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 ...
While there is a lot of interest and fascination surrounding existing digital assets, like cryptocurrencies and non-fungible tokens (“NFTs”), many individuals and corporations are ramping up their efforts to market and provide virtual goods and services in the Metaverse ...
What is your outlook for Chinese businesses and investment as we approach the end of 2021? China is, and will continue to be, the strongest market for offshore law firms in Asia. China's outbound investment activity has been subdued since 2016, due to domestic constraints on outbound capital flows and tighter scrutiny of Chinese investments abroad ...
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 ...
The Process Migration is the process which allows an overseas company to be registered as a Guernsey company in accordance with the provisions of The Companies (Guernsey) Law, 2008 (as amended) (the "Law") ...
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”) ...
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 ...
We are seeing renewed interest in these types of structures – particularly from fund managers who have not previously targeted Shariah investors - as (i) sovereign wealth funds, pension funds and HNW individuals from the Middle East and South East Asia diversify into alternative assets like private equity (PE), and (ii) traditional or "western" managers look to expand into the Shariah market by establishing bespoke feeder or parallel funds in Guernsey which offer a Shariah complian
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 ...
The Federal Trade Commission (FTC) has made several recent announcements signaling its intention to increase antitrust merger enforcement under the leadership of Chairperson Lina Kahn, appointed by President Biden. Some relate to the Hart-Scott-Rodino (HSR) pre-merger notification requirements, which apply regardless of whether a transaction is substantively reviewed by the FTC or the Department of Justice (DOJ) ...
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 ...
In February 2012, the FATF published the revised FATF Recommendations (also known as the Standards). The Standards continue to develop to detect and prevent new money laundering and terrorist-financing techniques impacting the international financial system, such as misuse of virtual assets and COVID-19 related threats ...
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 ...
