Opinion ID: 169651
Heading Depth: 4
Heading Rank: 3

Heading: cigna cpn 156

Text: Having disposed of the statements in CPB 28, we turn to TMJI's allegations that CIGNA published defamatory statements about TMJI products in its TMJ-surgery bulletin, CPN 156. That bulletin states that CIGNA HealthCare does not cover partial joint replacement with the Christensen Fossa Eminence Prosthesis (TMJ Implants, Inc.) Partial TMJ Replacement System because it is considered experimental, investigational, or unproven, Aplt.App. at 194, and that [t]here is insufficient evidence in the published medical literature to establish the clinical efficacy or long-term outcome of implantation of partial TMJ prostheses, id. at 197. TMJI complains that saying that its partial-joint devices are considered experimental, investigational, or unproven, id. at 194, is defamatory. The bulletin does not otherwise define the terms experimental, investigational, or unproven ; we must therefore discern their meanings from the context in which they are used. Once again we italicize the allegedly defamatory statements in our quotations from the bulletin. The bulletin begins with a paragraph instructing the reader on how to use the bulletin. Like Aetna's bulletin, it tells readers that their individual benefit plans always control in the event of a conflict between a statement of coverage in CPN 156 and one in the individual plan. It informs readers that some benefit plans exclude TMJ treatment altogether. It then states that CIGNA covers arthrocentesis, arthroscopy, and arthrotomy (open-joint surgery) when certain listed medical-necessity criteria are met. For such a procedure to be covered, pain must have persisted despite at least six months of scientifically recognized non-invasive therapies, including pain medication, intra-oral devices, and physical therapy. Id. at 193. In addition, clinical examinations must document specific joint conditions for each treatment. The bulletin then states: CIGNA . . . covers arthrotomy with total prosthetic joint replacement using The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis for temporomandibular disorder when ALL the following medical necessity criteria are met and indication for surgery is confirmed by MRI, CT or corrected tomogram:  inflammatory arthritis involving the TMJ not responsive to other modalities of treatment  recurrent fibrosis and/or bony ankylosis not responsive to other modalities of treatment  failed tissue graft  failed alloplastic joint reconstruction  loss of vertical mandibular condylar height due to bone resorption, trauma, developmental abnormality or pathologic lesion CIGNA . . . does not cover partial joint replacement with the Christensen Fossa Eminence Prosthesis  (TMJ Implants, Inc.) Partial TMJ Replacement System because it is considered experimental, investigational, or unproven. Id. at 194 (emphasis added). The bulletin does not discuss TMJI's total-joint prosthesis. CPN 156 then provides a General Background that describes the anatomy of the TMJ and sets forth several symptoms that may indicate the presence of TMJ disorders, including pain in the face or jaw, headaches, dizziness, limited mouth opening, and clicking or popping sounds. It discusses the prevalence of TMJ disorders, noting that [a] majority of the general population have at least one sign of TM[J disorders]. Id. The bulletin states that [t]here is no widely accepted standard test to diagnose TM[J disorder], id. at 195, but that physical examination combined with reported symptoms generally provides sufficient information for a diagnosis. Regarding treatment options the bulletin states that [n]on-invasive, reversible therapies are used in the initial treatment of [TMJ disorders]. Id. These include pain-control drug therapies, physical therapy, and intra-oral appliances. When these conservative therapies are unsuccessful, surgical options may be considered. In discussing surgical treatment, the bulletin states that the most invasive surgical technique to treat TMJ disorders is arthrotomy, id. at 196, which can involve total  or partial-joint reconstruction with prosthetic implants. Because [t]here is inadequate guidance in the published medical literature regarding patient-selection criteria for these procedures, this surgical option should be considered only when all appropriate conservative treatment has failed and minimally invasive surgery . . . is not indicated. Id. CPN 156 explains that there are two FDA-approved prosthetic systems, the TMJ Concepts system and TMJI's devices. The TMJ Concepts device is approved for total-joint reconstruction in certain patients but should only be considered for end-stage [TMJ disorders] when no other medical or surgical options are available. Id. As to TMJI's partial-joint prosthesis, the bulletin acknowledges that the FDA approved it in 2001 for use in patients with any of five indications and that a retrospective study reported that patients who had received the implant experienced significant pain relief. But it notes that the study also advised that rigorously controlled prospective studies were needed to investigate the procedure. Id. at 197. CIGNA thus concludes that [t]here is insufficient evidence in the published medical literature to establish the clinical efficacy or long-term outcome of implantation of partial TMJ prostheses. Id. (emphasis added). The bulletin ends with a list of 20 references relied on for the information and determinations in the bulletin. As with the Aetna bulletin, the terms experimental, investigational, or unproven take on meaning only as the CIGNA bulletin explains why a procedure or device merits those adjectives. The bulletin's statement that there is insufficient evidence in the published medical literature to establish the clinical efficacy or long-term outcome of implantation of partial TMJ prosthesis amounts to its definition of those terms as they are used in CPN 156. In other words, in the context of the bulletin, to say that the partial-joint prosthesis is experimental, investigational, or unproven is to say that there is insufficient evidence supporting its efficacy. The statement that evidence is insufficient, however, is not defamatory because it is not provably false. As we said in the discussion of the Aetna bulletin, people may differ on the quantity or quality of information that they require before they deem it sufficient. The challenged statements in CPN 156 are therefore not defamatory.