High Frequency Chest Wall Oscillation Devices - 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").  
  
High frequency chest wall oscillation devices are covered under the Durable
Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a
beneficiary's equipment 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.  
  
 **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
the claim.

  
MODIFIERS  
  
KX, GA, AND GZ MODIFIERS:  
  
Suppliers must add a KX modifier to codes for an HFCWO device and accessories
only if all of the criteria in the Coverage Indications, Limitations, and/or
Medical Necessity section of the related LCD have been met.  
  
If all of the criteria in the Coverage Indications, Limitations and/or Medical
Necessity section of the related LCD have not been met, the GA or GZ modifier
must be added to the code. When there is an expectation of a denial as not
reasonable and necessary, suppliers must enter GA on the claim line if they
have obtained a properly executed Advance Beneficiary Notice (ABN) or GZ if
they have not obtained a valid ABN.  
  
There must be information in the beneficiary's medical record that describes
in detail the underlying medical condition(s) that cause the accumulation of
pulmonary secretions, the treatment interventions (for example, chest
physiotherapy, postural drainage, medications used, mechanical modalities such
as in-exsufflation devices (not all-inclusive)) and the effectiveness of the
treatment. This information must be available upon request.  
  
Claim lines billed without a KX, GA, or GZ modifier will be rejected as
missing information.  
  
 **CODING GUIDELINES**  
  
HCPCS code E0483 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM, WITH FULL
ANTERIOR AND/OR POSTERIOR THORACIC REGION RECEIVING SIMULTANEOUS EXTERNAL
OSCILLATION, INCLUDES ALL ACCESSORIES AND SUPPLIES, EACH) devices (HFCWO) use
positive and negative pressure changes to augment peripheral and tracheal
mucus movement towards the airway opening. This function is performed by
extra-thoracic oscillations generated by forces external to the respiratory
system. External chest wall oscillations are applied using a vest worn around
the torso, which vibrates at variable frequencies and intensities, as set by
the operator. E0483 devices may use differing technologies, e.g. air-pulse
generators and an inflatable vest, an array of mechanical oscillators in a
vest providing synchronized oscillation. E0483 is all-inclusive regardless of
the technique used to produce HFCWO.

HCPCS code A7025 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM VEST,
REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH) describes a complete
replacement vest. This includes all components such as mechanical oscillators,
electrical componentry, inflatable air sacs, connectors. Separate billing of
vest components when an entire vest is replaced is incorrect coding -
unbundling.

HCPCS code A7026 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM HOSE,
REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH) describes the tubing
used with an air pulse generator type of HFCWO device.

HCPCS code E0483 describes a complete system. Separate billing of A7025 and/or
A7026 in combination with E0483 is incorrect coding - unbundling.

HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO
PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG
NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES,
COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that
integrates the function of multiple types of equipment into a single device.
Code E0467 combines the function of a ventilator with all of the following:

  * Oxygen equipment
  * Nebulizer and compressor
  * Aspirator (suction device)
  * Cough stimulator (multiple products)

If the multifunction ventilator does not include all of the functions listed
above, then the ventilator must not be coded as E0467. Multifunction
ventilators that combine some but not all, of the listed functions, must be
coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).

Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and
custom fabricated oral appliances, are considered same or similar to the
features of products coded E0467.

The following high frequency chest wall oscillation devices HCPCS codes for
individual items are included in the functionality of code E0467:

  * HCPCS codes E0483, A7025, A7026

For E0467 claims with dates of service before April 3, 2020:

Claims for any of the HCPCS codes listed above that are submitted on the same
claim or that overlap any date(s) of service for E0467 is considered to be
unbundling.

In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS
code for replacement items) of beneficiary-owned equipment identified by HCPCS
codes listed above is considered as unbundling if the date(s) of service for
the repair overlaps any date(s) of service for code E0467.

Claims for code E0467 with a date(s) of service that overlaps date(s) of
service for any of the following scenarios are considered as a claim for same
or similar equipment when the beneficiary:

  * Is currently in a rental month for any of the items listed above
  * Owns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.

For E0467 claims with dates of service on or after April 3, 2020:

Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for
replacement items) of beneficiary-owned equipment identified by HCPCS codes
listed above is considered as unbundling if the date(s) of service for the
repair overlaps any date(s) of service for code E0467.

Claims for code E0467 with a date(s) of service that overlaps date(s) of
service in a rental month for any of the items listed above are considered as
a claim for same or similar equipment.

CODING VERIFICATION REVIEW

The only products which may be billed using the following list of HCPCS codes
are those for which a written coding verification review (CVR) has been made
by the PDAC contractor and subsequently published on the Product
Classification List (PCL). Information concerning the documentation that must
be submitted to the PDAC for a CVR can be found on the PDAC website or by
contacting the PDAC. A PCL with products which have received a coding
verification can be found on the PDAC website. The effective date of the CVR
is included for each code.

Effective for claims with dates of service on or after January 1, 2022:  
E0467

If a product is billed to Medicare using a HCPCS code that requires written
CVR, but the product is not on the PCL for that particular HCPCS code, then
the claim line will be denied as incorrect coding.

Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC)
contractor for guidance on the correct coding of these items.