Core Legal and Regulatory Framework Statutes, Regulations, and Enforcement

Volume 1 of this compendium laid out the architecture a compliance program needs — governance, risk assessment, the seven elements, honest effectiveness measurement. Volume 2 completes that picture: the specific federal statutes and regulatory frameworks that architecture exists to address, and the working legal foundation every compliance officer needs to run a genuinely risk-based program.

This volume treats each statute not as an entry in a glossary but as a structural argument worth understanding on its own terms — why it exists, how courts have actually applied it, and where it intersects with the others. It opens with the core fraud and abuse triad: the False Claims Act, the Anti-Kickback Statute, and the Stark Law, developed individually and at the specific points where they collide in real enforcement. From there it builds outward into HIPAA privacy and security, EMTALA, exclusion authorities, the criminal healthcare fraud statutes, and the internal-investigation and privilege questions that follow a finding. A substantial middle section addresses the regulatory terrain most compliance references leave thin: FDA oversight of AI and digital health devices, the emerging law of healthcare AI specifically, privacy obligations that apply where HIPAA doesn't, laboratory regulation under CLIA, and the post-LDT-vacatur landscape. Later chapters take up ERISA, the No Surprises Act, nonprofit tax-exemption requirements under Section 501(r), the 340B program's ongoing rebate-model litigation, information blocking, hospital antitrust, DEA and controlled substance regulation, medical malpractice's intersection with the FCA, credentialing and peer review, state false claims acts, and the Medicare Advantage risk adjustment landscape currently unsettled by active litigation.

Written jointly for compliance officers who need real command of these statutes and for the attorneys who advise them, the volume is candid about where the law is genuinely still moving — dated caveats mark every chapter addressing an area in active flux, rather than presenting settled-sounding answers to unsettled questions. Extended case studies throughout translate the legal framework into realistic scenarios, and each chapter closes with quick reference cards and discussion questions built for board reporting and committee use.

Core Legal & Regulatory Framework is Volume 2 of a six-volume Healthcare Compliance & Quality Compendium, building directly on the architecture Volume 1 established.