The Physician Payments Sunshine Act and the Open Payments program play an important role in promoting transparency around financial relationships between healthcare professionals, teaching hospitals, pharmaceutical companies, and medical device manufacturers.

In this episode of Compliance Deconstructed, Jessica Zeff, Lorie Davis, and guest Clivetty Martinez explore how Open Payments works, which organizations and healthcare professionals fall within its scope, and why accurate reporting matters for healthcare compliance.

The conversation examines reportable transfers of value, including consulting fees, speaker honoraria, meals, travel, research payments, and ownership interests, while addressing exclusions and differences between federal and state reporting requirements.

Clivetty shares her experience in life sciences compliance to explain how organizations can interpret CMS definitions, identify potential reporting gaps, and understand the relationship between Open Payments, conflict of interest management, the Anti-Kickback Statute, and the False Claims Act.

Key Takeaways From Episode 36

• Understand the purpose of the Physician Payments Sunshine Act. Open Payments promotes transparency by requiring applicable manufacturers and group purchasing organizations to report qualifying payments and transfers of value to covered recipients through the Centers for Medicare & Medicaid Services (CMS).
• Identify who falls within reporting requirements. Applicable manufacturers, certain group purchasing organizations, covered healthcare professionals, and teaching hospitals may be subject to federal requirements, while state laws can introduce additional obligations.
• Recognize reportable financial relationships. Consulting fees, speaker honoraria, meals, travel, research payments, and ownership interests may require reporting depending on the circumstances, applicable definitions, and exclusions.
• Integrate Open Payments with conflict of interest oversight. Comparing financial disclosures with reported payments can help compliance teams identify potential conflicts and assess risks involving the Anti-Kickback Statute or False Claims Act.
• Use CMS public data to support compliance audits. Organizations can review Open Payments records, compare them with internal disclosures, and investigate discrepancies through risk-based monitoring and audit activities.
• Maintain accurate records and review reported data. Reporting entities should capture relevant payments throughout the year and meet submission deadlines, while healthcare professionals should review published information and request corrections when necessary.

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

Whistleblower litigation plays an important role in healthcare compliance, particularly when employees identify suspected fraud, improper billing practices, or conduct that puts patients and public funds at risk.

In this episode of Compliance Deconstructed, Jessica Zeff, Lorie Davis, and Elvan Baker welcome Pittsburgh-based attorney Darth Newman to discuss whistleblower protections, the federal False Claims Act, and the legal considerations healthcare professionals should understand when reporting potential misconduct.

This in-depth conversation explores how whistleblowers can raise concerns internally through compliance officers and reporting hotlines or externally through government agencies and experienced legal counsel, while examining how anti-retaliation protections vary depending on the applicable law.

Darth explains how False Claims Act cases, including qui tam lawsuits brought on behalf of the government, can expose healthcare fraud involving upcoding, improper billing, inadequate clinical supervision, and other practices that may lead to false claims for government reimbursement.

The discussion also addresses the practical challenges whistleblowers face, including workplace retaliation, confidentiality obligations, the careful handling of protected health information, and the emotional toll of prolonged litigation.

For healthcare leaders and compliance professionals, the episode reinforces the importance of maintaining accessible reporting channels, responding appropriately to concerns, and fostering a culture where employees can raise potential compliance issues without fear of retaliation.

Key Takeaways

• Whistleblower protections vary by law and jurisdiction, so healthcare organizations and employees should understand which reporting activities are protected and what actions may constitute unlawful retaliation.
• The False Claims Act addresses fraud involving government funds, including practices such as upcoding, billing for services not provided, inadequate supervision, and misrepresentations related to government reimbursement.
• Healthcare organizations should take internal reports seriously, investigate potential misconduct, correct identified issues, and protect employees from retaliation.
• Whistleblowers should carefully consider confidentiality obligations and the handling of company records and protected health information before collecting or sharing evidence.
• Consulting an attorney experienced in whistleblower litigation can help individuals understand their legal protections, evaluate evidence, and make informed decisions about reporting suspected misconduct and navigating litigation.

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

Healthcare fraud can take many forms, and some are much easier to recognize than others.

In this episode of Compliance Deconstructed, Jessica Zeff, Lorie Davis, and Elvan Baker examine the nature of fraud in healthcare, starting with the traditional understanding of fraudulent billing and moving into less obvious situations involving inaccurate claims, inflated services, and misrepresentation.

They also explore how the understanding of healthcare fraud has evolved, particularly in the aftermath of the COVID-19 pandemic, and why healthcare organizations need to pay close attention to how fraud, compliance, and contractual obligations can intersect.

This conversation takes a closer look at what happened during COVID-19 and how providers were forced to make decisions while dealing with unprecedented patient volumes, changing regulations, limited information, and emergency circumstances.

Jessica, Elvan, and Lorie raise important questions about how organizations should evaluate potential fraud when providers were trying to deliver care with the information available at the time, particularly when documentation, billing practices, telehealth, disaster recovery plans, and other processes changed rapidly.

The episode also examines how government agencies, health plans, and compliance teams can identify potential fraud through whistleblower reports, data mining, claims analysis, and artificial intelligence. Healthcare organizations generate enormous amounts of claims and clinical data, creating opportunities to identify unusual billing patterns, coding trends, utilization patterns, and activity that differs significantly from peers.

The discussion emphasizes why organizations should pay attention when a payer raises concerns about billing patterns and why smaller healthcare practices still need processes for auditing, monitoring, documentation, and responding to potential compliance issues.

Key Takeaways From This Episode

• Healthcare fraud can involve much more than billing for services that were never provided. Misrepresentation, inaccurate claims, inflated services, cloned records, copied signatures, and failure to fulfill contractual compliance requirements can create significant compliance concerns.
• The COVID-19 pandemic created complex compliance challenges because healthcare organizations had to operate under rapidly changing conditions while treating patients, adapting to new rules, expanding telehealth, and working within emergency circumstances. Organizations now face questions about how those decisions should be evaluated after the fact.
• Data analytics and artificial intelligence have changed how healthcare fraud can be detected. Government agencies, health plans, and other organizations can analyze claims data to identify unusual patterns, billing behavior, utilization trends, and activity that differs from comparable providers.
• Smaller healthcare practices still need effective compliance monitoring even when they cannot support a full internal compliance department. Electronic medical records, revenue cycle management systems, periodic external reviews, and qualified compliance consultants can provide additional oversight and help organizations identify potential issues.
• Healthcare organizations should understand the compliance requirements contained in their contracts with Medicare, Medicaid, health plans, and other payers. When an organization agrees to maintain specific compliance processes and then fails to implement them, that gap can create exposure beyond the underlying operational issue.

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

Healthcare compliance and legal teams often work in the same areas, but knowing when an issue belongs with compliance, when legal counsel should be involved, and when both teams need to work together can create confusion.

In Episode 33 of Compliance Deconstructed, Jessica Zeff, Lorie Davis, Elvan Baker, and special guest Gabby Morella, Managing Partner at Morella & Associates, explore the relationship between healthcare compliance and legal counsel and explain why collaboration between these functions matters when organizations face regulatory, contractual, operational, and legal issues.

The conversation begins by breaking down the different forms of compliance that healthcare organizations encounter, including contract compliance and operational compliance. The group also discusses how compliance professionals help organizations monitor whether policies, procedures, agreements, and regulatory requirements actually work in practice, while legal professionals bring specialized knowledge to contractual interpretation, regulatory interpretation, liability, and legal risk.

Another major focus is attorney-client privilege and the misconceptions that often surround it. Gabby explains that the client holds the privilege, that privilege does not automatically apply to every conversation with an attorney, and that involving additional people in certain communications can affect whether privilege applies.

This in-depth episode also emphasizes that organizations should understand the limits of attorney-client privilege and should not treat it as a blanket protection for decisions or conduct that may create legal or regulatory problems.

Key Takeaways From Episode 33:

• Compliance covers ongoing risk management, auditing, policies, contracts, and regulatory requirements
• Involve legal early when an issue could create significant liability, contractual, regulatory, or reporting risk
• Compliance oversees implementation and day-to-day adherence, while legal provides legal advice and risk guidance
• The level of legal involvement should reflect the organization, situation, and potential risk
• Attorney-client privilege has specific boundaries and can be affected by who is included in communications
• Strong collaboration between compliance, legal, and operations supports better decisions and stronger compliance outcomes

Connect with Gabby on her website

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

Medical billing and coding is one of the most complex operational areas in healthcare, with providers and billing organizations required to navigate hundreds of codes, modifiers, reimbursement rules, payer requirements, and changing regulations.

In Episode 32 of Compliance Deconstructed, Jessica Zeff, Lorie Davis, and special guest Nancy Worthy of Worthy Billing and Consulting discuss the medical billing and coding challenges that can create compliance risks, reimbursement problems, claim denials, and audit exposure for healthcare organizations.

Nancy draws on more than 35 years of medical billing experience to explain how seemingly small details can affect whether a claim gets paid correctly, including time-based codes, telehealth place of service codes, modifiers, units, provider credentialing, and payer-specific requirements.

The discussion highlights how frequently billing and coding rules can change and why healthcare providers need processes that help them monitor those changes and apply the correct requirements to each claim, particularly in areas such as mental health and telehealth.

Medical records and prior authorizations also play an important role in supporting accurate healthcare billing, because the services represented on a claim need appropriate documentation and required approvals.

This episode provides practical insight into how billing teams, compliance professionals, healthcare providers, and health plans can work together to identify billing errors, correct claims, monitor recurring issues, and build processes that reduce unnecessary risk while supporting accurate reimbursement.

Key Takeaways From This Episode:

• Medical billing and coding requires ongoing attention because codes, modifiers, reimbursement rates, payer requirements, and billing rules can change throughout the year
• Time-based billing requires accurate documentation, including the appropriate amount of service time and, when required, start and stop times that support the code billed
• Telehealth billing can create additional complexity because place of service codes and modifiers depend on where the patient receives the service and payer requirements can change over time
• Incident-to billing, supervision billing, and billing for interns or pre-licensed providers have specific requirements, and healthcare organizations should verify the rules for each applicable payer before submitting claims
• Healthcare providers serving Medicaid patients in Pennsylvania may need to consider county-specific managed care arrangements and verify that the provider participates with the appropriate plan before billing
• Accurate medical records, prior authorizations, credentialing, claim forms, codes, modifiers, and reimbursement rates all contribute to billing compliance, making collaboration between billing, compliance, clinical, operational, and leadership teams essential

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

The Office of Inspector General’s new Medicare Advantage Industry Segment-Specific Compliance Program Guidance (ICPG) provides healthcare organizations with a more focused framework for identifying and managing compliance risks within the Medicare Advantage sector.

In this episode, Jessica Zeff, Elvan Baker, and special guest Brian Burton of Healthicity discuss how the new guidance fits alongside the OIG’s General Compliance Program Guidance and the seven elements that form the foundation of an effective healthcare compliance program.

While the Medicare Advantage ICPG does not carry the force of a regulation, the guidance provides a blueprint for the compliance activities the OIG expects organizations to consider, particularly when evaluating enforcement matters and Corporate Integrity Agreements. The discussion examines why Medicare Advantage has received increased attention, including its growth to more than half of all Medicare enrollment in 2025 and the significant number of beneficiaries now receiving coverage through Medicare Advantage plans.

The conversation also explores the organizations and individuals who may need to understand the Medicare Advantage compliance guidance, including Medicare Advantage organizations, healthcare providers, vendors, first-tier downstream and related entities, brokers, marketers, and investors.

Jessica, Elvan, and Brian also examine specific areas of compliance risk identified by the OIG, including risk adjustment and data integrity, utilization management and prior authorization, marketing and enrollment, network adequacy, claims and payment integrity, quality of care, and vertically integrated or financially motivated ownership structures.

Key Takeaways:

• The Medicare Advantage ICPG works alongside the OIG’s General Compliance Program Guidance and provides sector-specific direction for organizations operating within the Medicare Advantage environment
• Medicare Advantage compliance guidance addresses a broad range of participants, including health plans, providers, vendors, first-tier downstream and related entities, brokers, marketers, and investors
• Risk adjustment and data integrity require close attention to diagnosis coding, documentation, health risk assessments, and potential overpayments, making ongoing monitoring an important part of Medicare Advantage compliance
• Utilization management, prior authorization, and artificial intelligence create compliance considerations involving medical necessity, access to care, claims decisions, and the appropriate use of technology in clinical and reimbursement processes
• Marketing and enrollment, network adequacy, provider directories, claims and payment integrity, quality of care, and financially motivated ownership structures represent additional risks identified within the Medicare Advantage ICPG

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

California Medicaid, known as Medi-Cal, is one of the largest and most complex Medicaid programs in the United States, serving approximately 15 million members across diverse geographic and socioeconomic communities.

In this Part 2 episode of Compliance Deconstructed, Jessica Zeff, Elvan Baker, Lorie Davis, and special guest Marwan Kanafani continue to explore what makes California Medicaid unique, how its managed care model operates, and why organizations entering this market must understand both regulatory expectations and operational realities.

The discussion examines how California has become a leader in developing innovative healthcare delivery models by addressing Social Drivers of Health alongside traditional medical services. The conversation highlights how federal waiver programs allow Medi-Cal to invest in interventions that improve long-term patient outcomes while helping healthcare organizations reduce avoidable utilization and improve the overall quality of care.

Jessica, Elvan, Lorie, and Marwan also take a closer look at Enhanced Case Management (ECM) and the operational challenges that come with delivering high-touch, community-based care. From workforce development and documentation requirements to liability considerations and care coordination, the episode explains why implementing these programs requires thoughtful planning and collaboration across clinical, operational, and compliance teams.

The conversation also explores what organizations should expect when entering the California Medicaid market, including rigorous regulatory oversight, vendor accountability, annual audits, and NCQA accreditation requirements. Whether you are a healthcare executive, compliance professional, managed care organization, or healthcare vendor, this episode provides practical insight into building sustainable operations while meeting the evolving expectations of California Medicaid.

Key Takeaways

• California Medicaid serves approximately 15 million beneficiaries through one of the nation's largest and most complex managed care systems
• Social Drivers of Health continue to shape Medi-Cal's approach to improving patient outcomes through upstream, community-based interventions
• Enhanced Case Management requires significant operational planning, workforce investment, and cross-functional coordination to deliver high-touch care effectively
• Healthcare vendors performing delegated functions are held to the same rigorous compliance expectations as the managed care organizations they support
• Annual audits, NCQA accreditation, and comprehensive documentation remain fundamental components of operating successfully within the California Medicaid environment
• County-level differences, regional demographics, and local healthcare infrastructure all influence how organizations should approach expansion within California Medicaid

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.

California's Medicaid program, Medi-Cal, serves more than 14 million residents and continues to shape how managed care, compliance, and healthcare delivery evolve across the country.

In this episode of Compliance Deconstructed, Jessica Zeff, Elvan Baker, and special guest Marwan Kanafani explore how Medi-Cal operates, why California's regulatory environment is so complex, and what healthcare organizations need to understand to successfully navigate one of the nation's largest Medicaid programs.

The conversation examines the role of the California Department of Health Care Services (DHCS), the state's managed care model, and the extensive oversight health plans experience through ongoing audits and regulatory reviews. The trio also dives into how federal waivers allow California Medicaid to test innovative care models while balancing accountability, operational demands, and patient access across a diverse population.

Medi-Cal addresses social determinants of health by supporting initiatives that extend beyond traditional medical care, including housing stability, food security, environmental improvements, and transition planning for justice-involved populations. From a compliance standpoint, these programs require healthcare organizations, health plans, community partners, and government agencies to work together while demonstrating measurable outcomes that support continued funding and regulatory approval.

Additionally, Jessica, Elvan, and Marwan also discuss the operational challenges created by carve-outs, data sharing, NCQA accreditation, and the continued integration of Medicare and Medi-Cal programs for dual-eligible populations. Whether you work in healthcare compliance, managed care, health plan operations, or provider leadership, this conversation offers practical insight into the regulatory expectations, implementation challenges, and collaborative strategies that help organizations succeed within California's evolving Medicaid landscape.

Key Takeaways

• Medi-Cal's managed care structure delegates responsibility to private health plans while remaining under the oversight of the California Department of Health Care Services
• California health plans often operate in a continuous audit environment and how organizations prepare for overlapping regulatory reviews
• Medicaid waivers allow California to develop innovative programs that address Social Determinants of Health and improve long-term patient outcomes
• Housing support, nutrition assistance, environmental interventions, and reentry programs contribute to better health while creating new compliance and operational considerations
• Hear practical recommendations for strengthening compliance through data-sharing agreements, outcome measurement, NCQA readiness, and planning for Medicare and Medi-Cal integration

Learn more about Healthcare Compliance and discover how Simply Compliance can help your company at simplycomplianceconsulting.com.