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.

The purpose of a Local Coverage Determination (LCD) is to provide information
regarding "reasonable and necessary" criteria based on Social Security Act 
1862(a)(1)(A) provisions.

In addition to the "reasonable and necessary" criteria contained in this LCD
there are other payment rules, which are discussed in the following documents,
that must also be met prior to Medicare reimbursement:

  * The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  * The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  * Refer to the Supplier Manual for additional information on documentation requirements.
  * Refer the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act  1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.

A custom fabricated mandibular advancement oral appliance (E0486) used to
treat obstructive sleep apnea (OSA) is covered if criteria A - D are met.

  1. The beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea testing. Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.
  2. The beneficiary has a Medicare-covered sleep test that meets one of the following criteria (1 - 3): 
    1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,
    2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of: 
      1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
      2. Hypertension, ischemic heart disease, or history of stroke; or,
    3. If the AHI> 30 or the RDI> 30 and meets either of the following(a or b): 
      1. The beneficiary is not able to tolerate a positive airway pressure (PAP) device; or,
      2. The treating practitioner determines that the use of a PAP device is contraindicated.
  3. The device is ordered by the treating practitioner following a review of the report of the sleep test. (The practitioner who provides the order for the oral appliance could be different from the one who performed the clinical evaluation in criterion A.)
  4. The device is provided and billed for by a licensed dentist (DDS or DMD).

If all of these criteria (A-D) are not met, the custom fabricated oral
appliance (E0486) will be denied as not reasonable and necessary.

Refer to the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the
Policy Article for information about coverage for appliances that achieve
their effect through positioning of the tongue (A9270).

A prefabricated oral appliance (E0485) will be denied as not reasonable and
necessary. There is insufficient evidence to show that these items are
effective therapy for OSA.

**Definitions**

As used in this policy, treating practitioner refers to a licensed MD, DO,
nurse practitioner, clinical nurse specialist, or physician's assistant
working within their scope of practice. The term treating practitioner does
not include a dentist (DDS or DMD).

Apnea is defined as the cessation of airflow for at least 10 seconds.

Hypopnea is defined as an abnormal respiratory event lasting at least 10
seconds associated with at least a 30% reduction in thoracoabdominal movement
or airflow as compared to baseline, and with at least a 4% decrease in oxygen
saturation.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of
apnea and hypopnea per hour of sleep without the use of a positive airway
pressure device. For purposes of this policy, respiratory effort related
arousals (RERAs) are not included in the calculation of the AHI. Sleep time
can only be measured in a Type I (facility-based polysomnogram) or Type II
sleep study (see descriptions below).

The respiratory disturbance index (RDI) is defined as the average number of
apneas plus hypopneas per hour of recording without the use of a positive
airway pressure device. For purposes of this policy, respiratory effort
related arousals (RERAs) are not included in the calculation of the RDI. The
RDI is reported in Type III, Type IV, and Other home sleep studies.

If the AHI or RDI is calculated based on less than 2 hours of sleep or
recording time, the total number of recorded events used to calculate the AHI
or RDI (respectively) must be at least the number of events that would have
been required in a 2-hour period (i.e., must reach _ >_30 events without
symptoms or _ >_10 events with symptoms). Projections of AHI or RDI based upon
shorter testing times and/or fewer events are not acceptable for use in
determining eligibility for payment.

**Sleep Tests**

Coverage and payment rules for diagnostic sleep tests may be found in the CMS
National Coverage Determination (NCD) 240.4.1 (CMS Pub. 100-03, Chapter 1,
Part 4), the applicable A/B MAC LCDs and Billing and Coding articles.

Coverage of an oral appliance for the treatment of OSA is limited to claims
where the diagnosis of OSA is based upon a Medicare-covered sleep test. The
sleep test must be either a polysomnogram performed in a facility-based
laboratory (Type I study) or an inpatient hospital-based or home-based sleep
test (HST) (Types II, III, IV, Other).

Coverage of an oral appliance device for the treatment of OSA is limited to
claims where the diagnosis of OSA is based upon all of the following:

  1. A sleep test (Type I, II, III, IV, Other) that meets the Medicare requirements for a valid sleep test as outlined in NCD 240.4.1 and the applicable A/B MAC LCD and Billing and Coding article; and,
  2. A sleep test that is approved by the Food and Drug Administration (FDA) as a diagnostic device; and,
  3. The sleep test results meet the coverage criteria in effect for the date of service of the claim for the oral appliance device; and,
  4. The sleep test is ordered by the beneficiary's treating practitioner; and,
  5. The sleep test is conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements. 

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.

Analysis of the Medicare Coverage Database indicates that the A/B MAC
contractors have LCDs and Billing and Coding articles that address the
coverage, coding and payment rules for diagnostic sleep testing. Furthermore,
CMS addresses diagnostic sleep testing device requirements in the CMS National
Coverage Determination (NCD) 240.4.1 (CMS Pub. 100-03, Chapter 1, Part 4).



The DME MACs received a reconsideration request that prompted an analysis of
the language in NCD 240.4.1 and the A/B MAC policies (LCDs and Billing and
Coding articles). After that analysis, we determined that the home sleep test
information in the Oral Appliances for Obstructive Sleep Apnea (L33611) was
duplicative. Due to the jurisdictional assignment for coverage and payment of
diagnostic sleep testing to the A/B MAC contractors, the DME MACs have elected
to remove sleep testing requirements from the DME MAC Oral Appliances for
Obstructive Sleep Apnea LCD. Coverage of oral appliance devices for the
treatment of OSA will continue to rely on a Medicare-covered diagnostic sleep
test with qualifying values (as described in the _Coverage Indications,
Limitations, and/or Medical Necessity_ section above) that is eligible for
coverage and reimbursement by the A/B MAC contractor. No changes to any
additional oral appliance device coverage criteria were made as a result of
this reconsideration.