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Daily News

October 13, 2020

The Democratic leaders of congressional health care committees asked the Government Accountability Office to quickly review the legality of the president’s plan to send $200 Medicare drug discount cards to seniors before the election.

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CMS announced that, since August, it has sent 171 cease-and-desist letters to labs that the agency says are not properly certified, a move that a medical device lawyer asserts could be an attempt by CMS to increase public trust in laboratory-developed tests in light of HHS’ controversial move to scrap FDA oversight of LDTs, including for COVID-19.

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Johnson & Johnson’s decision to temporarily pause its COVID-19 vaccine phase 3 clinical trial because of an “unexplained illness” in a trial participant does not affect the company’s manufacturing processes and plans, a J&J official told investors on Tuesday (Oct. 13).

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In an effort to respect the sovereignty of tribal nations, the federal government will allow tribes to choose whether they receive future COVID-19 vaccines through their states or through the Indian Health Service, Jay Butler, deputy director for infectious diseases at the Centers for Disease Control and Prevention, said on a Friday (Oct. 9) press call.

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Radiation oncologists raised concerns that CMS is not listening to their concerns about starting the 90-day pay bundle demonstration for certain physicians during a pandemic, and CMS staff responded on an informational call last week that they have relayed the concerns to agency leaders but any changes to the Jan. 1 start date would have to go through a new rulemaking process.

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Ryan White clinics have sued the Health Resources and Services Administration for not acting against drug makers that cut off 340B discounts for drugs provided through contract pharmacies, coming as the agency also faces growing pressure from lawmakers and other 340B providers to take action.

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Ryan White clinics have sued the Health Resources and Services Administration for not acting against drug makers that cut off 340B discounts for drugs provided through contract pharmacies, coming as the agency also faces growing pressure from lawmakers and other 340B providers to take action.

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October 09, 2020

House Energy & Commerce ranking Republican Greg Walden (OR) and Senate health committee Chair Lamar Alexander (R-TN) on Friday (Oct. 9) asked stakeholders for suggestions on how to reform the 340B drug discount program, taking aim in part at contract pharmacies as some drug makers look to limit the discounts providers can access through those entities.

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An Operation Warp Speed official on Friday (Oct. 9) said the federal government is on track to have a hundred million or more doses of COVID-19 vaccine manufactured by year-end -- enough to vaccinate the most vulnerable Americans -- and that there could be upwards of 700 million total doses available by March or April 2021.

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HHS is demanding Nevada rescind its directive that skilled nursing homes in the state immediately discontinue use of all COVID-19 point-of-care test machines provided by CMS because they yield too many false positives, HHS Assistant Secretary of Health Brett Giroir told reporters Friday (Oct. 9), calling the state’s action unwise, uniformed and unlawful.

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The government is paying AstraZeneca $486 million to test and make a COVID-19 antibody cocktail candidate as the administration races to buy enough antibody drugs to last until coronavirus vaccines are available.

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A former FDA official believes that Regeneron Pharmaceuticals has not collected enough clinical data for its investigational antibody cocktail, REGN-COV2, to wisely be given an emergency use authorization, despite President Donald Trump’s recent calls for FDA to quickly authorize the treatment for COVID-19 patients.

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HHS Deputy Chief of Staff for Policy Paul Mango told Inside Health Policy the government is buying additional lots of COVID-19 antibody candidates so that it will have enough antibody drugs to give away until vaccines are available.

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FDA drug center chief Janet Woodcock, who is currently detailed to the government’s Operation Warp Speed initiative, said the use of experimental monoclonal antibodies in conjunction with antivirals and other standard-of-care drugs to treat COVID-19 doesn’t raise huge concerns about drug-drug interactions since antibodies and antivirals have different mechanisms of action.

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The nation’s largest insurer recently unveiled a health reform proposal under which states could use the Affordable Care Act’s waiver authority to move lower-income exchange enrollees into a new Medicaid buy-in program, which it says could lower costs by more than 40%, and regulatory authority for the individual market would be returned to the states.

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A new article in Health Affairs recommends federal and state health officials draw on the protective regulatory approaches for seatbelts, alcohol and smoking to mandate use of face masks to mitigate the spread of COVID-19 -- offering a roadmap Democratic presidential-contender Joe Biden could use to seek a mask mandate should he win the presidency.

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October 08, 2020

CMS on Thursday (Oct. 8) laid out Medicare loan repayment terms as revised by the latest continuing resolution, including the option for providers to request an extended repayment schedule if they are facing financial hardships.

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After shutting down COVID-19 relief package negotiations Tuesday (Oct. 6), President Donald Trump said Thursday (Oct. 8) that both sides are again making progress on another stimulus package, but House Speaker Nancy Pelosi (D-CA) said the two still can’t agree on the overall cost or how to spend additional relief funds.

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Though some stakeholders are praising CMS’ proposed increases to evaluation and management payments in the 2021 physician fee schedule, many physicians groups -- including the American Medical Association -- are loudly decrying the budget neutral cuts tied to those pay hikes, and lawmakers recently asked CMS to mitigate the cuts to give Congress time to step in.

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If a Senate vote on Supreme Court nominee Amy Coney Barrett is delayed until after the election because of growing COVID-19 cases on Capitol Hill, there could be major ramifications for the future of the Affordable Care Act.

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