Key Points A permitting agency's blanket designation of an entire category of permit decisions as ministerial for purposes of the California Environmental Quality Act (CEQA) may be held to be improper if the agency has the ability to modify or deny the permit based on any concern that may be examined under CEQA review. Courts will afford a larger degree of deference to an agency’s designation of a single permit decision as ministerial on a case-by-case basis ...
For the past decade or so, the regulated community and federal courts alike grappled with the outer reaches of the Clean Water Act (CWA) point source permitting program. The core of the program—the National Pollutant Discharge Elimination System (NPDES)—is clear enough. Under the NPDES program, discharges from point sources to navigable waters (what qualifies as “navigable waters,” i.e ...
A wastewater facility on the island of Maui, Hawaii, collects sewage, treats it, and pumps the treated water through underground wells. The water then travels half a mile, through groundwater, into the Pacific Ocean. Must the facility possess an EPA permit to do this? In April, the Supreme Court of the United States answered this question with a rather drawn-out "maybe ...
The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers ...
Skilled nursing facilities have faced unprecedented challenges since the outbreak of the coronavirus pandemic. Individuals with many high-risk characteristics are the typical patients of these facilities. Add to this, necessarily close proximity of these patients, scarcity of personal protective equipment and shortage of testing common across the healthcare industry, and you have a perfect storm of increased risk with limited options for mitigation ...
On August 6, 2020, the U.S. Court of Appeals for the First Circuit affirmed the conviction of Massachusetts gynecologist Rita Luthra for criminal HIPAA violations and obstructing a health care investigation. Although such HIPAA prosecutions are uncommon, the case underscores the risks health care providers and others run when handling protected patient information and when speaking with government investigators ...
In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19 ...
Did you know? The new Trade Marks (Amendment) Ordinance 2020 which came into effect on 19 June 2020 empowers the Registrar of Trade Marks to make the rules for implementing the long-awaited Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (the “Madrid Protocol”) in Hong Kong ...
Article previously published in insider.co.uk Why are we not treating climate change like the pandemic? The COVID-19 pandemic has received 24/7 media coverage across the globe, and with good reason. Coronavirus has had a catastrophic impact, claiming the lives of hundreds of thousands of people, devastating our economies and materially changing the lives of millions as we try to adapt to the profound societal changes it has inflicted ...
The Hong Kong Money Authority (HKMA) published a White Paper on 30 June 2020 to set out its recommendations and supervisory expectations on green and sustainable banking around four areas: governance, strategy, risk management and disclosure. The HKMA advised AIs which are subsidiaries of international banks to assess relevance of any parent bank’s climate policy in the context of its Hong Kong operations and ensure that local specialties are addressed ...
In May 2020, the Asia Pacific Loan Market Association (APLMA), the Loan Market Association (LMA) and the Loan Syndications and Trading Association (LSTA) jointly published two guidance papers on green loan principles and sustainability linked loan principles, seeking to address some of the most frequently asked questions about green loans and sustainability linked loans (SLLs) ...
Key Points New York federal district court vacates the DOL’s “health care provider” definition in the DOL’s Final Rule implementing the Families First Coronavirus Response Act. The court also vacates the DOL’s employer consent requirement for intermittent leave and the “unable to work” requirement for receipt of leave benefits. The national impact of the decision is currently unknown as the DOL contemplates next steps ...
Electronic cigarettes and vaping have been heralded by many as a safer alternative to smoking traditional cigarettes. An outbreak of illnesses last fall allegedly related to vaping, however, ignited public hysteria and will almost certainly lead to substantial mass tort litigation aimed at manufacturers of e-cigarette devices and vaping liquids ...
The High Court has left the door open for a negligence claim to be pursued against a UK company on behalf of a shipyard worker who fell to his death dismantling an oil tanker at a Bangladeshi yard.1 The vessel had been sold to a buyer on terms requiring it to be scrapped in an environmentally sound manner and in accordance with good health and safety practices ...
The Department of Labor’s Wage and Hour Division (WHD) recently released streamlined forms employers may use to coordinate leave under the Family and Medical Leave Act (FMLA) ...
As workplaces continue to reopen, the U.S. Department of Labor (DOL) and Centers for Disease Control and Prevention (CDC) issued additional guidance addressing various return to work issues and leave under the Family and Medical Leave Act (FMLA) and Families First Coronavirus Response Act (FFCRA). The new DOL guidance, summarized below, appears on the DOL’s FFCRA Questions and Answers page ...
California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent ...
Key Points New CEQ rule updating NEPA to go into effect September 14, 2020. Development and other projects funded, assisted, or regulated by federal agencies will receive less scrutiny in the future. Highlights The Council on Environmental Quality (CEQ) issued a final rule to update its regulations for federal agencies implementing the National Environmental Policy Act (NEPA) ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
SB 977 was passed by the California Senate on June 26, 2020. If the bill is passed by the Assembly and becomes law, it will require health care systems, private equity groups, hedge funds, and academic medical centers to obtain advance approval by the California Attorney General for substantially all acquisitions or change of control transactions with health care facilities and providers ...
Eligible dental providers may now apply for Provider Relief Funds, but the deadline to do so, July 24, 2020, is quickly approaching. On July 10, 2020, the U.S. Department of Health and Human Services (“HHS”) announced an additional $4 billion in relief payments to healthcare providers and, notably, opened its provider portal to dental providers ...
As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system ...
In a landmark victory for Federally-qualified health centers, a California Court of Appeal confirmed last October that federal and state law requires the State of California to pay FQHCs “100 percent” of their costs of furnishing core and other ambulatory services to Medi-Cal beneficiaries. (Tulare Pediatric Health Care Center v. State Department of Health Care Services (2nd Dist. 2019) 41 Cal.App.5th 163 ...
