On May 14, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Final Rule (the Final Rule) until no earlier than Dec. 15, 2021 ...
The rapid spread of Covid-19 has placed the healthcare system in Thailand under severe pressure. Following the outbreak of the pandemic, new startups focusing on telemedicine have sprung up to take on the challenge of innovating the way healthcare services can be provided to patients ...
Regulation (EU) 2017/745 of 5 April came into force on 26 May to create a single set of rules applicable to all medical devices, other than in vitro diagnostic medical devices. Here are some of the main changes to the rules that now come into force: 1. Broadening of the scope of application of the rules and of the concept of medical device With this Regulation, medical devices without a medical purpose that have characteristics similar to medical devices (e.g ...
Earlier this year, Scotland won the Calcutta Cup at Twickenham for the first time since 1983, thanks to a try from Duhan Van Der Merwe. The football team heads to Wembley this summer hoping to replicate the success of their rugby counterparts. The attack will likely be led by a strike pairing born in Leicester and the Gold Coast. Both these footballers qualify for Scotland due to family connections ...
Remember Nirvana? There have been reports about an interesting copyright infringement case involving the grunge band Nirvana, a band that is still associated by many with frontman Kurt Cobain. Yet this case does not involve music copyright. Rather it deals with copyright in an artistic work, a drawing. How about Dante’s Inferno? The case has been brought by a lady called Jocelyn Susan Bundy. Bundy is the granddaughter of C.W. Scott-Giles, a heraldry expert who died in 1982 ...
Our latest article in the series looking at the impact of the pandemic on different groups focuses on how COVID-19 has affected those within ethnic minorities, what this has meant for the BLM movement and what employers can do to better support employees. Impact of COVID-19 The latest statistics all point to the fact that the COVID-19 pandemic has disproportionately affected those within ethnic minorities ...
New measures for state contracting for economic reactivation. Through Decree 579 of 2021, issued on May 31 by the National Planning Department, certain transitory paragraphs enshrined in Decree 1082 of 2015 or the sole Regulatory Decree of the Administrative Planning Sector, were replaced in matters of state contracting ...
Introduction The Covid-19 vaccine is currently being rolled out, and according to the authorities’ vaccination-plan, a large part of the population will receive their first dose during the summer months. As a rule, one must take the vaccine in one’s own home municipality, and not in the municipality where one has a summer house etc. In addition, the authorities are working on a corona certificate ...
The Centers for Medicare & Medicaid Services (CMS) recently issued a new rule modernizing the “Stark Law” regulations. The rule aims to advance value-based care and ease the regulatory burden on physicians. Most of the reforms are effective January 2021; however, the rule includes important changes to how physician group practices may share profits that take effect next year ...
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...
The world is in an upheaval now with the pandemic raging for over a year. The discussions and decisions that probably would never have been made a few years ago are being made today in the interest of the greater good and the public at large. When Bill Gates expressed his reservations against lifting IP protection on vaccine patents, it left the world reeling and his comments understandably criticised by experts and laymen alike ...
OSHA Adopts CDC Vaccine Guidance. On May 17, 2021, the federal Occupational Health and Safety Administration (“OSHA”) updated its online COVID-19 portal to announce that OSHA is revising its employer materials to reflect recent interim guidance from the Centers for Disease Control and Prevention (“CDC”). In the meantime, OSHA recommends that employers “refer to the CDC guidance for information on measures appropriate to protect fully vaccinated workers ...
In Markit Systems (Pty) Limited v Fulcrum Group (Pty) Limited, the Gauteng Local Division of the High Court held that the customer was within its rights to cancel an agreement it had with a service provider because the parties had not been able to agree on the scope and details to be included in the schedule to the agreement ...
The third wave of COVID-19 is now spreading all over Thailand. The rise in confirmed numbers of cases and deaths has been reported by the Centre for the COVID-19 Situation Administration (“CCSA”). In response to the outbreak, the Ministry of Public Health announced a vaccination plan which ultimately aims to reduce the spread of COVID-19 infections by having around 50 million people (roughly 70% of the population) in Thailand vaccinated by the end of the year ...
We would like to inform you that the Russian President has signed amendments to Article 1360 the Civil Code of the Russian Federation ('Russian Civil Code'), in terms of providing compulsory licenses to use an invention, utility model or industrial design ('patent rights') on 30 April, 2021. The amendments came into force on 11 May, 2021 ...
The health crisis has not eased the tensions between the management and the trade unions of the Belgian National Orchestra (“BNO”). The pandemic has even caused an additional outbreak of ‘fever’, which even a Brussels Court of Appeal ruling on 7 May 2021 will probably not be enough to ‘cure’... At issue is the fate of musicians' rights to reproductions and broadcasts of their performances ...
The negative impact of COVID-19 across the social and economic spectrum is undeniable. We reflect on the findings from the Social Mobility Commission and consider how employers can help give a much-needed boost to social mobility moving forwards. Research recently published by the Social Mobility Commission has given a snapshot of public perceptions of where and whom the pandemic has impacted most ...
On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication ...
Following Prime Minister Boris Johnson’s recent announcement in Parliament, it is now certain that there will be a Public Inquiry into the handling of the pandemic. What is the planned Inquiry likely to consider, and who might be involved? For over a year now, the government’s focus has been on the here and now - managing and responding to the rollercoaster that is the COVID-19 crisis ...
On Thursday, May 13, 2021, the Centers for Disease Control (CDC) announced new guidance stating it is safe for fully vaccinated people to not wear masks or physically distance in any non-health care setting.1 Per this guidance, fully vaccinated people can now resume most activities without wearing a mask or physically distancing ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020 ...
On May 11, 2021, the Center for Medicare & Medicaid Services (CMS) announced a new rule that will require long-term care facilities and residential facilities serving clients with intellectual disabilities to educate and offer COVID-19 vaccines to residents, clients and staff. This new requirement will closely align with current requirements for influenza and pneumococcal vaccines in long-term care facilities ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life ...
