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Daily News

December 19, 2020

FDA biologics center director Peter Marks revealed that the agency is considering whether polyethylene glycol -- the common ingredient in both Pfizer’s and Moderna’s two-dose mRNA vaccines -- could be causing the allergic reactions to Pfizer’s vaccine that have been reported in the United Kingdom and in the United States.

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December 18, 2020

CMS on Friday (Dec. 18) touted preliminary enrollment figures that show 8.2 million people selected health care plans through healthcare.gov, which is on par with the number in 2020, even though two states transitioned away from the federal marketplace this year, and easily beats the about 7.65 million enrollees that a policy expert had said would be needed to meet last year’s levels.

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FDA on Friday evening (Dec. 18) granted emergency use authorization to Moderna’s two-dose mRNA COVID-19 vaccine, one day after the agency’s advisory committee voted that the vaccine’s benefits outweigh the risks.

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The House on Friday evening (Dec. 18) passed a two-day stopgap continuing resolution that gives lawmakers the weekend to hammer out the details of a year-end package that wraps together spending and pandemic relief measures, and possibly also surprise billing legislation, health extenders and other key health policies.

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HHS will replace direct shipments of Abbott BinaxNOW COVID-19 tests to states and territories next year with a program run by the General Services Administration where localities will buy tests from the federal government for a fixed cost, HHS Assistant Secretary for Health Brett Giroir said Thursday (Dec. 17).

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CMS on Friday (Dec. 18) told hospitals that, starting in January, it will audit a sample of providers to make sure they are complying with the hospital price transparency rule -- which one attorney said signals CMS will be more proactive than expected in making sure hospitals follow the requirements.

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FDA is proposing to revoke its regulations covering human tissue products intended for transplantation that were recovered before May 25, 2005, the agency says in a Friday (Dec. 18) Federal Register notice.

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The Senior Care Pharmacy Alliance is urging the Centers for Disease Control and Prevention (CDC) to consider matching nursing homes to pharmacies they have a relationship with for coronavirus vaccinations, instead of matching nearly everyone with Walgreens and CVS.  

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The Trump administration on Thursday argued that an initiative aimed at facilitating trade in medical goods put forward by a group of members, including the European Union, was unnecessary because its advocates have not proven there is a problem to be solved.

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December 17, 2020

FDA’s vaccine advisers on Thursday (Dec. 17) voted overwhelmingly in favor of authorizing Moderna’s COVID-19 vaccine for emergency use for people 18 and older, with 20 voting “yes” that the benefits outweigh the risks and one abstaining, but the advisers were mixed on Moderna’s plan to redesign and unblind its trial once an emergency use authorization is issued.

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As lawmakers continue to negotiate a year-end package, hospitals, doctors, nursing homes and home health providers are urging them to extend the moratorium on the 2% Medicare sequester cuts through the end of the COVID-19 public health emergency -- but some lobbyists say getting such an extension could be an uphill battle.

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HHS is distributing $24.5 billion in provider relief -- nearly $5 billion more than what was previously announced for phase 3 -- to more than 70,000 providers so they can make up nearly 90% of their lost revenues and net change in expenses caused by the pandemic, according to the department.

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FDA and Pfizer will revise fact sheets and prescribing information for the company’s COVID-19 vaccine to draw attention to the Centers for Disease Control and Prevention’s tempered guidelines on monitoring for and managing severe allergic reactions that potentially could occur immediately post-vaccination, Doran Fink, deputy director of FDA’s vaccine review office, said Thursday (Dec. 17).

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Stakeholders are hearing that provisions banning anticompetitive actions, included in the bipartisan Lower Health Care Costs Act (S. 1895) passed by the Senate health committee last year, might be wrapped into the final COVID-19 relief bill, but the final status is unclear.

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CMS has pushed back the deadline for doctors to apply for extreme and uncontrollable circumstances exceptions from the Merit-based Incentive Payment System to Feb. 1, and is reminding providers that that process can include a request to leave out one or more performance categories from their score due to the COVID-19 pandemic.

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Generic drug lobbyists are scrambling after learning that health extenders might be paid for with legislation that would stop generic drug makers from blocking competitors by parking 180-day exclusivity periods.

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December 16, 2020

FDA on Wednesday evening (Dec. 16) revealed that some vials of Pfizer’s COVID-19 vaccine contain more than the five doses that are indicated on the product’s label, and the agency urged vaccine providers to use all of the product available in the vial, coming as the Trump administration and Operation Warp Speed officials say they’re working with Pfizer to quickly ramp up supply of the company’s two-dose mRNA vaccine so there will be more doses by the second quarter of 2021.

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National health care spending on hospitals and physicians increased in 2019, but that was offset in part by a decline in the net cost of health insurance that was driven by the health insurance tax moratorium.

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HHS Secretary Alex Azar on Wednesday (Dec. 16) said the federal government will use “any power” it has to ensure Pfizer supplies the United States with the number of vaccine doses stipulated in the company’s contract as well as extra supply when the United States needs it.

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The Trump administration on Tuesday (Dec. 15) asked a federal judge to reject the drug industry’s request for a temporary restraining order and preliminary injunction against the most-favored nation drug pricing demonstration.

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