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Dinsmore & Shohl LLP | November 2021

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 ...

MinterEllisonRuddWatts | November 2021

As New Zealand gets ready for the new traffic light system and living with COVID all employers should be taking steps to address the risks that COVID-19 presents in the workplace and how these risks can be best managed. There are a lot of questions being raised. We have put together this short guide and flowchart of the things that all employers of sizes should be considering and putting in place now ...

Dinsmore & Shohl LLP | November 2021

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 ...

Waller | November 2021

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”) ...

Dinsmore & Shohl LLP | November 2021

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 ...

Waller | November 2021

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 ...

Schwabe, Williamson & Wyatt | November 2021

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 ...

Dinsmore & Shohl LLP | November 2021

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 ...

Shoosmiths LLP | November 2021

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 ...

Carey | November 2021

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 ...

Waller | November 2021

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 ...

Dinsmore & Shohl LLP | October 2021

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 ...

Waller | October 2021

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 ...

Kudun and Partners | October 2021

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 ...

Dinsmore & Shohl LLP | October 2021

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 ...

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 ...

Hanson Bridgett LLP | October 2021

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

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 ...

Shoosmiths LLP | October 2021

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 ...

Hanson Bridgett LLP | October 2021

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 ...

The Department of Defense (DoD) and the Civilian Agency Acquisition Council (CAAC) have both issued new Class Deviations from the FARs that implement Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors (i.e., the federal contractor vaccine mandate) ...

Buchalter | October 2021

October 6, 2021 By: Jennifer Guerrero While a remote work environment can provide many benefits to all of the parties involved, it also can present significant challenges for organizations that need to remain Healthcare Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliant ...

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