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The New York State Office of Medicaid Inspector General ("OMIG") has long required Medicaid providers to implement compliance programs as a condition of enrollment with Medicaid. However, now under Federal law, practitioners, regardless of the size of their practice, will have to develop a comprehensive compliance program. Under Section 6401 of the Patient Protection and Affordable Care Act ("PPACA" or "Obamacare"), all healthcare providers enrolled in a federal healthcare program, must implement an effective compliance program. The Department of Health and Human Services (HHS) and its Office of Inspector General (OIG) have consistently cited the following components in guidance materials as the basic elements for inclusion in compliance programs for health care providers:

Implement Written Policies, Procedures, and Standards of Conduct: Practices must maintain documentation that clearly and specifically outlines the policies and procedures for ensuring such compliance. This often includes a comprehensive "Compliance Plan" and separate written policies and procedures. The Compliance Plan should describe compliance expectations as embodied in a code of conduct or code of ethics, implement the operation of the compliance program, provide guidance to employees and others on dealing with potential compliance issues, and identify how to communicate compliance issues to appropriate compliance personnel. A basic outline of an effective compliance program will consist of:

a. Compliance Officer/Committee Designation and High Level Oversight

b. Effective Training and Education

c. Effective Lines of Communication & Whistleblower Protections

d. Effective System for Monitoring, Auditing and I dentification of Compliance Risks

e. Procedures and System for Prompt Response to Compliance Issues

f. Well-Publicized Disciplinary Standards

With enforcement initiatives against healthcare providers ever-increasing, physician and practices which have not implemented comprehensive compliance plans, specifically meeting necessary criteria, risk exclusion from government healthcare programs. Additionally, effective compliance programs enable providers to avoid or mitigate the significant penalties associated with violations of existing health care regulations. ***For example, a physician who unknowingly violates the PPACA, such as the recent Stark Law amendment requiring physicians to inform patients in writing that they have ownership or compensation relationships with providers of in-office ancillary services, could be subject to penalties of up to $15,000 for each service in violation of the Stark Law. Moreover, violations of the Anti-Kickback Statute now implicate the False Claims Act. Thus a simple gift from a physician to a referrer can subject the physician to monetary penalties of up to $25,000 and/or imprisonment of up to 5 years, as well as a penalty of $11,000 per false claim submitted, plus three times the amount of damages sustained by the federal government.

Physicians and medical practices are strongly urged to obtain proper legal guidance in this time of high regulatory turbulence in the healthcare arena and ever-increasing complexity of the administrative aspects of the practice of medicine. For answers to all of your compliance related questions, as well as with audit resolution assistance, regulatory counsel, liability avoidance guidance or when in need of an expert professional licensure defense attorney please feel free to contact the healthcare group of our firm at or by phone at 212.668.0200. For more information on our practice areas and the backgrounds of our experienced attorneys please visit our website www.mdrxlaw.comwhere healthcare practitioners find answers to their legal questions.

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Saturday, September 23, 2023