Ambulatory surgery centers have continued to flourish this year, a trend accelerated by the COVID-19 pandemic. There are still some barriers to this shift, however, including a reimbursement gap for procedures performed at a hospital outpatient department versus an ambulatory surgery center. That's why it's smart for medical device companies, like Stryker, to pursue reimbursement codes for their devices to be used at ambulatory surgery centers.

Stryker recently announced that the Centers for Medicare & Medicaid Services (CMS) has established a new Healthcare Common Procedure Coding System (HCPCS) code for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker's InSpace balloon implant.

"Pursuing an HCPCS code for InSpace has been a top priority for us to enable greater access for patients and surgeons in the treatment of MIRCTs," said Matt Moreau, Stryker's sports medicine VP/GM. "Reimbursement for new technologies can be a significant barrier for healthcare professionals and their patients. We are excited about the CMS code decision and are committed to continuing to provide opportunities to help create better care and access for patients."

The Kalamazoo, MI-based company said the new HCPCS 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 biodegradable implant is used in procedures for massive irreparable rotator cuff tears (MIRCTs), a common cause of shoulder dysfunction.

The InSpace balloon implant is designed to restore the subacromial space, provides a less invasive solution compared to other surgical treatment options that require fixation devices or grafts, and has been demonstrated to improve shoulder motion and function, Stryker noted.

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 implant compared to partial repair. The study evaluated 184 (n=93 InSpace; n=91 partial repair) randomized patients over 40 with symptomatic massive full thickness rotator cuff tears that failed non-operative management, through 24 months of follow-up.

The results of the Level 1 InSpace study were published recently in the Journal of Bone and Joint Surgery. Results of the two-year study demonstrated the InSpace implant as an appropriate alternative to partial repair in patients with MIRCTs. The study also revealed notable patient benefits including early functional recovery and pain relief combined with a shorter operative time.

Stryker CEO: There is a monumental shift that will occur over the next decade of procedures moving out of the hospital toward surgery centers

Before COVID-19, Stryker's patients were somewhat reticent about going to a surgery center, Stryker CEO Kevin Lobo said during a panel discussion in October 2020 at The Virtual MedTech Conference, hosted by AdvaMed.

"Now the idea of going home the same day is very appealing. They just don’t want to be in the hospital around other sick people, and a lot of the rehab can happen at home," Lobo said. "Telerehab will be big in the future."

That shift toward ambulatory surgery centers means significant changes to the way Stryker does business, Lobo said.

"We've had to change our company. The center of our universe was the hospital operating room, and you cannot show up the same way to a surgery center with 22 sales reps all calling on the surgery center. They're not able to receive that," Lobo said. "I think the medtech companies that are in the hospital OR as the center of gravity have to change their approach and really have a different offense for their surgery centers. It's a big change for us."