Are HRSA 340B Audits Keeping You Up At Night?

HRSA’s budget was recently increased from $4.4 million to $10.2 million. The increase in funding is expected to enable HRSA to implement 340B program integrity compliance initiatives.

HRSA plans to conduct risk based and targeted audits of 340B covered entities. Using an audit protocol specific to the 340B Program, the HRSA risk based and targeted audits will involve an in depth review and focused audit of covered entities’ 340B Program operations and compliance.

340B Coalition Annual Conference

The 340B conference held July 7-9, 2013 brought over a thousand attendees in what was considered, another successful and informative event.  The HRSA recertification deadline and the Orphan Drug exclusion were the hot topics from the event.

The popularity of the 340B program further prompted discussions around audit and compliance and scrutiny from Congress and HRSA  for program accountability. HRSA continues its plans to audit Covered Entities, with at least 30 audits completed so far this year, with many more expected before the end of the year.

Benefits of 340B Drug Program

The 340B program's merit has consistently been scrutinized.  Recent news suggests the 340B program is indeed beneficial to the healthcare society.  Twenty-nine members of the senate are advocates of the program.  Members of the house champion the 340B program and have concluded that the results indicate reduced pharmaceutical costs, to serve low-income patients and other vulnerable patients.