The Health Policy War Room
Medicare Insights
My most recent insights on the state of health policy in the U.S. and how it is impacting the pharmaceutical, medical technology and clinical diagnostics industries
Understanding Genetic Testing for Hereditary Cancers: Empowering Personalized Care
The 2025 NCCN Guidelines for Patients highlight the critical role of genetic testing in managing hereditary cancers like breast, ovarian, pancreatic, and prostate cancers. The guidelines emphasize early identification of pathogenic gene variants to enable personalized screening, preventive surgeries, or targeted treatments like PARP inhibitors. They advocate for pre-test counseling, multi-gene panel testing, and tailored follow-up care based on patient history and familial risk. For payers, this shift encourages reconsideration of restrictive policies that exclude testing for asymptomatic individuals, aligning with preventive healthcare goals. Developers of genetic tests can leverage these recommendations to support coverage and reimbursement by demonstrating clinical utility and economic value.
TCET — Navigating Medicare’s Transitional Coverage for Emerging Technologies Policy: A Roadmap for Success
For medical device manufacturers, securing Medicare coverage is a critical milestone, yet navigating the complexities of the coverage determination process has long been a challenge. With the introduction of Medicare’s Transitional Coverage for Emerging Technologies...
Medicare Advantage Growth vs. Plan Reductions: What It Means for Health Tech Developers
As the Medicare Advantage market continues to evolve, thinking strategically and leveraging the expertise of an experienced consultant can make the difference between a product that flounders and one that thrives. By understanding the landscape, aligning with payer priorities, and planning market entry carefully, health technology developers can navigate the challenges brought on by plan reductions and policy shifts. Consultants provide the insight and experience necessary to turn these challenges into opportunities, ensuring that companies not only survive but succeed in the competitive and ever-changing world of Medicare Advantage.
Navigating the Headwinds: How Regulatory Healthcare Challenges Affect the Commercialization of Novel Healthcare Products
Becker’s Payer Issues recently interviewed 16 healthcare executives about issues that are presenting challenges to the payer community. In today’s evolving healthcare landscape, it’s not just insurance payers feeling the strain of regulatory and political...
Digital Mental Health Treatment: Here Are 4 Fundamentals You Have to Know to Uncomplicate CMS’s Proposed Policy
The Centers for Medicare & Medicaid Services (CMS) recently unveiled a proposal in the 2025 Medicare Physician Fee Schedule to cover Digital Mental Health Treatment (DMHT) devices. This policy marks a significant step towards integrating digital health...
Gene Therapy: The Unexpected Twist That Could Unlock Massive Medicare Payment Bumps
In their FY 2025 Inpatient Prospective Payment System proposed rule, CMS proposes a policy that would increase Medicare payment for gene therapy targeting sickle cell disease. CMS asserts that these additional New Technology Add-on Payments would increase access to...