Local Coverage Determination (LCD):Ostomy Supplies (L27227)

Contractor InformationContractor NameNational Government Services,Inc. opens in new window

Contract Number17003

Contract TypeDME MAC

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LCD InformationDocument Information

LCD IDL27227

LCD TitleOstomy Supplies

AMA CPT/ADA CDT Copyright StatementCPT only copyright 2002-2012 American MedicalAssociation. All Rights Reserved. CPT is a registeredtrademark of the American Medical Association.Applicable FARS/DFARS Apply to Government Use. Feeschedules, relative value units, conversion factorsand/or related components are not assigned by theAMA, are not part of CPT, and the AMA is notrecommending their use. The AMA does not directly orindirectly practice medicine or dispense medicalservices. The AMA assumes no liability for datacontained or not contained herein. The Code on DentalProcedures and Nomenclature (Code) is published inCurrent Dental Terminology (CDT). Copyright ©American Dental Association. All rights reserved. CDTand CDT-2010 are trademarks of the American DentalAssociation.

Jurisdiction opens in new windowIllinoisIndianaKentuckyMichiganMinnesotaOhioWisconsin

Original Effective DateFor services performed on or after 10/01/1993

Revision Effective DateFor services performed on or after 01/01/2013

Revision Ending DateN/A

Retirement DateN/A

Notice Period Start Date 08/01/1993

Notice Period End Date N/A

CMS National Coverage PolicyNone

Coverage GuidanceCoverage Indications, Limitations, and/or Medical Necessity

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

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For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before aclaim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completedDWO, the item will be denied as not reasonable and necessary.

Refer to the Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article forinformation about the statutory coverage requirements for ostomy supplies.

The quantity of ostomy supplies needed by a beneficiary is determined primarily by the type of ostomy, itslocation, its construction, and the condition of the skin surface surrounding the stoma. There will be variationaccording to individual beneficiary need and their needs may vary over time. The table below lists the maximumnumber of items/units of service that are usually reasonable and necessary. The actual quantity needed for aparticular beneficiary may be more or less than the amount listed depending on the factors that affect thefrequency of barrier and pouch change.

The explanation for use of a greater quantity of supplies than the amounts listed must be clearly documented inthe beneficiary’s medical record. If adequate documentation is not provided when requested, the excessquantities will be denied as not reasonable and necessary.

USUAL MAXIMUM QUANTITY OF SUPPLIES:

Code # perMonth

A4357 2A4362 20A4364 4A4367 1A4369 2A4377 10A4381 10A4397 4A4402 4A4404 10A4405 4A4406 4A4414 20A4415 20A4416 60A4417 60A4418 60A4419 60A4420 60A4423 60A4424 20A4425 20A4426 20A4427 20A4429 20A4431 20A4432 20A4433 20A4434 20A4450 40A4452 40

A5051 60A5052 60A5053 60A5054 60A5055 31A5056 40A5057 40A5061 20A5062 20A5063 20A5071 20A5072 20A5073 20A5081 31A5082 1A5083 150A5093 10A5121 20A5122 20A5126 20A5131 1A6216 60

Code# per

6Months

A4361 3A4371 10A4398 2A4399 2A4455 16A5102 2A5120 150

When a liquid barrier is necessary, either liquid or spray (A4369) or individual wipes or swabs (A5120) areappropriate. The use of both is not reasonable and necessary.

Beneficiaries with continent stomas may use the following means to prevent/manage drainage: stoma cap(A5055), stoma plug (A5081), stoma absorptive cover (A5083) or gauze pads (A6216). No more than one ofthese types of supply would be reasonable and necessary on a given day.

Beneficiaries with urinary ostomies may use either a bag (A4357) or bottle (A5102) for drainage at night. It is notreasonable and necessary to have both.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, notretrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contactthe beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even ifauthorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable andnecessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to theorder. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar daysprior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product nosooner than 10 calendar days prior to the end of usage for the current product. This is regardless of whichdelivery method is utilized. (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5,Section 5.2.6).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with thebeneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refillswithout a refill request from a beneficiary. Items delivered without a valid, documented refill request will bedenied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers muststay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with theordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier mustnot dispense more than a 1-month supply at a time for a beneficiary in a nursing facility and a 3-month supplyfor a beneficiary at home.

For information on tracheostomy supplies, see the Tracheostomy Care Supplies policy.

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Coding InformationBill Type Codes:

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

N/A

Revenue Codes:

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

N/A

CPT/HCPCS Codes

Group 1 Paragraph: The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

AU - Item furnished in conjunction with a urological, ostomy or tracheostomy supplyEY - No physician or other licensed health care provider order for this item or service

HCPCS CODES:

Group 1 Codes:A4331

EXTENSION DRAINAGE TUBING, ANY TYPE, ANY LENGTH, WITH CONNECTOR/ADAPTOR, FOR USE WITHURINARY LEG BAG OR UROSTOMY POUCH, EACH

A4357 BEDSIDE DRAINAGE BAG, DAY OR NIGHT, WITH OR WITHOUT ANTI-REFLUX DEVICE, WITH OR WITHOUTTUBE, EACH

A4361 OSTOMY FACEPLATE, EACHA4362 SKIN BARRIER; SOLID, 4 X 4 OR EQUIVALENT; EACHA4363 OSTOMY CLAMP, ANY TYPE, REPLACEMENT ONLY, EACHA4364 ADHESIVE, LIQUID OR EQUAL, ANY TYPE, PER OZA4366 OSTOMY VENT, ANY TYPE, EACHA4367 OSTOMY BELT, EACHA4368 OSTOMY FILTER, ANY TYPE, EACHA4369 OSTOMY SKIN BARRIER, LIQUID (SPRAY, BRUSH, ETC), PER OZA4371 OSTOMY SKIN BARRIER, POWDER, PER OZ

A4372 OSTOMY SKIN BARRIER, SOLID 4X4 OR EQUIVALENT, STANDARD WEAR, WITH BUILT-IN CONVEXITY,EACH

A4373 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDIAN), WITH BUILT-IN CONVEXITY,ANY SIZE, EACH

A4375 OSTOMY POUCH, DRAINABLE, WITH FACEPLATE ATTACHED, PLASTIC, EACHA4376 OSTOMY POUCH, DRAINABLE, WITH FACEPLATE ATTACHED, RUBBER, EACHA4377 OSTOMY POUCH, DRAINABLE, FOR USE ON FACEPLATE, PLASTIC, EACHA4378 OSTOMY POUCH, DRAINABLE, FOR USE ON FACEPLATE, RUBBER, EACHA4379 OSTOMY POUCH, URINARY, WITH FACEPLATE ATTACHED, PLASTIC, EACHA4380 OSTOMY POUCH, URINARY, WITH FACEPLATE ATTACHED, RUBBER, EACHA4381 OSTOMY POUCH, URINARY, FOR USE ON FACEPLATE, PLASTIC, EACHA4382 OSTOMY POUCH, URINARY, FOR USE ON FACEPLATE, HEAVY PLASTIC, EACHA4383 OSTOMY POUCH, URINARY, FOR USE ON FACEPLATE, RUBBER, EACHA4384 OSTOMY FACEPLATE EQUIVALENT, SILICONE RING, EACH

A4385 OSTOMY SKIN BARRIER, SOLID 4X4 OR EQUIVALENT, EXTENDED WEAR, WITHOUT BUILT-IN CONVEXITY,EACH

A4387 OSTOMY POUCH, CLOSED, WITH BARRIER ATTACHED, WITH BUILT-IN CONVEXITY (1 PIECE), EACHA4388 OSTOMY POUCH, DRAINABLE, WITH EXTENDED WEAR BARRIER ATTACHED, (1 PIECE), EACHA4389 OSTOMY POUCH, DRAINABLE, WITH BARRIER ATTACHED, WITH BUILT-IN CONVEXITY (1 PIECE), EACH

A4390 OSTOMY POUCH, DRAINABLE, WITH EXTENDED WEAR BARRIER ATTACHED, WITH BUILT-IN CONVEXITY(1 PIECE), EACH

A4391 OSTOMY POUCH, URINARY, WITH EXTENDED WEAR BARRIER ATTACHED (1 PIECE), EACH

A4392 OSTOMY POUCH, URINARY, WITH STANDARD WEAR BARRIER ATTACHED, WITH BUILT-IN CONVEXITY (1PIECE), EACH

A4393 OSTOMY POUCH, URINARY, WITH EXTENDED WEAR BARRIER ATTACHED, WITH BUILT-IN CONVEXITY (1PIECE), EACH

A4394 OSTOMY DEODORANT, WITH OR WITHOUT LUBRICANT, FOR USE IN OSTOMY POUCH, PER FLUID OUNCEA4395 OSTOMY DEODORANT FOR USE IN OSTOMY POUCH, SOLID, PER TABLETA4396 OSTOMY BELT WITH PERISTOMAL HERNIA SUPPORTA4397 IRRIGATION SUPPLY; SLEEVE, EACHA4398 OSTOMY IRRIGATION SUPPLY; BAG, EACHA4399 OSTOMY IRRIGATION SUPPLY; CONE/CATHETER, WITH OR WITHOUT BRUSHA4402 LUBRICANT, PER OUNCEA4404 OSTOMY RING, EACHA4405 OSTOMY SKIN BARRIER, NON-PECTIN BASED, PASTE, PER OUNCEA4406 OSTOMY SKIN BARRIER, PECTIN-BASED, PASTE, PER OUNCE

A4407 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE, OR ACCORDION), EXTENDED WEAR, WITHBUILT-IN CONVEXITY, 4 X 4 INCHES OR SMALLER, EACH

A4408 OSTOMY SKIN BARRIER, WTIH FLANGE (SOLID, FLEXIBLE OR ACCORDION), EXTENDED WEAR, WITHBUILT-IN CONVEXITY, LARGER THAN 4 X 4 INCHES, EACH

A4409 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), EXTENDED WEAR, WITHOUTBUILT-IN CONVEXITY, 4 X 4 INCHES OR SMALLER, EACH

A4410 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), EXTENDED WEAR, WITHOUTBUILT-IN CONVEXITY, LARGER THAN 4 X 4 INCHES, EACH

A4411 OSTOMY SKIN BARRIER, SOLID 4X4 OR EQUIVALENT, EXTENDED WEAR, WITH BUILT-IN CONVEXITY,EACH

A4412 OSTOMY POUCH, DRAINABLE, HIGH OUTPUT, FOR USE ON A BARRIER WITH FLANGE (2 PIECE SYSTEM),WITHOUT FILTER, EACH

A4413 OSTOMY POUCH, DRAINABLE, HIGH OUTPUT, FOR USE ON A BARRIER WITH FLANGE (2 PIECE SYSTEM),WITH FILTER, EACH

A4414 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), WITHOUT BUILT-INCONVEXITY, 4 X 4 INCHES OR SMALLER, EACH

A4415 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), WITHOUT BUILT-INCONVEXITY, LARGER THAN 4X4 INCHES, EACH

A4416 OSTOMY POUCH, CLOSED, WITH BARRIER ATTACHED, WITH FILTER (1 PIECE), EACH

A4417 OSTOMY POUCH, CLOSED, WITH BARRIER ATTACHED, WITH BUILT-IN CONVEXITY, WITH FILTER (1PIECE), EACH

A4418 OSTOMY POUCH, CLOSED; WITHOUT BARRIER ATTACHED, WITH FILTER (1 PIECE), EACH

A4419 OSTOMY POUCH, CLOSED; FOR USE ON BARRIER WITH NON-LOCKING FLANGE, WITH FILTER (2 PIECE),EACH

A4420 OSTOMY POUCH, CLOSED; FOR USE ON BARRIER WITH LOCKING FLANGE (2 PIECE), EACHA4421 OSTOMY SUPPLY; MISCELLANEOUS

A4422 OSTOMY ABSORBENT MATERIAL (SHEET/PAD/CRYSTAL PACKET) FOR USE IN OSTOMY POUCH TOTHICKEN LIQUID STOMAL OUTPUT, EACH

A4423 OSTOMY POUCH, CLOSED; FOR USE ON BARRIER WITH LOCKING FLANGE, WITH FILTER (2 PIECE), EACHA4424 OSTOMY POUCH, DRAINABLE, WITH BARRIER ATTACHED, WITH FILTER (1 PIECE), EACH

A4425 OSTOMY POUCH, DRAINABLE; FOR USE ON BARRIER WITH NON-LOCKING FLANGE, WITH FILTER (2PIECE SYSTEM), EACH

A4426 OSTOMY POUCH, DRAINABLE; FOR USE ON BARRIER WITH LOCKING FLANGE (2 PIECE SYSTEM), EACH

A4427 OSTOMY POUCH, DRAINABLE; FOR USE ON BARRIER WITH LOCKING FLANGE, WITH FILTER (2 PIECESYSTEM), EACH

A4428 OSTOMY POUCH, URINARY, WITH EXTENDED WEAR BARRIER ATTACHED, WITH FAUCET-TYPE TAP WITHVALVE (1 PIECE), EACH

A4429 OSTOMY POUCH, URINARY, WITH BARRIER ATTACHED, WITH BUILT-IN CONVEXITY, WITH FAUCET-TYPETAP WITH VALVE (1 PIECE), EACH

A4430 OSTOMY POUCH, URINARY, WITH EXTENDED WEAR BARRIER ATTACHED, WITH BUILT-IN CONVEXITY,WITH FAUCET-TYPE TAP WITH VALVE (1 PIECE), EACH

A4431 OSTOMY POUCH, URINARY; WITH BARRIER ATTACHED, WITH FAUCET-TYPE TAP WITH VALVE (1 PIECE),EACH

A4432 OSTOMY POUCH, URINARY; FOR USE ON BARRIER WITH NON-LOCKING FLANGE, WITH FAUCET-TYPE TAPWITH VALVE (2 PIECE), EACH

A4433 OSTOMY POUCH, URINARY; FOR USE ON BARRIER WITH LOCKING FLANGE (2 PIECE), EACH

A4434 OSTOMY POUCH, URINARY; FOR USE ON BARRIER WITH LOCKING FLANGE, WITH FAUCET-TYPE TAPWITH VALVE (2 PIECE), EACH

A4435 OSTOMY POUCH, DRAINABLE, HIGH OUTPUT, WITH EXTENDED WEAR BARRIER (ONE-PIECE SYSTEM),WITH OR WITHOUT FILTER, EACH

A4450 TAPE, NON-WATERPROOF, PER 18 SQUARE INCHESA4452 TAPE, WATERPROOF, PER 18 SQUARE INCHESA4455 ADHESIVE REMOVER OR SOLVENT (FOR TAPE, CEMENT OR OTHER ADHESIVE), PER OUNCEA4456 ADHESIVE REMOVER, WIPES, ANY TYPE, EACHA5051 OSTOMY POUCH, CLOSED; WITH BARRIER ATTACHED (1 PIECE), EACHA5052 OSTOMY POUCH, CLOSED; WITHOUT BARRIER ATTACHED (1 PIECE), EACHA5053 OSTOMY POUCH, CLOSED; FOR USE ON FACEPLATE, EACHA5054 OSTOMY POUCH, CLOSED; FOR USE ON BARRIER WITH FLANGE (2 PIECE), EACHA5055 STOMA CAP

A5056 OSTOMY POUCH, DRAINABLE, WITH EXTENDED WEAR BARRIER ATTACHED, WITH FILTER, (1 PIECE),EACH

A5057 OSTOMY POUCH, DRAINABLE, WITH EXTENDED WEAR BARRIER ATTACHED, WITH BUILT IN CONVEXITY,WITH FILTER, (1 PIECE), EACH

A5061 OSTOMY POUCH, DRAINABLE; WITH BARRIER ATTACHED, (1 PIECE), EACHA5062 OSTOMY POUCH, DRAINABLE; WITHOUT BARRIER ATTACHED (1 PIECE), EACHA5063 OSTOMY POUCH, DRAINABLE; FOR USE ON BARRIER WITH FLANGE (2 PIECE SYSTEM), EACHA5071 OSTOMY POUCH, URINARY; WITH BARRIER ATTACHED (1 PIECE), EACHA5072 OSTOMY POUCH, URINARY; WITHOUT BARRIER ATTACHED (1 PIECE), EACHA5073 OSTOMY POUCH, URINARY; FOR USE ON BARRIER WITH FLANGE (2 PIECE), EACHA5081 CONTINENT DEVICE; PLUG FOR CONTINENT STOMAA5082 CONTINENT DEVICE; CATHETER FOR CONTINENT STOMAA5083 CONTINENT DEVICE, STOMA ABSORPTIVE COVER FOR CONTINENT STOMAA5093 OSTOMY ACCESSORY; CONVEX INSERT

A5102 BEDSIDE DRAINAGE BOTTLE WITH OR WITHOUT TUBING, RIGID OR EXPANDABLE, EACHA5120 SKIN BARRIER, WIPES OR SWABS, EACHA5121 SKIN BARRIER; SOLID, 6 X 6 OR EQUIVALENT, EACHA5122 SKIN BARRIER; SOLID, 8 X 8 OR EQUIVALENT, EACHA5126 ADHESIVE OR NON-ADHESIVE; DISK OR FOAM PADA5131 APPLIANCE CLEANER, INCONTINENCE AND OSTOMY APPLIANCES, PER 16 OZ.

A6216 GAUZE, NON-IMPREGNATED, NON-STERILE, PAD SIZE 16 SQ. IN. OR LESS, WITHOUT ADHESIVEBORDER, EACH DRESSING

A9270 NON-COVERED ITEM OR SERVICE

ICD-9 Codes that Support Medical Necessity

Group 1 Paragraph: Not specified. For ICD-9 codes relating to statutory coverage, see Policy Article.

Group 1 Codes: N/A

ICD-9 Codes that DO NOT Support Medical NecessityParagraph: Not specified.

N/A

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General InformationAssociated Information DOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has beenfurnished such information as may be necessary in order to determine the amounts due such provider.” It isexpected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary'smedical records include the physician's office records, hospital records, nursing home records, home healthagency records, records from other healthcare professionals and test reports. This documentation must beavailable upon request.

PRESCRIPTION (ORDER) REQUIREMENTS

GENERAL (PIM 5.2.1)

All items billed to Medicare require a prescription. An order for each item billed must be signed and dated by thetreating physician, kept on file by the supplier, and made available upon request. Items dispensed and/or billedthat do not meet these prescription requirements and those below must be submitted with an EY modifier addedto each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)

Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require awritten order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record ofthe dispensing order on file. It must contain:

• Description of the item

• Beneficiary's name

• Prescribing Physician's name

• Date of the order and the start date, if the start date is different from the date of the order

• Physician signature (if a written order) or supplier signature (if verbal order)

For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbalorders) or the date entered by the physician (for written dispensing orders).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirementsoutlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order beforesubmitting a claim.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the ordering physician mayproduce the DWO. However, the ordering physician must review the content and sign and date the document. Itmust contain:

• Beneficiary's name

• Physician's name

• Date of the order and the start date, if start date is different from the date of the order

• Detailed description of the item(s) (see below for specific requirements for selected items)

• Physician signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:

• Item(s) to be dispensed

• Dosage or concentration, if applicable

• Route of Administration

• Frequency of use

• Duration of infusion, if applicable

• Quantity to be dispensed

• Number of refills

For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbalorders) or the date entered by the physician (for written dispensing orders).

Frequency of use information on orders must contain detailed instructions for use and specific amounts to bedispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state “PRN” or“as needed” utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

The detailed description in the written order may be either a narrative description or a brand name/modelnumber.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirementsoutlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered as part of the medical record. Medical information intended to demonstratecompliance with coverage criteria may be included on the prescription but must be corroborated by informationcontained in the medical record.

Items billed before a signed and dated order has been received by the supplier must be submitted with an EYmodifier 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 ofsupply used.

The supplier must enter the ICD-9 diagnosis code for the ostomy on each claim submitted for ostomy supplies. Ifthere is more than one ostomy, enter the appropriate codes.

When supplies used are greater than the usual maximum quantity listed in the Indications and Limitations ofCoverage and/or Medical Necessity section, there must be adequate, clear documentation in the beneficiary’smedical records corroborating the medical necessity of this amount. Copies of the beneficiary’s medical recordsthat corroborate the order and any additional documentation that pertains to the medical necessity of the itemsand quantities billed must be available upon request.

MEDICAL RECORD INFORMATION

GENERAL (PIM 5.7 - 5.9)

The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD containsnumerous reasonable and necessary (R&N) requirements. The Nonmedical Necessity Coverage and PaymentRules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category andstatutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters ofmedical necessity) are deemed not to be part of a medical record for Medicare payment purposes.

• Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration withinformation in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify paymentexcept as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician’s officerecords but may include records from hospitals, nursing facilities, home health agencies, other healthcareprofessionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interestin the claim outcome are not considered sufficient by themselves for the purpose of determining that an item isreasonable and necessary.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies. No monitoring ofpurchased items or capped rental items that have converted to a purchase is required. Suppliers mustdiscontinue billing Medicare when rental items or ongoing supply items are no longer being used by thebeneficiary.

Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be usedby the beneficiary. Any of the following may serve as documentation that an item submitted for reimbursementcontinues to be used by the beneficiary:

1. Timely documentation in the beneficiary's medical record showing usage of the item, relatedoption/accessories and supplies

2. Supplier records documenting the request for refill/replacement of supplies in compliance with the RefillDocumentation Requirements (This is deemed to be sufficient to document continued use for the baseitem, as well)

3. Supplier records documenting beneficiary confirmation of continued use of a rental item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere inthis policy.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is firstordered; therefore, beneficiary medical records demonstrating that the item is reasonable and necessary arecreated just prior to, or at the time of, the creation of the initial prescription. For purchased items, initial monthsof a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will comefrom this initial time period. Entries in the beneficiary’s medical record must have been created prior to, or at thetime of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicablecoverage policy.

For ongoing supplies and rental DME items, in addition to information described above that justifies the initialprovision of the item(s) and/or supplies, there must be information in the beneficiary’s medical record to supportthat the item continues to be used by the beneficiary and remains reasonable and necessary. Information used tojustify continued medical need must be timely for the DOS under review. Any of the following may serve asdocumentation justifying continued medical need:

A recent order by the treating physician for refills

A recent change in prescription

A properly completed CMN or DIF with an appropriate length of need specified

Timely documentation in the beneficiary's medical record showing usage of the item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere inthe policy.

REFILL DOCUMENTATION (PIM 5.2.5-6)

A routine refill prescription is not needed. A new prescription is needed when:

• There is a change of supplier

• There is a change in the item(s), frequency of use, or amount prescribed

• There is a change in the length of need or a previously established length of need expires

• State law requires a prescription renewal

For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a copy of the itemizedsales receipt is sufficient documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request for refill must be either a writtendocument received from the beneficiary or a contemporaneous written record of a phone conversation/contactbetween the supplier and beneficiary. The refill request must occur and be documented before shipment. Aretrospective attestation statement by the supplier or beneficiary is not sufficient. The refill record must include:

• Beneficiary's name or authorized representative if different than the beneficiary

• A description of each item that is being requested

• Date of refill request

• For consumable supplies, i.e., those that are used up (e.g., ostomy or urological supplies, surgicaldressings, etc.), the supplier should assess the quantity of each item that the beneficiary still hasremaining, to document that the amount remaining will be nearly exhausted on or about the supplyanniversary date

• For non-consumable supplies, i.e., those more durable items that are not used up but may need periodicreplacement (e.g., PAP and RAD supplies), the supplier should assess whether the supplies remainfunctional, providing replacement (a refill) only when the supply item(s) is no longer able to function.Document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the causeof the dysfunction that necessitates replacement (refill).

This information must be kept on file and be available upon request.

PROOF OF DELIVERY (PIM 4.26, 5.8)

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain PODdocumentation in their files. For medical review purposes, POD serves to assist in determining correct coding andbilling information for claims submitted for Medicare reimbursement. Regardless of the method of delivery, thecontractor must be able to determine from delivery documentation that the supplier properly coded the item(s),that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) areintended for, and received by, a specific Medicare beneficiary.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibitedfrom signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of thebeneficiary). The signature and date the beneficiary or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as any person who can sign and acceptthe delivery of DMEPOS items on behalf of the beneficiary.

Proof of delivery documentation must be available to the Medicare contractor on request. All services that do nothave appropriate proof of delivery from the supplier will be denied and overpayments will be requested. Supplierswho consistently fail to provide documentation to support their services may be referred to the OIG for impositionof Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. For items addressed in this policy there arethree methods of delivery:

1. Delivery directly to the beneficiary or authorized representative

2. Delivery via shipping or delivery service

3. Delivery of items to a nursing facility on behalf of the beneficiary

Method 1 - Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a beneficiary must be asigned and dated delivery slip. The POD record must include:

• Beneficiary's name

• Delivery address

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number,narrative description)

• Quantity delivered

• Date delivered

• Beneficiary (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiaryor designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiaryreceived the DMEPOS supply must be the date of service on the claim.

Method 2 - Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete recordtracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of deliverywould include both the supplier's own detailed shipping invoice and the delivery service's tracking information.The supplier's record must be linked to the delivery service record by some clear method like the deliveryservice's package identification number or supplier's invoice number for the package sent to the beneficiary. ThePOD record must include:

• Beneficiary's name

• Delivery address

• Delivery service's package identification number, supplier invoice number or alternative method that linksthe supplier's delivery documents with the delivery service's records

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number,narrative description)

• Quantity delivered

• Date delivered

• Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of serviceon the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. Thistype of POD record must contain the information specified above.

Method 3 - Delivery to Nursing Facility on Behalf of a Beneficiary

When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (seeabove) is required.

When a delivery service or mail order is used to deliver the item to a nursing facility, the documentationdescribed for Method 2 (see above) is required.

Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information fromthe nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and usedby the beneficiary must be available upon request.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

For quantities of supplies that exceed the usual maximum amount, there must be information in the medicalrecord that explains the need for the increased amount. This information must be available upon request.

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

AppendicesPIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8.

Utilization GuidelinesRefer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for DecisionReserved for future use.

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Revision History InformationPlease note: The Revision History information included in this LCD prior to 1/24/2013 will now display with aRevision History Number of "R1" at the bottom of this table. All new Revision History information entriescompleted on or after 1/24/2013 will display as a row in the Revision History section of the LCD and numberingwill begin with "R2".

RevisionHistory

Date

RevisionHistoryNumber

Revision History Explanation Reason(s) forChange

01/01/2013 R2Revision Effective Date: 01/01/2013CODING:Added: HCPCS code A4435

• ProviderEducation/Guidance

• Revisions Due ToCPT/HCPCS CodeChanges

01/01/2012 R1

Revision History Effective Date: 01/01/2012 - JULYINDICATIONS AND LIMITATIONS OF COVERAGE AND MEDICALNECESSITY:Revised: Order requirements language to specify a “detailedwritten order” (omitted in error from the last revision)Added: Reference to Policy Article for information about thestatutory coverage requirements for ostomy suppliesAdded: Refill requirements per PIM 5.2.6 (effective 08/02/2011per CR7452)Added: Reference to information in Tracheostomy Care SuppliesLCDAdded: POLICY SPECIFIC DOCUMENTATION REQUIREMENTSAdded: Usual maximum quantity of supplies table restored

Revision History Effective Date: 01/01/2012INDICATIONS AND LIMITATIONS OF COVERAGE AND MEDICALNECESSITY:Revised: Order requirement language to specify a “detailedwritten order”HCPCS CODES:Added: A5056 and A5057DOCUMENTATION REQUIREMENTS:(Note: The effective date above is not applicable to this section.These revised and added requirements are existing Medicarerequirements which are now included in the LCD for easyreference)Added: General medical record information requirements andproof of delivery requirements

Revision Effective Date: 01/01/2011INDICATIONS AND LIMITATIONS OF COVERAGE:Revised: Preamble languageHCPCS CODES AND MODIFIERS:Revised: A4399, A4407, A4408

Revision Effective Date: 01/01/2010INDICATIONS AND LIMITATIONS OF COVERAGE:Added: Requirements concerning request for refillHCPCS CODES AND MODIFIERS:Deleted: A4365Added: A4456

• TypographicalCorrection

RevisionHistory

Date

RevisionHistoryNumber

Revision History Explanation Reason(s) forChange

December 2009 - Typographical error in Usual MaximumQuantity of Supplies list was discovered - A4405 was listedtwice. This error was corrected by replacing incorrect code withA4406.

Revision Effective Date: 01/01/2009INDICATIONS AND LIMITATIONS OF COVERAGE:Revised: Usual maximum quantity for A5083

3/1/2008 - In accordance with Section 911 of the MedicareModernization Act, this policy was transitioned to DME MACNational Government Services (17003) LCD L27227 from DMEPSC TriCenturion (77011) LCD L11502.

Revision Effective Date: 01/01/2008INDICATIONS AND LIMITATIONS OF COVERAGE:Added: Usual maximum quantity for A5083HCPCS CODES AND MODIFIERS:Added: A5083

06/01/2007 - In accordance with Section 911 of the MedicareModernization Act of 2003, Virginia and West Virginia weretransitioned from DME PSC TriCenturion (77011) to DME PSCTrustSolutions (77012).

Revision Effective Date: 01/01/2007INDICATIONS AND LIMITATIONS OF COVERAGE:Removed references to the DMERC.HCPCS CODES AND MODIFIERS:Revised: A4394DOCUMENTATION REQUIREMENTS:Removed references to the DMERC.

03/01/2006 - In accordance with Section 911 of the MedicareModernization Act of 2003, this policy was transitioned to DMEPSC TriCenturion (77011) from DMERC Tricenturion (77011).

Revision Effective Date: 01/01/2006INDICATIONS AND LIMITATION OF COVERAGE AND/ORMEDICAL NECESSITYRemoved deleted HCPCS code A5119 from 6 month UsualMaximum Amount and added new HCPCS code A5120 to UsualMaximum Amount array.HCPCS CODES & MODIFIERS:Added HCPCS Codes A4363, A4411, A4412 and A5120Deleted HCPCS CodeA5119Verbiage change to HCPCS Code A4372

Revision Effective Date: 04/01/2005LMRP converted to LCD and Policy ArticleHCPCS CODES & MODIFIERS:Revised A5119INDICATIONS AND LIMITATIONS OF COVERAGE:A5119 verbiage change incorporated into example of codeamount.DOCUMENTATION REQUIREMENTS:Deleted the requirement for the ICD-9 or narrative to be on theinitial order.

Revision Effective Date 04/01/2004HCPCS CODES and MODIFIERS:

RevisionHistory

Date

RevisionHistoryNumber

Revision History Explanation Reason(s) forChange

Added A4366, A4416, A4417, A4418, A4419, A4420, A4423,A4424, A4425, A4426, A4427, A4428, A4429, A4430, A4431,A4432, A4433, A4434Deleted K0581, K0582, K0583, K0584, K0585, K0586, K0587,K0588, K0589, K0590, K0591, K0592, K0593, K0594, K0595,K0596, K0597INDICATIONS AND LIMITATIONS OF COVERAGE:Updated Usual Maximum Quantity of Supplies with the followingcodes: A4416, A4417, A4418, A4419, A4420, A4423, A4424,A4425, A4426, A4427, A4429, A4431, A4432, A4433, A4434and A5061CODING GUIDELINES:Referenced new A4420 code. AddedA4416-A4419, A4423-A4425, and A4427 to the unbundling list.Added definition to A4366.

Revision Effective Date: 10/01/2003INDICATIONS AND LIMITATIONS OF COVERAGE:Changed the denial from not medically necessary to noncoveredwhen supplies are used for other conditions rather than on asurgically created opening to divert urine, or fecal contentsoutside the body.

Revision effective date: 07/01/03Documentation: Included in the requirement to accept eitherICD-9 or narrative…

Revision effective date: 04/01/03HCPCS CODES AND MODIFIERS:Added: AU and EY modifier, A4368, A4405, A4406, A4407,A4408, A4409, A4410, A4413, A4414, A4415, A4422, A4450,A4452, K0581, K0582, K0583, K0584, K0585, K0586, K0587,K0588, K0589, K0590, K0591, K0592, K0593, K0594, K0595,K0596, K0597Reinstated: A4368 A5061Discontinued: K0561, K0562, K0563, K0564, K0565, K0566.K0567, K0568 K0569 K0570, K0571, K0572, K0573, K0574,K0575, K0576, K0577, K0578, K0579, K0580Revised: A4372, A4373, A4387, A4388, A4389, A4391, A5051,A5052, A5053, A5054, A5061, A5062, A5063, A5071 A5072,A5073INDICATIONS AND LIMITATIONS OF COVERAGE:Added: Standard language concerning coverage of itemswithout an order.Added verbiage regarding billing for excess quantity utilization.Updated: Usual Maximum Quantity of Supplies table to reflectHCPCS code changes.Removed: References to the add-on feature HCPCS codes withinthe policy.Updated Unbundling table, and Maximum Quantity table toreflect HCPCS code changes.CODING GUIDELINES:Added Instructions for using AU modifier with tape codes(A4450 and A4452).Added definitions to this section of policy.DOCUMENTATION REQUIREMENTS:Added: Standard language concerning use of EY modifier foritems without an order.Verbiage regarding excess quantity utilization requirement.

The revision dates listed below are the dates the revisions werepublished and not necessarily the effective dates for therevisions.

RevisionHistory

Date

RevisionHistoryNumber

Revision History Explanation Reason(s) forChange

07/01/2002 - Added codes K0561-K0580. HCPCS codesA4368, A4370, A4374, A4386, A5061, A5123, A6265 becomeinvalid for DMERC submission. Definitions expanded to includenew code features. Specific diagnoses for certain productsremoved from policy. Billing instructions included in coverageand payment rules when using K0561-K0580. Usual MaximumQuantity of Supplies table updated and crosswalked toappropriate new codes.

10/01/2001 - Revisions included updates to HCPCS codessince the policy's last publication, definitional changes to helpwith clarity and inclusion of material from various previouslypublished bulletins.

06/01/1997 – No revision – reprinted due to page format.

12/01/1996 – HCPCS codes updated (various). RevisedDefinitions sections.

04/01/1996 – Revised usual maximum medically necessary forA4399 from 1 to 2 per every 6 months. Added statement that abrush is included in irrigation supplies and should not be billedseparately.

10/01/1995 - Added HCPCS codes K0265, K0277, K0278, andK0280.

06/01/1994 – Added ICD-9 codes for codes A5051-A5054 andA5061-A5065; added ICD-9 code for codes A5071-A5075 inCoverage and Payment Rules section.

12/01/1993 – Added HCPCS codes XX006-XX008.

11/21/2010 - For the following CPT/HCPCS codes either theshort description and/or the long description was changed.Depending on which description is used in this LCD, there maynot be any change in how the code displays in the document:A4399 descriptor was changed in Group 1A4407 descriptor was changed in Group 1A4408 descriptor was changed in Group 1

11/21/2011 - For the following CPT/HCPCS codes either theshort description and/or the long description was changed.Depending on which description is used in this LCD, there maynot be any change in how the code displays in the document:A4407 descriptor was changed in Group 1A4408 descriptor was changed in Group 1

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Associated DocumentsAttachmentsN/ARelated Local Coverage DocumentsArticle(s)A47237 - Ostomy Supplies - Policy Article - Effective January 2013 opens in new windowRelated National Coverage DocumentsN/AAll VersionsUpdated on 03/17/2013 with effective dates 01/01/2013 - N/A

Updated on 07/16/2012 with effective dates 01/01/2012 - 12/31/2012Updated on 07/16/2012 with effective dates 01/01/2012 - N/AUpdated on 07/06/2012 with effective dates 01/01/2012 - N/AUpdated on 03/31/2012 with effective dates 01/01/2012 - N/AUpdated on 03/09/2012 with effective dates 01/01/2012 - N/AUpdated on 02/26/2012 with effective dates 01/01/2012 - N/ASome older versions have been archived. Please visit the MCD Archive Site opens in new window to retrievethem.Back to Top

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