Articles and Blogs

On June 7, 2022, the Federal Trade Commission (“FTC”) announced that it would launch an inquiry into the business practices of the nation’s six largest pharmacy benefit managers (“PBMs”). The inquiry will investigate the impact of vertically integrated PBMs on the access and affordability of prescription drugs. This news comes at a time when... READ MORE

On December 10, 2020, the Supreme Court of the United States (the “Supreme Court”) unanimously overturned an Eighth Circuit decision in the case of Rutledge v. Pharmaceutical Care Management Association. In the case, the Supreme Court held that an Arkansas law known as Act 900, which regulates the rates at which pharmacy benefit managers... READ MORE

In the closing days of the Trump administration, OIG finalized a controversial rule (the “Final Rule”) to amend the discount safe harbor (“Discount Safe Harbor”) to the federal Anti-Kickback Statute (“AKS”), effectively changing the treatment of prescription drug rebates under the AKS. Beginning January 1, 2022,[1] certain reductions in price or other remuneration from... READ MORE

On July 24, 2020, President Trump announced four Executive Orders (“Executive Orders”) characterized as focusing on lowering drug prices via various mechanisms. These Executive Orders, described in more detail below, include: (1) Executive Order on Access to Affordable Life-saving Medications; (2) Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; (3)... READ MORE

On January 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an Informational Bulletin titled “Best Practices for Avoiding 340B Duplicate Discounts in Medicaid” (“Bulletin”). The Bulletin outlines best practices that CMS encourages state Medicaid agencies to consider to avoid the situation where a manufacturer provides both a Medicaid drug rebate and... READ MORE

Congressional Leaders Discuss Health Care Priorities Congress’ top leaders, Senate Majority Leader Mitch McConnell (R-KY) and House Speaker Nancy Pelosi (D-CA), announced they are not embracing “Medicare for All” as a priority at the American Hospital Association’s annual Washington conference. Both leaders reinforced that each chamber will pursue largely separate health care agendas in... READ MORE

Beginning April 1, 2019, Medicare Part C and D plans, PACE organizations and 1876 cost contract plans (“Plans”) will be required to deny payment for services rendered or prescriptions ordered by any provider on the new Centers for Medicare & Medicaid Services (“CMS”) Preclusion List. The Preclusion List, which was first made available to... READ MORE

On January 31, 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a proposed rule that, if finalized, would eliminate Anti-Kickback Statute (“AKS”) safe harbor protection for prescription drug rebates paid by manufacturers to pharmacy benefit managers (“PBMs”), Medicare Part D plans and Medicaid managed care organizations (“Proposed Rule”).... READ MORE

On August 7, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a Memorandum (“Memorandum”) announcing a policy change to allow Medicare Advantage (“MA”) plans to implement step therapy programs for physician-administered and other Part B drugs. Step therapy is a type of prior authorization for drugs in which a health plan requires... READ MORE