For most of the last five years, a spine implant with an FDA breakthrough device designation had a reliable head start on Medicare payment. The designation was treated as proof that a device represented a substantial clinical improvement over existing treatments, one of three tests every applicant for a new technology add-on payment, or NTAP, must clear. That shortcut is disappearing, however. Under a provision of the fiscal 2027 inpatient prospective payment system final rule, CMS is eliminating the alternative NTAP pathway beginning with applications for fiscal 2028. Every applicant, regardless of FDA designation, will have to prove substantial clinical improvement through the traditional pathway.
Spine devicemakers have used this shortcut. Here is what its elimination could mean for the industry.
1. Two spine implant manufacturers used this shortcut to secure additional reimbursement.
Carlsmed’s aprevo personalized interbody implants were among the spine technologies to benefit from the pathway. The device received breakthrough designation and 510(k) clearance, and Carlsmed secured an NTAP for lumbar fusion procedures beginning in fiscal 2022. Its cervical implant later secured an NTAP beginning in fiscal 2026.
SI-Bone’s iFuse Bedrock Granite implant, used for pelvic fixation and sacroiliac joint fusion in conjunction with lumbar spinal fusion, also received breakthrough designation and an NTAP. The company’s iFuse TORQ TNT implant system received an NTAP for pelvic fracture treatment beginning in fiscal 2026.
2. Spine devices already in the program keep their payments.
Aprevo and the iFuse implants will not lose payments they have already secured because of the repeal.
CMS also created a transition period: A device that receives breakthrough designation by Sept. 30, 2026, can still use the alternative pathway for fiscal 2028 and 2029 add-on payments, provided it receives marketing authorization for the covered indication by May 1, 2028.
That gives spine technologies already moving through the FDA process a window to qualify under the existing pathway.
3. Spine devicemakers stand to lose a payment premium.
The repeal addresses supplemental payments rather than whether Medicare covers a device. Without an NTAP, qualifying inpatient procedures are generally reimbursed through the applicable Medicare severity diagnosis-related group without the additional new technology payment.
Those add-on payments can be significant. Carlsmed’s cervical aprevo implant, for example, became eligible for up to $21,125 in additional reimbursement for qualifying inpatient cases beginning Oct. 1, 2025. SI-Bone’s iFuse TORQ TNT system became eligible for up to $4,136 in additional inpatient reimbursement.
For a spine sector increasingly developing personalized and AI-planned implants, the additional reimbursement can help hospitals absorb the cost of adopting new technology. Losing the fast track does not shut those devices out of Medicare, but it does mean future products will have to make a stronger clinical case to secure the additional payment.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
