Tracheostomy Care Supplies - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**  
  
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. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").  
  
Tracheostomy Supplies are covered under the Prosthetic Benefit (Social
Security Act 1861(s)(8)). In order for a beneficiary's supplies to be
eligible for reimbursement, the reasonable and necessary (R&N) requirements
set out in the related Local Coverage Determination must be met. In addition,
there are specific statutory payment policy requirements, discussed below,
that also must be met.  
  
Supplies for care of a tracheostomy site are covered for a beneficiary
following an open surgical tracheostomy which has been open or is expected to
remain open for at least three months. The quantities of supplies included in
a tracheostomy care kit are to provide all necessary quantities for the care
of the tracheostomy site and there must not be any additional quantity billed
of these codes for this purpose. Additional supplies may be billed, as
appropriate and necessary, only for care other than for a tracheostomy site,
such as for speaking valves.  
  
Claims for tape (A4450 or A4452) or for wipes or swabs (A5120) that are billed
without an AU modifier will be rejected as missing information.



**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD, it will be eligible
for coverage.

  
  
**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**  
  
In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.  
  
Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed
below.  
  
The diagnosis code that justifies the need for these items must be included on
each claim.  
  
 **CODING GUIDELINES**  
  
A tracheostomy care or cleaning starter kit (A4625) contains the following:

Item

|

Number included  
  
---|---  
  
plastic tray

|

1  
  
basin

|

1  
  
sterile gloves

|

1 pair  
  
tube brush

|

1  
  
pipe cleaners

|

3  
  
pre-cut tracheostomy dressing

|

1  
  
gauze

|

1 roll  
  
4x4 sponges

|

4  
  
cotton tip applicators

|

2  
  
twill tape

|

30 inches  
  
  
A tracheostomy care kit for an established tracheostomy (A4629) contains the
following:

Item

|

Number included  
  
---|---  
  
tube brush

|

1  
  
pipe cleaners

|

2  
  
cotton tip applicators

|

2  
  
twill tape

|

30 inches  
  
4x4 sponges

|

2  
  
  
A Column II code is included in the allowance for the corresponding Column I
code when provided at the same time.

Column I

|

Column II  
  
---|---  
  
A4625

|

A4626  
  
A4629

|

A4626  
  
  
Tracheostomy care kits provided in the first two postoperative weeks should be
coded as A4625.  
  
Tracheostomy care kits provided after the first two postoperative weeks should
be coded as A4629.  
  
When codes A4450, A4452 and A5120 are used with Tracheostomy Care Supplies,
they must be billed with the AU modifier. For this policy, codes A4450, A4452
and A5120 are the only codes for which the AU modifier may be used.  
  
A7526 is a tracheostomy collar/holder that is used to secure the tracheostomy
tube's positioning, minimize movement of the tracheostomy tube and reduce the
risk of cannula disruption or decannulation. Fastener tabs attach to the
tracheostomy tube to hold the collar in place. A7526 should not be used for
billing twill ties, or twill tape or equivalent fabric or plastic supplies.  
  
Heat/Moisture Exchangers  
  
Heat/Moisture Exchangers (HME; see below for specific component codes) are a
type of stoma cover which help laryngectomees partially restore functions
previously performed by the nose and upper airway. During exhalation, warmth
and humidity are conveyed from the lungs and deposited into the filter. During
inhalation, the warmth and moisture are picked back up by incoming air and
returned to the lungs.  
  
HME consist of a plastic cassette/holder that contains a filter. The holder
fits into a plastic housing which is held in place over the tracheostoma by
adhesive. An HME may be used by itself or in addition to a tracheostoma valve
(A7501).  
  
A4481 is a small filter usually having adhesive along one edge which is
attached to the skin and simply covers the tracheostoma to keep large piece of
debris out. It is not an HME.  
  
A4483 is a moisture exchanger that is used only with an invasive mechanical
ventilator and should not be billed as an HME over a tracheostoma.  
  
A7503 is a device that connects to the tracheostoma cassette and holds an HME
filter. The holder/cap can open and close to replace the HME filter.  
  
A7504 is a filter that fits into A7503.  
  
A7506 is a double sided adhesive disc that attaches the HME cassette to the
beneficiary's skin.  
  
A7507 is an integrated filter and holder that utilizes A7506 to fit over the
tracheostomy or may utilize liquid adhesive on both sides of the cassette to
attach the HME to the beneficiary.  
  
A7508 is integrated housing and adhesive used with either an HME or
tracheostoma valve.  
  
A7509 is the integrated filter holder and housing used with the HME system.  
  
A tracheostomy valve with diaphragm (A7501) is a device used over the
tracheostomy stoma by a beneficiary who has had the larynx removed and has a
tracheo-esophageal voice prosthesis, but does not have a tracheostomy tube.

Tracheostomy tubes (A7520, A7521, A7522) are all-inclusive. All variations in
tracheostomy tube construction such as dimensions, materials, cuffs,
connectors etc., including all variations often classified by manufacturers as
"customized" are included in HCPCS codes A7520, A7521, and A7522.

Miscellaneous or NOC (not otherwise classified) codes such as E1399 (DURABLE
MEDICAL EQUIPMENT, MISCELLANEOUS) or A9999 (MISCELLANEOUS DME SUPPLY OR
ACCESSORY, NOT OTHERWISE SPECIFIED) must not be used to bill Medicare for any
tracheostomy tube. Use of a miscellaneous code to bill Medicare for any
tracheostomy tubes is incorrect coding.  
  
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
Contractor for guidance on the correct coding of these items.