42 C.F.R. Part 2 Final Rule to Align with the HIPAA Privacy Rules

The US Department of Health and Human Services, Office for Civil Rights (OCR)
and the Substance Abuse and Mental Health Services Administration issued a Final Rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), and to SUD patient records (Part 2 Records).

The effective date of the Final Rule is April 16, 2024, and entities have until February 16, 2026, to comply.

The Final Rule includes several changes to align Part 2 more closely with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which applies to protected health information, and to reduce administrative burdens, as summarized below:

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President Biden Announces Groundbreaking Restrictions on Access to Americans’ Sensitive Personal Data by Countries of Concern

On February 28, 2024, President Biden issued a groundbreaking executive order (EO) establishing the framework for new restrictions on transactions involving US persons’ sensitive personal data and “countries of concern,” including China, or related parties.

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FEPA: the New Tool in the DOJ’s Fight Against Corruption

Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA).  The Act, which has been referred to as  “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a U.S. citizen or company. Understanding FEPA is critical for US companies with international business interactions and other companies whose business subjects them to US jurisdiction. Read on at the link below for an outline of FEPA’s core provisions and relevant enforcement considerations for companies, international organizations and foreign governments.

FEPA: the New Tool in the DOJ’s Fight Against Corruption | Global Investigations & Compliance Review

The End of “Chevron” or Its Rebirth?

Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US Supreme Court is in the spotlight as it hears pivotal cases – Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo, which may presage the dismantling of “Chevron”. Squire Patton Boggs attorneys Keith Bradley, Peter Gould, Rebekah Singh, and Austin Harrison discuss the Court’s review and possible implications in a recent article, available here.

Beware the Ides of March: Four Questions and Answers to Guide Your Organization’s Preparation for the Upcoming Appropriations Process

Federal appropriations provide annual discretionary funding for our government to carry out its mission and, in turn, spur various healthcare organizations towards efficiencies and achievements. Whether you serve an entity interested in the government’s work in disease research or a nonprofit hospital requesting community project funding for infrastructure needs, it is important for those seeking funding provided through Congress’ annual appropriations cycle to understand the process and current legislative landscape.

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Webinar:  The New Foreign Extortion Prevention Act – What It Means for US Companies

On Tuesday January 30, we hope you will join a seasoned team of former Department of Justice (DOJ) prosecutors for what will certainly be a robust a discussion on “the most consequential anti-foreign-bribery law passed in almost 50 years”: the Foreign Extortion Prevention Act (FEPA). Passed as part of the National Defense Authorization Act (NDAA), FEPA allows the DOJ to prosecute foreign officials who demand or accept a bribe from a U.S. citizen or company.   For any entity doing business abroad, understanding FEPA is critical.

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US Antitrust Agencies Release 2023 Merger Guidelines

On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the government may view certain transactions, including those involving healthcare entities. The Guidelines also reflect the Biden Administration’s aggressive stance on merger enforcement. Squire Patton Boggs attorneys Barry Pupkin, Christopher Gordon, Martin Mackowski and Kaitlin Rittgers provide a discussion of the Guidelines and present key takeaways, available here.

Starting this Month, California Health Care Entities Will Need to Provide State Notice of Mergers Set to Close on or After April 1, 2024

In 2022, the state of California passed into law the California Health Care Quality and Affordability Act which requires that health care entities give the state 90-day notice of certain mergers, acquisitions, or other transactions projected to close on or after April 1, 2024.  Review of these transactions began on January 1, 2024.  Health care entities subject to this obligation include payers, fully integrated delivery systems, and providers, including large physician organizations, that meet certain thresholds.  Captured transactions are those that involve the sale of a material amount of assets of a California health care entity or the transfer of control of a California health care entity.  Transactions involving an out-of-state entity may also be captured if a California entity is involved.  Entities already required to file a federal merger control notice pursuant to the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), are not exempt from this notification requirement.

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Singapore Consults on Groundbreaking Health Information Bill

On December 11, 2023, Singapore’s Ministry of Health launched a public consultation exercise on a proposed Health Information Bill (Bill), with a draft expected to be tabled in Parliament in the first half of 2024.

Whilst extensive industry consultations have been conducted on the proposed provisions of the Bill involving 39 focus groups and over 1,000 stakeholders, this is the first time that the general public at large (including patients) can submit comments.

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Federal Courts Continue to Grapple with Causation in Anti-Kickback-Based False Claims Act Cases

Courts around the country continue to disagree on the causation standard to be applied in False Claims Act cases based on alleged Anti-Kickback Statute violations.  Two recent federal district court decisions out of the District of Massachusetts, United States v. Regeneron Pharms., Inc., No. 20-11217-FDS, 2023 WL 7016900 (D. Mass. Oct. 25, 2023) and United States v. Teva Pharmaceuticals USA, Inc., No. 20-11548-NMG, 2023 WL 4565105 (D. Mass. July 14, 2023), add to differing conclusions on what the causation standard should be, i.e., “but-for,” “exposure,” or some other, less demanding standard. Squire Patton Boggs attorneys Vipal Patel, Kevin Kumar, and Shams Hirji discuss these cases on our Global Investigations & Compliance Review Blog, available here.