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Local Coverage Articles, Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article, A52457

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L1980 (ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT FREE PLANTAR DORSIFLEXION, SOLID STIRRUP, CALF BAND/CUFF (SINGLE BAR 'BK' ORTHOSIS), CUSTOM FABRICATED) describes a custom fabricated AFO designed to control inversion and eversion motions of the ankle foot complex. Primary construction is a single metal upright (medial or lateral) joined to a rigid calf band, free motion ankle joint, and stirrup component attached to an orthopedic shoe. Height of calf cuff/band terminates well above the ankle (usually to near the top of the calf) and is fastened around the lower leg above the ankle.Included in the code are components for closures and attaching the footwear.This AFO is custom fabricated per the DMEPOS quality standards, Appendix C.L1990 (ANKLE FOOT ORTHOSIS, DOUBLE UPRIGHT FREE PLANTAR DORSIFLEXION, SOLID STIRRUP, CALF BAND/CUFF (DOUBLE BAR 'BK' ORTHOSIS), CUSTOM FABRICATED) describes a custom fabricated AFO designed to control inversion and eversion motions of the ankle foot complex. Primary construction are two metal uprights (medial and lateral) joined to a rigid calf band, free motion ankle joints, and stirrup component attached to an orthopedic shoe. Height of calf cuff/band terminates well above the ankle (usually to near the top of the calf) and is fastened around the lower leg above the ankle. Included in the code are components for closures and attaching the footwear. This AFO is custom fabricated per the DMEPOS quality standards, Appendix C.Code L4631 describes a Charcots restraint orthotic walker (CROW) orthosis. Code L4631 is a custom fabricated ankle-foot orthosis which has all of the following characteristics:

Local Coverage Articles, Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article, A52457

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Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)

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Designed to maintain the foot at a fixed position of 0 (i.e., perpendicular to the lower leg); and,Allows for varus or valgus deformity correction; and,Contains a rocker bottom sole with a custom arch support; and,Incorporates a rigid anterior tibial shell; and,Used by a beneficiary who is ambulatory; and,Has a soft interfaceTotally encapsulated.Code L4631 includes all additions including straps and closures. No additional codes may be billed with code L4631.KNEE-ANKLE-FOOT ORTHOSESL2005 (KNEE ANKLE FOOT ORTHOSIS, ANY MATERIAL, SINGLE OR DOUBLE UPRIGHT, STANCE CONTROL, AUTOMATIC LOCK AND SWING PHASE RELEASE, ANY TYPE ACTIVATION, INCLUDES ANKLE JOINT, ANY TYPE, CUSTOM FABRICATED) describes a custom fabricated, single or double upright KAFO with an automatic lock and swing phase release knee joint. Automatic knee lock is activated by any method such as mechanical or electrical. The custom fabricated KAFO can be constructed from thermosetting materials, thermoplastics, or composite type materials. It includes any type ankle joint and closure components. There are no additional add-on codes for L2005. This KAFO is custom fabricated per the DMEPOS Quality Standards, Appendix C.L2006 (KNEE ANKLE FOOT DEVICE, ANY MATERIAL, SINGLE OR DOUBLE UPRIGHT, SWING AND STANCE PHASE MICROPROCESSOR CONTROL WITH ADJUSTABILITY, INCLUDES ALL COMPONENTS (E.G., SENSORS, BATTERIES, CHARGER), ANY TYPE ACTIVATION, WITH OR WITHOUT ANKLE JOINT(S), CUSTOM FABRICATED) describes a custom fabricated, single or double upright KAFO with an adjustable microprocessor control feature which provides resistance to stance and swing phase knee joint motion. The custom fabricated KAFO can be constructed from thermosetting materials, thermoplastics, or composite type materials. There are no additional add-on codes for this KAFO. This KAFO is custom fabricated per the DMEPOS Quality Standards, Appendix C.L2034 (KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, SINGLE UPRIGHT, WITH OR WITHOUT FREE MOTION KNEE, MEDIAL LATERAL ROTATION CONTROL, WITH OR WITHOUT FREE MOTION ANKLE, CUSTOM FABRICATED) describes a custom fabricated, single upright KAFO designed to control (1) knee flexion, extension, and rotation motions (2) ankle inversion, eversion, dorsiflexion, plantarflexion, and rotation motions of the ankle foot complex. Primary construction is a rigid shell-like or equal structure which can be; (1) with or without free range of motion knee hinge or joint mechanism; (2) with or without free range of motion ankle hinge(s). Through a series of straps/supports that cross over and around the knee joint, rotational control and varus or valgus force is exerted on the knee joint. Structure contacts thigh, calf, lower leg, and foot to provide control. Foot plate must extend to the metatarsal heads. The custom fabricated KAFO can be constructed from thermosetting materials, thermoplastics, or composite type materials. Included in the code are closure components. The predicate product is the Generation II KAFO with hinged ankle manufactured by Generation II USA, Inc. This KAFO is custom fabricated per the DMEPOS Quality Standards, Appendix C.L2036 (KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, DOUBLE UPRIGHT, WITH OR WITHOUT FREE MOTION KNEE, WITH OR WITHOUT FREE MOTION ANKLE, CUSTOM FABRICATED) describes a custom fabricated, double upright KAFO designed to control (1) knee flexion, extension, rotation motions (2) ankle inversion, eversion, dorsiflexion, plantarflexion, and rotation motions of the ankle foot complex. Primary construction is a rigid shell-like or equal structure which can be with or without free range of motion hinge or joint mechanisms at the knee and/or ankle. Structure contacts thigh, calf, lower leg, and foot to provide control. Foot plate must extend to the metatarsal heads. The custom fabricated KAFO can be constructed from thermosetting materials, thermoplastics, or composite type materials. Included in the code are closure components. This KAFO is custom fabricated per the DMEPOS Quality Standards, Appendix C.LOWER EXTREMITY ADDITIONSCustom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics unless a product has been previously assigned an addition code per PDAC/CMS prior to 1/1/2023. Correct coding with use of addition codes should not include, or partially include, features or functions described by other codes billed for a specific device.L2200 (ADDITION TO LOWER EXTREMITY, LIMITED ANKLE MOTION, EACH JOINT) describes an ankle joint product which can control dorsiflexion and/or plantarflexion of the ankle joint. The range of motion is set during fabrication. Joints can be deployed as a pair (two UOS) or singly (one UOS) with appropriate custom fabricated AFO or KAFO. Product will be distinctly identifiable from other components of the orthosis.L2210 (ADDITION TO LOWER EXTREMITY, DORSIFLEXION ASSIST (PLANTAR FLEXION RESIST), EACH JOINT) describes an ankle joint product which can control plantarflexion of the ankle joint. The range of motion is adjustable post-delivery of the orthosis. Initial setting is set by the supplier during fabrication. Joints can be deployed as a pair (two UOS) or singly (one UOS) with appropriate custom fabricated AFO or KAFO. Product will be distinctly identifiable from other components of the orthosis.L2220 (ADDITION TO LOWER EXTREMITY, DORSIFLEXION AND PLANTAR FLEXION ASSIST/RESIST, EACH JOINT) describes an ankle joint product which can control dorsiflexion and/or plantarflexion of the ankle joint. The range of motion is adjustable post-delivery of the orthosis. Initial setting is set by the supplier during fabrication. Joints can be deployed as a pair (two UOS) or singly (one UOS) with appropriate custom fabricated AFO or KAFO. Product will be distinctly identifiable from other components of the orthosis.L2280 (ADDITION TO LOWER EXTREMITY, MOLDED INNER BOOT) describes a custom molded device which encircles the ankle and to at least the mid-foot to provide multi-directional support to the ankle foot complex with compression from semi-rigid or rigid material(s). Inner boot is fully circumferential with closure components included such as lacing/eyelets or hook/loop. Lacer material and construction must conform to DMEPOS Quality Standards, Appendix C.L2330 (ADDITION TO LOWER EXTREMITY, LACER MOLDED TO PATIENT MODEL, FOR CUSTOM FABRICATED ORTHOSIS ONLY) describes an upgrade to the cuff (including closures) to cover the rigid structures of the orthosis. Custom fabrication would capture shapes and contours of the anatomy to improve function of the included cuff/closure component. Lacer is fully circumferential with closure components included such as lacing/eyelets or hook/loop. Lacer material and construction must conform to DMEPOS Quality Standards, Appendix C.L2340 (ADDITION TO LOWER EXTREMITY, PRE-TIBIAL SHELL, MOLDED TO PATIENT MODEL) is a pre-tibial shell, custom fabricated, that provides a rigid overlapping interlocking anterior tibial control between the tibial tuberosity to a point no greater than 3 inches proximal to the medial malleolus. The pre-tibial shell can be constructed from thermosetting materials, thermoplastics, or composite type materials.Code L2755 (ADDITION TO LOWER EXTREMITY ORTHOSIS, HIGH STRENGTH, LIGHTWEIGHT MATERIAL, ALL HYBRID LAMINATION/PREPREG COMPOSITE, PER SEGMENT, FOR CUSTOM FABRICATED ORTHOSIS ONLY) describes an addition to a lower extremity orthosis composed of high strength and/or lightweight material such as Kevlar, carbon fiber or other laminated or impregnated composite material.L2820 (ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, BELOW KNEE SECTION) describes a moldable and compliant material which has been fabricated as an integral part of a custom fabricated orthosis. The interface is designed to allow cushioning and contouring over pressure-sensitive areas of the limb in greater capacity than what may be included in the base orthosis that is constructed from thermosetting materials, thermoplastics, or composite type materials. The soft interface material and construction must conform to DMEPOS Quality Standards, Appendix C.POSITIONING DEVICESA non-ambulatory ankle-foot orthosis may be either an ankle contracture splint, night splint or a foot drop splint.A static or dynamic positioning ankle-foot orthosis (L4396, L4397) is a prefabricated ankle-foot orthosis which has all of the following characteristics:Designed to accommodate either plantar fasciitis or an ankle with a plantar flexion contracture up to 45; and,Applies a dorsiflexion force to the ankle; and,Used by a beneficiary who is minimally ambulatory, or non-ambulatory; and,Has a soft interface.A foot drop splint/recumbent positioning device (L4398) is a prefabricated ankle-foot orthosis which has all of the following characteristics:Designed to maintain the foot at a fixed position of 0 (i.e., perpendicular to the lower leg); and,Not designed to accommodate an ankle with a plantar flexion contracture; and,Used by a beneficiary who is non-ambulatory; and,Has a soft interface.SHOE INSERTSFoot orthoses are shoe inserts that do not extend above the ankle. Shoes, inserts, and shoe modifications that are integral components of a leg brace are referred to as orthopedic footwear (ORF). These shoes, inserts, and shoe modifications are only covered if they are an integral part of a covered leg brace that is described by HCPCS code L1900, L1920, L1980, L1990, L2000, L2005, L2010, L2020, L2030, L2050, L2060, L2080, or L2090. In addition to being an integral component of the covered leg brace, these products must also be medically necessary for the proper functioning of the leg brace. When billing for ORF, the leg brace and ORF must be billed by the same supplier (refer to the Orthopedic Footwear policy for more information).Multiple density foot orthotics that are provisioned in the treatment of a beneficiarys diabetes-related condition(s), must not be billed using L-codes but rather must be billed using A-codes. The A-codes for billing of such foot orthotics are A5512, A5513, and A5514 (code A5514 effective for DOS on or after 01/01/2019) (refer to the Therapeutic Shoes for Persons with Diabetes policy for more information).CONCENTRIC TORSION JOINTSAll claims for devices that contain a concentric adjustable torsion style mechanism in the knee joint for any condition other than an assistive function to joint extension motion must be coded as durable medical equipment using code E1810 (DYNAMIC ADJUSTABLE KNEE EXTENSION / FLEXION DEVICE, INCLUDES SOFT INTERFACE MATERIAL). If a concentric adjustable torsion style mechanism in the knee joint is used solely to provide an assistive function for joint extension, it must be coded as L2999 (See Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD).All claims for devices that contain a concentric adjustable torsion style mechanism in the ankle joint for any condition other than an assistive function to joint plantar- or dorsiflexion motion must be coded as durable medical equipment using code E1815 (DYNAMIC ADJUSTABLE ANKLE EXTENSION/FLEXION DEVICE, INCLUDES SOFT INTERFACE MATERIAL). If a concentric adjustable torsion style mechanism in the ankle joint is used solely to provide an assistive function for joint plantar or dorsiflexion, it must be coded as L2999 (See Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD).Claims for devices that contain a concentric adjustable torsion style mechanism in the knee or ankle joint and that are being used to treat any condition other than an assistive function to joint extension motion are not covered under the braces benefit and will be denied as incorrect coding when billed using code L2999 (See Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD).WALKING BOOTSPrefabricated walking boots are coded using codes L4360, L4361, L4386 or L4387.These codes describe complete products.Claims for add-on codes used with walking boots coded L4360, L4361, L4386 or L4387 will be denied as unbundling.Certain products may have both covered and non-covered uses, as defined by the braces benefit category, and must be coded based on the beneficiarys condition. For example, when used as a brace for the treatment of an orthopedic condition, walking boots are coded L4360, L4361, L4386, L4387 and L4631. However, walking boots must be coded A9283 when used solely for the prevention or treatment of a lower extremity ulcer or pressure reduction.OTHER DEVICES

Local Coverage Articles, Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article, A52457

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Claims for devices that contain a concentric adjustable torsion style mechanism in the knee or ankle joint and that are being used to treat any condition other than an assistive function to joint extension motion are not covered under the braces benefit and will be denied as incorrect coding when billed using code L2999 (See Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD).WALKING BOOTSPrefabricated walking boots are coded using codes L4360, L4361, L4386 or L4387.These codes describe complete products.Claims for add-on codes used with walking boots coded L4360, L4361, L4386 or L4387 will be denied as unbundling.Certain products may have both covered and non-covered uses, as defined by the braces benefit category, and must be coded based on the beneficiarys condition. For example, when used as a brace for the treatment of an orthopedic condition, walking boots are coded L4360, L4361, L4386, L4387 and L4631. However, walking boots must be coded A9283 when used solely for the prevention or treatment of a lower extremity ulcer or pressure reduction.OTHER DEVICESCode A9283 (FOOT PRESSURE OFF LOADING/SUPPORTIVE DEVICE, ANY TYPE, EACH) is used for an item that is designed primarily to reduce pressure on the sole or heel of the foot. It may be a shoe-like item, an item that is used inside a shoe and may or may not extend outside the shoe, or an item that is attached to a shoe. It may be prefabricated or custom fabricated. Code A9283 does not include items that meet the definition of a therapeutic shoe for diabetes (A5500, A5501).When using code A9283, there is no separate billing using addition codes. Replacement liners for devices billed with A9283 must be billed with code A9270 (NON-COVERED ITEM OR SERVICE).Code A9285 (INVERSION/EVERSION CORRECTION DEVICE) is designed to provide off-loading pressure to the knee for the treatment of knee osteoarthritis. The device is applied at the foot and extends across the ankle to apply pressure to the side of the leg below the knee. It does not provide any support at the ankle.REPAIR/REPLACEMENTCode L4205 (REPAIR OF ORTHOTIC DEVICE, LABOR COMPONENT, PER 15 MINUTES) may only be billed for time involved with the actual repair of an orthosis or for medically necessary adjustments made more than 90 days after delivery. Code L4205 must not be used to bill for time involved with other professional services including, but not limited to:Evaluating the beneficiaryTaking measurements, making a cast, making a model, use of CAD/CAMMaking modifications to a prefabricated item to fit it to the individual beneficiaryFollow-up visitsMaking adjustments at the time of or within 90 days after deliverySuppliers must distinguish between repair and replacement of an orthosis. When an orthotic is replaced, there is no separate billing for the above services because reimbursement for these services is included in the allowance for the replacement item.Repairs to a covered orthosis due to wear or to accidental damage are covered when they are necessary to make the orthosis functional. The reason for the repair must be documented in the supplier's record. If the expense for repairs exceeds the estimated expense of providing another entire orthosis, no payment will be made for the amount in excess.The allowance for the labor involved in replacing an orthotic component that is coded with a specific L-code is included in the allowance for that component. The allowance for the labor involved in replacing an orthotic component that is coded with the miscellaneous code L4210 is separately payable in addition to the allowance for that component.Addition codes L4002, L4010, L4020, L4030, L4040, L4045, L4050, L4055, L4060, L4070, L4080, L4090, L4100, L4110,L4130, and L4392 are for billing of replacement components and are not payable at initial issue of a base orthosis. When claims for code(s) L4002, L4010, L4020, L4030, L4040, L4045, L4050, L4055, L4060, L4070, L4080, L4090, L4100, L4110,L4130, and L4392 are billed at the time of initial issue of a base orthosis, the addition code(s) will be rejected as incorrect coding.Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.HCPCS codes L4050 and L4055 do not describe replacement soft interfaces used with contracture orthoses.Some replacement items have unique Healthcare Common Procedure Coding System (HCPCS) codes. Replacement components that do not have a unique HCPCS code must be billed with a "not otherwise specified" code - L2999. Items that have unique codes must not be billed using a NOC code.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC web site or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC web site. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after April 1, 2012:L1906Effective for claims with dates of service on or after January 1, 2020:L2006If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.

Local Coverage Articles, Automatic External Defibrillators - Policy Article, A52458

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Article - Automatic External Defibrillators - Policy Article (A52458)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Automatic external defibrillators are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6). In order for a beneficiarys DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter andWritten Order Prior to DeliveryList is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The diagnosis code that justifies the need for these items must be included on the claim.MODIFIERSKX, GA, GZ AND KF MODIFIERS:Suppliers must add a KX modifier to a code only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GZ, or KX modifier will be rejected as missing information.Devices coded K0606 and E0617 are classified by the Food and Drug Administration as Class III devices; therefore, all claims for code K0606 and E0617 must include the KF modifier. Claim lines billed without a KF modifier will be rejected as missing information.CODING GUIDELINESAutomatic defibrillators are devices that are capable of monitoring cardiac rhythms, detecting dysrhythmias, and delivering a defibrillation shock to the heart when appropriate without any user decision-making.Non-wearable, automatic external defibrillators with integrated electrocardiogram capability are coded using HCPCS code E0617.Wearable, automatic, external defibrillators with integrated electrocardiogram analysis are coded using HCPCS code K0606.Other types of defibrillators are coded as A9270. No separate payment is made for carrying cases or mounting hardware.Replacement supplies and accessories for use with K0606 are coded using K0607, K0608, and K0609 as appropriate.Replacement supplies and accessories for use with E0617 are coded using A9999.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Canes and Crutches - Policy Article, A52459

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Article - Canes and Crutches - Policy Article (A52459)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Canes and Crutches are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A white cane for a blind person is noncovered since it is more of an identifying and self-help device than an item which makes a meaningful contribution in the treatment of an illness or injury (see CMSNational Coverage Determinations Manual(CMS Pub. 100-03), Chapter 1, Part 4, Section 280.2).REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.CODING GUIDELINESCode A9270 must be used for a white cane for a blind person.All canes and crutches are billed using the specific codes listed in the Local Coverage Determination regardless of their stated weight capacity. Do not use code E1399 (DME, miscellaneous) to code any type of cane or crutch regardless of special features or weight capacity.Code E0117 describes an articulating crutch which has two crutch legs connected by a bar between them which helps propel the beneficiary forward.Code E0118 describes a crutch substitute which can be either a device strapped to the lower leg with a platform or a device with wheels and a platform the beneficiary propels with their sound limb.Canes or crutches which contain a spring that reduces impact and vibration against the ground should not be billed with E1399. These types of canes or crutches should be coded with the existing codes for canes or crutches.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Cold Therapy - Policy Article, A52460

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Cold therapy devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.CODING GUIDELINESCode A9270 is used for billing non DME items such as:disposable single use fluid packs which generate cold temperature by a chemical reaction,devices in which ice water is put in a reservoir and then circulated through a pad by means of gravity orself-made containers used to administer cold therapy.Code A9273 describes products such as insulated cold or hot bottles, ice caps or collars, heat and/or cold wraps of any type that are reusable.Code E0218 describes a device which has an electric pump that circulates cold fluid through a pad.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Commodes - Policy Article, A52461

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a975b86d-1ff9-4596-8611-98accc04700f

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Commodes are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A raised toilet seat (E0244) is noncovered; therefore, a commode chair that is used as a raised toilet seat by positioning it over the toilet is also noncovered. When a commode chair is provided for use in this manner, the GY modifier must be added to the code for the commode chair and the KX modifier must not be used.Toilet seat lift mechanisms (E0172) are not primarily medical in nature; therefore do not meet the statutory definition of durable medical equipment. They are non-covered.A footrest (E0175) is non-covered because it is not medical in nature.Bidets and bidet toilet seats are non-covered because they are not primarily medical in nature.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The diagnosis code that justifies the need for these items must be included on the claim.KX, GA, GY, AND GZ MODIFIERS:For commodes (E0163, E0165, E0168, E0170, and E0171) used as a raised toilet seat by positioning it over the toilet, the GY modifier must be added to the code, and the KX, GA, or GZ modifier must not be used.For commodes (E0163, E0165, E0168, E0170, and E0171) not used as a raised toilet seat, the KX modifier must be added to the code only if all of the coverage criteria as described in the Coverage Indication, Limitations and/or Medical Necessity section of the related LCD have been met.For commode chairs with seat lift mechanism (E0170 and E0171), the KX modifier must be added to the code only if the beneficiary meets all of the criteria for a seat lift mechanism.If all of the criteria in the Coverage Indication, Limitations and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter a GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or a GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GY, GZ or KX modifier will be rejected as missing information.CODING GUIDELINESA commode with seat lift mechanism (E0170, E0171) is a free-standing device that has a commode pan and that has an integrated seat that can be raised with or without a forward tilt while the beneficiary is seated. An integrated device is one which is sold as a unit by the manufacturer and in which the lift and the commode cannot be separated without the use of tools.A toilet seat lift mechanism is a device with a seat that can be raised with or without a forward tilt while the beneficiary is seated, allowing the beneficiary to stand and ambulate once he/she is in an upright position. It may be manually operated or electric. It is attached to the toilet. These devices are coded as E0172.A raised toilet seat (E0244) is a device that adds height to the toilet seat. It is either fixed height or adjustable. It is either attached to the toilet or is unattached, resting on the bowl.Note: A freestanding raised toilet seat supported by legs on the floor is coded as a commode.Bidets, bidets incorporated into toilet seats and similar genitalia/perineum/buttocks cleansing devices are products that utilize a stream of water to irrigate and wash the buttocks and perineal area. Bidets and similar devices are coded A9270 (NONCOVERED ITEM OR SERVICE).Extra wide/heavy duty commode chairs (E0168) have a width of greater than or equal to 23 inches and are also capable of supporting a beneficiary who weighs 300 pounds or more.A Column II code is included in the allowance for the corresponding Column I code when provided at the same time.Column IColumn IIE0163E0167E0165E0167E0168E0167E0170E0167, E0627, E0629E0171E0167, E0627, E0629Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Eye Prostheses - Policy Article, A52462

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00197cd2-1721-4247-a240-d0a532be43ca

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Eye prostheses are covered under the Medicare Artificial Legs, Arms and Eyes benefit (Social Security Act 1861(s)(9)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Trial scleral cover shells are not separately payable. They are included in the allowance for scleral cover shells, V2627.The following services and items are included in the allowance for an eye prosthesis and, therefore, are not separately billable to or payable by Medicare under the prosthetic device benefit:Evaluation of the beneficiaryPre-operative planningCost of materialsLabor involved in the fabrication and fitting of the prosthesisModifications to the prosthesis made at the time delivery of the prosthesis or within 90 days thereafterRepair due to normal wear or tear within 90 days of deliveryFollow-up visits within 90 days of delivery of the prosthesisModifications to a prosthesis are separately payable when they occur more than 90 days after delivery of the prosthesis and they are required because of a change in the beneficiarys condition.Repairs are covered when there has been accidental damage or extensive wear to the prosthesis that can be repaired. If the expense for repairs exceeds the estimated expense for a replacement prosthesis, no payments can be made for the amount of the excess.Follow-up visits which occur more than 90 days after delivery and which do not involve modification or repair of the prosthesis are noncovered services.Physicians who are enrolled as a DMEPOS supplier are to submit claims for eye prostheses provided in an office or nursing home setting by nonphysicians or physicians to the DME MAC. Claims for eye prostheses provided in an outpatient hospital setting are submitted to the applicable A/B MAC. Eye prostheses provided in an inpatient hospital setting are included in the payment made to the hospital; therefore, claims should not be submitted to the DME MAC.Claims for implanted components (e.g., titanium studs, magnets, etc.) and procedures used to affix the ocular prosthesis to the beneficiary are not the jurisdiction of the DME MAC. Claims for these items and services will be denied as wrong jurisdiction.Replacement of an ocular prosthesis because of loss or irreparable damage may be reimbursed without a treating practitioner's order when it is determined that the prosthesis as originally ordered still fills the beneficiary's medical needs.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.When billing for an item or service at a greater frequency than that described in the policy, there must be documentation in the beneficiarys medical records that corroborates the order and supports the medical necessity of the items and quantities billed. This information must be available upon request.The treating practitioner's records must contain information which supports the medical necessity of the item ordered. The ocularist's documentation of the necessity for a replacement prosthesis is appropriate documentation for that claim if the replacement is necessitated by other than medical reasons.MODIFIERSThe right (RT) and/or left (LT) modifiers must be used with all HCPCS codes in this policy. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for bilateral items (left and right) is billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without the RT and/or LT modifiers, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.CODING GUIDELINESTrial scleral shells must be billed with code L9900.PROSE DevicePROSE (BostonSight, Needham, MA) devices are designed to rest on the sclera or white part of the eye and are used to treat ocular surfaces diseases, including some types of "dry eye." For Medicare billing purposes the correct HCPCS coding for this item is determined based upon the condition(s) being treated. When the PROSE device is used as a treatment for either of the following indications listed below, the correct HCPCS code to use is V2627 (SCLERAL COVER SHELL):Treatment of an eye rendered sightless and shrunken by inflammatory disease; or,Treatment of "dry eye" where the PROSE device serves as a substitute for the function of the diseased lacrimal gland.When the PROSE device is used for any conditions other than those listed above, the device must be coded with HCPCS code V2531(CONTACT LENS, SCLERAL, GAS PERMEABLE, PER LENS (FOR CONTACT LENS MODIFICATION, SEE 92325))and is subject to the Medicare refractive lens statutory coverage exclusion.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Facial Prostheses - Policy Article, A52463

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CMS National Coverage PolicyN/AArticle TextNONMEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Facial prostheses are covered under the Medicare Artificial Legs, Arms and Eyes benefit (Social Security Act 1861(s)(9)). In order for a beneficiary to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition to meeting the benefit policy, there are specific statutory payment policy requirements, discussed below, that also must be met.Adhesives, adhesive remover, skin barrier wipes, and tape used in conjunction with a facial prosthesis are covered.The following services and items are included in the allowance for a facial prosthesis and, therefore, are not separately billable to or payable by Medicare under the prosthetic device benefit:Evaluation of the beneficiaryPre-operative planningCost of materialsLabor involved in the fabrication and fitting of the prosthesisModifications to the prosthesis made at the time delivery of the prosthesis or within 90 days thereafterRepair due to normal wear or tear within 90 days of deliveryFollow-up visits within 90 days of delivery of the prosthesisModifications to a prosthesis are separately payable when they occur more than 90 days after delivery of the prosthesis and they are required because of a change in the beneficiarys condition.Repairs are covered when there has been accidental damage or extensive wear to the prosthesis that can be repaired. If the expense for repairs exceeds the estimated expense for a replacement prosthesis, no payments can be made for the amount of the excess.Follow-up visits which occur more than 90 days after delivery and which do not involve modification or repair of the prosthesis are noncovered services.Replacement of a facial prosthesis is covered in cases of loss or irreparable damage or wear or when required because of a change in the beneficiarys condition that cannot be accommodated by modification of the existing prosthesis. When replacement involves a new impression/moulage rather than use of a previous master model, the reason for the new impression/moulage must be clearly documented in the supplier's records and available upon request.Physicians who are enrolled as a DMEPOS supplier are to submit claims for facial prostheses provided in an office or nursing home setting by nonphysicians or physicians to the DME MAC.Claims for facial prostheses provided in an outpatient hospital setting are submitted to the applicable A/B MAC. Facial prostheses provided in an inpatient hospital setting are included in the payment made to the hospital; and, therefore should not be submitted to the DME MAC.Claims for implanted components (e.g., titanium studs, magnets, etc.) and procedures used to affix the external facial prosthesis to the beneficiary are not the jurisdiction of the DME MAC. Claims for these items and services will be denied as wrong jurisdiction.If an ocular prosthesis is dispensed to the beneficiary as an integral part of a facial prosthesis, the ocular prosthesis component must be billed by the supplier of the facial prosthesis. (For information on ocular prostheses that are not part of orbital prostheses, refer to the Eye Prostheses LCD.)Skin care products related to the prosthesis, including but not limited to cosmetics, skin cream, cleansers, etc., are noncovered.Claims for tape and adhesive (A4450, A4452, A5120) that are billed without an AV modifier or another modifier indicating coverage under a different policy will be rejected as missing information.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.When either code V2629 or L8048 is billed, the claim must be accompanied by a brief description of the item in the narrative field. When L8048 is provided, a drawing/photograph of the item provided must be available upon request.The treating practitioner's records must contain information which supports the medical necessity of the item ordered. The prosthetists documentation of the necessity for a replacement prosthesis is appropriate documentation for that claim if the replacement is necessitated by other than medical reasons.MODIFIERSAV, KM, KN, RT and LT MODIFIERS:Claims for tape and adhesive (A4450, A4452, A5120) that are submitted without AV modifier will be rejected as missing information.When a replacement prosthesis is fabricated starting with a new impression/moulage, the KM modifier should be added to the code. When a replacement prosthesis is fabricated using a previous master model, the KN modifier should be added to the code.The right (RT) and/or left (LT) modifiers must be used with facial prosthesis codes when applicable. Effective for claims with dates of service (DOS) on or after 3/1/2019, if bilateral prostheses using the same code are billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed with codes L8042, L8043 and L8045, L8046, without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.CODING GUIDELINESCodes for a facial prosthesis (L8040, L8041, L8042, L8043, L8044, L8045, L8046, L8047) describe a complete prosthesis, except as noted below for the use of code L8048 (UNSPECIFIED MAXILLOFACIAL PROSTHESIS, BY REPORT, PROVIDED BY A NON-PHYSICIAN).A nasal prosthesis (L8040) is a removable superficial prosthesis, which restores all or part of the nose. It may include the nasal septum.A midfacial prosthesis (L8041) is a removable superficial prosthesis, which restores part or all of the nose plus significant adjacent facial tissue/structures, but does not include the orbit or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek, upper lip, or forehead.An orbital prosthesis (L8042) is a removable superficial prosthesis, which restores the eyelids and the hard and soft tissue of the orbit. It may also include the eyebrow. This code does not include the ocular prosthesis component.An upper facial prosthesis (L8043) is a removable superficial prosthesis, which restores the orbit plus significant adjacent facial tissue/structures, but does not include the nose or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek or forehead. This code does not include the ocular prosthesis component.A hemi-facial prosthesis (L8044) is a removable superficial prosthesis, which restores part or all of the nose plus the orbit plus significant adjacent facial tissue/structures, but does not include any intraoral maxillary component. This code does not include the ocular prosthesis component.An auricular prosthesis (L8045) is a removable superficial prosthesis, which restores all or part of the ear.A partial facial prosthesis (L8046) is a removable superficial prosthesis which restores a portion of the face but which does not specifically involve the nose, orbit, or ear.A nasal septal prosthesis (L8047) is a removable prosthesis, which occludes a hole in the nasal septum but does not include superficial nasal tissue.Code L8048 is a miscellaneous code. There are limited scenarios where the use of miscellaneous code L8048 is appropriate:If a facial prosthesis is not described by a specific code, L8040, L8041, L8042, L8043, L8044, L8045, L8046, or L8047.If a facial prosthesis has a component which is used to attach it to a bone-anchored implant or to an internal prosthesis (e.g., maxillary obturator), that component should be billed separately using code L8048. This code should not be used for implanted prosthesis-anchoring components.Covered modifications or repairs are billed using code L8048 for any materials used and code L8049 for the labor components.Code V2623 describes an ocular prosthesis, which is custom fabricated.Code V2629 is used for an ocular prosthesis that is not custom fabricated (i.e., stock prosthesis).When a new ocular prosthesis component is provided as an integral part of an orbital, upper facial or hemi-facial prosthesis, it should be billed using code V2623 or V2629 on a separate claim line. When a replacement facial prosthesis utilizes an ocular component from the prior prosthesis, the ocular prosthesis code should not be billed.When a prosthesis is needed for adjacent facial regions, a single code must be used to bill for the item whenever possible. For example, if a defect involves the nose and orbit, this should be billed using the hemi-facial prosthesis code and not separate codes for the orbit and nose. This would apply even if the prosthesis is fabricated in two separate parts.When codes A4450, A4452 and A5120 are used with a facial prosthesis, they must be billed with the AV modifier. For this policy, codes A4450, A4452 and A5120 are the only codes for which the AV modifier may be used.Covered modifications or repairs are billed using code L8049 for the labor components and code L8048 for any materials used. Time reported using code L8049 should only be for laboratory modification/repair time and associated prosthetic evaluation used only for services after 90 days from the date of delivery of the prosthesis. Evaluation not associated with repair or modification is noncovered and should not be coded as L8049.Adhesives, adhesive remover, and tape used in conjunction with a facial prosthesis should be billed using codes A4364, A4455, A4456, A4450, or A4452. The unit of service is specified for each code. For tape, one unit of service is 18 square inches. Therefore, a roll of tape 1/2" X 3 yds. would be 3 units; 1" x 3 yds. would be 6 units. Other skin care products related to the prosthesis should generally not be billed; but, if they are billed at the beneficiary's request, code A9270 (noncovered item or service) should be used.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Glucose Monitor - Policy Article, A52464

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Article - Glucose Monitor - Policy Article (A52464)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Home blood glucose monitors (BGMs) and continuous glucose monitors (CGMs) are covered under the Durable Medical Equipment (DME) benefit [Social Security Act 1861(s)(6)]. In order for a beneficiarys DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Effective for claims with dates of service on or after January 12, 2017, Medicare began coverage of therapeutic (non-adjunctive) CGM devices under the DME benefit. CGM devices covered by Medicare were defined in CMS Ruling 1682R as therapeutic (non-adjunctive) CGMs.A non-adjunctive CGM can be used to make treatment decisions without the need for a stand-alone BGM to confirm testing results. An adjunctive CGM requires the user verify their glucose levels or trends displayed on a CGM with a BGM prior to making treatment decisions. On February 28, 2022, CMS determined that both non-adjunctive and adjunctive CGMs may be classified as DME. CGM devices that solely display results on a smartphone and do not have a stand-alone receiver or integration into an insulin infusion pump do not meet the definition of DME and will be denied as non-covered (no benefit).The supply allowance for supplies used with a CGM system (A4238, A4239) encompassesall itemsnecessary for the use of the device and includes but is not limited to, CGM sensors and transmitters. For non-adjunctive CGMs, the supply allowance (A4239) also includes a home BGM and related supplies (test strips, lancets, lancing device, calibration solution, and batteries), if necessary. Supplies or accessories billed separately will be denied as unbundling.For adjunctive CGMs, the supply allowance (A4238) encompassesall itemsnecessary for the use of the device and includes but is not limited to, CGM sensors and transmitters. Separate billing of CGM sensors and transmitters will be denied as unbundling. Code A4238 does not include a home BGM (HCPCS codes E0607, E2100, E2101) and related BGM testing supplies (HCPCS codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259). These items may be billed separately, in addition to code A4238.Coverage of a CGM system supply allowance (code A4238 or A4239) is available for CGM systems when the beneficiary uses a stand-alone receiver or insulin infusion pump classified as DME to display glucose data. In addition, Medicare coverage is available for a CGM system supply allowance if a non-DME device (watch, smartphone, tablet, laptop computer, etc.) is usedin conjunctionwith the durable CGM receiver (code E2102 or E2103). The following are examples of this provision:Medicare coverage of a CGM supply allowance is available when a beneficiary uses a durable CGM receiver to display their glucose data and also transmits that data to a caregiver through a smart phone or other non-DME receiver.Medicare coverage of a CGM system supply allowance is available when a beneficiary uses a durable CGM receiver on some days to review their glucose data but uses a non-DME device on other days.If a beneficiary never uses a DME receiver or insulin infusion pump to display CGM glucose data, the supply allowance is not covered by Medicare.Smart devices are non-covered by Medicare because they do not meet the definition of DME (i.e., not primarily medical in nature and are useful in the absence of illness). Claims for smart devices must be billed using code A9270 (non-covered item or service).To be eligible for Medicare reimbursement, all CGM devices billed as E2103 must have received coding verification review by the Pricing, Data Analysis and Coding (PDAC) contractor and be listed on the Product Classification List (PCL) for HCPCS code E2103. Effective July 1, 2022, all CGMs billed to Medicare using HCPCS code E2102 must have received coding verification review by the PDAC contractor and be listed on the PCL for HCPCS code E2102. If a CGM system is billed using HCPCS E2102 or E2103 but the CGM system is not on the PCL for the particular HCPCS code, then the claim will be denied as incorrect coding. Products reviewed by the PDAC which do not meet the DME benefit category requirements must be coded as A9276, A9277, A9278, or A9279 and will be denied as non-covered (no Medicare Benefit). See the CODING GUIDELINES section below.Alcohol or peroxide (codes A4244, A4245), betadine or hexachlorophene (pHisohex) (codes A4246, A4247) are non-covered since these items are not required for the proper functioning of the device.Urine test reagent strips or tablets (code A4250) are non-covered since they are not used with a glucose monitor.Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for use in the home because their need for frequent professional re-calibration makes them unsuitable for home use.Glucose monitors that are not designed for use in the home must be coded A9270 and will be denied as statutorily non-covered (no benefit category).Home blood glucose disposable monitors, including test strips (code A9275) are non-covered because these monitors do not meet the definition of DME.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFINAL RULE1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article (A55426), located at the bottom of this Policy Article under the Related Local Coverage Documents section, for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.For beneficiaries who exceed the usual utilization amounts of BGM testing supplies, there must be sufficient information in the beneficiarys medical record to determine that:The treating practitioner has had an in-person or Medicare-approved telehealth visit to evaluate the beneficiarys diabetes control; and,The specific quantities of supplies ordered are reasonable and necessary; and,The beneficiary is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed (e.g., a specific narrative statement that adequately documents the frequency at which the beneficiary is actually testing or a copy of the beneficiary's log).For the in-person or Medicare-approved telehealth treating practitioner visit that is required as part of the initial provision of a CGM, there must be sufficient information in the beneficiarys medical record to determine that the beneficiary has diabetes mellitus (criterion 1), the beneficiary (or the beneficiary's caregiver) has received appropriate training in the use of the device as evidenced by a prescription(criterion 2), the CGM is being prescribed in accordance with FDA indications for use (criterion 3), and the CGM is being prescribed to improve glycemic control for a beneficiary who is insulin treated or has a history of problematic hypoglycemia (criterion 4).For criterion 4B, the treating practitioners medical record must document the beneficiary has a history of problematic hypoglycemia consistent with one of the following pathways to coverage:Beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 hypoglycemic eventsThe treating practitioner must document at least one of the following in the medical record for each event:The glucose values for the qualifying event(s)(glucose <54mg/dL (3.0mmol/L)); or,Classification of the hypoglycemic episode(s) as level 2 event(s); or,Incorporate a copy of the beneficiarys BGM testing log into the medical record reflecting the specific qualifying events(glucose <54mg/dL (3.0mmol/L)); and,Documentation of more than one previous medication adjustment and/or modification to the treatment plan (such as raising A1c targets) prior to the most recent level two event.Beneficiaries with non-insulin treated diabetes and a history of at least one level 3 hypoglycemic eventThe treating practitioner must document at least one of the following in the medical record:The glucose value for the qualifying event(glucose <54mg/dL (3.0mmol/L)); or,Classification of the hypoglycemic episode as level 3 event; or,Incorporate a copy of the beneficiarys BGM testing log into the medical record reflecting the specific qualifying event(glucose <54mg/dL (3.0mmol/L)); and,An indication in the medical record that the beneficiary required third party assistance for treatment.For the in-person or Medicare-approved telehealth treating practitioner visit that is required as part of the ongoing provision of a CGM, there must be sufficient information in the beneficiarys medical record to determine that the beneficiary continues to adhere to their diabetes treatment regimen and use of the CGM device.MODIFIERSCG, KF, KS and KX MODIFIERS:For blood glucose monitors (codes E0607, E2100, E2101) and related supplies (codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259) and CGM devices (code E2102 or E2103) and supply allowance (code A4238 or A4239), the following modifiers must be added to the code(s) on every claim submitted:Use modifier KX if the beneficiary is insulin treated; or,Use modifier KS if the beneficiary is non-insulin treated.

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An indication in the medical record that the beneficiary required third party assistance for treatment.For the in-person or Medicare-approved telehealth treating practitioner visit that is required as part of the ongoing provision of a CGM, there must be sufficient information in the beneficiarys medical record to determine that the beneficiary continues to adhere to their diabetes treatment regimen and use of the CGM device.MODIFIERSCG, KF, KS and KX MODIFIERS:For blood glucose monitors (codes E0607, E2100, E2101) and related supplies (codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259) and CGM devices (code E2102 or E2103) and supply allowance (code A4238 or A4239), the following modifiers must be added to the code(s) on every claim submitted:Use modifier KX if the beneficiary is insulin treated; or,Use modifier KS if the beneficiary is non-insulin treated.The KX modifier must not be used for a beneficiary who isexclusively treated with oral hypoglycemic agents.For initial coverage of non-adjunctive CGM devices (code E2103) and the supply allowance (code A4239) the CG modifier must be added to the claim line only if all of the CGM coverage criteria (1)-(5) in the Glucose Monitors LCD are met.For continued coverage of non-adjunctive CGM devices (code E2103) and the supply allowance (code A4239) the CG modifier must be added to the claim line only if the continued coverage criterion in the Glucose Monitors LCD is met. If any of the coverage criteria are not met, the CG modifier must not be used.The CG modifier must be added to the claim line for an adjunctive CGM (E2102) incorporated into an insulin infusion pump and supply allowance (code A4238) only if all of the initial CGM coverage criteria (1)-(5) in the Glucose Monitors LCD and the coverage criteria for an insulin infusion pump as outlined in the External Infusion Pumps LCD (L33794) are met. For continued coverage of adjunctive CGM devices incorporated into an insulin infusion pump (code E2102) and the supply allowance (code A4238), the CG modifier must be added to the claim line only if the continued coverage criteria in the Glucose Monitors LCD and the External Infusion Pumps LCD are met. If any of the coverage criteria are not met, the CG modifier must not be used.CGMs (E2102 and E2103) and related supplies (A4238 and A4239) which are classified by the Food & Drug Administration as Class III devices must include the KF modifier.CODING GUIDELINESFor claims with dates of service on or after July 1, 2017, through December 31, 2022, a non-adjunctive CGM must be billed with code K0554 and code K0553 for the supply allowance. For claims with dates of service on or after January 1, 2023, a non-adjunctive CGM must be billed with code E2103 and code A4239 for the supply allowance. Code E2103 or K0554 describes a non-adjunctive CGM that meets the requirements of the DME benefit.For claims with dates of service on or before March 31, 2022, adjunctive CGMs which meet the definition of DME must be billed with code E1399. For claims with dates of service on or after April 1, 2022, adjunctive CGMs which meet the definition of DME must be billed with code E2102. There are currently no stand-alone adjunctive CGMs on the United States (US) market which meet the definition of DME (as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section). However, there are adjunctive CGMs incorporated into an insulin infusion pump on the US market which may meet the definition of DME. Refer to the External Infusion Pumps LCD (L33794) for additional information on billing a CGM receiver incorporated into an insulin infusion pump.For claims with dates of service on or before March 31, 2022, adjunctive CGM disposable supplies which fall under the DME benefit (as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section) must be billed with code A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED) for the supply allowance. When submitting a claim for A9999, suppliers must enter adjunctive in loop 2300 (claim note) and/or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI X12N, version 5010A1 professional electronic claim format or in Item 19 of the paper claim form, so that the items can be identified as adjunctive CGM supplies and accessories when processing the claim.For claims with dates of service on or after April 1, 2022, adjunctive CGM disposable supplies which fall under the DME benefit (as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section) must be billed with code A4238 for the supply allowance.The CGM supply allowance includesall itemsnecessary for the use of the device and includes, but is not limited to, CGM sensors and transmitters. For non-adjunctive CGMs, the supply allowance (A4239) also includes a home BGM and related supplies (test strips, lancets, lancing device, calibration solution, and batteries), if necessary. Supplies used with a non-covered CGM are considered non-covered (no Medicare benefit) and must not be billed using HCPCS code A4238 or A4239.A supplier does not have to deliver supplies used with a CGM every month in order to bill code A4238 or A4239 every month. In order to bill code A4238 or A4239, the supplier must have previously delivered quantities of supplies that are sufficient to last for one (1) full month, thirty (30) days, following the DOS on the claim. Suppliers must monitor usage of supplies. Billing for code A4238 or A4239 may continue on a monthly basis as long as sufficient supplies remain to last for one (1) full month, thirty (30) days, as previously described. If there are insufficient supplies to be able to last for one (1) full month, thirty (30) days, additional supplies must be provided before the supply allowance is billed.Up to a maximum of three (3) months, ninety (90) days of the supply allowance may be billed for code A4238 or A4239 to the DME MAC at a time and suppliers may not dispense more than a ninety (90) day supply.For dates of service prior to April 1, 2022, and dates of service on or after January 1, 2023, codes A9276 (SENSOR; INVASIVE (E.G., SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLY) and A9277 (TRANSMITTER; EXTERNAL, FOR USE WITH NON-DURABLE MEDICAL EQUIPMENT INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM) describe the supplies used with a CGM that does not meet the definition of DME. Codes A9276 and A9277 are not used to bill for supplies used with a non-adjunctive CGM (E2103) or for adjunctive CGM supplies furnished in conjunction with an insulin infusion pump used as a CGM receiver.For dates of service prior to April 1, 2022, and dates of service on or after January 1, 2023, code A9278 (RECEIVER (MONITOR); EXTERNAL, FOR USE WITH NON-DURABLE MEDICAL EQUIPMENT INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM) describes any CGM system that fails to meet the DME Benefit requirements as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section.For dates of service between April 1, 2022, through December 31, 2022, code A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) is used to describe any CGM system and/or related supplies that fail to meet the DME benefit requirement as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section.Home BGMs (code E0607) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen and may be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.BGMs with integrated voice synthesizers (code E2100) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen but are also digitized and converted to sound output. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.BGMs with integrated lancing and/or blood sampling (code E2101) are devices that measure capillary whole blood for determination of blood glucose levels. The lancing device for obtaining the capillary blood sample is integrated into the glucose monitor rather than a separate accessory. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.Code A4256 describes control solutions containing high, normal, and low concentrations of glucose that can be applied to test strips to check the integrity of the test strips. This code does not describe the strip or chip which is included in a vial of test strips and which calibrates the glucose monitor to that particular vial of test strips.A laser skin lancing device (code E0620) uses laser technology to pierce the skin in order to obtain capillary blood for use in home blood glucose monitors.For glucose test strips (code A4253), 1 unit of service = 50 strips. For lancets (code A4259), 1 unit of service = 100 lancets.Blood glucose test or reagent strips that use a visual reading and are not used in a glucose monitor must be coded A9270 (non-covered item or service). Do not use code A4253 for these items.With the exception of batteries (see below), suppliers may bill test strips, lancing devices, lancets and other glucose monitor supplies with the initial issue of a glucose monitor.In the following table, a Column II code is included in the allowance for the corresponding Column I code when provided at the same time.Column IColumn IIE0607A4233, A4234, A4235, A4236E2100A4233, A4234, A4235, A4236E2101A4233, A4234, A4235, A4236E2103E0607, E2100, E2101, A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259Suppliers should contact the PDAC contractor for guidance on the correct coding of items addressed in this policy.

Local Coverage Articles, Knee Orthoses - Policy Article, A52465

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).For a beneficiarys orthosis to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Knee orthoses (KO) are covered under the Medicare braces benefit (Social Security Act 1861(s)(9)). For coverage under this benefit, the orthosis must be a rigid or semi-rigid device, which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. Items that are not sufficiently rigid to be capable of providing the necessary immobilization or support to the body part for which it is designed do not meet the statutory definition of the braces benefit. Items that do not meet the definition of a brace are statutorily noncovered, no benefit.Both off-the-shelf (OTS) and custom-fit items are considered prefabricated braces for Medicare coding purposes. 42 CFR 414.402 establishes that correct coding of KO items is dependent upon whether there is a need for minimal self-adjustment during the final fitting at the time of delivery. (See definitions below in CODING GUIDELINES.)If a custom fit code is billed when minimalself-adjustment was provided at the final delivery, or if an OTS code is billed when more than minimal self-adjustments were made at the final delivery, the claim will be denied as incorrect coding.Elastic or other fabric support garments (A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE)) with or without stays or panels do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices. Code A4467 is denied as noncovered (no Medicare benefit). Refer to the CODING GUIDELINES section below for additional information.There is no separate payment for computer-aided design/computer-aided manufacturing (CAD/CAM) technology when it is used to fabricate an orthosis. Reimbursement, of the CAD/CAM technology utilized in the fabrication of an orthosis, is included in the allowance of the orthosis HCPCS code.Evaluation of the beneficiary, measurement and/or casting, and fitting/adjustments of the orthosis are included in the allowance for the orthosis. There is no separate payment for these services.Payment for knee orthoses are included in the payment to a hospital or skilled nursing facility (SNF) if:The orthosis is provided to a beneficiary prior to an inpatient hospital admission or Part A covered SNF stay; andThe medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after knee surgery).A claim should not be submitted to the DME MAC in this situation.Payment for knee orthoses are also included in the payment to a hospital or a Part A covered SNF stay if:The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; andThe beneficiary uses the item for medically necessary inpatient treatment or rehabilitation.A claim must not be submitted to the DME MAC in this situation.Payment for knee orthoses delivered to a beneficiary in a hospital or a Part A covered SNF stay is eligible for coverage by the DME MAC if:The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; andThe orthosis is provided to the beneficiary within two days prior to discharge to home; andThe orthosis is not needed for inpatient treatment or rehabilitation but is left in the room for the beneficiary to take home.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFINAL RULE1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter andWritten Order Prior to DeliveryList is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.General RequirementsThe supplier must include on the claim line the diagnosis code(s) for HCPCS codes L1830, L1831, L1832, L1833, L1834, L1836, L1840, L1843, L1844, L1845, L1846, L1850, L1851, L1852 and L1860.For a custom-fabricated orthosis, there must be documentation in the supplier's records to support the medical necessity of that type of device rather than a prefabricated orthosis. This information must be available upon request.When providing orthoses suppliers must:Provide the product that is specified by the treating practitionerBe sure that the treating practitioners medical record justifies the need for the type of product (i.e., prefabricated versus custom fabricated)Only bill for the HCPCS code that accurately reflects both the type of orthosis and the appropriate level of fittingHave detailed documentation in supplier's records that justifies the code selectedFor prefabricated orthoses (L1810, L1812, L1820, L1830, L1831, L1832, L1833, L1836, L1843, L1845, L1847, L1848, L1850, L1851, L1852), there is no physical difference between orthoses coded as custom fitted versus those coded as OTS. The differentiating factor for proper coding (see definitions in the CODING GUIDELINES section below) is the need for minimal self-adjustment at the time of fitting by the beneficiary, caretaker for the beneficiary, or supplier. This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training (as defined in the CODING GUIDELINES section). Items requiring minimal self-adjustment are coded as OTS orthoses. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.Items requiring more than minimal self-adjustment by a qualified practitioner (as defined in the CODING GUIDELINES below) are coded as custom fitted (L1810, L1832, L1843, L1845, L1847). Documentation must be sufficiently detailed to include, but is not limited to, a detailed description of the modifications necessary at the time of fitting the orthosis to the beneficiary. This information must be available upon request.For custom fabricated orthoses (L1834, L1840, L1844, L1846, L1860), there must be detailed documentation in the treating practitioners records to support the medical necessity of the custom fabricated orthosis rather than a prefabricated orthosis as described in the "Coverage Indications, Limitations, and/or Medical Necessity" section of the related LCD. This information will be corroborated by the functional evaluation in the orthotists records and the method of custom fabrication should adhere to the DMEPOS Quality Standards, Appendix C. This information must be available upon request.MODIFIERSKX, GA, GZ, LT and RT MODIFIERS:Suppliers must add a KX modifier to the KO base and addition codes only if all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request.If all of the criteria in the "Coverage Indications, Limitations, and/or Medical Necessity" section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claims lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.The right (RT) and/or left (LT) modifiers must be used when billing for orthosis base codes, additions and replacement parts. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for bilateral items (left and right) is billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.MISCELLANEOUSIf the item is custom fabricated and does not have a specific HCPCS code, a complete and clear description of the item, including what makes this item unique, and a breakdown of charges (material and labor used in fabrication) should be entered in the narrative field of an electronic claim or on Item 19 of a paper claim. (Refer to the LCD-related Standard Documentation Requirements article (A55426) for more information regarding billing of items with HCPCS codes that include miscellaneous, NOC, unlisted, or non-specified in their narrative descriptions.)A claim for code L4205 must include an explanation of what is being repaired. A claim for code L4210 must include a description of each item that is billed. This information should be entered in the narrative field of an electronic claim. (Refer to the REPAIR/REPLACEMENT section for more information regarding billing of L4205 and L4210 HCPCS codes.)All codes for orthoses or repairs of orthoses billed with the same date of service must be submitted on the same claim.CODING GUIDELINES:CUSTOM FABRICATEDA custom fabricated item is one that is individually made for a specific patient. No other patient would be able to use this item. A custom fabricated item is a device which is fabricated based on clinically derived and rectified castings, tracings, measurements, and/or other images (such as X-rays) of the body part.The fabrication may involve using calculations, templates, and components. This process requires the use of basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of uncut or unshaped sheets, bars, or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, and finishing prior to fitting on the patient. Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics.Use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated.Molded-to-Patient-ModelA particular type of custom fabricated device in which either:An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; orA digital image of the patients body part is made using CAD/CAM systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.Positive Model of the PatientA positive model is an exact replica of the actual body part for which the custom fabricated item is being constructed. A positive model can be produced by any of these methods:Molded-to-patient-model, which is a negative impression taken of the patients body member and which is used to make a positive model rectification.CAD/CAM software, which uses digitizers to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the modified shape goes to a commercial milling machine that carves the rectified model.

Local Coverage Articles, Knee Orthoses - Policy Article, A52465

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Molded-to-Patient-ModelA particular type of custom fabricated device in which either:An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; orA digital image of the patients body part is made using CAD/CAM systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.Positive Model of the PatientA positive model is an exact replica of the actual body part for which the custom fabricated item is being constructed. A positive model can be produced by any of these methods:Molded-to-patient-model, which is a negative impression taken of the patients body member and which is used to make a positive model rectification.CAD/CAM software, which uses digitizers to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the modified shape goes to a commercial milling machine that carves the rectified model.Direct formed model, in which the patient serves as the positive model. The device is constructed over the patient's model, and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made.Additive ManufacturingAdditive manufacturing (such as 3D printing) is an advanced technology that constructs three-dimensional items modeled and designed from CAD software and/or from digital scanning. Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C.Specialized TrainingSpecialized training is defined as training that provides the knowledge, skills, and experience in theprovision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements.PREFABRICATEDA prefabricated orthosis is an item that is manufactured in quantity without a specific beneficiary in mind. A prefabricated orthosis may be considered an OTS or a custom fitted device that may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific beneficiary. An orthosis that is assembled from prefabricated components is considered prefabricated. It is inherent in the definition of prefabricated that a particular item is complete.Off-the-shelf (OTS) orthotics are:Items that are prefabricated.They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual.This fitting does not require expertise of a certified orthotist or an individual who has specialized training in the provision of orthoses to fit the item to the individual beneficiary.The term minimal self-adjustment is defined at 42 CFR 414.402 as an adjustment the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. See more than minimal self-adjustment definition below for additional information.Custom fitted orthotics are:Devices that are prefabricated.They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.Classification as custom fitted requiresmore than minimal self-adjustmentat the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.This fitting at delivery does require expertise of a certified orthotist or an individual who has specialized training in the provision of the orthosis to fit the item to the individual beneficiary.In contrast to "minimal self-adjustment,""more than minimalself-adjustment"is defined as changes made to achieve an individualized fit during the final fittingat the time of delivery of the itemthat requires the expertise of a certified orthotist or an individual who has specialized training in the provision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements.A certified orthotist is defined as an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification.Correct coding of prefabricated orthoses is dictated by actions that take place at the time of fitting to the beneficiary, either custom fitted (requiring expertise) or OTS (requiring minimal self-adjustment).Corresponding HCPCS Code SetsFor many prefabricated orthoses, corresponding sets of HCPCS codes are available which describe the identical types of items. The corresponding code sets, when available for identical products, are only differentiated by the nature of the final fitting performed at the time of delivery. The corresponding HCPCS code types are:HCPCS codes which describe PREFABRICATED, OFF-THE-SHELF. These HCPCS codes must be used when minimal self-adjustment is the extent of the fitting performed at delivery.HCPCS codes which describe PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE. These HCPCS codes must be used whenmore than minimal self-adjustmentis necessary and performed at delivery.In the following table, the HCPCS codes located in Column I and Column II within the same row are considered a corresponding HCPCS code set. These codes represent identical products which are only differentiated by the nature of the final fitting performed at the time of delivery.Column IColumn IIL1810L1812L1832L1833L1843L1851L1845L1852L1847L1848For some prefabricated orthoses, corresponding sets of HCPCS codes (which describe the identical types of items) are not available. HCPCS codes with long descriptions of PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT describe custom fitted items. For these HCPCS codes there are no corresponding OTS codes. When the unique HCPCS code that most closely describes the product includes PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT in the HCPCS long description, the supplier must:Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary; or,Code the product using a miscellaneous HCPCS code, if the product was not custom fitted at delivery to the beneficiary and, instead, was provided as OTS to the beneficiary. The miscellaneous HCPCS code for billing of KOs is HCPCS code L2999.Kits are:A collection of components, materials, and parts that require further assembly before delivery of the final product.The elements of a kit may be packaged and complete from a single source or may be an assemblage of separate components from multiple sources by the supplier.ELASTIC AND SIMILAR STRETCHABLE MATERIALSFor items where the HCPCS code specifies elastic or other similar terminology for stretchable material, use the code that is most applicable to the item. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS code.For items where the HCPCS code does not specify elastic or other similar terminology for stretchable material, the following guidelines apply:Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra) (not all-inclusive)) must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra) (not all-inclusive)) that contain stays and/or panels must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS code.Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and relevant coding guideline for the criteria applicable for each HCPCS code.Items that are not capable of providing the necessary immobilization or support to the body part for which it is designed (regardless of materials) must be coded using A9270 (NON-COVERED ITEM OR SERVICE).

Local Coverage Articles, Knee Orthoses - Policy Article, A52465

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Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS code.Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and relevant coding guideline for the criteria applicable for each HCPCS code.Items that are not capable of providing the necessary immobilization or support to the body part for which it is designed (regardless of materials) must be coded using A9270 (NON-COVERED ITEM OR SERVICE).KNEE ORTHOSESCodes L1810 (KNEE ORTHOSIS, ELASTIC WITH JOINTS, PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE) and L1812 (KNEE ORTHOSIS, ELASTIC WITH JOINTS, PREFABRICATED, OFF-THE-SHELF) describe prefabricated knee orthoses constructed of latex, neoprene, spandex or other elastic material. There are no condylar pads. There are hinges or joints.Code L1820 (KNEE ORTHOSIS, ELASTIC WITH CONDYLAR PADS AND JOINTS, WITH OR WITHOUT PATELLAR CONTROL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT) describes a prefabricated knee orthosis with hinges or joints, constructed of latex, neoprene, spandex or other elastic material. There are medial and lateral condylar pads.Code L1830 (KNEE ORTHOSIS, IMMOBILIZER, CANVAS LONGITUDINAL, PREFABRICATED, OFF-THE-SHELF) describes a prefabricated knee orthosis immobilizer, with rigid metal or plastic stays placed laterally and posteriorly. The interface material is constructed of canvas, closed cell foam or equal. The thigh and calf cuffs are one-piece construction held in place by Velcrostraps or equal. The orthosis immobilizes the knee joint and prevents flexion or extension. There are no hinges or joints.Codes L1831 (KNEE ORTHOSIS, LOCKING KNEE JOINT(S), POSITIONAL ORTHOSIS, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT), L1847 (KNEE ORTHOSIS, DOUBLE UPRIGHT WITH ADJUSTABLE JOINT, WITH INFLATABLE AIR SUPPLY CHAMBER(S), PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE) and L1848 (KNEE ORTHOSIS, DOUBLE UPRIGHT WITH ADJUSTABLE JOINT, WITH INFLATABLE AIR SUPPLY CHAMBER(S), PREFABRICATED, OFF-THE-SHELF) describe prefabricated knee orthoses with joint(s) which lock the knee into a particular position. Codes L1847 and L1848 are distinguished from L1831 by the addition of an air bladder in the space behind the knee. These orthoses are designed for beneficiaries who are nonambulatory. They are typically used to treat flexion/extension contractures of the knee.An adjustable flexion and extension joint is one that enables the practitioner to set limits on flexion and extension but allows the beneficiary free motion of the knee within those limits. The increments of adjustability must be, at a minimum, 15 degrees. The joint may be either unicentric or polycentric.Codes L1832 (KNEE ORTHOSIS, ADJUSTABLE KNEE JOINTS (UNICENTRIC OR POLYCENTRIC), POSITIONAL ORTHOSIS, RIGID SUPPORT, PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE) and L1833 (KNEE ORTHOSIS, ADJUSTABLE KNEE JOINTS (UNICENTRIC OR POLYCENTRIC), POSITIONAL ORTHOSIS, RIGID SUPPORT, PREFABRICATED, OFF-THE-SHELF) describe prefabricated knee orthoses that have double uprights and adjustable flexion and extension joints. Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. They may have condylar pads. These orthoses are designed for a beneficiary who can bear weight on the knee and is capable of ambulation. They are typically used for early rehabilitation following knee surgery.Codes L1834 (KNEE ORTHOSIS, WITHOUT KNEE JOINT, RIGID, MOLDED TO PATIENT MODEL, CUSTOM-FABRICATED) and L1836 (KNEE ORTHOSIS, RIGID, WITHOUT JOINT(S), INCLUDES SOFT INTERFACE MATERIAL, PREFABRICATED, OFF-THE-SHELF) describe rigid knee orthoses without a knee joint. Both are designed to prevent knee motion. These orthoses are designed for beneficiaries who can bear weight on the knee, are capable of ambulating, and need additional support provided through immobilization of the knee joint. Code L1834 refers to a custom fabricated knee orthotic while L1836 refers to one that is pre-fabricated.Code L1840 (KNEE ORTHOSIS, DEROTATION, MEDIAL-LATERAL, ANTERIOR CRUCIATE LIGAMENT, CUSTOM-FABRICATED) describes a custom fabricated knee orthosis with knee joints designed to protect the ligaments of the knee through medial-lateral torsion, providing stability and preventing rotation.Codes L1843 (KNEE ORTHOSIS, SINGLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE), L1844 (KNEE ORTHOSIS, SINGLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, CUSTOM FABRICATED ), and L1851 (KNEE ORTHOSIS, SINGLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, PREFABRICATED, OFF-THE-SHELF) describe prefabricated and custom fabricated knee orthoses which are constructed of rigid thigh and calf cuffs and a single upright with an adjustable flexion and extension knee joint. These orthoses must have condylar pads. Through a series of straps/supports that cross over and around the knee joint, rotational control and varus or valgus force is exerted on the knee joint. These orthoses are designed to open the medial or lateral compartment of the knee to provide pain relief due to osteoarthritis. These orthoses are designed for beneficiaries who are fully ambulatory.Codes L1845 (KNEE ORTHOSIS, DOUBLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE), L1846 (KNEE ORTHOSIS, DOUBLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, CUSTOM FABRICATED), and L1852 (KNEE ORTHOSIS, DOUBLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, PREFABRICATED, OFF-THE-SHELF) describe prefabricated and custom fabricated knee orthoses that have double uprights, condylar pads, and an adjustable flexion and extension joint and provide both medial-lateral and rotation control. Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. Rotation control is accomplished by the combination of (1) solid metal (or similar material) in the anterior or posterior portion of the thigh and calf cuffs and (2) the condylar pads. These orthoses are designed for beneficiaries who are fully ambulatory.Code L1850 (KNEE ORTHOSIS, SWEDISH TYPE, PREFABRICATED, OFF-THE-SHELF) describes a prefabricated knee orthosis with double uprights and thigh and calf pads. It may or may not have joints. These orthoses are used to prevent hyperextension of the knee joint in ambulatory beneficiaries.Code L1860 (KNEE ORTHOSIS, MODIFICATION OF SUPRACONDYLAR PROSTHETIC SOCKET, CUSTOM-FABRICATED (SK)) describes a custom fabricated knee orthosis without joints, constructed of plastic or other similar material. These orthoses are used to prevent hyperextension of the knee joint in ambulatory beneficiaries.LOWER EXTREMITY ADDITIONSCustom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics unless a product has been previously assigned an addition code per PDAC/CMS prior to 1/1/2023. Correct coding with use of addition codes should not include, or partially include, features or functions described by other codes billed for a specific device.Code L2755 (ADDITION TO LOWER EXTREMITY ORTHOSIS, HIGH STRENGTH, LIGHTWEIGHT MATERIAL, ALL HYBRID LAMINATION/PREPREG COMPOSITE, PER SEGMENT, FOR CUSTOM FABRICATED ORTHOSIS ONLY) describes an addition to a lower extremity orthosis composed of high strength and/or lightweight material such as Kevlar, carbon fiber or other laminated or impregnated composite material.Addition codes are grouped into four (4) categories in relation to knee orthosis base codes.Eligible for separate paymentNot reasonable and necessaryNot separately payableIncompatibleAddition codes in the first two categories are addressed in the related LCD. Addition codes that are not separately payable are addressed in the tables below.The following table lists addition codes which describe components or features that can be physically incorporated in thespecified prefabricated baseorthosisbut are considered to be included in the allowance for the orthosis.Base CodeAddition Codes - Not Separately PayableL1810L2390, L2750, L2780, L4002L1812L2390, L2750, L2780, L4002L1820L2390, L2750, L2780, L2810, L4002L1830K0672, L4002L1831K0672, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1832K0672, L2390, L2425, L2430, L2750, L2780, L2820, L2830, L4002L1833K0672, L2390, L2425, L2430, L2750, L2780, L2820, L2830, L4002L1836K0672, L2750, L2780, L2810, L2820, L2830, L4002L1843K0672, L2275, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1845K0672, L2275, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002

Local Coverage Articles, Knee Orthoses - Policy Article, A52465

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L1820L2390, L2750, L2780, L2810, L4002L1830K0672, L4002L1831K0672, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1832K0672, L2390, L2425, L2430, L2750, L2780, L2820, L2830, L4002L1833K0672, L2390, L2425, L2430, L2750, L2780, L2820, L2830, L4002L1836K0672, L2750, L2780, L2810, L2820, L2830, L4002L1843K0672, L2275, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1845K0672, L2275, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1847K0672, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1848K0672, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1850K0672, L2750, L2780, L2810, L2820, L2830, L4002L1851K0672, L2275, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1852K0672, L2275, L2390, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002The following table lists addition codes which describe components or features that can be physically incorporated in thespecified custom fabricated base orthosisbut are considered to be included in the allowance for the orthosis. The addition codes will be denied as not separately payable if they are billed with the related base code.Base CodeAddition Codes - Not Separately PayableL1834K0672, L2820, L2830, L4002L1840K0672, L2320, L2330, L2750, L2780, L2810, L2820, L2830, L4002L1844K0672, L2275, L2320, L2330, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1846K0672, L2275, L2320, L2330, L2425, L2430, L2750, L2780, L2810, L2820, L2830, L4002L1860K0672, L2820, L2830, L4002All addition codes that are not listed as either separately payable or not reasonable and necessary in the tables in the LCD or as not separately payable in the tables above, describe components or features that either cannot be physically incorporated in the specified base orthosis or whose narrative description is incompatible with base orthosis code (e.g., billing a prefabricated base code with an addition code which specifies that it is only used with custom fabricated orthoses). These incompatible addition codes will be rejected as incorrect coding.L-coded additions to knee orthoses (L2275, L2320, L2330, L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2492, L2750, L2755, L2780, L2785, L2795, L2800, L2810, L2820, L2830, K0672) will be denied as noncovered when the base orthosis is noncovered.A replacement removable soft interface for a knee orthosis is billed with code K0672 (ADDITION TO LOWER EXTREMITY ORTHOSIS, REMOVABLE SOFT INTERFACE, ALL COMPONENTS, REPLACEMENT ONLY, EACH). One unit of service includes all the components that are used at the same time on a single orthosis.Either a nonremovable soft interface, L2820 (ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, BELOW KNEE SECTION), L2830 (ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, ABOVE KNEE SECTION), or two (2) removable soft interfaces (K0672) are included in the allowance for a knee orthosis. Soft interfaces billed separately at the time of initial issue will be denied as not separately payable.Codes L2320 (ADDITION TO LOWER EXTREMITY, NON-MOLDED LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY) and L2330 (ADDITION TO LOWER EXTREMITY, LACER MOLDED TO PATIENT MODEL, FOR CUSTOM FABRICATED ORTHOSIS ONLY), non-molded and molded lacers, respectively, may only be billed as replacement items.CONCENTRIC TORSION JOINTSAll claims for devices that contain a concentric adjustable torsion style mechanism in the knee joint for any condition other than an assistive function to joint extension motion must be coded as durable medical equipment using code E1810 (DYNAMIC ADJUSTABLE KNEE EXTENSION/FLEXION DEVICE, INCLUDES SOFT INTERFACE MATERIAL). If a concentric adjustable torsion style mechanism in the knee joint is used solely to provide an assistive function for joint extension, it must be coded as L2999 (See the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD).Claims for devices that contain a concentric adjustable torsion style mechanism in the knee joint and that are being used to treat any condition other than an assistive function to joint extension motion are not covered under the braces benefit and will be denied as incorrect coding when billed using code L2999 (See the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD).REPAIR/REPLACEMENTCode L4205 (REPAIR OF ORTHOTIC DEVICE, LABOR COMPONENT, PER 15 MINUTES) may only be billed for time involved with the actual repair of an orthosis or for medically necessary adjustments made more than 90 days after delivery. Code L4205 must not be used to bill for time involved with other professional services including, but not limited to:Evaluating the beneficiaryTaking measurements, making a cast, making a model, use of CAD/CAMMaking modifications to a prefabricated item to fit it to the individual beneficiaryFollow-up visitsMaking adjustments at the time of or within 90 days after deliverySuppliers must distinguish between repair and replacement of an orthosis. When an orthotic is replaced, there is no separate billing for the above services because reimbursement for these services is included in the allowance for the replacement item.Repairs to a covered orthosis due to wear or to accidental damage are covered when they are necessary to make the orthosis functional. The reason for the repair must be documented in the supplier's record. If the expense for repairs exceeds the estimated expense of providing another entire orthosis, no payment will be made for the amount in excess.The allowance for the labor involved in replacing/repairing an orthotic component that is coded with a specific L-code is included in the allowance for that component. The allowance for the labor (L4205) involved in replacing/repairing an orthotic component that is coded with the miscellaneous code L4210 (REPAIR OF ORTHOTIC DEVICE, REPAIR OR REPLACE MINOR PARTS) is separately payable in addition to the allowance for that component. (Code L4210 must not be used for casting supplies or other materials used in the fitting or fabrication of an orthosis.)The following chart reflects the reasonable useful lifetime of prefabricated knee orthoses:L18101 yearL18121 yearL18201 yearL18301 yearL18312 yearsL18322 yearsL18332 yearsL18363 yearsL18433 yearsL18453 yearsL18502 yearsL18513 yearsL18523 yearsThe reasonable useful lifetime of a custom fabricated orthosis is 3 years.Replacement during the reasonable useful lifetime, is covered if the item is lost or irreparably damaged. Replacement for other reasons, including but not limited to irreparable wear, during the period of reasonable useful lifetime is denied as noncovered.Addition codes K0672, L2390, L2750, L2780, L4002 are for billing of replacement component(s) and are not payable at initial issue of a base orthosis. When code L4002 is billed at the time of initial issue of a base orthosis, it will be denied as not separately payable.Should a supplier wish to submit a claim for services/items that are included in the allowance for the orthosis, code L9900 (ORTHOTIC AND PROSTHETIC SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS "L" CODE) must be used. Code L9900 is denied as not separately payable.Some replacement items have unique Healthcare Common Procedure Coding System (HCPCS) codes. Replacement components that do not have a unique HCPCS code must be billed with a "not otherwise specified" code - L2999. Items that have unique codes must not be billed using a NOC code.Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC web site or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC web site. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after July 1, 2008:L1845Effective for claims with dates of service on or after January 1, 2017:L1852Effective for claims with dates of service on or after October 10, 2022:L1832, L1833 and L1851If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Nebulizers are covered under the Durable Medical Equipment (DME) benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A large volume pneumatic nebulizer (E0580) and water or saline (A4217 or A7018) are not separately payable and should not be separately billed when used for beneficiaries with rented home oxygen equipment.If a large volume nebulizer, related compressor/generator, and water or saline are used predominantly to provide room humidification it will be denied as noncovered.A prefilled disposable large volume nebulizer (A7008) is noncovered under the DME benefit because it is a convenience item. An unfilled nebulizer (A7007, A7017, or E0585) filled with water or saline (A4217 or A7018) by the beneficiary/caregiver is an acceptable alternative.Kits and concentrates for use in cleaning respiratory equipment will be denied as noncovered.Aztreonam lysine is an inhalation solution that is indicated for beneficiaries with cystic fibrosis with chronic Pseudomonas aeruginosa infection. Because it has been determined that the nebulizer that is FDA-approved for administration of aztreonam lysine is not sufficiently durable to meet the statutory requirements for coverage under the DME benefit, claims for that nebulizer, aztreonam lysine inhalation solution and related accessories will be denied as noncovered (no Medicare benefit).Drugs that are not administered through DME (e.g. Foradil Aerolizer and metered-dose inhalers (MDIs)) are not billed to the DME MAC but may be covered under other Medicare benefits (i.e., Medicare Part D). If the supplier chooses to submit a claim for drugs not administered through DME, the drug must be billed using code J3535 (DRUG ADMINISTERED THROUGH A METERED DOSE INHALER) and is non-covered by the DME MACs.Disposable equipment or equipment in which a major component required for their function is disposable do not meet the definition of durable medical equipment and must be billed using code A9270 (noncovered item or service).DISPENSING FEE:An initial dispensing fee (G0333) is payable to a pharmacy for the initial 30-day supply of covered inhalation drug(s) regardless of the number of drugs dispensed, the number of shipments, or the number of pharmacies used by the beneficiary during that time. This initial 30-day dispensing fee is a once in a lifetime fee and only applies to beneficiaries who are using inhalation drugs for the first time as a Medicare beneficiary on or after 01/01/2006. If code G0333 is billed for a 30-day supply of covered inhalation drugs and it is not the initial 30-day supply (i.e., G0333 has already been billed to Medicare for that beneficiary), the claim will be denied as incorrect coding. When code G0333 has been billed once in a beneficiarys lifetime, subsequent claims for a 30-day dispensing fee must be billed using code Q0513.Medicare will only pay for one of the following for covered inhalation drugs regardless of the number of drugs dispensed, the number of shipments, or the number of pharmacies used by the beneficiary during that time period - an initial dispensing fee (G0333), a 30-day dispensing fee (Q0513), or a 90-day dispensing fee (Q0514).For a refill prescription, payment of a dispensing fee will be allowed no sooner than 10 days before the end of usage for the current 30-day or 90-day period for which a dispensing fee was previously paid. Medicare will not pay for more than 12 months of dispensing fees per beneficiary per 12-month period.If the dispensing fee is billed sooner than the interval specified above, it will be denied as not separately payable. For example, if a 90-day fee (Q0514) is billed on 1/30/06 and is covered and there is a subsequent claim for a 30-day fee (Q0513) on 4/10/06, the dispensing fee on 4/10/06 will be denied as not separately payable.Both a Q0513 and a Q0514 dispensing fee are not covered on the same date of service. If a supplier dispenses a 90-day supply of one drug and a 30-day supply of another drug on the same day, code Q0514 (90-day fee) must be billed.The dispensing fee must be billed on the same claim as the inhalation drug(s). If it is not, it will be denied as incorrect billing.A dispensing fee is not separately billable or payable for saline, whether used as a diluent or for humidification therapy.Medicare will not pay for a separate fee for the compounding of inhalation drug(s).REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFINAL RULE1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.MISCELLANEOUSA diagnosis code describing the condition which necessitates nebulizer therapy must be included on each claim for equipment, accessories, and/or drugs.MODIFIERSJW AND JZ MODIFIERS:Effective for claims with dates of service on or after January 1, 2017, the JW modifier is required when billing for unused and discarded amounts of drugs and biologicals from single-dose containers that are administered by the supplier.Effective for claims with dates of service on or after July 1, 2023, the JZ modifier is required when billing for drugs and biologicals from single-dose containers that are administered by the supplier but have no unused and discarded amounts. Effective January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers that are dispensed by the supplier but self-administered by the beneficiary or the beneficiarys caregiver.The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or the beneficiarys caregiver in the beneficiarys home, as it is not expected that the beneficiary or their caregiver provide discarded drug information to the supplier. The JZ modifier is required in this scenario (effective for claims with dates of service on or after January 1, 2024).Multi-use vials are not subject to payment for discarded amounts of drug or biologicals.The DME MACs expect rare use of the JW modifier on claims due to HCPCS code descriptors and their associated Units of Service (UOS) for DMEPOS in addition to the limited instructions for use.Below are two scenarios in regard to the JW modifier.Scenario 1When the HCPCS code UOS is less than the drug quantity contained in the single use vial or single dose package, the following applies:The quantity administered is billed on one claim line without the JW modifier; and,The quantity discarded is billed on a separate claim line with the JW modifier.In this scenario, the JW modifier must be billed on a separate line to provide payment for the amount of discarded drug or biological. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 1 mg.95 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.5 mg remaining in the vial are discarded.The 95 mg dose is billed on one claim line as 95 UOS.The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.Both claim line items would be processed for payment.Scenario 2When the HCPCS code UOS is equal to or greater than the total of the actual dose and the amount discarded, use of the JW modifier is not permitted. As of July 1, 2023, the JZ modifier is required in this situation. If the quantity of drug administered is less than a full UOS, the billed UOS is rounded to the appropriate UOS. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 100 mg.70 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.30 mg remaining in the vial are discarded.The 70 mg dose is billed correctly by rounding up to one UOS (representing the entire 100 mg vial) on a single line item with the JZ modifier.The single line item of 1 UOS would be processed for payment of the combined total 100 mg of administered and discarded drug.The discarded 30 mg must not be billed as another 1 UOS on a separate line item with the JW modifier. Billing an additional 1 UOS for the discarded drug with the JW modifier is incorrect billing and will result in an overpayment.KX, GA, AND GZ MODIFIERS:Suppliers must add a KX modifier to codes for E0574, J7686, K0730 and Q4074 only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESEQUIPMENT:In this policy, nebulization of inhalation solutions is accomplished by two types of devices. Pneumatic compressor nebulizers achieve nebulization of liquid by means of air flow. Ultrasonic or electronic nebulizers produce nebulization of liquid by means of a vibrating mechanism.HCPCS code E0565 describes an aerosol compressor, which can be set for pressures above 30 psi at a flow of 6-8 L/m and is capable of continuous operation.A nebulizer with compressor (E0570) is an aerosol compressor, which delivers a fixed, low pressure and is used with a small volume nebulizer. It may be AC-powered, DC-powered or both.A light duty adjustable pressure compressor (E0572) is a pneumatic aerosol compressor which can be set for pressures above 30 psi at a flow of 6-8 L/m, but is capable only of intermittent operation.

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Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESEQUIPMENT:In this policy, nebulization of inhalation solutions is accomplished by two types of devices. Pneumatic compressor nebulizers achieve nebulization of liquid by means of air flow. Ultrasonic or electronic nebulizers produce nebulization of liquid by means of a vibrating mechanism.HCPCS code E0565 describes an aerosol compressor, which can be set for pressures above 30 psi at a flow of 6-8 L/m and is capable of continuous operation.A nebulizer with compressor (E0570) is an aerosol compressor, which delivers a fixed, low pressure and is used with a small volume nebulizer. It may be AC-powered, DC-powered or both.A light duty adjustable pressure compressor (E0572) is a pneumatic aerosol compressor which can be set for pressures above 30 psi at a flow of 6-8 L/m, but is capable only of intermittent operation.HCPCS code E0574 describes an ultrasonic/electronic generator used with a small volume chamber for medication delivery. Aerosolization of the inhalation solution occurs in a nebulization chamber by means of a vibrating mechanism such as (not all inclusive) a vibrating disk, pizo-electric device or vibrating mesh.Accessories used in conjunction with ultrasonic nebulizers coded E0574 should be billed on separate claim lines. The dome and mouthpiece should be billed with code A7016. Other accessories should be billed with code A9999. When code A9999 is used, the claim must clearly describe the type and quantity of accessories provided.For dates of service on or after April 1, 2011, products coded E0574 must have received coding verification review (CVR) from the Pricing, Data Analysis and Coding (PDAC) contractor. The only products that may be billed using code E0574 are those that are specified in the Product Classification List (PCL) on the PDAC contractor web site.If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.HCPCS code E0575 describes a large volume ultrasonic nebulizer system which is used for medication and humidification delivery, and which is capable of continuous operation.HCPCS code K0730 describes a controlled dose inhalation drug delivery system. Aerosol is delivered in pulses during the inspiration. The duration of each pulse is adapted according to the breathing pattern.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following nebulizers and related accessories HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0565, E0570, E0572, E0585, A4619, A7003, A7004, A7005, A7006, A7007, A7012, A7013, A7014, A7015, A7017, A7525, and E1372For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by the HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.ACCESSORIES:HCPCS codes A7003, A7005, and A7006 include the lid, jar, baffles, tubing, T-piece and mouthpiece. In addition, code A7006 includes a filter.HCPCS code A7004 includes only the lid, jar and baffles.HCPCS code A7012 describes a device to collect water condensation, which is placed in line with the corrugated tubing, used with a large volume nebulizer.HCPCS code A7016 describes the dome and mouthpiece containing the aerosolization mechanism for an ultrasonic/electronic nebulizer system.HCPCS code E0585 is used when a heavy-duty aerosol compressor (E0565), durable bottle type large volume nebulizer (A7017), and immersion heater (E1372) are provided at the same time. If all three items are not provided initially, the separate codes for the components would be used for billing. Code A7007 or A7017 is billed when an unfilled large volume nebulizer is used with an E0572 compressor or a separately billed E0565 compressor. Code A7007 or A7017 would not be separately billed when an E0585 system was also being billed. Code E0580 (Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flow meter) describes the same piece of equipment as A7017, but should only be billed when this type of nebulizer is used with a beneficiary-owned oxygen system.INHALATION DRUGS:The following instructions apply to claims billed using J codes. When claims are billed in NCPDP format using NDC numbers, different instructions may apply. Refer to the NCPDP Companion Document available through the CMS website.A compounded inhalation solution is one in which the product that is delivered to the beneficiary is not an FDA-approved preparation. It is produced by a pharmacy that is not an FDA-approved manufacturer and involves the mixing, combining, or altering of ingredients for an individual beneficiary. Even if one the ingredients is an FDA-approved product (e.g., an injectable form of the drug), if that is mixed by the pharmacy with other ingredients, the solution that is dispensed to the beneficiary is considered to be a compounded product.There are distinct codes for FDA-approved final products and for compounded final products. The appropriate code must be used when a claim is submitted. Code J7999 (COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED) does not apply to compounded nebulizer drugs and must not be used. Claims for compounded nebulizer drugs using J7999 will be denied as incorrect coding.HCPCS codes J2545 (pentamidine), J7608 (acetylcysteine), J7631 (cromolyn), J7639 (dornase alfa) and Q4074 (iloprost) may only be used for inhalation solutions which are FDA-approved. If compounded versions of these drugs are provided, they must be billed using code J7699.There are no FDA-approved final products that are described by the following codes: J7633 (budesonide, concentrate), J7648 (isoetharine, concentrate), J7649 (isoetharine, unit dose), J7658 (isoproterenol, concentrate), J7659 (isoproterenol, unit dose), and J7668 (metaproterenol, concentrate). These codes are invalid for claim submission.HCPCS codes J7602 (Albuterol, all formulations including separated isomers, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, per 1 mg (albuterol) or per 0.5 mg (levalbuterol)) and J7603 (Albuterol, all formulations including separated isomers, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose, per 1 mg (albuterol) or per 0.5 mg (levalbuterol)) were effective for claims with dates of service from 1/1/2008 3/31/2008. They are invalid for claim submission for dates of service on or after 4/1/2008.Unit dose form of an inhalation drug or a combination of drugs is one in which the medication is dispensed to a beneficiary (1) in a bottle/vial/ampule which contains the dose usually used for a single inhalation treatment, and (2) in a concentration which is dilute enough that it may be administered to a beneficiary without adding any separate diluent.Concentrated form of a drug used for inhalation is one in which the drug is dispensed to a beneficiary in a concentration which requires that a separate diluent (usually saline) be added to the nebulizer when the drug is administered to a beneficiary.The coding of a unit dose form or a concentrated form of an inhalation drug is determined by the formulation of the drug as it is dispensed to the beneficiary. For example, if a pharmacist takes a concentrated form of a single inhalation drug (e.g., 0.5% albuterol) and dilutes it to a ready-to-use concentration (e.g., 0.083% albuterol), which is then dispensed to the beneficiary in a single-dose bottles/vials/ampules, the inhalation solution is billed as the compounded unit dose form, not the concentrated form.When there is a single drug in a unit dose container, the KO modifier is added to the unit dose form code. (Exception: The KO modifier is not used with code J2545 or Q4074.)Except for code J7620, when two or more drugs are combined and dispensed to the beneficiary in the same unit dose container, each of the drugs is billed using its unit dose form code. The KP modifier is added to only one of the unit dose form codes and the KQ modifier is added to the other unit dose code(s).Whenever a unit dose form code is billed, it must have a KO, KP or KQ modifier. (Exception: The KO, KP and KQ modifiers should not be used with code J7620.) If a unit dose code does not have one of these modifiers, it will be denied as an invalid code. The KO, KP, and KQ modifiers are not used with the concentrated form codes.The only FDA-approved unit dose preparation containing more than one drug is J7620, the combination of albuterol and ipratropium. Therefore, if the following FDA-approved unit dose codes are billed with a KP or KQ modifier, they will be rejected as invalid for claim submission: J7605, J7606, J2545, J7608, J7613, J7614, J7626, J7631, J7639, J7644, J7669, J7682, J7686, and Q4074.The billing unit of service for inhalation drug codes varies. Suppliers must be sure that they use the correct billing unit or the code when calculating the number of units of service to enter on the claim. The following is guidance on a few codes where errors are commonly seen:

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Whenever a unit dose form code is billed, it must have a KO, KP or KQ modifier. (Exception: The KO, KP and KQ modifiers should not be used with code J7620.) If a unit dose code does not have one of these modifiers, it will be denied as an invalid code. The KO, KP, and KQ modifiers are not used with the concentrated form codes.The only FDA-approved unit dose preparation containing more than one drug is J7620, the combination of albuterol and ipratropium. Therefore, if the following FDA-approved unit dose codes are billed with a KP or KQ modifier, they will be rejected as invalid for claim submission: J7605, J7606, J2545, J7608, J7613, J7614, J7626, J7631, J7639, J7644, J7669, J7682, J7686, and Q4074.The billing unit of service for inhalation drug codes varies. Suppliers must be sure that they use the correct billing unit or the code when calculating the number of units of service to enter on the claim. The following is guidance on a few codes where errors are commonly seen:HCPCS code J7620 is used for an FDA-approved combination of albuterol and ipratropium which contains 3.0 mg of albuterol sulfate (which is 2.5 mg of albuterol base) and 0.5 mg of ipratropium bromide in each unit dose vial. For these products, 1 unit of service of J7620 equals 1 unit dose vial.For HCPCS codes J7626 and J7627 (budesonide, unit dose), bill one unit of service for each vial dispensed, regardless of whether a 0.25 mg vial or a 0.5 mg vial is dispensed.The concentration of the drug in the dispensed solution can be converted to mg or gm as follows: A solution with a labeled concentration of 1% has ten (10) mg of drug in each milliliter (ml) of solution. Therefore, a 0.083% albuterol solution has 0.83 mg of albuterol in each ml of solution. Since albuterol 0.083% solution typically comes in a 3 ml vial/ampule, each vial/ampule contains 2.5mg of albuterol (3 X 0.83 equals 2.5). If a pharmacist provides 120 ampules of an FDA-approved inhalation solution of 0.83% albuterol solution each containing 3 ml, the billed units of service would be 300 (2.5 X 120) units of code J7613 (for albuterol, 1 mg equals 1 unit).When a compounded unit dose preparation is billed, the diluent must not be billed separately.The nebulizer used to administer aztreonam lysine must be coded and billed using HCPCS code A9270, noncovered item or service.HCPCS code A4218 is used for metered dose sterile saline products that are used to dilute the concentrated form of inhalation drugs.When a drug is provided in a concentration which is dilute enough that it may be administered to the beneficiary without adding any separate diluent and is dispensed in a multidose container, use J7699.Claims for revefenacin for dates of service on or after November 9, 2018, through June 30, 2019, must be submitted using the HCPCS code J7699 (NOC DRUGS, INHALATION SOLUTION ADMINISTERED THROUGH DME).Claims for revefenacin for dates of service on or after July 1, 2019, must be submitted using HCPCS code J7677 (REVEFENACIN INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, 1 MICROGRAM).HCPCS code J7699 is also used for an inhalation drug which does not have a valid specific code. Claims for drugs that are incorrectly coded J7699 instead of the appropriate code will be denied for invalid coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Positive airway pressure devices are covered under the Durable Medical Equipment benefit [Social Security Act 1861(s)(6)]. In order for a beneficiarys DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Accessories are separately reimbursable at the time of initial issue and when replaced.No aspect of a home sleep test, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests or to tests conducted in facility-based sleep laboratories.A liner used in conjunction with a PAP mask is considered comfort/convenience item. There is no additional payment for liners used with a PAP mask. These products should be coded A9270 (Noncovered item or service) in accordance with the Medicare Benefit Policy Manual (CMS Pub. 100-02) Chapter 15, Section 110.1.Claims for A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) are denied as statutorily non-covered (No Medicare benefit).REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFINAL RULE1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.INITIAL EVALUATION:For the initial in-personevaluation, the report would commonly document pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation.HistorySigns and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headachesDuration of symptomsValidated sleep hygiene inventory such as the Epworth Sleepiness Scale (see Appendices of related LCD)Physical ExamFocused cardiopulmonary and upper airway system evaluationNeck circumferenceBody mass index (BMI)Suppliers are reminded that all Medicare coverage and documentation requirements for DMEPOS also apply. There must be sufficient information included in the medical record to demonstrate that all of the applicable coverage criteria are met. This information must be available upon request.For beneficiaries changing from an E0601 to E0470 due to ineffective therapy while on E0601 (either during a facility-based titration or in the home setting), the treating practitioner must document that both of the following issues were addressed prior to changing to an E0470 device:Interface fit and comfort. An appropriate interface has been properly fit and the beneficiary is using it without difficulty. This properly fit interface will be used with the E0470 device; and,E0601 pressure settings. The current pressure setting of the E0601 prevents the beneficiary from tolerating the therapy and lower pressure settings of the E0601 were tried but failed to:Adequately control the symptoms of OSA; or,Improve sleep quality; or,Reduce the AHI/RDI to acceptable levels.The re-evaluation must take place within the first 3 months of treatment; however, formal assessment of improvement cannot be documented before the 31st day. The re-evaluation must document both improvement in subjective symptoms of OSA and objective data related to adherence to PAP therapy.Documentation of adherence to PAP therapy shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating practitioner and included in the beneficiarys medical record. This information does not have to be submitted with the claim but must be available upon request.Many suppliers have created forms which have not been approved by CMS which they send to practitioners and ask them to complete. Even if the practitioner completes this type of form and puts it in his/her chart, this supplier-generated form is not a substitute for the comprehensive medical record as noted above. Suppliers are encouraged to help educate practitioners on the type of information that is needed to document a beneficiarys need for PAP therapy.Proper use of modifiers is discussed below. Specific modifiers must be used and differ depending on whether or not the requirements outlined in the documentation section have been met.INITIAL COVERAGE (FIRST THREE MONTHS):On claims for the first through third months, suppliers must add a KX modifier to codes for PAP equipment (E0470 or E0601) and accessories only if all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD ("Initial Coverage") have been met.CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:On the fourth months claim (and any month thereafter), the supplier must add a KX modifier to codes for PAP equipment (E0470 or E0601) and accessories only if both the "Initial Coverage" criteria and the "Continued Coverage" criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met.If the supplier does not obtain information from the treating practitioner that the beneficiary has demonstrated improvement in their OSA symptoms and is adhering to PAP therapy in time for submission of the fourth or succeeding months claims, the supplier may still submit the claims, but a KX modifier must not be added.If the supplier chooses to hold claims for the fourth and succeeding months pending receipt of information from the treating practitioner that the beneficiary received a clinical re-evaluation between the 31st and 91st day, had documented improvement in OSA symptoms and is adhering to PAP therapy, those claims may then be submitted with the KX modifier.If the supplier chooses to hold claims for the fourth and succeeding month pending receipt of information from the treating practitioner but learns that the beneficiary did not receive a clinical re-evaluation between the 31st and 91st day but rather was re-evaluated at a later date and had documented improvement in OSA symptoms and is adhering to PAP therapy, those claims may then be submitted with the KX modifier but only for dates of service following the date of the clinical re-evaluation.For a PAP device dispensed prior to November 1, 2008, if the initial coverage criteria in effect at the time were met and the criteria for coverage after the first 3 months that were in effect at the time were met, the KX modifier may be added to claim with dates of service on or after November 1, 2008 as long as the beneficiary continues to use the device.REPLACEMENT OF ACCESSORIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT:For claims for replacement accessories (e.g., interfaces, tubing, filters, humidifier chambers), if Medicare paid for the base PAP device initially (i.e., for 13 months of continuous use), the medical necessity for the beneficiary-owned base PAP device is assumed to have been established. Therefore, to make a payment determination, there must only be documentation that the base DME item continues to meet medical need; and (2) The replacement of specific accessories or furnishing of new accessories remain medically necessary and are essential for the effective use of the base DME.Documentation of continued medical need for the base item must come from the treating practitioners records.The supplier's documentation records must support the need to replace the accessory to maintain the equipment's functionality and meet the beneficiary's medical need.This guidance does not apply to PAP devices when Medicare did not originally provide payment for the base item. In cases where Medicare did not originally pay for the DME item, all coverage, coding and documentation requirements in effect for the date of service (DOS) on the claim under review must be met (see below for beneficiary-owned devices entering Medicare).BENEFICIARIES ENTERING MEDICARE:For beneficiaries who received a PAP device prior to enrollment in fee for service (FFS) Medicare and are seeking Medicare coverage of either rental of the device, a replacement device or accessories, the supplier may add the KX modifier only if both of the criteria listed in the Coverage Indications, Limitations, and/or Medical Necessity for Beneficiaries Entering Medicare section of the related LCD have been met.The supplier may hold claims, pending confirmation that the above requirements are met, and then submit claims with the KX modifier beginning with the date of FFS Medicare enrollment.CONCURRENT USE OF OXYGEN WITH PAP THERAPY:In the rare instance where beneficiaries require the simultaneous use of home oxygen therapy and a PAP device, documentation by the treating practitioner in the beneficiarys medical record must clearly demonstrate that the requirements for coverage outlined in the PAP LCD Coverage Indications, Limitations, and/or Medical Necessity have been met. In addition, the beneficiarys medical record must also clearly demonstrate that the requirements for coverage outlined in the Oxygen and Oxygen Equipment LCD Coverage Indications, Limitations, and/or Medical Necessity have been met. This information does not have to be submitted with the claim but must be available upon request.Suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.MODIFIERSGA, GZ, and KX MODIFIERS:In all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the PAP equipment and accessories. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.MISCELLANEOUS:Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.The order must include the type(s) of supplies ordered and the approximate quantity to be used per unit of time. A new order is required if there is an increase in the quantity of the supply used per month and/or the type of supply used.The supplier must enter the diagnosis code for the PAP device on each claim submitted for PAP supplies.Refer to the Supplier Manual for additional information on documentation requirements.CODING GUIDELINES

Local Coverage Articles, Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article, A52467

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Article - Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467)

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MODIFIERSGA, GZ, and KX MODIFIERS:In all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the PAP equipment and accessories. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.MISCELLANEOUS:Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.The order must include the type(s) of supplies ordered and the approximate quantity to be used per unit of time. A new order is required if there is an increase in the quantity of the supply used per month and/or the type of supply used.The supplier must enter the diagnosis code for the PAP device on each claim submitted for PAP supplies.Refer to the Supplier Manual for additional information on documentation requirements.CODING GUIDELINESA respiratory cycle is defined as an inspiration, followed by an expiration.A single-level continuous positive airway pressure (CPAP) device (E0601) delivers a constant level of positive air pressure (within a single respiratory cycle) by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.For auto-titrating single-level CPAP devices use HCPCS code E0601.A bi-level respiratory assist device without backup rate (E0470) allows independent setting of inspiratory and expiratory pressures to deliver positive airway pressure within a single respiratory cycle by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.A bi-level respiratory assist device with backup rate (E0471) allows independent setting of inspiratory and expiratory pressures to deliver positive airway pressure within a single respiratory cycle by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. In addition, E0471 devices have a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur.HCPCS code A4604 describes tubing used with a heated humidifier and has a heated wire running the length of the tubing. It is designed for use with a positive airway pressure device and a non-invasive interface i.e., nasal or face mask, nasal cannula, or oral interface.HCPCS code A7032 is used for a replacement nasal mask interface that goes around the nose, but not into the nostrils. The unit of service for this code is each.HCPCS code A7033 is used for a replacement nasal cannula-type interface. This interface extends a short distance into the nostrils. The unit of service for this code is pair. For some products, there are two physically separate cushions or pillows one for each nostril. Two cushions/pillows equals one unit of service of A7033. For other products, the interface is a single piece with two protrusions that extend into the nostrils. One of these interfaces equals one unit of service of A7033.HCPCS code A7027 (Combination oral/nasal mask, used with continuous positive airway pressure device, each) is a two piece system with separate elements for oral and nasal use. One unit of service for A7027 includes both the oral and the nasal components.A liner is soft, flexible material which is placed between the patients skin and the PAP mask interface. Liners used with a PAP mask are made of cloth, silicone or other materials.Liners are not interfaces for use with a PAP mask. Consequently, liners should not be billed as replacement features of a PAP mask such as A7031 (Face mask interface, replacement for full face mask, each) or A7032 (Cushion for use on nasal mask interface, replacement only, each).Monitoring devices (integrated or modular) are capable of tracking data generated by a RAD or PAP device, which can be subsequently downloaded for further analysis by a healthcare provider, DME supplier, or beneficiary. Such technologies include, but are not limited to:Smart cards and readersUSB/Thumb drive accessoriesWired telephonic transmission modulesWireless modemsHCPCS code A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) describes any type of monitoring technology. Code A9279 is all-inclusive, and is to be used whether the monitoring technology is incorporated as part of a base item, supplied as an add-on module or is a stand-alone item.Use of multiple instances of A9279 to bill separately for individual monitoring features is incorrect coding.There is no Medicare benefit or payment to DMEPOS suppliers for remote monitoring services. Suppliers must not bill A9279 for remote monitoring services.Claims billed for monitoring technologies using other NOC codes such as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS) will be denied as incorrect coding.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following positive airway pressure devices HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0470, E0471, E0472, E0601, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046, E0561, E0562For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetimeFor E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Pressure Reducing Support Surfaces - Group 3- Policy Article, A52468

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Article - Pressure Reducing Support Surfaces - Group 3- Policy Article (A52468)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Pressure-reducing support surfaces are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFINAL RULE1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.MODIFIERSKX, GA, AND GZ MODIFIERSSuppliers must add a KX modifier to E0194 on the initial claim only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request.For each subsequent months claim use a KX modifier only if the treating practitioners monthly certification indicates that continued use is necessary. Discontinue use of the KX modifier if the coverage criteria are not met or use is discontinued.In all of the situations above describing use of the KX modifier, if all of the specific coverage criteria have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claims lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.MISCELLANEOUSOn a monthly basis, the treating practitioner must document the need for the equipment with a written statement specifying:The size of the ulcer;If the ulcer is not healing, what other aspects of the care plan are being modified to promote healing;Continued use of the bed is reasonable and necessary for wound management.This monthlytreating practitionerstatement must be kept on file by the supplier and be available for inspection upon request.Refer to the Supplier Manual for additional information on documentation requirements.CODING GUIDELINESAn air-fluidized bed (E0194) is a device employing the circulation of filtered air through silicone coated ceramic beads creating the characteristics of fluid.Heavy duty and bariatric devices are included in the Group 3 pressure reducing support surfaces coded E0194.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Speech Generating Devices (SGD) - Policy Article, A52469

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Article - Speech Generating Devices (SGD) - Policy Article (A52469)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Speech generating devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.As noted in the related Local Coverage Determination (LCD), speech generation defined as audible generation of words or phrases and in addition, may include:Communication via written text (i.e., email or text (SMS) messaging); or,Communication via phone messaging.To meet the DME benefit category requirements, the speech generating device must meet all of the following requirements:Can withstand repeated use; and,Has an expected life of at least 3 years; and,Is primarily and customarily used to serve a medical purpose; and,Generally is not useful to an individual in the absence of an illness or injury; and,Is appropriate for use in the home; and,Be limited to use by a patient with a severe speech impairment; and,Be primarily used for the purpose of generating speech, as defined above.For criterion 7, a device utilizing tablet, smartphone or computer hardware must be designed by the manufacturer to function solely as a speech generation device, as defined above, at the time of initial issue.Desktop, laptop, tablet, smartphone and other hand-held computers (i.e. general computing devices) are not considered DME because they do not meet criteria 3, 4, 6 and 7 above, even though they may serve a medical purpose. Medicare will reimburse for speech generating software only (HCPCS code E2511) when installed on a general computing device. The device itself must be coded A9270.The following features of a speech generating device are non-covered because they do not fall within the scope of the durable medical equipment benefit:Specific features of a speech generating device that are not used by the individual who has a severe speech impairment to meet his or her functional speaking needs.Video communications or conferencing.Any computing hardware or software not necessary to allow for generation of speech, email, text or phone messages. Examples include, but are not limited to:Hardware or software used to create documents and spreadsheets; or,Hardware or software used to play games or music.Internet service provider (ISP), phone service subscriptions or any modification to a patients home to allow use of the speech generating device are non-covered because such services or modifications could be used for non-medical equipment such as standard phones or general computing devices.A carrying case (including shoulder strap or carrying handle, any type) (E2599) is a convenience item and is denied as non-covered.Accessories used with non-covered devices will be denied as non-covered.Upgrades to speech generating devices and/or software programs that are provided within the 5 year useful lifetime of the device will be denied as statutorily non-covered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The medical necessity requirements for each accessory (E2599) for E2500, E2502, E2504, E2506, E2508, E2510 must be clearly documented in the formal evaluation by the SLP. For alternative input devices, there must be information in the SLP evaluation about why standard input access devices are unable to be used.When codes E2511, E2512,E2599 are billed, the claim must include all of the following information:Description of the item or serviceManufacturer nameProduct name and numberIf billing a multicomponent mounting system, list each components manufacturer and product name and number.MODIFIERSKX, GA, AND GZ MODIFIERS:Suppliers must add a KX modifier to codes E2500, E2502, E2504, E2506, E2508, E2510, E2511,E2512,E2599 only if all of the coverage criteria in the "Coverage Indications, Limitations and/or Medical Necessity" section of the related LCD have been met and evidence of such is retained in the suppliers files and available upon request.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claims lines billed for E2500, E2502, E2504, E2506, E2508, E2510, E2511,E2512, E2599 without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESCode A4601 describes any lithium ion rechargeable battery used with an SGD or related accessory.Digitized speech (E2500, E2502, E2504, E2506), sometimes referred to as devices with "whole message" speech output, utilize words or phrases that have been recorded by an individual other than the SGD user for playback upon command of the SGD user.Synthesized speech (E2508, E2510), unlike the pre-recorded messages of digitized speech, is a technology that translates a user's input into device-generated speech. Users of synthesized speech SGDs are not limited to pre-recorded messages but rather can independently create messages as their communication needs dictate.E2508 devices require that the user make physical contact with a keyboard, touch screen or other display containing letters.E2510 devices permit the user multiple methods of message formulation and multiple methods of device access. Multiple methods of message formulation must include the capability for message selection by two or more of the following methods: letters, words, pictures or symbols. Multiple methods of access must include the capability to access the device by two or more of the following: direct physical contact with a keyboard or touch screen, indirect selection techniques with a specialized access device such as a joystick, head mouse, optical head pointer, switch, light pointer, infrared pointer, scanning device, or Morse Code.Devices that have the capability to generate both digitized and synthesized speech are coded as E2508 or E2510, depending on the method of synthesized speech formulation and device access.Codes E2500, E2502, E2504, E2506, E2508 and E2510 include all applicable speech generating software programs (whether they are on the device when shipped by the manufacturer or added by the supplier prior to delivery), batteries, battery chargers and AC adapters. These items may not be billed separately. There is also no separate payment if a nonintegrated keyboard is provided with an SGD.To be coded as E2510, a desktop, tablet, smartphone or modified laptop computer must only be capable of speech generation, as defined above. General computing devices (i.e., desktop, laptop, tablet, smartphone or other hand-held computers) with additional non-covered features (see Non-Medical Necessity Coverage and Payment Rules above) included at the time of initial issue must be coded A9270.A device that provides the same functionality as a desktop, tablet, smartphone or laptop computer at the time of issuance is considered a general use computer and is not considered a speech generating device.Effective for claims with dates of service on or after June 1, 2016, the only products which may be billed to Medicare using code E2510 are those for which a written coding verification has been made by the PDAC contractor and are listed on the Product Classification List (PCL) in the Durable Medical Equipment Coding System (DMECS) maintained on the PDAC website.If a product is billed to Medicare using a HCPCS code that requires written coding verification review, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Code E2511 is used to code for speech generating software programs that enable a laptop computer, desktop computer, tablet, smartphone or other hand-held general computing device to generate speech. The allowance for code E2511 includes the speech generating software program only. Installation of the program or technical support must not be billed separately. Code E2511 must not be used to code for software programs that are installed at the time of delivery of an SGD (codes E2500, E2502, E2504, E2506, E2508 or E2510).Code E2511 must not be used to code for software programs installed at the time of the initial provision of an SGD accessory or alternative access device. Software for the accessory or alternative access device is included in the reimbursement for the accessory or alternative access device. Claims for code E2511 billed with an accessory or alternative access device will be denied as unbundling.E2511 is used for upgrade programs for SGDs (codes E2500, E2502, E2504, E2506, E2508 or E2510) or when code E2511 is used to bill for software only when installed on a general computing device. Replacement or upgrade of speech generating software loaded onto a covered speech generating device is not covered unless the replacement software is necessary due to a change in the patients condition, or in cases where the software has been lost, stolen, irreparably damaged, or has been in continuous use for the reasonable useful lifetime of 5 years.Mounting systems and stands (E2512) are accessories that are needed to place the SGD, switches or other access devices within the reach of the beneficiary. For systems with multiple components, bill system on a single claim line with one (1) unit of service. There is no separate billing for any software, interfaces, cables, adapters, interconnects or switches necessary for the access device to interface with the SGD. Those components are included in the reimbursement for the access device itself.A protective case or cover, any type (E2599) is not separately payable as they are required to make the SGD durable under the definition of DME (see criterion 2 above under Non-Medical Necessity Coverage and Payment Rules). Claims for protective cases or covers when billed with a covered SGD will be denied as unbundled.Code E2599 is used for other separately payable accessories for speech generating devices. Examples include:Ocular tracking device, any type, describes an SGD accessory used with an SGD or SGD software to allow a speech-impaired person to use his or her eyes to communicate. Ocular tracking devices track the users eye movement and determine where on screen their gaze is targeted.Head control mouse, any type, describes an SGD accessory that monitors head movement and translates those movements into actions by the pointer on the SGD screen.Alternative input device, any type, describes any accessory other than an ocular tracking device or head control mouse, not integrated into the SGD hardware, used to control the actions of an SGD. Examples of alternative input devices include (not all-inclusive): specialty keyboards, joysticks, trackballs, trackpads, buddy buttons, jelly beans, beamers, roller balls, round pads, pal pads.Protective key guard, any type describes an overlay for a keyboard, alternative input device or SGD screen that assists the beneficiary in preventing inadvertent selection of a button, icon or other input.Protective case or cover, any type describes any protective case or cover used to enclose the SGD to prevent the ingress of liquids, dirt, dust, etc. (see above Coding Guidelines for more information).Carrying case, includes shoulder strap or carrying handle, any type describes any soft-sided or hard-sided carrying container for the SGD and any related accessories (See Non-Medical Necessity Coverage and Payment Rules for more information).

Local Coverage Articles, Speech Generating Devices (SGD) - Policy Article, A52469

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Ocular tracking device, any type, describes an SGD accessory used with an SGD or SGD software to allow a speech-impaired person to use his or her eyes to communicate. Ocular tracking devices track the users eye movement and determine where on screen their gaze is targeted.Head control mouse, any type, describes an SGD accessory that monitors head movement and translates those movements into actions by the pointer on the SGD screen.Alternative input device, any type, describes any accessory other than an ocular tracking device or head control mouse, not integrated into the SGD hardware, used to control the actions of an SGD. Examples of alternative input devices include (not all-inclusive): specialty keyboards, joysticks, trackballs, trackpads, buddy buttons, jelly beans, beamers, roller balls, round pads, pal pads.Protective key guard, any type describes an overlay for a keyboard, alternative input device or SGD screen that assists the beneficiary in preventing inadvertent selection of a button, icon or other input.Protective case or cover, any type describes any protective case or cover used to enclose the SGD to prevent the ingress of liquids, dirt, dust, etc. (see above Coding Guidelines for more information).Carrying case, includes shoulder strap or carrying handle, any type describes any soft-sided or hard-sided carrying container for the SGD and any related accessories (See Non-Medical Necessity Coverage and Payment Rules for more information).Electronic components that allow the SGD to be operated by the drive control interface of a power wheelchair.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Billing and Coding: Venipuncture Necessitating Physician’s Skill for Specimen Collection – Supplemental Instructions Article, A52470

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NOT AN LCD REFERENCE ARTICLE

Article - Billing and Coding: Venipuncture Necessitating Physician’s Skill for Specimen Collection – Supplemental Instructions Article (A52470)

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CMS National Coverage PolicyN/AArticle TextThe information in this Supplemental Instructions Article (SIA) contains coding or other guidelines for Venipuncture Necessitating Physicians Skill for Specimen Collection.Coding Guidelines:General Guidelines for claims submitted to Part A or Part B MAC:Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.The diagnosis code(s) must best describe the patient's condition for which the service was performed.Advance Beneficiary Notice of Noncoverage (ABN) Modifier GuidelinesAn ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04,Medicare Claims Processing Manual, Chapter 30, for complete instructions.Effective from April 1, 2010, non-covered services should be billed with modifier GA, -GX, -GY, or GZ, as appropriate.The GA modifier (Waiver of Liability Statement Issued as Required by Payer Policy) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and theydo havean ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections1862(a)(1), 1862(a)(9),1879(e), or 1879(g)of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts responsibility for payment. The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.Modifier GX (Notice of Liability Issued, Voluntary Under Payer Policy) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisionsotherthan medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, Part A MAC systems will automatically deny the services.The GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and theyhave nothad an ABN signed by the beneficiary.If the service is statutorily non-covered, or without a benefit category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.Submit CPT code 36415 for all routine venipunctures, not requiring the skill of a physician, for specimen collection. This includes all venipunctures performed on superficial peripheral veins of the upper and lower extremities.Submit CPT code 36410 only for venipunctures necessitating physician skill when performed by a physician on veins of the neck, (e.g., external or internal jugular), or from deep (central) veins of the thorax (e.g., subclavian) or groin (e.g., femoral); and for venipuncture of superficial extremity veins when the skill of a qualified individual properly trained in venipuncture techniques (e.g., nurse, phlebotomist, medical technician) has been clearly demonstrated, according to the terms of this policy, to be insufficient ICD-10-CM I87.8, I99.8 or R68.89 must be submitted on all claims for CPT 36410.Multiple venipunctures (36410 or 36415) during the same encounter, to draw blood specimen(s), may only be billed as a single procedure with units of service = 1 (one) regardless of the number of attempts or veins entered. In an ER setting, an "encounter" is considered admission until discharge. The venipuncture may be billed by the hospital as an outpatient charge. Physicians may not generally bill for routine venipuncture in a hospital site of service.For claims submitted to the Part B MAC:All services/procedures performed on the same day for the same beneficiary by the physician/provider should be billed on the same claim.Claims for Venipuncture Necessitating Physician's Skill for Specimen Collection services are payable under Medicare Part B in the following places of service:Office (11), Home (12), Assisted living facility (13), Mobile unit (15), Urgent care facility (20), Inpatient hospital (21), Outpatient hospital (22), Emergency room (23), Skilled nursing facility (31), Nursing facility (32), Clinic (49).For claims submitted to the Part A MAC:Hospital Inpatient Claims:The hospital should report the patient's principal diagnosis in Form Locator (FL) 67 of the UB-04.The principal diagnosis is the condition established after study to be chiefly responsible for this admission.The hospital enters ICD-10-CM codes for up to eight additional conditions in FLs 67A-67Q if they co-existed at the time of admission or developed subsequently, and which had an effect upon the treatment or the length of stay. It may not duplicate the principal diagnosis listed in FL 67.For inpatient hospital claims, the admitting diagnosis is required and should be recorded in FL 69. (See CMS Publication 100-04,Medicare Claims Processing Manual, Chapter 25, Section 75 for additional instructions.)Hospital Outpatient Claims:The hospital should report the full ICD-10-CM code for the diagnosis shown to be chiefly responsible for the outpatient services in FL 67. If no definitive diagnosis is made during the outpatient evaluation, the patient's symptom is reported. If the patient arrives without a referring diagnosis, symptom or complaint, the providershould report an ICD-10-CM code for Persons Without Reported Diagnosis Encountered During Examination and Investigation of Individuals and Populations (Z00.00-Z13.9).The hospital enters the full ICD-10-CM codes in FLs 67A-67Q for up to eight other diagnoses that co-existed in addition to the diagnosis reported in FL 67.

Local Coverage Articles, Immunosuppressive Drugs - Policy Article, A52474

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Immunosuppressivedrugs are covered under the immunosuppressive therapy benefit [Social Security Act 1861(s)(2)(J)]. In order for a beneficiarys immunosuppressive drugs to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met (CMS Claims Processing Manual, Internet-Only Manual, CMS Pub. 100-04, Chapter 17, Section 80.3):Prescription drugs used in immunosuppressive therapy are covered only if all of the following criteria (I-V) are met:Immunosuppressive drugs are prescribed following transplants either:Kidney, heart, liver, bone marrow/stem cell, lung, or heart/lung transplant; or,Whole organ pancreas transplant performed concurrent with or subsequent to a kidney transplant because of diabetic nephropathy (performed on or after July 1, 1999); orIntestinal transplant (performed on or after April 1, 2001); orPancreatic islet cell transplant or partial pancreatic tissue transplantation performed on or after October 1, 2004 that is conducted as part of a National Institutes of Health (NIH)-sponsored clinical trial; orPancreas transplants alone (performed on or after April 26, 2006) that meet the following criteria:The transplant is performed in a facility that is Medicare-approved for kidney transplantation; andBeneficiary must have a diagnosis of type I diabetes and:Must be beta cell autoantibody positive; orMust demonstrate insulinopenia, (fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method). A fasting glucose must be obtained when performing a fasting C-peptide determination. Fasting C-peptide levels are considered valid when a concurrently obtained fasting glucose is<225 mg/dL; andMust have a history of labile (brittle or medically-uncontrollable) insulin-dependent diabetes mellitus resulting in documented recurrent, severe, acutely life-threatening metabolic complications requiring hospitalization(s). Complications may include frequent hypoglycemia where the beneficiary is unaware, recurring severe ketoacidosis, or recurring severe hypoglycemic attacks; andMust have been under the care of an endocrinologist and have clinical documentation denoting optimal and intensive management was provided for at least 12 months, having received the most medically-recognized advanced insulin formulations and delivery systems; andMust demonstrate being able to emotionally and mentally understand the significant risks associated with surgery and be able to effectively manage the lifelong need for immunosuppression; and,Must otherwise be a suitable candidate for transplantation; andThe transplant met Medicare coverage criteria in effect at the time (e.g., approved facility for kidney, heart, intestinal, liver, lung, or heart/lung transplant; national and/or local medical necessity criteria; etc.); andThe beneficiary was enrolled in Medicare Part A at the time of the transplant; andThe beneficiary is enrolled in Medicare Part B at the time that the drugs are dispensed; andDelivery requirements:For DOS prior to August 1, 2016 the drugs are furnished on or after the date of discharge from the hospital following a covered organ transplant.For DOS on or after August 1, 2016 through April 2, 2019, mail-order deliveries may be mailed one or two days prior to a beneficiarys discharge from an inpatient facility to a qualified place of service (such as home or custodial facility). The DOS on the claim must be the date of discharge.For DOS on or after April 3, 2019 mail-order deliveries may be mailed one or two days prior to a beneficiarys anticipated date of discharge from an inpatient facility to a qualified place of service or alternate address, such as the inpatient hospital that performed the transplant or alternative location where the beneficiary is temporarily staying (such as temporary housing). The DOS on the claim must be the date of discharge.If criteria I-V are not met, the drug(s) will be denied as noncovered.If criteria I, II, and III are met, the transplant is considered a "covered transplant" for purposes of this policy whether payment for the transplant was made by Medicare or by another insurer.For islet cell transplants or partial pancreatic tissue transplants conducted as part of an NIH-sponsored clinical trial, Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services. The term "routine costs" means reasonable and necessary routine beneficiary care costs, including immunosuppressive drugs and other follow-up care. In addition, Medicare will cover transplantation of pancreatic islet cells. Coverage includes the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.Immunosuppressive drugs used following partial pancreatic tissue transplantation or islet cell transplantation performed outside the context of a clinical trial or performed before October 1, 2004 will continue to be noncovered.Immunosuppressive drug coverage is limited to 36 months for beneficiaries whose Medicare entitlement is based solely on end-stage renal disease (ESRD)and enrolled in other types of coverage (e.g., group health plan, TRICARE, or a Medicaid state plan that covers immunosuppressive drugs).Coverage continues beyond 36 months for beneficiaries eligible and enrolled in the Medicare Part B immunosuppressive drug benefit (PBID). See the Medicare General Information, Eligibility and Entitlement Manual (CMS Pub. 100-01), Chapter 2, Section 40.9.Immunosuppressive drugs are denied as noncovered when used for the treatment of beneficiaries with non-transplant related diagnoses (e.g., rheumatoid arthritis, connective tissue diseases, vasculitis).Immunosuppressive drugs are denied as noncovered if they are used following a whole organ pancreas transplant that was not simultaneous with or preceded by a kidney transplant for diabetic nephropathy unless the beneficiary meets the criteria forpancreas transplant alonelisted above in I(E). Coverage of immunosuppressive drugs already exists and will continue for beneficiaries who have had a pancreas transplant simultaneous with a kidney transplant because in these situations, coverage is based on the kidney transplant.There is no coverage under the immunosuppressive drug benefit for supplies used in conjunction with the administration of parenteral immunosuppressive drugs.SUPPLY FEE INFORMATION:One unit of service of supply fee code Q0511 is covered for the first covered immunosuppressive drug that is dispensed in a 30-day period. If covered drugs are dispensed by more than one pharmacy during a 30 day period, one unit of Q0511 is covered for each pharmacy. One unit of service of supply fee code Q0512 is covered for each subsequent covered immunosuppressive drug that is dispensed in that 30-day period (See exception below when Q0510 is covered in place of Q0511 or Q0512.) If two dosage strengths of the same drug are dispensed on the same day, one unit of service of the appropriate supply fee is payable for each one. If more than one unit of service of code Q0511 is billed per 30 days by a single pharmacy, the excess units of service will be denied as incorrect coding. If the billed units of service of Q0511 or Q0512 exceed the number of drugs on the claim, the excess units will be denied as not separately payable.One unit of service for code Q0510 is payable in place of Q0511 or Q0512 for one drug on the first claim for immunosuppressive drugs following a transplant. For example, if three drugs are dispensed, the correct coding for the supply fees on the first claim is one unit of service of Q0510 and two units of service of Q0512. If more than one organ is transplanted at the same time (e.g., heart-lung transplant), only one unit of service of Q0510 is payable. Q0510 is payable to only one supplier after each transplant. If the beneficiary has another transplant at a later date, another unit of service of code Q0510 is payable. If more than one unit of service of code Q0510 is billed per beneficiary per transplant, the excess units of service will be denied as incorrect billing/coding.There is no separate coding or payment for a compounding fee.If the drug on the claim is denied as noncovered, the supply fee will be denied as noncovered.The supply fee must be billed on the same claim as the drug. If it is not, it will be denied as incorrect billing.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription.Ongoing immunosuppressive medication need is assumed to be established by the performance of the transplant and the successful maintenance of its function. There is no requirement for further documentation of continued need for the life of the transplant.CONTINUED USEContinued use describes the ongoing utilization of immunosuppressive medications by a beneficiary.Ongoing immunosuppressive medication use is assumed to be established by the performance of the transplant and the successful maintenance of its function. Continued use of immunosuppressive medication is demonstrated by meeting the Refill Documentation requirements.MODIFIERSKX and GY MODIFIERS:The KX modifier must be added to the claim line(s) for the immunosuppressive drug(s) only if all of the following four requirements are met:The supplier has obtained from thetreating practitionerthe specific date of the organ transplant, andThe supplier is retaining this documentation of the transplant in its files, andThe beneficiary was enrolled in Medicare Part A, at the time of the organ transplant (whether or not Medicare paid for the transplant), andThe transplant date precedes the date of service on the claim.If these four requirements are not met, the KX modifier must not be added to the claim.If any of criteria I V listed above have not been met, the GY modifier must be added to the claim line(s).The diagnosis code(s) that justify the need for these items must be included on the claim. See the below list for covered transplant diagnosis codes.A new order is required if a new drug(s) is added to the beneficiary's immunosuppressive regimen or if there is a change in dose or frequency of administration of an already allowed drug.If code J7599 is billed, the claim must list the name of the drug, the dosage strength, number dispensed and administration instructions.CODING GUIDELINESThe following instructions apply to claims billed using J codes. When claims are billed in NCPDP format using NDC numbers, different instructions may apply. Refer to the NCPDP Companion Document available through the CMS website.Code J7599 should be used for immunosuppressive drugs that do not have a specific HCPCS code.For all immunosuppressive drugs, the number of units billed must accurately reflect the definition of one unit of service in each code narrative. For example, if fifty 10 mg prednisolone tablets are dispensed, bill J7510, 100 units (1 unit of J7510 = 5 mg). If fifty 2.5 mg prednisolone tablets are dispensed, bill J7510, 25 units.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Cervical Traction Devices - Policy Article, A52476

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Article - Cervical Traction Devices - Policy Article (A52476)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. "reasonable and necessary").Cervical traction devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiary's DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.MODIFERSKX, GA, AND GZ MODIFIERS:Suppliers must add a KX modifier to code E0849 or E0855 only if all of the criteria in the "Coverage Indications, Limitations and/or Medical Necessity" section of the related LCD have been met and evidence of such is maintained in the supplier's files. This information must be available upon request.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section in the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claims lines billed without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESCode E0855 describes cervical traction devices that provide traction on the cervical anatomy without the use of a door or external frame or stand. Traction may be applied by means of mandibular or occipital pressure.Code E0856 describes a cervical traction device that may or may not use an external frame and uses an inflatable bladder(s) to generate traction forces.Code E0860 describes cervical traction devices that provide traction on the cervical anatomy through a system of pulleys and rope and are attached to a door. Traction may be applied in either the upright or supine position.Code E0849 describes cervical traction devices that provide traction on the cervical anatomy through the use of a free-standing frame. Traction force is applied by means of pneumatic displacement to anatomical areas other than the mandible (e.g., the occipital region of the skull). Devices described by code E0849 must be capable of generating traction forces greater than 20 pounds. In addition, code E0849 devices allow traction to be applied with alternative vectors of force (e.g., 15 degrees of lateral neck flexion).Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Infrared Heating Pad Systems - Policy Article, A52477

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Article - Infrared Heating Pad Systems - Policy Article (A52477)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Infrared Heating Pad Systems are considered for coverage under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)); however, the CMS National Coverage Determination 270.6 precludes payment for these items (see Infrared Heating Pad Systems Local Coverage Determination). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CODING GUIDELINESAn infrared heating pad system (E0221) consists of a pad or pads containing mechanisms (for example, luminous gallium aluminumarsenidediodes) that generate infrared (or near infrared) light and a power source. Replacement pads are coded A4639.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, External Breast Prostheses - Policy Article, A52478

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).External Breast Prostheses are covered under the Prosthetic Devices benefit (Social Security Act 1861(s)(8)). In order for a beneficiarys supplies to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A mastectomy sleeve (L8010) is denied as noncovered, since it does not meet the definition of a prosthesis.The useful lifetime expectancy for silicone breast prostheses is 2 years. The useful lifetime expectancy for a nipple prostheses is 3 months. For fabric, foam, or fiber filled breast prostheses, the useful lifetime expectancy is 6 months. Replacement sooner than the useful lifetime because of ordinary wear and tear will be denied as noncovered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The diagnosis code must be included on each claim for the prosthesis or related item.If the patient's medical condition changes, this should be documented by the patient'streating practitionersubmitting a new order which explains the need for a different type of breast prosthesis. The order must be kept in the supplier's files but need not be submitted with the claimCODING GUIDELINESCode L8000 describes a bra with pockets that are intended to hold a mastectomy form or breast prosthesis held adjacent to the chest wall. Bras coded L8000 do not include an integrated breast prosthesis (for bras with integrated breast prosthesis, see codes L8001 and L8002). Products described by code L8000 may be constructed of any material (e.g., cotton, Lycra, polyester or other materials), any size, and with or without integrated structural support (e.g., underwire).Codes L8001 and L8002 describe a bra with integrated breast prosthesis, either unilateral or bilateral, respectively. Products described by codes L8001 and L8002 may be constructed of any material (e.g., cotton, polyester or other materials), with any type or location of closure, any size, with or without integrated structural support (e.g., underwire).Code L8015 describes a camisole type undergarment with polyester fill used post mastectomy.A custom fabricated prosthesis is one which is individually made for a specific patient starting with basic materials. Code L8035 describes a molded-to-patient-model custom breast prosthesis. It is a particular type of custom fabricated prosthesis in which an impression is made of the chest wall and this impression is then used to make a positive model of the chest wall. The prosthesis is then molded on this positive model.Code A4280 should be used when billing for an adhesive skin support that attaches an external breast prosthesis directly to the chest wall.The right (RT) and/or left (LT) modifiers must be used with these codes. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for bilateral items (left and right) is billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT,or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding. Bras and similar inherently bilateral items (L8000 - L8002, L8015) are exempt from the RTLT requirement.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Oral Anticancer Drugs - Policy Article, A52479

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Oral anticancer drugs are covered under the oral anticancer drug benefit [Social Security Act 1861(s)(2)(Q)]. In order for a beneficiarys oral anticancer drugs to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as non-covered.Oral Anticancer DrugsFor an oral anticancer drug to be covered, all of the following criteria (1-4) must be met (CMS Claims Processing Manual, Internet-Only Manual, CMS Pub. 100-4, Chapter 17, Section 80.1).It is a drug or biological that has been approved by the Food and Drug Administration (FDA), andIt has the same active ingredients as a non-self-administrable anticancer chemotherapeutic drug or biological that is covered when furnished incident to a practitioners service. The oral anticancer drug and the non-self-administrable drug must have the same chemical/generic name as indicated by the FDA's Approved Drug Products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drug compendium, or it is a prodrug which, when ingested, is metabolized into the same active ingredient which is found in the non-self-administrable form of the drug, andIt is used for the same anticancer chemotherapeutic indications, including unlabeled or off label uses, as the non-self-administrable form of the drug, andIt is prescribed by a practitioner licensed under state law to prescribe such drugs as anticancer chemotherapeutic agents.A drug that is not available in an injectable form does not meet criterion 2. If an oral anticancer drug is used for immunosuppression (rather than the treatment of cancer), criterion 3 is not met, and the drug cannot be covered under the oral anticancer drug benefit. (If the drug is used for immunosuppression following organ transplant, refer to the Immunosuppressive Drugs policy.)If criteria 1-4 are not met, the drug will be denied as non-covered.A claim denied for the reason that a diagnosis does not fall in the section below in this Policy Article titled "ICD-10 Codes that Support Medical Necessity" will receive a statutory denial as non-covered, but may be covered at appeal if and only if it can be shown to be allowed under CMS IOM 100-02, Chapter 15, Section 50 Drugs and Biologicals, and under the Social Security Act, Sec.1861(s)(Q).The quantity of oral anticancer drugs that is dispensed should be limited to a 30-day supply. Prescriptions may be refillable.Antiemetic Drugs Used With Oral Anticancer DrugsA self-administered antiemetic drug billed with code J8498 or J8597 is covered if all of the following criteria are met:It is used in conjunction with a covered oral anticancer drug, andIt is likely that administration of the covered oral anticancer drug will induce emesis if the antiemetic drug is not administered, andThe antiemetic drug is administered within 2 hours before the covered oral anticancer drug is administered.Antiemetic drugs are covered under the oral anticancer drug benefit for the sole purpose of allowing the absorption of the covered oral anticancer drug. Therefore, coverage is limited to doses of antiemetic drugs, which are administered during the two hours before administration of the covered oral anticancer drug. Doses of antiemetic drugs administered after the administration of the oral anticancer drug (e.g., to treat nausea or vomiting which is caused by the oral anticancer drug or other etiology) are non-covered.If all of the criteria are not met, the antiemetic drug will be denied as non-covered.For information on the coverage of oral antiemetic drugs when they are used as a full replacement for intravenous antiemetic drugs used in conjunction with intravenous cancer chemotherapeutic regimens, refer to the Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) policy.Supply FeeOne unit of service of supply fee code Q0511 is covered for the first covered oral anticancer drug that is dispensed in a 30-day period. If covered drugs are dispensed by more than one pharmacy during a 30 day period, one unit of Q0511 is covered for each pharmacy. One unit of service of supply fee code Q0512 is covered for each subsequent covered oral anticancer drug that is dispensed in that 30-day period. If two dosage strengths of the same drug are dispensed on the same day, one unit of service of the appropriate supply fee is payable for each one. If more than one unit of service of code Q0511 is billed per 30 days by a single pharmacy, the excess units of service will be denied as incorrect coding. If the billed units of service of Q0511 or Q0512 exceed the number of drugs on the claim, the excess units will be denied as not separately payable.Supply fees are eligible for coverage only for drugs that are covered under this LCD. If the drug on the claim is denied as non-covered, the supply fee will be denied as non-covered.The supply fee code must be billed on the same claim as the drug(s). If it is not, the supply fee will be denied as incorrect billing.J8498 is not eligible for payment of a supply fee.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The ICD-10 diagnosis code describing the condition for which the drug is used must be included on each claim.Claims for codes J8498 or J8597 must identify the name of the drug, the manufacturer, and the dosage strength of each tablet/suppository/etc. Only quantities of these drugs which meet the coverage criteria listed in the Policy Article may be billed using these codes. The claim must also indicate which oral anticancer drug is being used and the prescribed frequency of administration of the anticancer drug. This information must be entered in the narrative field of an electronic claim.CODING GUIDELINESFor the instructions below that apply to J codes, when claims are billed in NCPDP format using NDC numbers, different instructions may apply. Refer to the NCPDP Companion Document available through the CMS web site.The National Drug Code (NDC) is a number, which uniquely identifies a manufacturer's product in terms of the strength of each tablet/capsule, quantity of tablets/capsules in a package, and other packaging details. Suppliers must use the NDC that matches the product dispensed.For all NDC numbers, 1 unit of service = 1 tablet or 1 capsule. Under the Metric Decimal Quantity and the Billing Unit Standard for NCPDP, solid oral dosage forms (tablets, capsules, etc.) are billed as each i.e., 1 unit of service = 1 tablet or 1 capsule each. Suppliers must use the NDC that matches the product dispensed. HCPCS J codes for these drugs must not be used when billing for these drugs.For codes J8498 and J8597, 1 unit of service = 1 mg. Under no other circumstances should the number of grams, milligrams, etc. be used for the UOS of drugs addressed in this policy.National Drugs Codes (NDCs) may be billed only when the drug is used as an oral anticancer drug. If cyclophosphamide or methotrexate are prescribed as an oral immunosuppressive drug following an organ transplant, code J8530 or J8610 respectively must be used. (Refer to the Immunosuppressive Drugs policy for additional information.) If, for example, cyclophosphamide or methotrexate is prescribed as an oral immunosuppressive drug for other conditions (e.g., lupus, rheumatoid arthritis, etc.), a claim should not be submitted to Medicare (unless requested by the beneficiary; and in which case it would be submitted with a GY modifier) because there is no statutory benefit for oral immunosuppressive drugs in these conditions.Code J8498 or J8597 may be billed only when the antiemetic drug is used in conjunction with a covered oral anticancer drug. Suppliers may bill only for quantities of antiemetic drugs that are to be used within 2 hours before the covered oral anticancer drug. Refer to the Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) policy for information on billing oral antiemetics used in conjunction with intravenous cancer chemotherapeutic regimens.A list of valid NDC numbers called the NDC/HCPCS Crosswalk for covered oral anticancer drugs can be found on the Pricing, Data Analysis and Coding (PDAC) Contractor web site. Until a new NDC number is added to the list, suppliers must submit claims using code J8999.Oral anticancer drugs which are not covered under the oral anticancer drug benefit (i.e., those that are not specifically listed in this policy) must be billed using code A9270 (noncovered item or service) if the supplier chooses to submit a claim.Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) - Policy Article, A52480

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Article - Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) - Policy Article (A52480)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. "reasonable and necessary").Oral Antiemetic Drugs are covered under the Oral Antiemetic Drug benefit (Social Security Act 1861(s)(2)(T)). In order for a beneficiarys oral antiemetic drugs to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as non-covered.An oral antiemetic drug (J8650, J8670, Q0161,Q0162, Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0174, Q0175, Q0177, Q0180,Q0181) is covered if all of the following criteria (1-4) are met:The drug has been approved by the Food and Drug Administration (FDA) for use as an antiemetic, andThe drug has been ordered by the treating practitioner as part of a cancer chemotherapy regimen, andThe drug is used as a full therapeutic replacement for an intravenous antiemetic drug that would otherwise have been administered at the time of the chemotherapy treatment, andOral anti-emetic drugs administered with a particular chemotherapy treatment must be initiated within two hours of the administration of the chemotherapeutic agent and may be continued for a period not to exceed 48 hours from that time.Criterion 3 is not met when the chemotherapy drug is an oral drug or when the chemotherapy drug is administered intravenously in the home setting because the type and dosage of chemotherapy drugs administered in these situations do not require intravenous antiemetic drugs. If all of the criteria are not met, the oral antiemetic drug will be denied as non-covered.A 3-drug combination regimen consisting of an NK-1 antagonist, a 5HT3 antagonist and dexamethasone is covered when all of the criteria above (1-4) are met and all 3 drugs are given in combination.If the NK-1 antagonist and/or dexamethasone is given as an oral anti-emetic outside of the 3-drug regimen, claims will be denied as statutorily non-covered, no benefit.There are three NK-1 antagonists approved for this use, Aprepitant (J8501), rolapitant (J8670) and netupitant/palonosetron (J8655). Covered 3-drug regimens are:Aprepitant (J8501) or rolapitant (J8670) are covered when given as part of a 3-drug regimen that includes a 5HT3 antagonist (Q0162, Q0166, or Q0180) and dexamethasone (J8540).Netupitant/palonosetron (J8655) is covered when given in conjunction with dexamethasone (J8540). A separate 5HT3 antagonist is not needed. Netupitant/palonosetron has had multiple HCPCS codes assigned, depending on the date of service. Refer to the Coding Guidelines section (below) for instructions.If all of the above criteria (1-4) are met, the quantity of oral antiemetic drugs covered for each episode of chemotherapy cannot exceed the initial loading dose plus 48 hours of therapy. However, for the drugs granisetron (Q0166) and dolasetron (Q0180), the quantity of drugs covered for each episode of chemotherapy is limited to the initial loading dose plus 24 hours of therapy. Quantities of drugs in excess of these amounts are non-covered.More than one oral antiemetic drug may be covered for concurrent use if more than one oral drug is needed to fully replace the intravenous drugs that would otherwise have been given.The quantity of oral antiemetic drugs that is dispensed should be limited to a 30-day supply. Orders may be refillable.Supply FeeOne unit of service of supply fee code Q0511 is covered for the first covered oral antiemetic drug that is dispensed in a 30-day period. If covered drugs are dispensed by more than one pharmacy during a 30-day period, one unit of Q0511 is covered for each pharmacy. One unit of service of supply fee code Q0512 is covered for each subsequent covered oral antiemetic drug that is dispensed in that 30-day period. If two dosage strengths of the same drug are dispensed on the same day, one unit of service of the appropriate supply fee is payable for each one. If more than one unit of service of code Q0511 is billed per 30 days by a single pharmacy, the excess units of service will be denied as incorrect coding. If the billed units of service of Q0511 or Q0512 exceed the number of drugs on the claim, the excess units will be denied as not separately payable.Supply fees are eligible for coverage only for drugs that are covered under the related LCD. If the drug on the claim is denied as non-covered, the supply fee will be denied as non-covered.The supply fee code must be billed on the same claim as the drug(s). If it is not, the supply fee will be denied as incorrect billing.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and WOPD list is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The supplier must enter a diagnosis code corresponding to the beneficiary's cancer diagnosis on each claim.The billing of an oral antiemetic 3-drug combination is accomplished by one of the following methods:Netupitant with its fixed combination of palonosetron (J8655) and dexamethasone (J8540), must be billed on the same claim.Aprepitant (J8501) or rolapitant (J8670) used with a separate 5HT3 antagonist (Q0162, Q0166 or Q0180) and dexamethasone (J8540) must be billed on the same claim.In addition to the diagnosis code corresponding to the beneficiarys cancer diagnosis, claims for oral aprepitant (J8501), rolapitant (J8670) or netupitant/palonosetron (J8655) must also be accompanied with a diagnosis code of an encounter for antineoplastic chemotherapy.Claims for code Q0181 must identify the name of the drug, the manufacturer, the dosage strength dispensed, each tablet/suppository/etc and frequency of administration during the covered time period (24-48 hours) as specified on the order. This information must be entered in the narrative field of an electronic claim.KX, GA AND GZ MODIFIERSIf dexamethasone (J8540) and either aprepitant (J8501), rolapitant (J8670) or 300mg netupitant/0.5mg palonosetron (J8655) are used in conjunction with one of the anticancer chemotherapeutic agents listed in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD, a KX modifier must be added to each code.If dexamethasone (J8540) and either aprepitant (J8501), rolapitant (J8670) or 300mg netupitant/.5mg palonosetron (J8655) are not used in conjunction with one of the anticancer chemotherapeutic agents listed in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD the GA or GZ modifier must be added to a claim line for aprepitant, rolapitant, netupitant/palonosetron or dexamethasone. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESThe following instructions apply to claims billed using J codes. When claims are billed in NCPDP format using NDC numbers, different instructions may apply. Refer to the NCPDP Companion Document available through the CMS web site.Netupitant/palonosetron has had multiple HCPCS codes assigned.For claims with dates of service prior to July 1, 2015, use HCPCS code Q0181 (UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN)For claims with dates of service on or after July 1, 2015 through December 31, 2015, use HCPCS code Q9978 (NETUPITANT 300 MG AND PALONOSETRON 0.5 MG, ORAL)For claims with dates of service on or after January 1, 2016, use HCPCS code J8655 (NETUPITANT 300 MG AND PALONOSETRON 0.5 MG, ORAL)The individual drugs contained in netupitant/palonosetron must not be unbundled and billed separately.Rolapitant has had multiple HCPCS codes assigned.For claim on or after September 02, 2015 and before July 1, 2016 use HCPCS code Q0181 (UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN)For dates of service on or after July 1, 2016 and before January 1, 2017 use HCPCS code Q9981 (ROLAPITANT, ORAL, 1 MG).For dates of service on or after January 1, 2017 use HCPCS code J8670 (ROLAPITANT, ORAL, 1 MG).Codes J8501, J8540, J8650, J8655 and Q0162,Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0174, Q0175, Q0177, Q0180,Q0181 or J8670 may be billed only when the oral antiemetic drug is used in the situations described in Non-Medical Necessity Coverage and Payment Rules section. The quantity of drugs billed using codes Q0162,Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0174, Q0175, Q0177, Q0180,Q0181 must not exceed the 24 or 48 hours of therapy specified above.Refer to the Oral Anticancer Drugs policy for information on coding antiemetic drugs used in conjunction with oral anticancer drugs.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Orthopedic Footwear - Policy Article, A52481

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Article - Orthopedic Footwear - Policy Article (A52481)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. "reasonable and necessary").Orthopedic footwear is covered under the leg, arm, back, and neck braces, and artificial legs, arms and eyes benefit (Social Security Act 1861(s)(9)). In order for a beneficiary's DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Shoes, inserts, and modifications are covered in limited circumstances. They are covered in selected beneficiaries with diabetes for the prevention or treatment of diabetic foot ulcers. However, different codes are used for footwear provided under this benefit. See the medical policy on Therapeutic Shoes for Persons with Diabetes for details.Shoes are also covered if they are an integral part of a covered leg brace described by codes L1900, L1920, L1980,L1990, L2000, L2005, L2010, L2020,L2030, L2050, L2060, L2080, or L2090. Oxford shoes (L3224, L3225) are covered in these situations. Other shoes, e.g. high top, depth inlay or custom for non-diabetics, etc. (L3649), are also covered if they are an integral part of a covered brace and if they are medically necessary for the proper functioning of the brace. Heel replacements (L3455, L3460), sole replacements (L3530, L3540), and shoe transfers (L3600, L3610,L3620, L3630 andL3640) involving shoes on a covered brace are also covered. Inserts and other shoe modifications (L3000, L3001, L3002, L3003, L3010, L3020, L3030, L3031, L3040, L3050, L3060, L3070, L3080, L3090, L3100, L3140, L3150, L3160, L3170, L3300, L3310, L3320, L3330, L3332, L3334, L3340, L3350, L3360, L3370, L3380, L3390, L3400, L3410, L3420, L3430, L3440, L3450, L3465, L3470, L3480, L3485, L3500, L3510, L3520, L3550, L3560, L3570, L3580, L3590 and L3595) are covered if they are on a shoe that is an integral part of a covered brace and if they are medically necessary for the proper functioning of the brace. Shoes and related modifications, inserts, heel/sole replacements or shoe transfers billed without a KX modifier will be denied as noncovered because coverage is statutorily excluded.According to a national policy determination, a shoe and related modifications, inserts, and heel/sole replacements, are covered only when the shoe is an integral part of a brace. A matching shoe which is not attached to a brace and items related to that shoe must not be billed with a KX modifier and will be denied as noncovered because coverage is statutorily excluded.Shoes which are incorporated into a brace must be billed by the same supplier billing for the brace. Shoes which are billed separately (i.e., not as part of a brace) will be denied as noncovered. A KX modifier must not be used in this situation.Shoes are denied as noncovered when they are put on over a partial foot prosthesis or other lower extremity prosthesis (L5010, L5020, L5050, L5060, L5100, L5105, L5150, L5160, L5200, L5210, L5220, L5230, L5250, L5270, L5280, L5301, L5312, L5321, L5331, L5341, L5400, L5410, L5420, L5430, L5450, L5460, L5500, L5505, L5510, L5520, L5530, L5535, L5540, L5560, L5570, L5580, L5585, L5590, L5595 and L5600) which is attached to the residual limb by other mechanisms because there is no Medicare benefit for these items.A foot pressure off-loading/ supportive device (A9283) is denied as noncovered because there is no Medicare benefit category for these items.With the exception of the situations described above, orthopedic footwear billed using codes L3000,L3001, L3002, L3003, L3010, L3020, L3030, L3031, L3040, L3050, L3060, L3070, L3080, L3090, L3100, L3140, L3150, L3160, L3170, L3201, L3202, L3203, L3204, L3206, L3207, L3208, L3209, L3211, L3212, L3213, L3214, L3215, L3216, L3217, L3219, L3221, L3222, L3224, L3225, L3230, L3250, L3251, L3252, L3253, L3254, L3255, L3257, L3260, L3265, L3300, L3310, L3320, L3330, L3332, L3334, L3340, L3350, L3360, L3370, L3380, L3390, L3400, L3410, L3420, L3430, L3440, L3450, L3455, L3460, L3465, L3470, L3480, L3485, L3500, L3510, L3520, L3530, L3540, L3550, L3560, L3570, L3580, L3590, L3595, L3600, L3610, L3620, L3630, L3640, and L3649will be denied as noncovered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.An order is not required for a heel or sole replacement or transfer of a shoe to a brace.MODIFIERSGY, KX, LT and RT MODIFIERS:When billing for a shoe that is an integral part of a leg brace or for related modifications, inserts, heel/sole replacements or shoe transfer, a KX modifier must be added to the code. If the shoe or related item is not an integral part of a leg brace, the KX modifier must not be used.When billing for a shoe replacement or shoe transfer that is an integral part of a leg brace, a KX modifier must be added to the code.If the shoe and related modifications, inserts, and heel/sole replacements are not an integral part of a brace, 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.When billing for prosthetic shoes (L3250) and related items, diagnosis code(s) to the highest level of specificity describing the condition which necessitates the prosthetic shoes, must be included on each claim for the prosthetic shoes and related items.When code L3649 with a KX modifier is billed, the claim must include a narrative description of the item provided as well as a brief statement of the medical necessity for the item. This must be entered in the narrative field of an electronic claim.The right (RT) and/or left (LT) modifiers must be used with all footwear HCPCS codes in this policy (refer to the CODING GUIDELINES section for additional information).CODING GUIDELINESOxford shoes that are an integral part of a brace are billed using codes L3224 or L3225 with a KX modifier. For these codes, one unit of service is each shoe. Oxford shoes that are not part of a leg brace must be billed with codes L3215 or L3219 without a KX modifier.Other shoes (e.g., high top, depth inlay or custom shoes for non-diabetics, etc.) that are an integral part of a brace are billed using code L3649 with a KX modifier. Other shoes that are not an integral part of a brace must be billed using codes L3216, L3217, L3221, L3222, L3230, L3251, L3252, L3253, or L3649 without a KX modifier.Depth-inlay or custom molded shoes for diabetics and related inserts and modifications are billed using A codes whether or not the shoe is an integral part of a brace. See the medical policy on Therapeutic Shoes for Persons with Diabetes for coverage, documentation, and additional coding guidelines.Code A9283 (FOOT PRESSURE OFF LOADING/SUPPORTIVE DEVICE, ANY TYPE, EACH) is used for an item that is designed primarily to reduce pressure on the sole or heel of the foot but that does not meet the definition of:A therapeutic shoe for diabetics or related insert or modification; orAn orthopedic shoe or modification; orA walking bootIt may be a shoe-like item, an item that is used inside a shoe and may or may not extend outside the shoe, or an item that is attached to a shoe. It may be prefabricated or custom fabricated.Code L3250 may be used only for a shoe that is custom fabricated from a model of a beneficiary and has a removable custom fabricated insert designed for toe or distal partial foot amputation. The shoe serves to hold the insert on the leg. Code L3250 must not be used for a shoe that is put on other types of leg prostheses (L5010,L5020, L5050, L5060, L5100, L5105, L5150, L5160, L5200, L5210, L5220, L5230, L5250, L5270, L5280, L5301, L5312, L5321, L5331, L5341, L5400, L5410, L5420, L5430, L5450, L5460, L5500, L5505, L5510, L5520, L5530, L5535, L5540, L5560, L5570, L5580, L5585, L5590, L5595 and L5600) that are attached to the residual limb by other mechanisms.The right (RT) and/or left (LT) modifiers must be used with all footwear HCPCS codes in this policy. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for bilateral items (left and right) is billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Ostomy Supplies - Policy Article, A52487

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act Section 1862(a)(1)(A) provisions (i.e. "reasonable and necessary").Ostomy supplies are covered under the Prosthetic Device benefit (Social Security Act Section 1861(s)(8)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Ostomy supplies are covered for use on a beneficiary with a surgically created opening (stoma) to divert urine, or fecal contents outside the body. Ostomy supplies are appropriately used for colostomies, ileostomies or urinary ostomies (see covered diagnosis codes below.) Use for other conditions will be denied as noncovered.A pouch cover should be coded A9270 and will be denied as a noncovered item.Ostomy supplies are not separately payable when a beneficiary is in a covered home health episode. Ostomy supplies must be provided by the home health agency and payment is included in the home health Medicare payment rate. It is not appropriate to bill these to the DME MAC.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.For quantities of supplies that exceed the usual maximum amount, there must be information in the medical record that explains the need for the increased amount. This information must be available upon request.Claims for tape and adhesive (A4450, A4452, A5120) that are billed without an AU modifier or another modifier indicating coverage under a different policy will be rejected as missing information.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, ongoing need for ostomy supplies is assumed to be met. There is no requirement for further documentation of continued medical need as long as the beneficiary continues to meet the Prosthetic Devices benefit.CODING GUIDELINESBARRIERS:A solid barrier (wafer) is an interface between the beneficiary's skin and the pouching system, has measurable thickness and has an adhesive property. Barriers may be integrated into a "1 piece" pouch, they may be manufactured with a flange and be part of a "2 piece" pouch system (skin barrier with flange, e.g., A4414), or they may be used independently (e.g., A4362), usually with a pouch that does not have its own integral skin barrier. An extended wear barrier (e.g., A4409) is a pectin-based barrier with special additives which achieve a stronger adhesive seal, resist breakdown by urine or bowel effluent, permit longer wear times between changes, and normal wear times for those who cannot achieve them with standard barriers. There are distinct codes for extended wear compared to standard wear barriers.A barrier with built-in convexity (e.g., A4407 or A4411) is one in which an outward curve is usually achieved with plastic embedded in the barrier, allowing better protrusion of the stoma and adherence to the skin. There are distinct codes for barriers with built-in convexity compared to flat barriers.Ostomy skin barriers greater than 4x4 inches (e.g., A4408) refer to the size of the skin barriers themselves, and not to the area of any surrounding tape.FACEPLATES:A faceplate is a solid interface between the beneficiarys skin and the pouch. It is usually made of plastic, rubber or encased metal. It does not have an adhesive property and there is no pectin-based or karaya material that is an integral part of a faceplate. It can be taken off the skin and reattached repeatedly. It is secured by means of a separate adhesive and/or an elastic belt. The clips for attaching the belt are usually a part of the faceplate. There is no coding distinction between flat and convex faceplates.The following table lists codes for faceplate systems. When supplying a pouch with faceplate attached (Column I) a claim may not be made for a component product from Column II provided at the same time.Column IColumn IIA4375A4361, A4377A4376A4361, A4378A4379A4361, A4381, A4382A4380A4361, A4383A4416A4366A4417A4366A4418A4366A4419A4366A4423A4366A4424A4366A4425A4366A4427A4366POUCHES:A pouch is a device for collecting stomal output. A pouch for collecting bowel effluent may be either "drainable" with an opening at the bottom through which the fecal contents are emptied, or closed with a sealed bottom and no outlet. A "urinary" pouch normally incorporates anti-reflux devices and a tap or spigot to empty the urine contents.A pouch "with barrier attached" is one type of "1 piece" system in which a solid barrier is part of the pouch. There are distinct codes for 1-piece pouches with convex barriers and extended wear barriers (see "Barriers").A pouch "without barrier attached" is a pouch with or without a thin adhesive coating that is applied either directly to the skin or to a separate barrier. It is also described as a "1 piece" system.A pouch, which is part of a 2 piece system, has a flange, which enables it to be coupled to a skin barrier with flange.A pouch "with faceplate attached" or "for use on a faceplate" is generally rubber or heavy plastic. It is drainable, cleanable, and reusable for periods of weeks to months, depending on the product.A "high output" pouch (A4412, A4413, A4435) has a capacity of greater than or equal to 0.75 liters, is drainable with a large bore solid spout with cap or plug, and is either part of a 2 piece system (A4412, A4413) or a single-piece system (A4435).Codes for pouches with filters (e.g., A4416) describe pouches that have an opening which allows venting of trapped gas. They typically include materials such as charcoal to deodorize the vented gas. Code A4368 describes replacement filter material.Code A4366 describes a separate ostomy vent that can be added by the beneficiary to a pouch to allow the release of gas. This code must not be used for pouches in which a vent with a filter is incorporated in the pouch by the manufacturer. Those products are described by the codes for ostomy pouches with a filter (A4416, A4417, A4418, A4419, A4423, A4424, A4425, A4427).Absorbent material (A4422) that is added to the ostomy pouch may come as sheets, pads or crystals.An ostomy pouch with faucet-type tap with valve (e.g., A4429) has a valve for draining urine.A locking flange (e.g., A4420) is a lever type flange locking mechanism. It differs from simple push-on pouch securing mechanisms. The mechanism may be incorporated either in the pouch flange or skin barrier flange (2 piece system).PASTES:A paste is used as a protective layer and sealant beneath ostomy appliances, and is applied directly on the skin. It may be primarily pectin based (A4406), or non-pectin based, e.g., karaya (A4405).MISCELLANEOUS:Code A4436 (IRRIGATION SUPPLY; SLEEVE, REUSABLE, PER MONTH) describes an ostomy accessory that is secured around the stoma using a belt or by locking onto a faceplate that is attached to the peristomal skin. They are typically used for a week or more, cleaned and dried between irrigations, before finally being discarded.Code A4437 (IRRIGATION SUPPLY; SLEEVE, DISPOSABLE, PER MONTH) describes an ostomy accessory that is applied directly onto the peristomal skin, and is discarded after each irrigation due to inability to re-adhere to the skin surface.Codes A4436 (IRRIGATION SUPPLY; SLEEVE, REUSABLE, PER MONTH) and A4437 (IRRIGATION SUPPLY; SLEEVE, DISPOSABLE, PER MONTH) describe a monthly supply allowance for irrigation sleeves. No more than 1 unit of service is billable per thirty (30) days.Code A4400 (Ostomy irrigation set) is not valid for claim submission. If an irrigation kit is supplied, the individual components should be billed using individual codes, A4398 and A4399.Ostomy clamps (A4363) are used with drainable pouches and are not used with urinary pouches. Ostomy clamps are only payable when ordered as a replacement. Claims for ostomy clamps billed with ostomy pouches will be denied as not separately payable with ostomy pouches.When codes A4450, A4452, and A5120 are used with ostomy supplies, they must be billed with the AU modifier. For this policy, codes A4450, A4452, and A5120 are the only codes for which the AU modifier may be used.Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Pneumatic Compression Devices - Policy Article, A52488

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Pneumatic Compression Devices (PCDs) are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.PREVENTION OF VENOUS THROMBOEMBOLISMA PCD that provides intermittent limb compression for the purpose of prevention of venous thromboembolism (E0676) is a preventive service. Items that are used for a preventative service or function are excluded from coverage under the Medicare DME benefit.Therefore, claims for E0676 (INTERMITTENT LIMB COMPRESSION DEVICE (INCLUDES ALL ACCESSORIES), NOT OTHERWISE SPECIFIED) will be statutorily denied as no Medicare benefit.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.GENERALFor PCDs coded E0650 or E0651 the medical record must contain sufficient detailed and specific information to show that the applicable coverage criteria for I - LYMPHEDEMA or II - CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS (CVI) are met.For PCDs coded as E0652 the medical record must contain sufficient detailed and specific information to show that the applicable coverage criteria in III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN are met.Certificate of Medical Necessity (CMN)Providers and suppliers no longer need to submit a Certificate of Medical Necessity (CMN) for services rendered on or after January 1, 2023.For claims with dates of service on or after January 1, 2023 Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023 If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.For dates of service for which a CMN is required, a CMN which has been completed, signed, and dated by the treating practitioner must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the standard written order (SWO) if it contains the same information as required in a SWO. The CMN for pneumatic compression pumps is CMS Form 846. The initial claim must include an electronic copy of the CMN. In addition to the order information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.For dates of service for which a CMN is required, if question #1 on the CMN ("Does the beneficiary have chronic venous insufficiency with venous stasis ulcers?") is answered "Yes," documentation reflecting all of the following must be in the beneficiary's medical record and made available upon request:The location of venous stasis ulcer(s),How long each ulcer has been continuously present,Previous treatment with a compression bandage system or compression garment, appropriate dressings for the ulcer(s), exercise and limb elevation for at least the past 6 months,Evidence of regular practitioner visits for treatment of venous stasis ulcer(s) during the past 6 months.Refer to the Supplier Manual for more information on documentation requirements.CODING GUIDELINES

Local Coverage Articles, Pneumatic Compression Devices - Policy Article, A52488

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The location of venous stasis ulcer(s),How long each ulcer has been continuously present,Previous treatment with a compression bandage system or compression garment, appropriate dressings for the ulcer(s), exercise and limb elevation for at least the past 6 months,Evidence of regular practitioner visits for treatment of venous stasis ulcer(s) during the past 6 months.Refer to the Supplier Manual for more information on documentation requirements.CODING GUIDELINESPCDs consist of an electrical pneumatic pump and an inflatable appliance that encloses the applicable body part. The pump fills the appliance with compressed air to predetermined pressures and intermittently alternates inflation and deflation to preset cycle times. The pressures and cycles vary between devices and, in some devices, are user-adjustable.PCDs for the Treatment of Lymphedema or Chronic Venous Insufficiency (CVI) With UlcersPCDs used for the treatment of lymphedema or CVI with ulcers are coded based on the characteristics of the compression pump. The only HCPCS codes for PCDs used to treat lymphedema or CVI with ulcers are:E0650 - PNEUMATIC COMPRESSOR, NON-SEGMENTAL HOME MODELE0651 - PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITHOUT CALIBRATED GRADIENT PRESSUREE0652 - PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITH CALIBRATED GRADIENT PRESSUREThe HCPCS codes used for the inflatable appliances used with PCDs E0650 - E0652 are:E0655 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF ARME0656 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, TRUNKE0657 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, CHESTE0660 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL LEGE0665 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL ARME0666 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF LEGE0667 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL LEGE0668 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL ARME0669 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF LEGE0670 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, INTEGRATED, 2 FULL LEGS AND TRUNKE0671 - SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL LEGE0672 - SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL ARME0673 - SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, HALF LEGA non-segmented pneumatic compressor (E0650) is a device that has a single outflow port on the compressor. Pressurized air from the single outflow port is transmitted to an appliance with single or multiple segments. The segment(s) inflate and deflate based on the compressor-specified pressure and cycle times. The number of segments contained in the appliance does not affect HCPCS coding of the compressor. Appliances appropriate for use with an E0650 PCD are E0655, E0660, E0665, E0666, E0671, E0672 and E0673.Segmental gradient pressure pneumatic appliances (E0671, E0672, E0673) are appliances/sleeves which are used with a non-segmented pneumatic compressor (E0650) but which achieve a pressure gradient through the design of the tubing and/or air chambers.A segmented pneumatic compressor (E0651, E0652) is a device that has multiple outflow ports on the compressor. The pressurized air from each outflow ports is transmitted to corresponding segments on the appliance. The segments inflate and deflate based on the compressor-specified pressures and cycle times.A segmented device without calibrated gradient pressure (E0651) is one in which either the same pressure is present in each segment or there is a predetermined pressure gradient in successive segments. E0651 PCDs cannot individually set or adjust pressures in separate appliance segments. In an E0651 PCD, the pressure is usually set by a single control on the distal segment. Appliances appropriate for use with an E0651 PCD are E0667, E0668, E0669.A segmented device with calibrated gradient pressure (E0652) is characterized by manual control on at least three outflow ports that can deliver an individually determined pressure to each corresponding appliance segment. Use of tubing and/or appliances that can create a pressure gradient independently from the compressor does not qualify to classify the compressor as E0652. These methods are not considered as calibrated gradient pressure. Appliances appropriate for use with an E0652 PCD are E0656, E0657, E0667, E0668, E0669 and E0670.All limb appliances (E0655, E0660,E0665, E0667, E0668, E0669, E0670, E0671, E0672, E0673) used with PCDs E0650, E0651, E0652 must enclose the affected limb(s) sufficiently to prevent retrograde edema fluid flow (distally). All limb appliances (E0655, E0660,E0665, E0667, E0668, E0669, E0670, E0671, E0672, E0673) used with PCDs E0650, E0651, E0652 must avoid a tourniquet effect during compression that would prevent distal fluid from moving proximally. Appliances that create a tourniquet effect or cause retrograde flow of edema fluid must be coded A4600 - SLEEVE FOR INTERMITTENT LIMB COMPRESSION DEVICE, REPLACEMENT ONLY, EACH.PCDs for the Treatment of Peripheral Artery DiseaseThe only HCPCS code for PCDs used for the treatment of peripheral artery disease is:E0675 - PNEUMATIC COMPRESSION DEVICE, HIGH PRESSURE, RAPID INFLATION/DEFLATION CYCLE, FOR ARTERIAL INSUFFICIENCY (UNILATERAL AND BILATERAL SYSTEM)The HCPCS codes used for the inflatable appliances used with PCD E0675 are:E0667 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL LEGE0668 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL ARME0669 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF LEGAn E0675 is a PCD that delivers high pressure and rapid inflation/deflation cycles for the treatment of arterial insufficiency (peripheral artery disease). HCPCS code E0675 is all-inclusive, i.e. all product variations in pressures, cycle characteristics, timing, control systems, appliance configurations (not all-inclusive) are considered as described by the code. Appliances appropriate for use with an E0675 PCD are E0667, E0668, E0669.PCDs for Deep Venous Thrombosis (DVT)The only HCPCS code for PCDs used for the prevention of DVT is:E0676 - INTERMITTENT LIMB COMPRESSION DEVICE (INCLUDES All ACCESSORIES), NOT OTHERWISE SPECIFIEDAn E0676 is a PCD that delivers pressure and inflation/deflation cycles for the prevention of deep venous thrombosis. HCPCS code E0676 is all-inclusive, i.e. all product variations in pressures, cycle characteristics, timing, control systems, appliance configurations (not all-inclusive) are considered as described by the code.The appliance(s) and any other accessories, options, and supplies used with PCD E0676 are included in the payment for HCPCS code E0676 at the time of initial issue and must not be billed separately to Medicare. If a supplier chooses to bill separately for these items at the time of initial issue, then HCPCS code A9900 - MISCELLANEOUS DME SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS CODE must be used to bill Medicare for the item(s).HCPCS code A4600 SLEEVE FOR INTERMITTENT LIMB COMPRESSION DEVICE, REPLACEMENT ONLY, EACH is used only when the appliance used with an E0676 device is being replaced. HCPCS codes E0655,E0656, E0657, E0660, E0665, E0666, E0667, E0668, E0669, E0670, E0671, E0672, E0673 must not be used when billing for appliances used with E0676 devices.MiscellaneousWhen a foot or hand segment is used in conjunction with any leg or arm appliance respectively, there must be no separate billing for this segment. It is considered included in the code for the leg or arm appliance.The only products that may be billed to the DME MACs using codes E0650, E0651, E0652 and E0675 are those for which the Pricing, Data Analysis, and Coding (PDAC) contractor has completed a Coding Verification Review. The coding determination subsequently is published on the appropriate Product Classification List (PCL).Information concerning the documentation that must be submitted to the PDAC for a Coding Verification Review can be found on the PDAC website or by contacting the PDAC.If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the clam line will be denied as incorrect coding.

Local Coverage Articles, Pressure Reducing Support Surfaces - Group 1 - Policy Article, A52489

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CMS National Coverage PolicyN/AArticle TextNONMEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act Section 1862(a)(1)(A) provisions (i.e. "reasonable and necessary").Pressure-reducing support surfaces are covered under the Durable Medical Equipment benefit (Social Security Act Section 1861(s)(6)). In order for a beneficiarys DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A foam overlay or mattress which does not have a waterproof cover is not considered durable and will be denied as non-covered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.RELATED CLINICAL INFORMATIONA beneficiary needing a pressure reducing support surface should have a care plan which has been established by the beneficiary'streating practitioneror home care nurse, which is documented in the beneficiary's medical records, and which generally should include the following:Education of the beneficiary and caregiver on the prevention and/or management of pressure ulcersRegular assessment by a nurse,treating practitioner, or other licensed healthcare practitionerAppropriate turning and positioningAppropriate wound care (for a stage 2, 3 or 4 ulcer)Appropriate management of moisture/incontinenceNutritional assessment and intervention consistent with the overall plan of careMODIFIERSKX, GA AND GZ MODIFIERSSuppliers must add a KX modifier to a code only if all of the criteria in the "Coverage Indications, Limitations and/or Medical Necessity" section of the related LCD have been met and evidence of such is maintained in the supplier's files. This information must be available upon request.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.When code E1399 is billed, the claim must include a narrative description of the item, the manufacturer, the product name/number, and information justifying the medical necessity for the item.CODING GUIDELINESCodes E0185, E0197, E0198 and E0199 termed "pressure pad for mattress" describe nonpowered pressure reducing mattress overlays. These devices are designed to be placed on top of a standard hospital or home mattress.A gel/gel-like mattress overlay (E0185) is characterized by a gel or gel-like layer with a height of 2 inches or greater.An air mattress overlay (E0197) is characterized by interconnected air cells having a cell height of 3 inches or greater that are inflated with an air pump.A water mattress overlay (E0198) is characterized by a filled height of 3 inches or greater.A foam mattress overlay (E0199) is characterized by all of the following:Base thickness of 2" or greater and peak height of 3" or greater if it is a convoluted overlay (e.g., eggcrate) or an overall height of at least 3 inches if it is a non-convoluted overlay, andFoam with a density and other qualities that provide adequate pressure reduction, andDurable, waterproof coverCodes E0184, E0186, E0187 and E0196 describe nonpowered pressure reducing mattresses.A foam mattress (E0184) is characterized by all of the following:Foam height of 5 inches or greater, andFoam with a density and other qualities that provide adequate pressure reduction, andDurable, waterproof cover, andCan be placed directly on a hospital bed frameAn air, water or gel mattress (E0186, E0187, E0196) is characterized by all of the following:Height of 5 inches or greater of the air, water, or gel layer (respectively), andDurable, waterproof cover, andCan be placed directly on a hospital bed frameCodes E0181, E0182, and A4640 describe powered pressure reducing mattress overlay systems (alternating pressure or low air loss). They are characterized by all of the following:An air pump or blower which provides either sequential inflation and deflation of air cells or a low interface pressure throughout the overlay, andInflated cell height of the air cells through which air is being circulated is 2.5 inches or greater, andHeight of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure overlays), and air pressure provide adequate patient lift, reduce pressure and prevent bottoming outA foam overlay or mattress which does not have a waterproof cover should be coded using A9270. Other Group 1 support surfaces which do not meet the characteristics specified in this section should be billed using code E1399.Alternating pressure mattress overlays or low air loss mattress overlays are coded using codes E0181, E0182, and A4640.Code A4640 or E0182 should only be billed when they are provided as replacement components for a beneficiary-owned E0181 mattress overlay system.A Column II code is included in the allowance for the corresponding Column I code when provided at the same time.Column IColumn IIE0181A4640, E0182Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Pressure Reducing Support Surfaces - Group 2 - Policy Article, A52490

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act Section 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Pressure-reducing support surfaces are covered under the Durable Medical Equipment benefit (Social Security Act Section 1861(s)(6)). In order for a beneficiarys DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.MODIFIERSKX, GA, AND GZ MODIFIERSSuppliers must add a KX modifier to a code only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met and evidence of such is maintained in the supplier's files. This information must be available upon request.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.When code E1399 is billed, the claim must include the manufacturer and the model name/number.CODING GUIDELINESHeavy duty and bariatric devices are included in the codes for pressure reducing support surfaces: E0193, E0277, E0371, E0372 and E0373.Code E0277 describes a powered pressure reducing mattress (alternating pressure, low air loss, or powered flotation without low air loss) which is characterized by all of the following:An air pump or blower which provides either sequential inflation and deflation of the air cells or a low interface pressure throughout the mattress, andInflated cell height of the air cells through which air is being circulated is 5 inches or greater, andHeight of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure mattresses), and air pressure provide adequate beneficiary lift, reduce pressure and prevent bottoming out, andA surface designed to reduce friction and shear, andCan be placed directly on a hospital bed frame.Code E0193 describes a semi-electric or total electric hospital bed with a fully integrated powered pressure reducing mattress which has all the characteristics defined above.Code E0371 describes an advanced nonpowered pressure-reducing mattress overlay which is characterized by all of the following:Height and design of individual cells which provide significantly more pressure reduction than a group 1 overlay and prevent bottoming out, andTotal height of 3 inches or greater, andA surface designed to reduce friction and shear, andDocumented evidence to substantiate that the product is effective for the treatment of conditions described by the coverage criteria for group 2 support surfaces.Code E0372 describes a powered pressure reducing mattress overlay (low air loss, powered flotation without low air loss, or alternating pressure) which is characterized by all of the following:An air pump or blower which provides either sequential inflation and deflation of the air cells or a low interface pressure throughout the overlay, andInflated cell height of the air cells through which air is being circulated is 3.5 inches or greater, andHeight of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure overlays), and air pressure to provide adequate beneficiary lift, reduce pressure and prevent bottoming out, andA surface designed to reduce friction and shear.Code E0373 describes an advanced nonpowered pressure reducing mattress which is characterized by all of the following:Height and design of individual cells which provide significantly more pressure reduction than a group 1 mattress and prevent bottoming out, andTotal height of 5 inches or greater, andA surface designed to reduce friction and shear, andDocumented evidence to substantiate that the product is effective for the treatment of conditions described by the coverage criteria for group 2 support surfaces, andCan be placed directly on a hospital bed frame.The only products that may be billed using codes E0371 or E0373 are those for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a Coding Verification Request can be found on the PDAC web site or by contacting the PDAC. A PCL with products that have received a coding verification can be found on the PDAC web site. If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Group 2 support surfaces are coded based on the characteristics specified in the above definitions. Products which do not meet these definitional characteristics but meet the characteristics for another support surface grouping (i.e., Group 1 support surfaces) will be coded based on the characteristics specified in the Coding Guidelines section of the Group 1 Pressure Reducing Support Surfaces related Policy Article. Products which do not meet the characteristics specified in either the Group 1 or Group 2 Support Surfaces related Policy Article must be coded using code E1399.Either alternating pressure mattresses or low air loss mattresses are coded using code E0277.Products containing multiple components are categorized according to the clinically predominant component (usually the topmost layer of a multi-layer product). For example, a product with 3" powered air cells on top of a 3" foam base would be coded as a powered overlay (code E0181) not as a powered mattress (E0277).Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.

Local Coverage Articles, Tracheostomy Care Supplies - Policy Article, A52492

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Tracheostomy Supplies are covered under the Prosthetic Benefit (Social Security Act 1861(s)(8)). In order for a beneficiarys supplies to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Supplies for care of a tracheostomy site are covered for a beneficiary following an open surgical tracheostomy which has been open or is expected to remain open for at least three months. The quantities of supplies included in a tracheostomy care kit are to provide all necessary quantities for the care of the tracheostomy site and there must not be any additional quantity billed of these codes for this purpose. Additional supplies may be billed, as appropriate and necessary, only for care other than for a tracheostomy site, such as for speaking valves.Claims for tape (A4450 or A4452) or for wipes or swabs (A5120) that are billed without an AU modifier will be rejected as missing information.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The diagnosis code that justifies the need for these items must be included on each claim.CODING GUIDELINESA tracheostomy care or cleaning starter kit (A4625) contains the following:ItemNumber includedplastic tray1basin1sterile gloves1 pairtube brush1pipe cleaners3pre-cut tracheostomy dressing1gauze1 roll4x4 sponges4cotton tip applicators2twill tape30 inchesA tracheostomy care kit for an established tracheostomy (A4629) contains the following:ItemNumber includedtube brush1pipe cleaners2cotton tip applicators2twill tape30 inches4x4 sponges2A Column II code is included in the allowance for the corresponding Column I code when provided at the same time.Column IColumn IIA4625A4626A4629A4626Tracheostomy care kits provided in the first two postoperative weeks should be coded as A4625.Tracheostomy care kits provided after the first two postoperative weeks should be coded as A4629.When codes A4450, A4452 and A5120 are used with Tracheostomy Care Supplies, they must be billed with the AU modifier. For this policy, codes A4450, A4452 and A5120 are the only codes for which the AU modifier may be used.A7526 is a tracheostomy collar/holder that is used to secure the tracheostomy tube's positioning, minimize movement of the tracheostomy tube and reduce the risk of cannula disruption or decannulation. Fastener tabs attach to the tracheostomy tube to hold the collar in place. A7526 should not be used for billing twill ties, or twill tape or equivalent fabric or plastic supplies.Heat/Moisture ExchangersHeat/Moisture Exchangers (HME; see below for specific component codes) are a type of stoma cover which help laryngectomees partially restore functions previously performed by the nose and upper airway. During exhalation, warmth and humidity are conveyed from the lungs and deposited into the filter. During inhalation, the warmth and moisture are picked back up by incoming air and returned to the lungs.HME consist of a plastic cassette/holder that contains a filter. The holder fits into a plastic housing which is held in place over the tracheostoma by adhesive. An HME may be used by itself or in addition to a tracheostoma valve (A7501).A4481 is a small filter usually having adhesive along one edge which is attached to the skin and simply covers the tracheostoma to keep large piece of debris out. It is not an HME.A4483 is a moisture exchanger that is used only with an invasive mechanical ventilator and should not be billed as an HME over a tracheostoma.A7503 is a device that connects to the tracheostoma cassette and holds an HME filter. The holder/cap can open and close to replace the HME filter.A7504 is a filter that fits into A7503.A7506 is a double sided adhesive disc that attaches the HME cassette to the beneficiarys skin.A7507 is an integrated filter and holder that utilizes A7506 to fit over the tracheostomy or may utilize liquid adhesive on both sides of the cassette to attach the HME to the beneficiary.A7508 is integrated housing and adhesive used with either an HME or tracheostoma valve.A7509 is the integrated filter holder and housing used with the HME system.A tracheostomy valve with diaphragm (A7501) is a device used over the tracheostomy stoma by a beneficiary who has had the larynx removed and has a tracheo-esophageal voice prosthesis, but does not have a tracheostomy tube.Tracheostomy tubes (A7520, A7521, A7522) are all-inclusive. All variations in tracheostomy tube construction such as dimensions, materials, cuffs, connectors etc., including all variations often classified by manufacturers as customized are included in HCPCS codes A7520, A7521, and A7522.Miscellaneous or NOC (not otherwise classified) codes such as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS) or A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED) must not be used to bill Medicare for any tracheostomy tube. Use of a miscellaneous code to bill Medicare for any tracheostomy tubes is incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, High Frequency Chest Wall Oscillation Devices - Policy Article, A52494

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).High frequency chest wall oscillation devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFinal Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The diagnosis code that justifies the need for these items must be included on the claim.MODIFIERSKX, GA, AND GZ MODIFIERS:Suppliers must add a KX modifier to codes for an HFCWO device and accessories only if all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter GA on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or GZ if they have not obtained a valid ABN.There must be information in the beneficiarys medical record that describes in detail the underlying medical condition(s) that cause the accumulation of pulmonary secretions, the treatment interventions (for example, chest physiotherapy, postural drainage, medications used, mechanical modalities such as in-exsufflation devices (not all-inclusive)) and the effectiveness of the treatment. This information must be available upon request.Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESHCPCS code E0483 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM, WITH FULL ANTERIOR AND/OR POSTERIOR THORACIC REGION RECEIVING SIMULTANEOUS EXTERNAL OSCILLATION, INCLUDES ALL ACCESSORIES AND SUPPLIES, EACH) devices (HFCWO) use positive and negative pressure changes to augment peripheral and tracheal mucus movement towards the airway opening. This function is performed by extra-thoracic oscillations generated by forces external to the respiratory system. External chest wall oscillations are applied using a vest worn around the torso, which vibrates at variable frequencies and intensities, as set by the operator. E0483 devices may use differing technologies, e.g. air-pulse generators and an inflatable vest, an array of mechanical oscillators in a vest providing synchronized oscillation. E0483 is all-inclusive regardless of the technique used to produce HFCWO.HCPCS code A7025 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM VEST, REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH) describes a complete replacement vest. This includes all components such as mechanical oscillators, electrical componentry, inflatable air sacs, connectors. Separate billing of vest components when an entire vest is replaced is incorrect coding unbundling.HCPCS code A7026 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM HOSE, REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH) describes the tubing used with an air pulse generator type of HFCWO device.HCPCS code E0483 describes a complete system. Separate billing of A7025 and/or A7026 in combination with E0483 is incorrect coding unbundling.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following high frequency chest wall oscillation devices HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0483, A7025, A7026For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Intrapulmonary Percussive Ventilation System - Policy Article, A52495

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. "reasonable and necessary").Intrapulmonary Percussive Ventilation Systems are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). However, in order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.CODING GUIDELINESAn intrapulmonary percussive ventilation system (IPV) delivers a series of pressurized gas minibursts at rates greater than 100 cycles per minute to the respiratory tract.E0481 includes the compressor, hand held units, tubing and all related accessories. This includes both systems in which the minibursts of air are generated by the compressor and systems in which the minibursts of air are generated by a hand held percussive nebulizer used with a standard high-pressure compressor.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Lower Limb Prostheses - Policy Article, A52496

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Lower limb prostheses are covered under the Medicare Artificial Legs, Arms and Eyes benefit (Social Security Act 1861(s)(9)). In order for a beneficiary's lower limb prosthesis to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition to meeting the benefit policy, there are specific statutory payment policy requirements, discussed below, that also must be met.GENERAL:A repair is a restoration of the prosthesis to correct problems due to wear or damage.An adjustment is any modification to the prosthesis due to a change in the beneficiary's condition or to improve the function of the prosthesis.The following items are included in the reimbursement for a prosthesis and, therefore, are not separately billable to Medicare under the prosthetic benefit:Evaluation of the residual limb and gaitFitting of the prosthesisCost of base component parts and labor contained in HCPCS base codesRepairs due to normal wear or tear within 90 days of deliveryAdjustments of the prosthesis or the prosthetic component made when fitting the prosthesis or component and for 90 days from the date of delivery when the adjustments are not necessitated by changes in the residual limb or the beneficiary's functional abilities.Payment for Prostheses Provided During a Medicare Part A Covered Hospital StayPayment by Medicare Part A for a prosthesis provided to a beneficiary for use during a Medicare Part A covered hospital stay is eligible for inclusion in the payment for the hospital stay if the following criteria (1 and 2) are met:The prosthesis is provided to a beneficiary during the inpatient hospital stay; and,The beneficiary uses the prosthesis for reasonable and necessary inpatient treatment or rehabilitation.In this situation, a claim must not be submitted to the DME MAC.Payment by the DME MAC for a prosthesis delivered to a beneficiary,notfor use during a Medicare Part A covered hospital stay, is eligible for DME MAC coverage if the following criteria (1 3) are met:The prosthesis is reasonable and necessary for a beneficiary after discharge from a hospital; and,The prosthesis is delivered to the beneficiary no more than two days prior to discharge to home; and,The prosthesis isnotused for inpatient treatment or rehabilitation.Payment for Prostheses Provided During a Medicare Part A Covered Skilled Nursing Facility (SNF) StayPayment by Medicare Part A for a prosthesis provided to a beneficiary, described by codes L5000, L5010, L5020, L5400, L5410, L5420, L5430, L5450, L5460, L5987, L8400, L8410, L8417, L8420, L8430, L8440, L8460, L8470, and L8480, for use during a Medicare Part A covered SNF stay is eligible for inclusion in the payment for the SNF stay if the following criteria (1 and 2) are met:The prosthesis is provided to a beneficiary during the SNF stay; and,The beneficiary uses the prosthesis for reasonable and necessary treatment or rehabilitation.In this situation, a claim must not be submitted to the DME MAC.Claims (other than for the above HCPCS codes) for a lower limb prosthesis provided to a beneficiary during a Medicare Part A covered SNF stay (see below), and claims for any lower limb prosthesis provided to a beneficiary during a non-covered Medicare Part A SNF stay, are to be submitted to the DME MAC.Payment by the DME MAC for a prosthesis delivered to a beneficiary during a Part A covered SNF stay is eligible for DME MAC coverage if:The prosthesis is reasonable and necessary for a beneficiarys use during the Medicare Part A covered SNF stay; and,The prosthetic components are classified as major category III codes under the SNFs consolidated billing.ADJUSTMENTS, REPAIRS, AND COMPONENT REPLACEMENT:Routine periodic servicing, such as testing, cleaning, and checking of the prosthesis is noncovered. Adjustments to a prosthesis required by wear or by a change in the beneficiary's condition are covered under the initialtreating practitioner'sorder for the prosthesis for the life of the prosthesis.Repairs to a prosthesis are covered when necessary to make the prosthesis functional. If the expense for repairs exceeds the estimated expense of purchasing another entire prosthesis, no payments can be made for the amount of the excess. Maintenance which may be necessitated by manufacturer's recommendations or the construction of the prosthesis and must be performed by the prosthetist is covered as a repair.Replacement of a prosthesis or prosthetic component is covered if the treatingpractitioner orders a replacement device or part because of any of the following:A change in the physiological condition of the beneficiary; orIrreparable wear of the device or a part of the device; orThe condition of the device, or part of the device, requires repairs and the cost of such repairs would be more than 60% of the cost of a replacement device, or of the part being replaced.Replacement of a prosthesis or prosthetic components required because of loss or irreparable damage may be reimbursed without a practitioner's order when it is determined that the prosthesis as originally ordered still fills the beneficiary's medical needs.MISCELLANEOUS:A prosthetic donning sleeve (L7600) will be denied as noncovered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.When submitting a prosthetic claim, the billed code for knee, foot, ankle and hip (HCPCS codes L5610, L5611, L5613, L5614, L5616, L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, L5848, L5856, L5857, L5858, L5859, L5930, L5961, L5970, L5971, L5972, L5973, L5974, L5975, L5976, L5978, L5979, L5980, L5981, L5982, L5984, L5985, L5986, L5987) components must be submitted with modifiers K0 - K4, indicating the expected beneficiary functional level. This expectation of functional ability information must be clearly documented and retained in the prosthetist's records. The simple entry of a K modifier in those records is not sufficient. There must be information about the beneficiarys history and current condition which supports the designation of the functional level by the prosthetist.For L5859, the medical records should describe the nature and extent of the comorbidity of the spine or the sound limb which is what is limiting this beneficiary to a household ambulator, and clearly document how this feature will enable the beneficiary to function as a community ambulator.Refer to the Supplier Manual for more information on documentation requirements.REPAIR/REPLACEMENT (BPM Ch 15, 120)Adjustments and repairs of prostheses and prosthetic components are covered under the original order for the prosthetic device.Medicare payment may be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if atreating practitionerdetermines that the replacement device, or replacement part of such a device, is reasonable and necessary. Claims involving the replacement of a prosthesis or major component (foot, ankle, knee, socket) must be supported by a new treating practitioner's order and documentation supporting the reason for the replacement. The reason for replacement must be documented by the treating practitioner, either on the order or in the medical record, and must fall under one of the following:A change in the physiological condition of the patient resulting in the need for a replacement. Examples include but are not limited to, changes in beneficiary weight, changes in the residual limb, beneficiary functional need changes; or,An irreparable change in the condition of the device, or in a part of the device resulting in the need for a replacement; or,The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.The prosthetist must retain documentation of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved irrespective of the time since the prosthesis was provided to the beneficiary. This information must be available upon request. It is recognized that there are situations where the reason for replacement includes but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive beneficiary weight or prosthetic demands of very active amputees.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, unless continued coverage requirements are specified in the LCD, ongoing need for the lower limb prosthesis is assumed to be met. There is no requirement for further documentation of continued medical need as long as the beneficiary continues to meet the Artificial Legs, Arms and Eyes benefit.MODIFIERSLT and RT MODIFIERS:The right (RT) and left (LT) modifiers must be used with prosthesis codes (refer to the CODING GUIDELINES section for additional information).CODING GUIDELINESREPAIR AND LABOR CODINGCode L7510 is used to bill for any "minor" materials (i.e., those without specific HCPCS codes) used to achieve the adjustment and/or repair.Code L7520 is used to bill for labor associated with adjustments and repairs that either do not involve replacement parts or that involve replacement parts billed with code L7510. Code L7520 must not be billed for labor time involved in the replacement of parts that are billed with a specific HCPCS code. Labor is included in the allowance for those codes.One unit of service of code L7520 represents 15 minutes of labor time. Documentation must exist in the supplier's records indicating the specific adjustment and/or repair performed and the time involved. The time reported for L7520 must only be for actual repair time. Time performing the following services (not all-inclusive) must not be billed using code L7520:Evaluation to determine the need for a repair or adjustment or follow-up assessmentEvaluation of problems regarding the fit or function of the prosthesisGeneral beneficiary education or gait instructionProgramming of electronic componentrySUSPENSIONCode L5671 includes both the part of the suspension locking mechanism that is integrated into the prosthesis socket and the pin(s), lanyard, or other component which is attached to the socket insert. L5671 does not include the socket insert itself. The socket inserts used in conjunction with a suspension locking mechanism are billed with codes L5673, L5679, L5681, or L5683, as appropriate. These codes include socket inserts with or without a distal umbrella adapter for attaching the pin or lanyard of the locking mechanism.

Local Coverage Articles, Lower Limb Prostheses - Policy Article, A52496

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Article - Lower Limb Prostheses - Policy Article (A52496)

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One unit of service of code L7520 represents 15 minutes of labor time. Documentation must exist in the supplier's records indicating the specific adjustment and/or repair performed and the time involved. The time reported for L7520 must only be for actual repair time. Time performing the following services (not all-inclusive) must not be billed using code L7520:Evaluation to determine the need for a repair or adjustment or follow-up assessmentEvaluation of problems regarding the fit or function of the prosthesisGeneral beneficiary education or gait instructionProgramming of electronic componentrySUSPENSIONCode L5671 includes both the part of the suspension locking mechanism that is integrated into the prosthesis socket and the pin(s), lanyard, or other component which is attached to the socket insert. L5671 does not include the socket insert itself. The socket inserts used in conjunction with a suspension locking mechanism are billed with codes L5673, L5679, L5681, or L5683, as appropriate. These codes include socket inserts with or without a distal umbrella adapter for attaching the pin or lanyard of the locking mechanism.Codes L5681 and L5683 are for use only with the initial issue of a custom fabricated socket insert. Additional inserts (either custom fabricated or prefabricated) provided at the time of initial issue or replacement socket inserts are coded L5673 and L5679, whichever is applicable.Codes L5647 and L5652 describe a modification to a prosthetic socket that incorporates a suction valve in the design. The items described by these codes are not components of a suspension locking mechanism (L5671).L5781 describes a complete device that is an addition to a lower limb prosthesis. The primary function of the vacuum pump is to suspend the prosthetic limb. Additionally, products coded L5781 provide residual limb volume management and moisture evacuation. The pump mechanism evacuates air and accumulated moisture between the limb and socket walls. The pump mechanism can be actuated by either external power and/or mechanical system(s).L5782 describes a complete device that is an addition to a lower limb prosthesis. The primary function of the vacuum pump is to suspend the prosthetic limb. It also provides residual limb volume management and moisture evacuation. The pump mechanism evacuates air and accumulated moisture between the limb and socket walls. The pump mechanism can be actuated by either external power and/or mechanical system(s). Products described by this code would have components built to withstand higher prosthetic limb forces than L5781.Code L7700 (GASKET OR SEAL, FOR USE WITH PROSTHETIC SOCKET INSERT, ANY TYPE, EACH) describes a stand-alone (i.e., not integrated into or a part of a prosthetic socket insert) sealing ring that is added to a socket insert to assist in providing or maintaining negative pressure for socket suspension.The ring creates a seal against the outer surface of theinsert and against the inner wall of the socket.L7700 is not intended for use with mechanical socket suspensions such as a pin-lock system.It may be made of any suitable material.L7700 may be used with upper or lower extremity sockets.Unit of service (UOS) is 1 (one) item.This code is not to be used to bill for gaskets, seals, or other sealing materials that are included as part of an insert. Integrated seals are included in the code for the insert. Separate billing of integrated gaskets or seals as L7700 is unbundling.PROSTHETIC SYSTEMSExoskeletal prosthetic lower limb codes L5200, L5250, L5270, L5280 include a molded prosthetic socket, and exoskeletal single axis knee-shin system, and a SACH foot.L5150 and L5160 includes a knee disarticulation molded prosthetic socket, external knee joints, and a SACH foot.Endoskeletal prosthetic lower limb codes L5312, L5321, L5331, L5341 include molded prosthetic socket, an endoskeletal single axis knee-shin system and a SACH foot.L5100, L5105, L5301 includes a below knee molded prosthetic socket, and a SACH foot.PROSTHETIC CONNECTORSL5991 describes a complete endoskeletal product that is used as an osseointegrated external limb prosthetic connection device. The product provides a standard connection between an osseointergrated implantable limb component and endoskeletal prosthetic components. L5991 describes a complete device, and the use of additional codes would be considered incorrect coding (unbundling). The predicate product is the Axor II osseointegrated external prosthetic connection device manufactured by Integrum, S.E.SOCKETSCodes L5940, L5950, and L5960 for ultra-light materials may only be used when materials such as carbon fiber, fiberglass, Kevlar, or other advanced composite lamination materials are used in the fabrication of a socket for an endoskeletal prosthesis. They are not used for ultralight materials used in other components of a prosthesis e.g., knee/shin system, pylon, ankle, foot. For codes L5940, L5950, and L5960, the unit of service is per limb.L5301, L5540, L5321, L5590 should not be used when billing a replacement socket for an existing prosthesis. The use of L5301, L5540, L5321, L5590 with a replacement socket is incorrect coding (unbundling). Code L5999 (LOWER EXTREMITY PROSTHESIS, NOT OTHERWISE SPECIFIED) must not be used to bill for any features or functions included in the socket or addition codes. Use of L5999 is incorrect coding (unbundling).Infinite Socket (LIM Innovations) is an open-socket design that has distinct below knee and above knee products. These sockets are custom-fabricated from a model of the patient's residual limb and utilize struts that extend from a base to an adjustable brim enclosing an inner shell to form the primary structure of the socket. The LIM Innovations socket is functionally equivalent to design features of current HCPCS codes. The correct combination of HCPCS codes for the Infinite Socket TT-S (below-knee socket) are L5301 or L5700 with the addition of L5629, L5637, and L5940. The correct combination of HCPCS codes for the Infinite Socket T/F (above-knee socket) are L5321 or L5701 with the addition of L5631, L5649, and L5950.PROTECTIVE COVERSLower limb prosthetic covers (L5704, L5705, L5706, and L5707) are complete products and afford shape, protection and waterproofing for normal daily usage of the prosthesis. They offer sufficient protection and weatherproofing for beneficiaries who require lower limb prosthetics.Protective outer surface covering systems (L5962, L5964, and L5966) are specialized covers intended to be worn over an existing prosthesis. They are used by a beneficiary who has special needs for protection against unusually harsh environmental situations where it is necessary to protect the lower limb prosthesis beyond the level of protection that is afforded by L5704, L5705, L5706, and L5707.They are not for cosmetic or convenience reasons, or for everyday usage in a typical environment. Protective outer surface coverings are different from the covering that is already reimbursed as part of L5704, L5705, L5706, andL5707.FOOT COVERSFoot covers are included in the codes for a prosthetic foot component and are not separately payable.KNEESWith the exception of items described by specific HCPCS codes, there should be no separate billing and there is no separate payment for a component or feature of a microprocessor controlled knee, including but not limited to real time gait analysis, continuous gait assessment, or electronically controlled static stance regulator.Addition codes for exoskeletal knee-shin systems (L5614, L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780) are considered an upgrade to the knee-shin system. The beneficiary may qualify for an upgraded knee-shin system depending on their assigned K-level modifier (K0-K4), as referenced in the LCD. These HCPCS codes can fully describe a complete prosthetic knee-shin system commonly referred to as a base knee code. A single addition code can fully describe a complete knee-shin system and thus the use of two codes from the list would be considered incorrect coding (unbundling).Addition codes for endoskeletal knee-shin systems (L5610, L5611, L5613, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840) are considered an upgrade to the knee-shin system. The beneficiary may qualify for an upgraded knee-shin system based on their assigned K-Level modifier (K0-K4), as referenced in the LCD. These HCPCS codes can fully describe a complete prosthetic knee-shin system commonly referred to as a base knee code. A single addition code can fully describe a complete knee-shin system and thus the use of two codes (L5610, L5611, L5613, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840) would be considered incorrect coding (unbundling).L5925, L5930, L5845, L5848, L5850, L5856, L5857, L5858, L5859 are additional features and/or functions that do not describe a complete endoskeletal knee-shin system and must be used in combination with an L-code for a knee-shin system (L5610, L5611, L5613, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840). The use of additional feature L-codes may also depend on the assigned K-Level modifier (K0-K4), as referenced in the LCD.L5845 describes an endoskeletal product that is used as an addition to L-code Knee-Shin Systems for lower limb prosthesis construction. The product provides shock absorption during the initial stance phase of gait. It is designed to simulate the eccentric contraction of the quadriceps to reduce trauma on the residual limb. The predicate product is the Stance Flexion Feature, Adjustable manufactured by Endolite North America.L5848 refers to a feature of an endoskeletal knee component which is incorporated into the entire knee-shin system. The Hydraulic Stance Extension Dampening Feature restricts the prosthetic knee joints extension moment during the transition of mid to late stance phase of gait. The predicate products are the Otto Bock 3R60, 3C98 and 3C88 Hydraulic Knees.L5856 refers to a feature of an endoskeletal knee component which is incorporated into the entire knee-shin system. The microprocessor componentry with sensors, any type, provide automated adjustment for controlling the swing and stance phase of gait. This feature would be discernable from schematic drawings and user manual documentation. The documentation would provide details for all of the adjustments for the dynamic properties of this sub-system within the knee component. Adjustments could factor user characteristics such as the activity level, body weight, or gait preferences, among others. This adjustment feature is energized by an on-board rechargeable battery source. The code would include any external components needed to access the microprocessor for modification of the settings.L5857 refers to a feature of an endoskeletal knee component which is incorporated into the entire knee-shin system. The microprocessor componentry with sensors, any type, provide automated adjustment for controlling the swing phase of gait. The documentation would provide details for all of the adjustments for the dynamic properties of this sub-system within the knee component. Adjustments could factor user characteristics such as the activity level, body weight, or gait preferences, among others. This adjustment feature is energized by an on-board rechargeable battery source. The code would include any external components needed to access the microprocessor for modification of the settings.L5858 refers to a feature of an endoskeletal knee component which is incorporated into the entire knee-shin system. The microprocessor componentry with sensors, any type, provide automated adjustment for controlling the stance phase of gait. The documentation would provide details for all of the adjustments for the dynamic properties of this sub-system within the knee component. Adjustments could factor user characteristics such as the activity level, body weight, or gait preferences, among others. This adjustment feature is energized by an on-board rechargeable battery source. The code would include any external components needed to access the microprocessor for modification of the settings.L5926 describes an endoskeletal above the knee positioning device that allows 360 degrees of rotation and locks the endoskeletal prosthetic knee and foot system in a neutral position for ambulation. The predicate product is the Ottobock 4R57 Rotation Adapter.

Local Coverage Articles, Lower Limb Prostheses - Policy Article, A52496

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ANKLE AND LOWER EXTREMITY MOTION UNITSCodes L5968, L5982, L5984, L5985, L5986 and L5988 describe separate products which provide either a single motion or a combination of motions generally attributed to functional movement of the lower limb during ambulation. The use of these codes can be used to fully describe additional features or functions not found in the prosthetic foot system (L5969, L5970, L5971, L5972, L5973, L5974, L5975, L5976, L5978, L5979 L5980, L5981 and L5987).L5968 describes a product that is used as an addition to L-code foot systems for lower limb prosthesis construction. The product provides multiaxial motion in the coronal and sagittal plane from articulating components. At transition of stance phase to swing phase, the product will increase the ankles dorsiflexion angle and maintain it throughout swing phase. The product provides an accommodation of changing heel heights without the users input. The predicate product is the Rincoe R-Hab Ankle manufactured by R.G. Rincoe & Associates, Inc.L5982 describes an exoskeletal device that allows adjustable amount of vertical twisting motion between the foot and pelvis during ambulation. Motion of this product is separate from any similar incidental prosthetic foot/ankle motions.L5984 describes an endoskeletal device that allows an adjustable, or non-adjustable, amount of vertical twisting motion between the foot and pelvis during ambulation. Motion of this product is separate from any similar incidental prosthetic foot/ankle motions.L5985 describes an endoskeletal pylon device that provides simulated multiaxial ankle motion through a dynamic vertical shank separate from any similar incidental prosthetic foot motions. The predicate product is The Seattle Ankle manufactured by Seattle Medical Systems Group.L5986 describes a product that is used as an addition to L-code foot systems for lower limb prosthesis construction. The product provides multiaxial motion in all three planes of motion, sagittal, coronal, and transverse. This code does not describe the multiaxial motion achieved from the inherent flexibility of the prosthetic keel or a split keel/heel prosthetic foot design. The predicate product is a device that was manufactured by Medical Center Prosthetic, which is represented in the coding narrative by MCP.Use of L5968, L5982, L5984 or L5986 is based on the beneficiarys K-level modifier (K0-K4), as referenced in the LCD.L5988 describes an endoskeletal pylon device that allows vertical shock reduction between the foot and pelvis during ambulation. The vertical shock reducing pylon feature of L5988 is a separate function from other products which use a piston/telescoping mechanism such as products described by L5781 or L5782. The predicate product is the Total Shock that was manufactured by Century XXII International, Inc.FEETAddition codes for lower extremity prostheses, L5970, L5971, L5972, L5974, L5975, L5976, L5978, L5979, L5980, L5981, L5987 are considered an upgrade to the SACH foot. The beneficiary may qualify for an upgraded prosthetic foot based on their assigned K-level modifier (K0-K4) as referenced in the LCD. A single addition code (L5970, L5971, L5972, L5974, L5975, L5976, L5978, L5979, L5980, L5981, L5987) can fully describe a complete foot and thus the use of more than one code would be considered incorrect coding (unbundling).L5968, L5982, L5984, L5985, L5986, L5988, L5990 are additional features and/or functions that do not describe a complete prosthetic foot and may be used in combination with L5970, L5971, L5972, L5974, L5975, L5976, L5978, L5979, L5980, L5981, and L5987. The use of additional feature L-codes may also depend on the assigned K-Level modifier (K0-K4) as referenced in the LCD.L5980 describes a product that can be used for either endoskeletal or exoskeletal lower limb construction. The Flex Foot has an energy storing J-shaped keel design. Heel component is attached onto the J-shaped keel section. The Flex Foot Systems J-shaped keel design extends proximally as a monolithic composite shank. Shank height is determined and modified by supplier to utilize the dynamics of the composite shank. L5980 includes foot cover.L5981 describes a product that can be used for either endoskeletal or exoskeletal lower limb construction. The Flex Walk has an energy storing J-shaped keel design. Heel component is attached to the J-shaped keel section. The Flex Walk J-shaped keel design proximally terminates at a nonadjustable fixed height determined and modified by the prosthetic foot manufacturer. L5981 includes foot cover.L5987 describes a product that can be used for either endoskeletal or exoskeletal lower limb construction. All components are integrated as a single product, i.e. not an assembly of separate products or components. The product has an energy storing J-shaped keel design. Heel component is attached onto the J-shaped keel section. Vertical loading pylon allows controlled motion for shock absorption. This code does not describe vertical loading or shock absorption achieved from the inherent flexibility of the J-shaped keel section. L5987 includes foot cover.PARTIAL FOOT AND TOE FILLER INSERTSCodes L5000, L5010, and L5020 describe products that are necessary for standing balance and toe off support in beneficiaries who are missing the forefoot or digits including the hallux (great toe) and who require the rigidity and support offered by these products, in order to achieve or maintain an effective gait.L5000 describes a shoe insert with a rigid longitudinal arch support that also incorporates material accommodating the void left by the missing digit(s) or forefoot. Additional soft material is added where contact is made with the residual limb or toes. These inserts are designed to provide standing balance and toe off support for improved gait. L5000 is inclusive of variations in materials or combinations such as differing stiffnesses or Shore value.L5010 describes a partial foot device including a molded socket for the residual limb with a proximal height terminating at the ankle or extending proximally as needed to achieve appropriate support and function. L5010 is inclusive of a rigid longitudinal arch support that also incorporates material accommodating the void left by the missing digit(s) or forefoot. Additional soft material is added where contact is made with the residual limb or toes. L5010 devices are designed to provide standing balance and toe off support for improved gait. All closures are included, any type. L5010 is inclusive of variations in materials or combinations such as differing stiffnesses or Shore value.L5020 describes a partial foot device including a molded socket for the residual limb with a proximal height terminating at or near the tibial tubercle to achieve appropriate support and function. L5020 is inclusive of a rigid longitudinal arch support that also incorporates material accommodating the void left by the missing digit(s) or forefoot. Additional soft material is added where contact is made with the residual limb or toes. L5020 devices are designed to provide standing balance and toe off support for improved gait. All closures are included, any type. L5020 is inclusive of variations in materials or combinations such as differing stiffnesses or Shore value.MICROPROCESSOR ANKLE FOOT SYSTEMSWith the exception of items described by specific HCPCS codes, there should be no separate billing and there is no separate payment for a component or feature of a microprocessor controlled foot, including but not limited to real time gait analysis, continuous gait assessment, or electronically controlled static stance regulator.L5973 describes an endoskeletal device with integrated energy storage and release foot and microprocessor ankle system. The integrated microprocessor is programmable along with sensors to optimize plantar and dorsiflexion angles for stance and swing phase. L5973 includes foot cover, power source(s) and charger.A microprocessor ankle-foot system with power assist (BiOM Ankle-Foot System by iWalk, Inc) is coded as the combination of L5969 (ADDITION, ENDOSKELETAL ANKLE-FOOT OR ANKLE SYSTEM, POWER ASSIST, INCLUDES ANY TYPE MOTOR(S)) and L5973 (ENDOSKELETAL ANKLE FOOT SYSTEM, MICROPROCESSOR CONTROLLED FEATURE, DORSIFLEXION AND/OR PLANTAR FLEXION CONTROL, INCLUDES POWER SOURCE).The right (RT) and left (LT) modifiers must be used with prosthesis codes. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for prostheses, sockets, or components for bilateral amputees are billed on the same date of service bill each item on two separate claim lines using theRT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claim lines billed without the RT and/or LT modifiers,or with RTLT on the same claim line and 2 UOS,will be rejected as incorrect coding.Coding Batteries and Chargers Concurrently With a Powered Base ItemPowered base items are those that contain the power source (battery). At the time that a base item is billed, all necessary batteries and/or battery chargers are considered as included in the payment for the powered base item. There is no separate payment for batteries (L7360, L7364, and L7367) and/or battery chargers (L7362, L7366, and L7368) billed concurrently with a powered base item.Payments for items listed in Column II are included in the payment for each Column I code. Claims for Column II items billed with the provision of a Column I item will be denied as unbundling.Column IColumn IIBase codes with battery, charger and/or power includedBatteriesL5781L7360L5782L7364L5856L7367L5857L5858L5859ChargersL5973L7362L7366L7368Suppliers should contact the DME PDAC contractor for guidance on the correct coding of these items.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC web site or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC web site. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2014:L5969Effective for claims with dates of service on or after January 1, 2021:L5856, L5857, L5858, L5973, L5980, L5987If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.

Local Coverage Articles, Manual Wheelchair Bases - Policy Article, A52497

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Manual wheelchairs are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.If the manual wheelchair is only for use outside the home, it will be denied as noncovered, no benefit, as the DME benefit requires use within the home for coverage eligibility.Reimbursement for wheelchair codes includes all labor charges involved in the assembly of the wheelchair. Reimbursement also includes support services such as emergency services, delivery, set-up, education, and on-going assistance with use of the wheelchair.A custom manual wheelchair base (K0008) must be uniquely constructed or substantially modified for a specific beneficiary according to the description and orders of the beneficiarys treating practitioner. The beneficiarys needs cannot be accommodated by any other existing manual wheelchair and accessories, including customized seating arrangements. See 42 CFR Section 414.224, and Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Chapter 20, Section 30.3 for more information on customized DME.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.Information showing that the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met must be present in the beneficiarys medical record. Information about whether the beneficiarys home can accommodate the wheelchair (Criterion C), also called the home assessment, must be fully documented in the medical record or elsewhere by the supplier. For manual wheelchairs, the home assessment may be done directly by visiting the beneficiarys home or indirectly based upon information provided by the beneficiary or their designee. When the home assessment is based upon indirectly obtained information, the supplier must, at the time of delivery, verify that the item delivered meets the requirements specified in criterion C. Issues such as the physical layout of the home, surfaces to be traversed, and obstacles must be addressed by and documented in the home assessment. Information from the beneficiarys medical record and the suppliers records must be available upon request.If documentation of the medical necessity for a K0005 wheelchair is requested, it must include a description of the beneficiarys routine activities. This may include the types of activities the beneficiary frequently encounters and whether the beneficiary is fully independent in the use of the wheelchair. Describe the features of the K0005 base which are needed compared to the K0004 base.If documentation of the medical necessity for a K0008 wheelchair is requested, contractors must be able to determine that the item delivered is a customized item. Documentation must include a description of the beneficiarys unique physical and functional characteristics that require a customized manual wheelchair base. This must include a detailed description of the manufacturing of the wheelchair base, including types of materials used in custom fabricating or substantially modifying it, and the construction process and labor skills required to modify it. The record must document that the needs of the beneficiary cannot be met using another manual wheelchair base that incorporates seating modifications or other options or accessories (prefabricated and/or custom). The documentation must demonstrate that the K0008 is so different from another wheelchair base that the two items cannot be grouped together for pricing purposes.If documentation of the medical necessity for a transport chair (E1037, E1038 and E1039) is requested, it must include a description of why the beneficiary is unable to make use of a standard manual wheelchair (K0001, K0002, K0003, K0004, and K0005) on their own, and provide specific information that the beneficiary has a caregiver who is available, willing, and able to provide assistance with the wheelchair.SPECIALTY EVALUATION:The specialty evaluation provides detailed information explaining why the particular wheelchair and the special features of the wheelchair are necessary to address the beneficiarys mobility limitation. There must be a written report of this evaluation available on request. The PT, OT, or practitioner who performs the specialty evaluation may have no financial relationship with the supplier. (Exception: If the supplier is owned by a hospital, the PT, OT, or practitioner working in the inpatient or outpatient hospital setting may perform the specialty evaluation.)MODIFIERSKX, GA, GY, AND GZ MODIFIERS:Suppliers must add a KX modifier to the code for the manual wheelchair base only if all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request. If the coverage criteria are not met, the KX modifier must not be used.If all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.If the wheelchair is only to be used for mobility outside the home, the GY modifier must be added to the code.Claim lines billed without a KX, GA, GY, or GZ modifier will be rejected as missing information.CODING GUIDELINESFor Medicare coding purposes, all manual wheelchair base codes describe a complete product.This includes items described by HCPCS codes:Rollabout Chair (E1031)Transport Chairs (E1037, E1038, E1039)Manual Wheelchair Bases (E1161, E1229, E1231, E1232, E1233, E1234, E1235, E1236, E1237, E1238, K0001, K0002, K0003, K0004, K0005, K0006, K0007, K0009)A complete manual wheelchair base includes:A complete framePropulsion wheelsCastersBrakesA sling seat, seat pan which can accommodate a wheelchair seat cushion, or a seat frame structured in such a way as to be capable of accepting a seating systemA sling back, other seat back support which can accommodate a wheelchair back cushion, or a back frame structured in such a way as to be capable of accepting a back systemStandard leg and footrestsArmrestsSafety accessories (other than those separately billable in the Wheelchair Accessories Local Coverage Determination)Adult manual wheelchairs (K0001, K0002, K0003, K0004, K0005, K0006, K0007, K0008, K0009, E1161) are those which have a seat width and a seat depth of 15 or greater. For codes K0001, K0002, K0003, K0004, K0005, K0006, K0007, K0008, K0009, the wheels must be large enough and positioned such that the wheelchair could be propelled by the user. In addition, specific codes are defined by the following characteristics:Standard wheelchair (K0001)Weight: Greater than 36 lbs.Seat Height: 19 inches or greaterWeight capacity: 250 pounds or lessStandard hemi (low seat) wheelchair (K0002)Weight: Greater than 36 lbsSeat Height: Less than 19 inchesWeight capacity: 250 pounds or lessLightweight wheelchair (K0003)Weight: 34-36 lbsWeight capacity: 250 pounds or lessHigh strength, lightweight wheelchair (K0004)Weight: Less than 34 lbsLifetime Warranty on side frames and crossbracesUltralightweight wheelchair (K0005)Weight: Less than 30 lbsAdjustable rear axle positionLifetime Warranty on side frames and crossbracesHeavy duty wheelchair (K0006)Weight capacity: Greater than 250 poundsExtra heavy duty wheelchair (K0007)Weight capacity: Greater than 300 poundsCustom manual wheelchair/base (K0008)In addition to meeting the statutory criteria above in the Non-Medical Necessity Coverage and Payment Rules, custom manual wheelchairs must also have a lifetime warranty on side frames and crossbraces.Adult tilt-in-space wheelchair (E1161)Ability to tilt the frame of the wheelchair greater than or equal to 20 degrees from horizontal while maintaining the same back to seat angle. Lifetime Warranty: On side frames and crossbracesWheelchairs with less than 20 degrees of tilt must not to be coded based upon the tilt feature. The appropriate base product must be coded as K0001, K0002, K0003, K0004, K0005, K0006,or K0007. The product must not be coded as E1161 or K0108.Weight represents the weight of the wheelchair itself in pounds without the front rigging as in the case of the K0001, K0002, K0003, K0004, and K0005. Weight capacity represents the carrying capacity or the amount of weight (beneficiary plus all accessories) that the wheelchair can carry for safe operation as in the case of the K0001, K0002, K0003, K0006 and K0007.The following features are included in the allowance for all adult manual wheelchairs:Seat Width: 15" - 19"Seat Depth: 15" 19Arm Style: Fixed, swingaway, or detachable; fixed heightFootrests: Fixed, swingaway, or detachableCodes K0003, K0004, K0005, K0006, K0007, K0008 and E1161 include any seat height.Manual wheelchair bases (K0001, K0002, K0003, K0004, K0005, K0006, K0007, K0008, andK0009) include construction of any type material, including but not limited to, titanium, carbon, or any other lightweight high strength material. Suppliers must not bill HCPCS code K0108 in addition to the base wheelchair for construction materials or for a heavy duty package reflecting the type of material used to construct the manual wheelchair base. Billing for construction material is considered incorrect coding unbundling.Refer to the medical policy on Wheelchair Options and Accessories for information on other features included in the allowance for the wheelchair base.Effective for claims with dates of service on or after June 1, 2013, the only products which may be billed to Medicare using HCPCS code K0009, are those for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the Product Classification List (PCL).If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.A manual wheelchair with a seat width and/or depth of 14 or less is considered a pediatric size wheelchair and is billed with codes E1231, E1232, E1233, E1234, E1235, E1236, E1237, E1238 or E1229.Manual wheelchairs with additional options and accessories, other than tilt, are billed by selecting the correct code for the wheelchair base and then using appropriate codes for wheelchair options and accessories. (Refer to the Wheelchair Options and Accessories policy.)Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.

Local Coverage Articles, Power Mobility Devices - Policy Article, A52498

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Power mobility devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, added section 1834(a)(1)(E)(iv) which provides that payment may not be made for a motorized or power wheelchair unless the treating practitioner conducts the face-to-face encounter and writes the Standard Written Order (SWO). If the treating practitioner does not conduct the face-to-face encounter or write the SWO for the PMD base item, the claim will be denied as statutorily noncovered.A power mobility device may not be ordered by a podiatrist. If it is, it will be denied as statutorily noncovered.FACE-TO-FACE ENCOUNTER:If the POV or PWC is a replacement during the 5-year useful lifetime of an item in the same performance group that was previously covered by Medicare, a face-to-face encounter is not required. Note: Replacement during an items useful lifetime is limited to situations involving loss or irreparable damage from a specific accident or natural disaster (e.g., fire, flood, etc.).The treating practitioner may conduct the entire mobility face-to-face encounter or may refer the beneficiary to a licensed/certified medical professional (LCMP), such as a physical therapist (PT) or occupational therapist (OT), who has experience and training in mobility evaluations to perform part of the face-to-face encounter. This person may have no financial relationship with the supplier. (Exception: If the supplier is owned by a hospital, the PT or OT working in the inpatient or outpatient hospital setting may perform part of the face-to-face encounter.)To accommodate the requirements at 42 CFR 410.38, when the treating practitioner sees the beneficiary, regardless of whether a referral to an LCMP is made, that visit date starts the six (6) month timeline for completion of the SWO for the wheelchair base. If the treating practitioner chooses to refer the beneficiary to an LCMP for a mobility evaluation, the treating practitioner's co-signature, dating and indicating agreement or disagreement with the LCMP evaluation must occur within this six (6) month timeframe. In cases where the LCMP evaluation is being adopted into the practitioner's documentation to substantiate the need for the base item, the SWO may not be written until the LCMP report is signed, dated and agreement/disagreement indicated.MISCELLANEOUS:A custom motorized/power wheelchair base (K0013) must be uniquely constructed or substantially modified for a specific beneficiary according to the description and orders of the beneficiarys treating practitioner. The beneficiarys needs must not be able to be accommodated by any other existing PMD and accessories, including customized seating arrangements. See 42 CFR Section 414.224(a).If any POV or PWC is only for use outside the home, it will be denied as noncovered.Reimbursement for the wheelchair codes includes all labor charges involved in the assembly of the wheelchair. Reimbursement also includes support services, such as delivery, set-up, and education about the use of the PMD.Upgrades that are beneficial primarily in allowing the beneficiary to perform leisure or recreational activities are noncovered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATIONIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.If documentation of the medical necessity for a K0013 wheelchair is requested, contractors must be able to determine that the item delivered is a customized item. Documentation must include a description of the beneficiarys unique physical and functional characteristics that require a custom motorized/power wheelchair base. This must include a detailed description of the manufacturing of the wheelchair base, including types of materials used in custom fabricating or substantially modifying it, and the construction process and labor skills required to modify it. The record must document that the needs of the beneficiary cannot be met using another power wheelchair base that incorporates seating modifications or other options or accessories (prefabricated and/or custom). The documentation must demonstrate that the K0013 is so different from another power wheelchair base that the two items cannot be grouped together for pricing purposes.SPECIALTY EVALUATION:The specialty evaluation provides detailed information explaining why each specific option or accessory i.e., power seating system, alternate drive control interface, or push-rim activated power assist is needed to address the beneficiarys mobility limitation. There must be a written report of this evaluation available on request. The PT, OT, or practitioner who performs the specialty evaluation may have no financial relationship with the supplier. (Exception: If the supplier is owned by a hospital, the PT, OT, or practitioner working in the inpatient or outpatient hospital setting may perform the specialty evaluation.)MODIFIERSKX, GA, GY, AND GZ MODIFIERS:If the requirements related to a face-to-face encounter have not been met, the GY modifier must be added to the codes for the power mobility device and all accessories.If the power mobility device or push-rim activated power assist device that is provided is only needed for mobility outside the home, the GY modifier must be added to the codes for the item and all accessories.A KX modifier may be added to the code for a power mobility device and all accessories only if one of the following conditions is met:If all of the coverage criteria specified in the related LCD have been met for the product that is provided; orIf there is an affirmative Advance Determination of Medicare Coverage (ADMC) for the product that is provided.If the requirements for use of the KX modifier or GY modifier are not met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter GA on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or GZ if they have not obtained a valid ABN.Claim lines billed without a KX, GA, GY, or GZ modifier will be rejected as missing information.CODING GUIDELINESDEFINITIONS:Power Mobility Device (PMD) - Base codes include both integral frame and modular construction type power wheelchairs (PWCs) and power operated vehicles (POVs).Power Wheelchair - Chair-like battery powered mobility device for people with difficulty walking due to illness or disability, with integrated or modular seating system, electronic steering, and four or more wheel non-highway construction.Power Operated Vehicle - Chair-like battery powered mobility device for people with difficulty walking due to illness or disability, with integrated seating system, tiller steering, and three or four-wheel non-highway construction.Beneficiary Weight Capacity The terms Standard Duty, Heavy Duty, etc., refer to weight capacity, not performance. For example, the term Group 3 heavy duty power wheelchair denotes that the PWC has Group 3 performance characteristics and beneficiary weight handling capacity between 301 and 450 pounds. A device is not required to carry all the weight listed in the class of devices, but must have a beneficiary weight capacity within the range to be included. For example, a PMD that has a weight capacity of 400 pounds is coded as a Heavy Duty device.Portable - A category of devices with lightweight construction or ability to disassemble into lightweight components that allows easy placement into a vehicle for use in a distant location.Performance Testing - Term used to denote the RESNA based test parameters used to test PMDs. The PMD is expected to meet or exceed the listed performance and durability figures for the category in which it is to be used when tested. There is no requirement to test the PMD with all possible accessories.Test Standards - Performance and durability acceptance criteria defined by ANSI/RESNA standard testing protocols.Crash Testing - Successful completion of WC-19 testing.Top End Speed - Minimum speed acceptable for a given category of devices. It is to be determined by the RESNA test for maximum speed on a flat hard surface.Range - Minimum distance acceptable for a given category of devices on a single charge of the batteries. It is to be determined by the appropriate RESNA test for range.Obstacle Climb - Vertical height of a solid obstruction that can be climbed using the standing and/or 0.5 meter run-up RESNA test.Dynamic Stability Incline - The minimum degree of slope at which the PMD in the most common seating and positioning configuration(s) remains stable at the required beneficiary weight capacity. If the PMD is stable at only one configuration, the PMD may have protective mechanisms that prevent climbing inclines in configurations that may be unstable.Radius Pivot Turn The distance required for the smallest turning radius of the PMD base. This measurement is equivalent to the minimum turning radius specified in the ANSI/RESNA bulletins.PWC Basic Equipment Package - Each power wheelchair code is required to include all these items on initial issue (i.e., no separate billing/payment at the time of initial issue, unless otherwise noted). The statement that an item may be separately billed does not necessarily indicate coverage.Lap belt or safety belt. Shoulder harness/straps or chest straps/vest may be billed separately.Battery charger, single modeComplete set of tires and casters, any typeLegrests. There is no separate billing/payment if fixed, swingaway, or detachable non-elevating legrests with or without calf pad are provided. Elevating legrests may be billed separately.Footrests/foot platform. There is no separate billing/payment if fixed, swingaway, or detachable footrests or a foot platform without angle adjustment are provided. There is no separate billing for angle adjustable footplates with Group 1 or 2 PWCs. Angle adjustable footplates may be billed separately with Group 3, 4 and 5 PWCs.Armrests. There is no separate billing/ payment if fixed, swingaway, or detachable non-adjustable height armrests with arm pad are provided. Adjustable height armrests may be billed separately.Any weight specific components (braces, bars, upholstery, brackets, motors, gears, etc.) as required by beneficiary weight capacity.Any seat width and depth. Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately:For Standard Duty, seat width and/or depth greater than 20 inches;For Heavy Duty, seat width and/or depth greater than 22 inches;For Very Heavy Duty, seat width and/or depth greater than 24 inches;For Extra Heavy Duty, no separate billingAny back width. Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately:For Standard Duty, seat back width greater than 20 inches;For Heavy Duty, back width greater than 22 inches;For Very Heavy Duty, back width greater than 24 inches;For Extra Heavy Duty, no separate billingController and Input DeviceThere is no separate billing/payment if a non-expandable controller and a standard proportional joystick (integrated or remote) is provided. An expandable controller, a nonstandard joystick (i.e., nonproportional or mini, compact or short throw proportional), or other alternative control device may be billed separately.Refer to the bundling table in the Wheelchair Options/Accessories Policy Article for a list of codes that are not separately billable at the time of initial issue of a PWC.POV Basic Equipment Package - Each POV is to include all these items on initial issue (i.e., no separate billing/payment at the time of initial issue):Battery or batteries required for operationBattery charger, single modeWeight appropriate upholstery and seating systemTiller steeringNon-expandable controller with proportional response to inputComplete set of tiresAll accessories needed for safe operation

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For Very Heavy Duty, seat width and/or depth greater than 24 inches;For Extra Heavy Duty, no separate billingAny back width. Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately:For Standard Duty, seat back width greater than 20 inches;For Heavy Duty, back width greater than 22 inches;For Very Heavy Duty, back width greater than 24 inches;For Extra Heavy Duty, no separate billingController and Input DeviceThere is no separate billing/payment if a non-expandable controller and a standard proportional joystick (integrated or remote) is provided. An expandable controller, a nonstandard joystick (i.e., nonproportional or mini, compact or short throw proportional), or other alternative control device may be billed separately.Refer to the bundling table in the Wheelchair Options/Accessories Policy Article for a list of codes that are not separately billable at the time of initial issue of a PWC.POV Basic Equipment Package - Each POV is to include all these items on initial issue (i.e., no separate billing/payment at the time of initial issue):Battery or batteries required for operationBattery charger, single modeWeight appropriate upholstery and seating systemTiller steeringNon-expandable controller with proportional response to inputComplete set of tiresAll accessories needed for safe operationCross Brace Chair - A type of construction for a power wheelchair in which opposing rigid braces hinge on pivot points to allow the device to fold.Power Options - Tilt, recline, elevating legrests, seat elevators, or standing systems that may be added to a PWC to accommodate a beneficiarys specific need for seating assistance.No Power Options A category of PWCs that is incapable of accommodating a power tilt, recline, or standing system. If a PWC can only accept power elevating legrests and/or seat elevation, it is considered to be a No Power Option chair.Single Power Option - A category of PWCs with the capability to accept and operate a power tilt or power recline or power standing or, for Groups 3, 4, and 5, a power seat elevation system, but not a combination power tilt and recline seating system. It may be able to accommodate power elevating legrests, seat elevator, and/or standing system in combination with a power tilt or power recline. A PMD does not have to be able to accommodate all features to qualify for this code. For example, a power wheelchair that can only accommodate a power tilt could qualify for this code.Multiple Power Options - A category of PWCs with the capability to accept and operate a combination power tilt and recline seating system. It may also be able to accommodate power elevating legrests, a power seat elevator, and/or a power standing system. A PWC does not have to accommodate all features to qualify for this code.Actuator A motor that operates a specific function of a power seating system i.e., tilt, back recline, power sliding back, elevating legrest(s), seat elevation, or standing.Proportional Control Input Device - A device that transforms a user's drive command (a physical action initiated by the wheelchair user) into a corresponding and comparative movement, both in direction and in speed, of the wheelchair. The input device shall be considered proportional if it allows for both a non-discrete directional command and a non-discrete speed command from a single drive command movement. (Note: In the Wheelchair Options/Accessories policy, the term interface is used instead of control input device.)Non-Proportional Control Input Device - A device that transforms a user's discrete drive command (a physical action initiated by the wheelchair user, such as activation of a switch) into perceptually discrete changes in the wheelchair's speed, direction, or both.Alternative Control Device - A device that transforms a users drive commands by physical actions initiated by the user to input control directions to a power wheelchair that replaces a standard proportional joystick. Includes mini-proportional, compact, or short throw joysticks, head arrays, sip and puff and other types of different input control devices.Non-Expandable Controller - An electronic system that controls the speed and direction of the power wheelchair drive mechanism. Only a standard proportional joystick (used for hand or chin control) can be used as the input device. This system may be in the form of an integral controller or a remotely placed controller. The non-expandable controller:May have the ability to control up to 2 power seating actuators through the drive control (for example, seat elevator and single actuator power elevating legrests). (Note: Control of the power seating actuators though the Control Input Device would require the use of an additional component, E2310 or E2311.)May allow for the incorporation of an attendant control.Expandable Controller - An electronic system that is capable of accommodating one or more of the following additional functions:Proportional input devices (e.g., mini, compact, or short throw joysticks, touchpads, chin control, head control, etc.) other than a standard proportional joystick.Non-proportional input devices (e.g., sip and puff, head array, etc.)Operate 3 or more powered seating actuators through the drive control. (Note: Control of the power seating actuators though the Control Input Device would require the use of an additional component, E2310 or E2311.)An expandable controller may also be able to operate one or more of the following:A separate display (i.e., for alternate control devices)Other electronic devices (e.g., control of an augmentative speech device or computer through the chairs drive control)An attendant controlIntegral Control System - Non-expandable wheelchair control system where the joystick is housed in the same box as the controller. The entire unit is located and mounted near the hand of the user. A direct electrical connection is made from the Integral Control box to the motors and batteries through a high power wire harness.Remotely Placed Controller - Non-expandable or expandable wheelchair control system where the joystick (or alternative control device) and the controller box are housed in separate locations. The joystick (or alternative control device) is connected to the controller through a low power wire harness. The separate controller connects directly to the motors and batteries through a high power wire harness.Codes E2310 and E2311 describe electronic components that allow the patient to control two or more of the following motors from a single interface, e.g., proportional joystick, touchpad, or nonproportional interface:Power tiltPower recline, with or without shear reductionCombination power tilt and recline, with or without shear reductionPower leg elevation with or without articulation, power center mount elevating foot platform with or without articulating properties.The interface includes a function selection switch that allows the patient to select the motor that is being controlled and an indicator feature to visually show which function has been selected. When the wheelchair drive function has been selected, the indicator feature may also show the direction that has been selected (forward, reverse, left, right). This indicator feature may be in a separate display box or may be integrated into the wheelchair interface. Payment for the interface code includes an allowance for fixed mounting hardware for the control box and the display box, if present.A harness (E2313) describes all the wires, fuse boxes, fuses, circuits, switches, etc. that are required for the operation of an expandable controller (E2377). It also includes all the necessary fasteners, connectors, and mounting hardware.Sling Seat/Back - Flexible cloth, vinyl, leather or equal material designed to serve as the support for buttocks or back of the user respectively. They may or may not have thin padding but are not intended to provide cushioning or positioning for the user.Solid Seat/Back - Rigid metal or plastic material usually covered with cloth, vinyl, leather or equal material, with or without some padding material designed to serve as the support for the buttocks or back of the user respectively. They may or may not have thin padding but are not intended to provide cushioning or positioning for the user. PWCs with an automotive-style back and a solid seat pan are considered as a solid seat/back system, not a captains chair.Captains chair - A one or two-piece automotive-style seat with rigid frame, cushioning material in both seat and back sections, covered in cloth, vinyl, leather or equal as upholstery, and designed to serve as a complete seating, support, and cushioning system for the user. It may have armrests that can be fixed, swingaway, or detachable. It may or may not have a headrest, either integrated or separate.Stadium Style Seat - A one or two piece stadium-style seat with rigid frame and cushioning material in both seat and back sections, covered in cloth, vinyl, leather or equal as upholstery, and designed to serve as a complete seating, support, and cushioning system for the user. It may have armrests that can be fixed, swingaway, or detachable. It will not have a headrest. Chairs with stadium style seats are billed using the captains chair codes.Highway Use - Mobility devices that are powered and configured to operate legally on public streets.Push-rim activated power assist (E0986) An option for a manual wheelchair in which sensors in specially designed wheels determines the force that is exerted by the beneficiary upon the wheel. Additional propulsive and/or braking force is then provided by motors in each wheel. E0986 is all-inclusive. All components, e.g., drive wheels, batteries, chargers, controls, mounting hardware, etc, for a manual wheel chair conversion are considered as included in 1 UOS of the code.CODE-SPECIFIC REQUIREMENTS:There are five PWC Groups and two POV Groups. Groups are divided based on performance. Each group of PMDs has subdivisions based on beneficiary weight capacity, seat type, portability, and/or power seating system capability.All POVs (K0800, K0801, K0802, K0806, K0807,K0808, K0812) must have the specified components and meet the following requirements:Have all components in the POV Basic Equipment PackageSeat Width: Any width appropriate to weight groupSeat Depth: Any depth appropriate to weight groupSeat Height: Any height (adjustment requirements-none)Back Height: Any height (minimum back height requirement-none)Seat to Back Angle: Fixed or adjustable (adjustment requirements none)Meet the following testing requirements:Fatigue test 200, 000 cyclesDrop test 6,666 cyclesGroup 1 POVs (K0800, K0801,K0802) must meet the following requirements:Length - less than or equal to 48 inchesWidth - less than or equal to 28 inchesMinimum Top End Speed - 3 MPHMinimum Range - 5 milesMinimum Obstacle Climb - 20 mmRadius Pivot Turn - less than or equal to 54 inchesDynamic Stability Incline - 6 degreesGroup 2 POVs (K0806, K0807,K0808) must meet the following requirements:Length - less than or equal to 48 inchesWidth - less than or equal to 28 inchesMinimum Top End Speed - 4 MPHMinimum Range - 10 milesMinimum Obstacle Climb - 50 mmRadius Pivot Turn - less than or equal to 54 inchesDynamic Stability Incline - 7.5 degreesThe following requirements describe the configurations of power wheelchairs as they are coded by the Pricing, Data Analysis, and Coding (PDAC) contractor. Items provided to the beneficiary may include upgraded components which are substituted for the basic component and are billed separately. One example is a power seating system. When this is provided, the base code used should be that with a sling/solid seat/back. Another example is the provision of an expandable controller when the base code includes a non-expandable controller but is capable of an upgrade.All PWCs (K0813, K0814, K0815, K0816, K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828, K0829, K0830, K0831, K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842, K0843, K0848, K0849, K0850, K0851, K0852, K0853, K0854, K0855, K0856, K0857, K0858, K0859, K0860, K0861, K0862, K0863, K0864, K0868, K0869, K0870, K0871, K0877, K0878, K0879, K0880, K0884, K0885, K0886, K0890,K0891, K0898) must have the specified components and meet the following requirements:Have all components in the PWC Basic Equipment PackageHave the seat option listed in the code descriptorSeat Width: Any width appropriate to weight groupSeat Depth: Any depth appropriate to weight groupSeat Height: Any height (adjustment requirements-none)Back Height: Any height (minimum back height requirement-none)Seat to Back Angle: Fixed or adjustable (adjustment requirements none)May include semi-reclining backMeet the following testing requirements:Fatigue test 200, 000 cyclesDrop test 6,666 cyclesAll Group 1 PWCs (K0813, K0814, K0815,K0816) must have the specified components and meet the following requirements:Standard integrated or remote proportional joystickNon-expandable controllerIncapable of upgrade to expandable controller

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Have all components in the PWC Basic Equipment PackageHave the seat option listed in the code descriptorSeat Width: Any width appropriate to weight groupSeat Depth: Any depth appropriate to weight groupSeat Height: Any height (adjustment requirements-none)Back Height: Any height (minimum back height requirement-none)Seat to Back Angle: Fixed or adjustable (adjustment requirements none)May include semi-reclining backMeet the following testing requirements:Fatigue test 200, 000 cyclesDrop test 6,666 cyclesAll Group 1 PWCs (K0813, K0814, K0815,K0816) must have the specified components and meet the following requirements:Standard integrated or remote proportional joystickNon-expandable controllerIncapable of upgrade to expandable controllerIncapable of upgrade to alternative control devicesMay have crossbrace constructionAccommodates non-powered options and seating systems (e.g., recline-only backs, manually elevating legrests) (except captains chairs)Length - less than or equal to 40 inchesWidth - less than or equal to 24 inchesMinimum Top End Speed - 3 MPHMinimum Range - 5 milesMinimum Obstacle Climb - 20 mmDynamic Stability Incline - 6 degreesFor Group 1 portable wheelchairs (K0813, K0814), the largest single component may not exceed 55 pounds.All Group 2 PWCs (K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828, K0829, K0830, K0831, K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842,K0843) must have the specified components and meet the following requirements:Standard integrated or remote proportional joystickMay have crossbrace constructionAccommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports) (except captains chairs)Length - less than or equal to 48 inchesWidth - less than or equal to 34 inchesMinimum Top End Speed - 3 MPHMinimum Range - 7 milesMinimum Obstacle Climb - 40 mmDynamic Stability Incline - 6 degreesFor Group 2 portable PWCs (K0820, K0821), the largest single component may not exceed 55 pounds.Group 2 no power option PWCs (K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828,K0829) must have the specified components and meet the following requirements:Non-expandable controllerIncapable upgrade to expandable controllerIncapable of upgrade to alternative control devicesIncapable of accommodating a power tilt, recline, standing systemAccommodates non-powered options and seating systems (e.g., recline-only backs, manually elevating legrests) (except captains chairs)Group 2 seat elevator PWCs (K0830, K0831) must have the specified components and meet the following requirements:Non-expandable controllerIncapable of upgrade to expandable controllerIncapable of upgrade to alternative control devicesAccommodates only a power seat elevating systemGroup 2 single power option PWCs (K0835, K0836, K0837, K0838, K0839,K0840) must have the specified components and meet the following requirements:Non-expandable controllerCapable of upgrade to expandable controllerCapable of upgrade to alternative control devicesSee Single Power Option definition for seating system capabilityGroup 2 multiple power option PWCs (K0841, K0842,K0843) must have the specified components and meet the following requirements:Non-expandable controllerCapable of upgrade to expandable controllerCapable of upgrade to alternative control devicesSee Multiple Power Options definition for seating system capabilityAccommodates a ventilatorAll Group 3 PWCs (K0848, K0849, K0850, K0851, K0852, K0853, K0854, K0855, K0856, K0857, K0858, K0859, K0860, K0861, K0862, K0863,K0864) must have the specified components and meet the following requirements:Standard integrated or remote proportional joystickNon-expandable controllerCapable of upgrade to expandable controllerCapable of upgrade to alternative control devicesMay not have crossbrace constructionAccommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports) (except captains chairs)Drive wheel suspension to reduce vibrationLength - less than or equal to 48 inchesWidth - less than or equal to 34 inchesMinimum Top End Speed - 4.5 MPHMinimum Range - 12 milesMinimum Obstacle Climb - 60 mmDynamic Stability Incline - 7.5 degreesAll Group 4 PWCs (K0868, K0869, K0870, K0871, K0877, K0878, K0879, K0880, K0884, K0885, K0886) must have the specified components and meet the following requirements:Standard integrated or remote proportional joystickNon-expandable controllerCapable of upgrade to expandable controllerCapable of upgrade to alternative control devicesMay not have crossbrace constructionAccommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports) (except captains chairs)Drive wheel suspension to reduce vibrationLength - less than or equal to 48 inchesWidth - less than or equal to 34 inchesMinimum Top End Speed - 6 MPHMinimum Range - 16 milesMinimum Obstacle Climb - 75 mmDynamic Stability Incline - 9 degreesGroup 3 and 4 no power option PWCs (K0848, K0849, K0850, K0851, K0852, K0853, K0854,K0855, K0868, K0869, K0870, K0871) must have the specified components and meet the following requirements:Incapable of accommodating a power tilt, recline, standing systemAccommodates non-powered options and seating systems (e.g., recline-only backs, manually elevating legrests)Group 3 and 4 single power option PWCs (K0856, K0857, K0858, K0859, K0860, K0877, K0878, K0879, K0880) must have the specified components and meet the following requirements:See Single Power Option definition for seating system capabilityGroup 3 and 4 multiple power option PWCs (K0861, K0862, K0863, K0864, K0884, K0885,K0886) must have the specified components and meet the following requirements:See Multiple Power Options definition for seating system capabilityAccommodates a ventilatorAll Group 5 PWCs (K0890, K0891) must have the specified components and meet the following requirements:Standard integrated or remote proportional joystickNon-expandable controllerCapable of upgrade to expandable controllerCapable of upgrade to alternative control devicesSeat Width: minimum of 5 one-inch optionsSeat Depth: minimum of 3 one-inch optionsSeat Height: adjustment requirements- 3 inchesBack Height: adjustment requirements minimum of 3 optionsSeat to Back Angle: range of adjustment-minimum of 12 degreesAccommodates non-powered options and seating systemsAccommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports)Adjustability for growth (minimum of 3 inches for width, depth and back height adjustment)Special developmental capability (i.e., seat to floor, standing, etc.)Drive wheel suspension to reduce vibrationLength - less than or equal to 48 inchesWidth - less than or equal to 34 inchesMinimum Top End Speed - 4 MPHMinimum Range - 12 milesMinimum Obstacle Climb - 60 mmDynamic Stability Incline - 9 degreesCrash testing - PassedGroup 5 single power option PWC (K0890) must have the specified components and meet the following requirements:See Single Power Option definition for seating system capabilityGroup 5 multiple power option PWC (K0891) must have the specified components and meet the following requirements:See Multiple Power Options definition for seating system capabilityAccommodates a ventilatorMISCELLANEOUS:The only products that may be billed using codes K0800, K0801, K0802, K0806, K0807, K0808, K0812, K0813, K0814, K0815, K0816, K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828, K0829, K0830, K0831, K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842, K0843, K0848, K0849, K0850, K0851, K0852, K0853, K0854, K0855, K0856, K0857, K0858, K0859, K0860, K0861, K0862, K0863, K0864, K0868, K0869, K0870, K0871, K0877, K0878, K0879, K0880, K0884, K0885, K0886, K0890, K0891, K0898 are those products for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor. Information concerning the documentation that must be submitted to the PDAC for a written CVR can be found on the PDAC web site or by contacting the PDAC. A Product Classification List (PCL) with products which have received a written CVR can be found on the PDAC web site. Note that code K0013 is not included in the list of products requiring CVR.Manufacturers and suppliers should refer to the PDAC web site or contact the PDAC for information concerning testing requirements.If a power mobility device has not received a written CVR from the PDAC or if the PDAC has reviewed and determined that the product does not meet the requirements of any code, then it must be billed with code K0899.If a product is billed to Medicare using one of the HCPCS codes that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.

Local Coverage Articles, Refractive Lenses - Policy Article, A52499

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Refractive lenses are covered under the prosthetic devices benefit category (Social Security Act 1861(s)(8)). In order for a beneficiarys equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Refractive lenses are covered when they are used to restore the vision normally provided by the natural lens of the eye of an individual lacking the organic lens because of surgical removal or congenital absence. Covered diagnoses are limited to pseudophakia (condition in which the natural lens has been replaced with an artificial intraocular lens [IOL]), aphakia (condition in which the natural lens has been removed but there is no IOL), and congenital aphakia. Lenses provided for other diagnoses will be denied as noncovered.Refractive lenses are covered even though the surgical removal of the natural lens occurred before Medicare entitlement.For beneficiaries with pseudophakia, coverage is limited to one pair of eyeglasses or contact lenses after each cataract surgery with insertion of an IOL. Replacement frames, eyeglass lenses and contact lenses are noncovered. If a beneficiary has a cataract extraction with IOL insertion in one eye, subsequently has a cataract extraction with IOL insertion in the other eye, and does not receive eyeglasses or contact lenses between the two surgical procedures, Medicare covers only one pair of eyeglasses or contact lenses after the second surgery. If a beneficiary has a pair of eyeglasses, has a cataract extraction with IOL insertion, and receives only new lenses but not new frames after the surgery, the benefit would not cover new frames at a later date (unless it follows subsequent cataract extraction in the other eye).Refer to the Local Coverage Determination (LCD) for information about coverage of lenses for aphakic beneficiaries (i.e., those who do not have an IOL).Because coverage of refractive lenses is based upon the Prosthetic Device benefit category, there is no coverage for frames or lens add-on codes unless there is a covered lens(es). Frames provided without a covered lens(es) will be denied as noncovered.Tinted lenses (V2745), including photochromatic lenses (V2744), used as sunglasses, which are prescribed in addition to regular prosthetic lenses to a pseudophakic beneficiary, will be denied as noncovered.Scratch resistant coating (V2760), mirror coating (V2761), polarization (V2762), deluxe lens feature (V2702) and progressive lenses (V2781) will be denied as noncovered.Use of polycarbonate or similar material (V2784) or high index glass or plastic (V2782, V2783) for indications such as light weight or thinness will be denied as a noncovered deluxe feature.Specialty occupational multifocal lenses (V2786) will be denied as noncovered.Only standard frames (V2020) are covered. Additional charges for deluxe frames (V2025) will be denied as noncovered.When hydrophilic soft contact lenses (V2520, V2521, V2522, V2523) are used as a corneal dressing, they are denied as noncovered because in this situation they do not meet the definition of a prosthetic device.Eyeglass cases (V2756) will be denied as noncovered.Contact lens cleaning solution and normal saline for contact lenses will be denied as noncovered.Low vision aids (V2600, V2610, V2615) will be denied as noncovered because coverage under the Medicare prosthetic benefit is limited to persons with congenital absence or surgical removal of the lens of the eye.Vision supplies, accessories, and/or service components of another HCPCS vision code (V2797) will be denied as not separately payable.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The diagnosis code that justifies the need for these items must be included on the claim.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, unless continued coverage requirements are specified in the LCD, ongoing need for the lens(es) is assumed to be met. There is no requirement for further documentation of continued medical need as long as the beneficiary continues to meet the prosthetic devices benefit.MODIFIERSKX, GA, GY and GZ MODIFIERS:For anti-reflective coating (V2750), tints (V2744, V2745) or oversized lenses (V2780), if medical necessity is documented by the treating practitioner, the KX modifier must be added to the code. For polycarbonate or TrivexTMlenses (V2784), if they are for a beneficiary with monocular vision, the KX modifier must be added to the code. The KX modifier may only be used when these requirements are met. When the KX modifier is billed, documentation to support the medical necessity of the lens feature must be available upon request.For anti-reflective coating (V2750), polycarbonate or TrivexTMlenses (V2784), tints (V2744, V2745) or oversized lenses (V2780), if the coverage criteria have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines for anti-reflective coating (V2750), tints (V2744, V2745), oversized lenses (V2780) or polycarbonate or TrivexTMlenses (V2784) billed without a KX, GA, GY or GZ modifier will be rejected as missing information.Refer to the Supplier Manual for more information on documentation requirements.CODING GUIDELINESDeluxe lens features (V2702) include services and features such as lens edge treatments and lens drilling.Photochromatic lenses (V2744) and contacts (V2524) are those in which the degree of tint changes in response to changes in ambient light. Code V2744 is used for any type of photochromatic lens, either glass or plastic. Code V2524 is used for any type of photochromatic contact lens.Code V2745 is used for any type or color of lens tint, excluding photochromatic lenses.Code V2755 must be used only if a UV coating is applied to a lens and not as an add-on code for the UV protection inherent in the lens material.Anti-reflective coating (V2750) is a clear lens treatment used to decrease glare and internal/external reflections.Mirror coatings (V2761) are colored, highly reflective lens treatments.Progressive lens (V2781) is a multifocal lens that gradually changes in lens power from the top to the bottom of the lens, eliminating the line(s) that would otherwise be seen in a bifocal or trifocal lens.Code V2784 is an add-on used for lenses made of impact-resistant material such as polycarbonate or TrivexTM. Codes V2782 and V2783 (high index) must not be billed in addition to code V2784.Codes V2100, V2101, V2102, V2103, V2104, V2105, V2106, V2107, V2108, V2109, V2110, V2111, V2112, V2113, V2114, V2199, V2200, V2201, V2202, V2203, V2204, V2205, V2206, V2207, V2208, V2209, V2210, V2211, V2212, V2213,V2214, V2299, V2300, V2301, V2302, V2303, V2304, V2305, V2306, V2307, V2308, V2309, V2310, V2311, V2312, V2313,V2314, V2399, V2410, V2430,V2499, V2700, and V2770 describe specific eyeglass lenses. Only one of these codes may be billed for each lens provided. These codes include both aspheric and nonaspheric lenses.Codes V2115, V2118, V2121, V2215, V2218, V2219, V2220,V2221, V2315, V2318, V2319, V2320,V2321, V2710, V2715, V2718, V2730, V2744, V2745, V2750, V2755, V2756,V2760, and V2780, V2781, V2782, V2783, V2784, V2786,V2797 describe add-on features of lenses. They are billed in addition to codes for the basic lens.When billing claims for deluxe frames, use code V2020 for the cost of standard frames and a second line item using code V2025 for the difference between the charges for the deluxe frames and the standard frames.When billing claims for progressive lenses, use the appropriate code for the standard bifocal (V2200, V2201, V2202, V2203, V2204, V2205, V2206, V2207, V2208, V2209, V2210, V2211, V2212, V2213, V2214, V2215, V2218, V2219, V2220, V2221,V2299) or trifocal (V2300, V2301, V2302, V2303, V2304, V2305, V2306, V2307, V2308, V2309, V2310, V2311, V2312, V2313, V2314, V2315, V2318, V2319, V2320, V2321,V2399) lenses and a second line item using code V2781 for the difference between the charge for the progressive lens and the standard lens.

Local Coverage Articles, Refractive Lenses - Policy Article, A52499

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When billing claims for deluxe frames, use code V2020 for the cost of standard frames and a second line item using code V2025 for the difference between the charges for the deluxe frames and the standard frames.When billing claims for progressive lenses, use the appropriate code for the standard bifocal (V2200, V2201, V2202, V2203, V2204, V2205, V2206, V2207, V2208, V2209, V2210, V2211, V2212, V2213, V2214, V2215, V2218, V2219, V2220, V2221,V2299) or trifocal (V2300, V2301, V2302, V2303, V2304, V2305, V2306, V2307, V2308, V2309, V2310, V2311, V2312, V2313, V2314, V2315, V2318, V2319, V2320, V2321,V2399) lenses and a second line item using code V2781 for the difference between the charge for the progressive lens and the standard lens.The RT and/or LT modifiers must be used with all HCPCS codes in this policy except codes V2020, V2025 and V2600. Effective for claims with dates of service (DOS) on or after 3/1/2019, when lenses are provided bilaterally and the same code is used for both lenses, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.PROSEDevicePROSE(BostonSight, Needham, MA) devices are designed to rest on the sclera or white part of the eye and are used to treat ocular surface diseases, including some types of "dry eye." For Medicare billing purposes correct HCPCS coding for this item is determined based upon the condition(s) being treated. When the PROSEdevice is used as a treatment for either of the following indications listed below, the correct HCPCS code to use is V2627 (SCLERAL COVER SHELL):Treatment of an eye rendered sightless and shrunken by inflammatory disease; or,Treatment of "dry eye" where the PROSEdevice serves as a substitute for the function of the diseased lacrimal gland.When the PROSEdevice is used for any conditions other than those listed above, the device must be coded with HCPCS code V2531 (CONTACT LENS, SCLERAL, GAS PERMEABLE, PER LENS (FOR CONTACT LENS MODIFICATION, SEE 92325)) and is subject to the Medicare refractive lens statutory coverage exclusion.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Spinal Orthoses: TLSO and LSO - Policy Article, A52500

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).In order for a beneficiarys orthosis to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Lumbar-sacral orthoses (LSO) and thoracic-lumbar-sacral orthoses (TLSO) are covered under the Medicare braces benefit (Social Security Act 1861(s)(9)). For coverage under this benefit, the orthosis must be a rigid or semi-rigid device, which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. Items that are not sufficiently rigid to be capable of providing the necessary immobilization or support to the body part for which it is designed do not meet the statutory definition of the braces benefit. Items that do not meet the definition of a brace are statutorily noncovered, no benefit.Elastic or other fabric support garments (A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANYTYPE)) with or without stays or panels do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices. Code A4467 is denied as noncovered (no Medicare benefit). Refer to the CODING GUIDELINES section below for additional information.Both off-the-shelf (OTS) and custom-fit items are considered prefabricated braces for Medicare coding purposes. 42 CFR 414.402 establishes that correct coding of a spinal orthosis is dependent upon whether there is a need for minimal self-adjustment during the final fitting at the time of delivery. (See definitions below in CODING GUIDELINES.) If a custom fit code is billed when minimal self-adjustment was provided at the final delivery, or if an OTS code is billed when more than minimal self-adjustments were made at the final delivery, the claim will be denied as incorrect coding.A protective body sock (L0984) does not meet the definition of a brace and is noncovered.There is no separate payment for computer-aided design/computer-aided manufacturing (CAD/CAM) technology when it is used to fabricate an orthosis. Reimbursement, of the CAD/CAM technology utilized in the fabrication of an orthosis, is included in the allowance of the orthosis HCPCS code.Evaluation of the beneficiary, measurement and/or casting, and fitting/adjustments of the orthosis are included in the allowance for the orthosis. There is no separate payment for these services.Payment for a spinal orthosis is included in the payment to a hospital or SNF if:The orthosis is provided to a beneficiary prior to an inpatient hospital admission or Part A covered SNF stay; andThe medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after spinal surgery).A claim should not be submitted to the DME MAC in this situation.Payment for a spinal orthosis is also included in the payment to a hospital or a Part A covered SNF stay if:The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; andThe beneficiary uses the item for medically necessary inpatient treatment or rehabilitation.A claim must not be submitted to the DME MAC in this situation.Payment for a spinal orthosis delivered to a beneficiary in a hospital or a Part A covered SNF stay is eligible for coverage by the DME MAC if:The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; andThe orthosis is provided to the beneficiary within two days prior to discharge to home; andThe orthosis is not needed for inpatient treatment or rehabilitation, but is left in the room for the beneficiary to take home.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.When providing orthoses suppliers must:Provide the product that is specified by the treating practitionerBe sure that the treating practitioner's medical record justifies the need for the type of product (i.e., prefabricated versus custom fabricated)Only bill for the HCPCS code that accurately reflects both the type of orthosis and the appropriate level of fittingHave detailed documentation in the suppliers record that justifies the code selectedFor prefabricated orthoses, there is no physical difference between orthoses coded as custom fitted versus those coded as OTS. The differentiating factor for proper coding (refer to the definitions in the CODING GUIDELINES section below) is the need for minimal self-adjustment at the time of fitting by the beneficiary, caretaker for the beneficiary, or supplier. This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training (as defined in the CODING GUIDELINES section). Items requiring minimal self-adjustment are coded as OTS orthoses. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.Items requiring more than minimal self-adjustment by a qualified practitioner are coded as custom fitted (L0454, L0456, L0458, L0460, L0462, L0464, L0466, L0468, L0470, L0472, L0488, L0490, L0491, L0492, L0626, L0627, L0630, L0631, L0633, L0635, L0637 and L0639). Documentation must be sufficiently detailed to include, but is not limited to, a detailed description of the modifications necessary at the time of fitting the orthosis to the beneficiary. This information must be available upon request.For a custom fabricated orthosis (L0452, L0480, L0482, L0484, L0486, L0622, L0624, L0629, L0632, L0634, L0636, L0638 and L0640), there must be detailed documentation in the treating practitioners records to support the medical necessity of the custom fabricated orthosis rather than a prefabricated orthosis as described in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD. This information will be corroborated by the functional evaluation in the orthotists records and the method of custom fabrication should adhere to the DMEPOS Quality Standards, Appendix C. This information must be available upon request.MODIFIERSCG ModifierThe CG modifier must be added to code L0450, L0454, L0455, L0621, L0625, or L0628 only if it is one made primarily of nonelastic material (e.g., canvas, cotton or nylon) or having a rigid posterior panel. (Refer to the Coding Guidelines section below for instructions on the use of code A4467 for elastic spinal garments.)CODING GUIDELINESCUSTOM FABRICATEDA custom fabricated item is one that is individually made for a specific patient. No other patient would be able to use this item. A custom fabricated item is a device which is fabricated based on clinically derived and rectified castings, tracings, measurements, and/or other images (such as X-rays) of the body part.The fabrication may involve using calculations, templates, and components. This process requires the use of basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of uncut or unshaped sheets, bars, or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, and finishing prior to fitting on the patient. Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics.Use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated.Molded-to-Patient-ModelA particular type of custom fabricated device in which either:An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; or,A digital image of the patients body part is made using CAD/CAM systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.Positive Model of the PatientA positive model is an exact replica of the actual body part for which the custom fabricated item is being constructed. A positive model can be produced by any of these methods:Molded-to-patient-model, which is a negative impression taken of the patients body member and which is used to make a positive model rectification.CAD/CAM software, which uses digitizers to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the modified shape goes to a commercial milling machine that carves the rectified model.Direct formed model, in which the patient serves as the positive model. The device is constructed over the patients model, and then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made.Additive ManufacturingAdditive manufacturing (such as 3D printing) is an advanced technology that constructs three-dimensional items modeled and designed from CAD software and/or from digital scanning. Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C.Specialized TrainingSpecialized training is defined as training that provides the knowledge, skills, and experience in the provision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements.PREFABRICATEDA prefabricated orthosis is an item that is manufactured in quantity without a specific beneficiary in mind. A prefabricated orthosis may be considered an OTS or a custom fitted device that may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific beneficiary. An orthosis that is assembled from prefabricated components is considered prefabricated. It is inherent in the definition of prefabricated that a particular item is complete.Off-the-shelf (OTS) orthotics are:Items that are prefabricated.They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, and molding, assembling, or customizing to fit an individual.This fitting does not require expertise of a certified orthotist or an individual who has specialized training in the provision of orthoses to fit the item to the individual beneficiary.The term minimal self-adjustment is defined at 42 CFR 414.402 as an adjustment the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. See more than minimal self-adjustment definition below for additional information.Custom fitted orthotics are:

Local Coverage Articles, Spinal Orthoses: TLSO and LSO - Policy Article, A52500

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Items that are prefabricated.They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, and molding, assembling, or customizing to fit an individual.This fitting does not require expertise of a certified orthotist or an individual who has specialized training in the provision of orthoses to fit the item to the individual beneficiary.The term minimal self-adjustment is defined at 42 CFR 414.402 as an adjustment the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. See more than minimal self-adjustment definition below for additional information.Custom fitted orthotics are:Devices that are prefabricated.They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.Classification as custom fitted requires more than minimal self-adjustment at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.This fitting at delivery does require expertise of a certified orthotist or an individual who has specialized training in the provision of the orthosis to fit the item to the individual beneficiary.In contrast to minimal self-adjustment, more than minimal self-adjustment is defined as changes made to achieve an individualized fit during the final fitting at the time of delivery of the item that requires the expertise of a certified orthotist or an individual who has specialized training in the provision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements. A certified orthotist is defined as an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification.Correct coding of prefabricated orthoses is dictated by actions that take place at the time of fitting to the beneficiary, either custom-fitted (requiring expertise) or OTS (requiring minimal self-adjustment).Corresponding HCPCS Code SetsFor many prefabricated orthoses, corresponding sets of HCPCS codes are available which describe the identical types of items. The corresponding code sets, when available for identical products, are only differentiated by the nature of the final fitting performed at the time of delivery. The corresponding HCPCS code types are:HCPCS codes which describe PREFABRICATED, OFF-THE-SHELF. These HCPCS codes must be used when minimal self-adjustment is the extent of the fitting performed at delivery.HCPCS codes which describe PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE. These HCPCS codes must be used when more than minimal self-adjustment is necessary and performed at delivery.In the following table, the HCPCS codes located in Column I and Column II within the same row are considered a corresponding HCPCS code set. These codes represent identical products which are only differentiated by the nature of the final fitting performed at the time of delivery.Column IColumn IIL0454L0455L0456L0457L0466L0467L0468L0469L0626L0641L0627L0642L0630L0643L0631L0648L0633L0649L0637L0650L0639L0651For some prefabricated orthoses, corresponding sets of HCPCS codes (which describe the identical types of items) are not available. HCPCS codes with long descriptions of PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT describe custom fitted items. For these HCPCS codes there are no corresponding OTS codes. When the unique HCPCS code that most closely describes the product includes PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT in the HCPCS long description, the supplier must:Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary; or,Code the product using a miscellaneous HCPCS code, if the product was not custom fitted at delivery to the beneficiary and, instead, was provided as OTS to the beneficiary. The miscellaneous HCPCS code for billing of spinal orthoses is HCPCS code L1499.SPINAL ORTHOSESSpinal orthoses (L0450, L0452, L0454, L0455, L0456, L0457, L0458, L0460, L0462, L0464, L0466, L0467, L0468, L0469, L0470, L0472, L0480, L0482, L0484, L0486, L0488, L0490, L0491, L0492, L0621, L0622, L0623, L0624, L0625, L0626, L0627, L0628, L0629, L0630, L0631, L0632, L0633, L0634, L0635, L0636, L0637, L0638, L0639, L0640, L0641, L0642, L0643, L0648, L0649, L0650, L0651) have the following characteristics:Used to immobilize the specified areas of the spineIntimate fit and generally designed to be worn under clothingNot specifically designed for beneficiaries in wheelchairsIn addition to (1) and (2), the body jacket type orthoses (L0458, L0460, L0462, L0464, L0480, L0482, L0484, L0486, L0488, L0490, L0491, L0492, L0639, L0640, L0651) are characterized by a rigid plastic shell that encircles the trunk with overlapping edges and stabilizing closures and provides a high degree of immobility. The entire circumference of the plastic shell must be the same rigid material.A rigid or semi rigid orthotic device eliminates or restricts motion in the planes being controlled by an orthosis.A spinal orthosis is designed to control gross movement of the trunk and intersegmental motion of the vertebrae in one or more planes of motion:Lateral/flexion (side bending) in the coronal/frontal plane. Control of this plane is achieved by a rigid panel in the mid-axillary line, which is either an integral part of a posterior or anterior panel, or a separate panel.Anterior flexion (forward bending) or posterior extension (backward bending) in the sagittal plane. Control of this plane is achieved by a rigid posterior panelAxial rotation (twisting) viewed in the transverse plane. Straps over the shoulders attaching to a posterior panel alone do not provide transverse spinal control.The purpose of a rigid or semi-rigid LSO and TLSO spinal orthosis is to restrict the effect of the forces within a three-point pressure system. The posterior panel must encompass the paraspinal muscle bodies from one lateral border to another in order to provide sufficient surface area to enhance the three-point pressure system. The posterior panel must provide coverage to meet the minimum height requirements as described in the individual HCPCS codes. Spinal Orthoses that do not meet the Medicare definition of a brace should be coded as A9270.For an item to be classified as a TLSO the posterior portion of the brace must extend from the sacrococcygeal junction to just inferior to the scapular spine. This excludes elastic or equal shoulder straps or other strapping methods. The anterior portion of the orthosis must at a minimum extend from the symphysis pubis to the xiphoid. Some TLSOs may require the anterior portion of the orthosis to extend up to the sternal notch.Maternity support garments, which are products that are designed to provide support for the abdomen during pregnancy, do not meet the definition of a brace. These products are coded using A9270 (NON-COVERED ITEM OR SERVICE). L-codes for orthoses must not be used for these items.ELASTIC AND SIMILAR STRETCHABLE MATERIALSFor items where the HCPCS code specifies elastic or other similar terminology for stretchable material, use the code that is most applicable to the item. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS code.For items where the HCPCS code does not specify elastic or other similar terminology for stretchable material, the following guidelines apply:Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra) (not all-inclusive)) must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANYTYPE).Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra]) (not all-inclusive)) that contain stays and/or panels must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANYTYPE).Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANYTYPE).Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANYTYPE).Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS code.Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and relevant coding guideline for the criteria applicable for each HCPCS code.Items that are not capable of providing the necessary immobilization or support to the body part for which it is designed (regardless of materials) must be coded using A9270 (NONCOVERED ITEM OR SERVICE).Codes L0450, L0454, L0455, L0621, L0625, and L0628 may only be used for orthoses that are made primarily of nonelastic material (e.g., canvas, cotton or nylon).

Local Coverage Articles, Spinal Orthoses: TLSO and LSO - Policy Article, A52500

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Codes L0450, L0454, L0455, L0621, L0625, and L0628 may only be used for orthoses that are made primarily of nonelastic material (e.g., canvas, cotton or nylon).CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC web site or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC web site. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after July 1, 2010:L0450, L0454, L0456, L0458, L0460, L0462, L0464, L0466, L0468, L0470, L0472, L0488, L0490, L0491, L0492, L0625, L0626, L0627, L0628, L0630, L0631, L0633, L0635, L0637, L0639Effective for claims with dates of service on or after January 1, 2014:L0455, L0457, L0467, L0469, L0641, L0642, L0643, L0648, L0649, L0650, L0651There are two categories of custom fabricated spinal orthoses (codes L0452, L0480, L0482, L0484, L0486,L0629, L0632, L0634, L0636, L0638, and L0640):Orthoses that are custom fabricated by a manufacturer/central fabrication facility and then sent to someone other than the beneficiary. Effective for claims with dates of service on or after July 1, 2010, these items may be billed using one of these codes only if they are listed in the Product Classification List on the PDAC web site.Orthoses that are custom fabricated from raw materials and are dispensed directly to the beneficiary by the entity that fabricated the orthosis. These items do not have to be listed on the PDAC web site in order to be billed using a custom fabricated spinal orthosis code. However, the supplier must provide a list of the materials that were used and a description of the custom fabrication process on request.If a product is billed to Medicare using a HCPCS code that requires written coding verification review, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Therapeutic Shoes for Persons with Diabetes - Policy Article, A52501

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Therapeutic Shoes and inserts are covered under the Therapeutic Shoes for Individuals with Diabetes benefit (Social Security Act 1861(s)(12)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.For an item addressed in this policy to be covered by Medicare, aStandard WrittenOrder (SWO)must be communicated to the supplier prior to claim submission. If the supplier bills for an item without first receiving the SWO, the item will be denied as statutorilynoncovered.The Certifying Physician is defined as a doctor of medicine (M.D.) or a doctor of osteopathy (D.O.) who is responsible for diagnosing and treating the beneficiarys diabetic systemic condition through a comprehensive plan of care. The certifying physician may not be a podiatrist or clinical nurse specialist. Consequent to the M.D. or D.O. restriction, a nurse practitioner (NP) and a physician assistant (PA) may not serve in the role of the certifying physician, unless practicing incident to the supervising physicians authority, as described below.NPs or PAs providing ancillary services as auxiliary personnel could meet the incident to requirements in their provision of therapeutic shoes to beneficiaries with diabetes if all of the following criteria are met:The supervising physician has documented in the medical record that the patient is diabetic and has been, and continues to provide, the patient follow-up under a comprehensive management program of that condition; and,The NP or PA certifies that the provision of the therapeutic shoes is part of the comprehensive treatment plan being provided to the patient; and,The supervising physician must review and verify (sign and date) all of the NP or PA notes in the medical record pertaining to the provision of the therapeutic shoes, acknowledging their agreement with the actions of the NP or PA.In states where the NP may practice independently, the NPs employment situation would require compliance with Medicare incident to rules in order to serve as the certifying physician. Please refer to the applicable A/B MAC for further information.The Prescribing Practitioner is the person who actually writes the order for the therapeutic shoe, modifications and inserts. This practitioner must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing practitioner may be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribing practitioner 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 and that bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Practitioner may be the supplier. The Certifying Physician may only be the supplier if the certifying physician 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 are met:The beneficiary has diabetes mellitus (Reference diagnosis code section below); andThe certifying physician has documented in the beneficiary's medical record one or more of the following conditions:Previous amputation of the other foot, or part of either foot, orHistory of previous foot ulceration of either foot, orHistory of pre-ulcerative calluses of either foot, orPeripheral neuropathy with evidence of callus formation of either foot, orFoot deformity of either foot, orPoor circulation in either foot; andThe certifying physician has certified that indications (1) and (2) are met and that he/she is treating the beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs diabetic shoes. For claims with dates of service on or after 01/01/2011, the certifying physician must:Have an in-person visit with the beneficiary during which diabetes management is addressed within 6 months prior to delivery of the shoes/inserts; andSign the certification statement (refer to the Policy Specific Documentation Requirements section below) on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the beneficiary. (Refer to the Policy Specific Documentation Requirements section below.)At the time of in-person delivery to the beneficiary of the items selected, thesuppliermust conduct an objective assessment of the fit of the shoe and inserts and document the results. A beneficiarys subjective statements regarding fit as the sole documentation of the in-person delivery does not meet this criterion.If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied as noncovered. When codes are billed without a KX modifier (see Policy Specific Documentation Requirements section below), they will be denied as noncovered.In order to meet criterion 2, the certifying physician must either:Personally document one or more of criteria a f in the medical record of an in-person visit within 6 months prior to delivery of the shoes/inserts and prior to or on the same day as signing the certification statement; orObtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of an in-person visit with a podiatrist, other M.D or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that is within 6 months prior to delivery of the shoes/inserts, and that documents one of more of criteria a f.The requirement that the in-person visit(s) be within 6 months prior to delivery of the shoes/inserts is effective for claims 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 had both a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the items that meet the beneficiarys 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 practitioner within 6 months prior to delivery of the shoes/inserts.For beneficiaries 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 2 additional pairs of inserts (A5512, A5513, or A5514); orOne pair of depth shoes (A5500) and 3 pairs of inserts (A5512, A5513, or A5514) (not including the non-customized removable inserts provided with such shoes).A modification of a custom molded or depth shoe may be covered as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications: rigid rocker bottoms (A5503), roller bottoms (A5503), wedges (A5504), metatarsal bars (A5505), or offset heels (A5506). Other modifications to 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 beneficiary's foot over time through the heat and pressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contact at 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 or prescription of the footwear. Claims for unrelated evaluation and management services provided by the practitioner are 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 for footwear provided under this benefit. See the medical policy on Orthopedic Footwear for details.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.An order for each item billed must be signed and dated by the prescribing practitioner, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.If the prescribing practitioner is the supplier, a separate order is not required, but the item provided must be clearly noted in the beneficiary'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 the replacement of any shoe. A new order is also required for the replacement of an insert or modification more than one year from the most recent order on file. TheSWO must be signed on or after the date of the visit with the Prescribing Practitioner.The supplier must obtain a signed statement from the practitioner who is personally managing the beneficiarys systemic diabetes condition (i.e., the certifying physician) specifying that the beneficiary has diabetes mellitus, has one of conditions 2a-2f above, 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 or clinical nurse specialist. An NP or PA may not serve in the role of the certifying physician, unless practicing incident to the supervising physicians authority.The "Statement of Certifying Physician for Therapeutic Shoes" form (see related LCD Attachments section) is recommended. Whatever form is used must contain all of the elements contained on the recommended form attached to the related LCD. This statement must be completed, signed, and dated by the certifying physician. If an NP or PA is practicing incident to a supervising physician, the NP or PA completes, signs, and dates the statement; however, the supervising physician (M.D. or D.O.) must review and verify (sign and date), acknowledging agreement with the NP or PA. A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file.There must be information in the medical records of the certifying physician that:Documents management of the beneficiarys diabetes; andDocuments detailed information about the condition (2a-2f listed above) that qualifies the beneficiary for coverage.The Certification Statement by itself does not meet this requirement for documentation in the medical records.The in-person evaluation of the beneficiary by the supplier at the time of selecting the items that will be provided (refer to Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include at least the following:An examination of the beneficiarys feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.For all shoes, taking measurements of the beneficiarys feet.For custom molded shoes (A5501) and inserts (A5513 and A5514), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiarys feet that will be used in creating positive models of the feet.

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There must be information in the medical records of the certifying physician that:Documents management of the beneficiarys diabetes; andDocuments detailed information about the condition (2a-2f listed above) that qualifies the beneficiary for coverage.The Certification Statement by itself does not meet this requirement for documentation in the medical records.The in-person evaluation of the beneficiary by the supplier at the time of selecting the items that will be provided (refer to Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include at least the following:An examination of the beneficiarys feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.For all shoes, taking measurements of the beneficiarys feet.For custom molded shoes (A5501) and inserts (A5513 and A5514), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiarys feet that will be used in creating positive models of the feet.The in-person evaluation of the beneficiary by the supplier at the time of delivery (refer to Non-Medical Necessity Coverage and Payment Rules, criterion 5) must be conducted with the beneficiary wearing the shoes and inserts and must document that the shoes/inserts/modifications fit properly.The diagnosis code that justifies the need for these items must be included on the claim.MODIFIERSKX, GA, GY AND GZ MODIFIERS:Suppliers must add a KX modifier to codes for shoes, inserts, and modification only if criteria 1-5 in the Non-Medical Necessity Coverage and Payment Rules section have been met. This documentation must 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 have not been met, the GY modifier must be added to each code.If a KX or appropriate GA, GY or GZ modifier is not included on the claim line, the claim line will be rejected as missing information.CODING GUIDELINESA depth shoe (A5500) is one that:Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16" of additional depth used to accommodate custom-molded or customized inserts; andIs made from leather or other suitable material of equal quality; andHas some form of shoe closure; andIs available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoe according to the American standard last sizing schedule or its equivalent. (The American last sizing schedule is the numerical shoe sizing system used for shoes in the United States.)The shoe may or may not have an internally seamless toe.A custom-molded shoe (A5501) is one that:Is constructed over a positive model of the beneficiary's foot; andIs made from leather or other suitable material of equal quality; andHas removable inserts that can be altered or replaced as the beneficiary's condition warrants; andHas some form of shoe closure.The shoe may or may not have an internally seamless toe.Code A5512 describes a total contact, multiple density, prefabricated removable inlay that is directly molded to the beneficiarys foot. Direct molded means it has been conformed by molding directly to match the plantar surface of the individual beneficiarys foot. Total contact means it makes and retains actual and continuous physical contact with the weight-bearing portions of the foot, including the arch throughout the standing and walking phases of gait.The A5512 insert must retain its shape during use for the life of the insert. The layer responsible for shape retention is called the base layer in the code descriptor. This material usually constitutes the bottom layer of the device and must be of a sufficient thickness and durometer to maintain its shape during use (i.e., at least inch of 35 Shore A or higher or at least 3/16 inch of 40 Shore A or higher). The material responsible for maintaining the shape of the device must be heat moldable. The specified thickness of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes.Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a model of the beneficiarys foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length, or toe shape.The A5513 insert must retain its shape during use for the life of the insert. The base layer of the device must be at least 3/16 inch of 35 Shore A or higher material. The base layer is allowed to be thinner in the custom fabricated device because appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact and accommodate each beneficiarys specific needs. The central portion of the base layer of the heel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be of a lower durometer and must also be heat moldable. The materials used should be suitable with regards to the beneficiarys condition.CodeA5514 describes a total contact, custom fabricated, multiple density, removable inlay that is directly milled from a rectified virtual model of the beneficiary's foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length, or toe shape.TheA5514 insert must retain its shape during use for the life of the insert.The base layer of the device must be at least 3/16 inch of 35 Shore A or higher material.The base layer is allowed to be thinner in the custom fabricated device because appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact and accommodate each beneficiary's specific needs.The central portion of the base layer of the heel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction.The specified thickness of the lateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be of a lower durometer and must also be heat moldable.The materials used should be suitable with regards to the beneficiary's condition.Rigid rocker bottoms (A5503) are exterior elevations with apex position for 51 percent to 75 percent distance measured from the back end of the heel. The apex is a narrowed or pointed end of an anatomical structure. The apex must be positioned behind the metatarsal heads and tapering off sharply to the front tip of the sole. Apex height helps to eliminate pressure at the metatarsal heads. Rigidity is ensured by the steel in the shoe. The heel of the shoe tapers off in the back in order to cause the heel to strike in the middle of the heel.Roller bottoms (sole or bar) (A5503) are the same as rocker bottoms, but the heel is tapered from the apex to the front tip of the sole.Wedges (posting) (A5504) are either of hind foot, fore foot, or both and may be in the middle or to the side. The function is to shift or transfer weight bearing upon standing or during ambulation to the opposite side for added support, stabilization, equalized weight distribution, or balance.Metatarsal bars (A5505) are exterior bars which are placed behind the metatarsal heads in order to remove pressure from the metatarsal heads. The bars are of various shapes, heights, and construction depending on the exact purpose.Offset heel (A5506) is a heel flanged at its base either in the middle, to the side, or a combination, that is then extended upward to the shoe in order to stabilize extreme positions of the hind foot.A deluxe feature (A5508) does not contribute to the therapeutic function of the shoe. It may include, but is not limited to style, color, or type of leather.Code A5507 is only to be used for not otherwise specified therapeutic modifications to the shoe or for repairs to a diabetic shoe(s).Deluxe features must be coded using code A5508.Codes for inserts or modifications (A5503, A5504, A5505, A5506, A5507, A5508, A5510, A5512, A5513, A5514) may only be used for items related to diabetic shoes (A5500, A5501). They must not be used for items related to footwear coded with codes L3215, L3216, L3217, L3219, L3221, L3222, L3224, L3225, L3230, L3250, L3251, L3252, L3253. Inserts and modifications used with L-coded footwear must be coded using L codes (refer to the Orthopedic Footwear LCD and LCD-related Policy Article for more information).The right (RT) and/or left (LT) modifiers must be used when billing shoes, inserts, or modifications. Effective for claims with dates of service (DOS) on or after 3/1/2019, if bilateral items arebilled on the same date of service, billeach item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT,or with RTLT on the same claim line and 2 UOS,will be rejected as incorrect coding.Inserts for missing toes or partial foot amputation should be coded L5000 or L5999, whichever is applicable. When seeking coverage for devices for missing toes and partial foot amputations under the prosthetic devices benefit category, refer to the Lower Limb Prostheses LCD and LCD-related Policy Article for the applicable coding, coverage, and payment requirements.The only products that may be billed using codes A5512 are those that are specified in the Product Classification List (PCL) 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 someone other than the beneficiary. These items may be billed using code A5513 only if they are listed on the PDAC web site.Inserts that are custom fabricated from raw materials that are dispensed directly to the beneficiary by the entity that fabricated the insert. These items do not have to be listed on the PDAC web site in order to be billed using code A5513. However, the supplier must provide a list of the materials that were used and a description of the custom fabrication process on request.The only products that may be billed using codes A5514 are those that are specified in the PCL on the PDAC contractor web site.If an insert is not included in one of these categories of items (A5512, A5513, A5514), it must be billed with code A5510 or A9270 (noncovered item).If a product is billed to Medicare using a HCPCS code that requires written coding verification review, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.

Local Coverage Articles, Heating Pads and Heat Lamps - Policy Article, A52502

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Article - Heating Pads and Heat Lamps - Policy Article (A52502)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Heating pads are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A nonelectric heating pad or wrap (A9273) does not meet the definition of durable medical equipment (DME) and will be denied as noncovered.Hydrocollator units (E0225, E0239) are considered institutional equipment and will be denied as statutorily noncovered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.CODING GUIDELINESA standard electric heating pad (E0210) is a flexible device containing electric resistive elements producing heat. It must have a fabric cover. It must have a timing device for automatic shut-off. It may include heat-retaining material (e.g., gel, fluid, vegetable matter). If so, the heat retaining materials must be contained in an enclosed pouch or bag in or around the heating elements. The heating pad must be certified byan Occupational Safety and Health Administration (OSHA) Nationally Recognized Testing Laboratory (NRTL) (29 CFR 1910.7). A heating pad that includes a cover or other element that utilizes water vapor (humidity) drawn from the air to create moisture when heated is billed using this code.A moist electric heating pad (E0215) is a flexible device containing electric resistive elements producing heat. It must have a fabric cover. It must have a timing device for automatic shut-off. It must have a component that absorbs and retains liquid water. The water containing element must be protected from contact with the electrical components and the water must be in direct contact with the skin on application. The heating pad must be certified byan OSHA NRTL (29 CFR 1910.7). A cover or other element that utilizes water vapor (humidity) drawn from the air to create moisture when heated does not meet the definition of this code. Water must be added to the device to meet the description of this code.A water circulating heat pad with pump (E0217) is a flexible pad containing a series of channels through which water is circulated by means of an electrical pumping mechanism. The water is heated in an external reservoir. The pump, pad, and all accessories needed for the pad to be functional are included in the code. The device must be certified byan OSHA NRTL (29 CFR 1910.7).A hydrocollator unit (E0225, E0239) is a container which is filled with water and then heated. Bags of silicone dioxide or other material are placed in the heated water. These packs/pads are then applied to the body part over towels. They are used to heat the body part prior to physical therapy.Code E0249 is a durable replacement pad used with a water circulating heat pump system (E0217). It is made of rubber, heavy plastic, or durable fabric. It can be cleaned and is designed for long term use. A replacement pad made of other material that is designed for shorter term use must be billed using code A9999 (Miscellaneous DME supply or accessory, not otherwise specified).Heating pads that do not meet the coding criteria described above for E0210, E0215 or E0217 must be billed with code E1399.Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Walkers - Policy Article, A52503

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Article - Walkers - Policy Article (A52503)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Walkers are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Enhancement accessories of walkers will be denied as noncovered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC INFORMATIONIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.When code E0147 is billed, the claim must include the manufacturers name and product name/number.When code E1399 is billed, the claim must include the manufacturer name and the product name/number.MODIFIERSKX, GA, GY AND GZ MODIFIERS:If a heavy duty walker (E0148, E0149) is provided and if the supplier has documentation in their records that the beneficiary's weight (within one month of providing the walker) is greater than 300 pounds, the KX modifier should be added to the code.If the above criterion has not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.If the walker that is provided is only needed for mobility outside the home, the GY modifier must be added to the codes for the item and all accessories.Claims lines billed with codes E0148 and E0149 without a KX, GA, GY or GZ modifier will be rejected as missing information.CODING GUIDELINESA wheeled walker (E0141, E0143, E0149) is one with either 2, 3, or 4 wheels. It may be fixed height or adjustable height. It may or may not include glide-type brakes (or equivalent). The wheels may be fixed or swivel.A glide-type brake consists of a spring mechanism (or equivalent) which raises the leg post of the walker off the ground when the beneficiary is not pushing down on the frame.Code E0144 describes a rigid or folding wheeled walker which has a frame that completely surrounds the beneficiary and an attached seat in the back.A heavy duty walker (E0148, E0149) is one which is labeled as capable of supporting beneficiaries who weigh more than 300 pounds. It may be fixed height or adjustable height. It may be rigid or folding.Code E0147 describes a 4-wheeled, adjustable height, folding-walker that has all of the following characteristics:Capable of supporting beneficiaries who weigh greater than 350 pounds,Hand operated brakes that cause the wheels to lock when the hand levers are released,The hand brakes can be set so that either or both can lock both wheels,The pressure required to operate each hand brake is individually adjustable,There is an additional braking mechanism on the front crossbar,At least two wheels have brakes that can be independently set through tension adjustability to give varying resistance.The only walkers that may be billed using code E0147 are those products for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the Product Classification List (PCL). Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Codes A4636, A4637, and E0159 are only used to bill for replacement items for covered, beneficiary-owned walkers. Codes E0154, E0156, E0157, and E0158 can be used for accessories provided with the initial issue of a walker or for replacement components. Code E0155 can be used for replacements on covered, beneficiary-owned wheeled walkers or when wheels are subsequently added to a covered, beneficiary-owned nonwheeled walker (E0130, E0135). Code E0155 cannot be used for wheels provided at the time of, or within one month of, the initial issue of a non-wheeled walker.Hemi-walkers must be billed using code E0130 or E0135, not E1399.A gait trainer (or sometimes referred to as a rollator) is a term used to describe certain devices that are used to support a beneficiary during ambulation. Gait trainers are billed using one of the codes for walkers. If a gait trainer has a feature described by one of the walker attachment codes (E0154, E0156, E0157) that code may be separately billed. Other unique features of gait trainers are not separately payable and may not be billed with code E1399. If a supplier chooses to bill separately for a feature of a gait trainer that is not described by a specific HCPCS code, then code A9900 must be used.An enhancement accessory is one which does not contribute significantly to the therapeutic function of the walker. It may include, but is not limited to style, color, hand operated brakes (other than those described in code E0147), or basket (or equivalent). Use code A9270 when an enhancement accessory of a walker is billed.Brakes other than hand operated brakes, provided at the same time as a walker (E0141, E0143, E0149) may not be billed separately to the DME MACs or the beneficiary upon initial issue. However if billed separately upon initial issue the brakes must be billed using A9900, and the brakes will deny as not separately payable. HCPCS code E0159 (Brake attachment for wheeled walker, replacement, each) is applicable for replacement brakes only.A Column II code is included in the allowance for the corresponding Column I code when provided at the same time and must not be billed separately at the time of billing the Column I code.Column IColumn IIE0130A4636, A4637E0135A4636, A4637E0140A4636, A4637, E0155, E0159E0141A4636, A4637, E0155, E0159E0143A4636, A4637, E0155, E0159E0144A4636, A4637, E0155, E0156, E0159E0147A4636, E0155, E0159E0148A4636, A4637E0149A4636, A4637, E0155, E0159Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Wheelchair Options/Accessories - Policy Article, A52504

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Article - Wheelchair Options/Accessories - Policy Article (A52504)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Wheelchair options and accessories are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.The allowance for a power operated vehicle (POV) includes all options and accessories that are provided at the time of initial issue, including but not limited to batteries, battery chargers, seating systems, etc. If a beneficiary-owned POV meets coverage criteria, medically necessary replacement items are covered.The allowance for a rollabout chair includes all options and accessories that are provided at the time of initial issue. The allowance for a transport chair includes all options and accessories that are provided at the time of initial issue except for elevating legrests (E0990, K0195). If a rollabout chair or transport chair are covered, medically necessary replacement items are covered.An option/accessory that is beneficial primarily in allowing the beneficiary to perform leisure or recreational activities is non-covered.If an option or accessory that is included in another code is billed separately, the claim line will be denied as not separately payable. (Refer to Coding Guidelines section for additional information on correct coding.)BATTERIES/ CHARGERS:A sealed battery (E2359, E2361, E2363, E2365, E2371, E2397, K0733) is separately payable from a power wheelchair base.There is no additional/separate payment when a dual mode battery charger is provided at the time of initial issue of a power wheelchair.A battery charger (E2366, E2367) is included in the allowance for a power wheelchair base.POWER STANDING SYSTEM:A power standing feature (E2301) is non-covered because it is not primarily medical in nature. If a wheelchair has an electrical connection device described by code E2310 or E2311 and if the sole function of the connection is for a power standing feature, it will be denied as non-covered.POWER WHEELCHAIR DRIVE CONTROL SYSTEMS:If an attendant control (E2331) is provided in addition to a beneficiary-operated drive control system, it will be denied as non-covered. (See the related LCD for situations in which it is provided in place of a beneficiary-operated system.)OTHER POWER WHEELCHAIR ACCESSORIES:An electronic interface used to control lights or other electrical devices is non-covered because it is not primarily medical in nature.The following features of a power wheelchair will be denied as non-covered: stair climbing (A9270), electronic balance (A9270), ability to elevate the seat by balancing on two wheels (A9270), and remote operation (A9270).MISCELLANEOUS ACCESSORIES:Swingaway, retractable, or removable hardware (E1028) is non-covered if the primary indication for its use is to allow the beneficiary to move close to desks or other surfaces. If it is ordered for this indication, a GY modifier must be added to the code.A manual standing system for a manual wheelchair (E2230) is non-covered (no benefit category) because it is not primarily medical in nature.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.SPECIALTY EVALUATION:The specialty evaluation provides detailed information explaining why each option and accessory e.g., power tilt and/or recline seating systems, or gear reduction drive wheel is needed to address the beneficiarys mobility limitation. There must be a written report of this evaluation available on request. The PT, OT, or practitioner who performs the specialty evaluation may have no financial relationship with the supplier. (Exception: If the supplier is owned by a hospital, the PT, OT, or practitioner working in the inpatient or outpatient hospital setting may perform the specialty evaluation.)MODIFIERSKX, GA, GY, AND GZ MODIFIERS:For accessories for a power mobility device (PMD), if the requirements related to a standard written order (SWO) for the PMD base and face-to-face encounter in the Power Mobility Devices Policy Article have not been met, the GY modifier must be added to the codes for all accessories.For accessories provided with a manual wheelchair or power mobility device, if it is only needed for mobility outside the home, the GY modifier must be added to the codes for all accessories.If the conditions for use of the GY modifier are not met, the KX modifier must be added to the code for the accessory only if (a) the coverage criteria that are specified in the Manual Wheelchair Bases or Power Mobility Devices LCD have been met and (b) any specific coverage criteria for the accessory in the related LCD have been met. If the coverage criteria are not met, the KX modifier must not be used.If the conditions for use of the GY modifier are not met and if the requirements for use of the KX modifier are not met, the GA or GZ modifier must be added to a claim line for the accessory. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.If the GY modifier is used, the KX, GA, and GZ modifiers should not be used.Claim lines billed without a GA, GY, GZ, or KX modifier will be rejected as missing information.CODING GUIDELINESGENERAL:Power Wheelchair Basic Equipment Package - Each power wheelchair code is required to include all these items on initial issue (i.e., no separate billing/payment at the time of initial issue, unless otherwise noted). The statement that an item may be separately billed does not necessarily indicate coverage.Lap belt or safety belt. Shoulder harness/straps or chest straps/vest may be billed separately.Battery charger, single modeComplete set of tires and casters, any typeLegrests. There is no separate billing/payment if fixed, swingaway, or detachable non-elevating legrests with or without calf pad are provided. Elevating legrests may be billed separately.Footrests/foot platform. There is no separate billing/payment if fixed, swingaway, or detachable footrests or a foot platform without angle adjustment are provided. There is no separate billing for angle adjustable footplates with Group 1 or 2 PWCs. Angle adjustable footplates may be billed separately with Group 3, 4 and 5 PWCs.Armrests. There is no separate billing/ payment if fixed, swingaway, or detachable non-adjustable height armrests with arm pad are provided (K0015). Adjustable height armrests (E0973, K0020) may be billed separately.Any weight specific components (braces, bars, upholstery, brackets, motors, gears, etc.) as required by beneficiary weight capacity.Any seat width and depth. Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately:For Standard Duty, seat width and/or depth greater than 20 inches;For Heavy Duty, seat width and/or depth greater than 22 inches;For Very Heavy Duty, seat width and/or depth greater than 24 inches;For Extra Heavy Duty, no separate billingAny back width. Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately:For Standard Duty, back width greater than 20 inches;For Heavy Duty, back width greater than 22 inches;For Very Heavy Duty, back width greater than 24 inches;For Extra Heavy Duty, no separate billingController and Input Device. There is no separate billing/payment if a non-expandable controller and a standard proportional joystick (integrated or remote) is provided. An expandable controller, a nonstandard joystick (i.e., non-proportional or mini, compact or short throw proportional), or other alternative control device may be billed separately.Power Operated Vehicle (POV) Basic Equipment Package - Each POV is to include all these items on initial issue (i.e., no separate billing/payment at time of initial issue):Lap belt or safety belt. Shoulder harness/straps or chest straps/vest may be billed separatelyBattery or batteries required for operationBattery charger, single modeWeight appropriate upholstery and seating systemTiller steeringNon-expandable controller with proportional response to inputComplete set of tiresAll accessories needed for safe operationA table at the end of this section defines the bundling guidelines for wheelchair bases and options/accessories. Codes listed in Column II are not separately payable from the wheelchair base and must not be billed separately at the time of initial purchase or rental of the wheelchair.A replacement option/accessory for POV is billed using a wheelchair option/accessory code. All options and accessories provided at the time of initial issue of a POV are not separately billable.Accessories provided at the time of initial issue of a rollabout chair are not separately billable. Accessories provided with the initial issue of a transport chair are not separately billable with the exception of elevating legrests (E0990, K0195). A replacement accessory for a rollabout or transport chair is billed using code E1399.The RB modifier is used when an option or accessory is provided as a replacement for the same part which has been worn or damaged (e.g., replacing a tire of the same type). The RB modifier must not be used for an upgrade subsequent to providing the wheelchair base (e.g., replacing a standard seat of a power wheelchair with a power seating system). The RB modifier must not be used if the accessory is provided at the same time as the wheelchair base, even if the option/accessory is the same as one that the beneficiary had on a prior wheelchair. (See section on Power Wheelchair Drive Control Systems for instructions on the use of the KC replacement modifier.)Miscellaneous options, accessories, or replacement parts for wheelchairs that do not have a specific HCPCS code and are not included in another code should be coded K0108. If multiple miscellaneous accessories are provided, each should be billed on a separate claim line using code K0108. When billing more than one line item with code K0108, ensure that the additional information can be matched to the appropriate line item on the claim. It is also helpful to reference the line item to the submitted charge. If a supplier chooses to bill separately for a component that is included in another code, code A9900 must be used.The right (RT) and left (LT) modifiers are optional on claim lines billed for wheelchair options and accessories. Effective for claims with dates of service (DOS) on or after 3/1/2019, if RT and LT modifiers are appended to claim lines billed for bilateral wheelchair options and accessories (left and right) and the unit of service of the code is each, then bill each item on two separate claim lines with the RT modifier on one line and the LT modifier on the other, and 1 unit of service (UOS) on each claim line. If the RT and LT are appended, do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims with RTLT on the same claim line and 2 UOS will be rejected as incorrect coding. If RT and LT modifiers are not appended, then the bilateral items (left and right) with a unit of service each may be billed on a single claim line with 2 UOS. If bilateral items are provided and the unit of service is pair, the LT and RT modifiers are not applicable.

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The right (RT) and left (LT) modifiers are optional on claim lines billed for wheelchair options and accessories. Effective for claims with dates of service (DOS) on or after 3/1/2019, if RT and LT modifiers are appended to claim lines billed for bilateral wheelchair options and accessories (left and right) and the unit of service of the code is each, then bill each item on two separate claim lines with the RT modifier on one line and the LT modifier on the other, and 1 unit of service (UOS) on each claim line. If the RT and LT are appended, do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims with RTLT on the same claim line and 2 UOS will be rejected as incorrect coding. If RT and LT modifiers are not appended, then the bilateral items (left and right) with a unit of service each may be billed on a single claim line with 2 UOS. If bilateral items are provided and the unit of service is pair, the LT and RT modifiers are not applicable.Codes E0968, E0969, E0970, E0980, E0994, E1227, E1228, E1296, E1297, E1298, and E2340, E2341, E2342, E2343 are not valid for claim submission.FOOTREST/ LEGREST:A footbox, E0954, is a padded box designed to position a beneficiarys foot. This item comes in multiple configurations,i.e., it may be for a single foot or for both feet. Regardless of configuration, the unit of service (UOS) is per foot. E0954 includes both prefabricated and custom fabricated products. The code also includes all mounting hardware.Elevating legrests that are used with a wheelchair that is purchased or owned by the beneficiary are coded E0990. This code is per legrest. Elevating legrests that are used with a capped rental wheelchair base are coded K0195. This code is per pair of legrests.NONSTANDARD SEAT FRAME DIMENSIONS:For all adult manual wheelchairs (E1161, K0001, K0002, K0003, K0004, K0005, K0006, K0007, K0008, K0009), payment for seat widths and/or seat depths of 15-19 inches is included in the payment for the base code. These seat dimensions should not be billed separately. Codes E2201, E2202, E2203, E2204 describe seat widths and/or depths of 20 inches or more for manual wheelchairs.For power wheelchairs, there is no separate billing for nonstandard seat frame dimensions (width, depth, or height) with the following exceptions: For Group 3 and 4 power wheelchairs, with a sling/solid seat/back, the following items may be billed separately using code K0108:For Standard Duty, seat width and/or depth greater than 20 inches;For Heavy Duty, seat width and/or depth greater than 22 inches;For Very Heavy Duty, seat width and/or depth greater than 24 inches;For Extra Heavy Duty, no separate billingFor Group 3 and 4 PWCs with a sling/solid seat/back, the following items may be billed separately using code K0108:For Standard Duty, back width greater than 20 inches;For Heavy Duty, back width greater than 22 inches;For Very Heavy Duty, back width greater than 24 inches;For Extra Heavy Duty, no separate billingCode K0108 may not be billed for nonstandard dimensions of a power tilt and/or recline seating system (E1002, E1003, E1004, E1005, E1006, E1007, E1008). The definition of those codes includes any frame width and depth.WHEELS/TIRES FOR MANUAL WHEELCHAIRS:A propulsion wheel is a large wheel which can be used by a beneficiary to propel the wheelchair with his/her arms.A caster is a small wheel that is in contact with the ground during normal operation of the wheelchair and which cannot be used for arm propulsion. This includes rear tires on tilt-in-space wheelchairs that are not used for arm propulsion.A lever activated drive (E0988) is an alternative drive mechanism for propulsion of a manual wheelchair. It includes a user-powered lever-arm mechanism attached to one or both wheel hub(s). The lever activates adjustable-ratio gears and has the capability to shift between forward, reverse and braking.A pneumatic tire (E2211, E2214) is a rubber tire which is used in conjunction with a separate tube (E2212, E2215) which is filled with air.A flat free insert (E2213) is a removable ring of firm material that is placed inside of a pneumatic tire to allow the wheelchair to continue to move if the pneumatic tire is punctured. This code may not be used for a foam filled tire.A foam filled tire (E2216, E2217) is one in which a rubber tire shell has been filled with foam which is non-removable.A foam tire (E2218, E2219) is one which is made entirely of self-skinning urethane.A replacement only solid tire (E2220, E2221, E2222) is one which is made of hard plastic or rubber.A gear reduction drive wheel (E2227) is one that has more than one gear ratio option. Pushing on the rim allows the user to manually shift between the gears in order to provide additional leverage to assist propulsion of a manual wheelchair.A wheel braking and lock system (E2228) is a caliper or disc type braking system that permits the controlled slowing of a manual wheelchair or the controlled descent on inclines. It also has full wheel lock capability.A replacement only rear wheel assembly (K0069, K0070) includes a wheel rim plus a tire. For pneumatic tires, it also includes the tire tube, but not a flat free insert.A replacement only caster assembly (K0071, K0072, K0077) includes a caster fork, wheel rim, and tire.For information concerning a push-rim activated power assist device for a manual wheelchair, refer to the Power Mobility Devices medical policy.POWER SEATING SYSTEMS:A power tilt seating system (E1002) includes: a solid seat platform and a solid back; any frame width and depth; detachable or flip-up fixed height or adjustable height armrests; fixed or swingaway detachable legrests; fixed or flip-up footplates; a motor and related electronics with or without variable speed programmability; a switch control which is independent of the power wheelchair drive control interface; any hardware that is needed to attach the seating system to the wheelchair base. It does not include a headrest. It must have the following features: ability to tilt to greater than or equal to 20 degrees from horizontal; back height of at least 20 inches; ability for the supplier to adjust the seat to back angle; ability to support beneficiary weight of at least 250 pounds.A power recline seating system (E1003, E1004, E1005) includes: a solid seat platform and a solid back; any frame width and depth; detachable or flip-up fixed height or adjustable height arm rests; fixed or swingaway detachable legrests; fixed or flip-up footplates; a motor and related electronics with or without variable speed programmability; a switch control which is independent of the power wheelchair drive control interface; any hardware that is needed to attach the seating system to the wheelchair base. It does not include a headrest. It must have the following features: ability to recline to greater than or equal to 150 degrees from horizontal; back height of at least 20 inches; ability to support beneficiary weight of at least 250 pounds.A power tilt and recline seating system (E1006, E1007, E1008) includes: a solid seat platform and a solid back; any frame width and depth; detachable or flip-up fixed height or adjustable height armrests; fixed or swingaway detachable legrests; fixed or flip-up footplates; two motors and related electronics with or without variable speed programmability; a switch control which is independent of the power wheelchair drive control interface; any hardware that is needed to attach the seating system to the wheelchair base. It does not include a headrest. It must have the following features: ability to tilt to greater than or equal to 20 degrees from horizontal; ability to recline to greater than or equal to 150 degrees from horizontal; back height of at least 20 inches; ability to support beneficiary weight of at least 250 pounds.Coding for a power tilt system (E1002), power recline system (E1003, E1004 and E1005), and tilt/recline system (E1006, E1007 and E1008) are all-inclusive. Usage of K0108 to bill for additional heavy duty or bariatric features is considered unbundling and is not allowed.A power tilt seating system or power tilt and recline seating system which does not achieve a tilt of greater than or equal to 20 degrees is considered to be the same as the standard seat included in the base wheelchair. Codes E1002, E1003, E1004, E1005, E1006, E1007,E1008 must not be used to describe a power tilt seating system or a power tilt and recline seating system which does not achieve a tilt of greater than or equal to 20 degrees. These seating systems must be coded as A9900 and are not separately payable.A mechanical shear reduction feature (E1004 and E1007) consists of two separate back panels. As the posterior back panel reclines or raises there is a mechanical linkage between the two panels which allows the beneficiary's back to stay in contact with the anterior panel without sliding along that panel.A power shear reduction feature (E1005 and E1008) consists of two separate back panels. As the posterior back panel reclines or raises there is a separate motor which controls the linkage between the two panels and allows the beneficiary's back to stay in contact with the anterior panel without sliding along that panel.A mechanically linked leg elevation feature (E1009) involves a pushrod which connects the legrest to a power recline seating system. With this feature, when the back reclines, the legrest elevates; when the back raises, the legrest lowers.A power leg elevation feature (E1010, E1012) involves dedicated motor(s) and related electronics with or without variable speed programmability which allows the legrest to be raised and lowered independently of the recline and/or tilt of the seating system. It includes a switch control which may or may not be integrated with the power tilt and/or recline control(s). It includes either articulating or non-articulating legrests. The unit of service of code E1010 is a pair. The unit of service for code E1012 is each.HCPCS code E1012 includes all components of the leg rest, including fixed angle footplates and foot platforms. Adjustable angle footplates coded K0040 (ADJUSTABLE ANGLE FOOTPLATE, EACH) are separately payable when provided with leg rests coded as E1012.A power seat elevation system (E2300) includes: a motor and related electronics with or without variable speed programmability; a switch control which is independent of the power wheelchair drive control interface; any hardware that is needed to attach the seating system to the wheelchair base. It must provide a seat elevation of at least 6 inches.A power standing system (E2301) includes: a solid seat platform and a solid back; detachable or flip-up fixed height armrests; hinged legrests; anterior knee supports; fixed or flip-up footplates; a motor and related electronics with or without variable speed programmability; a basic switch control which is independent of the power wheelchair drive control interface; any hardware that is needed to attach the seating system to the wheelchair base. It does not include a headrest. It must have the following features: ability to move the beneficiary to a standing position; ability to support beneficiary weight of at least 250 pounds.Codes E2310 and E2311 describe the electronic components that allow the beneficiary to control two or more of the following motors from a single interface (e.g., proportional joystick, touchpad, or non-proportional interface): power wheelchair drive, power tilt, power recline, power shear reduction, power leg elevation, power seat elevation, power standing. It includes a function selection switch which allows the beneficiary to select the motor that is being controlled and an indicator feature to visually show which function has been selected. When the wheelchair drive function has been selected, the indicator feature may also show the direction that has been selected (forward, reverse, left, right). This indicator feature may be in a separate display box or may be integrated into the wheelchair interface. Payment for the code includes an allowance for fixed mounting hardware for the control box and for the display box (if present).POWER WHEELCHAIR DRIVE CONTROL SYSTEMS:The term interface in the code narrative and definitions describes the mechanism for controlling the movement of a power wheelchair. Examples of interfaces include, but are not limited to, joystick, sip and puff, chin control, head control, etc. (Note: In the Power Mobility Devices policy, the term "control input device" is used instead of "interface".)A proportional interface is one in which the direction and amount of movement by the beneficiary controls the direction and speed of the wheelchair. One example of a proportional interface is a standard joystick.A non-proportional interface is one which involves a number of switches. Selecting a particular switch determines the direction of the wheelchair, but the speed is pre-programmed. One example of a non-proportional interface is a sip-and-puff mechanism.

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POWER WHEELCHAIR DRIVE CONTROL SYSTEMS:The term interface in the code narrative and definitions describes the mechanism for controlling the movement of a power wheelchair. Examples of interfaces include, but are not limited to, joystick, sip and puff, chin control, head control, etc. (Note: In the Power Mobility Devices policy, the term "control input device" is used instead of "interface".)A proportional interface is one in which the direction and amount of movement by the beneficiary controls the direction and speed of the wheelchair. One example of a proportional interface is a standard joystick.A non-proportional interface is one which involves a number of switches. Selecting a particular switch determines the direction of the wheelchair, but the speed is pre-programmed. One example of a non-proportional interface is a sip-and-puff mechanism.The term controller describes the microprocessor and other related electronics that receive and interpret input from the joystick (or other drive control interface) and convert that input into power output which controls speed and direction. A high power wire harness connects the controller to the motor and gears.A non-expandable controller has the following features:May have the ability to control up to 2 power seating actuators through the drive control (for example, seat elevator and single actuator power elevating legrests). (Note: Control of the power seating actuators though the Control Input Device would require the use of an additional component, E2310 or E2311.)Can accommodate only an integral joystick or a standard proportional remote joystickMay allow for the incorporation of an attendant controlAn expandable controller is capable of accommodating one or more of the following additional functions:Other types of proportional input devices (e.g., mini-proportional or compact joysticks, touchpads, chin control, head control, etc.)Non-proportional input devices (e.g., sip and puff, head array, etc.)Operate 3 or more powered seating actuators through the drive control. (Note: Control of the power seating actuators though the Control Input Device would require the use of an additional component, E2310 or E2311.)An expandable controller may also be able to operate one or more of the following:A separate display (i.e., for alternate control devices)Other electronic devices (e.g., control of an augmentative speech device or computer through the chair's drive control)An attendant controlFor power wheelchairs which are capable of being upgraded to an expandable controller (K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842, K0843, K0848, K0849, K0850, K0851, K0852, K0853, K0854, K0855, K0856 K0857, K0858, K0859, K0860, K0861 K0862, K0863, K0864, K0868, K0869, K0870, K0871, K0877, K0878, K0879, K0880, K0884, K0885, K0886, K0890,K0891), E2377 is used if an expandable controller is provided at the time of initial issue. Code E2376 is used with complete replacement of an expandable controller.A harness (E2313) describes all of the wires, fuse boxes, fuses, circuits, switches, etc. that are required for the operation of an expandable controller. It also includes all the necessary fasteners, connectors, and mounting hardware. Code E2313 is separately billable in addition to an expandable controller both at initial issue and with complete replacement of the expandable controller. Code K0108 must not be used for any component or feature of an expandable controller at the time of initial issue. The reimbursement for any type of complete expandable controller is included in the allowance for codes E2377/E2376 plus E2313. However, if individual components of the harness are replaced, code K0108 should be used.A switch is an electronic device which turns power to a particular function either "on" or "off". The external component of a switch may be either mechanical or non-mechanical. Mechanical switches involve physical contact in order to be activated. Examples of the external components of mechanical switches include, but are not limited to, toggle, button, ribbon, etc. Examples of the external components of non-mechanical switches include, but are not limited to, proximity, infrared, etc. Some of the codes include multiple switches. In those situations, each functional switch may have its own external component or multiple functional switches may be integrated into a single external switch component or multiple functional switches may be integrated into the wheelchair control interface without having a distinct external switch component.A stop switch allows for an emergency stop when a wheelchair with a non-proportional interface is operating in the latched mode. (Latched mode is when the wheelchair continues to move without the beneficiary having to continually activate the interface.) This switch is sometimes referred to as a kill switch.A direction change switch allows the beneficiary to change the direction that is controlled by another separate switch or by a mechanical proportional head control interface. For example, it allows a switch to initiate forward movement one time and backward movement another time.A function selection switch allows the beneficiary to determine what operation is being controlled by the interface at any particular time. Operations may include, but are not limited to, drive forward, drive backward, tilt forward, recline backward, etc.An integrated proportional joystick and controller is an electronics package in which a joystick and controller electronics are in a single box, which is mounted on the arm of the wheelchair.The interfaces described by codes E2312, E2321, E2322, E2325, E2327, E2328, E2329, E2330, E2373, E2374, E2375, E2376, E2377 must have programmable control parameters for speed adjustment, tremor dampening, acceleration control, and braking.A remote joystick is one in which the joystick is in one box that is typically mounted on the arm of the wheelchair and the controller electronics are located in a different box that is typically located under the seat of the wheelchair. The joystick is connected to the controller through a low power wire harness. A remote joystick may be used for either hand control, chin control, or attendant control.A standard proportional remote joystick is one which requires approximately 340 grams of force to activate and which has an excursion (length of throw) of approximately 25 mm from neutral position. It can be used with a non-expandable or an expandable controller. There is no separate billing for a standard proportional remote joystick when it is provided at the time of initial issue of a power wheelchair whether it is used for hand or chin control by the beneficiary or whether it is used as an attendant control in place of a beneficiary-operated drive control interface.A mini-proportional (short throw) remote joystick (E2312) is one which can be activated by a very low force (approximately 25 grams) and which has a very short displacement (a maximum excursion of approximately 5 mm from neutral). It can only be used with an expandable controller. It can be used for hand or chin control or control by other body part (e.g., tongue, lip, fingertip, etc.). There is no separate billing for control buttons, displays, switches, etc. There is no separate billing for fixed mounting hardware, regardless of the body part used to activate the joystick.A compact proportional remote joystick (E2373) is one which has a maximum excursion of about 15 mm from neutral position but requires approximately 340 grams of force to activate. It can only be used with an expandable controller. It can be used for hand or chin control or control by other body part (e.g., foot, amputee stump, etc.). There is no separate billing for control buttons, displays, switches, etc. There is no separate billing for fixed mounting hardware, regardless of the body part used to activate the joystick.A touchpad is an interface similar to the pad-type mouse found on portable computers. It is billed with code K0108.Code E2321 is used for a non-proportional remote joystick, regardless of whether it is used for hand or chin control.When code E2312, E2321, E2373, or E2374 is used for a chin control interface, the chin cup is billed separately with code E2324.Code E2322 describes a system of 3-5 mechanical switches which are activated by the beneficiary touching the switch. The switch that is selected determines the direction of the wheelchair. A mechanical stop switch and a mechanical direction change switch, if provided, are included in the allowance for the code.Code E2323 includes prefabricated joystick handles that have shapes other than a straight stick - e.g., U shape or T shape - or that have some other nonstandard feature - e.g., flexible shaft.A sip and puff interface (E2325) is a non-proportional interface in which the beneficiary holds a tube in their mouth and controls the wheelchair by either sucking in (sip) or blowing out (puff). A mechanical stop switch is included in the allowance for the code. E2325 does not include the breath tube kit which is described by code E2326.A proportional, mechanical head control interface (E2327) is one in which a headrest is attached to a joystick-like device. The direction and amount of movement of the beneficiary's head pressing on the headrest control the direction and speed of the wheelchair. A mechanical direction control switch is included in the code.A proportional, electronic head control interface (E2328) is one in which a beneficiary's head movements are sensed by a box placed behind the beneficiary's head. The direction and amount of movement of the beneficiary's head (which does not come in contact with the box) control the direction and speed of the wheelchair. A proportional, electronic extremity control interface (E2328) is one in which the direction and amount of movement of the beneficiary's arm or leg control the direction and speed of the wheelchair.A non-proportional, contact switch head control interface (E2329) is one in which a beneficiary activates one of three mechanical switches placed around the back and sides of their head. These switches are activated by pressure of the head against the switch. The switch that is selected determines the direction of the wheelchair. A mechanical stop switch and a mechanical direction change switch are included in the allowance for the code.A non-proportional, proximity switch head control interface (E2330) is one in which a beneficiary activates one of three switches placed around the back and sides of their head. These switches are activated by movement of the head toward the switch, though the head does not touch the switch. The switch that is selected determines the direction of the wheelchair. A mechanical stop switch and a mechanical direction change switch is included in the allowance for the code.An attendant control is one which allows a caregiver to drive the wheelchair instead of the beneficiary. The attendant control is usually mounted on one of the rear canes of the wheelchair. This code is limited to proportional control devices, usually a joystick. Code E2331 is used when an attendant control is provided in addition to a beneficiary-operated drive control interface.Codes E2374, E2375, E2376 describe components of drive control systems. They may only be used for replacements other than at the time of initial issue.Code K0108 is appropriately used at the time of initial issue only when the drive control interface that is provided is not included in the base code and there is no specific E code which describes it. K0108 must not be used for additional features of a joystick.Code K0108 is appropriately used at the time of replacement in the following situations:An integrated proportional joystick and controller box are being replaced due to damage; orAn interface other than a remote joystick (e.g. sip and puff, head control) is being replaced but the controller is not being replaced; orThere is no specific E code which describes the type of drive control interface system which is provided.The KC modifier (replacement of special power wheelchair interface) is used in the following situations:Due to a change in the beneficiary's condition an integrated joystick and controller is being replaced by another drive control interface - e.g., remote joystick, head control, sip and puff, etc.; orThe beneficiary had a drive control interface described by codes E2321, E2322, E2325, E2327, E2328, E2329, E2330, or E2373 and both the interface (e.g., joystick, head control, sip and puff) and the controller electronics are being replaced due to irreparable damage.The KC modifier would never be used at the time of initial issue of a wheelchair. The KC modifier specifically states replacement, therefore, the RB modifier is not required.OTHER POWER WHEELCHAIR ACCESSORIES:A drive wheel is one which is directly controlled by the motor of the power wheelchair. It may be either a rear wheel, mid wheel, or front wheel, depending on the model of the power wheelchair.A caster is a smaller wheel that is in contact with the ground during normal operation of the wheelchair and which not directly controlled by the motor. It may be in the front and/or rear, depending on the location of the drive wheel.A pneumatic tire (E2381, E2384) is a rubber tire which is used in conjunction with a separate tube (E2382, E2385) which is filled with air.A flat free insert (E2383) is a removable ring of firm material that is placed inside of a pneumatic tire to allow the wheelchair to continue to move if the pneumatic tire is punctured. This code may not be used for a foam filled tire.A foam filled tire (E2386, E2387) is one in which a rubber tire shell has been filled with foam which is non-removable.

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The KC modifier would never be used at the time of initial issue of a wheelchair. The KC modifier specifically states replacement, therefore, the RB modifier is not required.OTHER POWER WHEELCHAIR ACCESSORIES:A drive wheel is one which is directly controlled by the motor of the power wheelchair. It may be either a rear wheel, mid wheel, or front wheel, depending on the model of the power wheelchair.A caster is a smaller wheel that is in contact with the ground during normal operation of the wheelchair and which not directly controlled by the motor. It may be in the front and/or rear, depending on the location of the drive wheel.A pneumatic tire (E2381, E2384) is a rubber tire which is used in conjunction with a separate tube (E2382, E2385) which is filled with air.A flat free insert (E2383) is a removable ring of firm material that is placed inside of a pneumatic tire to allow the wheelchair to continue to move if the pneumatic tire is punctured. This code may not be used for a foam filled tire.A foam filled tire (E2386, E2387) is one in which a rubber tire shell has been filled with foam which is non-removable.A foam tire (E2388, E2389) is one which is made entirely of self-skinning urethane.A solid tire (E2390, E2391, E2392) is one which is made of hard plastic or rubber.All types of tires and wheels are included in the code for a power mobility base. Codes E2381, E2382, E2383, E2384, E2385, E2386, E2387, E2388, E2389, E2390, E2391, E2392, E2393, E2394, E2395, E2396 may only be used for replacements other than at the time of initial issue.Code E2351 describes an electronic interface used with a speech generating device. An electronic interface that is used to allow lights or other electrical devices to be operated using the power wheelchair control interface must be billed with code A9270 (non-covered item).Codes E2368, E2369, E2370 are for a replacement motor and/or gearbox. These codes are not used at the time of initial issue. If the item is a rebuilt component, the UE (used DME) modifier must be added to the code.MISCELLANEOUS:Code E1028 is used forSwingaway hardware used with remote joysticks or touchpads,Swingaway or flip-down hardware for head control interfaces E2327, E2328, E2329, E2330, andSwingaway hardware for an indicator display box that is related to the multi-motor electronic connection codes E2310 or E2311.Code E1028 is not to be used for swingaway hardware used with a sip and puff interface (E2325) because swingaway hardware is included in the allowance for that code. Code E1028 is not to be used for hardware on a wheelchair tray (E0950). Do not use E1028 in addition to E1020 (Residual limb support system) as it includes swingaway hardware.Code E1029 describes a ventilator tray which is attached in a fixed position to the wheelchair base or back. Code E1030 describes a ventilator tray which is attached to the seat back and is articulated so that the tray will remain horizontal when the seat back is raised or lowered.Code E1225 describes a manually operated reclining back that can recline greater than 15 degrees but less than 80 degrees. Code E1226 describes a manually operated reclining back that reclines 80 degrees or greater.Code E2398 describes a wheelchair component attached to a wheelchair frame that allows for dynamic movement of the seat back or pelvis component in response to increased musculoskeletal tone or spasticity.A Column II code is included in the allowance for the corresponding Column I code when provided at the same time. When multiple codes are listed in column I, all the codes in column II relate to each code in column IColumn IColumn IIPower Operated Vehicle (K0800, K0801, K0802, K0806, K0807, K0808, K0812)All options and accessoriesRollabout Chair (E1031)All options and accessoriesTransport Chair (E1037, E1038, E1039)All options and accessories except E0990, K0195Manual Wheelchair Base (E1161, E1229, E1231, E1232, E1233, E1234, E1235, E1236, E1237, E1238, K0001, K0002, K0003, K0004, K0005, K0006, K0007, K0009)E0967, E0981, E0982, E0995, E2205, E2206, E2210, E2220, E2221, E2222, E2224, E2225, E2226, K0015, K0017, K0018, K0019, K0042, K0043, K0044, K0045, K0046, K0047, K0050, K0052, K0069, K0070, K0071, K0072, K0077Power Wheelchair Base Groups 1 and 2 (K0813, K0814, K0815, K0816, K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828, K0829, K0830, K0831, K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842, K0843)E0971, E0978, E0981, E0982, E0995, E1225, E2366, E2367, E2368, E2369, E2370, E2374, E2375, E2376, E2378, E2381, E2382, E2383, E2384, E2385, E2386, E2387, E2388, E2389, E2390, E2391, E2392, E2394, E2395, E2396, K0015, K0017, K0018, K0019, K0037, K0040, K0041, K0042, K0043, K0044, K0045, K0046, K0047, K0051, K0052, K0077, K0098Power Wheelchair Base Groups 3, 4, and 5 (K0848, K0849, K0850, K0851, K0852, K0853, K0854, K0855, K0856 K0857, K0858, K0859, K0860, K0861 K0862, K0863, K0864, K0868, K0869, K0870, K0871, K0877, K0878, K0879, K0880, K0884, K0885, K0886, K0890, K0891)E0971, E0978, E0981, E0982, E0995, E1225, E2366, E2367, E2368, E2369, E2370, E2374, E2375, E2376, E2378, E2381, E2382, E2383, E2384, E2385, E2386, E2387, E2388, E2389, E2390, E2391, E2392, E2394, E2395, E2396, K0015, K0017, K0018, K0019, K0037, K0041, K0042, K0043, K0044, K0045, K0046, K0047, K0051, K0052, K0077, K0098E0973K0017, K0018, K0019E0950E1028E0954E1028E0990E0995, K0042, K0043, K0044, K0045, K0046, K0047Power tilt and/or recline seating systems (E1002, E1003, E1004, E1005, E1006, E1007, E1008)E0973, K0015, K0017, K0018, K0019, K0020, K0042, K0043, K0044, K0045, K0046, K0047, K0050, K0051, K0052E1009, E1010, E1012E0990, E0995, K0042, K0043, K0044, K0045, K0046, K0047, K0052, K0053, K0195E2325E1028E1020E1028K0039K0038K0045K0043, K0044K0046K0043K0047K0044K0053E0990, E0995, K0042, K0043, K0044, K0045, K0046, K0047K0069E2220, E2224K0070E2211, E2212, E2224K0071E2214, E2215, E2225, E2226K0072E2219, E2225, E2226K0077E2221, E2222, E2225, E2226K0195E0995, K0042, K0043, K0044, K0045, K0046, K0047Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on correct coding of these items.

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).There is no separate payment for a solid insert (E0992) (see definition in Coding Guidelines) that is used with a seat or back cushion because a solid base is included in the allowance for a wheelchair seat or back cushion.There is no separate payment for mounting hardware for a seat or back cushion.There is no separate payment for a wheelchair seat or back cushion when it is used with a rollabout chair (E1031).REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.SPECIALTY EVALUATION:The specialty evaluation (also known as a comprehensive written evaluation) provides detailed information explaining why a prefabricated seating system is not sufficient to meet the beneficiarys seating and positioning needs. There must be a written report of this evaluation available on request. The PT, OT, or practitioner who performs the specialty evaluation may have no financial relationship with the supplier. (Exception: If the supplier is owned by a hospital, the PT, OT, or practitioner working in the inpatient or outpatient hospital setting may perform the specialty evaluation.)MODIFIERSKX MODIFIER:For a skin protection seat cushion (E2603, E2604, E2622, E2623), a KX modifier must be added to the code only if one of the following criteria (a), (b), or (c) is met:There is a past history of, or current, pressure ulcer in the area of contact with the seating surface (refer to the Group 1 codes in the ICD-10 code list section); orThere is absent or impaired sensation in the area of contact with the seating surface due to one of the diagnoses listed as a covered diagnosis in the Group 2 ICD-10 code list section; orThere is an inability to carry out a functional weight shift due to one of the diagnoses listed as a covered diagnosis in the Group 2 ICD-10 code list section.For a positioning seat cushion (E2605, E2606), positioning back cushion (E2613, E2614, E2615, E2616, E2620, E2621), or positioning accessory (E0953, E0956, E0957, E0960), a KX modifier must be added to the code only if the beneficiary has significant postural asymmetries due to one of the diagnoses listed as a covered diagnosis in Group 2 or Group 3 of the ICD-10 code list section.For a headrest (E0955), a KX modifier must be added to the code only if one of the coverage criteria specified in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD has been met.For a combination skin protection and positioning seat cushion (E2607, E2608, E2624, E2625), a KX modifier must be added to the code only if criterion (a) or (b) or (c) is met and criterion (d) is met:There is a past history of, or current, pressure ulcer in the area of contact with the seating surface (refer to the Group 1 codes in the ICD-10 code list section); orThere is absent or impaired sensation in the area of contact with the seating surface due to one of the diagnoses listed as a covered diagnosis for skin protection cushions (refer to the Group 2 codes in the ICD-10 code list section); orThere is an inability to carry out a functional weight shift due one of the diagnoses listed as a covered diagnosis for skin protection cushions (refer to the Group 2 codes in the ICD-10 code list section); andThe beneficiary has significant postural asymmetries due to one of the diagnoses listed as a covered diagnosis for positioning cushions (refer to the Group 2 and Group 3 codes in the ICD-10 code list section).For a custom fabricated seat or back cushion (E2609, E2617), a KX modifier must be added to the code only if criterion (a) is met and criterion (b), (c), or (d) is met:For E2609 or E2617, there is a comprehensive written evaluation by a licensed/certified medical professional, such as a PT or OT (who has no financial relationship with the supplier) which explains why a prefabricated seating system is not sufficient to meet the beneficiarys seating and positioning needs; andFor E2609, there is a past history of, or current, pressure ulcer in the area of contact with the seating surface; orFor E2609, there is absent or impaired sensation in the area of contact with the seating surface or an inability to carry out a functional weight shift due to one of the diagnoses listed as a covered diagnosis for skin protection cushions (refer to the ICD-10 code list section); orFor E2609 or E2617, the beneficiary has significant postural asymmetries due to one of the diagnoses listed as a covered diagnosis for positioning cushions (refer to the ICD-10 code list section).In addition to meeting the specific requirements listed above, for all seat and back cushions and positioning accessories, the KX modifier must be added to the code only if the item is being used with a wheelchair that meets coverage criteria specified in the Manual Wheelchair Bases or Power Mobility Devices LCD.GA, GY, AND GZ MODIFIERS:For a cushion or positioning accessory that is used with a power mobility device (PMD), if the requirements related to astandard written order (SWO) for the PMD baseand face-to-face encounter in the Power Mobility Devices Policy Article have not been met, the GY modifier must be added to the codes for all items.For items provided with a manual wheelchair or power mobility device, if it is only needed for mobility outside the home, the GY modifier must be added to the codes for all items.In all of the situations above describing use of the KX modifier, if all of the specific coverage criteria have not been met or if the wheelchair that it is being used with does not meet the coverage criteria in the Manual Wheelchair Bases or Power Mobility Devices LCD, the GA or GZ modifier must be added to a claim line for the seat or back cushion or positioning accessory.When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.If the GY modifier is used, the KX, GA, and GZ modifiers should not be used.Claim lines billed without a GA, GY, GZ, or KX modifier will be rejected as missing information.MiscellaneousWhen billing for a custom fabricated cushion (E2609, E2617), the claim must include the manufacturer and model name/ number of the product (if applicable), or if not, a detailed description of the product that was provided.Refer to the Supplier Manual for additional information on documentation requirements.CODING GUIDELINES:The following definitions of seat cushions include results of simulation testing or human subject testing. See the Testing Methodologies section for technical information about the required testing.A general use seat cushion (E2601, E2602) is a prefabricated cushion, which has the following characteristics:It has the following minimum performance characteristics:Simulation tests demonstrate a loaded contour depth of at least 25mm with an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 125% of that of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andFollowing testing simulating 12 months of use:Simulation tests demonstrate an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 125% of those of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andIt has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the American Society for Testing and Materials (ASTM), the Environmental Protection Agency (EPA), or other national or international standards agencies), for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 12 months.A nonadjustable skin protection seat cushion (E2603, E2604) is a prefabricated cushion, which has the following characteristics:It has the following minimum performance characteristics:Simulation tests demonstrate a loaded contour depth of at least 40 mm with an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 85% of that of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andFollowing testing simulating 18 months of use:Simulation tests demonstrate an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 85% of those of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andIt has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the ASTM, the EPA, or other national or international standards agencies),for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 18 months.An adjustable skin protection seat cushion (E2622, E2623) has all the characteristics of a E2603 or E2604 cushion and is determined to be adjustable by the PDAC.A positioning seat cushion (E2605, E2606) is a prefabricated cushion that has the following characteristics:It has the minimum structural features described in (a) or (b):The feature must be at least 25 mm in height in the pre-loaded state. It has two or more of the following:A pre-ischial bar or ridge which is placed anterior to the ischial tuberosities and prevents forward migration of the pelvis,Two lateral pelvic supports which are placed posterior to the trochanters and are intended to maintain the pelvis in a centered position in the seat and/or provide lateral stability to the pelvis,A medial thigh support which is placed in contact with the adductor region of the thigh and provides the prescribed amount of abduction and prevents adduction of the thighs,Two lateral thigh supports which are placed anterior to the trochanters and provide lateral stability to the lower extremities and prevent unwanted abduction of the thighs.It has two or more air compartments located in areas which address postural asymmetries, each of which must have a cell height of at least 50 mm, must allow the user to add or remove air, and must have a valve which retains the desired air volume; andIt has the following minimum performance characteristics:Simulation tests demonstrate a loaded contour depth of at least 25mm with an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 125% of that of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andFollowing testing simulating 18 months of use:Simulation tests demonstrate an overload deflection of at least 5 mm, or

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A pre-ischial bar or ridge which is placed anterior to the ischial tuberosities and prevents forward migration of the pelvis,Two lateral pelvic supports which are placed posterior to the trochanters and are intended to maintain the pelvis in a centered position in the seat and/or provide lateral stability to the pelvis,A medial thigh support which is placed in contact with the adductor region of the thigh and provides the prescribed amount of abduction and prevents adduction of the thighs,Two lateral thigh supports which are placed anterior to the trochanters and provide lateral stability to the lower extremities and prevent unwanted abduction of the thighs.It has two or more air compartments located in areas which address postural asymmetries, each of which must have a cell height of at least 50 mm, must allow the user to add or remove air, and must have a valve which retains the desired air volume; andIt has the following minimum performance characteristics:Simulation tests demonstrate a loaded contour depth of at least 25mm with an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 125% of that of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andFollowing testing simulating 18 months of use:Simulation tests demonstrate an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 125% of those of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andIt has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the ASTM, the EPA, or other national or international standards agencies),for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 18 months.A positioning cushion may have materials or components that can be added or removed to help address orthopedic deformities or postural asymmetries. This definition includes cushions which have a planar surface but have positioning features within the cushion which are made of a firmer material than the surface material.A nonadjustable skin protection and positioning seat cushion (E2607, E2608) is a prefabricated cushion which has the following characteristics:It has the minimum structural features described in (a) or (b):The feature must be at least 25 mm in height in the pre-loaded state. It has two or more of the following:A pre-ischial bar or ridge which is placed anterior to the ischial tuberosities and prevents forward migration of the pelvis,Two lateral pelvic supports which are placed posterior to the trochanters and are intended to maintain the pelvis in a centered position in the seat and/or provide lateral stability to the pelvis,A medial thigh support which is placed in contact with the adductor region of the thigh and provides the prescribed amount of abduction and prevents adduction of the thighs,Two lateral thigh supports which are placed anterior to the trochanters and provide lateral stability to the lower extremities and prevent unwanted abduction of the thighs.It has two or more air compartments located in areas which address postural asymmetries, each of which must have a cell height of at least 50 mm, must allow the user to add or remove air, and must have a valve which retains the desired air volume; andIt has the following minimum performance characteristics:Simulation tests demonstrate a loaded contour depth of at least 40mm with an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 85% of that of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andFollowing testing simulating 18 months of use:Simulation tests demonstrate an overload deflection of at least 5 mm, orHuman subject tests demonstrate an average peak pressure index that is less than 85% of those of a standard reference cushion within the area of the ischial tuberosities and sacrum/coccyx; andIt has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the ASTM, the EPA, or other national or international standards agencies),for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 18 months.This definition includes cushions which have a planar surface but have positioning features within the cushion which are made of a firmer material than the surface material.An adjustable skin protection and positioning seat cushion (E2624, E2625) has all the characteristics of a E2607 or E2608 cushion and is determined to be adjustable by the PDAC. The adjustability feature only relates to the skin protection properties of the cushion.Wheelchair cushions containing a fluid medium (air, gas, liquid, or gel) that have the capability for the immersion characteristics of the cushion to be altered by addition or removal of fluid will be considered adjustable. The adjustment may be in the manner of direct addition or removal of the fluid (e.g. add or remove air) or indirectly by addition or removal of packets of fluid.Adjustment applies to the skin protection portion of the cushion's function only.All cushions are considered to be adjustable up to the point of delivery to the beneficiary. Fitting of the cushion to the individual beneficiary may involve various forms of adjustment. Adjustable as applied here, requires that the procedure is capable of being performed by the beneficiary or caregiver using items supplied at the time of initial issue of the device in response to the beneficiary's need for more or less skin protection because of weight loss or gain or muscle tone changes.A general use back cushion (E2611, E2612) is a prefabricated cushion, which has the following characteristics:It is planar or contoured; andIt has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the ASTM, the EPA, or other national or international standards agencies),for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 12 months.A positioning back cushion (E2613, E2614, E2615, E2616, E2620, E2621) is a prefabricated cushion which has the following characteristics:For codes E2613, E2614, E2615, E2616, there is at least 25 mm of posterior contour in the pre-loaded state. A posterior contour is a backward curve measured from a horizontal line in the midline of the cushion; andFor posterior-lateral cushions (E2615, E2616) and for planar cushions with lateral supports (E2620, E2621), there is at least 75 mm of lateral contour in the pre-loaded state. A lateral contour is a backward curve measured from a horizontal line connecting the lateral extensions of the cushion; andFor posterior pelvic cushions (E2613, E2614), there is mounting hardware that is adjustable for horizontal position, depth, and angle; andIt has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the ASTM, the EPA, or other national or international standards agencies),for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 18 months.Included in this definition are cushions which have a planar surface but have positioning features within the cushion which are made of a firmer material than the surface material.A positioning back cushion may have materials or components that may be added or removed to help address orthopedic deformities or postural asymmetries.A custom fabricated seat cushion (E2609) and a custom fabricated back cushion (E2617) are cushions that are individually made for a specific beneficiary starting with basic materials including:liquid foam or a block of foam andsheets of fabric or liquid coating material.The cushion must be fabricated using one or more of the following techniques to capture the individual shape of the beneficiary:molded-to-beneficiary-model technique;direct molded-to-beneficiary technique;CAD/CAM technology, which:allows for the use of direct digital scanning of the beneficiary or of a mold made directly from the beneficiary;allows for direct milling of either (1) a beneficiary-specific model used to shape the cushion contour or (2) the cushion contours; ordetailed measurements of the beneficiary used to create a configured cushion.The cushion must have structural features that significantly exceed the minimum requirements for a seat or back positioning cushion. The cushion must have a removable vapor permeable or waterproof cover or it must have a waterproof surface. A custom fabricated cushion may include certain prefabricated components (e.g., gel or multi-cellular air inserts); these components must not be billed separately. If a custom fabricated seat and back are integrated into a one-piece cushion, code as E2609 plus E2617.If foam-in-place or other material is used to fit a substantially prefabricated cushion to an individual beneficiary, the cushion must be billed as a prefabricated cushion, not custom fabricated.A powered wheelchair seat cushion (E2610) is a battery-powered, prefabricated cushion in which an air pump provides either sequential inflation or deflation of the air cells or a low interface pressure throughout the cushion. One type of powered seat cushion is an alternating pressure cushion.Pediatric seating system codes E2291, E2292, E2293, E2294 may only be billed with pediatric wheelchair base codes.A headrest extension (E0966) is a sling support for the head. Code E0955 describes any type of cushioned headrest.A headrest (E0955) describes any type of cushioned headrest which may contain one or more cushions to position the head and fixed mounting hardware.Lateral positioning items are used to provide lateral thigh or knee support (E0953) or lateral trunk or hip support (E0956). These are provided in a variety of shapes and sizes to suit the needs of the user.The code for a seat or back cushion includes any rigid or semi-rigid base or posterior panel, respectively, that is an integral part of the cushion.A solid insert is a separate rigid piece of wood or plastic which is inserted in the cover of a cushion to provide additional support. If a supplier chooses to bill separately for a solid insert used with a seat cushion use code E0992 whether it is a manual or a power wheelchair. Code A9900 must be used for a solid insert used with a back cushion.A solid support base for a seat cushion is a rigid piece of plastic or other material which is attached with hardware to the seat frame of a wheelchair in place of a sling seat. A cushion is placed on top of the support base. Use code E2231 for a solid support base that is used with a manual wheelchair. A solid support base is included in the allowance for the power wheelchair codes. There should be no separate billing with power wheelchairs.If a supplier chooses to bill separately for mounting hardware, either nonadjustable or adjustable, for a seat or back cushion or solid support base, code A9900 must be used.The only products which may be billed using codes E2601, E2602, E2603, E2604, E2605, E2606, E2607, E2608, E2610, E2611, E2612, E2613, E2614, E2615, E2616, E2620, E2621, and E2622, E2623, E2624, E2625 and the only brand name products that may be billed using codes E2609 or E2617 are those products for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor. Information concerning the documentation that must be submitted to the PDAC for a written CVR can be found on the PDAC web site or by contacting the PDAC. A Product Classification List (PCL) with products which have received a written CVR can be found on the PDAC web site.If the prefabricated seat cushion, prefabricated back cushion, or a brand name custom fabricated seat or back cushion has not received a written CVR from the PDAC or if the PDAC has reviewed and determined that the product does not meet the criteria for the code, then it must be billed with code K0669.If a product is billed to Medicare using one of the HCPCS codes that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Pediatric size positioning accessories are billed with the codes described in this policy. Codes E1025, E1026, E1027 (lateral thoracic and lateral/anterior supports) are invalid for claim submission.

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If the prefabricated seat cushion, prefabricated back cushion, or a brand name custom fabricated seat or back cushion has not received a written CVR from the PDAC or if the PDAC has reviewed and determined that the product does not meet the criteria for the code, then it must be billed with code K0669.If a product is billed to Medicare using one of the HCPCS codes that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Pediatric size positioning accessories are billed with the codes described in this policy. Codes E1025, E1026, E1027 (lateral thoracic and lateral/anterior supports) are invalid for claim submission.Code E1028 (swingaway or removable mounting hardware upgrade) may be billed in addition to codes E0953, E0955, E0956, E0957. It must not be billed in addition to code E0960. It must not be used for mounting hardware related to a wheelchair seat cushion or back cushion code.Wheelchair seat and back cushion codes are all-inclusive. Use of HCPCS code K0108 or any other HCPCS code to separately bill for added components such as the foam blocks, gel packs, air cells, or equivalent material is incorrect coding.The right (RT) and left (LT) modifiers must be used when applicable. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same HCPCS code for bilateral items (left and right) is billed on the same DOS, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.TESTING METHODOLOGYThere are two testing methods that may be used to document wheelchair seat cushion criteria: the simulation method and the human subject method. Simulation tests are used to measure loaded contour depth and bottoming out. Human subject tests are used to measure peak interface pressure.Simulation TestSimulation tests measure loaded contour depth and bottoming out. They use standardized models of the human buttocks known as cushion-loading indenters (CLIs). There are two CLIs that are used for simulation testing, a 25 mm CLI and a 40 mm CLI. Specific design features of acceptable CLIs can be found on the PDAC web site.Test method for determining 25 mm and 40 mm of contour depth:Place the test cushion on a flat, horizontal surface. Cushions with curved bases must be stable during contour measurement testing.Align the CLI so that it is centered from the sides of the cushion and so that the ischial tuberosities of the models are 11-15 cm from the rear edge of the cushion. The ischial tuberosity portion of the CLI should be aligned with the analogous portion of the test cushion.Load the CLI to 140 Newtons (31 pounds) & wait 5 minutes.Contact of the lateral buttons with the cushion indicates that the cushion has contoured to 25 or 40 mm depending on the CLI used - i.e., that it has passed the test for that trial.Repeat the test two times waiting 5 minutes between trials.A cushion must pass the respective contour test during all trials to meet the minimum criteria specified in the cushion definition section.Overload test method for measuring bottoming out:Record the height of the CLI from the horizontal surface at the end of the loaded contour depth test described above.Add 47 Newtons (10 pounds) to the CLI and record the height from the horizontal surface after 1 minute.Subtract the height at overload (#2) from the height at standard load (#1).Round the value in #3 to the nearest 5mm.Remove the overload weight and repeat the test twice, waiting 5 minutes between tests and measuring the height in #1 and #2 each time.Determine the median of the three values recorded in #4. This is the "overload deflection".If the overload deflection is greater than or equal to 5mm, then the cushion is determined not to have bottomed out during the test.Simulated use testing:There must be simulation of 12 or 18 months of use of the cushion (depending on the cushion type - see Definitions section). Following simulated use, the measurements for loaded contour depth and overload as described above must be repeated.Test report:There must be a report of the tests which includes:The name and address of the facility performing the tests and the date(s) of the tests; andThe manufacturer and brand name/number of the test cushion; andThe weight of the cushion to the nearest 250 gm; andThe width and length of the cushion; andThe temperature and relative humidity of the room where the tests are conducted; andIdentification of which CLI was used (25 mm or 40mm); andThe results of the three loaded contour depth tests and the overload deflection test prior to simulated used testing; andA description of the method used to simulate cushion use; andA statement specifying the number of months of use that were simulated; andMeasurements as described in #7 obtained after simulated use testing; andA statement attesting that the testing methodology described in this policy was followed; andThe printed name and signature of the person performing or supervising the tests and the signature date.Human Subject TestsThe ability to demonstrate that there is an important reduction in interface pressure in comparison with a standard reference cushion when tested with human subjects is the basis for this approach. Human subject tests must be performed by an entity that has received human subject testing approval from an Institutional Review Board approved by the US Department of Health and Human Services. Ten (10) wheelchair users must be studied, at least five of which must be clinically insensate on the body surface contacting the cushion.Interface pressure measurements are taken with each subject seated on the cushion being tested as well as on a standardized reference cushion (see below). The measurements are obtained with a transducer placed on top of the cushion. Subjects must be seated on the cushion and interface pressure transducer for at least 60 seconds before data is collected. The subject should be positioned in their typical posture as determined by query and independent facility judgment. Three measurements are taken on each subject on each cushion separated by a complete unloading of the cushion for at least 60 seconds.The standard reference cushion must be an uncovered 75 mm ( 5mm) thick high resiliency foam with a rated 25% indentation force deflection (IFD) equal to 45 pounds (density range of 2.6-2.9 pounds/cubic ft and IFD range of 40-49 pounds).There must be a report of the tests which includes:The name and address of the facility performing the tests and the date(s) of the tests; andThe manufacturer and brand name/number of the test cushion; andInformation about the interface pressure measurement device utilized:Manufacturer and brand nameDate of most recent calibrationPercent error of measurement at 50 and 100 mm Hg pressure; andActual 25% IFD and density of the reference cushion (obtained from the foam manufacturer or supplier) and actual thickness of the reference cushion; andInformation on each subject (coding subjects to preserve confidentiality) including:AgeHeightWeightDisabilityButtocks sensation status; andInterface pressure measurements for each subject on the test cushion and on the reference cushion:If the transducer covers the entire seating area, the entire map showing the pressure in each cell must be submitted. The anatomical locations (as determined by palpation) of the right and left ischial tuberosities and the sacrum/coccyx must be identified on each map. (Data can be submitted as a hard copy map or utilizing the device software.) or,If the transducer only covers a portion of the seat surface, measurements must be taken at the following three locations (as determined by palpation): right and left ischial tuberosities and sacrum/coccyx. The report must identify the anatomical location of each set of measurements. The report must list the pressure in each cell at each specified location. The values for the three locations are considered a single test; andThe Peak Pressure Index (PPI) for each subject on the test cushion and on the reference cushion. The PPI is determined as follows:For each test, identify the cell in the sacro-ischial zone with the highest pressure;Determine the greatest sum of pressures in the identified cell and the adjacent cells in a 9-10 square centimeter area. If there are multiple cells with the same "highest pressure", consider all of them in the determination of the "greatest sum". [Note: A 3 cm by 3 cm square or a 3.5 cm diameter circular area are examples of a 9-10 sq cm area. For example, if using an interface pressure sensing array with a cell size of 1 sq cm, 9 cells (a 3 by 3 array) are used and if using a sensing array with a cell size of 2.5 sq cm, 4 cells (a 2 by 2 array) are used.];For each test, calculate the average of the cells with the greatest sum of pressures;Calculate the average of the results obtained in step (c) for the 3 tests on the test cushion and the 3 tests on the reference cushion. These values are the PPIs for the subject on each cushion; andA statement attesting that the testing methodology described in this policy was followed; andThe printed name and signature of the person performing or supervising the tests and the signature date.To determine if the minimum performance characteristics specified in the Definitions section for a particular type of cushion have been met, calculate the average PPI for the 10 subjects on the test cushion and the average PPI for the 10 subjects on the reference cushion. Divide the average PPI on the test cushion by the average PPI on the reference cushion and multiply the value by 100 to give the percentage comparison of Peak Pressure Indexes. If the comparative pressures are less than the specified values (125% or 85% depending on the cushion), then the minimum performance characteristics with respect to pressure have been met.

Local Coverage Articles, External Infusion Pumps - Policy Article, A52507

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).External infusion pumps are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Drugs are only covered as a supply to a covered DME infusion pump. Drugs billed alone (without a covered pump being used) will be denied as statutorily noncovered (no benefit).Infusion drugs started in a practitioners office, whether with or without a pump, must be billed to the local carrier and not the DME MAC. In these cases, the drug or biological may potentially be covered under section 1861(s)(2)(A) and (B) of the Act and is billable to the A/B MAC even though the entire administration of the drug or biological did not occur in the practitioners office or the hospital outpatient department. Equipment, such as an external infusion pump used to begin administration of the drug or biological that the patient takes home to complete the infusion, is not separately billable as durable medical equipment for a drug or biological paid under the section 1861(s)(2)(A) and (B) incident to benefit. These claims will be rejected as wrong jurisdiction.Disposable drug delivery systems, including elastomeric infusion pumps (A4305, A4306, A9274) are non-covered devices because they do not meet the Medicare definition of durable medical equipment. Drugs and supplies used with disposable drug delivery systems are also non-covered items.Catheter insertion devices for use with external insulin infusion pump infusion cannulas are included in the allowance for code A4224 and are not separately payable.The DME MACs do not process claims for implantable infusion pumps (E0782, E0783, E0785, and E0786) or drugs and supplies used in conjunction with an implantable infusion pump. Claims for these items must be submitted to the A/B MAC.Replacement batteries (K0601, K0602, K0603, K0604, K0605) are not separately payable when billed with a rented infusion pump.Medicare only pays for one pump (K0455) for administering epoprostenol and treprostinil; the supplier is responsible for ensuring that there is an appropriate and acceptable contingency plan to address any emergency situations or mechanical failures of the equipment. A second pump provided as a backup will be denied as not separately payable.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD- related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSCoverage of an external infusion pump for the administration of continuous subcutaneous insulin as outlined in the related LCDs Coverage Indications, Limitations, and/or Medicalsectionunder criteria IV. C. and D. requires a frequency of glucose self-testing an average of at least 4 times per day. A beneficiary using a continuous glucose monitor (CGM) is inherently testing more than the 4 times per day glucose monitoring requirement. Documentation of the use of a CGM device in the beneficiarys medical records would meet the testing requirement in the External Infusion Pump LCD.In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.DME INFORMATION FORM (DIF)Providers and suppliers no longer need to submit a DME Information Form (DIF) for services rendered on or after January 1, 2023.For claims with dates of service on or after January 1, 2023 Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023 If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.For dates of service for which a DIF is required, a DIF which has been completed, signed, and dated by the supplier, must be kept on file by the supplier and made available upon request.The DIF for External Infusion Pumps is CMS Form 10125. The initial claim must include an electronic copy of the DIF.For claims with dates of service prior to January 1, 2023 the following requirements for new initial and revised DIFs remain in effect:A revised DIF must be submitted if:A beneficiary begins using an infusion for one drug and subsequently the drug is changed, another drug is added, or if the code for a current drug changes. The additional new or changed drug or the new HCPCS code for the existing drug must be listed along with all other drugs for which the pump is used.There is a change in the route of administration or a change in the method of administration of a drug.The length of need previously entered on the DIF has expired and the ordering practitioner is extending the length of need for the item(s).If information on an inotropic drug is requested, the supplier must submit a copy of the order and clinical documentation which includes information relating to each of the criteria (D1-D4) defined in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD. This information must come from the medical record.For parenteral inotropic drugs, the cardiologist with training in the management of advanced heart failure who performs the initial evaluation does not need to be the prescriber for the parenteral inotropic drug. However, the prescribing practitioner must:Verify that an initial evaluation was performed by a cardiologist with training in the management of advanced heart failure; andHave documentation of the evaluation; and,Provide a copy of the initial evaluation and the prescription for the item(s) to the DMEPOS supplier.Parenteral inotropic claims that are grandfathered must also be in compliance with Medicare Claims Processing Manual (CMS Internet Only Manual 100-04) Chapter 20 break-in-service rules.If additional information on epoprostenol or treprostinil is requested, the supplier should submit signed and dated information from the treating practitioner stating the beneficiary's diagnosis, the beneficiary's current symptoms caused by pulmonary hypertension, and date and results of the pulmonary artery pressure. There must be a statement that the pulmonary hypertension is not secondary to pulmonary venous hypertension or a disorder of the respiratory system. There must be a statement of whether oral calcium channel blocking agents were tried and if so, the results, and if not, why a trial was not conducted.MODIFIERSJB MODIFIERFor immune globulins (J1551, J1555, J1558, J1559, J1561, J1562 and J1569) and associated infusion pump (E0779) claims where the route of administration is subcutaneous, a JB modifier must be added to each HCPCS code.For immune globulin (J1551, J1558 and J1575) and associated infusion pump (E0781) claims where the route of administration is subcutaneous, a JB modifier must be added to each HCPCS code.For other methods of administration, no modifier should be added.JK AND JL MODIFIERSThe JK and JL modifiers will be effective for claims with dates of service on or after April 1, 2023, for insulin (J1817) administered through an external insulin infusion pump (E0784), and for claims with dates of service on or after July 1, 2023, for insulin (fiasp) (J1811) and insulin (lyumjev) (J1813) administration through an external insulin infusion pump (E0784).For a one-month or less supply of insulin, JK modifier must be added to HCPCS codes J1811, J1813 or J1817For a three-month supply of insulin, JL modifier must be added to HCPCS codes J1811, J1813 or J1817Effective for claims with dates of service on or after July 1, 2023, a beneficiarys coinsurance for a months supply of insulin (J1811, J1813 or J1817) furnished through an external insulin infusion pump (E0784) is not to exceed $35. In order to ensure beneficiaries are not charged more than the $35 maximum allowed for the month of July 2023, suppliers must not bill a three-month supply of insulin (J1817) between May 1, 2023 and June 30, 2023.For claims with dates of service in May or June 2023, suppliers must only bill a one-month supply of insulin (J1817) and append the JK modifier. Claims with dates of service in May or June 2023 with the JL modifier appended will be returned as unprocessable.JW AND JZ MODIFIERSEffective for claims with dates of service on or after January 1, 2017, the JW modifier is required when billing for unused and discarded amounts of drugs and biologicals from single-dose containers that are administered by the supplier.Effective for claims with dates of service on or after July 1, 2023, the JZ modifier is required when billing for drugs and biologicals from single-dose containers that are administered by the supplier but have no unused and discarded amounts. Effective January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers that are dispensed by the supplier but self-administered by the beneficiary or the beneficiarys caregiver.The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or caregiver in the beneficiary's home,as it is not expected that the beneficiary or their caregiver provide discarded drug information to the supplier. The JZ modifier is required in this scenario (effective for claims with dates of service on or after January 1, 2024).Multi-use vials are not subject to payment for discarded amounts of drug or biologicals.The DME MACs expect rare use of the JW modifier on claims due to HCPCS code descriptors and their associated Units of Service (UOS) for DMEPOS in addition to the limited instructions for use.Below are two scenarios in regard to the JW modifier.Scenario 1When the HCPCS code UOS is less than the drug quantity contained in the single use vial or single dose package, the following applies:The quantity administered is billed on one claim line without the JW modifier; and,The quantity discarded is billed on a separate claim line with the JW modifier.In this scenario, the JW modifier must be billed on a separate line to provide payment for the amount of discarded drug or biological. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 1 mg.95 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.5 mg remaining in the vial are discarded.The 95 mg dose is billed on one claim line as 95 UOS.The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.Both claim line items would be processed for payment.Scenario 2When the HCPCS code UOS is equal to or greater than the total of the actual dose and the amount discarded, use of the JW modifier is not permitted. As of July 1, 2023, the JZ modifier is required in this situation. If the quantity of drug administered is less than a full UOS, the billed UOS is rounded to the appropriate UOS. For example:

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The quantity administered is billed on one claim line without the JW modifier; and,The quantity discarded is billed on a separate claim line with the JW modifier.In this scenario, the JW modifier must be billed on a separate line to provide payment for the amount of discarded drug or biological. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 1 mg.95 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.5 mg remaining in the vial are discarded.The 95 mg dose is billed on one claim line as 95 UOS.The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.Both claim line items would be processed for payment.Scenario 2When the HCPCS code UOS is equal to or greater than the total of the actual dose and the amount discarded, use of the JW modifier is not permitted. As of July 1, 2023, the JZ modifier is required in this situation. If the quantity of drug administered is less than a full UOS, the billed UOS is rounded to the appropriate UOS. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 100 mg.70 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.30 mg remaining in the vial are discarded.The 70 mg dose is billed correctly by rounding up to one UOS (representing the entire 100 mg vial) on a single line itemwith the JZ modifier.The single line item of 1 UOS would be processed for payment of the combined total 100 mg of administered and discarded drug.The discarded 30 mg must not be billed as another 1 UOS on a separate line item with the JW modifier. Billing an additional 1 UOS for the discarded drug with the JW modifier is incorrect billing and will result in an overpayment.GA, GY, GZ AND KX MODIFIERSFor claims submitted on or after March 1, 2023 suppliers must add the KX modifier to claim lines billed for the external infusion pump, drugs and supplies for dates of service on or after January 1, 2023, only if all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section in the related LCD have been met. Evidence supporting the use of the KX modifier must be retained in the suppliers files and available to the DME MAC upon request. The KX modifier requirement will continue to be required for HCPCS E0784 and J1817 for any date of service billed, if applicable.If all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed for the above services without a KX, GA, or GZ modifier will be rejected as missing information for claims submitted on or after March 1, 2023 for all codes.An infusion drug not administered using a durable infusion pump must be billed using the appropriate HCPCS code plus the GY modifier.CODING GUIDELINESAn ambulatory infusion pump (E0781) is an electrical or battery operated device, which is used to deliver solutions containing a parenteral drug under pressure at a regulated flow rate. It is small, portable, and designed to be carried by the beneficiary.A stationary infusion pump (E0791) is an electrical device, which serves the same purpose as an ambulatory pump but is larger and typically mounted on a pole.A disposable drug delivery system (A4305, A4306, A9274) is a device used to deliver solutions containing injectable drugs that is not reusable, i.e., it is used by a single beneficiary for a limited time and then discarded.An infusion controller (E1399) is an electrical device, which regulates the flow of parenteral solutions under gravity pressure.A reusable mechanical infusion pump (E0779) is a device used to deliver solutions containing parenteral drugs under pressure at a constant flow rate determined by the tubing with which it is used. It is small, portable, and designed to be carried by the beneficiary. It must be capable of a single infusion cycle of at least 8 hours.Code E0780 describes a mechanical infusion pump which is similar to an E0779 pump, but which is only capable of a single infusion cycle of less than 8 hours.Code K0455 describes an ambulatory electrical infusion pump, which is used for the administration of epoprostenol (J1325) and treprostinil (J3285).Code A4221 describes all necessary supplies, such as dressings for the catheter site and flush solutions, not directly related to non-insulin drug infusions. The catheter site may be a peripheral intravenous line, a subcutaneous infusion catheter, a peripherally inserted central catheter (PICC), a centrally inserted intravenous line with either an external or a subcutaneous port, or an epidural catheter.Code A4222 includes the cassette or bag, diluting solutions, tubing and other administration supplies, port cap changes, compounding charges, and preparation charges. This code is not used for a syringe-type reservoir.Code K0552 describes a syringe-type reservoir that is used with the K0455 pump when it is used to administer epoprostenol/treprostinil, or with an E0779 pump used to administer subcutaneous immune globulin. The reservoir may be either glass or plastic and includes the needle for drawing up the drug. This code does not include the drug for use in the reservoir. Code A4232 is invalid for submission to Medicare and should not be used for this purpose.Claims for codes A4221, A4222 and K0552 must only be used with a non-insulin external infusion pump (E0779, E0780, E0781, E0791 or K0455). Claims with dates of service on or after January 01, 2017 for codes A4221, A4222 and K0552 used with an external infusion pump HCPCS code E0784 are incorrectly coded.Code A4224 is all-inclusive and describes all necessary supplies (excluding the insulin reservoir see code A4225) used with an external infusion pump (E0784) for the administration of continuous subcutaneous insulin and includes, but is not limited to, all cannulas, needles, dressings and infusion supplies. Separate billing for any item including an item using a specific HCPCS code, if one exists, will be denied as unbundling.Code A4225 describes a syringe-type reservoir that is used with the external insulin infusion pump (E0784).Claims for codes A4224 and A4225 must only be used with insulin infusion pumps (E0784). Claims with dates of service on or after January 01, 2017 for codes A4224 and A4225 used with an external infusion pump other than code E0784 are incorrectly coded.HCPCS Supply Codes Associated with External Infusion Pumps HCPCS CodesThe following table describes HCPCS supply codes that are used with different types of external infusion pumps. The HCPCS codes listed in the Associated Codes column should be used with the corresponding Pump HCPCS code. Claims for supply codes listed in the Non-Associated Codes column will be denied as incorrect coding, if they are being used with an external infusion pump listed in the Pump HCPCS Code column of the same line.Pump HCPCS CodeAssociated CodesNon-Associated CodesE0779A4221, A4222, K0552*A4224, A4225E0780A4221, A4222A4224, A4225, K0552E0781A4221, A4222A4224, A4225, K0552E0784A4224, A4225, A4238**, A4239**A4221, A4222, K0552E0791A4221, A4222A4224, A4225, K0552K0455A4221, A4222, K0552*A4224, A4225

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Pump HCPCS CodeAssociated CodesNon-Associated CodesE0779A4221, A4222, K0552*A4224, A4225E0780A4221, A4222A4224, A4225, K0552E0781A4221, A4222A4224, A4225, K0552E0784A4224, A4225, A4238**, A4239**A4221, A4222, K0552E0791A4221, A4222A4224, A4225, K0552K0455A4221, A4222, K0552*A4224, A4225*For E0779 and K0455 pumps, either A4222 or K0552 may be billed, but not both.**For E0784 pumps, either A4238 or A4239 may be billed if used in conjunction with an integrated adjunctive or non-adjunctive CGM, respectively.Prior to January 1, 2023, insulin infusion pumps with integrated continuous glucose sensing capabilities must be coded using HCPCS codes E0784 (EXTERNAL AMBULATORY INFUSION PUMP, INSULIN) and K0554 (RECEIVER (MONITOR), DEDICATED, FOR USE WITH THERAPEUTIC GLUCOSE CONTINUOUS MONITOR SYSTEM). On or after January 1, 2023, insulin infusion pumps with integrated continuous glucose sensing capabilities must be coded using HCPCS codes E0784 (EXTERNAL AMBULATORY INFUSION PUMP, INSULIN) and E2103 (NON-ADJUNCTIVE, NON-IMPLANTED CONTINUOUS GLUCOSE MONITOR OR RECEIVER).Prior to January 1, 2023, the related accessories/supplies for these integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and K0553 (SUPPLY ALLOWANCE FOR THERAPEUTIC CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE). On or after January 1, 2023, the related accessories/supplies for these integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and A4239 (SUPPLY ALLOWANCE FOR NON-ADJUNCTIVE, NON-IMPLANTED CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE).For claims with dates of service on or before March 31, 2022, insulin infusion pumps with integrated adjunctive continuous glucose monitor receiver functionality must be coded using HCPCS codes E0784 (EXTERNAL AMBULATORY INFUSION PUMP, INSULIN) and E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS) for an adjunctive continuous glucose monitor or receiver. Suppliers must bill as a rental (RR) both E0784 and E1399 to describe the rental of an insulin pump with integrated adjunctive CGM receiver functionality. When submitting a claim for E1399, suppliers must enter adjunctive in loop 2300 (claim note) and/or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI X12N, version 5010A1 professional electronic claim format or in Item 19 of the paper claim form, so that the items can be identified as adjunctive CGM devices when processing the claim. The related accessories/supplies for these integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED) for supplies and accessories used in conjunction with an insulin pump, which also performs the functions of an adjunctive continuous glucose monitor or receiver. Suppliers may bill 1 UOS per thirty (30) days. Code A9999 is all-inclusive; when used to bill for adjunctive CGM supplies and accessories it includes, but is not limited to, the CGM sensor, CGM transmitter and insertion devices. When submitting a claim for A9999, suppliers must enter adjunctive in loop 2300 (claim note) and/or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI X12N, version 5010A1 professional electronic claim format or in Item 19 of the paper claim form, so that the items can be identified as adjunctive CGM supplies and accessories when processing the claim.For claims with dates of service on or after April 1, 2022, insulin infusion pumps with integrated adjunctive continuous glucose monitor receiver functionality must be coded using HCPCS codes E0784 (EXTERNAL AMBULATORY INFUSION PUMP, INSULIN) and E2102 (ADJUNCTIVE, NON-IMPLANTED CONTINUOUS GLUCOSE MONITOR OR RECEIVER). The related accessories/supplies for these integrated units must be coded using HCPCS codes A4224 (SUPPLIES FOR MAINTENANCE OF INSULIN INFUSION CATHETER, PER WEEK), A4225 (SUPPLIES FOR EXTERNAL INSULIN INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH), and A4238 (SUPPLY ALLOWANCE FOR ADJUNCTIVE, NON-IMPLANTED CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE).Please refer to the Glucose Monitors LCD-related Policy Article (A52464) for more information regarding coding guidelines for continuous glucose monitors.Codes A4230 (INFUSION SET FOR EXTERNAL INSULIN PUMP, NON-NEEDLE CANNULAS TYPE) and A4231 (INFUSION SET FOR EXTERNAL INSULIN PUMP, NEEDLE TYPE) are not valid for claim submission to the DME MAC because they are included in code A4224.Use A4223 for infusion supplies not used with a covered external infusion pump.Drugs used in a durable external infusion pump must be coded using the appropriate HCPCS codes. If the drug does not have a distinct code, then use the unclassified drug code J7799. Do not use code J9999 - this code is not valid for claims billed to the DME MAC.An infusion drug not administered using a durable infusion pump must be billed using the appropriate HCPCS code plus the GY modifier. If the drug does not have a unique code, use the unclassified drug code, J3490.Use code J2274 only for morphine sulfate that is labeled "preservative free. Morphine sulfate that is not labeled "preservative free" must be coded J2270.Use code J1811, J1813 or J1817 for insulin administered through an external insulin pump (E0784).Codes A4602, K0604 and K0605 describe lithium batteries commonly used in external infusion pumps. Note that each code has an associated voltage. Claims for lithium batteries for external insulin infusion pumps (E0784) that do not use a voltage described by either code A4602, K0604 and K0605 must be billed using code A9999.Levodopa-Carbidopa enteral suspension is supplied as a single-use cassette. One unit of service contains 2000 mg levodopa and 500 mg carbidopa in 100 mL of enteral suspension.Claims for levodopa-carbidopa for dates of service on or after January 09, 2015 through December 31, 2015, must be submitted using the DME miscellaneous code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).Claims for levodopa-carbidopa for dates of service on or after January 01, 2016 must be submitted using the HCPCS code J7340 (CARBIDOPA 5 MG/LEVODOPA 20 MG ENTERAL SUSPENSION, 100 ML).One unit of service (UOS) of blinatumomab (J9039) equals one (1) microgram (mcg), and thus, 1 vial equals 35 UOS. Reconstituted blinatumomab must be prepared using the combination of vials that result in the least amount of wastage for the dosage amount being administered. There are two alternative infusion protocols that can be used. For each protocol, the following apply:For beneficiaries using a 2-day infusion protocol, five (5) vials (175 UOS) should be used to reconstitute three bags, each containing 56 mcg (56 UOS) of blinatumomab, which can be refrigerated (2C to 8C), and used within six-days.For beneficiaries utilizing a 7-day infusion protocol, six (6) vials (210 UOS) should be used to reconstitute one bag (containing 210 mcg of blinatumomab), which is infused over 7 days.Claims for blinatumomab for dates of service on or after December 03, 2014 through December 31, 2015, must be submitted using the DME miscellaneous code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).Claims for blinatumomab for dates of service on or after January 01, 2016, must be submitted using the HCPCS code J9039 (INJECTION, BLINATUMOMAB, 1 MICROGRAM).HYQVIA is administered subcutaneously through an E0781 pump that is pre-programmed, and the E0781 pump must be delivered to the Medicare beneficiary in a locked mode (i.e., the patient is unable to self-adjust the infusion rate).Claims for HYQVIA for dates of service on or after September 12, 2015 through December 31, 2015, must be submitted using the DME miscellaneous code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME).Claims for HYQVIA for dates of service on or after January 01, 2016 must be submitted using the HCPCS code J1575 (INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN).Code J7999 (COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED) must be used for any compounded drugs administered using an external infusion pump for dates of service on or after January 01, 2016.When Q9977 or J7999 is billed for a compounded drug, the claim must be accompanied by the standard written order information, and a clear statement of the amount dispensed.Claims for CUVITRU for dates of service on or before December 31, 2017 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). One UOS equals one hundred (100) milligrams (mg).Claims for CUVITRU for dates of service on or after January 01, 2018 must be submitted using HCPCS code J1555 (INJECTION, IMMUNE GLOBULIN (CUVITRU), 100 MG). One UOS equals one hundred (100) mg.Claims for Xembify for dates of service on or after July 3, 2019 through June 30, 2020 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). One UOS equals one hundred (100) mg. Claims for Xembify for dates of service on or after July 1, 2020 must be submitted using the HCPCS code J1558 (INJECTION, IMMUNE GLOBULIN (XEMBIFY), 100 MG).Claims for Cutaquig for dates of service on or after December 12, 2018 through June 30, 2022 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). One UOS equals one hundred (100) mg. Claims for Cutaquig for dates of service on or after July 1, 2022 must be submitted using HCPCS code J1551(INJECTION, IMMUNE GLOBULIN (CUTAQUIG), 100 MG).Claims for Hizentra for beneficiaries with CIDP for dates of service on or after July 18, 2021 must be submitted using the HCPCS code J1559 (INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG). One UOS equals one hundred (100) mg.Specific infusion pump HCPCS codes are used with specific SCIg preparations according to the table below.Infusion PumpSCIg PreparationE0779J1555, J1559, J1561, J1562, J1569E0781J1575

Local Coverage Articles, External Infusion Pumps - Policy Article, A52507

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Infusion PumpSCIg PreparationE0779J1555, J1559, J1561, J1562, J1569E0781J1575E0779 or E0781J1551, J1558Professional ServicesProfessional services include nursing services, training and education (not otherwise paid for as durable medical equipment), remote monitoring, and monitoring services for the provision of home infusion therapy furnished by a qualified home infusion supplier with administration of certain transitional home infusion drugs administered through an item of DME.For claims with dates of service on or after January 01, 2019 through December 31, 2020, codes G0068, G0069, and G0070 are used to bill for the professional services rendered on the applicable infusion drug administration calendar day for each payment category. Providers should report visit length in 15-minute increments (15 minutes = 1unit). Suppliers must ensure that the appropriate drug associated with the visit is billed with the visit or no more than 30 days prior to the visit.In the event that multiple visits occur on the same date of service, suppliers must only bill for one visit and should report the highest paying visit with the applicable drug. Claims reporting multiple visits on the same line item date of service will be returned as unprocessable.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Hospital Beds And Accessories - Policy Article, A52508

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Hospital Beds are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A bed board (E0273, E0315) is noncovered since it is not primarily medical in nature.An over bed table (E0274, E0315) is noncovered because it is not primarily medical in nature.Trapeze bars attached to a bed (E0910, E0911) are noncovered when used on an ordinary bed.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.MODIFIERSKX, GA, AND GZ MODIFIERS:Suppliers must add a KX modifier to a hospital bed code only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met.The KX modifier should also be added for an accessory when the applicable accessory criteria are met. If the requirements for the KX modifier are not met, the KX modifier must not be used.If all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for a hospital bed and accessories. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA or GZ modifier will be rejected as missing information.UPGRADE MODIFIERS:When a hospital bed upgrade is provided, the GA, GK, GL and/or GZ modifiers must be used to indicate the upgrade. Fully electric hospital beds must always be billed with these modifiers.CODING GUIDELINESA fixed height hospital bed is one with manual head and leg elevation adjustments but no height adjustment.A variable height hospital bed is one with manual height adjustment and with manual head and leg elevation adjustments.A semi-electric bed is one with manual height adjustment and with electric head and leg elevation adjustments.A total electric bed is one with electric height adjustment and with electric head and leg elevation adjustments.An ordinary bed is one that is typically sold as furniture. It may consist of a frame, box spring and mattress. It is a fixed height and may or may not have head or leg elevation adjustments.E0301 and E0303 are hospital beds that are capable of supporting a beneficiary who weighs more than 350 pounds, but no more than 600 pounds.E0302 and E0304 are hospital beds that are capable of supporting a beneficiary who weighs more than 600 pounds.E0316 is a safety enclosure used to prevent a beneficiary from leaving the bed.E1399 should be used for products not described by the specific HCPCS codes above.A Column II code is included in the allowance for the corresponding Column I code when provided at the same time and must not be billed separately at the time of billing the Column I code.Column IColumn IIE0250E0271, E0272, E0305, E0310E0251E0305, E0310E0255E0271, E0272, E0305, E0310E0256E0305, E0310E0260E0271, E0272, E0305, E0310E0261E0305, E0310E0265E0271, E0272, E0305, E0310E0266E0305, E0310E0290E0271, E0272E0292E0271, E0272E0294E0271, E0272E0296E0271, E0272E0301E0305, E0310E0302E0305, E0310E0303E0271, E0272, E0305, E0310E0304E0271, E0272, E0305, E0310E0328E0271, E0272, E0305, E0310E0329E0271, E0272, E0305, E0310When mattress or bedside rails are provided at the same time as a hospital bed, use the single code that combines these items.E0271, E0272: Mattress, innerspring/foam rubberWhen combined with E0251, bill as E0250When combined with E0291, bill as E0290When combined with E0293, bill as E0292When combined with E0295, bill as E0294When combined with E0266, bill as E0265When combined with E0297, bill as E0296When combined with E0301, bill as E0303When combined with E0302, bill as E0304E0305, E0310: Bedside rails, half-length/full-lengthWhen combined with E0290, bill as E0250When combined with E0291, bill as E0251When combined with E0292, bill as E0255When combined with E0293, bill as E0256When combined with E0294, bill as E0260When combined with E0295, bill as E0261When combined with E0296, bill as E0265When combined with E0297, bill as E0266E0271, E0272: Mattress, innerspring/foam rubber plusE0305, E0310: Bedside rails, half-length/full-lengthWhen combined with E0291, bill as E0250When combined with E0293, bill as E0255When combined with E0295, bill as E0260When combined with E0297, bill as E0265Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Intravenous Immune Globulin - Policy Article, A52509

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Intravenous immune globulin used for the treatment of primary immunodeficiency is covered under the Intravenous Immune Globulin benefit. (IOM 100-2, Ch. 15, 50.6) In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Intravenous immune globulin (IVIG) is covered if all of the following criteria are met:It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease; andThe patient has a diagnosis of primary immune deficiency disease (See Diagnosis Codes that Support Medical Necessity section below); andThe IVIG is administered in the home; andThe treatingpractitioner has determined that administration of the IVIG in the patients home is medically appropriate.If all of the criteria are not met the IVIG and the related services, supplies and accessorieswill be denied as noncovered - no benefit category.Services, supplies and accessories used in the home for the administration of IVIG are billed to the DME MAC using HCPCS code Q2052. Only one unit of service of Q2052 shall be paid per infusion date of service.Codes J1573 and J2791 are non-covered. They are not indicated for the treatment of primary immune deficiency disease (#2 above).Refer to the External Infusion Pumps LCD for information concerning coverage of subcutaneous immune globulin.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.The supplier must enter a diagnosis code corresponding to the patient's diagnosis on each claim.MODIFIERSJW AND JZ MODIFIERSEffective for claims with dates of service on or after January 1, 2017, the JW modifier is required when billing for unused and discarded amounts of drugs and biologicals from single-dose containers that are administered by the supplier.Effective for claims with dates of service on or after July 1, 2023, the JZ modifier is required when billing for drugs and biologicals from single-dose containers that are administered by the supplier but have no unused and discarded amounts. Effective January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers that are dispensed by the supplier but self-administered by the beneficiary or the beneficiarys caregiver.The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or caregiver in the beneficiary's home, as it is not expected that the beneficiary or their caregiver provide discarded drug information to the supplier. The JZ modifier is required in this scenario (effective for claims with dates of service on or after January 1, 2024).Multi-use vials are not subject to payment for discarded amounts of drug or biologicals.The DME MACs expect rare use of the JW modifier on claims due to HCPCS code descriptors and their associated Units of Service (UOS) for DMEPOS in addition to the limited instructions for use.Below are two scenarios in regard to the JW modifier.Scenario 1When the HCPCS code UOS is less than the drug quantity contained in the single use vial or single dose package, the following applies:The quantity administered is billed on one claim line without the JW modifier; and,The quantity discarded is billed on a separate claim line with the JW modifier.In this scenario, the JW modifier must be billed on a separate line to provide payment for the amount of discarded drug or biological. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 1 mg.95 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.5 mg remaining in the vial are discarded.The 95 mg dose is billed on one claim line as 95 UOS.The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.Both claim line items would be processed for payment.Scenario 2When the HCPCS code UOS is equal to or greater than the total of the actual dose and the amount discarded, use of the JW modifier is not permitted. As of July 1, 2023, the JZ modifier is required in this situation.If the quantity of drug administered is less than a full UOS, the billed UOS is rounded to the appropriate UOS. For example:A single use vial is labeled to contain 100 mg of a drug.The drug's HCPCS code UOS is 1 UOS = 100 mg.70 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.30 mg remaining in the vial are discarded.The 70 mg dose is billed correctly by rounding up to one UOS (representing the entire 100 mg vial) on a single line item with the JZ modifier.The single line item of 1 UOS would be processed for payment of the combined total 100 mg of administered and discarded drug.The discarded 30 mg must not be billed as another 1 UOS on a separate line item with the JW modifier. Billing an additional 1 UOS for the discarded drug with the JW modifier is incorrect billing and will result in an overpayment.CODING GUIDELINESHCPCS code Q2052is billed for services, supplies, and accessories used in the home for the administration of IVIG. HCPCS code Q2052 may be billed separately from, or on the same claim as, the IVIG. Q2052 should be billed as a separate claim line on the same claim and for the same place of service asthe related IVIG HCPCS. In cases where the IVIG product is mailed or delivered to the patient prior to administration, the date of service (DOS) for the administration of the IVIG may be no more than 30 calendar days after the DOS on the IVIG product claim line. Claims for Q2052 will cycle for a total of 15 business days to identify an eligible IVIG drug billed in the previous 30 days. After 15 business days, if no eligible IVIG HCPCS is found in history, the claim line for the Q2052 will be denied.Q2052 must be billed on a separate claim line for each date of service when billed on a single claim. Claims that contain more than one claim line of Q2052 on the same date of service will be returned as unprocessable.Suppliers should report the infusion visit length in 15-minute increments (15 minutes=1 unit) when billing for Q2052 in accordance with rounding rules below. The units are for informational purposes only and a maximum of one unit of service of Q2052 per infusion date will be paid regardless of the units of service billed.UnitTime1<23 minutes2= 23 minutes to <38 minutes3= 38 minutes to <53 minutes4= 53 minutes to <68 minutes5= 68 minutes to <83 minutes6= 83 minutes to <98 minutes7= 98 minutes to <113 minutes8= 113 minutes to <128 minutes9= 128 minutes to <143 minutes10= 143 minutes to <158 minutesClaims for Panzyga for dates of service from August 2, 2018 to June 30, 2023 must be submitted using the HCPCS code J1599 (INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), NOT OTHERWISE SPECIFIED, 500 MG). One UOS equals five hundred (500) milligrams (mg).Claims for Panzyga for dates of service on or after July 1, 2023 must be submitted using HCPCS code J1576 (INJECTION, IMMUNE GLOBULIN (PANZYGA), INTRAVENOUS, INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID, 500 MG). One UOS equals five hundred (500) mg.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Mechanical In-exsufflation Devices - Policy Article, A52510

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Article - Mechanical In-exsufflation Devices - Policy Article (A52510)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Mechanical in-exsufflation equipment is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.Reimbursement may be made for replacement of A7020 (INTERFACE FOR COUGH STIMULATING DEVICE, INCLUDES ALL COMPONENTS, REPLACEMENT ONLY) only if the beneficiary owns or is purchasing the mechanical in-exsufflation device.The diagnosis code that justifies the need for these items must be included on the claim.CODING GUIDELINESMechanical in-exsufflation devices are designed to slowly inflate the lungs with positive pressure during inspiration and simulate cough with rapidly applied negative pressure during expiration.HCPCS code A7020 (INTERFACE FOR COUGH STIMULATING DEVICE, INCLUDES ALL COMPONENTS, REPLACEMENT ONLY) is for replacement only. It must not be billed at the time of initial issue.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following mechanical in-exsufflation HCPCS codes for individual items are included in the functionality of code E0467:HCPCScodes E0482 and A7020For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Negative Pressure Wound Therapy Pumps - Policy Article, A52511

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Article - Negative Pressure Wound Therapy Pumps - Policy Article (A52511)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Negative pressure wound therapy equipment is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Disposable wound suction pumps and related supplies (A9272) will be denied as statutorily noncovered because they do not meet the DME benefit.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.Information describing the history, previous treatment regimens (if applicable), and current wound management for which a NPWT pump is being billed must be present in the beneficiarys medical record and be available for review upon request. This documentation must include such elements as length of sessions of use, dressing types and frequency of change, and changes in wound conditions, including precise measurements, quantity of exudates, presence of granulation and necrotic tissue and concurrent measures being addressed relevant to wound therapy (debridement, nutritional concerns, support surfaces in use, positioning, incontinence control, etc.).Information describing the wound evaluation and treatment, recorded in the beneficiarys medical record, must indicate regular evaluation and treatment of the beneficiarys wounds, as detailed in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD.Documentation of quantitative measurements of wound characteristics including wound length and width (surface area), and depth, and amount of wound exudate (drainage), indicating progress of healing must be entered at least monthly. The supplier of the NPWT equipment and supplies must obtain from the treating clinician, an assessment of wound healing progress, based upon the wound measurement as documented in the beneficiarys medical record, in order to determine whether the equipment and supplies continue to qualify for Medicare coverage. (The supplier need not view the medical records in order to bill for continued use of NPWT. Whether the supplier ascertains that wound healing is occurring from month to month via verbal or written communication is left to the discretion of the supplier. However, the beneficiarys medical records may be requested in order to corroborate that wound healing is/was occurring as represented on the suppliers claims for reimbursement.)When billing for NPWT, a diagnosis code (specific to the 5th digit or narrative diagnosis), describing the wound being treated by NPWT, must be included on each claim for the equipment and related supplies.The medical record must include a statement from the treatingpractitioner describing the initial condition of the wound (including measurements) and the efforts to address all aspects of wound care (listed in A1 through A4 in the related LCD). For each subsequent month, the medical record must include updated wound measurements and what changes are being applied to effect wound healing.Month-to-month comparisons of wound size must compare like measurements i.e. depth compared to depth or surface area compared to surface area.If the initiation of NPWT occurs during an inpatient stay, in order to accurately account for the duration of treatment, the initial inpatient date of service must be documented. This date must be available upon request.When NPWT therapy exceeds 4 months on the most recent wound and reimbursement ends, individual consideration for one additional month at a time may be sought using the appeals process. Information from the treating practitioners medical record, contemporaneous with each requested one-month treatment time period extension, must be submitted with each appeal explaining the special circumstances necessitating the extended month of therapy. Note, the LCD provides coverage for the use of NPWT limited to initiating healing of the problem wounds described in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD rather than continuation of therapy to complete healing since there is no published medical literature demonstrating evidence of a clinical benefit for the use of NPWT to complete wound healing. Therefore, general, vague or nonspecific statements in the medical record such as doing well, want to continue until healed provide insufficient information to justify the need for extension of treatment. The medical record must provide specific and detailed information to explain the continuing problems with the wound, what additional measures are being undertaken to address those problems and promote healing and why a switch to alternative treatments alone is not possible.When billing for quantities of canisters greater than those described in the related LCD as the usual maximum amounts, there must be clear and explicit information in the medical record that justifies the additional quantities.WRITTEN ORDER PRIOR TO DELIVERY (WOPD)Effective for claims with dates of service on or after 05/25/2017, a WOPD is no longer required.MODIFIERSKX, GA, and GZ Modifiers:Suppliers must add a KX modifier to a code only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met.The KX modifier must not be used with a NPWT pump and supplies for wounds if:The pump has been used to treat a single wound and the claim is for the fifth or subsequent months rental, orThe pump has been used to treat more than one wound and the claim is for the fifth or subsequent months rental after therapy has begun on the most recently treated wound. In this situation, the KX modifier may be billed for more than four total months of rental.In all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the NPWT pump and supplies. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA or GZ modifier will be rejected as missing information.CODING GUIDELINESNPWT is provided with an integrated system of components. This system contains a pump (E2402), dressing sets (A6550) and a separate collection canister (A7000). Wound suction systems that do not contain all of the required components are not classified as NPWT. See below for component specifications.EQUIPMENT:Code E2402 describes a stationary or portable Negative Pressure Wound Therapy (NPWT) electrical pump which provides controlled sub-atmospheric pressure that is designed for use with NPWT dressings (A6550) and canisters (A7000) to promote wound healing. The NPWT pump must be capable of being selectively switched between continuous and intermittent modes of operation and is controllable to adjust the degree of sub-atmospheric pressure conveyed to the wound in a range of 40-80 mm Hg sub-atmospheric pressure. The system must contain sensors and alarms to monitor pressure variations and exudate volume in the collection canister.Disposable wound suction system pumps and related supplies must be coded A9272 (WOUND SUCTION, DISPOSABLE, INCLUDES DRESSING, ALL ACCESSORIES AND COMPONENTS, ANY TYPE, EACH).SUPPLIES:Code A6550 describes an allowance for a dressing set which is used in conjunction with a stationary or portable NPWT pump (E2402). A single code A6550 is used for each single, complete dressing change, and contains all necessary components, including but not limited to any separate, non-adherent porous dressing(s), drainage tubing, and an occlusive dressing(s) which creates a seal around the wound site for maintaining sub-atmospheric pressure at the wound.HCPCS code A7000 describes a canister set which is used in conjunction with a stationary or portable NPWT pump and contains all necessary components, including but not limited to a container, to collect wound exudate. Canisters may be various sizes to accommodate stationary or portable NPWT pumps.Code A9272 (WOUND SUCTION, DISPOSABLE, INCLUDES DRESSING, ALL ACCESSORIES AND COMPONENTS, ANY TYPE, EACH) describes a disposable wound suction device. Suction is developed through the use of any type of mechanism. This device includes all components, accessories and dressings. Code A9272 is all-inclusive. Supplies used with disposable wound suction systems are not separately billable. Examples (not all-inclusive) include: SNaP (Spiracure), PICO (Smith and Nephew), VAC Via (KCI). Disposable wound suction items other than those coded as A9272 must be coded A9270 (noncovered item or service). For example, an elastomeric suction device would be correctly coded A9270.The only products which may be billed using codes E2402 are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List.Suppliers should contact the PDAC for guidance on the correct coding of these items.

Local Coverage Articles, Oral Appliances for Obstructive Sleep Apnea - Policy Article, A52512

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Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Oral appliances used to treat obstructive sleep apnea (OSA) are covered under the Durable Medical Equipment benefit (SSA 1861(s) (6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that must be met.No aspect of a home sleep test, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests or to tests conducted in facility-based laboratories.Oral appliances generally are classified as dental devices and are not classified as durable medical equipment. The following items (not all-inclusive) are considered to be dental devices and will be denied as non-covered, not DME:Oral occlusal appliances used to treat temporomandibular joint (TMJ) disordersTongue retaining devices used to treat OSA and/or snoringAll oral appliances used only to treat snoring without a diagnosis of OSAOral appliances used to treat other dental conditionsOral appliances that require repeated fitting and/or adjustments, beyond the first 90-days, in order to maintain fit and/or effectivenessAll follow-up care, including fitting, adjustments, modifications, professional services (not all-inclusive) required during the first 90 days after provision of the oral appliance are considered to be included in the payment for device. Claims for these will be denied as not separately payable.After the initial 90-day period, adjustments, modifications and follow-up visits are not eligible for coverage under the DME benefit and are therefore not within the jurisdiction of the DME MAC.Repairs are covered for items that meet the coverage criteria. To repair means to fix or mend and to put the item back in good condition after damage or wear. Repairs are covered when necessary to make the item serviceable. If the expense for repairs exceeds the estimated expense of purchasing another item, no payment can be made for the excess.Oral appliances are eligible for replacement at the end of their 5-year reasonable useful lifetime (RUL). These items may be replaced prior to the end of the 5-year RUL in cases of loss, theft, or irreparable damage. Irreparable damage refers to a specific accident or to a natural disaster (e.g., fire, flood). Replacement due to wear-and-tear as the result of everyday use will be denied as statutorily non-covered prior to the expiration of the 5-year RUL.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.Treating practitioners shall document the in-person clinical evaluation in a detailed narrative note in their charts in the format that they use for other entries. The report would commonly document pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation.HistorySigns and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headachesDuration of symptomsValidated sleep hygiene inventory such as the Epworth Sleepiness Scale (see Appendices of related LCD)Physical ExamFocused cardiopulmonary and upper airway system evaluationNeck circumferenceBody mass index (BMI)MODIFIERSSuppliers must add a KX modifier to a code only if all of the criteria in the "Coverage Indications, Limitations, and/or Medical Necessity" section of the related LCD have been met. If the requirements for the KX modifier are not met, the KX modifier must not be used.If all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the oral appliance. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN. Claim lines billed without a GA, GZ, or KX modifier will be rejected as missing information.CODING GUIDELINESOral appliances are used to reposition oral and pharyngeal tissues in an effort to create and maintain a beneficiary's airway during sleep.Mandibular advancement devices reposition the mandible in a forward position.Tongue positioning devices reposition the tongue through the use of a vacuum-bulb or other mechanism such as bars, prongs or extensions (not all-inclusive) in a depressed and/or more anterior position.A prefabricated oral appliance (E0485) is one, which is manufactured in quantity without a specific beneficiary in mind. A prefabricated oral appliance may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific beneficiary (i.e., custom fitted). Any appliance that does not meet the definition of a custom fabricated oral appliance is considered prefabricated. E0485 is used for all prefabricated oral appliances used for the treatment of OSA including, but not limited to, mandibular advancement devices, tongue positioning appliances, etc.A custom fabricated oral appliance (E0486) is one that is uniquely made for an individual beneficiary. It involves taking a full arch, negative impression of the beneficiarys teeth, either using appropriate materials or digital images, from which a positive model is created. Basic materials are then cut, bent, and molded using the positive model in order to construct the final oral appliance. A custom fabricated oral appliance may include a prefabricated component (e.g., the joint mechanism).HCPCS code E0486 may only be used for custom fabricated mandibular advancement devices. To be coded as E0486, custom fabricated mandibular advancement devices must meet all of the criteria below:Have a fixed mechanical hinge (see below) at the sides, front or palate; and,Be able to protrude the individual beneficiary's mandible beyond the front teeth when adjusted to maximum protrusion; and,Incorporate a mechanism that allows the mandible to be easily advanced by the beneficiary in increments of one millimeter or less; and,Retain the adjustment setting when removed from the mouth; and,Maintain the adjusted mouth position during sleep; and,Remain fixed in place during sleep so as to prevent dislodging the device; and,Require no return dental visits beyond the initial 90-day fitting and adjustment period to perform ongoing modification and adjustments in order to maintain effectiveness (see below)A fixed hinge is defined as a mechanical joint, containing an inseparable pivot point. Interlocking flanges, tongue and groove mechanisms, hook and loop or hook and eye clasps, elastic straps or bands, mono-block articulation, traction-based articulation, compression-based articulation, etc. (not all-inclusive) do not meet this requirement.Items that require repeated adjustments and modification beyond the initial 90-day fitting and adjustment period in order to maintain fit and/or effectiveness are not eligible for classification as DME. These items are considered as dental therapies, which are not eligible for reimbursement, by Medicare under the DME benefit. They must not be coded using E0486.Custom fabricated mandibular advancement devices that do not incorporate all of the criteria above must use HCPCS code A9270 (NON-COVERED ITEM OR SERVICE). Do not use HCPCS code E0486.Tongue positioning appliances are coded A9270.Oral appliances used to treat snoring without a diagnosis of OSA established with a sleep test as described in the LCD are coded A9270 (NON-COVERED ITEM OR SERVICE).Oral occlusal appliances used to treat temporomandibular joint (TMJ) disorders are coded D7880 - occlusal orthotic appliance. Claims for these devices should not be submitted to the DME MACs.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following HCPCS code for individual items are included in the functionality of code E0467:HCPCS code E0486For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS code listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS code listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after September 1, 2011:E0486Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Osteogenesis Stimulators - Policy Article, A52513

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Article - Osteogenesis Stimulators - Policy Article (A52513)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Osteogenesis stimulators are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.The DME MAC does not process claims for an invasive osteogenesis stimulator.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CERTIFICATE OF MEDICAL NECESSITY (CMN)Providers and suppliers no longer need to submit Certificate of Medical Necessity (CMN) for services rendered on or after January 1, 2023.For claims with dates of service on or after January 1, 2023 Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023 If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.For dates of service for which a CMN is required, a CMN, which has been completed, signed, and dated by the treating practitioner, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the Standard Written Order (SWO) if it contains the same information as required in a SWO. The CMN for both electrical and ultrasonic osteogenesis stimulators is CMS Form 847. In addition to the order information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.MODIFIERSGA, GZ, KF and KX MODIFIERSDevices coded E0747, E0748 and E0760 are classified by the Food and Drug Administration as Class III devices; therefore, all claims for codes E0747, E0748 and E0760 must include the KF modifier. Claim lines billed without a KF modifier will be rejected as missing information.Suppliers must add the KX modifier to claim lines billed for osteogenesis stimulators only if all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section in the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request.If all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.CODING GUIDELINESAn electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. A noninvasive electrical stimulator is characterized by an external power source which is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site.An ultrasonic osteogenesis stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.Ultrasound conductive coupling gel is billed using code A4559.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary) and Social Security Act 1834(a)(5)(E).Oxygen and oxygen equipment is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REASONABLE USEFUL LIFETIME (RUL):The reasonable useful lifetime for oxygen equipment is 5 years. The RUL is not based on the chronological age of the equipment. It starts on the initial date of service and runs for 5 years from that date.RUL also does not take into account exchanges of equipment, new suppliers, or changes of modality (concentrator, gaseous, liquid).Stationary and portable oxygen equipment is often provided at the same time therefore the RUL for both items runs concurrently. When the RUL of a beneficiarys portable oxygen equipment differs from the RUL of the beneficiarys stationary oxygen equipment, the RUL of the stationary oxygen equipment shall govern the application of RUL-based rules and processes for both types, stationary and portable, of oxygen equipment.Until such time as the end date of the RUL of the stationary oxygen equipment is reached, the supplier must continue to furnish both the portable and stationary oxygen equipment.If the end date of the RUL of the portable oxygen equipment precedes the end date of the RUL of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is adjusted (extended) to coincide with the end date of the RUL of the stationary oxygen equipment.If the end date of the RUL of the portable oxygen equipment follows the end date of the RUL of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is adjusted (shortened) to coincide with the end date of the RUL of the stationary oxygen equipment.When the end date of the RUL of the stationary oxygen equipment occurs, the beneficiary may elect to obtain replacement of both the stationary and the portable oxygen equipment.If the beneficiary elects to obtain replacement of the stationary and the portable oxygen equipment, both types of oxygen equipment must be replaced at the same time.When the stationary and the portable oxygen equipment are replaced, a new 36-month rental period and new RUL is started for both the replacement stationary oxygen equipment and the replacement portable oxygen equipment.Beginning January 1, 2011, a beneficiary who resides in a DMEPOS competitive bidding area (CBA) may obtain replacement of both the stationary and portable oxygen systems only from a contract supplier having a competitive bidding contract for the CBA in which the beneficiary permanently resides.A grandfathered supplier for oxygen and other grandfathered equipment as of January 1, 2011, who has continued to furnish such equipment that has not yet reached the 36-month rental cap, does not qualify to furnish replacement equipment once the end date of the RUL of the stationary equipment is reached, if the beneficiary resides in the CBA when the end of the RUL has been reached, unless the status of the grandfathered supplier has changed to a contract supplier for the current round of the competitive bidding program.OXYGEN EQUIPMENT:Initial 36 monthsReimbursement for oxygen equipment is limited to 36 monthly rental payments. Payment for accessories (e.g., cannula, tubing, etc.), delivery, back-up equipment, maintenance, and repairs is included in the rental allowance. Payment for oxygen contents (stationary and/or portable) is included in the allowance for stationary equipment (E0424, E0439, E1390, E1391).Payment for stationary equipment is increased for beneficiaries requiring greater than 4 liters per minute (LPM) of oxygen flow and decreased for beneficiaries requiring less than 1 LPM. If a beneficiary qualifies for additional payment for greater than 4 LPM of oxygen and also meets the requirements for portable oxygen, the appropriate modifiers (QB or QF) must be used.The supplier who provides oxygen equipment for the first month must continue to provide any necessary oxygen equipment and all related items and services through the 36-month rental period, unless one of the following exceptions is met:Beneficiary relocates temporarily or permanently outside of the suppliers service areaBeneficiary elects to obtain oxygen from a different supplierIndividual case exceptions made by CMS or DME MACItem becomes subject to competitive biddingProviding different oxygen equipment/modalities (e.g., concentrator [stationary or portable], gaseous, liquid, trans-filling equipment) is not permitted unless one of the following requirements is met:Supplier replaces the equipment with the same or equivalent itemTreating practitioners orders different equipmentBeneficiary chooses to receive an upgrade and signs an Advance Beneficiary Notice of Non-coverage (ABN)CMS or the DME MAC determines that a change in equipment is warrantedA new 36-month rental period can begin only in the following situations:Specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lostBreak-in-need for at least 60 days plus the days remaining in the month of discontinuation and new medical necessity is established (see BREAK-IN-SERVICE below)A new 36-month rental period doesnotstart in the following situations:Replacing equipment due to malfunction, wear and tear, routine maintenance, repairProviding different equipment based on a treating practitioner order or beneficiary request for an upgradeBreak-in-need less than 60 days plus the days remaining in the month of discontinuation (see BREAK-IN-SERVICE below)Break-in-billing (see BREAK-IN-SERVICE below)Changing suppliersMonths 37-60There is no further payment for oxygen equipment during the 5-year reasonable useful lifetime (RUL) of the equipment after 36 rental payments have been made. If use of portable equipment (E0431, E0433, E0434, E1392, K0738) begins after the use of stationary equipment begins, payment for the portable equipment can continue after payment for the stationary equipment ends until 36 rental payments have been made for the portable equipment.For information on payment for contents and maintenance, see separate sections below.The supplier who provided the equipment during the 36th rental month is required to continue to provide the equipment, accessories, contents (if applicable), maintenance, and repair of the oxygen equipment during the 5 year reasonable useful lifetime of the equipment.Rules for providing different equipment/modalities are the same in months 37-60 as they are in the initial 36 months (see above).A new 36-month rental period can begin only in the following situation:There is a specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lostA new 36-month rental period does not start in the following situations:Replacing equipment due to malfunction, wear and tear, routine maintenance, repairProviding different equipment based on a treating practitioner order or beneficiary request for an upgradeBreak-in-need (see BREAK-IN-SERVICE below)Break-in-billing (see BREAK-IN-SERVICE below)Changing suppliers

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There is a specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lostA new 36-month rental period does not start in the following situations:Replacing equipment due to malfunction, wear and tear, routine maintenance, repairProviding different equipment based on a treating practitioner order or beneficiary request for an upgradeBreak-in-need (see BREAK-IN-SERVICE below)Break-in-billing (see BREAK-IN-SERVICE below)Changing suppliersMonths 61 and afterAt any time after the end of the 5-year reasonable useful lifetime for oxygen equipment, the beneficiary may elect to receive new equipment, thus beginning a new 36-month rental period.If the beneficiary elects not to receive new equipment after the end of the 5-year reasonable useful lifetime and if the supplier retains title to the equipment, all elements of the payment policy for months 37-60 remain in effect. There is no separate payment for accessories or repairs. If the beneficiary was using gaseous or liquid oxygen equipment during the 36th rental month, payment can continue to be made for oxygen contents.If the beneficiary elects not to receive new equipment after the end of the 5-year reasonable useful lifetime and if the supplier transfers title of the equipment to the beneficiary, accessories, maintenance, and repairs are statutorily non-covered by Medicare. Contents are separately payable for beneficiary-owned gaseous or liquid systems.If a beneficiary enters Medicare FFS with beneficiary-owned equipment, accessories, maintenance, and repairs are statutorily non-covered by Medicare. Contents are separately payable for beneficiary-owned gaseous or liquid systems.OXYGEN CONTENTS:Payment for stationary and portable contents is included in the fee schedule allowance for stationary equipment. No payment can be made for oxygen contents in a month in which payment is made for stationary equipment.If the beneficiary was using stationary gaseous or liquid oxygen equipment during the 36th rental month, payment for stationary contents (E0441 or E0442) begins when the rental period for the stationary equipment ends.If the beneficiary was using portable gaseous or liquid equipment during the 36th rental month ofstationaryequipment (gaseous, liquid, or concentrator), payment for portable contents (E0443, E0444 or E0447) begins when the rental period for thestationaryequipment ends. If the beneficiary began using portable gaseous or liquid equipment after starting on stationary equipment, payment for the portable equipment would continue until the end of the 36-month rental period for that equipment even though payment was also being made for the portable contents.If the beneficiary was using both stationary and portable gaseous or portable equipment during the 36th rental month of stationary equipment, payment for both stationary contents (E0441 or E0442) and portable contents (E0443, E0444 or E0447) begins when the rental for the stationary equipment ends.If the beneficiary is using only portable gaseous or liquid equipment and not stationary equipment during months 1 through 36 of the portable equipment rental, payment for portable contents begins when the rental period for the portable equipment begins. If stationary equipment is subsequently added, separate payment for portable contents ends because payment for contents is included in the payment for stationary equipment.If the beneficiary was not using gaseous or liquid equipment (stationary or portable) in the 36th month, but was subsequently switched to gaseous or liquid oxygen based on a treating practitioner order, contents may be paid.If the beneficiary has a stationary concentrator, portable liquid equipment, and a stationary liquid tank to fill the portable cylinders, when payment for contents begins, payment will only be made for portable liquid contents.Suppliers must provide whatever quantity of oxygen contents are needed for a beneficiarys activities both inside and outside the home.A maximum of 3 months of oxygen contents may be delivered at any one time. (Refer to Billing Information section [below] for additional information concerning billing oxygen contents.)There is no difference in payment for oxygen contents for beneficiaries receiving more than 4 LPM or less than 1 LPM.No more than 1 unit of service (UOS) for stationary contents and/or 1 UOS for portable contents per month are billable.Refer to the Coverage Indications, Limitations and/or Medical Necessity section of the LCD for additional information about refills of oxygen contents.MAINTENANCE OF EQUIPMENT:Initial 36 monthsThere is no separate payment for maintenance and servicing (M&S).Months 37 through 60If a beneficiary was using a stationary concentrator, portable concentrator, or trans-filling equipment during the 36th rental month, Medicare will pay for an M&S visit no more often than every 6 months, beginning no sooner than 6 months following the end of the rental period. If the equipment is covered under a warranty that covers labor related to routine/general maintenance and servicing (e.g., inspection, changing filters, cleaning, and calibration), payment for the first M&S visit can be no sooner than 6 months following the end of that warranty.A supplier must actually make a visit to bill the service. If multiple M&S visits are made during a 6 month period, only one will be paid.There is no M&S payment for gaseous or liquid equipment.Month 61 and afterIf the beneficiary elects not to replace a concentrator or trans-filling equipment and if the supplier retains title to the equipment, coverage for M&S is the same as in months 37-60.If the beneficiary elects not to replace a concentrator or trans-filling equipment and if the supplier transfers title to the beneficiary, M&S is statutorily non-covered.OXYGEN ACCESSORIES:Accessories, including but not limited to, trans-tracheal catheters (A4608), cannulas (A4615), tubing (A4616), mouthpieces (A4617), face tent (A4619), masks (A4620, A7525), oxygen conserving devices (A9900), oxygen tent (E0455), humidifiers (E0555), nebulizer for humidification (E0580), regulators (E1353), and stand/rack (E1355) are included in the allowance for rented oxygen equipment. The supplier must provide any accessory ordered by the treating practitioner. Accessories used with beneficiary-owned oxygen equipment will be denied as non-covered.RELOCATION and TRAVEL:Months 1 through 36If the beneficiary relocates outside the suppliers service area (either short-term travel, extended temporary relocation, or permanent relocation), then for the remainder of the rental month for which it billed, the home supplier is required to provide the equipment and related items/service itself or make arrangements with a different supplier to provide the equipment, items, and services. For subsequent rental months that the beneficiary is outside the service area, the home supplier is encouraged to either provide the equipment and related items/services itself or assist the beneficiary in finding another supplier in the new location. The home supplier may not bill for or be reimbursed by Medicare if it is not providing oxygen equipment or has not made arrangements with a different supplier to provide the equipment on the anniversary billing date. Medicare will pay only one supplier to provide oxygen during any one-rental month.Months 37 through 60If the beneficiary relocates outside the suppliers service area (either short-term travel, extended temporary relocation, or permanent relocation), the home supplier is required to either provide the equipment and related items/services itself or make arrangements with a different supplier to provide the equipment and related items/services.MiscellaneousOxygen services furnished by an airline to a beneficiary are non-covered. Payment for oxygen furnished by an airline is the responsibility of the beneficiary and not the responsibility of the supplier.Medicare does not cover items or services provided/used outside the United States and its territories. The supplier is not required to provide or arrange for oxygen use in those situations.BREAK-IN-SERVICE:Break-in-billing/Part B payment without break-in-medical necessityIf beneficiary enters hospital or SNF or joins Medicare HMO and continues to need/use oxygen, when beneficiary returns home or rejoins Medicare FFS, payment resumes where it left offBreak-in-medical necessity (break-in-need)If need/use of oxygen ends for less than 60 days plus the remainder of the rental month of discontinuation and then resumes, payment resumes where it left offDuring the 36-month rental period, if need/use of oxygen ends for more than 60 days plus the remainder of the rental month of discontinuation and new medical necessity is established, a new 36 month rental period would beginDuring months 37-60, if need/use of oxygen ends for more than 60 days plus the remainder of the rental month of discontinuation and new medical necessity is established, a new rental period does not begin. The supplier who provided the oxygen equipment during the 36th rental month must provide all necessary items and services for the duration of the reasonable useful lifetime.MISCELLANEOUS:Only rented oxygen equipment is eligible for coverage. Purchased oxygen equipment is statutorily non-covered.Oximeters (E0445) and replacement probes (A4606) will be denied as non-covered because they are monitoring devices that provide information to the treating practitioner to assist in managing the beneficiarys treatment.Respiratory therapist services are non-covered under the DME benefit.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.DOCUMENTATION REQUIREMENTS FOR INITIAL CLAIMS FOR OXYGENDocumentation for initial coverage requires information in the medical record showing:Evidence of qualifying test results at the time of need; and,Evidence of an evaluation of the qualifying test results by a treating practitionerIn order to provide initial coverage for beneficiaries in Groups I, II and III, there must be evidence in the medical record documenting one of the following A-C criteria:Asymptomatic, hypoxemic patient who meets criteria for Group I or II; or,A symptomatic, normoxemic patient with a medical condition that improves with oxygen therapy; or,For beneficiaries with concurrent Obstructive Sleep Apnea (OSA), the qualifying oxygen saturation test is performed following optimal treatment of the OSA as described in the Coverage Indications, Limitations and/or Medical Necessity.DOCUMENTATION FOR CONTINUED PAYMENT OF OXYGEN AFTER INITIAL COVERAGEIn order to continue payment of oxygen and oxygen equipment claims, there must be evidence in the medical record documenting:Group IWhile there is no formal requirement for re-evaluation and retesting, providers should ensure that once qualified for home oxygen therapy, the oxygen therapy and oxygen equipment remain reasonable and necessary pursuant to Social Security Act 1862 (a)(1)(A).Group IIEvaluation and documentation of a repeat qualifying blood gas test by the treating practitioner between the 61stand 90thdays after initiation of therapy pursuant to Social Security Act 1834(a)(5)(E); and,A new SWO by the treating practitioner.Group IIIEvaluation and documentation of a repeat, normoxemic, qualifying blood gas test by the treating practitioner between the 61stand 90thdays after initiation of therapy, pursuant to National Coverage Determination (NCD) 240.2 and Social Security Act 1834(a)(5)(E); and,A new SWO by the treating practitioner.

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A symptomatic, normoxemic patient with a medical condition that improves with oxygen therapy; or,For beneficiaries with concurrent Obstructive Sleep Apnea (OSA), the qualifying oxygen saturation test is performed following optimal treatment of the OSA as described in the Coverage Indications, Limitations and/or Medical Necessity.DOCUMENTATION FOR CONTINUED PAYMENT OF OXYGEN AFTER INITIAL COVERAGEIn order to continue payment of oxygen and oxygen equipment claims, there must be evidence in the medical record documenting:Group IWhile there is no formal requirement for re-evaluation and retesting, providers should ensure that once qualified for home oxygen therapy, the oxygen therapy and oxygen equipment remain reasonable and necessary pursuant to Social Security Act 1862 (a)(1)(A).Group IIEvaluation and documentation of a repeat qualifying blood gas test by the treating practitioner between the 61stand 90thdays after initiation of therapy pursuant to Social Security Act 1834(a)(5)(E); and,A new SWO by the treating practitioner.Group IIIEvaluation and documentation of a repeat, normoxemic, qualifying blood gas test by the treating practitioner between the 61stand 90thdays after initiation of therapy, pursuant to National Coverage Determination (NCD) 240.2 and Social Security Act 1834(a)(5)(E); and,A new SWO by the treating practitioner.Reimbursement ends unless these continued payment and documentation requirements are met. At such time that these continued payment and documentation requirements are met, payment will resume at the month in the rental cycle where the rental was stopped. A new, initial rental cycle does not begin when the continued payment documentation requirements are met.REPAIRS:The supplier must maintain detailed records describing the need for and nature of all repairs including a detailed explanation of the justification for any component or part replaced as well as the labor time to restore the item to its functionality.REPLACEMENT EQUIPMENT:Claims for the initial rental month (and only the initial rental month) must have the RA modifier (Replacement of DME item) added to the HCPCS code for the equipment when there is replacement due to reasonable useful lifetime or replacement due to damage, theft, or loss.Claims for the initial rental month must include a narrative explanation of the reason why the equipment was replaced and supporting documentation must be maintained in the supplier's files.A treating practitioners order is needed to reaffirm the medical necessity of the item for replacement of an item.MODIFIERSGA, GY, GZ, KX, N1, N2 and N3 MODIFIERS:For oxygen claims covered by Medicare prior to April 1, 2023, suppliers may continue to use the KX modifier or may use the N-modifiers for claims with dates of service on or after April 1, 2023.For initial claims for oxygen or new 36-month oxygen rental periods with dates of service on or after April 1, 2023, suppliers must use the N1, N2 or N3 modifier as described below:N1 modifier only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met for Group I beneficiaries.N2 modifier only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met for Group II beneficiaries.N3 modifier only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met for Group III beneficiaries.For initial claims for oxygen or new 36-month oxygen rental periods with dates of service on or after April 1, 2023, submitted with the KX modifier will be rejected for invalid modifier.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section have not been met, the GA, GY or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN), a GZ modifier if they have not obtained a valid ABN, or a GY modifier if the item or service is statutorily excluded.Depending on the claim date of service described above, claim lines billed without a GA, GY, GZ, KX, N1, N2 or N3 modifier will be rejected as missing information.QA, QB, QE, QF, QG and QR MODIFIERS:42 CFR Section 414.226(e) stipulates:If prescribed flow rate is different for stationary versus portable, the flow rate for stationary is used.If prescribed flow rate is different for the patient at rest versus the patient with exercise, the flow rate at rest is used.If prescribed flow rate is different for nighttime versus daytime use, the flow rates are averaged.QA: For scenarios where the beneficiary has different daytime and nighttime oxygen flow requirements. Used if the average documented flow requirement from a daytime at rest qualifying test and flow rate for nocturnal oxygen requirement (standard arithmetic rounding rules apply) is <1 LPM.QB: For scenarios where the beneficiary has different daytime and nighttime oxygen flow requirements. Used if the average documented flow requirement from a daytime at rest qualifying test and flow rate for nocturnal oxygen requirement (standard arithmetic rounding rules apply) is >4 LPM, and portable oxygen is prescribed.QE: Used if the documented flow requirement on an at rest qualifying test is <1 LPM.QF: Used if the documented flow requirement on an at rest qualifying test is >4 LPM, and portable oxygen is prescribed. DO NOT use a flow requirement from a with exercise qualifying test.QG: Used if the documented flow requirement on an at rest qualifying test is >4 LPM. DO NOT use a flow requirement from a with exercise qualifying test.QR: For scenarios where the beneficiary has different daytime and nighttime oxygen flow requirements. Used if the average documented flow requirement from a daytime at rest qualifying test and flow rate for nocturnal oxygen requirement (standard arithmetic rounding rules apply) is >4 LPM.For normoxemic patients, with non-respiratory conditions, Q-modifiers may be billed for medically necessary high flow rates, as defined in the Coverage Indications, Limitations and/or Medical Necessity section of the Oxygen and Oxygen Equipment LCD.CODING GUIDELINESThe appropriate modifier must be used if the prescribed flow rate is less than 1 LPM (QA or QE) or greater than 4 LPM (QG or QR).For claims with dates of service on or after 04/01/2018 the modifier QB or QF should be used in conjunction with claims submitted for stationary oxygen (codes E0424, E0439, E1390, or E1391) and portable oxygen (codes E0431, E0433, E0434, E1392, or K0738) when the prescribed amount of oxygen is greater than 4 liters per minute (LPM).HCPCS code E1391 (Oxygen concentrator, dual delivery port) is used in situations in which two beneficiaries are both using the same concentrator. In this situation, this code should only be billed for one of the beneficiaries.HCPCS codes E1405 and E1406 describe oxygen and water vapor enriching systems with or without heated delivery respectively. These devices both extract oxygen from the surrounding air (similar to an oxygen concentrator) and add humidification. They require substantially higher oxygen flow rates in order to deliver the same concentration of oxygen as that achieved by standard oxygen delivery systems (for example, concentrators or liquid/gaseous systems). Since codes E1405 and E1406 require a higher flow rate but do not provide a benefit to the beneficiary in terms of the inspired concentration of oxygen, modifiers QB, QF, QG, and QR, which are appended to claim lines to indicate oxygen flow rates greater than 4 liters/minute, must not be used with codes E1405 and E1406.HCPCS code E1392 describes an oxygen concentrator which is designed to be portable, is capable of delivering 85% or greater oxygen concentration, and is capable of operating on either AC or DC (e.g., auto accessory outlet) power. Code E1392 includes the device itself, an integrated battery or beneficiary-replaceable batteries that are capable of providing at least 2 hours of remote portability at a minimum of 2 LPM equivalency, a battery charger, an AC power adapter, a DC power adapter, and a carry bag and/or cart. The combined weight of the concentrator and the battery/batteries capable of 2 hours of portability must be 20 pounds or less. If a concentrator meets all of these criteria and is also capable of functioning as a stationary concentrator, operating 24 hours per day, 7 days per week, the stationary concentrator code (E1390) is billed in addition to code E1392.HCPCS code K0738 describes a feature of an oxygen concentrator that allows the beneficiary to fill portable gaseous oxygen cylinders from a stationary concentrator. This feature may be integrated into the stationary concentrator or be a separate component. When code K0738 is billed, code E0431 (portable gaseous oxygen system, rental) must not be used.HCPCS code E0433 describes a feature of an oxygen concentrator that allows the beneficiary to fill portable liquid oxygen cylinders from a stationary concentrator. This feature may be integrated into the stationary concentrator or be a separate component. When code E0433 is billed, code E0434 (portable liquid oxygen system, rental) must not be used.HCPCS code E1352 (OXYGEN ACCESSORY, FLOW REGULATOR CAPABLE OF POSITIVE INSPIRATORY PRESSURE) provides positive pressure inspiratory support for patients using oxygen. This product consists of multiple components - control unit, flow regulator, connecting hose and nasal interface (pillows). E1352 is an all-inclusive code for this product that includes all components.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following oxygen and oxygen equipment HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0424, E0431, E0433, E0434, E0439, E0441, E0442, E0443, E0444, E0447, E1390, E1391, E1392, E1405, E1406 and K0738For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.Has oxygen equipment that reached the 36-month rental but has not reached the end of its reasonable useful lifetime.

Local Coverage Articles, Oxygen and Oxygen Equipment - Policy Article, A52514

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HCPCS codes E0424, E0431, E0433, E0434, E0439, E0441, E0442, E0443, E0444, E0447, E1390, E1391, E1392, E1405, E1406 and K0738For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.Has oxygen equipment that reached the 36-month rental but has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2006:E1405E1406Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.BILLING INFORMATIONWhen billing oxygen contents (refer to the Policy Article, Non-Medical Necessity Coverage and Payment Rules section), suppliers should use a date of service (DOS) that is the anniversary date of the equipment whose rental period has ended. The billed DOS will usually not be the actual delivery date. The supplier must have a delivery slip for the actual delivery date.A supplier does not have to deliver contents every month in order to bill every month. In order to bill for contents, the supplier must have previously delivered quantities of oxygen that are expected to be sufficient to last for one month following the DOS on the claim. Suppliers should monitor usage of contents. Billing may continue on a monthly basis as long as sufficient supplies remain to last for one month as previously described. If there are insufficient contents to be able to last for a month additional contents should be provided.Suppliers may bill a flat rate for contents each month. The submitted charges do not have to vary with the quantity of tanks delivered.Claims for oxygen contents and/or oxygen accessories should not be submitted in situations in which they are not separately payable.

Local Coverage Articles, Patient Lifts - Policy Article, A52516

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Patient lifts are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met. E0625 is non-covered; not primarily medical in nature.Home modifications are noncovered by Medicare. Therefore suppliers must not submit claims for any structural changes or remodeling necessitated by the installation of a lift system.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.MODIFIERSWhen an upgrade is provided, the GA, GK, GL, and/or GZ modifiers must be used to indicate the upgrade.KX, GA and GZ MODIFIERSSuppliers must add a KX modifier to codes E0636, E1035 and E1036 only if all of the coverage criteria in the Coverage Indications, Limitations and or Medical Necessity section of the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request.If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claims lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.CODING GUIDELINESHeavy duty and bariatric lifts are included in the codes for patient lifts, E0630, E0635, E0636, E0639, E0640.A patient lift for a toilet/tub, any type (E0625) describes a device with which the beneficiary can be transferred from the toilet/tub to another seat (e.g., wheelchair). It is used for a beneficiary who is unable to ambulate. Devices included in this code may be attached to the toilet, ceiling, floor, or wall of the bathroom or may be freestanding. Some items may be placed in a tub for lifting the beneficiary in and out of the tub but may not necessarily be attached to the toilet, ceiling, floor, or wall of the bathroom.A multi-positional patient support system, with integrated lift, patient accessible controls (E0636) describes a device that can be used to transfer the bed-bound beneficiary in either a sitting or supine position. It has electric controls of the lift function.Code E0635 describes a patient lift used to transfer the bed-bound beneficiary by way of a sling or seat which is attached to the boom. The boom is attached to a spreader bar (base) to counterbalance the weight of the patient. The original device coded E0635 was the Hoyer by Ted Hoyer & Company, Inc.Code E0639 describes a device in which the lift mechanism is part of a floor-to-ceiling pole system that is not permanently attached to the floor and ceiling and which is used in a room other than the bathroom. The lift/transport mechanisms may be mechanical or electric. No separate payment is made for installation. All costs associated with installation are included in the payment for the device. When a device is only used in a bathroom, it is coded E0625.Code E0640 describes a device in which the lift mechanism is attached to permanent ceiling tracks or a wall mounting system and which is used in a room other than the bathroom. The lift/transport mechanisms may be mechanical or electric. No separate payment is made for installation. All costs associated with installation are included in the payment for the device. When a device is only used in a bathroom, it is coded E0625.A multi-positional patient transfer system, with integrated seat, operated by caregiver (E1035, E1036) describes a device that can be positioned and adjusted such that the bed-bound beneficiary can be transferred onto the device in the supine position. Once positioned on the device, it can then be adjusted to a chair-like position with multiple degrees of recline and leg elevation. It has small, castor wheels that are not accessible by the beneficiary for mobility. It has no electric controls.The only products that may be billed with codes E0636, E0639, E0640, E1035, or E1036 are those which have received a written Coding Verification Review from the Pricing, Data Analysis, and Coding (PDAC) contractor and that are listed in the Product Classification List on the PDAC web site.A Column II code is included in the allowance for the corresponding Column I code when provided at the same time.Column IColumn IIE0625E0621E0630E0621E0635E0621E0636E0621E0639E0621E0640E0621Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Respiratory Assist Devices - Policy Article, A52517

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE & PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Respiratory assist devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Accessories are separately reimbursable when used with E0470, E0471.No aspect of a home sleep test, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests or to tests conducted in facility-based sleep laboratories.Services of a respiratory therapist are non-covered under the DME benefit.A liner used in conjunction with a PAP mask is considered comfort/convenience item. There is no additional payment for liners used with a PAP mask. These products should be coded A9270 (Noncovered item or service) in accordance with the Medicare Benefit Policy Manual (CMS Pub. 100-02) Chapter 15, Section 110.1.Claims for A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) are denied as statutorily non-covered (No Medicare benefit).REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSREPLACEMENT OF ACCESSORIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT:For claims for replacement accessories (e.g., interfaces, tubing, filters, humidifier chambers), if Medicare paid for the base RAD initially (i.e., for 13 months of continuous use), the medical necessity for the beneficiary-owned base RAD is assumed to have been established. Therefore, to make a payment determination, there must only be documentation that the base DME item continues to meet medical need; and (2) The replacement of specific accessories or furnishing of new accessories remain medically necessary and are essential for the effective use of the base DME.Documentation of continued medical need for the base item must come from the treating practitioners records. The supplier's documentation records must support the need to replace the accessory to maintain the equipment's functionality and meet the beneficiary's medical need.This guidance does not apply RADs when Medicare did not originally provide payment for the base item. In cases where Medicare did not originally pay for the DME item, all coverage, coding and documentation requirements in effect for the date of service (DOS) on the claim under review must be met (see Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD).In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.MODIFIERSKX MODIFIER:Proper use of modifiers is discussed below. Specific modifiers must be used and differ depending on whether or not the requirements outlined in the documentation section have been met.Where permitted, KX must be added to codes E0470 and E0471 and codes for accessories used with E0470 and E0471. The KX modifier must not be used until the required documentation has actually been obtained and entered into the suppliers files.On claims for the first through third months, suppliers must add a KX modifier if all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met. If the requirements for the KX modifier are not met, the KX modifier must not be used.On the fourth months claim (and any month thereafter), the supplier must add a KX modifier if all the "Initial Coverage" criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met and the treating practitioner's signed and dated statement described in the Coverage Indications, Limitations, and/or Medical Necessity above, has been obtained for the supplier's files.If the completed and signed treating practitioner statement is not in the suppliers files in time for submission of the fourth or succeeding months claims, the supplier may still submit the claims, but a KX modifier must not be added. However, if the supplier chooses to hold claims for the fourth and succeeding months until the completed and signed forms are obtained, those claims may then be submitted with the KX modifier, so long as their answers indicate continued compliant use of and benefit from the therapy, according to the Coverage Indications, Limitations, and/or Medical Necessity section.GA AND GZ MODIFIERSIn all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the RAD equipment (E0470 or E0471) and accessories. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.CODING GUIDELINESA respiratory assist device (RAD) without backup rate (E0470) delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. A respiratory cycle is defined as an inspiration, followed by an expiration.A respiratory assist device (RAD) with backup rate (E0471) delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. In addition, it has a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur.HCPCS code A4604 describes tubing used with a heated humidifier and has a heated wire running the length of the tubing. It is designed for use with a positive airway pressure device and a non-invasive interface - i.e., nasal or face mask, nasal cannula, or oral interface.HCPCS code A7032 is used for a replacement nasal mask interface that goes around the nose, but not into the nostrils. The unit of service for this code is each.HCPCS code A7033 is used for a replacement nasal cannula-type interface. This interface extends a short distance into the nostrils. The unit of service for this code is pair. For some products, there are two physically separate cushions or pillows one for each nostril. Two cushions/ pillows equal one unit of service of A7033. For other products, the interface is a single piece with two protrusions that extend into the nostrils. One of these interfaces equals one unit of service of A7033.HCPCS code A7027 (Combination oral/nasal mask, used with continuous positive airway pressure device, each) is a two-piece system with separate elements for oral and nasal use.A liner is a soft, flexible material, which is placed between the patients skin and the PAP mask interface. Liners used with a PAP mask are made of cloth, silicone or other materials. Liners are not interfaces for use with a PAP mask. Consequently, liners should not be billed as replacement features of a PAP mask such as A7031 (Face mask interface, replacement for full face mask, each) or A7032 (Cushion for use on nasal mask interface, replacement only, each). Liners billed as replacement features of a PAP mask should be coded A9270 (Non-covered item or service).Monitoring devices (integrated or modular) are capable of tracking data generated by a RAD device, which can be subsequently downloaded for further analysis by a healthcare provider, DME supplier, or beneficiary. Such technologies include, but are not limited to:Smart cards and readersUSB/Thumb drive accessoriesWired telephonic transmission modulesWireless modemsHCPCS code A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) describes any type of monitoring technology. Code A9279 is all-inclusive and is to be used whether the monitoring technology is incorporated as part of a base item, supplied as an add-on module or is a stand-alone item.Use of multiple instances of A9279 to bill separately for individual monitoring features is incorrect coding.There is no Medicare benefit or payment to DMEPOS suppliers for remote monitoring services. Suppliers must not bill A9279 for remote monitoring servicesClaims billed for monitoring technologies using other NOC codes such as E1399 [DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS] will be denied as incorrect coding.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0470, E0471, E0472, E0561, E0562, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.

Local Coverage Articles, Respiratory Assist Devices - Policy Article, A52517

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HCPCS codes E0470, E0471, E0472, E0561, E0562, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Seat Lift Mechanisms - Policy Article, A52518

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Article - Seat Lift Mechanisms - Policy Article (A52518)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Seat lift mechanisms are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.A seat lift mechanism placed over or on top of a toilet, any type (E0172) is non-covered.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CERTIFICATE OF MEDICAL NECESSITY (CMN)Providers and suppliers no longer need to submit Certificate of Medical Necessity (CMN) for services rendered on or after January 1, 2023.For claims with dates of service on or after January 1, 2023 Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023 If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.For dates of service for which a CMN is required, a CMN, which has been completed, signed and dated by the treating practitioner, must be kept on file by the supplier, and made available upon request. The CMN may act as a substitute for theStandard Written Order (SWO) if it contains the same information as required in a SWO. The CMN for seat lift mechanisms is CMS Form 849. In addition to the order information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or thetreating practitioner can enter the other details directly.MODIFIERSGA, GZ, and KX MODIFIERS:Suppliers must add the KX modifier to claim lines billed for seat lift mechanisms only if all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section in the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request.If all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.CODING GUIDELINESA seat lift mechanism that is electrically operated is billed using HCPCS code E0627.A manually operated seat lift mechanism is billed using HCPCS code E0629.When providing a seat lift mechanism that is incorporated into a chair as a complete unit at the time of purchase, suppliers must bill the item using the established HCPCS code for the seat-lift mechanism. In this situation, the supplier may bill the seat lift mechanism using E0627 or E0629, and bill A9270 for the chair.A toilet seat lift mechanism (E0172) is a device with a seat that can be raised with or without a forward tilt while the beneficiary is seated, allowing the beneficiary to ambulate once he/she is in a more upright position. It may be manually operated or electric. It is attached to the toilet. (For information about seat lift mechanisms that are incorporated in a commode, see the Commodes policy.)Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Suction Pumps - Policy Article, A52519

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Article - Suction Pumps - Policy Article (A52519)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Suction equipment is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Saline used for tracheal lavage is a noncovered supply.All items used with any suction pump, such as tracheal suction catheters (A4605, A4624), sterile water, saline used for suctioning (A4216, A4217), dressings, gastric tubes, etc. (not all-inclusive) are considered to be supplies for durable medical equipment. Therefore, when supplied to beneficiaries in nursing facilities, Place of Service Codes 31 and 32, they will be denied as noncovered as DME items are statutorily excluded from payment in facilities.Disposable wound suction devices (A9270, A9272) and related supplies will be denied as statutorily noncovered because they do not meet the DME benefit durability requirement.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.When billing HCPCS code(s) A4605 and/or A4624 for beneficiaries with a tracheostomy, the diagnosis code indicating tracheostomy status must be entered on the claim form.When billing HCPCS code(s) E0600, A7002 and A7047, the diagnosis code(s) for the condition(s) that justify the need for the item(s) must be entered on the claim form.CODING GUIDELINESA portable or stationary home model respiratory suction pump (E0600) is an electric aspirator designed for oropharyngeal and tracheal suction. This code also includes devices designed for purposes other than the removal of secretions. One example is a device used to apply suction via a mouthpiece to increase the size of the airway as a treatment for obstructive sleep apnea (Winx (Apnicure) or similar systems).A portable or stationary home model gastric suction pump (E2000) is an electric aspirator designed to remove gastrointestinal secretions.A closed system tracheal suction catheter (A4605) is a type of suction catheter that is protected by an outer sheath. It is connected to the ventilator circuit of a patient on mechanical ventilation and left in place. Suctioning is accomplished without disconnection from ventilation.A tracheal suction catheter (A4624) is a long, flexible catheter.Anoral and/ororopharyngeal catheter (A4628) is a short, rigid (usually) plastic catheter of durable construction.An oral interface (A7047) is used as part of the Winx (Apnicure) or similar systems. This code is not to be used for oral appliances used to treat OSA or for any other type of oral suction appliances. Do not use the oral appliance HCPCS codes E0485 or E0486 for this interface.Wound suction is provided with an integrated system of components. This system contains a pump (K0743) and dressing sets (K0744 K0746). It does not include a separate collection canister (A7000), a defining component of Negative Pressure Wound Therapy (NPWT). Instead, exudate is retained in the dressing materials. Wound suction systems that do not contain all of the required components are not classified as wound suction systems. See below for component specifications.HCPCS code K0743 describes a suction pump for wounds which provides controlled subatmospheric pressure that is designed for use with dressings, (K0744 K0746) without a canister.HCPCS codes K0744, K0745, K0746 describe an allowance for dressing sets which are used in conjunction with a stationary or portable suction pump (K0743) but not used with a canister. Each of these codes (K0744, K0745, K0746) is used for a single, complete dressing change, and contains all necessary components, including but not limited to non-adherent porous dressing, drainage tubing, and an occlusive dressing which creates a seal around the wound site for maintaining subatmospheric pressure at the wound. These dressing sets are selected based upon wound size using the smallest size necessary to cover the wound. For multiple wounds located close together, a single large dressing must be used rather than multiple smaller dressing sets if it is possible to fit the wounds under a single larger dressing set.HCPCS codeA9272 (WOUND SUCTION, DISPOSABLE, INCLUDES DRESSING, ALL ACCESSORIES AND COMPONENTS, ANY TYPE, EACH) describes a disposable wound suction device. Suction is developed through the use of any type of mechanism. This device includes all components, accessories and dressings. Code A9272 is all-inclusive. Supplies used with disposable wound suction systems are not separately billable. Examples (not all-inclusive) include: SNaP (Spiracure), PICO (Smith and Nephew), VAC Via (KCI). Disposable wound suction items other than those coded as A9272 must be coded A9270 (noncovered item or service). For example, an elastomeric suction device would be correctly coded A9270.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0600, A4216, A4217, A4605, A4624, A4628, A7000, A7001, A7002, and A7047For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2012:K0743Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article, A52520

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Article - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Transcutaneous electrical nerve stimulation (TENS) equipment is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.During the rental of a TENS unit, supplies for the unit are included in the rental allowance; there is no additional allowance for items such as electrodes, lead wires, and batteries. If a TENS unit (E0720 or E0730) is purchased, the allowance is all-inclusive of items such as lead wires and one month's supply of items such as electrodes, conductive paste or gel (if needed), and batteries.Refer to the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the LCD for additional information about coverage criteria and associated documentation.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.For all claims for TENS and related supplies there must be information in the medical record demonstrating that the coverage criteria are met.For acute post-operative pain covered under criterion I of the related LCD, there must be information about:The date of surgeryThe nature of the surgeryThe location and severity of the painFor chronic pain covered under criterion II of the related LCD, there must be information in the medical record describing:The location of the painThe severity of the painThe duration of time the beneficiary has had the painThe presumed etiology of the painPrior treatment and results of that treatmentReevaluation of the beneficiary at the end of the trial period, must indicateHow often the beneficiary used the TENS unitThe typical duration of use each timeThe results (effectiveness of therapy)Each claim for code E0731 must be accompanied by the brand, name and model number of the conductive garment.CERTIFICATE OF MEDICAL NECESSITY (CMN)Providers and suppliers no longer need to submit Certificate of Medical Necessity (CMN) for services rendered on or after January 1, 2023.For claims with dates of service on or after January 1, 2023 Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023 If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.For dates of service for which a CMN is required, a CMN which has been completed, signed, and dated by the treating practitioner, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the Standard Written Order (SWO) if it contains the same information as required in a SWO. The CMN for TENS is CMS Form 848. In addition to the information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.A CMN is not needed for a TENS rental.MODIFIERSGA, GZ AND KX MODIFIERS:Suppliers must add a KX modifier to codes E0720, E0730, and E0731 only if all of the criteria in the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the related LCD have been met.For the situation where a KX modifier is required, if all of the criteria in the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the related LCD have not been met, the GA or GZ modifier must be added to these codes. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed for E0720, E0730, and E0731 without a GA, GZ or KX modifier as specified above will be rejected as missing information.CODING GUIDELINESA transcutaneous electrical nerve stimulator (TENS) (E0720, E0730) is a device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patient's perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. A TENS unit must be distinguished from other electrical stimulators (e.g., neuromuscular stimulators) which are used to directly stimulate muscles and/or motor nerves.A TENS supply allowance (A4595), is an all-inclusive code and includes items such as electrodes (any type), conductive paste or gel (if needed, depending on the type of electrode), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (9 volt or AA, single use or rechargeable), and a battery charger (if rechargeable batteries are used).Codes A4556 (Electrodes, [e.g., apnea monitor], per pair), A4558 (Conductive paste or gel), and A4630 (Replacement batteries, medically necessary TENS owned by patient) are not valid for claim submission to the DME MAC. A4595 should be used instead.For code A4557, one unit of service is for lead wires going to two electrodes. If all the lead wires of a 4 lead TENS unit needed to be replaced, billing would be for two units of service.There should be no billing and there will be no separate allowance for replacement electrodes (A4556), conductive paste or gel (A4558), replacement batteries (A4630), or a battery charger used with a TENS unit.Other supplies, including but not limited to the following, will not be separately allowed: adapters (snap, banana, alligator, tab, button, clip), belt clips, adhesive remover, additional connecting cable for lead wires, carrying pouches, or covers.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Urological Supplies - Policy Article, A52521

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Article - Urological Supplies - Policy Article (A52521)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Urological supplies are covered under the Prosthetic Device benefit (Social Security Act 1861(s)(8)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.GENERALUrinary catheters and external urinary collection devices are covered to drain or collect urine for a beneficiary who has permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that beneficiary within 3 months.If the catheter or the external urinary collection device meets the coverage criteria then the related supplies that are necessary for their effective use are also covered. Urological supplies that are used for purposes not related to the covered use of catheters or external urinary collection devices (i.e., drainage and/or collection of urine from the bladder) will be denied as non-covered.The beneficiary must have a permanent impairment of urination. This does not require a determination that there is no possibility that the beneficiary's condition may improve sometime in the future. If the medical record, including the judgment of the treating practitioner, indicates the condition is of long and indefinite duration (ordinarily at least 3 months), the test of permanence is considered met. Catheters and related supplies will be denied as non-covered in situations in which it is expected that the condition will be temporary.The use of a urological supply for the treatment of chronic urinary tract infection or other bladder condition in the absence of permanent urinary incontinence or retention is non-covered. Since the beneficiary's urinary system is functioning, the criteria for coverage under the prosthetic benefit provision are not met.When inserting an inFlow device or using urological supplies in a treating practitioners office as part of a professional service that is billed to Medicare, the supplies are considered incident to the professional services of the health care practitioner and are not separately payable. Claims for these devices must not be submitted. Claims for the professional service, which includes the device, must be submitted to the A/B MAC.If additional inFlow devices or urological supplies are sent home with the beneficiary, claims for these devices may be billed to the DME MAC only if the beneficiary's condition meets the definition of permanence as defined in the Prosthetic Device benefit. In this situation, use the place of service corresponding to the beneficiary's residence; Place of Service Office (POS) 11 must not be used. If the beneficiary's condition is expected to be temporary, urological supplies may not be billed. In this situation, they are considered as supplies provided incident to a treating practitioner's service and payment is included in the allowance for the treating practitioner services, which are processed by the A/B MAC.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.When the prescribing practitioner is also the supplier, and is permitted to furnish specific items of DMEPOS, a separate order is not required; however, the medical record must still contain all of the required order elements.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, unless continued coverage requirements are specified in the LCD, ongoing need for urological supplies is assumed to drain or collect urine for a beneficiary who has permanent urinary incontinence or permanent urinary retention. There is no requirement for further documentation of continued medical need as long as the beneficiary continues to meet the Prosthetic Devices benefit.MODIFIERSAU MODIFIER:When codes A4217, A4450, and A4452 are used with Urological Supplies, they must be billed with the AU modifier. For this policy, codes A4217, A4450, and A4452 are the only three codes for which the AU modifier may be used. Claim lines for codes A4217, A4450 and A4452 billed for urological supplies without an AU modifier will be rejected as missing information.KX, GA, GY and GZ MODIFIERS:Suppliers must add a KX modifier to a code for the inFlow device, a catheter, an external urinary collection device, or a supply used with one of these items only if both 1 and 2 are met.The statutory benefit criteria described in the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section above are met, andThe applicable reasonable and necessary (R&N) criteria described in the COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY section of the related LCD are met.If all of the criteria in the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section above are not met, a GY modifier must be added to the code.If all of the applicable R&N criteria in the COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY section in the related LCD have not been met, a GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity (R&N) denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a KX, GA, GY or GZ modifier will be rejected as missing information.MISCELLANEOUSAdhesive strips or tape used with male external catheters are included in the allowance for the code and are not separately payable.Catheter insertion trays (A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4353, and A4354) that contain component parts of the urinary collection system, (e.g., drainage bags and tubing) are inclusive sets and payment for additional component parts will be allowed only per the stated criteria in each section of the policy.Irrigation supplies that are used for care of the skin or perineum of incontinent beneficiaries are non-covered.Claims for sterile water/saline (A4217) and tape (A4450 or A4452) that are billed without an AU modifier or another modifier indicating coverage under a different policy will be rejected as missing information.Extension tubing (A4331) will be covered for use with a latex urinary leg bag (A5112). It is included in the allowance for codes A4314, A4315, A4316, A4354, A4357, A4358, and A5105 and should not be separately billed with these codes.Other supplies used in the management of incontinence, including but not limited to the following items, will be denied as non-covered because they are not prosthetic devices nor are they required for the effective use of a prosthetic device:Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products (A6250)Catheter care kits (A9270)Adhesive remover (A4455, A4456) (Coverage remains for use with ostomy supplies.)Catheter clamp or plug (A9270)Non-Disposable underpads (A4553)Disposable underpads, e.g., Chux (A4554)Diapers, or incontinent garments, disposable or reusable (A4520)Drainage bag holder or stand (A9270)Urinary suspensory without leg bag (A9270)Measuring container (A9270)Urinary drainage tray (A9270)Gauze pads (A6216, A6217, A6218) and other dressings (coverage remains under other benefits, e.g. surgical dressings)Other incontinence products not directly related to the use of a covered urinary catheter or external urinary collection device (A9270)Disposable external urethral clamp or compression device, with pad and/or pouch, (A4360)CODING GUIDELINESThe general term "external urinary collection devices" used in this policy includes male external catheters and female pouches or meatal cups. This term does not include diapers or other types of absorptive pads.A meatal cup female external urinary collection device (A4327) is a plastic cup, which is held in place around the female urethra by suction or pressure and is connected to a urinary drainage container such as a bag or bottle.A pouch type female external collection device (A4328) is a plastic pouch which is attached to the periurethral area with adhesive and which can be connected to a urinary drainage container such as a bag or bottle.A urinary catheter-anchoring device described by code A4333 has an adhesive surface, which attaches to the beneficiary's skin and a mechanism for releasing and re-anchoring the catheter multiple times without changing the anchoring device.A urinary catheter-anchoring device described by code A4334 is a strap, which goes around a beneficiary's leg and has a mechanism for releasing and re-anchoring the catheter multiple times without changing the anchoring device.An intermittent urinary catheter with insertion supplies (A4353) is a kit, which includes a catheter and all supplies necessary for a single, sterile insertion (see below). Code A4353 may be used if any of the following 1, 2 or 3 is supplied:A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies; orA sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies; orA sterile no-touch type of catheter system.

Local Coverage Articles, Urological Supplies - Policy Article, A52521

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Article - Urological Supplies - Policy Article (A52521)

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A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies; orA sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies; orA sterile no-touch type of catheter system.The insertion kit (A4353) described in #1 and #2 above contains an intermittent urinary catheter (packaged separately from the other components in #2), lubricant, gloves, antiseptic solution, applicators, a drape, and a collection tray/bag in a sterile package intended for single use. The collection tray/bag is a separate item included within the kit; therefore, materials that serve as non-sterile packaging to contain all of the items in the kit do not meet this requirement. Except as noted in #2 above, code A4353 must not be billed if individual insertion kit components are provided as separate items. When providing a sterile kit, all components are included and packaged as a kit. Separate billing of individual components is considered as unbundling.The product described in #3 is a single-catheter system that is functionally equivalent to a complete sterile insertion kit (A4353) containing a catheter and the additional components as described in the previous paragraph. In order to be coded as A4353, a no-touch type of catheter system must be a sterile, all-inclusive, self-contained system capable of accomplishing intermittent catheterization with sterile technique without the use of additional supplies such as gloves, lubricant, collection chamber, etc. Additional individual components must not be separately billed. Separate billing of additional supply items is considered as unbundling.Therapeutic agent for urinary irrigation (A4321) is defined as a solution containing agents in addition to saline or sterile water (for example acetic acid or hydrogen peroxide) which is used for the treatment or prevention of urinary catheter obstruction.Code A5105 should be used when billing for a urinary suspensory with leg bag.A4326 is a male external catheter with an integrated collection chamber that does not require the use of an additional leg bag.Irrigation solutions containing antibiotics and chemotherapeutic agents should be coded A9270. Irrigating solutions, such as acetic acid or hydrogen peroxide, which is used for the treatment or prevention of urinary obstruction, should be coded A4321.Adhesive strips or tape used with code A4349 (MALE EXTERNAL CATHETER, WITH OR WITHOUT ADHESIVE, DISPOSABLE, EACH) should not be billed separately.Adhesive catheter anchoring devices that are used with indwelling urethral catheters are billed using codes A4333 and A4334, respectively. An anchoring device used with a percutaneous catheter/tube (e.g., suprapubic tube, nephrostomy tube) is billed using code A5200.Replacement leg straps (A5113, A5114) are used with a urinary leg bag (A4358, A5105, or A5112). These codes are not used for a leg strap for an indwelling catheter.When codes A4217, A4450, and A4452 are used with Urological Supplies, they must be billed with the AU modifier. For this policy, codes A4217, A4450, and A4452 are the only three codes for which the AU modifier may be used.An external catheter that contains a barrier for attachment should be coded using A4335.Codes for ostomy barriers (A4369 and A4371) should not be used for skin care products used in the management of urinary incontinence.A percutaneous catheter/tube anchoring device (A5200) is a dressing with adhesive that is designed to be applied directly over the cutaneous opening through which the catheter/tube passes. This dressing has a hole through which the catheter/tube passes and a mechanism for firmly anchoring the catheter/tube to the dressing.For claims with date of service (DOS) July 26, 2020 through September 30, 2020, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1 unit of service (UOS) at initial issue, and is all inclusive (catheter, activator, charging base). Code A4335 must also be used on separate claim lines for replacement of any of the individual components of the inFlow Intraurethral Valve-Pump system (catheter, activator, charging base).For claims with DOS October 1, 2020 through March 31, 2021, the inFlow system must be billed using HCPCS code(s): K1010 (Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each), K1011 (Activation device for intraurethral drainage device with valve, replacement only, each) and/or K1012 (Charger and base station for intraurethral activation device, replacement only).For claims with DOS April 1, 2021 through March 31, 2023, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1 unit of service (UOS) at initial issue (see below), and is all-inclusive (catheter, activator, charging base). For replacement of individual components, code A4335 must be used on separate claim lines for any of the individual components of the inFlow Intraurethral Valve-Pump system (catheter, activator, charging base).For claims with DOS on or after April 1, 2023, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4341 (INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, PATIENT INSERTED, REPLACEMENT ONLY, EACH).The initial sizing and insertion of the inFlow device is performed by the treating practitioner in their office. Claims for these services must be billed to the Part B MAC. Replacement of the indwelling intraurethral drainage device with valve is done by a trained caregiver or the beneficiary at home and may be billed on a monthly basis. If a replacement of the indwelling intraurethral drainage device with valve is performed by the treating practitioner, claims for this service must be billed to the Part B MAC.Since the activator and charging base are provided at the time of initial issue in the treating practitioner's office to the beneficiary, these may only be billed to the DME MAC as a replacement using HCPCS code A4342 (ACCESSORIES FOR PATIENT INSERTED INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, REPLACEMENT ONLY, EACH).Payment for items listed in Column II are included in the payment for the Column I code. In the following table, when providing the items listed in Column II, the Column I code must be used instead of billing separate Column II codes when the items are provided at the same time.Column IColumn IIA4310A4332A4311A4310, A4332, A4338A4312A4310, A4332, A4344A4313A4310, A4332, A4346A4314A4310, A4311, A4331, A4332, A4338, A4354, A4357A4315A4310, A4312, A4331, A4332, A4344, A4354, A4357A4316A4310, A4313, A4331, A4332, A4346, A4354, A4357A4354A4310, A4331, A4332, A4357A4357A4331A4358A4331, A5113, A5114A5105A4331, A4358, A5112, A5113, A5114A5112A5113, A5114If a code exists that includes multiple products, that code should be used in lieu of the individual codes.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Self-Administered Drug Exclusion List: and Biologicals Excluded from Coverage - Medical Policy Article, A52527

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Article - Self-Administered Drug Exclusion List: and Biologicals Excluded from Coverage - Medical Policy Article (A52527)

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CMS National Coverage PolicyN/AArticle TextThe table below lists drugs that are not covered by Medicare, the effective date of non-coverage, and the rationale. (Please see "Process for Determining Self-Administered Drug Exclusions Medical Policy Article") The column, "Brand Names," provides one or more examples but not all. Information about drugs not separately reimbursed or not covered for reasons other than "usually self-administered," is found in other Part A and Part B MAC publications and sites.In the interest of consistent Medicare, the CGS Administrators Part A MAC will follow the coverage decision for self-administered drugs as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable.The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration.Claims billed with the JA modifier are not part of the SAD exclusion. The Contractor will process claims with the JA modifier applying the policy that not only the drug is medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary.Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.And mark all applicable drugs with *.

Local Coverage Articles, Process for Determining Self-Administered Drug Exclusions – Medical Policy Article, A52535

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Article - Process for Determining Self-Administered Drug Exclusions – Medical Policy Article (A52535)

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CMS National Coverage PolicyN/AArticle TextThe Centers for Medicare and Medicaid Services (CMS) published guidelines instructing contractors to develop a process to determine whether a drug or biological is usually self-administered and excluded from payment. (See CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 50.2). These instructions include the following:The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. Section 112 of the Benefits, Improvements & Protection Act of 2000 ( BIPA) amended sections 1861 (s)(2)(A) and 1861 (s)(2)(B) of the[Social Security]Act to redefine this exclusion. The prior statutory language referred to those drugs "which cannot be self administered." Implementation of the BIPA provision requires interpretation of the phrase "not usually self-administered by the patient."The term "administered" refers only to the physical process by which the drug enters the patient's body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the "incident to" benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient. For the purpose of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug.Contractors are further instructed to make this determination on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis."Apparent on its face"For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.Evidence Criteria for applying the Medicare Self-Administered Drug Exclusion:Peer reviewed medical literatureStandards of medical practiceEvidence-based practice guidelinesFDA approved labelPackage insertDrug compendia referencesSelf-administration utilization statisticsAcute:For the purpose of determining whether a drug is usually self-administered, an acute condition means a condition that begins over a short time period, is likely to be of short duration and/or the expected course of treatment is for a short, finite interval. A course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered acute.Usually:For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage and you may not make any Medicare payment for it.Drugs NOT Usually Self-administered:Drugs delivered intravenously may usually be presumed not usually self-administeredDrugs delivered intramuscularly may usually be presumed not usually self-administeredDrug Usually Self-administered:Drugs delivered subcutaneously may be usually presumed self-administeredDrugs delivered by other routes of administration such as oral, suppositories, and topical medications are all considered to be usually self-administeredNotice of Non-Covered DrugsContractors must provide notice 45 days prior to the date that these drugs will not be covered. During the 45-day time period, contractors will maintain existing medical review and payment procedures. After the 45-day notice, contractors may deny payment for the drugs subject to the notice.CMS further provided that Part A intermediaries or Part A MACs may opt to adopt the determinations of the Part B MACs within their jurisdiction(s). In the interest of providing consistent coverage for all providers within each state, the CGS Administrators, LLC Part A MACs will adopt the coverage decisions for injectable drugs subject to the self-administered drug exclusion as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable. The list of drugs excluded from Medicare coverage as self-administered drugs can be accessed on our contractor Web site at www.cgsmedicare.com. It can also be found on the Medicare Coverage Database at www.cms.gov/mcd.

Local Coverage Articles, Traumeel Injections, A52537

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Article - Traumeel Injections (A52537)

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CMS National Coverage PolicyN/AArticle TextCGS has determined that the injection of Traumeel, a homeopathic formulation, into the soft tissues, ligaments or other structures of the foot or ankle is not medically necessary. There are no published studies on Traumeel injections in humans in the peer-reviewed literature.CPT codes 20550-20553 will be denied if the material injected is determined to be Traumeel.HCPCS code J3490 will be denied when used to denote Traumeel.

Local Coverage Articles, Self-Administered Drug Exclusion List:, A52571

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Article - Self-Administered Drug Exclusion List: (A52571)

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CMS National Coverage PolicyN/AArticle TextBackgroundThe Social Security Act does not provide a comprehensive drug benefit for Medicare beneficiaries. For Part A (inpatient), drugs provided during acute inpatient stays and qualified skilled nursing facility stays are generally covered if Medicare requirements are met. For Part B (outpatient, including outpatient hospital such as the emergency room), drugs and biological coverage is generally limited to the type of drugs that cannot be self-administered (SA), are medically necessary and reasonable, are Food and Drug Administration (FDA) approved, and are incident to the services of physicians in the treatment of patients as defined in the Carrier, Intermediary and Hospital manuals. Payment for drugs and supplies used in the performance of procedures is included in the fee for the procedure and are not separately billable to Medicare or the beneficiary.Congress changed the Medicare definition of the type of drugs that cannot be self-administered with passage of the Medicare, Medicaid, and State Childrens Health Insurance Program (SCHIP) Benefits Improvement and Protection Act (BIPA) of 2000 to usually not self-administered. As a result of this benefit structure, SA drugs and biologicals (pill form or injection form) in the outpatient setting are usually not covered except where Congress has provided for additional coverage. Examples of such coverage include specific blood clotting factors, drugs used in immunosuppressive therapy, renal dialysis related erythropoietin, osteoporosis drugs for certain homebound patients, some oral anti-cancer drugs, and some anti-nausea drugs in combination with oral or intravenous chemotherapy.The Centers for Medicare and Medicaid Services (CMS) has published two Program Memorandums on this issue. Transmittal AB-02-072, Change Request 2200, which was released on May 15, 2002, provides clarification of Section 112 of the BIPA. Change Request 2200 supersedes the following program instructions:- Medicare Carriers Manual, Section 2049.2- Intermediary Manual, Sections 3112.4B & 3660.11- Hospital Manual, Sections 230.4, E205 & 422.This transmittal instructs contractors to define usually not self-administered as more than 50 percent of the time for all Medicare beneficiaries who use the drug. A drug self-administered by more than 50 percent of Medicare beneficiaries is excluded from coverage. This definition and other criteria in the transmittal will necessitate an evaluation process by Carriers and Intermediaries prior to applying the exclusion. Transmittal AB-02-139 Change Request 2311, which was released on 10/11/2002, provided additional guidance for applying the Medicare Self-Administered Drug Exclusion.The Medicare exclusion is clear for oral drugs, suppositories and topical medications. For drugs that have previously been covered as an integral part of the procedure, (e.g., a topical ophthalmic anesthetic is not separately reimbursed but is considered part of the fee for the procedure), there is no change. The issues arise with the drugs that are given by intravenous (IV), intramuscular (IM), subcutaneous (SQ) or multiple routes of administration.These transmittals instruct each individual contractor to develop a process for the determination on each drug. For drugs that have multiple indications and routes of administration, contractors will consider all of the indications and routes of administration when making a single determination for a drug.Contractors must continue to apply the policy that not only is the drug medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. In making the determination, the contractor must use the guidelines in the transmittals, as well as to the extent available, any peer reviewed medical literature; standards of medical practice; FDA approval language, package inserts, other drug compendia as appropriate; evidence-based practice guidelines; and other information submitted by interested individuals or groups.Terms Defined by the CMSAcute Condition: a condition that is likely to be of short duration and/or the expected course of treatment is for a short, finite interval (usually less than 2 weeks).Chronic Condition: a condition that is expected to last longer than 2 weeks.Infrequent Use: less than once per week (e.g., once per month).Frequent Use: once or more per week (e. g., once per week).Administered: the term administered refers to the physical process by which the drug enters the patients body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Only injectable (including intravenous) drugs are eligible for inclusion under the incident to benefit.Apparent on its Face: For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are NOT, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.By the Patient: the term by the patient means Medicare beneficiaries as a collective whole, which includes the patients themselves, and not other individuals who may assist with the administration of the drug. The contractor is not to consider individual beneficiaries who do not have the capacity to SA any drug due to a condition other than the condition for which they are taking the drug in question.Frequency: to determine frequency, consider how often the drug is administered. For example, if the drug is administered once per month, it is less likely to be SA. If the drug is administered once or more per week, it is likely that the drug is SA.Usually: for the purposes of applying this exclusion, the term usually means more than 50 percent of the time for all Medicare beneficiaries who use the drug, regardless of the indication or route of administration.Process For Determining List of Excluded Injectable DrugsDuring the implementation of this new process for determining coverage of drugs and biologicals, First Coast Service Options (FCSO), Inc.s current medical review and payment policies will continue to be in effect. Providers will be given a 45-day notice period if a previously covered drug is determined to be non-covered. Also, providers and beneficiaries will have the usual and customary appeal rights for denied coverage. Interested parties who wish to comment on the list should address their comments to First Coast Service Options Medical Affairs, 2020 Technology Parkway, Suite 100, Mechanicsburg, PA 17050-9419 or you may email the comments toMedicalAffairs@guidewellsource.com.The Process for Determining the List of Excluded Injectable Drugs involves a 10 step process.Step 1 represents the Apparent on its Face DeterminationIs it apparent on its face that the drug is self-administrable?Yes Presumed to be usually self-administered (USA), non-covered.No Go to Steps 2-6.Steps 2-6 represent the Presumptive Factors for the Determination of Self-AdministrationIs the drug administered orally, topically, or by suppository?Yes Presumed to be usually self-administered (USA), non-covered.No Go to question #3.Is it always administered IV? Absent evidence to the contrary, drugs delivered IV are presumed to not usually be self-administered (NUSA).Yes Presumed to be NUSA, covered, if other requirements are met.No Go to question #4.Is it always administered IM? Absent evidence to the contrary, drugs delivered IM are presumed to not usually be self-administered (NUSA).Yes Presumed to be NUSA, covered, if other requirements are met.No Go to question #5.Is it always administered SQ? Absent evidence to the contrary, drugs delivered SQ are presumed to be self-administered (SA) by the patient.Yes Presumed to be SA, excluded from coverage.No Go to steps 6-10.Steps 6-10 represents the Evidentiary Factors in the Determination Process (These steps are to be used when data exists to support the coverage determination of a drug.)List the outpatient clinical indication(s) (frequency, chronic/acute conditions as listed in the package insert).Determine % utilization by clinical indication and route of administration.Estimate the % SA(> or < 50%) by indication. Use a variety of sources/factors which include: acute/chronic, setting, clinical parameter, FDA/drug inserts, pharmacy data, hospital data, health plan data, formulary data, etc.Review claims data for setting, specialty, provider, clinical indication, etc.Review information from interested parties and prioritize all available levels of evidence and make the final determination.Was drug determined to be USA by more than 50% of Medicare beneficiaries?Yes Non-covered service, 45-day notice period if previously covered, notify via web site.No Covered service.Route of Administration ModifierThe use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous form of administration. Absent evidence to the contrary, the Contractor presumes that drugs delivered intravenously are not usually self-administered by the patient. The Contractor will process claims with the JA modifier still applying the policy as stated in theMedicare Benefit Policy Manual, Chapter 15, Section 50.2 that not only must the drug be medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.The drugs represented by HCPCS codes J0801 and J0802 are administered by IM or SQ, therefore they require the JB modifier to be reported for SQ administration and they should not have any modifier reported for the IM administration.

Local Coverage Articles, Tumor Treatment Field Therapy (TTFT) - Policy Article, A52711

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Article - Tumor Treatment Field Therapy (TTFT) - Policy Article (A52711)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary). Tumor treatment field therapy devices are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Code E0766 is in the frequent and substantial service payment category. Items included in this payment category are reimbursed a single monthly fee schedule amount for the device and all related supplies and accessories. Separate billing of supplies and/or accessories will be denied as unbundling.Code A4555 is not valid for billing to Medicare. If code A4555 is billed, it will berejected as an invalid code.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TOFINAL RULE1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.INITIAL COVERAGE (FIRST THREE MONTHS):On claims for the first through third months, suppliers must add a KX modifier to code E0766 only if all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD ("Initial Coverage") have been met.CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:On the fourth months claim (and any month thereafter), the supplier must add a KX modifier to code E0766 only if both the "Initial Coverage" criteria and the "Continued Coverage" criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have been met.If the supplier does not obtain information from the practitioner that the beneficiary has demonstrated benefit from the use of, and is adhering to, TTFT treatment in time for submission of the fourth or succeeding months claims, the supplier may still submit the claims, but a KX modifier must not be added.If the supplier chooses to hold claims for the fourth and succeeding months pending receipt of information from the treating practitioner that the beneficiary received a clinical re-evaluation between the 60th and 91st day, had documented benefit from the use of, and is adhering to, TTFT treatment, those claims may then be submitted with the KX modifier.If the supplier chooses to hold claims for the fourth and succeeding month pending receipt of information from the treating practitioner but learns that the beneficiary did not receive a clinical re-evaluation between the 60th and 91st day but rather was re-evaluated at a later date and had documented benefit from the use of, and is adhering to, TTFT treatment, those claims may then be submitted with the KX modifier but only for dates of service following the date of the clinical re-evaluation.Documentation of adherence to TTFT shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating practitioner and included in the beneficiarys medical record. This information does not have to be submitted with the claim but must be available upon request.If TTFT is interrupted for any reason, it is expected that the treating practitioner will document the reason for the interruption in therapy. This information does not have to be submitted with the claim but must be available upon request.EQUIPMENT RETAINED FROM A PRIOR PAYERWhen a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible for the Medicare Fee-For-Service (FFS) program, the first Medicare claim for that item or service is considered a new initial Medicare claim. Medicare does not automatically continue coverage for any item obtained from another payer when a beneficiary transitions to Medicare coverage.For Medicare to provide payment, the beneficiary must meet all Medicare coverage, coding, and documentation requirements for the DMEPOS items in effect on the DOS of the initial Medicare claim.A Proof of Delivery (POD) is required for all items, even those in the beneficiarys possession provided by another insurer prior to Medicare eligibility.PROOF OF DELIVERY REQUIREMENTS FOR RECENTLY ELIGIBLE MEDICARE FFS BENEFICIARIESThe supplier record must document:A statement, signed and dated by the beneficiary (or beneficiary's designee), that the supplier has examined the item, meets the POD requirements; and,A supplier attestation that the item meets Medicare requirements.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.MODIFIERSGA, GZ, KF and KX MODIFIERS:In all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for code E0766. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.Devices coded E0766 are classified by the Food & Drug Administration as Class III devices; therefore, all claims for code E0766 must include the KF modifier. Claim lines billed without a KF modifier will be rejected as missing information.MISCELLANEOUSThe supplier must enter the diagnosis code for code E0766 on each claim submitted.Refer to the Supplier Manual for additional information on documentation requirements.CODING GUIDELINESCode E0766 describes devices that generate electromagnetic fields utilized in the treatment of cancer. The electromagnetic energy generated is transmitted to the body by means of surface electrodes or transducers.Code E0766 is inclusive of all associated supplies necessary for the effective use of code E0766 including, but not limited to, transducers/surface electrodes, lead wires, adhesive patches, connectors, conductive gel and skin preps.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Local Coverage Articles, Vacuum Erection Devices (VED) - Policy Article, A52712

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Article - Vacuum Erection Devices (VED) - Policy Article (A52712)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Vacuum erection devices (L7900) and related supplies are considered Prosthetic Devices under the Prosthetic Devices benefit category (Social Security Act 1861(s)(8)). For dates of service on or after July 1, 2015, codes L7900 and L7902 are statutorily non-covered based on the Achieving a Better Life Experience (ABLE) Act of 2014 (see Social Security Act 1834(a)(1)(I)).REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List list is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.

Local Coverage Articles, Transcutaneous Electrical Joint Stimulation Devices (TEJSD) - Policy Article, A52713

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Article - Transcutaneous Electrical Joint Stimulation Devices (TEJSD) - Policy Article (A52713)

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CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).A Transcutaneous Electrical Joint Stimulation Device (TEJSD) is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.The DME benefit limits the coverage of DME items to those used the beneficiarys home. Provision of TEJSD to beneficiaries in a Place of Service or facility considered to be other than home will be denied as statutorily non-covered. This includes a TEJSD incorporated into or used with any type brace (see below).Braces are covered under the Braces benefit (Social Security Act 1861(s)(9)). Coverage of items under the Braces benefit is not limited to the home.Use of a TEJSD with a brace does not change the benefit category for the TEJSD device or of the brace. A TEJSD/brace combination does not extend the DME Benefit limitation of use in the home.Refer to the applicable brace Local Coverage Determination and related Policy Article for information about coverage requirements for braces.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CODING GUIDELINESA transcutaneous electrical joint stimulation device (TEJSD) coded (E0762) is a noninvasive device that delivers electrical stimulation intended to reduce the level of pain and symptoms associated with arthritis in a joint. TEJSD may have variation in the parameters of the current, how the current is applied, etc.A TEJSD coded E0762 must be distinguished from other electrical stimulators (e.g., neuromuscular stimulators, functional electrical stimulators and transcutaneous electrical nerve stimulators, etc.) which also have unique HCPCS codes and are used to directly stimulate muscles and/or nerves. The appropriate applicable HCPCS code for these devices must be used.TEJSD is sometimes provided in combination with an orthosis (brace). When these items are provided in combination, the TEJSD and brace are always coded separately, using the codes assigned to each individual product. Braces designed to accommodate placement of electrodes and/or lead wires, that contain integrated electrodes and/or lead wires, storage for the TEJSD, etc. are considered braces, not supplies or accessories to the TEJSD and must be coded with the HCPCS code that appropriately describes the brace.If the electronics are incorporated into a brace, the item is no longer considered a brace. Rather it is DME if it meets the benefit requirements for the DME Benefit or is statutorily non-covered (no benefit) if it does not.Code A4465 is used for replacement only of any wrap/strap used to position and hold electrodes used with TEJSD in place. Use of this code for replacement of wraps/straps used with a brace is incorrect coding.The supply allowance (A4595) includes electrodes (any type), conductive paste or gel (if needed, depending on the type of electrode), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (any type, single use or rechargeable), and a battery charger (if rechargeable batteries are used). One unit of service includes all necessary supplies for one months prescribed use of the device. Separate billing for individual supplies is considered unbundling.Codes A4556 (Electrodes, [e.g., apnea monitor], per pair) and A4558 (Conductive paste or gel), are not valid for claim submission to the DME MAC. Code A4595 should be used instead.For code A4557, one unit of service is for lead wires going to two electrodes.Other supplies, including but not limited to the following, will not be separately allowed: adapters (snap, banana, alligator, tab, button, clip), belt clips, adhesive remover, additional connecting cable for lead wires, carrying pouches, or covers.The only products which may be billed using code E0762 are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List. Suppliers may not submit claims using E0762 for any other item.Claims for unlisted items using HCPCS code E0762 will be denied as incorrect coding.Suppliers should contact the PDAC for guidance on the correct coding of these items.

Local Coverage Articles, Billing and Coding: Nerve Blockade for Treatment of Chronic Pain and Neuropathy, A52725

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Article - Billing and Coding: Nerve Blockade for Treatment of Chronic Pain and Neuropathy (A52725)

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CMS National Coverage PolicyN/AArticle TextThe following billing and coding guidance is to be used with its associated Local Coverage Determination.LCD L35457 states, "Nerve blockade and/or electrical stimulation are non-covered for the treatment of metabolic peripheral neuropathy. The peer-reviewed medical literature has not demonstrated the efficacy or clinical utility of nerve blockade or electrical stimulation, alone or used together, in the diagnosis and/or treatment of neuropathic pain."The use of peripheral nerve blocks for treating diabetic neuropathy is not considered reasonable and/or necessary and is not covered by Medicare Part A or B. Such use of peripheral nerve blocks is not supported by the current peer reviewed, published, evidence based scientific literature nor by specialty society guidelines. Claims are subject to review and recoupment.This notification does not affect those regional/local blocks done as part of an operative procedure (for example wound debridement in the operating room) when performed as an adjunct to or the sole means of regional/local anesthesia for the procedure.For somatic nerve blocks, it is inappropriate to bill for fluoroscopy (CPTcodes 77002 or 77003) with a 59 modifier when the procedure(s) billed on that date of service for the same patient by the same provider are included in the CPTdescription of the procedure(s) performed.Documentation RequirementsAll documentation must be maintained in the patients medical record and available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.The submitted medical record should support the use of the selected diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed.Sources:Neurology 2011;76;1758; V. Bril, J. England, G.M. Franklin, et al. Evidence-based guideline:Treatment of painful diabetic neuropathy: Report of the American Academy of Neurology, the American Association of Neuromuscular and Neurodiagnostic Medicine, and the American Academy of Physical Medicine and RehabilitationThis information is current as of February 7, 2013American Family Physician 2010;82(2):151-158 T. Lindsay, B. Rodgers, V. Savath, K. HettingerTreating Diabetic Peripheral Neuropathic Pain

Local Coverage Articles, Billing and Coding: Hydration Services, A52732

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NOT AN LCD REFERENCE ARTICLE

Article - Billing and Coding: Hydration Services (A52732)

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CMS National Coverage PolicyInternet Only Manual Pub 100-8; Medicare Program Integrity Manual Chapter 3, Section 3.6.2.2 - Reasonable and Necessary CriteriaArticle TextNoridian Medical Review (MR) has observed errors in billing for intravenous (IV) hydration services. This article is to assist in better understanding the proper usage of the below codes for billing and coding purposes.CPT Definition:96360: Intravenous Infusion, hydration; initial, 31 minutes to 1 hour96361: Intravenous Infusion, hydration; each additional hour (list separately in addition to code for primary procedure)These codes are intended to report a hydration IV infusion consisting of pre-packaged fluid with or without electrolytes (e.g. normal saline, D5-1/2 normal saline+30mEq KCl/liter) and are not used to report infusion of drugs or other substances.Hydration Defined:The hydration codes 96360 and 96361 were developed to report specific therapeutic interventions undertaken when a patient presents with dehydration and volume loss requiring clinically necessary intravenous fluid.The necessity for hydration should be supported in the medical record.Documentation would include but is not limited to:A. Clinical assessment, typically on the same date of service, of the patients anticipated fluid needs. This can be demonstrated from the patients history, clinical examination, and pertinent laboratory testing to support the need for IV hydration therapy as reasonable and necessary for the patients treatment or diagnosis.Documentation of the assessment should describe symptoms warranting hydration, such as those associated with dehydration, the inability to ingest fluids or clear clinical contraindication to oral intake, abnormal fluid losses, abnormal vital signs, and/or abnormal laboratory studies, such as an elevated BUN, creatinine, glucose or lactic acid.Nausea itself does not necessarily indicate fluid volume depletion nor support necessity of fluid repletion.B. These codes are not intended to be reported/billed by the physician or other qualified healthcare professional in thefacilitysetting, as these codes most likely represent facility charges with applicable reimbursement through the respective fee schedule. However,in the physicianofficesetting (example, Place of Service 11), the physician may report these codes when the physicians clinical staff or the physician administers the fluids.C. Forfacilityreporting, an initial infusion is predicated on using a hierarchy.D. When administering multiple infusions (e.g. IV fluids and subsequent IV chemotherapy infusion on same date of service), only one primary infusion code should be reported for a given date, unless protocol requires that two separate IV sites must be used.E. Hydration cannot be reportedconcurrentlywith any other infusion or drug administration service.F. The definition of infusion time is inherent and presented in the guidelines for these codes. In other words, a minimum time duration of 31 minutes of hydration infusion is required to report the service.G. Consequently, infusion time is calculated from the time the administration commences (i.e. the infusion starts dripping) to when it ends (i.e. the infusion stops dripping).H. In accordance withMedicare Reasonable and Necessary Criteria,(Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2), the benefit must meet butdoes not exceedthe beneficiarys medical need, and as such, IV fluids should be avoided if not deemed clinically necessary.For example, although some conditions may warrant intravenous rehydration, if documentation supports the same benefit could be achieved by oral hydration, IV hydration would not be considered reasonable and necessary.However, it is understood that there are clinical scenarios in which the patient's need for hydration cannot wait for oral trials, even if an option. The intent should be understood within the body of documentation.I.Examplesof Additional Payable Scenarios:If therapeutic fluid administration is medically necessary:for the correction of dehydration or prevention of nephrotoxicity immediately before or after transfusion, chemotherapy, or administration of potentially nephrotoxic medications.immediately before or after IV contrast infusion for a diagnostic procedure in a patient with renal insufficiency.J.Non-payable scenarios :The following infusion circumstancesdo not represent hydrationand should not be reported using any of these CPT codes:If the sole purpose of the intravenous fluid is to maintain patency (i.e. keep open) of an IV line prior to, during, or subsequent to a chemotherapeutic or therapeutic infusion, or transfusion.If used as maintenance IV therapy replacing normal sensible and insensible fluid losses, not losses associated with a pathological condition.When the purpose of the infusion is to accommodate a therapeutic IV piggyback through the same IV access to safely infuse the agent (e.g. IV fluids infused simultaneously with drug administration).If the fluid is used as the diluent to mix the drug (i.e. the fluid is the vehicle in which the drug is administered).Hydration that is integral to the performance of a surgical procedure to establish an initial and underlying IV flow for a diagnostic or therapeutic infusion is not separately billable (e.g. IV fluids administered preoperatively, intraoperatively, and/or postoperatively).Routine administration of IV fluids, pre/post operatively while the patient is NPO for example, without documentation supporting signs and/or symptoms including those of dehydration or fluid loss is not supported as medically necessary.Infusion of IV fluids with electrolytes for the purpose of treating an electrolyte deficiency (e.g. hypokalemic patient being treated specifically for low potassium level for which 20 mEq of KCL is added to an IV fluid).In conclusion, themain question that should be asked when considering billing for 96360 and 96361 is whether IV hydration is an appropriate, accepted standard of medical practice as a diagnostic or specific treatment for a beneficiarys condition,is one that meets, BUT does NOT exceed the beneficiarys medical need, and cannot be met with oral hydration.Note:It is understood that depending on the clinical scenario, upon presentation, an IV line may be established, fluids initiated, labs drawn and sent for evaluation and imaging completed with examinations. Although it may be reasonable to start fluids upon presentation, in order to bill the IV hydration codes, the medical necessity for the hydration services must also be supported. If the final clinical assessment does not support intravenous hydration was necessary for beneficiarys medical needs, hydration codes should not be billedReferences:CPT Assistant Coding Update:Infusion/Injection services; February 2009; Volume 19, Issue 2, pages 17-21).CPT Assistant Coding Clarification;Facility reporting-Multiple Infusions (Codes 96360, 96361, 96365-96367); December, 2011; Volume 21, Issue 12, pages 3-5).National Institute for Health and Care Excellence (NICE) Guidelines; Intravenous Fluid Therapy in Adults in Hospital;December, 2013.2020 CMS NCCI Policy Manual for MC Services; Ch. 11, Medicine E/M Services CPT codes 90000-99999 and corresponding CMS NCCI edits.5. Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2 - Reasonable and Necessary Criteria

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Medicare Program Integrity Manual Chapter 3 - Verifying Potential Errors and Taking Corrective Actions Table of Contents (Rev. 1 2056; Issued: 0 5-25-23) Transmittals for Chapter 3 3.1 - Introduction 3.2 - Overview of Prepayment and Postpayment Reviews 3.2.1 - Setting Priorities and Targeting Reviews 3.2.2 - Provider Notice 3.2.2.1 - Maintaining Provider Information 3.2.3 - Requesting Additional Documentation During Prepayment and Postpayment Review 3.2.3.1 - Additional Documentation Requests (ADR) . 3.2.3.2 - Time Frames for Submission 3.2.3.3 - Third -Party Additional Documentation Request 3.2.3.4 - Additional Documentation Request Required and Optional Elements 3.2.3.5 - Acceptable Submission Methods for Responses to ADRs 3.2.3.6 - Reimbursing Providers and HIHs for Additional Document ation 3.2.3.7 - Special Provisions for Lab Additional Documentation Requests 3.2.3.8 - No Response or Insufficient Response to Additional Documentation Requests 3.2.3.9 - Reopening Claims with Additional Information or Denied Due to Late or No Submission of Requested Information 3.2.3.10 - Record Retention and Storage 3.2.4 - Use of Claims History Information in Claim Payment Determinations 3.2.5 - Targeted Probe and Educate (TPE ) 3.3 - Policies and Guidelines Applied During Review 3.3.1 - Types of Review: Medical Record Review, Non- Medical Record Review and Automated Review 3.3.1.1 - Medical Record Review 3.3.1.2 - Non -Medical Record Review 3.3.1.3 Automated Reviews 3.3.2 - Medical Review Guidance 3.3.2.1 - Documents on Which to Base a Determination 3.3.2.1.1 - Progress Notes and Templates 3.3.2.1.2 DMEPOS Orders 3.3.2.2 - Absolute Words and Prerequisite Therapies 3.3.2.3 - Mandatory Policy Provisions 3.3.2.4 - Signature Requirements 3.3.2.5 Amendments, Corrections and Delayed Entries in Medical Documentation 3.3.2.6 - Psychotherapy Notes 3.3.2.7 - Review Guideli nes for Therapy Services 3.3.2.8 - MAC Articles 3.3.3 - Reviewing Claims in the Absence of Policies and Guidelines 3.4 - Prepayment Review of Claims 3.4.1 - Electronic and Paper Claims 3.4.1.1 - Linking LCD and NCD ID Numbers to Edits 3.4.1.2 - Not Otherwise Classified (NOC) Codes 3.4.1.3 - Diagnosis Code Requirements 3.4.1.4 - Prepayment Review of Claims Involving Utilization Parameters 3.4.1.5 - Prepayment Review Edits 3.4.2 - Prepayment Medical Record Review Edits 3.5 - Postpayment Medical Record Review of Claims 3.5.1 - Re-opening Claims 3.5.2 - Case Selection 3.5.3 - CMS Mandated Edits 3.5.4 - Tracking Medicare Contractors Prepayment and Postpayment Reviews 3.6 - Determinatio ns Made During Review 3.6.1 - Determining Overpayments and Underpayments 3.6.2 - Verifying Errors 3.6.2.1 - Coverage Determinations 3.6.2.2 - Reas onable and Necessary Criteria 3.6.2.3 - Limitation of Liability Determinations 3.6.2.4 - Coding Determinations 3.6.2.5 - Denial Types 3.6.3 - Beneficiary Notification 3.6.4 - Notifying the Provider 3.6.5 - Provider Financial Rebuttal of Findings 3.6.6 - Review Determination Documentation Requirements 3.7 - Corrective Actions 3.7.1 - Progressive Corrective Action (PCA) 3.7.1.1 - Provider Error Rate 3.7.1.2 - Vignettes 3.7.1.3 - Provider Notification and Feedback 3.7.2 - Comparative Billing Reports (CBRs) 3.7.3 - Evaluating the Effectiveness of Corrective Actions 3.7.3.1 - Evaluation of Prepayment Edits 3.7.3.2 - Evaluating Effectiveness of Established Automated Edits 3.7.3.3 - Evaluation of Postpayment Review Effectiveness 3.7.4 - Tracking Appeals 3.7.5 - Corrective Action Reporting Requirements 3.8 - Administrative Relief from MR During a Disaster 3.9 - Defending Medical Review Decisions at Administrative Law Judge (ALJ) Hearings 3.9.1 Election of Status 3.9.2 - Coordination of the ALJ Hearing 3.10 Prior Authorization 3.10.1 - Prior Authorization Program for Certain DMEPOS 3.10.1.1 Voluntary Prior Authorization (PA) for DMEPOS Accessories 3.10.2 - Prior Authorization Process for Certain Hospital Outpatient Department (OPD) Services 3.1 Introduction (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) All references to Medicare Administrative Contractors (MACs) include Affiliated Contractors (ACs). Affiliated Contractors are FIs and Carriers. A. Goals This section applies to Medicare Administrative Contractors (MACs), Comprehensive Error Rate Testing (CERT), and Recovery A uditors, as indicated. The Medicare Administrative Contractors (MACs) shall analyze claims to determine provider compliance with Medicare coverage, coding, and billing rules and take appropriate corrective action when providers are found to be non- compliant. The goal of MAC administrative actions is to correct the behavior in need of change and prevent future inappropriate billing. The priority for MACs is to minimize potential future losses to the Medicare Trust Funds through targeted claims re view while using resources efficiently and treating providers and beneficiaries fairly. For repeated infractions, MACs have the discretion to initiate progressively more severe administrative action, commensurate with the seriousness of the identified problem. (Refer to PIM chapter 3, 3.7.1). MACs shall deal with serious problems using the most substantial administrative actions available, such as 100 percent prepayment review of claims. Minor or isolated inappropriate billing shall be remediated through provider notification or feedback with reevaluation after notification. When medical review (MR) notification and feedback letters are issued, the MAC MR staff shall ensure that Provider Outreach and Education (POE) staff has access to copies of the letter s in case a provider requests further education or POE determines that future education is needed. While program savings are realized through denials of payment for inappropriate provider billing, the optimal result occurs when compliance is achieved and p roviders no longer incorrectly code or bill for non- covered services. The Medicare Fee For Service Recovery Audit program is a legislatively mandated program (Tax Relief and Health Care Act of 2006) that utilizes Recovery Auditors to identify improper payments paid by Medicare to fee -for-service providers. The Recovery Auditors identify the improper payments, and the MACs adjust the claims, recoup identified overpayments and return underpayments. MAC, CERT and Recovery Auditor staff shall not expend Medic are Integrity Program (MIP)/ MR resources analyzing provider compliance with Medicare rules that do not affect Medicare payment. Examples of such rules include violations of conditions of participation (COPs), or coverage or coding errors that do not change the Medicare payment amount. The COPs define specific quality standards that providers shall meet to participate in the Medicare program. A providers compliance with the COPs is determined by the CMS Regional Office (RO) based on the State survey agenc y recommendation. If during a review, any contractor believes that a provider does not comply with conditions of participation, the reviewer shall not deny payment solely for this reason. Instead, the contractor shall notify the RO and the applicable State survey agency. When a potential underpayment or overpayment is identified, certain steps are normally followed to determine if a payment error exists. These steps are referred to as the claims development process. The reviewer generally does the following: Investigates the claims and associated documentation; Performs appropriate research regarding liability, benefit categories, statutory requirements, etc.; Determines if a payment error exists and the nature of the error; Notifies the beneficiary and provider/supplier; and Starts the payment reconciliation process. B. New Provider/New Benefit Monitoring This section applies to the MACs. The MACs shall analyze data to identify patterns of billing aberrancies of providers new to the Medicare program. The MACs have the option of performing prepayment or postpayment review of claims submitted by new providers as needed. The CMS encourages the MACs to perform these reviews on a prepayment basis to have the greatest chance of identifying and reducing the error rate of new providers. When MACs review the claims of a new provider, the MACs shall perform a limited review of generally 20- 40 claims in order to evaluate accurate billing. The MACs shall also monitor for provider use of new statutory benefits and to ensure correct coverage, coding, and billing from the beginning. New benefit edits shall continue until the MAC is satisfied that the new b enefits are being used and billed appropriately or until the MAC determines that resources would best be spent on other types of review. 3.2 Overview of Prepayment and Postpayment Reviews (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementatio n: 08 -27-20) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. This section applies to MACs, CERT, RACs, SMRCs, and Unified P rogram Integrity Contractors (UPICs), as indicated. A. Prepayment and Postpayment Review Prepayment review occurs when a reviewer makes a claim determination before claim payment has been made. Prepayment review always results in an initial determination. Postpayment review occurs when a reviewer makes a claim determination after the claim has been paid. Postpayment review results in either no change to the initial determination or a revised determination indicating that an overpayment or underpayment has occurred. B. Prepayment Edit Capabilities Prepayment edits shall be able to key on a be neficiary's Medicare beneficiary identifier (Mbi), National Provider Identifier (NPI) and specialty code, service dates, and diagnosis or procedure code(s) (i.e., Healthcare Common Procedure Coding System [HCPCS] and/or International Classification of Dise ases diagnoses codes), Type of Bill (TOB), revenue codes, occurrence codes, condition codes, and value codes. The MAC systems shall be able to select claims for prepayment review using different types of comparisons. At a minimum, those comparisons shall include: Procedure to Procedure - permits contractor systems to screen multiple services at the claim level and in history. Procedure to Provider - permits selective screening of services that need review for a given provider. Frequency to Time - permits contractors to screen for a certain number of services provided within a given time period. Diagnosis to Procedure - permits contractors to screen for services submitted with a specific diagnosis. For example, the need for a vitamin B12 injection is related to pernicious anemia, absent of the stomach, or distal ileum. Contractors must be able to establish edits where specific diagnosis/procedure relationships are considered in order to qualify the claim for payment. Procedure to Specialt y Code or TOB - permits contractors to screen services provided by a certain specialty or TOB. Procedure to Place of Service- permits selective screening of claims where the service was provided in a certain setting such as a comprehensive outpatient rehab ilitation facility. Additional MAC system comparisons shall include, but are not limited to the following: Diagnoses alone or in combination with related factors. Revenue linked to the health care common procedure coding system (HCPCS). Charges related to utilization, especially when the service or procedure has an established dollar or number limit. Length of stay or number of visits, especially when the service or procedure violates time or number limits. Specific providers alone or in combination w ith other parameters.

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Frequency to Time - permits contractors to screen for a certain number of services provided within a given time period. Diagnosis to Procedure - permits contractors to screen for services submitted with a specific diagnosis. For example, the need for a vitamin B12 injection is related to pernicious anemia, absent of the stomach, or distal ileum. Contractors must be able to establish edits where specific diagnosis/procedure relationships are considered in order to qualify the claim for payment. Procedure to Specialt y Code or TOB - permits contractors to screen services provided by a certain specialty or TOB. Procedure to Place of Service- permits selective screening of claims where the service was provided in a certain setting such as a comprehensive outpatient rehab ilitation facility. Additional MAC system comparisons shall include, but are not limited to the following: Diagnoses alone or in combination with related factors. Revenue linked to the health care common procedure coding system (HCPCS). Charges related to utilization, especially when the service or procedure has an established dollar or number limit. Length of stay or number of visits, especially when the service or procedure violates time or number limits. Specific providers alone or in combination w ith other parameters. The MR edits are coded system logic that either automatically pays all or part of a claim, automatically denies all or part of a claim, or suspends all or part of a claim so that a trained clinician or claims analyst can review the claim and associated documentation (including documentation requested after the claim is submitted) in order to make determinations about coverage and payment under Section 1862(a) (1) (A) of the Act. Namely, the claim is for a service or device that is medically reasonable and necessary to diagnose or treat an injury or improve the functioning of a malformed body member. All non-automated review work resulting from MR edits shall: Involve activities defined under the MIP at 1893(b)(1) of the Act; Be articulated in the MACs medical review strategy; Be designed in such a way as to reduce the MACs CERT error rate or prevent the MACs CERT error rate from increasing, or; Prevent improper payments identified by the RACs. 3.2.1 Setting Priorities and Targeting Reviews (Rev. 399, Issued: 11- 04-11, Effective: 12 -05-11, Implementation: 12- 05-11) This section applies to MACs and Recovery Auditors, as indicated. Recovery Auditors perform targeted reviews consistent with their statements of work (SOWs). The MACs have the authority to review any claim at any time, however, the claims volume of the M edicare Program doesnt allow for review of every claim. The MACs shall target their efforts at error prevention to those services and items that pose the greatest financial risk to the Medicare program and that represent the best investment of resources. This requires establishing a priority setting process to assure MR focuses on areas with the greatest potential for improper payment. The MACs shall develop a problem -focused, outcome -based MR strategy and Strategy Analysis Report (SAR) that defines what risks to the Medicare trust fund the MACs MR programs will address and the interventions that will be implemented during the fiscal/option year as addressed in PIM chapter 7. The MACs shall focus their edits where the services billed have significant pot ential to be non-covered or incorrectly coded. Medical review staff may decide to focus review on problem areas that demonstrate significant risk to the Medicare program as a result of inappropriate billing or improper payments. The MACs shall have in plac e a program of systematic and ongoing analysis of claims and data from Recovery Auditors and CERT, among other sources, in order to focus intervention efforts on the most significant errors. The MACs shall initiate a targeted provider -specific prepayment review only when there is the likelihood of sustained or high level of payment error. MACs are encouraged to initiate targeted service- specific prepayment review to prevent improper payments f or services identified by CERT or Recovery Auditors as problem areas, as well as, problem areas identified by their own data analysis. The MACs have the discretion to select target areas because of: High volume of services; High cost; Dramatic change in frequency of use; High risk problem -prone areas; and/or, Recovery Auditor, CERT, Office of Inspector General (OIG) or Government Accounting Office (GAO) data demonstrating vulnerability. Probe reviews are not required when targeted areas are based on data from these entities. In an effort to identify the claims most likely to contain improper billing, MACs are encouraged to use prepayment and postpayment screening tools or natural language coding software. MACs shall not deny a payment for a service simply because the claim fails a single screening tool criterion. Instead, the reviewer shall make an individual determination on each claim. MACs have the discretion to post the screening tools in use to their Web site or otherwise disclose to the provide r community. Recovery Auditors shall use screening tools and disclose their use to the provider community consistent with the requirements in their statements of work (SOWs). MACs and Recovery Auditors shall NOT target a provider for review solely based on the providers preferred method of maintaining or submitting documentation. For example, a MAC or Recovery Auditor shall NOT choose a provider for review based only on the fact that the provider uses an electronic health record or responds to documentat ion requests using the Electronic Submission of Medical Documentation (esMD) mechanism. (More information about esMD can be found in Section (3.2.3.5) 3.2.2 - Provider Notice (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, RACs, UPICs, and SMRC as indicated. Because the CERT contractors select claims on a random basis, they are not required to notify providers of their intention to begin a review. Providers may submit unsolicited documentation to the MAC when submitting a claim. Providers are to list the PWK 02 Report Transmission Code (PWK (paperwork) modifier) on the claim when submitting this documentation. MACs should inform the providers that they are NOT required to submit unsolicited documentation (and the corresponding PWK modifier) and that the absence or presence of PWK modifier does not mean that their claim will be reviewed. MACs should, at their discretion, consider posting to their webs ite or sending letters to providers informing them of what additional documentation is needed to make a determination on the claim. A. Notice of Provider- Specific Review When MAC data analysis indicates that a provider -specific potential error exists that cannot be confirmed without requesting and reviewing documentation associated with the claim, the MAC shall review a sample of representative claims. Before deploying significant medical review resources to examine claims identified as potential problems through data analysis, MACs shall take the interim step of selecting a small "probe" sample of generally 20- 40 potential problem claims (prepayment or postpayment) to validate the hypothesis that such claims are being billed in error. This ensures that medic al review activities are targeted at identified problem areas. The MACs shall ensure that such a sample is large enough to provide confidence in the result, but small enough to limit administrative burden. The CMS encourages the MACs to conduct error validation reviews on a prepayment basis in order to help prevent improper payments. MACs shall select providers for error validation reviews in the following instances, at a minimum: The MAC has identified questionable billing practices (e.g., non-covered, incorrectly coded or incorrectly billed services) through data analysis; The MAC receives alerts from other MACs, Quality Improvement Organizations (QIOs), CERT, RACs, OIG/GAO, or internal/external components that warrant review; The MAC receives complai nts; or, The MAC validates the items bulleted in 3.2.1. Provider -specific error validation reviews are undertaken when one or a relatively small number of providers seem to be experiencing similar/recurrent problems with billing. The MACs shall document their reasons for selecting the provider for the error validation review. In all cases, they shall clearly document the issues noted and cite the applicable law, published national coverage determination, or local coverage determination. For provider-specific problems, the MAC shall notify providers in writing that a probe sample review is being conducted. MACs shall consider sending letters to providers informing them of what additional documentation is needed to make a determination on the claim. MACs have the discretion to use a letter similar to the letters in Exhibit 7 of the PIM when notifying providers of the probe review and requesting documentation. MACs have the discretion to advise providers of the probe sample at the same time t hat medical documentation or other documentation is requested. Generally, MACs shall subject a provider to no more than one probe review at any time; however, MACs have the discretion to conduct multiple probes for very large billers as long as they will not constitute undue administrative burden. MACs The MACs shall notify selected providers prior to beginning a provider- specific review by sending an individual written notice. MACs shall indicate whether the review will occur on a prepayment or postpayment basis. This notification may be issued via certified letter with return receipt requested. MACs shall notify providers of the specific reason for selection. If the basis for selection is comparative data, MACs shall provide the data on how the provider varies significantly from other providers in the same specialty, jurisdiction, or locality. Graphic presentations help to communicate the perceived problem more clearly. RACs The RACs are required to post a description of all approved new issues to the RACs Web site before correspondence is sent to the provider. After posting, the RAC should issue an additional documentation request (ADR) to the provider, if warranted. Unified Program Integrity Contractor (UPIC) The UPICs shall notify selected providers prior to beginning a provider- specific review by sending an individual written notice. UPICs shall indicate whether the review will occur on a prepayment or postpayment basis. UPICs shall maintain a copy of the letter and the date it was mailed. This notification shall be mailed the same day that the edit request is forwarded to the MAC. Refer to Exhibit 45 for the letter to be sent. B. Notice of Service -Specific Review This section applies to MACs, RACs and SMRC as indicated. Service- specific reviews ar e undertaken when the same or similar problematic process is noted to be widespread and affecting one type of service (e.g., providing tube feedings to home health beneficiaries across three (3) states). MACs Web site postings The MACs shall provide notification prior to beginning a service- specific review by posting a review description on their Web site. MACs should, at their discretion, state what additional documentation is needed from providers to make a claim determination on their Web site. MACs shall keep the Web site current by posting active reviews. MACs should, at their discretion, create an archive for old review topics that are no longer under active review. Active review is defined as the time period during which ADRs are sent, determinations are made and findings are communicated to the providers. MACs should categorize the active review topics by provider type. Individual written notices MACs have the discretion to also notify providers about a service- specific review by sending individual notices to the affected providers. MACs have the discretion to issue the notice separately or include it in the ADR. MACs should, at their discretion, state what additional documentation is needed from providers to make a claim determination in the written notices. RACs Before beginning widespread service-specific reviews, RACs shall notify the provider community that the RAC intends to initiate review of certain items/services through a posting on the RAC Web site describing the item/servi ce that will be reviewed. Additionally, for medical record reviews, the RACs shall send ADRs to providers that clearly articulate the items or services under review and indicate the appropriate documentation to be submitted. Unified Program Integrity Contractors (UPICs) The UPICs shall provide notification prior to beginning a service- specific review by sending individual written notices to the affected providers. This notification shall be mailed the same day that the edit request is forwarded to the MAC. The UPICs shall maintain a copy of the letter and the date it was mailed. Refer to Exhibit 45 for the letter to be sent. SMRC The SMRC shall operate/maintain a public Web site that displays what types of issues are under review. For each area, the S MRC shall include a link to the relevant OIG/GAO or other reports available. In addition to the Web site, the SMRC shall notify providers about a service -specific review by sending an ADR. The SMRC shall state what additional documentation is needed from p roviders to make a claim determination in the ADR. 3.2.2.1 - Maintaining Provider Information (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) The term Medicare beneficiary identifier (Mbi) is a general term describing a bene ficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes.

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The SMRC shall operate/maintain a public Web site that displays what types of issues are under review. For each area, the S MRC shall include a link to the relevant OIG/GAO or other reports available. In addition to the Web site, the SMRC shall notify providers about a service -specific review by sending an ADR. The SMRC shall state what additional documentation is needed from p roviders to make a claim determination in the ADR. 3.2.2.1 - Maintaining Provider Information (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) The term Medicare beneficiary identifier (Mbi) is a general term describing a bene ficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. This section applies to MAC. A. Provider Tracking System (PTS) The MACs shall have a PTS in place to identify and track all individual providers currently under action plans to correct identified problems, such, as not reasonable and necessary, incorrect coding, and inappropriate billing. MACs shall use the provider tracking system (PTS) to coordinate contacts with providers such as MR notifications, telephone calls directly related to probe reviews, and referrals to POE. The MACs shall ensure that if a provider is to be contacted as a result of more than one problem, redundant contacts are minimized. The MACs shall also coordinate corrective action information with the UPICs to ensure contacts are not in conflict with benefit integrity related activities. The MAC PTS shall contain the date a provider is put on a provider - specific edit. The MAC shall reassess all providers on provider -specific prepayment or postpayment review on a quarterly basis to determine whether the behavior has improved. The MAC shall note the results of these quarterly assessments in the PTS. If the behavior has improved sufficiently and the edit was turned off, note that date as well in the PTS. When a MAC becomes aware that the provider has appealed a medical review determination to an Administrative Law Judge (ALJ), the MAC should send a letter to the ALJ and describe the information in the PTS to demonstrate the corrective actions that have been taken by the MAC. B. Recovery Auditor Case Files The Recovery Auditor shall maintain case files following the guidelines in the Recovery Auditor SOW. C. Provider Addresses This section applies to MACs, CERT, and Recovery Auditors, as indicated. The MACs, CERT and Recovery Auditors shall mail the ADR to the best known address for the provider. MACs are encouraged to indicate the procedure a provider can f ollow to update address information in their ADRs and on their Web sites. If a provider wishes to have ADRs sent to one address but demand letters sent to a different address, MACs are encouraged to accommodate this request. Note: Providers and suppliers must complete and submit a Medicare enrollment application (either the paper CMS -855 or a submission via Internet -based Provider Enrollment, Chain & Ownership [PECOS] to change existing information in the Medicare enrollment record.) D. When the Provider or Supplier No Longer Occupies a Physical Address This section applies to MACs and UPICs, as indicated. When the MACs and UPICs become aware that the provider or supplier no longer occupies a physical address, any future correspondence shall reference only the claim control numbers and not list the individual beneficiary data (e.g., names and Medicare beneficiary identifiers). This process is contingent on current automated system limits. The following are situations where the MAC and UPIC can assume the pr ovider or supplier no longer occupies the last known location. This list is not exhaustive and the MACs and UPICs should use other means to confirm addresses, at their discretion. The MAC and UPIC receive mail that has been returned by the post office indicating no known address; An onsite visit has confirmed the address is vacant or is occupied by another occupant; or, A beneficiary complaint(s) is on record stating the provider or supplier is no longer at the address and follow up confirms the complaint. In the above situations, correspondence from the MACs and UPICs shall only contain the claim control number and advise the provider or supplier to contact them for a list of the specific claims associated with the overpayment. This process wi ll prevent the potential compromise of Medicare beneficiary names and/or Medicare beneficiary identifiers being sent to an abandoned address (or a location with a new occupant). If the letter is returned from the post office, maintain the notification on f ile for evidence. 3.2.3 - Requesting Additional Documentation During Prepayment and Postpayment Review (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, CERT, RACs, and UPICs, as indicated. A. General In certain circumstances, the MACs, CERT, RACs, and UPICs may not be able to make a determination on a claim they have chosen for review based upon the information on the claim, its attachments, or the billing history found in claims processing system (if applicable) or the Common Working File (CWF). In those instances, the reviewer shall solicit documentation from the provider or supplier by issuing an a dditional documentation request (ADR). The term ADR refers to all documentation requests associated with prepayment review and postpayment review. MACs, CERT, RACs, and UPICs have the discretion to collect documentation related to the beneficiarys conditi on before and after a service in order to get a more complete picture of the beneficiarys clinical condition. The MAC, RAC, and UPIC shall not deny other claims submitted before or after the claim in question unless appropriate consideration is given to t he actual additional claims and associated documentation. The CERT contractor shall solicit documentation in those circumstances in accordance with its Statement of Work (SOW). The term additional documentation refers to medical documentation and other documents such as supplier/lab/ambulance notes and includes: Clinical evaluations, physician evaluations, consultations, progress notes, physicians office records, hospital records, nursing home records, home health agency records, records from other hea lthcare professionals and test reports. This documentation is maintained by the physician and/or provider. Supplier/lab/ambulance notes include all documents that are submitted by suppliers, labs, and ambulance companies in support of the claim (e.g., Cer tificates of Medical Necessity, supplier records of a home assessment for a power wheelchair). Other documents include any records needed from a biller in order to conduct a review and reach a conclusion about the claim. NOTE: Reviewers shall consider documentation in accordance with other sections of this manual. The MAC and UPIC have the discretion to deny other related claims submitted before or after the claim in question, subject to CMS approval as described below. If documentation associated with one claim can be used to validate another claim, those claims may be considered related. Approved examples of related claims that may be denied as related are in the following situations: When the Part A Inpatient surgical claim is denied as not reasonable and necessary, the MAC may recoup the surgeon's Part B services. For services where the patients history and physical (H&P), physician progress notes or other hospital record documentation does not support the medical necessity for performing the procedure, postpayment recoupment may occur for the performing physicians Part B service. Reserved for future approved related claim review situations. The MAC shall report to their BFL and COR prior to initiating denial of related claims situations. The MAC and UPIC shall await CMS approval prior to initiating requested related claim(s) review. Upon CMS approval, the MAC shall post the intent to conduct related claim review(s) to their Web site within 1 month prior to initiation of th e approved related claim review(s). The MAC shall inform CMS of the implementation date of the related claim(s) review 1 month prior to the implementation date. If related claims are denied automatically, MACs shall count these denials as automated review. If the related claims are denied after manual intervention, MACs shall count these denials as non- medical record review. The RAC shall utilize the review approval process as outlined in their SOW when performing reviews of related claims. The MAC, RAC, and UPIC are not required to request additional documentation for the related claims before issuing a denial for the related claims. Contactors shall process appeals of the related claim(s) separately. B. Authority to Collect Medical Documentation Contractors are authorized to collect medical documentation by the Social Security Act. Section 1833(e) states No payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period. Section 1815(a) states no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period. The OMB P aperwork Reduction Act collection number for prepayment medical review is 0938- 0969. MACs shall use this number on every additional documentation request or any other type of written request for additional documentation for prepayment medical review. It can be in the header, footer or body of the document. CMS suggests the information read OMB #: 0938- 0969 or OMB Control #: 0938- 0969. Postpayment medical review does not require an OMB control number. C. PWK (Paperwork) Modifier MAC medical review departments are only required to review unsolicited documentation when the claim suspends for a medical review edit/audit. MACs shall not send an ADR request for a claim with a PWK modifier until after review of the PWK unsolicited documentation or the waiting days have elapsed without receipt of documentation. MACs shall allow 7 calendar waiting days (from the date of receipt of the claim) for additional unsolicited documentation to be submitted or 10 calendar waiting days for the unsolicited documentation to be mailed. Contractors serving island territories shall have the flexibility to adjust waiting days as is necessary. CMS expects that any adjustment from the core 7/10 days will be discussed with and approved by your contracting officer prior to implementation. When the documentation is received, the contractor has 30 calendar days to make a determination on the claim. If the contractor cannot make a determination on the claim after reviewing the unsolicited documentation submitted, they shall request additional documentation using their normal business procedures for ADR that are outlined in Chapter 3 of the Program Integrity Manual. 3.2.3.1 - Additional Documentation Requests (ADR) (Rev.933; Issued: 01-10- 20; Effective: 02 - 03- 20; Implementati on: 01-06- 20) This section applies to MACs, Recovery Auditors, CERT and UPICs , as indicated. The MACs, CERT, Recovery Auditors, and UPICs shall specify in the ADR only those individual pieces of documentation needed to make a determination. When reviewing documentation, the reviewer shall give appropriate consideration to all documentation that is provided in accordance with other sections of this manual. The MACs and the RACs shall also support soliciting documentation from the provider or supplier via Electronic Submission of Medical Documentation (esMD). The contractors shall send an Electronic Medical Documentation Request (eMDR) via es MD to those providers/suppliers that have registered to receive the request electronically. The contractors are encouraged to explore other ways to send eMDRs electronically (For example, using direct exchange, clearinghouses, state Health Information Exchange (HIEs)). Providers interested in submitting documentation via esMD can find information on the CMS esMD website at http://www.cms.gov/esMD. A. Outcome Assessment Information Set (OASIS) Medicares Home Health PPS Rate Update for CY 2010 final rule, published in the November 10, 2009 Federal Register, includes a provision to require the submission of the OASIS as a condition of payment, that is codified in regulations 42 CFR484.210(e). Beginning January 1, 2010, home health agencies (HHAs) are required to submit an OASIS as a condition for payment. The MACs shall deny the claim if providers do not meet this regulatory requirement. The assessment must be patient specific, accur ate and reflect the current health status of the patient. This status includes certain OASIS elements used for calculation of payment. These include documentation of clinical needs, functional status, and service utilization. B. Plan of Care (POC)

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Providers interested in submitting documentation via esMD can find information on the CMS esMD website at http://www.cms.gov/esMD. A. Outcome Assessment Information Set (OASIS) Medicares Home Health PPS Rate Update for CY 2010 final rule, published in the November 10, 2009 Federal Register, includes a provision to require the submission of the OASIS as a condition of payment, that is codified in regulations 42 CFR484.210(e). Beginning January 1, 2010, home health agencies (HHAs) are required to submit an OASIS as a condition for payment. The MACs shall deny the claim if providers do not meet this regulatory requirement. The assessment must be patient specific, accur ate and reflect the current health status of the patient. This status includes certain OASIS elements used for calculation of payment. These include documentation of clinical needs, functional status, and service utilization. B. Plan of Care (POC) Com prehensive care planning is essential to good patient care under the Medicare program. In fact, it is specifically written into the coverage and/or certification requirements for a number of healthcare settings. For purposes of the Part A benefit for home health, inpatient rehabilitation facility and hospice, the Social Security Act describes criteria and standards used for covering these services. This includes establishing an individualized POC. The POC identifies treatment goals and coordination of se rvices to meet patient needs as set forth in CFR 418.200 requirement for coverage. The POC must be established by a physician(s). However, in the case of a hospice, in addition to the physician, an interdisciplinary group shall establish a POC. Section 1814(a)(2)(C), Part B 1835(a)(2)(A) of the Act, and CFR 409.43 state that a POC established by a treating physician must contain all pertinent information, such as, the patient history, initial status, treatment goals, procedures/services duration, and progress notes. CFR412.622 requires an individualized POC by a rehabilitation physician that meets the requirements listed in the regulation. MACs shall deny the claim as not meeting statutory requirements under the Social Security Act when the provider of services fails to comply with the POC requirements. Pursuant to 42 CFR 489.21, a provider of services shall not charge a beneficiary for services that have been denied for the reasons stated above. 3.2.3.2 - Time - Frames for Submission (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, RACs, CERT, SMRC, and UPICs, as indicated. In certain circumstances, the MACs, CERT, SMRC, RACs, UPICs and other contractors may not be able to make a determination on prepayment or post -payment claims they have chosen for review based upon the information on the claim, its attachments, or the billing history found in claims processing system (if applicable) or the Common Working File (CWF). In those instances, the reviewer shall solicit documentation from the provider or supplier by issuing an ADR. Contractors are authorized to collect medical do cumentation by the Social Security Act (the Act). Section 1815(a) of the Act states that "no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period." Section 1833(e) of the Act states that "[n]o payment shall be made to any provider of services or other person under this part unless there has bee n furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period." In addition, Contractors are required to ensure that payment is limited to those items and services that are reasonable and necessary. Section 1862(a)(1)(A) of the Act states that [n]otwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body m ember. Contractors are required, when authoring correspondence related to ADRs, to cite sections 1815(a), 1833(e), and 1862(a)(1)(A) of the Act exclusively when referring to the authority for requiring submission of documentation. A. Prepayment Review Time Frames When requesting documentation for prepayment review, the MACs and UPICs shall notify providers when they expect documentation to be received. The reviewer should not grant extensions to providers who need more time to comply with the re quest. Reviewers shall deny claims when the requested documentation to support payment is not received by the expected timeframe. B. Post-payment Review Time Frames When requesting documentation for post -payment review, the MACs, CERT, SMRC, UPICs and RACs shall notify providers when they expect documentation to be received. MACs, CERT, SMRC, UPICs and RACs have the discretion to grant extensions to providers who need more time to comply with the request. The MACs, CERT, SMRC, UPICs and RACs shall deny cla ims when the requested documentation to support payment is not received by the expected timeframe (including any applicable extensions) . C. For esMD submissions The esMD review contractor shall use the Enterprise File Transfer (EFT) system receipt date as the date the documentation was received. If the EFT receipt date is outside of the contractors normal business hours, the following business day shall be used as the rec eipt date. Contractors shall pull for esMD files at least every 4 hours (business hours) daily; including a mandatory pulling between the hours of 6- 7pm EST daily. If unforeseeable circumstances occur, in which contractors are not technically capable of re trieving documentation in a timely manner due to issues outside of their control, contractors are to notify the esMD Team and can use the date documentation was available to be retrieved once issues have been resolved in the EFT system. 3.2.3.3 - Third -party Additional Documentation Request (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, RACs, CERT and UPICs, as indicated. Unless otherwise specified, the MAC, RAC and UPIC shall reques t information from the billing provider/supplier. The treating physician, another clinician, provider, or supplier should submit the requested documentation. However, because the provider selected for review is the one whose payment is at risk, it is this provider who is ultimately responsible for submitting, within the established timelines, the documentation requested by the MAC, CERT, RAC and UPIC. The CERT reviewer shall request medical record documentation from the referring provider as submitted/identified by National Provider Identifier/Unique Physician Identification Number on the claim when such information is not sent in by the billing supplier/provider initially and after a request for additional documentation fails to produce medical documentati on necessary to support the service billed and supported by the Local and National Coverage Determinations. The MAC, UPIC and RAC have the discretion to send a separate ADR to third- party entities involved in the beneficiarys care. They shall not solici t documentation from a third party unless they first or simultaneously solicit the same information from the billing provider or supplier. The following requirements also apply: The MACs, UPICs and RACs shall notify the third party and the billing provide r or supplier that they have 30 calendar days to respond for a prepayment review or 45 calendar days for a postpayment review for MACs and RACs and 30 calendar days for UPICs. For prepayment review, the MACs and UPICs shall pend the claim for 45 calendar days. This 45 day time period may run concurrently as the 45 days that the billing provider or supplier has to respond to the ADR letter; The MACs and UPICs have the discretion to issue as many reminder notices as they deem appropriate to the third party via email, letter or phone call prior to the 30th or 45th calendar day, as discussed above; When information is requested from both the billing provider or supplier and a third party and a response is received from one or both that fails to support the medical necessity of the service, the MACs and UPICs shall deny the claim, in full or in part, using the appropriate denial code. Contractors shall count these denials as medical record reviews. Contractors shall include language in the denial notice remi nding providers that beneficiaries cannot be held liable for these denials unless they received proper liability notification before services were rendered, as detailed in CMS Pub.100- 04, Medicare Claims Processing Manual, chapter 30. Refer to3.2.3.7 for ADR to ordering providers for lab services. 3.2.3.4 - Additional Documentation Request Required and Optional Elements (Rev. 557, Issued: 11- 26-14, Effective: 12 -29-14, Implementation: 12- 29-14) This section applies to Medicare Administrative Contractors ( MAC), Recovery Auditors, Comprehensive Error Rate Testing ( CERT), and Supplemental Medical Review Contractors ( SMRC), as indicated. The MAC shall use discretion to ensure that the amount of medical documentation requested does not negatively impact the providers ability to provide care. The Recovery Auditors shall issue Additional Documentation Requests (ADR) in accordance with limits established by their Contracting Officers Representative (COR) for each calendar year. The MACs, CERT, SMRCs, and Recovery Auditors, shall request records related to the claim(s) being reviewed and have the discretion to collect documentation related to the beneficiarys condition before and after a service. The MACs, Recovery Auditors, and SMRCs have the discretion to issue as many reminder notices as they deem appropriate. Reminder notices can be issued via email, letter, or phone call. The CERT shall issue reminder notices in accordance with its SOW. The MACs, Recovery Auditors, and S MRCs shall not target their ADRs to providers based solely on the providers electronic health record status or chosen method of submitting records. When requesting documentation for postpayment medical review, the MACs, CERT, SMRCs and Recovery Auditors shall use the unified postpayment ADR letter format. Contractors shall maintain the format of the letter, but have the discretion to insert case -specific information. In other words, contractors shall not change the order of the sections on the letter, but should modify the text underneath each section to provide detailed information and accurately reflect the information specific to the subject of the letter. The detailed text in the Exhibit 46 templates serves only to provide an example of what types of information belong under each section heading. The templates show the format and order contractors shall use when constructing postpayment ADR letters. If any of the elements are lengthy, contractors have the discretion to utilize an attachment to provide the details. If a contractor does not have attachments, but has supplementary information to provide in the text of the letter, the contractor should insert the text beneath the section title Attachments / Supplementary Information). The MACs, CERT, S MRCs and Recovery Auditors shall include the following elements in their ADRs and shall use the appropriate templates provided in Exhibit 46: A. Introductory Paragraph CMS as the government agency making the request; The program making the request (e.g. the MAC program, the SMRC program, the Recovery Audit Program, the CERT program); and The regulations and/or laws that apply to the request. The first paragraph in the ADR may identify the following: The program purpose; Where additional information about the program and regulations can be found, for example, a website reference; and Additional program information that may be helpful to the provider or supplier. B. Reason for Selection The reason the provider or supplier was sent the ADR le tter and notes about the claims under review. C. Action The action(s) the provider or supplier shall take as a result of receiving the ADR letter. D. When The date a provider/supplier shall reply to the ADR letter and submit the documentation to the contractor. E. Consequences The consequences if the provider or supplier fails to submit the requested documentation. F. Instructions Instructions and notes that will help the provider or supplier respond to the ADR letter. G. Submission Methods The methods the provider or supplier can submit the requested documentation. H. Questions Contractor contact information for provider inquiries related to the ADR. I. Attachments / Supplementary Information If there are attachments or other supplementary info rmation associated with the ADR, provide a listing of the attachment titles or provide the supplementary information.

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The first paragraph in the ADR may identify the following: The program purpose; Where additional information about the program and regulations can be found, for example, a website reference; and Additional program information that may be helpful to the provider or supplier. B. Reason for Selection The reason the provider or supplier was sent the ADR le tter and notes about the claims under review. C. Action The action(s) the provider or supplier shall take as a result of receiving the ADR letter. D. When The date a provider/supplier shall reply to the ADR letter and submit the documentation to the contractor. E. Consequences The consequences if the provider or supplier fails to submit the requested documentation. F. Instructions Instructions and notes that will help the provider or supplier respond to the ADR letter. G. Submission Methods The methods the provider or supplier can submit the requested documentation. H. Questions Contractor contact information for provider inquiries related to the ADR. I. Attachments / Supplementary Information If there are attachments or other supplementary info rmation associated with the ADR, provide a listing of the attachment titles or provide the supplementary information. 3.2.3.5 - Acceptable Submission Methods for Responses to ADRs (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, Recovery Auditors, CERT, and UPICs, as indicated. Reviewers shall be clear in their ADR letters about what documentation submission methods they will accept from a provider or Health Information Handler (HIH). The MACs, CERT, and Recovery Auditors shall accept documents via paper, fax, CD/DVD, and electronic submission of medical documentation (esMD). A. Paper The MACs, CERT, and Recovery Auditors are encouraged to state in the ADRs that paper medical documentation c an be mailed by any means including US Postal Service, FedEx, UPS, or certified mail. To facilitate delivery of documentation, MACs, CERT and Recovery Auditors should provide a physical mailing address instead of a P.O. Box. B. Fax If the MACs, CERT, or Recovery Auditors have the capability to offer fax confirmation, they are encouraged to send such confirmations with every successfully received fax. C. Imaged Medical Documentation File(s) Sent on CD/DVD The MACs and CERT shall state in the ADR that imaged medical documentation files on CD/DVD may be mailed by any means. Recovery Auditor ADRs shall provide a Web site link or phone number that provides information regarding the requirements for submitting imaged documentation on CD or DVD. D. Medical Documentation Sent via Electronic Submission of Medical Documentation (esMD) Transmission Electronic Submission of Medical Documentation (esMD) is a system that allows providers/HIHs to submit medical documentation over secure electronic means. Information about the esMD system can be found at www.cms.gov/esMD. MACs and CERT are encouraged to state in their ADRs how providers can get more information about submitting medic al documentation via the esMD mechanism. Any time a new esMD service or document type is being offered, and any contractor wants to publish a public announcement (Web posting, list serve, tweet, etc.) the contractor must clear the announcement with CMS. 3.2.3.6 - Reimbursing Providers and HIHs for Additional Documentation (Rev. 786, Issued: 04-13-18, Effective: 05-14-18, Implementation: 05-14-18) A. General 1. Rules for MACs, SMRC, CERT, and UPICs The MACs, SMRC, CERT, and UPICs are not required to pay for medical documentation for either prepayment or post payment review. 2. Rules for RACs RACs performing post payment review of hospital inpatient prospective payment system (PPS) and long term care facilities are required to pay the providers for submitting requested medical records. RACs shall pay according to the payment rate schedule listed in section B below. RACs performing post payment review of provider types other than hospital inpatient PPS and long term care facilities are required to pay the providers for submitting requested medical records, according to the payment rate schedule listed in section B below. Providers under a Medicare reimbursement system (such as Critical Access Hospitals) receive no reimbursement for submitting medical records. RACs shall pay a maximum of $15.00 per record, including first class postage if applicable, for requested documents submitted via mail/fax/CD/DVD. RACs shall pay a maximum of $27.00 per record, including a transaction fee of $2.00/case, for requested documents submitted via esMD. Payments will not be made for blank pages or documents/records that are not related to the claim being reviewed. RACs shall issue documentation submission payments on at least a monthly basis and shall issue all photocopying payments within 45 calendar days of receiving the documentation. RACs shall honor all requests from providers to issue photocopying payments to HIHs. RACs should gather, from the provider, all necessary information, such as, the HIHs name, phone number and bank routing number, etc. Providers interested in submitting documentation via esMD can find information on the CMS esMD website at http://www.cms.gov/esMD. B. Payment Schedule for Requested Medical Records Hospital Inpatient Prospective Payment System (PPS) Facilities and Long Term Care Facilities Non-PPS Institutions and Practitioners Documentation sent via mail, fax, CD/DVD - 12 cents per page - Plus first class postage, if applicable - $15.00 maximum per record - 15 cents per page - Plus first class postage, if applicable - $15.00 maximum per record Documentation sent via esMD - 12 cents per page - Plus $2.00 transaction fee, per record - $27.00 maximum per record - 15 cents per page - Plus $2.00 transaction fee, per case - $27.00 maximum per record *Note: Providers under a Medicare reimbursement system (such as Critical Access Hospitals) receive no reimbursement for submitting medical records. Also, payments will not be made for blank pages or documents/records that are not related to the claim being reviewed. 3.2.3.7 - Special Provisions for Lab Additional Documentation Requests (Rev. 10365; Issued : 10-02-20; Effective: 08 -27-20; Implementation: 08-27-20) This section applies to MACs, CERT, RACs, UPICs, and SMRC as indicated. ICD-10-CM is used for diagnoses on inpatient discharges and for other services provided upon implementation of ICD -10. ICD -9-CM is used for discharges and other services before that implementation. When the MACs, CERT, RACs, and UPICs send an ADR for a lab service, the following documentation shall be requested from the billing lab: The order for the service billed (including sufficient information to allow the reviewer to identify and contact the ordering provider); Verification of accurate processing of the order and submission of the claim; and Diagnostic or other medical information supplied to the lab by the ordering provider, including any diagnosis codes or narratives. The contractor shall deny the claim if a benefit category, statutory exclusion, or coding issue is in question, or send an ADR to the ordering provider in order to determine medical necessi ty. The contractor shall review information from the lab and find it insufficient before the ordering provider is contacted. The contractor shall send an ADR to the ordering provider that shall include sufficient information to identify the claim in question. If the documentation received does not demonstrate that the service was reasonable and necessary, the contractor shall deny the claim. These denials count as medical record reviews. Contractor denial notices shall remind providers that beneficiaries cannot be held liable for these denials unless they have received proper liability notification before services were rendered, as detailed in CMS Pub. IOM 100-04, chapter 30. 3.2.3.8 - No Response or Insufficient Response to Additional Documentation Reques ts (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, RACs, CERT, SMRC, and UPICs, as indicated. A. Additional Documentation Requests The reviewer authority to request that documentation be submitted, to support claims payment, is outlined in Section 3.2.3.2 of this chapter. If information is requested from both the billing provider or supplier and/or a third party and no response is received within the expected timeframes (or within a reasonable time following an extension), the MACs, RACs, SMRC, and UPICs shall deny the claim, in full or in part, as not reasonable and necessary. Contractors shall use Group Code: CO - Contractual Obligation and Claim Adjustment Reason Code (CARC) 50 - these are non -covered services because this is not deemed a medical necessity by the payer and Remittance Advice Remark Code (RARC) M127 - Missing patient medical record for this service. MACs shall count these denials as automated review or non- medical reco rd review depending whether the denial is automated or requires manual intervention. For claims that had a PWK modifier, and the unsolicited documentation was reviewed, the review shall be counted as medical record review . B. No Response During prepayment r eview, if no response is received within the expected timeframes, the MACs and UPICs shall deny the claim. During post -payment review, if no response is received within the expected timeframes (or extension), the MACs, RACs, UPICs and SMRC shall deny the claim as not reasonable and necessary. These contractors shall cite sections 1815(a), 1833(e), and 1862(a)(1)(A) of the Act exclusively when referring to the authority for requiring submission of documentation, when denying claims for no response within the expected timeframes. The MACs shall count these denials as non- medical record reviews . C. Insufficient Response If the MAC, CERT, RAC, SMRC, or UPIC requests additional documentation to verify compliance with a benefit category requirement, and the submitted documentation lacks evidence that the benefit category requirements were met, the reviewer shall issue a benefit category denial. If the submitted documentation includes defective information (the documentation does not support the physicians ce rtification), the reviewer shall deny the claim as not meeting the reasonable and necessary criteria. 3.2.3.9 - Reopening Claims with Additional Information or Denied due to Late or No Submission of Requested Information (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) Contractors shall make available general reopening process information via their website, in their ADR letters, or through remittance advice notices. If the MACs receive the requested information from a provide r or supplier after a denial has been issued but within a reasonable number of days (generally 15 calendar days after the denial date), they have the discretion to reopen the claim. MACs who choose to reopen a specific claim shall notify the provider or supplier of their intent to reopen that claim. Notification to the provider/supplier of the intent to reopen a specific claim shall be completed through any of the following mechanisms: Interactive Voice Response (IVR), contractor website portal, telephone c ontact, by letter, fax, email or secure messaging within 3 business days of identification of the request to reopen or receipt of medical record documentation. MR will make an MR determination on the lines previously denied due to failure to submit request ed documentation, and do one of the following, within 60 calendar days of receiving documentation in the mailroom: For claims originally selected for postpayment review, the reviewer shall issue a new letter containing the revised denial reason and the information required by PIM chapter 3 3.6.4; For claims originally selected for prepayment review, the MAC shall enter the revised MR determination into the shared system, generating a new Medicare Summary Notice (MSN) and remittance advice with the new denial reason and appeals information; The workload, costs, and savings associated with this activity shall be allocated to the appropriate MR activity (e.g., MR reopenings);

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For claims originally selected for postpayment review, the reviewer shall issue a new letter containing the revised denial reason and the information required by PIM chapter 3 3.6.4; For claims originally selected for prepayment review, the MAC shall enter the revised MR determination into the shared system, generating a new Medicare Summary Notice (MSN) and remittance advice with the new denial reason and appeals information; The workload, costs, and savings associated with this activity shall be allocated to the appropriate MR activity (e.g., MR reopenings); In cases where the MAC or UPIC denied a claim and the denial is appealed, the appeals entity will send the claim to the contractors MR department for reopening in accordance with CMS Pub. IOM 100- 04, chapter 34, 10.3. The claim sent back to the contractors MR department must have been denied using Group Code: CO - Contractual Obligation and Claim Adjustment Reason Code (CARC) 50 - these are non -covered services because this is not deemed a medical necessity by the payer and Remittance Advice Remark Code (RARC) M127 - Missing patient medical record for this service . The MR department of the contractor (AC, MAC, or UPIC) who initiated the prepayment edit shall be responsible for conducting the reopening. The MACs who choose not to reopen claims when documentation is received past the deadline shall retain the infor mation (hardcopy or electronic) in a location where it can be easily accessed. If the RAC receives requested documentation from a supplier after a denial has been issued they shall not reopen the claim. If a RAC receives documentation after the submissio n deadline, but before they have issued a demand letter, the RAC shall review and consider the late documentation when making a claim determination; If the RAC receives a late response to a documentation request after they have issued a demand letter, the RAC shall retain the documentation so that it is available for review during the appeal process. For information on how CERT handles late documentation, please refer to Chapter 12, Section 12.3.9. 3.2.3.10 - Record Retention and Storage (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) The MACs, CERT, and UPICs shall abide by all documentation retention requirements listed in all litigation holds issued via Joint Signature Memoranda or Technical Direction Letters (JSM/TDL). Recovery Auditors shall comply with the record retention requirements in its SOWs. 3.2.4 - Use of Claims History Information in Claim Payment Determinations (Rev. 802; Issued: 06- 22-18; Effective: 07 -24-18; Implementation: 07 -24-18) A. Contractors to Which This Section Applies This section applies to MACs, CERT, SMRC, and RACs. B. General In certain circumstances it may be appropriate for medical reviewers to use relevant and accessible claims history to assist in making medical record re view determinations. Examples of when this may be used for payment purposes, include, but are not limited to: 1. Reviewers have the discretion to use beneficiary payment history to identify other providers, other than the billing entity, who may have documentation to support payment of a claim. MAC, CERT and RAC reviewers have the discretion to contact identified providers for supporting documentation. Example: A diabetic beneficiary may have an order from a family practitioner but is also seeing an endocrinologist. The documentation from the family practitioner does not support the level of diabetic testing, but medical records from the endocrinologist do support the level of testing. 2. Reviewers have the discretion to use claims history information to document an event, such as a surgical procedure, that supports the need for a service or item billed in limited circumstances. In some cases, this event occurs a number of years prior to the date of service on the claim being reviewed, making it difficult to collect medical record documentation. If repeated attempts to collect medical record of the event are unsuccessful, contractors have the discretion to consider claims history information as documentation of the event. Contractors shall document their repeated attempts to collect the medical record if they chose to consider claims history information as documentation of the event. Example: A beneficiary is eligible for immunosuppressant drugs only if they received an organ transplant. Patients generall y remain on these life -saving drugs for the rest of their life so it is possible for the transplant to have occurred many years prior to the date of service being reviewed. If there was no record of the transplant in the medical documentation provided by t he ordering physician, the contractor may use claims history to validate the transplant occurred. 3. Reviewers shall use claims history information to verify that the frequency or quantity of supplies provided to a beneficiary do not exceed policy guidel ines. 4. Reviewers shall use claims history information to identify duplication and overutilization of services. 3.2.5 - Targeted Probe and Educate (TPE) (Rev. 10132; Issued: 05- 15-2020; Effective: 06- 16-2020; Implementation: 06- 16-2020) This section applies to MACs. A. Overview The purpose of Targeted Probe and Educate (TPE) is to decrease provider burden, reduce appeals, and improve the medical review/education process. This section describes requirements that MACs shall follow when perfor ming medical review as part of TPE. TPE reviews can be either prepayment or postpayment and involve MACs focusing on specific providers/suppliers that bill a particular item or service. A round of TPE typically involves the review of 20- 40 claims, per pr ovider/supplier, per service/item, and corresponding education. In rare circumstances, CMS may approve a probe sample of other than 20- 40 claims. This process is typically repeated for up to three rounds, but may involve additional rounds at CMS direction. MACs discontinue the process if/when providers/suppliers become compliant. Providers/suppliers who remain non-compliant after three rounds of TPE are referred to CMS for further action. B. Provider Selection The MACs shall initiate a provider -specific, prepayment or postpayment review based upon data analysis, as discussed in 3.2.1. MACs shall also initiate targeted, provider-specific, prepayment or postpayment review upon referral from the Recovery Auditor Contractor (RAC), Comprehensive Error Rate Testing (CERT), Unified Program Integrity Contractor (UPIC), Office of Inspector General (OIG), or Government Accountability Office (GAO) when directed by CMS. MACs shall target providers/suppliers who have historically high claim denial rates, who have billing practices that vary from their peers, or when evidence suggests that there is a potential risk to the Medicare Trust Fund. Probe Selection The MACs shall select probe samples of typically 20-40 claims. Probe samples of different sizes may be deemed appropriate on a case-by-case basis, with approval by CMS. Provider Notification Letter The MACs shall send a notification letter to providers/suppliers being targeted for review that: Outlines the targeted probe & educate process, Explains the process by which providers/suppliers will be able to receive one-on-one education and the types of education that will be available, Notifies providers/suppliers that MACs shall have the option to refer providers/suppliers to the RAC or UPIC as a result of non-response to Additional Development Requests (ADRs), and Includes the following language to remind providers of 42 CFR 424.535 In addition, we remind you that the regulation at 42 CFR 424.535 authorizes us to revoke Medicare billing privileges under certain conditions. In particular, we note that per 42 CFR 424.535(a)(8)(ii), CMS has the authority to revoke a currently enrolled provider or suppliers Medicare billing privileges if CMS determines that the provider or supplier has a pattern or pr actice of submitting claims that fail to meet Medicare requirements. C. TPE One -On-One Education For the TPE process, one-on- one education is defined as teleconference calls, face- to-face visits, electronic visits using webinar technology, or other simil ar technologies that enable direct communication between the MAC educator and the provider/supplier. MACs shall record these activities in monthly reporting to CMS as well as document and maintain the results of the education, and/or attempts for education, for data analysis and possible future reporting. Intra -Probe Education The MAC may identify errors in the claim(s) that can be easily resolved during the course of providers/suppliers probe reviews. Easily curable errors include, but are not limited to, missing documentation that can be resolved through the submission of additional documentation and missing signatures that can be resolved with a signature attestation. When the MAC identifies an easily curable error, the MAC shall contact the provider to address the error and allow the provider to submit missing documentation, etc. Post-Probe Education The MAC shall contact the provider/supplier via telephone (or face- to-face, electronic visits using webinar technology, or other similar technologies a s they become available) to offer a one -on-one educational session after each round of probe review. If the provider/supplier declines the offer for one-on-one education, MACs shall maintain a record of the effort and the reason for denial. The purpose of this one-on-one education is to: 1) Alert the provider of errors identified and how they may be resolved for future claim submissions; and 2) Provide education regarding the review topic to help prevent new issues from arising during future rounds of review. This post-probe one-on- one education should be individualized, claims-specific, and conducted in a format that is interactive, allowing the provider/supplier to ask questions as needed. The MAC shall provide a minimum of 45 days after each post-probe educational session, before selecting new claims for review, to allow time for the provider/supplier to cure identified errors. D. Post- Probe Activity Final Results Letter The MAC shall send the provider/supplier a letter detailing the results of the claims reviewed at the conclusion of each round of review. The MAC shall include details regarding the providers/suppliers specific claim errors. For providers/suppliers who will be released from review due to meeting the established error rate goal, res ults letters shall indicate that the provider is being released from review for one year, with the caveat that additional review may occur at any time should the MAC identified changes in billing pattern. For providers/suppliers who continue to have high e rror rates after three rounds of TPE review, results letters shall indicate that they have not met the established goal error rate and will be referred to CMS for additional action, which may include additional rounds of TPE review, 100 percent prepayment review, extrapolation, referral to a Recovery Auditor, and/or referral for revocation. Additionally, the letter shall include the following language to remind providers of 42 CFR 424.535. In addition, we remind you that the regulation at 42 CFR 424.535 authorizes us to revoke Medicare billing privileges under certain conditions. In particular, we note that per 42 CFR 424.535(a)(8)(ii), CMS has the authority to revoke a currently enrolled provider or suppliers Medicare billing privileges if CMS determi nes that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements. Determining the Need for Additional TPE The MAC shall calculate the provider/supplier claim error rate and payment error rate at the conclusion of each round of TPE. The MAC shall use the provider/supplier error rate to determine whether an additional round of TPE is appropriate. Closure and Monitoring A provider/supplier may be removed from TPE after any round if they demonstrate l ow error rates or sufficient improvement in error rates, as determined by the MAC. MACs shall use data analysis to monitor the providers/suppliers who have been discontinued from the TPE process. MACs shall conduct follow-up review in one year or sooner if data analysis indicates changes in billing patterns or when potential risk to the Medicare Trust Fund is identified. E. Referrals If a provider/supplier continues to have a high error rate at the conclusion of three rounds of TPE, the MAC shall refer to CMS for further action. Referrals shall include details regarding the reason the provider/supplier was selected for TPE review, TPE review results, results of appealed denials (to the extent available at the time of referral), any education provided (or offered and refused), and any other relevant information that may be helpful in determining appropriate next steps. The MAC shall refer suspected fraudulent providers to the UPIC at any time during the TPE process. F. Next Steps Once the MAC refers a pro vider/supplier to CMS, details are reviewed to determine if additional action must be taken by the MAC. Additional actions that may be required include, but are not limited to, additional rounds of TPE review, 100 percent prepayment review, extrapolation, referral to a Recovery Auditor, and/or referral for revocation. If CMS directs the MAC to conduct an additional round of TPE review, the MAC shall send the provider/supplier a notification letter indicating that an additional round of review is required. These reviews shall be of claims with dates of service at least 45 days after the prior rounds post probe education and after the provider/supplier has received the aforementioned notification letter.

(Medicare Program Integrity Manual)

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Program Integrity Manual 100-8 Chapter 3, Section 3.6.2.2

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If a provider/supplier continues to have a high error rate at the conclusion of three rounds of TPE, the MAC shall refer to CMS for further action. Referrals shall include details regarding the reason the provider/supplier was selected for TPE review, TPE review results, results of appealed denials (to the extent available at the time of referral), any education provided (or offered and refused), and any other relevant information that may be helpful in determining appropriate next steps. The MAC shall refer suspected fraudulent providers to the UPIC at any time during the TPE process. F. Next Steps Once the MAC refers a pro vider/supplier to CMS, details are reviewed to determine if additional action must be taken by the MAC. Additional actions that may be required include, but are not limited to, additional rounds of TPE review, 100 percent prepayment review, extrapolation, referral to a Recovery Auditor, and/or referral for revocation. If CMS directs the MAC to conduct an additional round of TPE review, the MAC shall send the provider/supplier a notification letter indicating that an additional round of review is required. These reviews shall be of claims with dates of service at least 45 days after the prior rounds post probe education and after the provider/supplier has received the aforementioned notification letter. 3.3 Policies and Guidelines Applied During Review (Rev. 10365; Issued: 10- 02-20; Effective: 08 -27-20; Implementation: 08 -27-20) This section applies to MACs, CERT, Recovery Auditors, Supplemental Medical Review Contractors (SMRCs) and UPICs, as indicated. A. Statutes, Regulations, the CMS Rulings, National Coverage Determinations, Coverage Provisions in Interpretive Medicare Manuals, and Local Coverage Determinations The primary authority for all coverage provisions and subsequent policies is the Social Security Act. In general, MACs, CERT, Recovery Audit ors, SMRCs, and UPICs shall apply the provisions of the Act according to the following hierarchy of documents in effect at the time the item(s) or service(s) was provided to make medical review decisions: Social Security Act Code of Federal Regulations C MS Rulings National Coverage Determination (NCDs) Coverage provisions in Interpretive Manuals or Internet Only Manuals (IOM) which includes Medical Review Guidance in the Medicare Program Integrity Manual CMS coding policies Technical Direction Letters (TDLs)* The relevant MACs Local Coverage Determination (LCDs) The relevant MACs local articles AHA Coding Clinics. *TDLs that contain MR guidance may provide an exception to this hierarchy. B. Coding Guidelines The MACs, CERT, Recovery Auditors, and UPICs shall apply coding guidelines to services selected for review. All contractors shall determine that an item/service is correctly coded when it meets all the coding guidelines listed in the Current Procedural Terminology- 4 (CPT ) book, International Classification of Diseases Guidelines (ICD), CMS HCPCS or ICD policy or guideline requirements, LCDs, or MAC articles. C. Internal Medical Review Guidelines The MAC, CERT, Recovery Auditor, and UPIC staffs have the discretion to develop detailed written review guidelines to guide staff during claim reviews. Internal MR guidelines shall specify the information to be reviewed by reviewers and the appropriate resulting determination. Recovery Auditors are required to develop written review guidelines in accordance with their SOW. The MACs, CERT, Recovery Auditors, and UPICs shall make their internal MR guidelines available to their staff, as needed. Internal MR Guidelines shall not create or change the CMS policy. 3.3.1 - Types of Review: Medical Record Review, Non -Medical Record Review, and Automated Review (Rev. 10365; Issued: 10-02- 20; Effective: 08 -27-20; Implementation: 08-27-20) This section applies to MACs, CERT, SMRC, and UPICs, as indicated. A. General Most o f the claim review activities completed for the purpose of identifying inappropriate billing and avoiding improper payments are divided into three distinct types: Medical Record Review, Non- Medical Record Review, and Automated Review. The chart below indicates which contractors perform which types of review: Prepayment Postpayment Medical Non- Medical Non- Contractor Record Medical Automated Record Medical Type Review Record Reviews Review Record Review review MACs Yes Yes Yes Yes Yes CERT No No No Yes No RACs No No No Yes No SMRC No No No Yes Yes UPIC Yes No No Yes Yes 3.3.1.1 - Medical Record Review (Rev. 11529; Issued: 07-28-2022; Effective: 08- 30-2022; Implementation: 08-30-2022) This section applies to MACs, CERT, RACs, Supplemental Medical Review Contractor(s) and UPICs, as indicated. A. Definition Medical record review involves requesting, receiving, and reviewing medical documentation associated with a claim. Medical record review, for the purpose of determining medica l necessity, requires a licensed medical professional to use clinical review judgment to evaluate medical record documentation. B. Clinical Review Judgment Clinical review judgment involves two steps: 1. The synthesis of all submitted medical record information (e.g. progress notes, diagnostic findings, medications, nursing notes, etc.) to create a longitudinal clinical picture of the patient; and 2. The application of this clinical picture to the review criteria is to make a reviewer determination on whether the clinical requirements in the relevant policy have been met. MAC, CERT, RAC, and UPIC clinical review staff shall use clinical review judgment when making medical record review determinations about a claim. Clinical review judg ment does not replace poor or inadequate medical records. Clinical review judgment by definition is not a process that MACs, CERT, RACs and UPICs can use to override, supersede or disregard a policy requirement. Policies include laws, regulations, the CMS rulings, manual instructions, MAC policy articles attached to an LCD or listed in the Medicare Coverage Database, national coverage decisions, and local coverage determinations. C. Credentials of Reviewers The MACs, MRAC, and CERT shall ensure that medical record reviews for the purpose of making coverage determinations are performed by licensed nurses (RNs), therapists or physicians. Current LPNs may be grandfathered in and can continue to perform medical record review. The MACs, MRAC, and CERT shall not hire any new LPNs to perform medical record review. UPICs, RACs and the SMRC shall ensure that the credentials of their reviewers are consistent with the requirements in their respective SOWs. During a medical record review, nurse and physician reviewers m ay call upon other health care professionals (e.g., dieticians or physician specialists) for advice. The MACs, MRAC, and CERT, shall ensure that services reviewed by other licensed health care professionals are within their scope of practice and that their MR strategy supports the need for their specialized expertise in the adjudication of particular claim type (i.e., speech therapy claim, physical therapy). RACs and the SMRC shall follow guidance related to calling upon other healthcare professionals as outlined in their respective SOWs. RACs shall ensure that a licensed medical professional will perform medical record reviews for the purpose of determining medical necessity, using their clinical review judgment to evaluate medical record documentation. Ce rtified coders will perform coding determinations. CERT and MACs are encouraged to make coding determinations by using certified coders. UPICs have the discretion to make coding determinations using certified coders. D. Credential Files The MACs, MRAC, CERT, RACs, and UPICs shall maintain a credentials file for each reviewer (including consultants, contract staff, subcontractors, and temporary staff) who performs medical record reviews. The credentials file shall contain at least a copy of the reviewers active professional license. E. Quality Improvement (QI) Process The MACs, CERT, RACs, and SMRCs shall establish a Quality Improvement (QI) process that verifies the accuracy of MR decisions made by licensed health care professionals. The MACs, CERT, RACs, and SMRCs shall attend the annual medical review training conference as directed by the CMS and/or their SOW. The MACs, CERT, RACs, and SMRCs shall include inter -rater reliability assessments in their QI process and shall report these results as directed by CMS. F. Advanced Beneficiary Notice (ABN) The MACs, CERT, RACs, UPICs, and SMRCs shall request as part of the ADR, during a medical record review, a copy of any mandatory ABNs, as defined in Pub. 100- 04, Medicare Claims Processing Manual Chapter 30 sect ion 50.3.1. If the claim is determined not to be reasonable and necessary, the contractor will perform a face validity assessment of the ABN in accordance with the instructions stated in Pub. 100- 04 Medicare Claims Processing Manual chapter 30 section 50.6.3. The Face Validity assessments do not include contacting beneficiaries or providers to ensure the accuracy or authenticity of the information. Face Validity assessments will assist in ensuring that liability is assigned in accordance with the Limitatio ns of Liability Provisions of section 1879 of the Social Security Act. G. MAC Funding Issues The MAC -medical record review work performed by medical review staff for purposes other than MR (e.g., appeals) shall be charged, for expenditure reporting purposes, to the area requiring medical review services. All medical record review work performed by MACs shall: Involve activities defined under the Medicare Integrity Program (MIP) at Section 1893(b)(1) of the Act; Be articulated in its medical review strategy; and Be designed in such a way as to reduce its Comprehensive Error Rate Testing (CERT) error rate or prevent the contractors error rate from increasing. The MACs shall be mindful that edits suspending a claim for medical review to check for issues other than inappropriate billing (i.e. completeness of claims, conditions of participation, quality of care) are not medical review edits as defined under Section 1893(b)(1) of the Act and cannot be funded by MIP. Therefore, edits resulting in work other than that defined in Section1893 (b) (1) shall be charged to the appropriate Program Management activity cost center. Activities associated with claims processing edits shall not be charged to MIP. H. Review Timeliness Requirements Prepayment Review Requirements for MACs When a MAC receives requested documentation for prepayment review within 45 calendar days of the date of the ADR, the MAC shall do the following within 30 calendar days of receiving the requested documentation: 1) make and doc ument the review determination and 2) enter the decision into the Fiscal Intermediary Shared System (FISS), Multi -Carrier System (MCS), or the VIPS Medicare System (VMS). The 30 calendar day timeframe applies to prepayment non- medical record reviews and prepayment medical record reviews. The 30 calendar day timeframe does not apply to prepayment reviews of Third Party Liability claims. The MACs shall make and enter a review determination for Third Party Liability claims within 60 calendar days. Counting the 30 Calendar Day Timeframe The MACs and RACs shall count day one as the date each new medical record is received in the mailroom. The MACs and RACs shall give each new medical record received an independent 30 day review time period. Prepayment Review Requirements for UPICs When a UPIC receives all documentation requested for prepayment review within 45 calendar days of the date of the ADR, the UPIC shall make and document the review determination and notify the MAC of its determination within 60 calendar days of receiving all requested documentation. Medical review for the purpose of fraud, waste, or abuse requires 60 days to allow for the integration of information from the investigative process. This information may be a result of recent/concurrent investigative actions such as beneficiary/provider/supplier interviews, site visits and/or receipt of additional internal/external information. Post-payment Review Requirements for MACs The MAC shall make a review determination, and mail the review results notification letter to the provider within 60 calendar days of receiving the requested documentation. For claims associated with any referrals to the UPIC for program integrity investigation, MACs shall stop counting the 60-day time period on the date the referral is made. The 60-day time period will be restarted on the date the MAC received requested input from the UPIC or is notified by the UPIC that the referral has been declined. For claims sent to MR for reopening by the contractor appeals de partment, in accordance with Pub. 100-04, chapter 34, 10.3, begin counting the 60 days from the time the medical records are received in the MR department. Post-payment Review Requirements for RACs When a RAC receives requested documentation for review within 45 calendar days of the date of the ADR, the RAC shall do the following within 30 calendar days of receiving the requested documentation: 1) make and document the review determination, and 2) communicate the results to the provider. State Laws that Affect Prepayment Review Timeliness Requirements