Boston Scientific's Single-Use Duodenoscope Gets TPT Class Nod

Boston Scientific Corporation BSX recently announced the receipt of the Centers for Medicare & Medicaid Services’ (CMS) approval for its application regarding a transitional pass-through (TPT) payment category for single-use endoscopes under the Medicare hospital outpatient prospective payment system. Notably, such single-use endoscopes include the company’s EXALT Model D Single-Use Duodenoscope.

For investors’ note, the latest TPT code, C1748, can be used while billing for EXALT Model D post its usage in the treatment of Medicare beneficiaries in the hospital outpatient setting, effective Jul 1, 2020.

With this latest regulatory clearance, Boston Scientific’s Endoscopy business under the broader MedSurg arm is expected to strengthen its global footprint.

A Peek Into the EXALT Model D Duodenoscope

Boston Scientific’s EXALT Model D Single-Use Duodenoscope is the first and the only FDA-approved single-use flexible duodenoscope approved in the world. Notably, the device received the regulatory body’s Breakthrough Devices Designation.

The designation was granted through a program aimed at accelerating the development and prioritizing the review of certain medical devices, thereby facilitating effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The tag further provides more timely access to novel medical devices.

Notably, the EXALT Model D got the FDA’s nod in December 2019 and has been subsequently commercially launched as an alternative to reusable duodenoscopes. This eradicates the need for duodenoscope reprocessing and repairs, thus allowing physicians to use a new and sterile scope for every procedure.

The EXALT Model D belongs to the category of first few devices that received the CMS’s TPT approval via an alternative pathway for innovative technologies with FDA’s marketing authorization and a Breakthrough Devices Designation to qualify for device pass-through payment.

Significance of the Approval

The TPT payment is aimed at easing the Medicare beneficiary’s access to the advantages of new and innovative devices. This is done by allowing adequate payment for these new devices while the required cost data is collected to incorporate the costs for these devices into the procedure Ambulatory Payment Classifications (APC) rate.

Per the medical fraternity, the approval of the latest payment category in the outpatient setting will enable healthcare providers to access EXALT Model D for a new and sterile duodenoscope for every procedure. This will help minimize the risks of infection for patients, physicians as well as the hospital staff.

Industry Prospects

Per a report by Grand View Research, the global endoscopes market size was valued at $10.4 billion in 2019 and is expected to see a CAGR of 8.8% between 2020 and 2027. Factors like rising elderly population, growing awareness of the benefits of minimally invasive surgeries over open invasive surgeries and the rising prevalence of chronic diseases are likely to drive the market.

Given the market potential, this well-timed clearance will provide a boost to the company’s business.

Recent Developments

Of late, Boston Scientific has been witnessing a slew of developments across its business arms.

The company announced the U.S. launch of its tool for monitoring the effect of radiofrequency (RF) energy delivery, the DIRECTSENSE Technology, in June following its FDA approval in April.

In May, the company reported favorable 12-month results from the PINNACLE FLX clinical trial, which evaluated the safety and efficacy of the next-generation WATCHMAN FLX Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation.

In the same month, the company also announced the final results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator System.

Price Performance

Shares of the company have lost 8.1% in the past year compared with the industry’s 1.4% fall. The same came against the S&P 500’s 10.8% rise.

Zacks Rank & Key Picks

Currently, Boston Scientific carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Illumina, Inc. ILMN, Hologic, Inc. HOLX and QIAGEN N.V. QGEN.

Illumina’s long-term earnings growth rate is projected at 11%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Hologic’s long-term earnings growth rate is estimated at 7%. The company presently has a Zacks Rank #2.

QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.

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