Tag archives: COVID-19

COVID-19 Update: CDC Increasing Sequencing for Virus Variants

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 26, 2021 Posted in Coronavirus, General

The Biden Administration recently announced additional funding to increase genomic sequencing of COVID-19 to 25,000 samples a week. In a recent article in the Journal for the American Medical Association, U.S. Centers for Disease Control and Prevention (“CDC”) Director Rochelle Walensky and Dr. Anthony Fauci of the U.S. National Institute of Allergy and Infectious Diseases … Continue reading

COVID-19 Update: CDC Recommends Double Masking and Changes Quarantine Guidelines

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 11, 2021 Posted in Coronavirus, General

Two recent updates in COVID-19 guidelines from the U.S. Centers for Disease Control and Prevention (“CDC”) demonstrate the challenges faced by public health officials to appreciate and incorporate the ever-changing science surrounding the global pandemic. New guidance from the CDC recommends wearing a cloth mask over a medical mask. The CDC’s guidelines recommend: Choosing a … Continue reading

The Joint Commission’s First Special Edition Sentinel Event Alert

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on February 3, 2021 Posted in Coronavirus, General, Regulatory

Recognizing its unique position to understand and shed light on the collective experience of America’s health care organizations during the COVID-19 pandemic, on February 2, 2021, the Joint Commission published the first in its series of special edition Sentinel Event Alerts. The special edition publication addresses COVID-19-specific concerns and comments that the Joint Commission’s Office … Continue reading

COVID-19 Update: Biden Executive Order Creates Special Enrollment Period

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 1, 2021 Posted in Coronavirus, General, News from DC

On January 28, 2021, President Biden issued an Executive Order entitled Executive Order on Strengthening Medicaid and the Affordable Care Act (“Executive Order”). “In light of the exceptional circumstances caused by the ongoing COVID-19 pandemic”, the Executive Order creates a special enrollment period in states that operate Federally-facilitated exchanges from February 15, 2021 – May … Continue reading

COVID-19 Update: US President Joe Biden Releases COVID-19 Roadmap and Executive Orders

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on January 22, 2021 Posted in Coronavirus, News from DC, Regulatory

On January 20, 2021, Joseph R. Biden was sworn in as the 46th President of the United States. Within hours of taking the oath, President Biden signed an executive order entitled Executive Order on Protecting the Federal Workforce and Requiring Mask-Wearing that requires wearing masks and encouraging social distancing in Federal buildings and on Federal … Continue reading

COVID-19 Update: Reflections on a Pandemic

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 22, 2021 Posted in Coronavirus

Much has been written to acknowledge the solemn milestone of 2 million deaths worldwide, and 400,000 deaths in the US from COVID-19. Yesterday marked one year since the first known diagnosis of the coronavirus in the US. We have been blogging on the pandemic for one year today (read first HL Pulse post, US Prepares for … Continue reading

COVID-19 Update: Secretary Azar Extends Pubic Health Emergency

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 8, 2021 Posted in Coronavirus, General, News from DC

On January 6, 2021 U.S. Department of Health and Human Services Secretary Alex Azar renewed the Public Health Emergency declaration, effective January 21, 2021. In a tweet, Secretary Azar announced the renewal and stated that “[o]ur work to combat the virus will continue, as will our work to ensure a peaceful and orderly transition.” The … Continue reading

COVID-19 Update: Healthcare provisions (Including Medicare GME Revisions) in the Consolidated Appropriations Act, 2021

By Mark Faccenda (US), Andrew Roth (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 4, 2021 Posted in Coronavirus, General, News from DC

On December 27, 2020, President Trump signed into law the fourth round of COVID-19 emergency relief that passed both the U.S. Senate and the U.S. House of Representatives. The Consolidated Appropriations Act, 2021 (“Act”) includes approximately $900 billion in pandemic relief and is reportedly the longest bill (5,593 pages) to be passed in Congress’s history. … Continue reading

COVID-19 Update: First Person Receives COVID-19 Vaccine in U.S.

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on December 14, 2020 Posted in Coronavirus, General

Almost eleven months after the first confirmed coronavirus patient in the State of Washington (HL Pulse post here), the first dose of Pfizer and BioNTech’s COVID-19 vaccine was administered in the U.S. to a critical care nurse a little after 9:00 a.m. ET. This happened just three days after the U.S. Food and Drug Administration … Continue reading

COVID-19 Update: First COVID-19 vaccine approved in UK

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on December 2, 2020 Posted in Coronavirus, FDA & Food Safety, International

On December 2, 2020 the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (“MHRA”) announced approval of Pfizer and BioNTech’s coronavirus vaccine. According to a press release from the U.K. government: This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a … Continue reading

COVID-19 Update: First EUA for COVID-19 Vaccine Filing Imminent; CDC Urges Americans Not to Travel for Thanksgiving

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on November 20, 2020 Posted in Coronavirus, FDA & Food Safety, General

On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate. Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective. In addition to the effectiveness, … Continue reading

OSHA Releases Information on its Recent COVID-19 Related Enforcement Activity

By Kevin Mayer (US) on November 17, 2020 Posted in Coronavirus, General

On Friday, November 13, the United States Occupational Safety & Health Administration (“OSHA”) issued a news release on its recent enforcement activities for violations that are related to the coronavirus pandemic. More specifically, OSHA stated that it has issued 204 citations arising from inspections for COVID-19 violations and that this has resulted in proposed penalties … Continue reading

COVID-19 Update: Progress toward a vaccine candidate

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on November 10, 2020 Posted in Coronavirus, FDA & Food Safety, General

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading

COVID-19 Update: CMS Releases Fourth COVID-19 Interim Final Rule with Comment Period

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on November 4, 2020 Posted in Coronavirus, General, News from DC, Regulatory

On Wednesday, October 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”), with the Departments of Treasury and Labor, issued a fourth interim final rule (“IFR”) with comment period addressing the public health emergency (“PHE”). The policies in the IFR will become effective upon publication in the Federal Register. The IFR’s stated goal is … Continue reading

COVID-19 Update: CDC Updates Guidance on Public Transportation and Close Contacts

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 23, 2020 Posted in Coronavirus, General, News from DC

The U.S. Centers for Disease Control (“CDC”) continues to update COVID-19 guidance as more information is known about how the coronavirus spreads. On October 21, 2020, the CDC made a significant update to the definition of “close contact”. Individuals that have spent 15 cumulative minutes within six feet of an infected individual during a 24-hour … Continue reading

COVID-19 Update: HHS Renews COVID-19 Public Health Emergency Declaration

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on October 12, 2020 Posted in Coronavirus, General, News from DC

On October 2, 2020, Secretary Azar of the Department of Health and Human Services (“HHS”) renewed his public health emergency (“PHE”) declaration because of “the continued consequences” of the COVID-19 pandemic. This renewal will become effective on October 23, 2020 when the previous July 23 renewal was set to expire and will continue to January … Continue reading

COVID-19: OSHA Updates and Reporting Requirements

By Yvonne Puig (US), Kevin Mayer (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 5, 2020 Posted in Coronavirus, News from DC, Regulatory

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19. Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic. OSHA recently updated its COVID-19 … Continue reading

Norton Rose Fulbright US LLP Leads Conversation with PE Leaders Re the Future of Healthcare

By Purvi Maniar (US) and Maxwell Karasek (US) on October 1, 2020 Posted in General

On September 22, 2020, Norton Rose Fulbright US LLP and Ernst & Young LLP held their 5th Annual Health Care Private Equity Conference. As with most other conferences this year, this event was hosted virtually. NRF Partner Warren J. Nimetz, led an insightful and lively discussion on the annual panel “What’s Hot and What’s Not” … Continue reading

COVID-19 Update: U.S. Surpasses 200,000 Fatalities; CDC Releases Holiday Guidelines

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on September 27, 2020 Posted in Coronavirus, General

This past week the United States surpassed the grim milestone of 200,000 COVID-19 deaths and seven million cases of COVID-19. The spread of the virus has altered the way we work, live, and play around the world and will soon touch on one of the most treasured times of the year, the holiday season. The … Continue reading

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on September 15, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda. The MFAR, which was proposed in November of 2019, would have added new reporting requirements for state governments to receive state … Continue reading

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on September 9, 2020 Posted in Coronavirus, FDA & Food Safety, General

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 28, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … Continue reading

HHS Issues Proposed Rule on Good Guidance Practices

By Jeff Wurzburg (US), Thomas Dowdell (US) and Hayley White (US) on August 25, 2020 Posted in Coronavirus, General, Regulatory

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

COVID-19 Update: CMS Announces Resumption of Survey Activities

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, … Continue reading