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Trump administration cannot proceed with pilot drug rebate program, US court rules

The Trump administration cannot require hospitals serving low-income Americans to pay full price upfront for the first 10 medications to become subject to Medicare drug price negotiations and wait for rebates, a U.S. appeals court ruled on Jan. 7. A three-judge panel of the Boston-based 1st U.S. Circuit Court of Appeals rejected a request by President Donald Trump's administration to put on hold an injunction a judge in Maine issued at the behest of the American Hospital Association and several healthcare providers that blocked the new program. The panel said the Health Resources and Services Administration's program upended a decades-long practice of providing safety-net hospitals serving rural and low-income communities with upfront discounts to buy prescription drugs. The judges pointed to a lack of evidence that the agency considered the impact the program would have on hospitals, who said the plan would saddle them with hundreds of millions of dollars in new costs. Rich Pollack, the head of the American Hospital Association, in a statement welcomed the ruling, saying the program "would have a devastating effect on America’s most vulnerable patients and communities, and the hospitals that serve them." The U.S. Department of Health and Human Services, which oversees the agency, did not immediately respond to requests for comment. The Inflation Reduction Act, a 2022 law enacted under Biden, allowed the government to negotiate a maximum fair price that Medicare, the healthcare program for people aged 65 and older or those with disabilities, would pay for certain costly drugs. State Medicaid programs, which provide health insurance for low-income Americans in collaboration with the federal government, receive a rebate to ensure they only pay the Medicare-negotiated price on behalf of qualifying patients. The first 10 drugs to be subject to negotiations include the blood thinner Eliquis sold by Pfizer and Bristol Myers Squibb; Johnson & Johnson's rival medication Xarelto; and Merck & Co's diabetes drug Januvia. Several of the medications were already subject to the federal 340B Drug Pricing Program, which for decades has required drugmakers seeking Medicaid and Medicare coverage for their drugs to provide upfront discounts to safety-net healthcare providers. HRSA said its 340B Rebate Model Pilot Program, which it announced in July, was intended to help drugmakers avoid duplicate price concessions to hospitals, which they were allowed to avoid under the IRA. Drug companies under the pilot program could charge hospitals their products' wholesale prices and issue rebates later to reflect their ultimate discount. The American Hospital Association sued last month, saying the pilot program was adopted in violation of the Administrative Procedure Act. U.S. District Judge Lance Walker agreed and issued an injunction on Dec. 29 that blocked the planned Jan. 1 implementation.

US appeals court appears skeptical of Meta, social media companies’ bid to cut off addiction lawsuits

A U.S. appeals court on Jan. 6 appeared inclined to allow lawsuits alleging major social media platforms were designed to be addictive for young users to proceed, as several judges questioned whether it was too early to consider whether the companies are immune from such claims. Facebook and Instagram parent Meta Platforms and other social media companies urged a three-judge panel of the 9th U.S. Circuit Court of Appeals to reverse rulings forcing them to face more than 2,200 lawsuits. The companies, which also include Snapchat and parent Snap Inc., YouTube and parent Alphabet Inc. and TikTok and parent ByteDance, argue that a federal law known as Section 230 of the Communications Decency Act of 1996 shields them from liability stemming from what is posted on their sites, including allegations they failed to warn the public about the addictive nature of their platforms. Filed by states, municipalities, school districts and individuals, the lawsuits allege that social media has contributed to a wave of depression, anxiety and body image issues in children, creating a mental health emergency among American youth in recent years. The cases, which have been centralized before U.S. District Judge Yvonne Gonzalez Rogers in Oakland, California, seek damages, penalties and restitution from the companies. The companies are appealing Rogers’ orders in 2023 and 2024 that largely allowed the litigation to move forward. An attorney for Meta, which led the companies' appeal, faced skeptical questions from all three of the judges on the panel, who questioned whether it was appropriate for the appeals court to weigh in at this early stage in the case, as Meta was requesting. Most appeals come after a court has made a conclusive, final decision in a case, the judges said. Meta attorney James Rouhandeh responded that Rogers' orders were conclusive because they force Meta to defend against the litigation. "It would be an enormous thing to require defendants to have to defend these types of suits," especially when they are precluded by Section 230, Rouhandeh said. Circuit Judge Jacqueline Nguyen, an appointee of Democratic former President Barack Obama, said Rogers had indicated in her orders that she was open to considering the companies' argument that they are shielded from liability later in the litigation. All three of the judges also questioned Meta's argument that Section 230 provides the companies with immunity from all lawsuits. The plaintiffs argued that Section 230 doesn't cover the claims in the lawsuits because it only protects against liability related to content published by third parties on the websites. "Here our complaints are about features that they can remedy without looking at any third party content at all," Shannon Stevenson, the solicitor general of Colorado who is representing the states that have sued, told the panel. Meta's argument that Section 230 shields the company from all the plaintiffs' claims isn't borne out in the statute's language, Nguyen told Rouhandeh. "When Congress wants to give immunity from suit, it knows how to say that," Nguyen said. Circuit Judge Mark Bennett, an appointee of President Donald Trump, and U.S. District Judge Kiyo Matsumoto of the Eastern District of New York, sitting by designation, who was appointed by Republican former President George W. Bush, were also on the panel. The case is People of the State of California v. Meta Platforms Inc, 9th U.S. Circuit Court of Appeals, No. 24-7032.

US appeals court fast tracks $100,000 H-1B visa fee dispute

A U.S. appeals court on Jan. 5 agreed to expedite an appeal of a court loss by U.S. business and research groups that are challenging President Donald Trump's $100,000 fee on new H-1B visas for highly skilled foreign workers. The U.S. Chamber of Commerce, the nation's largest business lobbying group, had argued that a speedy review was needed in order to preserve employers' rights ahead of the once-annual H-1B visa lottery scheduled to begin in March. The Trump administration did not oppose the quicker timeline, and the court agreed to a plan that will allow oral arguments to proceed in February. The Chamber of Commerce and White House did not immediately respond to requests for comment. The annual process is the only opportunity for most U.S. employers that wish to hire skilled workers through the H-1B program to apply for the visas, according to the Chamber’s court filings. "Those employers' ability to participate in the H-1B program this year therefore hinges on the outcome of this appeal; without relief by March, it will be too late,” the Chamber said in court papers filed on Jan. 2. The Chamber is appealing a December 24 decision by a U.S. district judge, who concluded that the new fee fell within the president's broad powers to regulate immigration. Before Trump imposed the new $100,000 fee in September, H-1B visas had typically come with about $2,000 to $5,000 in fees depending on various factors. The H-1B program allows U.S. employers to hire foreign workers with training in specialty fields. Technology companies in particular rely heavily on workers who receive H1-B visas. The program offers 65,000 visas annually, with another 20,000 visas for workers with advanced degrees, approved for three to six years. The U.S. Department of Homeland Security has separately issued a new regulation that replaces the random selection of the lottery with a new allotment system that prioritizes visas for higher-skilled and higher-paid foreign workers. The rule is scheduled to go into effect on February 27. The Trump administration has said that the H1-B program has been abused by U.S. employers who seek to replace American workers with lower-paid foreign workers. The Chamber said in its lawsuit that the new fee would force businesses that rely on the H-1B program to choose between dramatically increasing their labor costs or hiring fewer highly-skilled foreign workers. A group of Democratic-led U.S. states and a coalition of employers, nonprofits and religious organizations have also filed lawsuits challenging the fee. The case is Chamber of Commerce v. Department of Homeland Security, U.S. Court of Appeals for the District of Columbia Circuit, No. 25-5473.