Regulatory and Compliance Analyst is needed to perform the following duties: Responsible for REGULATORY COMPLIANCE leading to pharmacy management:o Ensuring continued compliance with all national, state, and local regulations related to medications and their management.
o Responsible for the implementation of state board of pharmacy, Drug Enforcement Administration, Centers for Medicare and Medicaid Services, the Joint Commission, and other medication management programs.
o Implementation of best practices. When applicable, responsible for compliance oversight of the 340B Drug Pricing Program for the covered entity, all covered outpatient departments, and contract pharmacy arrangements.
o Policy and practice compliance with applicable state and federal laws, rules, and regulations.o Fraud, waste, and Abuse (FWA),
o Centers for Medicare & Medicaid Services (CMS),
o Drug Enforcement Agency (DEA),
o Food and Drug Administration (FDA)
o Health Insurance Portability and Accountability Act (HIPAA),
o Office of Inspector General's (OIG), Prescription drug monitoring program (PDMP),
o Medication therapy management (MTM),
o Mirixa management and Patient Compliance.
o Review Perspectives monthly to meet the FWA requirements of 45 CFR of Part 46 regulated by Office for Human Research Protections (OHRP)
o Complete annual CMS review and go through the policy and manuals for the required changes needed to be implemented to the pharmacy laws and regulation including durable medical equipment (DME including medical devices).
o Ensure biannual licensure renewals and other ongoing required education and/or monitoring for the employee’s workflow and job duties.
o Develop compliance-related staff education programs and materials upon frequent changes made to the regulatory bodies.
o Coordinating and participating in on-site, virtual, and paper audits as required by regulatory bodies.
o Working collaboratively with other pharmacy and organizational departments and managers to plan, coordinate and implement compliance improvement projects and programs for the pharmacy benefit.
o Tracking data and creating reports to assist in the analysis of compliance and safety issues including but not limited to ongoing regulatory monthly inspections, tracers, adverse event reporting, core measures and other accountability measures.· Participation in reviewing patient complaints for Medication safety and Patient awareness for health.o Timely analysis of medication-related event trends.
o Monitoring of medication safety alerts from external bodies (ISMP, ASHP, etc.) and coordination of internal review and follow up.
o Coordination of review and maintenance of medication safety metrics, including the medication safety dashboard.
o Assistance in coordination and participation in performance improvement initiatives to promote safe medication use.
o Support of a Just medication safety culture within pharmacy department· Monitoring, analyzing, interpreting, and communicating regulatory changes by utilizing available resources from regulatory organizations :Job duties including periodical meeting with Pharmacy staff and pharmacist to keep tract for ongoing process of the pharmacy operation to comply with current regulation requirements.
o Prepare the implementation of strategic plan with Gantt chart for the task to perform vs duration of time.· Provide the required State, Federal, Medicaid and Medicare Laws compliance support and lead in DEA Regulations. Respond to complaints from the state, OIG complains, state inspections, PDMP, DEA Inspection findings, Insurance audit findings and its response.o Attending the insurance audits and providing them the necessity documents as proof of compliance with regulatory requirements.
o Responding on the audit findings by submitting the missing documents, to justify the claim discrepancies and amount deduction applied to the pharmacy.
o Checking the PDMP website prior to dispensing the controlled Rx’s and submission of the claims to the PDMP website through prime Rx system (Electricals claim submission vendor) on daily bases for the regulatory bodies to find discrepancies in claim submission or overuse of opioid medicine by patient.
o Resolve the discrepancies findings responded by PDMP software.
o OIG complain handling, state inspection handling by submitting current employee’s information including HIPAA and FWA certification, employee criminal background checking, Technician Protocol submission, OIG exclusion verification page, the e-signature logs for Rx’s through the system software, copies of Rx’s required by the auditors and all the regulatory policy and procedure related to the regulations of the Pharmacy.· Prepare the protocols and SOPs for regular operations of the pharmacy and keep updated in timely manner.o Prepare SOPs for Starting of the month
o Prepare SOPs for Ending of the month
o Prepare protocol for regular pharmacy operation.
o Prepare SOP for Medication delivery operation.
o Prepare SOP for checking Prescription Drug monitoring website prior to dispensing the CII Rx’s.
o Addition of new SOPs as per pharmacy requirements for keep employees in same track to follow the pattern in accordance with the government regulatory authorities.· Responsible for medication inventory-the DEA regulations compliance including bringing together the documentation of expired controlled substance and the inventory management of control substance consistent with the strategic plan of the company.o Assist in maintain the inventory record of CII, CIII, CIV and CV drugs
o Review and assist pharmacists with DEA-106 forms for loss or theft of federal controlled substances.
o Assist the employee in recall medication and its return procedure.
o Updating Inventories for controlled and non-controlled medications every 6 month and assist in returning of the medication through legal way. Bachelor's Degree is required in Pharmacy or Pharmaceutical Science or Drug Regulatory Affairs.
