Archives: Health Issues

Subscribe to Health Issues RSS Feed

Past as Prologue: The Wave of Investigations to Follow the Pandemic Recovery and Actions that Companies Can Take Now to Prepare

On March 30, 2020, the inspectors general of several major agencies selected the Department of Defense Inspector General, Glenn Fine, to lead a newly created federal oversight entity that will investigate waste, fraud, and abuse in connection with the massive new coronavirus economic relief legislation. The inspectors general were exercising new authority contained in the … Continue Reading

New Paid Sick Leave Requirements Impact Government Contractors

Recent legislation significantly expanded many workers’ entitlement to paid sick leave and paid family leave.  These new benefits take effect on April 1st.  Our employment and benefits experts have described those requirements in a series of posts, including overviews here and here, and New York-specific considerations here.  Federal government contractors should pay particular attention to … Continue Reading

The CARES Act: What You Need to Know

Covington COVID-19 Task Force This afternoon Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act—the third wave of coronavirus relief legislation known by many as “Coronavirus 3.0.” President Trump is expected to quickly sign the bill into law. This alert provides analyses of some of the key provisions. Each linked section contains key … Continue Reading

Competition Guardrails for Collaborating in Response to COVID-19

COVID‑19 has caused a public health crisis and extreme disruption to economic markets.  As communities, governments, and businesses come together to combat these challenges, questions are naturally arising about how to comply with the antitrust laws under such extraordinary circumstances. The United States antitrust agencies have advised that, with limited exception, companies should rely on … Continue Reading

CARES Act Will Support Internet Connectivity for Remote Education, Healthcare, and Work

As millions of American workers, students, and patients stay home to help combat the novel coronavirus (COVID-19), the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act includes funding for the transition to remote life among its many relief provisions. With specific funding for broadband connections, distance learning, telehealth, and telework, the CARES Act … Continue Reading

Covington’s Ability to Help Respond to the COVID-19 Pandemic in Africa

 With African governments increasingly taking strong actions to impede the spread of the COVID-19 virus – including in a number of jurisdictions, imposing full lockdowns – we are able to provide assistance to our clients, financial institutions, developmental finance organizations, companies and organizations on the continent. We are available to get on a call at … Continue Reading

HHS Relaxes Enforcement of Certain HIPAA Provisions Amidst COVID-19 Nationwide Public Health Emergency

This month, the U.S. Department of Health and Human Services (“HHS”) issued guidance waiving enforcement of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) in response to the COVID-19 nationwide public health emergency. Covered Health Care Providers On March 17, 2020, the Department of Health and Human Services Office for Civil Rights … Continue Reading

Coronavirus: Potential Implications for Africa

The Coronavirus (hereinafter “COVID-19”) is upending lives around the world—equally in developed and developing countries. Some are already affected by the deadly impact of COVID-19 (e.g. China, Italy, and France), while others’ lives have been altered due to efforts taken to “flatten the curve,” to ensure hospital systems are not overrun with patients in need … Continue Reading

FinCEN Issues COVID-19-Related Guidance on SAR Filings, Heightened Risk of Disaster Fraud

The Financial Crimes Enforcement Network (FinCEN) issued guidance today, which: requested financial institutions affected by the COVID-19 pandemic to contact FinCEN’s Regulatory Support Section and their functional regulator as soon as practicable if they have concerns about potential COVID-19-related delays to their ability to timely file Bank Secrecy Act (BSA) reports, including Suspicious Activity Reports … Continue Reading

Federal Reserve Takes Extraordinary Actions Supporting Financial Markets to Mitigate COVID-19 Impact

Yesterday, on Sunday, March 15, 2020, in response to the COVID-19 pandemic’s impact on U.S. and global economic activity, the Federal Reserve’s Federal Open Market Committee (“FOMC”) cut the target range of the federal funds rate to 0 to 1/4 percent until such time as the FOMC is “confident that the economy has weathered recent … Continue Reading

A Coronavirus Contractor’s Guide to the PREP Act

We’ve covered several topics already this week on the U.S. Government’s varied responses to the COVID-19 outbreak and how these responses will affect contractors that do business with the government, including BARDA’s EZ-BAA for COVID-19 diagnostics, mission-essential services during the outbreak, and how excusable delay provisions may help federal contractors affected by the outbreak.  But … Continue Reading

Expanding the Coronavirus Disease 2019 (COVID-19) Response through Diagnostic Development

In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States.  The same day, WHO characterized COVID-19 as the first global … Continue Reading

The Show Must Go On: Mission-Essential Services During the Coronavirus Outbreak

As the COVID-19 virus extends its global reach, defense contractors may be called upon to begin implementing their contracts’ mission-essential services plans. These plans, required by DFARS 252.237-7023, facilitate mission-essential functions in extended crisis situations, including pandemics, which are explicitly noted in the DFARS. As the coronavirus outbreak continues, defense contractors should check whether their … Continue Reading

The EU Lifts Restrictions to Imports of Poultry Meat from Ukraine Following the Regionalization of the Country Due to an Outbreak of HPAI

The European Commission has just adopted a Regulation that will lift the existing ban on imports of poultry meat from Ukraine that was triggered by the January 2020 Highly Pathogenic Avian Influenza (“HPAI”) outbreak in the western part of the country. On January 19, 2020 the Ukrainian authorities informed the World Organization of Animal Health … Continue Reading

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies.  These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device.  In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading

Expanded Conditional Approval Draft Guidance Issued

On September 26, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that address a serious or life-threatening disease or condition or fill an … Continue Reading

Senators Introduce Legislation to Regulate Privacy and Security of Wearable Health Devices and Genetic Testing Kits

Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health data or … Continue Reading

What is the Prognosis for Health Care Issues in the Next Congress?

Joan Kutcher and Gary Heimberg delivered remarks during Covington’s post-election conference call with clients on November 8, 2018 on health care and drug pricing.  The health care segment follows:  The Affordable Care Act has been an issue in every election since it passed in 2010.  This election was the first time the Democrats could fully … Continue Reading

Level-setting the President’s Budget Blueprint and Rx Pricing: Putting the Process and Substance in Context

Today, the President will submit the Administration’s Fiscal Year 2019 budget blueprint to Congress.  The document will set in motion an annual process to analyze the substance, business implications and prospects for various proposals.  Draft documents have already begun to circulate that suggest that both the budget and a forthcoming addendum would, if enacted, have … Continue Reading

Trump Order Relating to Affordable Care Act

On January 20, 2017, President Donald J. Trump signed an Executive Order instructing federal agencies to work to “minimize the unwarranted economic and regulatory burdens” of the Affordable Care Act (“ACA”), and to increase the flexibility provided to States to run healthcare programs. While the Executive Order itself does not change any regulation or specific … Continue Reading

Trump and Health Care

It is safe to observe that modifying or repealing the Affordable Care Act (aka as Obamacare) will be the top health care-related priority of the Trump Administration. Trump spoke about repeal and replace often — he even called for a special session of Congress to repeal it — and while it was not among his … Continue Reading

No Business As Usual in Davos

This year, titans of business, government and society face a near tidal wave of anxiety-provoking events and trends in “The New Global Context” they will discuss this week.  Rather than upbeat discussions of start-ups and breakthroughs, they will confront some of the world’s most intractable issues just as global events highlight the failure of sufficient … Continue Reading

The Republican Senate Take-Over: Implications for the Affordable Care Act

The mid-term election brings an historic changing of the guard in the health care leadership in Congress.  Republicans will take control of the Senate in January and gain key chairmanships.  Senior Democrats like Senators Harkin and Rockefeller, and Representatives Dingell and Waxman, who have been leaders on health policy issues for decades, are retiring.  Congress … Continue Reading
LexBlog