As a healthcare professional, your primary responsibility is the well-being of your patients. While the regulations around the healthcare industry are made to reinforce that goal, the complications of maintaining compliance at both state and federal levels can distract from patient care.
You need to understand the role of compliance programs in reducing legal risk for healthcare facilities. This will help you ensure your facility remains stable, reputable, and open to serving those who need you most. At Cohen Cleary, P.C., our healthcare facility attorneys support you in lifting this burden so you can focus on what matters most.
Why Compliance Programs Matter in Healthcare
Compliance programs work as the backbone of your facility’s protocols. Without a compliance program in place, even the most well-intentioned healthcare organizations may be vulnerable.
The healthcare industry is governed by a dense and sometimes self-contradicting web of laws and regulations. From the Health Insurance Portability and Accountability Act (HIPAA) to the False Claims Act, these rules are designed to ensure patient safety and the integrity of your healthcare organization. When a facility embraces compliance programs, they send a message to the Department of Health and the Office of the Inspector General (OIG) that they operate with integrity.
Programs are designed to protect patients. When billing is accurate and privacy is maintained, a patient may rest easy knowing their trust is well-founded. In this age of high-stakes litigation, your reputation is your most valuable asset.
How Compliance Programs Reduce Legal Risk in Healthcare
An effective compliance program works to alert you to risks and issues before they turn into legal actions. A proactive approach can help you avoid immense fines, fees, and reputational damage that happen when legal issues occur.
Early Detection of Compliance Issues
Just like with most health issues, early detection is key. Through regular risk assessments, your facility can identify vulnerabilities in real time. Whether you have unintentional coding errors or a lapse in your data security, finding the problem internally allows for corrective action prior to an auditor or patient identifying the issue for you.
Early detection gives you visibility into compliance risks before they escalate. For example, it may allow you to spot consistent, irregular patterns in Medicare billing before it becomes a whistleblower lawsuit or leads to an in-depth audit. Identifying these issues in-house allows you to maintain control over the narrative and the resolution, demonstrating your dedication to compliance.
Preventing Regulatory Violations and Fraud Risk
The federal government is increasingly focused on preventing fraud, waste, and abuse. Even an honest billing mistake may be interpreted as fraud if a pattern of negligence exists. A robust compliance program ensures that your team understands the nuances of medical necessity and proper reimbursement, shielding you from the devastating reach of the False Claims Act.
Using Documentation to Reduce Legal Liability
Documentation is key in any legal issue, and your compliance program should reflect this. By strictly adhering to HIPAA guidelines regarding patient records, you can create a paper trail that serves as a strong defense in any malpractice case or regulatory inquiry.
Effective documentation serves as an objective witness to the high standard of patient care you provide. With it, you can show that consent was obtained, risks were explained, and privacy was prioritized. Comprehensive records show your compliance with concrete evidence and provide vital documentation for legal counsel if litigation should occur.
Reducing Penalties and Enforcement Exposure
If they suspect an issue, the Department of Health and Human Services (HHS) may initiate an investigation. When this occurs, having an enforced and effective compliance program becomes essential. Federal sentencing guidelines often allow for significantly reduced penalties for organizations that can prove they had a proactive andgood-faith compliance program in place prior to a violation occurring.
The government is often more lenient with healthcare organizations that show they tried to do the right thing and failed, compared to those that were willfully blind to their issues. Building this into your compliance program can help save you millions of dollars in fines and may prevent having to enter into a Corporate Integrity Agreement (CIA).
Responding Quickly to Compliance Issues
When a breach or error occurs, your quick response can make all the difference. Building a structured protocol for quickly responding to compliance issues can help your team follow a clear plan for self-reporting and mitigation. This practice may prevent exclusion from federal programs or the loss of a license.
Speed is essential in responses, and when you self-report a mistake to the Department of Health, it often results in a more favorable outcome than if they discover it themselves. A well-laid-out plan can ensure your staff does not panic, but moves through a predetermined remediation plan to contain the damage and preserve your facility’s legal standing.
Strengthening Oversight and Internal Accountability
Designating a specific person to work as a compliance officer can strengthen your protocols and internal accountability. By creating internal oversight, you can remove the silo effect where departments operate without checking with one another. This internal accountability works to ensure that everyone, from the front desk to the surgical suite, is aligned with the facility’s legal obligations.
Building a Culture of Compliance
When your healthcare facility is aligned with a common mindset of enforcing compliance, risk can be greatly reduced. Build into your compliance program regular training sessions and reminders for staff on regulatory requirements. Focus on the fact that compliance is not just red tape, but rather that it protects patients and keeps your organization running.
Your employees should feel empowered to speak up about concerns without fear of retaliation. Having all employees aligned on this is the ultimate safeguard against systemic failures that lead to high-profile lawsuits.
Building an Effective Compliance Program
Creating an effective compliance program is not just about getting it down in writing. A compliance program is more of a living document that needs to be regularly reviewed and updated to stay up-to-date on current laws and regulations, as well as shifts in company policy. According to the OIG, an effective compliance program in healthcare generally includes seven core elements:
- Written Policies and Standards: Your facility should have clear and accessible manuals that communicate complicated laws and regulations in everyday language for your employees.
- Designated Leadership: You will need to appoint a compliance officer with the authority and resources to effect change.
- Regular, Effective Training: Beyond an annual presentation on strong compliance, your training programs should include relevant training for individual teams and their individual roles.
- Open Communication Protocols: Build a system designed to anonymize reporting and encourage your staff to communicate concerns about potential fraud, waste, and abuse.
- Internal Monitoring and Audits: Regular monitoring and internal audits help ensure policies are being followed day-to-day.
- Consistent Enforcement: Establish disciplinary standards that apply to everyone, regardless of their rank or revenue-generating potential.
- Prompt Corrective Action: Have policies ready for when an error occurs. You will need to promptly resolve the issue to prevent recurrence.
By focusing on these pillars of effective compliance programs, you can build a resilient healthcare organization that reduces the risk of legal exposure. Reducing this risk allows you to continue to focus on exceptional patient care and keep your facility running for the long term.
Work with a Healthcare Compliance Attorney
The healthcare field is one of the most heavily regulated sectors in the United States. Trying to navigate it alone is difficult. Instead of facing the fines and reputational damage that come with litigation and audits, be proactive by creating a strong compliance program with the help of a healthcare compliance attorney.
Our role is to translate intimidating regulations into everyday language and actionable steps to protect your facility. Contact us today to schedule a free consultation and have your questions answered.
