Mechanical In-exsufflation 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").

Mechanical in-exsufflation equipment is 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.

Reimbursement may be made for replacement of A7020 (INTERFACE FOR COUGH
STIMULATING DEVICE, INCLUDES ALL COMPONENTS, REPLACEMENT ONLY) only if the
beneficiary owns or is purchasing the mechanical in-exsufflation device.

The diagnosis code that justifies the need for these items must be included on
the claim.

**  
CODING GUIDELINES**

Mechanical in-exsufflation devices are designed to slowly inflate the lungs
with positive pressure during inspiration and simulate cough with rapidly
applied negative pressure during expiration.

HCPCS code A7020 (INTERFACE FOR COUGH STIMULATING DEVICE, INCLUDES ALL
COMPONENTS, REPLACEMENT ONLY) is for replacement only. It must not be billed
at the time of initial issue.

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 mechanical in-exsufflation HCPCS codes for individual items are
included in the functionality of code E0467:

  * HCPCS codes E0482 and A7020

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.