On November 10, 2022, in the matter Variscite NY One, Inc. v. State of New York, et al., the U.S. District Court for the Northern District of New York granted the plaintiff’s a motion for a preliminary injunction against the State of New York (“NYS”), the New York State Office of Cannabis Management (“OCM”), and the Executive Officer of the OCM, Christopher Alexander issuing any cannabis licenses under NYS’s conditional adult-use retail dispensary (“CAURD”) application program in 5 of the state’s 14 geographic regions.
Who Is a “Designated Person”? Changes to California’s Medical Leave
The Bill
The Expansion of California Family Rights Act, AB 1041, was signed into law by Governor Newsom on September 29, 2022. AB 1041 expands the class of people for whom an employee may take leave to care for under the California Family Rights Act (“CFRA”) to include a “designated person.” AB 1041 also expands the term “family member” under the Healthy Workplaces, Healthy Families Act (“HWHFA”), which governs paid sick day leave, to include “designated person.”…
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Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS
Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. 22-19 (the “Advisory Opinion”), which declared that a charitable organization funded by manufacturers would violate the AKS if it offered certain cost-sharing subsidies under Medicare Part D (“Part D”), even if the organization was independently run and patients had equal access to discounts for 90% of drugs on the market. On November 9, 2022, the Pharmaceutical Coalition for Patient Access (“PCPA”), presumably the organization behind the Advisory Opinion, filed a lawsuit against OIG, seeking declaratory judgment that its cost-sharing program is legal under the AKS and that the Advisory Opinion violates the Administrative Procedure Act (“APA”) and the First Amendment.[1]…
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Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS
Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. 22-19 (the “Advisory Opinion”), which declared that a charitable organization funded by manufacturers would violate the AKS if it offered certain cost-sharing subsidies under Medicare Part D (“Part D”), even if the organization was independently run and patients had equal access to discounts for 90% of drugs on the market. On November 9, 2022, the Pharmaceutical Coalition for Patient Access (“PCPA”), presumably the organization behind the Advisory Opinion, filed a lawsuit against OIG, seeking declaratory judgment that its cost-sharing program is legal under the AKS and that the Advisory Opinion violates the Administrative Procedure Act (“APA”) and the First Amendment.[1]…
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Nasdaq, FINRA and NYSE Issue Warnings of Small-Cap IPO Fraud
Yesterday, each of Nasdaq, FINRA and NYSE released Regulatory Alerts highlighting concerns surrounding fraudulent activities in Small-Cap IPOs. Each of these alerts raises similar issues, highlights the importance of the Underwriter in the process, and stresses the obligations that Underwriters have as Gatekeepers in the IPO Process. Below is a link to each of these Alerts and some relevant excerpts from them.…
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China Tariffs: Opportunity to Request Modifications
On November 15, 2022, the United States Trade Representative (USTR) opened its docket (USTR-2022-0014) seeking public comments in its review of Lists 1 and 2 of the Trump-era tariffs on Chinese imports. The tariffs were issued by then-President Donald J. Trump under Section 301 of the Trade Act of 1974.…
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Could the Supreme Court’s Decision in the Harvard and UNC Cases Indirectly Affect Corporate Diversity Initiatives?
The United States Supreme Court is currently considering two cases concerning whether race-conscious admissions programs are permissible under federal law. While these cases are limited to the relatively narrow universe of college admissions, the Court’s decision may be instructive to private employers and will likely have implications beyond the classroom.…
Organizational Integrity Shorts: Let’s Be Disciplined About Discipline
Discipline is a complicated thing. Ask any parent. The fifth installment of OIG Shorts focuses on discipline as a core component of an effective Ethics & Compliance Program.
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PFAS and Food Packaging: Regulatory Changes Create Ripple Effects for PFAs-Related Litigation
This article was originally published at FoodNavigator-USA.
Federal and state agencies are considering restrictions or bans of individual ‘forever chemicals’ PFAS (Perfluoroalkyl and polyfluoroalkyl compounds) or PFAS as a class, while at least 24 putative class actions targeting packaged goods purportedly containing PFAS were filed from January 1 to August 1, 2022 alone. So how widely used are PFAS in the food industry, and how can firms protect themselves from litigation?…
Inflation Reduction Act: Wage and Apprenticeship Requirements
President Joe Biden signed into law the Inflation Reduction Act of 2022 (“HR 5376”) (the “IRA” or the “Act”), on August 16, 2022.
There are numerous tax credits in the legislation that intend to facilitate access to clean energy. For the most part, these credits are available to energy producers or to support the construction or alteration of facilities to include energy efficient components. For example, the Act substantially changes and expands existing federal income tax benefits for renewable energy, including the existing Section 45 of the Internal Revenue Code production tax credit (“PTC”) and Section 48 of the Internal Revenue Code investment tax credit (“ITC”). Specifically, the Act replaced the renewable energy credit regime with a two-tiered system that would provide a “base” credit equal to 20% of the maximum credit and an “increased” credit equal to an additional 80% of the maximum credit that would be available only if certain prevailing wage and apprenticeship requirements are satisfied in connection with the relevant project.…
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Federal Cannabis Banking Reform: What Happened?
This article was originally published in the November/December issue of ELFA’s Equipment Leasing & Finance magazine.
In mid-July 2022, the United States House of Representatives passed provisions that would allow legitimate cannabis-related businesses to access federally regulated financial services. This marks the seventh time the House has approved a version of the Secure and Fair Enforcement (SAFE) Banking Act. The original version of federal cannabis banking reform was introduced nine years ago by Rep. Ed Perlmutter (D-Colo). The passage of the SAFE Banking Act, either as stand-alone legislation or as amendments attached to must-pass bills, would prohibit federal banking regulators from penalizing a federally regulated depository institution for providing banking services to cannabis businesses. Presently, cannabis businesses are essentially deprived of federally regulated financial services, which include the ability to raise capital, obtain loans and process payment. …
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Part 2: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights
The abortion debate continues in America after the Supreme Court decision in Dobbs v. Jackson and the midterm elections on November 8th. Following our first post in this series, there have been a number of noteworthy developments* that occurred over the past month including several significant events at both federal and state levels as well as recent activity by registered voters during the midterms to protect access to reproductive care.…
FTC Extends Deadline for Safeguards Rule Compliance to June 9, 2023
On November 15, the FTC announced a six month extension to the deadline for companies to comply with the Safeguards Rule. The Safeguards Rule requires non-banking financial institutions, such as mortgage brokers, motor vehicle dealers, and payday lenders, to develop, implement, and maintain a comprehensive security program to keep their customers’ information safe (we discussed the Safeguards Rule in a previous blog post here). The deadline for complying with some of the updated requirements of the Safeguards Rule is now June 9, 2023.
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Up In Smoke – CA Court of Appeal Dismisses Prop 65 Case Against Water Pipe Manufacturer Narrowly Construing The Term “Expose”
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Health & Safety Code § 25249.5 et seq.) (“Prop 65”) is a California law that prohibits any person in the course of doing business from “knowingly and intentionally expos[ing]” individuals to listed carcinogens and reproductive toxins without adequate warning. Recently, in Environmental Health Advocates, Inc. v. Sream, Inc., 83 Cal. App. 5th 721 (2022), the First District Court of Appeal had the opportunity to interpret the word “expose” as used in Health & Safety Code § 25249.6, concluding that possible indirect contact with a listed Prop 65 chemical, depending on how a consumer chooses to use a product, is insufficient to constitute a cause of action under Prop 65. …
Inflation Reduction Act: Wage and Apprenticeship Requirements
President Joe Biden signed into law the Inflation Reduction Act of 2022 (“HR 5376”) (the “IRA” or the “Act”), on August 16, 2022.…
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FTC Policy Statement on the Scope of Unfair Methods of Competition – A Broad But Vague Warning
On November 10, 2022, the Federal Trade Commission issued its “Policy Statement Regarding the Scope of Unfair Methods of Competition Under Section 5 of the Federal Trade Commission Act.” The Statement replaces prior guidance on the subject that was rescinded by the FTC on July 1, 2021[1] and “supersedes all prior FTC policy statements and advisory guidance on the scope and meaning of unfair methods of competition under Section 5 of the FTC Act.”…