Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep
Apnea - 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").

Positive airway pressure devices are covered under the Durable Medical
Equipment benefit [Social Security Act 1861(s)(6)]. In order for a
beneficiary's DME 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 at the time of initial issue and when
replaced.

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.

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 prior to delivery,
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.  
  
INITIAL EVALUATION:  
  
For the initial in-person evaluation, the report would commonly document
pertinent information about the following elements, but may include other
details. Each element would not have to be addressed in every evaluation.

History

  * Signs and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headaches

  * Duration of symptoms

  * Validated sleep hygiene inventory such as the Epworth Sleepiness Scale (see Appendices of related LCD)

Physical Exam

  * Focused cardiopulmonary and upper airway system evaluation

  * Neck circumference

  * Body mass index (BMI)

Suppliers are reminded that all Medicare coverage and documentation
requirements for DMEPOS also apply. There must be sufficient information
included in the medical record to demonstrate that all of the applicable
coverage criteria are met. This information must be available upon request.

For beneficiaries changing from an E0601 to E0470 due to ineffective therapy
while on E0601 (either during a facility-based titration or in the home
setting), the treating practitioner must document that both of the following
issues were addressed prior to changing to an E0470 device:

  1. Interface fit and comfort. An appropriate interface has been properly fit and the beneficiary is using it without difficulty. This properly fit interface will be used with the E0470 device; and,

  2. E0601 pressure settings. The current pressure setting of the E0601 prevents the beneficiary from tolerating the therapy and lower pressure settings of the E0601 were tried but failed to:

    1. Adequately control the symptoms of OSA; or,

    2. Improve sleep quality; or,

    3. Reduce the AHI/RDI to acceptable levels.

The re-evaluation must take place within the first 3 months of treatment;
however, formal assessment of improvement cannot be documented before the 31st
day. The re-evaluation must document both improvement in subjective symptoms
of OSA and objective data related to adherence to PAP therapy.

Documentation of adherence to PAP therapy shall be accomplished through direct
download or visual inspection of usage data with documentation provided in a
written report format to be reviewed by the treating practitioner and included
in the beneficiary's medical record. This information does not have to be
submitted with the claim but must be available upon request.

Many suppliers have created forms which have not been approved by CMS which
they send to practitioners and ask them to complete. Even if the practitioner
completes this type of form and puts it in his/her chart, this supplier-
generated form is not a substitute for the comprehensive medical record as
noted above. Suppliers are encouraged to help educate practitioners on the
type of information that is needed to document a beneficiary's need for PAP
therapy.

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.  
  
INITIAL COVERAGE (FIRST THREE MONTHS):  
  
On claims for the first through third months, suppliers must add a KX modifier
to codes for PAP equipment (E0470 or E0601) and accessories only if all of the
criteria in the "Coverage Indications, Limitations, and/or Medical Necessity"
section of the related LCD ("Initial Coverage") have been met.  
  
CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:  
  
On the fourth month's claim (and any month thereafter), the supplier must add
a KX modifier to codes for PAP equipment (E0470 or E0601) and accessories only
if both the "Initial Coverage" criteria and the "Continued Coverage" criteria
in the "Coverage Indications, Limitations, and/or Medical Necessity" section
of the related LCD have been met.

If the supplier does not obtain information from the treating practitioner
that the beneficiary has demonstrated improvement in their OSA symptoms and is
adhering to PAP therapy 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.

If the supplier chooses to hold claims for the fourth and succeeding months
pending receipt of information from the treating practitioner that the
beneficiary received a clinical re-evaluation between the 31st and 91st day,
had documented improvement in OSA symptoms and is adhering to PAP therapy,
those claims may then be submitted with the KX modifier.

If the supplier chooses to hold claims for the fourth and succeeding month
pending receipt of information from the treating practitioner but learns that
the beneficiary did not receive a clinical re-evaluation between the 31st and
91st day but rather was re-evaluated at a later date and had documented
improvement in OSA symptoms and is adhering to PAP therapy, those claims may
then be submitted with the KX modifier but only for dates of service following
the date of the clinical re-evaluation.

For a PAP device dispensed prior to November 1, 2008, if the initial coverage
criteria in effect at the time were met and the criteria for coverage after
the first 3 months that were in effect at the time were met, the KX modifier
may be added to claim with dates of service on or after November 1, 2008 as
long as the beneficiary continues to use the device.

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 PAP device initially
(i.e., for 13 months of continuous use), the medical necessity for the
beneficiary-owned base PAP device 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 to PAP devices 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 below for beneficiary-owned devices entering Medicare).  
  
BENEFICIARIES ENTERING MEDICARE:  
  
For beneficiaries who received a PAP device prior to enrollment in fee for
service (FFS) Medicare and are seeking Medicare coverage of either rental of
the device, a replacement device or accessories, the supplier may add the KX
modifier only if both of the criteria listed in the Coverage Indications,
Limitations, and/or Medical Necessity for Beneficiaries Entering Medicare
section of the related LCD have been met.

The supplier may hold claims, pending confirmation that the above requirements
are met, and then submit claims with the KX modifier beginning with the date
of FFS Medicare enrollment.  
  
CONCURRENT USE OF OXYGEN WITH PAP THERAPY:  
  
In the rare instance where beneficiaries require the simultaneous use of home
oxygen therapy and a PAP device, documentation by the treating practitioner in
the beneficiary's medical record must clearly demonstrate that the
requirements for coverage outlined in the PAP LCD Coverage Indications,
Limitations, and/or Medical Necessity have been met. In addition, the
beneficiary's medical record must also clearly demonstrate that the
requirements for coverage outlined in the Oxygen and Oxygen Equipment LCD
Coverage Indications, Limitations, and/or Medical Necessity have been met.
This information does not have to be submitted with the claim but must be
available upon request.

Suppliers should refer to the Oxygen and Oxygen Equipment LCD and related
Policy Article for additional coverage, coding and documentation requirements.  
  
**MODIFIERS**  
  
GA, GZ, and KX 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 PAP equipment and accessories. When there is an
expectation of a reasonable and necessary 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.  
  
MISCELLANEOUS:

Items billed before a signed and dated order has been received by the supplier
must be submitted with an EY modifier added to each affected HCPCS code.

The order must include the type(s) of supplies ordered and the approximate
quantity to be used per unit of time. A new order is required if there is an
increase in the quantity of the supply used per month and/or the type of
supply used.

The supplier must enter the diagnosis code for the PAP device on each claim
submitted for PAP supplies.

Refer to the Supplier Manual for additional information on documentation
requirements.  
  
  
 **CODING GUIDELINES**  
  
A respiratory cycle is defined as an inspiration, followed by an expiration.

A single-level continuous positive airway pressure (CPAP) device (E0601)
delivers a constant level of positive air pressure (within a single
respiratory cycle) 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.

For auto-titrating single-level CPAP devices use HCPCS code E0601.

A bi-level respiratory assist device without backup rate (E0470) allows
independent setting of inspiratory and expiratory pressures to deliver
positive airway pressure within a single respiratory cycle 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 bi-level respiratory assist device with backup rate (E0471) allows
independent setting of inspiratory and expiratory pressures to deliver
positive airway pressure within a single respiratory cycle 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, E0471 devices have 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 equals 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. One unit of service for A7027 includes both the oral and
the nasal components.

A liner is 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).

Monitoring devices (integrated or modular) are capable of tracking data
generated by a RAD or PAP 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 positive airway pressure devices HCPCS codes for individual
items are included in the functionality of code E0467:

  * HCPCS codes E0470, E0471, E0472, E0601, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046, E0561, E0562

_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.