BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
Introduction While the long-term litigation effects of the COVID-19 pandemic may not materialize for months – or even years – it is important for tort litigation attorneys and their clients to begin preparing now for potential legal issues that may arise. This bulletin is intended to serve as a non-exhaustive list of tort-focused legal considerations for health care providers, product manufacturers, and their attorneys in the new and ever-evolving COVID-19 landscape ...
May 31, 2023 By: Marissa Alkhazov Governor Jay Inslee signed HB 1047, Washington State’s Toxic-Free Cosmetic Act (the Act) into law on May 15, 2023. The Act bans some of the most concerning chemicals added into cosmetic and personal care products, including PFAS, phthalates, formaldehyde and formaldehyde releasing agents ...
This article has been updated based on the available information until 20th February 2021. As Government notifications are constantly revised, it is advisable to consult your attorney or visit the website of the relevant Government agency prior to travelling. Further, in additional to the guidelines published by the Central Government, passengers are also requested to refer to State specific official websites to be well informed about any additional requirements ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1] The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...
We look at the legal framework within which the dispute between the UK Covid-19 Inquiry and the Cabinet Office over the former Prime Minister’s WhatsApp messages and diaries has developed, and possible consequences for the Inquiry depending on the outcome. What has the Cabinet Office been asked to provide? On 21 April 2023, Baroness Heather Hallett, Chair of the UK Covid-19 Inquiry (‘the Inquiry’) issued a Section 21 Notice to the Cabinet Office (‘the Notice’) ...
On 31 August 2022, the UK COVID-19 Inquiry (“the Inquiry”) opened its second Module. Module 2 will examine the political and administrative decision making of the UK and devolved governments, with a particular focus on early 2020 ...
As the Covid-19 Inquiry reaches Module 2 of its timeline and it turns its attention to the political and administrative decisions made at the height of the pandemic, Shoosmiths looks at the history of public inquiries to reflect on their purpose and effectiveness in preventing future mistakes of the same kind. Reviewing previous public inquiries may inform us about the likely trajectory of the Covid-19 Inquiry ...
Shock to UK employment world The UK employment model was turned on its head by COVID-19 and the restrictions brought in by the Government. The seismic effects of the restrictions and the speed with which they were introduced tested the adaptability and resilience of employers and employees in a way not seen previously in the UK ...
As we gear up for the UK Covid-19 Inquiry’s first full public hearing on 13 June, here is a reminder of what has been covered to date, followed by a list of issues to be covered within the scope of the first (Module 1) investigation. Inquiry to date the Inquiry was formally established by the Chair (Baroness Heather Hallett) on 28 June 2022, at which time the final Terms of Reference were published by the Government (UK COVID-19 Inquiry: terms of reference - GOV.UK (www.gov ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
Introduction The UK government has recently adopted a series of recommendations aimed to face the Coronavirus outbreak due to the rise in the number of infections and deaths caused by this virus. The strict approach of the UK Government would be in line with the measures adopted by the other countries in Europe, such as Italy or Spain ...
On 30 March 2020, the Ukrainian Parliament adopted the Law "On Amendments to Certain Legislative Acts Aimed to Ensure Additional Social and Economic Guarantees Due to the Coronavirus Disease (COVID-2019) Spread" (the Law), which introduces to the Ukrainian legislative environment new complex rules aimed at minimizing the negative impact of the spread of the COVID-19 in Ukraine. The below summary focuses on key changes introduced by the Law ...
Under a new state law that takes effect January 1, 2020, California health care facilities and other entities must report any written allegations that a physician or other healing arts licensee has sexually abused or engaged in sexual misconduct with respect to a patient. Sexual misconduct is defined as "inappropriate contact or communication of a sexual nature." SB 425 (Hill) amends the Business and Professions Code to add a new provision, Section 805.8 ...
WHAT IS A CON? A Certificate of Need (CON) is a permit authorizing the establishment, modification, or construction of a healthcare institution, facility, or service at a designated location. Obtaining a CON is a prerequisite to obtaining licensure from the State of Tennessee for certain enumerated health services and facilities. The Health Services and Development Agency (HSDA) regulates the healthcare industry in Tennessee through the CON program ...
The White House announced on Monday, Sept. 20, 2021, that in early November of this year, it intends to end the COVID-19 travel bans imposed in 2020 and replace them with vaccination and COVID-19 testing requirements for almost all travelers ...
This eighth edition of Unprecedented, our weekly update on COVID-19-related litigation, follows what we hope was a restful and meaningful Memorial Day weekend. For the third week in a row, shutdown challenges, workers' compensation claims, and wrongful death lawsuits have dominated the news cycle. But, we are also seeing a continuation in refund claims and an uptick in fraud claims involving everything from alleged misuse of sick days to corporate press releases ...
This fall, an outbreak of lung illnesses allegedly related to vaping ignited public hysteria and legislative reactions in many states. The vaping and cannabis industries are already paying, and will continue to pay, high reputational and policy costs associated with these events, and the industries should also be aware that the widespread nature of reported injuries could lead to a substantial amount of costly mass tort litigation ...
After over two years of statewide eviction moratoria in the forms of executive orders, Judicial Council rules, and legislation, California's eviction moratorium was scheduled to come to an end on March 31, 2022. However, on March 31, 2022, Lt. Gov. Eleni Kounalakis, serving as acting governor while Governor Gavin Newsom was out of state, signed Assembly Bill 2179 into law, which took effect immediately ...
California Health and Safety Code section 1418.8 outlines the requirements a skilled nursing facility (SNF) must follow when a physician prescribes a medical intervention that requires informed consent for an "unfriended" resident, meaning an individual who lacks capacity and does not have a person with legal authority to make health care decisions on their behalf. Section 1418 ...
Earlier in the year, we reported on the government’s announcement of increases to visa and nationality fees. These increases to application fees came into force on 4 October 2023, other than the substantial increase to the Immigration Health Surcharge (IHS) which was expected to come ‘later in the autumn’ ...
We would like to provide you with an update on some changes in the legal regulation of medicines in Russia made due to dynamic spread of the coronavirus (COVID-19) ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
Even though OSHA has advised that no specific standard covers the novel coronavirus, human resource and safety personnel must be mindful of the generally-applicable standards that might apply. OSHA has issued several guidelines that, while not the rule of law, do offer guidance on addressing COVID-19 issues, including recordkeeping and 300 log reporting obligations. On April 10, OSHA issued guidance that appeared to limit what cases would be required to be reported on OSHA 300 logs ...
