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Daily News

April 26, 2019

Drug-pricing policies in Japan, Korea, Canada and elsewhere are undermining innovation and curbing market access, the Office of the U.S. Trade Representative says in its annual Special 301 report on the intellectual property practices of U.S. trading partners.

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April 25, 2019

New Hampshire wants a federal judge to let the state help defend CMS’ approval of its plan to implement Medicaid work requirements.

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A federal judge in Washington state on Thursday (April 25) issued a nationwide injunction blocking a Trump administration rule that bars federal funds from going to clinics providing, or referring patients for, abortions, and which many conservatives say targeted Planned Parenthood.

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Vermont is freezing approvals of new association health plans (AHPs) and barring existing plans from enrolling new members or marketing their products following a federal judge’s March 28 decision that invalidated key parts of the Trump administration’s AHP rule and remanded the regulation back to the Department of Labor.

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The Trump administration will no longer require navigators to train assisters to help people with chronic illness and limited English proficiency, and other vulnerable populations, and will limit how much help navigators must give individuals after they’ve signed up for health coverage.

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A Democratic aide says that House lawmakers have yet to receive a response to a series of questions regarding the Trump administration’s decision not to defend the Affordable Care Act from a constitutional challenge.

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CMS Administrator Seema Verma said stakeholders can expect more Center for Medicare and Medicaid Innovation (CMMI) models to be mandatory and for all upcoming payment models to include resources for state Medicaid adoption as she teased new rural health models and a long-awaited radiation oncology model in a speech to the National Association of Accountable Care Organizations (NAACOS) on Thursday (April 25).

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Plans and provider advocates are optimistic about new models for primary care introduced Monday (April 22) by HHS, but questions remain about who might be able to participate, how benchmarks might be set, and what services the models might include.

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Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

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CMS Administrator Seema Verma said the agency is working to get a final rule updating the Program of All-Inclusive Care for the Elderly published as part of CMS’ commitment to improving care for those dually eligible for Medicare and Medicaid.

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A leading pediatric neurologist said he welcomed FDA’s approval of the first-ever device for treating attention-deficit/hyperactivity disorder (ADHD).

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FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.

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As FDA works to develop an agricultural water rule as a part of its obligations under the Food Safety Modernization Act (FSMA), one consumer advocate said the agency could learn a thing or two from new agricultural water safety standards recently approved by the California Leafy Greens Marketing Agreement (LGMA).

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Information about a drug’s effectiveness compared to alternative treatments could help drug makers argue for formulary placement in a system without rebates, Deloitte’s head of life sciences said.

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April 24, 2019

Members of Congress from both parties are intervening on opposite sides of a hot-button lawsuit that will help determine whether Medicaid beneficiaries can sue their state government if the state removes certain medical providers -- such as those that perform abortions -- from the state’s Medicaid program.

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CMS Administrator Seema Verma on Wednesday (April 24) invited states that aren’t currently participating in the duals demonstration to talk with the agency about starting their own version, whether through the capitated financial alignment model, the managed fee-for-service model or some other state-specific model worked out with the agency.

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Siding with brand-drug makers, the Commerce Department on Wednesday (April 24) said the government should clarify that high drug prices are no basis for breaking patents.

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Centene officials told investors that the company sees the final exchange regulation out last week as generally neutral or slightly positive since they expect provisions that lower the user fee and allow issuers to limit drug coupons will offset the estimated $980 million loss in tax credits due to the premium index change.

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A federal judge in Oregon said he would block the Trump administration’s Title X changes that bar federal funds from going to clinics providing, or referring patients for, abortions, but the geographic scope of the preliminary injunction is unclear.

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The House Energy & Commerce health subcommittee will hold a hearing Tuesday (April 30) on the cost of drugs in Medicare Part B and Part D as members prepare to take up bills to lower drug costs for seniors.

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