HRSA Releases 340B Program "Mega-Guidance": 18 Key Points

August 27, 2015

Becker's Hospital Review (Ellison, 8/27) reported that the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) has released the long-awaited "mega-guidance" on the 340B Drug Pricing Program.The 90-page guidance on the 340B program was formally published in the Federal Register on August 28. There will be a 60-day comment period, with comments due on or before October 27. Becker's Hospital Review has provided 18 takeaways on the guidance, including that “the guidance addresses a broad range of topics within the 340B Program, including the definition of patient, contract pharmacy compliance requirements, hospital eligibility criteria and eligibility of off-site outpatient locations.”