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Daily News

March 20, 2020

The American Clinical Laboratory Association is pressing Congress to provide surge capacity funding and other resources to labs conducting COVID-19 testing. In a letter sent to Senate and House leaders Thursday (March 19), ACLA calls for $5 billion for labs, and requests Congress clarify that labs can qualify for loans and other resources under the Defense Production Act.

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CMS on Thursday (March 19) approved a 1135 waiver for Washington’s Medicaid program, marking the second such waiver following one approved for Florida on Tuesday (March 17).

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March 19, 2020

Medical device makers would be required to report potential device shortages or supply disruptions to FDA should Congress pass the Senate’s latest coronavirus stimulus bill, which also includes expanded drug shortage reporting requirements for drug makers.

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The Senate Finance and Senate health committees released their proposals for a third coronavirus stimulus package on Thursday (March 19) that includes new supplemental funding for community health centers, ups pay to hospitals treating COVID-19 patients and further expands telehealth.

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The Senate’s coronavirus stimulus bill, released Thursday (March 19), encourages further development and use of antimicrobial drugs by allowing inpatient hospitals to get paid for qualifying antibiotics under Medicare.

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The GOP-led COVID-19 stimulus bill released Thursday would ease restrictions on high-deductible health plans’ ability to cover telehealth services prior to the deductible as some large employers had been pushing, but on a temporary basis.

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A federal appeals court will hear oral arguments Friday (March 20) on the Trump administration’s expansion of short-term insurance plans that do not comply with the Affordable Care Act’s market reforms.

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FDA hopes to use its compassionate use program to get potential COVID-19 therapies to health care providers and patients while also gathering information on safety and efficacy, agency chief Stephen Hahn announced Thursday (March 19) during a White House press briefing.

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FDA has postponed all routine domestic facility inspections in order to protect the health and well-being of agency staff and to address industry’s concern over visitors, FDA announced Wednesday (March 18), coming as the Trump administration advises against unnecessary travel due to the nationwide spread of COVID-19.

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FDA issued a guidance on Wednesday (March 18) offering flexibility around clinical trial policies in a bid to maintain patient safety and test integrity amid the challenges posed by the COVID-19 pandemic, including the possibility of virtual and phone visits for trial participants.

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Stakeholders are urging CMS and lawmakers to make sure the COVID-19 pandemic doesn’t derail providers in value-based pay arrangements, including in accountable care organizations, with some warning of potential mass exits from such arrangements due spending spikes driven by coronavirus care and treatment.

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Pharmacies are asking the federal government to grant them permission in Medicare to take on services that doctors typically provide to help adjust to shortages and alleviate pressure that the coronavirus is expected to exert on hospitals and doctors' offices.

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The ACA’s catastrophic health plans can cover services related to diagnosis and treatment of COVID 19 prior to a beneficiary hitting the deductible without risk of enforcement action, CMS says in new guidance out Wednesday.

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Oral arguments in the lawsuit challenging the Trump administration’s expansion of short-term insurance plans may be delayed or canceled after a federal appeals court suspended arguments in all cases in light of the COVID-19 crisis.

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Three liberal-leaning judges will decide the fate of CMS’ so-called site neutral policy, a federal appeals court revealed Wednesday (March 18).

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White House trade adviser Peter Navarro’s push to “reshore” the pharmaceutical and medical supplies supply chain is unrealistic and ultimately will cause more harm than good to Americans, a Chinese foreign ministry spokesman said on Tuesday.

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March 18, 2020

The Senate passed a second legislative package to tackle the coronavirus pandemic on Wednesday (March 18) that includes provisions to ensure all individuals, including those with private plans, Medicare or Medicare Advantage and Medicaid can access COVID-19 tests at no cost and allow states to cover the uninsured under Medicaid for COVID-19 testing and related medical visits.

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Connecticut’s state-based health exchange will re-open Thursday (March 19) for a brief special enrollment period (SEP) that will let uninsured resident enroll in one of the exchange’s two carriers to help curb the spread of the pandemic, after other non-exchange insurers agreed to a reinsurance mechanism to mitigate financial risk.

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Senate health committee Chair Lamar Alexander (R-TN) and House Energy & Commerce Chair Frank Pallone (D-NJ) are trying to tack their surprise medical bill legislation onto the third coronavirus stimulus package emerging on Capitol Hill, multiple sources close to negotiations say.

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As the Senate moves to pass a second coronavirus stimulus package and draft a third, provider groups are continuing to urge Congress to provide them with more funding and expanded telehealth authority.

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