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ENSafrica | March 2020

This article is an updated version of the article published on 16 March 2020. On 15 March 2020, South African President Ramaphosa announced the declaration of a national state of disaster, as a result of the recent events surrounding the rise in coronavirus (COVID-19) infections in South Africa. The declaration of a national disaster was made in terms of the Disaster Management Act, 2002 (the "DMA") ...

ENSafrica | March 2020

At their core, the Regulations in terms of the Disaster Management Act, 2002 issued and brought into operation yesterday, 18 March 2020, outline the responsibilities of all government departments, the release and allocation of resources, and the conditions under which liquor industry may function. In the wake of the coronavirus (COVID-19) epidemic being declared a national state of disaster, the Regulations are intended to contain the spread of the virus ...

ENSafrica | March 2020

On 15 March 2020, South African President, Cyril Ramaphosa, declared a national state of disaster in terms of the Disaster Management Act, 2002. This declaration will enable government to have an integrated and coordinated disaster management mechanism that will focus on preventing and reducing the outbreak of Covid-19, otherwise known as the Coronavirus. The president announced measures that South Africa will take to prevent and control of the Coronavirus ...

ENSafrica | March 2020

Following the South African President’s speech on 15 March 2020 that a national state of disaster has been declared in terms of the coronavirus (COVID-19), a number of measures were implemented to counteract the impact of the virus by the South African Government. We cover below the legal implications of some of these measures, particularly the repayment of bookings and data protection ...

Shoosmiths LLP | May 2023

The Pensions Regulator's General Code could be published any day now, but what is it, and why has it been so delayed? Back in March Charles Counsell, then CEO of the Pensions Regulator (TPR) confirmed in an interview with Pensions Age Magazine that the long anticipated consolidated code of practice would be published in the spring, under the new title of the “General Code” ...

Dinsmore & Shohl LLP | December 2018

On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...

Waller | January 2021

The most recent changes to the Stark Physician Self-Referral Law (Stark) and the Anti-Kickback Statute (AKS), described previously here, create a new lexicon and framework to guide healthcare providers from payment for volume-based services to payment for value-based healthcare. These value-based rules go into effect on January 19, 2021 ...

On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the physician self-referral law or Stark law ("Stark Law") ...

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 ...

Haynes and Boone, LLP | November 2011

Medicaid providers will be subject to new audits by Medicaid Recovery Audit Contractors (RACs), beginning in January 2012. These new audits will be in addition to existing audits being conducted by Medicare RACs, Medicaid Integrity Contractors (MICs) and Zone Program Integrity Contractors (ZPICs), among others.1 The Medicaid RAC audits, mandated as part of the 2010 Patient Protection and Affordable Care Act (the Health Reform Act), are expected to result in the recovery of $2 ...

Following the passage of House Bill 122 last year, the State Medical Board of Ohio (“Ohio Board”) has released final administrative rules governing the provision of telehealth services by Ohio physicians and certain other provider types.[i]  The final rules, which became effective February 28, 2023, continue the recent trend of regulators, such as the Drug Enforcement Agency,[ii] largely reverting back to pre-pandemic telehealth restrictions ...

Dinsmore & Shohl LLP | January 2018

The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio.  While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...

Dinsmore & Shohl LLP | March 2022

Following the passage of House Bill (HB) 122[i] and its corresponding expansion of telehealth services by Ohio health care providers, the State Medical Board of Ohio (Ohio Board) has released proposed administrative rules in furtherance of the recent legislation ...

Dinsmore & Shohl LLP | March 2020

On March 18, 2020, the State Medical Board of Ohio (“Board”) held a special meeting, which resulted in the temporary suspension of certain regulatory enforcement activities in response to the COVID-19 pandemic. Telemedicine Effective immediately, the Board will suspend enforcement of any regulations requiring in-person visits between providers and patients ...

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 ...

A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...

Dinsmore & Shohl LLP | July 2021

Dinsmore's Chris Cashen, Anne Guillory, Chris Jackson, and Kyle Bunnell were published in dri Strictly Speaking, Vol. 18 Issue 1. Their article, "States’ COVID-19 Immunity Statutes and Product Liability Claims Related to COVID-19," examines states’ COVID-19 immunity statutes for product designers, manufacturers, and distributors concerning COVID-19-related lawsuits. An excerpt is below ...

PLMJ | August 2022

Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...

Hanson Bridgett LLP | April 2019

In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce ...

Dinsmore & Shohl LLP | March 2020

In the early hours of Saturday, March 14, 2020, the United States House of Representatives passed the Families First Coronavirus Response Act (FFCRA), which is designed to expand relief in response to the COVID-19 outbreak, through access to free testing, enhancing food assistance, increasing Medicaid funding, and providing paid sick leave and unemployment benefits to workers ...

Schwabe, Williamson & Wyatt | September 2021

Summary On September 9, 2021, President Biden issued his Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors (the “Executive Order”) that, when implemented, will require most federal contractors to comply with all guidance for federal contractor and subcontractor workplace locations published by the Safer Federal Workforce Task Force (see www.saferfederalworkforce.gov) ...

Dinsmore & Shohl LLP | October 2018

In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...

Shoosmiths LLP | November 2023

This week marks National Fertility Awareness Week in the UK. This annual event, organised by Fertility Network UK, a national charity dedicated to supporting individuals on their fertility journeys, aims to change perceptions and raise awareness for those undergoing fertility treatment. The theme for this year is "Forward4Fertility," emphasising progress and inclusivity in the journey towards parenthood. The staggering fact that over 3 ...

In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...

Dinsmore & Shohl LLP | July 2023

A month after nixing the “objectively reasonable interpretation” (Safeco) defense under the False Claims Act, the Supreme Court has vacated and remanded two other cases for further consideration of the defendant’s subjective state of mind when it filed payment claims with the government. The Fourth Circuit in Sheldon and the Eleventh Circuit in Olhausen will provide the first tests of the High Court’s newly minted FCA intent standard ...

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