In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed sweeping changes to the popular “short-form” Proposition 65 warning. On January 8, 2021, OEHHA issued a proposal to amend Article 6 “Clear and Reasonable Warnings” Section 25601. This Article sets forth “safe harbor” warning methods, including warnings for consumer product exposures ...
Current State of Shopping Centers Our legacy shopping centers are often well-located, near transportation routes, population centers and employment hubs. Post-recession enthusiasm for shopping encouraged the expansion of many retail stores and product lines, and rental rates for prime shopping locations continues to grow ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus ...
A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives ...
CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use ...
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 ...
Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018 ...
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 ...
There were big changes in 2020 in the world of restructuring and insolvency legislation with the introduction of two new restructuring tools: the Moratorium and the Restructuring Plan, as well as the reintroduction of Crown preference. However, due to the government-imposed moratorium while the pandemic runs its course, we have seen hardly any real effects of those reforms ...
This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK ...
The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery ...
If parents cannot agree whether their children should be vaccinated, they can make an application under Section 8 of the Children Act 1989 to ask a judge to determine the issue. In M v H (Private Law Vaccination) [2020], the mother objected to the parties' two children aged six-years-old and four-years-old being given routine childhood vaccines in accordance with the NHS vaccination schedule ...
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) ...
The Court of Protection is a specialist Court, focussing solely on supporting vulnerable individuals. This past year has acutely highlighted the needs of those most vulnerable in our society and their dependency on others to help manage their affairs. The Court has had to adjust its practices in order to ensure that help and solutions are found for those lacking capacity with minimal delay ...
The Brexit transition came to an end on 31 December 2020. Moving forward, the EU rules of law and legal system will no longer bind the UK, including for intellectual property matters ...
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 ...
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 ...
A case note by Elyse Diong Tze Mei. INTRODUCTION The recent case of Bellini Resources (M) Sdn Bhd v Mohamad Zaini bin Md Taha1 sets out the criteria for the preservation of the status quo pending trial where the ownership of a trade mark is in dispute ...
Over the last 4 years, the Belgian Competition Authority (“BCA”) has increasingly scrutinised anticompetitive restraints in vertical agreements and assessed these restraints under Article IV.1 of the Belgian Code of Economic Law and Article 101 TFEU ...
Coming to Grips with Hospital Price Transparency – DC Circuit Rejects American Hospital Association’s Effort to Invalidate Price Transparency Requirements Rule Since 2010, Section 2718(e) of the Public Health Service Act has required hospitals to establish and publish annually “a list of the hospital’s standard charges for items and services provided by the hospital ...
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 ...
