CDC RECOMMENDS PFIZER SHOT FOR KIDS — The Centers for Disease Control and Prevention late Tuesday endorsed the first Covid-19 vaccine for kids aged 5 to 11, hours after an advisory panel unanimously recommended the shot , showing more confidence in broad vaccination than Food and Drug Administration advisers just days earlier.
The background: Some members of FDA’s vaccine advisory committee last week suggested they would have been more comfortable supporting emergency use authorization for Pfizer and BioNTech’s vaccine if the shot were recommended only for kids of color or those with certain underlying health conditions, given the higher risk for disease for those groups and the still-thin safety data, Lauren Gardner reports. But the CDC advisers did not share those concerns. They argued that existing data, particularly for teens, laid out the known risks for side effects like myocarditis and multisystem inflammatory syndrome — and the benefits outweighed the risks. "We need to acknowledge the unknowns, but I think we’ve done that today," said Matthew Daley, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado and a member of the CDC panel. CDC Director Rochelle Walensky within hours endorsed the shots' administration, and federal officials have said that 15 million children’s doses — one-third the amount of adult doses — were being shipped to distribution centers ahead of the vote. FIRST IN PULSE: KING WANTS ROYALTY-FREE VAX RAMP UP — Sen. Angus King is pressuring Moderna and Pfizer to open their vaccines up for generic manufacturing, calling it a critical step to producing the doses needed to curb the pandemic worldwide. In a letter to the companies, King highlighted Merck’s recent decision to license its new Covid-19 antiviral pill to the UN-backed Medicines Patent Pool, a move that will make the treatment available in more than 105 countries. “We clearly need more of every aspect of the vaccination supply chain, but we critically need to increase the production of vaccines,” he wrote, urging Moderna and Pfizer to follow suit. The senator also asked the companies to consider participating in the World Health Organization’s South African technology transfer hub and the Pan American Health Organization’s Latin American hubs — as well as commit to a royalty-free license to the MPP for any additional Covid-19 treatments they may develop. CMS HIKES PENALTIES TIED TO PRICE TRANSPARENCY — The federal government will penalize hospitals as much as $5,500 a day for failing to make their prices accessible to the public, according to new CMS regulations finalized Tuesday. The steeper fines starting Jan. 1 come after the agency said that it found “sub-optimal compliance” among providers subject to the transparency requirements. Smaller hospitals that refuse to follow the rules will face a minimum penalty of $300 a day, while larger hospitals with bed counts greater than 30 will now be charged $10 per bed per day. Among the other decisions that CMS is rolling out: The agency is maintaining a Trump-era 340B cut. The Biden administration will continue paying a sharply lower rate for drugs acquired through the 340B program that was first finalized during the Trump administration. The decision to keep the rate — which is the average sale price minus 22.5 percent for certain drugs — intact drew immediate criticism from some provider groups, with America’s Essential Hospitals warning it would deepen safety net hospitals’ financial challenges. CMS will restore a list of “inpatient-only” services. The agency is reversing the Trump administration’s planned elimination of a list of services that Medicare only pays for when performed in inpatient settings. The decision was driven by patient safety concerns, CMS said, and will add back to the IPO list nearly all of the 298 services that were cut last year. Pay cuts for specialist providers. The reimbursement reductions in areas like vascular surgery and radiation oncology will phase in over time to soften the blow. But it still left physician groups outraged, and prompted vows from some lawmakers to pass legislation reversing the cuts. “Many of the specialists who will be affected by these misguided cuts provide treatment for diseases that disproportionately affect Black and Latino patients,” Rep. Bobby Rush said Tuesday.
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