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Daily News

September 29, 2020

Durable medical equipment suppliers have put planning for 2021 on hold as the Medicare landscape remains unclear because key CMS policies have yet to come out, a DME lobbyist said.

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The House on Tuesday (Sept. 29) passed a bipartisan bill that would create a new state plan option to extend Medicaid eligibility for up to one year after a beneficiary gives birth, which maternal health advocates applauded.

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Democratic presidential candidate Joe Biden’s proposal to reform the Affordable Care Act’s tax credits by removing the so-called “subsidy cliff” would reduce health care costs for nearly all current marketplace enrollees, according to a Kaiser Family Foundation analysis out just prior to the first presidential debate.

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The insurers suing the administration for cutting off the ACA’s cost-sharing reduction reimbursements want the full Federal Circuit Court to review last month’s ruling that found the government must reimburse insurers for the CSRs due in 2017 but can lower the amount due in 2018 because of the higher tax credits resulting from insurers’ silver-loading workaround.

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Democratic Sen. Dianne Feinstein (CA) and several colleagues in the House joined a Republican proposal to extend the timeline for states to spend their existing COVID-19 relief -- a move government organizations say would help but would not ease the budget shortfalls states are facing.

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HHS strongly defends Operation Warp Speed chief Moncef Slaoui’s financial ties to drug companies in a letter sent to the House coronavirus select subcommittee the same day Sen. Elizabeth Warren (D-MA) said Slaoui should be fired from the role because of his investments in several biotech companies, including some making COVID-19 vaccines.

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September 28, 2020

House Democrats unveiled a revised $2.2 trillion version of their HEROES legislation that creates a special enrollment period in healthcare.gov and ACA tax credits for anyone who has lost a job, and increases Medicaid matching funds, but does not include subsides for COBRA that large employers, unions and other stakeholders have sought.

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The coalition of large employers, unions and other stakeholders that want Congress to subsidize COBRA coverage have ramped up lobbying as talks over the COVID-19 package resumed, releasing a survey that found 7.5 million Americans lost private health insurance in April and May alone and blasting lawmakers for failing to act.

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CMS is updating its state guidance for investigating serious nursing home complaints after a new HHS Office of Inspector General report found that 21 states failed to meet the federal government’s timeliness threshold for investigating serious nursing home complaints from 2016 through 2018.

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CMS needs to release guidance before the end of the public health emergency on how states should restart the Medicaid redetermination process, Medicaid and Children's Health Insurance Program Payment and Access Commission members said, as they fear states might be too anxious to remove beneficiaries and overwhelm the system.

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FDA’s latest clarification of the types of evidence it will use to determine whether companies intend for drugs and devices to be used off-label removes language that industry argued would have unfairly exposed companies to misbranding violations.

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FDA recently launched its new Digital Health Center of Excellence with the goal of promoting digital health research and partnerships. However, one industry expert says he has doubts about the intent of the program, asserting that it could just be a marketing move to push the agency’s device precertification program.

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September 26, 2020

President Donald Trump’s nomination of Seventh-Circuit Judge Amy Coney Barrett to the Supreme Court on Saturday (Sept. 26) replaces liberal Justice Ruth Bader Ginsburg with a staunch conservative who has critiqued the Affordable Care Act’s constitutionality multiple times and who is expected to side with conservative justices in the case to overturn the health law, which the high court will hear Nov. 10.

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September 25, 2020

CMS says it is pleased Congress is working to change the repayment terms of Medicare loans to providers and to mitigate Part B premium hikes as part of the continuing resolution that the Senate is set to take up Tuesday (Sept. 29), after key Democrats wrote to the agency raising concerns with lack of clarity on provider repayment, the effects of the program on Medicare premiums and the overall amount of Part B loans given to providers.

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An executive order President Donald Trump unveiled Thursday night (Sept. 25) includes a provision to make HHS update Hospital Compare when providers are not in compliance with the hospital price transparency final rule.

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FDA cannot approve state plans to import Canadian drugs until 60 days after the final drug import rule is posted in the Federal Register, which hasn’t yet happened, and FDA officials don’t know whether they could begin reviewing state plans in the meantime.

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Only some seniors will receive the president’s $200 Medicare Part D cards for copays before the election because it will take months to issue the cards, White House officials said Friday (Sept. 25).

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Sen. Patty Murray (D-WA) said President Donald Trump and HHS Secretary Alex Azar need to “be quiet” and let FDA move forward on guidance that’s expected to strengthen the criteria for emergency use authorization of COVID-19 vaccines.

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Congress’ Medicaid and Children’s Health Insurance Program advisers want to look deeper into how Medicaid provider relief efforts are going, after finding that less than 15% of potentially eligible providers applied for Medicaid relief funding by the end of August.

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September 24, 2020

HHS on Thursday (Sept. 24) proposed a rule to implement the president’s recent executive order to lower insulin prices, which gives the administration about a week to turn around the final rule if the order is to take effect before the election.

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