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He said that once implemented, the prices on negotiated drugs will decrease for up to 9 million seniors who currently pay as much as $6,497 in out-of-pocket costs per year for these prescriptions. This kicks off the negotiation process for the 10 drugs whose new prices will go into effect in 2026. U.S. laws had prohibited Medicare from negotiating pharmaceutical prices as part of its prescription drug program that began about 20 years ago. CMS Director Dr. Meena Seshamani said Medicare plans to use a review process to make sure insurance companies keep clinically appropriate access to negotiated drugs. Two analysts said they expect the negotiated prices to move beyond Medicare and affect commercial markets for these drugs by 2026, when they come into effect.
Persons: Joe Biden, Jonathan Ernst, Biden, Joe Biden’s, Januvia, Xarelto, Johnson, Boehringer Ingelheim, Eli Lilly's, Jardiance, Mohit Bansal, Entresto, Eli Lilly, Merck, Bristol Myers, Giovanni Caforio, Caforio, enrollees, Meena Seshamani, Stelara, Amgen, Evan Seigerman, Patrick Wingrove, Mike Erman, Manas Mishra, Nandita Bose, Caroline Humer, Bill Berkrot Organizations: Social Security, University of Tampa, REUTERS, U.S, Bristol Myers Squibb, Pfizer, Merck, Co's, Johnson, Novo Nordisk, NYSE Arca Pharmaceutical, U.S . Centers, Medicare, Medicaid Services, Reuters Graphics Wells, Novartis, AstraZeneca, Bristol, J, U.S . Department of Health, Human Services, BMO Capital, Thomson Locations: Tampa , Florida, U.S, Amgen's, Jardiance, Germany, Bengaluru, Washington
REUTERS/Brendan McDermid/File Photo/File Photo Acquire Licensing RightsAug 25 (Reuters) - AstraZeneca (AZN.L) said on Friday it has sued the U.S. government to block parts of a program that gives the Medicare health insurance plan the power to negotiate lower drug prices. The program faces at least seven other court challenges, including from leading industry group PhRMA and drugmakers Johnson & Johnson (JNJ.N), Merck & Co (MRK.N), Bristol Myers Squibb (BMY.N) and privately-held Boehringer Ingelheim. The drug price negotiation program is part of President Joe Biden's signature Inflation Reduction Act (IRA). ‍AstraZeneca said the program would deter continued development of treatments such as its cancer drug Lynparza and rare blood disorder drug Soliris, which carry orphan drug status for multiple conditions. An HHS spokesperson said in a statement that the agency "will vigorously defend the President's drug price negotiation law, which is already helping to lower healthcare costs for seniors and people with disabilities."
Persons: Brendan McDermid, drugmakers Johnson, Johnson, Joe Biden's, AstraZeneca, Bhanvi, Dhanya Ann Thoppil, Shilpi Majumdar Organizations: AstraZeneca, New York Stock Exchange, REUTERS, U.S, Merck & Co, Bristol Myers Squibb, U.S . Department of Health, Human Services, Thomson Locations: British, Delaware, United States, U.S, Bengaluru
The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsCompanies Regeneron Pharmaceuticals Inc FollowAug 22 (Reuters) - The U.S. government said on Tuesday it had awarded $1.4 billion for the development of new therapies and vaccines against COVID-19, including a $326 million contract with Regeneron Pharmaceuticals (REGN.O) for a next-generation antibody therapy for prevention of infections. The funding to Regeneron is a part of a $5 billion initiative dubbed "Project NextGen" by the U.S. Department of Health and Human Services (HHS). The funding also includes $1 billion for four mid-stage clinical trials of new COVID vaccines, and $100 million to Global Health Investment Corp - a non-profit organization that invests in new technologies that will accelerate responses to diseases. Reporting by Pratik Jain in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.
Persons: Brendan McDermid, Regeneron, Pratik Jain, Maju Samuel Organizations: Regeneron Pharmaceuticals, REUTERS, U.S, COVID, U.S . Department of Health, Human Services, U.S . Food, Drug Administration, Omicron, Global Health Investment Corp, Thomson Locations: Westchester, Tarrytown , New York, U.S, Bengaluru
While the work can be emotionally taxing, DMORT members already confront death in their day jobs as funeral directors, medical examiners and coroners. DNA samples have become a crucial tool; Sebastian said the Maui team has partnered with a company that can process DNA in just hours. But the Sept. 11, 2001, attacks represented a pivot point, when DMORT teams helped city authorities sift through thousands of remains. Wildfires represent a relatively new response area for DMORTs; teams responded to the 2018 Camp fire that killed 85 in California and the 2020 Oregon wildfires. "As we're starting to see this era of 'polycrisis,' making sure we have enough DMORT team members that we can deploy is going to be really important," O'Connell, the senior HHS official, said.
Persons: Mike Blake, it's, Frank Sebastian, Kathryn Pinneri, Sebastian, Paul Sledzik, Sledzik, Dawn O'Connell, I've, DMORTs, Hurricane Maria, David Hunt, I'm, Hunt, O'Connell, Joseph Ax, Paul Thomasch, Diane Craft Organizations: REUTERS, U.S . Department of Health, Human Services, Maui, federal, HHS, World Trade Center, Thomson Locations: Lahaina, Maui, Hawaii, U.S, Seattle, United States, hijackings, Montgomery County , Texas, MAUI, Long, Shanksville , Pennsylvania, Puerto Rico, New York, Indiana, DMORTs, California, Oregon
Federal regulators have suspended research on human subjects at the Columbia-affiliated New York State Psychiatric Institute, one of the country’s oldest research centers, as they investigate safety protocols across the institute after the suicide of a research participant. The decision affected 417 studies, of which 198 have continuing participation. Of those, 124 receive federal funding. It is unusual for the U.S. regulatory office to suspend research, and this suggests that investigators are concerned that potential violations of safety protocols occurred more broadly within the institute. Almost 500 studies, with combined budgets totaling $86 million, are underway at the institute, according to its website.
Persons: Kate Migliaccio, , Carla Cantor Organizations: Columbia, New, Psychiatric Institute, U.S . Department of Health, Human Services, Human
What Happens When You Stop at One Glass of Wine a Day?
  + stars: | 2023-07-27 | by ( Lettie Teague | ) www.wsj.com   time to read: 1 min
SMALL DOSES One glass of wine per day means exactly that. According to government guidelines, you can’t save up your allotment and splurge on the third day. Illustration: Mitch BluntREADING THE MOST recent Dietary Guidelines for Americans from the U.S. Department of Agriculture and U.S. Department of Health and Human Services, I found that women are advised to drink one glass of wine or less and men two glasses or less daily. Do many follow this advice?
Persons: Mitch Blunt Organizations: U.S . Department of Agriculture, U.S . Department of Health, Human Services Locations: U.S
U.S. orders antiviral drugs worth $138 million from SIGA Tech
  + stars: | 2023-07-27 | by ( ) www.reuters.com   time to read: +1 min
Companies SIGA Technologies Inc FollowJuly 27 (Reuters) - SIGA Technologies Inc (SIGA.O) on Thursday said it has won a new contract for its antiviral drug, Tpoxx, from the U.S. Department of Health and Human Services, sending the company's shares up about 20% after the bell. The order is for delivery of about $113 million worth of oral Tpoxx treatment courses and about $25 million worth of the intravenous formulation of the treatment, SIGA said. SIGA expects to fully deliver the order of oral Tpoxx drugs in 2023 and expects to start delivering IV TPOXX in 2024. Prior to the delivery of the IV drugs, it will focus on fulfilling a prior IV order, the company said. The U.S. Centers for Disease Control and Prevention expanded its use to help tackle the spread of mpox in 2022.
Persons: SIGA, Phil Gomez, Sriparna Roy, Devika Organizations: SIGA Technologies, U.S . Department of Health, Human Services, U.S . Food, Drug Administration, U.S . Centers for Disease Control, U.S . Department of Defense, World Health Organization, Thomson Locations: mpox, Bengaluru
Victims of Cyberattack on File-Transfer Tool Pile Up
  + stars: | 2023-07-19 | by ( Catherine Stupp | ) www.wsj.com   time to read: +6 min
The list of companies hit by a cyberattack on a widely used software tool continues to expand and several victims have filed lawsuits alleging mishandling of data. The continued disclosure of new victims affected by hackers exploiting a vulnerability in MoveIt, a common file-transfer tool from Progress Software, underscores how cyberattacks can ripple through supply chains. Some companies have been drawn into data breaches without having used MoveIt because their business partners use it. The Cl0p ransomware group has taken responsibility for the cyberattacks and posted data from some victims on its underground website. A 2021 cyberattack on a tool similar to MoveIt—Accellion’s File Transfer Appliance—had similar ripple effects.
Persons: , Brett Callow, cyberattacks, Callow, Genworth, PBI, , Shell, Rob Carr, Suzie Squier, Johns, Johns Hopkins, Emsisoft’s Callow, Catherine Stupp Organizations: Progress Software, . Progress, Progress, Shell, BBC, Energy Department, Genworth Financial, Social, PBI Research Services, U.S . Department of Health, Human Services, Colorado State University, BG Group, Johns Hopkins University, Getty Locations: British, MoveIt, Kaseya, Johns Hopkins
Private health insurance companies paid by Medicaid denied millions of requests for care for low-income Americans with little oversight from federal and state authorities, according to a new report by U.S. investigators published Wednesday. Medicaid, the federal-state health insurance program for the poor that covers nearly 87 million people, contracts with companies to reimburse hospitals and doctors for treatment and to manage an individual’s medical care. About three-quarters of people enrolled in Medicaid receive health services through private companies, which are typically paid a fixed amount per patient rather than for each procedure or visit. The report by the inspector general’s office of the U.S. Department of Health and Human Services details how often private insurance plans refused to approve treatment and how states handled the denials. Doctors and hospitals have increasingly complained about what they consider to be endless paperwork and unjustified refusals of care by the insurers when they fail to authorize costly procedures or medicines.
Organizations: Medicaid, U.S, U.S . Department of Health, Services
July 18 (Reuters) - Johnson & Johnson (JNJ.N) sued the U.S. government on Tuesday, becoming the latest drugmaker seeking to block a program that gives the Medicare government health insurance plan the power to negotiate lower drug prices. The pharmaceutical industry says the drug price negotiation program under President Joe Biden's signature Inflation Reduction Act law will curtail profits and compel drugmakers to curb development of groundbreaking new treatments. The U.S. Centers for Medicare and Medicaid Services (CMS) in September is expected to select the first 10 drugs to target for negotiations with settled prices set to take effect in 2026. The law is on our side," a spokesperson for the U.S. Department of Health and Human Services said in a statement. It broadly follows the other related lawsuits, arguing that the program is unconstitutional and amounts to "confiscation of constitutionally protected property."
Persons: Johnson, Joe Biden's, drugmakers, Biden, Janssen, Bhanvi, Michael Erman, Krishna Chandra Eluri, Susan Heavey Organizations: Johnson, U.S, drugmakers Bristol Myers Squibb, Merck & Co, U.S . Chamber of Commerce, Pharmaceutical Research, Manufacturers of America, Commerce, U.S . Centers, Medicare, Medicaid Services, U.S . Department of Health, Human Services, District of, Thomson Locations: U.S, District of New Jersey, Bengaluru, New Jersey
WASHINGTON, June 28 (Reuters) - The U.S. Department of Health and Human Services (HHS) was among those affected by a wide-ranging hack centered on a piece of software called MOVEit Transfer, Bloomberg News reported on Wednesday. The report comes as the hackers behind the massive breach claimed credit for stealing data from two major law firms, Kirkland & Ellis LLP and K&L Gates LLP. Kirkland and K&L did not immediately return messages left after hours. The group has previously insisted it doesn't deliberately steal data from government organizations, but that doesn't mean that data hasn't been compromised. Bloomberg cited a person familiar with the incident at HHS as saying that tens of thousands of records could have been exposed.
Persons: Ellis, cl0p, Gates, Kirkland, doesn't, Cl0p didn't, Jon Clay, TrendMicro, Raphael Satter, Lincoln Organizations: U.S . Department of Health, Human Services, Bloomberg, Kirkland, Gates, HHS, Progress Software, Thomson Locations: Russian
[1/2] A worker arrives at the Department of Health and Human Services in Washington, October 1, 2013. REUTERS/James Lawler Duggan/File PhotoWASHINGTON, June 28 (Reuters) - The U.S. Department of Health and Human Services (HHS) was among those affected by a wide-ranging hack centered on a piece of software called MOVEit Transfer, a source at HHS said on Wednesday. "While no HHS systems or networks were compromised, attackers gained access to data by exploiting the vulnerability in the MOVEit Transfer software of third-party vendors," a health department official familiar with the matter said. Hackers behind the massive breach also claimed credit for stealing data from two major law firms, Kirkland & Ellis LLP and K&L Gates LLP. Kirkland and K&L did not immediately return messages left after hours.
Persons: James Lawler Duggan, Ellis, cl0p, Gates, Kirkland, doesn't, Cl0p didn't, Jon Clay, TrendMicro, Raphael Satter, Lincoln Organizations: Department of Health, Human Services, REUTERS, WASHINGTON, U.S . Department of Health, HHS, Kirkland, Gates, Bloomberg, Progress Software, Thomson Locations: Washington, Russian
Opinion | Approaches to Mental Illness
  + stars: | 2023-06-17 | by ( ) www.nytimes.com   time to read: +1 min
To the Editor:Re “There’s a Reason So Many People Quit Antipsychotic Drugs,” by Daniel Bergner (Opinion guest essay, June 4):Thank you to Mr. Bergner and The New York Times for countering hate and prejudice and raising a voice of reason on the subject of forced psychiatric treatment. There are so many of us: those who were harmed by forced treatment, those whose loved ones were harmed, those who lost loved ones to horrible physical side effects of psychotropic medications or to suicide when people chose death over another round of forced treatment. Patients flock to the few places that offer effective, humane treatment modalities (Open Dialogue, Soteria House). Providing housing without preconditions along with access to voluntary mental health services is the best evidence-based practice recommended by the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and used with great results all over the world. But it does not create a lot of profit for pharmaceutical companies and psychiatric hospitals.
Persons: Daniel Bergner, Bergner Organizations: New York Times, Mental Health Services Administration, U.S . Department of Health
The deal would preserve the mandate nationwide while appeals play out, but allow the employer challenging the mandate, Texas-based Braidwood Management, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services without co-pays for its employees for now. The preventive care mandate, part of the Affordable Care Act (ACA) often referred to as Obamacare, covers services recommended by a federal task force. The ruling does not apply to services the task force recommended before the ACA was enacted in 2010, including breast cancer screening. More than 150 million people were eligible for preventive care free of charge as of 2020 under the ACA, according to data from the U.S. Department of Health and Human Services. The Biden administration has said O'Connor's ruling threatens public health.
Persons: Biden, District Judge Reed O'Connor, O'Connor, Brendan Pierson, Alexia Garamfalvi, Bill Berkrot Organizations: U.S, Circuit, Appeals, Braidwood Management, Affordable, PrEP, HIV, District, . Constitution, U.S . Senate, U.S . Department of Health, Human Services, Major, Thomson Locations: Texas, Braidwood, U.S, Fort Worth , Texas, ., New York
June 9 (Reuters) - The U.S. Chamber of Commerce on Friday sued the federal government, challenging a new law that for the first time gives Medicare the power to negotiate drug prices with pharmaceutical companies. In a complaint filed in federal court in Dayton, Ohio, the chamber said the pricing program violated drugmakers' due process rights under the U.S. Constitution by giving the government "unfettered discretion" to dictate maximum prices. Other drugmakers have also objected to the pricing program, which is part of last year's Inflation Reduction Act. The chamber also warned that allowing the pricing program would set a bad precedent. The case is Dayton Area Chamber of Commerce et al v Becerra et al, U.S. District Court, Southern District of Ohio, No.
Persons: Biden, Karine Jean, Pierre, Neil Bradley, Becerra, Jonathan Stempel, Bill Berkrot Organizations: U.S . Chamber, Commerce, U.S, U.S . Department of Health, Human Services, Medicare, Medicaid Services, Merck & Co, CMS, Merck, Dayton Area, Court, Southern District of, Thomson Locations: Dayton , Ohio, Washington ,, Dayton, U.S, Southern District, Southern District of Ohio, New York
NEW YORK, June 6 (Reuters) - Merck & Co (MRK.N) sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues is violates the Fifth and First Amendments to the U.S. Constitution. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for Medicare. Merck called the talks with CMS coercive and forces drugmakers to participate in "political Kabuki theater" by pretending negotiations are voluntary. The first ever Medicare drug price reduction process is due to begin in September when CMS identifies its 10 most costly drugs. Merck's top selling drug, cancer immunotherapy Keytruda, could be subject to negotiations as soon as 2028.
Persons: drugmakers, Merck, Ameet, Robin Feldman, Wells, Mohit Bansal, Xavier Becerra, Chiquita Brooks, Michael Erman, Patrick Wingrove, Edwina Gibbs, Nick Zieminski Organizations: YORK, Merck & Co, U.S, U.S . Constitution, Biden, Medicare, District of Columbia, Merck, Reuters, CMS, Harvard Medical School, UC College of the, Supreme, U.S . Department of Health & Human Services, Centers, Medicaid Services, LaSure, HHS, Thomson Locations: U.S ., U.S, San Francisco
Biden taps Bertagnolli to lead National Institutes of Health
  + stars: | 2023-05-15 | by ( ) www.reuters.com   time to read: +1 min
WASHINGTON, May 15 (Reuters) - U.S. President Joe Biden will appoint Monica Bertagnolli, director of the National Cancer Institute, to lead the National Institutes of Health, the White House said on Monday. Bertagnolli will become the second woman to serve as a permanent director of the NIH after a yearlong search to find a permanent replacement for the agency's long-serving leader, Francis Collins. "Dr. Bertagnolli is a world-class physician-scientist whose vision and leadership will ensure NIH continues to be an engine of innovation to improve the health of the American people," Biden said in a statement. Bertagnolli was appointed in October to head the National Cancer Institute, which is a part of NIH, and also served as head of surgical oncology at the Dana-Farber Brigham Cancer Center, one of the nation's top cancer research facilities. Lawrence Tabak has been performing the director duties since December of that year after previously holding the roles of principal deputy director and deputy ethics counselor since 2010 at NIH.
Homeland Security Secretary Alejandro Mayorkas defended the Biden regulation, saying it aims to encourage migrants to enter using legal pathways. U.S. asylum officers hurried to figure out the logistics of applying the new asylum regulation. COVID EMERGENCY ENDS, ASYLUM BAN BEGINSTrump first implemented Title 42 in March 2020 as COVID swept the globe. The order allowed American authorities to quickly expel migrants to Mexico or other countries without a chance to request asylum. Migrants have been expelled more than 2.7 million times under Title 42, although the total includes repeat crossers.
Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. Bourla referred to a provision in the Biden administration's Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. Some drugmakers are already preparing to fight Medicare drug negotiations, industry sources told Reuters. Another provision of the Inflation Reduction Act requires Pfizer and other prescription drug companies to refund Medicare through rebates if the prices of their drugs rise faster than the rate of inflation.
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.
Governments were able to tailor their data reporting so it could be aggregated. Pulling the data closest to the outbreaks allowed us to publish nearly real-time information as the pandemic spread. Politicized rhetoric about vaccines also drove decisions in some parts of the country to end data reporting. As of this spring, only seven states continued to publish data on cases and deaths more than once a week. There is still much to do to fix the hodgepodge of antiquated, disconnected surveillance data systems that exist across governments.
Circuit Court of Appeals, the U.S. Justice Department said the order, from U.S. District Judge Reed O'Connor in Fort Worth, Texas, "has no legal justification and threatens the public health." It asked the court to stop the order from taking effect until it can fully hear the administration's appeal. He found that the federal task force that decides what preventive care must be covered under the federal healthcare law, also known as Obamacare, was unlawfully appointed, voiding all of that task force's determinations since 2010. More than 150 million people were eligible for preventive care free of charge as of 2020 under Obamacare, according to U.S. Department of Health and Human Services data. Reporting By Brendan Pierson in New York; Editing by Alexia Garamfalvi and Jonathan OatisOur Standards: The Thomson Reuters Trust Principles.
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.
The Biden administration on Wednesday will propose new health privacy protections to prevent protected health information from being used to investigate or sue people who facilitate abortions, senior administration officials said. Vice President Kamala Harris will announce the new language, aimed at strengthening existing privacy rule protections under the Health Insurance Portability and Accountability Act of 1996, when she meets with a task force on access to reproductive health care Wednesday afternoon. The HHS proposal centers on barring using or disclosing protected health information that could be used to identify, investigate, prosecute or sue people, health care providers and others involved in seeking or providing abortion care. In a document outlining its proposal, the White House said taking steps to protect sensitive health information had taken on "renewed importance" in light of such efforts. The proposed rule would continue to allow a regulated entity such as a health insurance company or provider to use or disclose protected health information "for permissible purposes" under the privacy rule, a senior administration official said.
April 7 (Reuters) - The federal judge who on Friday suspended approval of the abortion pill mifepristone is a former Christian legal activist whose small courthouse in Amarillo, Texas, has become a go-to destination for conservatives challenging Biden administration policies. U.S. District Judge Matthew Kacsmaryk, an appointee of former Republican President Donald Trump, had a long track record of opposing abortion and LGBTQ rights before the U.S. Senate confirmed him in 2019 to a life-tenured position as a federal judge. FAVORED VENUESince then, his courthouse has become a favored venue for conservative legal activists and Republican state attorneys general pursuing lawsuits seeking to halt aspects of Democratic President Joe Biden's agenda - often with success. In October, Kacsmaryk vacated Biden administration guidance requiring employers to allow transgender workers to dress and use bathrooms consistent with their gender identities. Reporting by Nate Raymond in Boston, Editing by Alexia Garamfalvi, Bill Berkrot and Diane CraftOur Standards: The Thomson Reuters Trust Principles.
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