Category Archives: Covered Entities

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Finally! HRSA Proposes Manufacturer Civil Monetary Penalties

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

Near Miss on Congressional Overhaul of 340B Program

In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act. Had hospitals, health systems, and related lobbying groups not been closely watching the Act, the changes might have quietly gone through when the 21st Century Cures Act was unanimously passed out of Committee on May 21, 2015. The 21st Century Cures initiative, advanced by the House Energy … Continue Reading

Key Dates Approaching for Title X Family Planning Grantees in the 340B Program

Mark your calendars! Calling all Title X Family Planning clinics that participate in the 340B Program—recertification opens May 13, 2015 and that means 340B Participant Change Forms must be submitted before that date. Online 340B Participant Change Forms take between five and ten days to process. These forms will not be processed during recertification. However, change requests … Continue Reading

340B Program Covered Entities: Some Items for Your Worry List

When 340B covered entities contemplate the future, they can find a number of issues to worry about. Here is a thumbnail on some of them. Orphan Drugs There is a possibility that the orphan drug issue will be resolved unfavorably to covered entities. That issue arises out of a 2014  court decision, Pharmaceutical Research and Manufacturers … Continue Reading

The Message Is Clear from OPA Director Pedley

Covered entities should be constantly preparing for  audit.  That  was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast  at the recent Winter Conference of the 340B Coalition in San Francisco.  That preparation, she said, should include making use of the compliance tools available through Apexus … Continue Reading

340B Program Participants: It’s Time to Ramp Up Compliance

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

340B and the OIG Work Plan

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
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