Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve the Rezum procedure or use of the UroLife System. 
 
You asked the Plan to pre-approve the Rezum procedure and UroLift system. You say that these services are 
accepted treatments for your condition and should be covered. The Plan denied your request. The Plan says that 
these services are not currently considered reasonable and necessary. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the Rezum procedure and UroLift 
system. Our reviewer says that the requested treatments are considered medically reasonable and necessary in 
this case. Our physician reviewer found the enrollee is a male with benign prostatic hypertrophy (BPH) with 
lower urinary tract symptoms. Management with tamsulosin and finasteride has not been effective with recent 
episodes of urinary retention. Finasteride was discontinued due to side effects (gynecomastia). Prostate size is 
30-35 cc. Cystoscopy reveals lateral lobe hypertrophy without median lobe. Request is for coverage of UroLift 
system or Rezum procedure. 
 
Prostatic urethral lift (PUL) using the UroLift System has been cleared for use by the FDA since 2013. The 
UroLift System is currently indicated for the treatment of symptoms due to urinary outflow obstruction 
secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 
years of age or older. The American Urological Association (AUA) develops scientifically rigorous, peer-
reviewed guidelines in their mission to promote the highest standards of urological clinical care. The 2018 
update to their Guidelines on the Surgical Management of Lower Urinary Tract Symptoms Attributed to 
Benign Prostate Hyperplasia positions the PUL procedure (using the UroLift System) as part of the standard of 
care alongside TURP, laser, and other established procedures. The current peer-reviewed, published scientific 
literature is more than adequate to establish the clinical utility, safety, and efficacy of this minimally invasive 
treatment for BPH. 
 
The American Urological Association (AUA) considers transurethral destruction of prostate tissue; by radio-
frequency generated water thermotherapy, also known as the Rezum procedure, to be a viable treatment of 
benign prostatic hyperplasia (BPH).  Therefore, this procedure should be covered for reimbursement.  The 
AUA does not consider this procedure to be investigational or experimental and, therefore, warrants coverage. 
Water vapor thermal therapy may be offered to patients with LUTS attributed to BPH provided prostate 
volume <80g; however, patients should be informed that evidence of efficacy, including longer-term 
retreatment rates, remains limited.  
 
 
Water vapor thermal therapy may be offered to eligible patients who desire preservation of erectile and 
ejaculatory function. The Rezum System is indicated for men 50 years and older with a prostate volume of = 
30cm3 and =80cm3. The Rezum System is also indicated for treatment of prostate with hyperplasia of the 
central zone and/or a median lobe. The use of Rezum is contraindicated for patients with a urinary implant or 
who have a penile prosthesis. 
 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the Rezum procedure and UroLift system have been met. Therefore, we decided 
that the Plan has to pre-approve the Rezum procedure or use of the UroLife System.  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.