Inauguration 2021: Anticipated Government Policy Updates and Changes Regarding COVID-19 Concerns

Duane Morris will be hosting the webinar, “Inauguration 2021: Anticipated Government Policy Updates and Changes Regarding COVID-19 Concerns,” on January 28, 2021, from 1:00 p.m. to 2:00 p.m. Eastern.

This is the first 2021 session of the Duane Morris COVID-19: Navigating Forward Webinar Series. For more information and the registration link, please visit the firm website.

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.

Reimbursement Rate for Out-of-Network Emergency Services: Executive Order Potentially Sets Precedent

On April 9, 2020, Governor Baker issued an emergency order, mandating that insurers cover all medically necessary emergency department and inpatient services costs of COVID-19 treatment at both out-of-network and in-network hospitals and other medical facilities, without any cost to the patient, setting the OON reimbursement rate at 135% of Medicare, and prohibiting providers from balance billing. The Governor appears to have relied on § 7 of the Massachusetts emergency preparedness and response law in issuing the Order.  Section 7 gives the Governor broad powers during a state of emergency, including “[r]egulation of the business of insurance and protection of the interests of the holders of insurance policies and contracts and of beneficiaries thereunder and of the interest of the public in connection therewith.”

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

FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

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

California Executive Order Presumes Employees Who Contract COVID-19 Are Eligible for Workers’ Compensation Benefits

By Brooke B. Tabshouri

On May 6, 2020, Governor Gavin Newsom issued Executive Order No. N-62-20. The order states that employees will be presumed to have contracted COVID-19 in the course and scope of employment for purposes of workers’ compensation benefits if all of the following conditions are satisfied:

  • The employee contracts it within 14 days of performing labor at the employer’s direction and at the employer’s worksite;
  • If such work occurred on or after March 19, 2020;
  • The worksite was not the employee’s home; and
  • The positive test is confirmed by a physician within 30 days.

Continue reading “California Executive Order Presumes Employees Who Contract COVID-19 Are Eligible for Workers’ Compensation Benefits”

Interim Guidance on Treatment of COVID-19 Released by American Thoracic Society, Including Discussion of Controversial Hydroxychloroquine Therapy

The American Thoracic Society (ATS) on April 3, 2020 published a guidance document providing several suggestions for treatment of COVID-19.  The document, entitled “COVID‐19: Interim Guidance on Management Pending Empirical Evidence,” was developed by an ATS-led international task force and addresses several recently publicized potential treatment regimens.

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

Protecting Against Government Intrusion for COVID-19 Therapies

As the COVID-19 pandemic continues to disrupt our lives, wreak havoc on our economy and force millions to social distance, shelter at home or even quarantine, scientists across the globe have turned their focus and expertise to developing new treatments and vaccines aimed at containing the effects of this virus.

The need for this life-saving work has never been more apparent or more urgent. We owe them a sincere debt of gratitude as our lives may literally depend on their success. And as the hard work of these scientists starts to bear fruit, the demand for these treatments will be so urgent and of such magnitude that no single company will likely be able to scale up, manufacture and distribute the treatment to all those in need.

The U.S. government has several options at its disposal to intervene―if necessary―to ensure a low priced treatment is rapidly made available to those in need.

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

How COVID-19 Could Shake Up Patent Strategies

The coronavirus pandemic may spur new thinking about patent issues, as owners of relevant patents face the risk of backlash for asserting them, and companies developing equipment or treatments consider ways to limit potential liability. […]

There has already been public outcry over patents related to COVID-19, and such responses will likely grow in intensity if an effective treatment is seen as being hindered by patents. So companies may have to think about using their patents differently than they normally would, attorneys say. […]

“Most companies are thinking differently right now than they were six months ago,” Patrick Gallagher of Duane Morris LLP said. “I would think there would definitely be hesitancy around pursuing [an infringement case] right now.” […]

To read more of Mr. Gallagher’s comments and for a link to the full article, please visit the firm website.

HHS Office of Civil Rights Issues Bulletin Regarding COVID-19 and Civil Rights Issues and Resource Allocation

By Colin Knisely

In response to a complaint from disability advocacy groups in Washington state regarding health care rationing, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued a reminder to entities covered by federal civil rights statutes of their ongoing obligation, amid the COVID-19 crisis, to prohibit discrimination on the base of race, color, national origin,  age, religion, sex, and disability.  OCR is responsible for enforcing the Americans with Disabilities Act (ADA), Section 1557 of the Affordable Care Act, and Section 504 of the Rehabilitation Act.  The bulletin reminds covered entities that “persons with disabilities should not be denied medical care based on stereotypes, assessments of quality of life, or judgments about a person’s relative ‘worth’ based on the presence or absence of disabilities.” Continue reading “HHS Office of Civil Rights Issues Bulletin Regarding COVID-19 and Civil Rights Issues and Resource Allocation”

FDA-Approved Anti-Malaria Drugs for COVID-19 Treatment Fall Within Liability Shield of the PREP Act

The Food and Drug Administration (“FDA”) gave emergency approval this week to two (2) anti-malaria drugs, hydroxychloroquine and chloroquine, to be used for treatment of COVID-19 patients.  Despite the limited studies as to the benefits of these drugs and the well-known risks of these drugs, the FDA took the position that, under the current circumstances, the potential benefits and effectiveness outweigh the risks.  While the FDA is conducting a trial as to the effectiveness of these drugs, millions of doses have already been shipped to hospitals nationwide for administration in an attempt to slow the spread of COVID-19.

To read the full text of this post by Duane Morris attorney Brittany Wakim, please visit the Duane Morris Products Liability Blog.