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Washington Healthcare Update - June 2021 #1 | McGuireWoods Consulting

HHS Reinstates the Unapproved Drugs Initiative FDA Releases Draft Guidances on Medical Devices FDA Issues Updated COVID-19 Vaccine EUA Guidance FDA Grants Emergency Use Authorization to GlaxoSmithKline’s Monoclonal Antibody FDA Finalizes Guidance on Pediatric Cancer Drugs CMS Joins Online Platforms to Encourage Gig Workers to Enroll in ACA Plans CMS Proposes Delay of Medicaid Multiple Best Price Policy Proposed Rules CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

Washington Healthcare Update - May 2021 #2 | McGuireWoods Consulting

An Update from Federal Officials on Efforts to Combat COVID-19” 10:00 a.m. May 12 COVID-19 Variants and Evolving Research Needs” 10:00 a.m. House Energy and Commerce Committee, Subcommittee on Health: “Hearing on the Fiscal Year 2022 HHS Budget” 10:30 a.m. Senate Committee on Veterans’ Affairs Hearing: “ Supporting Disabled Veterans: The State of Claims Processing During and After COVID-19” 3:00 p.m. May 13 House Appropriations Committee, Subcommittee on Departments of Labor, Health and Human Services, Education and Related Agencies Hearing: “ Mental Health Emergencies: Building a Robust Crisis Response System” 10:00 a.m. For more information, click here. House Foreign Affairs Committee, Subcommittee on Western Hemisphere, Civilian Security, Migration, and International Economic Policy Hearing: “

Washington Healthcare Update - May 2021 #1 | McGuireWoods Consulting

House Energy and Commerce to Hold Hearing on Drug Pricing Legislation Senate Senators Thune and Carper Reintroduce Bill on Chronic Disease Management Administration Biden Administration to Divert Raw Materials for COVID-19 Vaccine and Provide Other Supplies to India CDC Issues New Guidance for Vaccinated Americans FDA Panel Votes to Keep Tecentriq on the Market FDA to Propose Menthol Ban in Next Year HHS Will Distribute $1 Billion for Community Health Centers HHS Removes Some Prescribing Barriers for Buprenorphine Final Rules CMS Extends Comprehensive Joint Replacement Model Demonstration for Three Years Proposed Rules CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals

Washington Healthcare Update - April 2021 #3 | McGuireWoods Consulting

Examining Our COVID-19 Response: Using Lessons Learned to Address Mental Health and Substance Use Disorders” 10:00 a.m. Senate Appropriations Committee Subcommittee on the Interior, Environment, and Related Agencies Hearing: “Addressing Health Disparities in Indian Country: Review of the Indian Health Service’s COVID Response and Future Needs” 10:00 a.m. Senate Appropriations Committee Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Hearing: “VA Telehealth Program: Leveraging Recent Investments to Build Future Capacity” 3:00 p.m. May 4 House Energy and Commerce Committee Hearing: “ To Discuss the Reintroduction of the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3)” House House Republicans Introduce Drug Pricing Legislation

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