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Office of the Inspector General Regulatory Requirements Department of Health and Human Services (HHS)

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Husch Blackwell LLP on

In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Hogan Lovells

An evolving ‘nexus’: OIG approves sponsored testing program involving companion diagnostic

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more

Rivkin Radler LLP

OIG Audit of MACs Finds Deficiencies

Rivkin Radler LLP on

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

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

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

ArentFox Schiff

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

ArentFox Schiff on

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

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

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

Rivkin Radler LLP on

In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

Baker Donelson on

The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

McDermott Will & Emery

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

McDermott Will & Emery on

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

Paul Hastings LLP

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

Paul Hastings LLP on

In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

Dentons on

Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

Goodwin

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

Goodwin on

In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

Wilson Sonsini Goodrich & Rosati

Key Considerations for Contracting with Healthcare Revenue Cycle Management Companies

Revenue cycle management companies (RCM Companies) help healthcare organizations manage billing, coding, claim submissions, and collections. Partnering with an RCM Company can enhance efficiency, accuracy, and...more

Whiteford

Ambulatory Surgery Center Trends in Regulation, Compliance, and Enforcement

Whiteford on

Ambulatory Surgery Centers (ASCs) are experiencing significant shifts in regulation, reimbursement, and operational practices. These changes are driven by evolving healthcare policies, technological advancements, and the...more

Morgan Lewis - As Prescribed

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more

Arnall Golden Gregory LLP

Fourth Circuit Upholds OIG’s Unfavorable Advisory Opinion on Patient Assistance Program

On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more

Morgan Lewis - Health Law Scan

HHS OIG Sets Out Limited Guardrails for Patient Assistance Arrangements

In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

Bass, Berry & Sims PLC on

As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...more

Bass, Berry & Sims PLC

HHS’ Office of Inspector General Announces New Strategic Plan: What Contractors Should Know

Bass, Berry & Sims PLC on

On October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan for improving oversight of public grants and contracts “to strengthen compliance with HHS award...more

McDermott Will & Emery

OIG Recommends Additional Oversight of Remote Monitoring Services

McDermott Will & Emery on

On September 24, 2024, the Office of Inspector General (OIG) at the US Department of Health and Human Services issued a report recommending additional oversight of remote physiologic monitoring (RPM) services furnished to...more

Baker Donelson

Information Blocking: Disincentives Established for Health Care Providers

Baker Donelson on

The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

McDermott+ on

The long-awaited final reg is upon us! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final regulation earlier this week...more

Proskauer - Health Care Law Brief

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

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