Regulatory Waivers Under a Public Health Emergency
On January 31, 2020, the Secretary of Health and Human Services (“HHS”) Alex Azar declared a public health emergency (“PHE”) over the outbreak of the new coronavirus. The PHE response requires coordination with a complex set of federal, state, tribal and local laws and effective compliance calls for a comprehensive understanding of the legal implications and ramifications—which impose challenges from adherence to certain federal laws.
A Way Around HHS 340B Program Delays
Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute.