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Daily News

November 13, 2019

Senate Minority Leader Chuck Schumer (D-NY) blocked the passage of a bipartisan bill, introduced by Sen. John Cornyn (R-TX), that aimed to prevent drug companies from patent gaming, after Cornyn called up the bill on Wednesday (Nov. 13) for an expedited floor vote.

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Two FDA experts say 2020 presidential hopeful Sen. Elizabeth Warren’s (D-MA) plan to weed out government corruption by restricting how companies share data and information with federal agencies could have a chilling effect on FDA and regulated industries.

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The House Energy & Commerce health subcommittee on Wednesday (Nov. 13) sent to the full committee legislation that aims to curb youth e-cigarette use by, among other things, raising the minimum tobacco purchase age to 21 and banning all characterizing flavors.

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FDA plans to host a public workshop on the benefits of incorporating clinical outcome assessments (COAs) into regulatory decision making.

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November 12, 2019

CMS proposed a wide-ranging new rule Tuesday (Nov. 12) that the agency says will crack down on states manipulating Medicaid supplemental payments in order to obtain extra federal matching funds.

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CMS will soon release a highly anticipated guidance letter that will invite states to use federal block grants to cover non-disabled adult Medicaid beneficiaries, Administrator Seema Verma said Tuesday (Nov. 12).

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Federal circuit court judges asked government lawyers to explain why CMS believes it has authority to cut back 340B reimbursement, and HHS’ legal team responded that it is not compelled to overpay hospitals.

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Hospitals want a federal judge to enforce her court order to get rid of deep reimbursement cuts for clinic visits at certain off-campus hospital facilities after CMS in its final 2020 hospital outpatient pay rule said it was forging ahead with the second year of the so-called site-neutral cuts.

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Sources suggest that California progressive Rep. Ro Khanna’s legislation that would give states flexibility to design a single-payer health system using money from all existing public programs would be a heavy political lift, particularly since seniors are wary of changes to Medicare and employers oppose policies that give states authority over self-insured large group plans.

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Stakeholders that support and took advantage of the Trump administration rule expanding association health plans are hopeful a federal appeals court will overturn a district judge’s decision to toss key parts of the rule, which a pro-AHP source argued has upended coverage for thousands of Americans.

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November 11, 2019

Sen. Mark Warner (D-VA), co-chair of the Senate Cybersecurity Caucus, said HHS isn’t doing enough to protect health records covered by the Health Insurance Portability and Accountability Act and called on the administration to describe how it will prevent health record breaches after a massive exposure of health records occurred in September.

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White House Domestic Policy Council Director Joe Grogan is not a fan of including drug rebate reform in the Senate’s drug pricing bill, and he would rather spend what little time is left tweaking policies that ensure the bill doesn’t raise premiums and that spread more of the bill’s Part D savings to more seniors.

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FDA is laying the groundwork to study how the general public interprets drug promotion.

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November 08, 2019

White House Domestic Policy Advisor Joe Grogan suggested that lawmakers are close to an agreement on surprise billing legislation and believes that something will pass either stand alone or attached to drug pricing measures by the end of the year.

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Trump administration official Joe Grogan on Friday (Nov. 8) railed against FDA regulation of tobacco, arguing that FDA regulates products that help people, and making the agency regulate tobacco, which is “awful” and “has no redeeming qualities,” is a waste of the agency’s time and resources.

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As speculation about FDA’s impending electronic nicotine delivery system (ENDS) product compliance policy and what it will entail continues to swirl, comments from President Donald Trump and an HHS official are stoking rumors that FDA will not include vape shops in its guidance.

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White House Domestic Policy Council head Joe Grogan said Friday (Nov. 8) that CMS’ controversial hospital price transparency rule could be out by the end of the year, and he slammed opposition to the rule.

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Medicare payment policies are encouraging hospital systems to buy up physician practices, leading to higher costs for both the government and beneficiaries, according to data presented to the Medicare Payment Advisory Commission Thursday (Nov. 7).

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A proposed Medicare Advantage and Part D rule under review by the White House Office of Management and Budget could execute parts of an October executive order and include controversial extrapolation language previously introduced in a prior MA rule, a former senior CMS official says.

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A new study by the Commonwealth Fund highlights the dozens of states that have codified some of the Affordable Care Act’s protections for people with preexisting conditions that are under threat by Texas v. USA, but sources stress that state governments can only do so much for residents without federal support.

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