Providers might be concerned about how taking advantage of legal and regulatory flexibilities during the COVID-19 epidemic affects their compliance with 340B program requirements. Source: CDC
HRSA Tells COVID-19 Responders Concerned About 340B Compliance to Contact it Directly
The Health Resources and Services Administration (HRSA) is advising health care providers concerned about whether they are responding to the COVID-19 epidemic in compliance with 340B drug discount program requirements to contact HRSA directly for an evaluation.
“HRSA understands that many covered entities are concerned about the evolving impact of COVID-19,” HRSA told 340B Report this afternoon. “To the extent a covered entity has a specific circumstance where they believe their COVID-19 response may affect their ability to participate in or remain compliant with 340B program requirements, the covered entity should contact HRSA directly and we will evaluate each circumstance on a case-by-case basis. Additional information about Public Health Emergencies and participation in the 340B Program can be found here: https://www.hrsa.gov/opa/eligibility-and-registration/index.html.”
The federal and state governments have started easing staffing, facilities, and other requirements for hospitals and others that could soon be overwhelmed with patients sick with COVID-19. On March 13, for example, President Trump signed a national emergency declaration that will let Health and Human Services Secretary Alex Azar waive Medicare, Medicaid, and Children’s Health Insurance Program laws and rules touching on:
Licensing requirements so doctors can provide services in other states
Bringing additional doctors on board or obtaining additional office space
Restrictions on where hospitals can care for patients.
Providers enrolled in 340B have an ongoing responsibility to prevent diversion of 340B covered outpatient drugs to ineligible patients. Where a prescription for a 340B-purchased drug was written, by whom, and for whom could determine whether drug diversion occurred and whether a provider needs to repay a drug manufacturer. Legal requirements for providers responding to COVID-19 are being relaxed just as HRSA has announced it has no plans to issue new guidance due to concerns about its enforcement power. HRSA wants broad regulatory authority over the entire 340B program.