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Daily News

October 28, 2020

Former FDA chief Scott Gottlieb warned that the federal government’s COVID-19 vaccine allocation plan could create access issues for underserved communities and older populations, and he urged officials to focus on mitigating any potential disruptions, including weighing how to help states set up mobile vaccination sites.

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FDA has indicated that it might not conduct pre-approval inspections of sites that are manufacturing COVID-19 vaccines and that are being considered for emergency use authorization, but there’s a lack of clarity about the agency’s alternative approaches to site inspections.

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A leading pharmacy compounding group predicts that FDA might face lawsuits from states and compounding pharmacies over its final memorandum of understanding, which subjects compounding pharmacies located in states that don’t sign the MOU to a 5% sales cap on the amount of compounded product that can be shipped out-of-state.

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Lawmakers face a host of health policy areas to deal with after the election -- starting with funding the government and health extenders during the lame duck session, followed by COVID-19 stimulus legislation, drug pricing, surprise billing and potentially a fix to the Affordable Care Act in the next Congress, lobbyists say. Other areas that might come into play include easing pay cuts some providers are set to see in 2021 under the physician fee schedule, expanding telehealth and, if Democrats win big on Nov. 3, moving toward a public option.

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Key House and Senate committees that work on health care are set to look markedly different in 2021 regardless of the election results, coming as the next Congress is likely to take up hot button issues such as COVID-19 stimulus legislation, drug pricing and potentially a fix to the Affordable Care Act.

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October 27, 2020

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.

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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.

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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.

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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.

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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.

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The contract between the federal government and insurers who will be selling plans on the federal exchange in 2021 includes a new clause that says the plans might have cause to end their agreement if the ACA’s tax credits are ended.

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October 26, 2020

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.

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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.

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CMS has posted the plan and pricing information for the 2021 benefit year on healthcare.gov for consumers to preview ahead of this Sunday’s (Nov. 1) launch of the ACA’s eighth open enrollment period.

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At least two of the 36 states that rely on healthcare.gov to enroll residents into an Affordable Care Act plan are asking HHS to extend the 2021 open enrollment period now slated to end Dec. 15 until the end of January to ensure that residents, including first-time enrollees, have adequate time to purchase coverage.

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HHS and FDA are once again clashing over laboratory-developed tests. An HHS official tells Inside Health Policy that labs can still voluntarily seek emergency use authorization of COVID-19 LDTs to get liability protection even though the department axed FDA’s regulation of the tests in August, but FDA told labs on Oct. 7 it would no longer accept voluntarily submitted EUAs for the tests.

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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.

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October 23, 2020

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).

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Web-based brokers working to sign consumers up for Affordable Care Act or Medicare private coverage expect the pandemic to drive more people to online services, and one major broker has boosted capacity to prepare for the expected surge.

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An FDA advisory committee will vote Nov. 6 on whether to recommend that FDA approve the first drug to treat Alzheimer’s, and the Institute for Clinical and Economic Review already is planning the process of recommending a price for what might be a very expensive drug.

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