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HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts
Dinsmore & Shohl LLP, January 2021

The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021.  At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules...

DOJ Stats Show Dip in Fraud Recoveries in ’20, but Signs Point to Impending Rise in False Claims Act Litigation
Dinsmore & Shohl LLP, January 2021

The U.S. Department of Justice (DOJ) has just released its annual statistical overview[1] of False Claims Act (FCA) and other fraud actions for Fiscal Year 2020 (FY2020)[2], and the numbers tell a mixed story. The total of just over $2.2 billion in settlements and judgments represents a decline of more than one-quarter in recoveries from FY2019,[3] likely reflecting workforce, logistical, and judicial impacts of the COVID-19 pandemic...

International Air Travelers Entering the United States Must Have a Negative COVID-19 Test
Dinsmore & Shohl LLP, January 2021

Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline...

Ohio Court: Injured Workers Cannot Reject Valid Light-Duty Offers Made in Good Faith
Dinsmore & Shohl LLP, January 2021

In the state of Ohio, a light-duty job offer is a strategic way to either bring an injured worker back to the workforce or bar temporary total compensation, should the injured worker reject a valid offer. Either way, it can aid employers in eliminating, minimizing, and/or stopping temporary total disability compensation from being paid in a claim...

10 Steps for Out-of-State Contractors to Get Licensed in Florida Without an Exam
Dinsmore & Shohl LLP, January 2021

In July 2020, Florida changed its contractor licensing statute to make it easier for contractors who have been licensed in other states for at least 10 years to obtain a Florida contractor license without having to take a licensing exam. While Florida has not entered into any formal reciprocity agreements with other states, we do finally have guidance on exactly how to apply for a Florida contractor license using an existing license from another state...

A Proxy Season and Annual Report Guide to 2021
Dinsmore & Shohl LLP, January 2021

This is a summary of the Annual Report. Click here to access the full guide. The 2020 proxy season shareholder proposals were already submitted before the COVID-19 shadow loomed large over the season; however, such shadow likely impacted how shareholders voted on the proposals themselves, impacted business throughout 2020, and continues to jolt 2021 and the forthcoming 2021 proxy season...

Ohio’s HB 352 Simplifies and Clarifies Anti-Discrimination Statute
Dinsmore & Shohl LLP, January 2021

On Dec. 22, the Ohio Senate passed the Employment Law Uniformity Act – HB 352. Governor Mike DeWine signed the bill into law on Jan. 12, 2021. The bill is the culmination of 20 years of work by the Ohio Chamber of Commerce to address expansion of Ohio’s anti-discrimination statute resulting from Ohio Supreme Court decisions that interpreted Ohio Revised Code Section 4112 expansively...

New Federal Exceptions Favor Value-Based Care
Dinsmore & Shohl LLP, January 2021

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 Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules)...

Top Wage and Hour Updates From 2020
Dinsmore & Shohl LLP, January 2021

As employers adapt to the impacts of COVID-19, wage and hour compliance continues to present unique challenges. To help employers navigate these uncertain times, government enforcement agencies and legislatures have continued to issue new laws, opinion letters, and guidance all employers should understand and act upon...

State of Ohio Board of Pharmacy Adopts Resolution Regarding Responsible Person Requirements for Licensure of Terminal Distributor and Dangerous Drugs License
Dinsmore & Shohl LLP, January 2021

The State of Ohio Board of Pharmacy (OBP) is required to adopt a resolution specifying the required types of credentials for the responsible person of each business type of (i) terminal distributors of dangerous drugs and (ii) distributor of dangerous drugs. Only individuals who meet the credentials specified may be the responsible person for that type of business. On Jan...

FTC Settles Enforcement Actions Against CBD Companies: The Writing Was On The Wall
Dinsmore & Shohl LLP, January 2021

For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i]  the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions...

OCIE Risk Alert - Observations from Examinations of Broker-Dealers and Investment Advisers: Large Trader Obligations
Dinsmore & Shohl LLP, January 2021

On Dec. 16, 2020, OCIE issued a new Risk Alert focused on the compliance efforts of investment advisers and broker-dealers regarding Rule 13h-1 (the Rule). The Rule was enacted in order to help the SEC identify market participants that conduct significant amounts of trading activity in national market system (NMS) securities. Generally, NMS securities are exchange-listed equity securities and standardized options...

Improper CBD Product Marketing Lands in FDA’s Crosshairs
Dinsmore & Shohl LLP, January 2021

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...

Stark Law: Clarification of Key Terms
Dinsmore & Shohl LLP, January 2021

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...

Why Rental Property Owners Shouldn’t Defend Themselves Against a Fair-Housing Complaint
Dinsmore & Shohl LLP, December 2020

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...

Intellectual Property Measures Included in Spending and Coronavirus Relief Omnibus Bill
Dinsmore & Shohl LLP, December 2020

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...

New DOL Rule Allows Additional Workers to Participate In Tip Pooling and Eliminates 80/20 Rule
Dinsmore & Shohl LLP, December 2020

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...

FFCRA Paid Leave Requirements Not Extended; Tax Credits and Employer Aid is Extended
Dinsmore & Shohl LLP, December 2020

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...

CMS Clarifies Rules for Physician Group Practice Profit Distribution
Dinsmore & Shohl LLP, December 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 (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...

Tips For Litigating Against Pro Se Workplace Bias Plaintiffs
Dinsmore & Shohl LLP, December 2020

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...

EEOC Gives Vital Guidance for Employers on COVID-19 Vaccinations
Dinsmore & Shohl LLP, December 2020

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)...

Federal Judge Confirms Transgender Ohio Residents Are Entitled to Accurate Birth Certificates
Dinsmore & Shohl LLP, December 2020

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...

HRSA Publishes Long-Awaited 340B Program Administrative Dispute Resolution Procedures
Dinsmore & Shohl LLP, December 2020

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...

New Year, New Law: Florida’s New Mandatory E-Verify Law
Dinsmore & Shohl LLP, December 2020

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...

New Cybersecurity Donation Safe Harbor and Exception – AKS and Stark Final Rule
Dinsmore & Shohl LLP, December 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 (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules)...

 

 

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