Program Foundation
Nivano Physicians has established a comprehensive compliance program in accordance with 42 CFR §422.503 (Medicare Advantage) and §423.504 (Part D) requirements, incorporating the seven core elements mandated by the Centers for Medicare & Medicaid Services (CMS). Our program demonstrates our commitment to ethical healthcare delivery and regulatory compliance.
Regulatory Framework
Our compliance program is designed to meet requirements established by:
- 42 CFR Part 422, Subpart M – Medicare Advantage Compliance
- 42 CFR Part 423, Subparts M and U – Part D Prescription Drug Plan Compliance
- Medicare Managed Care Manual Chapter 21 – Compliance Program Guidelines
- Prescription Drug Benefit Manual Chapter 9 – Part D Compliance Requirements
- OIG General Compliance Program Guidance for Healthcare Organizations
Seven Core Compliance Program Elements
1. Internal Monitoring and Auditing Systems
Our organization maintains robust monitoring and auditing systems to detect compliance violations and assess program effectiveness.
Monitoring Activities
- Claims Review: Regular analysis of billing patterns and medical necessity
- Utilization Management: Monitoring of healthcare service utilization and appropriateness
- Marketing and Sales: Review of member communications and enrollment activities
- Provider Network: Oversight of credentialing, contracting, and performance
- Customer Service: Quality monitoring of member and provider interactions
Audit Programs
- Annual Risk Assessment: Comprehensive evaluation of compliance risks and vulnerabilities
- Targeted Audits: Focused reviews of high-risk areas and regulatory requirements
- External Audits: Independent third-party compliance assessments
- CMS Audit Support: Preparation for and response to government audits
- Corrective Action Monitoring: Follow-up on identified deficiencies and improvements
Data Analysis and Reporting
- Performance Metrics: Key performance indicators for compliance effectiveness
- Trend Analysis: Identification of patterns requiring attention or intervention
- Benchmark Comparisons: Assessment against industry standards and best practices
- Regular Reporting: Quarterly compliance reports to leadership and board
- Exception Reporting: Immediate escalation of significant compliance issues
2. Written Compliance Standards and Procedures
We maintain comprehensive written standards and procedures covering all aspects of our healthcare operations.
Policy Categories
- Clinical Operations: Medical necessity, prior authorization, and utilization management
- Administrative Functions: Enrollment, billing, claims processing, and member services
- Privacy and Security: HIPAA compliance, data protection, and information security
- Quality Assurance: Quality improvement, patient safety, and outcomes measurement
- Fraud Prevention: Detection, investigation, and reporting procedures
Policy Management
- Regular Updates: Annual review and revision of all compliance policies
- Regulatory Tracking: Monitoring of regulatory changes requiring policy updates
- Stakeholder Input: Incorporation of feedback from operations, legal, and clinical teams
- Version Control: Systematic management of policy versions and effective dates
- Distribution: Ensure all relevant personnel have access to current policies
3. Designated Compliance Officer
Nivano Physicians has appointed a Chief Compliance Officer with appropriate authority and resources to oversee the compliance program.
Compliance Officer Responsibilities
- Program Leadership: Direct oversight of all compliance program activities
- Policy Development: Creation and maintenance of compliance policies and procedures
- Training Coordination: Development and implementation of compliance training programs
- Investigation Management: Oversight of compliance violation investigations
- Regulatory Liaison: Primary contact with CMS and other regulatory agencies
Organizational Authority
- Direct Board Access: Regular reporting to the Board of Directors on compliance matters
- Budget Authority: Adequate resources to implement and maintain the compliance program
- Investigation Powers: Authority to investigate potential violations and implement corrective actions
- Training Requirements: Responsibility for ensuring organization-wide compliance training
- External Relations: Authority to engage with external auditors and regulatory agencies
Support Structure
- Compliance Committee: Cross-functional team supporting compliance initiatives
- Department Champions: Compliance liaisons in each operational department
- External Advisors: Legal counsel and compliance consultants as needed
- Administrative Support: Dedicated staff to support compliance program operations
4. Regular Compliance Training and Education
We maintain comprehensive training programs to ensure all personnel understand and comply with applicable regulations.
Training Components
- New Employee Orientation: Comprehensive compliance training for all new hires
- Annual Refresher Training: Updated training on regulatory changes and best practices
- Role-Specific Training: Targeted training based on job responsibilities and risk areas
- Remedial Training: Additional training for individuals involved in compliance violations
- Leadership Training: Enhanced training for managers and supervisors
Training Delivery
- Web-Based Platforms: Online training modules with progress tracking and certification
- In-Person Sessions: Group training for complex topics and interactive discussions
- Reference Materials: Accessible resources and job aids for ongoing reference
- Regular Communications: Updates on regulatory changes and compliance reminders
- Performance Support: Just-in-time training and decision support tools
5. Response Procedures for Compliance Violations
We have established clear procedures for investigating and correcting compliance violations promptly and effectively.
Investigation Process
- Intake and Assessment: Systematic review of reported violations and concerns
- Investigation Planning: Development of investigation scope, timeline, and resources
- Evidence Gathering: Collection and analysis of relevant documentation and testimony
- Root Cause Analysis: Identification of underlying causes and contributing factors
- Findings Documentation: Comprehensive reporting of investigation results and conclusions
Corrective Actions
- Immediate Actions: Prompt steps to stop ongoing violations and prevent harm
- Systemic Improvements: Process and policy changes to prevent recurrence
- Personnel Actions: Disciplinary measures and additional training as appropriate
- Financial Remediation: Refunds, adjustments, and financial corrections as required
- Monitoring and Follow-up: Ongoing assessment of corrective action effectiveness
Disclosure and Reporting
- Internal Reporting: Communication of findings to appropriate leadership and oversight bodies
- External Reporting: Disclosure to government agencies and other external parties as required
- Self-Disclosure: Voluntary reporting of violations to appropriate authorities when warranted
- Cooperation: Full cooperation with government investigations and enforcement actions
6. Open Communication Systems
We maintain multiple channels for reporting compliance violations without fear of retaliation.
Reporting Mechanisms
- Compliance Hotline: 24/7 confidential hotline for reporting violations and concerns
- Online Reporting: Secure web-based reporting system with anonymity options
- Email Communication: Direct email access to compliance officer and team
- Open Door Policy: Encouragement of direct supervisor and management discussions
- Anonymous Suggestions: Systems for anonymous submission of compliance improvement ideas
Protection Against Retaliation
- Non-Retaliation Policy: Strict prohibition against retaliation for good faith reporting
- Investigation Protection: Safeguards for individuals participating in compliance investigations
- Confidentiality Measures: Protection of reporter identity to the extent legally possible
- Regular Communication: Clear messaging about protection against retaliation
- Monitoring and Enforcement: Active monitoring for potential retaliation and swift corrective action
7. Well-Publicized Disciplinary Guidelines
We maintain clear, well-communicated disciplinary guidelines for compliance violations.
Disciplinary Framework
- Progressive Discipline: Escalating consequences based on violation severity and history
- Consistent Application: Fair and consistent application of disciplinary measures
- Due Process: Appropriate investigation and review procedures before disciplinary action
- Documentation: Comprehensive documentation of violations and disciplinary actions
- Appeal Process: Mechanisms for challenging disciplinary decisions
Communication and Training
- Policy Publication: Wide distribution of disciplinary policies and procedures
- Training Integration: Inclusion of disciplinary consequences in compliance training
- Regular Reminders: Ongoing communication about expectations and consequences
- Case Studies: Use of anonymized examples to illustrate disciplinary principles
- Leadership Modeling: Demonstration of commitment to accountability at all levels
Program Effectiveness Evaluation
Annual Assessment
We conduct comprehensive annual evaluations of our compliance program effectiveness, including:
- Risk Assessment Updates: Evaluation of emerging risks and changing regulatory requirements
- Program Performance Metrics: Analysis of key performance indicators and benchmarks
- Stakeholder Feedback: Input from employees, providers, members, and regulatory agencies
- External Benchmarking: Comparison with industry best practices and peer organizations
- Improvement Planning: Development of action plans to address identified gaps and opportunities
Board Oversight and Accountability
Board Responsibilities
- Program Oversight: Regular review of compliance program performance and effectiveness
- Resource Allocation: Ensuring adequate resources for compliance program operations
- Leadership Accountability: Holding management accountable for compliance performance
- Strategic Direction: Setting organizational tone and expectations for compliance
- Risk Management: Oversight of compliance risk assessment and mitigation strategies
Reporting and Communication
- Quarterly Reports: Regular compliance reports to the Board of Directors
- Annual Presentation: Comprehensive annual compliance program review
- Critical Issue Escalation: Immediate notification of significant compliance matters
- Action Plan Approval: Board review and approval of major compliance initiatives
- Performance Monitoring: Ongoing assessment of compliance program outcomes
Contact Information
Compliance Hotline
- Phone: (916) 407-2000
- Email: compliance@nivanophysicians.com
Forms
- Standard of Conduct
- Fraud, Waste, and Abuse
- HIPAA and PHI
- Compliance Program
- Notice of Privacy Practices
- Terms of Service
- Compliance Training
- Nivano SMS Privacy Policy
External Resources
Government Agencies
- Centers for Medicare & Medicaid Services (CMS): www.cms.gov
- Office of Inspector General (OIG): oig.hhs.gov
- Department of Health and Human Services: www.hhs.gov
Professional Organizations
- Health Care Compliance Association: www.hcca-info.org
- American Health Lawyers Association: www.healthlawyers.org
This compliance program overview demonstrates our commitment to the highest standards of healthcare compliance and ethical conduct. The program is regularly evaluated and updated to ensure continued effectiveness and regulatory compliance.
Document Version: 1.0
Effective Date: August 7, 2025
Board Approval Date: August 7, 2025
Next Review Date: August 7, 2026