Ambulatory Surgical Center Pass-Through Devices

What is a Pass-Through Device?

Pass-through status is determined for newly FDA-approved drug and device products on an individual basis. Drugs and devices qualifying for pass-through status include certain new drugs and biologicals, biosimilar drugs and newly approved devices.

When pass-through status is granted for a device or product, CMS designates a HCPCS code for use in billing, allowing payment for a product with pass-through status for at least two years but typically no longer than three years. These drugs and devices are updated quarterly when they are removed from pass-through status or assigned a permanent HCPCS or CPT code. After a drug or device's pass-through status expires, it may be packaged and reimbursed as part of the facility fee for which an ASC would otherwise receive payment.

Deduction

CMS deducts a portion of the APC payment amount from device pass-through payments under the OPPS.

This deduction is the device offset, or the portion of the APC amount associated with the cost of the pass-through device. The device offset represents a deduction from the ASC procedure payment for the applicable pass-through device.

Payment Indicators

ASC payment indicators are assigned to all ASC procedures. ASC Payment Rates include addendas. You can locate the addendas within the most recent quarterly files located on the ASC Payment Rates web page. Addenda BB provides a listing of the pass-through devices and payment indicators. The devices are identified with a 'J7' indicator, advising the device can be paid separately when provided integral to a surgical procedure on the approved ASC listing. These devices are contractor-priced and require invoice information.

ASC Fee Schedule

Prior to sending invoice information on your claim, review the ASC Fee Schedule based on your state and the CBSAs for your county. Once you download the file, review the code you are researching and determine if a fee is listed. Contractor-priced fees will have a 'C' (Carrier priced) in the "PROC IND" field on the fee schedule. If the fee isn't listed or has a zero-dollar ($0.00) amount, then invoice information is required.

Invoice Information

When required to ensure your claim is priced correctly, invoice information needs to be reported in item 19 of the CMS-1500 claim form or in loop 2400, segment NTE02 of the electronic claim using the following format:

Invoice: Include the name of the device, number of units and the total cost.

For more information, please visit the Ambulatory Surgical Centers (ASC) Center webpage and CMS IOM Publication 100-04, Claims Processing Manual, Chapter 14, Section 40.7.

The Provider Outreach and Education MAC Workgroup developed this material. Our joint effort ensures consistent communication and education so that providers have the information they need to submit claims appropriately and receive proper payment in a timely manner.

Posted 4/19/2022