This week the federal Office of Management & Budget (OMB), the last step before federal regulations are published, sent the 340B mega-guidance back to the federal Department of Health & Human Services (HHS). The OMB officially lists the mega-guidance as now “withdrawn.” This means that in order for the guidance to move forward, it would have to be resubmitted by HHS to the OMB.
“This week’s announcement is a pleasant reprieve,” said Jenny Boese, WHA vice president, federal affairs & advocacy. “With thousands upon thousands of pages of federal regulations coming at hospitals this past year alone, we appreciate that this proposal has been pulled back.”
With President Trump’s recent Executive Orders on regulations, the 340B mega-guidance is now stopped and current 340B policies remain in effect.
The mega-guidance was originally released in 2015 by the Health Resources & Services Administration (HRSA), an agency within HHS. In 2015, WHA worked in consultation with hospitals and health systems across the state to develop and submit detailed comments to HRSA, highlighting several key concerns. Among the 2015 proposed changes were:
- Covered entity requirements – including items such as eligibility, registration requirements (parent/child sites), compliance, and handling of Medicare/Medicaid Managed Care patients
- Covered outpatient drugs
- Definition of a patient – including creating a multi-part test that must be met by covered entities
- Contract pharmacy requirements – including oversight, registration requirements among others
- Manufacturer requirements
- Program integrity – applying to both covered entities and manufacturers
“A cross-section of Wisconsin hospitals qualify for this important program and plow 340B drug savings back into providing important prescriptions and services to patients and communities,” said Boese. “As Congress originally intended, they are using program savings to ‘stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.’”