Author:

Perri Nena Smith

Exploring COVID-19 Vaccine Authorization by the FDA   

As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or  Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.”  When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.

Vertical Healthcare Companies Merging Compliance Programs

Vertical Healthcare Companies Merging Compliance Programs           Perri Nena Smith Senior Editor Loyola University Chicago School of Law, JD 2021   In 2020, The Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) released guidelines for vertical mergers to give clarity to companies so they can avoid harmful mergers. Healthcare companies are an industry that has been …
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Federal Relief of Regulatory Oversight Burdens in Medicaid Final Rule   

he Centers for Medicare & Medicaid Services (“CMS”) refined the Medicaid and Children’s Health Insurance Program (“CHIP”) Managed Care final rules. CMS originally released the final rules in 2016 and another revision in 2018. After several cumulative comments on 2016 and 2018 final rules, CMS attempted to create more flexibility for States with managed care delivery methods. CMS’s third version of the final rules is more of an attempt to clarify and fix technical errors than giving States more flexibility to operate their managed care organizations.

COVID-19 Break in Regulation of Waivers for State Medicaid Agencies

COVID-19 was an unexpected pandemic that hit the United States, causing Centers for Medicare and Medicaid Services (“CMS”) to rush to make accommodations for the states. States administer their Medicaid programs following a state plan and under the regulation of federal rules. With approval, states are allowed to amend their state plan and apply for waivers to improve the effectiveness of their Medicaid program. During COVID-19, the Trump Administration made available for states to apply for 1115 waivers, creating a new section labeling 1115(a), the 1135 waiver, and Appendix K to amend 1915(c) waivers for national emergencies. As of May 2020, CMS reported over 200 approved waivers across multiple states.