From loosened restrictions for 3D printing to increased regulations for the use of stem cell-based products, here are the next regulatory changes that three spine surgeons want to see in the field.
Ask Spine Surgeons is a weekly series of questions posed to spine surgeons around the country about clinical, business and policy issues affecting spine care. We invite all spine surgeon and specialist responses.
Next week's question: What technology, not currently available, are you most looking forward to in spine?
Please send responses to Alan Condon at acondon@beckershealthcare.com by 5 p.m. CDT Wednesday, Oct. 14.
Note: The following responses were lightly edited for style and clarity.
Question: What is the next major regulatory change you would like to see in the spine field?
John Burleson, MD. Hughston Clinic Orthopaedics (Nashville, Tenn.): I am interested to see how 3D printing is regulated over the next few years. I would like to see standards that are very strict in terms of quality, but would like more freedom for implant manufacturers and surgeons to create patient-specific implants in shorter time frames.
Jeffrey Wang, MD. USC Spine Center (Los Angeles): I hope to see some guidelines, rules or requirements for some evidence in the field of stem cells for spinal pathologies. The availability of stem cell procedures around the world is full of unproven techniques and marketing materials, yet there is an enormous lack of evidence. We need to see some type of standardization — or at least appropriate labeling — of available treatments offered today, with some transparency regarding the evidence supporting the efficacy of the treatment offered. Today, patients are paying cash for these highly marketed "stem cell" injections in the spine with very little scientific support for improved outcomes, and in some cases, a lack of evidence that the injection even works.
Brian Gantwerker, MD. Craniospinal Center of Los Angeles: One simple change that could make an amazing difference is mandating insurance companies link authorization to reimbursement. It would allow physicians to stay open, get the patients access to physicians that are in their plans and still allow payers to stay liquid.