Medical Device Daily Washington Editor

Aetna (Hartford, Connecticut) has released a clinical policy bulletin stating that the evidence behind two electromagnetic field treatments for major depression is not enough to justify covering the treatments, putting makers of these devices in a position of needing to generate more evidence to support such coverage. One of the pressures on Aetna, however, is that one of the BlueCross/BlueShield carriers, Anthem (Chicago), does cover transcranial magnetic stimulation (TMS) for major depression, a fact device makers can use to pry other insurers off the fence. One of the effects of the Aetna bulletin may be to generate more activity on the parts of device makers to make their arguments to Aetna in the hopes of turning the situation around.

The Aug. 28 statement by Aetna indicates that a number of other disorders are deemed experimental as well, including schizophrenia and migraines for TMS and headaches for cranial electrotherapy stimulation (CES). However, schizophrenia did not fare well in the BlueCross/BlueShield (Chicago) technology evaluation of TMS either, with the evaluation deeming the evidence less than compelling even for treatment of auditory hallucinations associated with schizophrenia (Medical Device Daily, Dec. 21, 2011). The Aug. 13 decision by Anthem to cover TMS is limited to major depressive disorders for patients with one of five qualifying status indicators, including patients who are refractory to multiple efforts at pharmacological therapy. Anthem evinces no greater affection for the evidence behind schizophrenia than Aetna.

Among the studies cited by Aetna in justifying the announcement is a meta-analysis conducted in 2003 by Martin et al of randomized trials with a sham treatment control arm, but that analysis concluded that the trials were of “low quality“ and offered insufficient evidence to support the use of TMS in major depression. Anthem, too, cites the Martin meta-analysis, and both insurers discuss a 2011 assessment by the Agency for Healthcare Research and Quality (Gaynes et al) in their decisions. Anthem cites Gaynes more in the context of the epidemiology of major depression whereas Aetna states that the Gaynes effort disclosed little evidence comparing TMS to other approaches for treatment-resistant depression.

Aetna's citation of other conditions hints that the insurer has heard regarding these treatments for them, but Mary Hailey, VP for healthcare policy at Neuronetics (Malvern, Pennsylvania) told Medical Device Daily that major depression is almost certain to be covered before any of the others. “Clearly the majority of the literature on the conditions studied is on depression,“ she said.

When asked whether Aetna might reconsider the depression indication simply because at least one other insurer covers it – as opposed to hearing from device makers making the other-insurer argument – Hailey said, “it's a combination“ of the two. “Part of what you have to do is educate them on what they're being asked to pay for,“ she continued, and part of that persuasive case is the fact that another insurer is covering the treatment.

“Where one insurer may say 'that is clearly enough evidence,' another says 'no,'“ despite reviewing identical evidentiary bodies, Hailey observed. “But once you start to gain traction, you can address that with other payers. It's not a guarantee the other payers will start,“ she said, but “you do start to gain traction.“

Regarding whether Neuronetics sees a difference between the 15 regional Medicare carriers in terms of their amenability to covering this kind of treatment, Hailey said, “I think in general you do“ see some differences, adding “part of it has to do with the experience in the jurisdiction“ in terms of providers who have used the technology in question. “That's really how a lot of those decisions go“ at the local carrier level, she commented.

Aetna likes bone growth stimulators

Aetna posted several clinical policy bulletins on Aug. 28, including one addressing the use of ultrasonic bone growth stimulators for two indications, both of which Aetna deemed high-risk sites. Henceforth Aetna will cover the use of ultrasound bone growth stimulators for “fresh fractures, fusions or delayed unions“ of the navicular carpal bone and of open or segmental tibias. The statement also indicates coverage of the use of this technology for the limbs (appendicular skeleton) when the patient has been diagnosed with non-unions, failed arthrodesis, and congenital pseudarthrosis when the patient has had little luck with healing despite appropriate fracture care for three months or longer.

However, the insurer indicates it will stand pat on the question of the use of ultrasound to deal with fresh fractures, fusions or non-unions of the skull and spine, as is the case for avascular necrosis of the femoral head, Sever's disease of the heel, Charcot foot, stress fractures, and fractures due to malignancy. The bulletin states that Aetna will make an exception in the case of fractures due to malignancy upon demonstration that the the underlying disease is in remission.

FDA sets meetings for post-market surveillance

Post-market surveillance is of intense interest at FDA's Center for Devices and Radiological Health, and the agency has announced three meetings to discuss such matters, all of which will take place in the second week of September. All the meetings will be webcast, and the agency recommends registration by Sept. 5 for those interested in catching the webcasts.

On Sept. 10, FDA will hold a public meeting at the Greenbelt Marriott Hotel (Greenbelt, Maryland) to obtain public feedback “regarding the medical device post-market surveillance system in the U.S.“

The following day, FDA will hold a workshop at the Greenbelt Marriott sporting the ungainly title of “MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities.“ The topics will be setting strategic priorities and implementing an action plan for sustainable partnership toward improving regulatory science and the public health.

FDA's meeting at the Greenbelt Marriott on Sept. 12 will address registries. The contact person for these meetings is Danica Marinac-Dabic, PhD, (301–796–6689,

Mark McCarty, 703-268-5690