CMS Approves Transitional Pass-Through Reimbursement for BioSentry Tract Sealant System


June 22, 2015—Surgical Specialties Corporation announced that the Centers for Medicare & Medicaid Services (CMS) approved a transitional pass-through payment for the company’s BioSentry tract sealant system under the Medicare hospital outpatient prospective payment system. This supplemental reimbursement provision takes effect on July 1, 2015.

Used in percutaneous transthoracic lung biopsy procedures, the BioSentry system delivers a hydrogel plug placed into the lung along the biopsy needle tract, which expands to prevent air from leaking out and creating a pneumothorax.

The new provision aims to cover the additional cost to hospitals in the United States for treating Medicare beneficiaries with BioSentry in the outpatient setting. The Healthcare Common Procedure Coding System code for this new device category will be C2613 (“lung biopsy plug with delivery system”).

According to the company, the pass-through reimbursement approval removes a potential barrier to patient access to this new medical device, which offers the potential to improve outcomes for patients undergoing this procedure.

The BioSentry device, which was approved by the US Food and Drug Administration (FDA) based on clinical data from its pivotal trial, has demonstrated superior clinical outcomes to the current standard of treatment for this procedure. In a prospective, randomized, multicenter clinical trial of 339 patients, BioSentry was found to significantly reduce the risk of pneumothorax by a relative risk reduction of > 50% and demonstrated reduction of relative rates of additional radiographs by 44%, chest tube placements by 67%, and postprocedure admissions by 35%, stated the company.

In the company’s press release, Robert Suh, MD, commented, “Pneumothorax and, more so, pneumothorax requiring chest tube placement are significant concerns for clinicians performing and patients undergoing percutaneous lung biopsies. The BioSentry tract sealant system significantly reduces these risks.” Dr. Suh is Director of Thoracic Interventional Services at UCLA in Los Angeles, California.  

Brennan Marilla, Chief Commercial Officer of Surgical Specialties Corporation, also commented in the announcement, “We are thrilled that CMS has recognized the significant clinical and economic benefits of BioSentry with this approval, the first and only FDA-approved device for reducing pneumothorax after transthoracic percutaneous lung biopsy. Access to this technology will help physicians prevent patient complications and the cost of additional interventions with a straightforward, 2-minute procedure.”


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