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Daily News

February 05, 2019

HHS Secretary Alex Azar urged rural health advocates on Tuesday (Feb. 5) to consider new health care models for delivering rural health care in a sustainable manner, and indicated it may be time to rethink the role of hospitals in the future of rural health care.

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In keeping with the goals of the 21st Century Cures Act, FDA on Tuesday (Feb. 5) published draft guidance aimed at laying out predictable premarket review pathways for combination products.

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A bipartisan group of senators working on legislation to curb surprise medical billing sent a letter to prominent stakeholders Tuesday (Feb. 5) in a bid to strike common ground between insurers and hospitals, coming hours before President Donald Trump, who supports cracking down on so-called balance billing, was poised to address health care costs in his State of the Union address.

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Cigna CEO David Cordani said HHS’ proposed rebate rule would have little effect on Express Scripts, which Cigna owns, because the pharmacy benefit manager already gives 95 percent of rebates to its insurer clients and because the rule would not affect commercial markets.

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The House Ways & Means Committee next Tuesday (Feb. 12) will hold a drug-pricing hearing, which will be the fourth hearing on the topic over the course of a few weeks.

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A group of leading public health organizations and advocates pushed back on one coalition’s attempt to convince President Donald Trump to stop FDA from regulating e-cigarettes, saying the coalition’s efforts are an “orchestrated effort by the tobacco industry and its political allies” to protect industry’s profits.

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February 04, 2019

Fourteen state Medicaid programs are violating federal law by not covering a drug used to induce medical abortions, and one state -- South Dakota -- is violating federal law by refusing to provide Medicaid coverage of abortions in cases of rape and incest, the Government Accountability Office said in a report Monday (Feb. 4).

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A contentious proposal to replace Utah’s voter-approved Medicaid expansion plan with one from state lawmakers that is both more restrictive and more expensive advanced in the Utah legislature Monday (Feb. 4).

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In final guidance released Monday (Feb. 4), FDA lays out how it will apply least burdensome provisions of medical device review to a device’s total product lifecycle, rather than just the premarket phase, while still ensuring devices meet safety and efficacy standards.

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The Senate Finance Committee asked seven brand drug makers to testify Feb. 26 on rising drug prices after some of those companies refused to testify at a Jan. 29 hearing.

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The California insurance marketplace, Covered California, is asking the California state legislature to reinstate an individual mandate penalty, create a reinsurance program and expand premium cost sharing, among other suggestions, to lower costs for those on the state exchanges.

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Two small Northeastern states are the latest to explore state-level reinsurance programs and individual mandates to help stabilize their individual insurance markets.

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CMS will again ask stakeholders for feedback on how to reduce regulatory burden, according to CMS Administrator Seema Verma, even as work on two separate CMS burden-reduction rules continues.

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A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

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HHS wants Congress to ban drug rebates, and Senate Special Committee on Aging Chair Susan Collins (R-ME) said she’d like to work with the president on rebate legislation.

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Senate Finance Committee ranking Democrat Ron Wyden (OR) again on Friday (Feb. 1) called on CMS to change guidance on emergency preparedness for nursing homes.

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Sens. John Barrasso (R-WY) and Debbie Stabenow (D-MI) reintroduced a mental health bill that would lift a restriction barring certain mental health professionals from billing Medicare for their services.

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FDA will hold a public workshop on May 1 to weigh potential barriers to generic drug development and alternative ways to evaluate product equivalence outside of in vivo bioequivalence (BE) studies, the agency announced in the Federal Register Monday (Feb. 4).

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February 03, 2019

The group of 17 Democratic attorneys general appealing the district court ruling in Texas V. Azar that, if upheld, would invalidate the entire Affordable Care Act, are asking the Fifth Circuit appeals court to expedite the case, and propose that opening briefs be due at the end of March.

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February 01, 2019

Republican lawmakers in Utah are trying to fast-track a bill that would undo the Medicaid expansion that the state’s voters approved in November and replace it with a more limited expansion proposal containing work requirements and spending caps.

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