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This week, the top managed care stories included CMS giving chimeric antigen receptor T-cell payments a boost; a US task force announcing that those at risk for pancreatic cancer should be screened; FDA revealing Novartis withheld data about a high-cost gene therapy.

The FDA ordered 4 companies to stop selling 44 of their flavored e-liquid and hookah tobacco products that lack the required approval for sale; CMS has yet to implement a 2014 law preventing unnecessary, expensive screening tests (magnetic resonance imaging, computed tomagraphy scans and other tests) that could harm patients and waste resources; Amarin, which is seeking FDA approval for an expansion of Vascepa labeling to include data that showed a 25% reduction in the risk of heart attacks and strokes, said the FDA has scheduled an advisory committee meeting for November 14.

The fiscal year 2020 (FY2020) Inpatient Prospective Payment Systems (IPPS) proposed rule notably includes approximately 1500 complications or comorbidities (CC)/major complications or comorbidities (MCC) designation changes and 324 changes to International Classification of Diseases, Tenth Revision, Clinical Modification codes, along with several other updates. The designation changes are an effort to respond to the notion that the CC/MCC assignment are no longer appropriate as conditions and factors have shifted.

Novartis hid manipulated data about its $2 million gene therapy Zolgensma from the FDA; US District Judge Kristine Baker granted a preliminary injunction preventing Arkansas from enforcing 3 abortion restrictions; a federal judge in Ohio expressed support for a plan by attorneys representing cities and counties suing US opioid manufacturers and distributors that would bring every US community into their settlement talks despite objections from most states.

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