CMS Decision Provides Supplemental Reimbursement to U.S. Hospitals for New Medical Device with Potential to Improve Outcomes for Patients Undergoing a Percutaneous Transthoracic Lung Biopsy
BRAINTREE, MA, June 22, 2015 /CNW/ - Surgical Specialties Corporation (Surgical Specialties), a leading provider of branded, private label, and OEM medical devices for advanced surgery, wound closure, ophthalmology, and radiology announced today that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved a transitional pass-through payment for Surgical Specialties' BioSentryTM Track Sealant System under the Medicare hospital outpatient prospective payment system (OPPS). 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 U.S. Food and Drug Administration (FDA) based on clinical data from its pivotal trial, BioSentryTM offers clinicians and patients a new therapy option that has demonstrated superior clinical outcomes to the current standard of treatment for this procedure. The BioSentryTM 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, randomized, multicenter clinical trial of 339 patients, BioSentryTM was found to significantly reduce the risk of pneumothorax by a relative risk reduction of greater than 50%1. 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 BioSentryTM 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 CT-guided percutaneous lung biopsy, occurring in 15-42% of patients.
Dr. 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 BioSentryTM Tract Sealant System significantly reduces these risks."
This supplemental reimbursement provision takes effect on July 1, 2015 and aims to cover the additional cost to U.S. hospitals for treating Medicare beneficiaries with BioSentryTM in the outpatient setting. The Healthcare Common Procedure Coding System (HCPCS) code for this new device category will be C2613 (lung biopsy plug with delivery system).
Brennan Marilla, Chief Commercial Officer of Surgical Specialties Corporation commented, "We are thrilled that CMS has recognized the significant clinical and economic benefits of BioSentryTM 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."
- Zaetta JM, Licht MO, FisherJS, Avelar RL, et al. A Lung Biopsy Tract Plug for Reduction of Postbiopsy Pneumothorax and Other Complications: Results of a Prospective, Multicenter, Randomized, Controlled Clinical Study. J Vasc Interv Radiol 2010; 21:1235–1243
About Surgical Specialties Corporation
Surgical Specialties Corporation has developed and manufactured branded, private label, and OEM surgical instruments for over 40 years. Surgical Specialties Corporation offers one of the most comprehensive portfolios of blades and sutures available, including innovative products such as the Quill™ Knotless Tissue-Closure Device. Headquartered in Braintree, MA, Surgical Specialties Corporation devotes itself to exceeding the needs of the specialty surgery market, having trusted partnerships within dental, ophthalmic, plastic surgery, dermatology, orthopedics, urology, microsurgery, veterinary and trauma specialties. Visit us at www.surgicalspecialties.com and www.biosentrysystem.com
SOURCE Angiotech Pharmaceuticals, Inc.
For further information: Daniel Sutherby, Surgical Specialties Corporation, [email protected]