On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective ...
Most rental property owners (Owners) are subject to federal, state, and local anti-discrimination housing laws. When an Owner receives notice of a complaint alleging violations of these laws, it is important to take the complaint very seriously. There are significant business, financial, public relations, and personal risks involved with a fair-housing complaint ...
While most Americans are likely aware that President Donald Trump signed a pandemic relief and government spending bill into law on Dec. 27, 2020 (the “Omnibus Bill”),[i] it is important for those who have intellectual property assets to understand that tucked away into this nearly 5,600-page legislation are laws impacting copyrights, trademarks, and patents ...
On Dec. 23, 2020, The U.S. Department of Labor (DOL) issued its long-anticipated Final Rule addressing which employees may legally participate in “tip pooling” under the Fair Labor Standards Act (FLSA) and the conditions under which employers may claim “tip credit.” The Final Rule is effective 60 days after publication in the Federal Register and constitutes a major departure from past guidance ...
On Dec. 21, 2020, Congress passed the Consolidated Appropriations Act, 2021 (the Act), which provides additional COVID-19 relief to individuals and businesses. The long-anticipated COVID-19 relief bill will now head to President Trump for approval or veto. The Act does not extend requirements for employers to provide emergency paid sick leave or emergency paid family and medical leave under the Families First Coronavirus Response Act (FFCRA) past the original Dec ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules). This alert is a part of the Dinsmore Health Care practice group’s ongoing summary of the Final Rules ...
As Seen in Law360 Last month, the U.S. District Court for the Eastern District of Michigan issued its opinion in Roseman v. International Union, United Automobile, Aerospace and Agricultural Implement Workers Of America.[1] ruling in favor of the employer, Fiat Chrysler Automobiles US LLC, and the union, known as United Auto Workers, or UAW ...
On Dec. 16, 2020, the United Stated Equal Employment Opportunity Commission (EEOC) released much-anticipated guidance regarding employers’ ability to enact mandatory COVID-19 vaccination policies. The new guidance addresses many questions regarding the interaction between mandatory vaccination policies and the Americans with Disabilities Act (ADA), Title VII of the Civil Rights Act of 1963 (Title VII), and the Genetic Information Nondiscrimination Act (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 ...
The U.S. Health Resources and Services Administration (HRSA) recently released a draft final rule (Final Rule) that establishes a binding administrative dispute resolution (ADR) process concerning drug costs under the Federal 340B Drug Discount Program (340B Program). As per its terms, the Final Rule will be formally published on Dec. 13, 2020 and will take effect on Jan. 13, 2021 ...
Effective Jan. 1, 2021, Florida law will require all public employers, as well as some private employers, to enroll in and use the E-Verify system. What is E-Verify? E-Verify is a free federal electronic database that allows employers to quickly validate documentation presented by new hires to establish that a new employee is lawfully eligible for employment in the United States ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules) ...
The Ohio Board of Pharmacy (Board) recently issued updated guidance detailing certain conduct pharmacists and other regulated personnel (Licensees) must report to the Board ...
Three pharmaceutical companies, AstraZeneca, Moderna and Pfeizer, have announced COVID-19 vaccines, which the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, has announced could be available as early as late December 2020.[1] Governor Mike DeWine announced some Ohio health care professionals could receive the COVID vaccine as early as Dec. 15, 2020 ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations. The proposed rules were released in October of 2019 ...
As concern over cybersecurity continues to grow,[1] defense contractors have been waiting for the Department of Defense (DoD) to roll out its Cybersecurity Maturity Model Certification (CMMC) program. That rollout has occurred, with DoD’s recently published interim rule Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041)[2] (“Interim Rule”), effective Nov. 30, 2020, and providing for a five-year phase-in of CMMC ...
On Nov. 19, 2020, the Office of Compliance Inspections and Examinations (OCIE) issued a new Risk Alert focusing on common compliance deficiencies relating to the Advisers Act and Rule 206(4)-7, otherwise known as the Compliance Rule. As a brief refresher, the Compliance Rule requires advisers to adopt and implement written policies and procedures reasonably designed to prevent violations of the Advisers Act ...
The United States Trademark Office formally announced it will raise the vast majority of its trademark filings fees and implement some new fees as of Jan. 1, 2021. These higher costs will impact every aspect of trademark prosecution, including appeal, cancellation and opposition proceedings before the Trademark Trial and Appeal Board. Trademark owners would be wise to take a look at their upcoming deadlines and potentially take action on them before the end of the year ...
This article has been published in PLI Chronicle. The market for consumer products derived from cannabis and its components, including cannabidiol (CBD), is exploding. U.S. sales of CBD products is expected to exceed $20 billion by 2024, up from just $1.9 billion in 2018. TheCBD market is expected to develop across diverse industries such as cosmetics and skin care, health products, food and beverage, pet products, and pharmaceuticals ...
On Nov. 9, 2020 the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) issued a risk alert detailing its series of examinations of investment advisers operating from numerous branch offices and with operations geographically disbursed from the adviser’s main office. This examination initiative focused on the compliance and supervisory practices relating to advisory personnel working within the advisers’ branch offices ...
On Nov. 3, 2020, California voters approved Proposition 24, marking a significant shift in the U.S. privacy landscape. Proposition 24 enacted the California Privacy Rights Act of 2020 (CPRA),[1] a major expansion of the existing California Consumer Privacy Act (CCPA), which many businesses continue to grapple with since becoming effective in January 2020. Most notably, the CPRA establishes a stand-alone privacy regulator, the first U.S. state to do so ...
The Ohio Department of Health’s July 23, 2020 Order regarding facial covering mandates has been amended in light of the increasing number of COVID-19 cases in Ohio. The order became effective today, Nov. 16, 2020. See the order here. This new order includes the following additional mandates for retail stores (enterprises offering goods to the public) only. 1. Each business will be required to post at all public entrances to the store: A. A face covering requirement sign; B ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
Under the Medicare Secondary Payer Act (MSPA), a Medicare Secondary Payer is the entity which has an obligation to pay medical expenses before Medicare. In the face of rising costs, legislation was passed in 1980 making Medicare a secondary payer to various primary plans in order to shift medical expenses to those Medicare believed should be the primary source of payment ...
