OAT Reimbursement

To enroll as a DME Supplier with Medicare, you’ll need to complete these steps. This resource provides greater detail about each step.

1. Obtain NPI-National Provider Identification
2. Obtain accreditation from a CMS approved organization (Dentists are exempt from the accreditation requirement)
3. Obtain a valid surety bond for $50K
4. Ensure you have a valid state license for state(s) where services are rendered
5. Ensure you have general liability insurance for a minimum of $300K
6. Adhere to the DMEPOS Supplier Standards
7. Register for PECOS (Provider, Enrollment, Chain and Ownership System) - the online claims and reimbursement system
8. Submit required application fee (Year 2025, Amount: $730)
9. Complete 855-S form
10. Submit your application
    1. Novitas Solutions NPE East: Alabama, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, District of Columbia, Puerto Rico, US Virgin Islands
    2. Palmetto GBA NPE West: Alaska, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Iowa, Kansas, Louisiana, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wyoming, American Samoa, Guam, Northern Mariana Islands
11. Keep your enrollment information up to date
    1. Any changes to your enrollment file need to be reported within 30 days of the reportable event.
    2. These changes may include:
       1. change of ownership or control
       2. change in practice location
       3. any final adverse legal actions, such as revocation or suspension of a Federal or State license
       4. any change you may have an effect on your enrollment.
    3. You can submit a change of information, including a change of address, using PECOS or the 855S paper enrollment application.
    4. Revalidation: DMEPOS suppliers and providers must revalidate enrollment information every 3 years or upon CMS requests.

Local coverage determination LCD L33611 explains the criteria and documentation required to bill code E0486 for Medicare to reimburse for the custom-fabricated oral appliance.

The full code to use when billing Medicare is E0486-KX-NU. This includes the HCPCS code with two modifiers.

• Modifier KX indicates that all requirements explained in the LCD have been met.

Modifier NU indicates that the oral appliance is a new piece of equipment and is always used as OAT only uses new oral appliances.

When billing for OSA, ICD-10 diagnosis code G47.33 must be included to support medical necessity. However, this diagnosis must be from a licensed physician. Code G47.33 must be listed on the oral appliance prescription and on Health Insurance Claim Form CMS-1500.

FDA Clearance/Approval Does Not Mean Oral Appliance is Reimbursed   

The FDA looks at the safety of a medical device. Thus, when a device such as an oral appliance is cleared or approved by the FDA that device is deemed safe for use. The FDA does not look at how effective a device is, and it is important to note that FDA clearance/approval for an oral appliance does not mean that Medicare or private payers will reimburse for it.

Premarket approval by the FDA is a regulatory approval process that allows the manufacturer to market and distribute the device within the US.

Important Reminders

When reviewing this information, it is important to keep in mind the following caveats:

• PDAC verification should in no way be construed as an approval or endorsement of the product(s) by the PDAC, DME MACs, or Medicare, nor does it imply or guarantee claim reimbursement.
• PDAC verification or denial is not a statement about a device’s effectiveness. Being listed by PDAC simply verifies that a device meets Medicare requirements for classification as “durable medical equipment.” Oral devices that do not meet the DME benefit criteria are classified as dental appliances and are ineligible for Medicare reimbursement.
• Custom fabricated oral appliances that have not received PDAC verification may be eligible for reimbursement when treating patients with OSA who have commercial medical insurance. Contact the patient’s insurer for specific requirements.

What This Means to You

Custom-fabricated oral appliances for OSA will be eligible for Medicare reimbursement by the DME MACs only if the devices have been listed or reverified by PDAC according to the revised guidelines. To view the current status of reviewed devices, visit the PDAC website and enter "E0486" in the "HCPCS Code" box. Click "Search." On the search results screen, click the "E0486" hyperlink in the"HCPCS Code" column. Then on the "HCPCS Detail" screen, select the "Product Classification" tab and click the button that says, "View reviewed products on the DMEPOS Product Classification List for this code."

To search for the full list of devices that are FDA-cleared, visit the FDA’s 510 (k) Premarket Notification database and search using product code LQZ (Device, jaw repositioning) or LRK (Device, anti-snoring).

To see the indications for use of a cleared appliance:

• Click on the appliance’s name in the database’s search results
• Click on the linked summary for the device to see a summary of the indications for use, FDA’s approval letter, and the manufacturer’s application letter

PDAC Eligible Devices

Reviews oral appliances and deems whether they comply with the LCD. For oral appliances that are eligible for Medicare reimbursement, to search for the full list of devices that have been verified, visit the PDAC website

• Click on Product Classification List at the top
• Enter E0486 or K1027 in the HCPCS Codes box and click on search
• Click on Effective Begin Date twice to view most recent products

When coding for telehealth encounters, it is important to remember that all existing criteria for the type of visit must still be met. Practices that typically use the complexity method of billing may want to consider moving to billing via time if they are unable to complete all of the usual elements of a patient visit.

It is advised to confirm coverage with private payers as some contracts may not allow for telehealth services.

Below is a listing of Current Dental Terminology (CDT) codes for oral appliance therapy released by the American Dental Association (ADA).

NOTE: While these CDT codes exist for dental documentation, they are not commonly covered by dental insurance plans. Oral appliances for sleep apnea are often considered medical procedures and are typically billed to the patient's medical insurance plan.