ARTICLES BY RONALD W. LANTON III

  • HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?
    HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?

    On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”

  • Will PBM Transparency Help Biosimilar Utilization?
    Will PBM Transparency Help Biosimilar Utilization?

    With the list price of newer drugs rising, policy makers are continuing to debate the cost savings biosimilar medications may offer. To date there are 17 FDA-approved biosimilars targeting various disease states. While biosimilars could slow the dramatic rise in the overall drug spend, many questions about them remain such as litigation, interchangeability, and how they will be integrated into the market. The last question is the most intriguing, and it is heavily dependent on the decision of pharmacy benefit managers (PBMs) about their formularies.

  • How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    How Would Proposed Congressional Price Control Policies Impact Biosimilars?

     

    Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.

  • How Will Medicare’s International Pricing Index Model Affect Biosimilars?
    How Will Medicare’s International Pricing Index Model Affect Biosimilars?

    CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.

  • The Current State Of U.S. Biosimilar Policies — An Overview
    The Current State Of U.S. Biosimilar Policies — An Overview

    With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry. 

Ronald W. Lanton III

Ronald W. Lanton III

Ronald W. Lanton III, Esq., has over 25 years of experience in government affairs at the municipal, state, and federal government levels, with 15 years dedicated to the healthcare sector. He is currently the executive director and head lobbyist at Frier Levitt Government Affairs, LLC and senior counsel at Frier Levitt. He frequently consults Wall Street firms on financial issues related to the healthcare sector. Lanton is a featured industry speaker on issues such as pharmaceutical safety and healthcare cost containment, and he has authored numerous articles regarding pharmacy and healthcare law. He earned a B.A. from Miami University and a J.D. from The Ohio State University. He is also the chair of the Biologics Committee for the New York Bar Association.