Biden’s HHS Rescinds Trump-Era Vaccine Injury Payment Rule (1)

April 21, 2021, 12:52 PM; Updated: April 21, 2021, 5:04 PM

The HHS on Wednesday rescinded a Trump-era rule that would have made it more difficult for people who suffer shoulder injuries or faint after vaccination to get compensated.

The Department of Health and Human Services accepted comment for 30 days before withdrawing the rule. 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 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 initially delayed the effective date to review the regulation.

The move reflects the Biden administration’s effort to provide more incentives for people to get a Covid-19 vaccine as the supply expands. White House officials announced Wednesday that small businesses can get tax credits to fund employer-paid time off for employees to get vaccinated or take a sick day to recover from side effects.

White House health officials are “encouraged” by vaccine rates so far and “are eager to get into those people who we need to have conversations with about why they need to get vaccinated,” an administrative official told reporters Wednesday. Also important is “making sure the facts are available to everybody and also making sure that it’s more and more convenient,” they said.

‘Irregular in Its Haste’

The HHS earlier said the Trump-era final rule “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 HHS previously chastised the prior administration’s rush to get the rule out. “Members of the public believe that the promulgation of the final rule was irregular in its haste,” the proposal to withdraw said. The decision to remove shoulder harm and fainting from the injuries eligible for payment was a major contrast to the multi-year decision to add to them to the list.

Shoulder injury related to vaccine administration isn’t just a sore arm—something many people have complained of temporarily after Covid-19 vaccinations. It’s persistent pain and limited range of motion caused by inflammation of tendons or ligaments, often because the shot is injected too high on the arm.

The compensation 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.

(Updated to include additional comments on the status of U.S. vaccination efforts. )

To contact the reporters on this story: Fawn Johnson in Washington at fjohnson@bloombergindustry.com; Jacquie Lee in Washington at jlee1@bloomberglaw.com

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

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