Regulatory & Compliance Analyst is needed to perform the following duties:
· Responsible for REGULATORY COMPLIANCE leading to pharmacy management:
o Leading and coordinating regulatory compliance efforts within scope of responsibility across the Pharmacy.
o Chair the Pharmacy Performance Improvement and Regulatory Compliance requirements
o Evaluating and ensuring departmental and organizational policy and practice compliance with applicable state and federal laws, rules and regulations, including but not limited to,
o Fraud, waste and Abuse (FWA),
o Centers for Medicare & Medicaid Services (CMS),
o Drug Enforcement Agency (DEA),
o Food and Drug Administrations (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 in order 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 employees work flow 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 Coordination of a consistent and timely approach to medication-related event review and follow-up (in conjunction with the pharmacy patients and providers), under the direction of Medication Safety tips provided by MTM analysis, ensuring accurate documentation of root cause analysis and its Therapy management
o Conducting Medication Therapy Management Program (MTM) and Mirixa healthcare services providing bridge between pharmacy performances and Patient health assessment.
· Monitoring, analyzing, interpreting and communicating regulatory changes by utilizing available resources from regulatory organizations:
o Job duties including periodical meeting with Pharmacy staff and pharmacist to keep tract for ongoing process of the pharmacy operation in order 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 in order 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 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 to the government regulatory authorities.
· Lead the research of the pharmacy department through Development of automated processes and reporting, targeted to improve efficiency and ensure compliance of health plan policy/procedures and regulatory standards
o Monitors regulatory activity and rulemaking through weekly interaction with different organizations
o Online subscription of government regulated bodies including Medicare, Medicaid, State Federal, DEA, HIPAA and FWA newsletter etc. in order to get automatic update regarding the new law implementation or change in any existing laws and regulations.
o Coordinating creation and updates of Department of Pharmacy policies & procedures
o Ensure timely signature and posting to intranet page
o Business continuity disaster recovery.
· 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 regular and controlled medicines every 6 month and assist in returning of the medication through legal way.
Bachelor's Degree is required in Drug regulatory affairs or Pharmacy or Pharmaceutical Sciences or Pharmaceutics .