The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: Regulatory

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Regulatory

GSA AI Procurement Rules Would Introduce New Disclosure and Use-Rights Requirements for Federal Contractors

The General Services Administration Federal Acquisition Service has released draft contract terms and conditions related to AI-related procurements through a new proposed GSAR clause 552.239-7001, “Basic Safeguarding of Artificial Intelligence Systems” (February 2026), that would impose material new requirements on contractors and service providers supplying AI capabilities to the federal government. If adopted, the clause… Continue Reading
CMS Guidance, OIG, Regulatory

Long Anticipated Medicare Advantage Compliance Guidance Heightens Investor and Provider Scrutiny

In February 2026, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued its highly anticipated Industry Compliance Program Guidance for Medicare Advantage (MA ICPG), the first such compliance guidance for the MA industry in over 25 years. The MA ICPG is the second industry segment-specific compliance guidance published in a series… Continue Reading
Regulatory

New GSA Proposal Could Expose Federally Funded Institutions With Programs Perceived as DEI-Related

The General Services Administration has proposed requiring all federal funding recipients to certify that they do not maintain diversity, equity, inclusion and accessibility programs. Recipients also would also need to certify they are not knowingly hiring or recruiting undocumented staff. The GSA estimates the proposal would impact approximately 222,760 entities — including colleges and universities.… Continue Reading
OIG, Regulatory

HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch

In advance of the anticipated rollout of the “TrumpRx” website, a platform promising lower-priced drugs sold directly to consumers, the Office of Inspector General of the Department of Health and Human Services released a special advisory bulletin on Jan. 27, 2026, outlining the Federal Anti-Kickback Statute implications for direct-to-consumer drug sales. The OIG concludes that… Continue Reading
OIG, Regulatory

OIG Issues Remote Patient Monitoring Report: Billing Pitfalls and Compliance Risks

On August 25, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a report analyzing Medicare billing practices for remote patient monitoring (“RPM”) services during 2024. As RPM technologies have matured and become more accessible, their availability has driven widespread adoption and enhanced patient care by enabling continuous, data-informed… Continue Reading
OIG, Regulatory

OIG Approves Multi-MSO Telehealth Arrangement That Meets AKS Safe Harbor

On June 6, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion concerning a proposed telehealth staffing and services arrangement involving a management services organization (MSO), a physician-owned practice and third-party telehealth platforms. The proposed arrangement involved a situation in which the platforms would not… Continue Reading
FCA Litigation, OIG, Regulatory

Fourth Circuit Upholds OIG Advisory Opinion Process

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the Advisory… Continue Reading
FCA Litigation, Regulatory

Department of Justice Suggests “Aggressive” Enforcement of False Claims Act

On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active… Continue Reading
OIG, Regulatory

OIG Recommends Increased RPM Oversight

On September 24, 2024, the Department of Health and Human Services Office of Inspector General (“OIG”) published a report (the “Report), reviewing and recommending increased oversight of remote patient monitoring (“RPM”) services and billing in the Medicare program. In the Report, OIG focused on three main issues: (1) Patients and providers are not using RPM… Continue Reading
OIG, Regulatory

OIG Plans New Guidance for Medicare Advantage and Nursing Homes

On Feb. 21, the Office of Inspector General of the U.S. Department of Health and Human Services announced the first four subsectors for which it will publish industry segment-specific compliance program guidance. Guidance published in 2024 will focus on Medicare Advantage and nursing facilities. Subsequent guidance will focus on hospitals and clinical laboratories. Read on… Continue Reading
OIG, Regulatory

OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers

On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued its General Compliance Program Guidance for healthcare providers and other industry stakeholders. The guidance follows OIG’s previous announcement about a modernization initiative and signifies a major update to OIG’s prior approach to providing guidance on effective compliance… Continue Reading
Anti-Kickback Statute, FCA Litigation, OIG, Regulatory

Lessons for Providers and Practice Entities: Ophthalmology Groups Pay Millions to Settle Co-Management, Optometrist Relationship Allegations

Two ophthalmology practice groups recently reached settlements with the U.S. government totaling nearly $20 million to resolve allegations that their third-party cataract arrangements violated several healthcare laws. Read on to discover how the settlements offer guidance to vision providers with respect to the government’s focus on ophthalmology-optometry relationships, and whether the settlements’ lessons have broader… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

HHS Advisory Opinion Approves Profit-Based Bonus Plan for Bona Fide Physician Employees

On Oct. 13, the U.S. Department of Health and Human Services Office of Inspector General issued an advisory opinion approving a physician practice’s proposal to pay bonuses to each of its employed physicians based on net profits derived from the facility fee generated by procedures the physician performed at the practice’s ambulatory surgery center. Read… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

OIG to Expand Informal Guidance with New FAQs

The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the Federal anti-kickback statute (AKS), questions related to the civil monetary penalty (CMP) provision prohibiting remuneration to Medicare and State health care… Continue Reading
OIG

OIG Permits Healthcare Organization’s Smartphone Loan Program For Telehealth Services

On April 22, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-08) (the “Advisory Opinion”) approving a healthcare organization loaning smartphones to promote telehealth care that it provides to underserved populations. The Advisory Opinion provides context for healthcare organizations that may similarly want… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

OIG Approves Physician-Owned Medical Device Company With Several Safeguards

On April 20, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion regarding physician ownership of a medical device company that manufactures products ordered by the physician owners and other affiliated physicians. Read our alert to learn more about the opinion, which offers a path forward for… Continue Reading
CMS Guidance, OIG, Regulatory

Will 2022 Be The Year? OIG’s 25 Top Recommendations to Reduce Healthcare Fraud

Every year the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) releases an annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Unimplemented Recommendations. HHS released its most recent in Nov. 2021, outlining OIG’s top 25 unimplemented recommendations that, in OIG’s view, would most positively affect… Continue Reading
DOJ, OIG, Regulatory

Increasing OIG and DOJ Telehealth Fraud Enforcement Likely on Horizon

Three McGuireWoods’ attorneys, partners Andrea Lee Linna and Michael Podberesky, and associate Amanda Ray, have co-authored an article on the likely forthcoming increase in OIG and DOJ telehealth fraud enforcement that was published in the July issue of Compliance Today.   The article examines recent enforcement actions against individuals alleged to have committed telehealth fraud as… Continue Reading
CMS Guidance, DOJ, FCA Defenses, FCA Litigation, Investigations, OIG, Regulatory, Settlements, Stark Law

2021’s First-Half Notable Themes on The FCA Insider

As vaccination rates rise, the COVID-19 pandemic continues to reverberate through 2021. These reverberations also impacted the healthcare fraud and abuse landscape that is the basis of The FCA Insider’s coverage. To-date, 2021 has seen more than three dozen posts on topics ranging from False Claims Act (FCA) court opinions, U.S. Department of Justice (DOJ)… Continue Reading
OIG, Regulatory

Providers May Offer Incentives to Federal Beneficiaries for Receiving COVID-19 Vaccine

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

OIG Advisory Opinion Allows ASC Joint Venture by Management Company and Hospital-Employed Physicians

On April 29, 2021, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion offering first-time guidance on the development and investment of an ambulatory surgery center owned jointly by a hospital, management company and physician investors employed by the hospital. Read on for analysis of this opinion.… Continue Reading

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