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Focus On COVID-19

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CMS on Tuesday (Oct. 27) proposed a 2021 durable medical equipment pay rule that would permanently hike pay for rural areas, expand coverage of continuous glucose monitors, codify procedures for determining pay for new DME and expand coverage of external infusion pumps for certain drugs.

CMS on Tuesday (Oct. 27) announced it is only awarding competitive bidding contracts to durable medical equipment suppliers for off-the-shelf back and knee braces, but the agency claims it is not formally delaying the 2021 competitive bidding program for other DME categories and simply left them out for now because their inclusion wouldn’t save enough money.

About 40% of hospitals have not fully reported their COVID-19 data, CMS revealed Monday when it began allowing people to see which hospitals are reporting all required data every day.

Current COVID-19 testing levels are inadequate to know how many Americans are infected and to suppress the virus’ spread, the Association of American Medical Colleges said as it outlined its own national testing strategy -- a plan that HHS claims looks no different than what the department last sent Congress on Aug. 22.

States will have to cut services and lay off workers without additional COVID-19 relief and increased flexibility from Congress, the National Governors Association said after it found states on average have allocated nearly 90% of their relief and most are on target to spend it all by the end of the year.

FDA’s vaccine advisers disagreed with COVID-19 vaccine makers who claim they might have to unblind their placebo-controlled phase 3 trials should a vaccine become available through emergency use authorization.

FDA might allow COVID-19 vaccine makers to test the efficacy of their investigational vaccines against any vaccine that gains FDA approval, in a bid to help resolve ethical questions around placebo-controlled studies, although the agency continues to push for sponsors to use placebo-controlled trials for as long as possible.

HHS and FDA are once again clashing over laboratory-developed tests.

FDA updated its COVID-19 antigen test template Monday (Oct. 26) to recommend certain test developers seeking emergency use authorization include studies to support claims for screening asymptomatic patients, point-of-care testing and tests measuring multiple infections.

Administration officials are expected to say within days how they plan to make coronavirus vaccines free for everyone, HHS Deputy Chief of Staff for Policy Paul Mango said Friday (Oct. 23).