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Local Coverage Determination (LCD)

Tracheostomy Care Supplies

L33832

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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
L33832
Original ICD-9 LCD ID
Not Applicable
LCD Title
Tracheostomy Care 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.

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

A tracheostomy care or cleaning starter kit (A4625) is covered following an open surgical tracheostomy. Beginning two weeks post-operatively, code A4625 is no longer medically necessary and, if that code is billed, will be denied as not reasonable and necessary.

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 clinical factors that affect the frequency of supply changes.

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(unless noted)

A4364

4

A4402

4

A4450

40

A4452

40

A4456

50

A4481

62

A4623

62

A4625

31

A4626

2

A4629

31

A5120

150

A7501

1

A7502

1

A7503

1 per 6 months

A7504

62

A7505

2 per 3 months

A7506

62

A7507

62

A7508

62

A7509

62

A7520

1 per 3 months

A7521

1 per 3 months

A7522

1 per 12 months

A7524

1 per 3 months

A7526

31

A7527

2 per 3 months


A7523 is a convenience item and therefore not covered. Claims for A7523 will be denied as not reasonable and necessary.

A7527 (Tracheostomy/laryngectomy tube plug/stop) is used as an alternative to a tracheostomy/laryngectomy tube and therefore for a beneficiary receiving A7527 claims for A7520, A7521 and A7522 will be denied as not reasonable or necessary.


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 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 tracheal suction catheters and related supplies, see the Suction Pump 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

(27 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
A4364 ADHESIVE, LIQUID OR EQUAL, ANY TYPE, PER OZ
A4402 LUBRICANT, PER OUNCE
A4450 TAPE, NON-WATERPROOF, PER 18 SQUARE INCHES
A4452 TAPE, WATERPROOF, PER 18 SQUARE INCHES
A4456 ADHESIVE REMOVER, WIPES, ANY TYPE, EACH
A4481 TRACHEOSTOMA FILTER, ANY TYPE, ANY SIZE, EACH
A4623 TRACHEOSTOMY, INNER CANNULA
A4625 TRACHEOSTOMY CARE KIT FOR NEW TRACHEOSTOMY
A4626 TRACHEOSTOMY CLEANING BRUSH, EACH
A4629 TRACHEOSTOMY CARE KIT FOR ESTABLISHED TRACHEOSTOMY
A5120 SKIN BARRIER, WIPES OR SWABS, EACH
A7501 TRACHEOSTOMA VALVE, INCLUDING DIAPHRAGM, EACH
A7502 REPLACEMENT DIAPHRAGM/FACEPLATE FOR TRACHEOSTOMA VALVE, EACH
A7503 FILTER HOLDER OR FILTER CAP, REUSABLE, FOR USE IN A TRACHEOSTOMA HEAT AND MOISTURE EXCHANGE SYSTEM, EACH
A7504 FILTER FOR USE IN A TRACHEOSTOMA HEAT AND MOISTURE EXCHANGE SYSTEM, EACH
A7505 HOUSING, REUSABLE WITHOUT ADHESIVE, FOR USE IN A HEAT AND MOISTURE EXCHANGE SYSTEM AND/OR WITH A TRACHEOSTOMA VALVE, EACH
A7506 ADHESIVE DISC FOR USE IN A HEAT AND MOISTURE EXCHANGE SYSTEM AND/OR WITH TRACHEOSTOMA VALVE, ANY TYPE EACH
A7507 FILTER HOLDER AND INTEGRATED FILTER WITHOUT ADHESIVE, FOR USE IN A TRACHEOSTOMA HEAT AND MOISTURE EXCHANGE SYSTEM, EACH
A7508 HOUSING AND INTEGRATED ADHESIVE, FOR USE IN A TRACHEOSTOMA HEAT AND MOISTURE EXCHANGE SYSTEM AND/OR WITH A TRACHEOSTOMA VALVE, EACH
A7509 FILTER HOLDER AND INTEGRATED FILTER HOUSING, AND ADHESIVE, FOR USE AS A TRACHEOSTOMA HEAT AND MOISTURE EXCHANGE SYSTEM, EACH
A7520 TRACHEOSTOMY/LARYNGECTOMY TUBE, NON-CUFFED, POLYVINYLCHLORIDE (PVC), SILICONE OR EQUAL, EACH
A7521 TRACHEOSTOMY/LARYNGECTOMY TUBE, CUFFED, POLYVINYLCHLORIDE (PVC), SILICONE OR EQUAL, EACH
A7522 TRACHEOSTOMY/LARYNGECTOMY TUBE, STAINLESS STEEL OR EQUAL (STERILIZABLE AND REUSABLE), EACH
A7523 TRACHEOSTOMY SHOWER PROTECTOR, EACH
A7524 TRACHEOSTOMA STENT/STUD/BUTTON, EACH
A7526 TRACHEOSTOMY TUBE COLLAR/HOLDER, EACH
A7527 TRACHEOSTOMY/LARYNGECTOMY TUBE PLUG/STOP, EACH
N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

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

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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
N/A
Bibliography

NA

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/01/2024 R5

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)
01/01/2020 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”

02/27/2020: 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 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 under Miscellaneous
Removed: PIM reference under 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 Revision 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:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
(Note: Standard Documentation Language updates noted above are effective for DOS on or after 10/31/2014)
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: ICD-9 references
Added: Language for HCPCS codes A4450, A4452, A5120 when submitted without correct modifier
  • Provider Education/Guidance
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
12/07/2023 01/01/2024 - N/A Currently in Effect You are here
02/21/2020 01/01/2020 - 12/31/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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