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Daily News

October 20, 2020

FDA has brought in seven temporary voting members to fill out its 17-member vaccines advisory committee, which will meet this Thursday (Oct. 22) to discuss general COVID-19 vaccine development and licensure or emergency use authorization data standards and policy issues.

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The HHS Office for Civil Rights announced Tuesday (Oct. 20) that it had resolved two religious discrimination complaints in Maryland and Virginia after clergy members requested by COVID-19 positive patients or within units designated as COVID-19 units were not allowed to visit the patients.

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The head of the industry-led Antimicrobial (AMR) Action Fund said the group is on track to begin investing in companies that manufacture promising new antibiotics by the first quarter of fiscal 2021, despite the COVID-19 pandemic.

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A non-profit food safety group worries FDA’s decision to move forward on its own to develop a common name for cell-based seafood could lead to a more favorable marketplace for those products than for cell-based meat and poultry, for which FDA and the U.S. Department of Agriculture are jointly developing common names.

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October 19, 2020

The American Hospital Association says providers are considering asking the Supreme Court to take up their cases against the Part B reimbursement cuts for 340B drugs and Medicare pay cuts for outpatient clinic visits at certain off-campus hospital facilities after the full U.S. Court of Appeals for the District of Columbia Circuit declined to rehear those cases.

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The average premiums for qualified health plans (QHPs) sold through healthcare.gov will decrease by 2%, and 22 more insurers intend to sell plans in 2021, according to a new CMS report out on Monday.

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The average premiums for qualified health plans (QHPs) sold through healthcare.gov will decrease by 2%, and 22 more insurers intend to sell plans in 2021, according to a new CMS report out on Monday.

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Insurers are increasing 2021 plan rates moderately compared to last year and most carriers that mentioned COVID-19 in their rate filings didn’t account for the pandemic due to persistent uncertainties about service utilization, treatment costs, potential vaccinations and general morbidity, Kaiser Family Foundation experts say in an analysis of rate filings.

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Differences between House Democrats and the White House on a national pandemic testing plan emerged over the weekend as a key sticking point as the parties set a Tuesday night (Oct. 20) deadline to either reach a deal on a COVID-19 relief package or resume talks after the elections.

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The Supreme Court’s recent decision to punt back to a lower court a case over FDA’s in-person prescribing requirements for the abortion pill mifepristone has women’s health advocates, who oppose the requirements, on guard.

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As FDA continues to urge the courts to reinstate its in-person prescribing restrictions on mifepristone, one women’s health expert is using the opening to proceed with her plans to study the prescribing and dispensing of mifepristone through telehealth without the need for ultrasounds or physical exams.

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In three separate efforts, two consumer groups filed suits to try to force the government to hand over coronavirus-related contracts with drug makers and another group of government-oversight nonprofits filed Freedom of Information Act requests demanding access to contracts funneled through the private government contract management firm Advanced Technology International.

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A lobbying group called Infusion Providers Alliance has formed to oppose international reference pricing for drugs, specialty pharmacy mandates and a measure in the Senate Finance Committee’s drug pricing bill that would lower reimbursement at physician practices that generate a significant part of their revenue from administering drugs.

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A loose coalition of 33 patient organizations has developed a 100-day plan, tailor-made for a Democratic White House and Congress, that seeks to reverse Trump administration policies viewed as undermining the Affordable Care Act and Medicaid, and to institute patient-centered coverage expansions.

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October 16, 2020

President Donald Trump’s vision for a “big, beautiful stimulus” that he shared during Thursday (Oct. 15) night’s townhall is at odds with his own party’s smaller proposal in the Senate, which will see another vote on Monday (Oct. 19) but has so far been rejected by House Speaker Nancy Pelosi (D-CA).

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Center for Medicare and Medicaid Innovation Director Brad Smith said the ongoing bundled pay demo was on track to lose more than $2 billion prior to mid-model changes that some have worried could cause providers to drop out of the demonstration.

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If the demonstration that caps monthly insulin costs works, CMS might run similar demos for other drugs, Center for Medicare and Medicaid Innovation Center Director Brad Smith said Friday (Oct. 16).

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CVS and Walgreens will be delivering the COVID-19 vaccine, once available, free of charge to long-term care facilities that sign up beginning Monday (Oct. 19), Operation Warp Speed officials announced Friday (Oct. 16), saying this public-private partnership will be the quickest and easiest way to deliver vaccines to the most vulnerable.

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Support for the Affordable Care Act ticked up by 6% since last month and voters now trust Democratic presidential candidate Joe Biden more than President Donald Trump on every health care issue, including to lower drug costs, which had been the only topic where voters trusted the president over his rival in the September, according the Kaiser Family Foundation’s health tracking poll released Friday (Oct. 16).

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Three of the biggest provider groups are pushing back against a recent executive order signed by President Donald Trump that aims to restrict anti-racism and sensitivity training, saying this training is crucial in care settings especially during the COVID-19 pandemic.

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