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Record fine for fire safety breaches; the shape of things to come?
Shoosmiths LLP, January 2022

Private healthcare provider Bupa has been ordered to pay a purported record £1.04 million penalty (fine and costs combined) after admitting fire safety failings. London Fire Brigade, prosecuting, said it was the "highest ever fine for fire safety breaches in the UK, [highlighting] the seriousness of Bupa's failure to protect a vulnerable resident in its care...

Latest Federal Court Cases, 1/10/22
Schwabe, Williamson & Wyatt, January 2022

Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that claims of a pharmaceutical patent were supported by adequate written description under 35 U.S.C. § 112(a)...

Esther’s Law Allows Surveillance in Ohio Nursing Homes
Dinsmore & Shohl LLP, January 2022

On Dec. 22, 2021, Ohio Governor Mike DeWine signed “Esther’s Law,” allowing long-term care residents to install and use video cameras and recording devices in their rooms. The law is named for Esther “Mitzi” Piskor, who was a victim of elder abuse at a nursing home in Cleveland. Esther’s Law is intended to combat elder abuse and neglect and will likely lead to increased enforcement actions against Ohio nursing homes and long-term care facilities...

Eligible Uses of CARES Act Funds for Compliance and Management Expenses in 2022
Schwabe, Williamson & Wyatt, January 2022

Although the deadline for “incurring” CARES Act funds has passed, Alaska Native Corporations can still use CARES Act funds to pay for administrative and compliance related expenditures in 2022, including staff time spent administrating programs and CARES Act expenses incurred by December 31, 2022. According to U.S...

With a Heavy Heart, We Announce the Passing of Our Dear Friend, Al AuYeung
Schwabe, Williamson & Wyatt, January 2022

Although the deadline for “incurring” CARES Act funds has passed, Alaska Native Corporations can still use CARES Act funds to pay for administrative and compliance related expenditures in 2022, including staff time spent administrating programs and CARES Act expenses incurred by December 31, 2022. According to U.S...

Health Care Workers with Substance Use Disorder Histories Can Now Seek Ohio Licensure Without Discipline
Dinsmore & Shohl LLP, December 2021

With yet another recent uptick in COVID-19 cases, the need for additional health care practitioners in the state of Ohio continues to grow. Recognizing that this shortage will not be resolved in the near future, the Ohio General Assembly has eliminated another barrier for physicians with a prior history involving a substance use disorder to seek licensure in Ohio...

The Impact of New York's Profit Caps on Nursing Home Development
Bradley Arant Boult Cummings LLP, December 2021

As we get ready to turn the page to 2022, one hesitates to continue to discuss the COVID-19 pandemic. However, the fallout continues, with fresh ramifications for the long-term care industry. The industry continues to receive heightened scrutiny following the pandemic, and New York's legislative answer to the concerns are set to hit nursing home businesses in New York as of Jan. 1, 2022, with a cap on allowable profits. The impact on capital outlays and acquisitions remains to be seen...

CMS Plans to Regulate Pharmacy Benefit Manager DIR Fees
Dinsmore & Shohl LLP, December 2021

On Dec. 14, 2021, the Centers for Medicare and Medicaid Services (CMS) unexpectedly issued a letter to U.S. Senator Ron Widen (D-OR)[1] indicating that CMS plans to use its “administrative authority to issue proposed rulemaking” addressing price concessions and direct and indirect remuneration (DIR) fees that pharmacy benefit managers (PBMs) have increasingly charged to specialty and retail pharmacy providers in Medicare and other pharmacy benefit programs in recent years...

Ohio Permanently Expands Use of Telehealth Services
Dinsmore & Shohl LLP, December 2021

Prior to the onset of the COVID-19 pandemic, the use of telehealth across Ohio and the United States was steadily increasing. However, out of necessity over the last two years, telehealth has expanded exponentially in order to reduce risks of COVID-19 transmission to practitioners and patients alike. Nearly overnight, the health care community was forced to change the way services were accessed, delivered, and received...

OIG Report Highlights Focus on Fraud with Genetic Tests
Dinsmore & Shohl LLP, December 2021

On Dec. 21, 2021, the Office of Inspector General (OIG) released a Health & Human Services (HHS) OIG Data Brief on genetic tests provided under Medicare Part B. The goal of the OIG in reviewing this data was “to analyze nationwide trends in genetic tests provided and payments made under Medicare Part B.”[1] As a result of this analysis, the OIG determined that there is a significant risk of overuse and misuse of genetic testing...

Latest Federal Court Cases, 12/13/21
Schwabe, Williamson & Wyatt, December 2021

AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim...

The UK Government’s COVID-19 Inquiry: Political Tactics or Best Practice?
Shoosmiths LLP, December 2021

On 12 May 2021, Prime Minister Boris Johnson committed to holding a Public Inquiry into COVID-19 that will place "the state's actions under the microscope". Demonstrating that it is independent, objective and fair is fundamental to an Inquiry’s purpose. We take a look at the extent to which the State can effectively examine itself in a Public Inquiry when it has ultimate responsibility for determining the remit, and therefore inevitably the scope of any conclusions...

Latest Federal Court Cases, 12/6/21
Schwabe, Williamson & Wyatt, December 2021

Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range.  In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges.  Below, we discuss two of those cases in our “Also This Week” section...

The Death of Chevron? Supreme Court Hears Oral Arguments on Medicare cuts to 340B Reimbursement
Dinsmore & Shohl LLP, December 2021

On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals...

Tennessee Makes Major Changes to CON with Tennessee Health Services & Planning Act of 2021
Bradley Arant Boult Cummings LLP, December 2021

Tennessee healthcare providers now have a very different certificate of need (CON) law to consider when they plan new facilities or expand services. Tennessee's legislature and governor recently enacted the Health Services and Planning Act of 2021 (Public Chapter 557 or "the Act"), which became fully effective Oct. 1, 2021. The Act changes the substantive requirements for CON approval, as well as the application process to obtain a CON...

California’s AB 45 Opens the Door to Manufacture and Sale of Industrial Hemp Products
Hanson Bridgett LLP, November 2021

On October 6, 2021, Governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law. AB 45 permits the manufacture and sale of a wide range of products containing regulated amounts of industrial hemp. Below is a brief overview: What is industrial hemp? “Industrial hemp” is defined as cannabis plants that have no more than 0.3% tetrahydrocannabinol (THC)...

DEA Considering Regulation of Telepharmacy Practice
Dinsmore & Shohl LLP, November 2021

On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations...

Landmark FDA Proposal Seeks to Open Hearing Aid Manufacturing Market and Provide Millions with Access to Care
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...

COVID-19 Vaccinations: The Workplace Essentials
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...

CMS Removes All Nursing Home Visitation Restrictions as COVID-19 Cases Decrease
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...

OIG Revises and Renames its Provider Self-Disclosure Protocol
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...

Latest Federal Court Cases, 11/8/21
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...

CMS Requires COVID-19 Vaccine for Health Care Workers at all Facilities Participating in Medicare and Medicaid
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...

It’s Time to Talk About the Menopause
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...

Publication of Exempt Resolutions That Modify the Fourth Step-by-Step Plan and the Protected Borders Plan
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...

 

 

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