Opinion ID: 169651
Heading Depth: 5
Heading Rank: 1

Heading: Description of the Bulletin

Text: CPB 28 addresses Aetna's coverage determinations for treatment of TMJ syndrome and TMJ disorders. It contains several statements about TMJI's products that TMJI alleges are defamatory. We proceed to put these statements in context to determine whether they are actionable. In our quotations from CPB 28, we have italicized the allegedly defamatory statements. The bulletin begins with an Important Note stating the sources on which Aetna has relied in reaching the conclusions the bulletin sets forth. The note reads, in part: This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aplt.App. at 177. The bulletin then cautions readers that a conclusion in CPB 28 that Aetna considers a procedure to be medically necessary does not mean that the procedure is covered for a specific policy holder  rather, individual coverage determinations can be made only with reference to the individual's benefit plan, as the individual benefit plan controls over any determination made in the bulletin. Although not stated expressly, the implication of this statement is that a treatment determined in the bulletin not to be medically necessary will never be covered, but the specific circumstances determine whether there is coverage for a treatment that can be medically necessary. The next section, entitled Policy, sets forth Aetna's medical-necessity determinations. Following that section is the Background section, which explains the bases for those determinations. We now explore these sections in some detail. The Policy section lists several nonsurgical treatments that Aetna considers medically necessary. For example, the use of intra-oral devices such as bite guards is considered medically necessary when the patient has documented evidence of difficulty chewing because of TMJ pain or limited joint functionality. Physical therapy is considered medically necessary without the need to demonstrate pain or lack of functionality, but documentation of need is required before coverage will be provided for more than a six-week course of 14 sessions. Various categories of drugs are also considered medically necessary to treat different types of TMJ-related pain, as are relaxation and behavior-modification therapies. Treatment in specialized pain centers, however, is considered medically necessary only for those few individuals who have been unresponsive to less comprehensive interventions. Id. at 179. Other medically necessary pain-management techniques include acupuncture, injecting pain medication into the joint, and dry needling (sticking a needle into TMJ-related muscles without injecting any substance). Surgical management options are much more restricted. The bulletin reminds readers that any request for surgical intervention must be reviewed by the Oral and Maxillofacial Unit and will be granted only when the patient has been unresponsive to nonsurgical treatments and surgery is the only remaining option. Acceptable surgical interventions include arthrocentesis (surgically flushing fluid from the TMJ joint and stretching it), arthroscopy (using an instrument to diagnose and repair the joint), and joint-reconstruction surgery. The bulletin describes TMJ implants as the most invasive surgical option. Regarding such surgery, CPB 28 states: Aetna considers the TMJ Concepts prosthesis medically necessary when used as a salvage device for treatment of end-stage TMJ disease, when no other viable therapeutic alternatives are available. The use of the Christensen TMJ Fossa-Eminence Prosthesis System (partial TMJ prosthesis) and the Christensen TMJ Fossa-Eminence/Condylar Prosthesis System (Christensen total joint prosthesis) are considered experimental and investigational. Id. (emphasis added and internal quotation marks omitted). In other words, use of the TMJ Concepts device is strictly circumscribed, whereas TMJI's devices are not considered medically necessary under any circumstances because Aetna has determined that they are experimental and investigational. TMJI's devices are not unique in this regard. The list of treatments that Aetna will not cover because it has determined them to be experimental and investigational includes 10 diagnostic procedures and 16 nonsurgical management treatments. Four surgical treatments are considered experimental and investigational for diagnosis and treatment of TMJ disorders : . . .  Christensen total TMJ prosthesis  Modified condylotomy [(surgical division of the condyle)] or intraoral vertical ramus osteotomy [(cutting of the ramus)] . . . when submitted with a diagnosis of internal derangement of the temporomandibular joint  Treatment of alveolar cavitational osteopathosis . . .  Partial temporomandibular joint prostheses. Id. at 179-180 (emphasis added). The Background section contains a comprehensive explanation of Aetna's Policy decisions. The thrust of the discussion is that caution should be used in treating TMJ dysfunction, and surgery of any kind is an option of last resort. The bulletin explains that the causes of TMJ dysfunction are generally unknown, but that it is thought to be the result of trauma to the joint. The cause of some TMJ trauma is obvious, such as extreme force applied to the joint (as may occur in an accident), whereas other causes, such as stress, anxiety, and sleep disorders, create the damage over time. According to the bulletin, because of a paucity of evidence-based outcome research and lack of consensus on the appropriate management of [TMJ dysfunction], id. at 180-81, there is wide variation in how clinicians treat TMJ dysfunction. It states that there is a lack of [s]cientifically valid clinical trials for most TMJ therapies and there is no objective, generally accepted diagnostic approach for identifying TMJ dysfunction. Id. at 181. As general support for its limitations on coverage, the bulletin quotes the National Institutes of Health's (NIH) recommendation that TMJ therapies be CONSERVATIVE & REVERSIBLE. Id. The Background section then proceeds to discuss specific surgical treatments. A number of surgical techniques are considered experimental and investigational because of a lack of evidence supporting their efficacy. For example, it states: Aetna considers modified condylotomy to be experimental and investigational. There are no controlled studies of modified condylotomy. Controlled studies are important because, according to an NIH Consensus Conference, up to 90 percent of TMJ patients['] symptoms resolve spontaneously. In addition, the literature on modified condylotomy comes almost exclusively from a single group, raising questions about the generalizability of findings. Furthermore, disc displacement is extremely common, and there is no direct evidence that disc displacement is a cause of TMJ symptoms. Id. The discussion of the partial- and total-joint devices is lengthy: A partial TMJ prosthesis consists of a meniscectomy and placement of a metallic glenoid fossa metal prosthesis (Christensen fossa-eminence prosthesis, TMJ, [sic] Inc., Golden, CO) in place of the meniscus, such that a natural condyle articulates with a metal fossa prosthesis. There is inadequate evidence from published clinical outcome studies of the safety and effectiveness of partial joint prostheses in the treatment of [temporomandibular disorders]. The U.S. Food and Drug Administration Dental Products Advisory Panel reviewed clinical studies of the Christensen fossa prosthesis, and advised the FDA to approve the total prosthesis, but to not approve the partial joint prosthesis because of a lack of clinical data on its safety and effectiveness. The information submitted to the FDA on the safety and effectiveness of the partial TMJ prosthesis is limited and has not been published in a peer-reviewed journal. In an editorial, Laskin (2001), former editor-in-chief of the Journal of Oral and Maxillofacial Surgery, the official journal of the American Association of Oral and Maxillofacial Surgeons, commented on the data on the partial TMJ prosthesis presented to the FDA Dental Products Advisory Panel: At that meeting [of the FDA Dental Products Advisory Panel where the partial TMJ prosthesis was considered] the FDA staff presentation expressed concern regarding the lack of data on the effect of the natural condyle articulating against a metal fossa, the limited number of patients with long term follow-up, and the broad diagnosis of internal derangement as an indication for its use. The panel expressed similar concerns about these issues, as well as the fact that the registry data provided in support of the product did not include all the patients treated and the sample size was insufficient for each of the individual indications. They recommended clarification of the patient inclusion criteria in the clinical study, evaluation of failures and additional patient follow-up, more clearly defined indications for use of the device, and that a power analysis of the clinical data be done to place the PMA in an approvable form. However, despite these criticisms, and the panel's opinion that adequate safety and effectiveness data for the given surgical indications were lacking, the device was approved by the FDA for distribution in February 2001. Laskin (2001) concluded that there are insufficient data to answer questions about the safety and effectiveness of the partial TMJ prosthesis. For example, how reliable are clinical data based on a registry that did not include all patients treated with the device, in which there was a very small number of total patients with serial data and even smaller numbers in each diagnostic sub-category, and where in 1 group of 97 patients with a diagnosis of internal derangement and/or inflammatory arthritis, only 30% (12 subjects) had a follow-up of 3 or more years and 70% were either lost to follow-up, withdrawn, or potentially lost to follow-up. How can one make an informed decision with such information? Aetna considers the Christensen total joint prosthesis experimental and investigational because it has not been shown to be as effective as the TMJ Concepts total joint prosthesis. An evaluation study has reported significantly better post-surgical outcomes with the TMJ Concepts total joint prosthesis than the Christensen total joint prosthesis. Wolford, et al. (2003) reported the results of a study comparing the Christensen total joint prosthesis (TMJ, Inc., Golden, CO) with the TMJ Concepts total joint prosthesis (TMJ Concepts Inc., Camarillo, CA) in 45 patients, 23 of whom were treated with the Christensen prosthesis, and 22 of whom were treated with the TMJ Concepts Prosthesis. The investigators reported that, although subjects treated with either total joint prosthesis showed good skeletal and occlusal stability, the subjects treated with the TMJ Concepts Prosthesis had statistically significant improved outcomes compared to subjects treated with the Christensen prosthesis with respect to [various indicators]. The investigators concluded [a]s a result of our study, it appears that [TMJ Concepts Prosthesis] provides a more biologically accepted and functional prosthesis than the [Christensen prosthesis] for the complex TMJ patient. Id. at 181-82 (emphasis added). Finally, the bulletin concludes with a list of 57 references on which Aetna based its TMJ treatment-coverage determinations.