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Daily News

September 20, 2019

Senate appropriators call on FDA to take additional steps to address vaping-related illnesses in the fiscal 2020 FDA funding bill and accompanying report they marked up Thursday (Sept.19).

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September 19, 2019

A summary of House Speaker Nancy Pelosi’s (D-CA) long-awaited government drug price negotiation bill says that savings from the plan, unveiled Thursday (Sept. 19), could be used to add hearing, vision and dental benefits to Medicare.

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The House on Thursday (Sept. 19) passed a short-term continuing resolution to fund the government through Nov. 21 and avert a government shutdown Oct. 1, and the Senate reportedly will take up the CR next week.

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FDA’s law enforcement arm, the Office of Criminal Investigations, is investigating the outbreak of lung illnesses that have been associated with vaping products, the agency’s tobacco center director Mitch Zeller said Thursday (Sept. 19).

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Democratic presidential primary candidate Pete Buttigieg’s newly unveiled “Medicare for All who want it” proposal would create a public option with auto-enrollment, increase exchange subsidies and cap out-of-network costs at twice the Medicare rate.

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Providers are asking CMS why the first bonus payments for those in alternative payments models through the Quality Payment Program have yet to be paid, even though providers in the Merit-based Incentive Payment System started seeing their pay adjustments at the start of the year.

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Fifty-nine percent of Medicaid beneficiaries under the age of 21 received a well-child screening in fiscal 2017 -- a decrease of five percentage points from fiscal 2010 and well short of CMS’ target ratio of 80%, according to a new report from the Government Accountability Office.

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An FDA advisory committee on Wednesday (Sept. 18) supported the over-the-counter use of a proposed nicotine oral spray for smoking cessation by a vote of nine to six, but many of the committee members raised concerns about potential youth abuse of the product and said the labeling may not be adequate for OTC use.

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The Senate Appropriations Committee on Thursday (Sept. 19) passed a bill that would give FDA an $80 million funding boost in fiscal 2020, with substantial investments in the agency’s medical countermeasures initiatives, pathogen reduction efforts, compounding oversight, food safety and outbreak prevention, cannabidiol activities and infrastructure maintenance.

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FDA plans to reject citizen petitions submitted primarily to delay generic and biosimilar competition, and the agency will refer offenders to the Federal Trade Commission, according to final guidance released Wednesday (Sept. 18).

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House Speaker Nancy Pelosi (D-CA) on Thursday (Sept. 19) unveiled her long-awaited government price negotiation plan, which would give HHS the power to negotiate drug prices that would apply to all payers.

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September 18, 2019

A package of so-called health extenders was tucked into the continuing resolution introduced in the House late Wednesday (Sept. 18) to avert a government shutdown Oct. 1.

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House Speaker Nancy Pelosi (D-CA) will release a bill Thursday (Sept. 19) that directs Medicare to negotiate prices for at least 25 drugs, and up to 250 drugs, according to lawmakers who have been briefed on the bill.

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House Education & Labor Committee Chairman Bobby Scott (D-VA) said that his committee is sorting out technical issues to ensure its surprise billing fix applies to ERISA as well as all other forms of health coverage, and that the committee is also stuck on whether to use a benchmark payment rate or arbitration as the policy fix.

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FDA is launching a sweeping data modernization plan in a bid to make its regulatory practices more efficient and to keep pace with rapid developments in biomedical technology and the use of real-world evidence.

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Senate Appropriations health subcommittee Chair Roy Blunt (R-MO) released a fiscal 2020 HHS funding bill on Wednesday (Sept. 18) that would extend some health programs set to expire on Sept. 30 for an additional year, despite work done by the House Energy & Commerce Committee and the Senate health committee this summer to extend these programs for a longer period of time.

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Traditional Medicare remains the driver of risk-based pay models, according to a report released by Premier Inc. Tuesday (Sept. 17), but a Premier official said progress is slower than the hospital group had hoped for as few providers surveyed expect their total patient percentage in these models to exceed 50% within five years.

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A group of medicine and public health researchers and historians are calling on an Ohio court overseeing the national multidistrict opioid litigation to ensure that any settlement guarantees full and permanent access to records that contain information about and shed light on the abuse potential and distribution patterns of opioids.

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The American Association of Cancer Research (AACR) wants Congress to provide FDA an extra $316 million to support regulatory science initiatives for medical products, specifically cancer therapies.

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September 17, 2019

HHS’ Office of Civil Rights (OCR) is looking into using its authority under HIPAA to tackle concerns over surprise billing and discussed the idea with a group of insurance industry stakeholders on Tuesday, according to a source who attended the meeting.

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