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Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures
ENSafrica, April 2021

ENSafrica recently released Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures. This comprehensive report outlines the COVID-19 regulatory measures for each country across Sub-Sahara Africa, providing the sector, measure, effective date/status and key points and impact for each region. The information provided herein is intended to provide a general overview, and is not an exhaustive list of all legislatice developments across Sub-Sahara...

CMS Announces Proposed Rate Increases and Other Changes for Skilled Nursing Providers and Hospice Providers in Fiscal Year 2022
Dinsmore & Shohl LLP, April 2021

On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year.  This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184...

Freeports – Planning FAQs
Shoosmiths LLP, April 2021

The designation of eight new Freeports within England made headlines in the Budget and now the winning bidders have to put into effect their successful proposals. What will this mean in practice for those areas affected and what are the likely issues that Freeport authorities will face? We have pulled together some questions we are asked frequently on Freeports, together with the responses we have been providing to our clients...

Legislative Proposal on Health Technology Assessment
PLMJ, April 2021

On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare...

Clinical Trials in Portugal
PLMJ, April 2021

Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether...

Chile Announces Stricter Quarantine Measures due to New Wave of Covid-19
Carey, April 2021

The Chilean Ministry of Health, through a press conference, announced on Thursday, April 1 st , that the following measures will be implemented as of Monday April 5 th : The country's borders will be closed during the mont

Real Estate IHL Series – HeartMath
Shoosmiths LLP, March 2021

Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours...

Kudun & Partners Leads Largest Group of Creditors in Thai Airways Business Rehabilitation Proceeding
Kudun and Partners, March 2021

In August 2020, Kudun & Partners was appointed to represent the largest group of creditors, consisting of 87 savings cooperatives, in the wake of the recent Thai Airways’ petition for rehabilitation. Taken together, these investment entities hold 65% of the airline’s total debenture debt, making them the largest group of creditors...

Government Announces a Social Protection Network Strengthening
Carey, March 2021

On March 22, 2021, through a televised address, the President of the Republic announced the strengthening and extension of the Social Protection Network, destined to mitigate the adverse effects caused by the restrictions due to the COVID-19. These measures are based on 5 pillars: • Greater protection to the families’ incomes. • Strengthening of the middle-class support. • Greater job protection...

Bulletin Real Time: Latest News
Brigard Urrutia, March 2021

Beginning of Stage 2 of the National Vaccination Plan The Colombian Ministry of Health and Social Protection (Minsiterio de Salud y Protección Social) declared the initiation of stage 2 of the National Vaccination Plan against COVID-19 for the population between 60 and 79 years of age. This does not mean that vaccination for those over 80 years of age will be stopped; these people will continue to be vaccinated without any interruption...

How Does The American Rescue Plan Affect Welfare Benefit Plans?
Dykema, March 2021

President Biden signed the American Rescue Plan Act of 2021 (the Act) on March 11, 2021. The Act provides COBRA premium subsidies, increases the tax-exclusion amount for employer-sponsored dependent care assistance programs and expands who may be eligible to receive premium tax credits for marketplace coverage. This alert explains how these provisions may impact your welfare benefit plans. Please contact your Dykema benefits attorney to explore the new provisions in greater depth...

Does Pandemic Fatigue Give Rise to a Duty to Accommodate?
Lawson Lundell LLP, March 2021

Now that we have persevered through one year of the COVID-19 pandemic, much has been written about pandemic fatigue and associated social isolation, mental stress, and anxiety. Employers may be seeing an increase in the incidence of mental illness claims in their workplaces...

2021 Open Payments (Sunshine Act) Reporting Window Closes March 31
Dinsmore & Shohl LLP, March 2021

As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020...

Health-Care Providers Still Stymied on Evidence Needed to Prove FCA Violation
Bradley Arant Boult Cummings LLP, March 2021

Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S...

Comment Period Extended for Extensive Changes to HIPAA Privacy Rule
Dinsmore & Shohl LLP, March 2021

On March 9, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public-comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on Dec. 10, 2020, and it was published in the Federal Register on Jan. 21, 2021...

Nursing Home Visitation Resumes Amid COVID-19 Vaccination Rollout
Dinsmore & Shohl LLP, March 2021

On March 10, 2021, the Centers for Medicare & Medicaid Services (CMS), in association with the Centers for Disease Control and Prevention (CDC), issued updated guidance for nursing homes to resume visitation options during the COVID-19 pandemic. Nursing homes have been devastatingly effected by COVID-19, with outbreaks causing high rates of infection and death...

Amendment of the Rules on Affiliation and Financial Support for Healthcare Professionals
Plesner, March 2021

In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021...

David McCombs, Eugene Goryunov, Dina Blikshteyn and Roy Falik in Bloomberg Law: ‘COVID Testing and Patentability’
Haynes and Boone, LLP, March 2021

In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide...

Life Sciences & Healthcare January/2021
Veirano Advogados, March 2021

CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes"...

The Outlook for the Leisure Marine Sector
Shoosmiths LLP, March 2021

Shoosmiths hosted one if its best attended Shoosmiths Aviation & Marine Breakfast Association (SAMBA) webinars on 25 February. Joined by representatives from industries across the marine spectrum (boatbuilding, finance, insurance, marinas and the RYA) Elliot Bishop and Sarah Fairweather discussed the impact of Covid and Brexit on the leisure marine sector in particular and the outlook for the coming year...

Bulletin Real Time: Latest News
Brigard Urrutia, March 2021

Norms are issued for individual selective isolation with responsible distancing. The National Government issued a new decree to regulate selective distancing, individual responsibility and economic reactivation that will govern until May 2021...

COVID-19 Products: Health Canada and Competition Bureau Watch Out for Misleading Claims
Lavery Lawyers, February 2021

It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants...

Buchalter COVID-19 Client Alert: Cal-OSHA Wins First Round in Major Court Challenge to its COVID-19 Emergency Regulation
Buchalter, February 2021

Cal-OSHA’s COVID-19 regulation remains in effect after the trial court rejected a motion for a preliminary injunction filed by a coalition of employers. This included challenges to: (1) compensation for employees excluded from work; (2) mandated testing; and (3) health and safety requirements for employer-provided housing and transportation. Therefore, employers must continue to abide by the requirements of the emergency regulation...

Telehealth Fraud and Abuse: What’s Next in Compliance and Enforcement for Healthcare’s Hottest Area?
Bradley Arant Boult Cummings LLP, February 2021

In 2020, telehealth went from promising ancillary issue to center stage in the healthcare industry. Regulators and law enforcement took notice. With enforcers’ attention now squarely on telehealth fraud and abuse, telehealth providers and companies are poised to be among the main targets for civil and criminal enforcement in the coming years. Webinar Recording Key Takeaways Telehealth is a key enforcement priority for federal and state enforcement agencies, including the U...

Travel to India during COVID-19
Kochhar & Co. Advocates & Legal Consultants, February 2021

This article has been updated based on the available information until 20th February 2021. As Government notifications are constantly revised, it is advisable to consult your attorney or visit the website of the relevant Government agency prior to travelling. Further, in additional to the guidelines published by the Central Government, passengers are also requested to refer to State specific official websites to be well informed about any additional requirements...



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