If parents cannot agree whether their children should be vaccinated, they can make an application under Section 8 of the Children Act 1989 to ask a judge to determine the issue. In M v H (Private Law Vaccination) [2020], the mother objected to the parties' two children aged six-years-old and four-years-old being given routine childhood vaccines in accordance with the NHS vaccination schedule ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules) ...
The Court of Protection is a specialist Court, focussing solely on supporting vulnerable individuals. This past year has acutely highlighted the needs of those most vulnerable in our society and their dependency on others to help manage their affairs. The Court has had to adjust its practices in order to ensure that help and solutions are found for those lacking capacity with minimal delay ...
The State of Ohio Board of Pharmacy (OBP) is required to adopt a resolution specifying the required types of credentials for the responsible person of each business type of (i) terminal distributors of dangerous drugs and (ii) distributor of dangerous drugs. Only individuals who meet the credentials specified may be the responsible person for that type of business. On Jan ...
For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i] the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions ...
On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective ...
The City and County of San Francisco (SF) issued a COVID-19 surge-related travel and quarantine order (Quarantine Order) on Dec. 16, 2020, and an updated Shelter-In-Place Order (SIP Order) on December 9 (updated Dec. 30, 2020). Under those orders, every person who enters SF after having been outside the Bay Area within the last ten days must quarantine for 240 hours from the time of arrival in SF. However, two exceptions apply to those working on construction projects in SF ...
Coming to Grips with Hospital Price Transparency – DC Circuit Rejects American Hospital Association’s Effort to Invalidate Price Transparency Requirements Rule Since 2010, Section 2718(e) of the Public Health Service Act has required hospitals to establish and publish annually “a list of the hospital’s standard charges for items and services provided by the hospital ...
On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry ...
The 2020 Investment Priorities Plan (2020 IPP) has been promulgated by the Philippine President under Memorandum Order No. 50 dated November 18, 2020 (https://www.officialgazette.gov.ph/downloads/2020/11nov/20201118-MO-50-RRD.pdf), and it became effective on December 6, 2020. The IPP is issued pursuant to the Omnibus Investments Code of 1987 (Executive Order No. 226), as amended (Omnibus Investments Code) ...
Last week, the Equal Employment Opportunity Commission (“EEOC”) updated its COVID-19 guidance to address workplace issues related to COVID-19 vaccines, including mandatory vaccination policies. According to the EEOC, employers may mandate vaccines, but must attempt to accommodate employees who refuse vaccination because of disability or a sincerely held religious belief, practice, or observance ...
Introduction If 2020 has been defined by COVID-19 pandemic, the healthcare industry in 2020 might be defined by a related single issue — telehealth. Those phenomena are obviously connected. While telehealth has been around in varying forms for years, COVID-19 accelerated its growth, use, and acceptance in unprecedented ways. With that growth comes changes. Reimbursement rules have evolved as telehealth has grown and become more accepted ...
Introduction If 2020 has been defined by COVID-19 pandemic, the healthcare industry in 2020 might be defined by a related single issue — telehealth. Those phenomena are obviously connected. While telehealth has been around in varying forms for years, COVID-19 accelerated its growth, use, and acceptance in unprecedented ways. With that growth comes changes. Reimbursement rules have evolved as telehealth has grown and become more accepted ...
While most Americans are likely aware that President Donald Trump signed a pandemic relief and government spending bill into law on Dec. 27, 2020 (the “Omnibus Bill”),[i] it is important for those who have intellectual property assets to understand that tucked away into this nearly 5,600-page legislation are laws impacting copyrights, trademarks, and patents ...
Congress reached agreement on the third round of coronavirus-related relief measures (totaling approximately $900 Billion) as this issue was being written. The relevant statutory language is part of the massive Consolidated Appropriations Act, 2021 (the “Act”) and was released on December 21, 2020. Passage by the House and Senate was swift, and approval by the President is expected ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules). This alert is a part of the Dinsmore Health Care practice group’s ongoing summary of the Final Rules ...
Summary Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices. Although non-binding, these actions foreshadow the regulation of sesame as a major food allergen in the future. Two recent legislative actions and an FDA publication address emerging concerns about sesame as an allergen. The U.S ...
Key Points Employers may mandate employee COVID-19 vaccination programs, subject to certain exemptions. When requiring employee vaccinations, employers should consider the fact that these COVID-19 vaccines are currently approved under the FDA's Emergency Use Authorization (EUA). Mandatory employer COVID-19 vaccination programs must include religious and disability-related employee exemptions. INTRODUCTION On Dec ...
Is coronavirus vaccination a cure that will solve many challenges faced by employers or does it just inject further issues for employers to deal with? We answer the key questions. To be vaccinated or not to be vaccinated? That is the question... being discussed in homes and in workplaces up and down the country ...
With employees potentially returning to the workplace, we take a look at what will need to be done to tackle a number of mental health challenges – both for people and the companies they work for. Part three of our mental health series. With the second lockdown now over and the tier system fully in play, some employers are finding themselves able to open and trade again ...
All eyes were on health care in 2020, as the industry faced unprecedented challenges presented by the global coronavirus pandemic. Stories and images of overburdened frontline health care workers dominated the news cycle for most of the year, and the rapid development of one or more seemingly effective vaccines has engendered a cautious optimism for a return to normalcy in 2021 ...
Non-surgical extended duration therapeutic services (NSEDTS) are services which have a significant monitoring component that can: extend for a lengthy period of time, are not surgical, and typically have a low risk of complications after the assessment at the beginning of the service ...
