definiens: means all applicable foreign, federal, state, and local Requirements of Laws relating to the regulation, provision or administra tion of, or billing or payment for, healthcare prod ucts or services, whether criminal or civil, including : ( i ) the Medicare Statute ( Title XVIII of the Social Se curity Act ) ; ( ii ) the Medicaid Statute ( Title XIX of the Social Security Act ) ; ( iii ) TRICARE ( 10 U.S.C. Section 107 1 et seq . ) ; ( iv ) Veterans Health Administration Program ( 38 U.S .C. Chapter 17 ) ; ( v ) the federal Anti - Kickback Stat ute ( 42 U.S.C. § 1320a-7b(b ) ), the federal Stark Law ( 42 U.S .C. § 1395nn ), the federal Physician Payment Sunshi ne Act ( 42 U.S.C. § 1320a-7h ), the Federal Civil Monetary Penalties Law ( 42 U.S.C. § 1320a-7a ), the federal R eporting and Returning of Overpayments Law ( 42 U.S.C. § 1320 a-7k(d ) ), the federal Exclusion Laws ( 42 U.S.C. § 1320a-7 ), ), the Federal Program Fraud Civil Remedi es Act ( 31 U.S.C. § 3801 et seq . ), the federal crim inal False Claims Statutes ( 18 U.S.C. § § 286, 287 and 1001 ), t he federal Health Care Fraud Law ( 18 U.S.C. § 1347 ), and the federal Civil False Claims Act ( 31 U.S.C. § § 37 29 et seq . ) and all criminal laws relating to healt h care fraud and abuse ( e.g., 18 U.S.C. § § 286, 287, 664, 666, 6 69, 1001, 1035, 1341, 1343, 1347 ) ; ( vi ) the applica ble provisions of HIPAA ; ( vii ) the Public Health Servic e Act ( 42 U.S.C. § 201 et seq . ), including 42 U.S.C . § § 290dd-3, 290ee-3, 42 C.F.R. Part 2 ; ( viii ) the Fede ral Food, Drug and Cosmetics Act ; ( ix ) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 201 0 ; ( x ) all licensure and insurance Requirements of Laws re lating to the regulation, provision or administrati on of, or payment for, healthcare products or services ; and ( xi ) all Requirements of Law, Canadian federal and p rovincial government healthcare programs ( including as regula ted under the Canada Health Act and the provinces h ealth insurance acts and all laws, rules, regulations and policies governing the billing of such programs by healthcare professions ), and Federal Health Care Program polic ies and program guidance relating to billing and reimbursement of healthcare products or services ; a nd all comparable applicable foreign, federal, stat e, provincial and local Requirements of Laws for any o f the foregoing and the applicable rules and regula tions promulgated pursuant to all such Requirements of La ws