Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal - Low back pain.
Treatment: Neurosurgery/Spine services.
The insurer denied Neurosurgery/Spine services.
The denial is upheld.

This is a female patient diagnosed with chronic low back pain. Records indicate the patient was recommended the ReActiv8 Neuromodulation system, which was denied. The provider is appealing this determination.
There is a letter of medical necessity stating that they are requesting neurostimulation for chronic intractable musculoskeletal low back pain. It was stated the patient has suffered from chronic intractable back pain associated with lumbar multifidus muscle dysfunction. She has tried conventional treatments for at least six months including physical therapy, chiropractic care, behavioral modification, psychiatry, acupuncture, and massage. She has also failed pharmacological therapies including nonsteroidal anti-inflammatory drug (NSAID)s, opioids, muscle relaxers, narcotics, nerve medications but pain and functional limitations persist. It was stated that her work status has been impacted and she currently has to work from home from bed. The patient is not a candidate for spinal surgery and is recommended for neurostimulation for episodic contraction of the lumbar multifidus as a nonopioid based treatment for pain.
On the letter of appeal the provider states that the denial is inappropriate and should be reversed. The provider states that the device is approved by regulatory bodies in the United States, states that scientific evidence permits conclusion regarding health outcomes, states that it improves net health outcomes, the patient is a demonstrated candidate, and clinical improvements with the device are attainable outside of the investigational setting and therefore this device should be approved.
At issue is the medical necessity of Neurosurgery/Spine services.

The health plan's determination of medical necessity is upheld in whole.

No, the requested health service/treatment of Neurosurgery/Spine services is not medically necessary for this patient.
Per Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG) guidelines, "Not recommended, including several terms and device variations including percutaneous neuromodulation therapy (PNT), peripheral nerve stimulation (PNS), and peripheral nerve field stimulation (PNFS)...Evidence Summary - Available systems include but are not limited to: 1. Sprint Peripheral Nerve Stimulation System (SPR Therapeutics, Cleveland, Ohio), 2. StimQ Peripheral Nerve Stimulator (Stimwave Technologies Incorporated, Ft. Lauderdale, FL), 3. StimRouter Neuromodulation System (Bioness, Inc., Valencia, CA). Overview: While it has been suggested that peripheral nerve stimulation (PNS) may augment or be a monotherapy for pain treatment, there are still gaps in knowledge requiring further research. Data on these techniques has been limited to case reports, retrospective reviews, and small case series, primarily for occipital nerve stimulation for chronic migraine headache." Records provided indicate the patient has a history of chronic intractable back pain rated on average at 7/10. It was noted she has tried conventional treatments for at least six months including physical therapy, chiropractic care, behavioral modification, psychiatry, acupuncture, and massage, as well as multiple medications. The provider is requesting the ReActiv8 neurostimulation device, which was previously denied, and the provider is appealing this determination. However, the plan notes that peripheral nerve stimulation (PNS) and Reactiv8 stimulation are considered experimental and investigational and unproven. There is no high-quality evidence found in the peer-reviewed medical literature and it appears that available studies are all industry sponsored with potential for bias.
Therefore, the requested health service/treatment of Neurosurgery/Spine services is not medically necessary for this patient.