News & Analysis as of

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

McDermott Will & Schulte

OIG continues focus on RPM services in new data-driven report

On August 25, 2025, the US Department of Health and Human Services Office of Inspector General (OIG) issued a report analyzing Medicare billing for remote patient monitoring (RPM) services. With nearly one million Medicare...more

McDermott Will & Schulte

HHS announces information blocking enforcement “crackdown”

The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more

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

Arnall Golden Gregory LLP

When Patients Leave Against Medical Advice: What Hospitals Miss and Why It Matters

Delivering high-quality healthcare becomes difficult when patients disregard their doctors’ advice. A patient who chooses to leave the hospital against medical advice (“AMA”) represents a particularly severe case of...more

Arnall Golden Gregory LLP

OIG Advisory Opinion 25-09: Careful and Intentional Structure Yields Positive Results for Physician-Owned Entity

The Proposed Arrangement - On August 7, 2025, the OIG issued Advisory Opinion 25-09.1 In this instance, the Requestor was a medical device developer, manufacturer, and seller of certain medical devices related to emergency...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

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 & 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

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 & Schulte

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

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

69 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide