COVID-19

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Department of Labor Issues Updated Families First Coronavirus Response Act Regulations, But Does Little To Resolve Employer Uncertainty (US)

The Families First Coronavirus Response Act (FFCRA) was enacted on March 18, 2020. The sweeping federal legislation provides emergency paid sick leave (EPSL) and expanded paid Family and Medical Leave (EFML) to certain covered workers impacted by the COVID-19 pandemic. On April 1, 2020, the U.S. Department of Labor (DOL) issued regulations implementing the FFCRA … Continue Reading

Public Records Show Agencies Are Vigorously Enforcing New COVID-19 Requirements Against Healthcare Providers

Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially … Continue Reading

Growing Bullseye on Skilled Nursing Facilities

Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing.  Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors.  They face scrutiny over death rates from COVID-19, as well as how they will use relief money.… Continue Reading

Redefined by COVID-19 and Shaped by Current Events: What’s Ahead for US Federal Appropriations

Attention in Congress will soon turn to the annual appropriations process and passage of fiscal year 2021 spending bills.  In addition to funding the entire US government each year, the 12 Appropriations Committee bills in the House and Senate shape federal public policy that touches every person and business in the United States.  The new … Continue Reading

CARES Act Medicare Money – View From Former Prosecutors

The CARES Act requires Medicare providers to attest to multiple certifications.  Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.  Their article can be found here.  … Continue Reading

Federal Government Issues Alert on Top Ten Cybersecurity Vulnerabilities

Robust cybersecurity continues to be of paramount importance as the COVID-19 outbreak develops and cybercriminals seek to exploit a remote workforce, which necessitates that companies check their policies, procedures, and controls to ensure they are addressing the highest areas of risk.  On May 12, 2020, the Cybersecurity and Infrastructure Security Agency (“CISA”) at the U.S. … Continue Reading

CMS Implements New Round of Changes to Support U.S. Healthcare System

On April 30, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced new measures to support the healthcare system during the COVID-19 pandemic. These measures build upon past regulatory changes we have discussed elsewhere (see, for example, here and here), and CMS hopes to achieve five objectives with these measures: (1) expand the healthcare … Continue Reading

Business Integrity: Maintaining Transparency and Accountability Through the COVID-19 Crisis

“As countries face undeniable emergencies, concentration of power, derogation of rights and freedoms, and as large amounts of money are infused into the economy to alleviate the crisis, corruption risks should not be underestimated,” said Marin Mrcela, the president of the Group of States against Corruption (GRECO), an anti-corruption monitoring body that is part of … Continue Reading

HRSA COVID-19 Uninsured Program Portal Is Now Open

Health Care Providers may now register for the COVID-19 Uninsured Program, allowing them to be reimbursed for the COVID-19 tests and treatment they have provided to uninsured individuals. The Health Resources & Services Administration (“HRSA”) anticipates that providers may begin submitting claims on May 6, and will begin receiving reimbursements by the middle of May. … Continue Reading

CMS Pumps the Brakes on Additional Medicare Accelerated and Advanced Payments as it Simultaneously Deploys COVID-19 Emergency Fund Grants

The Centers for Medicare and Medicaid Services (CMS) announced that it is “reevaluating amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately.”  CMS explained that it is pumping the brakes because it has already made almost $100 billion in accelerated or advanced … Continue Reading

Complimentary Webinar: Privacy Law, Coronavirus, and Post-Pandemic Best Practices

On April 30, 2020, Partner, Elliot Golding will co-present a complimentary webinar,  Privacy Law, Coronavirus, and Post-Pandemic Best Practices.  The program, organized by Bloomberg Law, will address recent HIPAA changes and temporary waivers, telehealth privacy and cyber considerations, and practical tips and recommendations to manage privacy and cyber risk during these challenging times.  Additional information … Continue Reading

A Respite for Potential Liability for Face Masks

Since April 8, 2020, seven states (in order of adoption: New Jersey, Rhode Island, New York, Maryland, Hawaii, Connecticut and Pennsylvania) have issued executive orders (“EOs”) requiring the wearing of face masks in various situations, ranging from being in a public place where close contact may be unavoidable, riding public transportation, working or shopping at … Continue Reading

Tips for Providers to Avoid Telehealth Compliance Risk

One of the more unanticipated consequences of the CoVID-19 pandemic is the rapid shift to telehealth by health care providers.  Before the surge of CoVID-19,  the Centers for Medicare and Medicaid Services (CMS) limited Medicare reimbursements for virtual services to a narrow set of circumstances, which typically still required the patient to leave his or … Continue Reading

A Broad Emergency Use Authorization for Face Masks

On April 18, 2020, FDA issued a new Emergency Use Authorization (“EUA”) relating to non-surgical face masks with broad coverage and implications for recent industry participants manufacturing face masks. The EUA applies to the broad class of non-surgical face masks used to cover a person’s nose and mouth. Please see our prior blog post for … Continue Reading

CMS Lays Out Roadmap for Restarting In-Person Care Besides COVID-19 Treatment

As the White House looks to soon reopen parts of the United States, the Centers for Medicare & Medicaid Services (CMS) has released its first set of guidelines for healthcare providers in regions that have seen stabilizing COVID-19 trends. The guidelines relax prior CMS recommendations that facilities limit and postpone non-essential care and elective procedures. … Continue Reading

COVID-19: EC Publishes Guidance on Allowing Limited Cooperation Among Businesses

COVID-19 outbreak has caused major disruption of supply chains and a steep rise in demand for certain products and services, notably in the health sector. These circumstances risk leading to shortages in critical medical goods used to treat COVID-19 patients, but also in other essential goods and services outside the health sector. Tackling these exceptional general supply shocks … Continue Reading

Shortages of PPE Drive FDA Guidance and Emergency Use Authorizations

Background On January 31, 2020, the Secretary of the Department of Health and Human Services (“HHS”), Alex M. Azar II, declared a public health emergency due to a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes novel coronavirus disease 2019 (“COVID-19”).  In the weeks following the declaration of the public … Continue Reading

It’s Official: HHS Announces Hospitals and Medicare Providers to Get Immediate $30 Billion Disbursement of CARES Act Funding for Coronavirus Expenses and Lost Revenues

Following up on Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma’s statements on Tuesday, the Department of Health and Human Services (HHS) issued a press release announcing the immediate disbursement of $30 billion to Medicare hospitals and providers starting April 10. These payments have been or are already in the process of being … Continue Reading

European Union Policy Update on the Healthcare Response to the COVID-19 Pandemic

Until most recently, Europe had been at the epicenter of the COVID-19 outbreak – which now has shifted to the United States. This crisis heavily impacted many European countries and triggered a coordinated response by the European Union (‘EU’) led by the European Commission (‘EC’) to tackle this severe public health emergency (i.e. a Member State … Continue Reading

COVID-19: the EC extends the State aid Temporary Framework

The European Commission (EC) has recently adopted an amendment that extends the State aid Temporary Framework (described in our last blog post here) by adding five further types of aid measures that Member States may implement: Support for COVID-19 related research and development (R&D) to address the current health crisis; Support for the construction and … Continue Reading

The European Commission is Ready to Provide Ad Hoc Antitrust Guidance to Allow Cooperation Necessary in the COVID-19 Crisis

In a joint statement on the application of EU and national competition law during the coronavirus disease 19 (COVID-19) crisis, the European Competition Network (ECN) recognized that competitors, supplier and distributors may need to cooperate with each other to ensure the supply and fair distribution of scarce products to all consumers. For example, a few … Continue Reading

HHS OIG says “Ditto” to HHS Blanket Stark Waivers for Purposes of the Anti-Kickback Statute

On April 3, the Department of Health and Human Services Office of the Inspector General (HHS OIG) released a policy statement to align its enforcement of the federal Anti-Kickback Statute (AKS) with HHS’s recent Blanket Waivers of Stark (Blanket Waivers) during the COVID-19 pandemic. As previously reported, HHS issued the Blanket Waivers to allow for … Continue Reading
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