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Dozens Of Issuers Win CSR Cases; Feds Must Reimburse For 2017, 2018

The U.S. Court of Federal Claims handed issuers major wins in four cost-sharing reduction (CSR) cases, including a class action suit brought by Wisconsin’s Common Ground Health Cooperative in which Judge Margaret Sweeney ruled that the government is responsible for reimbursing plans unpaid CSRs in 2017 as well as in 2018, despite the silver-loading workaround. Sweeney issued that decision on Friday (Feb. 15), the same day she ruled in favor of Texas non-profit Community Health Choices and Maine Community Health Options.

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The insurance industry notched a win Friday with a federal judge ruling that the Trump administration violated the Affordable Care Act and breached an implied contract when it cut off cost-sharing reduction payments and is responsible for reimbursing Texas non-profit plan Community Health Choices, Inc. (CHC) for not only the fourth quarter of 2017, but also for 2018, despite the silver-loading workaround that resulted in higher premium tax credits.

CMS will require hospitals that administer the expensive new CAR-T gene therapy to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the treatments approved, according to a national coverage determination published Friday (Feb. 15) for chimeric antigen receptor (CAR) T-cells therapy.

House Ways & Means Chairman Rep. Richard Neal (D-MA) said Tuesday (Feb. 12) that he asked HHS Secretary Alex Azar to consider making prescription drug makers pay rebates to Medicare if they hike Part B drug prices faster than the rate of inflation.

FDA on Friday (Feb. 15) finalized a compounding rule that, for the first time, places six bulk drug substances on the list of bulk substances that can be used by compounders not registered as outsourcing facilities -- also known as the 503A bulks list.

Rep. Lloyd Doggett (D-TX) reintroduced his bill requiring hospitals notify patients if the care they are receiving is out of their insurance network, joining efforts by several other Capitol Hill lawmakers to cut back on surprise billing practices.

The federal judge overseeing two lawsuits challenging Medicaid work requirements scheduled back-to-back hearings in the cases for March 14.

FDA took another step toward encouraging more generic drug development by unveiling draft guidance on Friday (Feb. 15) that explains how drug developers can apply for the competitive generic therapy pathway, which is intended for generic versions of drugs that have little-to-no competition on the market.

CMS’ Center for Medicare and Medicaid Innovation (CMMI) announced a new model on Thursday (Feb. 14) that would allow emergency ambulances treating Medicare fee-for-service beneficiaries to treat them on-scene or transport them to a location other than a hospital, like an urgent care center, and still receive Medicare payment.

Two new Democratic governors told CMS in recent days that they intend to resist conservative Medicaid waivers that the agency approved late last year while both states were under Republican leadership, joining other newly tapped Democratic governors in bucking the Trump administration’s policy shifts under Medicaid.