HEALTH CARE BRIEFING: Fauci Cuts Death Projection, Raising Hopes

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One of President Donald Trump’s top medical advisers slashed projections for U.S. coronavirus deaths yesterday, saying that about 60,000 people could die—almost half as many as the White House estimated a week ago.

The falling projection, the result of aggressive social distancing behaviors that Americans have adopted to curb the spread of the coronavirus, may accelerate Trump’s efforts to develop a plan to urge Americans to leave their homes and return to work next month.

“The real data are telling us it is highly likely we are having a definite positive effect by the mitigation things that we’re doing, this physical separation,” said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, in an interview with NBC. “I believe we are going to see a downturn in that, and it looks more like the 60,000, than the 100,000 to 200,000” projected fatalities, he said. “But having said that, we better be careful that we don’t say: ‘OK, we’re doing so well we could pull back.’”

Deborah Birx, the State Department immunologist advising the White House’s coronavirus task force, projected March 31 that as many as 240,000 Americans could die as a result of the coronavirus outbreak, even with another 30 days of stringent public health restrictions. That analysis caused Trump to retreat from ambitions to get Americans back to work by Easter. But with the outbreak is now appearing to plateau in New York, the U.S. epicenter, Trump’s aides have begun initial planning to urge a re-opening in May.

At a White House news conference on Wednesday, Birx said that two prominent models for U.S. mortality from the Covid-19 pandemic—Covid Act Now and the Institute for Health Metrics and Evaluation at the University of Washington—had both lowered their fatality projections based on widespread social distancing. Read more from Kathleen Miller and Jennifer Jacobs.

Pence, CDC Head Lay Out Virus Criteria to Reopen U.S.: Vice President Mike Pence and CDC Director Robert Redfield said reopening the country’s economy hinges on the government seeing major communities at the end of their coronavirus outbreaks and developing treatments for the disease, among other hurdles. The country also should have widespread testing available, therapeutics for Americans who contract the disease, and guidance from the CDC on how large and small businesses can operate safely, Pence said yesterday evening at a White House briefing.

Redford later in an interview on CNN said officials need to understand the spread of the virus, strengthen public health infrastructure, prepare hospitals and other medical facilities, and foster a belief among Americans that it’s the right time to do this. Read more from Mario Parker and Josh Wingrove.

Despite the cut to overall death toll projections, New York City reported a record 824 deaths from Covid-19 in 24 hours, a grim reminder that despite flattening infection curves and lower hospital admissions, the crisis in the largest U.S. city is far from over. Statewide, the fatality rate has worsened every day. New York state reported 799 new deaths yesterday, with 779 on Wednesday and 731 on Tuesday.
Still, at his daily virus briefing yesterday, Gov. Andrew Cuomo (D) said there had been only 200 net new hospitalizations over 24 hours, the lowest number since the crisis broke out. That number had been as high as 1,400. Mayor Bill de Blasio (D) said yesterday the apparent flattening of the infection curve may mean that the city might reach a second phase as early as June that would relax restrictions on movement outside the home. Read more from Henry Goldman, Christian Berthelsen and Keshia Clukey.

Combating Shortages at Hospitals

Medical Supplies Free-for-All Has States Lashing Out at FEMA: The fierce competition for crucial medical supplies is fueling confusion and suspicions between the states and federal government over conflicting priorities and drawing allegations of political favoritism by the Trump administration. n Colorado, the tension boiled over when the state tried to secure ventilators for an expected spike in critically ill patients.

Colorado’s Democratic governor, Jared Polis, had made a direct plea to Vice President Mike Pence late last month for help in securing 10,000 ventilators and millions of masks and other protective equipment. When that request went unfulfilled, the state bought 500 ventilators from a private contractor. But the Federal Emergency Management Agency also needed the ventilators. The agency used its authority to jump to the front of the line, according to Colorado officials, and purchased the equipment.

“Before the ventilators could get shipped, FEMA superseded Colorado,” said Rep. Diana DeGette, a Democrat representing the Denver area. “They took those 500 ventilators and said they were putting them in the national stockpile.” It’s a situation being played out around the country as governors complain of shortages, delays and confusing demands as they try to supply hospitals beset by critically ill patients. Read more from Daniel Flatley, Polly Mosendz and Vincent Del Giudice.

Governors Plan to Skip Feds for Equipment: The nation’s governors say they can’t count on Washington to supply the medical equipment needed to fight the coronavirus pandemic, so they are making plans to band together and procure supplies themselves. The idea comes as a result of a depleted Strategic National Stockpile and a Federal Emergency Management Agency that’s repeatedly failed to get states what they need. Such a consortium has already been created in the Midwest, bringing together the combined buying power of Michigan, Wisconsin, and Minnesota.

Gov. Cuomo said such an expanded, nationwide group is necessary if the issues with aid continue. “If the federal government is not going to do it, then the states have to do it,” he said at a press conference yesterday. Read more from Polly Mosendz.

Overseas Drugmakers Get Free Pass: U.S. regulators are allowing overseas pharmaceutical facilities with checkered safety and quality records to make prescription drugs for Americans in an effort to fill supply gaps caused by the pandemic. Drugs needed to care for the sickest virus patients are becoming more scarce at the same time that a surge in U.S. infections is forcing hospitals to stretch staff, beds and supplies of protective equipment.

In an attempt to bolster the drug supply, companies in India are stepping in despite American inspectors having flagged their facilities for poor sanitation, manipulation of quality-control data and other infractions. Higher-than-normal demand for a range of medications is straining a supply chain that was never built to seamlessly handle a historic public-health shock. Read more from Anna Edney.

Shortage Prompts New N95 Guidance: Coronavirus-induced shortages of N95 respirators have led federal workplace safety regulators to temporarily set aside a rule for annual respirator fit testing. As long as employers make a “good faith effort” to comply with the Occupational Safety and Health Administration’s rule on respiratory protections and adhere to agency guidance, the agency won’t cite employers for violations of the annual respirator fit testing mandate, the agency announced. The exception expires once the public health crisis ends, OSHA said, Bruce Rolfsen reports.

Powered Respirator Rules Eased for Virus: The HHS trimmed rules yesterday allowing health-care workers to use air-purifying respirators to shield themselves from the coronavirus. The CDC issued the interim final rule updating standards around battery-powered air-purifying respirators and gas and vapor respirators. This move tailors the testing and approval requirements to health care and is intended to help manufacturers address the shortage of masks caused by Covid-19. Read more from Ayanna Alexander.

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Research, Treatment & Coordination

FEMA Deadline for State Testing Transition Too Short, Pallone Says: House Energy and Commerce Chairman Frank Pallone (D-N.J.) blasted FEMA for issuing an advisory yesterday requiring states to petition the federal government to continue supporting certain testing sites by the end of the day. Pallone asked the Trump administration to give states more time to decide if they want to take over managing Community-Based Testing Sites that the federal government has so far run and used to test nearly 80,000 Americans. Read the statement here.

Health Systems to Get Additional $17 Billion: The Centers for Medicare and Medicaid Services has approved a total of $51 billion in advance payments to health-care providers, an increase of $17 billion over what it initially planned, the agency announced yesterday. The CMS has approved 21,000 of the 32,000 requests for advance payments it has so far received under the policy created during the coronavirus outbreak. Providers can apply to receive three months of their Medicare payments in advance, and some can receive up to six months. Read more from Shira Stein.

Clearance for Virus Screening Steps: Hospitals don’t have to clear mandatory Covid-19 screening procedures with a research ethics board before sharing the results with a public health department or research subjects, an HHS research regulator clarified. The Office for Human Research Protection released a new guidance document yesterday on how human research regulations, known as the Common Rule, apply during the current outbreak. The guidance highlights flexibilities in the rule allowing scientists to make changes to protect research volunteers without having to clear them first with an institutional review board. Read more from Jeannie Baumann.

NIH Malaria Drug Trial: An NIH-funded study to test hydroxychloroquine as a potential therapy for patients hospitalized with the coronavirus began enrolling patients, the NIH announced yesterday. Trump has repeatedly touted the drug, used to treat malaria, rheumatoid arthritis and lupus, as a “game changer” for combating the virus. But scientists, including former FDA commissioners, have cautioned against promoting a treatment before it’s been shown to work. Read more from Jeannie Baumann.

Privacy Violations at Test Sites: Health-care providers and business associates operating coronavirus testing sites in communities won’t be penalized for some privacy rule violations, HHS said yesterday. It loosened regulations under health privacy laws to expand the number of local testing sites available. These sites include mobile, drive-through, or walk-up sites that collect Covid-19 specimens or provide testing services to the public, according to the guidance. Read more from Ayanna Alexander.

Democrats Press FDA on Test Accuracy: House Democrats want information from the FDA on the precautions the agency has taken to ensure the accuracy of Covid-19 tests, as well as manufacturers’ data provided to the agency on false negatives and positives. Chairman of the Ways and Means Health Subcommittee Lloyd Doggett (D-Texas) and Chairwoman of the Appropriations Labor, Health and Human Services and Education Subcommittee Rosa DeLauro (D-Conn.) wrote to the FDA yesterday about their concerns in light of the CDC’s history of faulty coronavirus tests. Read the letter here.

CMS Relaxes Rural Telemedicine Rules: Rural hospitals can have doctors offer patient care remotely, even if they normally practice medicine in another state, CMS said late yesterday. The measure is part of a number of rules the Centers for Medicare & Medicaid Services temporarily suspended to address a workforce shortage during the Covid-19 pandemic, reports Jeannie Baumann.

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What Else to Know Today

Small Business Aid Push Blocked: Senate Democrats blocked Majority Leader Mitch McConnell’s (R-Ky.) attempt to quickly pass a $250 billion boost in more aid to small businesses suffering revenue losses in the pandemic, likely delaying any action until leaders of both parties find a compromise. McConnell had sought unanimous consent in the Senate yesterday for the small business aid requested by Treasury Secretary Steven Mnuchin. Monday may be the next chance to quickly approve more aid without objection, and lawmakers aren’t scheduled to return to Washington until the week of April 20.

Senate Minority Leader Chuck Schumer (D-N.Y.) and House Speaker Nancy Pelosi (D-Calif.) are seeking to double the GOP’s $250 billion aid request for the slumping economy with more federal relief for state and local governments and added funding for hospitals struggling to treat a crush of coronavirus patients. Laura Litvan and Steven T. Dennis have more.

SCOTUS Urged to Ditch ACA Exemptions: Trump administration rules allowing certain employers to offer health plans that exclude coverage for birth control should be struck, lawmakers, civil rights groups, and medical organizations told the Supreme Court yesterday. The groups filed amicus briefs this week backing Pennsylvania and New Jersey, as they push back against an attempt to undo a Third Circuit verdict that blocked the government from enforcing religious and moral exemptions to Obamacare’s contraceptive mandate. Read more from Mary Anne Pazanowski.

Texas Abortion Ban Narrowed: Some abortions in Texas will be permitted to resume under an Austin judge’s ruling narrowing the scope of a temporary ban enacted by the state to conserve medical resources during the pandemic. The court order lets clinics perform medication abortions that don’t require masks and gloves as well as surgical abortions for women whose pregnancies will be too advanced by the time the governor’s ban expires. The clinics said they have had to turn away hundreds of patients since Texas clamped down.

U.S. District Judge Lee Yeakel’s latest order risks drawing a second rebuke from the New Orleans-based federal appeals court, which on April 7 blasted him for siding with the clinics in their challenge to Texas Gov. Greg Abbott’s (R) directive March 22 to preserve hospital beds and personal protective gear for treating Covid-19 patients. Yeakel said his order expires on April 19 unless he extends it. Read more from Laurel Brubaker Calkins.

Lobbyists Sign Covid-19 Clients: Lobbying firms close to Trump are capitalizing on the race to K Street, as industries flock to hire advocates who can help them navigate the federal government’s response to the pandemic. Lawmakers have authorized trillions in relief measures over the last month to help mitigate the economic downturn, with more aid likely in the coming weeks. Federal agencies, meanwhile, are untangling new loan and grant programs that affect millions of businesses. Read more from Megan R. Wilson.

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To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com

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