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Breaking Supreme Court News

Biden Admin To SCOTUS: Don’t Take Up Trump’s 340B, Site Neutral Cuts

Biden’s Department of Justice on Thursday (May 13) defended the Trump CMS’ Medicare Part B reimbursement cuts for 340B drugs and pay cuts for outpatient clinic visits at certain off-campus hospital facilities, saying there is no reason for the Supreme Court to take up either lawsuit.

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The Biden administration announced Friday (May 14) it’s delaying the Trump-era rule on Medicare instantly covering FDA-approved breakthrough devices until Dec. 15 despite a push by medical device makers and lawmakers to implement the pathway as soon as possible.

CMS released guidance Thursday (May 13) that authorizes states to offer up to three additional 30-day periods of retainer payments for home- and community-based services providers in calendar year 2021 if they choose to do so.

Providers applauded a bipartisan House bill reintroduced Thursday (May 13) that would create an electronic prior authorization system to streamline and increase transparency around prior authorization for Medicare Advantage plans.

The White House is reviewing a batch of four draft and final guidances from FDA that lay out how drug makers can comply with certain requirements under the Drug Supply Chain Security Act, including how they can identify and notify FDA of illegitimate drug products, and how to include product identifiers with product packages.

CMS released guidance Thursday (May 13) on the increase in federal Medicaid matching funds for home- and community-based services outlined in the American Rescue Plan that allows states to spend that money until March 31, 2024.

Democratic Sen. Michael Bennet (CO) plans to reintroduce his bipartisan antimicrobial drug reimbursement bill this year with revisions that include the Centers for Disease Control and Prevention’s recommendations for tackling antibiotic resistance, the lawmaker told former FDA chief Mark McClellan Wednesday (May 13).

The Federal Trade Commission published a report Tuesday (May 11) calling for right-to-repair laws based on what it says is a lack of evidence supporting original manufacturers’ justifications for repair restrictions, though the agency says it is unlikely a one-size-fits-all approach could encompass both medical devices and consumer products.

Post-acute care trade organizations have come together in support of legislation that would reset the implementation timeline for the development of a unified post-acute care payment system so the system prototype can reflect recent payment changes for post-acute providers and the effects of the COVID-19 pandemic.