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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Buchalter | July 2020

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 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 ...

Waller | July 2020

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 ...

Buchalter | July 2020

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 ...

Dykema | July 2020

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 ...

ALRUD Law Firm | July 2020

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 ...

Hanson Bridgett LLP | July 2020

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 ...

Waller | July 2020

The impacts of COVID-19 appear set to permanently expand telehealth and fundamentally transform how and where providers practice. Shortly after the start of the pandemic, CMS made major temporary federal policy changes in response to the pandemic, including expanding access to telehealth services for people with Medicare, such as home health visits, and reimbursement for additional services when furnished via telehealth ...

Waller | July 2020

The use of telehealth skyrocketed during the COVID-19 public health emergency, as many regulatory barriers restricting its use were temporarily removed at the federal and state level and by private payors. Providers and patients adapted to the changes and are now relying on these flexibilities to deliver and receive high quality virtual care. This rapid expansion of the use of telehealth has ignited the need for permanent telehealth reform ...

Buchalter | July 2020

On July 10, 2020, in United States v. Ruan, the Eleventh Circuit affirmed the convictions of two Alabama doctors for running an opiate “pill mill.” Among many other things, the government charged that the doctors used “incident to” billing to charge Blue Cross Blue Shield of Alabama under the doctor’s identification for visits conducted entirely by nurse practitioners, which that insurer (unlike some others) prohibited under its policy ...

Deacons | July 2020

On 23 June 2020, the Chinese government announced the Special Administrative Measures (Negative List) for Foreign Investment Access (2020 Edition) (2020 National Negative List) and the Special Administrative Measures (Negative List) for Foreign Investment Access in Pilot Free Trade Zones (2020 Edition) (2020 FTZ Negative List). The 2020 National Negative List and the 2020 FTZ Negative List (2020 Negative Lists) will come into force on 23 July 2020 ...

Deacons | July 2020

On 9 July 2020, the Employment (Amendment) Bill 2019 (Bill) was passed at the Legislative Council. The Bill introduces amendments to the Employment Ordinance (Ordinance) to extend the statutory maternity leave period from 10 weeks to 14 weeks, and technical amendments to rationalise the current statutory maternity leave regime (Amendments). We summarise the effect of the Amendments as follows:     Current position New position 1 ...

Buchalter | July 2020

U.S. Trademark laws are based on the premise that rights in a trademark exist so long as the mark is continuously used in interstate commerce. Once you cease use of the mark without an intention of resuming such use, the mark may be subject to cancellation or abandonment by a third party ...

Buchalter | July 2020

By: John Epperson San Francisco’s Board of Supervisors passed an Emergency Ordinance on July 7 entitled “Cleaning and Disease Prevention Standards in Tourist Hotels and Large Commercial Office Buildings” (the “EO”). The EO is expected to be signed by the Mayor and go into effect soon ...

Waller | July 2020

Rohit Chopra, the head of the Federal Trade Commission, recently issued a statement regarding private equity roll-ups in connection with the FTC’s annual report to Congress related to the Hart-Scott-Rodino (HSR) Act. The full text of the statement can be found here ...

Hanson Bridgett LLP | July 2020

Key Points The Supreme Court's upcoming decision regarding the Affordable Care Act could render its tax provisions retroactively unconstitutional. Depending on the outcome, there is a potential opportunity for refunds on open tax years for taxpayers who paid the net investment income tax and additional Medicare tax. For most taxpayers, the deadline for a protective claim of refund on a 2016 tax return, filed without extensions, is July 15, 2020 ...

ALTIUS/Tiberghien | July 2020

With the exit from lockdown in full swing, many companies are recalling their staff to the workplace. This article answers 10 FAQs that employers, business managers and HR specialists must consider during employees' return to work. FAQs Must employers respect health and safety measures on their employees' return to work and, if so, which ones?Yes, to the extent possible, social distancing (ie, maintaining a distance between people of at least 1 ...

Afridi & Angell | July 2020

During these unprecedented times, developers all over the world are actively looking for solutions to deal with underperforming real estate. For developers in the United Arab Emirates (UAE), real estate investment funds (otherwise known as REITs) may offer a solution to the problem. A REIT is a public or private investment fund which is established to invest a certain percentage (as stipulated by law) of its assets in real estate ...

Shearn Delamore & Co. | July 2020

Introduction The Covid-19 global pandemic which has swept the globe and caused many countries to introduce various degrees of lock down measures has given rise to various issues and scenarios which an employer must deal with and manage. This is no different for employers in Malaysia where the Government has implemented the Movement Control Order (“MCO”) since 18 March 2020 which saw the economic activity brought to a halt ...

Waller | July 2020

CHALLENGE Promise Healthcare Group, LLC was one of the nation’s largest healthcare providers focused on post-acute care services. The investor-owned company operated two freestanding medical-surgical hospitals, 14 long-term acute care hospitals (LTACHs), and two skilled nursing facilities. The company also had 45 affiliates across eight states ...

TSMP Law Corporation | July 2020

What lies in the new frontier of investment regulation? On May 26, the New York Times reported that the US Justice Department had dropped investigations into three US senators’ stock trades conducted shortly after they had been privately briefed on the novel coronavirus in January. The politicians had dumped millions of dollars of shares in Exxon Mobil, tech giants and real estate companies, some of which later lost value when markets plunged ...

The glacial pace at which the federal government has implemented cannabis policy–particularly in light of the rapid evolution of cannabis laws at the state level–is at the same time predictable and frustrating to those seeking a measure of certainty ...

As is painfully obvious to even the most casual of observers, the COVID-19 public health emergency has been disruptive to all industries. And, the healthcare industry has been at the epicenter of this disruption. Nonetheless, not all disruption is negative. One bright spot for many healthcare practitioners during this public health crisis has been the emergence and normalization of telehealth ...

As is painfully obvious to even the most casual of observers, the COVID-19 public health emergency has been disruptive to all industries. And, the healthcare industry has been at the epicenter of this disruption. Nonetheless, not all disruption is negative. One bright spot for many healthcare practitioners during this public health crisis has been the emergence and normalization of telehealth ...

Carey | July 2020

On July 2nd, the Ministry of Health published Decree No. 21 of 2020, amending Decree No. 4 of 2020, which declared sanitary alert in the country ...

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