Summary Of Evidence

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).

Analysis of Evidence

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.

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.