Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Prostate Adenocarcinoma
Treatment: SpaceOAR, perirectal spacer, procedure code 55874
The insurer denied the SpaceOAR, perirectal spacer), procedure code 55874
The denial was overturned.

This is a male patient with a history of clinically localized unfavorable intermediate risk adenocarcinoma of his prostate gland.  The treatment plan is for delivery of definitive external beam radiotherapy.  

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. There is a high quality prospective randomized clinical trial which was conducted in the claimant's setting, which proved that the inclusion of the SpaceOAR device with definitive radiotherapy was able to significantly reduce the risk for radiation induced morbidity and preserve the claimant's rectal, urinary, and sexual function.

Per Hamstra, D. A., et al. (2017), "The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy."

Per Mariados, N., et al. (2015), "Spacer application was rated as "easy" or "very easy" 98.7% of the time, with a 99% hydrogel placement success rate. Perirectal spaces were 12.6  3.9 mm and 1.6  2.0 mm in the spacer and control groups, respectively.  There were no device-related adverse events, rectal perforations, serious bleeding, or infections within either group. Pre-to postspacer plans had a significant reduction in mean rectal V70 (12.4% to 3.3%, P<.0001).  Overall acute rectal adverse event rates were similar between groups, with fewer spacer patients experiencing rectal pain (P=.02). A significant reduction in late (3-15 months) rectal toxicity severity in the spacer group was observed (P=.04), with a 2.0% and 7.0% late rectal toxicity incidence in the spacer and control groups, respectively.  There was no late rectal toxicity greater than grade 1 in the spacer group. At 15 months 11.6% and 21.4% of spacer and control patients, respectively, experienced 10-point declines in bowel quality of life. MRI scans at 12 months verified spacer absorption."

Per Karsh, et al. (2018), "Prostate-rectum hydrogel spacer application is a relatively safe technical procedure that is well tolerated and has a high technical success rate.  Spacer application significantly reduces rectal radiation dose and results in long-term reductions in rectal toxicity, as well as improvements in bowel, urinary, and sexual QOL."      

SpaceOAR, perirectal spacer, procedure code 55874 does have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is a good candidate for (SpaceOAR, perirectal spacer), procedure code 55874. The provided clinical documentation does not show that the patient has any evidence of extraprostatic extension nor high grade urinary obstructive symptoms.     

SpaceOAR, perirectal spacer), procedure code 55874 is the best available treatment for this claimant at this time. It is proven to maximize preservation of quality of life and safely allow for dose-escalated radiation delivery.     
  
SpaceOAR is proven to yield significantly reduced morbidity in prostate radiotherapy treatment. It is widely utilized nationwide throughout the radiation oncology community. 

SpaceOAR, perirectal spacer is likely to be more beneficial than any other standard health care service.                                                    

The carrier's denial of coverage for (SpaceOAR, perirectal spacer), procedure code 55874 should be overturned.