Download Denial due to experimental and investigational

MAC00115-01 Rev B - Sample Letter of Appeal Due to Experimental & Investigational for the
UroLift® System Treatment
[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 claim that I believe was erroneously denied as
experimental and investigational. The transprostatic implant procedure using the UroLift® System is
neither experimental nor investigational. This procedure also known in the clinical data as Prostatic
Urethral Lift (PUL) 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 was successful in their bid earlier this year for Category I CPT® coding that became effective
January 1, 2015. CMS has also supported the technology through the development of procedural HCPCS
codes, C9739 and C9740, that became effective earlier this year.
For appropriate patients, like Mr. [Patient Last Name], 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 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.
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.
Prior to PUL, my patient, Mr. [Patient Last Name], 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, he 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.
The procedure is currently being practiced in many countries, including over 100 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 addition, the National Institute for
Health and Care Excellence (NICE) issued guidance in January 2014 recommending the use of PUL under
normal arrangements.
In summary, the Prostatic Urethral Lift (PUL) procedure has been well-studied and reported in numerous
high quality peer-reviewed publications. 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 neither experimental
nor investigational.
Please reconsider Mr. [Patient Last Name] 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
Pertinent Medical Records
UroLift Bibliography
UroLift System Clinical Results