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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
About a year ago, on Nov. 20, 2020, the Department of Health and Human Services Office of Inspector General and the Centers for Medicare and Medicaid Services (CMS) issued two final rules implementing sweeping changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute regulations. For the most part, those new rules went into effect on Jan. 19, 2021 ...
The high street will of course evolve according to prevailing consumer habits. That evolution has been brought into sharp focus by the pandemic, where retailers have had to adapt to the restrictions imposed on non-essential retail at certain times combined with the general growth of e-commerce. That said, the retail market in Guernsey compares well to the UK market and is seen as an attractive opportunity for retailers, both for well-known UK brands and local independents alike ...
Marks & Spencer breached a court order to enforce a “keep-open” provision in one of its leases, when it carried on business only in a “half-hearted” manner ...
Freeports are obviously of immediate interest to importers, exporters, and manufacturers, as they allow the import of materials and manufacture or incorporation of those materials into items which are then exported, all without incurring tariffs and with minimal regulation. The government’s stated objectives in establishing Freeports were to establish national hubs for global trade and investment across the UK, promote regeneration and job creation and create hotbeds for innovation ...
On October 14, 2021, the Massachusetts Attorney General’s Office announced a $25 million healthcare fraud settlement against a private equity firm and former executives of the firm’s portfolio company. The settlement is significant because it is the largest healthcare fraud settlement in the country to date against a private equity firm based on the firm’s oversight of its healthcare portfolio company ...
Author(s) Senior Partner, Nishant Menon and Associate, Nikhil Bhatia The Supreme Court of India on 6th August 2021 in Amazon.com NV Investment Holdings LLC v Future Retail Limited & Others handed down a seminal decision in relation to enforcement of an Emergency Arbitrator’s (“EA”) award. The ruling has great significance as it furthers India’s mission of being a pro-arbitration State where there is greater ease of doing business ...
Kudun and Partners represented Thammasat University with the preparation of the licensing agreement with Antitoxin GmbH, a German company founded in 1966 and specializes in the development of certified blood typing reagents for automated and manual applications ...
Energy drink giant Red Bull recently received some negative press for issuing a cease and desist letter to Norwich-based gin maker Bullards for the use of the word ‘bull’ in its brand name. The case is a useful reminder that brand owners should make sure that their brand protection strategy reflects the organisation’s wider brand values ...
Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this case, if any does. If you don't know this story, I recommend The Immortal Life of Henrietta Lacks, by Rebecca Skloot. It is the true story of an apparently wonderful woman, Ms ...
Key Points Skilled nursing facilities must ensure their medical directors are certified within five years of the date of hire or by January 1, 2027, for medical directors already working in a SNF SNFs must report medical director certification status to CDPH by June 30, 2022 SNFs must report medical director changes to CDPH within 10 days of the change Effective January 1, 2022, a skilled nursing facility (SNF) will be prohibited from contracting with a medical director unless
The only thing crystal clear about health care price transparency requirements at the moment is that the government will continue implementing new price transparency laws, regulations, and rules ...
Twenty months in, Covid-19 continues to demand that we exercise flexibility and adaptation as it identifies winners and losers. The pandemic has had a significant impact on the practice of law and businesses that are involved in, or contemplating, litigation. Those who have been involved in litigation know that it can be expensive in “normal” times. Here are three ways the pandemic has impacted the costs associated with litigation. Time to trial ...
Since 1 October 2021, the requirements for prepacked for direct sale food labelling changed, offering increased protection to the estimated one in four people with food allergies in the UK. What is PPDS? Prepacked for direct sale (PPDS) is food that is: presented to the consumer in packaging; packaged before the consumer selects or orders it; and packaged at the same place it is sold ...
In our fourth article on whistleblowing claims we focus on the need, in sensitive situations where concerns of serious (and perhaps even criminal) wrongdoing are raised, for the complaint to be dealt with confidentially and/or anonymously where possible ...
Key Points Governor Newsom vetoed AB 339. AB 361 will continue to operate as currently construed. On October 7, 2021, Governor Newsom vetoed Assembly Bill (AB) 339 (Lee), a bill aimed at addressing Brown Act teleconferencing requirements for large public entities. AB 339 sought to add special rules for meetings of city councils or county board of supervisors that govern jurisdictions containing at least 250,000 people ...
