ARTICLE SUMMARY:
Lee Fleisher, former CMS medical director, has built a team of Medicare and FDA experts, who share their views here on current reimbursement challenges facing product companies. Key concerns include improving collaborations between the device industry and private payors, which is increasingly important with the rise of Medicare Advantage plans, along with the growing debate over the TCET program.
Transparency has long topped the list of industry concerns when it comes to working with regulators both at FDA and CMS. While things have improved on that score recently at FDA, reimbursement has replaced regulatory as the leading issue on the minds of many device company executives with the primary concern being a lack of transparency and accountability at CMS. And as opaque as the process often appears at the Medicare agency, it is relatively translucent in comparison with what companies encounter when trying to get products paid for by commercial insurers.
This issue is becoming increasingly important on two fronts. First, the regional Medicare Administrative Contractors (MACs) are administered by private payors. Further, Medicare Advantage (MA) plans, which now cover more than half of all Medicare beneficiaries with coverage continuing to grow at a rapid rate, are also handled by commercial carriers.
To discuss these and other current reimbursement issues facing medtech companies, we spoke with Lee Fleisher, MD, former medical director at CMS. Fleisher recently launched Rubrum Advising, a strategic advisory firm in the Philadelphia area, that includes former colleagues from both CMS and FDA, notably Nancy Stade, JD, a former assistant to former CDRH director Jeffrey Shuren, MD, JD, and his son, Matthew Fleisher, JD, MPH, who also previously was with CMS.
Among the topics discussed here is a recent article that Lee Fleisher co-authored with outgoing FDA Commissioner Robert Califf, MD, in the Journal of the American Medical Association (JAMA) titled, “Why Evidence Generation Should Matter to Payers and How They Can Help.”
The article and the following discussion focus on the need for greater collaboration between product companies and commercial insurers, and the obstacles that currently impede this partnership and how the situation can be improved.
The interview also addresses the current debate surrounding the TCET (Transitional Coverage for Emerging Technologies) program, which was implemented by CMS effective August 2024 after a long and tumultuous history in different incarnations dating back to the Obama administration. Here Lee Fleisher explains why he extended his tenure at CMS in order to see TCET through to fruition in its current form, while also addressing the current debate as to whether a reimbursement pathway for emerging technologies would be best achieved through an administrative program like TCET or in the form of new legislation such as the bipartisan bills that have been introduced in both the House and the Senate that address this issue in slightly different ways.
Finally, the theme of collaboration is extended to examining the value of the current parallel review program and ways in which working with FDA and CMS can be made more efficient for both regulators and product companies. Clearly, the different statutory standards that the respective agencies rely on (safe and effective for FDA, as compared with reasonable and necessary for CMS) impose different requirements for product companies and regulators. Nevertheless, the consensus view is that the parallel review program is currently underutilized and underresourced, perhaps leaving room to revise the process in the future to increase efficiency for both groups, resulting in benefits for patients and clinicians. (The interview has been edited for length and clarity.)
