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Daily News

October 22, 2020

FDA approved Gilead Science’s remdesivir therapeutic, Veklury, on Thursday (Oct. 22) for the treatment of hospitalized COVID-19 patients 12 years and older, making it the first fully FDA-approved treatment for the novel coronavirus in the United States.

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Dialysis patients are clashing with insurers in an ongoing lawsuit over whether a CMS rule inappropriately steers patients to in-home dialysis treatment by stating that Medicare Advantage plans no longer must cover treatments at clinics located near patients’ homes.

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In a meeting with the White House budget office earlier this month, Juul urged the Trump administration and FDA to make it clear to states and tobacco retailers that the new national law setting 21 as the minimum age to purchase tobacco products preempts state laws that still have 18 as the minimum age.

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A new World Health Organization-funded study that found remdesivir may not reduce mortality from COVID-19 could put pressure on its maker, Gilead, to cut the price of the antiviral, which is the only pandemic drug to receive an emergency use authorization.

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Regeneron disputes allegations it did not disclose that the U.S. government funded development of the company’s coronavirus antibody in its patent for REGN-COV2.

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October 21, 2020

FDA on Thursday (Oct. 22) will ask its vaccines advisors to consider whether COVID-19 vaccine sponsors should keep their phase 3 trials blinded even after an emergency use authorization is granted, coming as two of the leading vaccine developers, Pfizer and Johnson & Johnson, warn that if granted an EUA they might ethically need to unblind their studies to allow participants to access EUA vaccines or to cross over to the vaccine arm of a trial.

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CMS Administrator Seema Verma announced on Wednesday (Oct. 21) that, after listening to stakeholder feedback, the agency will delay the mandatory radiation oncology demonstration until July, giving providers an extra six months before the model goes into effect.

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A new survey of health care priorities among young to middle-aged women says the policy implications for the next administration are clear: The next president must ensure that preexisting conditions are protected, Medicaid is extended in all states, subsides are available to help buy coverage, mental health and substance abuse issues are covered with parity to medical benefits, and telehealth and other remote care is covered.

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Oklahoma is making its latest push to change its Medicaid system, now soliciting proposals from managed care organizations with plans to fully implement a privatized Medicaid program for most beneficiaries in October 2021.

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House Ways & Means oversight subcommittee lawmakers from both parties on Tuesday (Oct. 20) pledged support for protecting people with preexisting conditions, while also illustrating a wide gulf in what they believe such protections mean.

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Pediatricians and mental health providers want whoever wins the presidency to establish a White House Office on Children and Youth to tackle issues exacerbated by the pandemic that affect young Americans and their families, like child poverty as well as health and educational disparities.

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October 20, 2020

States already have all the resources they need to distribute a COVID-19 vaccine when it’s time, HHS Secretary Alex Azar said Monday (Oct. 19), contradicting the Centers for Disease Control and Prevention director and governors, who are asking the administration for more details on what role states will play in distributing a vaccine and what funding will be available to them.

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CMS on Tuesday (Oct. 20) approved a waiver that allows adult Medicaid beneficiaries in Nebraska to receive additional benefits, including vision and dental, if they participate in work requirements.

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FDA’s highly anticipated advisory panel meeting Thursday (Oct. 22) on policies surrounding approval and emergency authorization of COVID-19 vaccines will be streamed on YouTube in an apparent bid to build the public’s trust in an eventual vaccine, coming as polls show skepticism by consumers and also by some states in the agency’s approval process.

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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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