Compliance Lead

RxSense
Summary
Join RxSense, a leading healthcare technology company, as their Compliance Lead to establish and oversee a comprehensive compliance program for pharmacy benefit management operations, focusing on government healthcare programs like Medicare Part D, Medicaid, and ACA marketplace plans. This crucial role ensures operational integrity and adherence to complex federal and state regulations. You will develop and implement compliance policies, procedures, and internal controls, design training programs, and monitor evolving regulations. The position also involves conducting audits, managing risk, and ensuring compliance with government programs. You will serve as the primary compliance liaison with CMS and state regulators, presenting updates to leadership and managing relationships with external auditors. RxSense offers a great work environment and has received several prestigious awards.
Requirements
- Bachelor's degree required; JD, Master's in Healthcare Administration, or related advanced degree preferred
- 8+ years of healthcare compliance experience, with 5+ years in PBM or managed care
- 5 + years of experience with Medicare Part D compliance programs
- Proven track record of building compliance programs in regulated healthcare environments
- Expert knowledge of Medicare Part D regulations and CMS requirements
- Deep understanding of Medicaid pharmacy benefit regulations
- Familiarity with ACA requirements affecting PBMs
- Knowledge of HIPAA, fraud and abuse laws, and Anti-Kickback Statute
- Experience with state pharmacy practice acts and PBM licensing requirements
- Understanding of PBM operations, claims processing, and formulary management
- Knowledge of pharmacy network contracting and reimbursement methodologies
- Familiarity with Part D systems and data requirements
- Experience with compliance monitoring tools and audit software
- Proven ability to build and lead compliance teams
- Strong project management and organizational skills
- Excellent written and verbal communication abilities
- Ability to influence and drive compliance culture across organization
- Experience presenting to senior leadership and regulatory bodies
Responsibilities
- Establish and maintain comprehensive compliance program infrastructure meeting CMS requirements
- Develop and implement compliance policies, procedures, and internal controls for all PBM operations
- Create written compliance plans incorporating the seven elements of an effective compliance program
- Design and oversee compliance training programs for all staff levels
- Establish compliance committee structure and governance framework
- Monitor evolving federal and state regulations affecting PBM operations
- Interpret CMS guidance, HPMS Memos, DHHS-OIG advisories, and state regulatory updates
- Develop compliance monitoring protocols and oversight mechanisms
- Create regulatory change management processes to assess operational impact
- Maintain regulatory compliance calendar for all reporting requirements
- Develop comprehensive audit frameworks for CMS, state Medicaid, and internal compliance and readiness reviews
- Prepare organization for CMS program audits across all audit domains (ODAG, CDAG, formulary administration)
- Create mock audit programs and readiness assessments
- Establish corrective action plan (CAP) development and tracking systems
- Implement fraud, waste, and abuse (FWA) detection and prevention programs
- Ensure Medicare Part D compliance including: Coverage determinations and appeals processes
- Formulary management and P&T committee oversight
- Beneficiary communications and marketing materials
- Part D reporting requirements and data submissions
- Medication Therapy Management (MTM) program compliance
- Manage Medicaid compliance requirements: State-specific pharmacy benefit requirements
- Managed care organization (MCO) pharmacy services contract compliance
- Oversee ACA marketplace compliance: PBM transparency reporting requirements
- Rebate and discount disclosure protocols
- Price concession reporting standards
- Embed compliance controls directly into operational workflows
- Partner with operations teams to develop compliant processes
- Review and approve all member materials, communications, and system configurations
- Establish prior authorization and utilization management compliance protocols
- Ensure pharmacy network contracts meet regulatory requirements
- Conduct risk assessments across all operational areas
- Develop risk mitigation strategies and monitoring plans
- Manage regulatory investigations and enforcement actions
- Oversee responses to CMS notices and audit findings
- Coordinate with legal counsel on compliance matters
- Serve as primary compliance liaison with CMS and state regulators
- Present compliance updates to board of directors and executive leadership
- Manage relationships with external auditors and compliance consultants
- Coordinate with health plan partners on compliance requirements
- Represent organization at industry compliance forums and regulatory meetings
Preferred Qualifications
- Certified in Healthcare Compliance (CHC) or Certified Compliance Professional (CCP)
- Experience with PBMs or health plan compliance
- Background or experience with pharmacy operations or clinical pharmacy
- Familiarity with state Medicaid managed care regulations