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Daily News

March 27, 2020

President Donald Trump signed a third coronavirus stimulus package on Friday (March 27), just hours after the House passed it.

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The House passed a third coronavirus stimulus package on Friday (March 27) and it now goes to the president’s desk.

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Medical device groups are warning governments not to impose new restrictions on medical device exports, which they say would needlessly restrict global supply chains.

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A scenario where payrolls go down and medical costs go up as a result of the COVID-19 pandemic could significantly shorten the time before the Medicare Part A Trust Fund becomes insolvent, with one expert predicting the fund could become insolvent as soon as 2022.

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Health insurers are looking to future stimulus bills after the latest Senate COVID-19 response bill, which is on track to clear the House, didn’t include key marketplace stabilization measures requested by the industry -- even though many of insurers’ proposals made it into the House Democratic bill unveiled earlier this week.

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The Trump administration is working with COVID-19 vaccine developers to start producing their vaccines before they’re proven to work, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House coronavirus task force briefing Thursday night (March 26).

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March 26, 2020

Nine national hospital and physician organizations on Thursday (March 26) called on CMS to begin making periodic interim payments to providers to offset revenue losses from delayed procedures during the COVID-19 pandemic, and to ask that states do the same under Medicaid.

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Women’s health advocates are concerned that a provision in the third coronavirus stimulus package passed by the Senate late Wednesday night (March 25) excludes non-profits, such as Planned Parenthood, from accessing Small Business Administration loans, after the original draft provision was tweaked as to not exclude non-profits that receive Medicaid.

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CMS must set up an appeals process for certain Medicare beneficiaries who are placed under observation at hospitals rather than designated as inpatients, a federal judge ruled.

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HHS asked governors in a letter Tuesday (March 24) to expand access to providers during the COVID-19 emergency by relaxing provider licensure and supervision requirements, and increasing liability protections.

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FDA will not pursue enforcement action against the distribution and use for medical purposes of “improvised” face masks that have not complied with certain device regulatory requirements, the agency announced in a temporary policy released Thursday (March 26).

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FDA soon will release a temporary policy allowing manufacturers and restaurants with food that does not comply with FDA’s nutrition facts labeling requirements to divert those foods to retail stores during the COVID-19 outbreak, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said during a Food and Drug Law Institute virtual conference on Thursday (March 26).

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March 25, 2020

The latest version of the Senate stimulus package includes a fix clarifying that anyone with Medicaid benefits that are not considered minimum essential coverage will still be eligible to get coverage for COVID-19-related expenses, per the Coronavirus response legislation passed last week.

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Gilead on Wednesday (March 25) requested that FDA rescind orphan drug designation for the company’s investigational antiviral drug remdesivir after an outcry from public health consumer advocates who argued the designation would allow Gilead to benefit from market exclusivity and tax incentives that could cut out competition and raise prices for patients.

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CMS appears to be backing off a plan to issue a rule that was intended to tighten states’ Medicaid eligibility determinations.

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A portion of the pending coronavirus compromise legislation would require HHS to issue guidance laying out what health information can and cannot be shared during the pandemic, as the Trump administration relaxes some enforcement of privacy law.

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Food industry lawyers predict the United States won't experience long-term food supply chain problems even though COVID-19 is affecting staffing, retail, manufacturing and distribution of food and dietary supplements.

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The Senate’s draft stimulus compromise floated Wednesday (March 25) fails to include key FDA-related provisions that House Speaker Nancy Pelosi (D-CA) pushed for in her version of the stimulus package released earlier this week.

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340B hospitals are asking CMS to use its regulatory flexibility to delay a proposed Medicare survey of 340B hospitals’ drug acquisition costs and to suspend a controversial Part B pay cut for 340B drugs during the COVID-19 pandemic, among other steps.

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Durable medical equipment suppliers ask CMS to put off competitive bidding for a year in light of concerns around COVID-19, and raise concerns that the addition of non-invasive ventilators to the program will make it difficult for DME providers to supplement hospital care by caring for COVID-19 patients at home -- though the suppliers had opposed that addition prior to the national emergency.

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