News & Analysis as of

OIG: Exclusive laboratory arrangement may violate Antikickback Statute and result in exclusion for excessive charges

On March 25, 2015, the Office of Inspector General (“OIG”) issued Advisory Opinion 15-04, which found that an exclusive arrangement between a laboratory and its referring physician practices could violate the Federal...more

Blog: OIG Releases Advisory Opinion Regarding Laboratory and Physician Practice Agreement

On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements...more

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more

Should Health Care Providers Pay Attention to the Seventh Circuit’s New Definition of “Referral”? – Part Two

Tuesday’s post discussed the Seventh Circuit’s holding in United States v. Patel, broadly expanding the definition of “referring” under the Anti-Kickback Statute. Today’s post turns to the question of how other circuits have...more

Seventh Circuit Upholds Physician’s Conviction for Violation of the Anti-kickback Law Based on Expansive Definition of “Referral”

On February 10, 2015, the U.S. Court of Appeals for the Seventh Circuit upheld the conviction of Dr. Kamal Patel for violation of the anti-kickback law, reinforcing a broad definition of “referring” under the statute (U.S. v....more

Connecting the Dots: The Seventh Circuit Stretches the Definition of “Referral” to Find Anti-Kickback Liability Where a Physician...

The Seventh Circuit recently stretched the definition of “referral” under the federal Anti-Kickback Statute (AKS) to affirm a lower court’s ruling that a physician can trigger AKS violations even if such physician does not...more

7th Circuit Court of Appeals Creates Expansive Definition of “Referral” Under the Anti-Kickback Statute

On February 10, 2015, in United States v. Patel (Case No. 14-2607), the Seventh Circuit Court of Appeals ruled that a physician makes a “referral” within the meaning of the federal health care programs Anti-Kickback Statute...more

Health Care Reform Implementation Update

The Centers for Medicare and Medicaid Services (CMS) began sending reminders last week that open enrollment begins on November 15; CMS’s Marketplace CEO, Kevin Counihan, said that end-to-end testing of HealthCare.gov was...more

Health Law Alert: OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule that revises safe harbors under the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) rules regarding...more

Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing...

On October 3, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil...more

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

OIG Proposes New Safe Harbors to the Anti-Kickback Statute and New Exceptions to the Two Civil Monetary Penalty Provisions

On October 3, 2014, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to add new safe harbors to the federal health care program anti-kickback statute...more

Proposed Updates to the Civil Monetary Penalties Law for Health Care Providers

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”) that would amend certain rules under the Civil...more

Whistleblower Goes It Alone to Secure $5 Million Settlement under False Claims Act

The potential success of a whistleblower lawsuit filed under the False Claims Act (FCA) is significantly reduced when the government fails to intervene because such cases are often assumed to lack merit. However, a plaintiff...more

Sometimes the Government is Here to Help: OIG Proposes More Flexibility in Rules Governing Local Transportation, Beneficiary...

The U.S. Department of Health & Human Services, Office of Inspector General ("OIG") just released a proposed rule (“Proposed Rule”) that provides long awaited guidance on patient transportation services, relaxes the...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

HealthCare Fraud and Courtesies: What to Know Before Waiving a Copayment

Many healthcare facilities and physicians waive the insurance copayment for physicians and their families (known as professional courtesy) or other patients. Yet, despite how prevalent the practice is and the limited...more

OIG Issues “Special Fraud Alert” on Lab Payments for Specimen Processing and Data Registry

On June 25, 2014, the OIG issued a Special Fraud Alert addressing compensation paid by laboratories to referring physicians. This Special Fraud Alert supplements prior OIG guidance which emphasizes that providing free or...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

OIG issues special fraud alert on laboratory payments to referring physicians

On June 25, 2014, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) released a Special Fraud Alert addressing Laboratory Payments to Referring Physicians. ...more

OIG Sticks It to Physician Specimen Collectors

On June 25, the U.S. Department of Health & Human Services, Office of the Inspector General ("OIG") issued a Special Fraud Alert updating the previous guidelines concerning compensation by clinical laboratories to referring...more

OIG issues Special Fraud Alert on laboratory payments to referring physicians

The Health and Human Services Office of the Inspector General (OIG) recently issued a Special Fraud Alert on laboratory payments to referring physicians. Specifically, the alert is concerned with Specimen Processing...more

OIG Special Fraud Alert on Laboratory Payments to Referring Physicians

On June 25, 2014, the Office of Inspector General (OIG) published a Special Fraud Alert titled “Laboratory Payments to Referring Physicians” in which it addresses compensation arrangements and potential anti-kickback statute...more

OIG Issues Special Fraud Alert Regarding Laboratory Payments To Referring Physicians

On June 25, 2014, the United States Department of Health and Human Services, Office of the Inspector General ("OIG"), issued a Special Fraud Alert that addressed its concerns about compensation paid by clinical laboratories...more

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