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Dinsmore & Shohl LLP | June 2021

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 ...

Kudun and Partners | June 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 ...

Shoosmiths LLP | June 2021

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 ...

Brigard Urrutia | June 2021

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 ...

Simonsen Vogt Wiig AS | June 2021

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 ...

PLMJ | May 2021

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 ...

DFDL | May 2021

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 ...

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 ...

Shoosmiths LLP | May 2021

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 ...

Shoosmiths LLP | May 2021

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 ...

The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...

Shoosmiths LLP | May 2021

For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...

Buchalter | May 2021

By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...

On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...

More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...

The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access ...

On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations.  The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org,  a non-governmental website marketing consulting service ...

Shoosmiths LLP | May 2021

The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...

The COVID-19 pandemic has presented many novel challenges and questions for employers, from administration of Families First Coronavirus Response Act (“FFCRA”) leave to managing performance of remote workers. For healthcare providers, these challenges and questions have been only one of many burdens of operating during a pandemic. As vaccines become more widely available, the pandemic raises new challenges, some unique to employers in the healthcare industry ...

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