Proposed Legislation Targets a Critical Regulatory-Reimbursement Gap for Medical Devices

Reggie Dye went 15 years without seeing a physician, in part because he had always been incredibly healthy. He regularly does high-intensity worksouts, enjoys hiking, golf, and can't remember the last time he even had a cold. But a preventative health evaluation incentive program his company offered in 2016 taught him that even the healthiest individuals are not immune to prostate cancer. After two prostate-specific antigen (PSA) screening tests, followed by additional testing, Dye was diagnosed with localized prostate cancer. At first, he was given the choice of active surveillance, also known as "watchful waiting" or more aggressive treatment options such as radiation, cryotherapy, and surgery – all of which are associated with unpleasant side effects, including incontinence and impotence. Then he learned about high intensity focused ultrasound (HIFU). Dye was a candidate for HIFU because he had a low-grade cancer that hand not spread outside the prostate gland. He found it to be an attractive treatment option because the risks of "those dreaded side effects" are much lower, he said, and because he is aware that African-American men are twice as likely to die from prostate cancer than white men. "After I first got my diagnosis, I contacted my brother and sent an email to my black fraternity brothers telling them to get their PSA tests," Dye said. "They were stunned because they knew me to be someone in good s...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news