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Daily News

April 25, 2019

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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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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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FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they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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Arizona is the third state to require that insurance plans count copay coupons toward enrollees’ out-of-pocket costs, though the law aligns more closely with a recent CMS proposal than similar bills in Virginia and West Virginia. Gov. Doug Ducey (R) signed the law April 11.

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April 23, 2019

CMS proposes raising pay for low-wage hospitals -- and paying for that by cutting pay for high-wage hospitals -- in reforms to the hospital wage index that are part of the proposed fiscal 2020 hospital inpatient pay rule released Tuesday (April 23).

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CMS proposes raising the add-on pay for new technology and providing a path for breakthrough devices approved by the FDA to access add-on payments as part of the proposed fiscal 2020 hospital inpatient pay rule released Tuesday (April 23) -- a move the medical device lobby praised for including several of the industry’s suggestions.

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CMS proposed Tuesday (April 23) policy changes that would significantly increase Medicare pay to hospitals for administering expensive CAR-T cancer drugs and make it easier for hospitals to get the maximum possible reimbursement for administering the chimeric antigen receptor T-cell therapies.

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The advocacy arm of the American Cancer Society launched a major education campaign on Tuesday (April 23) to promote Medicaid in red states at a time when efforts to pass Medicaid expansion in some of those states appear to be gaining traction.

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The Heritage Foundation advocated for site neutrality as a way to lower Medicare costs at the American Enterprise Institute on Tuesday (April 23), just a day after the Medicare Trust Fund report projected Medicare costs to skyrocket through 2038.

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CMs Administrator Seema Verma encouraged states to take up the Trump administration’s new 1332 waiver concepts, saying the waivers would not undermine the Affordable Care Act’s risk pools and would protect coverage of preexisting conditions.

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FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).

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