Need to Know Medicare Guidelines for Oral Appliances for OSA: Friend or Foe? Part 4

by Ken Berley, DDS, JD, DABDSM and Courtney Snow, Medical Insurance Consultant

In this edition, I have asked Courtney to outline the Medicare rules and guidelines that dental offices MUST know in order to file Medicare. This is vital information! I encourage you to keep copies of this article for a quick reference for you and your employees. I want to thank Courtney for her commitment to the advancement of Dental Sleep Medicine.

It is crucial that dental practices understand the guidelines when billing Medicare DME. The importance is two-fold; first to ensure that your practice is protected in the event of an audit from Medicare, and second to ensure that your Medicare patients receive the coverage that is available to them. Frequently, we find practices that have billed Medicare for years are violating guidelines. In this article, we will discuss the need to know guidelines when billing Medicare for custom made oral appliances for Obstructive Sleep Apnea (OSA).[/vc_column_text]So how is a dental practice supposed to know the guidelines? It’s simple: get to know and love the Medicare Local Coverage Determination (LCD) and the related policy article. Sure, it may not be the most exciting read in the world, however, familiarity with this document could save your practice thousands of dollars in the long run. Each of the four Medicare DME Jurisdiction (A, B, C & D) have their own LCD; currently the language in all four is the same. You can locate your Jurisdiction’s LCD online from your DME Medicare Administrative Contractor’s (MAC) website, under the “Local Coverage Determinations” option. The LCD is titled Oral Appliances for Obstructive Sleep Apnea (L33611). The related policy article is titled Oral Appliances for Obstructive Sleep Apnea – Policy Article (A52512).

Without further ado, let’s explore some main points to be aware of when billing Medicare for oral appliances for OSA.

The practice location must be enrolled as a Medicare DME supplier, either participating or non-participating

Currently, custom made oral appliances for OSA are categorized as Durable Medical Equipment (DME) under Medicare. DME is a broad range of items that are used by a patient in a home setting to serve a medical purpose, such as wheelchairs, positive airway pressure devices, canes, the list goes on. To bill Medicare for DME items, a practice (or company) must enroll as a DME supplier using the 855s application. While this is not a quick process, it can be well worth it as Medicare is the largest medical insurer in the United States.

The coverage criteria is different for mild, moderate and severe OSA

The Medicare LCD for oral appliances for OSA states the coverage criteria for mild, moderate, and severe OSA as follows:
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:
    a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
    b. 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):
    a. The beneficiary is not able to tolerate a positive airway pressure (PAP) device; or,
    b. The treating physician determines that the use of a PAP device is contraindicated.

An important point to understand on the coverage criteria above: do not let the inclusion of “RDI” fool you! Later in the policy, RDI is defined:

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.

Without RERA’s being considered in the calculation for RDI for Medicare, many of the RDI’s listed on the sleep testing reports are inaccurate…in Medicare’s eyes.

The patient must have a face to face evaluation by a physician prior to undergoing the sleep study, and a physician must write an order for the oral appliance

In the LCD, included in the coverage criteria, it is stated: The beneficiary has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the beneficiary for obstructive sleep apnea testing.

Additionally, DME suppliers are responsible for collecting documentation of this evaluation! The LCD states: Upon request by a contractor, all DMEPOS suppliers must provide documentation of the face-to-face examination.

The good news here, is that the physician who performed the evaluation prior to the sleep test does not necessarily have to be the same physician who writes the order (a.k.a. prescription) for the oral appliance to the dental practice. The LCD states:
The device is ordered by the treating physician following a review of the report of the sleep test. (The physician who provides the order for the oral appliance could be different from the one who performed the clinical evaluation in criterion A.)

Only a DDS/DMD can provide and bill for the oral appliance

That’s right! The LCD clearly states as part of the coverage criteria: The device is provided and billed for by a licensed dentist (DDS or DMD).

So if you have a physician or lab in your area providing custom made sleep appliances to their Medicare patients – you may want to show them a copy of the LCD!

Each claim must be submitted with modifier NU, and either modifier KX, GA or GZ

Many practices do know they must submit a modifier or two on the claim – but understanding what these modifiers represent is extremely important. Modifier NU stands for “New durable medical equipment purchase”. This indicates the item has been purchased new, and it not refurbished or a rental item.

When a claim is submitted to Medicare DME for an oral appliance for OSA, modifier KX, GA or GZ must also be present or the claim will be rejected. It is important that practices do not simply use the KX modifier on every claim because they know it will be paid. Modifier KX stands for “Requirements specified in the medical policy have been met”. Modifier GA stands for “Waiver of liability statement issued, as required by payer policy”. Modifier GZ stands for “Item or service expected to be denied as not reasonable and necessary”.
So when to use the different modifiers? The Medicare LCD clarifies:

Suppliers must add a KX modifier to a code only if all of the criteria in the “Indications and Limitations of Coverage 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.

The oral appliance must be approved by Medicare Pricing, Data Analysis & Coding (PDAC) for HCPCS code E0486

HCPCS code E0486 stands for: oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, custom fabricated, includes fitting and adjustment.

Most custom made oral appliances on the market today meet this definition, of course. However, Medicare PDAC has a set of criteria the appliance must meet to be PDAC approved for E0486. The related policy article states:

  • 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.

If the appliance that is used is not listed on the PDAC list for E0486, you must use a different code when submitting the claim to Medicare! The policy article states:

The only products, which may be billed using code E0486, are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List.
All custom fabricated mandibular advancement devices that have not received a written PDAC Verification Review must use HCPCS code A9270 (NON-COVERED ITEM OR SERVICE).

Medicare DME suppliers cannot administer home sleep testing (HST)

This one is simple. The LCD states: No aspect of a HST, 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.

The patient must sign a proof of delivery form when the appliance is received

For an oral appliance that is delivered to the patient in the dental practice, the proof of delivery form must include:

  • Beneficiary’s name
  • Delivery
  • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description). The long description of the HCPCS code, may be used as a means to provide a detailed description of the item being delivered
  • Quantity delivered
  • Date delivered
  • Beneficiary (or designee) signature

Follow up care 90 days from the delivery date are included in the reimbursement

Follow up care for 90 days being included in the reimbursement for E0486 is not a foreign concept, as most medical insurers follow this guideline. However, it is important to know that the related policy article states:

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.

While this article is not intended to be a replacement guide for the Medicare LCD and related policy article for oral appliances for OSA, we hope it helps clarify some of the common questions we get, as well as correct some of the incorrect coding and documentation practices we see in the field today. If any dental sleep practices out there need assistance locating the link to the LCD and related policy article for your Medicare DME jurisdiction, please feel free to contact Nierman Practice Management at and the Nierman team will be happy to assist you.

Currently, Medicare audits and reviews of dental practice protocols are rare. However, as more dentists incorporate DSM into their practices, Medicare audits may increase. Now is the time to ensure that your protocols are compliant with Medicare rules and regulations. If you need our help, please contact us to assist you.

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