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Daily News

October 04, 2019

FDA approved the second HIV prevention drug, Descovy, Gilead said Thursday (Oct. 3), setting the stage for difficult coverage decisions as Gilead touts Descovy as safer than its other HIV prevention drug, Truvada, a year before Truvada goes generic.

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October 03, 2019

President Donald Trump on Thursday (Oct. 3) signed a wide-ranging executive order that directs HHS to move towards using market-driven rates for traditional Medicare and paying the same amount for a service regardless of whether it is provided by a physician or other type of clinician like a physician’s assistant.

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President Donald Trump said Thursday (Oct. 3) that his administration will “soon” allow states to import drugs from Canada.

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A prominent Canadian patient advocate alleged a U.S.-based biologics industry group is engaging in “fearmongering” in her country as part of a bid to reduce confidence in biosimilars, but the targeted group, the Alliance for Safe Biologic Medicines, told Inside Health Policy it is merely raising legitimate concerns over Canada’s new policy that requires biosimilar switching without the involvement of physicians.

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The House Ways & Means Committee Chair Richard Neal (D-MA) called on his committee to look at patient protections for nursing home and hospice residents this fall in a letter sent to committee Democrats on Friday (Sept. 27).

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Senate Finance Chair Chuck Grassley (R-IA) could lose leverage if the panel’s bipartisan drug pricing package is delayed until early 2020, but he would gain political maneuvering time, sources said.

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CMS announced Thursday (Oct. 3) that it is exploring releasing program data on social determinants of health from its Accountable Health Communities model and asked stakeholders what type of data from the model would be the most useful.

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FDA awarded a grant to the National Association of Boards of Pharmacy to set up an information-sharing system for drug compounding activities that are primarily overseen by states, the agency announced Wednesday (Oct. 2).

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The Federal Trade Commission is looking into the sales, advertising and promotional practices of six major e-cigarette makers: Juul Labs, R.J. Reynolds Vapor Company, Fontem US, Logic Technology Development, Nu Mark and NJOY.

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October 02, 2019

Health IT, provider and hospital groups called on Senate health committee leaders to slow down an Office of the National Coordinator for Health IT’s proposed interoperability rule until ONC resolves outstanding concerns and issues groups have with the proposal.

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Reps. Phil Roe (R-TN) and Kim Schrier (D-WA) introduced legislation to improve the accuracy of the information listed on health plans’ provider directories to prevent patients from receiving surprise out-of-network bills.

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The Department of Treasury is pondering the legalities of issuing a regulation that would increase the amount of tax-free flexible spending account (FSA) contributions that a worker could carry over from one year to the next and is considering whether a subsequent reduction in total contributions may be needed, according to sources tracking the rule.

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President Donald Trump reportedly is initiating the process to nominate MD Anderson Cancer Center Chief Medical Executive Stephen Hahn to fill the FDA commissioner position.

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An innovation center official told physicians that by 2025 the center aspires to move all Medicare fee-for-service beneficiaries into alternative pay models that include a significant amount of risk for providers.

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President Donald Trump tweeted Wednesday (Oct. 2) that House Speaker Nancy Pelosi (D-CA) is “incapable” of working on legislation to lower drug prices and is using the issue to distract from House Democrats’ impeachment inquiry.

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House Energy & Commerce Committee Democrats are considering changes to a measure in their drug pricing bill that would hurt many nonprofit hospitals by eliminating 340B discounts on drugs that are subject to government price negotiation.

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October 01, 2019

House Ways & Means Committee Chairman Richard Neal (D-MA) is floating a surprise billing fix that calls for negotiated rulemaking by three federal agencies to set out-of-network payment rates and to determine when to use arbitration, essentially punting the issue from the halls of Congress to the executive branch.

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The case to overturn the Trump administration's rule on short-term plans will not be decided until months after the start of the Affordable Care Act next open enrollment period, according to a recently released briefing schedule from the U.S. Court of Appeals for the District of Columbia Circuit.

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Hospitals and plans say CMS lacks authority to force hospitals and plans to publish standard charges for items and services, and also argue the agency’s proposed price transparency requirement would lead to higher prices, be burdensome for providers and confuse consumers.

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Hospitals asked CMS which version of its hospital wage index changes the agency plans to apply to the hospital outpatient pay system and suggest that if it plans to institute changes in a budget-neutral way, doing so would hurt some hospitals.

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