Pass-through Devices

This page contains the process and information required to apply for transitional pass-through payment status for drugs and biologicals, or for assignment and payment for new pass-through device categories.

Background

Status is determined by the FDA for newly approved drug and device products on an individual basis:

  • Certain new drugs and biologicals
  • Biosimilar drugs
  • Newly approved devices

When status is granted, CMS designates HCPCS to use for billing. This allows payment for pass-through products for 2-3 years.

Once this period expires, they will either be removed from the list, or assigned a permanent HCPCS code, at which time it may be considered under the Facility payment for the procedure.

Per CMS Change Request CR 5680, pass-through device pricing is based on acquisition cost or invoice

Deduction

Under the Outpatient Prospective Payment System (OPPS), there is a deduction from the Ambulatory Payment Classification (APC) payment from new device pass-through payments.

This deduction is called the device offset, or the portion of the APC amount associated with the cost of the pass-through device. You will see this deduction in your ASC procedure payment for the device.

In the update for Ambulatory Surgical Center (ASC) Payment System CR 12129, CMS added HCPCS codes J0390, J0745, J5260, 0583T, and Q5118 to the list of New Pass-Through Devices

Payment Indicators

ASC payment indicators are assigned to all procedures. This information can be located on CMS ASC Payment Rates - Addenda.

Addenda Explanation
AA ASC Covered Surgical Procedures
BB ASC Covered Ancillary Services
DD1 ASC Payment Indicators
DD2 ASC Comment Indicators
EE Excluded Surgical Procedures
FF ASC Device Offset Percentages

 

ASC Fee Schedule

Prior to sending invoice information on your claim:

  • Review the ASC fee schedule based on your state and core based statistical areas (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' in the "PROC IND" field on the fee schedule. If the fee isn't listed or has a zero-dollar amount, then invoice information is required.

CMS-1500 Claim Form

To ensure that your claim is paid correctly, put your invoice information in Item 19 (Freeform Field, paper claim) or loop 2400 segment NTE02 (electronic claim) using the following format: include the name of the device, number of units, and the total cost.

Paper invoice not required.

In certain situations, contractors must reduce the payment for certain procedures in conjunction with a specific pass-through device. This reduction is only applicable for certain code combinations provided on the same day, by the same provider.

CMS will inform contractors of impacted code pairs quarterly:

CMS Pass-Through Payment Status and New Technology Ambulatory Payment Classification

Place of Service for ASC claims will be 24.

Resources

 

Last Updated Dec 09 , 2023