First and only prostate cancer spacing device available for use in the U.S. clinically proven to preserve patient quality of life following radiation therapy
Truckee, CA (UroToday.com) Augmenix, Inc., a medical technology company that develops, manufactures and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy, announced that the American Medical Association (AMA) established a new Current Procedural Terminology (CPT®) code, 55874, for periprostatic implantation of biodegradable material, under which SpaceOAR hydrogel will be typically billed.1 The code, which goes into effect January 1, 2018, will enable both hospitals and physicians to receive payment, when medically necessary, for the SpaceOAR hydrogel procedure, where Medicare coverage is available.
Also, the Centers for Medicare and Medicaid Services (CMS) promulgated their 2018 Medicare Hospital Outpatient Prospective Payment System (HOPPS) rule through which the payment rate for the new code (55874) will provide for a national average Medicare reimbursement rate of $3,706 in the outpatient department and a national average rate of $1,757 when performed in an ambulatory service center (ASC).2 Additionally, CMS’ 2018 Medicare Physician Fee Schedule (MPFS) will provide for a Medicare reimbursement rate of $3,797 when the procedure is performed in a physician’s office.3
“CMS’ decision represents a significant step forward for the thousands of patients undergoing prostate cancer radiation therapy, as well as the physicians who treat them,” said John Pedersen, President and CEO of Augmenix. “Patients covered by Medicare will now have greater access to the SpaceOAR hydrogel procedure, which has been shown to reduce risks associated with prostate cancer radiation therapy, including rectal bleeding, incontinence, pain and loss of sexual function. We look forward to private insurers initiating adequate reimbursement in the coming months.”Treating prostate cancer with radiation therapy can cause unintended injury to adjacent healthy tissue, often leading to impairment of bowel, urinary and sexual function, negatively affecting patient health and quality of life (QOL). With SpaceOAR hydrogel, physicians place a hydrogel barrier to separate the prostate from the anterior rectal wall, reducing the risk of radiation exposure and these adverse side effects.
Earlier this year, Augmenix announced three-year post-treatment results from a prospective, randomized, multi-center clinical trial showing that patients treated with SpaceOAR hydrogel technology prior to prostate cancer radiotherapy demonstrated rectal (bowel), urinary and sexual benefit through three years of follow-up. Overall patient wellness at three years was assessed by analyzing the percent of patients with clinically significant declines in all three QOL areas, including bowel, urinary and sexual function. A total of 20 percent (1 in 5 patients) of men in the control arm had clinically significant declines in all three QOL areas compared to only 2.5 percent (1 in 40 patients) of men in the SpaceOAR hydrogel arm (p=0.002).4
Additionally, overall patient wellness at the 5-year mark has also been assessed. Patients treated with SpaceOAR hydrogel had significantly less problems with bowel urgency at 63 months post-treatment, compared to patients who did not receive SpaceOAR hydrogel (0 percent vs. 14 percent, p=0.01). A significant finding in terms of sexual quality of life was also reported, with SpaceOAR hydrogel treated patients having an 8 times greater likelihood of having erections sufficient for intercourse at 5-years post-treatment (24 percent vs. 3 percent, p<0.01).5
- American Medical Association, Current Procedural Terminology, CPT®, Professional Edition, 2018.
- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 414, 416, and 419
- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 414, 424, and 425
- Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; 2017 Volume 97, Issue 5, Pages 976–985.
- Pinkawa, M, et al. Quality of Life After Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: 5-Year Results. Int J Radiat Oncol Biol Phys; 2017 Oct 1;99(2):374-377. Epub 2017, May 31.
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