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 ...
With answer to ruling no. 839 of 21 December 2021 (the Ruling 839/2021), the Italian Tax Authorities (ITA) clarify that credit institutions established in the United Kingdom (UK) cannot benefit from the withholding tax exemption on interest and other proceeds from medium-long term loans provided for by Article 26, para. 5-bis, of Presidential Decree no. 600/1973 (the Decree 600/1973). https://www.gop.it/doc_pubblicazioni/935_qrpnmu9tzy_ita ...
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 ...
We have in 2021 seen a remarkable (continued) recovery in the Norwegian financial market. This is also evident from the perspective of our banking and financing team. We have assisted our clients with a considerable number of new financings and refinancings, across most sectors. It has especially been hectic within the shipping, aviation and renewable energy sectors and we have seen a steep increase within acquisition financing ...
On December 19, Gabriel Boric was elected as future President of Chile, and will take office on March 11, 2022. The following is a list of the main tax proposals1 of the recently elected candidate: New income tax regime: a disintegrated income tax regime is proposed for large companies, separating the tax paid at the company level from the one payable by its shareholders when withdrawing profits ...
Financial Services Climate risk — progress of Joint Committee on Climate Change In a joint statement, Bank Negara Malaysia (“BNM”) and Securities Commission Malaysia announced on 10 December 2021 the following: the Joint Committee on Climate Change (“JC3”) will issue a Reference Guide on Climate Risk Management and Scenario Analysis, which sets out expectations for financial institutions to integrate climate-related risks considerations in finan
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 ...
Corporate/M&A Collaboration between Bursa Malaysia Berhad with Capital Markets Malaysia through the Elevate Programme Bursa Malaysia Berhad (“Bursa”) has on 11 November 2021 announced that Bursa will be collaborating with Capital Markets Malaysia (“CMM”) to engage and work with mid-tier companies that are seeking to undertake initial public offering in the next 24 months ...
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 ...
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Earlier this month, the HHS Office of Inspector General (OIG)published an advisory opinionthat permitted a pain management practice to retain the profits it received from billing for the anesthesia services that an employed CRNA provided at an ASC partially owned by the practice’s physician-owner ...
The House narrowly passed the Build Back Better bill on Nov. 19 with a vote of 220 to 213, after an overnight delay. The $1.75 trillion social spending bill includes the ability for Medicare to negotiate drug prices, new hearing benefits for Medicare beneficiaries, and extended Affordable Care Act subsidies. The bill will still have to pass the Senate, and Senate Democrats are expected to make revisions ...
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 ...
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”) ...
Whether CMC of a Guernsey company is exercised in the UK is question of fact. This briefing summarises UK tax residence points arising out of UK tax case law, focussing in particular on the most recent case of Development Securities (No. 9) Ltd and other v HMRC2, and also provides some practical guidance on how Guernsey companies can minimise UK CMC risks when there is no intention to make the company UK tax resident ...
Key Points New tax reporting provisions on cryptocurrency, as well as criminal consequences for noncompliance, survived in the Infrastructure Investment and Jobs Act (H.R. 3684) signed into law. The legislation imposes potential felony charges for failures to report certain "receipt" of digital assets, as well as expands the definition of "broker" to target crypto exchanges. On November 5, 2021, President Biden signed the Infrastructure Investment and Jobs Act into law ...
