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Daily News

February 15, 2019

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.

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Hospitals that sued CMS over cuts to reimbursement for 340B drugs are asking the court to make CMS recalculate payments to make up for those cuts, but the government says that would require all hospital outpatient payments be recalculated in order to keep the pay system budget neutral and tells the court to let CMS figure out how to fix the situation.

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Hospitals are asking a federal court to give CMS 30 days to scrap its plans to continue lower reimbursement for 340B drugs in 2019, as the court already found the 2018 pay cuts beyond the scope of the agency’s authority.

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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.

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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.

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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.

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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.

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

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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.

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February 14, 2019

The Fifth Circuit Court of Appeals on Thursday (Feb. 14) decided to let the Democratic-led House intervene in 19 GOP-led states’ controversial challenge to the Affordable Care Act, Texas v. Azar, and said four additional states can join the 17 Democratic attorneys general who are already party to the case.

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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.

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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.

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Sen. Brian Schatz (D-HI) and Rep. Ben Ray Lujan (D-NM), along with 61 Democratic co-sponsors, reintroduced legislation to let anyone not currently eligible for Medicaid to buy into the program or leverage it to enhance their coverage in the individual market.

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A health policy expert last week suggested to House Appropriations health subcommittee members that revoking the Trump administration’s rule that promotes short-term health plans could help offset the costs of removing the Affordable Care Act’s so-called subsidy cliff which several Democratic lawmakers have proposed in various reform bills.

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Home care organizations were pleased with a bipartisan Senate bill introduced Monday (Feb. 11) that would keep CMS from implementing any behavioral adjustment as part of a new home health pay system until the agency sees how providers react.

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FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package to be voted on Thursday (Feb. 14) to avert another shutdown.

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FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

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A bipartisan group of House Energy & Commerce Committee leaders asked to meet with FDA Commissioner Scott Gottlieb to discuss challenges the agency faces in inspecting foreign drug manufacturing facilities.

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A food safety advocate said she was “crestfallen” that FDA’s final guidance detailing how the food industry and agency staff should issue public warnings and recall notifications does not require companies to disclose the names of retailers involved in the recall.

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February 13, 2019

In an in-person meeting, Senate Finance Committee Democrats on Wednesday (Feb. 13) asked HHS Secretary Alex Azar how the administration plans to eliminate Medicare Part D rebates without letting drug makers pocket that money instead of sharing it with seniors, according to a Democratic committee aide.

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