Sample Letter of Appeal Due to Experimental & Investigational for the UroLift® System Treatment; MAC00115-01 Rev D
[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 of prostatic urethral lift (PUL) as experimental and
investigational. PUL using the UroLift® system is neither experimental nor investigational. This procedure, also as the
transprostatic implant 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
outpatient procedural HCPCS codes, C9739 and C9740; and the National Institute for Clinical Excellence (NICE) issued
recommendation guidance in January 2014.
In 2015, three respected urological societies, the AUA, the Sexual Medicine Society of North America (SMS), and SUFU endorsed
PUL. The AUA letter indicates that UroLift is an appropriate therapeutic tool used by urologists, that it should not be considered
investigational, and that PUL warrants coverage. The SMS has stated that they do not consider the FDA-approved PUL
procedure to be investigational or experimental and states, “We believe that the UroLift® prostatic procedure is a standard
option for the treatment of BPH and that it should be recognized as an appropriate therapeutic tool, which is being used by
many urologists.” SUFU’s President also states that their organization “finds… [PUL] to be a well-studied, medically necessary
option for our patients” and that they “do not consider it to be investigational.”
PUL provides unique and necessary benefits that are both rapid acting and durable. 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 to at
least 3years. 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.
The PUL procedure consists of permanent transprostatic implants placed cystoscopically to retract the obstructing prostatic
lobes and hold open the urethra without requiring incision, resection, or thermal ablation of the prostate. 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 six implants are required. A final cystoscopic view confirms the effect and inspects that all implants are
appropriately positioned.
Prior to PUL, this patient suffered from [List all chief complaints: e.g. interrupted sleep due to nocturia, frequency, urgency
sometimes with urge incontinence, interrupted flow with frequent need to urinate, etc.] for [duration of condition]. After
discussing next steps and alternative treatment options, we elected the minimally invasive PUL treatment because it is
associated with rapid relief, no permanent disruption of sexual function, and can avoid other serious complications associated
with TURP, laser or thermal therapy procedures. In fact, the occasional transient adverse effects associated with PUL, including
mild to moderate hematuria, dysuria, urinary urgency, pelvic pain, and urge incontinence, usually resolve on their own within
two to four weeks. 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 sometimes
permanent negative collateral side effects.
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.
The procedure is currently being used in many countries, including over 300 centers in the USA. The AUA, AMA, and CMS have
determined that the totality of PUL evidence, and its acceptance within the urology community, warranted unique coding to
support it.
In summary, the Prostatic Urethral Lift procedure has been well-studied and reported in numerous high quality peer-reviewed
publications. Results demonstrate that this BPH procedure offers reliable, repeatable results, including rapid relief from
symptoms, increased urinary flow, and improvement in quality of life that are durable through two years. Based on the
abundance of information provided here, it is clear PUL is neither experimental nor investigational.
Please reconsider this claim for coverage and payment of the medically necessary, clinically supported and FDA cleared PUL
treatment.
If I can provide any additional information, please don’t hesitate to contact me at [phone number].
Sincerely,
[Physician’s name]
Enclosures:
Copy of EOB
Supporting Medical Records
UroLift bibliography
Supporting Letters from the AUA, SMS, and SUFU