As a result of the new European Union 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. In April 2020, the Medical Device...
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 Institute for Clinical and Economic Review (ICER). As part of the webinar, available here, they discussed ICER’s 2020...
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 2001 which designed to enable the adoption of new and clinically beneficial medical technologies used during inpatient...
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 companion diagnostic, and has a FDA-approved or -cleared indication for use in that patient’s cancer. The NCD also covers...
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. During the review of Zolgensma®, a gene therapy for spinal muscular...
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 “codify” internally...
Veranex Participates in the 3rd Annual Leaders in Life Sciences Breakfast Roundtable
Eight leaders in Life Sciences came together for a virtual breakfast roundtable devoted to leading Life Sciences organizations through these unprecedented times. The event was sponsored by Leaders in Life Sciences, led by Timmy Garde, Chief Innovation Leader, LevLane...
Veranex Partners with Alcon to Conduct Real-World Study Highlighting Efficiencies of Optical Biometer in Cataract Surgery
Alcon, a global leader in eye care, collaborated with Veranex (formerly Boston Healthcare Associates) to conduct a Time-and-Motion Study to support the value communication of its novel swept-source optical coherence tomography biometer, ARGOS®. In addition to superior...
Analysis of China’s First National Tender on Coronary Stents
In previous newsletters (Aggressive National Programs To Drive Down Drug Costs, published in January 2019 and Medical Disposables & Consumables Players Face Challenge of Government-Initiated Price Cuts in China, published in September 2019), Veranes (formerly...
MHRA Issues Guidance on New Medical Device Regulation in UK
As a result of Brexit, the In Vitro Diagnostic Medical Device Regulations (IVDR) will not apply to Great Britain (England, Wales and Scotland). Unlike Great Britain, the IVDR will apply in Northern Ireland from 26 May 2022. Guidance issued by the Medicines and...