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Our previous article, In Defense of IGTs from Governmental Health Care Providers, noted that the Secretary of the Department of Health and Human Services (“HHS”) is required to “consult with the States” before issuing any regulations changing the treatment of intergovernmental transfers (“IGTs”). We received requests for further information about this requirement following the publication of that article, and the requirement gained additional attention following the Secretary’s February 27, 2026, request for information (“RFI”) seeking stakeholder feedback on…
Continue Reading The Secretary of HHS Must Consult with the States Before Issuing Regulations Changing the Treatment of IGTs

On March 20, 2026, Federal Trade Commission (“FTC”) Chairman Andrew Ferguson announced the formation of an internal Healthcare Task Force (the “Task Force”) and, in a memorandum issued the same day, directed the FTC’s Bureaus of Competition, Consumer Protection, and Economics, along with the Office of Policy Planning and the Office of Technology, to form the Task Force with the intention of coordinating the FTC’s existing health care enforcement and advocacy efforts across the agency.
What the Task Force…
Continue Reading FTC Announces Formation of Healthcare Task Force

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On March 24, 2026, the U.S. Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”), published a long‑anticipated final rule adopting national Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) standards for health care claims attachments transactions and electronic signatures (the “Final Rule”). The Final Rule is intended to modernize HIPAA transactions by establishing standards for the electronic exchange of clinical documentation used to support health care claims and related inquiries…
Continue Reading HHS Finalizes HIPAA Standards for Health Care Claims Attachments and Electronic Signatures and Signals More Regulatory Updates in 2026

In a significant decision with implications for 340B enforcement and False Claims Act (“FCA”) whistleblower litigation, the United States Court of Appeals for the Ninth Circuit (the “Court”) held on March 17, 2026, that a health system (the “System”) may proceed with its qui tam action alleging that pharmaceutical manufacturers engaged in fraudulent price-inflation schemes under the 340B Drug Pricing Program (“340B”), in violation of the FCA. United States ex rel. Adventist Health System of West v. AbbVie, et…
Continue Reading Ninth Circuit Permits 340B-Based FCA Claims to Proceed Despite Lack of Private Right of Action

On March 19, 2026, the U.S. Court of Appeals for the Fifth Circuit denied the Federal Trade Commission’s (“FTC”) motion for a stay pending appeal of the U.S. District Court for the Eastern District of Texas’s (the “District Court”) decision vacating the FTC’s 2024 Final Rule (the “2024 Rule”) revising the Hart‑Scott‑Rodino (“HSR”) premerger notification requirements, including the HSR premerger notification form and instructions. As a result, the District Court’s judgment is effective immediately.
Background
As discussed in our…
Continue Reading Fifth Circuit Denies FTC Stay: HSR Filings Revert to Old Form Effective Immediately

The Tenth Circuit recently issued two companion decisions confirming the Occupational Safety and Health Administration’s (“OSHA”) authority to cite employers for workplace violence hazards under the General Duty Clause of the Occupational Safety and Health Act, 29 U.S.C. § 654(a)(1) (“General Duty Clause”). In both cases, the Tenth Circuit upheld OSHA’s enforcement actions and the citations issued in connection with workplace violence incidents in a psychiatric hospital.
Case Background
Both cases stem from OSHA’s investigation into a psychiatric hospital…
Continue Reading Tenth Circuit Affirms OSHA Authority to Cite Health Care Employers for Workplace Violence Incidents Under the General Duty Clause

Once again, 2025 was a busy year for health care data privacy. Ensuring up-to-date and compliant data privacy and security programs and being able to assess, understand and adapt to the risk of evolving technologies will remain critically important in 2026. We continue to await updated regulations under both the Health Insurance Portability and Accountability Act (“HIPAA”) of 1996 and the Information Blocking Rule, both of which are subject to proposed rules likely to be finalized this year, which…
Continue Reading Health Care Privacy Law Takeaways for a Compliant 2026: Pay Attention to Patient Concerns

The U.S. Department of Health & Human Services Office of Inspector General (“OIG”) has long been the north star for health care entities seeking guidance on creating and implementing an effective compliance program. As the author of the General Compliance Program Guidance (“GCPG”), OIG has used its years of investigative and oversight experience with health care entities to identify and recommend best practices for a wide range of entities in the U.S. health care industry.

To further OIG’s assistance…
Continue Reading Medicare Advantage Industry Segment-Specific Compliance Program Guidance Issued

The Centers for Medicare and Medicaid Services (“CMS“) issued a wide-ranging Request for Information (“RFI”) on February 26, which could reshape current program integrity efforts to prevent and detect fraud, waste and abuse in  government health care programs. CMS, under its new Comprehensive Regulations to Uncover Suspicious Healthcare (“CRUSH”) initiative, is seeking stakeholder input on potential regulatory and operational changes aimed at strengthening program integrity across Medicare, Medicaid, CHIP and the Health Insurance Marketplace (“Marketplace”). The RFI spans topics…
Continue Reading CMS Issues Sweeping Anti-Fraud RFI Under New CRUSH Initiative

HIPAA covered entities and Part 2 Programs should be aware of two important compliance deadlines that may require prompt action.
Annual HIPAA Small Breach Reporting
Under the Breach Notification Rule, HIPAA covered entities are required to submit reports of certain breaches of unsecured protected health information (“PHI”) affecting fewer than 500 individuals to the HHS Office for Civil Rights (“OCR”) on an annual basis. No later than March 1, 2026, covered entities must submit breaches discovered in 2025 through…
Continue Reading Important Deadlines for HIPAA Covered Entities and Part 2 Programs

Significant updates to the ALTA/NSPS Land Title Survey Standards will impact health care real estate transactions beginning February 23, 2026. The American Land Title Association (“ALTA”) and the National Society of Professional Surveyors (“NSPS”) have adopted updated Minimum Standard Detail Requirements for ALTA/NSPS Land Title Surveys (the “2026 Standards”), which take effect February 23, 2026, and replace the 2021 version. Although the fundamental purpose of an ALTA survey remains the same, the 2026 Standards introduce clarifications and new requirements…
Continue Reading New 2026 ALTA/NSPS Survey Standards: What Developers and Counsel Should Know

On December 15, 2025, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 25‑11 (“Advisory Opinion”) and concluded it would not impose administrative sanctions under the federal Anti‑Kickback Statute (“AKS”) on a biopharmaceutical manufacturer for a series of discounts and rebates offered on multiple vaccines. Although portions of the arrangement failed to meet the technical requirements of the discount safe harbor (42 CFR § 1001.952(h)), OIG determined that the overall fraud and abuse risk was sufficiently low.

This…
Continue Reading OIG Offers Contemporary Guidance on Various Discount Constructs in Recent Advisory Opinion

There is a growing circuit split between the Third and Fifth circuits over whether employers can block National Labor Relations Board (NLRB) proceedings while raising constitutional challenges. The disagreement centers on the Norris-LaGuardia Act (NLGA), a nearly century-old law designed to keep federal courts out of labor disputes, which is driving one of the biggest fights in labor and employment law at the moment. With two circuits now at odds, Supreme Court review is increasingly likely and the question

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Continue Reading Can Employers Block NLRB Proceedings? What the Circuit Split Means for Your Organization

On January 26, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued an Advance Notice of Proposed Rulemaking (“ANPRM”) seeking public input on potential policies to strengthen the domestic supply chain for personal protective equipment (“PPE”) and essential medicines used by Medicare‑participating hospitals. The initiative reflects lessons learned during the COVID‑19 public health emergency and signals a possible shift toward incentivizing or requiring greater reliance on U.S.-manufactured medical products within the Medicare program. This focus on domestic sourcing…
Continue Reading CMS Solicits Comments on Potential Approaches to Strengthen the American-Made Supply Chain

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Federal courts are showing diminishing tolerance for perpetual False Claims Act (“FCA”) litigation. Years-long seal periods, one-sided discovery and serial amendments are wearing thin. The Fifth Circuit’s recent decision in United States ex rel. Gentry v. Encompass Health Rehabilitation Hospital of Pearland, L.L.C., 157 F.4th 758 (5th Cir. 2025) (“Gentry“) reflects this shift and offers a blueprint for courts confronting repeated motions to amend.
The Gentry Decision
In Gentry, a terminated sales representative (the “Relator”) sued Encompass Health Rehabilitation…
Continue Reading Federal Courts Signal Frustration with Perpetual FCA Litigation

On February 3, 2026, after years of false starts, federal regulation of pharmacy benefit managers (“PBMs”) became reality when the Consolidated Appropriations Act, 2026 (the “Act”) was signed into law by President Trump. For the first time, the Act imposes federal requirements on PBMs related to compensation, transparency, reporting and other matters to be addressed via contracting requirements between PBMs and plan sponsors. This landmark piece of federal legislation follows years of increased state regulation of PBMs, and has…
Continue Reading Federal PBM Reform Is Here: Unpacking Key Provisions of the Landmark Legislation