Mid-Year Medicare 340B Drug Pricing Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program.  Providers participating in the 340B Program (covered entities), as well as their contract pharmacies and other stakeholders such as drug manufacturers, state Medicaid agencies, and Medicaid managed care plans, should be aware of the potential changes that may occur as these rules become effective.  Additionally, the Health and Human Services Office of Inspector General (OIG) recently issued a report making recommendations related to the 340B Program that could also affect 340B Program policy.  In addition, the Health Resources and Services Administration (HRSA) expects to publish significant new 340B Program regulations and guidance later this year.

HRSA Issues a Proposed Rule for Dispute Resolution in the 340(b) Program

On August 11, 2016, the Health Resources and Services Administration (HRSA) released a Notice of Proposed Rulemaking (NPRM) defining a proposed administrative dispute resolution (ADR) process for the 340B Drug Pricing Program (340B Program). The NPRM was published in the Federal Register on August 12, 2016, and comments are due within 60 days of publication, on or before October 11, 2016

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