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Cross-Post from Law360: The Legal Implications Of Mobile Health Advancements

This is a cross post from Law360.  Please contact Sarah Rathke, Kristin Bryan or John Wyand with any questions. In response to American health care needs during the COVID-19 pandemic, the U.S. is seeing a rapid acceleration in mobile health care, however, this new age form of health care does present some risk and legal implications.  In the recently published Law360 article, we … Continue Reading

Addressing COVID-19 Vaccine Supply Chain Challenges

At the time of this writing, two companies, Pfizer Inc. and Moderna, Inc., have announced promising early results from Phase 3 of their COVID-19 vaccine trials.  Additional promising results are hoped for from Johnson & Johnson, and AstraZeneca soon, and perhaps from others later.  This is good news. Developing a vaccine is one thing, however.  Distributing it is another.  Indeed, managing … Continue Reading

Cross-Post from Law360: Key Gov’t Tools For Addressing National PPE Shortages

This is a Cross-Post from Law360.  Please contact Sarah Rathke with any questions. The COVID-19 pandemic has revealed shortcomings in U.S. supply chains requiring immediate action to continue to provide personal protective equipment (“PPE”) during the ongoing crisis.  Here, we’ve been published in Law360, discussing federal solutions for our national PPE shortages.  Read the full … Continue Reading

HHS pirouettes back to original position that Provider Relief Fund payments may be used to replace gross revenue, not just profits, lost due to the coronavirus

On October 22, the Department of Health and Human Services (HHS) updated its guidance on how hospitals and other providers should report their use of the nearly $135 billion in Provider Relief Fund payments that have been distributed.  The Provider Relief Fund, initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, is … Continue Reading

CMS Adds 11 New Approved Telehealth Services During the COVID-19 Pandemic and Updates Guidance to States on Medicaid Telehealth Expansion

On October 14, the Centers for Medicare and Medicaid Services (CMS) announced that it has expanded its list of telehealth services approved for Medicare beneficiaries during the COVID-19 Public Health Emergency (PHE).  The eleven telehealth services CMS just added are for cardiac and pulmonary rehabilitation.  CMS approved them using an expedited process it unveiled in … Continue Reading

DOJ Prioritizes Health Care Fraud in the Pandemic

The Department of Justice (“DOJ”) recently announced its largest ever health care fraud and opioid enforcement action.  In a coordinated effort, DOJ charged 345 defendants with more than $6 billion in fraud losses for submitting false and fraudulent claims to federal health care programs and private insurers. The nationwide enforcement operation has been in motion since April … Continue Reading

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
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