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
In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act.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
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
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
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
Now that OPA has ramped up its audit activities, covered entities should not be surprised to find themselves on the receiving end of a 340B program review conducted by HRSA/OPA. The likelihood of this may be increased if the entity uses contract pharmacies. It is important therefore to be aware of what information is likely … 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
Although the 340B program accounts for only two percent of over $300 billion in annual drug purchases in the US, there continues to be a lot of ink spilled over the question of whether the 340B program is serving its legislative intent of stretching federal resources to reduce drug costs and expand health services to … 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
