Maxwell Healthcare Consulting provides advisory services related to the 340B Drug Pricing Program administered by the HRSA Pharmacy Support Services. Federal grantees and disproportionate share hospitals are eligible for participation in the cost saving program.
To purchase drugs utilizing the 340B drug pricing program, covered entities must meet the following ongoing requirements:
- Keep 340B database information accurate and up to date. Register new outpatient facilities and contract pharmacies as they are added.
- Recertify eligibility every year.
- Prevent duplicate discounts. Manufacturers are prohibited from providing a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must accurately report how they bill Medicaid drugs on the Medicaid Exclusion File.
- Prevent diversion to ineligible patients. Covered entities must not resell or otherwise transfer 340B drugs to ineligible patients.
- Prepare for program audits. Maintain auditable records documenting compliance with 340B Program requirements. Covered entities are subject to audit by manufacturers or the federal government. Any covered entity that fails to comply with 340B Program requirements may be liable to manufacturers for refunds of the discounts obtained.
340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements. Covered entities are subject to audit by manufacturers or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.
MHC can assist by determining whether the facility meets the requirements to participate in the program as well as assistance in filing the appropriate requests.