Fraud & Abuse Compliance

Healthcare providers face a myriad of complex regulations governing fraud and abuse. Our attorneys possess extensive knowledge of the regulatory landscape and have represented clients in matters involving the False Claims Act, Anti-Kickback Statute, Stark Law, and other state and federal laws related to healthcare fraud and abuse.

Our expertise covers a wide range of healthcare-related legal matters, including healthcare fraud and abuse. We have successfully guided numerous healthcare providers through internal investigations and self-disclosure processes under the Stark Self-Referral Disclosure Protocol and the OIG Self-Disclosure Protocol.

Fraud & Abuse Compliance

Healthcare providers face a myriad of complex regulations governing fraud and abuse. Our attorneys possess extensive knowledge of the regulatory landscape and have represented clients in matters involving the False Claims Act, Anti-Kickback Statute, Stark Law, and other state and federal laws related to healthcare fraud and abuse.

Our expertise covers a wide range of healthcare-related legal matters, including healthcare fraud and abuse. We have successfully guided numerous healthcare providers through internal investigations and self-disclosure processes under the Stark Self-Referral Disclosure Protocol and the OIG Self-Disclosure Protocol.

Stark Law

The Federal Physician Self-Referral Statute, also known as the “Stark Law,” is a U.S. law that prohibits doctors from referring patients to receive “designated health services” (DHS) from entities in which the doctor (or an immediate family member) has a financial interest, unless an exception applies. One of the exceptions to the Stark Law is the Personal Services Exception, which allows a doctor to refer a patient to an entity in which the doctor (or an immediate family member) has a financial interest, as long as the referral is for “personal services” rendered by the doctor.

Under the Personal Services Exception, the following conditions must be met:

  • The doctor must provide the personal services him or herself, and must not delegate the provision of the services to another person.
  • The doctor must receive compensation for the personal services that is consistent with the fair market value of the services.
  • The financial arrangement between the doctor and the entity must be in writing, and must specify the services to be provided and the term of the arrangement.
  • The financial arrangement must be signed by the doctor and the entity, and must be signed before the furnishing of the DHS.

The Personal Services Exception is intended to allow doctors to refer patients for DHS that are directly related to the personal services that the doctor provides. The exception is not intended to allow doctors to refer patients for DHS that are not directly related to the personal services that the doctor provides.

Anti-Kickback Statute

The Federal Anti-Kickback Statute is a U.S. law that makes it a crime to exchange anything of value in an effort to influence the referral of business covered by federal healthcare programs. The law applies to a wide range of activities, including the referral of patients, the sale of goods or services, and the payment of compensation. The purpose of the law is to protect federal healthcare programs and the beneficiaries of those programs from fraud and abuse.

Under the Federal Anti-Kickback Statute, it is illegal to offer, pay, solicit, or receive anything of value in exchange for the referral of federal healthcare program business. This includes the referral of patients, the sale of goods or services, and the payment of compensation. The law applies to a wide range of individuals and entities, including healthcare providers, pharmaceutical companies, and medical device manufacturers.

Violations of the Federal Anti-Kickback Statute can result in criminal penalties, including fines and imprisonment. In addition, individuals and entities that violate the law can be excluded from participation in federal healthcare programs, such as Medicare and Medicaid. The law is enforced by the Department of Justice, and cases are often brought in conjunction with other federal healthcare fraud statutes.

Civil Monetary Penalties

Civil monetary penalties (CMPs) are a critical component of the federal government’s enforcement tools against healthcare fraud and abuse, including violations of the Federal Anti-Kickback Statute (AKS), other healthcare fraud and abuse statutes, and regulations concerning inducements to beneficiaries. These penalties are imposed to deter illegal conduct affecting Medicare, Medicaid, and other federal healthcare programs. This summary outlines the framework and specific details regarding CMPs related to these areas.

Compliance Plans

Our Services: At the Health Law Center, we offer a comprehensive array of regulatory compliance services designed to meet the specific needs of healthcare organizations, including:

  • Regulatory Compliance Program Development & Implementation: Our team will work closely with your organization to develop and implement a robust, proactive and practical compliance program that addresses applicable healthcare regulations, such as HIPAA, Stark Law, Anti-Kickback Statute, the False Claims Act, Civil Monetary Penalties and state-specific regulations. We have an extensive amount of experience helping providers create customized policies, procedures, and controls to mitigate the risk of noncompliance, support the provider’s goals, and avoid simple mistakes triggering a government investigation.

  • Compliance Risk Assessment & Management: We conduct thorough compliance risk assessments to identify and prioritize potential vulnerabilities and areas of exposure within your organization. Our team then collaborates with you to develop and implement risk mitigation strategies, ensuring that your organization remains compliant and resilient in the face of changing regulations.

  • Compliance Training & Education: Our firm will work with you to develop tailored training programs to educate your employees, medical staff, and other stakeholders on the intricacies of healthcare regulations and the importance of compliance. Our interactive sessions promote a strong culture of compliance, empowering your team to make informed and ethical decisions in their daily operations.

  • Compliance Audits & Monitoring: We will assist you with developing and/or conducting ongoing compliance audits and monitoring services to help the provider maintain an effective and meaningful compliance program. We can work you’re your compliance team to evaluate your organization’s adherence to its policies, procedures, and controls, providing feedback and recommending any necessary adjustments.

  • Regulatory & Enforcement Support: The focus of most of our work described above is to help providers avoid and prepare for claims audits, investigations, and regulatory enforcement actions. However, health care is the most regulated sector of American life and if a provider finds itself under scrutiny through claims audits or an enforcement investigation, our seasoned legal team is well-versed in handling complex regulatory and enforcement matters and will be able to provide critical assistance, guidance and perspective on day 1. Engaging the Health Law Center will put your organization in the best possible position and provide your organization with peace of mind.

Code of Conduct Policy Development

We believe that a strong code of conduct is the cornerstone of any successful compliance program. Our experts will collaborate with your organization to draft a clear and comprehensive code of conduct that reflects your corporate values and guides employee behavior.

Stark Self-Referral Disclosure Protocol

The CMS Self-Referral Self-Disclosure Protocol (SR SDP) is a program that allows healthcare providers and suppliers to voluntarily disclose potential violations of the Federal Physician Self-Referral Law (also known as the Stark Law). The Stark Law prohibits physicians from making referrals for certain designated health services (DHS) to an entity with which the physician (or an immediate family member) has a financial relationship, unless an exception applies.

The benefits of using the SR SDP include:

  • Reduced penalties: Providers and suppliers who disclose potential Stark Law violations through the SR SDP may be eligible for reduced penalties.
  • Avoidance of exclusion: Providers and suppliers who disclose potential Stark Law violations through the SR SDP may be able to avoid exclusion from the Medicare and Medicaid programs.
  • Improved compliance: By disclosing potential Stark Law violations and taking corrective action, providers and suppliers can improve their compliance with the Stark Law and reduce the risk of future violations.

Overall, the CMS SR SDP provides a valuable resource for healthcare providers and suppliers to address potential Stark Law violations in a timely and effective manner.

OIG Self-Disclosure Protocol

The Office of Inspector General (OIG) Self-Disclosure Protocol allows healthcare providers to voluntarily disclose potential violations of federal fraud and abuse laws, often resulting in reduced penalties. Our team has extensive experience in:

  • Identifying potential violations requiring disclosure;
  • Assessing the benefits and risks of self-disclosure;
  • Preparing and submitting the self-disclosure to the OIG;
  • Calculating damages and negotiating settlement terms; and
  • Implementing corrective actions and compliance measures.