Appeal type: unknown
Decision: unknown

 
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 say that polyethylene-glycol (PEG) hydrogel is covered ONCE in patients with clinically localized 
prostate cancer with BOTH the following:  
 
    Inclusion criteria including ALL of the following: 
        Low* or Favorable Intermediate Prostate Cancer Risk Group (1-5) (AUA or NCCN criteria (6,7)) 
        Dose escalated (= 76 Gy) conventional fractionation (1.8-2 Gy fractions) or moderate hypofractionation 
(HFX) (2.4-3.4 Gy fractions) IG-IMRT planned (7,8,9,25-27) 
        Eastern Cooperative Oncology Group (ECOG) performance status = 1 (4) 
        Modern localization techniques insufficient to improve oncologic cure rates and/or reduce side effects due 
to AT LEAST ONE of the following (7): 
            Anatomic geometry precluding ideal rectal constraints  
                Conventional fractionation (V70 <10%, V65 <20%, V40 <40%) (10) 
                Moderate HPX (dose constraints not yet standardized; employ those used in the supporting phase III 
trials) (25) 
            Medication usage (e.g., anticoagulants) (8,11,12) 
            Comorbid conditions (e.g., increased age, Hx MI or CHF) (11) 
    No Exclusion criteria including ALL of the following: 
        Less than 5 year life-expectancy and asymptomatic (7) 
        Prior prostate cancer treatment (surgery or RT) (1,3,4,8) 
        Active bleeding disorder or clinically significant coagulopathy (8) 
        Active inflammatory or infectious disease in the perineum or injection area (e.g., prostatitis, anorectal 
IBD) (1,3,8) 
        Prostate volume > 80 cc (1,3,4) 
 
*Life expectancy = 20 y (very low risk); = 10 y (low risk) (7) 
 Prostate rectal spacers are various materials or devices placed between the prostate and anterior wall of the 
rectum for use in men receiving radiation therapy for prostate cancer. The anterior wall of the rectum is 
considered a major dose-limiting factor in radiation therapy of prostate cancer. Physical separation is proposed 
to allow reduced toxicity and treatment intensification. 
  
Data showed the spacer group had a smaller volume of rectal radiation for all volumes from V50 to V80 
(p<.0001). Relative reductions were 54% for V50, 79% for V70, and 96% for V80. Grade >1 rectal toxicity at 
three years was decreased by 75% in the spacer patients (spacer 2%, 95% CI 1%- 6%) and (control 9%, 95% 
CI 4% - 20%), p<.03. No grade >2 rectal toxicity was seen in the spacer patients with 6% in the control group 
and one case of grade 3. It was noted that the toxicity in the control group was less than usually reported, and 
no explanation was available. There were no differences in grades 1 or 2 urinary toxicities between the groups 
at three years with the exception of urinary incontinence in 15% of the controls and 4% in the spacer group (p = 
.046). 
 
You can find these rules in the Local Coverage Determination (LCD) Prostate Rectal Spacers L37485. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.