Medicare Clarifies Confusion Over Tests Covered by the NGS NCD
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.
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 complete clinical data at the time of approval.
China Establishes a Regulatory Pathway for Companion Diagnostics
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.
CMS New Technology Add-On Payment FY 2021 Proposed Rule
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 Quietly Moves to a Pure Digital Health Assessment
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.
EU Sets Benchmarks for Clinical Evidence Assessment for Recertification of Medical Devices
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.
Events
Press Releases and Publications
Boston Healthcare Presents Key Findings Associated With the Use of an AI-Enabled In Vitro Diagnostic Test
27 March 2020
The Boston Healthcare team presented key findings related to the health economic value associated with the use of an AI-enabled in vitro diagnostic test to identify CKD patients with type 2 diabetes at risk for rapid kidney function decline. BHA’s Senior Vice President, Thomas Goss, made a presentation during the late-breaker session at the National Kidney Foundation Spring Clinical Meeting in March 2020.
Read the article here: https://bit.ly/2UKaJks
View the poster here: https://bit.ly/2UFIx27
Diagnostics Developers Rapidly Utilizing New Payment Codes Established by PAMA
7 November 2018
Access the article from 360Dx here.
Clinical Omics
Compliance Conundrum: Genomic Health Faces DoJ Investigation after CMS Changes Date of Service Regs
Genomic Health has disclosed that it is the subject of a U.S. Department of Justice investigation into its compliance with changes that took effect in January to Medicare’s Date of Service billing regulation. Adam Crowther, Manager, spoke with Clinical Omics about the impact on diagnostics companies. Access the Article Here.
Medical Device & Diagnostics Industry
Considering Market Access Risk as Part of Today’s M&A Process
In an exclusive published today in Medical Device and Diagnostics Industry, Vice President, Rob Wenthold discusses the key market access issues examined during the M&A process and demonstrates the importance of market access to inform M&A through case studies and business decision-making in general. Read the article here.
Boston Healthcare Adds Seasoned Market Access Leader to Global Life Science Consulting Team.
Clinical Omics
Cost-Conscious MedSeq Project Provides Snapshot to Suggest Genomic Sequencing does not Increase Downstream Healthcare Costs
CEO, Joseph V. Ferrara commented on the value sequencing might bring to the clinical setting in the May-June 2018 Issue of Clinical Omics. Access the article here.
Global Business Reports
United States Biopharmaceuticals 2018
Thomas F. Goss spoke to Global Business Reports on the US Biopharmaceutical Industry. Read the report here.
Clinical Omics
Real-World Evidence in the Era of Advanced Diagnostics
Shivang Doshi, Director at Boston Healthcare wrote an op-ed for the March-April edition of Clinical Omics on real-world evidence for advanced diagnostics. Access the article here.
360Dx News
International Regulatory Group Proposes Principles for Evaluating Safety, Performance of Diagnostics
Joseph V. Ferrara, CEO of Boston Healthcare spoke with 360Dx News about the proposed Principles for safety and performance of medical devices, including IVD medical devices, put forward by the International Medical Device Regulators Forum (IMDRF). Read the article here.
C&EN
Year in Pharma
Senior Vice President, Thomas F. Goss speaks with Lisa Jarvis from C&EN about drug prices in 2017.