Healthcare Compliance: Benefits and Regulations

In 2023, Covenant Healthcare System had to pay more than $69 million for violating the Stark Law and Anti-Kickback Statute. An internal whistleblower revealed that improper financial relationships with referring physicians led to the submission of false claims to Medicare, Medicaid, and other federal programs. Healthcare compliance could have prevented this expensive settlement.

Compliance ensures healthcare organizations follow established laws and ethical standards. It helps them avoid legal risks and costly penalties. Non-compliance with the laws set by regulatory bodies like HIPAA can lead to legal actions, financial penalties, and damage to your organization's reputation. Healthcare compliance also directly affects patient safety and the quality of care delivered.

Our comprehensive blog post takes an in-depth look at healthcare compliance and industry regulations, and how you can benefit from them.

What is Healthcare Compliance?

Healthcare compliance means following state and federal healthcare laws and regulations that prevent fraud and waste in the healthcare industry. Providers and payers who comply with laws and regulations ensure the safety of patients and staff.

The stakeholders involved in ensuring healthcare compliance include regulatory bodies, legal experts, policymakers, healthcare providers, and payers. Compliance applies to all healthcare organizations and is a part of the holistic approach called healthcare governance, risk management, and compliance (GRC), vital for creating a safe and highly reliable healthcare environment.

Healthcare compliance laws govern patient data privacy, while cybersecurity protocols safeguard sensitive information. Adherence to treatment standards ensures quality patient care, and industry ethics guide healthcare professionals. This comprehensive approach helps healthcare organizations maintain regulatory compliance and safeguard patient welfare.

The Importance of Healthcare Compliance

Patient care and confidentiality are extremely important, and industry laws and regulations protect patients from harm. They establish standards for healthcare providers to follow. For example, medical practitioners must have proper licensing and credentialing, consent must be given for medical procedures, and patients’ privacy protection must be prioritized. Compliance laws and regulations in the health industry prioritize patient safety and hold healthcare professionals accountable for their actions. 

Healthcare compliance also protects patients against data thieves and other malicious attacks. In the US, HIPAA has strict regulations on storing, accessing, and sharing medical data to protect patient privacy. The law creates a strong framework and deters data thieves and other cybercriminals from accessing sensitive patient information. Patients also trust compliant companies that protect data and avoid regulatory penalties because they want high-quality care. They are more likely to disclose sensitive information necessary for accurate diagnoses and effective treatment plans.

Non-compliance can lead to patient harm, and healthcare professionals can face disciplinary actions that can impact their medical license. The organization may also pay fines and legal charges, damage its reputation, and lose patient trust. 

Who Regulates Healthcare Compliance?

Many regulatory bodies govern healthcare compliance to prevent patient harm, cyberattacks, and erroneous healthcare claims submission. Compliance focuses on preventing healthcare fraud, waste, and abuse. Here is a brief summary of the laws and acts related to healthcare compliance:

• The Department of Health and Human Services (HHS): This federal agency tracks fraud and abuse in federal programs like Medicare and Medicaid. 
• The Office of Inspector General (OIG): This office protects the integrity of DHS programs, launching investigations and prosecutions on suspected non-compliance.
• Centers for Medicare and Medicaid Services (CMS): CMS governs Medicaid and Medicare, approves and audits providers of these Federal programs, and outlines general guidelines for participants.
• Drug Enforcement Administration (DEA): A federal government agency that prevents, detects, and investigates drug trafficking and distribution in the U.S., including prescription drugs. 
• The Joint Commission: A not-for-profit institution in the US that sets quality standards for healthcare organizations to achieve accreditation.
• Food and Drug Administration (FDA): The FDA ensures the safety, efficacy, and security of medical products and food by regulating the information that must be disclosed about prescription drugs. It approves or disapproves prescription drugs to be used in healthcare.
• The Office for Civil Rights (OCR): This office is a subsidiary of HHS and handles HIPAA privacy regulations. Local health departments: These license practitioners and patient care facilities at the state level.

Healthcare Compliance Laws and Regulations

Most healthcare regulations are federal laws. To comply with them, include the most important and relevant laws when creating healthcare compliance policies. Here are the top laws:

• Health Insurance Portability and Accountability Act (HIPAA): Establishes strict standards for protecting patient privacy and security of their personal health information (PHI)
• Health Information Technology for Economic and Clinical Health (HITECH) Act: Expands the scope of HIPAA and sets standards for adopting electronic health records (EHRs) among healthcare providers.
• Emergency Medical Treatment & Labor Act (EMTALA): Guarantees access to emergency care for all individuals, regardless of a patient's ability to pay. 
• Patient Safety and Quality Improvement Act (PSQIA): Encourages a safety culture through voluntary reporting of medical errors and patient safety issues. Healthcare providers can analyze and learn from mistakes without fear of legal repercussions.
• False Claims Act (FCA): Holds healthcare providers accountable for billing practices that involve fraudulent or inaccurate information. It makes filing a false claim for federal program funds illegal and punishable.
• Anti-Kickback Statute: Prohibits medical providers from receiving financial incentives for patient referrals for federal healthcare programs.
• The Stark Law (the Physician self-referral law): This law prevents healthcare professionals from referring patients to entities with which they have a financial connection or to family members.
• The Social Security Act: Regulates healthcare providers that work with Federal government programs like Medicare or Medicaid.

Who is Responsible for Healthcare Compliance?

The Office of the Inspector General (OIG) within the U.S. Department of Health and Human Services (HHS) is responsible for ensuring healthcare organizations comply with federal healthcare laws. The government agencies and not-for-profit organizations we listed above are also involved in maintaining compliance programs. 

Some healthcare providers have a compliance officer or team to ensure they adhere to federal and state regulations regarding patient privacy, billing practices, and quality of care. Others use healthcare compliance tools to mitigate the risk of legal issues, costly penalties, and reputational damage. Our software proactively identifies and addresses potential compliance issues and helps healthcare organizations maintain ethical standards. 

Benefits of Healthcare Compliance

Healthcare compliance offers many benefits to both patients and healthcare organizations. Compliant providers quickly gain public trust and increase revenues. Here are some top benefits of healthcare compliance.

Enhances patient safety

Compliant organizations prioritize patient safety by adhering to regulations and best practices. Earning accreditation from regulatory bodies like The Joint Commission shows patients that your organization adheres to stringent standards, so they readily choose your facility.

Prevents fraud

Policies highlighting acceptable practices and penalties deter employees from engaging in fraudulent behavior due to the risk of detection and consequences. Fraudulent activities can have severe consequences on both patients and healthcare organizations.

Minimizes legal risks

Non-compliance can result in costly legal battles for healthcare organizations. Compliance protects your company against serious legal risks and financial penalties. A compliance program provides a framework for addressing legal risks, ensuring your organization operates legally.

Enhances company reputation

Compliant organizations are more trustworthy and credible. They easily earn the trust of patients, regulatory bodies, payers, and other stakeholders. Compliance is essential for maintaining credibility in an industry where trust is paramount.

Simplifies incident reporting

A robust healthcare compliance software can quickly highlight problems to simplify incident reporting. It can assess the frequency and type of incidents to help healthcare professionals streamline incident reporting and auditing. This improves safety, compliance, and accountability.

Best Practices to Ensure Healthcare Compliance

Adopting the right compliance strategies is necessary to ensure patient safety, maintain legal protection, and support financial and operational health. Here are 5 best practices for healthcare compliance.

Have a designated compliance team

This team can comprise staff in different departments to ensure all healthcare operations are legal and ethical. Determine individual responsibilities and how often the team will meet to address compliance issues. Outline how the team will work together and how new changes and updates will be communicated to achieve compliance goals.

Create a compliance code of conduct

Develop guidelines that outline the expected behavior of employees within the organization, focusing on adherence to all relevant regulations. The document should define how employees should act to maintain a high standard of conduct. This will ensure ethical and legal compliance in business operations.

Prioritize patient privacy

Nothing is more important in the healthcare industry than patient privacy. Healthcare providers should have detailed patient privacy policies related to compliance, like ensuring protected health information is encrypted. Digital systems must have a secure network to comply with government and industry regulations.

Adopt a compliance-first culture

This is the heart of any compliance initiative. Employees must know what’s expected of them and why compliance is necessary. By adopting a compliance-first culture, you shift focus from reactive measures to proactive measures. Every employee anticipates and prevents issues before they happen, helping the organization build resilience, protect its reputation, and gain a competitive edge.

Have clear communication channels

These are crucial for ensuring employees feel safe discussing their organization’s compliance program and reporting compliance concerns. When employees know they can openly communicate compliance issues without fear of retaliation, they quickly report compliance violations.

Challenges in Healthcare Compliance

Many healthcare organizations operate inefficient compliance programs due to different challenges. By taking compliance challenges into account, they can address issues that cause negative patient outcomes and prepare for compliance audits. Here are the top challenges in healthcare compliance.

Cybersecurity attacks

Cybersecurity attacks have become increasingly common in the healthcare industry. As healthcare providers digitize patient records and use electronic health systems, they have difficulty protecting physical and digital data.

Human error

Every year, human errors cost organizations and regulators time and money to fix. Medical professionals make mistakes due to fatigue, stress, or poorly designed systems, leading to incorrect diagnoses, patient harm, or privacy breaches. Simple errors can impact the quality of care and violate regulatory standards.

Poor data storage

Healthcare organizations are legally obligated to protect patient health information (PHI). But some use both digital and paper systems, which are hard to secure, and often experience data breaches. A cloud-based database makes data accessible to employees while restricting access to unauthorized entities.

Standardization issues

Multi-global or multi-state healthcare organizations have hundreds of administrative staff. If there are no guidelines on implementing compliance policies, non-compliance can quickly creep in. Inconsistencies in patient care, procedures, and documentation across different facilities can make adherence to regulatory requirements difficult.

Third-party vendors with weak systems

Vendors who don’t follow proper data handling procedures can cause breaches and non-compliance for healthcare providers. Providers must vet vendors’ practices and systems to ensure they adhere to the same compliance regulations as them.  

How do we Overcome the Challenges?

A healthcare compliance program protects patient rights, ensuring they receive safe and quality care. Non-compliance can endanger patient safety and lead to harmful outcomes. Organizations that want to overcome healthcare compliance challenges must take a proactive approach and prevent issues before they happen. Here’s how to go about it.

Hire a chief compliance officer (CCO)

This individual has extensive knowledge of healthcare compliance laws and regulations. They oversee compliance activities across all departments, identifying and minimizing potential compliance risks and ensuring adherence to healthcare regulations. They have the right tools to assess risks and implement controls.

Use a robust healthcare compliance system for risk assessment

A good healthcare compliance system can minimize the likelihood of human error and ensure patient safety. It can conduct regular risk assessments to identify vulnerabilities and stop them. It provides a structured framework to mitigate potential risks, ensuring patient safety and preventing costly penalties.

Create compliance policies

Compliance policies help healthcare companies adhere to regulations and mitigate reputational threats. Compliance must be integrated into core business strategies. Chief compliance officers can send employees digital copies of compliance policies and use digital signatures to verify the recipients have opened them.

Train employees on best practices

Training creates a strong culture of compliance within the organization. Employees can identify and address issues before they become significant problems. Healthcare companies should regularly update compliance training as new regulations are established.

Establish an internal reporting system for non-compliance

Some healthcare laws require that organizations empower their employees to report potential violations. A good compliance program should provide confidential communication channels for reporting and protect whistleblowers.

Penalize for compliance policy violations

This minimizes risks by deterring employees from breaking the rules. Penalties are a strong motivator for adherence to industry regulations and standards. The CCO should document internal penalties for compliance breaches and confirm employees understand these penalties. They should also use violations to reassess compliance policies.

Perform regular compliance audits

Audits prove healthcare organizations have achieved compliance and highlight problem areas. Your organization should schedule bi-annual compliance audits to identify privacy and security vulnerabilities for risk mitigation.

Standardize processes

Standardization minimizes variability in processes, ensuring consistent, high-quality patient care. It helps healthcare organizations reduce medical errors, protect patient privacy, adhere to regulatory requirements, and achieve better patient outcomes while avoiding legal penalties.

Thorough vendor vetting

Healthcare institutions must thoroughly vet vendors for compliance because they often handle sensitive patient data and medical supplies. They must ensure they adhere to regulations like HIPAA.

Try Atlas Systems, the Most Efficient Healthcare Compliance Software

Technological advancements directly affect healthcare compliance, and healthcare providers must be proactive in safeguarding their operations and patient data. They should mitigate risks and ensure adherence to industry standards by addressing key compliance challenges. 

As you navigate the complexities of modern healthcare, have an unwavering commitment to compliance to prioritize the well-being of your patients. Our healthcare compliance solution ensures you don’t fall victim to compliance errors. Let Atlas Systems Healthcare compliance monitoring solutions help you navigate healthcare regulations and compliance standards. Contact us today.

FAQs About Healthcare Compliance

How can healthcare providers improve patient confidence in their data protection practices?

They can apply a multifaceted approach that combines proactive compliance, robust security measures, and transparent communication.

How do healthcare providers ensure EHR systems are compliant with data regulations?

They should implement robust security measures, follow relevant regulatory standards, vet vendors, train staff, and monitor system usage for non-compliance.