Healthcare Regulatory Laws means Laws relating to healthcare regulatory matters, including, but not limited to: (i) 42 U.S.C. §§ 1320a-7, 7a, and 7b, which are commonly referred to as the “Federal Fraud Statutes;” (ii) Title XVIII of the Social Security Act (42 U.S.C. § 1395 et seq.), the “Medicare Laws;” (iii) 42 U.S.C. § 263a, which is commonly referred to as the “Clinical Laboratory Improvement Amendments of 1988” or “CLIA;” (iv) 42 U.S.C. § 1395nn, which is commonly referred to as the “Xxxxx Statute;” (v) 31 U.S.C. §§ 3729-3733, which is commonly referred to as the “Federal False Claims Act;” (vi) 42 U.S.C. §§ 1320d through 1320d-8 and 42 C.F.R. §§ 160, 162 and 164, which are commonly referred to as the “Health Insurance Portability and Accountability Act of 1996” or “HIPAA;” (vii) any federal, state or local applicable Law that regulates either the approval, clinical development, manufacturing, promotion or distribution of products; (viii) any state law regulating the interactions with health care professionals and reporting thereof; or (ix) any federal, state or local statute or regulation relevant to false statements or claims including knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit, payment or registration.
Healthcare Regulatory Laws has the meaning set forth in Section 3.20(a).
Healthcare Regulatory Laws means Laws relating to healthcare regulatory matters, including, but not limited to: (a) 42 U.S.C. §§ 1320a-7, 7a, and 7b, which are commonly referred to as the “Federal Fraud Statutes;” (b) Titles XVIII and XIX of the Social Security Act (42 U.S.C. §§ 1395 et seq. and 1396 et seq.), respectively, the “Medicare Laws” and the “Medicaid Laws;” (c) 42 U.S.C. § 263a, which is commonly referred to as the “Clinical Laboratory Improvement Amendments of 1988” or “CLIA;” (d) 42 U.S.C. § 1395nn, which is commonly referred to as the “Sxxxx Statute;” (e) 31 U.S.C. §§ 3729-3733, which is commonly referred to as the “Federal False Claims Act;” (f) 42 U.S.C. §§ 1320d through 1320d-8 and 42 C.F.R. §§ 160, 162 and 164, which are commonly referred to as the “Health Insurance Portability and Accountability Act of 1996” or “HIPAA;” (g) 21 U.S.C. § 301-399i, which is commonly referred to as the “Federal Food, Drug, and Cosmetic Act;” (h) any federal, state or local applicable Law that regulates the approval, clearance, clinical development, manufacturing, promotion or distribution of products; (i) any state law regulating the interactions with health care professionals and reporting thereof; (j) Section 340B of the Public Health Service Act (42 U.S.C. § 256B); (k) Section 603 of the Veterans Health Care Act (38 U.S.C. § 8126); (l) any federal, state or local statute or regulation requiring pharmaceutical or medical device manufacturers to report information to Governmental Entities relating to Product price changes; or (m) any federal, state or local statute or regulation relevant to false statements or claims including knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit, payment or registration.
Examples of Healthcare Regulatory Laws in a sentence
The Company and its Subsidiaries are in compliance in all material respects with all applicable Laws, including Healthcare Regulatory Laws, and none of the Company or its Subsidiaries has received any written or, to the Knowledge of the Company, oral, notice, audit, investigation or review alleging any such non-compliance that are currently pending.
The Company and its Subsidiaries are, and have been since August 18, 2015, in compliance with all applicable Laws, including Healthcare Regulatory Laws, except where the failure of such compliance would not be adverse to the Company or any of its Subsidiaries in any material respect, and none of the Company or its Subsidiaries has received any written or, to the Knowledge of the Company, oral, notice, audit, investigation or review alleging any such non-compliance that are currently pending.
As part of its corporate compliance program, the Company and its Subsidiaries have implemented administrative processes, policies and procedures that are designed to ensure that the Company and its Subsidiaries remain in compliance with Healthcare Regulatory Laws applicable to the MA Plans which the Company and its Subsidiaries offer.
More Definitions of Healthcare Regulatory Laws
Healthcare Regulatory Laws means Laws relating to healthcare regulatory matters, including, but not limited to: (i) 42 U.S.C. §§ 1320a-7, 7a, and 7b, which are commonly referred to as the “Federal Fraud Statutes;” (ii) Title XVIII of the Social Security Act (42 U.S.C. § 1395 et seq.), the “Medicare Laws;”(iii) 42 U.S.C. § 263a, which is commonly referred to as the “Clinical Laboratory Improvement Amendments of 1988” or “CLIA;” (iv) 42 U.S.C. § 1395nn, which is commonly referred to as the “Stark Statute;” (v) 31 U.S.C. §§ 3729-3733, which is commonly referred to as the “Federal False Claims Act;” (vi) 42U.S.C. §§ 1320d through 1320d-8 and 42 C.F.R. §§ 160, 162 and 164, which are commonly referred to as the “Health Insurance Portability and Accountability Act of 1996” or “HIPAA;” (vii) any federal, state or local applicable Law that regulates either the approval, clinical development, manufacturing, promotion or distribution of products; (viii) any state law regulating the interactions with health care professionals and reporting thereof; or (ix) any federal, state or local statute or regulation relevant to false statements or claims including knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit, payment or registration.
Healthcare Regulatory Laws as defined in Section 4.24(g). “Highest Lawful Rate” as defined in Section 11.19.
Healthcare Regulatory Laws means Laws relating to healthcare regulatory matters, including, but not limited to: (a) 42
Healthcare Regulatory Laws means the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§301 et seq.), as well as the False Claims Act (31 U.S.C. §§ 3729 et seq.); the following provisions of the Social Security Act: 42 U.S.C. § 1320a-7b(a) (criminal false statements), 42 U.S.C. § 1320a-7b(b) (anti-kickback statute), 42 U.S.C. § 1320a-7 (the exclusion law); 42 U.S.C. § 1320a-7a (the civil monetary penalties statute); 42 U.S.C. § 1395nn (the Xxxxx Law); and 42 U.S.C. § 1320a-7h (physician payments sunshine act); 18 U.S.C. §§ 286 and 287 (criminal health care fraud statutes); the Clinical Laboratory Improvement Amendments of 1988; state clinical laboratory licensing laws; the Eliminating Kickbacks in Recovery Act of 2018 (18 U.S.C. §220); the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Patient Protection and Affordable Care Act of 2010 (Pub. Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. Law 111-152), Title XVIII of the Social Security Act (Medicare), and Title XIX of the Social Security Act (Medicaid), in each case as amended, and the regulations promulgated thereunder and any other applicable federal, state, or local health care laws applicable to the practice or delivery of clinical laboratory, health care or related services or products, or billing or reimbursement therefor. The Company is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement with or imposed by any governmental authority or body. The Company has not received any notification, correspondence or any other written or oral communication, including, without limitation, warning letter, or other correspondence from the FDA or any similar regulatory authority, or any notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, from any court, arbitrator, governmental or regulatory authority or third party, of material non-compliance by, or material liability of, the Company under any applicable Healthcare Regulatory Laws;
Healthcare Regulatory Laws means Laws relating to healthcare regulatory matters applicable to Eton, which may include: (a) 42
Healthcare Regulatory Laws means all state and federal laws and regulations relating to the provision or administration of, or pricing or payment for the distribution, dispensing and possession of drugs and the provision of other healthcare products or services, including, without limitation: (i) all state and federal healthcare fraud and abuse laws and regulations, including, without limitation: (A) the Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x, 42 C.F.R. § 1001.952, (B) the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, (C) the federal physician self-referral prohibition, 42 U.S.C. § 1395nn, 42 C.F.R. § 411.351 et seq., and (D) the False Claims Act, 31 U.S.C. § 3729 et seq. (E) the federal false coding statute, 42 U.S.C. § 1320a-7a; (ii) the Food and Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.; (iii) the Controlled Substances Act, 21 U.S.C. § 801 et seq., 21 C.F.R. § 1300 et seq.; (iv) federal or state laws relating to billing or claims for reimbursement submitted to any third party payor; (iv) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, the regulations promulgated pursuant thereto and comparable state privacy and security laws and regulations; (v) federal or state laws or regulations relating to the provision of pharmacy benefit management and administration; (vi) Federal Healthcare Program; and (vii) state pharmacy laws or regulations including the operation of pharmacies, the repackaging of drug products, the distribution of prescription drugs or controlled substances, the dispensing of prescription drugs or controlled substances and the labeling, packaging, advertising or adulteration of prescription drugs or controlled substances.
Healthcare Regulatory Laws means Laws relating to healthcare regulatory matters, including, but not limited to: (a) 42 U.S.C. §§ 1320a-7, 7a, and 7b, which are commonly referred to as the “Federal Fraud Statutes;” (b) Title XVIII of the Social Security Act (42 U.S.C. § 1395 et seq.), the “Medicare Laws;” (c) 42 U.S.C. § 1395nn, which is commonly referred to as the “Xxxxx Statute;” (d) 31 U.S.C. §§ 3729-3733, which is commonly referred to as the “Federal False Claims Act;” (e) 42 U.S.C. §§ 1320d through 1320d-8 and 42 C.F.R. §§ 160, 162 and 164, which are commonly referred to as the “Health Insurance Portability and Accountability Act of 1996” or “HIPAA;” (f) any federal, state or local applicable Law that regulates either the approval, clinical development, manufacturing, promotion or distribution of products; (g) any state law regulating the interactions with health care professionals and reporting thereof; or (h) any federal, state or local statute or regulation relevant to false statements or claims including knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit, payment or registration.