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 ...
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 ...
Since the Department of Health and Human Services (HHS) Provider Relief Funds (PRF) first started arriving in provider bank accounts on April 10, 2020, HHS has stated that it will issue additional guidance “soon” on mandatory reporting requirements on how use of funds must be reported. The PRF funds are among the funds Congress appropriated to reimburse eligible healthcare providers for healthcare-related expenses or lost revenues attributable to COVID-19 ...
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 ...
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) ...
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 ...
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 ...
As healthcare providers pursue transactions during and in the wake of COVID-19, both buyers and targets should prepare for heightened scrutiny during the due diligence process. Getting organized ahead of a sale can dramatically expedite timelines and reduce deal fatigue for all parties, particularly in light of the heavier-than-normal due diligence process as a result of the pandemic. Click here for a full PDF of this report ...
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 ...
A new reimbursement model intended to address healthcare access and availability in rural communities was introduced by The Centers for Medicare & Medicaid Services (CMS) Innovation Center. The Community Health Access and Rural Transformation (CHART) Model will “provide up-front investments and predictable, capitated payments that pay for quality and patient outcomes,” according to CMS ...
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 ...
Tennessee Governor Bill Lee has signed into law the Tennessee COVID-19 Recovery Act which provides liability protection from claims related to the COVID-19 pandemic. The Waller Government Relations team worked closely with the Tennessee Chamber of Commerce and Industry and various stakeholders in recent months to achieve passage of the Tennessee COVID-19 Recovery Act ...
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 ...
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 ...
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 ...
The Federal Ministry of Transport and Digital Infrastructure (BMVI) is providing EUR 50 million annually until 2023 to promote computer games in order to strengthen Germany as a location for developers. In the first phase,de minimis funding will be provided with grants of up to EUR 200,000. In a second phase larger-scale funding will also be possible ...
On August 25, 2020, Board Resolution No. 003-2020-EF/68.0 was published in the Official Gazette “El Peruano”, approving the “Guidelines for the State's response to the potential impacts of the COVID-19 pandemic on Public Private Partnership projects” (the “Guidelines”) ...
Executive summary The COVID-19 pandemic has created significant challenges for smaller hospitals and health systems. It has presented significant challenges to smaller, less capitalized and otherwise distressed healthcare providers. In terms of operating performance, half of our country’s hospitals reported negative margins as Q1 of 2020 ...
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 ...
Key Points A new FDA rule clarifies when food manufacturers may label fermented or hydrolyzed foods as gluten-free. Manufacturers making gluten-free claims must maintain records showing that the foods or food ingredients used in the foods are gluten-free prior to fermentation or hydrolysis. A product marked as gluten-free may be deemed misbranded under the Food, Drug, and Cosmetics Act if its manufacturer does not maintain supporting documentation to the satisfaction of the FDA ...
