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: 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

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

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: OSHA Updates and Reporting Requirements

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

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

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

President Trump Signs Most Favored National Executive Order

President Trump signed a controversial Executive Order on September 13, 2020  entitled Executive Order on Lowering Drug Prices by Putting America First  with the intention of tying drug costs paid by the Medicare program to the costs borne by countries that have national health systems.   The Executive Order provides that “[i]t is the policy of … Continue reading

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

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

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

COVID-19 Update: CMS Announces Resumption of Survey Activities

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

COVID-19 Update: Trump Issues ‘Buy American’ Executive Order Related to Drugs

On August 6, 2020 President Trump signed an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States.  The Executive Order states that “the domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN (chemical, biological, radiological, and nuclear) threats … Continue reading
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