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Daily News

November 18, 2019

FDA cleared for marketing the first duodenoscope with a sterile, disposable elevator component, which is intended to reduce the number of parts that need to be cleaned and disinfected between uses, the agency announced Friday (Nov. 15).

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November 15, 2019

The Trump administration plans to implement a controversial price transparency rule in 2021 and officials insisted the administration is on solid footing against litigation promised by the hospital industry.

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The Trump administration’s proposal that health insurers be required to disclose the rates they negotiate with providers was immediately blasted by insurers, who said the rule if finalized would confuse patients with complex information and undermine competition.

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Academics and beneficiary advocates are continuing to raise concerns with the Medicare Plan Finder tool as open enrollment continues -- namely that the updated website puts too much emphasis on the least expensive Medicare premium, rather than the smallest overall cost, and has missing or inaccurate cost information.

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CMS has approved state plan amendments formally allowing Idaho to implement Medicaid expansion as scheduled on Jan. 1, the state said.

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The House Ways & Means Committee's rural health and underserved area task force is asking stakeholders what issues should be considered as lawmakers draft bipartisan legislation -- in particular, the task force wants to pinpoint policies that have had a demonstrable, positive impact on health outcomes and workforce shortages in rural and underserved areas as well as the availability of long-term care.

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FDA sent Greenbrier International Inc. (Dollar Tree) a warning letter for selling potentially harmful over-the-counter (OTC) foreign drugs, some of which were imported from China.

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November 14, 2019

A federal appeals court panel seems inclined to issue a narrow ruling in a lawsuit challenging the Trump administration’s rule expanding association health plans, with two of the three judges on the panel repeatedly asking during oral arguments Thursday (Nov. 14) if they can resolve the case without directly deciding whether the rule violates the Affordable Care Act.

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House and Senate Democrats called on the Senate Appropriations health subcommittee to reschedule a previously postponed markup of the Labor-HHS spending bill, which includes a Democratic-authored amendment to block the Trump administration’s rule withholding Title X funding from facilities that perform abortions or refer patients for abortion.

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The Consumer Healthcare Products Association (CHPA) says FDA should quickly establish a regulatory pathway to allow dietary supplements containing hemp-derived cannabidiol (CBD) to be legally marketed.

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The HHS Office of Civil Rights and lawmakers on Capitol Hill are concerned by the revelation that the health system Ascension is sharing millions of personal health records with Google as part of a partnership, but consumer advocates say the issue is less about any potential privacy violations and more about what consumers expect when it comes to their health data.

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Sens. Bill Cassidy (R-LA) and Jacky Rosen (D-NV) unveiled a bill Thursday (Nov. 14) to strengthen privacy protections for consumer health data amid scrutiny over Google’s planned acquisition of Fitbit and its current partnership with Ascension.

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White House Domestic Policy Council head Joe Grogan recently said CMS included controversial cuts to 340B drug reimbursement and certain off-campus clinics in the 2020 hospital outpatient pay rule because it stands by the policies, and if the courts overturn them that just shows lawmakers where statutory changes are needed.

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Congress should hold hearings on the United States’ growing reliance on pharmaceuticals and active pharmaceutical ingredients (APIs) from China, and direct FDA to compile a list of Chinese-made drugs critical to American health and to certify that Chinese drug makers are up to par with U.S. standards, the U.S.-China Economic and Security Review Commission says in its new annual report released Thursday (Nov. 14).

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Republicans on the Energy & Commerce health subcommittee say legislation to stop brands from using citizen petitions to unfairly delay generic competition might violate the First Amendment, but Rep. Morgan Griffith (R-VA) said he must do his homework before taking a firm stance on whether to make an adjustment to the bill.

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As biologics companies urge FDA to consider allowing development of authorized biosimilars -- where a reference biologic manufacturer would make a biosimilar version of that product -- experts question whether doing so would undercut the value of biosimilar exclusivity in the same way authorized generics have been accused of undercutting generic drug incentives.

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A shortage of vincristine, one of the drugs essential to treating pediatric cancer, has the pediatric oncology community calling for both long-term and short-term drug shortage reforms.

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November 13, 2019

Plan selections leapt from 177,000 to more than 930,000 through Nov. 9, according to CMS’ second weekly snapshot on healthcare.gov activity, which indicates that sign-ups are stable despite the technical problems on the first day of enrollment.

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The House Energy & Commerce health subcommittee on Wednesday (Nov. 13) unanimously approved two bills to improve maternal health, including a bill that would allow states to extend Medicaid eligibility for up to one year after a beneficiary gives birth and receive a higher federal match rate.

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HHS Secretary Alex Azar said his agency is working at the White House’s direction to modify its International Pricing Index plan to ensure the United States pays less for drugs than other developed nations.

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