Transitional pass-through devices/questions and answers

Due to the interest shown regarding these devices, we will list a few questions and answers regarding transitional pass-through devices. These frequently asked questions and more can be found on HCFA’s website at: http://www.hcfa.gov QUESTION 2: When may hospitals bill for transitional passthrough payments for reprocessed devices? ANSWER 3: The regulations defining a device eligible for transitional pass-through payments require that a device meet a number of criteria, including that they be for “single use.” Hospitals may thus bill for transitional passthrough payments only for those devices that are “single use.” Reprocessed...

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Note:  The following article synopsis was NOT provided by the AHA. It was created by Find-A-Code/innoviHealth.

Article Overview

This article summarizes frequently asked questions about transitional pass-through devices under Medicare, with emphasis on hospital billing, reprocessed devices, pass-through list status, and the distinction between payment and coverage. It is relevant to hospital coders, reimbursement staff, and others working with HCFA guidance, FDA reprocessing policies, and category C-code reporting for drugs, biologicals, and related items.

Why This Topic Matters

The article helps readers understand a narrow Medicare payment topic that can affect how hospitals evaluate device eligibility, interpret pass-through status, and distinguish payment guidance from coverage decisions. It also highlights the role of HCFA and FDA guidance in the handling of certain device and product categories.

Article Sections

  1. Introductory note

    A brief introduction explaining that the page presents selected questions and answers about transitional pass-through devices and points readers to related HCFA resources.

  2. Question 2 / Answer 3

    Discussion of hospital billing considerations for reprocessed devices within the transitional pass-through context and reference to FDA guidance.

  3. Question 10 / Answer 10

    Explanation of how pass-through list status relates to Medicare coverage decisions and the roles of HCFA and local medical review authorities.

  4. Question 35 / Answer 35

    Information about reporting certain category C-codes associated with drugs and biologicals in the pass-through setting.

  5. Question 37 / Answer 37

    Clarification of how category-based pass-through payment relates to manufacturer identification and eligibility considerations.

What You Will Learn

  • How transitional pass-through device questions are framed in a Medicare reimbursement context.
  • How reprocessed devices are discussed in relation to FDA guidance and hospital billing.
  • How pass-through list status differs from coverage determinations.
  • How category C-code reporting is addressed for certain hospital items.
  • How broader category-based eligibility is discussed for devices in pass-through payment policy.

Who Should Read This

  • Hospital coders
  • Reimbursement specialists
  • Billing staff
  • Compliance staff
  • Health information management professionals

Codes Discussed


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