Regulatory & Compliance Analyst is needed to perform the following duties:

Help the pharmacist keep continuous process updates with new compliance initiatives.

• Work with Pharmacist in reviewing Center of Medicare & Medicaid service (CMS) prescription data claims as well as from third party insurance providers.
• Work with Pharmacist in business operations including inventory control, medication adherence, drug-utilization review (DUR), medication therapy management (MTM), and Comprehensive medication review (CMR), and price reconciliation.
• Ensure Pharmacy is compliant with all regulatory, legal and statutory requirements set forth by state and federal governments.
• Follow CDC Board (Centre of Disease Control) guidelines and news to update any changes in Immunization methods of practice.
• Making sure biennial licensure renewals and required continuous education programs specific to retail pharmacy practice. In addition, conspicuous display of all mandated certifications/license/registrations to the public and on-site visits.
• Work with Pharmacist in developing new methodologies for effective prescription data entry, central claims for immediate retrieval of records.
• Apply initiatives from Department of environmental conservation (DEC) to help retail pharmacies prevent violations and protect public health and the environment.

Assure overall regulatory compliance promoting continuous improvement in our internal audit process and risk assessment affecting our business by coordinating all bits and pieces of our pharmacy research.

• Draft policy and procedure manual for pharmacy to perform Internal Audit every 3 months to achieve Regulatory Compliance.
• Record and maintain annual inventory of controlled substances in addition to developing real time inventory checks after each dispensing.
• Customer Service Flow
• Use Outcomes MTM and Equipp Services to synchronize medications to Improve patient compliance of taking maintenance medication on a regular basis and decreasing hospitalization by improving patient health outcomes.
• Maintain an infectious disease preparedness and response plan provided by state , federal and local health agency that help guide protective action against COVID-19.

Support the research component 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.

• Implementation of system-wide programs, policies, and procedures to ensure system compliance with applicable federal and state laws and regulations.
• Submit daily reports required by the State Of Massachusetts Prescription Monitoring (PMP) Programme for controlled substances on a day to day basis, this helps Prescribers and Pharmacies to work together to provide better patient care and prevent drug misuses, diversion and abuse.
• Retrospective data analysis of prescribing patterns of primary care providers.
• Complete annual CMS review and continuous updates for Durable medical equipment (DME) regulations as per the state.
• Ensure the long-term care licensing or contracting up to date.

Develop operating procedures ensuring corrective and preventive action.

• Develop quality assurance techniques to ensure a safe and effective inventory control system.
• To prevent Fraud, Waste and Abuse (FWA) by literature research on dosing codes along with diagnosis codes to substantiate the claims.
• Develop and maintain the standard operating procedures (SOP) for retail pharmacy.
• To make protocols for Dispense As Written (DAW) codes in accordance with state legislature.
• Draft new procedures for preventative action when conducting Medication Therapy management sessions as well as documentation of root cause analysis.

Provide the required State, Federal, Medicaid and Medicare laws compliance support and Work in 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.

• Strict maintenance of HIPPA regulations and updating in a timely manner, Maintaining Office of Inspector General (OIG) checklist for employees and vendors and reporting any exclusion list.
• Review perspectives monthly in order to meet the FWA requirements of 45 CFR of part 46 regulated by office for Human Research Protections (OHRP)
• Ensuring Compliance with new rules, regulations as set forth by DEA, Center for Medicare services and Medicaid, state of Massachusetts Board of Pharmacy and other state and federal laws and regulation
• Maintain Up to date Standard Operating Procedures (SOP) for handling of prescriptions, filling prescriptions, storage of medications, Refrigerator logs, Daily logs, controlled substance storage.
• Review and Work with pharmacists with DEA-106 forms for loss or theft of federal controlled substances.

Work in the internal audit of our overrides, billing over-dues, coordinating the diagnostic codes entered in the system regarding use of prescription and non-prescription drugs.

• Timely review of Unbilled and under-payed prescription claims from Centre of Medicaid and Medicare claims (CMS) and third-party payers.
• Working along with Elevate Provider Network regarding the medication reconciliation and identifying potential MTM opportunities by using MTM outcomes.
• Internal auditing of the overrides and the DUR codes used in billing in Prime Rx.
• Maintaining the use of proper HCPCS codes and ICD-10 diagnosis codes used in billing the EMEDNY and EPACES.
• Process employees time card and payroll (Bi-Wkly)
• Daily cash activity processing and third-party payments
• Process sales tax due (monthly)
• Inventory ordering, receiving and stocking OTC and Prescription Medications
• Employee performance Measurement.

Involve in the procedures of review of third-party audit, monitoring drug recall and product recall.

• Making sure any and all overpayment will be refunded to the appropriate third-Party plan, Medicaid or CMS program within 60 days as per Affordable Care Act 2010.
• Monitor Food and Drug Administration (FDA) periodically for voluntary medication recall, the most effective way to protect the public from defective or detrimental products.

Bachelor's Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Sciences.