HEALTH CARE BRIEFING: Biden’s HHS to Inherit Legal Fights
By Brandon Lee
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Legal battles left over from the prior administration are likely to dictate which health-care policy priorities President-elect Joe Biden and his officials must focus on first.
Fights are ongoing over the scope of Trump administration rules that scaled back Obamacare’s anti-discrimination protections, gave health-care workers the right to refuse patients care based on their religious beliefs, and expanded access to skimpier health plans. Court schedules in the cases could force the new administration to make some quick decisions come Jan. 20.
“The Biden administration is going to be pretty quickly put in a position where it has to decide whether it’s going to defend Trump-era regulations, including at the Supreme Court,” said Katie Keith, a health law professor at Georgetown University.
Officials will have to decide whether to drop appeals, seek extensions, or ask for cases to be put on hold. If confirmed as Health and Human Services Secretary, Xavier Becerra could have to rely on his deputy to determine what to do with the cases he brought against the agency as California attorney general.
The justices agreed Dec. 4 to hear the Trump administration’s appeal of court decisions tossing out approvals of state Medicaid programs that impose a work requirement on its beneficiaries. The government’s opening briefs are due just days before Biden is set to take office.
“They are walking into an incredible situation where the government will be on record arguing for the legality of experiments that the administration considers neither legal nor found policy,” said Sara Rosenbaum, a professor of health law and policy at George Washington University.
While the Biden administration is expected to notify the justices that the government has changed its position in the case, “it’s literally going to be an incredible race against the clock,” she said. Respondents’ briefs are due Feb. 17 under the court’s rules and the arguments will likely be held in March. Read more from Lydia Wheeler.
HHS Starts Reviewing All Rules in Last Trump Days: Health regulations that aren’t reviewed every 10 years to consider whether they are still needed would expire under a rule finalized on Friday. The final rule exempts some Food and Drug Administration rules and yearly ACA rules, in addition to procedural rules, regulations issued jointly with other agencies, and regulations around internal management. The move comes just a week before Biden’s inauguration, and adds additional duties to his incoming HHS staff. Biden’s transition team said it plans to issue a memo on Jan. 20 to block regulations from taking effect that haven’t yet, Shira Stein reports.
Biden Says He’ll Release More Second Doses
Biden said he will distribute more available doses of coronavirus vaccines, reversing the Trump administration’s practice of holding back second doses to make sure they’re available for people who’ve already had their first shot.
The move unveiled by Biden’s office Friday and endorsed by several Democratic governors is his response to the current sluggish federal vaccine rollout. “He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” Biden spokesman TJ Ducklo said Friday in a written statement.
Trump’s administration has so far withheld about half of allocated doses of vaccines made by Pfizer-BioNTech and Moderna, both two-dose regimens. The Trump administration has said it wants to ensure doses are actually available when people return weeks later for their second dose to fortify efficacy. Second shots are needed after 21 days for the Pfizer-BioNTech vaccine, and 28 days for the Moderna shot.
Biden’s statement did not make clear how many vaccines he would still withhold. Biden will release additional details this week, Ducklo said. The move risks that a hiccup in delivery of vaccines may leave the administration without enough when people’s second doses are due. Biden’s team is confident that manufacturers can meet the demand, a transition official said. They’ll use the Defense Production Act to force production if needed, the official said. Josh Wingrove, Jordan Fabian and John Tozzi have more.
- Meanwhile, the U.S.’s vaccine distribution plan relies too heavily on hospitals and chain drug stores to ensure everyone in the country has access, the head of the National Urban League said. Drug store representatives say they are up to the task once enough vaccines are available to distribute widely. But that claim may be hard to back up. There are about 40,000 drug stores signed up to participate in an expanded vaccine rollout that started this week. Read more from Jeannie Baumann and Jacquie Lee.
Biden’s Stimulus Plans Set Up Fresh Fight: Biden’s plan to pass a multi-trillion dollar economic stimulus package early in his administration faces challenges in a closely divided U.S. Senate, with a potential impeachment trial for Donald Trump that could add to delays. Biden is set to release his proposals — the price tag for which has yet to be unveiled — on Thursday. The package will feature a range of support for state and local authorities long blocked by Republicans, a bump in direct payments to $2,000 and expanded unemployment benefits, along with funding for vaccine distribution, school re-opening, tax credits, rental relief and aid to small businesses. Read more from Erik Wasson, Laura Davison and Nancy Cook.
Related:
- How Democrats Will Move on Impeaching Trump in His Last Week
- BGOV OnPoint: Covid-19 Relief Measures Top $3 Trillion
Divided Senate Looks to Bush Era Power-Sharing: Senate leadership may look to a power-sharing agreement forged two decades ago as they begin negotiations over the daily running of the chamber and its committees. Democrats’ two victories in Georgia last week mean the Senate will be split 50-50. Soon-to-be majority leader Chuck Schumer (D-N.Y.) said that changes in how the Senate is run can’t be made until Georgia certifies the wins of Democrats Raphael Warnock and Jon Ossoff, new senators are sworn in, and Harris presides over the Senate. “But I look forward to sitting down with Leader McConnell,” Schumer told reporters.
Members of both parties said a starting point is likely to be the agreement used by the parties in 2001, when they were also at parity and Vice President Dick Cheney provided tie-breaking votes to get Bush administration priorities through. Read more from Nancy Ognanovich.
The Coronavirus Pandemic
Connecticut Outpaces N.Y. in Race to Vaccinate Residents: Gov. Andrew Cuomo (D) has insisted that New York’s health-care workforce be fully vaccinated before others in the state are immunized, but in neighboring Connecticut, a looser approach is drawing results faster. Cuomo on Friday reversed course after criticism, saying that New York will start scheduling vaccine appointments for seniors, teachers and first responders. According to Bloomberg’s vaccine tracker, New York had administered just 38% of the doses it’s received from the U.S. government as of Jan. 7. Connecticut was through 46% of its supply. Angelica LaVito has more.
- New York City had 270,000 unused vaccine doses it was seeking to administer to residents over age 75, Mayor Bill de Blasio (D) said Friday. The city has about 565,000 vulnerable New Yorkers in the eldest category “who need this help right now,” he said, continuing to push for state approval to expand the criteria of eligibility. Read more.
College Openings Coincide With Community Surges: The reopening of college campuses last fall coincided with new coronavirus outbreaks in surrounding communities, the Centers for Disease Control and Prevention said. New cases increased by over 56% in counties where large colleges were located, 21 days after classes restarted, a CDC report released on Friday found. Meanwhile, counties where large colleges opted for remote instruction saw Covid-19 cases decline by 17.9%. Campus leaders hoped improved mitigation efforts adopted during the fall—such as mask wearing, rapid testing and quarantining of affected students—would allow them to continue in-person classes safely.
Holiday travel stoked fears over a surge in cases, leading many schools to reconsider spring start dates. The CDC’s report underscores public health risks linked to returning to classes in person. The CDC study didn’t adjust for mitigation strategies adopted at state or local levels or on campuses. It also couldn’t determine whether new cases were connected to campuses or community transmission. Read more from Andrew Kreighbaum.
WHO Gets Access to China After Delay: China said that a World Health Organization team of experts will arrive this week to investigate the origins of the coronavirus, after the country was criticized by the health body and other nations for a lack of transparency around tracking the pathogen’s source. The team of scientists will come to China from Jan. 14, the National Health Commission said today. The confirmation of a date comes after a rare rebukeby WHO Director-General Tedros Adhanom Ghebreyesus, who expressed disappointment last week that China had not yet given final permission for the experts’ entry, even as some had already started traveling. Read more.
More Headlines:
- Variants of Coronavirus Might Trigger False Negatives, FDA Says
- CVS, Walgreens Give 900,000 Covid Vaccinations at Nursing Homes
- Japan Detects New Virus Variant, Similar to U.K. and South Africa
- Japan Mulling Approving Pfizer Vaccine for Ages 16 and Up: NHK
What Else to Know
Drug Industry at a Crossroads: In 2020, the pharmaceutical industry raced to develop shots against a deadly new virus sweeping the globe — and succeeded, in record time. They did it while navigating the pandemic themselves, managing operations and supply chains amid profound disruption. As the J.P. Morgan Healthcare Conference, the sector’s biggest annual gathering, kicks off virtually today, drugmakers are set to revel in those accomplishments. But their enthusiasm is bound to be muffled by the prospect of increased regulation and price pressure.
As the pandemic raged, pharma companies continued to hike prices while their stocks soar. Now that Democrats stand ready to control Congress and the presidency, the industry faces newly empowered critics who don’t see them in the rosy light of altruism. “Millions of people in America have been changed by the pandemic, but it’s pretty clear the prescription drug corporations have not,” said Margarida Jorge, campaign director for the national coalition Lower Drug Prices Now. “Let’s get real. These companies would not have jumped into the fight for a vaccine if the federal government hadn’t heavily subsidized and funded it.” Read more from Emma Court.
Blue Cross Suspends Donations to Lawmakers Who Opposed Biden Win: The Blue Cross Blue Shield Association said it will suspend contributions to lawmakers who voted against certifying Biden’s electoral win. “In light of this week’s violent, shocking assault on the United States Capitol, and the votes of some members of Congress to subvert the results of November’s election by challenging Electoral College results, BCBSA will suspend contributions to those lawmakers who voted to undermine our democracy,” BCBSA CEO and President Kim Keck said in a statement issued Friday. Read more from Sara Hansard.
Lawmakers Exposed to Covid-19 During Attack: Lawmakers may have been exposed to the coronavirus while they were held in a secure room during Wednesday’s attack on Congress, the Capitol’s attending physician said yesterday. “Many members of the House community were in protective isolation in room located in a large committee hearing space,” physician Brian Monahan said in a statement. “During this time, individuals may have been exposed to another occupant with coronavirus infection.“ Read more from Billy House.
More Headlines:
- Drug Patent Database Revamp Falls Short of Tackling High Costs
- Cigna Sues Bristol-Myers Over Thalomid Generic Delay Allegations
- Medicare Home-Health Payment Model Approved for Full Country
- Tennessee Lump-Sum Medicaid Funding OK’d in Hurdle for Biden
- Neoleukin Sinks as FDA Puts Clinical Pause on Lead Drug Program
To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com
To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com
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