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Regulatory Requirements Healthcare Fraud

Robinson+Cole Health Law Diagnosis

OIG Shines Spotlight on Billing for Remote Patient Monitoring

On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more

Hendershot Cowart P.C.

EKRA Gets Its Second Major Court Test: What the Schena Decision Means for Lab Marketing and Sales Compensation

Hendershot Cowart P.C. on

On July, 11, 2025, the Ninth Circuit Court of Appeals affirmed laboratory operator Mark Schena’s conviction under Eliminating Kickbacks in Recovery Act (EKRA). This is the first time a higher court has addressed the lab...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

New Jersey Enacts Key Legislation Addressing Kickbacks and Deceptive Marketing Practices in the Substance Use Disorder Treatment...

On August 11, 2025, New Jersey’s Acting Governor, Tahesha Way, signed into law two bills to combat patient brokering and deceptive marketing practices in the Substance Use Disorder (“SUD”) treatment industry. The legislation,...more

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

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On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

Bass, Berry & Sims PLC

Key Considerations for Dental Service Organization Transactions

Dental service organizations (DSOs) enable dental practices and their providers to focus on patient care while outsourcing administrative, billing, and other non-clinical functions. As private equity interest in healthcare...more

Orrick, Herrington & Sutcliffe LLP

Opportunities and Risks in Remote Patient Monitoring and Remote Therapeutic Monitoring for 2026

The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (see Orrick’s analysis of the proposed rule here) contains important signals for the future of remote patient monitoring (RPM) and remote therapeutic...more

Greenbaum, Rowe, Smith & Davis LLP

Navigating New Jersey’s Medical Spa Regulatory Landscape: Key Compliance and Risk Management Considerations

The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses,...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

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In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

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The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Alston & Bird

Health Care Week in Review | Congress Passes One Big Beautiful Bill Act; CMS Releases Proposed Payment Rules for ESRD and Home...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Dentons

Ep. 68 – Before You Audit—Why Pre-Audit Planning Matters

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If you’re preparing to launch an audit within your healthcare organization, pause for a moment and consider this: how well you plan before the audit begins can significantly affect the outcome—and your risk exposure. This...more

Husch Blackwell LLP

Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials

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In an audit, election statement deficiencies can be costly. Auditors deny all claims covered by the problematic election statement, and those costs can multiply if more than one patient was affected. In this episode, Husch...more

Ankura

Forensic Analytics in Pharmaceutical Fraud Investigations: Lessons from Recent Cases

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The pharmaceutical industry faces escalating risks from sophisticated fraud schemes, including counterfeit drug distribution, billing irregularities, and corporate malfeasance. Forensic analytics—powered by AI and advanced...more

King & Spalding

OIG Releases Audit of Medicare Payments for Evaluation Management Services Billed on the Same Day as Eye Injections

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On May 27, 2025, HHS Office of Inspector General (OIG) issued a report outlining its finding that Medicare payments for evaluation management (E&M) services provided on the same day as eye injections were at risk for...more

Proskauer - Health Care Law Brief

CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts

On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more

Rivkin Radler LLP

OIG Audit of MACs Finds Deficiencies

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The 12 regional Medicare Administrative Contractors (MACs) were recently audited by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). Each of the MAC jurisdictions was found by the OIG to...more

Arnall Golden Gregory LLP

How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

McDermott Will & Schulte

CMS Poised for Medicare, Medicaid Integrity Enforcement Actions

The Trump administration and 119th Congress are preparing to reduce federal expenditures by targeting Medicare and Medicaid fraud, waste, and abuse. Medicare enrollment revocations, Medicaid enrollment terminations, and...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

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In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Health Care Compliance Association (HCCA)

UPIC Audits

An audit by a Unified Program Integrity Contractor auditor, better known as a UPIC audit, can be a very scary thing. Healthcare providers are often shocked and even indignant to receive a letter notifying them of the audit...more

Bass, Berry & Sims PLC

[Webinar] Healthcare Regulatory & Compliance Summit - May 1st - 2nd, 9:00 am - 12:45 pm CT

Please join us for the inaugural Healthcare Regulatory & Compliance Summit, hosted by Bass, Berry & Sims. The in-person event will take place in our Nashville office on Thursday, April 24 from 8:30 a.m. to 5:30 p.m. CT. The...more

Bass, Berry & Sims PLC

[Event] Healthcare Regulatory & Compliance Summit - April 24th, Nashville, TN

Please join us for the inaugural Healthcare Regulatory & Compliance Summit, hosted by Bass, Berry & Sims. The in-person event will take place in our Nashville office on Thursday, April 24 from 8:30 a.m. to 5:30 p.m. CT. The...more

White & Case LLP

China Released First-of-Its-Kind Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks

White & Case LLP on

On January 10, 2025, China's State Administration for Market Regulation ("SAMR"), the top anti-graft regulator, put into effect its first-of-its-kind Compliance Guidelines for Healthcare Companies to Prevent Commercial...more

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