COVID-19 VACCINE DEVELOPMENT AND DISTRIBUTION.
- GOOD NEWS ON COVID-19 VACCINE DEVELOPMENT. Over the last few weeks, there has been positive news on COVID-19 vaccine development. Currently, there are three vaccines testing at least 90% effective in late-stage trails. This is obviously welcomed and good news, but now we begin the process of planning how to distribute and pay for vaccines. The Centers for Disease Control and Prevention has outlined a three-phase plan for distribution. Before the end of the year, it is possible that a limited number of vaccines will be available, with priority populations receiving the vaccine first (these priority populations include healthcare providers, essential workers and those most vulnerable to COVID-19). However, the Biden Administration will likely pick up the largest portion of the vaccine distribution process. The Biden team has developed a COVID-19 task force and is beginning to plan for distribution. States and local governments are also developing their own plans for vaccine distribution. Needless to say, vaccine distribution at this scale will be a massive undertaking for any Administration and any government (federal, state or local). Vaccine payment has also been outlined in the fourth COVID-19 interim final rule with comment period, and the Centers for Medicare and Medicaid Services has developed a number of toolkits on the topic. Additionally, reporting and data collection, and the communication process with the public are all important pieces of the puzzle as well.
- REGULATION DROP LAST FRIDAY. Last Friday, November 20, four major healthcare regulations were published. The rules focused on drug pricing and reforms Stark and anti-kickback laws. Of note, last Friday was the final day to issue a rule with a 60-day implementation period that will take effect before Inauguration Day.
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