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Daily News

May 26, 2021

Key Democratic lawmakers will be crafting legislation on a public option they say would be available to everyone in America, and the Democrats seek answers to numerous design questions, including eligibility, a benefit package, subsidies, provider reimbursement, and the role of states.

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FDA on Wednesday (May 26) published two new draft guidances that detail the agency’s thoughts and recommendations for how sponsors should conduct post-approval studies for and continuous postmarket surveillance of agency-approved medical devices.

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CMS and several online platforms -- including Uber, DoorDash and Lyft -- are joining in a so-called Gig Workers’ Week of Action to encourage employees to sign up for coverage via healthcare.gov and access the more generous subsidies temporarily available under the American Rescue Plan.

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HHS and FDA officials announced Wednesday (May 26) that they are reversing a Trump-era directive to eliminate FDA’s Unapproved Drugs Initiative through which the agency has tried to remove from the market any unapproved drugs. The officials say the Trump administration’s November attempt to withdraw the unapproved drugs program was “legally and factually inaccurate.”

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A group of Senate Democrats lead by Jean Shaheen (D-NH) are urging the Biden administration to work to reduce the out-of-pocket costs for consumers, in addition to lowering premiums, in any health reform proposals.

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Wisconsin’s Republican lawmakers Tuesday (May 25) ended a special session the governor had called to take up Medicaid expansion legislation without discussing the bill, leaving over $1 billion in federal funding on the table.

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Bipartisan senators passed several maternal health bills through the Senate health committee Tuesday (May 25), advancing policy proposals like anti-bias training for providers and improving Centers for Disease Control and Prevention data collection for rural mothers.

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FDA on Tuesday (May 25) revealed that it may decline to review and process anymore emergency use authorization requests for COVID-19 vaccines, especially if the agency is unable to verify product and manufacturing quality information or when a vaccine falls lower on the agency’s EUA priority list.

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May 25, 2021

HHS says it will dedicate $4.8 billion from the American Rescue Plan to the COVID-19 Uninsured Program that reimburses providers for testing the uninsured.

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Moderna announced Tuesday (May 25) that it will soon ask FDA to clear the company’s COVID-19 vaccine for use in teens ages 12 to 17, coming as clinical trial data show the vaccine was 100% effective in teens.

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The Senate confirmed Chiquita Brooks-LaSure as CMS administrator Tuesday (May 25) 55-44, after her confirmation vote was delayed due to objections over a revoked Texas Medicaid waiver extension.

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FDA on Monday (May 24) finalized guidance that details how sponsors of molecularly targeted adult cancer drugs can demonstrate to FDA how those drugs can also be used in pediatric populations.

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A group of organizations representing workers, providers of and beneficiaries who use home- and community-based services sent a letter to Congressional leadership Tuesday (May 25) urging them to put HCBS funding in the next legislative package, as Republicans say a bipartisan infrastructure agreement is still far off and other advocates suspect the package will eventually move through reconciliation.

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A group of benefit advisors, brokers, carriers and other stakeholders Friday launched a non-partisan group -- the HRA Council -- to promote health reimbursement arrangements (HRAs) that let employers provide a defined contribution to help their workers afford individual market coverage.

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May 24, 2021

Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any major health legislation is passed, and they need that information quickly.

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The Senate advanced Chiquita Brooks-LaSure’s nomination to CMS administrator with a procedural vote Monday (May 24) that avoids a filibuster in the face of GOP opposition to her over the Biden administration’s cancellation of a Texas Medicaid waiver. The Senate voted 52 to 43 to invoke cloture on Brooks-LaSure's confirmation vote.

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Former FDA chief Scott Gottlieb and former HHS Assistant Secretary for Health Brett Giroir sparred over the safety of kratom and who’s to blame for the lack of strict scheduling, coming just minutes after FDA announced the seizure of $1.3 million worth of kratom-containing dietary supplements and bulk dietary ingredients.

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Lawmakers are urging HHS Secretary Xavier Becerra to consider exempting rural areas from upcoming pay cuts for physical and occupational therapy assistants -- coming as therapy groups are also seeking to meet with the administration and HHS on the issue as well as on changes to Medicare Part B direct supervision requirements.

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Food and drug law experts are closely watching a number of court cases in 2021, including one at the Supreme Court that involves consolidation of product liability lawsuits and could have implications for how courts handle case backlogs after COVID-19.

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Group medical practices are asking HHS for more than just time beyond June 30 to spend their provider relief funds; they want the department to address what they consider unnecessarily complex and administratively burdensome financial reporting requirements that make providers submit all their health care expenses to prove they needed the relief.

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