Topic: General

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

COVID-19 Update: OSHA Issues Emergency Workplace Rules Applicable to Health Care

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

As we previously announced, on June 10, 2021 the U.S. Department of Labor issued long anticipated emergency workplace guidelines. The Emergency Temporary Standard is applicable to health care entities such as hospitals, nursing homes, and assisted living facilities. The full regulation text may be found here. The new rules do not apply to dispensing of … Continue reading

COVID-19 Update: CDC Updates Mask Guidance

By Yvonne Puig (US), Daphne Calderon (US) and Mary Ytterberg (US) on May 13, 2021 Posted in Coronavirus, General

On May 13, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) released an update that fully vaccinated individuals no longer need to wear a mask in most settings. The update continues the trend of public health authorities relaxing previous guidelines for individuals that have received a COVID-19 vaccine. See Health Law Pulse posts … Continue reading

COVID-19 Update: Pfizer-BioNTech Vaccine Approved for Teens

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

On May 10, 2021 the U.S. Food and Drug Administration (“FDA”) announced that the Pfizer-BioNTech Emergency Use Authorization (“EUA”) would be expanded to include children ages 12-15. Previously, the vaccine had been approved for individuals 16 and older. The press release stated that between March 1, 2020 and April 30, 2021 there were approximately 1.5 … Continue reading

COVID-19 Update: U.S. Centers for Disease Control and Prevention Updates Mask Guidelines

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on April 28, 2021 Posted in Coronavirus, General

On Tuesday, April 27, 2021, the U.S. Centers for Disease Control and Prevention (“CDC) unveiled updated guidelines detailing activities that vaccinated people can safely resume. The guidelines continue the trend of public health authorities relaxing previous guidelines for individuals that have received a COVID-19 vaccine. See Health Law Pulse posts here, here and here. After … Continue reading

Urgent New Survey Standards From The Joint Commission Address Aisle Widths and CAH Suites

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 23, 2021 Posted in Coronavirus, General

This week The Joint Commission (“TJC”) announced new requirements that are effective immediately and require suites to have aisles with at least “36 inches of clearance from side to side to facilitate egress.” The standard aligns with the National Fire Protection Association’s (FPA) Life Safety Code and is applicable to hospitals accredited by TJC and … Continue reading

COVID-19 Update – HHS OCR Releases Legal Guidance for Expanding Vaccine Access to People with Disabilities and Older Adults

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 14, 2021 Posted in Coronavirus, General, News from DC

On April 13, 2021, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published a press release with resources, including from the Administration for Community Living (“ACL”) and the Office of the Assistant Secretary for Planning and Evaluation (“ASPE”), to improve access to vaccinations for individuals with disabilities and older adults. … Continue reading

COVID-19 Update: CDC Updates Travel Guidelines While New Double Variant Emerges

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 5, 2021 Posted in Coronavirus, General, International

The U.S. Centers for Disease Control and Prevention (“CDC”) has updated its travel guidelines, advising that there is low risk for fully vaccinated individuals to travel domestically. The CDC further provides that for fully vaccinated individuals COVID-19 testing or a quarantine period is unnecessary following travel. When traveling internationally, the CDC states that testing is … Continue reading

Litigation trends in life sciences and pharmaceuticals: What you need to know

By Allison Lange Garrison (US) on April 5, 2021 Posted in General

A team of Norton Rose Fulbright pharma and medical-device litigators recently presented to the Life Sciences and Healthcare Spring Webinar Series on “Pharma Delivers: Now What?” Pharmaceutical companies delivered pandemic-ending vaccines, and are rewarded with an increasingly positive public reputation. The presenters forecasted how this public-opinion bump might impact future litigation, and more broadly discussed … Continue reading