Government Investigation and Enforcement Defense

How does government investigation and enforcement affect companies?

Government investigation and enforcement defense can significantly impact companies in the healthcare industry, including hospitals, healthcare providers, pharmaceutical companies, medical device manufacturers, and health insurers. When a government agency, such as the Department of Justice (DOJ), the Office of Inspector General (OIG), or the Centers for Medicare & Medicaid Services (CMS), initiates an investigation or enforcement action, it can have far-reaching consequences for the company involved.

Government enforcement actions can result in significant financial penalties, fines, and settlements for companies found liable for violations of healthcare laws and regulations. Depending on the nature and severity of the alleged offenses, companies may face civil monetary penalties, disgorgement of profits, treble damages, or exclusion from federal healthcare programs. These financial consequences can have a profound impact on the company’s bottom line, profitability, and financial stability.

In response to government investigations and enforcement actions, companies in the healthcare industry must mount a robust defense strategy to protect their interests and mitigate potential liabilities. This may involve conducting internal investigations, cooperating with government authorities, engaging legal counsel and compliance experts, implementing remedial measures, and negotiating settlements or plea agreements. Companies must also take proactive steps to strengthen compliance programs, internal controls, and corporate governance practices to prevent future violations and enhance regulatory compliance. Need help regarding government investigation and enforcement defense? Schedule your consultation today with a top healthcare attorney.

In Florida, which laws and regulations apply to the government investigation and enforcement defense?

In Florida, hospital privileges, medical staff issues, peer reviews, and credentialing are governed by a combination of state laws, regulations, and professional standards. Some key laws and regulations that apply to these aspects of healthcare practice in Florida include: · Anti-Kickback Statute (AKS): This is a federal criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of business reimbursable by federal health care programs. Florida has a similar anti-kickback statute found here. Florida has a similar anti-kickback statute found here. · False Claims Act (31 U.S.C. §§ 3729-3733): The federal False Claims Act imposes liability on individuals and entities that defraud government healthcare programs, such as Medicare and Medicaid, by submitting false or fraudulent claims for reimbursement. The FCA allows for civil enforcement actions, whistleblower lawsuits (qui tam actions), and substantial penalties for violations. There is a similar law in Florida entitled the Florida False Claims Act (Florida Statutes Sections 68.081-68.092). · Stark Law: Stark Law: This federal law prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Florida has a similar law prohibiting self-referrals found here. Florida has a similar law prohibiting self-referrals found here.

What are common issues regarding government investigation and enforcement defense that can lead to litigation?

Common issues regarding government investigation and enforcement defense in healthcare that can lead to litigation include:

· Allegations of Fraud and Abuse: Government investigations often stem from allegations of fraud, kickbacks, false claims, or other improper conduct in the provision of healthcare services or billing practices. Healthcare providers may face litigation if they are accused of submitting false claims for reimbursement, engaging in illegal referral arrangements, or providing medically unnecessary services.

· Non-Compliance with Regulatory Requirements: Violations of federal and state healthcare laws and regulations, such as the Anti-Kickback Statute, Stark Law, False Claims Act, HIPAA, and state-specific regulations, can trigger government investigations and enforcement actions. Non-compliance with regulatory requirements related to patient privacy, billing practices, documentation standards, or quality of care may lead to litigation and legal liability.

· Improper Coding and Billing Practices: Allegations of coding errors, upcoding, unbundling, or billing for services not rendered can result in government scrutiny and enforcement actions. Healthcare providers may face litigation if they are accused of fraudulent billing practices, billing for medically unnecessary services, or misrepresenting services rendered to maximize reimbursement.

· Quality of Care Concerns: Government investigations may focus on allegations of substandard care, patient harm, medical errors, or regulatory violations related to patient safety and quality of care. Healthcare providers may face litigation if they are accused of negligence, malpractice, or violations of professional standards of practice that result in patient harm or adverse outcomes.

· Whistleblower Allegations: Whistleblower complaints and qui tam lawsuits filed under the False Claims Act can trigger government investigations into alleged fraud or misconduct by healthcare providers. Whistleblowers, including current or former employees, contractors, or competitors, may allege wrongdoing by healthcare companies and seek to recover damages on behalf of the government, leading to litigation.

· Anti-Competitive Conduct: Government investigations may focus on allegations of anti-competitive conduct, such as price-fixing, market allocation, or illegal tying arrangements among healthcare providers, insurers, or suppliers. Violations of antitrust laws can lead to civil litigation, enforcement actions by regulatory agencies, and private lawsuits by injured parties.

· Failure to Cooperate with Government Investigations: Non-cooperation with government investigators, such as withholding information, obstructing inquiries, or providing false statements, can escalate enforcement actions and lead to additional legal consequences. Healthcare providers have a duty to cooperate with government investigations and respond truthfully to inquiries to avoid allegations of obstruction or non-compliance.

We are value-based attorneys at Jimerson Birr, which means we look at each action with our clients from the point of view of costs and benefits while reducing liability. Then, based on our client’s objectives, we chart a path to seek appropriate remedies. To determine whether your unique situation may necessitate litigation, please contact our office to set up your initial consultation.

What steps should businesses take to minimize the risk of litigation over government investigation and enforcement defense?

To minimize the risk of litigation over government investigation and enforcement defense in the healthcare industry, businesses should take proactive steps to enhance compliance, mitigate legal risks, and protect their interests. Here are some key steps they can take:

· Implement Robust Compliance Programs: Establish comprehensive compliance programs tailored to the specific regulatory requirements and risks faced by the business. Compliance programs should include written policies and procedures, employee training and education, internal monitoring and auditing, reporting mechanisms for suspected violations, and corrective action protocols.

· Conduct Regular Risk Assessments and Audits: Conduct periodic risk assessments and internal audits to identify potential areas of non-compliance, operational vulnerabilities, or regulatory gaps. Assess risks related to billing practices, coding accuracy, documentation standards, patient privacy, quality of care, and relationships with third-party vendors.

· Promote a Culture of Compliance and Ethics: Foster a culture of compliance, integrity, and ethical conduct throughout the organization. Promote transparency, accountability, and open communication among employees, management, and stakeholders. Encourage reporting of suspected violations and provide whistleblower protections for employees who raise concerns.

· Establish Effective Internal Controls and Monitoring Systems: Implement internal controls, checks, and balances to prevent, detect, and mitigate compliance risks. Monitor key performance indicators, billing patterns, coding trends, and other metrics to identify anomalies or deviations from established norms that may signal potential compliance issues.

· Maintain Accurate and Complete Documentation: Ensure that all business activities, transactions, and interactions are accurately documented, recorded, and maintained in accordance with regulatory requirements. Keep comprehensive records of patient care, billing practices, financial transactions, contractual agreements, and compliance efforts.

· Cooperate with Government Investigations: Cooperate fully with government investigations, inquiries, or audits initiated by regulatory agencies, such as the Department of Justice (DOJ), Office of Inspector General (OIG), or Centers for Medicare & Medicaid

Services (CMS). Respond promptly to requests for information, provide truthful and accurate responses, and maintain open communication with government authorities.

· Conduct Internal Investigations as Needed: Conduct internal investigations promptly and thoroughly in response to allegations of misconduct, suspected violations, or compliance concerns. Retain independent counsel or forensic experts, if necessary, to conduct impartial investigations, gather evidence, and assess legal risks.

· Implement Remedial Measures and Corrective Actions: Take prompt corrective actions to address identified compliance deficiencies, mitigate legal risks, and prevent future violations. Implement remedial measures, such as policy revisions, staff training, process improvements, and disciplinary actions, to address root causes and ensure ongoing compliance.

Frequently Asked Questions

What triggers a government investigation?

Government investigations in healthcare may be triggered by various factors, including whistleblower complaints, allegations of billing fraud, data analysis indicating irregularities, complaints from patients or employees, audit findings, or referrals from other agencies. Suspected violations of healthcare laws and regulations, such as the False Claims Act, Anti-Kickback Statute, Stark Law, or HIPAA, may prompt government scrutiny.

What should healthcare organizations do if they receive a government inquiry?

If a healthcare organization receives a government inquiry, it should promptly assess the nature and scope of the inquiry, gather relevant information and documentation, and engage legal counsel experienced in healthcare law and regulatory compliance. The organization should cooperate with the government investigation while taking steps to protect its legal rights, preserve evidence, and mitigate potential liabilities.

Have more questions about government investigation and enforcement defense?

Crucially, this overview of government investigation and enforcement defense does not begin to cover all the laws implicated by this issue or the factors that may compel the application of such laws. Every case is unique, and the laws can produce different outcomes depending on the individual circumstances.

Jimerson Birr attorneys guide our clients to help make informed decisions while ensuring their rights are respected and protected. Our lawyers are highly trained and experienced in the nuances of the law, so they can accurately interpret statutes and case law and holistically prepare individuals or companies for their legal endeavors. Through this intense personal investment and advocacy, our lawyers will help resolve the issue’s complicated legal problems efficiently and effectively. Having a Jimerson Birr attorney on your side means securing a team of seasoned, multi-dimensional, cross-functional legal professionals. Whether it is a transaction, an operational issue, a regulatory challenge, or a contested legal predicament that may require court intervention, we remain tireless advocates at every step. Being a value-added law firm means putting the client at the forefront of everything we do. We use our experience to help our clients navigate even the most complex problems and come out the other side triumphant.

If you want to understand your case, the merits of your claim or defense, potential monetary awards, or the amount of exposure you face, you should speak with a qualified Jimerson Birr lawyer. Our experienced team of attorneys is here to help. Call Jimerson Birr at (904) 389-0050 or use the contact form to schedule a consultation.