Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Earlier this week, the government unsealed an indictment against Leo Joseph Govoni, the co-founder of the nonprofit Center for Special Needs Trust Administration (CSNT), and John Leo Witeck, an accountant for CSNT, charging...more
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
On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more
On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more
Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million - Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...more
Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...more
In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...more
Explore the unique issues that are pertinent to managed care professionals! This annual event dedicated to compliance management for health plan providers is returning to an in-person format for 2024. Join your peers and...more
A recent decision by the Supreme Court clarified the required intent for a defendant to be held liable under the False Claims Act. According to the Court, the FCA’s scienter requirement refers to a defendant’s knowledge and...more
On January 13, 2023, the United States Supreme Court granted certiorari1 to review the False Claims Act (“FCA”) scienter standard in two FCA whistleblower cases from the Seventh Circuit, U.S. ex rel. Schutte v. SuperValu...more
OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more
Can’t attend the conference in-person? The virtual Managed Care Compliance Conference, February 8–9, allows you to hear from industry professionals just like you—all from the comfort of your home or office. Geared towards...more
Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more
On May 28, 2021, OIG released its Semiannual Report to Congress (the Report). The Report describes OIG’s work during the 6-month semiannual reporting period of October 1, 2020, through March 31, 2021 (the Semiannual Reporting...more
Court Rules Prescription Drug Event and Enrollee Encounter Data Are 'Claims for Payment' Under the False Claims Act - US District Judge Noel L. Hillman approved a whistleblower’s request to file a Fourth Amended Complaint...more
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
On September 4, 2018, the Third Circuit revived a False Claims Act (FCA) suit against PharMerica Corporation that the District Court had dismissed based on the FCA’s public disclosure bar. ...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...more
United States Attorney for the District of Minnesota, Andrew Luger, spoke at a public event on March 3, 2016, at Mitchell-Hamline School of Law on the topic of health care fraud & abuse enforcement priorities in Minnesota....more
On June 18, 2015, the U.S. Department of Justice (DOJ), in collaboration with the U.S. Department of Health and Human Services (HHS), announced criminal charges against 243 individuals located in 14 states for various health...more
Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more