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Digital Mental Health Treatment: Here Are 4 Fundamentals You Have to Know to Uncomplicate CMS’s Proposed Policy

by John Warren | Jul 22, 2024

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

by John Warren | Apr 16, 2024

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

by John Warren | Apr 15, 2024

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

by John Warren | Feb 15, 2024

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

by John Warren | Feb 5, 2024

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...
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