Tag: FDA

FDA Warns of Pulse Oximeter Inaccuracies

Pulse oximeters, which measure blood oxygen levels, have been widely used during the COVID-19 public health emergency to track a patient’s oxygen saturation, but they may not always be accurate, according to new guidance released by the Food and Drug Administration last Friday. Skin color, nail polish, tobacco use, skin temperature and other factors can…

CMS Finalizes Definition of “Reasonable and Necessary”

A definition of “reasonable and necessary” is part of the recently finalized rule,  Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘‘Reasonable and Necessary’’.   As previously reported this rule also establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by…

FDA Publishes List of Essential Medicines, Medical Countermeasures

A recent executive order directed the U.S. Food and Drug Administration, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms. The goal of this work is to…

COVID -19 Therapeutic Receives Emergency Use Authorization

The Centers for Medicare & Medicaid Services announced that starting November 12, 2020, Medicare beneficiaries can receive coverage of monoclonal antibodies to treat coronavirus disease 2019 (COVID-19) with no cost-sharing during the public health emergency (PHE). CMS’ coverage of monoclonal antibody infusions applies to bamlanivimab, which received an emergency use authorization (EUA) from the U.S.…

CMS Updates Waived Tests

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).  87804QW, April 3, 2020, Sekisui Diagnostics, LLC, OSOM Ultra Plus Flu A&B Test {Nasal and Nasopharyngeal Swabs} 87880QW, November 26, 2019, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit…

IMPORTANT: Please Read this FDA-Required Updated REMS Safety Information

FDA-REQUIRED UPDATED REMS SAFETY INFORMATION Risk of: • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal • Neurological Toxicities, which may be severe, life-threatening or fatal • Preparation and Administration Errors April 2020 The Food and Drug Administration (FDA) has required this safety notice as part of the BLINCYTO® REMS (Risk Evaluation and…

Final Government Pain Report Stresses Importance of Patient-Centered Focus

—Acknowledges Misapplication of 2016 CDC Guidelines and Challenge of Medication Shortages In late May 2019 the Pain Management Best Practices Inter-Agency Task Force, a federal advisory committee established by the Comprehensive Addiction and Recovery Act of 2016, released its final report on acute and chronic pain management best practices, calling for a balanced, individualized, patient-centered…

Drug Shortage Crisis Concerns Hospice, Draws Bipartisan Interest

The Food and Drug Administration identified 39 new drug and biological product shortages in 2017 and multiple ongoing shortages from previous years, a sharp increase from 2016, according to the FDA’s most recent annual report on the issue. The main problems were caused by a major manufacturer shutting down a production facility, and devastation caused…

Right to Try Becomes Federal Law. What Does it Mean for Home Health and Hospice?

President Donald J. Trump signed into law the Right to Try Act on Wednesday, May 30, 2018, a piece of legislation he called for in his last State of the Union address, and predicted it would save a “tremendous number of lives.” Opinion is divided on how many lives it will save, if any, but…

Senate Committee Approves Opioid Package with Hospice Disposal Authority

On Tuesday, April 24, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a markup on S. 2680, the Opioid Crisis Response Act. This comprehensive legislative package takes many different angles to combat the opioid addiction crisis affecting people nationwide. Notable to the hospice industry was the inclusion of a provision allowing hospice providers…