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: 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

The Joint Commission releases sentinel event statistics for first six Months of 2019

On August 14, 2019 The Joint Commission (TJC) released sentinel event statistics for the first half of 2019, which included 426 events.  83% of the events were voluntarily self-reported by an accredited or certified organization.  The five most frequently reported sentinel events were: Unintended retention of a foreign body part – 60 Wrong-site surgery – … Continue reading

The Joint Commission Issues Sentinel Event Alert on Direct Oral Anticoagulants

On July 30, 2019, The Joint Commission (TJC) issued Sentinel Event Alert 61: Managing the risks of direct oral anticoagulants (“DOACs”).  The alert may be found here.  According to TJC, “anticoagulants have been named second of the top medications involved in error incidents causing death or serious harm.”  Because there are not FDA-approved reversal agents … Continue reading

Allina Update: Supreme Court holds Medicare statute requires notice and comment for DSH payment change

In a decision with potentially far reaching implications for Medicare hospital reimbursement, on June 3  the U.S. Supreme Court ruled 7-1 against the U.S. Department of Health and Human Services (“HHS”) in Azar v. Allina Health Services.   The Court affirmed the U.S. Court of Appeals for the D.C. Circuit decision that vacated a rate calculation … Continue reading

Texas Attorney General addresses prompt pay requirements for out-of-network emergency services

An Attorney General Opinion (KP-0250) released on May 22 provides that a court would likely find that the deadline provisions in the Texas Insurance Code applicable to Health Maintenance Organizations (“HMOs”) and Preferred Provider Organizations (“PPOs”) relating to prompt payment apply to out-of-network emergency care providers, while the penalty provisions contained do not apply to … Continue reading

The Joint Commission releases sentinel events for 2018

On March 13, 2019, The Joint Commission released Sentinel Event statistics for 2018.  There were 801 sentinel events in 2018, with 87% being voluntarily self-reported.  According to the Joint Commission, it is estimated that less than 2 percent of all sentinel events are reported.  The Joint Commission defines a sentinel event as: Any unexpected occurrence … Continue reading

FDA publishes new 510(K) guidance

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, … Continue reading

Hospital alert: CMS hospital transparency requirements in effect January 1, 2019

On January 1, 2019, all hospitals are required to make public a list of their standard charges.  As a reminder, Section 2718(e) of the Public Health Service Act, as enacted by the Affordable Care Act, requires: “each hospital operating within the United States” to “make public (in accordance with guidelines developed by the Secretary) a … Continue reading

DOJ announces Market Integrity and Consumer Fraud Task Force

On July 11 the U.S. Department of Justice (DOJ)  announced a new Task Force on Market Integrity and Consumer Fraud.  The wide-ranging Task Force will be chaired by the Deputy Attorney General and work towards: [T]he investigation and prosecution of cases involving fraud on the government, the financial markets, and consumers, including cyber-fraud and other … Continue reading

Joint Commission issues advisory on continuity of operations planning

On May 22, 2018, the Joint Commission released an advisory addressing the importance of continuity of operations planning (COOP).  When an emergency strikes, an ill-prepared health care organization can put patients at risk.  The goal of an COOP is “to protect the organization’s physical plant, information technology systems, business and financial operations, and other infrastructure … Continue reading

SCOTUS applies ERISA exemption to plans established by church-affiliated hospitals

In an 8-0 decision, the Supreme Court unanimously held that ERISA’s exemption of “church plans” from its regulation of employee benefit plans extends to church-affiliated hospitals even if an actual church did not establish the plan. The Petitioners, Advocate Health Care Network, Saint Peter’s Healthcare System, and Dignity Health, are church-affiliated nonprofits that run hospitals … Continue reading

CMS proposes to remove a ban on pre-dispute arbitration agreements at long-term care facilities

On June 5, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to revise requirements established by the Reform of Requirements for Long-Term Care Facilities final rule (2016 Final Rule). Specifically, the proposed rule would remove regulations prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with residents or their … Continue reading

DC Circuit affirms injunction against US$54b Anthem-Cigna merger

A split DC Circuit panel affirmed a U.S. District Court’s permanent injunction against the US$54 billion merger between Anthem and Cigna, holding the district court did not abuse its discretion in enjoining the merger based on Anthem’s failure to show the extraordinary efficiencies necessary to offset the anticompetitive effect of the merger in fourteen states. … Continue reading

ONDCP addresses urgent public health threat posed by illicit fentanyl

On February 23, 2017, leaders of the Committee on Energy and Commerce, in a letter to the Office of Natural Drug Control Policy (“ONDCP”), urged ONDCP to address how it and other federal agencies intend to confront the immediate public health threat posed by illicit fentanyl.  The Committee correspondence also directed ONDCP to respond to … Continue reading

Joint Commission links safety culture to health care organization leadership

On March 1, 2017, the Joint Commission issued a Sentinel Event Alert warning of the link between inadequate safety cultures within health care organizations and a rise in the occurrence of adverse events, and further urging health care organization leadership to adopt a culture of safety through formal initiatives and a top-down model behavioral approach.  … Continue reading

FDA approves opioid drug Arymo ER for chronic pain management

On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse … Continue reading

Mississippi Federal judge temporarily blocks CMS pre-dispute arbitration ban

On November 7, 2016, the U.S. District Court for the Northern District of Mississippi granted a preliminary injunction against CMS’s enforcement of the mandatory pre-dispute arbitration agreement ban, which has recently triggered a flurry of litigation. As the Order explains, in enacting the final rule promoting the pre-dispute arbitration ban, CMS relied fundamentally upon disparities in … Continue reading

U.S. Supreme Court to consider case involving pre-admission arbitration agreements

On October 28, 2016, the U.S. Supreme Court accepted review of a case involving the enforceability of pre-admission arbitration agreements. The case is brought by Kindred Nursing Centers, who filed a petition for writ of certiorari on July 1, 2016, challenging the Kentucky Supreme Court’s refusal to enforce the parties’ arbitration agreements on the basis … Continue reading
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