Medicare Wouldn't Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Aut [View all]

Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization

Medicare wouldn’t cover the cost of administering any coronavirus vaccine approved for emergency use, leaving Trump administration officials exploring options to quickly fix the government’s plan to make the vaccine free for all Americans.

Lawmakers in March passed the Coronavirus Aid, Relief, and Economic Security Act, or Cares Act, which ensures free coronavirus vaccine coverage, including no out-of-pocket costs for people on Medicare. But Medicare doesn’t cover costs for drugs approved under emergency-use designations.

The Food and Drug Administration authorizes certain drugs for emergency use to provide speedy access to treatments for serious diseases during a health crisis. Standards for emergency-use authorization aren’t as high as they are for its typical drug approvals.

Trump administration officials recently came to the conclusion that Medicare’s exclusion of emergency-use drug costs could leave millions of people paying out-of-pocket for vaccines the government intends to make free, according to three people familiar with the matter. About 62 million people, or about 19% of the U.S. population, are covered by Medicare.

The Department of Health and Human Services is exploring coverage options for a Covid-19 vaccine approved under an emergency-use authorization, and any vaccine doses bought by the government will be provided at no cost, an HHS spokeswoman said. The White House is pushing to get a vaccine as early as next month that would be approved by the FDA under an emergency-use authorization. The White House didn’t immediately respond to a request for comment.

The White House and HHS may press Congress to change the language in the Cares Act so that it includes Medicare coverage for a vaccine approved under an emergency-use authorization, according to a senior administration official familiar with the matter. But administration officials are worried about whether the changes can be accomplished in time for a possible October vaccine rollout, the official said.
Understanding Coronavirus

The problem can’t be fixed with an executive order, the official said, so HHS is also looking at whether any creative interpretation of existing regulations could allow for Medicare coverage for administering the vaccine. The discovery has officials questioning why no one in Congress realized the problem existed before legislation ensuring free coverage was passed, according to a senior administration official familiar with the matter.

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https://www.wsj.com/articles/medicare-wouldnt-cover-costs-of-administering-coronavirus-vaccine-approved-under-emergency-use-authorization-11600704447 (subscription)

Also

https://www.cnbc.com/2020/09/23/medicare-may-not-pay-for-early-coronavirus-vaccines-without-legal-fix.html