# 28 Tex. Admin. Code § 21.3011: 28 TAC § 21.3011. Minimum Standards of Coverage for Off-Label Drug Use, DIVISION 3. OFF-LABEL DRUGS

> Texas · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3011

## Section

- **Citation:** 28 Tex. Admin. Code § 21.3011
- **Heading:** 28 TAC § 21.3011. Minimum Standards of Coverage for Off-Label Drug Use, DIVISION 3. OFF-LABEL DRUGS
- **Jurisdiction:** Texas
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Texas Administrative Code / Title 28 INSURANCE / Part 1 TEXAS DEPARTMENT OF INSURANCE / Chapter 21 TRADE PRACTICES / 28 TAC § 21.3011

## Text

(a) An issuer of a health benefit plan that provides
 coverage for drugs must provide coverage for any drug prescribed to
 treat an enrollee for a covered chronic, disabling, or life-threatening
 illness if the drug:
(1) has been approved by the Food and Drug Administration
 for at least one indication; and
(2) is recognized for treatment of the indication for
 which the drug is prescribed in:
(A) a standard drug reference compendium; or
(B) substantially accepted peer-reviewed medical literature.
(b) Coverage of a drug required under subsection (a)
 of this section:
(1) must include services medically necessary to administer
 the drug, including any supply medically necessary to administer the
 drug, if the supply is a covered benefit under the health benefit
 plan;
(2) may be denied based on a finding that the use of
 the drug is not medically necessary to treat the enrollee's disease,
 syndrome, or condition, so long as the finding is not based on the
 fact that the drug is being prescribed for an off-label use;
(3) may not be denied solely on the basis that the
 drug does not appear on the formulary. If the issuer of a health benefit
 plan refuses to provide an off-label drug that is not included in
 a drug formulary, and the enrollee's physician or provider has determined
 it is medically necessary for an off-label use, the refusal constitutes
 an adverse determination for purposes of Insurance Code §4201.002(1).
 An enrollee may appeal the adverse determination under Insurance Code
 Chapter 4201, Subchapters H and I;
(4) may be denied for a drug prescribed to treat any
 disease or condition that is excluded from coverage under the health
 benefit plan;
(5) may be denied for a drug prescribed for outpatient
 use if coverage of drugs under that particular health benefit plan
 is limited to the hospitalization of the enrollee; or
(6) may be denied for a drug that the Food and Drug
 Administration has determined to be a contraindication for treatment
 of the current disease or condition.

## Nearby sections

- [28 Tex. Admin. Code § 21.3001 28 TAC § 21.3001. Applicability and Severability, DIVISION 1. GENERAL PROVISIONS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3001.md)
- [28 Tex. Admin. Code § 21.3002 28 TAC § 21.3002. Definitions; Pharmacy Identification Cards, DIVISION 2. IDENTIFICATION CARDS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3002.md)
- [28 Tex. Admin. Code § 21.3003 28 TAC § 21.3003. Standard Identification Cards, DIVISION 2. IDENTIFICATION CARDS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3003.md)
- [28 Tex. Admin. Code § 21.3004 28 TAC § 21.3004. Issuance of Standard Identification Cards, DIVISION 2. IDENTIFICATION CARDS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3004.md)
- [28 Tex. Admin. Code § 21.3010 28 TAC § 21.3010. Definitions; Coverage of Off-Label Drugs, DIVISION 3. OFF-LABEL DRUGS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3010.md)
- [28 Tex. Admin. Code § 21.3011 28 TAC § 21.3011. Minimum Standards of Coverage for Off-Label Drug Use, DIVISION 3. OFF-LABEL DRUGS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3011.md)
- [28 Tex. Admin. Code § 21.3020 28 TAC § 21.3020. Definitions; Prescription Drug Formulary, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3020.md)
- [28 Tex. Admin. Code § 21.3022 28 TAC § 21.3022. Continuation of Benefits, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3022.md)
- [28 Tex. Admin. Code § 21.3023 28 TAC § 21.3023. Nonformulary Prescription Drugs; Adverse Determination, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3023.md)
- [28 Tex. Admin. Code § 21.3030 28 TAC § 21.3030. Availability of Formulary Information, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3030.md)
- [28 Tex. Admin. Code § 21.3031 28 TAC § 21.3031. Formulary Information for Individual Health Benefit Plans on Issuer's Website, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3031.md)
- [28 Tex. Admin. Code § 21.3032 28 TAC § 21.3032. Formulary Disclosure Requirements for Individual Health Benefit Plans, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3032.md)
- [28 Tex. Admin. Code § 21.3033 28 TAC § 21.3033. Facilitating Comparison Shopping for Individual Health Benefit Plans, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3033.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3011. Check the current official text before relying on it. Not legal advice.