Recently questions have arisen about reimbursement for custom fabricated oral appliances coded as E0486 (ORAL DEVICE/APPLIANCE USED TO REDUCE UPPER AIRWAY COLLAPSIBILITY, ADJUSTABLE OR NON-ADJUSTABLE, CUSTOM FABRICATED, INCLUDES FITTING AND ADJUSTMENT). Only oral appliances used for the treatment of obstructive sleep apnea (OAOSA) that meet the durable medical equipment (DME) statutory benefit category requirements are eligible for Medicare reimbursement by the Durable Medical Equipment Medicare Administrative Contractors (DME MACs). All requirements of the definition must be met before an item can be considered to be DME (CMS IOM 100-2, Ch. 15, §100). Oral devices that do not meet the DME benefit criteria are classified as dental appliances and are not eligible for reimbursement under the DME benefit by the DME MACs.
Since the OAOSA Local Coverage Determination first became effective in January 2011, numerous devices have been submitted to the Pricing, Data Analysis and Coding (PDAC) contractor for inclusion into HCPCS code E0486. Many of these items vary significantly from the characteristics of the predicate product upon which the initial benefit category determination and subsequent HCPCS code were developed. The coding guidelines for OAOSA contained in the Oral Appliances for Obstructive Sleep Apnea Local Coverage Determination related Policy Article describe the requirements that must be met for an OAOSA to be classified as DME and coded as E0486. Based on the wide variety of products that have been submitted for review, the DME MACs are revising the coding guidelines to provide more detailed and specific information to assist with product classification.
Effective July 1, 2012 the coding guidelines for OAOSA items coded as E0486 are revised to state:
A custom fabricated oral appliance (E0486) is one which is individually and uniquely made for a specific patient. It involves taking an impression of the patient's teeth and making a positive model of plaster or equivalent material. Basic materials are used with the positive model to produce the final product. Custom fabrication requires more than trimming, bending, or making other modifications to a substantially prefabricated item. A custom fabricated oral appliance may include a prefabricated component (e.g., the joint mechanism).
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, 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 be coded as A9270.
Effective July 1, 2012 all product submissions will be reviewed using these coding guidelines. All products currently listed on DMECS must be re-reviewed and will be evaluated based on these requirements by the PDAC. The PDAC will not require a resubmission of applications for products that have already been coded and listed on DMECS. Current file information will be used for this re-review. Effective November 1, 2012, only those products that have been re-reviewed through the PDAC coding verification review process and listed as code E0486 on the PDAC Durable Medical Equipment Coding System (DMECS) web site may use this code. All unlisted devices must use HCPCS code A9270 (NON-COVERED ITEM OR SERVICE).
The PDAC DME and Supplies coding verification application required for these products is located on the PDAC website at: https://www.dmepdac.com/review/apps_check.html. Coding decisions are updated frequently. Suppliers should refer to the Product Classification List often to ensure that items billed have been coded by the PDAC. The Product Classification List in DMECS is located on the PDAC web site at: https://www.dmepdac.com/dmecsapp/.
For questions about correct coding, contact the PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form located on the PDAC website: https://www.dmepdac.com.
Refer to the Local Coverage Determination, related Policy Article and Supplier Manual for additional information.
Published by Noridian as the PDAC, July 2012. Republished by Palmetto GBA as the PDAC, February 2019. Please note that links in this document were accurate at the time of original publication and may change over time and are no longer active