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Blog > What is Healthcare Compliance: A Comprehensive Guide

What is Healthcare Compliance: A Comprehensive Guide

VComply Editorial Team
June 7, 2024
12 minutes

Compliance is more than just following rules; it’s about patient safety, quality care, and trust.  It requires ongoing dedication and adaptability to meet legal standards and maintain public trust. Healthcare entities must craft detailed compliance strategies, perform regular assessments, and utilize tools like cloud storage and audit software to ensure robust compliance. 

Healthcare compliance is the practice of adhering to a range of local, state, and federal regulations designed to prevent fraud, waste, and abuse within the healthcare industry.  It’s key for keeping medical services up to standards. The core goal of healthcare compliance is to ensure that providers not only adhere to regulatory and legal frameworks but also commit to delivering safe, high-quality care. 

Not following the rules can cause big problems like fines, cyber risks, and bad reputation. Professionals specializing in compliance health are vital in helping healthcare facilities and organizations manage these multifaceted regulations. These standards govern the confidentiality and handling of patient information, uphold the quality of patient care, deter fraudulent activities, and safeguard healthcare workers.

Let’s take a comprehensive look at the significant healthcare laws, acts, and regulations that must be continually observed and updated by compliance professionals. 

What is Healthcare Compliance?

Healthcare compliance refers to the systematic practice of following laws, regulations, and professional standards that apply to healthcare organizations and providers. It encompasses a wide range of areas including patient privacy rights safeguarded by several regulatory and  safety standards. Compliance health programs are vital for preventing fraud, protecting patient information, and ensuring the delivery of high-quality health services.

These programs require ongoing education and training for healthcare professionals, as well as regular audits and policy reviews to ensure continuous adherence. This field not only mitigates legal risks but also fosters a culture of ethical healthcare delivery.

Key Stakeholders in Healthcare Compliance: Ensuring Integrity and Legality

There are many people behind the successful implementation of compliance healthcare , each playing a critical role in upholding the industry’s integrity and legality.

  • The first group of stakeholders consists of the organizations themselves. It’s essential for these entities to regularly update and ensure their policies and procedures align with all current laws and regulations.
  • Secondly, government agencies play an important role as regulators of the healthcare sector. These bodies provide necessary guidelines and enforce compliance with the regulations governing the industry.
  • The third group involves external auditors. These professionals are tasked with evaluating an organization’s compliance framework. They thoroughly review policies, procedures, audit data, and conduct interviews with staff to verify that all compliance standards are met.

Finally, healthcare providers are fundamental stakeholders in healthcare compliance. They are responsible for delivering quality care that adheres to compliance standards.

Historical Overview and Evolution of Healthcare Compliance

Healthcare compliance has changed a lot over time with new tech, globalization, and complex services. This evolution has been driven by the need to maintain patient safety, uphold quality care, and ensure ethical standards across borders.

One of the major shifts has been the adoption of digital technologies. The integration of Electronic Health Records (EHRs), the rise of telemedicine, and advancements in data analytics have introduced new challenges and opportunities in protecting patient data and ensuring privacy.

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Key Milestones in Healthcare Compliance

  • Early 20th Century: The origins of healthcare compliance trace back to this era, focusing primarily on the quality of medical services provided. Licensing and credentialing systems were introduced to regulate professionals and ensure standard levels of care.
  • 1960s: The introduction of Medicare and Medicaid marked a significant expansion of government-funded healthcare, increasing the need for stringent compliance measures to oversee billing practices and prevent fraud and abuse.
  • 1996: HIPAA set a new benchmark for the confidentiality and security of patient information, shifting the focus of compliance efforts towards protecting data.  Subsequent years saw the introduction of the Privacy Rule (2003) and the Security Rule (2005), further emphasizing data confidentiality and security.
  • 2015: The Medicare Access and CHIP Reauthorization Act (MACRA) was implemented, introducing systems like the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) which require compliance with new reporting and care delivery standards.
  • 2020s: The advent of telemedicine, wearable health devices, and health apps has ushered in a new era of compliance health challenges related to data security, patient consent, and the provision of care remotely.

These developments underscore the dynamic nature of healthcare compliance, illustrating its critical role in adapting to new technologies and global standards to effectively manage and safeguard the evolving healthcare ecosystem.

Healthcare Spending and Fraud Estimates:

In 2022, U.S. healthcare expenditures reached $4.5 trillion, according to the Centers for Medicare and Medicaid Services (CMS). Estimates suggest that healthcare fraud costs the U.S. healthcare system between 3% to 10% of its expenditures annually. However, these figures should be interpreted with caution due to the difficulties in accurately measuring illegal activities that are deliberately concealed. Between 2005 and 2019, it was reported by numerous professionals that the cumulative count of people impacted by healthcare data breaches amounted to 249.09 million individuals. To combat such kinds of losses, numerous laws, statutes, and dedicated units have been developed. 

Who Regulates Healthcare Compliance?

These are set forth by government agencies such as the

  • U.S. Food and Drug Administration (FDA)
  • The Centers for Medicare & Medicaid Services (CMS)
  • The Department of Health and Human Services (HHS), alongside various professional organizations and accrediting bodies.

Significant regulations impacting healthcare compliance include the

  • Health Insurance Portability and Accountability Act (HIPAA)
  • FDA
  • CMS

Moreover, the HHS oversees other critical departments such as the Centers for Disease Control and Prevention (CDC) in Atlanta, which monitors public health issues including birth defects, environmental health, and potential infectious disease outbreaks, ensuring comprehensive public health oversight and compliance with healthcare standards.

Regulatory Bodies Overseeing Healthcare Compliance

Healthcare compliance is governed by several key federal and state agencies, each playing a distinct role in ensuring adherence to various regulations:

  • The Office of Inspector General (OIG): Operating under the Department of Health and Human Services (HHS), the OIG plays a critical role in monitoring fraud and abuse within federal programs like Medicare and Medicaid. The OIG is empowered to initiate investigations and legal actions against entities suspected of non-compliance with laws such as HIPAA.
  • Centers for Medicare and Medicaid Services (CMS): CMS oversees the administration and auditing of providers participating in Medicare and Medicaid programs. This agency is instrumental in investigating non-compliance and setting overarching guidelines for program participants.
  • The Office for Civil Rights (OCR): As a branch of HHS, the OCR regulates adherence to HIPAA privacy regulations. It oversees healthcare providers, insurance companies, and clearinghouses, with the authority to prosecute violations and impose fines for data breaches and privacy issues.
  • State Health Departments: At the state level, health departments license healthcare practitioners and facilities. States also have the autonomy to enforce healthcare policies in areas not covered by federal legislation, such as infection control standards and reporting thresholds for adverse events.
  • Healthcare Compliance Officers: These individuals conduct risk assessments based on applicable regulations, recommend security measures, develop policies, and oversee compliance audits within their organizations.And with those guardians at the gate, how do organizations keep up? It’s not just about playing defense against fines and penalties. It’s about building a culture of compliance, piece by piece. Let’s break it down

Overview of Key Healthcare Compliance Regulations and Acts

Healthcare compliance involves adhering to a myriad of significant regulations and acts that have been established by governmental agencies and professional organizations. These laws are crucial for safeguarding patient data, ensuring quality of care, and maintaining the integrity of healthcare services. According to research by the NIH, the healthcare industry has been inundated by hackers in the last five years, compromising 90.49% of health records during this time period. Below is a structured overview of the critical regulations and acts governing healthcare compliance in the United States.

1. Data Protection and Privacy Laws:

  • Health Insurance Portability and Accountability Act (HIPAA) (1996): HIPAA is pivotal in protecting patient data, mandating stringent measures to ensure the confidentiality and security of individually identifiable health information. It covers all forms of media and gives patients the right to access their Protected Health Information (PHI). HIPAA requires healthcare entities to continually adapt their security measures to protect medical records.
  • Health Information Technology for Economic and Clinical Health (HITECH) Act (2009): HITECH enhances HIPAA by increasing penalties for data breaches and promoting the adoption and meaningful use of Electronic Health Records (EHRs). It emphasizes secure electronic health information exchanges and mandates periodic audits by the Department of Health and Human Services to ensure compliance.
  • General Data Protection Regulation (GDPR) (EU): Though an EU regulation, GDPR affects U.S. healthcare entities dealing with European patients. It enforces strict rules on data handling and requires explicit consent for data processing, with significant fines for non-compliance.

Note:  GDPR applies to any organization, regardless of location, that processes the personal data of individuals residing in the EU and the European Economic Area (EEA). For U.S. healthcare entities, this means GDPR compliance is necessary if they offer goods or services to, or monitor the behavior of, EU and EEA residents

2. Financial and Billing Integrity Laws:

  • False Claims Act (FCA): The FCA penalizes entities that submit fraudulent claims to government healthcare programs. It aims to recover damages and enforce accountability. Originating during the Civil War to prevent fraud by defense contractors, the False Claims Act imposes civil liabilities for fraudulent acts against the government. Amendments during the Reagan Administration increased the incentives for whistleblowers to report fraud. Although applicable to various types of fraud, healthcare fraud constitutes the majority of the cases under this Act. In 2015, $1.9 billion of the $3.5 billion recovered from False Claims Act cases involved healthcare organizations.
  • Anti-Kickback Statute: This law prohibits any exchange of remuneration for referrals of services that are reimbursable by federal healthcare programs, helping to ensure medical decisions are made without improper financial influences. Violations can result in fines up to $50,000 per incident, targeting both the providers of and recipients of kickbacks.
  • Stark Law: Specifically, Stark Law forbids physicians from referring patients for certain health services payable by Medicare or Medicaid if the physician has a financial relationship with the entity, unless an exemption applies.

A Slice of Legislative History: Pete Stark was a prominent American politician and a longstanding member of the U.S. House of Representatives from 1973 to 2013. Representing California’s 13th district, he was celebrated for his progressive stance and strong advocacy for healthcare reform. Throughout his tenure, Stark was a staunch advocate for universal healthcare, significantly influencing healthcare policy. His contributions include the enactment of the Stark Law, designed to curb conflicts of interest in healthcare referrals.

  • Although designed to eliminate profit-motivated referrals, this law has shown potential conflicts with other healthcare regulations. However, the Department of Health and Human Services has recognized that current fraud and abuse laws may impede innovative programs aimed at aligning financial incentives with quality care, cost savings, and patient welfare.

3. Patient Care and Safety Regulations:

  • Emergency Medical Treatment and Labor Act (EMTALA): EMTALA mandates that Medicare-participating hospitals provide immediate emergency medical treatment to all individuals, regardless of their ability to pay, and is closely monitored due to its implications on patient care and hospital operations.
  • Patient Safety and Quality Improvement Act (PSQIA): This act established Patient Safety Organizations (PSOs) to collect data on adverse medical events and to promote safe healthcare practices, enhancing the overall quality of care.

4. Healthcare Accessibility and Quality Improvement Programs:

  • Affordable Care Act (ACA) (2010): The ACA, also known as Obamacare, has significantly influenced healthcare compliance, introducing value-based care models that focus on quality and patient outcomes. It requires healthcare organizations to implement compliance health programs and report on performance to enhance healthcare accessibility and reduce costs.The Affordable Care Act introduces several quality and performance improvement initiatives, such as the Medicare Shared Savings Program, which facilitates the creation of Accountable Care Organizations (ACOs)
  • 21st Century Cures Act (2016): This act fosters scientific innovation and data sharing while enhancing patient privacy protections and administrative efficiency in healthcare settings.

5. Digital Health and Information Management:

  • Information Blocking Rule (2021): Managed by the Office of the National Coordinator for Health IT (ONC), this rule aims to prevent practices that obstruct the sharing of electronic health information, promoting greater interoperability.
  • Interoperability and Patient Access Final Rule (2021): Enforced by CMS, this rule mandates that healthcare providers facilitate patient access to their electronic data upon request, enhancing transparency and patient control over their health information.

Protection for Healthcare Workers and the Public

  • Occupational Safety and Health Administration (OSHA): Established by the Occupational Safety and Health Act of 1970, OSHA is part of the U.S. Department of Labor and sets and enforces standards to ensure workplace safety, including in healthcare settings. Its regulations cover a wide range of safety issues, from the operation of x-ray machines to protocols for handling infectious diseases, aligned with prevention guidelines from the Centers for Disease Control and Prevention (CDC).
  • National Incident Management System (NIMS): Developed by the U.S. Department of Homeland Security and managed by the Federal Emergency Management Agency (FEMA), NIMS provides a framework for government, private sector, and non-governmental organizations to collaborate in preparing for, preventing, and responding to large-scale incidents, including epidemics and bioterrorism events. HHS requires healthcare organizations to implement NIMS protocols to qualify for preparedness funding.

6. State and Federal Regulatory Bodies:

  • Centers for Medicare & Medicaid Services (CMS) and Other Federal Agencies: These include agencies like the Drug Enforcement Administration (DEA) which regulates the handling of controlled substances to prevent abuse and diversion, and the Agency for Healthcare Research and Quality (AHRQ) which aims to improve healthcare quality at lower costs.

By adhering to these regulations, healthcare organizations not only ensure legal compliance but also foster a safer, more effective, and equitable healthcare system.

Challenges in Healthcare Compliance

Compliance helps organizations deliver high-quality care that meets patient expectations and regulatory standards, thereby mitigating legal risks and penalties. Managing compliance in healthcare is filled with challenges due to traditional methodologies and the complex nature of the healthcare environment:

  • Paperwork: Compliance health traditionally involves extensive documentation, from policy manuals to training records and audit logs. Paper-based management systems are not only resource-intensive but also prone to errors and inconsistencies.
  • Manual Audits: Manual audits require substantial time and manpower. These audits, essential for reviewing compliance and identifying areas for improvement, are susceptible to human error and can sometimes overlook critical issues.
  • Fragmented Systems: Many healthcare organizations use disjointed systems to manage compliance activities. Lack of integration can lead to inefficiencies, duplicated efforts, and communication barriers, complicating a unified approach to compliance management.
  • Data Management Challenges: The healthcare sector generates a significant volume of data daily, including patient records and transactional data. Effective management, organization, and protection of this data are paramount due to the risks of unauthorized access and data breaches.
  • Security Risks: The sensitive nature of patient data makes security a top priority. Healthcare organizations must deploy advanced security measures to protect against cyber threats, data breaches, and insider threats.
  • Regulatory Complexity: The regulatory landscape in healthcare is dynamic, with frequent updates and new guidelines. Organizations must continuously monitor these changes to ensure their compliance programs remain current and effective.

Ensuring compliance in healthcare requires a proactive approach, leveraging technology to streamline processes, enhance data security, and reduce reliance on outdated systems. By addressing these challenges, healthcare organizations can better protect patient information, meet regulatory requirements, and improve overall compliance efficacy. Advanced compliance management platforms like VComply can greatly reduce the burden of these challenges by offering efficient ways to streamline processes, enhance data security, and ensure continuous regulatory adherence.

Maintaining and Evaluating Effective Compliance Programs

Regular checks and careful watching are key for sticking to healthcare standards. It’s essential that disciplinary guidelines are clearly defined and uniformly enforced to maintain compliance. This ongoing supervision helps in promptly identifying and correcting any discrepancies. By implementing such measures, healthcare organizations can foster a culture of accountability and safety. This proactive stance not only reduces risks but also improves the quality of patient care. Incorporating a cloud-based solution like VComply into your compliance program can provide the visibility and control needed to manage the dynamic regulatory environment successfully.

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Strategies for Maintaining an Effective Compliance Program

To keep programs effective, there needs to be ongoing audits, careful monitoring, and strict rules.  Utilizing tools and resources like risk assessments is key to developing compliance programs that effectively respond to changing legal and regulatory environments. The healthcare sector is continuously evolving, necessitating that organizations stay vigilant and proactive in their compliance strategies. Listed below are 10 essential strategies to ensure regulatory compliance within healthcare organizations

Governance Structure Establishment

  • Define clear roles and responsibilities.
  • Establish regular communication among stakeholders with compliance responsibilities.
  • Establish a comprehensive compliance program that  includes detailed policies and procedures that meet specific regulatory demands, appointment of a dedicated compliance officer to oversee the program, routine training for staff on compliance-related issues, mechanisms for internal audits, and clear protocols for reporting potential violations.
  • Identify accountable individuals for the program, including daily compliance managers.
  • Set up a system for escalating compliance information.
  • Allocate sufficient resources for compliance activities.
  • Ensure the compliance health officer has direct access to the CEO and board.
  • Periodic Risk Assessments
  • Customize the program to the company’s specific needs and challenges.
  • Regularly update the risk assessment to account for new business activities and changes in regulations.

Code of Conduct Implementation

  • Make the code of conduct easily accessible to all employees.
  • Ensure the code reflects the company’s mission, values, and culture.
  • Incentive Program Design
  • Design incentives that promote achieving organizational goals without encouraging unethical behavior.
  • Review incentive programs from a compliance health perspective to identify and mitigate risks.

Stay Updated on Regulatory Changes:

  • The dynamic nature of healthcare legislation requires organizations to be well-informed about ongoing and new regulatory changes.
  • Consistent monitoring of updates from regulatory bodies, participation in industry seminars and conferences, involvement in professional networks, and regular consultations with legal experts specializing in healthcare regulations.

Cultivate a Compliance-Oriented Culture:

  • Fostering a culture that emphasizes compliance is fundamental to long-term success. This culture should promote the significance of adhering to regulations, facilitate open discussions about compliance questions or incidents, and encourage ethical behavior across all levels of the organization.

Employ Technology to Enhance Compliance:

  • Utilizing advanced technology can significantly streamline compliance efforts. Electronic Health Records (EHRs) with integrated security features not only enhance the protection of patient health information (PHI) but also improve data accessibility and sharing among authorized users.
  • Specialized compliance management software can automate many compliance tasks, keep track of regulatory updates, and provide real-time monitoring of compliance adherence.

Effective Communication Among Teams

  • Ensure coordination among various departments responsible for compliance.
  • Establish a process for routing compliance issues to appropriate groups without duplication of efforts.

Regular Employee Training

  • Provide tailored training on the code of conduct and compliance procedures.
  • Communicate who employees can contact for compliance guidance and how to report violations.
  • Streamlined Process for Reporting Misconduct
  • Detail various reporting mechanisms such as hotlines or direct contacts with managers.
  • Implement and enforce a no-retaliation policy for reporting issues in good faith.

Conduct Thorough Internal Audits:

  • Regular internal audits are vital in identifying and addressing compliance gaps within an organization. Auditing processes, documentation, and conformity to regulatory standards enables healthcare providers to proactively rectify issues before they escalate into more serious compliance violations.

Incident Management and Response Plan

  • Develop a clear process for handling compliance incidents.
  • Prepare for potential non-compliance costs and public exposure.
  • Ongoing Monitoring and Evidence Collection
  • Continuously document the compliance process and gather evidence of effective controls.
  • Regularly review and update compliance documentation to prepare for external audits.
  • Technology Integration for Compliance Management
  • Utilize technology like VComply for mapping controls, managing evidence, and automating compliance tasks.
  • Ensure the technology provides a holistic view of the compliance program and facilitates collaboration with stakeholders.

These points will guide you in establishing a robust and effective compliance program that addresses governance, risk management, and continuous improvement. By implementing these strategies, healthcare organizations can better manage the complexities of regulatory compliance, ultimately leading to enhanced patient care, improved operational efficiency, and reduced risk of legal or financial penalties.

Seven Elements of an Effective Compliance Program

The OIG outlines 7 must haves for a good program to reduce damage from fraud.  Below are the ways in which these elements are implemented:

Implementing Written Policies and Procedures:

  • Standards of Conduct Guide
  • Ethics Policy

Designating a Compliance Officer and Compliance Committee:

  • Compliance Advisory Committee
  • Conducting Effective Training and Education:
  • Compliance Training

Developing Effective Lines of Communication:

  • Hotline

Conducting Internal Monitoring and Auditing:

  • Internal Audits
  • Compliance Inspections
  • Peer Reviews
  • External Audits, Reviews, and Inspections

Enforcing Standards Through Well-Publicized Disciplinary Guidelines:

  • Consistent enforcement of disciplinary actions, regardless of the employee’s stature within the organization
  • HR’s managing conduct webpage

Responding Promptly to Detected Problems and Undertaking Corrective Action:

  • Hotline procedures requiring action within two weeks; escalation to VP/President
  • These elements are designed to ensure that compliance programs are comprehensive, effectively managed, and responsive to the organizational needs and regulatory requirements.

Consequences of Failing to Meet Healthcare Compliance Standards

Not adhering to healthcare regulations can have serious repercussions.These include legal ramifications and financial penalties, which can extend to the loss of contracts with insurance providers and even the revocation of medical licenses. For example:

  • HIPAA Violations: These can incur fines ranging from $100 to $50,000 per incident, based on the severity of negligence.
  • Anti-Kickback Statute Violations: Involvement in kickback schemes can lead to both civil and criminal penalties, including fines up to $100,000 per violation and possible imprisonment.
  • Stark Law Violations: Non-compliance with the Stark Law, which prohibits certain types of self-referrals by physicians, can result in fines of up to $15,000 per service and exclusion from federal health programs.
  • Noncompliance can harm an organization’s reputation and undermine its financial health.
  • Noncompliance could result in patient harm, leading to possible disciplinary actions against healthcare professionals that could affect their licensing.

Considering patients prioritize quality care, they are likely to opt for providers that maintain a clean record, free from legal entanglements and complaints. As we’ve seen, steering clear of compliance pitfalls isn’t just about dodging fines; it’s about upholding a golden standard of care and trust. Which brings us to our final act. What does the future hold for healthcare compliance?

Roles and Responsibilities in Healthcare Compliance

Healthcare organizations, including hospitals and insurers, must adhere to a range of regulations to ensure patient safety and confidentiality:

  • Developing a Compliance Plan: Organizations should identify relevant regulations, assess associated risks, implement appropriate compliance procedures, and regularly review and monitor compliance.
  • Ensuring Awareness and Training: All employees should be aware of and trained in these regulations. Policies should be regularly updated and communicated within the organization.
  • Handling Non-Compliance: Organizations should have protocols in place to address any non-compliance issues that arise.

Future of Healthcare Compliance

With regulations becoming increasingly complex, the demand for skilled compliance professionals is expected to grow. These professionals are crucial in efficiently managing the regulatory landscape efficiently, using tools such as cloud-based platforms for better management of compliance tasks.

By implementing robust compliance programs and staying vigilant about regulatory changes, healthcare organizations can ensure they not only meet legal requirements but also provide safe, high-quality care to their patients.

Final Thoughts

Compliance is more than just following rules; it’s about patient safety, quality care, and trust.  It requires ongoing dedication and adaptability to meet legal standards and maintain public trust. Healthcare entities must craft detailed compliance strategies, perform regular assessments, and utilize tools like cloud storage and audit software to ensure robust compliance. 

An effective compliance program not only safeguards patients and staff but also enhances operational efficiency and minimizes legal risks. By prioritizing comprehensive compliance, healthcare providers can deliver superior care while avoiding significant penalties.  Adopting comprehensive GRC platforms such as VComply equips organizations with the tools necessary to manage compliance efficiently, mitigating risks while maintaining a focus on delivering high-quality patient care.