Healthcare compliance refers to the proactive efforts to prevent fraud, waste, or abuse within a healthcare organization. A compliance program is an ongoing process to ensure that legal, ethical, and professional standards are upheld and effectively communicated across the organization. Compliance fosters a culture where everyone within the healthcare entity works to prevent, detect, and address actions that could lead to fraud, waste, or abuse. These are the critical aspects to address when formulating a healthcare compliance program.
Understand Rules and Regulations
The foundation of a healthcare compliance plan starts with a clear understanding of the relevant healthcare laws and regulations. A healthcare compliance attorney can give you an exhaustive list of rules and regulations for your organization. Some of the key regulations to consider include:
- Health Insurance Portability and Accountability Act (HIPAA) – Establishes standards for protecting patient data.
- Affordable Care Act (ACA) – Includes provisions on insurance coverage, healthcare providers, and billing practices.
- False Claims Act—This act prohibits healthcare providers from submitting fraudulent claims for payment to federal programs like Medicare or Medicaid.
- Stark Law – Prohibits physicians from referring patients to facilities where they have a financial interest.
- Anti-Kickback Statute – Prohibits any remuneration intended to induce referrals for services reimbursed by federal programs.
Conduct a Risk Assessment
Before crafting a healthcare compliance plan, an organization should conduct a thorough risk assessment to identify potential areas where vulnerabilities to non-compliance may exist. With the applicable rules and regulations in mind, the organization can identify areas of potential noncompliance. These risks could involve billing practices, privacy issues, employee conduct, or patient care.
Here are some common compliance risks:
- Billing errors: Mistakes in coding, overcharging, or fraud.
- Conflicts of interest: Financial interests that could influence clinical decisions.
- Failure to meet standards of care: Neglecting clinical or operational guidelines.
- Privacy violations: Mishandling patient information.
This is a good exercise for the team, as different staff will handle different aspects of the organization and can identify areas of potential noncompliance. Additionally, a healthcare compliance attorney can share common areas of noncompliance that you may not have considered.
Outline the Compliance Officer’s Role
A healthcare compliance plan must assign responsibility for overseeing the plan. This person, often called the Compliance Officer, will manage the compliance efforts within the organization, monitor adherence to regulations, and serve as the point of contact for any compliance-related issues. The Compliance Officer should have a solid understanding of healthcare law, organizational operations, and risk management. The major responsibilities of the Compliance Officer include ensuring compliance with all legal, regulatory, and ethical standards, conducting regular compliance audits and assessments, reporting compliance issues, and providing training and guidance to staff on compliance matters.
Establish Policies and Procedures
Once you clearly understand the regulatory framework and risks, establish policies and procedures to guide your organization toward compliance. These policies should be comprehensive and tailored to address the specific risks identified in the assessment. Ensure all policies and procedures are clear, concise, and regularly updated as regulations change. This means that a healthcare compliance plan is not something that is completed once but is a document that is constantly modified to reflect changing rules and regulations. In healthcare, especially, the legal landscape is constantly evolving. Some common areas that policies should cover include:
- Billing and coding: Procedures for accurate documentation, billing, and coding to avoid fraud and errors.
- Conflict of interest: Guidelines for avoiding financial conflicts or unethical relationships.
- Privacy and confidentiality: Steps for protecting patient information, in compliance with HIPAA.
- Training: Ongoing education for staff on compliance matters.
- Workplace behavior: Codes of conduct that ensure ethical behavior by all employees.
Develop a Training and Education Program
Education is essential to ensure that all employees understand their compliance roles. A well-developed training program helps employees stay informed about new regulations, ethical standards, and internal procedures. Training should address key compliance topics like HIPAA, fraud prevention, billing and coding accuracy, and patient rights, be tailored to different organizational roles, and be offered regularly.
Create a Monitoring and Audit Plan
A critical component of a healthcare compliance plan is establishing an ongoing monitoring and auditing process. Regular audits will help identify compliance gaps and allow the organization to address issues before escalating. These audits may be internal, performed by the Compliance Officer or a designated team, or external, conducted by third-party auditors.
Come Up With a Response and Corrective Action Plan
When compliance issues are identified, it is important to have a clear process for addressing them. A Response and Corrective Action Plan should outline steps to investigate and resolve non-compliance situations.
Major components of the plan should include:
- Immediate response: This includes responding immediately to a potential violation (e.g., suspending certain practices or conducting an immediate internal review).
- Investigation: This will lay out how to investigate the issue thoroughly and fairly and who will investigate.
- Corrective actions: These actions will rectify the issue and prevent it from happening again (e.g., revising policies, providing additional training, or taking disciplinary action).
Documentation
Finally, an effective healthcare compliance plan is achieved through thorough documentation. This includes maintaining records of training sessions, audits, investigations, corrective actions, and compliance reports. Comprehensive documentation serves as proof of your organization’s commitment to compliance and can be critical in the event of a regulatory authority audit.
Consult With an Experienced Healthcare Compliance Attorney
Writing a healthcare compliance plan involves much more than simply drafting policies. Rather, it is about creating a culture of compliance within your organization. By understanding the laws, addressing risks, creating clear policies, providing ongoing training, and conducting regular audits, you can ensure that your healthcare organization complies with all regulatory requirements, ultimately improving patient care and minimizing legal and financial risks. Contact our office today to learn how our healthcare compliance attorney can help.