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Daily News

December 07, 2018

House Democratic leaders are telling the federal DC district court that the Trump administration’s final rule that changed the definition of an employer in order to promote the creation of more association health plans (AHPs) conflicts with text, structure and history of the Affordable Care Act and should be thrown out.

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FDA’s Bob Temple, a drug center veteran of 46 years, will soon become senior advisor for the Office of New Drugs’ Immediate Office -- becoming the center’s point person on medical decisions that are controversial, complex or critical, center director Janet Woodcock said in an internal email on Friday (Dec. 7).

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Congress’ Medicare payment advisers discussed possible 2020 pay for a wide range of providers at their December meeting Thursday and Friday (Dec. 6 and Dec. 7), including draft recommendations to tie some hospital pay to the advisers’ Hospital Value Incentive Program, but the commissioners plan to look again at what to pay long-term care hospitals in January as they didn’t agree on whether to provide LTCHs a pay increase in 2020.

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Senate Finance Committee Ranking Democrat Ron Wyden (OR) called on CMS Thursday (Dec. 6) to “be straight with the seniors about all of their health care options” amid concerns from some beneficiary advocates that the agency is favoring Medicare Advantage over traditional Medicare.

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Industry lawyers expect more in vitro diagnostic test makers to apply for CLIA waivers thanks to newly issued FDA guidances that make the process less prescriptive and clarify that tests for which trained and untrained users get comparable results are entitled to a waiver.

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Thirteen Democratic senators are urging FDA Commissioner Scott Gottlieb to take stronger steps to prevent and reduce youth use of e-cigarettes by including mint- and menthol-flavored e-cigarettes among the types of products that would require stricter age verification and sales practices.

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Congressional Medicare advisers said Thursday (Dec. 6) that Medicare spending on drugs doctors administer is growing fast, and on the same day, CMS actuaries said Medicare retail drug spending growth has slowed.

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HHS hit back at conservative critics of its international price referencing Medicare Part B demo Thursday (Nov. 6) in a blog post authored by its new senior adviser for drug pricing reform, John O’Brien.

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December 06, 2018

An online broker is now marketing a short-term health plan package in at least 20 states that includes automatic renewals and allows consumers to lock-in rates for 36-months through a renewability guarantee rider that protects them from premium hikes or coverage denials should they fall ill.

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Through its new real-world evidence framework, FDA will evaluate how RWE can be used to support changes to labeling about a drug or biologic product’s effectiveness.

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In a surprise move Thursday (Dec. 6), bipartisan duos of House and Senate lawmakers released draft legislation that lays out a framework for FDA to regulate in vitro clinical tests, such as test kits and laboratory developed tests (LDTs).

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A Maine judge on Thursday (Dec. 6) set a new deadline of Feb. 1 for the state to adopt regulations to begin enrolling people in Medicaid expansion, essentially guaranteeing that outgoing Gov. Paul LePage (R) will not have to take any further steps to implement the voter-approved expansion law he has blocked for more than a year.

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Spending on health care grew at a slower rate in 2017 than in 2016 in part because Medicaid spending slowed due to the lull in Medicaid expansions and drug spending growth slacked off following the spike in spending to treat hepatitis C, according to the CMS actuary’s office.

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The Supreme Court heard oral arguments Tuesday (Dec. 4) in a case that pits brands versus generics over whether secret sales of drugs trigger the one-year countdown to file a patent.

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To mitigate drug shortages, a not-for-profit generic drug company is proposing FDA, on its own and through collaboration with other government agencies, provide manufacturers with myriad incentives, including: reduced regulatory oversight, increased time between inspections, tax credits or federal grants, and fee waivers for certain generic companies.

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The Federal Trade Commission says it stands ready to help FDA thwart citizen petition abuses aimed at delaying generic and biosimilar competition, but FTC’s comments to FDA offer no insights into how the antitrust enforcer would improve upon its past, limited performance in curtailing citizen petition abuses.

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December 05, 2018

Minnesota’s insurance department says the state will receive about $100 million less in federal “pass through” funding to support its reinsurance program for the 2019 plan year due to lower-than-expected premiums, but a department spokesperson says the updated federal funding estimate will not affect program operations.

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The Republican-controlled Wisconsin legislature, in an unusual all-night session, hurriedly passed legislation designed to prevent the incoming Democratic governor and attorney general from changing the state’s position on two controversial health care issues.

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The White House Office of Management and Budget on Monday (Dec. 3) began reviewing a final rule aimed at improving the Medicare provider enrollment process in order to beef up program integrity.

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The Trump administration is pushing ideas that could improve health care price transparency but says those steps will be futile without changes that put consumers in direct control of their health spending.

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