Page 16 - Sheppard Mullin Capabilities Overview Prepared for Regeneron

Population Health Management and Value-Based/Global Risk Arrangements
We are leaders in advising clients on the transition to value-based and risk-based reimbursement, including global risk. We assist clients in establishing technical and management provider support organizations, as well as in integrating pro- vider operations and establishing clinically integrated networks, ACOs, Medicare-bundled payment initiatives and other novel value-based and risk-sharing reimbursement models. We work with our payer clients as they expand their missions to leverage their provider operations to market as multi-payer platforms, and also develop value and outcomes-based reimbursement models in the pharmaceuticals and medical device arenas. Our experience includes advising numerous healthcare industry clients on harnessing recent anti-kickback and Stark Law regulatory flexibilities in order to facilitate, structure, restructure and implement various forms of innovative, value-based arrangements.
Pricing and Reimbursement
Long-standing concerns about the prices Medicare pays for drugs have recently become a focus of the Biden Adminis- tration and CMS. We closely track and advise our clients on the evolution and implementation of the new laws and reg- ulations that impact drug pricing, price transparency and relationships between payors, PBMs and drug manufacturers. We also track and advise on litigation developments relevant to drug pricing including in the area of the 340B program.
Government Investigations and Internal Investigations
For most healthcare entities, the federal and state civil and criminal laws governing fraud and abuse pose the single most significant area of legal risk, and government investigations of conduct implicating those laws can pose the single most significant area of legal costs. Fraud and abuse risk and investigations can be uniquely challenging for companies that include both health plans and healthcare providers, as they largely operate under different fraud and abuse laws. Our attorneys have a wealth of expertise and practical experience counseling clients throughout the healthcare industry with respect to not just their potential exposure to such laws, but also with respect to the complete navigation of both government investigations – from receipt of a subpoena or civil investigative demand through resolution – and internal investigations – from identifying and maintaining scope, though preservation of privilege and confidentiality, to formu- lating proper findings, reporting and recommendations.
The differences between a simple administrative or billing error, a civil False Claims Act prosecution and a criminal indict- ment can often depend upon counsel’s advocacy. Our attorneys have handled hundreds of False Claims Act and other government investigations, including matters pertaining to alleged kickbacks, upcoded services, services not rendered, improper documentation (including forgery), HCC-RAF scoring, bundling and unbundling, lack of medical necessity, re- search grant fraud, improper financial interests (Stark), inflation of cost reports, red-lining and Medicare Part D fraud. Our team of experienced attorneys includes former federal and state prosecutors, former government attorneys and substantive practice area specialist practitioners in the healthcare field.
Healthcare Team - Market Access
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