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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
A ship may be arrested in Malaysia as long as the claim of the arresting party falls under any of the provisions of Section 20(2) and Section 21 of the Supreme Court Act 1981 of England and Wales.Any party that wants to arrest a ship in Malaysia must strictly comply with Order 70 of the Rules of Court 2012 (the ROC 2012), which governs admiralty proceedings in the High Court.On the arrest of a ship, it will not be allowed to work without the sheriff's express permission ...
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 ...
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 ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
This new Workplaces Manual covers all General Preventative Measures set for the by the following: Governmental Agreement 79-2020 Ministerial Agreement 146-2020 Presidential provisions in force Provisions of the Ministry of Public Health and Social Assistance Guide to the identification of occupational hazards by Covid-19 and preventive measures in the workplace - IGSS Regulation of Occupational Health and Safety The Manual covers the specifics of all factors involved in halting
On June 25, 2020, the U.S. Center for Disease Control and Prevention (CDC) broadened its guidance on who’s at risk of severe illness from COVID-19 due to underlying medical conditions and age. Under the new guidance, the CDC departs from previous guidance stating that only individuals over 65 years of age were at increased risk of COVID-19 due to age, and now states that risk from severe illness from COVID-19 increases with age ...
Report of the Department of Banks and Financial Institutions Health Emergency - BCRA Communication “A” 7048: adjustments to the national payment system. Yesterday, the Central Bank of the Argentine Republic (BCRA) issued Communication "A" 7048 (the " Communication "), through which certain adjustments were established on the national payment system. The Communication was issued in accordance with the provisions of Decree No ...
Civil Aviation Authority: All international flightsshall remain suspended untilJuly 22, 2020. National Immigration Authority: All identifications issued by the National Immigration Authoritythat weredue to expirebetween March 13 and July 31, 2020,willremain validuntilOctober 31, 2020,without incurring in fines or surcharges ...
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
