Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
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
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
As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...more
Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...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
Friday the 13th is not all bad luck. On September 13, 2024, the United States Court of Appeals for the Eighth Circuit’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors,...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
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...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 April 5, the Centers for Medicare & Medicaid Services (“CMS”) released the 2024 Medicare Advantage and Prescription Drug Benefit Programs Final Rule (“Final Rule”), which will be codified at 42 C.F.R. Parts 417, 422, 423,...more
On Friday, March 31, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Rate Announcement). This Rate...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
Last week, the Supreme Court granted review to clarify the scienter requirement in False Claim Act (31 U.S.C. §§ 3729 et seq.) (FCA) cases. This significant decision will affect the scope of FCA liability by addressing what...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
In a much-awaited Seventh Circuit decision, the court joined four other circuits in endorsing the “objective reasonableness” defense under the federal False Claims Act (FCA). In a 2-1 panel decision, the court not only upheld...more
A federal judge recently ruled that submission of electronic data to the government can, under appropriate circumstances, give rise to liability under the False Claims Act. In U.S. ex rel. Marc Silver et al. v. Omnicare Inc....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
Most health care providers have at least a basic understanding of the Anti-Kickback Statute. This federal law prohibits providers from offering, paying, soliciting, or accepting any form of “remuneration” for patient...more