Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Temporomandibular joint disorder

Treatment: J0585, Botulinum Toxin (Botox) injection

The insurer denied coverage for J0585, Botulinum Toxin (Botox) injection

The denial is upheld

This is female patient with a history of temporomandibular disorder (TMD). She presented to the Pain Management physician's office for the evaluation of TMD. The physical examination revealed dystonia of jaw muscles and significant crepitus with jaw closing and opening. When the patient talks, she does not fully open her mouth. The patient had trigger point injections of the bilateral masseter, buccinators, and lateral pterygoid. There was 15 percent (%) relief. The physician recommended Botox injections to treat TMD symptoms.

Medical necessity is not substantiated nor supported by current medical literature for the treatment of TMD. Although there is evidence that Botox is helpful for certain conditions such as muscle contractures in cerebral palsy, migraine headaches, cervical dystonia, and hyperhidrosis, there is insufficient evidence to support the treatment of this patient's myofascial pain. In a network meta-analysis (NMA) of randomized trials for myofascial pain of the masticatory muscles it was concluded that Botox may hold some promise as an injection therapy, but no definite conclusions could be drawn (1). In a separate review of clinical effectiveness, la Fleur concluded "None of the included systematic reviews expressed confidence in the clinical effectiveness of Botox for treating temporomandibular disorder (TMD). While there were some primary studies indicating improvements in pain scores for botulinum toxin relative to saline injections, this finding was not consistently reported across all studies and the clinical significance of the improvements was uncertain. The evidence suggests that botulinum toxin is not superior to occlusive devices, dry needling or fascial manipulation."

Botox is not FDA (Food and Drug Administration) approved for the treatment of this patient's diagnosis of TMD, dystonia of jaw muscles (buccinators, masseters) with significant crepitus with jaw closing and opening.

Per submitted medical records the patient has not tried any other medical therapies or treatments. Furthermore, "trigger point injections of bilateral masseter, buccinators, and lateral pterygoid" provided the patient minimal relief.

Alternative therapies such as anti-inflammatories, muscle relaxants, physical therapy, oral splints, or mouth guards (currently being used by patient), acupuncture and relaxation techniques are all equivalent treatment options in terms of outcomes and quality of life.

Repeat Botox injections may cause permanent muscle paralysis. Misplacement of Botox injections may cause temporary denervation of adjacent muscles outside of the intended treatment area. Injections of any kind bring risk of allergic reaction, infection, pain, or bleeding.

Upon review of submitted documentation which includes treatment records and narrative report of treating providers, it appears that this patient has a primary diagnosis of TMD, dystonia of jaw muscles (buccinators, masseters) with significant crepitus with jaw closing and opening. This patient has been under the care of her dentist and Physical Medicine and Rehabilitation (PM&R) physician who recommended Botox injections as enumerated above to treat the jaw/muscle pain. Although there is evidence that Botox is helpful for certain conditions there is insufficient evidence to support this treatment as being of value in managing this patient's myofascial pain based on the information presented. The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of J0585, Botulinum Toxin (Botox) injection should be upheld.