Yvonne Puig (US)

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US Head of Life Sciences and Healthcare Yvonne Puig has a substantial commercial litigation practice in both state and federal courts. She represents hospitals, HMOs, managed care organizations, medical schools and other institutional health care providers and educational services companies. A partner in Norton Rose Fulbright’s Austin office, Yvonne’s practice involves commercial and health care litigation, antitrust, regulatory and compliance advice, crisis management, staff privileges, exclusive contracting and administrative law.

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

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 Issues COVID-19 Vaccine Mandate Interim Final Rule

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

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

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

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

COVID-19 update: Efficacy of mask use and vaccinations for children

On October 1, 2021, the CDC issued its weekly “Morbidity and Mortality” report and noted according to a July 1 – September 4, 2021 study that “[s]chool mask requirements, in combination with other prevention strategies, including COVID-19 vaccination, are critical to reduce the spread of COVID-19 in schools.” The study analyzed “differences between county-level pediatric … Continue reading

COVID-19 update: CDC panel recommends Pfizer booster shot for some

On September 23, 2021, a panel of experts from the CDC, the Advisory Committee on Immunization Practice (“ACIP”), recommended that three categories of people should receive a COVID-19 booster shot: (1) those aged 65 and older; (2) those in long-term care residencies; and (3) those over 18 with underlying medical conditions. ACIP members voted unanimously … Continue reading

COVID-19 update: Availability of the Pfizer vaccine

On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. The advisory committee was tasked with discussing Pfizer’s supplemental application for administration of this third dose for individuals aged 16 and older, and … Continue reading

COVID-19 update: FDA warns against COVID-19 vaccine for children younger than twelve

On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the vaccination of children under the age of twelve. The FDA noted there are different issues that need … Continue reading

COVID-19 Update: Biden Administration requires COVID-19 vaccine or proof of negative COVID-19 test for employees at large companies

On September 9, 2021, President Biden announced a new, upcoming mandate that requires all employers with 100 or more employees “to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.” The Biden Administration projects this … Continue reading

COVID-19 update: United States military requires COVID-19 vaccine

Secretary of Defense Lloyd J. Austin III issued a memorandum on August 25, 2021, mandating immediate and full COVID-19 vaccines for all members of the United States Armed Forces, including the Ready Reserve and National Guard. The memorandum began, “To defend this Nation, we need a healthy and ready force.” The Secretary of Defense noted … Continue reading

COVID-19 Update: Pfizer vaccine fully approved by FDA

On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted approval by the FDA in the United States. For individuals aged twelve through fifteen, the … Continue reading

COVID-19 update: White House recommends COVID-19 booster shot for most Americans

On August 18, 2021, the Biden Administration announced with top US health officials a recommendation that Americans receive a COVID-19 booster shot eight months after their second dose was administered. The Administration is not recommending a booster for the one-dose Johnson & Johnson vaccine pending additional data. The statement began, “The COVID-19 vaccines authorized in … Continue reading

COVID-19 Update: FDA announces availability of COVID-19 booster shot for immunocompromised

On August 12, 2021, the United States Food and Drug Administration (“FDA”) authorized a COVID-19 vaccine booster for immunocompromised individuals. Because booster vaccines were not previously authorized under the FDA’s emergency use authorization, the FDA’s announcement today was a necessary step to begin administering booster vaccines. This is the first time an additional dose of … Continue reading

World Health Organization urges moratorium for COVID-19 booster shots

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

Biden administration requires federal employees to receive COVID-19 vaccination with Delta variant on the rise

On Thursday, July 29, 2021, the White House confirmed that the Biden Administration would articulate new goals related to COVID-19 and the Delta variant: Strengthening safety protocols for federal employees and federal contractors. Protecting those who serve our country. Expanding paid leave to get families and kids vaccinated. Calling on state and local governments to … Continue reading

COVID-19 update: CDC releases updated masking recommendations

On July 27, 2021, Dr. Rochelle Walenksy updated the United States Centers for Disease Control and Prevention’s (“CDC”) recommendation regarding mask use for vaccinated individuals in a Media Telebriefing concerning COVID-19. At the time of this writing, the transcript is not yet available on the CDC’s media announcements. During the update, Dr. Walensky explained the … Continue reading

The Joint Commission seeks to address disparities in the health care system

The Joint Commission issued a new advisory to encourage health care providers to take tangible steps to better understand and meet the needs of the diverse populations of which they serve. The Joint Commission recognized that COVID-19 has “shed a light on the many gaps in health care that diverse populations have experienced for decades.” … Continue reading

COVID-19 update: CDC student guidelines and Delta variant

On Friday, July 9, 2021, the Centers for Disease Control and Prevention (“CDC”) released new guidelines for students in kindergarten through twelfth grade. The CDC updated its guidelines to “provide safe and supportive learning environments for students.” It recognized that outbreaks of COVID-19 have occurred in schools; however, it indicated that multiple studies show that … Continue reading

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

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

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

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

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

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

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
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