On June 17, 2015 the Health Resources and Services Administration (“HRSA”) finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Comments must be submitted via the online portal, email, or US Mail by August 17, 2015. Keep in mind, all submitted comments will be … 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
HRSA/OPA announced the withdrawal of the so-called mega rule last November. This major piece of legislative rulemaking had been over four years in the works. The rule had spent the past six months at the Office of Management and Budget, the last step prior to publication. The DC District Court ruling in Pharmaceutical Research and … Continue Reading
