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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

On February 2, 2026, the Centers for Medicare & Medicaid Services (“CMS”) released a new guidance letter (“February 2 Letter”) regarding state directed payments (“SDPs”) as governed by Section 71116 of Public Law 119-21 (which CMS refers to as the “Working Families Tax Cuts” or “WFTC legislation”). Per CMS, its previous September 9, 2025, guidance letter (“September 9 Letter”) has been rescinded.

The February 2 Letter largely repeats everything in the September 9 Letter. For example, the preprint-related criteria…
Continue Reading CMS Issues New Guidance Letter for State Directed Payments

On January 30, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would substantially revise portions of the Conditions for Coverage for Organ Procurement Organizations (“OPOs”) (the “Proposed Rule”). According to CMS, the Proposed Rule is characterized as building on changes in the 2020 OPO Conditions for Coverage rule aimed at increasing accountability, clarifying and strengthening re-certification standards and reinforcing public trust in organ procurement and allocation practices, and in doing so is intended…
Continue Reading Proposed OPO Rule Signals Broad Operational and Compliance Changes Across the Donation and Transplantation System

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On January 21, 2026, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released its Semiannual Report to Congress for the six-month period ending September 30, 2025 (“Report”). OIG’s enforcement actions during this period resulted in “the largest health care fraud takedown in the Department of Justice history, involving more than $14.6 billion in intended losses,” and improved the return on investment in OIG to $12.70 in expected recoveries and receivables (money agreed to be…
Continue Reading OIG Recounts Historic Recovery Numbers in Its Latest Semiannual Report to Congress

Piggy bank with stethoscope isolated on light blue background with copy space. Health care financial checkup or saving for medical insurance costs concept.

Some of the advocacy groups and think tanks that lobbied for the Medicaid provider tax restrictions in last year’s H.R. 1 are now renewing their criticisms of the states’ use of “intergovernmental transfers” (“IGTs”) from governmental health care providers to fund the non-federal share of Medicaid payments to those same providers.[1] The critics’ goal appears to be twofold: first, to shift Medicaid costs away from the federal government despite the federal government’s shared financial responsibility with the states…
Continue Reading In Defense of Intergovernmental Transfers from Governmental Health Care Providers

The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”), as amended, requires all persons contemplating certain mergers or acquisitions that meet or exceed the jurisdictional thresholds (shown below) to file a premerger notification (an “HSR Filing”) with the Federal Trade Commission (“FTC”) Premerger Notification Office and the Department of Justice (“DOJ”) Antitrust Division and to wait a period of time before consummating the transaction.

Each fiscal year, the jurisdictional filing thresholds are adjusted to reflect the percentage change in…
Continue Reading FTC Announces Annual Hart-Scott-Rodino Premerger Notification Filing Thresholds Increase for 2026

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The U.S. Department of Labor (DOL) recently released a new set of opinion letters addressing recurring questions under the Fair Labor Standards Act (FLSA) and the Family and Medical Leave Act (FMLA).

While opinion letters are based on specific fact patterns, they provide valuable insight into how the DOL analyzes common compliance questions and foreshadow DOL enforcement priorities, and they are often relied upon by courts and investigators.

The latest batch addresses employee classification, overtime calculations, collective bargaining agreements,

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Continue Reading U.S. Department of Labor Issues New FLSA and FMLA Opinion Letters: Key Compliance Takeaways for Employers

The health care transactional landscape may have been quieter than anticipated at the beginning of 2025, with providers experiencing financial strains, but the year finished out with a high level of activity, marked by opportunistic growth strategies. Transactions will continue to be anything but “cookie-cutter.” In this article, we highlight eight M&A trends demonstrating how the financial landscape, regulatory considerations, cross-disciplinary strategies and market disruptors shaped deals in 2025 and how these same factors will continue to impact deals…
Continue Reading Bottom Line: Health Care Transactions Are More Bespoke Than Ever – Lessons Learned from 2025 and What’s to Come in 2026