Respiratory Assist Devices - Policy Article

**NON-MEDICAL NECESSITY COVERAGE & 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").

Respiratory assist 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.

Accessories are separately reimbursable when used with E0470, E0471.

No aspect of a home sleep test, including but not limited to delivery and/or
pickup of the device, may be performed by a DME supplier. This prohibition
does not extend to the results of studies conducted by hospitals certified to
do such tests or to tests conducted in facility-based sleep laboratories.

Services of a respiratory therapist are non-covered under the DME benefit.

A liner used in conjunction with a PAP mask is considered comfort/convenience
item. There is no additional payment for liners used with a PAP mask. These
products should be coded A9270 (Noncovered item or service) in accordance with
the Medicare Benefit Policy Manual (CMS Pub. 100-02) Chapter 15, Section
110.1.

Claims for A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY
TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE
CLASSIFIED) are denied as statutorily non-covered (No Medicare benefit).

**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**

REPLACEMENT OF ACCESSORIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT:

For claims for replacement accessories (e.g., interfaces, tubing, filters,
humidifier chambers), if Medicare paid for the base RAD initially (i.e., for
13 months of continuous use), the medical necessity for the beneficiary-owned
base RAD is assumed to have been established. Therefore, to make a payment
determination, there must only be documentation that the base DME item
continues to meet medical need; and (2) The replacement of specific
accessories or furnishing of new accessories remain medically necessary and
are essential for the effective use of the base DME.

Documentation of continued medical need for the base item must come from the
treating practitioner's records. The supplier's documentation records must
support the need to replace the accessory to maintain the equipment's
functionality and meet the beneficiary's medical need.

This guidance does not apply RADs when Medicare did not originally provide
payment for the base item. In cases where Medicare did not originally pay for
the DME item, all coverage, coding and documentation requirements in effect
for the date of service (DOS) on the claim under review must be met (see
Coverage Indications, Limitations, and/or Medical Necessity section of the
related LCD).

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.

**MODIFIERS**

KX MODIFIER:

Proper use of modifiers is discussed below. Specific modifiers must be used
and differ depending on whether or not the requirements outlined in the
documentation section have been met.

Where permitted, KX must be added to codes E0470 and E0471 and codes for
accessories used with E0470 and E0471. The KX modifier must not be used until
the required documentation has actually been obtained and entered into the
supplier's files.

On claims for the first through third months, suppliers must add a KX modifier
if all of the criteria in the Coverage Indications, Limitations, and/or
Medical Necessity section of the related LCD have been met. If the
requirements for the KX modifier are not met, the KX modifier must not be
used.

On the fourth month's claim (and any month thereafter), the supplier must add
a KX modifier if all the "Initial Coverage" criteria in the Coverage
Indications, Limitations, and/or Medical Necessity section of the related LCD
have been met and the treating practitioner's signed and dated statement
described in the Coverage Indications, Limitations, and/or Medical Necessity
above, has been obtained for the supplier's files.

If the completed and signed treating practitioner statement is not in the
supplier's files in time for submission of the fourth or succeeding months'
claims, the supplier may still submit the claims, but a KX modifier must not
be added. However, if the supplier chooses to hold claims for the fourth and
succeeding months until the completed and signed forms are obtained, those
claims may then be submitted with the KX modifier, so long as their answers
indicate continued compliant use of and benefit from the therapy, according to
the Coverage Indications, Limitations, and/or Medical Necessity section.

GA AND GZ MODIFIERS

In all of the situations above describing use of the KX modifier, if all of
the coverage criteria have not been met, the GA or GZ modifier must be added
to a claim line for the RAD equipment (E0470 or E0471) and accessories. When
there is an expectation of a medical necessity denial, suppliers must enter
the GA modifier on the claim line if they have obtained a properly executed
Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained
a valid ABN.

Claim lines billed without a GA, GZ or KX modifier will be rejected as missing
information.

**CODING GUIDELINES**

A respiratory assist device (RAD) without backup rate (E0470) delivers
adjustable, variable levels (within a single respiratory cycle) of positive
air pressure by way of tubing and a noninvasive interface (such as a nasal,
oral, or facial mask) to assist spontaneous respiratory efforts and supplement
the volume of inspired air into the lungs. A respiratory cycle is defined as
an inspiration, followed by an expiration.

A respiratory assist device (RAD) with backup rate (E0471) delivers
adjustable, variable levels (within a single respiratory cycle) of positive
air pressure by way of tubing and a noninvasive interface (such as a nasal or
oral facial mask) to assist spontaneous respiratory efforts and supplement the
volume of inspired air into the lungs. In addition, it has a timed backup
feature to deliver this air pressure whenever sufficient spontaneous
inspiratory efforts fail to occur.

HCPCS code A4604 describes tubing used with a heated humidifier and has a
heated wire running the length of the tubing. It is designed for use with a
positive airway pressure device and a non-invasive interface - i.e., nasal or
face mask, nasal cannula, or oral interface.

HCPCS code A7032 is used for a replacement nasal mask interface that goes
around the nose, but not into the nostrils. The unit of service for this code
is "each".

HCPCS code A7033 is used for a replacement nasal cannula-type interface. This
interface extends a short distance into the nostrils. The unit of service for
this code is "pair". For some products, there are two physically separate
cushions or "pillows" - one for each nostril. Two cushions/ pillows equal one
unit of service of A7033. For other products, the interface is a single piece
with two protrusions that extend into the nostrils. One of these interfaces
equals one unit of service of A7033.

HCPCS code A7027 (Combination oral/nasal mask, used with continuous positive
airway pressure device, each) is a two-piece system with separate elements for
oral and nasal use.

A liner is a soft, flexible material, which is placed between the patient's
skin and the PAP mask interface. Liners used with a PAP mask are made of
cloth, silicone or other materials. Liners are not interfaces for use with a
PAP mask. Consequently, liners should not be billed as replacement features of
a PAP mask such as A7031 (Face mask interface, replacement for full face mask,
each) or A7032 (Cushion for use on nasal mask interface, replacement only,
each). Liners billed as replacement features of a PAP mask should be coded
A9270 (Non-covered item or service).

Monitoring devices (integrated or modular) are capable of tracking data
generated by a RAD device, which can be subsequently downloaded for further
analysis by a healthcare provider, DME supplier, or beneficiary. Such
technologies include, but are not limited to:

  * Smart cards and readers
  * USB/Thumb drive accessories
  * Wired telephonic transmission modules
  * Wireless modems

HCPCS code A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY
TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE
CLASSIFIED) describes any type of monitoring technology. Code A9279 is all-
inclusive and is to be used whether the monitoring technology is incorporated
as part of a base item, supplied as an add-on module or is a stand-alone item.

Use of multiple instances of A9279 to bill separately for individual
monitoring features is incorrect coding.

There is no Medicare benefit or payment to DMEPOS suppliers for remote
monitoring services. Suppliers must not bill A9279 for remote monitoring
services

Claims billed for monitoring technologies using other NOC codes such as E1399
[DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS] will be denied as incorrect coding.

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

  * HCPCS codes E0470, E0471, E0472, E0561, E0562, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046

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.