Standard Met? Compliance Checklist Approaches/ Notes Options 18. Required manual Manual manipulations of the accumulator are often required by the manipulations of the entity staff when drugs are purchased directly, purchased through a accumulator will be minimal. specialty distributor, not purchased by the pharmacy (e.g., or when handling certain controlled substances (CII). Software may be able to accept electronic data interface (EDI) invoices from alternate suppliers as well as primary wholesalers. Software must have a mechanism to record purchases outside the EDI mechanism (including alternate suppliers and borrow-lends). 19. The software will have the Reports typically enable the entity to audit the accumulator capability to provide adequate for the following: reports for auditing of Compare drug purchased with drugs dispensed to all inpatients • accumulations and and outpatients. dispensations for compliance with the 340B Program. Patient eligibility should include provider and location of service. • Audit for addition of new CDMs and new NDCs to ensure • correct mapping of the drugs to all for appropriate accumulations. Review multipliers that will be used to purchase appropriate • package size versus charge codes used in billing (e.g., a multiplier of 10 is needed for infliximab that is billed in units of 10 mg but purchased in units of 100 mg). The software vendor may send out an annual audit review report. A summary of all filters, data reports, payors, providers, special rules, and other indicators is provided so that the entity can review data for accuracy. The vendor essentially assists with identifying potential areas of liability.
Standard Met? Compliance Checklist Approaches/ Options Notes 18. Required manual manipulations of the accumulator will be minimal. Manual manipulations of the accumulator are often required by the entity staff when drugs are purchased directly, purchased through a specialty distributor, not purchased by the pharmacy (e.g., or when handling certain controlled substances (CII). Software may be able to accept electronic data interface (EDI) invoices from alternate suppliers as well as primary wholesalers. Software must have a mechanism to record purchases outside the EDI mechanism (including alternate suppliers and borrow-lends). 19. The software will have the capability to provide adequate reports for auditing of accumulations and dispensations for compliance with the 340B Program. Reports typically enable the entity to audit the accumulator for the following: • Compare drug purchased with drugs dispensed to all inpatients and outpatients. • Patient eligibility should include provider and location of service. • Audit for addition of new CDMs and new NDCs to ensure correct mapping of the drugs to all for appropriate accumulations. • Review multipliers that will be used to purchase appropriate package size versus charge codes used in billing (e.g., a multiplier of 10 is needed for infliximab that is billed in units of 10 mg but purchased in units of 100 mg). The software vendor may send out an annual audit review report. A summary of all filters, data reports, payors, providers, special rules, and other indicators is provided so that the entity can review data for accuracy. The vendor essentially assists with identifying potential areas of liability.
340b-vendor-decision-checklist.docx