1-1 AN ACT 1-2 relating to coverage by a health benefit plan of certain 1-3 prescription drugs. 1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-5 SECTION 1. Subchapter E, Chapter 21, Insurance Code, is 1-6 amended by adding Article 21.53M to read as follows: 1-7 Art. 21.53M. COVERAGE FOR OFF-LABEL DRUG USE 1-8 Sec. 1. DEFINITIONS. In this article: 1-9 (1) "Contraindication" means the potential for, or the 1-10 occurrence of, an undesirable alteration of the therapeutic effect 1-11 of a prescribed drug prescription because of the presence, in the 1-12 patient for whom it is prescribed, of a disease condition, or the 1-13 potential for, or the occurrence of, a clinically significant 1-14 adverse effect of the drug on the patient's disease condition. 1-15 (2) "Drug" has the meaning assigned by Section 5, 1-16 Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil 1-17 Statutes). 1-18 (3) "Health benefit plan" means a plan described by 1-19 Section 2 of this article. 1-20 (4) "Indication" means any symptom, cause, or 1-21 occurrence in a disease that points out the cause, diagnosis, 1-22 course of treatment, or prognosis of the disease. 1-23 (5) "Peer-reviewed medical literature" means published 1-24 scientific studies in any peer-reviewed national professional 2-1 journal. 2-2 Sec. 2. SCOPE OF ARTICLE. (a) This article applies only to 2-3 a health benefit plan that provides benefits for medical or 2-4 surgical expenses incurred as a result of a health condition, 2-5 accident, or sickness, including an individual, group, blanket, or 2-6 franchise insurance policy or insurance agreement, a group hospital 2-7 service contract, or an individual or group evidence of coverage or 2-8 similar coverage document that is offered by: 2-9 (1) an insurance company; 2-10 (2) a group hospital service corporation operating 2-11 under Chapter 20 of this code; 2-12 (3) a fraternal benefit society operating under 2-13 Chapter 10 of this code; 2-14 (4) a stipulated premium insurance company operating 2-15 under Chapter 22 of this code; 2-16 (5) a reciprocal exchange operating under Chapter 19 2-17 of this code; 2-18 (6) a health maintenance organization operating under 2-19 the Texas Health Maintenance Organization Act (Chapter 20A, 2-20 Vernon's Texas Insurance Code); 2-21 (7) a multiple employer welfare arrangement that holds 2-22 a certificate of authority under Article 3.95-2 of this code; or 2-23 (8) an approved nonprofit health corporation that 2-24 holds a certificate of authority issued by the commissioner under 2-25 Article 21.52F of this code. 2-26 (b) This article does not apply to: 2-27 (1) a plan that provides coverage: 3-1 (A) only for a specified disease or other 3-2 limited benefit; 3-3 (B) only for accidental death or dismemberment; 3-4 (C) for wages or payments in lieu of wages for a 3-5 period during which an employee is absent from work because of 3-6 sickness or injury; 3-7 (D) as a supplement to liability insurance; 3-8 (E) for credit insurance; 3-9 (F) only for dental or vision care; 3-10 (G) only for hospital expenses; or 3-11 (H) only for indemnity for hospital confinement; 3-12 (2) a small employer health benefit plan written under 3-13 Chapter 26 of this code; 3-14 (3) a Medicare supplemental policy as defined by 3-15 Section 1882(g)(1), Social Security Act (42 U.S.C. Section 1395ss), 3-16 as amended; 3-17 (4) workers' compensation insurance coverage; 3-18 (5) medical payment insurance coverage issued as part 3-19 of a motor vehicle insurance policy; or 3-20 (6) a long-term care policy, including a nursing home 3-21 fixed indemnity policy, unless the commissioner determines that the 3-22 policy provides benefit coverage so comprehensive that the policy 3-23 is a health benefit plan as described by Subsection (a) of this 3-24 section. 3-25 Sec. 3. MINIMUM STANDARDS OF COVERAGE. (a) A health 3-26 benefit plan that provides coverage for drugs must provide coverage 3-27 for any drug prescribed to treat an enrollee for a covered chronic, 4-1 disabling, or life-threatening illness if the drug: 4-2 (1) has been approved by the Food and Drug 4-3 Administration for at least one indication; and 4-4 (2) is recognized for treatment of the indication for 4-5 which the drug is prescribed in: 4-6 (A) a prescription drug reference compendium 4-7 approved by the commissioner for the purpose of this article; or 4-8 (B) substantially accepted peer-reviewed medical 4-9 literature. 4-10 (b) Coverage of a drug required by this section shall 4-11 include coverage of medically necessary services associated with 4-12 the administration of the drug. 4-13 (c) A drug use that is covered under this section may not be 4-14 denied based on a "medical necessity" requirement except for 4-15 reasons that are unrelated to the legal status of the drug use. 4-16 (d) This section does not require coverage for: 4-17 (1) experimental drugs not otherwise approved for any 4-18 indication by the Food and Drug Administration; or 4-19 (2) any disease or condition that is excluded from 4-20 coverage under the plan. 4-21 (e) A health benefit plan is not required to cover a drug 4-22 the Food and Drug Administration has determined to be 4-23 contraindicated for treatment of the current indication. 4-24 Sec. 4. RULES. The commissioner may adopt rules to 4-25 implement this article. 4-26 SECTION 2. This Act takes effect September 1, 1999, and 4-27 applies only to a health benefit plan that is delivered, issued for 5-1 delivery, or renewed on or after January 1, 2000. A health benefit 5-2 plan that is delivered, issued for delivery, or renewed before 5-3 January 1, 2000, is governed by the law as it existed immediately 5-4 before the effective date of this Act, and that law is continued in 5-5 effect for that purpose. 5-6 SECTION 3. The importance of this legislation and the 5-7 crowded condition of the calendars in both houses create an 5-8 emergency and an imperative public necessity that the 5-9 constitutional rule requiring bills to be read on three several 5-10 days in each house be suspended, and this rule is hereby suspended. _______________________________ _______________________________ President of the Senate Speaker of the House I certify that H.B. No. 2061 was passed by the House on April 22, 1999, by a non-record vote; and that the House concurred in Senate amendments to H.B. No. 2061 on May 17, 1999, by a non-record vote. _______________________________ Chief Clerk of the House I certify that H.B. No. 2061 was passed by the Senate, with amendments, on May 13, 1999, by the following vote: Yeas 30, Nays 0. _______________________________ Secretary of the Senate APPROVED: _____________________ Date _____________________ Governor