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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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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

Nursing home providers file suit against CMS in response to pre-dispute arbitration ban

In response to the recent Centers for Medicare & Medicaid Services (“CMS”) final rule prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with its residents (the “Arbitration Rule”), several plaintiffs (including the American Health Care Association and other long-term care facility (“LTC”) providers) collectively filed a complaint on October 17, 2016 against CMS … Continue reading

CMS final rule promotes post-dispute arbitration, giving residents more bargaining power

On October 4, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule that implements sweeping changes to the requirements long-term care facilities (“LTCs”) must meet to participate in the Medicare and Medicaid programs. These new and modified requirements offer heightened protections for residents.  Most notably, the final rule prohibits Medicare and … Continue reading

FDA now demands its strongest black box warnings for certain opioid and other drugs

On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid medicines and benzodiazepines. FDA prepared a Drug Safety Communication directed to health care professionals and … Continue reading

Texas supreme court temporarily halts state Medicaid cuts for home health therapy programs for disabled children

The Texas Supreme Court has temporarily blocked the Texas Health and Human Services Commission’s planned rate reductions for Medicaid home health services for severely disabled children, holding that a temporary injunction issued by a trial court enjoining the rate cuts from taking effect remains binding pending the issuance of a mandate by the Texas Third … Continue reading

Senators urge HHS to further expand patient access to opioid drug treatment

On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act.  MAT involves the use of medication in combination with certain behavioral … Continue reading

Medicaid could cover benefits aimed to prevent, diagnose and treat Zika virus

On June 1, 2016, CMS released a Center for Medicaid and CHIP Services (CMCS) Informational Bulletin, entitled “Medicaid Benefits Available for the Prevention, Detection and Response to the Zika Virus.” In the Bulletin, CMS explains the prevention and treatment services that state Medicaid agencies and stakeholders may choose to cover at their discretion. As the … Continue reading

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
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