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Daily News

January 28, 2019

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

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Higher-than-expected medical claims coupled with state and federal policy requirements drove premium increases and market participation in the health insurance exchanges, the Government Accountability Office (GAO) concluded in an Affordable Care Act-mandated report released Monday (Jan. 26).

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The American College of Emergency Physicians is joining the effort to craft legislation that would mitigate so-called surprise billing and is pushing insurers to make more of an effort to cover emergency services and to take responsibility for payments.

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Lobbyists say a BioCentury report Friday (Jan. 25) that the board of the Pharmaceutical Research and Manufacturers of America is considering a cap on drug price increases is correct, but a brand drug lobbyist said it is difficult to determine whether the board will vote to commit its members to such a pledge.

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FDA is taking new steps to advance the use of real-world evidence and real-world data in the digital technologies and drug product labeling space, agency chief Scott Gottlieb announced Monday (Jan. 28).

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Washington state’s health care authority is in the final stages of a plan to pay a subscription for hepatitis C drugs that would cover its Medicaid beneficiaries, prisoners and state employees, including teachers, and the winner-take-all model could be extended to the commercial market and other states.

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In comments to the agency, two health advocacy organizations urge FDA to partner with other federal agencies to address youth e-cigarette and tobacco product use and addiction.

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January 25, 2019

Philadelphia on Friday (Jan. 25) signed onto the multi-city lawsuit that alleges the administration violated the Constitution’s “take care” clause by acting to undermine the Affordable Care Act.

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Senate Finance Committee Chair Chuck Grassley (R-IA) is pushing CMS to explain how it is making sure the agency isn’t overpaying for lab tests under the new lab pay system after a Government Accountability Office report said CMS could be paying billions more than necessary for tests -- a claim that the American Clinical Laboratory Association alleges doesn’t reflect reality.

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An FDA advocacy group is stumped as to how FDA will resume operations and receive funding from Congress after President Donald Trump agreed on Friday (Jan. 25) to reopen the federal government for three weeks.

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Officials with Families USA wrote in a Health Affairs blog Thursday (Jan. 24) that CMS needs to rewrite the objective of Medicaid to successfully respond to legal challenges to Medicaid work requirements, as advocates for those suing over the requirements say the coverage losses in Arkansas, and expected losses in Kentucky, show that the waivers do not further the point of the program.

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CMS recently provided states with four concepts could consider under the revised guidance for the Affordable Care Acts 1332 waivers, but Administrator Seema Verma is making clear that she has a favorite: In an editorial published last week, Verma strongly endorsed the idea of allowing states to create health expense accounts that consumers could use to purchase health coverage, similar to the Health Indiana Plan Medicaid waiver that she helped craft as a consultant.

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Ensuring generic drug manufacturers have access to samples necessary for drug development, allowing personal drug importation, banning settlements that delay generic competition and improving transparency of the rebate system are realistic legislative goals this session, a health policy aide to Rep. Lloyd Doggett (D-TX) said.

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Massachusetts Governor Charlie Baker (R) is requesting state legislation to let its Medicaid program negotiate supplemental rebates for expensive drugs.

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The generic, brand and biologic drug lobbies have joined a coalition that is organizing against Medicare for All proposals.

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January 24, 2019

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

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D.C. federal district court judge John Bates showed interest in the Democratic attorneys general’s complaints challenging the Trump administration’s expansion of association health plans, repeatedly saying during Thursday’s hearing that the administration’s underlying intention in the rule was to modify the Affordable Care Act, not the definition of an employer under ERISA.

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A bipartisan group of House lawmakers on Thursday (Jan. 24) reintroduced legislation that would fully repeal the 40 percent excise tax on high-cost health plans, commonly known as the “Cadillac tax,” garnering immediate praise from wide-ranging stakeholders that have long worked to strike the provision from the Affordable Care Act.

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Piggybacking on providers’ requests, a bipartisan group of four House lawmakers is pressing CMS to delay the Feb. 19 deadline for applications to participate in the revamped accountable care organization program that kicks offs in July.

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Federal Medicaid advisers voted Thursday (Jan. 24) to recommend that Congress alter scheduled payment cuts to disproportionate-share hospitals so the cuts are phased in more gradually and redistributed among states based upon their percentage of low-income residents.

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