HB3265 - Relating to discriminatory practices by a health benefit plan issuer, pharmacy benefit manager, and third-party payor and certain prescription drug manufacturers, distributors, and related persons with respect to certain entities participating in a federal drug discount program; providing a civil penalty.

  89R24623 RDS-D     By: Darby, Craddick, Harris, Harless, Rose, H.B. No. 3265       et al.     Substitute the following for H.B. No. 3265:     By:  Dean C.S.H.B. No. 3265       A BILL TO BE ENTITLED   AN ACT   relating to discriminatory practices by a health benefit plan   issuer, pharmacy benefit manager, and third-party payor and certain   prescription drug manufacturers, distributors, and related persons   with respect to certain entities participating in a federal drug   discount program; providing a civil penalty.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Subchapter N, Chapter 431, Health and Safety   Code, is amended by adding Section 431.416 to read as follows:           Sec.   431.416.     DISCRIMINATION WITH RESPECT TO FEDERAL 340B   DRUG DISCOUNT PROGRAM PROHIBITED. (a)   In this section:                 (1)     "340B drug" and "covered entity" have the meanings   assigned by Section 1369.701, Insurance Code.                 (2)     "Package" has the meaning assigned by 21 U.S.C.   Section 360eee(11)(A).                 (3)     "Pharmacist" and "pharmacy" have the meanings   assigned by Section 551.003, Occupations Code.           (b)     Except as provided by Subsections (c) and (d), a   manufacturer, repackager, logistics provider, third-party   logistics provider, wholesale distributor, or agent of a   prescription drug may not, either directly or indirectly:                 (1)     discriminate against a covered entity, a   pharmacist or pharmacy that is under contract with the covered   entity, or another entity that is authorized under the contract to   receive the drug on behalf of the covered entity;                 (2)     deny, restrict, prohibit, or otherwise limit the   acquisition of a 340B drug by, or delivery of the drug to, a covered   entity, a pharmacist or pharmacy that is under contract with the   covered entity, or another entity that is authorized under the   contract to receive the drug on behalf of the covered entity; or                 (3)     require a covered entity, a pharmacist or pharmacy   that is under contract with the covered entity, or another entity   that is authorized under the contract to receive a 340B drug on   behalf of the covered entity to submit any claim or utilization data   as a condition for the acquisition of a 340B drug by, or delivery of   a 340B drug to, the covered entity, pharmacist or pharmacy under   contract with the covered entity, or other entity authorized to   receive the drug, as applicable.           (c)  This section does not apply to:                 (1)     the receipt of a 340B drug that is prohibited by   the United States Food and Drug Administration;                 (2)     the submission of a claim or utilization data that   is required by the United States Department of Health and Human   Services or the department; or                 (3)     the Texas HIV medication program established under   Section 85.061.           (d)     Subsection (b)(3) does not apply to a pharmaceutical   manufacturer audit that:                 (1)     pertains directly to a covered entity's compliance   with the requirements of 42 U.S.C. Section 256b(a)(5)(A)(i) or   (a)(5)(B); and                 (2)     is conducted in accordance with procedures   established by the United States Department of Health and Human   Services.           (e)     A person who has reasonable cause to believe another   person has violated this section may submit a complaint to the   department.   The department may investigate the complaint. If the   department finds that the person subject to the complaint committed   a violation of this section, the department:                 (1)     shall refer the complaint to the attorney general;   and                 (2)     may, in accordance with Section 431.414, suspend   or revoke a license issued under this subchapter and held by the   person subject to the complaint.           (f)     A person who violates this section commits a false,   misleading, or deceptive act or practice under Section 17.46,   Business & Commerce Code, except that a civil penalty may be   assessed in an amount not greater than $50,000 for each violation. A   person commits a separate violation for each package of 340B drugs   that is the subject of a violation of this section.           (g)     The executive commissioner shall adopt rules necessary   to implement this section.           (h)     This section does not create a private cause of action   against a person who violates this section.             (i)     Nothing in this section may be construed or applied to   be:                 (1)     less restrictive than any federal law as to any   person regulated by this section; or                 (2)  in conflict with:                       (A)  federal law or a related regulation; or                       (B)     any law of this state that is compatible with   applicable federal law.          SECTION 2.  Chapter 1369, Insurance Code, is amended by   adding Subchapter O to read as follows:   SUBCHAPTER O. PROHIBITION ON DISCRIMINATION WITH RESPECT TO   FEDERAL 340B DRUG DISCOUNT PROGRAM           Sec. 1369.701.  DEFINITIONS. In this subchapter:                 (1)     "340B drug" means a covered outpatient drug within   the meaning of 42 U.S.C. Section 256b that has been subject to any   offer for reduced prices by a manufacturer under the 340B program   and is purchased, or is intended to be purchased, by a covered   entity.                 (2)     "340B program" means the federal drug discount   program established by Section 340B, Public Health Service Act (42   U.S.C. Section 256b).                 (3)     "Covered entity" has the meaning assigned by 42   U.S.C. Section 256b(a)(4).                 (4)     "Manufacturer" has the meaning assigned by Section   431.401, Health and Safety Code.                 (5)     "Non-covered entity" means an entity that is not a   covered entity.                 (6)     "Pharmacy benefit manager" has the meaning   assigned by Section 4151.151.                 (7)     "Third-party payor" means any person, other than a   pharmacy benefit manager, health benefit plan issuer, patient, or   individual paying for a patient's drugs on the patient's behalf,   that makes payment for drugs dispensed by a pharmacist or pharmacy   or administered by a health care professional.           Sec.   1369.702.     APPLICABILITY OF SUBCHAPTER. (a) This   subchapter applies only to a health benefit plan that provides   benefits for medical or surgical expenses incurred as a result of a   health condition, accident, or sickness, including an individual,   group, blanket, or franchise insurance policy or insurance   agreement, a group hospital service contract, or an individual or   group evidence of coverage or similar coverage document that is   issued by:                 (1)  an insurance company;                 (2)     a group hospital service corporation operating   under Chapter 842;                 (3)     a health maintenance organization operating under   Chapter 843;                 (4)     an approved nonprofit health corporation that   holds a certificate of authority under Chapter 844;                 (5)     a multiple employer welfare arrangement that holds   a certificate of authority under Chapter 846;                 (6)     a stipulated premium company operating under   Chapter 884;                 (7)     a fraternal benefit society operating under   Chapter 885;                 (8)  a Lloyd's plan operating under Chapter 941; or                 (9)  an exchange operating under Chapter 942.           (b)     Notwithstanding any other law, this subchapter applies   to:                 (1)     a small employer health benefit plan subject to   Chapter 1501, including coverage provided through a health group   cooperative under Subchapter B of that chapter;                 (2)     a standard health benefit plan issued under   Chapter 1507;                 (3)  a basic coverage plan under Chapter 1551;                 (4)  a basic plan under Chapter 1575;                 (5)  a primary care coverage plan under Chapter 1579;                 (6)     a plan providing basic coverage under Chapter   1601;                 (7)     alternative health benefit coverage offered by a   subsidiary of the Texas Mutual Insurance Company under Subchapter   M, Chapter 2054;                 (8)     group health coverage made available by a school   district in accordance with Section 22.004, Education Code;                 (9)     a regional or local health care program operated   under Section 75.104, Health and Safety Code;                 (10)     a self-funded health benefit plan sponsored by a   professional employer organization under Chapter 91, Labor Code;                 (11)     county employee group health benefits provided   under Chapter 157, Local Government Code; and                 (12)     health and accident coverage provided by a risk   pool created under Chapter 172, Local Government Code.           Sec.   1369.703.     EXCEPTIONS.   This subchapter does not apply   to:                 (1)     the state Medicaid program, including the Medicaid   managed care program operated under Chapter 540, Government Code;   or                 (2)     the Texas HIV medication program established under   Section 85.061, Health and Safety Code.           Sec.   1369.704.     PROHIBITION ON DISCRIMINATORY ACTIONS. (a)     Except as provided by Subsection (b), a health benefit plan issuer,   pharmacy benefit manager, or third-party payor may [Text truncated for display. Full text available on Congress.gov.]