Healthcare Compliance: The Complete Operator's Guide

Healthcare compliance in the United States operates under more federal and state regulatory layers than any other industry. Federal laws include HIPAA (45 CFR Parts 160, 162, 164), the Conditions of Participation under 42 CFR for Medicare and Medicaid providers, the Anti-Kickback Statute (42 USC 1320a-7b), the Physician Self-Referral Law (Stark Law, 42 USC 1395nn), the Emergency Medical Treatment and Labor Act (EMTALA, 42 USC 1395dd), the Medicare and Medicaid Patient Protection Act, and the Drug Enforcement Administration's controlled substance rules under 21 CFR Part 1304. State regulation adds licensing for facilities and practitioners, scope-of-practice rules, telehealth licensure, and state-specific privacy frameworks. Accreditation programs (Joint Commission, DNV, HFAP, AAAHC, ACHC) overlay additional standards for facilities seeking deemed status under Medicare. This guide covers the operational compliance framework spanning all these layers.

Healthcare Compliance Frameworks

• HIPAA (45 CFR 160-164) — Privacy, Security, Breach Notification — up to $2,067,813/year per provision
• CMS Conditions of Participation (42 CFR 482, 483, 484, 418) — Hospitals, SNFs, HHAs, hospices
• Anti-Kickback Statute (42 USC 1320a-7b) — $135,000+ per violation, criminal exposure
• Stark Law (42 USC 1395nn) — Strict liability physician self-referral
• EMTALA (42 USC 1395dd) — $135K-$270K per violation for hospitals with EDs
• DEA Controlled Substances (21 CFR 1304) — $25,000+ per violation
• False Claims Act (31 USC 3729-3733) — Treble damages plus per-claim penalties
• Joint Commission Standards — Private accreditation, deemed status pathway

Healthcare Compliance Topics

• Joint Commission Tracer Methodology: Patient Tracers, System Tracers, and How to Survive an Unannounced Survey
• CMS Conditions of Participation: Hospital, SNF, Home Health, Hospice, and ASC Requirements Under 42 CFR
• F-Tag Deficiency Response Playbook: Reading the CMS-2567, Plan of Correction Strategy, and Avoiding Compounding Citations
• HIPAA Security Risk Analysis Requirements: 45 CFR 164.308(a)(1)(ii)(A) and How to Pass an OCR Audit
• HIPAA Breach Notification: 60-Day Individual Notification Rule, OCR Reporting, and Media Notification Thresholds
• Provider Credentialing Complete Guide: Initial Credentialing, Re-Credentialing, NPDB Queries, and Joint Commission Standards
• Stark Law and Anti-Kickback Statute Compliance: Physician Self-Referral, Safe Harbors, and OIG Advisory Opinions
• Telehealth State Licensure: Multi-State Practice, Interstate Compacts, and Telehealth Prescribing Rules

FileFlo Healthcare Resources

• Home Health Agency Directory — 12,000+ HHAs with quality data
• Skilled Nursing Facility Directory — 14,500+ SNFs with 5-star ratings
• Hospice Directory — 6,900+ hospices with HCI scores
• Free CMS Survey-Readiness Score — 3-minute audit covering 42 CFR Parts 484, 418, 483