Page 15 - Sheppard Mullin Capabilities Overview Prepared for Regeneron

Healthcare Team — Market Access
Operating in the healthcare industry today means navigating a highly complex and constantly evolving array of federal and state laws and regulations. Sheppard Mullin has a 250+ attorney full-service, diverse national Healthcare Team that has been named “U.S. Health Law Practice of the Year” three times by Law360 (including 2021) for our innovative work in healthcare mergers and acquisitions, joint ventures, population health management and healthcare reform.
We provide counsel to healthcare clients in virtually all areas of regulatory compliance and enforcement issues. Areas in which we routinely advise clients include: government and private reimbursement issues, the anti-kickback statute and applicable safe harbors, physician self-referral laws, the overpayment report and return laws, other fraud and abuse laws, corporate practice of medicine and fee-splitting prohibitions, HIPAA privacy, antitrust, licensure, provider and vendor contracting, pharmacy and PBM contracting, accreditation, Medicare and Medicaid documentation, coding and other requirements implicating payment and reimbursement.
Federal Healthcare Programs Experience
We have a deep bench of attorneys who advise on a broad range of issues related to Medicare and Medicaid compliance — both the fee-for-service and managed care components of those programs. Our experience extends beyond Medicare and Medicaid, as we routinely advise clients on issues related to the healthcare programs administered by the Depart- ments of Defense and Veterans Affairs. Issues on which we advise clients include:
• Beneficiary eligibility and coverage rules
• Anti-Kickback Statute
• Pricing and reimbursement
• Coverage and reimbursement
• Federal Supply Schedule Program
• Patient Assistance Programs • HHS OIG Advisory Opinions • CMMI Innovation Models
• Billing and coding
• Group Purchasing Organizations
• Inflation Reduction Act
• Compliance Programs
Our experience includes conducting training for drug manufacturer patient access teams on Medicare program eligibility and coverage rules for both fee-for-service as well as Part D. This training includes an in-depth review of eligibility and coverage rules for dual eligible beneficiaries, as well as the Part D low-income subsidy.
Brussels | Century City | Chicago | Dallas | Houston | London | Los Angeles | New York | Orange County
San Diego (Downtown) | San Diego (Del Mar) | San Francisco | Seoul | Shanghai | Silicon Valley | Washington, D.C. www.sheppardmullin.com
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