Senate Finance Kicks Off Physician Pay Reform Deliberations With Hearing Next Week

The Senate Finance Committee is taking a first step toward potential large-scale Medicare physician payment reform with a hearing next Thursday that will focus on how Medicare can incentivize providers to better treat and manage chronic conditions. The hearing comes shortly after Congress mitigated a 3.4% Medicare physician payment cut that went into effect in January and as a bipartisan group of senators, many on the Finance Committee, are working on long-term reforms to the physician pay system. Titled “Bolstering...
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Inside CMS - 04/11/2024
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Senate Finance To Hold Hearing On Change Cyberattack

The Senate Finance Committee plans to hold a hearing on lessons learned from the Change Healthcare cyberattack within the next week or so, according to a key lawmaker and a physician stakeholder group. Susan Dentzer, CEO of America’s Physician Groups, said she anticipates discussion around legislation that would improve options for hospitals that are impacted by cyberattacks and to prevent cyberattacks moving forward. Sen. Mark Warner’s (D-VA) office confirmed that a hearing will take place within the next week or...
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FDA To Increase Food Additive Transparency As States Propose Bans

FDA will share more data with states about its scientific reasoning for approving food substances as more states propose legislation to ban food additives already approved by the agency, according to FDA’s top official for food additive regulation. “What we are hoping to do is by providing more external information on our scientific thinking of these substances, that information will be available to states and if they reach out to us and question what was the basis, what is our...
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FDA Week - 04/12/2024
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Supplement Lobby Seeks To Block NY Law On Weight Loss, Muscle-Building Products

The Council for Responsible Nutrition (CRN) filed a preliminary injunction motion Thursday (April 4) asking the New York State Attorney General not to enforce a state law passed in 2023 that restricts the sale of weight-loss and muscle-building supplements to only people over 18. CRN filed a lawsuit challenging the constitutionality of the law in March and the law is set to go into effect on April 22. Gov. Kathy Hochul (D) signed the bill in October , restricting the...
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Accelerated Approval Drug For ALS Withdrawn After Failed Phase III Trial

Amylyx Pharmaceuticals is formally withdrawing from the market its accelerated approval drug for amyotrophic lateral sclerosis (ALS), Relyvrio, after a Phase III clinical trial showed it failed to perform better than a placebo, the company announced Thursday (April 4). FDA approved the drug in September 2022, after its advisers initially recommended against approval but then pivoted after Amylyx submitted new analyses the company said confirmed Relyvrio’s effectiveness. But at the time both FDA and the company committed to pull the...
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ACLA Launches Ad Blitz Urging Congress To Stave Off Yearly Lab Cuts

The American Clinical Laboratory Association (ACLA) has launched a digital advertising blitz aimed at galvanizing Congress to come up with a permanent solution to stave off yearly Medicare payment cuts to labs before the next cuts kick in Jan. 1. ACLA's latest ad campaign, launched on March 26, will be visible on specific online platforms in certain states and Beltway news websites to effectively reach policymakers, stakeholders, and patients, according to the group. Susan Van Meter, president of the ACLA,...
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E&C To Discuss Slew Of Telehealth Permanency Bills Next Week

The House Energy & Commerce Committee announced Wednesday (April 3) that its health panel will hold a hearing on April 10 to discuss over a dozen legislative telehealth proposals, including those seeking to make pandemic-era telehealth flexibilities and reimbursements permanent for Medicare beneficiaries and providers. Rep. Debbie Dingell's (D-MI) Advancing Access to Telehealth Act and Rep. Buddy Carter's (R-GA) Telehealth Modernization Act are among the 15 bills that lawmakers are to discuss, as Inside Health Policy scooped Monday (April...
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Peptide Therapy Companies Sue FDA Over Compounding Bans

FDA is facing a lawsuit over its decision not to allow pharmacy compounding of several peptides, including some commonly used by bodybuilders, brought by providers who prescribe them. While FDA says it has safety concerns about compounding of the substances, the suit alleges the decision was arbitrary and the peptides are prescribed for legitimate health purposes. The lawsuit was filed March 29 by EVEXIAS Health Solutions, EVEXIAS Medical Centers and FarmaKeio Pharmacy, which prescribe peptide therapies, in the Northern District...
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FDA Issue: 
FDA Week - 04/05/2024
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Vol. 30, No. 14
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FCC To Vote On Restoring Net Neutrality This Month

The Federal Communications Commission on Wednesday (April 3) announced it will vote later this month on a landmark proposal to restore net neutrality and reestablish the commission’s authority over broadband internet service access -- a move that would reverse policies by former President Donald Trump, with important implications for telehealth and digital care. The planned move by the Democrat-heavy commission would restore policies in place in the Obama administration, and follow up on a July 2021 Biden executive order on...
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Biden Touts Success In Pressuring Pharma To Lower Inhaler Prices

President Joe Biden on Wednesday (April 3) touted his administration’s and Sen. Bernie Sanders’ (I-VT) success in pressuring three of four of the nation’s top inhaler manufacturers to cap out-of-pocket costs for patients at no more than $35 a month, saying the administration will look for more ways to get drug makers, who are already backed in a corner due to Medicare drug negotiations, to cut their prices. Biden spotlighted the work of Sanders, who heads the Senate health committee,...
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