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Goodwin Virtual Series: Foundations in Healthcare Compliance for Life Sciences Companies

In the ever-evolving life sciences industry, compliance is top-of-mind for investors, business leaders, the public and the government.  Life sciences companies are subject to increased enforcement efforts and greater public scrutiny, and boards, investors, and other key stakeholders call for more and better compliance controls.  As a result, there are…

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Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets, including healthcare, noting that industry consolidation has exacerbated racial, income and wealth inequality and emphasizing that robust competition is critical…

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Disrupt + Innovate + Transform: Key Regulatory Issues for Digital Health Companies Webinar

Goodwin Life Sciences and Healthcare partner Roger Cohen and associate Anne Brendel along with Life Sciences and FDA associate Steven Tjoe kicked off Goodwin’s multi-part webinar series “Disrupt + Innovate + Transform: A Healthcare Webinar Series” with “Key Regulatory Issues for Digital Health Companies” discussing the key regulatory issues affecting…

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Goodwin Webinar - Healthcare Issues + Trends: The False Claims Act and Other Government Enforcement

Healthcare companies are facing unprecedented challenges as a result of the COVID-19 crisis. This includes heightened enforcement risks. A key area of risk is the federal False Claims Act (FCA), a powerful tool for the DOJ to seek substantial penalties including three times the amount of money a company received…

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Qualifying for Immunity Under the U.S. PREP Act During COVID-19

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As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. § 247d-6d. This Declaration activated immunity from personal injury, property damage,…

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Update: U.S. Health and Human Services Clarifies Broad Eligibility of Providers for Payments Under $30 Billion CARES Act Healthcare Provider Relief Fund

Lady Liberty

As discussed in Goodwin’s prior Client Alert, on April 10, 2020, the U.S. Department of Health and Human Services (HHS) began disbursing $30 billion to Medicare providers and suppliers under the Public Health and Social Services Emergency Fund (PHSS Emergency Fund). HHS is requiring providers to agree to certain terms and…

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U.S. Health and Human Services to Begin Disbursing $30 Billion of CARES Act Healthcare Provider Relief Fund

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On Friday, April 10, 2020, the U.S. Department of Health and Human Services (HHS) announced it will begin disbursing $30 billion of the $100 billion of the Public Health and Social Services Emergency Fund recently allocated by the Coronavirus Aid, Relief, and Economics Security Act (CARES Act), signed March 27,…

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U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

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Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs since that process was first established in 1972. The Act draws from recent legislative proposals to reform OTC regulation, incorporating…

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U.S. CARES Act Supply Shortage Provisions: What Drug and Device Manufacturers Need to Know

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On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion and concern over the availability and accessibility of critical medical devices, such as ventilators, and the…

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CMS Expands Availability of Advances on Medicare Reimbursement; U.S. CARES Act Increases Medicare Reimbursement Rates

Lady Liberty

In response to the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) announced on Saturday March 28, 2020, that it is expanding its Medicare Accelerated and Advance Payment Program (AAPP) to allow nearly all Medicare providers and suppliers to receive advances on future Medicare reimbursement. To…

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