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Local Coverage Determination (LCD)

Ostomy Supplies

L33828

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33828
Original ICD-9 LCD ID
Not Applicable
LCD Title
Ostomy Supplies
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 01/01/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description

The LCD is revised to align refill requirements with CMS Final Rule CMS-1780-F. This revision allows contact with the beneficiary regarding refills to take place no sooner than 30 calendar days prior to the end of the current supply and to document an affirmative response.
Issue - Explanation of Change Between Proposed LCD and Final LCD

No proposed LCD issued.

CMS National Coverage Policy

None

Coverage Guidance

Coverage 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) 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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • Refer to the Supplier Manual for additional information on documentation requirements.
  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.


For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

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

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

A4436

1

A4437

1

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.


GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.



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, and document an affirmative response, 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 expected to end, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee and document an affirmative response, prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request and an affirmative response 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 treating practitioners that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a one (1) -month supply at a time for a beneficiary in a nursing facility and a three (3) -month supply for a beneficiary at home.

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

NA
Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

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Group 1

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

HCPCS CODES:

 Group 1 Codes
Code Description
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 4 X 4 OR EQUIVALENT, STANDARD WEAR, WITH BUILT-IN CONVEXITY, EACH
A4373 OSTOMY SKIN BARRIER, WITH FLANGE (SOLID, FLEXIBLE OR ACCORDION), 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 4 X 4 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
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, WITH 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 4 X 4 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 4 X 4 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
A4435 OSTOMY POUCH, DRAINABLE, HIGH OUTPUT, WITH EXTENDED WEAR BARRIER (ONE-PIECE SYSTEM), WITH OR WITHOUT FILTER, EACH
A4436 IRRIGATION SUPPLY; SLEEVE, REUSABLE, PER MONTH
A4437 IRRIGATION SUPPLY; SLEEVE, DISPOSABLE, PER MONTH
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 STOMA PLUG OR SEAL, ANY TYPE
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
N/A

ICD-10-CM Codes that Support Medical Necessity

Expand All | Collapse All

Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Expand All | Collapse All

Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

DOCUMENTATION 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 treating practitioner’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.


GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO
  • Medical Record Information (including continued need/use if applicable)
  • Correct Coding
  • Proof of Delivery


Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

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

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.


POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.


MISCELLANEOUS


APPENDICES


UTILIZATION GUIDELINES

Refer to Coverage Indications, Limitations and/or Medical Necessity.
Sources of Information
Reserved for future use.
Bibliography

NA

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/01/2024 R6

Revision Effective Date: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
Revised: “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.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.
  • Provider Education/Guidance
  • Other (CMS Final Rule CMS-1780-F)
01/01/2022 R5

Revision Effective Date: 01/01/2022
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: HCPCS code A4397 from Usual Maximum Quantity of Supplies table
Added: HCPCS codes A4436 and A4437 to Usual Maximum Quantity of Supplies table
CODING INFORMATION:
Removed: HCPCS code A4397 from Group 1 Codes (invalid code on or after DOS 01/01/2022)
Added: HCPCS codes A4436 and A4437 to Group 1 Codes (valid on or after DOS 01/01/2022)

12/30/2021: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2020 R4

Revision Effective Date: 01/01/2020
GENERAL:
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: “ordering physicians” to “treating practitioners”
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
DOCUMENTATION REQUIREMENTS:
Revised: “physician’s” to “treating practitioner’s”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: “Prescriptions (orders)” to “SWO”

02/20/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.
  • Provider Education/Guidance
  • Other
01/01/2017 R3 Revision History Effective Date: 01/01/2017:
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Supplier Manual reference from Miscellaneous
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
10/01/2015 R1 Revsion History Effective Date: 08/01/2015
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Removed: ICD-9 references
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
(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)
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Language for HCPCS codes A4450, A4452 and A5120 when submitted without correct modifier
  • Provider Education/Guidance
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Associated Documents

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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
12/07/2023 01/01/2024 - N/A Currently in Effect You are here
12/20/2021 01/01/2022 - 12/31/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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