Gary Keeler

3 min read

CMS Proposes Changes to Part B Medicare Reimbursement for Physician-Administered Drugs Approved Under the 505(b)(2) Approval Pathway

The Centers for Medicare and Medicaid Services (CMS) intends to alter assignment of Healthcare Common Procedure Coding System (HCPCS) Level II codes for certain physician-administered 505(b)(2) drugs. At its core, CMS has stated its desire to...

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9 min read

MedTech Pioneers – Redesigning Healthcare Amidst a Pandemic

Desert Horse-Grant and Dr. Jennifer McCaney, Co-Executive Directors, UCLA Biodesign This female dynamic duo founded UCLA’s Biodesign program in 2019...

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5 min read

MedTech Pioneers – SV Health Investors Discuss the Firm’s New $90M Early-stage Medtech Convergence Fund

Paul LaViolette Managing Partner & COO, SV Health Investors Forging where others are tentative to trod, SV Health Investors, in partnership with...

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1 min read

Medicare Clarifies Confusion Over Tests Covered by the NGS NCD

The Medicare NGS NCD grants national coverage for somatic testing in patients with advanced cancer if the test has FDA-approval or -clearance as a...

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2 min read

G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First Case

In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without...

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1 min read

CMS New Technology Add-On Payment FY 2021 Proposed Rule

The Centers for Medicare and Medicaid Services’ (CMS) New Technology Add-On Payment (NTAP) program is a system enacted by Congress and implemented in...

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2 min read

China Establishes a Regulatory Pathway for Companion Diagnostics

The Chinese government has implemented a series of efforts to improve access to novel oncology therapies, one example of this is the significant...

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1 min read

ICER Quietly Moves to a Pure Digital Health Assessment

In March, leaders from our health economics team, Tom Goss and Jordan Hinahara shared insights on health technology assessments in the US under the...

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1 min read

EU Sets Benchmarks for Clinical Evidence Assessment for Recertification of Medical Devices

As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark...

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4 min read

An Overview of Digital Health in China

We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health...

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