First Edition: Jan. 11, 2021

KHN: Is Your Covid Vaccine Venue Prepared To Handle Rare, Life-Threatening Reactions? 
As the rollout of covid-19 vaccines picks up across the U.S., moving from hospital distribution to pharmacies, pop-up sites and drive-thru clinics, health experts say it’s vital that these expanded venues be prepared to handle rare but potentially life-threatening allergic reactions. “You want to be able to treat anaphylaxis,” said Dr. Mitchell Grayson, an allergist-immunologist with Nationwide Children’s Hospital in Columbus, Ohio. “I hope they’re in a place where an ambulance can arrive within five to 10 minutes.” (Aleccia, 1/11)

KHN: Even With Senate Control, Democrats Will Need Buy-In From GOP On Key Health Priorities
Democrats have argued for more generous pandemic relief, more pressure on drugmakers to lower prices and more attention to systemic racism in health care. On Jan. 20, with control of the Senate and the House of Representatives, they’ll have the power to choose which health care proposals get a vote in Congress. The victories of the Rev. Raphael Warnock and Jon Ossoff in Georgia last week gave Democrats two more Senate seats and the upper hand in the Senate’s now 50-50 split. After Vice President-elect Kamala Harris takes the oath of office, she will serve as the tiebreaker as needed — in effect, Democrats’ 51st vote. (Huetteman, 1/11)

KHN: One Ambulance Ride Leads To Another When Packed Hospitals Cannot Handle Non-Covid Patients 
Keely Connolly thought she would be safe once the ambulance arrived at Hutchinson Regional Medical Center in Kansas. She was having difficulty breathing because she’d had to miss a kidney dialysis treatment a few days earlier for lack of child care. Her potassium was dangerously high, putting her at risk of a heart attack. But she trusted she would be fine once she was admitted and dialysis was begun. (West, 1/11)

KHN: ‘An Arm And A Leg’: How A Former Health Care Executive Became A Health Care Whistleblower 
Former health care executive Wendell Potter spent part of 2020 publishing high-profile apologies for the work he used to do — the lies he said he told the American people for his old employers. These days, he said, he’s also trying to debunk myths he once sold. “What I used to do for a living was mislead people into thinking that we had the best health care system in the world,” Potter said. (Weissmann, 1/11)

KHN: ‘Peer Respites’ Provide An Alternative To Psychiatric Wards During Pandemic 
Mia McDermott is no stranger to isolation. Abandoned as an infant in China, she lived in an orphanage until a family in California adopted her as a toddler. She spent her adolescence in boarding schools and early adult years in and out of psychiatric hospitals, where she underwent treatment for bipolar disorder, anxiety and anorexia. The pandemic left McDermott feeling especially lonely. She restricted social interactions because her fatty liver disease put her at greater risk of complications should she contract covid-19. The 26-year-old Santa Cruz resident stopped regularly eating and taking her psychiatric medications, and contemplated suicide. (Kown, 1/11)

KHN: Trump Administration Approves First Medicaid Block Grant, In Tennessee 
The approval is a 10-year “experiment.” Instead of the open-ended federal funding that rises with higher enrollment and health costs, Tennessee will instead get an annual block grant. The approach has been pushed for decades by conservatives who say states too often chafe under strict federal guidelines about enrollment and coverage and can find ways to provide care more efficiently. But under the agreement, Tennessee’s annual funding cap will increase if enrollment grows. What’s different is that unlike other states, federal Medicaid funding in Tennessee won’t automatically keep up with rising per -person Medicaid expenses. (Galewitz, 1/8)

The Hill: US Reports New Daily Record, Tops 4,000 Coronavirus Deaths For The First Time 
The United States on Friday once again reported a new record for daily coronavirus deaths, surging past 4,000 for the first time. The U.S. recorded 4,085 coronavirus deaths on Thursday, according to a count from Johns Hopkins University, topping the previous record of 3,865 set Wednesday. (Williams, 1/8)

The Hill: White House Task Force Warns Case Surge Could Be Due To New US Virus Variant 
The White House coronavirus task force warned in a report to states this week that a rapid increase in cases this winter could be the result of a domestic variation of the virus, separate from the U.K. variant. “This fall/winter surge has been at nearly twice the rate of rise of cases as the spring and summer surges,” the task force wrote in its weekly report, which was obtained by The Hill. (Samuels and Sullivan, 1/8)

Reuters: Global Coronavirus Cases Surpass 90 Million In Battle On New Variant 
Worldwide coronavirus cases surpassed 90 million on Monday, according to Reuters tally, as nations around the globe scramble to procure vaccines and continue to extend or reinstate lockdowns to fight new coronavirus variants. The new COVID-19 variants discovered initially in the United Kingdom and South Africa are rapidly spreading globally. The novel coronavirus has picked up pace in the past few months with about one-third of total cases registered in the last 48 days, according to a Reuters tally. (1/11)

San Francisco Chronicle: Bay Area Seeing More COVID-19 Patients With No Underlying Health Conditions
The rampaging coronavirus is revealing new unpredictability as the promised post-holiday surge continues, with some hospitals now seeing a rise in patients sick with COVID-19 who had no underlying medical conditions, officials say. Hospitals in the Bay Area and beyond are seeing an increase in such patients, Dr. Peter Chin-Hong, an infectious disease expert with UCSF, said Sunday. “It’s not just people in nursing homes or people who are ill with immuno-compromising conditions who are the ones getting sick,” Chin-Hong said. “With COVID, it’s an equal opportunity disease, in some sense.” (Sanchez, 1/10)

The Washington Post: Biden Plans To Release Nearly All Available Vaccine Doses To Speed Inoculations 
A Biden transition official, speaking on the condition of anonymity to reveal greater detail than the public statement, said the Biden team has “faith in our manufacturers that they can produce enough vaccines to ensure people can get their second dose in a timely manner.” In addition, the official said, the incoming administration will, if necessary, make greater use of the Defense Production Act, a law that gives the government powers to step up manufacturing during wars and other emergencies. (Goldstein, McGinley, Stanley-Becker and Nirappil, 1/8)

AP: With Virus Surging, Biden To Speed Release Of COVID Vaccines
With COVID-19 surging and vaccinations off to a slow start, President-elect Joe Biden will rapidly release most available vaccine doses to protect more people, his office said Friday, a reversal of Trump administration policies. “The president-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible,” spokesman T.J. Ducklo said in a statement. Biden “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.” (Alonso-Zaldivar and Miller, 1/8)

Yahoo News: Experts Express Concern About Biden's Plan To Release Nearly All Available Vaccine Doses
President-elect Joe Biden plans to release nearly every available dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines when he takes office later this month rather than holding back millions of second doses, his transition team said Friday. The decision is meant to "ensure the Americans who need it most get it as soon as possible. "The Trump administration has insisted it's necessary to retain second doses, with Health and Human Services Secretary Alex Azar on Friday expressing concern that Biden's plan could backfire if there are any manufacturing mishaps. (O'Donnell, 1/9)

Politico: Tensions Grow On Biden's Team Over Odds Of Making Vaccination Goal 
President-elect Joe Biden has grown frustrated with the team in charge of plotting his coronavirus response, amid rising concerns that his administration will fall short of its promise of 100 million vaccinations in the first 100 days, according to people familiar with the conversations. Biden has expressed criticism on multiple occasions to groups of transition officials — including one confrontation where Biden conveyed to Covid coordinator Jeff Zients and his deputy, Natalie Quillian, that their team was underperforming. (Cancryn and Pager, 1/11)

Politico: Hospitals Say Syringes Supplied By Feds Waste Vaccine Doses 
Hospitals are throwing out doses of Pfizer’s coronavirus vaccine because the federal government is giving some of the facilities syringes that can only extract five doses from vials that often contain more. Pharmacists discovered early in the U.S. vaccination push that the standard five-dose vials of the vaccine from Pfizer and its German partner BioNTech often contained enough material for six or even seven shots. (Luthi and Roubein, 1/10)

The Sun: Fears Up To 150,000 Pfizer Covid Vaccine Doses Could Have Been Wasted
As many as 150,000 Covid vaccine doses may be have been wasted because doctors are "wrongly being told to throw away a potential sixth dose". Every vial of the Pfizer vaccine was expected to include five doses - enough for five people - but GPs have found it's possible to get six doses out of each. (Mullin, 1/8)

The Hill: FDA Chief Urges States To Allow COVID-19 Vaccinations Of Lower-Priority Groups 
The leader of the Food and Drug Administration (FDA) on Friday urged states to allow lower-priority groups to get vaccinated against COVID-19 if their doses would otherwise go to waste. FDA Commissioner Stephen Hahn told reporters he thinks the federal guidelines for vaccination, which recommend starting with health workers and nursing home staff and employees, make sense. (Weixel, 1/8)

The New York Times: Pressure Grows For States To Open Vaccines To More Groups Of People 
Just weeks into the country’s coronavirus vaccination effort, states have begun broadening access to the shots faster than planned, amid tremendous public demand and intense criticism about the pace of the rollout. Some public health officials worry that doing so could bring even more chaos to the complex operation and increase the likelihood that some of the highest-risk Americans will be skipped over. But the debate over how soon to expand eligibility is intensifying as deaths from the virus continue to surge, hospitals are overwhelmed with critically ill patients and millions of vaccine doses delivered last month remain in freezers. (Goodnough, 1/19)

The Hill: WHO Panel Approves Delaying Time Between Coronavirus Vaccine Doses 
Experts at the World Health Organization on Friday approved delaying the times between doses of Pfizer and BioNTech’s coronavirus vaccine. The organization’s Strategic Advisory Group of Experts on immunization published guidance stating that the interval between doses “may be extended up to 42 days (6 weeks), on the basis of currently available clinical trial data,” The Associated Press reported. (Williams, 1/8)

The New York Times: After Unused Vaccines Are Thrown In Trash, Cuomo Loosens Rules 
Across New York State, medical providers in recent weeks had the same story: They had been forced to throw out precious vaccine doses because of difficulties finding patients who matched precisely with the state’s strict vaccination guidelines — and the steep penalties they would face had they made a mistake. On Saturday, state health officials responded to the outcry over discarded vaccines by again abruptly loosening guidelines as coronavirus cases continued to rise. (Rubinstein, 1/10)

The Hill: Under Pressure, Cuomo To Widen Vaccine Eligibility 
Facing mounting criticism, New York Gov. Andrew Cuomo (D) on Friday said the state will expand COVID-19 vaccination eligibility to a wider range of the public, including those over the age of 75 and first responders. Cuomo has been under fire for rigidly adhering to prioritizing health workers and nursing homes, despite numerous instances of vaccine doses sitting unused in freezers or even being thrown out. (Weixel, 1/8)

The New York Times: ‘It Became Sort Of Lawless’: Florida Vaccine Rollout Turns Into A Free-For-All 
Linda Kleindienst Bruns registered for a coronavirus vaccine in late December, on the first day the health department in Tallahassee, Fla., opened for applications for people her age. Despite being 72, with her immune system suppressed by medication that keeps her breast cancer in remission, she spent days waiting to hear back about an appointment. “It’s so disorganized,” she said. “I was hoping the system would be set up so there would be some sort of logic to it.” (Mazzei, Adelson and Kelly, 1/10)

Los Angeles Times: COVID-19 Vaccine Rollout Painfully Slow To Nursing Homes
No group has suffered more during the COVID-19 pandemic than staff and residents of nursing homes, where high concentrations of elderly people with serious health problems created the perfect killing ground for the virus. Still, the effort to vaccinate people in those homes is rolling out at a frustratingly slow pace, according to experts nationwide. As of Friday, only about 17% of the more than 4 million vaccine doses distributed to long-term care facilities had been injected, according to the federal Centers for Disease Control and Prevention. (Dolan, 1/9)

The New York Times: At Elite Medical Centers, Even Workers Who Don’t Qualify Are Vaccinated 
A 20-something who works on computers. A young researcher who studies cancer. Technicians in basic research labs. These are some of the thousands of people who have been immunized against the coronavirus at hospitals affiliated with Columbia University, New York University, Harvard and Vanderbilt, even as millions of frontline workers and older Americans are waiting their turns. (Mandavilli, 1/10)

NPR: Are You Old Enough To Get Vaccinated? In Tennessee, They're Using The Honor System
As the states start to widen the eligibility for who can get a COVID-19 vaccine, health officials are often taking people's word that they qualify, thereby prioritizing efficiency over strict adherence to their own distribution plans. "We are doing everything possible to vaccinate only those 'in phase,' but we won't turn away someone who has scheduled their vaccine appointment and tells us that they are in phase if they do not have proof or ID," says Bill Christian, spokesman for the Tennessee Department of Health. (Farmer, 1/9)

Reuters: COVID-19 Vaccine Roll-Out Won't Achieve Herd Immunity This Year- Health Experts
The roll-out of coronavirus vaccines in many countries will not provide herd immunity from the global pandemic this year, several health experts said on Monday, citing limited access for poor countries, community trust problems and potential virus mutations. “We won’t get back to normal quickly,” Dale Fisher, chairman of the World Health Organization’s (WHO) Outbreak Alert and Response Network, told the Reuters Next conference. (Wardell, 1/11)

The Hill: Biden Previews COVID-19 Proposal 'In The Trillions Of Dollars' 
[Joe] Biden criticized the size of the direct payments from the $900 billion relief bill passed last month, saying $600 "is simply not enough when you have to choose between paying rent or putting food on the table and keeping the lights on." Biden said his relief package would also focus on investments regarding infrastructure and health care. "The price tag will be high," Biden said, but argued that investing in the economy now would pay off, and even help keep the debt under control. (Elis, 1/8)

The New York Times: Biden Picks Dr. Nunez-Smith To Lead Health Equity Task Force
Growing up in the United States Virgin Islands, Dr. Marcella Nunez-Smith saw firsthand what can happen in a community with limited access to health care. Her father, Moleto “Bishop” Smith Sr., was only in his 40s when he suffered a debilitating stroke that left him partly paralyzed and with slurred speech. ... Now, tapped by President-elect Joseph R. Biden Jr. to lead a new federal task force, Dr. Nunez-Smith, an associate professor of internal medicine, public health and management at Yale University, will address a terrible reality of American medicine: persistent racial and ethnic disparities in access and care, the sort that contributed to her father’s disability. (Rabin, 1/8)

Newsweek: Donald Trump Needs Psychiatric Assessment, Mental Health Doctors Tell Congress
A team of Washington, D.C.-licensed psychiatrists and the president of an organization of mental health professionals that has been warning against the mental unfitness of President Donald Trump are submitting documents to Congress calling for the commander-in-chief to be psychiatrically assessed. World Mental Health Coalition President Bandy X. Lee hopes the move will provide information that can make the 25th Amendment possible at the same time as offering immediate security measures. (Cole, 1/8)

FiercePharma: Pharma Condemns Pro-Trump 'Thugs' And Riots—And Backs Manufacturing Group's Call For Consequences 
The National Association of Manufacturers (NAM)—which counts reps from Pfizer, Merck & Co., Johnson & Johnson, Eli Lilly and Mallinckrodt among its executive committee members—called for consideration of the 25th Amendment to remove Trump from office. It condemned the attacks as sedition and placed the blame squarely at his feet. “Throughout this whole disgusting episode, Trump has been cheered on by members of his own party, adding fuel to the distrust that has enflamed violent anger. This is not law and order. This is chaos. It is mob rule. It is dangerous. This is sedition and should be treated as such," said NAM President and CEO Jay Timmons in a statement. "The outgoing president incited violence in an attempt to retain power, and any elected leader defending him is violating their oath to the Constitution and rejecting democracy in favor of anarchy." (Snyder Bulik, 1/7)

Politico: Lawmakers Warned Of Possible Coronavirus Exposure During Riot 
Lawmakers who huddled together for safety last week — as a deadly siege overtook the U.S. Capitol — were potentially exposed to someone infected with the coronavirus, the Office of the Attending Physician warned Sunday. On Jan. 6, House lawmakers "were in protective isolation" in a room located in a large committee hearing space, according to an email from attending physician Brian Monahan that was sent to all lawmakers and their staff on Sunday. (Tamborrino, 1/10)

The Washington Post: Lawmakers May Have Been Exposed To The Coronavirus In Capitol Lockdown, Attending Physician Says 
Two House aides confirmed to The Washington Post that [Brian] Monahan was referring to a room where scores of House members were taken to during the riot. Video first published by Punchbowl News on Friday showed maskless Republicans — including Reps. Andy Biggs (Ariz.), Michael Cloud (Tex.), Markwayne Mullin (Okla.) and Scott Perry (Pa.) — refusing masks offered by Democratic Rep. Lisa Blunt Rochester (Del.) while in the room. (Firozi, Wang and DeBonis, 1/10)

AP: Possible Virus Exposure For Lawmakers Sheltering During Riot
Some lawmakers and staff were furious after video surfaced of Republican lawmakers not wearing their masks in the room during lockdown. Newly elected Georgia Rep. Marjorie Taylor Greene, a presidential ally aligned with a pro-Trump conspiracy group, was among those Republicans not wearing masks. (Mascaro, 1/10)

AP: Congress, LA Take Divergent Paths After COVID Test Warning
Los Angeles will continue using a coronavirus test that federal regulators warned may produce false results while Congress, which has used the same test, is seeking an alternative. The different responses Thursday followed a Food and Drug Administration alert to patients and health care providers that Curative’s test, which is used in at least three of the nation’s largest cities, could particularly produce false negatives. Those faulty results pose the biggest risk from a health perspective because people who are erroneously told they don’t have the virus can unknowingly spread it. (Melley and Perrone, 1/8)

ProPublica: CDC Shut Down A Lab Involved In Making Faulty Coronavirus Tests 
With no public notice, the Centers for Disease Control and Prevention in October shut down a key lab involved in making faulty COVID-19 tests for state and local health authorities early in the pandemic. The move came less than six hours after ProPublica published an investigation that detailed for the first time the chain of mistakes and disputes that unfolded inside CDC labs, which culminated in one of the biggest fumbles in the agency’s 74-year history. A CDC acting branch chief told the staff of the Respiratory Viruses Diagnostics Team lab on Oct. 15 that the closure would be for two to four weeks while the CDC investigated and the staff worked on corrective action plans, according to internal sources. But more than two months later, the lab still is not performing tests. (Bandler, Callahan and Rotella, 1/8)

NPR: Trump Team Approves Controversial Request To Revamp Medicaid In Tennesssee
With less than a dozen days left in power, the Trump administration on Friday approved a radically different Medicaid financing system in Tennessee. With this move, the federal government is for the first time granting a state broader authority in the operation of its health insurance program for the poor without interference from Washington, allowing Tennessee to make decisions on such issues as whether to add new benefits or eligibility categories or spend Medicaid dollars outside of health care, if it thinks that would help enrollees. Instead of the open-ended federal contribution to the funding of Medicaid in all other states — which increases with higher enrollment and associated health costs — Tennessee will instead get a capped amount of money, via an annual block grant. (Galewitz, 1/9)

Stat: Tennessee To Become First State To Run A Closed Medicaid Drug Formulary
In a first-of-its-kind move, the Trump administration will allow Tennessee officials to restrict medicines covered by the state Medicaid program, which is currently required to provide coverage for all treatments. As part of an effort to overhaul spending by the state program, Tennessee will be permitted to maintain a so-called closed formulary, which is the same approach to coverage taken by private health plans. (Silverman, 1/8)

FierceHealthcare: CMS Approves First Block Grant Waiver, Giving Tennessee Ability To Remake Medicaid Program
The Trump administration has approved a federal waiver to enable Tennessee to convert its Medicaid program into a block grant, the first waiver of its kind to be cleared. It remains unclear whether the waiver, approved Friday by the Centers for Medicare & Medicaid Services (CMS), will survive under President-elect Joe Biden’s administration set to start in a few weeks. The waiver, which will last for a 10-year period, would create a budgetary cap for federal spending based on recent historical spending and enrollment in Medicaid in the state. Medicaid is a federal-state partnership where the federal government matches any costs for the program, even if costs unexpectedly go up. (King, 1/8)

The Hill: Trump Administration Approves Controversial Changes To Tennessee's Medicaid Program 
The Trump administration on Friday approved a request from Tennessee that would allow the state to receive Medicaid funding through a block grant, a change critics argue will lead to cuts to the health care program for low-income individuals. The change would give Tennessee more authority to make changes to its Medicaid program, which is jointly run by each state and the federal government. (Hellmann, 1/8)

Modern Healthcare: CMS Approves First Medicaid Block Grant
CMS on Friday approved the country's first Medicaid block grant plan in Tennessee, following through on a top priority for CMS Administrator Seema Verma. Under the plan—dubbed "TennCare III"—Tennessee will accept a fixed budget target for its Medicaid program in exchange for more flexibility in spending its Medicaid money and an opportunity to earn shared savings. According to CMS, the agency will work with Tennessee to evaluate historical enrollment and Medicaid cost information to establish a fixed spending target for its Medicaid program. (Brady, 1/8)

FierceHealthcare: HHS Finalizes Rule That Mandates Exhaustive Review Of Older Regulations 
The Department of Health and Human Services (HHS) has finalized a rule that requires the agency to review all of its existing regulations and sunset any that don’t meet certain criteria. The final rule, released Friday, is a regulatory overhaul that could impact rules across the healthcare industry. Since proposing the rule in November, HHS made several changes intended to make it easier for the public to determine when a rule is under review and to comment on it. “I do believe that by doing this it will be the boldest and most significant regulatory reform ever undertaken, for sure by HHS and also by the federal government,” said Brian Harrison, HHS chief of staff, in an exclusive interview with Fierce Healthcare. (King, 1/8)

NPR: Pandemic Strain Pushes Some Health Care Workers Toward Unions
In September, after six months of exhausting work battling the pandemic, nurses at Mission Hospital in Asheville, N.C., voted to unionize. The vote passed with 70%, a high margin of victory in a historically anti-union state, according to academic experts who study labor movements. The nurses had originally filed paperwork to hold this vote in March but were forced to delay it when the pandemic began heating up. And the issues that had driven them toward unionizing were only heightened by the crisis. It raised new, urgent problems too, including struggles to get enough PPE, and inconsistent testing and notification of exposures to COVID-positive patients. (Pattani, 1/11)

Modern Healthcare: Health Systems Leaders Encourage Workforce COVID-19 Vaccination
“(Identify) who the influencers (at an organization) are. It may be the ICU nurse who is a major influencer in the hospital system. Really highlighting the influencers getting vaccinated and then sharing the message of new hope, is a potential strategy,” said Dr. David Zieg, clinical services leader at human resources consultancy Mercer. It’s a tactic major health systems are deploying. Lloyd Dean, CEO of CommonSpirit Health, received the vaccine Dec. 29 after weeks of it being offered to front-line caregivers, a spokesman said in an email, adding, “We think it’s important for our hospital and system leaders to show that they’re willing to receive the vaccine alongside their staff.” (Castellucci, 1/9)

Bloomberg: Covid Patients’ Symptoms Persist Six Months in Foreboding Study
More than three-quarters of Covid-19 patients hospitalized in Wuhan between January and May had at least one persistent symptom six months later, according to a report that forebodes the enduring pain of the pandemic. Almost two-thirds of those followed still experienced fatigue or muscle weakness half a year after their acute illness, while 26% had sleep difficulties and 23% had anxiety or depression, according to the peer-reviewed study of 1,733 patients in The Lancet medical journal. (Loh, 1/8)

Stat: For People With Type 1 Diabetes, CDC Covid Guidelines Are Puzzling
Laura Woerner has diligently managed her type 1 diabetes since she was diagnosed at age 11. She’s remained vigilant about anything that might throw her blood sugar levels out of balance, and now, at 36, she has had two healthy pregnancies and avoided such severe complications of diabetes as limb neuropathy or eye disease. (Cooney, 1/11)

Stat: Most Hospitalized For Covid Still Affected 6 Months Later, China Study Finds
Three-quarters of Covid-19 patients still have at least one symptom six months after first falling ill, researchers who followed hospital patients in China reported Friday. The new findings suggest symptoms linger longer and in a higher proportion of patients than previously thought. (Cooney, 1/8)

Fortune: Bayer Strikes Deal To Aid CureVac In COVID-19 Vaccine Rollout 
The German biopharma firm CureVac has announced a tie-up with the country's biggest pharmaceutical beast, Bayer, for the development and supply of CureVac's candidate COVID-19 vaccine. The companies did not disclose the financial terms of the deal. Bayer's stock jumped more than 2% on the news Thursday morning. The collaboration and services agreement should aid the supply of "several hundred million" vaccine doses, the companies said. CureVac said in November that it intends to produce up to 300 million doses this year, and up to 600 million doses in 2022. (Meyer, 1/7)

FiercePharma: Roche's Actemra, Regeneron's Kevzara Win U.K.'s Favor In COVID-19 After Study Shows 24% Drop In Death Risk 
The question of whether seriously ill COVID-19 patients can benefit from anti-inflammatories like Roche’s Actemra and Sanofi and Regeneron’s Kevzara has dogged practitioners in the United States thanks to conflicting clinical trial results. The United Kingdom, on the other hand, has reached a definitive answer on the two drugs, both of which are IL-6 inhibitors: They significantly reduce the risk of death in COVID-19 patients needing intensive care, and they should be used to ease the pressure hospitals are now facing as the coronavirus pandemic continues to intensify, the country’s National Institute for Health Research (NIHR) said Thursday. The recommendation came after data from an NIHR-sponsored study showed that Actemra and Kevzara can cut hospital stays for COVID-19 patients admitted to intensive care by 10 days and can lower the risk of death by 24% in patients who receive either drug within a day of admission. (Weintraub, 1/8)

FiercePharma: Should Pharma Charity Contributions Be Publicly Disclosed, Just Like Doctor Payments? Senators Say Yes
Pharma companies have inked a series of federal settlements over payments to charity organizations, which the federal government argues are a “conduit” to boosting drug sales. Now, after an opioid investigation, two Senators want all those charity payments disclosed publicly. And they have just the mechanism for it. Sens. Chuck Grassley and Ron Wyden have called for an expansion of the Centers for Medicare and Medicaid Services Open Payments database. That database now includes payments from pharma companies to doctors and other medical providers, but the senators propose adding payments to tax-exempt groups, too. Further, the senators have called for a new requirement that the HHS secretary formulate guidelines to boost transparency around research organizations and others contracted by the health agency.  (Sagonowsky, 1/8)

FiercePharma: Look Out, Pharma. A 'Tidal Wave' Of Side Effect Reports Is Coming Amid COVID-19 Vaccine Rollouts
With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow. With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said. All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview. (Sagonowsky, 1/7)

FiercePharma: FDA Extends Immunodeficiency Drug's Shelf Life As Pandemic Exacerbates Shortages 
The U.S. immunoglobulin supply just got a little more secure, thanks to a label change enabling one of Octapharma's chief rare disease meds to sit in the fridge for up to three years. The FDA has stretched the expiration date of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig and granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. The drug was previously cleared to last 24 months when refrigerated. Cutaquig’s six-month shelf life at room temperature remains unchanged, Octapharma said Tuesday. (Kansteiner, 1/6)

FierceHealthcare: UnitedHealth Group Subsidiary Indicted On Antitrust Charges
Surgical Care Affiliates, a subsidiary of UnitedHealth Group, was indicted this week by a federal grand jury on charges that it entered agreements with competitors to not poach executives. The Department of Justice (DOJ) alleges that the company, which operates outpatient medical centers, engaged in "two bilateral conspiracies" with other healthcare companies that aimed to avoid competition between them for senior executives, which violates the Sherman Act. (Minemyer, 1/8)

CIDRAP: Cats Infected With SARS-CoV-2 Show Immunity, Long-Term Lesions
Nine domestic cats inoculated with SARS-CoV-2, the virus that causes COVID-19, showed lung lesions and other long-term inflammation in the respiratory tract after the virus had cleared from their system, reports an Emerging Infectious Diseases research letter published yesterday. Despite these lingering effects, however, six cats who were re-infected showed protection against the disease. (1/8)

CIDRAP: Three Studies Highlight Low COVID Risk Of In-Person School
A trio of new studies demonstrate low risk of COVID-19 infection and spread in schools, including limited in-school COVID-19 transmission in North Carolina, few cases of the coronavirus-associated multisystem inflammatory syndrome in children (MIS-C) in Swedish schools, and minimal spread of the virus from primary school students in Norway. (Van Beusekom, 1/8)

The New York Times: Covid-19: Chicago Is Reopening Schools Against Fierce Resistance From Teachers 
Across the country, many big cities like New York have struggled to resume even limited in-person instruction, while a number, including Los Angeles, have simply given up on the idea, choosing to stick with all-remote education into the spring. Few places have seen as much acrimony over the issue as Chicago, whose public school system is the nation’s third-largest. Now, with 6,000 prekindergarten and special education students preparing to return to the city’s public school buildings on Monday for the first time since March, a question looms: How many of their teachers will be there to greet them? (1/11)

The Washington Post: Chicago Teachers Balk At Reopening Plan, Face Pay Loss If They Don’t Return 
Chicago Public Schools will reopen for some students Monday for the first time since last spring amid an escalating clash between city officials, who are threatening to withhold pay from teachers who do not show up, and the powerful Chicago Teachers Union, which contends that schools are not properly outfitted to combat the coronavirus. Teachers who don’t show up for work Monday “will be deemed absent without leave and will not be eligible for pay,” said Janice Jackson, CEO of the nation’s third-largest school district. (Reiss, 1/9)

The Washington Post: Scores Of Nurses In Chicago Public Schools Say Reopening Buildings Is Still Unsafe 
Scores of nurses in the Chicago Public Schools district have objected to officials’ plans to begin bringing students back to classrooms on Monday, saying they do not think it is safe to do so. Chicago public schools have been closed since March. A statement signed by 147 school nurses says: “Many of us are CPS parents ourselves, and all wish to be back in school buildings, but the simple fact is that it is currently not safe to do this.” (Strauss, 1/10)

The Wall Street Journal: The NBA Postpones Another Game As Covid Problems Multiply 
The NBA is facing the first major Covid-19 test of its new season with cases spiking, games teetering and more than two dozen players on 13 teams in quarantine or isolation over the weekend as the league struggles to keep playing through the worst days of the pandemic. The league postponed the Boston Celtics vs. Miami Heat game scheduled for Sunday night after contact tracing left the Heat without the eight players needed to field a team and the Celtics barely had enough themselves.  (Cohen, 1/10)

AP: Prosecutor: Veteran Embezzled Nearly $1M In Benefits
A North Carolina Vietnam veteran embezzled nearly $1 million in health care benefits from the government that helped support a lifestyle that included dancing, playing basketball and buying a beach condo, according to federal prosecutors. Federal prosecutors based in Winston-Salem said in a news release that 73-year-old Willie Dosher Cain of Fayetteville had pleaded guilty in 2020 to one count of embezzlement and was sentenced on Jan. 5 of this year to five years of probation. United States District Judge Thomas D. Schroeder said that Cain’s age and the COVID-19 pandemic influenced his sentencing decision. (1/10)

AP: Anti-Abortion Faith Leaders Support Use Of COVID-19 Vaccines
In a growing consensus, religious leaders at the forefront of the anti-abortion movement in the United States are telling their followers that the leading vaccines available to combat COVID-19 are acceptable to take, given their remote and indirect connection to lines of cells derived from aborted fetuses. One outspoken foe of abortion based in Dallas, Southern Baptist megachurch pastor Robert Jeffress, has called the vaccines a “present from God.” (Crary, 1/10)