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Biden’s HHS to Rescind Trump-Era Vaccine Injury Payment Rule

March 12, 2021, 9:40 PM

The HHS plans to rescind a Trump-era rule that stops people who suffer shoulder injuries or faint after vaccination from getting compensated.

The Department of Health and Human Services will accept comment on the proposal to withdraw for 30 days, and will likely rescind the rule at that point. Comments have been largely in opposition to the change, which removed vaccine-related shoulder harm and fainting from a list of injuries for which people are entitled to payment under the National Vaccine Injury Compensation Program.

The HHS under former President Donald Trump issued the rule (RIN 0906-AB24) one day before President Joe Biden took office, and it would have taken effect Feb. 22. The HHS under Biden delayed the effective date to review the regulation. The Biden administration also provided a brief public comment period on delaying the effective date. It got 29 comments supporting the delay and two anonymous comments opposing it.

The HHS is proposing to rescind the final rule “because it is concerned that it could have a negative impact on vaccine administrators, which would be at odds with the federal government’s efforts to increase vaccinations in the United States to respond to the Coronavirus Disease 2019 (COVID-19) pandemic, as well as to make up for observed delays in routine vaccinations that have occurred during the pandemic,” the notice said.

The proposal to withdraw the rule is also due to prior administration’s rush to get it out. “Members of the public believe that the promulgation of the final rule was irregular in its haste,” the notice said. The decision is a major contrast to the multi-year decision to add shoulder harm and fainting to the injury list.

The program is a no-fault avenue for people who incur injuries as a result of a vaccination to seek recompense. It was created to ensure an adequate supply of vaccines and stabilize vaccine costs.

Before the Covid-19 pandemic, vaccine manufacturing wasn’t a lucrative project for drugmakers, and civil lawsuits further deterred them. They weren’t able to secure affordable product liability insurance, which meant the vaccine prices would be higher or the manufacturer would be unable to enter the market. The program is intended to keep drugmakers in the vaccine making business and also make sure vaccine-injured persons can be compensated “quickly, easily, and with certainty,” according to the law.

To contact the reporter on this story: Fawn Johnson in Washington at fjohnson@bloombergindustry.com

To contact the editors responsible for this story: Jo-el J. Meyer at jmeyer@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com

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