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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that water vapor thermal therapy uses convective water vapor energy to ablate prostatic tissue. 
The Rezum system for delivering water vapor thermal therapy received FDA 510(k) clearance in 2015 to treat 
LUTS/BPH in men = 50 years old with a prostate volume 30-80cc, and includes treatment of hyperplasia of the 
central prostate zone and median lobe (12).   
 
This technology uses radiofrequency current to generate wet thermal energy in the form of water vapor 
(steam). Using a TUNA approach, the steam is injected into the hyperplastic prostate, passing through the 
tissue interstices and disrupting cell membranes to effect rapid cell death and necrosis. Unlike conductive 
thermal ablation (TUNA, TUMT), steam convection at a physical phase change boundary best realizes a 
prescribed temperature boundary condition, effectively precluding a temperature gradient beyond the 
targeted prostate (usually the transition zone) (13). This was confirmed by histologic and imaging studies using 
gadolinium enhanced MRI (14,15). According to the manufacturer, water vapor thermal therapy requires 
fewer joules per gram of tissue, ~1/61/23, to produce cell necrosis in prostate tissue compared to TUNA and 
TUMT, respectively (16).   
 
A prospective, open-label, multicenter, pilot study reported the 1- and 2-year outcomes of 65 men with IPSS 
defined moderate (32.3%) to severe (67.7%) LUTS (overall mean IPSS: 21.6; Qmax: 7.9 mL/s; prostate 
volume (PV) 48.6 cc) (17,18). Clinically and statistically significant improvements in urinary symptoms were 
evident as early as one month after treatment and optimal at 312 months. The maximum IPSS improvement (-
13.4) occurred at 3 months (N=62) and gradually decreased (-12.1) at 24 months (N=43); both were 
significantly different from baseline (p<.001). The maximum Qmax improvement (4.7 mL/s) occurred at 3 
months (N=61) and decreased to (3.7 mL/s) at 24 months (N=39); both were significantly different from 
baseline (p<.001). Prostate volume was reported significantly decreased at all time points (p=0.001). Adverse 
events were reported to be transient and mild to moderate, primarily related to endoscopic instrumentation. No 
clinically significant changes in sexual function were reported.   
 
 
 
 A retrospective study analyzed 131 consecutive patients with moderate (53.1%) to severe (46.9%) LUTS 
treated with water vapor thermal therapy by seven urologists in a large group-community practice (19). While 
patient demographics were similar to the pilot study, some notable differences included older mean age (70.9 
years), broader range of prostate volumes (mean 45.1 [12.9-183] cc), and higher post-void residual (PVR) 
volumes (mean 216.8 [0-2,000] mL, and three in retention. The maximum IPSS improvement (-10.1, -47.2%) 
occurred at 3-6 months (N=115) and decreased (-9.4, -45.2%) at 12 months (N=87); both were significantly 
different from baseline (p<.0001). The maximum Qmax improvement (3.0 mL/s, 75.3%) occurred at 3-6 
months (N=38) but was markedly decreased (1.5 mL/s, 51.4%) at 12 months (N=7); only the 3-6 month value 
was significantly different from baseline (p=0.0388). PVR was significantly decreased at all time points. The 
safety profile was similar to the pilot study.   
 
The single level 1 study of water vapor thermal therapy is a multicenter RCT involving 197 men =50 years old 
with an IPPS =13, Qmax =15 mL/s, and PV 30-80 cc, randomized to thermal therapy with Rezum System or 
control (2:1) (20-22). Rigid cystoscopy with simulated active treatment sound effects served as the control 
procedure. The primary end point was the IPSS at 3 months. Both IPSS and Qmax (but not PVR) were 
significantly improved relative to sham at 3 months (p<0.0001). After the 3-month blinded comparison, 53 of 
61 control subjects enrolled in a separate crossover active treatment study. The original active treatment group 
was followed annually for 3 years. The maximum IPSS improvement (-12.2, -54%) occurred at 6 months 
(N=129) and decreased (-11.0, -50%) at 36 months (N=97); both were significantly different from baseline 
(p<.0001). The greatest Qmax improvement (6.4 mL/s, 69%) occurred at 3 months (N=125) and decreased 
markedly (3.5 mL/s, 39%) by 36 months (N=80); both were significantly different from baseline (p<.0001). 
The surgical retreatment rate was 4.4 percent (6/135) over three years (open prostatectomy (1), plasma-button 
transurethral vaporization (3), water vapor thermal therapy re-treatment (2)). Subjects with a median lobe or 
central zone hyperplasia achieved similar significant relief of symptoms. Sexually active subjects had no 
negative changes in the International Index of Erectile Function (IIEF-15) and Male Sexual Health 
Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) function scores throughout 3 years of follow-up. 
Adverse events reported were infrequent and of short duration. The most common were dysuria (16.9%), 
hematuria (11.8%), frequency and urgency (5.9%), acute urinary retention (3.7%), and suspected urinary tract 
infection (3.7%); all were treated routinely or resolved without treatment within 3 weeks. There were no late 
occurring related adverse events.  Four year results were reassuring, with IPSS relatively stable (-10.1, -46.7%, 
N=90), and Qmax improved (4.2 mL/s, 49.5%, N=81) (33). The surgical retreatment rate was unchanged at 
4.4%. 
 
You can find this information in the Local Coverage Determination (LCD) Water Vapor Thermal Therapy for 
LUTS/BPH L37808. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.