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Government Taking Proactive Steps to Address COVID-19

Government Taking Proactive Steps to Address COVID-19

FOR IMMEDIATE RELEASE - March 19, 2020

The federal government continues to take proactive steps to address the COVID-19 threat as the health and safety of the American people remain a top priority. Please see below for the latest guidance and releases in response to COVID-19.

CMS Updates FAQs for Medicaid and CHIP: CMS released updated FAQs that address issues raised by states over the prior few days. The document includes answers to questions related to the flexibilities CMS is affording to states in managed care, benefits, financing, 1115 demonstrations, and leveraging “1135” waivers offered as part of the President’s declaration of a national emergency. States may submit questions to CMS through their state leads. The FAQs can be found here.

CMS Guidance to Programs of All-Inclusive Care for the Elderly (PACE) Organizations: Medicare and Medicaid beneficiaries that participate in PACE typically have chronic conditions, are older and therefore at higher risk for COVID-19. The guidance offers clear, actionable information to PACE Organizations on accepted policies and standard procedures with respect to infection control. The guidance outlines that POs can ensure access to Part D drugs by relaxing “refill-too-soon” edits & providing maximum extended day supply & waiving prior authorization requirements at any time that they otherwise would apply to drugs used to treat or prevent COVID-19. More information about the guidance can be found here.

Updated FAQs for Healthcare Professionals: CDC updated their frequently asked questions for healthcare personnel to include information for pregnant healthcare workers. The FAQs generally address symptoms, risks, treatment and waste management issues for healthcare professionals treating patients with COVID-19. The FAQs can be found here.

Key Leaders with Messages: Key leaders have written or taped short videos to explain different roles and responsibilities for individuals as part of community mitigation.

Phase 1 of Vaccine Trial: On Monday, the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health announced that a Phase 1 clinical trial evaluating an investigational vaccine designed to protect against COVID-19 has begun at Kaiser Permanente Washington Health Research Institute in Seattle, funded by NIH. More information can be found here.

FDA Guidance for Conducting Clinical Trials during COVID-19 Pandemic: FDA issued guidance today to help inform industry and investigators adjust their clinical trials during the COVID-19 pandemic. The guidance can be found here.

FDA FAQs on Food Safety: FDA provided additional resources to industry members and consumers on COVID-19 and food safety. The FAQs can be found here.

Recommended Preventive Practices and FAQs for Faith-based and Community Leaders: HHS recognizes faith and community leaders are a valuable source of comfort and support for members and communities during times of distress, including the growing presence of COVID-19 in different parts of the U.S. To support these efforts, the HHS Partnership Center released the an FAQ document on COVID-19 for this population.

HHS Expanding Public-Private Partnerships: HHS announced a public-private partnership to create a U.S.-based, high-speed, high-volume emergency drug packaging solution using low-cost prefilled syringes. This partnership will enable the Strategic National Stockpile (SNS) to fill and finish, on a rapid basis, hundreds of millions of prefilled syringes to respond quickly and efficiently to widespread health emergencies, such as the novel coronavirus outbreak. More information can be found here.

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