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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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

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

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

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

COVID-19 Update: CDC Updates School Guidelines

On March 19, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) released updated guidelines for K-12 schools that is anticipated to facilitate the reopening of schools across the country.  The CDC states that “[o]pening schools for in-person learning as safely and quickly as possible, and keeping them open, is important given the many … Continue reading

COVID-19 Update: CDC Releases Guidance for Vaccinated Individuals

Ever since the U.S. declaration of a public health emergency on March 13, 2020, Americans have wondered what life would look like if and when a vaccine was developed.  In December, the first vaccine was administered in the U.S.  On March 8, 2021, the positive momentum accelerated when the U.S. Centers for Disease Control and … Continue reading

COVID-19 Update: CDC Increasing Sequencing for Virus Variants

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

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

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

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

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: HHS OGC Issues PREP Act Advisory Opinion

On January 8, 2021, the U.S. Department of Health and Human Services released Advisory Opinion 22-01  entitled On The Public Readiness and Emergency Preparedness Act Scope of Preemption Provision.   The Advisory Opinion addresses the Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of … Continue reading

COVID-19 Update: Secretary Azar Extends Pubic Health Emergency

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

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

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

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

COVID-19 Update: Progress toward a vaccine candidate

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
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