On June 25, 2018, the Chinese Ministry of Justice announced amendments to the Supervision and Administration of Medical Devices Regulations (the Regulation) and called for public comment. The proposal is being celebrated by a variety of stakeholders across the medical device and IVD industry following years of lobbying to have the Regulation amended. However, some apprehension regarding the implementation of the proposed Regulation remains.
Read the full document here: BHA China Medical Device IVD Policy Update – Proposed Regulations, 6.28.2018 (FINAL): PDF
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.
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.