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Tracheostomy care supplies — coverage criteria and DME medical necessity

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This policy governs coverage and medical necessity criteria for tracheostomy care kits and related supplies for members following an open surgical tracheostomy, including quantity limits and coding guidance. It affects providers ordering or billing for tracheostomy supplies under Northwood plans.

Policy Summary

Payernorthwood

PolicyTracheostomy care supplies — coverage criteria and DME medical necessity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionEnsure tracheostomy care kits are ordered by the treating practitioner and document medical necessity for quantities beyond one kit per day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentnorthwoodPolicy N/A

Tracheostomy care supplies — coverage criteria and DME medical necessity

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Policy Summary

Payernorthwood

PolicyTracheostomy care supplies — coverage criteria and DME medical necessity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionEnsure tracheostomy care kits are ordered by the treating practitioner and document medical necessity for quantities beyond one kit per day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

max routine kits/day

2 wksA4625 coding window

A4625,A4629primary kit codes

A7523explicit exclusion

HNEspecial pediatric plan

annualreview cadence

Coverage Criteria

Tracheostomy care supplies are reasonable and necessary when ALL of the following are met:

Ordering: Must be ordered by the member's treating practitioner.

Clinical setting: Used for individuals following an open surgical tracheostomy which has been open or is expected to remain open for at least three months.>=3 months expected

Starter kit timing: A4625 (tracheostomy care/cleaning starter kit) is covered following an open surgical tracheostomy but is no longer medically necessary beginning two weeks post-operatively.2 weeks

Tracheostomy care kits provided in the first two postoperative weeks should be coded as A4625; after two weeks use A4629 for established tracheostomy kits.

Routine kit frequency: One tracheostomy care kit (A4625 or A4629) per day is considered necessary for routine care.1 per day

Claims for additional kits for non-routine care must have substantiating documentation available upon request.

Quantity justification: Quantities of supplies greater than those described in the policy or per state guidelines as the usual maximum amounts require documentation clearly explaining medical necessity.

Absent documentation such excess quantities will be considered not reasonable and necessary.

Bundle/column II note: The quantity of supplies included in a tracheostomy care kit is intended to provide necessary quantities for tracheostomy site care; Column II code A4626 is included in allowance when provided with A4625 or A4629.

Do not bill additional quantity of kit components separately for the tracheostomy site care purpose.

Modifier/coverage risk: Claims for tape (A4450/A4452) or wipes/swabs (A5120) billed without an AU modifier (when required) will be considered not reasonable and necessary.

Special Coverage / Tube characterization

Special coverage statements and tube characterization (including plan-specific pediatric guidance):

HNE Pediatric A4623 criteria: Health New England (Medicaid and Commercial Plans - Pediatrics up to 21 years): Indications for A4623 (tracheostomy inner cannula) include ventilator dependence, respiratory failure, or upper airway obstruction related to subglottic stenosis, craniofacial abnormality, or trauma. Initial fulfillment: 2 each (initial insertion plus a spare); maintenance: 1 each per month.

Applies to HNE pediatric members up to age 21.

Tracheostomy tube characterization: Tracheostomy/laryngectomy tubes A7520, A7521, A7522 are described as all-inclusive (variations and features are included in these HCPCS codes).

When A7527 (tube plug/stop) is provided as an alternative, requests or claims for A7520/A7521/A7522 will be denied.

Shower protectors for tracheostomies billed under HCPCS code A7523 are expressly excluded. These items are not reasonable and necessary and should be denied when submitted for coverage.

When HCPCS A7527 (tracheostomy/laryngectomy tube plug/stop) is provided as an alternative to a tracheostomy or laryngectomy tube, claims and requests for the tube codes A7520, A7521, and A7522 will be denied as not reasonable and necessary. Providers should not bill those tube codes when A7527 is furnished in lieu of a tube.

Tape items (A4450 and A4452) and wipes/swabs (A5120) that require an AU (wound care) modifier must be submitted with that modifier. If these items are billed without the required AU modifier, they will be considered not reasonable and necessary and may be treated as not covered.

The starter tracheostomy care kit (A4625) is intended for use in the immediate postoperative period following an open surgical tracheostomy. A4625 is covered only during the first two postoperative weeks; beginning at two weeks post-operatively, A4625 is no longer medically necessary and claims for that code will be denied. After the first two weeks, providers should use the established kit code A4629 for routine tracheostomy care.

Quantities of tracheostomy supplies that exceed the amounts described in this policy or applicable state guideline usual maximums require documentation that clearly explains the medical necessity for the excess. Absent such documentation, excess quantities will be considered not reasonable and necessary. Documentation must be available upon request to support additional kits or larger quantities for non-routine care.

Coding and HCPCS

HCPCS Codes ListedHCPCS

A4623	Tracheostomy inner cannula (replacement only)
A4625	Tracheostomy care kit for new tracheostomy
A4626	Tracheostomy cleaning brush, each
A4629	Tracheostomy care kit for established tracheostomy
A7503	Filter holder or filter cap, reusable, for use in a tracheostoma heat and moisture
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 a 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

1–10 of 19

1/2

Tracheostomy tube HCPCS (all-inclusive)HCPCSCovered

A7520	Tracheostomy tube (one of group described as all-inclusive)
A7521	Tracheostomy tube (one of group described as all-inclusive)
A7522	Tracheostomy tube (one of group described as all-inclusive)

Other referenced HCPCS codes and itemsHCPCS

A4623	Tracheostomy Tube (Health New England pediatric indications/quantity guidance)
A4450	Tape (noted billing without AU modifier may be considered not [covered])
A4452	Tape (noted billing without AU modifier may be considered not [covered])
A5120	Wipes (noted billing without AU modifier may be considered not [covered])
A7527	Referenced with limitation information previously added

Routine kit frequency — One kit per day

Routine kit frequencyOne tracheostomy care kit (A4625 or A4629) per day is considered necessary for routine care.

Non-routine kitsAdditional kits for non-routine tracheostomy care require substantiating documentation available upon request.

Billing noteThe quantity of supplies included in a tracheostomy care kit is intended to provide all necessary quantities for tracheostomy site care; do not bill additional quantities of these kit codes for that purpose.

Starter kit coding window — Use A4625 for first two postoperative weeks; after two weeks use A4629

Starter kit coding windowUse A4625 for tracheostomy care kits provided during the first two postoperative weeks; beginning two weeks post-operatively A4625 is no longer medically necessary and A4629 should be used.

Provider Actions and Billing Requirements

Prior Authorization

Order and authorization: treating practitioner order required; extra kits need documentation

Tracheostomy care kits (A4625 or A4629) must be ordered by the member's treating practitioner; additional kits or quantities beyond the routine maximum (one kit per day) require documentation substantiating medical necessity and may require plan authorization per payer processes.

One kit per day is considered necessary for routine care; additional kits for non‑routine care must have substantiating documentation available upon request.
A4625 is intended for the first two postoperative weeks; after two weeks A4625 is no longer medically necessary and A4629 should be used.

Prior Authorization

Health New England (Pediatrics): A4623 indications and quantity limits

For Health New England pediatric plans (Medicaid and Commercial, up to age 21), A4623 requires specified indications and follows plan quantity rules: initial fulfillment is 2 each (initial insertion plus spare) and maintenance is 1 each per month.

Indications: ventilator dependence, respiratory failure, or upper airway obstruction related to subglottic stenosis, craniofacial abnormality, or trauma.

DME Medical Necessity

DME coverage requires the following:

Indication: Supplies are for individuals following an open surgical tracheostomy which has been open or is expected to remain open for at least three months.>=3 months expected

Ordering: Must be ordered by the member's treating practitioner.

Starter kit coding window: A4625 is intended for tracheostomy care kits provided in the first two postoperative weeks; beginning two weeks post‑operatively A4625 is not medically necessary and A4629 should be used for established tracheostomy kits.2 weeks

Rental and Purchase Rules

Item / HCPCS	Purchase vs Rental	Notes / Policy language
A7520 - Tracheostomy/laryngectomy tube, non-cuffed (PVC, silicone, or equal)
Purchase
Tracheostomy tubes (A7520, A7521, A7522) are all-inclusive; variations in construction (dimensions, materials, cuffs, connectors), including manufacturer-classified 'customized' features, are included in these HCPCS codes.
A7521 - Tracheostomy/laryngectomy tube, cuffed (PVC, silicone, or equal)
Purchase
Tracheostomy tubes (A7520, A7521, A7522) are all-inclusive; variations in construction (dimensions, materials, cuffs, connectors), including manufacturer-classified 'customized' features, are included in these HCPCS codes.
A7522 - Tracheostomy/laryngectomy tube, stainless steel or equal (sterilizable and reusable)
Purchase
Tracheostomy tubes (A7520, A7521, A7522) are all-inclusive; variations in construction (dimensions, materials, cuffs, connectors), including manufacturer-classified 'customized' features, are included in these HCPCS codes.

Replacement Components

General tracheostomy components

Tube brushCleaning brush used to clean inner cannula and tube (A4626 referenced as Column II inclusion).

Pipe cleanersSmall pipe cleaners included for lumen cleaning (A4625 lists 3; A4629 lists 2).

Cotton tip applicators & spongesCotton tip applicators and 4x4 sponges for site cleaning and dressing changes (A4625 and A4629 list cotton tip applicators and sponges).

Twill tape30-inch twill tape for tube stabilization included in both starter and established kits.

Dressing and gauzePre-cut tracheostomy dressing and roll of gauze included in starter kit; gauze/dressings serve as replacement items.

Documentation Requirements

Documentation Required

Provide medical justification for additional kits or excess quantities

Documentation explaining medical necessity must be available upon request to justify additional kits beyond one per day or quantities greater than usual maximums.

Absent documentation, excess quantities will be considered not reasonable and necessary.

Note

Refer to cited Medicare NCD/LCD for requirements

Policy references specific Medicare NCD and LCD documents; providers should consult those cited determinations for detailed documentation requirements and coverage criteria.

Cited references include CMS National Coverage Documents and Local Coverage Determination L33832 as noted in the policy.

Background

Tracheostomy care supplies are used to maintain an open surgical tracheostomy that has been created by open surgery or is expected to remain open for at least three months. Supplies and kits (e.g., A4625 for new tracheostomies and A4629 for established tracheostomies) are intended to support routine site and tube maintenance, wound care, and cleaning of the tracheostomy site and inner cannula as appropriate.

Definitions

A4625 (starter kit) — Definition and components of the starter kit.

DefinitionA4625: Tracheostomy care or cleaning starter kit for a new tracheostomy — intended for the immediate postoperative period (first two weeks).

Minimum components1 plastic tray; 1 basin; 1 pair sterile gloves; 1 tube brush; 3 pipe cleaners; 1 pre-cut tracheostomy dressing; 1 roll of gauze; 4 4x4 sponges; 2 cotton tip applicators; 30-inch twill tape.

Coding noteA4625 is covered following an open surgical tracheostomy but is not medically necessary beginning two weeks post-operatively; do not bill A4625 after that period.

A4629 (established kit) — Definition and components of the established tracheostomy care kit.

DefinitionA4629: Tracheostomy care kit for an established tracheostomy — intended for use after the first two postoperative weeks.

Components

Not Covered / Exclusions

Not covered items and scenarios include: 1) Tracheostomy shower protectors billed under A7523 (excluded as not reasonable and necessary); 2) Starter kit A4625 billed beginning two weeks post-operatively (no longer medically necessary after the first two postoperative weeks); 3) Tape (A4450, A4452) or wipes/swabs (A5120) billed without the required AU modifier when that modifier applies — such claims may be considered not covered; and 4) Tracheostomy tube codes (A7520, A7521, A7522) billed for members when A7527 (tube plug/stop) has been provided as an alternative, which will be denied.

Policy Summary

Payernorthwood

PolicyTracheostomy care supplies — coverage criteria and DME medical necessity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionEnsure tracheostomy care kits are ordered by the treating practitioner and document medical necessity for quantities beyond one kit per day.

SourceLink

On This Page

Timing guidanceTracheostomy care kits provided in the first two postoperative weeks should be coded as A4625; kits provided after the first two postoperative weeks should be coded as A4629.

Denial triggerClaims for A4625 billed beginning two weeks post-operatively will be considered not reasonable and necessary.

Initial fulfillment: 2 each; maintenance: 1 each per month.

Step Therapy

Alternate-device exclusion: A7527 precludes A7520/A7521/A7522

If A7527 (tube plug/stop) is provided as an alternative, claims and requests for tracheostomy tubes A7520, A7521, and A7522 will be denied as not reasonable and necessary.

Providers should not bill A7520/A7521/A7522 when A7527 is supplied for the same need; such claims will be denied.

Documentation Required

Required documentation for excess quantities or additional kits

Documentation that clearly explains the medical necessity must be available upon request for quantities greater than the policy or state guideline usual maximums and for additional kits provided for non‑routine care; absent such documentation, excess quantities will be considered not reasonable and necessary.

Keep clinical notes describing the clinical condition and rationale for additional supplies or kits.
Documentation must be producible upon request to support prior authorization or claim review.

Documentation Required

Order requirement: treating practitioner must order supplies

Tracheostomy supplies must be ordered by the member's treating practitioner; orders should be retained in the medical record to support coverage.

Ordering practitioner must be the member's treating practitioner (not a supplier).

Note

Reference documentation: consult Medicare NCD/LCD citations

Consult the referenced Medicare National and Local Coverage Determinations (NCD/LCD) included in the policy for additional documentation and coverage requirements; these references were reviewed and updated in policy history.

Referenced documents include CMS Medicare Coverage Database (National Coverage Documents) and Local Coverage Determination L33832 (CGS and Noridian).
Use the NCD/LCDs to confirm documentation standards and local billing requirements.

Denial Risk

Triggers for denial: timing, frequency, and modifier issues

Common denial triggers include: billing starter kit A4625 after the first two postoperative weeks; billing kit codes in excess of one per day without supporting documentation; and billing tape or wipes without required AU modifier when modifier is required.

A4625 billed beginning two weeks post‑op will be considered not reasonable and necessary.
More than one kit per day requires documentation of non‑routine need.
Tape (A4450/A4452) or wipes (A5120) billed without an AU modifier, if required, will be considered not reasonable and necessary.

Denial Risk

Modifier-related denial risk: missing AU modifier may cause denials

Items such as tape (A4450/A4452) and wipes (A5120) billed without the AU modifier when required may be considered not covered and denied.

Verify and append the AU modifier for wound care items when the clinical situation and payer rules require it.
Claims lacking required modifiers are at risk for denial.

Routine kit frequency: One tracheostomy care kit (A4625 or A4629) per day is considered necessary for routine care.1 per day

Additional kits for non-routine care require documentation available upon request.

Documentation requirement: Documentation explaining medical necessity must be available upon request for additional kits beyond one per day or for quantities greater than usual maximum amounts.

Absent documentation, excess quantities will be considered not reasonable and necessary.

Coding and bundling: The tracheostomy care kit contains necessary supplies for site care and the Column II code (A4626) is included in the allowance when provided with A4625 or A4629; do not bill duplicate kit components separately for the tracheostomy site.

HNE Pediatric MNC for A4623

Health New England (HNE) pediatric medical necessity criteria for HCPCS A4623 (tracheostomy inner cannula):

Age and plan: Applies to Health New England Medicaid and Commercial pediatric plans for members up to 21 years of age.<=21 years

Clinical indications (any of the following): Ventilator dependent OR respiratory failure OR upper airway obstruction related to subglottic stenosis, craniofacial abnormality, or trauma.

These indications support medical necessity for A4623 under HNE pediatric plans.

Quantity limits: Initial fulfillment: 2 each (initial insertion plus a spare). Maintenance requests: 1 each per month.Initial: 2; Maintenance: 1/month

1 tube brush; 2 pipe cleaners; 2 cotton tip applicators; 30-inch twill tape; 2 4x4 sponges.

Coding noteKits provided after the first two postoperative weeks should be coded as A4629; A4629 is the appropriate code once A4625 is no longer medically necessary.