Pass-through Devices - JE Part B
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.
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
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
|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:
Place of Service for ASC claims will be 24.
- CMS IOM, Publication 100-04, Claims Processing Manual, Chapter 14, section 40.7
- CMS MM MM3606
- CR 12129
Last Updated Mon, 13 Nov 2023 21:33:20 +0000