On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the physician self-referral law or Stark law ("Stark Law") ...
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
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 ...
The UAE continues to implement new measures on a daily basis to curb the spread of COVID-19. Those measures are being adopted, announced and implemented at a very rapid pace. For ease of reference, we present here a summary of the key measures that have been implemented by various UAE authorities between 18 March 2020 and the time of this inBrief, 9:00 a.m. on Friday, 3 April 2020 ...
“With our nation’s health care providers on the front lines in the fight against COVID-19, dollars and cents shouldn’t be adding to their worries.” - CMS Administrator Seema Verma. During this Public Health Emergency, the Centers for Medicare & Medicaid Services (“CMS”) has expanded its accelerated and advanced payment program (“Program”) to all Medicare-enrolled providers and suppliers (“Providers”) ...
On Friday, March 27, 2020, the CARES ACT was signed into law. The Cares Act includes provisions for changing deadlines for patents, trademarks, and copyrights. For patents and trademarks, the Act permits the Under Secretary of Commerce for Intellectual Property and the Director of the United States Patent and Trademark Office to change the deadlines imposed by Title 35 of the United States Code, the Trademark Act, Section 18 of the Leahy-Smith America Invents Act ...
Federal and state agencies continue to deliver tools and information to help healthcare providers respond to the COVID-19 pandemic since the President declared the COVID-19 outbreak a national emergency. The declaration gave the Secretary of the U.S. Department of Health and Human Services (“HHS”) authority to temporarily waive or modify certain requirements of federal healthcare programs ...
The Coronavirus pandemic is impacting every business sector across the globe. Many new resources, however, including the new Coronavirus Aid, Relief, and Economic Security (CARES) Act, provide franchise and hospitality businesses with opportunities for relief. The following information is intended to aid franchise and hospitality companies in understanding options available to them during this time ...
The United Nations has issued a “Global Call to Creatives” (the “Call”) asking content creators, influencers, advertisers, and others to help in translating public health messages “into work that will engage and inform people across different cultures, languages, communities and platforms ...
Many employers are facing diminishing revenues during the current Covid-19 epidemic. Many of those employers also face the need to reduce overhead. To provide some relief for employers, the Minister of Human Resources and Emiratisation promulgated Ministerial Resolution No. 279 of 2020 (the “Resolution”) on Employment Stability in Private Sector during the Period of Application of Precautionary Measures to Curb the Spread of Novel Coronavirus ...
Please note: The information, facts, and figures in this article are correct as of the publication date (1st April 2020). For up-to-date information and advice on this matter, please contact the author. The global COVID-19 pandemic has caused widespread instability in global markets and the resolution is not yet in sight. Thailand’s geographic and economic ties to China, where the outbreak began, initially positioned it as one of the highest-risk countries worldwide ...
Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines ...
On March 25, 2020, Governor Jim Justice signed into law House Bill 4497, which shall be known as The Alex Miller Law. The Alex Miller Law will take effect June 5, 2020, but the mandated requirements do not take effect until the 2021-2022 school year. Alex Miller, was a Roane County football player who collapsed and died during a high school football game. The Alex Miller Law (W. Va. Code 18-5-25c) requires defibrillators (AED devices) at certain events by the 2021-2022 school year ...
As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...
In an effort to streamline the provision of COVID-19 patients’ Protected Health Information (PHI) to public health authorities, the United States Department of Health and Human Services Office for Civil Rights (OCR) recently published practical guidance explaining the methods by which Health Insurance Portability and Accountability Act (HIPAA) Covered Entities may disclose COVID-19 patient PHI to law enforcement, first responders, and public health authorities ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...
As a growing number of the workforce is being affected by the COVID-19 pandemic, employers are raising several benefit related questions, particularly with respect to group health plans. The Employee Benefits Group at Hanson Bridgett will be providing updated information on possible issues arising in the benefits area through Benefits Alerts and postings on Hanson Bridgett's Online COVID-19 Resource Center ...
Pharmaceutical companies are meeting with numerous legal challenges resulting from the ongoing COVID-19 pandemic and the corresponding Government measures. Among the most discussed topics are the legal obligations relating to availability of medicinal products, securing of medicinal products for treatment of patients with COVID-19, control over the distribution channel, clinical trials, and relations with healthcare professionals ...
The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
In recent days, COVID-19 has been the greatest destabilizer worldwide. The World Health Organization defines coronavirus as an extensive family of viruses that cause respiratory infections that can range from common cold to serious health complications such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) ...
INVIMA’s specialized board for Medical Devices and other technologies issued a list of declared as Non-Available Vital Products to attend the emergency arising from COVID-19, which means that the import and / or local distribution of said products will be allowed in Colombia without having a Marketing Authorization ...
Due to the preventive isolation order issued through Decree 457 of March 22nd, 2020 and the powers granted to INVIMA in the sense of guaranteeing the prevention, diagnosis and treatment of Covid-19, within the current state of Economic, Social and Ecological energency ...
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
