The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) ...
For more than 15 years, the process of selecting a hearing officer for a medical staff peer review proceeding has been strongly influenced by the decision in Yaqub v. Salinas Valley Memorial Healthcare System 122 Cal. App. 4th 474 (2004). That decision held that a hearing officer in a peer review proceeding was disqualified for a financial bias based upon the hearing officer's “long–standing and continuous relationship" with the hospital, which created a “possible temptation" to favor the hospital.
The court disqualified the hearing officer despite the fact that “there ...
In anticipation of its November Board meeting this past week, the Medical Board released its Medical Board Staff Report along with a long-awaited draft of the enabling regulations for its Physician Health and Wellness Program.
While the re-establishment of a Physician Health and Wellness Program is a positive development, the new Program is structured in a way which fails to encourage physicians with substance abuse problems to enter the Program voluntarily at an early stage of their addiction ...
As of January 1, 2020, when a patient (or their representative) submits a written allegation of sexual abuse or sexual misconduct to a health care entity, that entity must report the allegation to the appropriate state licensing agency (e.g., the Medical Board of California) within 15 days of receipt. (SB 425, codified at Cal. Bus. & Prof. Code Section 805.8) After making its way through the state legislature with little to no opposition from state lawmakers, California Governor Gavin Newsom signed this bill into law on October 12. The purpose of the bill was to not only accelerate the process in which state licensing boards receive notification about these serious allegations, but also to expand the types of entities that must report these events ...
The Medical Board of California (“MBC”) began this project in 2013 when it required coroners to inform it of deaths resulting from opioids. The influx of coroners’ reports triggered an intense enforcement effort by the MBC to mine the data in the CA Department of Justice’s Controlled Substance Utilization Review and Evaluation System (“CURES”) to identify physicians who prescribed for the persons identified in death certificates. The MBC has conducted a veritable deluge of formal investigations of physicians and has filed an unprecedented number of accusations based on this single source.
The U.S. Supreme Court is now in its summer recess and we anecdotally have heard of Justice “sightings” in Europe and beyond. This last session of the Court addressed many issues capturing both the political and popular imagination. Less headline-grabbing and relatively modest in length (at only nine pages) was Justice Clarence Thomas’ opinion for a unanimous Court in Cochise Consultancy, Inc. et al. v. U.S. ex rel. Hunt. (587 U.S. ____ (2019)) It directly impacts our healthcare compliance practice here at Nossaman by interpreting the statute of limitations for a False Claims Act (“FCA”) case so as to stretch it as long as possible.
On July 22, 2019, the California Supreme Court issued its long-awaited opinion in Wilson v. CNN.1 The primary question before the court concerned the application of the anti-SLAPP statute, Civil Procedure Code Section 425.16, to employment, discrimination, and retaliation claims. The factual scenario before the court involved a journalist who alleged that his employer, CNN, denied him promotions, gave him unfavorable assignments, and ultimately fired him for unlawful discriminatory and retaliatory reasons.2 The employer responded by contending that the journalist was ...
On May 7, 2019, the California Supreme Court heard oral arguments in Wilson v. Cable News Network, Inc., et al., where plaintiff was a producer at CNN who sued the media giant for employment discrimination, retaliation, wrongful termination, and defamation after he was terminated for alleged plagiarism. Wilson is of particular importance to the healthcare community, including hospitals, medical staffs, peer review committees, and practitioners, because it will impact the application of anti-SLAPP Special Motions to Strike under Civil Procedure Code Section 425.16 in suits ...
A Civil Investigative Demand, often referred to as a CID, is a pre-litigation mechanism used to collect information and evidence for use in civil false claims act and other investigations. CIDs are typically lengthy documents, broadly drafted, invasive, and even frightening. In the past decade since the passage of the Fraud Enforcement and Recovery Act of 2009, CIDs have been issued at exponentially higher rates than in years past, and have become more comprehensive and more aggressive.
While this post will focus on Department of Justice CIDs in federal health care cases, CIDs are ...
Effective January 1, 2019, Health & Safety Code Sections 11161.5, 11162.1, and 11165 were amended to, among other things, provide that the Department of Justice implement a system by which prescription forms for controlled substance prescriptions should each have a uniquely serialized number."
The statutory amendments established the way in which the prescription forms must be printed, the various features that the prescription forms must include, and the way in which the dispenser of controlled substances must report the serial number to the Controlled Substance Utilization ...
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