Industry

Healthcare Regulatory

Combining Deep Healthcare Regulatory Experience and Operational Insight to Deliver Strategic Solutions

Sheppard’s national healthcare practice advises providers, payors, other industry participants, and investors navigating complex regulatory, compliance and enforcement risks.

Our federal healthcare program and state law expertise includes Medicare, Medicaid, licensing, corporate practice of medicine and fraud and abuse compliance.

Serving Clients Across the Care Continuum

From traditional providers and payors to digital health innovators, we tailor regulatory guidance to each client's needs.

We work with healthcare clients across the care continuum representing health plans, health systems and their affiliated providers, physician organizations, behavioral health providers, skilled nursing facilities, home health and hospice agencies, labs, pharmacies and home and community-based service providers.

We also counsel innovators, disruptors and strategic investors, including digital health and telehealth companies, care management companies and physician inventors, as they develop and leverage AI and other technologies to change the health insurance and care delivery landscape.

Areas of Focus

We structure and assess risk associated with both commonplace and bespoke financial relationships, including physician alignment, co-management, professional service, employment, directorship, lease, joint venture and value-based arrangements, to help mitigate fraud and abuse exposure under federal and state law. We also assist with the fraud and abuse risk implications of day-to-day business decisions and support internal investigations, compliance reviews and remediation planning.

We advise on licensing and accreditation issues including scope of practice, supervision and delegation, fee-splitting and corporate practice of medicine, helping clients navigate complex regulatory requirements across multiple jurisdictions.

We support clients on all aspects of provider reimbursement and billing compliance, including Medicare and Medicaid conditions of payment or participation, enrollment, change of ownership and value-based and other reimbursement methodologies.

We provide interdisciplinary regulatory support throughout the lifecycle of healthcare transactions, including regulatory due diligence, deal structuring, negotiating healthcare-specific provisions in definitive agreements, licensing, government healthcare program filings and regulatory approvals.

We support clients in connection with government investigations and enforcement actions, including pre-interventional False Claims Act investigations and both interventional and non-interventional False Claims Act litigation, agency and contractor billing and coding audits and appeals, as well as assessments of compliance program effectiveness.

We advise health plans, including Medicare Advantage, Medicare Part D and Medicaid managed care organizations, and other risk-bearing entities on state licensure, government healthcare contracting and compliance with state and federal regulatory requirements such as network and provider contracting, utilization management, claims adjudication and coverage-related compliance. Our experience includes advising on value-based care, risk models and alternative payment methodologies, including related contractual and regulatory risk.

Healthcare Regulatory

Serving Clients Across the Care Continuum From traditional providers and payors to digital health innovators, we tailor regulatory guidance to each client's needs.

Areas of Focus

Fraud and Abuse / Anti-Kickback Statute / Stark Law / Civil Monetary Penalties

Licensing and Accreditation

Billing and Reimbursement

Healthcare Transactions

Government Investigations, Audits, Enforcement and Litigation Support

Managed Care and Payor-Related Regulatory Issues

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Areas of Focus

Fraud and Abuse / Anti-Kickback Statute / Stark Law / Civil Monetary Penalties

Licensing and Accreditation

Billing and Reimbursement

Healthcare Transactions

Government Investigations, Audits, Enforcement and Litigation Support

Managed Care and Payor-Related Regulatory Issues

Serving Clients Across the Care Continuum

From traditional providers and payors to digital health innovators, we tailor regulatory guidance to each client's needs.