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 ...
Effective Nov. 9, 2020, the Securities and Exchange Commission’s (SEC) amendments to “modernize the description of business, legal proceedings, and risk factor disclosures” required under Regulation S-K take effect. These amendments largely follow the proposed amendments, dated Aug. 8, 2019,[1] with some clarifications. The intent of the amendments is to improve the disclosure regime, which has not had a major overhaul in over thirty years ...
In Brown v. Morehouse College, a False Claims Act (FCA) retaliation action, the U.S. Court of Appeals for the Eleventh Circuit affirmed the case’s dismissal, agreeing with the district court that while the plaintiff’s ethics complaints may have led to retaliation against him by the College, the complaints did not allege FCA fraud and therefore were not protected by the statute. No. 19-13773, 2020 U.S. App. LEXIS 33444 (11th Cir. Oct. 23, 2020) ...
The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps ...
On Oct. 21, 2020, the Centers for Disease Control and Prevention (CDC) released a new definition for “close contact.” The new definition was expanded to account for the cumulative amount of exposure one might have had with a person infected with COVID-19. Under the new definition, close contact is defined as being “within six feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period beginning two days before illness onset ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
On July 10, 2020, the Office of Compliance Inspections and Examinations (OCIE) released a Risk Alert highlighting the dangers of ransomware to SEC-registered entities, including investment advisers. The Risk Alert is a response to a marked uptick in both the prevalence and sophistication of ransomware attacks in recent months. Ransomware is a type of malware used by criminals to gain control of your or your firm’s confidential information and customer data ...
In response to the ongoing disruption caused by COVID-19, OCIE issued a Risk Alert on Aug. 12, 2020. In the Risk Alert, OCIE makes various observations and recommendations which fall into six different categories: (1) protection of investors’ assets; (2) supervision of personnel; (3) practices relating to fees, expenses, and financial transactions; (4) investment fraud; (5) business continuity; and (6) the protection of investor and other sensitive information ...
OCIE’s most recent Risk Alert, published Sept. 15, 2020, address another cybersecurity issue, this time highlighting the dangers of “credential stuffing.” Credential stuffing is a method of cyberattack that uses compromised client login credentials and can lead to loss of customer assets and the disclosure of confidential or other personal information. Hackers will obtain groups or lists of usernames, email addresses, and their passwords from sellers on the dark web ...
On July 28, 2020, the SEC announced a pair of settled administrative actions against Houston-based VALIC Financial Advisors (VFA). In the first action, the SEC charged VFA with failing to disclose that its parent company paid a for-profit entity owned by a Florida teacher’s union to promote VFA to Florida teachers. The second action involved VFA’s wrap fee arrangements with clients ...
Effective Oct. 15, 2020[1], the Committee on Foreign Investment in the United States’ (CFIUS) mandatory filing requirement will shift from a critical technology[2], industry-specific focus to one focused on export controls. It will focus on whether the U.S. regulatory authorization would be required to export the target U.S. business’ critical technology to the foreign person party to the transaction, including certain parties in the foreign person’s ownership chain ...
On Oct. 8, 2020 the SEC issued a joint statement on additional Form CRS guidance regarding firms’ disciplinary history. The statement was released in tandem with several new FAQs, which help clarify firms’ disclosure obligations as they relate to disciplinary history. The update guidance comes in response to the SEC’s early review of firms’ Form CRS filings ...
