It is official: The Health Resources and Services Administration (“HRSA”) has published the long-awaited “Mega Guidance.” The Proposed 340B Drug Pricing Program Omnibus Guidelines (“Guidelines”) were published in the Federal Register on August 28, 2015. Any comments must be submitted on or before October 27, 2015. The proposed Guidelines aim to “add clarity in the marketplace for all … Continue Reading
340B covered entities need to revisit and perhaps ramp up their compliance efforts. The director of the Health Resources and Services Administration’s Office of Pharmacy Affairs has been very open in touting the fact that HRSA has invested in program integrity to make sure that manufacturers and covered entities remain compliant and that benefits for … Continue Reading
OIG’s recently issued FY 2015 Work Plan has made duplicate discounts a new focus for FY 2015. OIG “will assess the risk of duplicate discounts for 340B-purchased drugs paid through Medicaid managed care organizations (MCOs) and describe States’ efforts to prevent them.” Under the Affordable Care Act, states were required to collect rebates for drugs … Continue Reading
