Are Two Shots Enough? Health Groups Call for Booster Mandate

Feb. 1, 2022, 10:07 AM UTC

Health-care workers should be required to get Covid-19 booster shots, an array of organizations representing medical professionals, patients, and seniors is urging the Biden administration.

They say the government’s mandate needs to be updated in order to keep patients and staff safe as the fast-spreading omicron variant continues to overwhelm hospitals and other facilities.

When the Centers for Medicare & Medicaid Services released its vaccine mandate in early November, South African researchers had yet to discover the omicron variant, which carries a greater risk of breakthrough infection or reinfection than previous variants.

Deaths are still rising in the U.S. as total cases drop. Nearly 2,300 people died daily of Covid over the past week, adding to the 880,000 death toll since the beginning of the pandemic, according to the Centers for Disease Control and Prevention. While new hospital admissions for patients with Covid-19 have trended downward since the middle of January, they are still higher than at any other point of the pandemic.

The CDC recently decided to “pivot the language” from a focus on being fully vaccinated to being “up to date” with vaccines, which includes a booster dose five months after a two-dose series, CDC Director Rochelle Walensky said in a White House press briefing Jan. 21.

Given the growing evidence that booster doses help fend off the virus, advocates at organizations including the Society for Healthcare Epidemiology of America, the Center for Elder Law and Justice, the National Hospice and Palliative Care Organization, AARP, and the Service Employees International Union are asking the CMS to align its mandate with the CDC’s recommendation.

“If it’s true that people should be vaccinated when they’re serving a really frail population, then it’s true that they should be up to date in their vaccinations,” said Edo Banach, president and CEO of the National Hospice and Palliative Care Organization.

Other major industry groups, like the American Hospital Association, have stayed quiet on the matter.

The Supreme Court allowed the CMS to enforce its vaccine mandate across the U.S. after dozens of Republican-led states tried to strike it down. The agency released the mandate without giving affected people time to submit comments before the rule took effect, but the CMS is developing a final version of the rule that may take feedback into account.

‘Responsible Thing to Do’

The CMS “strongly encourages individuals to get vaccinated for Covid-19 and stay up to date with booster doses when they are eligible in accordance with CDC guidelines,” a spokesperson for the agency said. “It is important to note, however, that the definition of a Covid-19 primary vaccination series has not changed.” Therefore, the agency’s mandate does not require a booster.

Booster shot uptake has been spotty for Americans across the board. Just over 40% of fully vaccinated people have received their booster dose, according to the CDC.

The percentage is even lower for nursing home staff—28% as of early January.

“We’re most concerned about the people who are receiving care,” Banach said. “We don’t want anything that we do to put at risk the people that we care for.”

Booster shots also help preserve the shrinking health-care workforce. Many health-care facilities, already short-staffed and have been forced activate crisis standards of care as their caseloads soared under omicron. Personal protective equipment safeguards health-care workers when they’re at the bedside, but they can still be exposed to Covid in the break room or in their community.

A study published in the journal JAMA Network Open found a booster dose significantly reduced coronavirus infection among health-care workers in Israel in the short term.

“It’s the responsible thing to do to try to reduce our risk of infection as much as possible so that we can continue to do our jobs—so that we can continue to care for our patients and protect ourselves,” said Mary Hayden, chief of the division of infectious diseases at Rush Medical College. Hayden is the past president of the Society for Healthcare Epidemiology of America.

California, Connecticut, Massachusetts, New Jersey, and New Mexico all require health-care workers to be up to date on their vaccines. New York is also planning to impose a booster requirement.

Administrative Burden

While vaccines are widely accepted by the medical community as the most important tool to combat the pandemic, vaccine mandates remain controversial.

Several states said in legal filings that they are a burden on the already-taxed health-care system, imposing “hundreds of million dollars in cost.”

The CMS’s original mandate requires health-care facilities to track and document booster shot uptake among staff. The language in the rule has health-care facilities wondering whether the CMS will add a booster dose to the requirement.

“CMS appeared to be forecasting that if it has the power to mandate vaccines, it will eventually extend the mandate to include booster shots,” states said in their complaint.

If the agency’s “intent is to also require booster shots,” the final rule will need to be delayed to give health-care facilities time “to implement this unexpected change in position,” the Wisconsin Hospital Association wrote in comments to the CMS.

America’s Essential Hospitals agreed that facilities will need “reasonable notice” if the definition of fully vaccinated under the rule changes.

Tracking boosters will also “require substantial administrative time and effort for providers since boosters are voluntary and staff schedules for receiving a booster vaccine will vary dramatically,” Mary Carr, vice president of regulatory affairs for the National Association for Home Care & Hospice, wrote in comments to the CMS.

Regulatory Change

A booster mandate could spark more litigation because final rules need to be a “logical outgrowth” of proposed or interim final rules under the Administrative Procedure Act.

Legal scholars said the CMS’s authority to mandate a booster is clear as long as the agency obeys the APA.

If the agency determined a booster was necessary, it would be “exercising the exact same statutory charge” that the Supreme Court greenlit for the original mandate, said Brian Dean Abramson, who teaches vaccine law at Florida International University College of Law.

“I would not be surprised if the final rule reflected what we’re suggesting,” Banach said.

To contact the reporter on this story: Allie Reed in Washington at areed@bloombergindustry.com

To contact the editors responsible for this story: Brent Bierman at bbierman@bloomberglaw.com; Fawn Johnson at fjohnson@bloombergindustry.com

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