Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
On January 25, 2021, the German federal Cabinet introduced the draft for the new Cyber Security Act (“IT Security Act 2.0”) into the legislative process ( Draft of a Second Act to Increase the Security of Information Technology Systems, printed matter 19/26106 [draft of a second law to increase the security of information technology systems, document 19/26106] ). The new German Cyber Security Act is intended to replace the old German Cyber Security Act of July 2015 ...
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 Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
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 ...
When it comes to the general transfer of data to third countries, even, for example, intra-group data transfers, recourse to US providers such as Microsoft (Office 365), Amazon (AWS), Google or Salesforce has been ill-fated since the ECJ ruling of July 16, 2020 (C-311/18 “Schrems II”) ...
Some facts and figures that set out the landscape of merger control, antitrust enforcement and competition litigation in Portugal in 2020. Interim Measures The PCA ordered the Portuguese Professional Football League to suspend its decision preventing teams in the First and Second Football Leagues from signing players that have unilaterally terminated their contracts due to the COVID-19 pandemic ...
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 ...
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 ...
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 ...
To boost the economy post-Brexit the government is committed to establishing up to 10 freeports across the UK. In our latest freeport bitesize article, we look at some of the planning implications of which bidders and bid participants should be aware. Back in August 2019 the UK Government announced plans to create ten new freeports that would be free of “unnecessary checks and paperwork, and include customs and tax benefits” ...
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 ...
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 second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative ...
Key issues The EU Insolvency Regulation has ceased to apply to the UK The English court acquires new grounds for jurisdiction under the EU EXIT Regulations Insolvency proceedings opened in an EU Member State may be recognised by the UK courts based on the UNCITRAL Model Law Cross-border insolvencies between the EU and the UK will likely become more time consuming, complex and expensive Recognition of UK scheme of arrangements is subject to the Hague Choice of Court Convention or t
The U.S. Department of Health and Human Services (HHS) just announced that Provider Relief Fund Program (PRF) recipients will now be required to submit reports regarding their use of these funds later than previously announced. The previous deadline was February 15, 2021. Currently, a specific new timeline was provided, but HHS is encouraging providers to register to receive updates ...
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 ...
