Oral Appliances for 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").  
  
Oral appliances used to treat obstructive sleep apnea (OSA) are covered under
the Durable Medical Equipment benefit (SSA 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 must be met.

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 laboratories.

Oral appliances generally are classified as dental devices and are not
classified as durable medical equipment. The following items (not all-
inclusive) are considered to be dental devices and will be denied as non-
covered, not DME:

  * Oral occlusal appliances used to treat temporomandibular joint (TMJ) disorders
  * Tongue retaining devices used to treat OSA and/or snoring
  * All oral appliances used only to treat snoring without a diagnosis of OSA
  * Oral appliances used to treat other dental conditions
  * Oral appliances that require repeated fitting and/or adjustments, beyond the first 90-days, in order to maintain fit and/or effectiveness

All follow-up care, including fitting, adjustments, modifications,
professional services (not all-inclusive) required during the first 90 days
after provision of the oral appliance are considered to be included in the
payment for device. Claims for these will be denied as not separately payable.

After the initial 90-day period, adjustments, modifications and follow-up
visits are not eligible for coverage under the DME benefit and are therefore
not within the jurisdiction of the DME MAC.

Repairs are covered for items that meet the coverage criteria. To repair means
to fix or mend and to put the item back in good condition after damage or
wear. Repairs are covered when necessary to make the item serviceable. If the
expense for repairs exceeds the estimated expense of purchasing another item,
no payment can be made for the excess.

Oral appliances are eligible for replacement at the end of their 5-year
reasonable useful lifetime (RUL). These items may be replaced prior to the end
of the 5-year RUL in cases of loss, theft, or irreparable damage. Irreparable
damage refers to a specific accident or to a natural disaster (e.g., fire,
flood). Replacement due to wear-and-tear as the result of everyday use will be
denied as statutorily non-covered prior to the expiration of the 5-year RUL.

**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.

Treating practitioners shall document the in-person clinical evaluation in a
detailed narrative note in their charts in the format that they use for other
entries. 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)

**MODIFIERS**

Suppliers must add a KX modifier to a code only 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.

If all of the coverage criteria have not been met, the GA or GZ modifier must
be added to a claim line for the oral appliance. 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**

Oral appliances are used to reposition oral and pharyngeal tissues in an
effort to create and maintain a beneficiary's airway during sleep.

Mandibular advancement devices reposition the mandible in a forward position.

Tongue positioning devices reposition the tongue through the use of a vacuum-
bulb or other mechanism such as bars, prongs or extensions (not all-inclusive)
in a depressed and/or more anterior position.

A prefabricated oral appliance (E0485) is one, which is manufactured in
quantity without a specific beneficiary in mind. A prefabricated oral
appliance may be trimmed, bent, molded (with or without heat), or otherwise
modified for use by a specific beneficiary (i.e., custom fitted). Any
appliance that does not meet the definition of a custom fabricated oral
appliance is considered prefabricated. E0485 is used for all prefabricated
oral appliances used for the treatment of OSA including, but not limited to,
mandibular advancement devices, tongue positioning appliances, etc.

A custom fabricated oral appliance (E0486) is one that is uniquely made for an
individual beneficiary. It involves taking a full arch, negative impression of
the beneficiary's teeth, either using appropriate materials or digital images,
from which a positive model is created. Basic materials are then cut, bent,
and molded using the positive model in order to construct the final oral
appliance. A custom fabricated oral appliance may include a prefabricated
component (e.g., the joint mechanism).

HCPCS code E0486 may only be used for custom fabricated mandibular advancement
devices. To be coded as E0486, custom fabricated mandibular advancement
devices must meet all of the criteria below:

  * Have a fixed mechanical hinge (see below) at the sides, front or palate; and,
  * Be able to protrude the individual beneficiary's mandible beyond the front teeth when adjusted to maximum protrusion; and,
  * Incorporate a mechanism that allows the mandible to be easily advanced by the beneficiary in increments of one millimeter or less; and,
  * Retain the adjustment setting when removed from the mouth; and,
  * Maintain the adjusted mouth position during sleep; and,
  * Remain fixed in place during sleep so as to prevent dislodging the device; and,
  * Require no return dental visits beyond the initial 90-day fitting and adjustment period to perform ongoing modification and adjustments in order to maintain effectiveness (see below)

A fixed hinge is defined as a mechanical joint, containing an inseparable
pivot point. Interlocking flanges, tongue and groove mechanisms, hook and loop
or hook and eye clasps, elastic straps or bands, mono-block articulation,
traction-based articulation, compression-based articulation, etc. (not all-
inclusive) do not meet this requirement.  
  
Items that require repeated adjustments and modification beyond the initial
90-day fitting and adjustment period in order to maintain fit and/or
effectiveness are not eligible for classification as DME. These items are
considered as dental therapies, which are not eligible for reimbursement, by
Medicare under the DME benefit. They must not be coded using E0486.  
  
Custom fabricated mandibular advancement devices that do not incorporate all
of the criteria above must use HCPCS code A9270 (NON-COVERED ITEM OR SERVICE).
Do not use HCPCS code E0486.

Tongue positioning appliances are coded A9270.

Oral appliances used to treat snoring without a diagnosis of OSA established
with a sleep test as described in the LCD are coded A9270 (NON-COVERED ITEM OR
SERVICE).

Oral occlusal appliances used to treat temporomandibular joint (TMJ) disorders
are coded D7880 - occlusal orthotic appliance. Claims for these devices should
not be submitted to the DME MACs.

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

  * HCPCS code E0486

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

Claims for any of the HCPCS code 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
code 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 September 1, 2011:

E0486

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 PDAC Contractor for guidance on the correct
coding of these items.