News & Analysis as of

Compliance Department of Health and Human Services (HHS) Medicare

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

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In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Husch Blackwell LLP

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

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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

Health Care Compliance Association (HCCA)

HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance

In November 2024, the Office of Inspector General at Health and Human Services released its Nursing Facility: Industry Segment-Specific Compliance Program Guidance. The document is part of an effort to modernize how HHS OIG...more

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

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On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

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The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

Health Care Compliance Association (HCCA)

Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)

In addition to releasing its General Compliance Program Guidance, the OIG at HHS announced plans to publish a series of Industry Segment-Specific Compliance Program Guidances (ICPG). The first of these, addressing nursing...more

McDermott Will & Emery

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

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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

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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

Foley & Lardner LLP

Key Takeaways: 7th Annual “Let’s Talk Compliance” Conference

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Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...more

Snell & Wilmer

Healthcare Price Transparency Executive Order Mandates Enforcement

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On Tuesday, February 25, 2025, President Trump signed an Executive Order aimed at promoting healthcare price transparency (the 2025 Executive Order).1 The 2025 Executive Order mandates that certain federal departments must...more

Sheppard Mullin Richter & Hampton LLP

Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these...more

Whiteford

Ambulatory Surgery Center Trends in Regulation, Compliance, and Enforcement

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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

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Bass, Berry & Sims PLC

Fourth Circuit Holds that Violation of CIA Can Support Reverse False Claims and Adopts Relaxed Rule 9(b) Presentment Requirement

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On February 3, the U.S. Court of Appeals for the Fourth Circuit reversed a district court’s grant of a motion to dismiss, holding in relevant part that: - Violations of a Corporate Integrity Agreement (CIA) can create an...more

Sheppard Mullin Richter & Hampton LLP

May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace

The Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) recently issued the final “HHS Notice of Benefit and Payment Parameters for 2026” (hereinafter referred to as the “Rule”)...more

McDermott Will & Emery

HHS OIG Releases Updated Nursing Facility Compliance Program Guidance: Quality and Safety Lessons

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Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

The Emergency Room—The Front Door to the Hospital (Fraud Schemes)?

Fraud related to hospital services – both inpatient and outpatient – has led to over $511 million in damages and hundreds of millions of dollars in False Claims Act (FCA) settlements over the past 15 years. The ER has been...more

Hendershot Cowart P.C.

Texas Healthcare Providers Paid $21.3 Million to Resolve Stark Law Violations in 2024

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Healthcare fraud enforcement continues to be a top priority for federal authorities, with Stark Law violations remaining under particular scrutiny. The complex nature of physician self-referral regulations, combined with...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

Mintz - Health Care Viewpoints

EnforceMintz — Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024

The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more

McCarter & English, LLP

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

ArentFox Schiff

At Long Last, the OIG Issues Its Compliance Program Guidance for Nursing Facilities

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On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG)....more

McDermott Will & Emery

CMS Updates Scope of Providers Subject to Provisional Period of Enhanced Oversight

The Centers for Medicare & Medicaid Services’ (CMS) 2025 Home Health Prospective Payment System final rule (Final Rule) expanded the scope of providers subject to a provisional period of enhanced oversight (PPEO) to include...more

Baker Donelson

Enhancing Compliance in Nursing Facilities: OIG's New Guidance

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The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued new Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG) for nursing facilities...more

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