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 Releases Interim Guidelines on Antibody Testing

On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests.  The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to monitor and respond to the COVID-19 pandemic.”  The interim guidelines specifically address: Development of Antibodies … Continue reading

COVID-19 Update: CDC Publishes Additional Guidance on Reopening

The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations.  The document, entitled  CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again,  builds upon the decision tools issued by the CDC last week.  The … Continue reading

COVID-19 Update: CDC Releases Guidance for Reopening

On May 14, 2020, the U.S. Centers for Disease Control (“CDC”) published voluntary guidance that provides checklists for reopening certain workplaces and activities.  The decision tools state that “[i]t is important to check with state and local health officials and other partners to determine the most appropriate actions while adjusting to meet the unique needs … Continue reading

COVID-19 Update: FBI Warns of Hackers Targeting COVID-19 Research

In a Public Service Announcement issued May 13, 2020, the U.S. Federal Bureau of Investigation (“FBI”) and Cybersecurity and Infrastructure and Security Agency (“CISA”) warned of the targeting and compromise of U.S. organizations conducting COVID-19 research.   More specifically, the announcement warns that “actors have been observed attempting to identify and illicitly obtain valuable intellectual property … Continue reading

COVID-19 Update: U.S. and U.K. Issue Joint Alert Regarding COVID-19 Research Cyber Threat

The U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency and the U.K.’s National Cyber Security Centre issued a joint alert on Tuesday that advanced persistent threat groups “are actively targeting organizations involved in both national and international COVID-19 responses.”   This warning should be heeded by hospitals, health systems, pharmaceutical companies, and academic medical … Continue reading

COVID-19 update: WHO urges cautions on immunity passports

As countries around the world seek creative policy solutions to permit the opening of their economies, the World Health Organization (“WHO”) released a Scientific Brief on April 24, 2020 finding that “[t]here is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”  The WHO is … Continue reading

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion here).  The Declaration provides immunity to certain individuals and entities for liability against “all claims for … Continue reading

COVID-19 Update: Texas Medical Board Adopts Emergency Rule Regarding Elective Surgeries

The Texas Medical Board (“TMB”) has adopted an emergency rule based on Governor Greg Abbott’s April 17, 2020 Executive Order, which permits certain elective procedures beginning at 11:59 p.m. on April 21, 2020.  The emergency rule incorporates a violation of the Executive Order to the definition of “Unprofessional and Dishonorable Conduct” under 22 Texas Administrative … Continue reading

COVID-19 Update: CMS Issues Recommendations for Re-Opening Facilities for Non-Emergent Care

On Sunday April 19, 2020, CMS issued guidance for permitting non-emergent, non-COVID-19 healthcare in states that have passed the Gating Criteria provided in the Guidelines for Opening Up America Again.  CMS reiterated support for telehealth, stating that “[m]aximum use of all telehealth modalities is strongly recommended.” Decisions should be” consistent with public health information and … Continue reading

COVID-19 Update: American Medical Association and Other Physician Organizations Request Liability Protections

In an April 15, 2020 letter to Congress, the American Medical Association and other physician organizations requested additional protection from “increased liability risk facing physicians and other clinicians” responding to the COVID-19 pandemic.   The organizations request liability protections broader than the protections provided to health care volunteers in section 3215 of the CARES Act.  The … Continue reading

COVID-19 Update: New CDC Guidance on Critical Workforce

On April 8, 2020, the U.S. Centers for Disease Control (“CDC”) issued updated guidance for critical infrastructure workers returning to work.  Previously, the CDC had provided that an individual exposed to the coronavirus should self-quarantine for fourteen days.  The CDC now recommends that critical infrastructure workers “may be permitted to continue to work following a … Continue reading

COVID-19 Update: FEMA Issues Interim Final Rule Allocating Scarce or Threatened Materials

On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020.  HL Pulse summary is available here.  Specifically, the Executive Order … Continue reading

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
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