On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...
On Friday, November 12, 2021, in BST Holdings, L.L.C., et. al. vs. Occupational Health and Safety Administration, et. al., Case: 21-60845, the Fifth Circuit Court of Appeals granted the plaintiffs’ motion to stay implementation of OSHA’s November 5, 2021 Emergency Temporary Standard (the “ETS”) requiring employees of covered employers to undergo COVID-19 vaccination or take weekly COVID-19 tests and wear a mask ...
CMS approved the Alabama Medicaid Agency’s applicationfor a 1115 Demonstration on October 21, 2021. The 1115 Demonstration, in combination with a 1915(c) Home and Community-Based Services (“HCSB”) Waiver and a 1915(i) Medicaid State Plan HCBS Program, will facilitate the creation of a new Community Waiver Program (the “Program”) ...
Apple Inc. v. Qualcomm Inc., Appeal Nos. 2020-1683, -1763, -1764, 1827 (Fed. Cir. Nov. 10, 2021) Our Case of the Week reinforces a developing body of law concerning standing to appeal from an adverse PTAB decision in an IPR. This is the second such decision arising from a global settlement between Apple and Qualcomm this year. We wrote about the first case, in April this year, here ...
In the recent case of Shanghai Shipyard Co. Ltd. V. Reignwood International Investment (Group) Company Limited [2021] EWCA Civ 1147 the Court of Appeal (COA) unanimously overturned the first instance decision and found a parent company guarantee to be a guarantee “on demand”. Despite arbitration proceedings having commenced under the underlying contract, the COA found the guarantor liable to pay $170 million under the guarantee ...
Circular Letter No. CL-2021-080, issued on 18 October 2021 by the Bangko Sentral ng Pilipinas (“BSP”), disseminates to all BSP-Supervised Financial Institutions (“BSFI”) the Anti-Money Laundering Council’s (“AMLC”) Guidelines on Digitization of Customer Records (“DIGICUR”) adopted via the AMLC Regulatory Issuance (“ARI”) A, B, and C, No. 2, Series of 2018 ...
On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...
Two new categories of tax-exempt bonds were created by the Infrastructure Investment and Jobs Act (H.R. 3684) (the Act) adopted by the House on Nov. 6, 2021: “Qualified Broadband Projects” and “Carbon Dioxide Capture Facilities ...
In Lloyd v Google, the Supreme Court denied claims for mere 'loss of control' and ruled against mass class actions for data claims. Here, Philip Tansley and Matthew MacLachlan consider the court's reasoning and the broader implications for such claims. Case In its landmark judgment today, the Supreme Court unanimously held that a representative class action brought on behalf of approximately 4 ...
In Kabab-Ji SAL v Kout Food Group, the UK Supreme Court recently considered the question of which system of law the English courts must apply to decide whether there is an enforceable arbitration agreement. This case illustrates the different approaches taken in determining questions of applicable law and the consequences this can have for both annulment and enforcement proceedings in different countries ...
The Centers for Medicare and Medicaid Services (CMS) has finalized its proposal to expand the experimental Home Health Value-Based Purchasing (HHVBP) Model to all 50 states and conclusively transition Medicare home health services to outcome-driven, value-based reimbursement beginning in calendar year (CY) 2023 ...
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art. This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...
The FCA has updated its guidance on remote and hybrid working – firms (and applicants) need to ensure they are up to speed with the revisions. On 11 October 2021, the FCA published an update on its guidance to firms (and applicants) on remote and hybrid working models ...
Increased public awareness of data protection regulations has sparked a rise in claims for damages associated with distress caused by data breaches. Many claims are made in response to serious breaches that have caused financial loss or significant distress, however organisations are increasingly receiving significant financial claims for relatively minor breaches ...
In association with Macmillan Davies and led by Employment Partner, Emma Morgan and Associate, Lauren Bholé, this webinar focused on the menopause in the workplace. With World Menopause Day having just passed (18 October 2021) and a parliamentary debate on the menopause having entered the House of Commons in September 2021, the menopause has been a focal point for media coverage ...
On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022. The vaccine rule that was also released on Nov ...
OSHA’s long-anticipated (as we have previously discussed) COVID-19 Emergency Temporary Standard ("ETS") is out and, as promised, it will require companies with at least 100 employees – across all facilities – to either institute a vaccine mandate or compel unvaccinated employees to submit to weekly testing and workplace masking for at least the next six months ...
Some West Virginia businesses have implemented COVID-19 vaccine mandates for employees. While the West Virginia COVID-19 Jobs Protection Act (W. Va. Code § 55-19-1 through § 55-19-9) protects people, businesses, and entities from some COVID-19 related claims, the Act does not address whether employees who suffer an injury from a COVID-19 vaccine mandated by their employers may bring a workers' compensation claim ...
Do you have a unionised workforce? If so, the Kostal (Kostal UK Ltd v Dunkley and others [2021] UKSC 47 (27 October 2021)) decision is a must read. If you are an employer which recognises a union - or unions - then the Kostal decision is unlikely to have escaped your notice. The case was brought because an employer ‘went around’ the recognised union and made a pay offer direct to employees despite there being an agreement with the union in place ...
On October 29, 2021, the following resolutions were published in the Official Gazette: Exempt Resolution No. 1,080 of the Undersecretary of Public Health amending Exempt Resolution No. 994, of 2021, of the Ministry of Health, which establishes the fourth Step-by-Step Plan; and Exempt Resolution No. 1,079 of the Undersecretary of Public Health, which amends Exempt Resolution No. 672, of 2021, of the Ministry of Health, which establishes the Protected Borders Plan ...
In a decision issued in July 2021, the Dubai Court of Appeal held that an arbitration clause should be construed narrowly, and emphasized that everything that may be waived or prevents its [i.e., the arbitration clause’s] application must be sought. This judgment, which rejected a challenge to the jurisdiction of the Dubai Courts based on the existence of a purported arbitration agreement, was discussed in our inBrief dated 12 September 2021 ...
On Monday, November 1, 2021, CNBC reported the Office of Management and Budget ("OMB") completed its review of OSHA's Emergency Temporary Standard ("ETS") that will require larger employers to either adopt a policy for mandatory employee vaccinations or an alternative allowing weekly testing and masking for all unvaccinated employees. OMB approval of the ETS is the last step prior to finalizing the rule and its publication in the Federal Register ...
After convening for a special legislative session to address COVID-19 countermeasures, the Tennessee General Assembly passed sweeping legislation in the early hours of Saturday morning that limits the authority of public schools, local health departments, government entities, and private businesses to implement COVID-19 related restrictions ...
