The Health Policy War Room
Our most recent writings on the state of health policy in the U.S. and how it is impacting the pharmaceutical, medical technology and clinical diagnostics industries
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...
The Little-Known Rule That Could Disrupt the Medicare Essential Medicines Market
As a part of the CMS FY 2025 Inpatient Prospective Payment System proposed rule, CMS followed up on its promise from last year to propose policies that would help the hospital industry to maintain access to essential medicines. But could this Medicare Essential...
Medicare Advantage Coverage Criteria and Utilization Management Requirements
Last April, the Centers for Medicare & Medicaid Services (CMS) released the 2024 Medicare Part D rule. CMS recently issued a list of frequently asked questions addressing parts of these Medicare Advantage coverage criteria and utilization management requirements...
Unpacking Impacts of FDA Reclassification on Diagnostic Innovation and Access
Recently, an FDA reclassification process was announced that will reclassify many high-risk medical devices into the less burdensome "moderate risk" category. This includes certain infectious disease and companion diagnostic tests, allowing them to go through 510(k)...
Advancing Women’s Health Research: What the New White House Initiative Means for Healthcare Innovation
Earlier this month, President Biden established a new White House Initiative on Women's Health Research aimed at closing critical gaps in our understanding of women's health needs. This initiative signals exciting opportunities for innovation in healthcare, especially...