Tag Archives: Epstein Becker & Green

FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic

On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”). FDA’s stated purpose in issuing the guidance is to help sponsors to assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risk to the integrity of trials during the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic.

The Guidance recognizes the impact COVID-19 may have on the conduct of ongoing clinical trials, including quarantines, site closures, travel limitations, interruptions to the supply chain, and other considerations should individuals involved in the studies become infected with COVID-19. FDA acknowledges that these factors may impact a sponsor’s ability to meet protocol-specified procedures, and that protocol modifications may be necessary and deviations unavoidable.

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The EEOC Issues Reminder and Guidance Regarding ADA and Rehabilitation Act Compliance During Pandemic

On March 17, 2020, the Equal Employment Opportunity Commission (EEOC) posted an article on its website, “What You Should Know About the ADA, the Rehabilitation Act, and COVID-19.”  The article confirms that workplace anti-discrimination laws enforced by the EEOC remain applicable, but that nothing in those laws interferes with or prevents “employers from following the guidelines and suggestions made by the CDC or state/local public health authorities about steps employers should take regarding COVID-19.”

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Telehealth Flexibility: Key Regulatory Changes that Providers Should Know

While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth.

On March 6, 2020, President Donald Trump signed into law an $8.3 billion emergency coronavirus disease 2019 (“COVID-19”) response funding package. In addition to providing funding for the development of treatments and public health funding for prevention, preparedness, and response, the bill authorizes the U.S. Secretary of Health and Human Services, Alex Azar (referred to herein as the “Secretary”), to waive Medicare restrictions on the provision of services via telehealth during this public health emergency.

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Benefits Guidance in the time of COVID-19: Additional Cybersecurity Concerns as Employees “Work-From-Home”

As the United States and the rest of the world hunker down in their homes to slow the spread of the novel coronavirus (COVID-19), many organizations have implemented “working-from-home” procedures that are designed to protect the health of the employees.  Working-from-home, however, presents heightened threats to the cybersecurity of benefit plans, including the plan’s assets and employee data that is collected, transmitted, and stored with regard to employee benefit plans.  Plan sponsors and fiduciaries have asked about the particular risks that working-from-home might present to the protection of sensitive data and whether there are additional proactive measures they can take to reduce those risks.

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COVID-19 – New York Expands Telehealth Utilization

We hope that everyone is staying safe during the COVID-19 crisis. State health departments are, of course, doing what they can to facilitate management of transmission of COVID-19 by healthcare providers. Some recent actions by the New York Department of Health (“DOH”) to allow or promote telephonic and telehealth services include:

Telephonic Evaluation – Beginning with dates of service of March 13, Medicaid will reimburse telephonic evaluation and management services for established patients where face-to-face visits may not be recommended and it is medically appropriate to evaluate and manage the patient by phone. Additionally, where a patient face-to-face visit is not possible due to the State of Emergency, telephonic visits documented as clinically appropriate by the provider will be considered medically necessary for Medicaid payment purposes.

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Health Care Employers: How to Prepare for the Impact of COVID-19 on Your Workforce

By Nathaniel M. GlasserArthur J. Fried, Steven M. Swirsky & Maxine Adams

On March 11, 2020, the World Health Organization declared that the 2019 novel coronavirus (known as “COVID-19”) is now a pandemic. The effects continue to be felt in the United States, which currently has well over 1,000 cases of COVID-19. As of March 12, 2020, 19 states have declared a state of emergency to ensure there are resources to address the coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020, which was extended to the United Kingdom and Ireland on March 15th. Additionally, on March 13, 2020 President Trump declared a national emergency.   Given the prevalence of the coronavirus in the United States and the growing numbers of cases globally, health care employers should take extra precaution with their employees. As all public health communications are making clear, efforts to limit the spread of COVID-19 will not only prevent illness, but they will also reduce the pandemic’s potential to overwhelm critical health care resources.

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Colorado Mandates 4 Days of Paid Leave for COVID-19 Testing

On March 10, 2020, Colorado Governor Jared Polis issued an executive order directing he Colorado Department of Labor and Employment (“DLE”) to create emergency rules to “ensure workers in food handling, hospitality, child care, health care, and education can get paid sick leave to miss work if they exhibit flu-like symptoms and have to miss work awaiting testing results for COVID-19.”

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Recommendations for Health Care Providers in Managing COVID-19

On March 11, 2020, the World Health Organization declared that COVID-19 is now a pandemic.  The effects continue to be felt in the United States, which now has well over 1,000 confirmed novel Coronavirus disease (COVID-19) cases.  As of March 12, 2020, nineteen states have declared a state of emergency to ensure there are resources to address the Coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020.  Given the prevalence of the Coronavirus in the U.S. and the growing numbers of cases globally, health care providers should take extra precaution with their patients, employees, and visitors.  As all public health communications are making clear, efforts to limit the spread of COVID-19 will not only prevent illness, but they will also reduce the pandemic’s potential to overwhelm critical health care resources.

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Coronavirus Emergency Declarations Trigger Anti-Price Gouging Laws

At the time of publication, at least twenty four states, plus Washington D.C. have declared states of emergency related to the novel coronavirus (“COVID-19”), with that number growing by the hour.  In addition to making more resources available to residents, in many cases, the declarations also trigger additional protections to consumers in the form of anti-price gouging laws.  These laws, which automatically go into effect, are intended to prevent merchants from significantly increasing the cost of consumer goods and services during a crisis.

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IRS Memo Concludes No There is Statute of Limitations for ACA Employer Mandate Penalties Under Internal Revenue Code § 4980H

The IRS Office of Chief Counsel recently issued a memo which, in a surprise to many, concluded that the filing of the Affordable Care Act (“ACA”) Forms 1094-C and 1095-C (“C Forms”) does not start the statute of limitations on the Employer Shared Responsibility Payments (“ESRP”) under Internal Revenue Code (“Code”) § 4980H and, in fact, that there is no statute of limitations with respect to ESRP assessments.

In short, the ESRP is a penalty that may be assessed against “applicable large employers” (“ALEs”)[1] when, in certain circumstances, a full-time employee obtains a premium tax credit for health coverage purchased on an Exchange.  Employers file C Forms annually to report information about their offers of health care coverage to employees so that the IRS can assess potential ESRP liability under Code § 4980H.  Until the memo’s issuance, the consensus opinion was that the filing of the C Forms started the Code’s general 3-year statute of limitations that runs from the date a “return” is filed or the return’s due date, whichever is later.  The instructions on the C Forms, in fact, refer to the C Forms as “returns” and advise filers to keep copies of information returns and supporting documents for at least three years from the returns’ due date.

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