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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House passes comprehensive opioid legislation in advance of negotiations with the Senate

During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016.  This bill authorizes … Continue reading

FDA establishes bright-line recommendations for human drug compounding

On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition … Continue reading

Joint Commission revises deemed status accreditation requirement for psychiatric hospitals

On March 25, 2016, the Joint Commission revised an accreditation requirement related to written patient care plans for psychiatric hospitals that use Joint Commission accreditation for deemed-status purposes.  Psychiatric hospitals may achieve deemed status through Joint Commission surveys that meet or exceed the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoP). Specifically, … Continue reading

FDA announces approval of investigational blood screening test for Zika virus

On March 30, 2016, the US Food and Drug Administration (FDA) announced that an investigational blood screening test is available to screen blood donations for Zika virus.  The FDA clarified that the investigational blood screening test may be used under an Investigational New Drug Application (IND).  The IND process enables sponsors of investigational drugs to … Continue reading

FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties

On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent properties.  The FDA’s draft guidance follows its April 2015 final guidance for brand name opioids, which marked the … Continue reading

FDA requires new “black-box” safety warnings for opioid drugs

On March 22, 2016, the US Food and Drug Administration (FDA) issued a safety announcement that includes required labeling changes for immediate-release (IR) opioid pain medication (and the entire class of opioid drugs) and recommendations and information for patients and health care professionals.  The FDA’s new safety warnings and required labeling changes come shortly after … Continue reading

Senate passes critical bills for managing the Zika virus and establishing federal oversight of opioid painkillers

On March 17, 2016, the Senate passed two independent bills in response to growing concerns with the Zika virus outbreak and current opioid painkiller prescribing practices.  The Senate bill addressing the Zika virus aims to fuel the development of countermeasures to address the Zika virus outbreak by providing for expedited US Food and Drug Administration … Continue reading

CDC releases guidance on recommended opioid prescribing

On March 15, 2016, in response to an epidemic of opioid overdose deaths, the Centers for Disease Control and Prevention (CDC) issued guidance intended to assist primary care providers in prescribing opioid medications for chronic pain (pain lasting greater than three months or past the time of normal tissue healing).  CDC clarifies that its guidance … Continue reading

FDA issues guidance on screening blood and tissue donors for the Zika Virus

On March 1, 2016, the U.S. Food and Drug Administration (FDA) issued guidance on screening donors of human cells, tissues, and cellular and tissue-based products for risk of evidence of infection with Zika virus. The FDA’s guidance identifies Zika virus as a relevant communicable disease agent or disease (RCDAD) and provides recommendations for reducing the … Continue reading

The Joint Commission issues guidance for providers on how to manage patients at risk for suicide

On February 24, 2016, The Joint Commission (TJC) issued a Sentinel Event Alert with guidance for detecting and treating suicide ideation applicable to all health care settings. Because providers often fail to detect suicidal thoughts in their patients at the point of care, with some of these patients eventually succumbing to their suicidal ideations, TJC … Continue reading

OIG publishes compliance oversight guidance for health care governing boards

On April 20, 2015, the HHS Office of Inspector General (OIG) published guidance for health care governing boards, articulating general features of effective compliance oversight and highlighting specific practical approaches available to boards. The guidance encourages organizations to draw functional boundaries in organizational documents between the compliance, legal, and internal audit functions, while also “setting … Continue reading

China healthcare reforms: Foreign-owned hospitals to be established in 7 cities and provinces

On August 27 2014, China announced a pilot programme allowing foreign investors to establish wholly foreign-owned hospitals in seven cities and provinces across China. This is a major breakthrough for healthcare services in China and is a particularly welcome development for foreign investors who wish to benefit from China’s booming healthcare sector. Previously, foreign investors … Continue reading

Sixth Circuit upholds FTC order in ProMedica case

Continuing the Federal Trade Commission’s string of wins in hospital merger cases, the United States Court of Appeals for the Sixth Circuit this week upheld an FTC decision ordering the largest hospital provider in the Toledo, Ohio area to divest a smaller independent community hospital acquired in 2010 due to the acquisition’s likely anticompetitive effects. ProMedica … Continue reading