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Daily News

December 16, 2020

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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Senate Finance ranking Democrat Ron Wyden (OR) and committee member Tom Carper (D-DE) are pressing Finance Chair Charles Grassley (R-IA) to begin the confirmation process for President-elect Joe Biden’s HHS and Treasury nominees so they’ll be ready to tackle the pandemic and the economy on day one of the new administration.

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The Centers for Disease Control and Prevention’s distribution of $140 million for COVID-19 vaccine preparedness and nearly $87 million for tracking and testing is far below the more than $8 billion health officials estimate they will need to support rolling out the vaccine -- and complicating matters further, one expert says there’s no guarantee the latest funds will make it to the frontlines.

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Health policy experts, including former FDA Commissioner Scott Gottlieb, are blasting Operation Warp Speed officials’ decision to hold back distribution of nearly 3 million doses of Pfizer’s COVID-19 vaccine until it’s time to ship out second doses next month, saying that more lives could be saved by sending out additional initial doses now and getting more people vaccinated with the first dose upfront.

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December 15, 2020

A bipartisan group of 27 senators, led by Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH), sent a letter to Senate leaders Monday (Dec. 14) urging them to include the compromise surprise billing legislation in the year-end spending bill.

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Sen. Mark Warner (D-VA) Tuesday (Dec. 15) praised CMS and IRS for agreeing to pause plans to strip Affordable Care Act advance premium tax credits away from consumers who might be victims of an IRS backlog, but he asked the agency to publicize the decision and create a special enrollment period to make sure no consumers fall through the cracks.

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Sen. Mark Warner (D-VA) Tuesday (Dec. 15) praised CMS and IRS for agreeing to pause plans to strip Affordable Care Act advance premium tax credits away from consumers who might be victims of an IRS backlog, but he asked the agency to publicize the decision and create a special enrollment period to make sure no consumers fall through the cracks.

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Sen. Mark Warner (D-VA) Tuesday (Dec. 15) praised CMS and IRS for agreeing to pause plans to strip Affordable Care Act advance premium tax credits away from consumers who might be victims of an IRS backlog, but he asked the agency to publicize the decision and create a special enrollment period to make sure no consumers fall through the cracks.

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CMS confirms that healthcare.gov is seeing a heavy volume of consumers trying to enroll in ACA coverage by Tuesday’s (Dec. 15) deadline, and consumers unable to get through are being asked to leave their contact information and will still be able to enroll in a plan with a Jan. 1 effective date.

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Nursing home advocates say Pfizer’s COVID-19 vaccine distribution timeline is on schedule, but nursing homes say states ultimately decide where doses are allocated and are pressing governors to ensure long-term care facilities receive the vaccine by March 1, coming as nursing homes work through patient consent hurdles.

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Compromise surprise billing legislation, the No Surprises Act, relies heavily on providers’ preferred surprise billing solution, arbitration, but national hospital groups want Congress to change the bill’s arbitration process more in hospitals’ favor and route savings to providers.

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Moderna will conduct a real-world study to assess the effectiveness of its COVID-19 vaccine once it’s on the market under emergency use authorization, FDA and Moderna say in briefing materials posted on the agency’s website Tuesday (Dec. 15).

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FDA on Tuesday (Dec. 15) authorized for emergency use the first fully at-home over-the-counter COVID-19 diagnostic test.

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CMS is laying out plans for a demonstration next year that will require inpatient rehabilitation facilities to submit their Medicare fee-for-service claims for pre-pay or post-pay review until they can show they have a good track record of correctly submitting claims, according to a notice published in the Federal Register Tuesday (Dec. 15).

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The 8th annual ACA open enrollment ends Tuesday (Dec. 15) for the 36 states using healthcare.gov, and experts tracking the signups expect to see strong final numbers while warning that apples-to-apples comparisons from earlier years will be difficult due to various changes this season.

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December 14, 2020

Liability protections have become enough of a sticking point for the bipartisan coalition of senators who proposed a $908 billion COVID-19 relief package that they’ve broken it into two bills -- tying in a separate, narrow bill the $160 billion for state, local and tribal governments to whether lawmakers can agree on liability protections.

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Xavier Becerra, California attorney general and President-elect Joe Biden’s pick for HHS secretary, is spearheading an effort by 29 AGs to get the Health Resources and Services Administration to stop drug makers from limiting 340B discounts accessed via contract pharmacies, saying the drug makers are unjustifiably flouting 340B requirements and their actions cannot be ignored -- especially in the middle of the COVID-19 pandemic.

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Pfizer will move forward with administering its COVID-19 vaccine to placebo recipients -- and thus unblinding its study -- on a rolling basis once the vaccine is available to trial participants’ demographic groups based on federal and state prioritization plans, company officials said, despite FDA’s repeated objections to unblinding vaccine studies immediately after emergency use authorization.

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World Trade Organization members decided Thursday (Dec. 10) to continue discussing a proposal to waive certain intellectual property protections for COVID-19 vaccines and medical products after a 90-day deadline passes, though consensus on the waiver remains unlikely as many of the largest developed members remain against it.

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Pfizer and the U.S. government will send out another 581 shipments of the company’s COVID-19 vaccine on Thursday (Dec. 17), in addition to the 636 shipments that began shipping out Sunday (Dec. 13), Operation Warp Speed Chief Operating Officer Gen. Gustave Perna said.

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