Yvonne Puig (US)

Yvonne Puig (US)

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 Recommends Use of Cloth Face Coverings and President Issues Executive Order on PPE

On Friday April 3, the U.S. Centers for Disease Control (“CDC”) recommended “the wearing of cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission.”   The CDC provides citations for several studies finding that individuals with coronavirus may … Continue reading

COVID-19 Update: CDC Issues Guidance on Decontamination of FFR and President Trump Issues Executive Orders for Medical Equipment

Earlier this week the U.S. Centers for Disease Control (CDC) provided recommendations for the decontamination and reuse of filtering facepiece respirators (FFR).  The guidance states that a study found the coronavirus is able to survive for up to 72 hours on plastic, stainless steel, and cardboard.  The CDC provides that “decontamination and subsequent reuse of … Continue reading

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients.  However, this “strategy should only be … Continue reading

COVID-19 Update: New Model for Allocating Hospital Resources Released/Payors Strengthening COVID-19 Coverage

The spread of COVID-19 in the United States is requiring providers to consider difficult questions regarding resource allocation.   On March 26, 2020 Dr. Douglas White of the University of Pittsburgh Department of Critical Care Medicine and Dr. Scott Halpern of the University of Pennsylvania Perelman School of Medicine released Allocation of Scarce Critical Resources During … Continue reading

COVID-19 Update: HHS Issues Notice of Designation to Prevent Hoarding and OIG launches COVID-19 Portal

On March 25, in response to President Trump’s Executive Order, HHS issued a Notice of Designation a list of health and medical resources necessary to respond to COVID-19 that are necessary to combat the spread of the disease.  The Defense Production Act “prohibits any person from accumulating designated materials (1) in excess of the reasonable … Continue reading

COVID-19 Update: CDC publishes criteria for when healthcare professionals with confirmed and suspected COVID-19 can return to work

On Tuesday, March 24, 2020, the Centers for Disease Control and Prevention (CDC) issued interim guidance on criteria that can be used to determine whether a healthcare professional with a confirmed or suspected case of COVID-19 should return to work. The CDC states that this criteria can be further “adapted by state and local health … Continue reading

COVID-19 Update: President Trump Issues Executive Order on Hoarding

On March 23, 2020 President Trump signed an Executive Order directing the Secretary of HHS, under the authority of the Defense Production Act, to “prevent hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States.”  It also delegates to the Secretary of HHS the: [A]uthority to prescribe … Continue reading

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic.  FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading

COVID-19 Update: HHS Declaration Provides Liability Immunity Related to Certain COVID-19 Countermeasures

The Public Readiness and Emergency Preparedness Act provides the Secretary of HHS authority to issue a declaration providing immunity to certain individuals and entities during a public health emergency.  On March 17, 2020, the U.S. Secretary of Health and Human Services published a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures … Continue reading

Coronavirus | COVID-19 Update: CMS issues guidance to all PACE Organizations to implement policies and procedures to prevent the spread of COVID-19

On Tuesday, March 17, 2020, the Centers for Medicare & Medicaid Services (CMS) released guidance to all Programs of All-Inclusive Care for the Elderly (PACE) Organizations (POs) on policies and standard practices to follow in regards to the COVID-19 public health emergency.… Continue reading

COVID-19 Update: Trump administration expands access to telehealth services for Medicare beneficiaries to combat COVID-19

On Tuesday, March 17, 2020, the Trump administration announced that it will immediately expand access to telehealth services for all Medicare beneficiaries during the COVID-19 outbreak. In coordination with this announcement, the Office for Civil Rights at the Department of Health & Human Services (HHS) released a notification stating that HHS has temporarily suspended certain … Continue reading

COVID-19 Update: CMS Approves First Section 1135 Waiver

Following President Trump’s declaration of a national emergency on March 13, 2020, CMS approved the first Section 1135 waiver related to Medicaid on Monday.  The State of Florida received permission to eliminate the limits on instances of care furnished and how many participants receive care from an out-of-state provider for the duration of the 1135 … Continue reading

COVID-19 Update: Coronavirus Designated a Pandemic by WHO

On Wednesday the World Health Organization declared COVID-19 a pandemic.  WHO Director-General Tedros Adhanom Ghebreyesus stated that “In the days and weeks ahead, we expect to see the number of cases, the number of deaths and the number of affected countries climb even higher.”  In a hearing before the House Oversight and Reform Committee Dr. … Continue reading

COVID-19 Update: Telehealth flexibility and CMS Provides Additional Information

On Sunday, March 8, 2020, the known cases of coronavirus in the United States surpassed 500.  Cases have been identified in more than 30 states and the District of Columbia.   Worldwide there are 109,835 confirmed cases, resulting in 3,803 deaths.  Eight states have declared states of emergency: Washington, Florida, California, New York, Kentucky, Maryland, Utah, … Continue reading

COVID-19 Update: CMS Releases Guidance for Hospitals and Nursing Homes

On Wednesday March 4, 2020, the Centers for Medicare & Medicaid Services (CMS) released three guidance documents for health care providers relating to the coronavirus.  Worldwide there have been 96,888 confirmed cases, resulting in 3,305 fatalities, including 11 deaths in the United States. In a press release, CMS stated that the actions taken were “focused … Continue reading

COVID-19 Update: US Expands Travel Restrictions After First Fatality

On Saturday, the State of Washington announced the first fatality in the United States arising from the coronavirus, with a second announced on Sunday. Washington Governor Jay Inslee has declared a state of emergency.  As of Monday March 2, 2020, there were 89,197 total confirmed cases of COVID-19 worldwide and 3,048 resulting deaths.  U.S. Secretary … Continue reading

COVID-19 Update: CDC says Spread of Coronavirus Virus “Inevitable”

On Tuesday February 25, 2020, Nancy Messonnier, director of the U.S. Center for Disease Control’s National Center for Immunization and Respiratory Disease warned in a call with reporters that “[u]ltimately we expect we will see community spread in the United States. It’s not a question of if this will happen, but when this will happen, … Continue reading

COVID-19 Update: Death Toll Surpasses 2,000

As of Thursday February 20, 2020, there have been more than 75,000 known coronavirus infections and over 2,000 deaths.  According to the Centers for Disease Control, there have been fifteen confirmed cases of the coronavirus in the United States, and there have been no deaths reported.  Deaths from the coronavirus have occurred in China, Iran, … Continue reading

COVID-19 Update: Over 60,000 Confirmed Cases

Earlier this week the WHO announced that COVID-19 would be the name for the disease caused by the coronavirus.  On Wednesday, China announced 14,840 new cases of the coronavirus after changing the way cases are confirmed to include where a test was negative but other methods such as symptoms and x-rays show evidence of the … Continue reading

Coronavirus Update: More Than 40,000 Cases Confirmed

As of Monday morning, the Chinese National Health Commission announced a total of 40,171 confirmed cases of the Coronavirus with 908 related deaths, surpassing the totals of the SARS epidemic of 2002.  There have now been more than 300 cases confirmed outside of China, including 12 in the United States.  On Saturday, it was announced … Continue reading

U.S. Declares Coronavirus a Public Health Emergency

As of Monday February 3, the death toll of the Coronavirus had risen to 362 and there were over 17,300 known cases around the world.  The number of coronavirus deaths in China has now exceeded the severe acute respiratory syndrome epidemic in 2003.  There have been eight confirmed cases in the United States, with Massachusetts … Continue reading

WHO Deems Coronavirus Global Health Emergency and White House Announces Task Force

On January 30, 2020, the World Health Organization (WHO)  declared the coronavirus a global health emergency.  The coronavirus has now been identified in 18 countries and has infected 9,709 people. 213 people have died from the coronavirus.  Countries are beginning to evacuate citizens from China and the United Kingdom, Australia, South Korea, Singapore and New … Continue reading

Public Health Officials Try to Contain Coronavirus

Governments around the world are continuing to take steps to contain the spread of the coronavirus.  As of Monday morning, 2,744 people worldwide have become infected with the coronavirus and 80 people have died.  There have been five confirmed cases in the United States, with one case in Washington, Arizona, and Illinois, and two cases … Continue reading

Texas Finalizes New Nursing Peer Review Committee Requirement for ASCs and Freestanding EDs

In final rules published in the January 24, 2020 Texas Register, the  Texas Department of State Health Services established a new operational requirement for ambulatory surgical centers and freestanding emergency medical care facilities to establish a nursing peer review committee.  The changes had been proposed on September 13, 2019.  The Department did not receive any … Continue reading
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