The Cole Schotz Healthcare Group, led by Paul W. Kim, Esq., a former employee of the Centers for Medicare and Medicaid Services, represents a variety of individuals and corporations in the healthcare industry including:
• Air and Ground Ambulances
• Ambulatory Surgical Centers
• Billing Agents
• Clinical Community Mental Health Centers
• Comprehensive Outpatient Rehabilitation Facilities and Rehabilitation Agencies
• Durable Medical Equipment Suppliers
• End Stage Renal Disease Dialysis Facilities
• Federally Qualified Health Centers and Rural Health Clinics
• Health Information Technology Firms
• Health Maintenance Organizations and Managed Care Organizations
• Home Health Agencies
• Hospitals and Academic Medical Centers
• Independent Diagnostic Testing Facilities
• Inpatient Rehabilitation Facilities
• Institutional Review Boards and Clinical Research Organizations
• Physicians and Non-Physician Practitioners
• Pharmaceutical and Medical Device Manufacturers
• Pharmacies and Medical Supply Companies
• Professional Trade Associations
• Skilled Nursing Facilities and Continuing Care Retirement Communities
• Telehealth Providers
We offer a wide range of legal services including counsel on corporate formation and governance, mergers and acquisitions, real estate and commercial finance transactions, intellectual property rights, labor and employment, and bankruptcy and restructuring.
With respect to Medicare reimbursement issues, we assist with conditions of participation and enrollment matters (e.g., initial enrollment or change of ownership; prepare corrective action plans; appeal initial denials, suspensions, or revocations) as well as conditions of payment matters (e.g., billing and coding compliance for providers/suppliers; new HCPCS coding applications for manufacturers), including contesting national and local coverage determinations. We provide representations in appealing overpayments assessed by the Office of Inspector General or CMS auditors (e.g., Medicare Administrative Contractors, Recovery Audit Contractors, Program SafeGuard Contractors, Zone Program Integrity Contractors).
Ranging from the "incident to" policy to non-physician practitioners to the Part B teaching physician policy, our attorneys have an intimate knowledge and understanding of the Medicare rules given that Paul W. Kim drafted those regulations and manual provisions. We also advise providers/suppliers on new CMS initiatives, such as the Meaningful Use Program, and represent clients in appeals. We counsel covered providers and manufacturers on Open Payments (Sunshine) Act compliance. With respect to non-Medicare payers, we help providers with credentialing, contracting, medical policies, audits, and appeals. In addition, we assist health maintenance organizations and managed care organizations comply with CMS and OIG requirements.
For both providers/suppliers and manufacturers, we help navigate through the fraud and abuse maze of the Anti-Kickback Statute, Stark Law, and False Claims Act, e.g., prepare or update corporate compliance plans and policies; conduct privileged audits; analyze, advise, and apply safe harbors and exceptions; prepare disclosures to CMS and OIG. When faced with government investigations and qui tam lawsuits, we negotiate settlements with OIG, Department of Justice and whistleblowers. And when necessary, we provide white collar defense and investigations counsel.
With respect to privacy and security matters, we provide Health Insurance Portability and Accountability Act compliance advice for both Covered Entities and Business Associates. We prepare, update, or audit HIPAA compliance programs, policies, and forms. Furthermore, we represent clients when they are audited by the Office for Civil Rights. With respect to clinical research matters, we represent both sponsors and investigators to not only ensure compliance with the mandates issued by the Office for Human Research Protections or National Institutes of Health but also respond to their audits.
In addition to Federal health law issues, we provide counsel on certain State health law issues (e.g., state-by-state survey, Medicaid maters) and engage local counsel as needed.