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.
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G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First CaseSam Barnum2020-08-04T14:31:15-04:00
In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without complete clinical data at the time of approval.
The National Health Commission of China recently released a clinical practice to regulate physician prescribing behavior for novel cancer therapies which echoes the government's efforts to control costs.
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.
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.
As a result of the new EU Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark under the previous Medical Devices Directive (MDD), will need to be re-certified.
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.
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.
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.
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.