L5013-LCD

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Automated World Health

Local Coverage Determination (LCD) for Ostomy Supplies (L5013)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number

18003

Contractor Type

DME MAC

Jurisdiction

J - G

LCD Information

Document Information

LCD ID Number L5013

LCD Title Ostomy Supplies

Contractor's Determination Number OSTY

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993 Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2012

Revision Ending Date

CMS National Coverage Policy None

Indications and Limitations of Coverage and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) 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. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a detailed written order (DWO) 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 DWO, 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 for information 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, its location, its construction, and the condition of the skin surface surrounding the stoma. There will be variation according to individual beneficiary need and their needs may vary over time. The table below lists the maximum number of items/units of service that are usually reasonable and necessary. The actual quantity needed for a particular beneficiary may be more or less than the amount listed depending on the factors that affect the frequency of barrier and pouch change.

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

USUAL MAXIMUM QUANTITY OF SUPPLIES:

Code # per Month

A4357 2

A4362 20

A4364 4

A4367 1

A4369 2

A4377 10

A4381 10

A4397 4

A4402 4

A4404 10

A4405 4

A4406 4

A4414 20

A4415 20

A4416 60

A4417 60

A4418 60

A4419 60

A4420 60

A4423 60

A4424 20

A4425 20

A4426 20

A4427 20

A4429 20

A4431 20

A4432 20

A4433 20

A4434 20

A4450 40

A4452 40

A5051 60

A5052 60

A5053 60

A5054 60

A5055 31

A5056 40

A5057 40

A5061 20

A5062 20

A5063 20

A5071 20

A5072 20

A5073 20

A5081 31

A5082 1

A5083 150

A5093 10

A5121 20

A5122 20

A5126 20

A5131 1

A6216 60

Code # per 6

Months

A4361 3

A4371 10

A4398 2

A4399 2

A4455 16

A5102 2

A5120 150

When a liquid barrier is necessary, either liquid or spray (A4369) or individual wipes or swabs (A5120) are appropriate. 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 of these 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 not reasonable and necessary to have both.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery 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 the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

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

for a beneficiary at home.

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

Coding Information

Bill Type Codes:

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

Revenue Codes:

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

CPT/HCPCS Codes

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 supply EY - No physician or other licensed health care provider order for this item or service

HCPCS CODES:

A4331 EXTENSION DRAINAGE TUBING, ANY TYPE, ANY LENGTH, WITH CONNECTOR/ADAPTOR, FOR USE WITH URINARY LEG BAG OR UROSTOMY POUCH, EACH

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

A4361 OSTOMY FACEPLATE, EACH

A4362 SKIN BARRIER; SOLID, 4 X 4 OR EQUIVALENT; EACH

A4363 OSTOMY CLAMP, ANY TYPE, REPLACEMENT ONLY, EACH A4364 ADHESIVE, LIQUID OR EQUAL, ANY TYPE, PER OZ A4366 OSTOMY VENT, ANY TYPE, EACH

A4367 OSTOMY BELT, EACH

A4368 OSTOMY FILTER, ANY TYPE, EACH

A4369 OSTOMY SKIN BARRIER, LIQUID (SPRAY, BRUSH, ETC), PER OZ A4371 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, EACH A4376 OSTOMY POUCH, DRAINABLE, WITH FACEPLATE ATTACHED, RUBBER, EACH A4377 OSTOMY POUCH, DRAINABLE, FOR USE ON FACEPLATE, PLASTIC, EACH A4378 OSTOMY POUCH, DRAINABLE, FOR USE ON FACEPLATE, RUBBER, EACH A4379 OSTOMY POUCH, URINARY, WITH FACEPLATE ATTACHED, PLASTIC, EACH A4380 OSTOMY POUCH, URINARY, WITH FACEPLATE ATTACHED, RUBBER, EACH A4381 OSTOMY POUCH, URINARY, FOR USE ON FACEPLATE, PLASTIC, EACH

A4382 OSTOMY POUCH, URINARY, FOR USE ON FACEPLATE, HEAVY PLASTIC, EACH A4383 OSTOMY POUCH, URINARY, FOR USE ON FACEPLATE, RUBBER, EACH

A4384 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), EACH A4388 OSTOMY POUCH, DRAINABLE, WITH EXTENDED WEAR BARRIER ATTACHED, (1 PIECE), EACH

A4389 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 (1 PIECE), EACH

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

A4394 OSTOMY DEODORANT, WITH OR WITHOUT LUBRICANT, FOR USE IN OSTOMY POUCH, PER FLUID OUNCE A4395 OSTOMY DEODORANT FOR USE IN OSTOMY POUCH, SOLID, PER TABLET

A4396 OSTOMY BELT WITH PERISTOMAL HERNIA SUPPORT A4397 IRRIGATION SUPPLY; SLEEVE, EACH

A4398 OSTOMY IRRIGATION SUPPLY; BAG, EACH

A4399 OSTOMY IRRIGATION SUPPLY; CONE/CATHETER, WITH OR WITHOUT BRUSH A4402 LUBRICANT, PER OUNCE

A4404 OSTOMY RING, EACH

A4405 OSTOMY SKIN BARRIER, NON-PECTIN BASED, PASTE, PER OUNCE A4406 OSTOMY SKIN BARRIER, PECTIN-BASED, PASTE, PER OUNCE

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

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

A4409 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), EXTENDED WEAR, WITHOUT BUILT-IN CONVEXITY, 4 X 4 INCHES OR SMALLER, EACH

A4410 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), EXTENDED WEAR, WITHOUT BUILT-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-IN CONVEXITY, 4 X 4 INCHES OR SMALLER, EACH

A4415 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), WITHOUT BUILT-IN CONVEXITY, 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 (1 PIECE), 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), EACH A4421 OSTOMY SUPPLY; MISCELLANEOUS

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

A4423 OSTOMY POUCH, CLOSED; FOR USE ON BARRIER WITH LOCKING FLANGE, WITH FILTER (2 PIECE), EACH A4424 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 (2 PIECE 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 PIECE SYSTEM), EACH

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

A4429 OSTOMY POUCH, URINARY, WITH BARRIER ATTACHED, WITH BUILT-IN CONVEXITY, WITH FAUCET-TYPE TAP 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 TAP WITH 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 TAP WITH VALVE (2 PIECE), EACH

A4450 TAPE, NON-WATERPROOF, PER 18 SQUARE INCHES A4452 TAPE, WATERPROOF, PER 18 SQUARE INCHES

A4455 ADHESIVE REMOVER OR SOLVENT (FOR TAPE, CEMENT OR OTHER ADHESIVE), PER OUNCE A4456 ADHESIVE REMOVER, WIPES, ANY TYPE, EACH

A5051 OSTOMY POUCH, CLOSED; WITH BARRIER ATTACHED (1 PIECE), EACH A5052 OSTOMY POUCH, CLOSED; WITHOUT BARRIER ATTACHED (1 PIECE), EACH A5053 OSTOMY POUCH, CLOSED; FOR USE ON FACEPLATE, EACH

A5054 OSTOMY POUCH, CLOSED; FOR USE ON BARRIER WITH FLANGE (2 PIECE), EACH A5055 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), EACH A5062 OSTOMY POUCH, DRAINABLE; WITHOUT BARRIER ATTACHED (1 PIECE), EACH

A5063 OSTOMY POUCH, DRAINABLE; FOR USE ON BARRIER WITH FLANGE (2 PIECE SYSTEM), EACH A5071 OSTOMY POUCH, URINARY; WITH BARRIER ATTACHED (1 PIECE), EACH

A5072 OSTOMY POUCH, URINARY; WITHOUT BARRIER ATTACHED (1 PIECE), EACH A5073 OSTOMY POUCH, URINARY; FOR USE ON BARRIER WITH FLANGE (2 PIECE), EACH A5081 CONTINENT DEVICE; PLUG FOR CONTINENT STOMA

A5082 CONTINENT DEVICE; CATHETER FOR CONTINENT STOMA

A5083 CONTINENT DEVICE, STOMA ABSORPTIVE COVER FOR CONTINENT STOMA A5093 OSTOMY ACCESSORY; CONVEX INSERT

A5102 BEDSIDE DRAINAGE BOTTLE WITH OR WITHOUT TUBING, RIGID OR EXPANDABLE, EACH A5120 SKIN BARRIER, WIPES OR SWABS, EACH

A5121 SKIN BARRIER; SOLID, 6 X 6 OR EQUIVALENT, EACH A5122 SKIN BARRIER; SOLID, 8 X 8 OR EQUIVALENT, EACH A5126 ADHESIVE OR NON-ADHESIVE; DISK OR FOAM PAD

A5131 APPLIANCE CLEANER, INCONTINENCE AND OSTOMY APPLIANCES, PER 16 OZ.

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

A9270 NON-COVERED ITEM OR SERVICE

ICD-9 Codes that Support Medical Necessity Not specified.

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

AsteriskNoteText

Diagnoses that Support Medical Necessity Not Specified

ICD-9 Codes that DO NOT Support Medical Necessity Not specified

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

Diagnoses that DO NOT Support Medical Necessity Not Specified

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available 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 the treating physician, kept on file by the supplier, and made available upon request. Items dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to 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 a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the 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 verbal orders) 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 requirements outlined 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 before submitting a claim.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. It must 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 verbal orders) 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 be dispensed. 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/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined 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 demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

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 ICD-9 diagnosis code for the ostomy on each claim submitted for ostomy supplies. If there 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 of Coverage and/or Medical Necessity section, there must be adequate, clear documentation in the beneficiary’s medical records corroborating the medical necessity of this amount. Copies of the beneficiary's medical records that corroborate the order and any additional documentation that pertains to the medical necessity of the items and 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 contains numerous reasonable and necessary (R&N) requirements. The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory 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 of medical 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 with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician’s office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable 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 of purchased items or capped rental items that have converted to a purchase is required. Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

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

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

2. Supplier records documenting the request for refill/replacement of supplies in compliance with the Refill Documentation Requirements (This is deemed to be sufficient to document continued use for the base item, 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 in this policy.

CONTINUED MEDICAL NEED

For 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. For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period. Entries in the beneficiary’s medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary’s medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. Information used to justify continued medical need must be timely for the DOS under review. Any of the following may serve as documentation 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 in the 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 itemized sales 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 written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary. The refill request must occur and be documented before shipment. A retrospective 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, surgical dressings, etc.), the supplier should assess the quantity of each item that the beneficiary still has remaining, to document that the amount remaining will be nearly exhausted on or about the supply anniversary date

• For non-consumable supplies, i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies), the supplier should assess whether the supplies remain functional, 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 cause of 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 POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement. Regardless of the method of delivery, the contractor 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) are intended 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 prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary). 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 accept the 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 not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested. Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. There are three 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 a signed 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 beneficiary or designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiary received 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 record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would 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 delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary. The POD record must include:

• Beneficiary's name

• Delivery address

• Delivery service's package identification number, supplier invoice number or alternative method that links the 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 service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type 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 (see above) is required.

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

Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and used by 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 medical record 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.

Appendices PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8

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

Sources of Information and Basis for Decision

Reserved for future use. Advisory Committee Meeting Notes

Start Date of Comment Period 04/30/1993

End Date of Comment Period 06/14/1993

Start Date of Notice Period 08/01/1993

Revision History Number 018

Revision History Explanation Revision History Effective Date: 01/01/2012 (July Publication) INDICATIONS AND LIMITATIONS OF COVERAGE AND MEDICAL NECESSITY:

Revised: Order requirements language to specify a “detailed written order” (omitted in error from the last revision)

Added: Reference to Policy Article for information about the statutory coverage requirements for ostomy supplies Added: Refill requirements per PIM 5.2.6 (effective 08/02/2011 per CR7452)

Added: Reference to information in Tracheostomy Care Supplies LCD Added: POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Revision History Effective Date: 01/01/2012

INDICATIONS AND LIMITATIONS OF COVERAGE AND MEDICAL NECESSITY:

Revised: Order requirement language to specify a “detailed written order” HCPCS CODES:

Added: A5056 and A5057 DOCUMENTATION REQUIREMENTS:

(Note: The effective date above is not applicable to this section. These revised and added requirements are existing Medicare requirements which are now included in the LCD for easy reference)

Added: General medical record information requirements and proof of delivery requirements

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

A4407 descriptor was changed in Group 1 A4408 descriptor was changed in Group 1

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Revision Effective Date: 01/01/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Preamble language HCPCS CODES AND MODIFIERS: Revised: A4399, A4407, A4408

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

A4399 descriptor was changed in Group 1 A4407 descriptor was changed in Group 1 A4408 descriptor was changed in Group 1

Revision Effective Date: 01/01/2010 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Requirements concerning request for refill HCPCS CODES AND MODIFIERS:

Deleted: A4365 Added: A4456

Revision Effective Date: 11/15/2009

CPT/HCPCS code A4365 was deleted from group 1

Revision Effective Date: 01/01/2009

Corrected typographical error for code A4406 in utilization table. Printed on 1/26/2013. Page 13 of 16

Revision Effective Date: 01/01/2009 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Usual maximum quantity for A5083

03/01/2008 In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 06/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Usual maximum quantity for A5083 HCPCS CODES AND MODIFIERS:

Added: A5083

06/01/2007 In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

Revision Effective Date: 01/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Removed: DMERC references HCPCS CODES AND MODIFIERS:

Revised: A4394

DOCUMENTATION REQUIREMENTS:

Removed: DMERC references

03/01/2006 In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006

INDICATIONS AND LIMITATION OF COVERAGE AND/OR MEDICAL NECESSITY

Removed deleted HCPCS code A5119 from 6 month Usual Maximum Amount and added new HCPCS code A5120 to Usual Maximum Amount array.

HCPCS CODES & MODIFIERS:

Added HCPCS Codes A4363, A4411, A4412 and A5120

Deleted HCPCS Code A5119

Verbiage change to HCPCS Code A4372

Effective Date: 04/01/2005

LMRP converted to LCD and Policy Article HCPCS CODES & MODIFIERS:

Revised A5119

INDICATIONS AND LIMITATIONS OF COVERAGE:

A5119 verbiage change incorporated into example of code amount. DOCUMENTATION REQUIREMENTS:

Deleted the requirement for the ICD-9 or narrative to be on the initial order.

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

Added A4366, A4416, A4417, A4418, A4419, A4420, A4423, A4424, A4425, A4426, A4427, A4428, A4429, A4430, A4431, A4432, A4433, A4434

Deleted K0581, K0582, K0583, K0584, K0585, K0586, K0587, K0588, K0589, K0590, K0591, K0592, K0593, K0594, K0595, K0596, K0597

INDICATIONS AND LIMITATIONS OF COVERAGE:

Updated Usual Maximum Quantity of Supplies with the following codes: A4416, A4417, A4418, A4419, A4420, A4423, A4424, A4425, A4426, A4427, A4429, A4431, A4432, A4433, A4434 and A5061

CODING GUIDELINES:

Referenced new A4420 code. Added A4416-A4419, A4423-A4425, and A4427 to the unbundling list. Added definition to A4366.

Revision Effective Date: 10/01/2003 INDICATIONS AND LIMITATIONS OF COVERAGE:

Changed the denial from not medically necessary to noncovered when supplies are used for other conditions rather than on a surgically created opening to divert urine, or fecal contents outside the body.

Revision Effective Date: 07/01/2003

DOCUMENTATION:

Included in the requirement to accept either ICD-9 or narrative.

Revision Effective Date: 04/01/2003 HCPCS 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, K0597

Reinstated: A4368, A5061

Discontinued: K0561, K0562, K0563, K0564, K0565, K0566. K0567, K0568 K0569 K0570, K0571, K0572, K0573, K0574, K0575, K0576, K0577, K0578, K0579, K0580

Revised: A4372, A4373, A4387, A4388, A4389, A4391, A5051, A5052, A5053, A5054, A5061, A5062, A5063, A5071 A5072, A5073

INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Standard language concerning coverage of items without an order. Added verbiage regarding billing for excess quantity utilization.

Updated: Usual Maximum Quantity of Supplies table to reflect HCPCS code changes. Removed: References to the add-on feature HCPCS codes within the policy.

Updated Unbundling table, and Maximum Quantity table to reflect 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 for items without an order. Verbiage regarding excess quantity utilization requirement.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

07/01/2002 - Added codes K0561-K0580. HCPCS codes A4368, A4370, A4374, A4386, A5061, A5123, A6265

become invalid for DMERC submission. Definitions expanded to include new code features. Specific diagnoses for certain products removed from policy. Billing instructions included in coverage and payment rules when using K0561-K0580. Usual Maximum Quantity of Supplies table updated and crosswalked to appropriate new codes.

10/01/2001 - Revisions included updates to HCPCS codes since the policy's last publication, definitional changes to help with clarity and inclusion of material from various previously published bulletins.

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

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

04/01/1996 – Revised usual maximum medically necessary for A4399 from 1 to 2 per every 6 months. Added statement that a brush is included in irrigation supplies and should not be billed separately.

10/01/1995 - Added HCPCS codes K0265, K0277, K0278, and K0280.

06/01/1994 – Added ICD-9 codes for codes A5051-A5054 and A5061-A5065; added ICD-9 code for codes A5071- A5075 in Coverage and Payment Rules section.

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

Reason for Change Typographical Correction