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The Impact of Legal and Regulatory Requirements in the Health Care Setting

The Impact of Legal and Regulatory Requirements in the Health Care Setting

The Chosen Law/Regulation

The False Claims Act (FCA) is considered a pivotal federal statute because it seeks to fight against fraudulent claims against the government, including corruption of allegations made to government healthcare programs like Medicare and Medicaid. Accordingly, taking advantage of the Claims Act is the responsibility of the Department of Justice, US, and involves anyone, including separately existing businesses, who submit fraudulent claims for payment (Ogan, 2022). It subjects liability to those guilty of offering corporations reimbursement for false claims. The Act is a salvation of the forefront protection of taxpayers’ dollars, and the government runs healthcare programs by providing transparency and accountability in billing practices. This allows whistleblowers to file lawsuits referred to as qui tam actions as the plaintiff so that the government can file a case against fraudulent activities and receive a portion of any money recovered by the government as an act of reporting fraudulent activities (Ogan, 2022). In other sectors, this also incentivizes fraud in healthcare matters to be detected and prosecuted.

The Entity that Oversees and Enforces the Law/Regulation

The Department of Justice (DOJ) is the authority that oversees the matter. Furthermore, with the assistance of several United States Attorney’s offices across the country, the Department of Justice’s Civil Division oversees the scope and non-compliance of the FCA through it. It will look into fraud charges, prosecute offenders, and greatly enhance the protection of the government’s assets by tracing damages, if any (Heese et al., 2020). Within the confines of the FCA, the authority of the DOJ is not limited to suing whistleblowers, that is, individuals who have made the claims or lodged suits autonomously; it is also allowed to intervene in the lawsuits the whistleblowers file. One particularly noteworthy aspect of the False Claims Act is the “Qui Tam” provision. Whistleblowers have the opportunity to start a qui tam action on behalf of the government and share some recoverable money. The DOJ’s enforcement initiatives under the FCA have resulted in several successful prosecutions and settlements, indicating its commitment to upholding the integrity of healthcare, and it can be characterized as one of the critical instruments in combating precipitation against government healthcare programs and sustaining the country’s healthcare system as a whole (Heese et al., 2020).

Evaluation of the Selected Law/Regulation’s Impact on the Healthcare Industry

One of the most vital consequences of the False Claims Act is its harsh impact on the healthcare system, changing how its business practices are performed and how medical bills are billed. Serving such a significant role of a federal statute that is only intended to fight the cases of fraud targeted against the government, the FCA severely and quantitatively stipulates entailed providers’ regulation. This has led to tightening billing perspectives and helping to build proper documentation and accurate coding (Reurink, 2019). Healthcare system entities are bound to enforce compliance programs that ensure adherence to the FCA rules, which entail policies, training, and in-house auditing since compliance with FCA has led to developments in billing practices and increased alertness of fraudulent activities, ultimately enhancing patient trust in the healthcare system.. For instance, FCA’s acceptable allocation procedures, supervised by the U.S. Department of Justice (DOJ), serve as a deterrent for any fraudulent activities performed under the agreement and help the promotion of transparency and good business ethics (Reurink, 2019). FCA adherence by providers goes beyond protecting the government’s finances; it even preserves the moral foundation of any public healthcare programs, consequently ensuring that the entire healthcare sector remains credible and trusted by the people.

What a Healthcare Organization Needs to do to Comply with the Law or Regulation

To meet the standard of a False Claims Act, healthcare organizations must build out and operationalize compliance programs tailored to the FCA’s unique virtues. This stage, however, involves a few primary steps, including designing guidelines and supervisory measures that control billing, documenting, and coding. This law should be routinely revised to correspond with FCA’s new rules and recommendations. Furthermore, enterprises should emphasize continual training and education rights for workers at all levels, which will lead to making knowledgeable and skilled workers, thus abiding by the FCA requirements (Szalados, 2021). Internal audits and control are indispensable for preventing fraud and fraudulent practices and rectifying violations of the rules of financial and accounting standards. Healthcare organizations need to establish compliance protocols, including whistleblower protection guidelines and procedures for examining and addressing claims of fraud. By adopting these measures, healthcare agencies can create a culture of compliance and complete transparency and provide governmental healthcare programs with protection from violations, minimizing the risk of FCA and ensuring both the organization and the integrity of the government healthcare programs (Szalados, 2021).

Requirements of Adhering to the Law/Regulation

Sticking to the FCA certainly means careful compliance with some important features to prevent severe implications. This requirement is achieved through thorough documentation, auditing, and training to address and detect any abnormalities in billing promptly. Firstly, healthcare organizations must ensure that the services they provide are properly documented alongside those claims they submitted to ensure that the due reimbursements are received. Included are service rendering records showing the actual service provided and fees charged by applying appropriate coding for the services. Second, organizations must include comprehensive compliance training modules to educate employees on the various elements covered under FCA and the significance of ethical invoicing procedures (Szalados, 2021). Training will include discussions on detecting the red flags of fraudulent activities, following accurate documentation procedures and determining the implications for non-compliance. Wide-ranging auditing and reviews of billing methods are necessary tools to detect and resolve any anomalies in billing procedures promptly. Through compliance with these regulations, healthcare providers will follow the ethics of government healthcare programs, eliminate the risk of FCA violation, and prevent bad actions on the field (Szalados, 2021).

The Penalties for Violations of the Law or Regulation

The criminal activities of healthcare organizations and individuals violating the FCA provisions may result in drastically heavy fines, terrible damages, and penalties for whistleblowers found guilty of misconduct. Infractions would prompt civil fines for monetary value, treble damages, and non-participation in healthcare programs, including Medicare and Medicaid. Moreover, whistleblowers who commit FCA misconduct are subject to greater penalties like fines, imprisonment, and reputation (Lieberman, 2024). In addition, the FCA is also involved in storing information for whoever submits it to the government, which leads to a lawsuit. This is known as quiescent action, in which whoever offers the information will receive a portion of the money recovered by the government. Applying these penalties emphasizes the significance of translating the FCA and discouraging fraudulent billing in the health sector (Lieberman, 2024). The FCA imposes fines upon noncompliant applicants, which is not just financial but also a violation of the integrity of the Government healthcare programs and the appropriate use of taxes.

References

Heese, J., Krishnan, R., & Ramasubramanian, H. (2020). The Department of Justice as a gatekeeper in whistleblower-initiated corporate fraud enforcement: Drivers and consequences. Journal of Accounting and Economics, 101357. https://doi.org/10.1016/j.jacceco.2020.101357

Lieberman, D. W. (2024, February 13). False Claims Act penalties: A complete guide. Whistleblower Law Collaborative. https://www.whistleblowerllc.com/false-claims-act-penalties/

Ogan, C. (2022). The False Claims Act’s first-to-file provision: How courts should apply the essential facts test. Houston Law Review, 60, 233. https://heinonline.org/HOL/LandingPage?handle=hein.journals/hulr60&div=10&id=&page=

Reurink, A. (2019). Financial fraud: A literature review. Contemporary Topics in Finance, 79–115. https://doi.org/10.1002/9781119565178.ch4

Szalados, J. E. (2021). Regulations and regulatory compliance: False Claims Act, Kickback and Stark Laws, and HIPAA. The Medical-Legal Aspects of Acute Care Medicine, 277–313. https://doi.org/10.1007/978-3-030-68570-6_12

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Question 


A compliance specialist must interpret laws and regulations to evaluate the impact of legal and regulatory requirements in their healthcare setting. Then, they explain the application to their department and other departments in the organization.

The Impact of Legal and Regulatory Requirements in the Health Care Setting

Preparation
Assume you are in a compliance specialist role. Select 1 law or regulation to research and use for this assignment:

Anti-Kickback Statute (AKS)
Emergency Medical Treatment & Labor Act (EMTALA)
False Claims Act (FCA)
HIPAA Privacy Rule
HITECH Act
Human research protections
Patient Protection and Affordable Care Act of 2010
Stark law (Physician Self-Referral Law)

Assessment Deliverable
Write a 700- to 1,050-word executive summary for your organization’s leadership team in which you:

Summarize the chosen law or regulation.
Describe the entity that oversees and enforces the law or regulation.
Evaluate the impact the selected law or regulation has on the healthcare industry.
Explain what a healthcare organization needs to do to comply with the law or regulation.
Explain 2 or 3 requirements of adhering to the law or regulation.
Explain the penalties for violations of the law or regulation.

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