Topic: General

A Solemn Milestone

By Yvonne Puig (US) and Daphne Calderon (US) on May 12, 2022 Posted in Coronavirus, General

Today, President Biden announced that one million persons have died in the United States due to Covid. Unfortunately, deaths from Covid-19 are on the rise again sparked by Omicron variants. The data on new cases are getting less reliable due to the widespread use of home tests. As experts warn, while the numbers are encouraging … Continue reading

COVID-19 Update: Federal Mask Mandate Struck Down by Florida Court

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on April 20, 2022 Posted in Coronavirus, Enforcement, General

On April 19, 2022, a federal district court in Florida determined the federal mask mandate from the Biden Administration was unlawful and therefore void. The mandate required patrons to wear a mask on public transportation, like airplanes, trains, and buses. The federal judge presiding over the case determined the mandate exceeded statutory authority created under … Continue reading

COVID-19 Update: Vaccine No. 4 and the CDC’s Quarantine and Isolation Calculator

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on March 30, 2022 Posted in Coronavirus, General

Yesterday, March 29, 2022, the CDC launched a new calculator designed to help individuals exposed to COVID-19 discern how many days of quarantine and/or isolation are necessary. This tool was created in order to aid in the prevention of spreading the virus. Users are first prompted to select whether they have tested positive for COVID-19 … Continue reading

Lundbeck v Sandoz – High Court decision

By Jackie O'Brien (AU) and Louise Connell on March 14, 2022 Posted in Enforcement, General

1. Introduction The High Court has delivered the latest instalment in Lundbeck and Sandoz’s lengthy saga concerning escitalopram. The particular circumstances giving rise to this dispute are unique, however, the High Court’s approach to interpreting a patent licence granted by Lundbeck to Sandoz should be considered when preparing patent licences. The High Court’s decision may … Continue reading

Australia – TGA updates the Therapeutic Goods Advertising Code

By Bernard O'Shea (AU) and Louise Connell on March 6, 2022 Posted in Enforcement, General, Regulatory

The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure that permitted advertising provides consumers with accurate and balanced information concerning the quality, safety and efficacy of … Continue reading

Congress Amends Federal Arbitration Act for Claims of Sexual Assault

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on February 25, 2022 Posted in General, News from DC

On February 10, 2022, senators observed that “[i]t has become increasingly clear that forced arbitration clauses have enabled sexual abusers to escape scrutiny while their victims are compelled to stay silent.” This is because “[f]orced arbitration clauses not only deny survivors their right to a day in court, they also conceal their allegations from public … Continue reading

COVID-19 Update: New Variants and Vaccine Research

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on February 11, 2022 Posted in Coronavirus, General

During a recent Q&A, a representative with the World Health Organization warned that the Omicron variant is not the last of its kind. Dr. Maria Van Kerkhove explained that the next variant is likely to be more transmissible and could be more deadly than any of the previous variants. Although receiving the COVID-19 vaccine remains … Continue reading

FTC announces 2022 HSR thresholds

By Robin Adelstein (US), Amanda Wait (US), Vic Domen (US) and Gerald Stein (US) on January 26, 2022 Posted in General, News from DC, Regulatory

On January 24, 2022, the Federal Trade Commission (FTC) announced increased reporting thresholds under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Most importantly, the minimum “size-of-transaction” threshold will be increased from US $92 million to US $101 million; acquisitions below this threshold will not be reportable. The increases will apply to all transactions that close … Continue reading

COVID-19 Update: More Reflections on a Pandemic

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on January 21, 2022 Posted in Coronavirus, General

Two years ago tomorrow, Norton Rose Fulbright shared the first of its many blog updates regarding the Coronavirus and the global pandemic that was about to unfold. On January 22, 2020, we shared news from the CDC that confirmed the United States identified its first infection in the country and authorities began scrambling to prepare. … Continue reading

COVID-19 Update: US Supreme Court decisions stay OSHA ETS, uphold CMS vaccine mandate

By Kevin Mayer (US), Mark Faccenda (US) and Hayley White (US) on January 19, 2022 Posted in Coronavirus, General, News from DC

In a 6-3 decision handed down on Thursday, January 13, 2022, the US Supreme Court ordered a stay on the federal OSHA COVID “vaccine-or-test” Emergency Temporary Standard (ETS). The stay is predicated on the Court’s finding that the petitioners’ challenges to the ETS are likely to succeed and will remain in effect until a final … Continue reading

COVID-19 Update: Omicron Variant Specifics

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on December 30, 2021 Posted in Coronavirus, General

Since its first detection, the Omicron variant of COVID-19 has been reported in numerous countries worldwide and in most of the United States. It is likely more transmissible than the other variants of COVID-19 and has officially surpassed the Delta variant contraction rates. As of December 25, 2021, the CDC reported the Omicron variant represents … Continue reading

COVID-19 Update: New CDC Guidance About the Omicron Variant

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on December 15, 2021 Posted in Coronavirus, General, Regulatory

The Centers for Disease Control and Prevention (“CDC”) reported that the Omicron variant has been detected in all but sixteen of the United States. The Delta variant continues to be the main variant circulating in the United States, however. The World Health Organization (“WHO”) reported on December 14, 2021, that seventy-seven countries have reported cases … Continue reading

COVID-19 Update: Omicron- The New Variant of the Coronavirus

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on November 29, 2021 Posted in Coronavirus, General

On Friday, November 26, 2021, the World Health Organization (“WHO”) reported a new variant of COVID-19, the Omicron variant, was detected in South Africa. There is no indication the new variant is more contagious or more lethal, or that it is resistant to the COVID-19 vaccine. The WHO did report, however, that the Omicron variant … Continue reading

CMS Publishes Final Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities

By Stacey Murphy (US), Mark Faccenda (US), Thomas Dowdell (US) and Hayley White (US) on November 16, 2021 Posted in General, Regulatory

On November 12, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued its final guidance for hospitals to clarify how CMS and state agency surveyors will evaluate space-sharing or contracted staff and service arrangements with other hospitals or healthcare providers for compliance with the Medicare Conditions of Participation (“CoPs”). According to CMS, “[c]o-location occurs … Continue reading

US 5th Cir. grants a nationwide stay of OSHA’s vaccine-or-test mandate

By Kevin Mayer (US) on November 9, 2021 Posted in Coronavirus, Enforcement, General

On November 6, 2021, the Fifth Circuit Court of Appeals granted a nationwide stay of the Occupational Health and Safety Administration (OSHA)‘s Emergency Temporary Standard (ETS) vaccine-or-test mandate that was issued on November 5, 2021. The court granted the nationwide stay due to “grave statutory and constitutional issues” with the mandate. The emergency stay was requested by numerous … Continue reading

CMS Issues COVID-19 Vaccine Mandate Interim Final Rule

By Yvonne Puig (US), Thomas Dowdell (US) and Mark Faccenda (US) on November 5, 2021 Posted in Coronavirus, General, Regulatory

On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring that Medicare-certified providers implement policies for vaccination of all health care workers against COVID-19. Compliance with the requirement will be a Condition of Participation in the Medicare program, and providers may be subject to survey, requests for … Continue reading

CMS issues Calendar Year 2022 OPPS/ASC Payment System final rule

By Mark Faccenda (US) and Thomas Dowdell (US) on November 4, 2021 Posted in General, News from DC, Regulatory

On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”)released its Calendar Year (“CY”) 2022 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System final rule. This final rule is scheduled to be published in the Federal Register on November 16, 2021. In the final rule, CMS implements … Continue reading

COVID-19 Update: Panel of FDA Vaccine Advisers Vote in Favor of Vaccination for Children

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on October 26, 2021 Posted in Coronavirus, General

On Tuesday, October 26, 2021, the FDA’s Vaccines and Related Biological Products Advisory Committee members voted to approve vaccinations for children aged 5 through 11. Specifically, the panel addressed the following question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer . . . Vaccine when administered as a 2-dose … Continue reading

COVID-19 Update: White House Plan for Vaccinating Children

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on October 21, 2021 Posted in Coronavirus, General

On Wednesday, October 20, 2021, the White House discussed in a press conference its plan for vaccinating children aged 5 through 11. The White House stated it has worked closely with “governors, pediatricians, pharmacies, community health centers, rural health centers, and other vaccine providers” in preparation of a vaccine rollout. Of course, these plans are … Continue reading

CMS issues proposed rule repealing Medicare pending new “reasonable and necessary” definition and HHS issues proposed rule implementing provisions of the No Surprises Act

By Mark Faccenda (US), Thomas Dowdell (US) and Hayley White (US) on September 20, 2021 Posted in General, Regulatory

On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts A and B scheduled to go into effect on December 15, 2021. Proposing to repeal … Continue reading

World Health Organization urges moratorium for COVID-19 booster shots

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on August 10, 2021 Posted in Coronavirus, General, Regulatory

On August 4, 2021, Director-General Tedros Adhanom Ghebreyesus of the World Health Organization (“WHO”) emphasized the import of delaying the administration of booster shots for the COVID-19 vaccine until at least September 2021. He believes this delay will allow at least 10% of the population of every country to be vaccinated against COVID-19. Director Ghebreyesus … Continue reading

CMS issues 2022 OPPS proposed rule

By Mark Faccenda (US), Thomas Dowdell (US) and Hayley White (US) on July 22, 2021 Posted in General, Regulatory

On Monday, July 19, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released its Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) proposed rule for Calendar Year (“CY”) 2022. In the proposed rule, CMS proposes a net increase of 2.3 percent in Medicare OPPS rates from CY 2021 to 2022 for … Continue reading

OSHA Updates Its COVID Interim Enforcement Response Plan

By Kevin Mayer (US) on July 12, 2021 Posted in Coronavirus, Enforcement, General

Based on an evaluation of current inspection and illness data, federal OSHA has revised its March 21, 2021 National Emphasis Program (NEP), adjusting the targeted industries to those most at risk for COVID-19 exposure. The revised NEP still includes healthcare and non-healthcare industries, including meat and poultry processing, but eliminates a prior appendix that provided … Continue reading

ACA Survives “[T]hird Installment in [U.S. Supreme Court’s] epic Affordable Care Act [T]rilogy”

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on June 17, 2021 Posted in Enforcement, General, News from DC

On Thursday, June 17, 2021, in a 7-2 opinion, the U.S. Supreme Court upheld the Affordable Care Act (“ACA”) in the case California v. Texas. The Court held that Texas, the other plaintiff states, and the two individual plaintiffs did not have standing to challenge as unconstitutional the ACA’s minimum essential coverage provision. The plaintiffs … Continue reading