The U.S. Department of Justice announced on June 5 that Arizona-based opioid manufacturer Insys Therapeutics agreed to pay $225 million to settle civil and criminal kickback charges. Last month, Insys’s founder and former CEO John Kapoor was found guilty on federal racketeering charges arising out of a bribery scheme that rewarded the company’s sales managers

On May 7, the U.S. Department of Justice (DOJ) introduced important new guidance for government attorneys explaining how DOJ will award credit to defendants who cooperate during a False Claims Act (FCA) investigation through voluntary self-disclosure, remediation (e.g., disciplining wrongdoers or others who failed in oversight, or implementing or improving an effective compliance program) and/or

The New York State Department of Financial Services has filed an amicus brief with the New York Court of Appeals reaffirming its position that a medical professional corporation “is not eligible for reimbursement” under the state’s No-Fault Law “if the provider fails to meet any applicable New York State or local licensing requirement necessary to

An April 30 article in Managed Care, “Centene, big in Medicaid managed care, wants to get even bigger,” discussed the business plans of Centene, the largest Medicaid managed care insurer in the U.S.  Rivkin Radler’s Christopher J. Kutner was quoted in the article.

Centene is hoping that its proposed acquisition of WellCare Health Plans will

On April 3, the U.S. Food and Drug Administration (FDA) sent warning letters to about 20 stem-cell clinics notifying them that their activities appear to require FDA approval. The letters, similar in form to this one, cited guidance materials that clinics can use as resources in becoming compliant with FDA requirements.

Stem-cell therapy involves removing

A three-month joint investigation of electronic health records (EHR) systems has culminated in a release of a March 18 article in Kaiser Health News (KHN) and Fortune Magazine, “Death By 1,000 Clicks: Where Electronic Health Records Went Wrong.” The lengthy, meticulously sourced article calls EHR systems “an unholy mess.”

KHN and Fortune have made the

At the Federation of American Hospitals’ 2019 Public Policy Conference on March 4, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced the agency’s plan to make dramatic changes to the federal physician self-referral prohibition, commonly known as the Stark Law. The changes are designed to support a value-based model of care in

On February 6, the U.S. Department of Justice announced that Greenway Health LLC, a Florida-based developer of electronic health records (EHR) software, will pay $57.25 million as part of a False Claims Act settlement. The United States had alleged that Greenway misrepresented the capabilities of its software product, called “Prime Suite,” causing healthcare providers to submit

Inform Diagnostics, a Texas-based pathology laboratory company, will pay the federal government $63.5 million to resolve allegations that the company violated the False Claims Act (FCA). The U.S. Department of Justice announced the settlement on January 30.

Inform Diagnostics was alleged to have engaged in improper financial relationships with physicians, including providing them with subsidies

On January 28, the Federal Trade Commission (FTC) published on its Business Blog a post titled “Hey Nineteen: Nine FTC developments that could impact your business in 2019.” Of most importance to the healthcare industry is the FTC’s promise to focus on unsubstantiated health claims in advertising. The relevant paragraph of the post reads as