Retired - Correct Coding – Eclipse™ Vaginal Insert System (Pelvalon, Inc.)

Joint DME MAC Article

The Eclipse™ Vaginal Insert system (Pelvalon, Inc.) is an inflatable vaginal insert designed to exert pressure on the rectal vault to treat fecal incontinence. FDA approval for marketing under this indication was granted on February 12, 2015. According to the manufacturer, the Eclipse™ system consists of a vaginal insert and a pressure-regulated pump. The insert, consisting of a silicone-covered stainless steel base and a posteriorly directed balloon, is placed in the vaginal vault and inflated. The balloon is deflated via the pump when the user needs to have a bowel movement.

The insert must first be fitted in the physician's office. This procedure is billed under a CPT code that is all-inclusive. Services rendered in a physician office and billed under a CPT code are not within the jurisdiction of the DME MACs. Items provided as part of that service are considered incident to the service and are not separately billable to the DME MACs.

The DME MACs have determined that the Eclipse™ Vaginal Insert system meets the requirements of the Prosthetic Devices benefit (Social Security Act §1861(s)(9)). To meet this benefit, the device must replace all or part of a non-functioning body member. There is currently no HCPCS code assigned to the Eclipse™ system. The DME MACs have determined that this item must be coded as:

• A4335  INCONTINENCE SUPPLY, MISCELLANEOUS

Suppliers are reminded that items billed with a miscellaneous HCPCS code require the following documentation to be submitted with the claim:

• Description of the item or service
• Manufacturer name
• Product name and number

Miscellaneous HCPCS codes billed without this information will be rejected for missing documentation and will need to be resubmitted with the missing information.

This information will be added to the Bowel Management Devices Local Coverage Determination and related Policy Article in an upcoming revision.

Questions concerning HCPCS code classifications should be directed to the Pricing, Data Analysis and Coding (PDAC) contractor - 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 www.dmepdac.com/dmecs.