Tag Archives: treatment

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.

FDA Unveils Program to Expedite Coronavirus Treatments

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

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

FDA Virtual Town Hall for Laboratories and Manufacturers Developing Diagnostics Tests for COVID-19

FDA is hosting a virtual town hall April 1, 2020, at 12:15 p.m. Eastern for clinical laboratories and commercial manufacturers developing diagnostic tests for the COVID-19 virus. FDA intends to help answer technical questions about validation and development of tests and FDA’s recently issued Guidance from March 16, 2020 outlining FDA policy for development of diagnostic tests during the COVID-19 public health emergency.  FDA will host subsequent virtual town halls for clinical laboratories and commercial manufacturers each Wednesday of April at 12:15 p.m. Eastern. Registration not required. Details to join the call are available on the event page.

For additional information, please contact Dana J. AshFrederick R. BallPatrick C. Gallagher, Ph.D.Jonathan LourieVicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.