CDC Advisory Committee Issues Recommendations for Initial COVID-19 Vaccine Prioritization

The afternoon of December 1, 2020, marked an important milestone in the fight against the coronavirus pandemic. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) voted 13-1 to approve recommendations to prioritize distribution of the initial doses of COVID-19 vaccines. ACIP took an unusual step, issuing the recommendations before the FDA issues emergency use approval (EUA) of any COVID-19 vaccines so that the recommendations could assist states in developing their own vaccine distribution plans.

To read the full text of this Duane Morris Alert, please visit the firm website.

USDOL Amends Temporary Regulations; Healthcare Employers Who Have Excluded Employees from COVID-related Leave Benefits under FFCRA Must Reconsider

The United States Department of Labor’s (DOL) initial temporary regulations that interpreted and implemented the Families First Coronavirus Response Act (FFCRA) permitted employers to elect to exclude healthcare provider employees from eligibility for the COVID-related leave benefits made available under FFCRA. The initial DOL regulations provided a broad definition of healthcare provider, allowing most employees working for a healthcare provider employer to be excluded from FFCRA leave benefits, including Paid Sick Leave (PSL) and Extended Family and Medical Leave (EFMLA). After a federal district court decision struck down parts of the DOL’s prior final rule, the DOL now has issued revised regulations, which became effective on September 16, 2020, and expire along with the FFCRA on December 31, 2020.

To read the full text of this post by Duane Morris attorneys Jennifer Long and Nicholas J. Lynn, please visit the Duane Morris Health Law Blog.

After COVID-19 Lockdown, Long-Term Care Facilities Reopening

Given the tragic loss experienced in nursing homes and the known impact that this virus has on seniors, long-term care facilities (including nursing homes and assisted living facilities) may be among the last business to undergo a “reopening.” Strict adherence to the federal, state and local precautions will be required, as well as close monitoring for outbreaks in the facility.

To read the full text of this post by Duane Morris attorney Lauren Perry, please visit the Duane Morris Health Law Blog.

FDA Issues Temporary Policy on Distribution of Drug Samples During COVID-19

In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

Pennsylvania Governor Issues Much-Anticipated Executive Order Extending Liability Protections for Healthcare Professionals Responding to COVID-19 Crisis

As the COVID-19 crisis continues to strain healthcare resources and professionals across the nation, Pennsylvania Governor Tom Wolf has responded by extending liability protections for healthcare workers responding to the crisis.

To read the full text of this Duane Morris Alert, please visit the firm website.

Federal Response to COVID-19 Relaxes Telehealth Restrictions

In the wake of the coronavirus outbreak and social-distancing mandates, the federal government enacted legislation to encourage the use of telehealth services. The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Preparedness Act), which includes the Telehealth Services During Certain Emergency Periods Act of 2020 (Telehealth Act), was signed into law on March 6, 2020. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) was signed into law on March 27, 2020.

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HHS Announces Initial $30 Billion Distribution from CARES Act Provider Relief Fund

Immediate funds are now available for providers to receive a cash influx at a critical time. The challenge will not be receiving the funds, but rather keeping the funds after a future audit of compliance with the terms and conditions.

On April 10, 2020, the United States Department of Health and Human Services (HHS) announced the immediate distribution of an initial $30 billion in relief funding to providers in support of the nationwide COVID-19 response. The distribution is part of the $100 billion provider relief fund included in the Coronavirus Aid, Relief and Economic Security (CARES) Act recently passed by Congress. Importantly, HHS has noted that these are payments, not loans, to healthcare providers, and will not need to be repaid unless the provider does not comply with the terms and conditions.

To read the full text of this Duane Morris Alert, please visit the firm website.

CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

Crisis Standards of Care Guidelines to Address the COVID-19 Pandemic

Since March 13, 2020, when President Trump declared a national state of emergency due to the COVID-19 crisis, we have been in a healthcare crisis. The United States’ response to the COVID-19 pandemic has been plagued by increasing shortages of personal protective equipment (PPE), supplies, beds and physicians necessary to care for COVID-19 patients. In addition, drastic patient surges, limited numbers of life-saving ventilators and healthcare providers who have been working tirelessly for weeks in a constant state of emergency all contribute to an extremely strained health system. Not only do more and more patients need care each day, healthcare providers must work quickly to diagnose, triage and treat patients, as well as make difficult decisions on how ventilators are assigned and reassigned. And we have yet to hit the anticipated spikes in COVID-19 cases.

Accordingly, states have either implemented or developed Crisis Standards of Care (CSC). A CSC is triggered when healthcare systems are so overwhelmed by a pervasive or catastrophic public health event, such as COVID-19, that it is impossible for them to provide the normal, or standard, level of care to patients. Instead of meeting the standard of care to avoid liability, providers must now meet the crisis standards of care as set-forth on a statewide basis or adapted by individual facilities.

To read the full text of this Duane Morris Alert, please visit the firm website.