News & Analysis as of

Healthcare Department of Health and Human Services (HHS) Civil Monetary Penalty

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Private Equity Throws FCA Enforcement Off-Kilter

Over the last 15 years, private equity (“PE”) firms have invested hundreds of billions of dollars in the healthcare sector, infiltrating every corner of the industry from emergency rooms and labs to billing providers and...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

Foley & Lardner LLP on

Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

Bass, Berry & Sims PLC on

On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

Quarles & Brady LLP

Million Dollar Maybe: Enforcement of Cures Act Information Blocking Prohibitions Begins

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As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...more

King & Spalding

OIG Publishes the Spring 2023 Semiannual Report to Congress

King & Spalding on

OIG released its Semiannual Report to Congress (the Report) which summarizes the agency’s activities from October 1, 2022, through March 31, 2023 (the Reporting Period). Among other accomplishments, the Report highlights...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 11. MD Anderson Won Against OCR, But Agency’s Response—Including on Fines—Keeps...

Report on Patient Privacy Volume 22, Number 11. (November 2022) Nearly five years passed from the time the University of Texas MD Anderson Cancer Center reported to the HHS Office for Civil Rights (OCR) that three...more

Faegre Drinker Biddle & Reath LLP

Fifth Circuit Decision Motivates Covered Entities to Appeal Unreasonable Enforcement Outcomes

The United States Court of Appeals for the Fifth Circuit (the “Court”) vacated a $4,348,000 civil monetary penalty (“CMP”) imposed by the U.S. Department of Health and Human Services’ Office for Civil Rights (“HHS-OCR”) in...more

Sheppard Mullin Richter & Hampton LLP

What Does the Fifth Circuit’s Vacating of HHS HIPAA Fines Mean for Companies This Year?

Will HHS’ approach for imposing penalties in the aftermath of a data breach become a little clearer in 2021? This is a distinct possibility in the wake of a Fifth Circuit decision vacating penalties against MD Anderson Cancer...more

Akerman LLP - Health Law Rx

Lack of Timely Action and Knowledge of Risk Results in $3.2 Million Civil Monetary Penalty for HIPAA Violations

Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

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With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Robinson & Cole LLP

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

Robinson & Cole LLP on

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

Proskauer Rose LLP

HHS OIG Adopts NewAnti-Kickback Safe Harbor and Civil Monetary Penalty Exceptions

Proskauer Rose LLP on

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more

McDermott Will & Schulte

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

McDermott Will & Schulte on

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

King & Spalding

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

King & Spalding on

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

McDermott Will & Schulte

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more

Akerman LLP - Health Law Rx

Illinois’ Largest Health System Agrees to Stringent HIPAA Breach Settlement

The Department of Health and Human Services Office for Civil Rights (OCR) announced on August 4, 2016, a settlement agreement with Advocate Health Care Network, an integrated healthcare system with ten hospitals and a...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Mintz on

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

Cadwalader, Wickersham & Taft LLP

In Closely Watched Case, Federal Court Upholds the Government’s Position on Provider Mandate to Report and Return Medicare and...

The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more

Foley & Lardner LLP

What to Expect From HHS-OIG's New Litigation Team

Foley & Lardner LLP on

The Office of Inspector General at the U.S. Department of Health and Human Services (“HHS-OIG”) announced, on June 30, 2015 (during a health care conference), the creation of a new litigation team that will focus solely on...more

Faegre Drinker Biddle & Reath LLP

Bill Would Extend CMPs to Federal Grants

The bill known as the “21st Century Cures,” H.R.6, would extend Civil Monetary Penalties (CMPs) to cover false claims and false statements relating to grants, contracts, and other agreements funded by the Department of Health...more

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