As the COVID-19 crisis continues to unfold, the Health Resources & Services Administration Office of Pharmacy Affairs (HRSA OPA) has taken unprecedented steps to provide 340B Program participants with additional flexibility to help meet surging patient demand. At the highest level, HRSA OPA acknowledges that “this public health emergency may warrant additional flexibilities, especially to … Continue Reading
On March 11, 2019, the President delivered his proposed 2020 budget to Congress. While a President’s budget proposal is the beginning of a lengthy budget process, this proposed budget nonetheless keeps the 340B Program in the national focus and delineates the President’s position on desired 340B Program changes.… Continue Reading
It’s been a roller coaster two years for the 340B Program, and we are now back to review some of the major developments and program changes during this time. On the highest level, despite a flurry of proposed legislative action, the 340B Program remains largely unchanged from where it stood prior to 2017. As covered … 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
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
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
