
The U.S. Centers for Medicare & Medicaid Services (CMS) established a new Healthcare Common Procedure Coding System code C9781 for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker’s InSpace balloon implant.
The new code will be used to facilitate the process of health insurance claims for individuals enrolled in Medicare and other health insurance programs, allowing for more patients to have access to care with InSpace.
The InSpace implant addresses massive irreparable rotator cuff tears and provides a simple surgical treatment option. InSpace is designed to restore the subacromial space and provide a less invasive solution vs. other surgical treatment options that require fixation devices or grafts, and has been demonstrated to improve shoulder motion and function.
The CMS decision was based on findings from the Level 1 InSpace pivotal study – a prospective, single-blinded, multi-center, randomized, controlled trial which assessed the safety and effectiveness of the InSpace Implant compared to Partial Repair. The study evaluated 184 randomized patients over 40 years of age with symptomatic massive full-thickness rotator cuff tears that failed non-operative management, through 24 months of follow-up.
InSpace, which Stryker acquired in 2019, received FDA 510(k) clearance in 2021.
Source: Stryker
The U.S. Centers for Medicare & Medicaid Services (CMS) established a new Healthcare Common Procedure Coding System code C9781 for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker's InSpace balloon implant.
The new code will be used to facilitate the process of health insurance claims for individuals...
The U.S. Centers for Medicare & Medicaid Services (CMS) established a new Healthcare Common Procedure Coding System code C9781 for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker’s InSpace balloon implant.
The new code will be used to facilitate the process of health insurance claims for individuals enrolled in Medicare and other health insurance programs, allowing for more patients to have access to care with InSpace.
The InSpace implant addresses massive irreparable rotator cuff tears and provides a simple surgical treatment option. InSpace is designed to restore the subacromial space and provide a less invasive solution vs. other surgical treatment options that require fixation devices or grafts, and has been demonstrated to improve shoulder motion and function.
The CMS decision was based on findings from the Level 1 InSpace pivotal study – a prospective, single-blinded, multi-center, randomized, controlled trial which assessed the safety and effectiveness of the InSpace Implant compared to Partial Repair. The study evaluated 184 randomized patients over 40 years of age with symptomatic massive full-thickness rotator cuff tears that failed non-operative management, through 24 months of follow-up.
InSpace, which Stryker acquired in 2019, received FDA 510(k) clearance in 2021.
Source: Stryker
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.