North America

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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Tax Coronavirus Alert

This notice is current as of 4:30 PM EST on Wednesday, March 18.
Howard & Howard remains committed to providing our clients with stability and exceptional service during these uniquely challenging times. In this alert, we offer you positive considerations and ideas to help you navigate the COVID-19 crisis. We will continue to look for creative options to assist you with your business and tax concerns in light of the ever-changing social and business landscape. Read more…

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COVID-19 impact on telehealth services

The Centers for Medicare & Medicaid Services, the Office of Inspector General of the Department of Health and Human Services and the Office for Civil Rights have each issued separate announcements that enhance the ability to furnish telehealth during the COVID-19 public health emergency. These policies will allow flexibility during the coronavirus emergency period to provide telehealth services:

  • Without collecting coinsurance and deductible amounts from federal health care program patients.
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  • Using applications such as FaceTime, Skype, Messenger video, or Google Hangouts even if the applications don’t meet HIPAA standards.
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  • Using smart phone for telehealth communication and providing services via telehealth even when the patient is at a location (such as his or her home) that does not satisfy Medicare telehealth originating site standards.
    Click here to read more
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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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Benefits Guidance in the time of COVID-19: Monitoring Retirement Plan Investments and Participant Communications

The COVID-19 global pandemic has created a multitude of business and workforce challenges for employers.  In addition to addressing organizational issues, employers that sponsor employee benefit plans and plan fiduciaries must continue to manage and administer the benefit plans as well as address plan participant inquiries during these unprecedented and uncertain times.

One area where plan fiduciaries are seeking guidance concerns oversight of defined contribution plan investment options and any additional actions that they can take now with respect to monitoring such investments and providing communications to participants.  In light of these concerns, plan sponsors and fiduciaries may wish to consider taking the following actions:

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New York Suspends 7-Day Waiting Period for Unemployment Benefits Due to COVID-19

As many employers and employees in the State of New York know, when an individual files claims for unemployment insurance benefits, New York Labor Law, Section 590, Subdivision 7, has a mandatory seven day waiting period before unemployment benefits may be paid.

On March 7, 2020, Governor Andrew Cuomo issued Executive Order No. 202.1, declaring a State disaster emergency for the entire State of New York (the “Order”). The Order, which is entitled “Suspension and Modification of Laws Relating to the Disaster Emergency,” suspends and modifies many existing laws.

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Congress’s COVID-19 Funding Legislation Expands Access to Telehealth Services for Medicare Beneficiaries

While the world continues to respond to the growing COVID-19 pandemic, the United States Congress recently passed legislation that provides for more than $8 billion in emergency funding to combat COVID-19. Part of this supplemental funding package, signed into law on March 6, 2020, includes the Telehealth Services During Certain Emergency Periods Act of 2020 (the “Act”),[1] which authorizes the Administration to loosen restrictions on telehealth in order to expand access to COVID-19 related telehealth services for Medicare beneficiaries—many of whom are especially vulnerable to this virus and in the event of future emergencies. On March 17, 2020, the Administration announced the implementation of this waiver with a retroactive effective date of March 6, 2020.

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