The increasing complexities of healthcare compliance have given rise to new challenges!

Healthcare compliance professionals must now contend with issues such as data breaches, fraudulent billing practices, identity theft, and cyberattacks, all of which demand advanced fraud detection and prevention methods.

The drastic transformations in the healthcare landscape have compelled a heightened focus on proactively preventing and identifying breaches of both state and federal healthcare regulations. A meticulously designed healthcare compliance program serves as a strong deterrent against fraudulent activities and also proves invaluable in the event that investigations become necessary.

Defining Healthcare Compliance

Healthcare compliance involves the continuous effort to adhere to the legal, ethical, and professional standards that pertain to a healthcare provider or organization. Multiple governmental, state, local, and private entities establish the laws and regulations governing healthcare compliance. Creating, executing, and upholding compliance programs that align with the stipulations of these entities is a demanding yet indispensable task. Compliance in healthcare isn’t merely a virtuous aim; it is a requirement mandated by the Patient Protection and Affordable Care Act (ACA), making it obligatory for providers to establish and maintain a compliance plan.

Major Laws Related to Healthcare Compliance

One of the major challenges in healthcare compliance for organizations is the broad spectrum of compliance standards and regulations in healthcare. They encompass a wide array of aspects, spanning patient care, billing, reimbursement, research, ADA compliance, OSHA regulations, the Joint Commission standards, and privacy and security stipulations under HIPAA.

Here are some major laws related to healthcare compliance:

Health Insurance Portability and Accountability Act (HIPAA)

HIPAA governs the privacy and security of patients’ health information. It mandates safeguards to protect sensitive patient data and sets standards for electronic health transactions.
Example: HIPAA ensures the protection of patients’ personal health information. Healthcare providers must obtain written consent from patients before sharing their medical records with third parties, such as insurance companies or other healthcare providers.

Patient Protection and Affordable Care Act (ACA)

Commonly known as Obamacare, the ACA includes provisions related to healthcare compliance, such as anti-fraud measures, expansion of Medicaid, and the establishment of healthcare exchanges.
Example: The ACA introduced mandatory health insurance coverage for most Americans. Individuals who don’t obtain health insurance may face penalties during tax season. This encourages compliance with the law’s coverage requirements.

Anti-Kickback Statute

This law prohibits offering, paying, soliciting, or receiving anything of value in exchange for referrals or the generation of business in federal healthcare programs. It aims to prevent fraud and abuse.
Example: A pharmaceutical company cannot provide monetary incentives to healthcare providers in exchange for prescribing their medications. Such financial arrangements would violate the Anti-Kickback Statute.

Stark Law (Physician Self-Referral Law)

Stark Law prohibits physicians from referring Medicare and Medicaid patients for certain designated health services to entities in which they have a financial interest. This law prevents self-referral and potential conflicts of interest.
Example: A physician cannot refer patients to a diagnostic imaging center in which they have a financial interest. This law prevents physicians from profiting from their own referrals and ensures that referrals are based on the patient’s best interests.

Emergency Medical Treatment and Labor Act (EMTALA)

EMTALA requires hospitals to provide emergency medical care to all patients, regardless of their ability to pay. It prevents patient dumping and ensures access to emergency care.
Example: EMTALA requires hospitals to provide emergency medical care to all patients, regardless of their ability to pay. If a hospital turns away an unstable patient in an emergency situation due to a lack of insurance or payment ability, it violates EMTALA.

False Claims Act

This law imposes liability on individuals and organizations that defraud government programs, including Medicare and Medicaid. It allows whistleblowers to bring actions on behalf of the government.
Example: A healthcare provider who submits false claims for Medicare or Medicaid reimbursement, knowingly billing for services not provided or falsely inflating costs, could face legal action and substantial penalties under the False Claims Act.

Health Information Technology for Economic and Clinical Health Act (HITECH)

HITECH complements HIPAA by setting stricter standards for electronic health records (EHR) and enforcing penalties for data breaches and violations of patient privacy.
Example: HITECH strengthens HIPAA regulations and introduces stricter penalties for breaches of patient data. If a healthcare organization experiences a data breach that affects more than 500 individuals, they must report it to the Department of Health and Human Services (HHS) and the affected individuals.

Occupational Safety and Health Act (OSHA)

OSHA sets workplace safety and health standards, applicable to healthcare settings, to protect employees from hazards and ensure safe patient care environments.
Example: OSHA sets standards for workplace safety in healthcare facilities. This includes regulations on the use of personal protective equipment (PPE) to protect healthcare workers from exposure to infectious diseases, such as COVID-19.

These major laws, among others, collectively create a framework that healthcare organizations and professionals must adhere to in order to ensure the highest standards of care and compliance with legal and ethical requirements in the healthcare industry.

7 Core Elements of Strong Healthcare Compliance

To build a strong healthcare compliance program, one must understand the eight core elements that serve as its foundation.

Written Policies and Procedures:

The foundation of any effective healthcare compliance program is the development of comprehensive written policies and procedures. These documents articulate the organization’s commitment to compliance, define the roles and responsibilities of employees, and establish guidelines for adhering to regulatory requirements.

Compliance Officer and Committee:

A designated compliance officer and committee are essential for overseeing the compliance program. The compliance officer is responsible for monitoring, auditing, and implementing the program, while the committee provides strategic guidance and ensures transparency.

Education and Training:

To promote a culture of compliance, healthcare organizations must provide ongoing education and training for their staff. These programs should cover regulatory requirements, ethical standards, and the organization’s specific policies and procedures.

Effective Communication:

Open lines of communication are vital for reporting compliance concerns. Healthcare organizations should establish mechanisms for employees to report potential violations, including anonymous reporting channels. Effective communication helps uncover issues early and facilitates their resolution.

Monitoring and Auditing:

Regular internal monitoring and auditing processes are crucial for identifying and rectifying compliance deficiencies. These processes allow organizations to review their practices, assess adherence to policies, and address areas of non-compliance promptly.

Response and Corrective Action:

Inevitably, compliance violations will occur. Healthcare organizations should be prepared to address these issues swiftly and systematically. Establishing processes for responding to complaints, conducting investigations, and applying corrective actions is vital to maintaining compliance.

Enforcement of Standards:

Enforcing compliance standards through well-publicized disciplinary guidelines is crucial. Persistent non-compliance, regardless of an individual’s position within the organization, should be met with consequences, such as temporary suspension or termination. These rules apply universally, fostering a culture of accountability.

Risk Assessment and Mitigation Play a Crucial Role:

To navigate the complex healthcare landscape effectively, organizations must conduct regular risk assessments. This involves identifying potential compliance risks and implementing strategies to mitigate them. It’s a proactive approach to stay ahead of evolving regulations and industry trends.

Best Practices for Healthcare Compliance Success

Currently, healthcare compliance places significant emphasis on program improvement and heightened efficiency. Various authoritative entities, such as the Federal Sentencing Commission, DHHS Office of Inspector General (OIG), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and the Sarbanes-Oxley Act, offer guidance aimed at elevating compliance standards in organizations. In addition to the core elements of effective healthcare compliance, as defined by OIG, we want to list the best practices that our customers have been applying to ensure compliance success.

Identify areas for enhancing compliance programs through independent assessments

Conducting regular independent assessments allows healthcare organizations to pinpoint vulnerabilities and weaknesses in their compliance programs, ensuring a proactive approach to risk mitigation.
These assessments can encompass areas such as data security, privacy practices, billing procedures, and adherence to regulatory standards, providing a comprehensive view of compliance strengths and areas in need of improvement.

Create metrics for evaluating these program improvements

Developing measurable metrics is crucial for tracking the effectiveness of compliance enhancements. Metrics can include reduced compliance violations, improved employee training completion rates, and enhanced patient data protection measures.
These quantifiable indicators enable healthcare organizations to gauge the impact of their compliance efforts and make data-driven decisions for continuous improvement.

Draw inspiration from successful practices in other organizations

Learning from the success of others allows healthcare organizations to adapt proven strategies to their specific needs and challenges, fostering innovation and efficiency.
While adopting best practices from external sources, it’s essential to customize them to align with the organization’s values, mission, and the intricacies of its healthcare environment.

Put these processes into action and monitor the outcomes

Implementing the identified best practices is the core of healthcare compliance. It’s the actionable step where plans turn into reality, and compliance programs are strengthened.
Continuous monitoring of the outcomes helps healthcare organizations remain agile, adjust strategies as needed, and demonstrate a commitment to both compliance and ongoing improvement.

Encourage whistleblowing in your compliance culture

Whistleblowers in healthcare play a vital role in upholding the integrity of the industry. They are the ethical compass, revealing instances of fraud, patient endangerment, and regulatory violations. Recognizing their importance is crucial in maintaining a culture of transparency and accountability, ultimately leading to improved patient care and the safeguarding of public trust in the healthcare system. Healthcare organizations and authorities must create an environment where whistleblowers are protected and encouraged to come forward, as their actions are essential for the well-being of patients and the overall healthcare community.

Leverage Three-Line Model

Collaboration between compliance officers and operational leaders in healthcare organizations is a common challenge, often stemming from a lack of awareness regarding their shared responsibilities in compliance programs. To address this issue, the Three Lines Model, developed by the Institute of Internal Auditors (IIA), proves instrumental in illustrating how these key organizational roles can work in synergy to bolster governance and risk management. This model delineates the three lines of responsibility within an organization: the first line (operational areas) identifies and mitigates risks within their departments, partnering with Compliance for compliance monitoring.

The second line (Compliance, General Counsel, Risk, and Quality) facilitates training, policy creation, auditing, and monitoring for operational leaders, while the third line (independent oversight) involves internal auditors or independent consultants to assess compliance with policies, procedures, laws, and regulations. This model encourages everyone in the organization to play a role in compliance, emphasizing that it’s not solely the responsibility of the Compliance department.

By combining the Three Lines Model with best practices, such as the OIG’s seven elements for compliance program effectiveness and the establishment of operational compliance committees, organizations can cultivate a collaborative approach that underlines the significance of shared responsibilities in healthcare compliance.

VComply Empowers Organizations Across the Spectrum

VComply serves as a comprehensive compliance software solution that empowers organizations in numerous critical aspects of compliance management. The platform helps in establishing a robust compliance framework by offering tools for defining roles, assigning responsibilities, and implementing controls. With VComply, tracking compliance activities becomes a streamlined process, ensuring that each task is accounted for and completed on time. This is further reinforced by the assignment of responsibilities to stakeholders, enhancing accountability and transparency across the compliance landscape.

VComply’s versatile workflows facilitate seamless collaboration between departments, while its due diligence scoring and compliance assessment capabilities provide a systematic approach to evaluating adherence to regulations. Risk assessment is made more effective through the platform’s insightful tools, allowing organizations to identify and prioritize potential compliance risks. Document sharing and evidence management become effortless with VComply, enabling easy access to necessary information. The platform’s dashboard reports offer a comprehensive overview of compliance activities, supported by alerts and notifications that keep teams informed in real time. With its multifaceted capabilities, VComply stands as a vital ally in the pursuit of comprehensive compliance management.

Request a demo today to learn more about how VComply can help your business.