ARTICLE SUMMARY:
After a long career at CMS, including running the Coverage and Analysis Group for the past 10 years, Tamara Syrek Jensen can now candidly share her views on medical device reimbursement generally, particularly when it comes to Medicare. She provides a frank assessment on the systemic challenges, including highlighting key differences between CMS and FDA in terms of legal requirements and expectations, and what product companies can do to improve their relations with both agencies.
With reimbursement clearly ranking as the leading concern facing medical device companies, among the biggest issues in that area is the real or perceived lack of transparency and accountability at CMS and the difficulties that product companies face in often interacting with the agency. Those concerns are made more stark by the improvements that have occurred in those same issues over the past decade at FDA.
Getting current CMS officials to address those concerns is difficult given the restrictions on their ability to speak openly about the present dynamics between industry and regulators. At the recent MedTech Strategist Innovation Summit in San Diego, we had the opportunity to explore those issues with long-time former CMS official Tamara Syrek Jensen, who in the last decade of her 25 years at the agency headed the Coverage and Analysis Group (CAG) before recently leaving government to join Rubrum Advising, a consulting firm founded by former CMS Chief Medical Officer Lee Fleisher, MD. Jensen provided a candid look at the challenges facing the agency in terms of Medicare reimbursement for medical devices, while also providing insights into the functional differences between working with CMS and FDA, and how product companies can best approach dealing with each agency.
