Due to emergence of the Omicrom variant, the new year brought with it some now familiar guidance: the government asked workers to avoid the office and to work from home where possible. In anticipation of returning to the office in early 2022, the Health and Safety Executive (the HSE) and the Scottish Government have issued guidance emphasising the importance of good ventilation and the role that plays,alongside other measures, in helping to reduce the spread of COVID-19 ...
This question was considered by the Employment Tribunal in the recent case of X v Y. In a decision that will be welcomed by employers, the tribunal held that such a fear is not a protected belief under the Equality Act 2010. The facts of the case The claimant brought proceedings against her employer for discrimination after she chose not to return to work in July 2021 with the result that her employer had stopped paying her ...
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 ...
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) ...
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 ...
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 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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 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 ...
As 2021 runs in search of what’s new, we realize that the pandemic disruption has continued through 2021. The NMLS Ombudsman Meeting was held virtually and the upcoming American Association of Residential Mortgage Regulators (AARMR) Annual Conference will be held in person, but with reduced capacity. These frame the search for “a” normal as licensed mortgage companies balance licensing requirements and health risks while serving their borrowers ...
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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) ...
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 ...
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 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 ...
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 ...
