidity is ensuredby the steel in the shoe.The heel of the shoe tapersoff in the back in order tocause the heel to strike inthe middle of the heel.

Roller bottoms (sole or bar)(A5503) are the same asrocker bottoms, but theheel is tapered from theapex to the front tip of thesole.

to the outside of theoutsole. This is donefor wedge or unitbottom soles. Forcustom shoes, seeFootnote X.

The rocker soleinvolves addingmaterial to the outsoleof the shoe to createan apex or fulcrumover which the shoewill “rock”. The distalapex of the rockersole will generally be51 percent to 75percent distancemeasured from theback end of the heel.The apex must bepositioned proximal tothe metatarsal headsand tapering offsharply to the front tipof the sole. Apexheight helps toeliminate pressure atthe metatarsal heads.Most often, the heel ofthe shoe tapers off inthe back in order tocause the heel tostrike in the middle ofthe heel.

This code does NOTinclude a shankmaterial (either steelor carbon fiber). Thatwork is an incrementalcode.



Roller bottoms functionsimilar to the rockerbottoms, but have avery pronouncedsecond apex at about25 percent-35 percentof the distance fromthe heel. Thisprovides a very small“flat” spot on thebottom of the shoeand gives the shoethe appearance ofhaving a curved base,similar to a semi-circle.

The PCC recommendsthe addition of this codein order to keep parallel-ism between the A-codes and the PCC’srevision of the L-codes

A5CEC For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole, rocker sole addedto wedge bottom shoe,inserted between midsoleand outsole, each foot.

Similar to L3BBB Shoemodification/addition:outsole, rocker soleadded to wedgebottom shoe, insertedbetween midsole andoutsole, each foot.

To be used when thesole is cut off, and therocker sole is donebetween the outsoleand midsole, and thesole replaced. This isdone for wedge or unitbottom soles. Thiscode requires thereplacement of theoutsole, so it willalmost always bebilled along with the fullsole code (seeA5CHC). For customshoes, see FootnoteX.



The rocker soleinvolves addingmaterial to the outsoleof the shoe to createan apex or fulcrumover which the shoewill “rock”. The distalapex of the rockersole will generally be51 percent to 75percent distancemeasured from theback end of the heel.The apex must bepositioned proximal tothe metatarsal headsand tapering offsharply to the front tipof the sole. Apexheight helps toeliminate pressure atthe metatarsal heads.Most often, the heel ofthe shoe tapers off inthe back in order tocause the heel tostrike in the middle ofthe heel.

This code does NOTinclude a shankmaterial (either steel orcarbon fiber). Thatwork is an incrementalcode.

Roller bottoms functionsimilar to the rockerbottoms, but have avery pronouncedsecond apex at about25 percent-35 percentof the distance from



the heel. Thisprovides a very small“flat” spot on thebottom of the shoeand gives the shoe theappearance of havinga curved base, similarto a semi-circle.

The PCC recommendsthe addition of this codein order to keep parallel-ism between the A-codes and the PCC’srevision of the L-codes

A5CED For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole, steel shank bent,inserted, and fastenedbetween outsole andmidsole of shoe, each foot.

Similar to L2360 Shoemodification/addition:outsole, steel shankbent, inserted, andfastened betweenoutsole and midsoleof shoe, each foot

This is a steel platedesigned to beinserted between themidsole and outsoleof the shoe. Thepurpose of the plate isto stop the sole of theshoe from bending. Itmust be molded byhand to follow theproper contour of theshoe.

The PCC recommendsthe addition of this codein order to keep parallel-ism between the A-codes and the PCC’srevision of the L-codes.

A5CED For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole, high strength,lightweight material, allhybrid lamination/prepregcomposites shank bent,inserted, and fastenedbetween outsole andmidsole of shoe, each foot.

Similar to L3BBC(must currently useL3649) Shoemodification/addition:outsole, high strength,lightweight material, allhybrid lamination/prepreg compositesshank bent, inserted,and fastened betweenoutsole and midsoleof shoe, eachfoot.Like 2360, butwhen the shank is



made from highstrength, lightweightmaterial, all hybridlamination/prepregcomposites. Thiscould include carbonfiber or fiberglass.

Footnote X: These codes are often applied to OTS shoes and can be used when coding-out a new custom shoeif it is 1) an upgrade over the base sole provided, and 2) there is an actual incremental charge paid to the lab for thisitem. These codes can be used to later modify an existing custom shoe. For more information, see the chapter oncustom shoes at chapter CJ.

FAQ:Q: What if a metatarsal bar or rocker bar is added outside of the sole of a Medical Grade shoe, then a protectiveoutsole is added to protect the bar (i.e. a rubber or firm crepe bar is added, and then an outsole or sole guardmaterial is added on top of that)?A: The bar would be a A5505 (like L3400). A half sole was then added, so the A5CHB (like L3530) half sole would beappropriate (see chapter CH). The higher A5CEA (like L3410) code would not be appropriate because the addedlabor of removing the old sole was not incurred.

Q: I had to add a shank to a Medical Grade shoe when I rockered it, what other code do I use for the shank?A: If you include a STEEL shank inside the rocker, you should also code A5CED. If you do a carbon shank orfiberglass shank, or other similar material, you should code A5CED with a description “Like L2360, but carbon fiber(or fiberglass)”. PCC has decided that this code has both the labor and materials component included for thisincremental step.

The other rocker sole/bar codes in the L-series would not be appropriate on a Medical Grade shoe, so nocorresponding code has been suggested.




CHAPTER CF: LIFTS AND ELEVATIONS

OverviewFor a complete discussion of Lifts and Elevations and their proper use in pedorthics, see chapter BC.

Use In Treating the Diabetic/Neuropathic FootDiabetes does not cause short limbs. Other pathologies or problems cause short limbs. However, short limbs cancreate plantar pressure problems because of the variances they cause in gait. A leg length discrepancy can causeexcessive plantar pressures during gait and this can become a problem for diabetics. Therefore, the PCC feels thatelevations should be covered by the TSD program.


Similar to L3300 Shoemodification/ addition:elevation; attached tosole of wedge bottomshoe, heel onlytapered to metatarsalheads, any material,per inch or fractionthereof (measured athighest point).

This code is foroutsole elevationstapered to themetatarsals. ITSHOULD NOT BEPRICED LOWER THANTHE NON-TAPEREDFULL SOLEELEVATION. It isactually more work andthe same materials.Compare this to L3334which is for separateheeled shoes. Forcustom shoes, seeFootnote X.

A5CFA For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:elevation; attached to soleof wedge bottom shoe,heel only tapered tometatarsal heads, anymaterial, per inch or fractionthereof (measured athighest point).




Similar to L3310 Shoemodification/addition:elevation; attached tosole of shoe, heel andsole, EVA crepe orsimilar material, perinch or fraction thereof(measured at highestpoint).

This code is foroutside full-footelevations. It is forEVA crepe or similarmaterial, although EVAcrepe is the mostcommon materialused. For customshoes, see FootnoteX.


A5CFB For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:elevation; attached to soleof shoe, heel and sole,EVA crepe or similarmaterial, per inch or fractionthereof (measured athighest point).

A5CFC For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition: lift;inside of shoe, tapered,removable or attached, anymaterial, per inch or fractionthereof (measured athighest point).

Similar to L3332 Shoemodification/addition:lift; inside of shoe,tapered, removable orattached, any material,per inch or fractionthereof (measured athighest point).

This is for removablelifts placed within theshoe, whetherattached or not.These are generallymade of rubber orother firm material(durometer of 55 orhigher). They aredifferent than heelpads used to cushionthe heel for pain.Pads require a softerdurometer to “cushion”


Footnote X: These are most typically done to OTS Shoes. They can be used when coding-out a new custom shoeif it is 1) an upgrade over the base sole provided, and 2) there is an actual incremental charge paid to the lab for thisitem. These codes can be used to later modify an existing custom shoe. For more information, see the chapter oncustom shoes at chapter CJ.

The other elevation codes in the L-series would not be appropriate on a Medical Grade shoe, so no correspondingcode has been suggested.


the heel whereas liftsrequire a firmerdurometer to “lift” theheel. For customshoes, see FootnoteX.




CHAPTER CG: WEDGES, FLARES, AND STABILIZERS

OverviewFor a complete discussion of Wedges, Flares, and Stabilizers and their proper use in pedorthics, see chapter BD.

Use In Treating the Diabetic/Neuropathic FootThese codes are important to the proper management of the diabetic/neuropathic foot because they are extremelypowerful tools to manage plantar pressure and to provide medial/lateral stability—which are key concerns in managingthe diabetic/neuropathic foot.

The main codes currently in existence are:A5504 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOEOR CUSTOM-MOLDED SHOE WITH WEDGE(S), PER SHOE

A5506 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOEOR CUSTOM-MOLDED SHOE WITH OFF-SET HEEL(S), PER SHOE



The CMS descriptionof this code shows thatit is trying to incorpo-rate several L-codes inone line item. ThePCC strongly believesthat there should be aone-to-one match withunderlying L-codes,and therefore thiscode should be retiredand the several newcodes created to allowall parties to trulyunderstand whatmodalities are beingused for these pa-tients. See below.

A5504 FOR DIABETICSONLY, MODIFICATION(INCLUDING FITTING) OFOFF-THE-SHELFDEPTH-INLAY SHOE ORCUSTOM-MOLDEDSHOE WITH WEDGE(S),PER SHOE

Wedges (posting) (A5504)are either of hind foot, forefoot, or both and may be inthe middle or to the side.The function is to shift ortransfer weight bearing uponstanding or duringambulation to the oppositeside for added support,stabilization, equalizedweight distribution, orbalance.



The PCC recommendsthis code be deleted(and the codes belowbe added). The PCChas done an informalsurvey of leadingpedorthists around thecountry and there ismuch disagreementover what this codemeans—and no clearevidence of what itshould mean. Mostexperts around thecountry feel that thedescription is for a so-called “flared heel” or“flared sole”, yet theCMS medical policy(see Chapter CD)clearly shows “flaredheel” as one of theexamples of A5507.See below.

A5506 FOR DIABETICSONLY, MODIFICATION(INCLUDING FITTING) OFOFF-THE-SHELFDEPTH-INLAY SHOE ORCUSTOM-MOLDEDSHOE WITH OFF-SETHEEL(S), PER SHOE

A5CGA For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; heel wedge-attached to bottom ofoutsole, each foot.

Similar to L3350 Shoemodification/addition:outsole; heel wedge-attached to bottom ofoutsole, each foot.

This could be a heelwedge applied toeither a separate heelshoe or wedgebottom shoe. Forcustom shoes, seeFootnote X.

The function is to shiftor transfer weightbearing upon standingor during ambulationto the opposite side

Offset heel (A5506) is a heelflanged at its base either inthe middle, to the side, or acombination, that is thenextended upward to theshoe in order to stabilizeextreme positions of thehind foot.

The PCC recommendsthe addition of this codein order to keepparallelism between theA-codes and the PCC’srevision of the L-codes.


for added support,stabilization,equalized weightdistribution, orbalance.


A5CGB For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; heel wedge,between sole, each foot.

Similar to L3BDA(currently must useL3649) Shoemodification/addition:outsole; heel wedge,between sole, eachfoot.

This is a heel wedgeapplied to a wedgebottom shoe—butattached BETWEENthe midsole and theoutsole/heel. Forcustom shoes, seeFootnote X.


A5CGC For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; sole wedgeforefoot only, attached tobottom of outsole, eachfoot.

Similar to L3360 Shoemodification/addition:outsole; sole wedgeforefoot only, attachedto bottom of outsole,each foot.

This code is used foreach wedge used inthe forefoot that isadded to the bottomof the outsole. Forcustom shoes, seeFootnote X.

The PCC recommendsthe addition of this codein order to keep paral-lelism between the A-codes and the PCC’srevision of the L-codes.

A5CGD For Beneficiaries inRisk Category 1 or HigherOnly, Including Face to FaceFitting, Dispensing and FollowUp-Shoe modification/addition: outsole; sole wedgeforefoot only, between sole,each foot.

Similar to L3370 Shoemodification/addition:outsole; sole wedgeforefoot only, betweensole, each foot.



A5CGE For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; aggressivemedial/lateral wedge, eachfoot.

Similar to L3380 Shoemodification/addition:outsole; aggressivemedial/lateral wedge,each foot.

This wedge isreserved foraggressive/pronounced medial orlateral wedging

This code is usedfor each wedgeused in the forefootthat is addedBETWEEN theoutsole andmidsole. Typically,the sole is partiallysplit and the wedgeis inserted and thenglued/stitched intoplace. However, ifthe whole sole wereto be detached toplace the wedge,the A5CHC Full Solecode would alsoneed to be billed.For custom shoes,see Footnote X.

The function is toshift or transferweight bearing uponstanding or duringambulation to theopposite side foradded support,stabilization,equalized weightdistribution, orbalance.




A5CGF For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; flared sole/heel,per side, each foot.

Similar to L3390 Shoemodification/addition:outsole; flared sole/heel, per side, eachfoot.

The PCC suggeststhat this code be usedfor sole flaring. Thiswould include flaringof the entire sole, orjust the heel. Forcustom shoes, seeFootnote X.

The function is to shiftor transfer weightbearing upon standingor during ambulationto the opposite sidefor added support,stabilization,equalized weightdistribution, orbalance.

needed (i.e. to controlclubfeet or othersevere deformities).The PCC hasdetermined thatwedges of tendegrees or less wouldget the normal wedgecode codes (i.e.A5CGA, A5CGB,A5CGC, and A5CGD)and wedges of greaterthan ten degrees canuse this code. Forcustom shoes, seeFootnote X.


Similar to L3450 Shoemodification/addition:outsole; heel, SACHcushion type, eachfoot.

This code is used forany sort of SACHmaterial added to theheel area. SACH isgenerally added tothe posterior aspect ofthe heel. For customshoes, see FootnoteX.

The function of theSACH material is toallow for a more fluidtransition from heelstrike to foot flat,especially for patientswith limited anklemotion. SACH standsfor Solid AnkleCushioned Heel.


A5CGH For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; medial stabilizers,each foot.


Similar to L3BDBShoe modification/addition: outsole;medial stabilizers,each foot.

This would be usedfor medial stabilizers.A stabilizer differsfrom a flare in that astabilizer is taller andhas more blockingforce. If the deviceextends upward pastthe sole into theupper, it is a stabilizer.If it is solely in the


A5CGG For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; heel, SACHcushion type, each foot.




A5CGI For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; lateral stabilizers,each foot.

Similar to L3BDCShoe modification/addition: outsole;lateral stabilizers,each foot.

This would be usedfor lateral stabilizers. Astabilizer differs from aflare in that a stabilizeris taller and has moreblocking force. If thedevice extendsupward past the soleinto the upper, it is astabilizer. If it is solelyin the sole, it is a flare.For custom shoes,see Footnote X.

The function is to shiftor transfer weightbearing upon standingor during ambulation

sole, it is a flare. Amedial stabilizer isharder to do than alateral stabilizerbecause of the extrawork required in thearch area. For customshoes, see FootnoteX.

The function is to shiftor transfer weightbearing upon standingor during ambulation tothe opposite side foradded support,stabilization, equalizedweight distribution, orbalance.


to the opposite sidefor added support,stabilization,equalized weightdistribution, orbalance.


A5CGJ For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/addition:outsole; split andpermanently spread theoutsole and midsole alongthe long axis to increasevamp area, each foot.


Similar to L3BDDShoe modification/addition: outsole; splitoutsole sole alonglong axis to increasevamp area, each foot.

This would be forwidening thecircumference of thewaist of the shoe bysplitting andspreading themidsole.

The function is toaccommodate theoversized diabetic/neuropathic footwithout having toresort to customfootwear. Thismodification is oftenused in the treatmentof Charcot Arthropathydeformity. This willsave CMS and thebeneficiary money inthe long run, andtherefore this codeshould be covered.


Footnote X: These are most typically done to OTS Shoes. They can be used when coding-out a new custom shoeif it is 1) an upgrade over the base sole provided, and 2) there is an actual incremental charge paid to the lab for thisitem. These codes can be used to later modify an existing custom shoe. For more information, see the chapter oncustom shoes at chapter CJ.

The other wedge codes in the L-series would not be appropriate on a Medical Grade shoe, so no correspondingcode has been suggested.




CHAPTER CH: OTHER MEDICAL GRADE SHOE ADDITIONS

OverviewFor a complete discussion of Other Pedorthic Shoe Additions and their proper use in pedorthics, see chapter BE.

Use In Treating the Diabetic/Neuropathic FootThese codes are important for two reasons: 1) they are sometimes component codes in a complex shoe modificationprocedure, and 2) they support the repair of Medical Grade footwear. The PCC believes that it is important tosupport repair of Medical Grade footwear for several reasons.

The PCC supports the repair of Medical Grade shoes because repairing of the shoes meets three important publicpolicy concerns: 1) a repaired “old shoe” gives the patient a backup pair to switch off to for emergencies1, 2) repairsare more environmentally friendly—keeping down destruction of new resources by preserving old ones, 3) it isinappropriate to treat the covered shoe code as a lesser code than a covered orthotic code (which has a repaircode, i.e. L4205)—if a shoe code is worthy of being covered it is worthy of being repaired.

The main codes currently in existence are:

ADDITIONS/REPAIRS/MODIFICATIONS TO OUTSOLE OF SHOETHERE ARE CURRENTLY NO MEDICAL GRADE CODES FOR THESE. THE DEFINITION OF A5507 DOES ALLOWFOR REPAIRS.



Similar to L3460 Shoemodification/addition:outsole; replace heelon pedorthic shoe,rubber, crepe, or othermaterial, each foot.

This code would beused for thereplacement of arubber, crepe, or othermaterial heel on ashoe. This could beto replace a worn heelof a covered shoe orcould be part of acovered modification(whether the shoe is


A5CHA For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/ addition:outsole; replace heel onMedical Grade shoe,rubber, crepe, or othermaterial, each foot.


covered or not) thatrequired replacementof the heel (i.e. acomplex elevation ona separate heeledshoe). For customshoes, see FootnoteY. The custom shoemust be covered.


A5CHB For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/ addition:outsole; replace halfoutsole on Medical Gradeshoe, any material, eachfoot.


Similar to L3530 Shoemodification/addition:outsole; replace halfoutsole on pedorthicshoe, any material,each foot.

This code would beused for thereplacement of a halfsole on a shoe. Thiscould be to replace aworn half sole of acovered shoe orcould be part of acovered modification(whether the shoe iscovered or not) thatrequired replacementof the half sole (i.e. acomplex elevation ona separate heeledshoe). For customshoes, see FootnoteY. The custom shoemust be covered.


Similar to L3540 Shoemodification/addition:outsole; replace fulloutsole on pedorthicshoe, any material,each foot.

This code would beused for thereplacement of a fullsole on a shoe. Thiscould be to replace aworn full sole of acovered shoe orcould be part of acovered modification(whether the shoe iscovered or not) thatrequired replacementof the full sole (i.e. acomplex elevation ona separate heeledshoe). For customshoes, see FootnoteY. The custom shoemust be covered.



A5CHC For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Shoemodification/ addition:outsole; replace fulloutsole on Medical Gradeshoe, any material, eachfoot.

Footnote X: These are most typically done to OTS Shoes. They can be used when coding-out a new custom shoeif it is 1) an upgrade over the base shoe/shoe component provided, and 2) there is an actual incremental chargepaid to the lab for this item. These codes can be used to later modify an existing custom shoe. For moreinformation, see the chapter on custom shoes at chapter CJ.

Footnote Y: This code cannot be used for new custom shoes as this work is generally included in the base priceof the new custom shoe. It can be used in the repair or modification of an existing covered custom shoe, if there isan incremental charge paid for such work. See chapter CJ on custom shoes.

The other shoe addition codes in the L-series would not be appropriate on a Medical Grade shoe, so no correspondingcode has been suggested.

(Chapter Footnotes)1 It is unreasonable to assume that someone who needs special shoes can get by with just one pair of shoes.




CHAPTER CI: CUSTOM AND OTS FOOT ORTHOSES

OverviewFor a complete discussion of custom and OTS foot orthoses, see chapter BH.

The key salient points of the PCC’s program are highlighted below:

Rigid shells would be shells made with base materials such as plastics, fiberglass, and carbon fiber or similar. Semi-rigid shells would be made with base materials from cork, or dense foams with a durometer from 45 and

higher. Soft shells would be shells made with base materials from soft materials, generally with a durometer of less than

45.

Type Description Closest L-code in today’s system

Closest A-code in today’s system

High control

Rigid shell (as defined above)—heel cup greater than or equal to14 mm

L3000 None

Medium Control

Rigid shell (as defined above)—heel cup less than 14 mm. Semirigid shell (as defined above)—heel cup of 8mm or

greater.

L3010 None

Low Control

Semirigid shell (as defined above)—heel cup less than 8mm Soft (as defined above) - heel cup of 8 mm or greater

L3002

A5513

Off the shelf orthoses generally fall into the PCC definition of Low Control. A5512 is an off the shelf orthosis used totreat the diabetic/neuropathic foot. To be an A5512, the orthosis must have a special base layer and be total contact.

Definitions of Foot ModelsThe Prescription Foot Orthotic Lab Association (PFOLA—www.pfola.org) has developed an excellent technicalstandards document that explains the key distinctions and types of fabrication processes. The complete documentis shown at Appendix EG. Certain key definitions are excerpted herein as they relate to our work in HCPCS coding.

Foot Modeling Definitions Anatomical Volumetric Foot Model (AVFM). A digital or physical model that captures a person’s three dimensional

plantar foot anatomy when the foot is non-weightbearing, semi-weightbearing, or fully-weightbearing.o A digital AVFM must use actual 3 dimensional data points taken directly from the foot to duplicate plantar

foot anatomy. The most common examples include laser 3D scanners, stereo-digital 3D imaging systems,and pin array systems.

o A physical AVFM captures foot anatomy through direct contact to duplicate plantar foot anatomy. Themost common examples are plaster of paris casts or foam impressions taken directly from the foot. Anymaterial or method that uses direct capture of the entire plantar foot anatomy creates an AVFM.

Extrapolated Volumetric Foot Model (EVFM). A digital model that approximates a person’s three dimensionalplantar foot anatomy through application of mathematical models that extrapolate pressure data, or extrapolate


temperature data, or extrapolate light data to form the digital model when the foot is non-weightbearing, semi-weightbearing, or fully-weightbearing. The most common examples are pressure mapping systems, photographsand ink or carbon paper imprinting systems.Orthotic Device Definitions

Foot Orthotic. An in shoe device that braces, supports, or protects the foot or part of the foot. Anatomical Custom Foot Orthotic (ACFO). An in shoe device that is made directly from an Anatomical Volumetric

Foot Model (AVFM). The AVFM is modified with the appropriate medial and/or lateral arch fill, lateral columnexpansion, heel expansion, and intrinsic forefoot and/or rearfoot corrections as defined by the prescribingphysician. The entire dorsal surface of said custom device matches the surface of the modified, or corrected,AVFM.

Extrapolation System Foot Orthotic (ESFO). An in shoe device that is made directly from an ExtrapolatedVolumetric Foot Model (EVFM). The EVFM is modified with the appropriate medial and/or lateral arch fill, lateralcolumn expansion, heel expansion, and intrinsic forefoot and/or rearfoot corrections as defined by the prescribingphysician. The entire dorsal surface of said custom device matches the surface of the modified, or corrected,EVFM.

Library System Foot Orthotic (LSFO). An in shoe device that is made from a library of premanufactured shells,pre-manufactured corrected positive molds or pre-determined digital shape files (from which shells or moldsare milled.) The foot orthotic shape is chosen by matching a library shape with either an AVFM or EVFM.

The PCC believes that diabetic/neuropathic foot orthoses should be restricted to ACFOs until reliable studies areperformed to compare the efficacy of ESFOs and LSFOs to ACFOs for this at-risk population. Since total contact isthe goal, the PCC believes that diabetic/neuropathic custom orthoses should be made over an AVFM, and that OTSdiabetic/neuropathic orthoses should be heat formed to the foot for coverage. The PCC will continue to monitor thestudies on these different types of devices and will modify its position, as necessary, as the studies indicate.

Use In Treating the Diabetic/Neuropathic FootDiabetic/Neuropathic OTS and custom orthoses (often called Diabetic/Neuropathic Inserts) are critical to managingthe plantar pressures on the diabetic/neuropathic foot. Without such inserts, pedorthists would be unable to preventdiabetic/neuropathic ulcerations.

The current breakdown used by CMS focuses on whether the device is OTS or custom, and provides a minimumstandard of base-layer durometer. Also, to be covered, CMS requires initial heat molding with an external heatsource.

The main codes currently in existence are:A5510 FOR DIABETICS ONLY, DIRECT FORMED, COMPRESSION MOLDED TO PATIENT’S FOOT WITHOUTEXTERNAL HEAT SOURCE, MULTIPLE-DENSITY INSERT(S) PREFABRICATED, PER SHOE

A5512 FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, DIRECT FORMED, MOLDED TO FOOT AFTEREXTERNAL HEAT SOURCE OF 230 DEGREES FAHRENHEIT OR HIGHER, TOTAL CONTACT WITH PATIENT’SFOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 1/4 INCH MATERIAL OF SHORE A 35 DUROMETER OR 3/16INCH MATERIAL OF SHORE A 40 DUROMETER (OR HIGHER), PREFABRICATED, EACH

A5513 FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, CUSTOM MOLDED FROM MODEL OF PATIENT’SFOOT, TOTAL CONTACT WITH PATIENT’S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 3/16 INCH MATERIALOF SHORE A 35 DUROMETER OR HIGHER), INCLUDES ARCH FILLER AND OTHER SHAPING MATERIAL, CUSTOMFABRICATED, EACH


Also, important related codes include:

L2755 ADDITION TO LOWER EXTREMITY ORTHOSIS, HIGH STRENGTH, LIGHTWEIGHT MATERIAL, ALL HYBRIDLAMINATION/ PREPREG COMPOSITE, PER SEGMENT, FOR CUSTOM FABRICATED ORTHOSIS ONLYL5000 PARTIAL FOOT, SHOE INSERT WITH LONGITUDINAL ARCH, TOE FILLER, EACH FOOTL5999 LOWER EXTREMITY PROSTHESIS, NOT OTHERWISE SPECIFIED

These code descriptions are not ME-CE—and have caused much confusion. In addition, there are important codesmissing from this area regarding newer advances, and they should be added.


Similar to L3000 FootOrthosis, removable,custom fabricated topatient AnatomicalVolumetric FootModel, longitudinalarch support and highcalcaneal control, asdefined, each foot.

Rigid shell (as definedabove)—heel cupgreater than or equalto14 mm

For treatment ofdiabetics/neuropathics, anappropriatelyprotective top covermust be used.



A5CIA For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,custom fabricated to patientAnatomical Volumetric FootModel, longitudinal archsupport and high calcanealcontrol, as defined, eachfoot.


Similar to L3BHA FootOrthosis, removable,custom fabricated topatient AnatomicalVolumetric FootModel, longitudinal /metatarsal archsupport and highcalcaneal control, asdefined, each foot.

Same as A5CIA/L3000, yet includesmetatarsal archsupport of anymaterial.



A5513 For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,custom fabricated to patientAnatomical Volumetric FootModel, longitudinal archsupport and low calcanealcontrol, as defined, baselayer minimum of 3/16 inchmaterial of Shore A 35durometer or higher),includes arch filler andother shaping material,each foot.

A5513 FOR DIABETICSONLY, MULTIPLEDENSITY INSERT,CUSTOM MOLDEDFROM MODEL OFPATIENT’S FOOT,TOTAL CONTACT WITHPATIENT’S FOOT,INCLUDING ARCH,BASE LAYER MINIMUMOF 3/16 INCHMATERIAL OF SHORE A35 DUROMETER ORHIGHER), INCLUDESARCH FILLER ANDOTHER SHAPINGMATERIAL, CUSTOMFABRICATED, EACH

Similar to L3002 FootOrthosis, removable,custom fabricated topatient AnatomicalVolumetric FootModel, longitudinalarch support and lowcalcaneal control, asdefined, each foot.

However, the A5513has the additionalCMS requirements ofthe base layerincluded, so allA5513’s are L3002,but not all L3002 areA5513.


A5CIB For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,custom fabricated to patientAnatomical Volumetric FootModel, longitudinal /metatarsal arch support andhigh calcaneal control, asdefined, each foot

Code A5513 describes atotal contact, customfabricated, multiple density,removable inlay that ismolded to a model of thepatient’s foot so that itconforms to the plantarsurface and makes totalcontact with the foot,including the arch. A customfabricated device is madefrom materials that do nothave predefined trim linesfor heel cup height, archheight and length, or toeshape.

The insert must retain itsshape during use for the lifeof the insert. The base layer



of the device must be atleast 3/16 inch of 35 ShoreA or higher material. Thebase layer is allowed to bethinner in the customfabricated device becauseappropriate arch fill or otheradditional material will belayered up individually tomaintain shape andachieve total contact andaccommodate eachpatient’s specific needs.The central portion of thebase layer of the heel maybe thinner (but at least 1/16inch) to allow for greaterpressure reduction. Thespecified thickness of thelateral portions of the baselayer must extend from theheel through the distalmetatarsals and may beabsent at the toes. The toplayer of the device may beof a lower durometer andmust also be heatmoldable. The materialsused should be suitablewith regards to the patient’scondition.

Semirigid shell (asdefined above)—heel cup less than8mm

Soft (as definedabove) - heel cupof 8 mm or greater

Code A5513describes a totalcontact, customfabricated, multipledensity, removableinlay that is molded toa AnatomicalVolumetric Foot Modelof the patient’s foot sothat it conforms to theplantar surface andmakes total contactwith the foot, includingthe arch. A customfabricated device ismade from materialsthat do not havepredefined trim linesfor heel cup height,arch height and length,or toe shape.

The insert must retainits shape during usefor the life of the insert.The base layer of thedevice must be atleast 3/16 inch of 35Shore A or highermaterial. The baselayer is allowed to bethinner in the customfabricated devicebecause appropriatearch fill or otheradditional material will


be layered upindividually to maintainshape and achievetotal contact andaccommodate eachpatient’s specificneeds. The centralportion of the baselayer of the heel maybe thinner (but at least1/16 inch) to allow forgreater pressurereduction. Thespecified thickness ofthe lateral portions ofthe base layer mustextend from the heelthrough the distalmetatarsals and maybe absent at the toes.The top layer of thedevice may be of alower durometer andmust also be heatmoldable. Thematerials used shouldbe suitable withregards to thepatient’s condition.




Similar to L3BHB FootOrthosis, removable,custom fabricated topatient AnatomicalVolumetric FootModel, longitudinal/metatarsal archsupport and lowcalcaneal control, asdefined, each foot.

Same as A5513/L3002, yet includesmetatarsal archsupport of anymaterial.



A5CID For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,custom fabricated to patientAnatomical Volumetric FootModel, longitudinal archsupport and mediumcalcaneal control, asdefined, each foot.


Similar to L3010 FootOrthosis, removable,custom fabricated topatient AnatomicalVolumetric FootModel, longitudinalarch support andmedium calcanealcontrol, as defined,each foot.

Rigid shell (asdefined above)—heel cup less than14 mm.

Semirigid shell(as definedabove)—heel cupof 8mm or greater.


A5CIC For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,custom fabricated to patientAnatomical Volumetric FootModel, longitudinal/metatarsal arch support andlow calcaneal control, asdefined, each foot.



A5512 For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,prefabricated devicecustomized to patient footwith external heat source of230 degrees Fahrenheit orhigher, longitudinal archsupport and all levels ofcalcaneal control, asdefined, base layer mini-mum of 1/4 inch material ofShore A 35 durometer (or

A5512 FOR DIABETICSONLY, MULTIPLEDENSITY INSERT,DIRECT FORMED,MOLDED TO FOOTAFTER EXTERNALHEAT SOURCE OF 230DEGREESFAHRENHEIT ORHIGHER, TOTALCONTACT WITHPATIENT’S FOOT,INCLUDING ARCH,BASE LAYER MINIMUMOF 1/4 INCH MATERIALOF SHORE A 35


The PCC recommendsthe addition of thiscode in order to keepparallelism between theA-codes and the PCC’srevision of the L-codes.

A5CIE For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Foot Ortho-sis, removable, customfabricated to patient Ana-tomical Volumetric FootModel, longitudinal/metatar-sal arch support andmedium calcaneal control,as defined, each foot.

Similar to L3020 FootOrthosis, removable,custom fabricated topatient AnatomicalVolumetric FootModel, longitudinal/metatarsal archsupport and mediumcalcaneal control, asdefined, each foot.

Same as A5CID/L3010,yet includes metatarsalarch support of anymaterial.

For treatment ofdiabetics/neuropathics,an appropriatelyprotective top covermust be used.

Code A5512 describes atotal contact, multipledensity, prefabricatedremovable inlay that isdirectly molded to thepatient’s foot. Direct moldedmeans it has beenconformed by moldingdirectly to match the plantarsurface of the individualpatient’s foot. Total contactmeans it makes and retainsactual and continuousphysical contact with theweight-bearing portions ofthe foot, including the arch

Similar to L3030 FootOrthosis, removable,prefabricated devicecustomized to patientfoot, longitudinal archsupport and all levelsof calcaneal control,as defined, each foot.

However, the A5512has the additionalCMS requirements ofthe base layerincluded, so allA5512’s are L3030, but



DUROMETER OR 3/16INCH MATERIAL OFSHORE A 40DUROMETER (ORHIGHER),PREFABRICATED,EACH

throughout the standing andwalking phases of gait.

The insert must retain itsshape during use for the lifeof the insert. The layerresponsible for shaperetention is called the “baselayer” in the codedescriptor. This materialusually constitutes thebottom layer of the deviceand must be of a sufficientthickness and durometer tomaintain its shape duringuse (i.e., at least ¼ inch of35 Shore A or higher or atleast 3/16 inch of 40 ShoreA or higher). The materialresponsible for maintainingthe shape of the devicemust be heat moldable. Thespecified thickness of thebase layer must extendfrom the heel through thedistal metatarsals and maybe absent at the toes.

higher) or 3/16 inch mate-rial of Shore A 40 durom-eter (or higher), each foot.

not all L3030 areA5512.

This code is forprefabricated footorthoses that arecustomized to thepatient’s foot throughthe application of heatmolding or chemicalmolding. This doesnot include heatmolding just fromwear, but requires anexternal heat source.The PCC does notbelieve that suchdevices warrantdistinction betweenpossible differencesin calcaneal control.Most of these devicesare low or mediumcalcaneal control.

This device must betotal contact, multipledensity, prefabricatedremovable inlay that isdirectly molded to thepatient’s foot. Directmolded means it hasbeen conformed bymolding directly tomatch the plantarsurface of theindividual patient’sfoot. Total contactmeans it makes andretains actual andcontinuous physicalcontact with theweight-bearingportions of the foot,


including the archthroughout thestanding and walkingphases of gait.

The insert must retainits shape during usefor the life of theinsert. The layerresponsible for shaperetention is called the“base layer” in thecode descriptor. Thismaterial usuallyconstitutes the bottomlayer of the deviceand must be of asufficient thicknessand durometer tomaintain its shapeduring use (i.e., atleast ¼ inch of 35Shore A or higher orat least 3/16 inch of 40Shore A or higher).The materialresponsible formaintaining the shapeof the device must beheat moldable. Thespecified thickness ofthe base layer mustextend from the heelthrough the distalmetatarsals and maybe absent at the toes.



Similar to L3BHI FootOrthosis, removable,prefabricated devicecustomized to patientfoot, longitudinal/metatarsal archsupport and all levelsof calcaneal control,as defined, each foot.



A5510 For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable, off-the-shelf device, longitudi-nal arch support and alllevels of calcaneal control,as defined, each foot.

A5510 FOR DIABETICSONLY, DIRECTFORMED,COMPRESSIONMOLDED TO PATIENT’SFOOT WITHOUTEXTERNAL HEATSOURCE, MULTIPLE-DENSITY INSERT(S)PREFABRICATED, PERSHOE

Similar to L3040 FootOrthosis, removable, off-the-shelf device,longitudinal archsupport and all levels ofcalcaneal control, asdefined, each foot.

This is the code for anyprefabricated, OTS footorthosis, insert, or fulllength arch support.There are manyvarieties available, butall are handled by thiscode.

This OTS device isNOT molded to thepatient’s foot to achievetotal contact and/or itotherwise fails animportant requirementof the covered code.Since it is not totalcontact and/orotherwise fails to meetan important criterion forcoverage, it will not becovered.


A5CIF For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable,prefabricated devicecustomized to patient foot,longitudinal/metatarsal archsupport and all levels ofcalcaneal control, asdefined, each foot.


Similar to L3060 FootOrthosis, removable,off-the-shelf device,longitudinal/metatarsalarch support and alllevels of calcanealcontrol, as defined,each foot.


This OTS device isNOT molded to thepatient’s foot toachieve total contactand/or it otherwisefails an importantrequirement of thecovered code. Sinceit is not total contactand/or otherwise failsto meet an importantcriterion for coverage,it will not be covered.


A5CIH For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Addition tocustom fabricated footorthosis, forefoot additionand/or unload to addressforefoot pathologies, perfoot.


Similar to L3BHM(must currently useL2999). Addition tocustom fabricated footorthosis, forefootaddition and/or unloadto address forefootpathologies, per foot.

This is an add-on to afoot orthosis when aforefoot addition and/or unload has beenadded to a footorthosis to address a


A5CIG For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-FootOrthosis, removable, off-the-shelf device, longitudi-nal/metatarsal arch supportand all levels of calcanealcontrol, as defined, eachfoot.



A5CIJ For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Addition tocustom fabricated footorthosis, rearfoot additionand/or unload to addressrearfoot pathologies, perfoot.


Similar to L3BHO(must currently useL2999). Addition tocustom fabricated footorthosis, rearfootaddition and/or unloadto address rearfootpathologies, per foot.

This is an add-on to afoot orthosis when arearfoot addition and/or unload has beenadded to a footorthosis to address arearfoot condition. Itcan also be used forextrinsic wedgingadded to the rearfootof a foot orthosis.This code cannot beused for metatarsal

forefoot condition. Itcan also be used forextrinsic wedgingadded to the forefootof a foot orthosis. Thiscode cannot be usedfor metatarsal pads. Itis only reasonable tocharge one unit ofservice for this codeper foot. It is meant toincorporate any and allwork done to theforefoot. Thesecodes are to be usedin the construction ofnew orthoses and foritems added afterinitial dispensing.See chapter CK onrefurbishment codes.



pads. It is onlyreasonable to chargeone unit of service forthis code per foot. Itis meant toincorporate any andall work done to therearfoot. These codesare to be used in theconstruction of neworthoses and foritems added afterinitial dispensing. Seechapter CK onrefurbishment codes.

The other custom and OTS foot orthosis codes in the L-series would not be appropriate in a Medical Gradecategory, so no corresponding code has been suggested.


CHAPTER CJ: CUSTOM SHOES

OverviewFor a complete discussion of Custom Molded Shoes, see chapter BI. Key points are highlighted below:

Use In Treating the Diabetic/Neuropathic FootCustom shoes are necessary when 1) the foot is so deformed that it cannot be managed in an OTS shoe, 2) theplantar pressures on the foot are so complicated or the plantar aspect of the foot is so sensitive that the foot cannotbe properly managed in OTS footwear or 3) when a beneficiary needs so much shoe modification work done to anOTS shoe that it is less expensive and more practical to do the work from scratch on a custom shoe than to try toretrofit an OTS shoe. The practitioner should document in the patient’s record WHY he/she had to resort to a customshoe rather than using an OTS shoe.

The PCC is advocating the use of the Risk Categorization factors. As discussed earlier, patients with a RiskCategory of 3 would be eligible for custom shoes. These patients need custom shoes for the first two reasonsabove.

Shoe ConstructionThe vast majority of labs offer a base shoe for a base price and then charge ala carte for inlays, rocker soles,elevations, hook-and-loop straps, special upgrades, etc. Generally included in the base price is: the lab standardleather uppers, the lab standard lace closing, the lab standard crepe soling materials, the lab standard BiomechanicalBalancing/unloading, the lab standard linings and collars, etc.

The Biomechanical Balancing is the part of the shoe that provides the support or “guts” of the shoe. This part iscustom formed around the last of the foot/inlay (on the dorsal side of the Biomechanical Balancing), and sanded flatto the ground on the plantar side of the Biomechanical Balancing. It provides the “cradling” and “posting” of theshoe. It can also contain unloads for sore/ulcerated areas of the plantar aspect of the foot.

To provide support, all Custom Molded Shoes have a layer that provides Biomechanical Balancing. The BiomechanicalBalancing is the portion of the shoe that provides the primary means of support, control, and weight redistribution.This balances the entire foot.

Custom shoe labs offer a vast variety of options, including options that are not Medically Necessary and/or generallyNot Covered, but serve to benefit the patient. Examples would include specialty leathers (ostrich), special soling(golf soles), safety features (steel toes), etc.

The PCC recognizes the following differences between Removable Biomechanical Balancing and Non-RemovableBiomechanical Balancing:

1. Removable is easier to adjust than Non-Removable because it is removable, and therefore the practitionercan more easily access any area or region of the Biomechanical Balancing. For instance, the practitionercan easily add an additional unload for an ulcer or bony prominence, simply by removing the BiomechanicalBalancing and grinding out a suitable unload.

2. The Removable Biomechanical Balancing is less torque-resistant than the Non-Removable BiomechanicalBalancing because it is not anchored to the lining and outsole. All else being equal, it provides less torquecontrol for the foot than the Non-Removable Biomechanical Balancing. This does not mean that it is necessarilyinsufficient control, but it would provide less control than a similar Non-Removable Biomechanical Balancing.


OptionsThe lab’s base price of the shoe includes all lab standard options. If the practitioner is going to order items aboveand beyond the lab standard, the lab is going to charge the practitioner for those items. Each incremental item isseparately billable above and beyond the base shoe code. The inlay, too, is separately billable above andbeyond the base shoe code. The following chart shows options that are offered by most shoe labs and how theyare usually handled:

ITEM MOST LIKELY L-CODE/ A-CODE

Generally Required for Diabetics/Neuropathics?

Generally Required for other medical reasons?

Leather T-Straps for brace (made and attached)

L2270 Not generally. For people with varus/valgus ankle/foot conditions that require an AFO/brace. See Section D.

Steel Shank L2360 Yes, often (when used with rocker sole). See chapter CI.

Can be used in conjunction with any rocker sole that needs extra rigidity.

Custom Inlay without firm support (as defined, see Footnote V and see chapter CI)

L3002/ A5513 & A5CIC

Yes, often. Has special needs to unload ulcers and pre-ulcerative spots. Must be total contact.

Used for all wearers of custom footwear to balance and protect foot.

Custom Inlay with firm support (as defined, see Footnote V and see chapter CI)

L3010/ A5CID & A5CIE

Yes, often. Has special needs to unload ulcers and pre-ulcerative spots. Must be total contact.

Used for all wearers of custom footwear to balance and protect foot.

Elevation, heel only (see Footnote W)

L3300/ A5CFA

Yes, often. Used to manage plantar pressures.

Related to LLD and/or equinus. However, not addressing it will create plantar pressure problems and therefore it should be covered. See chapter CF.

Elevation, heel and sole (see Footnote W)

L3310/ A5CFB


Related to LLD. However, not addressing it will create plantar pressure problems and therefore it should be covered. See chapter CF.

SACH heel L3450/ A5CGG


Related to fused ankle. However, not addressing it will create plantar pressure problems and therefore it should be covered. See chapter CF.

Wedge, external, medial or lateral

L3370/ A5CGD


Often used to manage biomechanical gait for a number of issues.

Metatarsal bar between outsole and midsole (see chapter CE)

L3410/ A5CEA




Footnote V: For more information on the PCC’s coding of foot orthoses, see chapter CI.The inlay consists of a molded single or multi-density layers that interfaces between the plantar surface of the footand the Biomechanical Balancing layer. A custom foot orthosis consists of the combination of the BiomechanicalBalancing and the inlay. A replacement inlay would have to be specifically molded and shaped for the specific pairof shoes it was fitting into.

Footnote W: Rocker soles versus elevations: Rocker soles are covered for people with diabetes/foot neuropathybecause they are used to unload the forefoot—specifically under an ulcer or a pre-ulcerative area. Elevations arenot as directly related to neuropathic foot unloading, but the PCC recommends coverage since LLDs can createplantar pressure issues which can be severe for neuropathic feet.

Footnote Z: Hook-and-loop straps: Usually required for ease of closure. This is especially true in people withmobility (i.e. stroke) and hand issues (i.e. Rheumatoid Arthritis). Sometimes used for fluctuating edema, but bothlaces and straps can be used for fluctuating edema. The straps are not necessary for edema, so they should not benecessary for diabetes management.

ITEM MOST LIKELY L-CODE/ A-CODE

Generally Required for Diabetics/Neuropathics?

Generally Required for other medical reasons?

Rocker sole between outsole and midsole (see Footnote W and chapter CE)

L3649 (L3BBB)/ A5CEB



Leather tip on sole L3550 Not generally. Used to protect soles from dragging foot gait.

Taps, heel or toe L3550 Not generally. Used to protect soles from dragging foot gait.

Hook-and-loop closure substituted for laces (leather covered) (see Footnote Z)

L3580 Not generally.

Used to allow easier donning and doffing, generally for people who have difficulty tying.

Caliper plate, installation

L3610 Not generally. For people with ankle conditions that require an AFO/brace.

Solid stirrup, installation L3630 Not generally. For people with ankle conditions that require an AFO/brace.

Toe Filler (i.e. trans metatarsal) with insole (see previous section)

L5000 Yes, often. See chapter BH.

Can also be for traumatic amputations.

Filler for missing toe (see previous section)

L5999 Yes, often. See chapter BH.

Can also be for traumatic amputations.


ITEM CODE DESCRIPTION High Top Construction, up to 6" A5508 Special construction above lab standard High Top Construction above 6" A5508 Special construction above lab standard Ankle and Boot Top Reinforcement (Polypro)

A5508 Special construction above lab standard

Heel counter rigid (medial and lateral)


Extended heel counter (medial or lateral)


Extra heavy duty construction A5508 Special construction above lab standard Heavy duty construction A5508 Special construction above lab standard Extra lightweight construction A5508 Special construction above lab standard Washable shoe construction A5508 Special construction above lab standard Waterproofing A5508 Special construction above lab standard Special leathers (exotic, deerskin, nubuck, boot leather, fleece, etc.)

A5508 Special upper work above lab standard

Leather heel bumpers A5508 Special upper work above lab standard Outside kiltie flap A5508 Special upper work above lab standard Pull loops A5508 Special upper work above lab standard Reinforcement stays, steel A5508 Special upper work above lab standard Toe caps, leather A5508 Special upper work above lab standard Zippers A5508 Special upper work above lab standard Metal eyelets A5508 Special upper work above lab standard Strap and buckle A5508 Special upper work above lab standard Tongue: Bellows A5508 Special tongue above lab standard Tongue: Fringe A5508 Special tongue above lab standard Tongues: extra padding A5508 Special tongue above lab standard Lining: specialty padding materials A5508 Special lining above lab standard Lining: antimicrobial materials A5508 Special lining above lab standard Lining: full leather A5508 Special lining above lab standard Lining: full synthetic (hypoallergenic) A5508 Special lining above lab standard Lining: special thermal protection (i.e. Thinsulate)

A5508 Special lining above lab standard

Lining: Genuine lambs wool A5508 Special lining above lab standard Collars: Inside padded collar A5508 Special collars above lab standard Collars: Leather Line Top A5508 Special collars above lab standard Collars: Outside padded collar A5508 Special collars above lab standard Welts, hand sewn A5508 Special sole work above lab standard Welts, cement A5508 Special sole work above lab standard Sole: golf A5508 Special sole work above lab standard Sole: leather A5508 Special sole work above lab standard Sole: lug A5508 Special sole work above lab standard Sole: work rated: oil resistant A5508 Special sole work above lab standard Sole: other specialty soling A5508 Special sole work above lab standard


ITEM CODE DESCRIPTION Metatarsal guards A5508 Special safety features above lab standard Safety toes, fiberglass A5508 Special safety features above lab standard Safety toes, plastic A5508 Special safety features above lab standard Safety toes, steel A5508 Special safety features above lab standard Brace Channels Removed A5508 Service for brace work Brace re-enforcement A5508 Service for brace work Leather covers on insoles A5508 Additional work done to inlay above lab standard Specialty top covers A5508 Additional work done to inlay above lab standard Reassemble broken casts A5508 Special services Cast adjustment for inferior cast A5508 Special services Duplicate Cast A5508 Special services Cast from existing shoes A5508 Special services Pattern change A5508 Special services Shoe laces, extra A5508 Special services Cast cosmetic front A5508 Special services for cosmetic purposes Double Soles Repair A5508 Repair Services Full re-cover high A5508 Repair Services Full re-cover low A5508 Repair Services Heel Tip- Neolite Repair A5508 Repair Services High top converted from oxford A5508 Repair Services Recondition old base/ high tops A5508 Repair Services Recondition old base/ low shoes A5508 Repair Services Re-stance heels or part of base A5508 Repair Services Single Soles Repair A5508 Repair Services Toe Cap Repair A5508 Repair Services

Note: The PCC recommends non-coverage of these A5508 items, as these items are outside the traditional realm of coveredand/or “medically necessary” items and almost all are special services, features, or options that are primarily for the benefit ofthe patient’s aesthetic and/or work related needs. Non-coverage will allow beneficiaries to get shoes exactly how theywant them using the market mechanism, and without interference of the third-party payor system.

The main codes currently in existence are (beginning on page 182):


Old Description Old Explanation PCC/New Description

PCC/New Explanation

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

A custom-molded shoe (A5501) is one that 1) is constructed over a positive model of the patient's foot; 2) is made from leather or other suitable material of equal quality; 3) has removable inserts that can be altered or replaced as the patient's condition warrants; and 4) has some form of shoe closure. This includes a shoe with or without an internally seamless toe.

A5501 For Beneficiaries in Risk Category 3 Only, Including Face to Face Fitting, Dispensing and Follow Up-Medical Grade Custom Molded Shoe, base model, any gender, uppers of leather or other accommodative yet formable material, low top with adjustable closure, closed toe, any bottom construction, any material bottom, room for separate depth inlay or foot orthosis, each foot.

Similar to L3252 Pedorthic Custom Molded Shoe, base model, any gender, low top with adjustable closure, closed toe, any bottom construction, any material bottom, room for separate depth inlay or foot orthosis, each foot. This is the code for a lab’s “low top base shoe” with lab standard: 1) leather uppers (or similar), 2) linings, 3) closure, 4) Biomechanical Balancing, 5) outsoles/heels, 6) collars, 7) toe and heel treatments, and 8) cast modification work. Contrary to previous definitions of A5501, the PCC’s definition does not include the inlay or foot orthosis. This previous treatment violated the incremental coding rules and caused great confusion for many practitioners. The PCC favors the one-to-one match with L-codes. The shoe must be made from leather or other suitable accommodative material of equal quality that maintains the shape and conforms to the deformity of the foot, but does not include any stretchable man-made material that will retain the original shape of the shoe when the foot is removed. It also does not include any other options and/or items which carry an incremental charge.


Q: I have a patient with the primary diagnosis of diabetes, I have a Custom Molded Shoe with a removable ToeFiller that meets the definition of L5000. Can I bill the underlying shoe code and the L5000, or is there adifferent code I must use?A: Yes, the code A5501 for the shoe, in combination with the code L5000 for the toe filler, can be billed. See thediscussion of L5000 and medical necessity at Chapter BH.

The other custom shoe codes in the L-series would not be appropriate in a Medical Grade category, so nocorresponding code has been suggested.




CHAPTER CK: REPAIR CODES

OverviewThe current A-codes have no codes for repairs of either diabetic/neuropathic orthoses or Medical Grade shoes.The L-code sets have a repair code for time spent repairing orthotic devices (L4205), but no similar code for timespent on shoe codes and/or shoe modifications. However, there are certain shoe repair L-codes for items that aremost prone to needing repair, i.e. full and half soles—and the PCC has proposed similar A-codes (see chapter CH).

The PCC supports the creation of incremental repair codes for Medical Grade shoe codes other than full and halfsoles, and repair codes for diabetic/neuropathic orthoses because such codes meets four important public policyconcerns: 1) repairs are often cheaper than replacement—keeping health care costs down, 2) repairs are moreenvironmentally friendly—keeping down destruction of new resources by preserving old ones, 3) a repaired “olddevice” gives the patient a backup device to switch off to for emergencies1, 4) it is inappropriate to treat the covereddiabetic/neuropathic codes as a lesser code than other covered orthotic codes—if a code is worthy of beingcovered it is worthy of being repaired.

All repairs must meet the following tests to be covered: 1) the underlying device had to be originally covered, 2) therepair must be medically necessary, 3) the repaired device must have a reasonable useful life once repaired, 4) therepair must be cheaper than a replacement, 5) the patient must pay their appropriate co-pay for the repair, 6) therepair must be incremental and distinct from the original fitting and adjusting of the device—it cannot be part of thatinitial fitting and adjusting process, and 7) the time must actually be spent on repairing the device.

Often, there is a bright line rule of 90 days to determine whether repairs are incremental, or part of the original fittingof the device. The 90 day rule has been criticized by practitioners as it allows no provision for repairs that are aresult of medical changes, damage or breakage not related to product construction, abuse or damage caused bytrauma, falls or other incidental issues (i.e., damage outside the control or responsibility of the provider). The PCCbelieves that such situations are common enough that they warrant an incremental code and that when that code isused, that the practitioner needs to provide supplemental documentation to establish medical necessity and that therepair falls within the rules.

Medicare policy dictates that the normal “repair codes” may only be billed for time involved with the actual repair ofa covered device or for medically necessary adjustments made more than 90 days after delivery. Medicare policydictates that these codes must not be used to bill for time involved with other professional services including, butnot limited to:

Evaluating the patient Taking measurements, making a cast, making a model, use of CAD/CAM Making modifications to a prefabricated item to fit it to the individual patient Follow-up visits Making adjustments at the time of or within 90 days after delivery

Reimbursement for these services is included in the allowance for the HCPCS codes which describe the device.

Similarly, the “repair plus minor parts/supplies” codes must not be used for casting supplies or other materials usedin the fitting or fabrication of an orthosis. These codes have a slightly higher reimbursement than the normal repaircode to account for the minor parts and supplies used for these types of repairs.

The PCC suggests the following code sets to create parallel code sets for diabetic/neuropathic patients (beginningon page 188):


Similar to L4205Repair, LaborComponent, CoveredOrthotic Device, after90 days fromdispensing, per 15minutes or fractionthereof, but just fordiabetic/neuropathicorthoses.


A5CKB For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Repair,Labor Component, Cov-ered Diabetic/NeuropathicOrthotic Device, within 90days from dispensing-special circumstance, per15 minutes or fractionthereof.


Similar to L3BJARepair, LaborComponent, CoveredOrthotic Device, within90 days fromdispensing-specialcircumstance, per 15minutes or fractionthereof, but just fordiabetic/neuropathicorthoses..This code issimilar to the codeabove, but allows forspecial repairs withinthe 90 day windowwhen the practitionercan prove that therepairs are not thefault of the practitioner.The practitionershould have specificdocumentation in thefiles relating to theserepairs and shouldsubmit thisdocumentation whenfiling this code.


A5CKA For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Repair,Labor Component, Cov-ered Diabetic/NeuropathicOrthotic Device, after 90days from dispensing, per15 minutes or fractionthereof.


Similar to L3BJBRepair, LaborComponent, CoveredShoe Device, notresoles, after 90 daysfrom dispensing, per15 minutes or fractionthereof, but just forcovered MedicalGrade Shoes.

This code is similar tothe L4205, but handlescovered shoe codesother than resoling.Any such repairshould meet all of thetests documentedabove.


A5CKD For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Repair,Labor Component,Covered Medical GradeShoe Device, not resoles,within 90 days fromdispensing-specialcircumstance, per 15minutes or fraction thereof.


Similar to L3BJCRepair, LaborComponent, CoveredShoe Device, notresoles, within 90 daysfrom dispensing-specialcircumstance, per 15minutes or fractionthereof, but just forMedical Grade shoes.

This code is similar tothe code above, butallows for specialrepairs within the 90 daywindow when thepractitioner can provethat the repairs are notthe fault of thepractitioner. Thepractitioner should havespecific documentationin the files relating tothese repairs andshould submit thisdocumentation whenfiling this code.


A5CKC For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Repair,Labor Component, Cov-ered Medical Grade ShoeDevice, not resoles, after90 days from dispensing,per 15 minutes or fractionthereof.


Similar to L4210Repair, Labor & MinorParts Component,Covered OrthoticDevice, after 90 daysfrom dispensing, per15 minutes or fractionthereof, but just fordiabetic/neuropathicorthoses..

This code is the samecode and rules ascurrently defined forL4210. Medicarecovers this code, sopractitioners areadvised to keepabreast of Medicareguidelines and to theextent they differ fromPCC guidance, theMedicare guidancecontrols.


A5CKF For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up- Repair,Labor & Minor PartsComponent, CoveredDiabetic/NeuropathicOrthotic Device, within 90days from dispensing-special circumstance, per15 minutes or fractionthereof.


Similar to L3BJDRepair, Labor & MinorParts Component,Covered OrthoticDevice, within 90 daysfrom dispensing-special circumstance,per 15 minutes orfraction thereof, butjust for diabetic/neuropathic orthoses.

This code is similar tothe code above, butallows for specialrepairs within the 90day window when thepractitioner can provethat the repairs are not


A5CKE For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up Repair,Labor & Minor PartsComponent, CoveredDiabetic/NeuropathicOrthotic Device, after 90days from dispensing, per15 minutes or fractionthereof.



A5CKG For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Repair,Labor & Minor PartsComponent, CoveredMedical Grade ShoeDevice, not resoles, after90 days from dispensing,per 15 minutes or fractionthereof.


Similar to L3BJERepair, Labor & MinorParts Component,Covered ShoeDevice, not resoles,after 90 days fromdispensing, per 15minutes or fractionthereof, but just forMedical Grade shoes.

This code is similar tothe L4210, but handlescovered shoe codesother than resoling.Any such repairshould meet all of thetests documentedabove.

the fault of thepractitioner. Thepractitioner shouldhave specificdocumentation in thefiles relating to theserepairs and shouldsubmit thisdocumentation whenfiling this code.


A5CKH For Beneficiaries inRisk Category 1 or HigherOnly, Including Face toFace Fitting, Dispensingand Follow Up-Repair,Labor & Minor Parts Com-ponent, Covered MedicalGrade Shoe Device, notresoles, within 90 days fromdispensing-special circum-stance, per 15 minutes orfraction thereof.

Similar to L3BJF (mustcurrently use L3649)Repair, Labor & MinorParts Component,Covered ShoeDevice, not resoles,within 90 days fromdispensing-specialcircumstance, per 15minutes or fractionthereof, but just forMedical Grade shoes.


This code is similar tothe code above, butallows for specialrepairs within the 90day window when thepractitioner can provethat the repairs are notthe fault of thepractitioner. Thepractitioner shouldhave specificdocumentation in thefiles relating to theserepairs and shouldsubmit thisdocumentation whenfiling this code.


FAQ:Q: Is this an area where Medicare/third party payors give extra scrutiny to potential up-coding?A: Yes, these codes are a potential area for Fraud and Abuse and are often scrutinized. The PCC recommends thatall practitioners keep meticulous notes on the repair work that they do and bill for to ensure they can meet the testsindicated above, namely 1) the underlying device had to be originally covered, 2) the repair must be medicallynecessary, 3) the repaired device must have a reasonable useful life once repaired, 4) the repair must be cheaperthan a replacement, 5) the patient must pay their appropriate co-pay for the repair, 6) the repair must be incrementaland distinct from the original fitting and adjusting of the device—it cannot be part of that initial fitting and adjustingprocess, and 7) the time must actually be spent on repairing the device.

(Chapter Footnotes)1 It is unreasonable to assume that someone who needs special shoes can get by with just one pair of shoes.