Polsinelli’s Health Care attorneys use their knowledge and experience to enable health care providers to identify, avoid, and (when necessary) resolve difficult regulatory compliance issues. Our top priority is to assist clients in structuring their relationships and business practices to promote compliance with federal and state health care laws. We regularly advise our clients on structuring transactions, day-to-day operational issues, and responding to government inquiries so they can achieve their business goals and minimize compliance risk.

We also recognize that potential noncompliance – actual or alleged – is ever-present in a highly regulated industry such as health care. We provide practical and effective strategies to clients who have identified compliance problems and who seek to avoid them. Our solutions are informed by our deep understanding of the health care industry and our knowledge of the complex rules of engagement in the U.S. health care system.

Our insights and experience combine to identify how government agencies may “think” about compliance issues, and what actually “works” to reduce risk and resolve issues. Compliance programs must scale to compliance risk. We advise clients to approach compliance in a nimble and efficient manner to appropriately reflect the goals of providers, suppliers, manufacturers and adjacent service providers balanced with the interest of regulators and law enforcement.

Our compliance work includes:

Compliance Program Development & Counseling

• Development and refinement of compliance program structures, policies, work plans and any operational aspect of a compliance program
• Practical guidance, counseling and assistance to compliance professionals and lawyers on a myriad of regulatory matters including reimbursement, licensure and enrollment compliance
• Risk assessments and development of risk mitigation strategies
• Legal and practical advice on negotiation and successful implementation of and exit from Corporate Integrity Agreements with HHS-OIG and state agencies
• Integration of “specialty” compliance requirements including the Physician Payment Sunshine Act, Eliminating Kickbacks in Recovery Act, Foreign Corrupt Practices Act and state health care law compliance requirements
• Creating specialized compliance plans for industry subcategories including hospitals, physician practices, DME suppliers, manufacturers, ancillary service providers including diagnostic testing, and behavioral health

Problem Avoidance & Problem Solving

• Internal reviews into employee and potential whistleblower claims and allegations of noncompliance, including strategies for bringing finality to instances of noncompliance and resolving potential liability
• Advice and counseling regarding potential overpayments, including practical methods for mitigating repaying obligations and minimizing the risk of unwarranted governmental scrutiny
• Providing advice about complex coding, billing and reimbursement issues
• Troubleshooting Medicare and Medicaid enrollment issues
• Obtaining formal Advisory Opinions from OIG and CMS
• Obtaining informal guidance from officials with OIG, CMS and state agencies on regulatory issues to reduce a risk or achieve a compliance outcome
• Providing advice to clients about medical necessity and quality of care issues, including guiding internal and external reviews
• Proactive evaluation of issues related to employment of individuals who are excluded from participation in federal health care programs and reactive remediation of excluded persons issues, including self-disclosure to OIG

Structuring of Arrangements & Transactions

• Development of joint venture and other alignment structures that address business realities and legal requirements
• Creation of structures that promote compliance with professional licensure requirements such as fee-splitting and corporate practice prohibitions
• Counseling clients on operational and contract issues that are impacted by state and federal fraud and abuse laws including discounts, referral standards, compensation practices
• Ensuring that complex health care transactions comply with applicable state and federal law including federal Anti-Kickback Statute, the Stark law, state self-referral and anti-kickback laws, licensure laws, and reimbursement requirements
• Regulatory due diligence within complex health care transactions

Advocacy & Defense of Allegations of Noncompliance

• Responding to and resolving investigations and audits initiated by the OIG, DOJ, and state attorney general’s offices
• Identification and resolution of overpayment including submission of refunds to Medicare Contractors and Medicaid Agencies to resolve coding, billing, documentation and other potential compliance issues
• Preparation and submission of self-disclosures OIG or other law enforcement agencies to achieve resolution of material compliance issues
• Responding to state and federal surveys and inspections, including developing plans of correction
• Responding to inquiries from state licensure boards