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[1/4] Employees work in the manufacturing of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo, in this undated handout picture. Pfizer/Handout via REUTERS Acquire Licensing RightsWASHINGTON, Nov 28 (Reuters) - Senior Biden administration officials met with RSV vaccine makers this week to underscore the need for manufacturers such as Sanofi (SASY.PA) and AstraZeneca (AZN.L) to urgently meet demand as winter approaches, the White House said on Tuesday. At a meeting at the White House on Monday, officials and manufacturers also agreed to plan now to meet next year's demand for the vaccines targeting respiratory syncytial virus, which generally causes mild, cold-like symptoms but can develop into severe illness in infants and older adults. "Monday's meeting follows numerous in-person and virtual meetings to seek ways manufacturers can make more RSV immunizations available for infants," the White House said in a statement. Reporting by Susan Heavey and Ahmed Aboulenein; Additional reporting by Mike Erman; Editing by Katharine Jackson and Nick ZieminskiOur Standards: The Thomson Reuters Trust Principles.

Persons: Susan Heavey, Ahmed Aboulenein, Mike Erman, Katharine Jackson, Nick Zieminski Organizations: Pfizer, Handout, REUTERS Acquire, Rights, Biden, Sanofi, AstraZeneca, White, U.S . Centers for Disease Control, Prevention, CDC, Thomson Locations: U.S

REUTERS/Evelyn Hockstein/Illustration Acquire Licensing RightsWASHINGTON, Nov 20 (Reuters) - The U.S. government on Monday will start taking orders for another round of free COVID-19 tests for delivery across the country, a Department of Health and Human Services (HHS) spokesperson said. Households that had ordered four free tests through COVIDTests.gov when they were offered again in September are eligible to order four more, while those that did not can submit two orders for a total of eight free tests. It resumed offering the tests in December 2022 as cases were surging, and opened another round of orders on Sept. 25 this year. The tests are paid for using COVID-19 supplemental funding from the American Rescue Plan, the HHS spokesperson said. HHS and the Department of Education plan to expand a program that brings tests to schools nationwide over the coming weeks.

Persons: Evelyn Hockstein, Joe Biden's, Biden, Ahmed Aboulenein, Bill Berkrot Organizations: District of Columbia, REUTERS, Rights, U.S, of Health, Human Services, Centers for Disease Control, Prevention, American, HHS, Department of, Thomson

The government has been overseeing distribution of the treatments, alongside vaccines and tests, but has transferring that work to traditional commercial channels. Commercial ordering for the treatments is set to start on Nov. 1. Returns will begin on Nov. 15, the official said, and will be accepted through the end of the year. The government is recommending returns start in December enough time for the establishment of patient assistance programs and securing of commercially-labeled doses. Reporting by Ahmed Aboulenein Editing by Marguerita ChoyOur Standards: The Thomson Reuters Trust Principles.

Persons: Lagevrio, Ahmed Aboulenein, Marguerita Choy Organizations: U.S, Pfizer, Paxlovid, U.S . Department of Health, Human Services, Thomson Locations: U.S

The U.S. government in May ended the COVID public health emergency declaration during which it bought the shots and provided them to all Americans for free. In the current privatized system, health insurance plans by law must cover the shots at no cost. McKesson (MCK.N), one of the largest U.S. wholesalers, said it has distributed over 3.8 million shots so far. "Health insurance providers continue to educate Americans about where and how to get their COVID vaccines within their plan’s coverage," David Allen, a spokesperson for insurance lobby group AHIP said. Now that the government is no longer footing the bill for their vaccine supply, pharmacy owners need to pay for the shots.

Persons: Kate MacDowell, MacDowell, Kaiser, David Allen, AHIP, David Kohll, James Daily, he's, Suzanne Berman, Michael Erman, Ahmed Aboulenein, Caroline Humer, Bill Berkrot Organizations: Pfizer, U.S . Department of Health, Human Services, Kaiser Permanente, COVID, Moderna, CVS, Walmart, Walgreens, Walgreens Boots Alliance, Cardinal Health, Reuters, Kohll's Pharmacy, Thomson Locations: WASHINGTON, U.S, Portland , Oregon, Oregon, California, Nebraska, Readington , New Jersey, Crossville , Tennessee, New York, Washington

[1/7] Healthcare workers strike in front of Kaiser Permanente Los Angeles Medical Center, as more than 75,000 Kaiser Permanente healthcare workers go on strike from October 4 to 7 across the United States, in Los Angeles, California, U.S. October 4, 2023. Kaiser said its hospitals and emergency departments remained open, staffed by doctors, managers and "contingency workers." They are represented by the SEIU United Healthcare Workers West. The Kaiser labor coalition, made up of eight unions representing medical professionals and support staff, insists the company needs to hire 10,000 new healthcare workers to fill current vacancies. Kaiser nationwide employs 68,000 nurses and 213,000 technicians, clerical workers, and administrative staff, alongside its 24,000 doctors.

Persons: Kaiser, Christina Andersen, Michael LeRoy, Ahmed Aboulenein, Bhanvi Satija, Bill Berkrot Organizations: Healthcare, Kaiser Permanente Los Angeles Medical Center, Permanente, REUTERS, Rights, Kaiser Permanente, U.S . Bureau of Labor Statistics, District Columbia, Kaiser, Labor, Tenet Healthcare, SEIU United Healthcare Workers, SEIU, University of Illinois, D.C, Thomson Locations: United States, Los Angeles , California, U.S, Kaiser, California , Oregon, Washington , Colorado, Virginia, Claremont , California, California, Los Angeles, Las Vegas, University of Illinois Urbana, Champaign, Washington, California , Colorado , Oregon

[1/7] Healthcare workers strike in front of Kaiser Permanente Los Angeles Medical Center, as more than 75,000 Kaiser Permanente healthcare workers go on strike from October 4 to 7 across the United States, in Los Angeles, California, U.S. October 4, 2023. "After six months of bargaining with the Coalition of Kaiser Permanente Unions, including a marathon effort that went through last night and into today, our bargaining sessions unfortunately ended without a settlement," Kaiser said. They are represented by the SEIU United Healthcare Workers West. The Kaiser labor coalition, made up of eight unions representing medical professionals and support staff, insists the company needs to hire 10,000 new healthcare workers to fill current vacancies. Kaiser nationwide employs 68,000 nurses and 213,000 technicians, clerical workers, and administrative staff, alongside its 24,000 doctors.

Persons: Kaiser, Christina Andersen, Michael LeRoy, Ahmed Aboulenein, Bhanvi Satija, Bill Berkrot, Navaratnam 私 Organizations: Healthcare, Kaiser Permanente Los Angeles Medical Center, Permanente, REUTERS, Rights, Kaiser Permanente, Reuters, Coalition, Kaiser Permanente Unions, U.S . Bureau of Labor Statistics, District Columbia, Kaiser, Labor, Tenet Healthcare, SEIU United Healthcare Workers, SEIU, University of Illinois, D.C Locations: United States, Los Angeles , California, U.S, California , Oregon, Washington , Colorado, Virginia, Claremont , California, California, Los Angeles, Las Vegas, University of Illinois Urbana, Champaign, Washington, California , Colorado , Oregon

[1/2] A Kaiser Permanente health care center is pictured in Anaheim, California, U.S., October 3, 2023 as more than 75,000 Kaiser Permanente healthcare workers could go on strike from Oct. 4 to Oct. 7 across the United States. REUTERS/Mike Blake Acquire Licensing RightsCompanies Kaiser Permanente FollowWASHINGTON, Oct 3 (Reuters) - Kaiser Permanente appeared headed for a labor clash with 75,000 of its healthcare workers as union leaders said contract talks had stalled on Tuesday, leaving the two sides hours away from a threatened three-day strike in several states. Kaiser said its hospitals and emergency departments would remain open in the event of a strike, staffed by doctors, managers and other non-union "contingency workers." As of Tuesday, the Coalition of Kaiser Permanente Unions said the healthcare giant had yet to offer acceptable terms to address severe staffing shortages, or to embrace adequate improvements in pay and benefits sought by the workers. Staffing levels have been a major sticking point, with the union insisting Kaiser needs to hire 10,000 new healthcare workers to fill current vacancies.

Persons: Mike Blake, Kaiser Permanente, Kaiser, Caroline Lucas, Hilary Costa, Ahmed Aboulenein, Steve Gorman, Bill Berkrot, Gerry Doyle Organizations: Kaiser Permanente, Permanente, REUTERS, D.C, Union, Coalition, Kaiser Permanente Unions, Kaiser, U.S . Bureau of Labor Statistics, Thomson Locations: Anaheim , California, U.S, United States, California , Oregon, Washington, , Colorado, Virginia, Georgia, Hawaii, California , Colorado , Oregon, Los Angeles

The nationwide online poll, which concluded on Thursday, showed that almost 30% of respondents were very interested in getting the vaccine and another 24% were somewhat interested. U.S. public health officials earlier this week recommended updated COVID-19 vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O) that target a recently circulating Omicron variant of the coronavirus. Almost 42% said they were mainly interested in getting the vaccine to reduce their risk of severe illness. During the last revaccination campaign, when most Americas had either already had the COVID virus or been previously vaccinated, only around 56.5 million people got the updated booster shots, CDC data shows. The Reuters/Ipsos poll was conducted online and nationwide between Sept. 8 and Sept. 14, gathering responses from 4,413 U.S. adults.

Persons: Adam Berman, Michelle Chester, Ron DeSantis, Jesse Goodman, Ahmed Aboulenein, Jason Lange, Michael Erman, Jennifer Rigby, Scott Malone, Leslie Adler Organizations: Jewish Medical Center, Northwell Health, Reuters, U.S . Centers for Disease Control, Pfizer, Moderna, Republicans, Republican, Wednesday, Georgetown University, U.S . Food, Drug Administration, Thomson Locations: Long, New Hyde Park , New York, WASHINGTON, United States, ., U.S, Americas, Washington, New York, London

Both sides blame each other for high drug prices. Senator Bernie Sanders, who chairs the Senate Health, Education, Labor, and Pensions (HELP) Committee, is a fierce critic of both industries and will likely grill the executives. Optum Rx CEO Heather Cianfrocco will say manufacturers alone set the drug prices and abuse patent protections to stifle competition, her written testimony shows. Lilly, Novo Nordisk, and Sanofi all said in March they were cutting list prices by more than 70% for some insulin products. Uninsured people often have to pay full list prices, an average of $900 a month, forcing many to ration or skip doses.

The emergency is also tied to telehealth flexibilities, Medicaid enrollment safeguards, and the ability of government health agencies to collect data on the spread of the coronavirus. Here is what will change after Thursday, and what does not:WILL THERE BE A COST FOR VACCINES, TESTS AND TREATMENTS? They will face co-pay or co-insurance costs for certain covered treatments and the full price of those that are not covered. People enrolled in state government Medicaid health plans for the poor will also get zero-cost vaccines. The U.S. Centers for Disease Control and Prevention (CDC) will have less authority to collect certain types of public health data after the emergency expires.

WASHINGTON, May 5 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said on Friday it would stop reporting or monitoring COVID-19 case data and transmission rates after the government ends the pandemic's public health emergency designation next week. The government on May 11 will end the COVID-19 public health emergency that allowed millions of Americans to receive vaccines, tests, and treatments at no cost during the pandemic. "The changes that we're discussing today are happening because the end of the Public Health Emergency means that CDC will have less authority to collect certain types of public health data," said CDC Principal Deputy Director Dr. Nirav Shah. The CDC will continue to provide COVID death rates but will no longer rely on aggregate case data reported by local jurisdictions and will instead use national death certificate data, Jackson said. COVID-19 surveillance will be folded into a wider integrated strategy for monitoring respiratory viruses, he said, adding that some data reporting including demographic case data, the CDC's work on long COVID, and wastewater surveillance for the virus will continue past May 11.

"The end of the COVID-19 public health emergency marks a tremendous transition for our country, for public health, and in my tenure as CDC Director," Walensky wrote to President Joe Biden in her resignation letter. "We have all benefited from her service and dedication to public health, and I wish her the best in her next chapter," Biden said in a statement. "For 75 years, CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations," she told CDC staff last summer. Public health experts said Walensky wrestled with political and technical challenges during her tenure. "Dr. Walensky was put into place at the CDC at a time when the agency was basically captive to politicians which clearly hampered her ability to lead," he said.

WASHINGTON, April 20 (Reuters) - Use of the drug misoprostol on its own to terminate pregnancies is on the rise in the United States as providers seek a preemptive alternative while a ban on abortion pill mifepristone is being considered in court. Misoprostol is already part of the only medication abortion protocol approved by the U.S. Food and Drug Administration, but only when taken in combination with mifepristone. The drug, which the FDA first approved in 1988 for gastric ulcers, is often prescribed off-label to treat miscarriages or induce abortions. "If providers are forced to stop providing mifepristone, misoprostol alone is also safe and effective," said Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco. Because misoprostol is approved for medication abortion in the United States as part of the two-drug combination, prescribing it alone to terminate pregnancies would also be considered off-label.

The proposal is aimed at protecting woman who live in states where abortion is illegal who travel out of state to have the procedure done - something thousands of women are already doing, research shows. It is unclear whether the proposed rule would actually stifle criminal investigations. The federal Employee Retirement Income Security Act of 1974 (ERISA) covers most health insurance and other company benefit plans and generally preempts state laws on abortion-related coverage. But it does not prevent states from prosecuting plans, sponsors, administrators and their employees in all instances. Reporting By Jarrett Renshaw and Heather Timmons; Editing by Heather Timmons and Mark PorterOur Standards: The Thomson Reuters Trust Principles.

[1/4] A pack of birth control pills is displayed in this illustration picture taken in Philadelphia, Pennsylvania, U.S., July 11, 2022. REUTERS/Hannah Beier/IllustrationApril 10 (Reuters) - Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc (PFE.N) CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. Last week's ruling by Judge Matthew Kacsmaryk undermines the FDA's authority, the letter's authors wrote, adding that it ignores decades of scientific evidence and legal precedent. The ruling could open the possibility to the banning of vaccines and contraception for women, said Levin. "It's the single worst threat to the industry in over 50 years."

WASHINGTON, April 10 (Reuters) - A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said. The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of U.S. abortions, over 20 years ago. Banning its sale calls into question the FDA's power to regulate all drugs nationwide, the experts said. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before Kacsmaryk, who is himself a conservative former Christian activist. Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.

Any impact on the FDA will depend on details of the judge's ruling in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a conservative former Christian activist. The court could order mifepristone pulled from the market while it considers a final ruling. It would call into question the entire drug approval process, said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation. 'SO MUCH UNCERTAINTY'The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.

WASHINGTON, March 31 (Reuters) - The U.S. government announced on Friday a lower than expected 1.1% average cut of 2024 reimbursement rates for health insurers that offer coverage through the Medicare Advantage program, boosting shares of the market's largest players. Health insurers who operate Medicare Advantage plans have come under pressure after the government last month proposed new rules for an audit program to avoid overpaying them. The companies are among the largest players in the Medicare Advantage market in which private insurers are paid a set rate by the government to manage member healthcare. Medicare Advantage covers nearly half of the 65 million people enrolled in the government's Medicare program for people aged 65 and older or disabled. The agency pegged the spending increase in the traditional Medicare program, which in previous years was the main factor determining how much the agency pays Medicare Advantage insurers, at 2.3%, up from 2.1% in its initial proposal.

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

"Starting on April 1, Medicare beneficiaries will pay lower coinsurance for Part B drugs that raise prices faster than inflation," White House Domestic Policy Adviser Susan Rice told reporters on a press call. Companies that raise prices higher than the inflation rate will be required to pay Medicare the difference in the form of a rebate. The government will start invoicing the companies for the rebates in 2025 but Medicare will start reducing out-pocket-costs for members in April. Medicare began examining the price increases in October 2022 for Medicare Part B drugs, often used in the hospital, that are complicated biologic drugs or drugs with only one manufacturer. Price increases for half of all drugs covered by Medicare outpaced inflation from 2019 to 2020, which averaged 1% that year.

[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.

The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor. The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP). CMS will announce the first model's start date "as soon as operationally feasible", it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.

WASHINGTON, Feb 9 (Reuters) - The Federal Emergency Management Agency (FEMA) said on Thursday it will close all COVID-19 disaster declaration incident periods on May 11 when the U.S. government ends two major pandemic-related emergency declarations. All 50 states, five territories and three tribal nations are seeing a major disaster declaration for COVID-19, said FEMA Associate Administrator for Response and Recovery Anne Bink. "With the administration's announcement to end the public health emergency and the national emergency declaration on May 11, 2023, today we announced the incident period for all FEMA COVID-19 disaster declarations will also close on May 11 2023," Bink told reporters on a press call. All eligible costs under the FEMA disaster declarations will continue to be eligible until May 11, and there will be a follow-up period afterwards for applicants to submit reimbursement requests, said Bink. Reporting by Ahmed Aboulenein; Additional reporting by Rami Ayyub; editing by Jonathan OatisOur Standards: The Thomson Reuters Trust Principles.

Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association (ADA). They tried, and failed, to extend the benefit to everyone with health insurance when they were voting on the IRA. Without Congressional approval, the Biden administration cannot impose the cap on private insurance plans and is unlikely able to create a subsidy for the uninsured, experts said. Some Medicaid plans for low-income individuals and private insurance plans also cap the monthly cost of insulin at $35. It is unclear if his proposal would include those without health insurance, who often have to pay the full price for the life-sustaining drug.

Crump said he and the Nichols family had spoken with President Joe Biden on Friday and urged him to use Nichols' death to galvanize support for the act's passage. Nichols' mother was coping with her son's death by believing he was destined to change the world, Crump said on ABC's "This Week" on Sunday. Nichols' death is the latest high-profile example of police using excessive force against Black people and other minorities. Crump said Nichols' death should finally prompt lawmakers to act. The officers were charged on Thursday with second-degree murder, assault, kidnapping, official misconduct and oppression in Nichols' death and dismissed from the department.

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