The US Centers for Medicare and Medicaid Services (CMS) has approved a transitional pass-through payment for Surgical Specialties’ BioSentry track sealant system under the Medicare hospital outpatient prospective payment system. This important approval removes a potential barrier to patient access to this new medical device, which offers the potential to improve outcomes for patients undergoing a percutaneous transthoracic lung biopsy.
Approved by the US Food and Drug Administration (FDA) based on clinical data from its pivotal trial, BioSentry offers clinicians and patients a new therapy option that has demonstrated superior clinical outcomes to the current standard of treatment for this procedure. The 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.
In a prospective, randomised, multicentre clinical trial of 339 patients, BioSentry was found to significantly reduce the risk of pneumothorax by a relative risk reduction of greater than 50%. Pneumothorax can require additional treatment costs and interventions including chest tube placements, additional radiographs, inpatient admission or emergency room visits, delayed time to ambulation and hospital discharge. The trial also demonstrated reduction of relative rates of additional radiographs by 44%, chest tube placements by 67% and post-procedure admissions by 35%. Pneumothorax is the most common cost and care-intensive complication of computed tomography-guided percutaneous lung biopsy, occurring in 15–42% of patients.
Robert Suh, director of thoracic interventional services at UCLA, said, “Pneumothorax, and more so, pneumothorax requiring chest tube placement are significant concerns for clinicians performing and patients undergoing percutaneous lung biopsies. The BioSentry system significantly reduces these risks.”
This supplemental reimbursement provision takes effect on 1 July and aims to cover the additional cost to US hospitals 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).
Brennan Marilla, chief commercial officer of Surgical Specialties commented, “We are thrilled that CMS has recognised 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, two minute procedure.”