The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers ...
The final rule promulgated by the Board of Governors of the Federal Reserve (Federal Reserve), the Farm Credit Administration, the Federal Deposit Insurance Corporation (FDIC), the National Credit Union Administration, and the Office of the Comptroller of the Currency (OCC) went into effect on July 1, 2019, to implement the portion of the Biggert-Waters Flood Insurance Reform Act mandating regulated lending institutions to accept private flood insurance policies ...
Effective Oct. 17, 2019, hospital outpatient departments (HOPDs) and other facilities which previously were exempt from the Ambulatory Surgical Facility (ASF) licensure requirement may now meet the criteria of an ASF. Governor Mike DeWine’s budget bill contained provisions which modified the definition of an ASF and will expand the number of facilities subject to regulation under Ohio law as an ASF ...
Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry ...
The Public Prosecutors’ Department in Dubai has the power to impose fines with respect to certain criminal misdemeanors and offences[i] without being required to refer the matter to a Court of Law. Such fines are issued under a Penal Order. This power stems from Dubai Law No. 1 of 2017, which authorises the Attorney General of Dubai to prescribe the offences and the corresponding fines which may be the subject of a Penal Order ...
On September 18, 2019, California Governor Gavin Newsom approved Assembly Bill 5 (AB 5) to limit the classification of workers as independent contractors in the state. The new law, effective January 1, 2020, will increase payroll tax responsibilities for California companies that must reclassify workers as employees ...
There is an ongoing controversy relating to search engine advertising. In particular regarding the legality of purchasing search terms incorporating third-party trademarks. In seeking a reasonable legal standard, this article discusses the latest legal development in trademark, unfair trading practices, marketing, and competition Law ...
FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams ...
Having a strategy when negotiating or participating in mediation is essential to a successful outcome that results in an agreement between the parties. Mediators see various levels of preparation and strategy by the parties participating in the process, and the party who approaches the mediation with a plan often achieves a more successful outcome. One effective strategy is anchoring: an effort to establish a reference point from which a party will make adjustments in negotiating ...
In a split decision on September 20 in Singletary v. Howard University, the D.C. Circuit reversed the dismissal of an FCA retaliation suit brought by a former Howard University veterinarian whose contract was cut short after she warned of unsafe conditions for animals in the medical school’s federally funded laboratories. No. 18-7158, 2019 U.S. App. LEXIS 28468 (Sept. 20, 2019) ...
The Norwegian Supreme Court delivered its judgement in the so-called Fosen-Linjen case 27 September 2019 (HR-2019-1801-A). The Fosen-Linjen case has been much debated the latter years, inter alia because it has been the only Norwegian case to have been subject to two EFTA Court referrals, cf. the decisions of the EFTA Court in cases E-16/16 (Fosen-Linjen I) and E-7/18 (Fosen-Linjen II) ...
Two recent opinions of the California Court of Appeal address the enforcement of arbitration agreements in the senior care setting when executed by someone other than the resident. The Court of Appeal's decisions in Valentine v. Plum Healthcare Group, LLC (2019) 37 Cal.App.5th 1076 (Valentine) and Lopez v. Bartlett Care Center LLC (2019) ____ Cal.App ...
On Thursday, September 12, the Third Circuit decided United States ex rel. Chang v. Children’s Advocacy Center of Delaware, No. 18-2311. In a precedential decision, the panel held that when a relator has not requested a hearing on a government motion to dismiss a federal False Claims Act (FCA) qui tam action, the court is not required to hold an in-person hearing before dismissing the action ...
California Health and Safety Code section 1418.8 outlines the requirements a skilled nursing facility (SNF) must follow when a physician prescribes a medical intervention that requires informed consent for an "unfriended" resident, meaning an individual who lacks capacity and does not have a person with legal authority to make health care decisions on their behalf. Section 1418 ...
On September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision for health care providers, especially those in the hospice industry. In U.S. v. AseraCare, Inc.,No.16-13004, Slip. Op. (11thCir. September 9, 2019), the Court held that a “reasonable disagreement between medical experts” about prognosis for a terminally ill patient, without more, cannot establish falsity. Slip. Op. at 3 ...
For those insurers that seek to circumvent California’s notice-prejudice rule, the California Supreme Court has just made that more difficult. In Pitzer College v. Indian Harbor Insurance Company, 845 F.3d 993 (9th Cir. 2017), the Ninth Circuit certified questions to the California Supreme Court, including: “Is California's common law notice-prejudice rule a fundamental public policy for the purpose of choice-of-law analysis?” (Pitzer College, 845 F.3d at 994 ...
For those insurers that seek to circumvent California’s notice-prejudice rule, the California Supreme Court has just made that more difficult. In Pitzer College v. Indian Harbor Insurance Company, 845 F.3d 993 (9th Cir. 2017), the Ninth Circuit certified questions to the California Supreme Court, including: “Is California's common law notice-prejudice rule a fundamental public policy for the purpose of choice-of-law analysis?” (Pitzer College, 845 F.3d at 994 ...
On August 16, 2019, the Ninth Circuit ruled in O'Rourke v. Northern California Electrical Workers Pension Plan, et al. that the board of trustees for an ERISA-covered multiemployer pension plan did not abuse its discretion by broadly interpreting the plan's ambiguous trade-based suspension of benefits provision to preclude a participant’s claim for early retirement benefits ...
Recently, the IRS has intensified enforcement of information reporting compliance under the Affordable Care Act (ACA). Information reporting penalties apply in addition to any penalties assessed for failures to meet the employer shared responsibility provisions, known as the employer mandate ...
For those insurers that seek to circumvent California’s notice-prejudice rule, the California Supreme Court has just made that more difficult. In Pitzer College v. Indian Harbor Insurance Company, 845 F.3d 993 (9th Cir. 2017), the Ninth Circuit certified questions to the California Supreme Court, including: “Is California's common law notice-prejudice rule a fundamental public policy for the purpose of choice-of-law analysis?” (Pitzer College, 845 F.3d at 994 ...
In 2016, the Centers for Medicare and Medicaid Services (CMS) issued regulations that prohibited long-term care facilities from entering into pre-dispute arbitration agreements with residents and their families. Shortly thereafter, those regulations were successfully challenged in federal court, and CMS has not attempted to enforce them. On July 18, 2019, CMS issued a final rule that will formally rescind the ban on pre-dispute arbitration agreements with long-term care residents ...
In Union of Medical Marijuana Patients v. City of San Diego, the California Supreme Court unanimously held that the City of San Diego failed to analyze the potential environmental impacts of its medical marijuana dispensary law. While the main issue in this case was the definition of a project under the California Environmental Quality Act (CEQA), the ruling has important ramifications for the legal cannabis market as a whole ...
The “good faith” requirement of a light-duty offer was just examined by the 10th District Court of Appeals and the Ohio Supreme Court with a somewhat surprising result. Light-duty job offers can be a good way for employers to minimize the payment of temporary total disability compensation and bring injured workers back to the workforce. However, these job offers must conform to very specific requirements under the Ohio Administrative Code ...
A website operator that embeds third party plugins on its website may become a joint controller in relation to the website visitors' personal data together with the third party service provider, according to a preliminary ruling by the Court of Justice of the European Union (CJEU) in case C-40/17 Fashion ID. The judgment upholds the broad interpretation of joint controllership of personal data established by the CJEU in its recent case law ...
In what appears to be a first under the False Claims Act, a case based on flawed cybersecurity has been settled, for nearly $9 million. On July 31, 2019, the Attorney General of New York announced that, alongside the U.S. Department of Justice, New York, eighteen other states, and the District of Columbia have reached an $8.6 million settlement with Cisco Systems, Inc. (“Cisco”) over sales of surveillance video software allegedly vulnerable to hacking ...
