Medical Device Daily Washington Editor

Cardiology is not the only space in the device industry that can give insurers indigestion over the cost of their offerings, and an Oct. 12 coverage policy memo by Aetna (Hartford, Connecticut) indicates the insurer is concerned about rapid adoption, failed procedures, and an inordinate level of outlays for total ankle arthroplasty (TAA). Aetna explains that its latest policy bulletin for TAA "has been revised to state that revision total ankle arthroplasty is considered experimental and investigational for individuals with failed total ankle prosthesis," a bit of news that will not find a receptive audience in at least one U.S. device maker's headquarters.

The coverage memo mentions the Scandinavian total ankle replacement (STAR) system made by Small Bone Innovations (SBI; Morrisville, Pennsylvania), which FDA approved roughly three years ago (Medical Device Daily, May 29, 2009). The following year, the firm indicated it had seen a 40% increase in procedure volume in August 2010 compared to the previous month (MDD, Sept. 20, 2010), a development surely not missed by the insurer.

Aetna remarks that TAA has become quite popular over the past few years, but asserts there are "limited long-term data on the effectiveness" of the procedure. The memo says also that the available data "suggest that total ankle replacement (TAR) has a relatively short lifespan." Consequently, the company says that replacements are ordinarily not recommended for those aged 49 and younger.

Noting that early implants "had a high failure rate," Aetna says that one of the entries in the literature (Guyer and Richardson, 2008) indicated that many orthopedic surgeons ditched the first- and second-generation TAA units over high complication and failure rates compared to arthrodesis, but that despite studies with longer-term data, "there continues to be much debate within the orthopedic community as to indications, patient selection [and] optimal component design."

The memo also makes note of another entry in the literature, Hintermann et al (2011), which is said to have observed that over the past two decades, TAR has "become a viable alternative to arthrodesis for end-stage osteoarthritis of the ankle," and numerous surgeons are said to have started performing the procedure "attracted by the encouraging intermediate results reported in the literature."

The memo adds that the increased market availability of devices has driven an expanded use of TAR in recent years, adding, "in particular, TAR may now be considered even in younger patients." As a consequence, "the number of failures may increase" despite progress in devices and procedures, Aetna remarks.

Aetna said that the FDA-approved labeling for the STAR device, a mobile-bearing system, reads that the safety and efficacy of the device "have not been studied in patients weighing more than 250 lbs," and that "certain vigorous physical activities . . . and trauma to the joint replacement may cause early failure." The memo adds that SBI had agreed to an eight-year follow-up study of the device as a condition of approval, adding that FDA has "already cleared several fixed-bearing ankle devices, which are also options to fusion surgery." Whether the entries in this class of device are satisfactory to patients, however, is another matter.

In what might seem an unusual thumbing of the nose to medical specialty societies, Aetna said the American Orthopaedic Foot and Ankle Society (AOFAS; Rosemont, Illinois) published a position statement in 2003 asserting that total ankle arthroplasty "is a viable option for the treatment of ankle arthritis," but Aetna claimed this position "was not supported by a systematic evidence review."

Aetna expands ultrasound coverage for newborns

Makers of ultrasound equipment fared better than others with Aetna (Hartford, Connecticut) in another Oct. 12 medical policy bulletin, this one declaring spinal ultrasound of newborns and infants medically necessary for a number of applications, including detection of intracranial hemorrhage and sequelae of injury, as well as for evaluation of suspected spinal defects. The procedure is also covered to guide lumbar puncture, in evaluation of spinal dysraphism, as a means of post-operative assessment of cord retethering, and in evaluation of caudal regression syndrome.

However, it should be pointed out that doctors weighed in on this evaluation of coverage, which unlike the total artificial foot issue (see story above) was successful. Aetna acknowledged that its policy is "based on position statements of the American College of Radiology (ACR; Reston, Virginia), and the American Academy of Neurology (AAN; Washington).

Despite the expanded coverage, the insurer indicates it is still unwilling to cover ultrasound in evaluation of neuromusculoskeletal conditions and as an assist for lumbar puncture, a policy that also applies to the practice of epidural and subarachnoid blocks due to lack of data supportive of these indications.

Anthem unenthused over sinus patency devices

Functional endoscopic sinus surgery (FESS) can be assumed to come of age when follow-on devices are coming to market, but Anthem BlueCross BlueShield (Chicago) declared in an Oct. 9 policy bulletin that devices used to maintain sinus ostial patency following FESS are not medically necessary, naming the Propel and Relieva Stratus devices as the two devices of interest.

The data behind the Propel (Intersect ENT, Menlo Park, California) consists of three studies, the third of which randomized more than 100 patients to the Propel or a stent that did not elute the embedded mometasone furonate, thus allowing double blinding. Only 23 patients on the device required post-operative surgical interventions compared to 33 on the comparator stent, a difference driven principally by a reduced need for surgical redress of scar tissue and secondarily by the use of oral corticosteroids. Anthem described the results of this pivotal trial "promising," but bemoaned the "small, heterogenous populations" for the Advance II study and its predecessor study.

Anthem said the Relieva Stratus, by Acclarent (Menlo Park, California) was cleared in 2009, but argued, "there is insufficient evidence from controlled clinical trials" to establish safety and efficacy. The memo mentions adverse events including at least one event in which misplacement of the device in the ethmoid sinus resulted in "penetration of the orbital space requiring surgical removal of the device as well as the surrounding tissue." Hence, Anthem argued, "well designed and conducted trials evaluating the use of these devices are warranted."

Mark McCarty, 703-268-5690

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