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Daily News

May 24, 2021

One of the largest clinical laboratory groups in the United States on Friday (May 21) asked the Biden administration to prevent FDA from overseeing laboratory-developed diagnostic tests, coming as key House Democrats press Biden’s HHS to go in the other direction and restore FDA’s lab test oversight that was taken away by a controversial Trump-era directive.

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May 21, 2021

CMS on Friday (May 21) said it will not extend the Next Generation Accountable Care Organization demonstrations beyond 2021, but it will allow participants in that demo to join the Global and Professional Direct Contracting (GPDC) Model in 2022, even though the agency had previously said it would not accept additional direct contracting applications for next year.

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The White House appears to be drawing a sharp line when it comes to including investments in the caregiving economy in a potential infrastructure compromise with Republicans, according to a memo the administration sent Friday (May 21) to Senate Environment and Public Works Committee ranking Republican Shelley Moore Capito (R-WV) offering to cut over $500 billion from its initial package.

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An amendment introduced in the Senate would curtail the Office of the U.S. Trade Representative’s authority to move ahead with World Trade Organization talks on a proposed waiver of certain intellectual property obligations through added “deliberation, transparency, and reinforced congressional oversight” provisions, according to Senate Finance Committee ranking member Mike Crapo (R-ID).

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The IRS issued long-awaited guidance on the 100% federal coverage of COBRA premiums put in place by the American Rescue Plan for April 1 through Sept. 30 that answers myriad questions posed by employers, insurers and other stakeholders about eligibility criteria and requirements.

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Days after HHS threatened to slap fines on drug makers, Eli Lilly on Thursday (May 20) asked a federal judge to stop HHS from penalizing companies, starting June 1, that restrict discounts to hospitals that dispense 340B drugs through multiple contract pharmacies.

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Three Missouri residents sued the state’s health department Thursday (May 20) for not moving forward on Medicaid expansion as called for in a state ballot initiative passed last year.

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May 20, 2021

Children’s health care advocates, who have long been worried about children’s mental health, are cheering the Biden administration’s latest investment of $14.2 million from the American Rescue Plan to create new state and regional pediatric mental health care teams.

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A bipartisan group of House lawmakers on Thursday (May 20) called on HHS Secretary Xavier Becerra to extend the Next Generation Accountable Care Organization demonstration, which is set to end this year, echoing some providers’ concerns that there will be no suitable alternative for demo participants after NextGen ACOs sunset.

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The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee.

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FDA has pushed back by another two years the deadline by which medical device manufacturers must switch over to using unique device identifiers, rather than legacy National Health Related Item Codes and National Drug Codes, on device labels and packaging.

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Wisconsin Governor Tony Evers (D) on Wednesday (May 19) called for a special session of the state legislature to discuss Medicaid expansion legislation, but the Republican majority has already committed to preventing debate on the issue at the special session set for Tuesday (May 25).

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The coalition backing employer-sponsored insurance is out with new data highlighting the value of employer-sponsored insurance (ESI) and showing many employers expanded benefits or added new resources to help employees during the pandemic.

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FDA on Thursday (May 20) released a revised, more detailed version of its 2019 draft guidance that explains how drug and biologics sponsors can use covariates in their clinical trials to more precisely estimate potential treatment effects on trial participants rather than using predictive biomarkers to identify groups of people that would more likely benefit from an investigational treatment.

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House Ways & Means Chair Richard Neal (D-MA) said he does not plan to hold a hearing on House Democrats’ government drug price negotiation bill, H.R. 3, for a few weeks because he is consumed by infrastructure legislation.

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The U.S. Supreme Court denied Sandoz’s petition to review a patent dispute over the company's biosimilar Erelzi, so the earliest Erelzi can be sold in the United States is 2029, even though FDA approved it in 2016.

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Since announcing U.S. support for a proposed waiver of World Trade Organization intellectual property rules, U.S. Trade Representative Katherine Tai has been making overtures to her holdout counterparts -- including, on Wednesday, those from Japan and Switzerland -- while proponents this week gained another high-profile backer in China.

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Researchers at the Duke Human Vaccine Institute are seeking funds from the National Institutes of Health to move Duke’s potential pan-coronavirus vaccine platform into phase 1 safety trials in humans.

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A new working group at the Federal Trade Commission is seeking public input on the commission’s reviews of drug industry mergers, which are becoming more common and have raised concerns about anticompetitive conduct.

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May 19, 2021

A bipartisan group of senators including Senate Finance Ranking Republican Mike Crapo (ID) are reintroducing legislation that would direct the Congressional Budget Office to consider savings from preventive services when estimating the cost of legislation and would let Congressional leaders get an analysis of those measures beyond the 10-year budget window.

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