Sidley has broad experience performing healthcare and FDA regulatory due diligence. We assist in the context of mergers and acquisitions for healthcare and life sciences companies and lenders and investors. Our experience includes public and privately-held company transactions, working on both sides of the transaction, as well as representing a wide range of investors, from lenders to investment banks, private equity and venture capital firms. Our lawyers have worked on deals involving pharmaceuticals, medical devices, biological products, in vitro diagnostic tests, diagnostic clinical laboratories, hospitals, managed care companies, healthcare professionals, electronic health records, medical software companies, and medical billing services.
Legal and regulatory risks are likely in any transaction relating to the healthcare and life sciences industry. These risks must be identified, evaluated, quantified and addressed in the transaction documents, and, in some cases, in public filings, prior to executing a transaction or making an investment. In relevant circumstances, these risks must be monitored once a transaction is consummated through the full integration of an acquired company into the new owner. This may include development and implementation of effective compliance and training programs to ensure ongoing stability and growth, revisions to existing agreements and/or restructuring of arrangements and unwinding or terminating activities that raise regulatory risk or do not reflect best business practices. Our lawyers assist clients in both evaluating risk up-front and protecting portfolio companies once acquired.
In particular, we can assist clients by:
- Providing insight, analysis and assessment of the legal and regulatory risks and opportunities involved in transactions and investment opportunities. We have experience in all aspects of healthcare and food and drug law. Our areas of substantive review include billing/reimbursement and pricing, Medicare and Medicaid conditions of participation and conditions of payment, and compliance with fraud and abuse laws, including the Anti-Kickback Statute, the Stark Law, the False Claims Act, the Civil Money Penalty Statute, the Exclusion Authority Statute, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), HIPAA, HITECH Act, the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act;
- Structuring transactions to mitigate legal and regulatory risks and enhance opportunities. This includes conducting Medicare and Medicaid change of ownership analyses to ensure proper structuring and regulatory approval of a transaction, and drafting and negotiating transaction agreements and securities and other government filings;
- Strategizing internally and with government regulators to ensure proper approvals, notifications and filings occur on time and according to applicable law; and
- Assisting with post-acquisition integration, including modifications to contracts and relationships, compliance policies and training, other compliance and regulatory integration efforts and government interactions.