The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery ...
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 regulatory change proposed by the Department of Health and Human Services (HHS) in the recent HIPAA Notice of Proposed Rulemaking (NPRM) is another step toward HHS’s objective to encourage a patient-centric healthcare environment. The HIPAA NPRM proposes to tilt the balance of protecting privacy and facilitating the availability of information toward loosening restrictions on disclosures of patient information ...
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 ...
The most recent changes to the Stark Physician Self-Referral Law (Stark) and the Anti-Kickback Statute (AKS), described previously here, create a new lexicon and framework to guide healthcare providers from payment for volume-based services to payment for value-based healthcare. These value-based rules go into effect on January 19, 2021 ...
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 ...
The underlying dispute relates to the MV «Cheshire» incident in 2017, where a cargo of fertiliser was subject to a major decomposition incident. The fertiliser that was carried on the vessel was damaged, and the vessel was declared a total loss. In February 2020, Oslo District Court ruled in favour of the cargo interests, holding the carriers liable for the cargo loss (approx. USD 25 million) (TOSLO-2017-180657-1). The carriers have appealed the judgement ...
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 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 ...
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 ...
Apparently, the OCR has a different concept of the holiday spirit than many others do. On December 22, OCR announced the 13th settlement agreement related to its Right of Access Initiative. This time, the provider settled for $36,000 and agreed to enter into a corrective action plan. This latest matter involved Peter Wrobel, M.D., P.C., d/b/a Elite Primary Care ("Elite"). The situation follows a very familiar pattern: a patient requested records but did not receive them ...
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 ...
At Lavery, we spend a lot of time searching patent databases on behalf of our clients. Occasionally, we come across certain patents / applications whose cleverness and creativity make a lasting impression. At this time of year, our attention is naturally drawn to those that are holiday themed. And so, in the spirit of the holidays, we thought it would be nice to share some of them with you ...
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 ...
