The North American Spine Society released revised coverage recommendations for recombinant human bone morphogenetic protein BMP-2, adding select off-label indications now supported by clinical data.
The update gives providers a basis for appropriate use of rhBMP-2 and gives payers a standard to build medical policy around, according to Mohamad Bydon, MD, co-chair of NASS’ Coverage Committee and chair of neurological surgery at University of Chicago Medicine. He said the change should reduce denials, appeals and peer-to-peer delays for patients who need the graft option.
While NASS positions the update as a long-overdue alignment of coverage policy with the evidence, physicians say it also raises questions about clinical autonomy, patient selection and the broader fight with payers over biologics. Four physician leaders joined Becker’s to discuss the revised guidance.
Question: How do you feel about NASS’ updated coverage recommendations for off-label rhBMP-2 use? What are your thoughts on the change?
Editor’s note: These responses were edited lightly for clarity and length.
Jay Turner, MD, PhD. Neurosurgeon at Barrow Brain and Spine and Barrow Neurological Institute (Phoenix): I think this is a very positive development, particularly for surgeons with complex deformity and reconstruction practices. There are many clinical scenarios in which off-label use of rhBMP-2 is appropriate and can meaningfully improve the likelihood of a successful fusion, and aligning coverage policies more closely with contemporary practice should reduce unnecessary denials, peer-to-peer reviews, and delays in care.
Alpesh Patel, MD. Orthopedic Surgeon and Co-Director of the Northwestern Center for Spine Health (Chicago): I appreciate the work of Dr. Bydon and the North American Spine Society committee in updating these coverage recommendations, which reflect a matured body of literature regarding rhBMP-2. Including off-label use of innovative spine technologies reinforces the principle of physician-directed decision-making, acknowledging that clinical autonomy is essential when navigating complex spinal pathologies. Nevertheless, as practicing surgeons, we must remain highly judicious; the use of rhBMP-2 in procedures such as anterior cervical discectomy and fusion and transforaminal lumbar interbody fusion carries well-documented complication profiles — including severe prevertebral swelling and heterotopic bone formation — that mandate strict patient selection rather than routine adoption. In many of these cases, there are excellent alternatives to rhBMP-2 already on the market.
From an administrative and advocacy standpoint, these guidelines arrive during an ongoing conflict between third-party payers and the delivery of evidence-based, high-quality care in the U.S. Regarding biologic products in spine surgery, insurance models frequently use restrictive utilization policies and a quagmire of prior authorization processes to override clinical judgment, deny necessary interventions, and delay the delivery of care to patients. I would hope that work from NASS and other scientific surgical specialties will serve as definitive benchmarks to reduce administrative friction, mitigate arbitrary denials, and ensure that treatment parameters remain firmly dictated by clinical data and bedside expertise. For now, guidelines like this are a helpful tool as we fight for timely and effective care for our patients.
Carl N. Graf, MD. Spine Surgeon at Illinois Spine Institute (Schaumburg): The revised NASS rhBMP-2 recommendations appropriately recognize that “off-label” use does not automatically mean experimental, medically unnecessary, or outside the standard of care. FDA labeling is often tied to a specific device, surgical approach, or indication rather than to the underlying clinical validity of the treatment.
BMP use in an ALIF is a good example. When Infuse was originally FDA approved, its indication was specifically tied to the LT-CAGE. As a result, using BMP in another standard, and even more structurally stable ALIF constructs, was technically considered “off-label,” even though the biologic and surgical application was essentially the same. I was personally involved as a member of the FDA Orthopaedic Panel in a meeting addressing this issue years ago. At that meeting, we voted to broaden the indications for BMP, and the FDA labeling was subsequently expanded to include additional interbody devices.
This history is important when evaluating current BMP applications. The relevant question should not simply be whether a particular use is “off-label,” but whether it is supported by current evidence, accepted spine practice, and the individual patient’s risk of a nonunion. The revised NASS recommendations appropriately recognize this distinction and support a more evidence-based, clinically relevant approach to determining the appropriate use of rhBMP-2.
Nitin Khanna, MD. Spine Surgeon at Spine Care Specialists (Munster, Ind.): Today healthcare is truly at a tipping point. Our societies, and more importantly their physician members, will need to take a stand on behalf of our patients and ourselves. BMP coverage is just one small example of what should have happened a long time ago. NASS and AAOS will need to be bold and brave to ensure the future remains in the hands of physicians.
Brian Gantwerker, MD. CEO of The Craniospinal Center of Los Angeles and President of the California Association of Neurological Surgeons: In light of the new coverage recommendations, I feel that this is definitely a step forward for a more pragmatic approach to the use of bone morphogenetic protein. Now that recommendations include the use of it in a cage in transforaminal lumbar interbody fusions and posterior lumbar interbody fusions, I feel that those recommendations offer a stronger pathway to getting insurance approval.
It also acknowledges bone morphogenetic protein’s important role in pseudoarthrosis and in patients with low bone density and osteoporosis. The recommendations do not allow for off-label application, such as in posterolateral fusions, which many surgeons do in lumbar and thoracolumbar cases and sometimes in tenuous posterior cervical operations. The recommendations still do not allow for anterior cervical applications, which I feel is appropriate to continue to not allow.
Overall, this is a good step forward. However, the question remains: will the insurance companies simply ignore it? Their track record has been to cherry-pick things as they see fit, or even make up recommendations based on internal memos and their standard opaque practices rather than actual peer-reviewed literature. In my opinion, insurance companies continue to make medical decisions without the attendant responsibilities or accountability, while doctors are left holding the bag with our patients. Insurers continue to help drive up costs, increase patient suffering, and add to the backlog of patients awaiting appropriate medical treatment as determined by their physicians.
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