Tag: Food and Drug Administration

FDA Removes REMS Requirement for BLINCYTO®

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.  The BLINCYTO® REMS was first approved by the FDA in 2014 and last updated in…

New Waived Tests for Home Health and Hospice

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows: 82010QW, 82962, May 27, 2022, AmVentureX Inc.…

New Tests Waived Under CLIA

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988).  80305QW, August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Cup;  80305QW, August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Dip;  80305QW, September 23, 2020, Axium BioResearchInc.DrugExam Multi Drug…

CMS Releases Interim Final Rule for COVID-19 Vaccine & Treatment, and CARES Act Provisions

Late in the day on Wednesday, October 29, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with Comment Period (IFC) primarily addressing COVID-19 vaccine coverage. The provisions of the IFC are effective immediately on the date of posting in the Federal Register or as otherwise specified in the rule. The…

CMS Proposes Definition of Reasonable and Necessary

A definition of “reasonable and necessary” was part of the recently proposed rule, Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘‘Reasonable and Necessary’’.  This proposed rule would also establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food…