- Health Care Risk Management and Regulatory Compliance
- Pharmacy Benefit Manager (PBM) Contracting
- Section 111 Insurer Reporting and MSP Reimbursement
Health Care Risk Management and Regulatory Compliance
For nearly two decades, the Wiley Rein Health Care Risk Management and Regulatory Compliance Team has been at the forefront of strategic and innovative counseling on health care risk management and regulatory compliance matters. Through their many and varied client engagements, members of the Risk Management and Compliance Team are routinely asked to sit at the table with business executives, in-house legal counsel, and company board members to provide legal and tactical guidance to inform cutting-edge business decisions and legal strategy.
The Risk Management and Compliance Team has assembled a multidisciplinary group to address the wide range of legal and operational issues that must be considered in identifying, managing, minimizing, and/or avoiding adverse legal risks, and to attain and maintain compliance with health care statutory and regulatory obligations. The Team assists clients that contract (or are seeking to contract) with federal or state agencies to provide services in connection with a government health care program, or that need guidance on statutory and regulatory requirements impacting commercial and government health care programs. Legal and strategic guidance is provided at all stages of health care program procurement, contracting, and administration processes—from identifying the statutory and regulatory obligations attendant to an initial risk assessment of contracting opportunities, to advising on the health care statutory and regulatory obligations that successful offerors must attain and maintain to be awarded and successfully administer a government health care program.
Knowledge and Experience
Providing meaningful, actionable risk management and compliance legal advice requires not only an understanding of objective legal and regulatory requirements, but also an awareness of what regulators expect and how compliance efforts will be viewed by these regulators. The members of the Wiley Rein Risk Management and Compliance Team bring a diverse range of tremendously synergistic experience to bear in providing risk management legal advice. The Team includes attorneys who have previously served as regulators, as in-house counsel for national and regional health care organizations, and as health care business executives.
The Team brings a deep, well-developed knowledge of health plans and other entities in the government health care program space; we understand their businesses and how they operate in compliance with the myriad regulations governing the industry today.
In their current role as outside legal counsel, members of the Risk Management and Compliance Team have undertaken matters including:
- Regulatory counseling and compliance engagements under Medicare, Medicaid, the Affordable Care Act, the Federal Employees Health Benefits Act (FEHBA), and TRICARE;
- Representation of contractors in agency audits and compliance reviews;
- Representation of contractors in disputes with procuring agencies and subcontractors;
- Defense of health care entities in federal and state fraud investigations and related litigation;
- Recovery of health plan monies obtained by health care providers through fraudulent activities.
The Risk Management and Compliance Team includes attorneys who have provided health care risk assessments and compliance advice and representation in related disputes and litigation in the following substantive areas:
- The Affordable Care Act
- Privacy, Security, and Cybersecurity (including HIPAA/HITECH)
- TCPA (Telephone Consumer Protection Act)
- Medicare Advantage
- Medicare Part D
- MAC (Medicare Administrative Contractors)
- MSP (Medicare Secondary Payer) reimbursement and Section 111 insurer reporting
- RAC (Recovery Audit Contractors)
- Medicare Integrity Program Contractors
- FEHBA (Federal Employees Health Benefits Act)
- Contracting and Oversight with Lower-Tier Entities
- Business Associates
- First Tier, Downstream, and Related Entities
- Health Plan – Provider Contracting
- Federal and State Health Care Fraud Laws
- Federal Health Care Anti-Kickback statute and regulations
- False Claims Act
- Civil Monetary Penalties Laws