The following words and terms when used in this division have the following meanings, unless the context clearly indicates otherwise:
  (1) Adverse determination--As defined in Insurance Code §4201.002.
  (2) Allowed amount--The amount that the applicable health benefit plan issuer allows as reimbursement for a health care service, supply, or prescription drug, including reimbursement amounts for which a patient is responsible due to deductibles, copayments, or coinsurance.
  (3) Contracted benefit level--The copayment amount or coinsurance percentage established at the beginning of the current plan year and described in the coverage documentation.
  (4) Coverage documentation--A policy, certificate of coverage, evidence of coverage, enrollee handbook, or a plan document distributed by an issuer or its delegated entity to an enrollee or to the master contract holder, for distribution to enrollees.
  (5) Delegated entity--An entity or an association of entities, including third-party administrators, as they are defined in Insurance Code §4151.001(1), and pharmacy benefit managers, as they are defined in Insurance Code §4151.151, that provides reimbursement for covered services or undertakes to arrange for or provide benefits or services to an enrollee under a health benefit plan, and that performs on behalf of the issuer of a health benefit plan, any function regulated by this division.
  (6) Direct electronic link--A hyperlink that, when clicked, delivers a user directly to the applicable website destination.
  (7) Drug--As defined in the Texas Pharmacy Act, Occupations Code §551.003.
  (8) Drug formulary or formulary--A list of drugs for which a health benefit plan provides coverage, approves payment, or encourages or offers incentives for physicians or other health care providers to prescribe. This term does not include a health benefit plan that:
    (A) offers coverage for any FDA approved drug;
    (B) does not include a tiered structure;
    (C) does not contain a list of drugs; and
    (D) does not include utilization requirements for particular drugs or classes of drugs.
  (9) Enrollee--As defined in Insurance Code §1369.051(2).
  (10) Health benefit plan--An insurance policy or evidence of coverage as described in Insurance Code §1369.052, but not those described in Insurance Code §1369.053, that provides coverage for a discrete package of benefits, paired with specific cost-sharing parameters. This term includes health benefit plans providing coverage for pharmacy benefits only.
  (11) Issuer--Those entities described in Insurance Code §1369.052, but not those excluded by Insurance Code §1369.053.
  (12) Multitier formulary--A drug formulary with benefit levels in addition to generic and brand-name prescription drug benefit levels.
  (13) Off-label drug use--The use of a drug that is approved by the Food and Drug Administration for the treatment of one medical condition but is used to treat another medical condition, or at different dosage forms, dosage regimens, populations, or other parameters not mentioned in the approved labeling.
  (14) Plain language--As prescribed in §3.602 of this title (relating to Plain Language Requirements).
  (15) Plan year--A 365-day period that begins on the date the health benefit plan's coverage commences, or a period of one full calendar year as defined in the health benefit plan's coverage documentation.
  (16) Prescription drug--As defined in Insurance Code §1369.051(4).
  (17) Renewal date--For each health benefit plan, the earlier of the date specified in the coverage documentation for renewal or the policy anniversary date. In determining the renewal date for association or multiple employer trust health benefit plans, issuers may use the date specified for renewal or the policy anniversary date of either the master contract, plan document, or certificate of coverage of each group in the association or trust. Issuers must use the same method of determining renewal dates for all health benefit plans.
  (18) Summary health plan document--A document summarizing the coverage provided under a health benefit plan, including:
    (A) a summary of benefits and coverage, as required under 42 U.S.C. §300gg-15 and 45 CFR §147.200; and
    (B) a disclosure of terms and conditions of a policy, as required under §3.3705(b) of this title (relating to Nature of Communications with Insureds; Readability, Mandatory Disclosure Requirements, and Plan Designations), or an evidence of coverage, as required under §11.1600(b) of this title (relating to Information to Prospective and Current Contract Holders and Enrollees).

Source Note: The provisions of this §21.3020 adopted to be effective December 20, 2000, 25 TexReg 12437; amended to be effective August 18, 2016, 41 TexReg 6035