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Dinsmore & Shohl LLP | March 2020

The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...

A&L Goodbody LLP | February 2005

Introduction Advocate General Jacobs, in delivering his Opinion in Syfait and others v Glaxosmithkline (Case C-53/03, 28 October 2004), has found in favour of Glaxosmithkline (GSK) by stating that the refusal by a dominant pharmaceutical company to fulfil all orders from wholesalers does not automatically constitute an abuse of a dominant position, despite such refusal clearly limiting parallel trade of the products in question ...

The Philippine Government has issued a slew of resolutions and circulars as part of its response to the COVID 19 pandemic and unsurprisingly, a number of legal and practical issues have beset businesses and persons under the Luzon-wide enhanced community quarantine (ECQ)1. Like the rest of the world, the country is bracing itself for a new normal – in the way enterprises are run, services are rendered, everyday tasks are undertaken ...

Covid-19 is upending capitalism as we know it. Amid the pandemic, how can businesses rewrite their rule books so as to emerge stronger? Americans have allegedly outbid the French for masks “right on the tarmac” just as the goods were to be flown off to their destination. From Amazon to Rakuten to Carousell, traders exploited fears by price-gouging on masks and hand sanitisers ...

On May 16, 2022, the Colorado Supreme Court issued an opinion that serves as a cautionary tale for health care providers hoping to bill patients at chargemaster rates. The court’s decision in French v. Centura Health turned on the meaning of the phrase “all charges of the Hospital,” as set forth in the hospital service agreement (HSA) signed by Ms. French. Centura argued that the phrase “unambiguously refers to a hospital’s chargemaster rates.” Ms ...

Dykema | June 2022

Hidden among its flurry of end-of-term blockbusters, on June 27, 2022, the U.S. Supreme Court issued a long-awaited opinion inRuan v. United States. InRuan,the Supreme Court addressed the issue of whatmens reaa physician must possess to be guilty of illegally distributing controlled substances through the use of allegedly improper prescriptions ...

The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...

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 ...

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 ...

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 ...

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 ...

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 | 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 ...

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 ...

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 ...

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 ...

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 | 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 ...

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 | 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 | 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 ...

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 ...

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 ...

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 ...

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") ...

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