Regulatory and Compliance Analyst

Regulatory and Compliance Analyst is needed to perform the following duties: · * Demonstrating an unyielding commitment to upholding legal and regulatory compliance, undertake rigorous research to ascertain and communicate requisite requisites while securing necessary approvals.

· Evaluate the system wide programs, policies, and procedure to ensure the Pharmacy compliance with all regulatory, legal, and statutory requirements set forth by state and federal governments.

· Serve as liaison to pharmacy staff to Develop compliance and provide broad oversight for accreditation standards, federal and state rules, education programs and material upon frequent changes made to the regulatory bodies to comply with current regulation requirements.

· Stay informed about industry trends, best practices, and changes in pharmacy regulations through ongoing professional development.

· Working collaboratively with other pharmacy and organizational departments and managers to plan, coordinate and implement compliance improvement projects and programs for the pharmacy benefit.

· Conduct in-depth compliance monitoring of key operational areas related to Medicare Pare D and assist in drafting Policy and Procedure (P & P) manual for Pharmacy to perform internal audit and to achieve regulatory compliance.

· Adjudicate the eligibility of patients for medications and thereby initiate prescriptions in accordance with the parameters stipulated by insurance requisites, thereby corroborating the seamless execution of Medicare Part D provisions.

· Assist Pharmacist in reviewing Center of Medicare & Medicaid service (CMS) prescription data claims as well as from third party insurance provide.

· Respond to complaints from the state, OIG complaints, state inspections, PDMP, DEA Inspection findings, Insurance audit findings and its response.

· Attending the insurance audits and providing them the necessity documents as proof of compliance with regulatory requirements

· Prepare reports by collecting, monitoring, analyzing, interpreting, and communicating regulatory changes by utilizing available resources from regulatory organizations.

· 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.

· Imbue the role with a meticulous attention to detail, primarily manifest through the discernment and rectification of disparities inherent within pharmacy compliance documents.

· Help the pharmacist keep continuous process update with new compliance initiatives.· Provide the required State, Federal, Medicaid and Medicare laws compliance support.

· Work with internal stakeholders to develop strategies for mitigating risks and ensuring ongoing compliance.

Responsible for developing, executing, and maintaining the regulatory commitments and requirements for assigned program.

· Develop procedures that follow applicable Federal and State laws (e.g., HIPAA), regulations, professional standards, and ethical principles; complies with CVS policies and procedures to ensure patient safety and protect patient privacy and security.

· To 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.

· To ensure the proper and accurate preparation and submission of claims to Federal health care programs.

· Develop and/or update policies and procedures whenever additions and changes to standards, rules, or regulations warrant. Provide timely and accurate communication, both written and verbal as appropriate, regarding interpretation of additions and changes and timelines for compliance.

· Serve as the pharmacy HEDIS (The Healthcare Effectiveness Data and Information Set) expert, including reviewing and updating data and materials for annual audit and accreditation.

· Develop and implement new processes that increase the accuracy of pharmacy compliance by introducing a standard audit checklist, improve data tracking and performing rigorous follow-ups.

· Collaborate in the oversight and meticulous documentation of the yearly inventory encompassing controlled substances classified as CII, CIII, CIV, and CV. Furthermore, undertake real-time inventory validations subsequent to each instance of dispensation.·

Nurtures ongoing rapport with regulatory personnel through the orchestration of consistent interactions and adeptly addressing any concerns that arise.

· Managing Electronic Quality Improvement Platform for Plans & Pharmacies [EQUIPP].· Monitor, review and analyze performance trends, compliance issues and provide a holistic compliance and performance analysis.

· Assist Pharmacist in business operations including medication adherence, drug-utilization review (DUR), Comprehensive medication review (CMR), and price reconciliation.

· Collaborating closely with the Elevate Provider Network to facilitate medication reconciliation and proactively discern potential Medication Therapy Management (MTM) opportunities through the utilization of MTM outcomes.

· Follow CDC Board (Centre of Disease Control) guidelines and news to update any changes in Immunization methods of practice.

· Assist Pharmacist in developing new methodologies for effective prescription data entry, central claims for immediate retrieval of records.

· Apply initiatives from the Department of environmental conservation (DEC) to help retail pharmacies prevent violations and protect public health and the environment.

· Checking the Prescription drug monitoring (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.

· Generated a report file to securely maintain Prescription Drug Monitoring program (NY PMP) to screen potential drug abuse/illegal activity along with automated submission to NY board of Pharmacy & DEA.

Conduct comprehensive annual assessments of the Centers for Medicare & Medicaid Services (CMS) guidelines, accompanied by a continuous regimen of refinements to align with the evolving landscape of Durable Medical Equipment (DME) regulations within the state.

Develop operating procedures ensuring corrective and preventive action.

· Curate, engender, and dispense training modules of an educational nature, designed with the express purpose of acquainting the pharmacy's workforce with the intricate tapestry of regulatory dictums, encompassing an exhaustive spectrum that spans dispensation protocols, the meticulous handling of controlled substances, and the labyrinthine choreography of record maintenance.

· Regularly review and interpret regulatory updates to identify potential impacts on the pharmacy's operations and practices.

· Ensure evaluation of regulations, directives, guidelines, and policies, etc. that could potentially impact on product development till approval and lifecycle management post approval.

· Develop and draft 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 to develop Policy and Procedure to improve medication adherence.

· Develop and maintain the standard operating procedures (SOP) for retail pharmacy for handling of prescriptions, filling prescriptions, storage of medications, Refrigerator logs, Daily logs, controlled substance storage to follow the pattern in accordance with the government regulatory authorities.

· Review and assist pharmacists with DEA-106 forms for loss or theft of federal controlled substances.

· Updating Inventories for regular and controlled medicines every 6 months and assist in returning of the medication through legal Way.

· Timely review of Unbilled and under-paid prescription claims from Centre of Medicaid and Medicare claims (CMS) and third-party payers.

· Perform market research relating to over-the-counter products to determine potential increase in sales.

· Gather data on competitors and analyze prices, sales and methods of marketing and distributors. Build in-depth patient profiles, zero in on underperforming patients, and see opportunities for better service, increased adherence, and revenue growth.Participation in reviewing patient complaints for Medication safety and Patient awareness for Health.

· Strict maintenance of HIPPA regulations and updating in a timely manner. 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.

· Ensuring compliance with new rules, regulations as set forth by the DEA, Centers for Medicaid and Medicare Services, New York state board of pharmacy and other state and Federal laws and regulations.

· Ensure compliance of employees’ security, sales and record keeping procedures.· Assist in 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.

· Assist in the procedures of review of third-party audit, Monitor Food and Drug Administration (FDA) periodically for voluntary product and medication recall and its return in the most effective way to protect public from defective or detrimental products.

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

Pay: $45.00 per hour

Benefits:

• Employee discount
• Paid time off
• Parental leave

Work Location: In person

Salary : $45