In the latest update to Kentucky’s Medical Cannabis Program (the “Program”), Governor Andy Beshear signed House Bill 829 which moved up the timeline to apply for cannabis business licenses by six months. Additionally, two emergency regulations were issued by the Program that explain how to apply for a cannabis business license ...
In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program ...
On April 23, 2024, the Federal Trade Commission (FTC) held a public hearing where members voted 3-2 to adopt a final rule effectively banning employers from enforcing non-compete clauses against employees with very limited exceptions. This rule, which is largely similar to the proposed rule first announced by the Commission in January of 2023, imposes a “comprehensive ban on new non-competes with all workers ...
Last week, in the culmination of a process that began in 2016, the Federal Trade Commission (FTC) issued a Final Rule to update the Safeguards Rule promulgated under the Gramm-Leach-Bliley Act ...
A birth certificate is more than a piece of paper. An accurate birth certificate allows us to account for our population; it is often required in many aspects of life, ranging from employment, to obtaining state identification cards, to enrolling in school, to participating in government programs; and perhaps most importantly, it is an essential tool for establishing identity ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
On March 8, 2024, just days before it was set to take effect, U.S. District Judge J. Campbell Barker of the Eastern District of Texas vacated the National Labor Relations Board’s (“NLRB’s”) recent rule on determining the standard for joint-employer status. The NLRB issued the rule on October 26, 2023. It established a seven-factor analysis, under a two-step test, for determining joint employer status ...
On Jan. 29, 2020, OCR released a notice regarding a recent federal court ruling in the case of Ciox Health, LLC v. Azar, et al ...
The Centers for Medicare and Medicaid Services' (CMS) vaccine mandate (Mandate)[1] has been preliminarily enjoined[2] on a nationwide basis due to a Nov. 30, 2021, decision by Judge Terry A. Doughty of the Western District Court of Louisiana, Monroe Division. Among other conclusions, Judge Doughty stated that mandating vaccination of health care workers should be done by Congress, not a government agency, although he also questioned whether even Congress had such authority ...
A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...
On Dec. 3, 2019, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation (FDIC), the Financial Crimes Enforcement Network (FinCEN) and the Office of the Comptroller of Currency (OCC) in conjunction with the Conference of State Bank Supervisors (CSBS) issued a joint statement entitled “Providing Financial Services to Customers Engaged in Hemp-Related Businesses ...
On March 27, 2020, President Donald Trump signed into law a $2 trillion emergency relief bill to ease the economic impact of coronavirus (COVID-19) and support response efforts. The CARES Act[1] included an allocation of $80 million in funding to the U.S. Food and Drug Administration (FDA) to continue its COVID-19 response efforts. The additional agency funding will be used, in part, for the development of medical countermeasures and vaccines ...
The U.S. Food and Drug Administration (FDA) recently issued a burst of COVID-19-related guidance documents to facilitate expanded availability of medical products during the current public health emergency created by COVID-19. FDA-regulated products under these temporary policies include: PPE, diagnostic tests, hand sanitizers, disinfectant devices, remote monitoring devices, ventilators, and electronic thermometers for clinical use ...
Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both ...
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 ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency ...
Those in the CBD sector should be mindful of their marketing tactics, as the FDA continues to police the industry. Manufacturers of CBD products must also evaluate their quality-control procedures to ensure safe products are hitting the marketplace. As we forecasted this past December in a previous legal alert, the U.S. Food and Drug Administration continues to referee the emerging cannabidiol (CBD) product market ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
Significant False Claims Act (FCA) developments in the courts during the latter part of 2022 have included the Supreme Court’s declining to take up one issue involving FCA qui tam actions (what level of pleading particularity Rule 9(b) requires) while holding argument on another (the scope of the government’s dismissal power following declination), and the D.C. Circuit’s adoption of the pro tanto rule in computing settlement offsets in multiple-defendant cases ...
It is rare that FCA defendants have their legal defenses paid for, and rarer still that DOJ must bear the expense. In United States ex rel. Wall v. Circle C Construction, the Sixth Circuit held that the government must pay roughly $500,000 in legal fees and expenses the defendant incurred as a result of the government’s unreasonable litigating position ...
Guided by the materiality standard from Escobar, a key safeguard for FCA defendants, the Western District of Pennsylvania found the Zaldonis relator failed to show the alleged fraud “would have any effect on the government’s decision to pay a claim.” Five years after the Supreme Court decided it, Escobar thus continues to set a high hurdle for plaintiffs ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
The Ohio Department of Commerce (Department) recently announced licensed medical marijuana cultivators who are maxing out their grow area capacity will be permitted to apply for an expansion. Presently, there are 20 Level I cultivators capable of growing up to 25,000 square feet of medicinal marijuana, and 15 Level II cultivator licensees that are smaller in scale and permitted up to 3,000 square feet of grow capacity ...
