Compliance Issues With Federal & State Laws

This assignment will explore compliance issues with federal and state laws and regulations governing healthcare organizations, such as the Anti-Kickback Law, the False Claims Act, the Stark Law, credentialing, medical errors, and patient safety. It is important to understand healthcare compliance for the benefit of improving patient care. It is also important to promote adherence to applicable laws, payer healthcare requirements, and to protect the organization against fraud, waste, abuse, and other potential liabilities.

Instructions
Write a 2–3 page paper in which you:

Summarize one statute, one regulation, and one guidance document that impose compliance obligations on healthcare organizations.
Explain what healthcare organizations must do to comply with legal requirements.

Describe the standards for corporate compliance programs set forth in the OIG Compliance Guidance and the Federal Register.
In addition to the textbook, provide two sources to support your writing. Choose sources that are credible, relevant, and valid. Cite each source listed on your source page at least one time within your assignment. For help with research, writing, and citation, access the library, or review library guides.

Develop a compliance plan associated with issues surrounding fraud, waste, and abuse

ANSWER

Compliance Plan

False Claim Act

This statute prohibits covered entities from submitting or filing a false claim. Penalties are administered when the covered entity had actual knowledge of the false claim or was deliberately ignorant and recklessly disregarded the truth. A false claim includes fabricating a statement to receive payment from the government, billing the same service several times, and billing a service not provided. The penalties include $11,000 for every false claim, imprisonment, treble damages, or criminal fine (U.S Department of Justice, n.d.). Treble statutes allow a plaintiff to receive compensation up to three times the actual damages.

Protections of Human Research Subjects

The Code of Federal Regulations (45 CFR 46) was created by the Human Health Services to protect research subjects from harm and exploitation. The code has five parts Subpart A, B, C, D, and E. Subpart A outlines the requirements for protecting all research subjects. Subpart B regulates research studies involving pregnant women, fetuses, dead fetuses, placenta, and neonates (HHS, n.d). Subpart C outlines prisoners’ protection, while Subpart D protects children. Sometimes, biomedical research is done in clinical settings with actual patients. For example, clinical trials must use patients with cancer to determine whether the drug or therapy will benefit that patient population. This regulation by HHS helps protect such patients and other research participants from harm, manipulation, and exploitation.

Guidance Document

The American Nursing Association (ANA) Code of Ethics outlines nine clinical practice provisions. The first provision requires nurses to practice compassion and respect for all persons. The second provision states that nurses should be committed to their patients, family, and the community. The third provision mandates them to promote and advocate for patients’ rights. The fourth provision states that nurses are accountable and responsible for their actions and decisions in clinical practice (ANA, 2015). The fifth provision says that nurses owe the duty for personal and professional growth to themselves and others. The sixth provision indicates that nurses should collaborate with others to create a safe environment for the patients. The seventh provision requires nurses to advance the profession through scholarly work and research, while the eighth provision directs them to reduce health disparities and promote human rights (ANA, 2015). The ninth provision requires all nurses to uphold nursing values and integrity during practice.

Explain what healthcare organizations must do to comply with legal requirements.

Organizations must create a compliance program to comply with legal requirements. They must also review and monitor their current practices and performance and ensure they are updated. Healthcare laws and regulations are ever-changing; hence, organizations must constantly review their policies and procedures to ensure their performance aligns with current legal requirements. These reviews can be monthly, quarterly, bi-annually, annually, etc.

Describe the standards for corporate compliance programs outlined in the OIG Compliance Guidance and the Federal Register.

The OIG indicates that an organization’s compliance program must have the following components at the bare minimum (Department of Regulatory Affairs and Compliance, 2018):

Develop Standards of Conduct

The organization must have written policies, procedures, and standards of conduct. These documents must explain how the organization will integrate the compliance measures into its day-to-day practice.

Establish an oversight Method

The OIG recommends designating a compliance officer or compliance committee to govern and oversee compliance issues. The organization must provide the committee or compliance officers with the necessary resources, authority, and autonomy to perform their roles. The designated person or group will be responsible for revising, monitoring implementation, and investigating violation allegations.

Conduct employee training and education.

The organization needs to improve employees’ knowledge and understanding of compliance issues. Employees must be capable of identifying and mitigating compliance issues that may arise while performing roles. The OIG recommends that the training cover claim processes and development, form signing, billing documentation, and legal consequences of fraudulent billing. Organizations should use evidence-based educational tools to train employees. The training should also be continuous and individualized according to employees’ needs.

Auditing and Monitoring

The organization should create standards to hold employees accountable for their actions. Auditing involves continuously reviewing and updating organizational procedures and policies to ensure completeness and timeliness. The organization should have an open communication line or reporting system to receive complaints or violation reports.

Enforcement Standards

The organization should outline disciplinary actions for when employees violate the policies. These include warnings, probation, reprimands, demotion, discharge, referral for civil prosecution, and restitution. The organization should ensure that it responds to offense or violation reports promptly.

Fraud, Waste, and Abuse (FWA) Compliance Plan

The organization will review existing policies, procedures, and codes of conduct against current regulatory requirements and modify them as required. Special attention will be given to the following areas:

• Billing processes (e.g., third-party billing, claims, & billing non-covered services)
• Referral processes
• Business continuity/Disaster Recovery Documentation
• Equipment and supplies certification
• Verification of services
• Improperly using medical symbols for advertising
• Clinical and administrative services.

Before January 31st each year, the organization will submit this FWA to the OHA Contract Administration Unit for review. All employees will the expected to uphold the highest professional and ethical standards in practice.

Designated Compliance Officer and Compliance Committee

The organization will identify a designated compliance officer responsible for managing and overseeing compliance issues. The compliance officer will also ensure the organization complies with all applicable state and federal laws and regulations. He is also responsible for fulfilling fiduciary tasks related to developing, monitoring, and evaluating the compliance program and contractual obligations.

Continuous Training and Education

The training goal is to ensure all employees and subcontractors can perform their roles within the stipulated laws and regulations. The Compliance Officer will be responsible for delivering training to senior management and all employees. The education will focus on fraud, abuse, waste, HIPAA, coding & billing, contracts, and quality. The Compliance Officer will also share information regarding legislative changes and disciplinary action.

Lines of Communication

The organization will use a hotline and DropBox system to receive questions, reports, and concerns related to compliance. Members will report these errors freely and without any repercussions. The organization will protect the identity of those who wish to remain anonymous.

Auditing and Monitoring

The organization will create a Work Plan for auditing and monitoring compliance. The work plan will include:

• Audit type (performed by an external versus internal auditor)
• Auditing/monitoring methodology
• Auditing/monitoring schedules
• Process of following up or modifying the results of the audit

Enforcement Standards

Regardless of their position, all employees will face disciplinary action for violating the organization’s policies and standards. Enforcement will be done through sanctions, corrective action plans, suspension, or contract termination, depending on disease severity. These disciplinary actions will be enforced consistently, fairly, and equitably.

Responding to Detected Offenses and Corrective Action

The compliance officer will be responsible for investigating reported complaints and violation allegations. The compliance officer will interview relevant parties and review relevant documents, medical records, and data to ascertain the presence of a violation. The compliance officer will convene with executive leadership to discuss the appropriate corrective action, including external reporting.

References

American Nursing Association (ANA). 2015. Interpretative Statements: Code of Ethics for Nurses. https://www.nursingworld.org/practice-policy/nursing-excellence/ethics/code-of-ethics-for-nurses/coe-view-only/

Department of Regulatory Affairs and Compliance. (2018). Compliance Program Description. Common Wealth Alliance. https://www.commonwealthcarealliance.org/ma/wp-content/uploads/2021/01/Compliance-Program-Description-2018-Update-FINAL.pdf

Human Health Services. 45 CFR 46. Human Health Services. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

U.S Department of Justice. (n.d.). The False Claims Act. U.S Department of Justice. https://www.justice.gov/civil/false-claims-act

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