Appeal type: Surgery
Decision: Unfavorable

We decided that the Plandoes not haveto pre-approvethe Vertiflex device for the enrollee.You asked the Planto pre-approvethe device. You say that this is medically necessary, as the device was dislodged at L4-5 and needs to bereplaced.The Plandenied your request. The Plansaysalternative medical services include physical therapy and epidural steroid injections.The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically necessary are not covered. We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying therequest to pre-approve the device. Our reviewer says that the requested device is not medically reasonable or necessary. Our physician reviewer found the enrollee underwent implantation of the Vertiflex device at the L3/4 and L4/5 levels on 12/14/19. She reported on-going grade 5/10 low back pain radiating into the anterior thighs, as well as groin pain, as of 5/27/20. She reported that she could not bend over and felt like her legs were weak. Additional work-up was recommended, including lumbar and hip MRIs and electrodiagnostic studies. She was involved in a high-speed rear-end motor vehicle accident on 6/8/20 with reported increased back pain. Subsequent imaging showed moderate central canal stenosis at L3/4 and L4/5 due to annular bulging and facet/ligamentum flavum hypertrophy with superimposed small central disc protrusion at L4/5, and central disc protrusion at L5/S1 with mild central canal stenosis and moderate bilateral neuroforaminal stenosis. There is MRI evidence of severe left hip arthritis. Theprovider has reported that x-rays showed that the Vertiflex device had dislodged upward from the inferior arms, however the level of dislodging is reported as both L3/4 and L4/5 in the records. Under consideration is a request for revision/replacement of the Vertiflex device. Current evidence based medical guideline and peer reviewed literature do not fully support the spinal decompression device procedure over the 'gold standard' of lumbar laminectomy. FDA indications include implantation of the Superion device at one or two adjacent lumbar levels in patients in whom operative treatment is indicated at no more than two levels, from L1 to L5. This enrollee has moderate central canal stenosis noted at L3/4 and L4/5, and moderate bilateral neuroforaminal stenosis at L5/S1, with milder foraminal narrowing at L1/2 and L2/3. Records prior to the motor vehicle accident indicated the same subjective complaints and objective findings as post-motor vehicle accident. Past medical history is positive for osteoporosis which is a contraindication for the Vertiflex device and is not fully discussed by the provider. Additionally, a search of PubMed did not evidence any evidence based medical literature support for the safety and effectiveness of percutaneous removal and reimplantation of the Vertiflex device. At this point, given the apparent failure of the Vertiflex device to adequately address the enrollee's symptoms prior to being dislodged, there is no compelling rationale presented as to why standard surgical decompression would not be indicated at this time. Therefore, this request for revision/replacement of the Vertiflex device would not be considered medically reasonable and necessary.We looked at this physician's review, the file, and Medicare rules. Based on thisinformation, we decided that Medicare rules for coverage of the device have not been met.Therefore, we decided that the Plandoes not haveto pre-approvethe Vertiflex device for the enrollee.