What categories and questions should healthcare entities consider?
Covered entities awaiting a response from the Health Resources and Services Administration (HRSA) for comments about the agency’s proposed “340B Drug Pricing Program Omnibus Guidance” (mega-guidance) can take meaningful steps now to increase the likelihood of being in compliance with the program by the time the final guidance goes into effect. Many anticipate a response during the fall of 2016.
Entities need to be ready when the time comes. Audits by HRSA have been doubling each year. If an organization has not already been audited, it very likely will be, which means it will be asked to provide hard data to support processes, ongoing monitoring, and compliance.
The article discusses three actions 340B Program participants can take during the next several months to prepare for the coming changes.