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Daily News

October 01, 2020

The Defense Department awarded a $20 million contract to On Demand Pharmaceuticals for domestic manufacturing of prescription drugs and ingredients as part of the government’s effort to avert drug shortages and price gouging during the pandemic.

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Sens. Michael Bennet (D-CO) and Todd Young (R-IN) on Wednesday (Sept. 30) introduced legislation that would establish a payment model under which antibiotic developers could get upfront payment for new antibiotics.

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September 30, 2020

A new Urban Institute analysis of coverage choices in 2018 finds the Trump administration’s decision to end cost-sharing reduction payments to insurers and the resulting “silver-loading” work-around ultimately drove more consumers to buy bronze plans that have lower premiums but higher out-of-pocket costs.

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The Senate on Wednesday (Sept. 30) passed a continuing resolution that funds the government through Dec. 11, narrowly avoiding a government shutdown, and extends funding for several Medicare and Medicaid programs, among other health care riders.

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FDA biologics center director Peter Marks doubled down on the agency’s stance that its emergency use authorization guidance, hung up at the White House, simply lays out stricter criteria for potential COVID-19 vaccines that industry has been aware of for months, despite suggestions from the White House that the guidance is a political ploy.

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FDA biologics center director Peter Marks thanked seven former FDA chiefs for their recent op-ed in which they voice concern about the negative effects that political interference from the White House could have on the public confidence in a COVID-19 vaccine, and in the FDA itself.

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The White House Office of Budget and Management is reviewing an interim rule that would extend the compliance timelines for the HHS Office of the National Coordinator’s information blocking and interoperability rule finalized in March, due to the COVID-19 pandemic.

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FDA has already shared its criteria for vaccine emergency use authorization directly with vaccine makers, even though the White House continues to stall publication of the guidance, former FDA chief Mark McClellan told House lawmakers Wednesday (Sept. 30).

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FDA has already shared its criteria for vaccine emergency use authorization directly with vaccine makers, even though the White House continues to stall publication of the guidance, former FDA chief Mark McClellan told House lawmakers Wednesday (Sept. 30).

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House Democrats want to give FDA $1.5 million to ensure the agency can hold advisory committee meetings for COVID-19 vaccines.

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North Carolina will be following up with 18 nursing homes after an HHS Office of Inspector General report found the facilities had problems related to life safety and emergency preparedness, although the state questioned the report’s validity.

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In the first presidential debate Tuesday, President Donald Trump contradicted Moncef Slaoui, the head of the administration’s Operation Warp Speed initiative, saying that a COVID-19 vaccine could be available as early as Nov. 1. Slaoui has said a vaccine could be available between April and June 2021.

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Drug pricing policy came up briefly following the opening bell of the presidential debate, with the president touting administrative measures he announced last week that lobbyists had suspected were timed for the debate. However, President Donald Trump didn’t mention the $200 Medicare Part D gift cards he promised last week.

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September 29, 2020

CMS on Tuesday (Sept. 29) lowered the thresholds for testing nursing home staff for COVID-19, basing its new methodology on the number of tests done in the county as well as COVID-19 positivity rates as opposed to just the latter.

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Durable medical equipment suppliers have put planning for 2021 on hold as the Medicare landscape remains unclear because key CMS policies have yet to come out, a DME lobbyist said.

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The House on Tuesday (Sept. 29) passed a bipartisan bill that would create a new state plan option to extend Medicaid eligibility for up to one year after a beneficiary gives birth, which maternal health advocates applauded.

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Democratic presidential candidate Joe Biden’s proposal to reform the Affordable Care Act’s tax credits by removing the so-called “subsidy cliff” would reduce health care costs for nearly all current marketplace enrollees, according to a Kaiser Family Foundation analysis out just prior to the first presidential debate.

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The insurers suing the administration for cutting off the ACA’s cost-sharing reduction reimbursements want the full Federal Circuit Court to review last month’s ruling that found the government must reimburse insurers for the CSRs due in 2017 but can lower the amount due in 2018 because of the higher tax credits resulting from insurers’ silver-loading workaround.

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Democratic Sen. Dianne Feinstein (CA) and several colleagues in the House joined a Republican proposal to extend the timeline for states to spend their existing COVID-19 relief -- a move government organizations say would help but would not ease the budget shortfalls states are facing.

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HHS strongly defends Operation Warp Speed chief Moncef Slaoui’s financial ties to drug companies in a letter sent to the House coronavirus select subcommittee the same day Sen. Elizabeth Warren (D-MA) said Slaoui should be fired from the role because of his investments in several biotech companies, including some making COVID-19 vaccines.

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