SAMPLE LETTER OF MEDICAL NECESSITY

[Date] [Insurer Name][Address] [City, ST, Zip] [Attn: Claims Department] Re:[Patient Name] [Policy Number, Group Number, Patient ID Number [DOB]] Treatment Date and Claim Number Amount [provide total dollar amount of charges filed] To whom it may concern: I am writing you in response to your denial of the enclosed claim for the administration of SYNVISC® (hylan G-F 20) to treat osteoarthritis of the knee. Your company has denied coverage for this treatment for [insert patient name] for the following reasons listed on the attached EOB: [List EOB reason for denial code and definition]. I am submitting the claim for reconsideration. This letter provides information about the patient’s medical history and diagnosis, a statement summarizing my treatment rationale, and a copy of the product’s labeling. Mr./Ms. [Insert Patient Last Name] was administered SYNVISC to treat pain associated with osteoarthritis of the knee. SYNVISC is a physician-administered injectable prosthetic device that supplements the synovial fluid of the osteoarthritic knee, helping to restore the elastoviscosity in the joint. Successful treatment reduces pain. The history of Mr./Ms. [Insert Patient Last Name]’s osteoarthritis is as follows: [Discuss patient’s diagnosis, treatment history, cause and degree of illness, and need for SYNVISC therapy.] SYNVISC is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). SYNVISC is manufactured and distributed by Genzyme Corporation. The U.S. Food and Drug Administration approved SYNVISC for marketing as a class III medical device on August 8, 1997. There is ample clinical literature to support the use of Synvisc for the treatment of osteoarthritis of the need. In summary, the use of SYNVISC is medically necessary and reasonable for [Mr./Ms Patient Last Name]’s condition, and warrants coverage. Please contact me if you require additional information. Sincerely, [Physician’s Name] [Title] 02/2005 [The following is a suggested list of relevant clinical articles that your office staff can use to support medical necessity for SYNVISC® (hylan G-F 20). This list is not exhaustive, and is intended to serve as a reference to help you prepare the prior authorization request. Your office should decide which documents are most appropriate for submission.] Adams M. The role of viscosupplementation with hylan G-F 20 (Synvisc®) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone; hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis and Cartilage. 1995;3:213-226. Jackson D. Accuracy of needle placement into the intra-articular space of the knee. Journal of Bone & Joint Surgery. 2002;84A:1522-1527. Scale D. Viscosupplementation of Osteoarthritic Knees With Hylan: A Treatment Schedule Study. Current Therapeutic Research. 1994;55(3). Wobig M. Viscosupplementation with Hylan G-F 20: A 26-Week Controlled Trial of Efficacy and Safety in the Osteoarthritic Knee. Clinical Therapeutics. 1998;20(3). 02/2005

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