This policy version was replaced July 4, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).
For low or intermediate risk prostate cancer, radiation therapy is a treatment option. Because the rectum lies in close proximity to the prostate, the risk of rectal toxicity is high, and the anterior wall of the rectum is considered a major dose-limiting factor in radiation therapy. One approach is to push the rectum away from the prostate, increasing the space between the two and reducing the radiation dose to the rectum. A variety of biomaterials, including polyethylene glycol hydrogels (e.g., SpaceOAR System) have been evaluated as perirectal spacers.
The U. S. Food and Drug Administration (FDA) granted marketing clearance for the SpaceOAR hydrogel spacer through the 513(a) (1) (de novo) process (DEN140030) in April 2015. “SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.”
Absorbable perirectal spacers are considered EXPERIMENTAL/INVESTIGATIVE for all indications, including but not limited to patients with prostate cancer undergoing radiotherapy, due to a lack of clinical evidence demonstrating an impact on improved health outcomes.
No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
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CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.