MAC00161-01 Rev A - Sample Letter of Appeal Due to Denial for Medical Necessity [Date] Re: [Insert Patient Name] [Insert Claim #] [Insert Date of Service] [Insert Patient ID #] [Insert Patient DOB] Dear [Name of Medical Director or Insurance Company]: I am requesting reconsideration of the above referenced denial for lack of medical necessity. Prostatic Urethral Lift (PUL), using the UroLift® transprostatic implant system was medically necessary for this patient. This procedure has been cleared for use by the FDA since 2013 for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men 50 years of age and older. PUL is also supported by numerous high level, well designed studies now published in notable peer reviewed journals, including the distinguished Journal of Urology (see attached bibliography). In addition, the American Urological Association supported the development of Category I CPT® codes 52441 and 52442 that became effective January 1, 2015; CMS has supported the technology through the development of current procedural HCPCS codes, C9739 and C9740; and the National Institute for Clinical Excellence (NICE) issued a recommendation guidance in January 2014. For medically appropriate patients, like Mr. [Patient Last Name], PUL provides unique and necessary benefits that are both rapid acting and durable. PUL was medically necessary for this patient due to his urinary symptoms caused by BPH. [Describe medical necessity, including length of symptoms, size of prostate, previous treatments tried and why they were discontinued, and the results of any other tests or assessments demonstrating medical necessity.] [Describe why UroLift® was appropriate for this patient, such as: On anticoagulants, therefore more invasive surgeries carry a risk of bleeding Need for a less invasive procedure or less anesthesia Patient concerned with preserving sexual function Fewer risks of permanent side effects such as incontinence, bladder neck contracture, retrograde ejaculation, etc. Less chance of post-op catheterization] Consistent across all studies, the totality of evidence demonstrates rapid symptom relief, improved urinary flow and an improvement in quality of life that is durable through 2 years. PUL also does not require an overnight stay, can be conducted under local anesthesia, shows return to preoperative activity in under a week, avoids complications associated with other BPH treatments, and uniquely preserves sexual function. TURP, laser vaporization or thermal therapy procedures are associated with potentially serious complications such as permanent incontinence, erectile dysfunction, strictures or bladder neck contracture. However, the occasional transient adverse events associated with PUL, including mild to moderate hematuria, dysuria, micturition urgency, pelvic pain and urge incontinence typically resolve on their own within two to four weeks. I believe this revolutionary treatment will change the way BPH is treated. The PUL procedure consists of small permanent transprostatic implants being placed cystoscopically to retract the obstructing prostatic lobes and hold open the urethra without requiring incision, resection, or thermal ablation of the prostate. PUL can be done under local anesthesia in any site of service, including the office. After applying appropriate anesthesia, cystoscopy is conducted to plan ideal placement of the implants. The cystoscopy bridge is then replaced with the UroLift delivery device housing a telescope and, after compressing the prostate lobe at the appropriate location, the implant is deployed. The urethra is again cystoscopically examined to assess the effect and determine the required number of implants. This process continues until a continuous channel is achieved through the prostatic urethra. Typically four to five implants are required. A final cystoscopic view confirms the effect and inspects that all implants are appropriately positioned. Not treating or delaying treatment of this condition can result in deterioration of bladder function, urinary retention, recurring urinary tract infection and deterioration in quality of life. It is my professional medical opinion that PUL was the best treatment option for this patient not interested in more invasive BPH treatments that include tissue resection or ablation and are commonly associated with increased bleeding, lengthy recovery and sometimes permanent negative collateral side effects. In summary, the Prostatic Urethral Lift (PUL) procedure has been well-studied and reported in numerous high quality peer-reviewed publications. Objective results demonstrate that this BPH procedure offers rapid relief from symptoms, increased urinary flow, and improvement in quality of life that are durable to at least two years. Based on the abundance of information provided here, it is clear PUL is not only broadly accepted in the urology community, but was medically necessary for this particular patient. Please reconsider this request for coverage and payment at your earliest convenience or contact me at [phone number] if I can provide additional information. Sincerely, [Physician’s Name] Enclosures: Copy of EOB Pertinent Medical Records UroLift Bibliography UroLift System Clinical Results