Health Care Regulatory Compliance

Health care is among the most heavily regulated industries. Today, the prevalent practice of many administrative agencies –  especially the Department of Health and Human Services (DHHS), the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) – is to regulate through rule-making and relying on regulatory guidance rather than express statutory provisions.

This approach requires an extensive experience and knowledge in regulatory interpretation and federal administrative law in order to discern the conduct, actions, and procedures that must be undertaken for regulatory compliance.  At Stilling & Harrison, we are devoted to staying current with the constantly changing interpretations of health care regulations and administrative guidance so that we can provide relevant and timely advice to health care provider clients concerning their operations, including the actions that should be taken to comply with the regulatory framework

Navigating the Maze of Health Care Regulations

Providers face a maze of regulations governing licensing, accreditation, clinical operations, business operations and financial activities.  The following list is just a sample of the regulations and regulatory schemes providers more commonly have questions about.

Fraud and Abuse Regulations

• Ethics in Patient Referrals Act (the “Stark” law)
• Anti-Kickback Statute (AKS)
• Civil Money Penalties Law (CMP)
• CMS Exclusion Authorities
• False Claims Act (FCA)
• Medicaid Fraud Control Units (MFCU)

Information Privacy and Security Regulations

• Health Insurance Portability and Accountability Act (HIPAA)
• Health Information Technology for Economic and Clinical Health Act (HITECH)
• Privacy Act of 1974
• The Federal Common Rule

Hospital Operations

• Emergency Medical Treatment and Labor Act (EMTALA)
• Americans With Disabilities Act (ADA)
• Clinical Laboratory Improvements Act (CLIA)
• Health Care Quality Improvement Act (HCQIA)
• National Practitioner Data Bank (NPDB)
• Occupational Safety and Health Act (OSHA)
• Title VII of the Civil Rights Act
• Medicare Conditions of Participation (CoPs)

Professional Practice Regulations

• Drug Enforcement Administration – Controlled Substances Act
• Division of Occupational and Professional Licensing (DOPL) – Professional Practice Acts
• Billing and Coding Compliance
• Health Information Privacy and Security

We would invite you to call us to learn more about how we can help you.