Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...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
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
On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
For the first time since 2006, CMS has issued updated rules affecting the Program for All-Inclusive Care for the Elderly, or PACE organizations. The final rule, published in the June 3, 2019 issue of the Federal Register,...more
Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice...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
On December 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) finalized [PDF] its proposal to update the civil monetary penalty (CMP) regulations – namely, incorporate new CMP authorities...more
On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more
On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more
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
A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP) enforcement actions in these two programs more than tripled from 2012 to 2013....more
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”), which would amend the Anti-Kickback Statute...more
On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more
On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs...more