Especially within healthcare, regulatory compliance is a fundamental aspect that requires precision and diligence. Adhering to regulations, laws, and standards ensures patient safety, data security, and financial and reputational integrity. However, understanding and keeping up with the complexities, volume, and ethical responsibility of healthcare regulatory compliance done right can be daunting.
As every compliance professional knows, failure to comply with healthcare regulations can result in severe consequences, including financial penalties, legal repercussions, damaged reputation, and compromised patient care. Staying informed and proactively addressing compliance requirements is vital to your business.
It was reported in May 2023 that there were 75 data breaches of 500 or more healthcare records, 23 data breaches of 10,000, and an over one-million record data breach of 2,550,922 reported to the HHS Office for Civil Rights (OCR). The majority of these breaches were a result of ransomware attacks following two months with no HIPAA enforcement actions. Due to this spike in compliance failures, “two financial penalties were imposed by OCR to resolve HIPAA violations, two enforcement actions were announced by state attorneys general, and the Federal Trade Commission (FTC) announced an enforcement action against a non-HIPAA-regulated entity for the impermissible disclosure of consumer health information.”
From understanding the key regulatory bodies and frameworks to implementing robust compliance measures, we will cover the crucial aspects that will empower you to meet the challenges of healthcare regulatory compliance head-on.
What is healthcare regulatory compliance?
Regulatory compliance in healthcare refers to the process and regulations all healthcare organizations must follow to maintain legal and ethical standards. It falls under the governance, risk, and compliance (GRC) umbrella, which covers all security matters designed to ensure companies operate safely and legally, even as they grow.
Healthcare regulatory compliance refers to the adherence and conformance to the laws, regulations, and guidelines set forth by governing bodies at the local, state, and federal levels. These regulations are established to safeguard patient rights, ensure the delivery of quality care, protect patient privacy and data security, prevent fraud and abuse, and maintain financial integrity within the healthcare industry.
Understanding healthcare compliance laws and regulations
Healthcare providers have an ethical obligation to understand the applicable regulations governing the healthcare industry comprehensively. Identifying the relevant regulatory bodies and investigating specific regulations pertaining to your organization’s scope of practice is a fundamental first step. By familiarizing yourself with these regulations, you can determine the compliance requirements you must adhere to.
When it comes to healthcare compliance, ensuring the delivery of safe, high-quality care protects patient privacy and data security and upholds the integrity of healthcare organizations. Understanding and complying with the important healthcare regulatory compliance laws is crucial for providers to ensure the delivery of safe, high-quality care, protect patient privacy, and avoid legal and financial consequences. Here are the six critical healthcare compliance laws that U.S. healthcare organizations need to understand and deliver on to successfully meet regulatory obligations.
Health Insurance Portability and Accountability Act
The Health Insurance Portability and Accountability Act (HIPAA) is one of the most significant healthcare regulatory compliance laws. HIPAA safeguards the privacy and security of patients’ protected health information and sets standards for electronic health records. Providers must comply with HIPAA’s Privacy, Security, and Breach Notification Rules. These rules outline requirements for patient consent, data encryption, physical and technical safeguards, and breach reporting, to name a few.
The Anti-Kickback Statute (AKS) prohibits offering, soliciting, receiving, or providing remuneration in exchange for referrals or generating federal healthcare program business in the U.S. It aims to prevent improper financial relationships that could lead to overutilization, unnecessary services, or compromised patient care. Understanding this statute prevents you from unintentionally participating in incentivized healthcare and ensures you comply with federal healthcare standards.
Emergency Medical Treatment and Labor Act
The Emergency Medical Treatment and Labor Act (EMTALA) ensures that patients with emergency medical conditions receive appropriate treatment regardless of their ability to pay or insurance status. It mandates that hospitals with emergency departments provide a medical screening examination and stabilize patients before transferring or discharging them. Compliance with EMTALA regulations is vital for hospitals and healthcare facilities to protect patient rights and safety during emergencies.
Affordable Care Act
The Affordable Care Act (ACA), also known as Obamacare, introduced sweeping reforms to the American healthcare system. It aims to improve access to healthcare, enhance quality, and reduce costs. Providers must understand various ACA provisions, such as individual and employer mandates, insurance marketplace requirements, essential health benefits, and preventive care guidelines. Compliance with ACA regulations ensures proper administration of insurance plans and equitable provision of healthcare services.
False Claims Act
The False Claims Act (FCA) is a crucial healthcare regulatory compliance law that combats fraud and abuse in federal healthcare programs. The FCA prohibits knowingly submitting false claims for payment to government programs such as Medicare and Medicaid. It covers fraudulent activities like billing for services not rendered, providing medically unnecessary services, or offering kickbacks for patient referrals. Providers must implement robust compliance programs and billing practices to prevent FCA violations.
Stark Law, also known as the Physician Self-Referral Law, prohibits physicians from referring patients for certain designated health services to entities with which they have a financial relationship unless an exception applies. This law aims to prevent financial incentives from influencing medical decision-making. Providers must ensure their financial relationships comply with Stark Law’s requirements, including fair market value, commercial reasonableness, and specific exceptions for permissible referrals.
Read: IT Compliance Frameworks Supported by Resolver
6 steps to comply with healthcare regulatory requirements
Maintaining healthcare regulatory requirements is a multifaceted endeavor that requires a proactive and comprehensive approach. It’s important to remember that compliance is an ongoing commitment that requires continuous education, adaptation, and a steadfast dedication to upholding the highest standards of patient care and ethical conduct and can be achieved in five easy steps.
1. Stay informed of healthcare compliance regulatory change
With constantly evolving healthcare regulatory requirements, staying informed about changes in laws, regulations, and guidelines is essential. Establishing a system to monitor updates from key regulatory bodies, regularly reviewing industry publications, attending conferences, and engaging in continuing education allows you to stay up-to-date with compliance trends and best practices.
As regulatory requirements change more frequently, it is nearly impossible for small compliance teams to manually capture regulatory updates and identify new obligations. In a webinar on “Transforming Regulatory Complexity into Risk Intelligence” with our partners at Ascend, a leading regulatory technology company, Pooja Azhalavan, Product Marketing Manager, Resolver, explained that compliance teams need to “increase efficiency, automate manual processes, and adapt quickly to a changing landscape.” Ascend’s Dominick Campagna added that having access to automated regulatory updates and centralizing a control library and risk register are just a few ways that technology can give compliance teams the insight, bandwidth, and foresight needed to become more strategic partners of the business.
An integrated GRC solution can “propagate the culture of compliance across the company with the least amount of effort” and help compliance teams stay on top of potential fines and breaches, Azhalavan explained. Engaging the first line of defense in an organization and providing staff with easy-to-use, accessible tools that integrate with their day-to-day work functions can help compliance teams stay on top of changes in regulations and simplify their workflows.
Watch: Transforming Regulatory Compliance into Risk Intelligence
2. Conduct a compliance gap analysis
Creating comprehensive policies and procedures is essential to guide your organization’s healthcare regulatory compliance efforts. But first, you need to assess your organization’s current compliance practices, identify non-compliance areas, and evaluate associated risks and potential consequences. The gap analysis provides valuable insights into areas that require improvement and serves as a foundation for developing a robust compliance plan.
3. Develop compliance plans and policies
With the insights gained from the compliance gap analysis, you can proceed to develop a comprehensive compliance plan. This plan should outline clear objectives and goals that align with the organization’s mission and values. Establishing policies and procedures that promote compliance, designing training programs to educate staff on regulatory requirements, and allocating appropriate resources are vital components of an effective compliance plan.
By identifying your organization’s critical healthcare regulatory requirements — such as patient privacy, data security, billing and coding, and fraud prevention — you can develop clear, well-documented policies that outline the specific steps and responsibilities for maintaining compliance in each area. Ensure these policies are easily accessible to staff and regularly reviewed and updated to reflect regulatory changes.
4. Protect patient privacy and data security
Ensuring compliance requires maintaining patient privacy and data security. Securely storing patient information in physical and electronic formats, and implementing appropriate safeguards such as encryption, access controls, and secure storage systems, can help achieve this. Additionally, developing and regularly testing an incident response plan to promptly and effectively address data breaches or security incidents can ensure a proactive approach that minimizes potential patient harm and reduces legal and reputational risks.
Learn more: Risk Assessment Frameworks 101: How RAFs Improve Security and Controls
5. Maintain proper documentation and record-keeping
Accurate and thorough documentation is crucial for demonstrating healthcare compliance. Maintaining accurate billing and coding practices allows you to stay updated with coding guidelines, conduct regular audits, and provide ongoing education to billing and coding staff. Establish mechanisms to prevent and detect potential fraud and abuse and ensure that documentation is securely stored, with appropriate access controls and retention periods. Regularly review documentation and properly maintain them for an outlined period to ensure they align with healthcare regulatory requirements and standards.
Also read: The Importance of Maintaining Records to Modern Risk Management Programs
6. Foster a culture of compliance
Creating a culture of compliance starts with leadership. Promote an environment where ethical behavior, integrity, and compliance are valued and rewarded. Encourage open communication and transparency regarding compliance concerns while offering staff adequate training tools. Recognize and celebrate staff who exemplify compliance best practices. Regularly communicate the importance of healthcare regulatory compliance and provide ongoing training and resources to support staff in meeting regulatory requirements.
Read more: Building a Culture of Compliance
Maintain better healthcare compliance with Resolver
Compliance is an ongoing process that requires continuous monitoring and adjustment. Regular compliance assessments and reviews are necessary to identify gaps or improvement areas. Staying updated on healthcare regulatory compliance changes and industry best practices is paramount, adapting compliance strategies accordingly. By remaining vigilant and responsive, organizations can maintain high compliance and adapt to evolving regulatory landscapes.
Leveraging advanced compliance management software can make a significant difference in ensuring ongoing success and streamlining your organization’s efforts. Resolver’s compliance management software is a powerful solution that can streamline and automate your compliance processes. With features including policy and procedure management, risk assessment, incident reporting, and auditing capabilities, Resolver empowers healthcare organizations to proactively address compliance requirements and mitigate risks effectively to increase overall agility and efficiency.
Watch our webinar, The 10 Must-Have Reports for Risk, Compliance, or Audit Leaders today to experience how our compliance management software with built-in data visualizations and compliance reporting capabilities delivers on our promise of “Compliance Made Simple.”