RETIRED - Correct Coding of ActaStim-S Spine Fusion Stimulator

IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.

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Joint DME MAC Publication
Posted May 2, 2024

The ActaStim-S Spine Fusion Stimulator registered with the Food and Drug Administration (FDA) under Premarket approval number P190030 by Theragen, Inc. is not considered Durable Medical Equipment (DME) because the device does not meet the statutory requirements for consideration to be DME.

The ActaStim-S Spine Fusion Stimulator has a lifetime of 270 days and will stop operating.

42 CFR 414.202 defines DME as:

Durable medical equipment means equipment, furnished by a supplier or a home health agency that meets the following conditions:

  1. Can withstand repeated use.
  2. Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years.
  3. Is primarily and customarily used to serve a medical purpose.
  4. Generally is not useful to an individual in the absence of an illness or injury.
  5. Is appropriate for use in the home.

The ActaStim-S Spine Fusion Stimulator is not considered DME and suppliers should not use E0748 (OSTEOGENESIS STIMULATOR, ELECTRICAL, NON-INVASIVE, SPINAL APPLICATIONS) for claim submission.

The correct code for the ActaStim-S Spine Fusion Stimulator is A9270 (NONCOVERED ITEM OR SERVICE).

Any supplier who has distributed this item to a beneficiary and billed E0748 must replace the equipment at no charge to the beneficiary.

This is in compliance with Medicare DMEPOS Supplier Standards 42 CFR 424.57(c)(15) Must accept returns from beneficiaries of substandard (less than full quality for the particular item or unsuitable items, inappropriate for the beneficiary at the time it was fitted and rented or sold).

Correct coding is an essential element for correct claim payment. The Pricing, Data Analysis and Coding (PDAC) contractor maintains a variety of resources to assist suppliers in determining the appropriate code for Medicare billing. For questions about correct coding, contact the PDAC HCPCS Helpline at (877) 735-1326 during the hours of 9:30 am to 5:00 pm ET, Monday through Friday. You may also visit the PDAC website to chat with a representative, or select the Contact Us website button at the top of the PDAC website for email, FAX, or postal mail information.

Publication History

Date of Change Description
05/02/24 Originally Published
05/31/24 Retired. The retirement of this publication is retro effective to the date of original publication.
Last Updated May 31 , 2024