About Sam Barnum

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So far Sam Barnum has created 35 blog entries.

Medicare Clarifies Confusion Over Tests Covered by the NGS NCD

2020-08-04T14:58:26-04:00

Recently, Medicare published two CRs associated with the NGS NCD, identifying covered tests and associated CPT and ICD-10 diagnosis codes. These CRs (CR11655 and CR11749) indicated that MSK-IMPACT and MyMRD NGS Panel were nationally covered under the NGS NCD.

Medicare Clarifies Confusion Over Tests Covered by the NGS NCD2020-08-04T14:58:26-04:00

CMS New Technology Add-On Payment FY 2021 Proposed Rule

2020-07-08T14:59:54-04:00

The Centers for Medicare and Medicaid Services’ NTAP program is a system enacted by Congress and implemented in 2001 designed to enable the adoption of new and clinically beneficial medical technologies used during inpatient hospital stays regularly paid under Medicare’s inpatient prospective payment system.

CMS New Technology Add-On Payment FY 2021 Proposed Rule2020-07-08T14:59:54-04:00

ICER Quietly Moves to a Pure Digital Health Assessment

2020-07-08T14:56:46-04:00

ICER has quietly moved forward with their first foray into a pure digital health assessment: their revised scoping document for analysis of digital apps in opioid use disorder was recently released.

ICER Quietly Moves to a Pure Digital Health Assessment2020-07-08T14:56:46-04:00

An Overview of Digital Health in China

2020-05-06T13:19:09-04:00

We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health care system. In this issue, we will discuss another industry sector that may benefit from this global pandemic, digital health.

An Overview of Digital Health in China2020-05-06T13:19:09-04:00

Boston Healthcare’s Webinar Library

2020-08-04T14:18:15-04:00

Browse a variety of recent webinars presented by the team at Boston Healthcare Associates. We will regularly update this library of free life science webinars as we continue to produce them throughout 2020.

Boston Healthcare’s Webinar Library2020-08-04T14:18:15-04:00

FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics

2020-04-21T17:02:39-04:00

The Food and Drug Administration recently published final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists several key considerations for companion diagnostic manufacturers.

FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics2020-04-21T17:02:39-04:00

The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?

2020-04-06T15:19:56-04:00

At its core, the VALID Act would explicitly grant the FDA authority to regulate LDTs through a risk-based framework that categorizes LDTs as high risk or low risk, with high-risk tests facing approval requirements that are comparable to existing medical device regulations.

The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?2020-04-06T15:19:56-04:00