HEALTH CARE BRIEFING: Privacy Questions Loom on Vaccine Passport

Privacy fears around the public display of vaccination status for Covid-19 threaten to hamper the rollout of a technology that could play a big part in reopening society and stemming the spread of the virus.

But absent government coordination or regulation—and the Biden administration has been adamant that it won’t get directly involved—it’s left to the private sector to build consumer trust and navigate the laws that dictate how to keep data secure and confidential.

The debate comes as the national vaccination effort is well underway. Almost 200 million doses have been administered in the U.S. as of April 16, according to the Bloomberg vaccine tracker.

“There are a lot of unanswered questions from a legal perspective,” said Sean Sullivan, a health-care attorney at Alston & Bird in Atlanta. “There’s not the same kind of privacy framework for this sort of thing.”

The federal government’s decision to remove itself from creating digital passports was made to avoid vaccine hesitancy from those “concerned the government will play too heavy-handed of a role in monitoring their vaccinations,” Andy Slavitt, the senior adviser for the White House’s Covid-19 response, said last month. Read more from Jake Holland, Jacquie Lee, and Robert Iafolla.

Happening on the Hill

House to Vote on Fentanyl Bill: The House is slated to vote this week on a bill that would extend through September the government’s power to ban fentanyl-like substances, Alex Ruoff reports. The extension would maintain the government’s ability to classify fentanyl-like substances as one of the most strictly controlled drugs, a tool the Biden administration has defended as necessary to combat the trafficking of powerful synthetic opioids. Civil rights and drug policy groups have opposed extending the temporary powers, saying it contributes to aggressive policing of people with substance use disorders.

Biden to Hold Bipartisan Lawmaker Meeting: Biden will meet today at 1:15 p.m. with a bipartisan group of lawmakers as outreach continues on his $2.25 trillion infrastructure-and-tax plan. White House Press Secretary Jen Psaki announced the plans at a briefing Friday, without specifying which members of Congress will be in the meeting. The group will discuss “historic investments in the American jobs plan including in highways, drinking water systems, broadband and the care economy,” she said, Jennifer Jacobs and Erik Wasson report.

THIS WEEK’S HEARINGS:

Medicare Coalition Supports Telehealth Bill: Better Medicare Alliance, an advocacy group supporting Medicare Advantage, sent a letter signed by 33 organizations including the U.S. Chamber of Commerce announcing support for a bipartisan measure that would “protect continuity of care for Medicare Advantage beneficiaries during the COVID-19 pandemic by allowing the use of audio-only telehealth for risk adjustment purposes,” the group write. The bill (S. 150, H.R. 2166) was unveiled by Sens. Catherine Cortez Masto (D-Nev.) and Tim Scott (R-S.C.) and Reps. Terri Sewell (D-Ala.) and Gus Bilirakis (R-Fla.). Read the letter here.

Bill Passed to Tackle Violence in Health-Care Workplaces: House lawmakers on Friday passed a bill targeting violence involving health-care and social service workers. The legislation (H.R. 1195), which was passed 254-166, would require the Occupational Safety and Health Administration to issue a rule requiring health-care and social service employers to implement workplace violence prevention plans. An interim final standard would be required within one year, and a final standard within 42 months. Read more from Andrew Kreighbaum.

Senators Press Biden on Vaccine Patents: Senate Democrats in a letter urged Biden to support a temporary patent waiver for Covid-19 vaccines that would allow countries to manufacture them locally. The letter comes ahead of a May 5 meeting of the World Trade Organization’s General Council. “To bring the pandemic to its quickest end and save the lives of Americans and people around the world, we ask that you prioritize people over pharmaceutical company profits by reversing the Trump position and announcing U.S. support for the WTO TRIPS waiver.”

Democrats Push Against Tax Deductions for Opioid Cos.: Sens.Maggie Hassan (D-N.H.) and Ron Wyden (D-Ore.) led lawmakers in a letter urging the Internal Revenue Service to challenge tax deductions that opioid companies may take for settlements that they are paying out related to opioid lawsuits. “We strongly encourage the IRS to fully enforce the tax code by challenging any erroneous interpretations of these recent regulations that opioid companies may use in an attempt to claim tax deductions for legal settlement expenses,” the senators wrote.

The Coronavirus Pandemic

Covid-19 Claims at Least 3 Million Lives: The relentless pace of death from the global Covid-19 pandemic is continuing unabated despite global vaccination efforts, and is now being increasingly borne by the poorest places in the world. More than 3 million lives have been lost as a result of the novel coronavirus that emerged in 2019, with the latest 1 million recorded deaths coming even faster than the first two. It took about 8.5 months after the initial fatality in China to mark the first million, another 3.5 months to reach the second million, and about another three months to reach the third.

The real death toll from Covid-19 is likely far higher than 3 million, due to under and patchy reporting around the world. Read more from Jinshan Hong.

U.S. to Spend $1.7 Billion to Track Variants: Biden’s administration is allocating $1.7 billion in funding to track the spread of Covid-19 variants, which are proving dangerous as they spread quickly and risk dragging out the pandemic. Biden will direct $1 billion to genomic sequencing, which helps federal agencies and states track which version of the virus is spreading. They also announced $400 million for epidemiological research and $300 million for health data and training. The announcement, with funding from the aid package Biden signed a month ago, comes as mutations of the virus fuel new outbreaks across the U.S.—especially in the upper Midwest. Read more from Josh Wingrove.

J&J Decision Soon, US Vaccine Milestone: A decision on how to resume vaccinating Americans with the Johnson & Johnson coronavirus shot will probably come by Friday, the top U.S. infectious-diseases specialist said, a faster timeline than other health officials have indicated. “I doubt very seriously if they just cancel” the J&J vaccine, one of three approved for use in the U.S., Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on NBC’s “Meet the Press,” one of four Sunday talk-show interviews.

  • Fauci spoke as the U.S. reached a vaccination milestone: the U.S. Centers for Disease Control and Prevention reported on its website yesterday that more than half of people in the U.S. age 18 and older have now had at least one Covid-19 vaccine dose. Read more from Ros Krasny.
  • In a study of 1,000 staffers at Cedars-Sinai Medical Center in Los Angeles, those who had recovered from Covid-19 responded to their first shot so robustly that the results rivaled never-infected colleagues who had received both shots. The implication was clear. If you’ve had Covid-19, you may only need one of the two doses recommended by Pfizer and Moderna. And with strained global supply, giving previously infected people just one mRNA vaccine shot could free up more than 110 million doses worldwide, according to a calculation by University of Maryland School of Medicine immunologist Mohammad Sajadi and colleagues. Read more from Carey Goldberg.

Which Vaccines Are the U.S. Shipping: Knowing which vaccines are being supplied in the U.S. is just as important as knowing how many shots are going into arms. But because of a bifurcated U.S. distribution system, the public is getting less and less detailed information from the federal government on how many doses each vaccine manufacturer is actually delivering. It’s a situation that makes it harder to know if drugmakers are meeting their delivery commitments and also how the federal government is allocating shots. Read more from Drew Armstrong.

More Headlines:

What Else to Know

HHS Pulls Back 10-Year Extension of Texas Medicaid Plan: The Department of Health and Human Services overturned Friday a last-minute approval by the Trump administration extending Texas’s Medicaid plan for 10 years. The Centers for Medicare and Medicaid Services “materially erred” in allowing the state to bypass the normal notice-and-comment process for approval of Medicaid waivers under Section 1115 of the Social Security Act, the department said in an April 16 letter.

Texas claimed in its request that an exemption from the notice-and-comment process was necessary to give health providers and the state’s low-income health program financial stability amid the Covid-19 pandemic. But the state didn’t show that the exemption request was related to the public health emergency or that a delay would harm beneficiaries, the department concluded after further review. Read more from Christopher Brown.

Fetal Tissue Research Restrictions Reversed: NIH-funded scientists who want to use fetal tissue in their studies will no longer face Trump-era restrictions favored by abortion opponents. The HHS is reversing a 2019 policy that effectively stopped the National Institutes of Health from funding research using tissue from aborted fetuses, according to a guide notice the NIH issued Friday. Read more from Jeannie Baumann.

Medical Device Data Excluded From FDA Review: Software that stores, transfers, or displays clinical lab tests or other medical data is excluded from FDA regulations governing medical devices, according to a final rule released Friday. The Food and Drug Administration’s rule amended descriptions in eight instances to conform to a provision in the law that says medical software that encourages a healthy lifestyle and is unrelated to the diagnosis or treatment of a disease or condition isn’t required to undergo FDA review. The law also says health facilities’ administrative support systems that track billing and claims information or appointment schedules aren’t considered medical devices. Read more from Fawn Johnson.

More Headlines:

With assistance from Alex Ruoff

To contact the reporter on this story: Zachary Sherwood in Washington at zsherwood@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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