definiens: means all federal and state laws, regulations and sub - regulatory rules and legally - binding guidance relating to health care providers and facilities, participation in Federal Health Care Programs, the practice ofmedicine, nursing, home health, pharmacology and dispending medicines or controlled substances, medical documentationand physician orders, medical record retention, laboratory services, unprofessional conduct, fee - splitting, referrals, billing andsubmission of false or fraudulent claims, claims processing, medical privacy and security and the hiring of employees oracquisition of services or supplies from Persons excluded from participation in Federal Health Care Programs, includingMedicare, Medicaid, CHIP, the TRICARE laws ( 10 U.S.C. § 1071, et seq . ), the False Claims Act ( 31 U.S.C. § 3729, et seq . ), theCivil Monetary Penalties Law ( 42 U.S.C. § 1320a-7a ), federal and state anti kickback statutes ( including 42 U.S.C. § 1320a7b ) federal and state referral laws ( including 42 U.S.C. § 1395nn ), criminal false claims statutes ( e.g. 18 U.S.C. § § 287 and1001 ), the Program Fraud Civil Remedies Act of 1986 ( 31 U.S.C. § 3801, et seq . ), the Beneficiary Inducement Statute ( 42U.S.C. § 1320a-7(a)(5 ) ), the Clinical Laboratory Improvement Act ( 42 U.S.C. § 263a, et seq . ), the Medicare Prescription Drug, Improvement and Modernization Act of 2003 ( P.L. 108 - 173, 117 Stat . 2066 ), the Food, Drug and Cosmetic Act of 1938 ( 21U.S.C. § 301, et seq