Ambu bronchoscope demonstrates superior clinical improvement over existing devices on the market.

Public Health

Single-Use Bronchoscope Earns TPT Payment Status

“The evidence demonstrates that the device is a substantial clinical improvement over currently available treatment options in the clinical setting."

Ambu Inc. was recently granted a transitional pass-through (TPT) payment for one of its newest bronchoscopes based in part on its substantial clinical improvement over existing options on the market.

The Ambu® aScope 5 Broncho HD received the TPT payment category and a new HCPCS C code effective Jan. 1, 2024, for use in the hospital outpatient department, to remain in effect for 24 to 36 months.

Ambu’s 5th-generation scope is the first and only bronchoscope to be granted the incremental payment by the Centers for Medicare & Medicaid Services (CMS).

“The evidence demonstrates that the device is a substantial clinical improvement over currently available treatment options in the clinical setting,” according to the 2024 CMS OPPS/ASC Final Rule.

TPT payments are intended to facilitate Medicare beneficiary access to the benefits of new and innovative medical devices, drugs and biologicals that demonstrate a substantial clinical improvement over existing technologies.

The Ambu scope received the TPT payment status dues to its:

  • High-definition (HD) chip on scope
  • Compatibility with high-frequency tools (APC, cryo, ND:YAG Laser)
  • Superior articulation with tool

The decision by CMS to award transitional pass-through payment to Ambu was based on its application, product analysis, public commentary, and a review of the peer-reviewed research on single-use bronchoscopy and other single-use endoscopes that have already established TPT status.

“TPT for single-use endoscopy has historically been about expanded access to safe, sterile single-use devices that have different cost structures than reusables,” said Christina Cool, Senior Director, Health Economics, Outcomes Research, and Market Access at Ambu USA. “In this case, the granting of TPT was also about the advanced performance currently unique to aScope 5 Broncho HD, which was necessary to meet the newness and significant clinical improvement criteria.”

The aScope 5 Broncho HD is designed to perform the wide array of diagnostic, interventional, and therapeutic procedures crucial for pulmonology disease management, including the use of energy devices, endotherapy tools, and the BronchoSampler.

It is compatible with both the full-HD Ambu® aBox™ 2 display designed for OR integration, and the full-HD aView 2 Advance 2nd Generation portable display.

The specific HCPCS code description required to receive the TPT payment is identified as C1601 — Endoscope, single-use (i.e. disposable), pulmonary, imaging/illumination device (insertable).

That code was awarded only to the Ambu aScope 5 HD and must be included on the claim in order to receive the TPT payment. This prompts additional reimbursement for Medicare FFS outpatient procedures performed with the aScope 5 Broncho HD.

Facilities will continue to code and submit charges as they have in the past and simply add C1601 to the claim.

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