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GOP Leadership Plans To Bring Graham-Cassidy To Floor Next Week

Senate Majority Leader Mitch McConnell (R-KY) plans to bring the health care overhaul bill by GOP Sens. Bill Cassidy (LA) and Lindsey Graham (SC) to a floor vote next week, although it isn’t clear whether 50 Republican senators support the measure as GOP aides report confusion about how the bill would affect their states.

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CMS is requesting advice for designing demonstrations, including pilots on new Medicare and Medicaid drug payment models, but House Republicans are warning their former colleague HHS Secretary Tom Price about messing with Part B drug reimbursement.

The 2019 Draft Notice of Benefit and Payment Parameters (NBPP), which will set policy for qualified health plans participating in the exchanges, is now under review by the White House Office of Management and Budget.

Congressional Diabetes Caucus Co-chairs Diana DeGette (D-CO) and Tom Reed (R-NY) wrote to FDA Commissioner Scott Gottlieb Wednesday (Sept. 20) urging the agency to revise guidance on the Biologics Price Competition Innovation and Act (BPCIA)'s “deemed to be a license” provisions, arguing FDA's existing policy discourages market entry for lower price insulin products.

The United States government has once again sided with the biosimilar industry in the latest iteration of litigation surrounding the so-called patent-dance provisions of the Biologics Price Competition and Innovation Act -- arguing in a remanded portion of the highly watched Amgen v. Sandoz Supreme Court case that no additional remedies are available under state law for non-compliance with the patent dance.

The Center for Science in the Public Interest, National Consumers League and FDA agreed Friday (Sept. 15) to ask the United States District Court for the District of Columbia to stay the advocacy groups' menu labeling lawsuit, citing FDA Commissioner Scott Gottlieb's promise to issue new guidance on menu labeling by the end of the year and not alter the underlying rule as instrumental to reaching the agreement.

Hospitals are urging lawmakers to support a bipartisan congressional push spearheaded by Reps. Eliot Engel (D-NY), John Culberson (R-TX) and Steven Palazzo (R-MS) to delay the Medicaid Disproportionate Share Hospital payment cuts -- which are set to kick in Oct. 1 -- by another two years.

FDA Commissioner Scott Gottlieb said that Congress should legislatively lay out the government's role in overseeing diagnostic tests, and that the broader diagnostic testing community should work together to understand how to commercialize tests so they better benefit patients.