By: Sibley S.B. No. 1543 99S0352/1 A BILL TO BE ENTITLED AN ACT 1-1 relating to insurance coverage for off-label uses of federal Food 1-2 and Drug Administration approved drugs. 1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-4 SECTION 1. Subchapter E, Chapter 21, Insurance Code, is 1-5 amended by adding Article 21.53H to read as follows: 1-6 Art. 21.53H. COVERAGE FOR OFF-LABEL USES OF FDA-APPROVED 1-7 DRUGS 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 given prescription because of the presence, in the patient for 1-12 whom it is prescribed, of a disease condition or the potential for, 1-13 or the occurrence of, a clinically significant adverse effect of 1-14 the drug on the patient's disease condition. 1-15 (2) "FDA" means the federal Food and Drug 1-16 Administration. 1-17 (3) "Health benefit plan" means a plan described by 1-18 Section 2 of this article. 1-19 (4) "Indication" means any symptom, cause, or 1-20 occurrence in a disease which points out its cause, diagnosis, 1-21 course of treatment, or prognosis. 1-22 (5) "Peer-reviewed medical literature" means published 1-23 scientific studies in any peer-reviewed national professional 1-24 journal. 2-1 (6) "Standard reference compendia" means any of the 2-2 following: 2-3 (A) The United States Pharmacopoeia-Drug 2-4 Information; 2-5 (B) The American Medical Association Drug 2-6 Evaluations; or 2-7 (C) The American Hospital Formulary Service Drug 2-8 Information. 2-9 Sec. 2. SCOPE OF ARTICLE. (a) This article applies to a 2-10 health benefit plan that provides coverage for drugs and that: 2-11 (1) provides benefits for medical or surgical expenses 2-12 incurred as a result of a health condition, accident, or sickness, 2-13 including: 2-14 (A) an individual, group, blanket, or franchise 2-15 insurance policy or insurance agreement, a group hospital service 2-16 contract, or an individual or group evidence of coverage that is 2-17 offered by: 2-18 (i) an insurance company; 2-19 (ii) a group hospital service corporation 2-20 operating under Chapter 20 of this code; 2-21 (iii) a fraternal benefit society 2-22 operating under Chapter 10 of this code; 2-23 (iv) a stipulated premium insurance 2-24 company operating under Chapter 22 of this code; or 2-25 (v) a health maintenance organization 2-26 operating under the Texas Health Maintenance Organization Act 3-1 (Chapter 20A, Vernon's Texas Insurance Code); or 3-2 (B) to the extent permitted by the Employee 3-3 Retirement Income Security Act of 1974 (29 U.S.C. Section 1001 et 3-4 seq.), a health benefit plan that is offered by: 3-5 (i) a multiple employer welfare 3-6 arrangement as defined by Section 3, Employee Retirement Income 3-7 Security Act of 1974 (29 U.S.C. Section 1002); 3-8 (ii) any other entity not licensed under 3-9 this code or another insurance law of this state that contracts 3-10 directly for health care services on a risk-sharing basis, 3-11 including an entity that contracts for health care services on a 3-12 capitation basis; or 3-13 (iii) another analogous benefit 3-14 arrangement; or 3-15 (2) is offered by an approved nonprofit health 3-16 corporation that is certified under Section 5.01(a), Medical 3-17 Practice Act (Article 4495b, Vernon's Texas Civil Statutes), and 3-18 that holds a certificate of authority issued by the commissioner 3-19 under Article 21.52F of this code. 3-20 (b) This article does not apply to: 3-21 (1) a plan that provides coverage: 3-22 (A) only for a specified disease or other 3-23 limited benefit; 3-24 (B) only for accidental death or dismemberment; 3-25 (C) for wages or payments in lieu of wages for a 3-26 period during which an employee is absent from work because of 4-1 sickness or injury; 4-2 (D) as a supplement to liability insurance; 4-3 (E) for credit insurance; 4-4 (F) only for dental or vision care; or 4-5 (G) only for indemnity for hospital confinement; 4-6 (2) a small employer health benefit plan written under 4-7 Chapter 26 of this code; 4-8 (3) a Medicare supplemental policy as defined by 4-9 Section 1882(g)(1), Social Security Act (42 U.S.C. Section 1395ss); 4-10 (4) workers' compensation insurance coverage; 4-11 (5) medical payment insurance issued as part of a 4-12 motor vehicle insurance policy; or 4-13 (6) a long-term care policy, including a nursing home 4-14 fixed indemnity policy, unless the commissioner determines that the 4-15 policy provides benefit coverage so comprehensive that the policy 4-16 is a health benefit plan as described by Subsection (a) of this 4-17 section. 4-18 Sec. 3. MINIMUM STANDARDS OF COVERAGE. (a) A health 4-19 benefit plan that provides coverage for drugs shall provide for any 4-20 drug prescribed to treat enrollees with chronic, disabling, or 4-21 life-threatening illnesses so long as the drug: 4-22 (1) has been approved by the FDA for at least one 4-23 indication; 4-24 (2) is supported by clinical research that appears in 4-25 peer-reviewed medical literature for that indication; or 4-26 (3) is supported or accepted in one of the standard 5-1 reference compendia. 5-2 (b) Coverage of the drug required by this section shall also 5-3 include medically necessary services associated with the 5-4 administration of the drug. 5-5 (c) A drug use that is covered under this section shall not 5-6 be denied coverage based on a "medical necessity" requirement 5-7 except for reasons that are unrelated to the legal status of the 5-8 drug use. 5-9 (d) This section shall not be construed to require coverage 5-10 for experimental drugs not otherwise approved for any indication by 5-11 the FDA. 5-12 (e) This section shall not be construed to require coverage 5-13 for a drug when the FDA has determined its use to be 5-14 contraindicated for treatment of the current indication. 5-15 SECTION 2. This Act takes effect September 1, 1999, and 5-16 applies only to a health benefit plan that is delivered, issued for 5-17 delivery, or renewed on or after January 1, 2000. A health benefit 5-18 plan that is delivered, issued for delivery, or renewed before 5-19 January 1, 2000, is governed by the law as it existed immediately 5-20 before the effective date of this Act, and that law is continued in 5-21 effect for that purpose. 5-22 SECTION 3. The importance of this legislation and the 5-23 crowded condition of the calendars in both houses create an 5-24 emergency and an imperative public necessity that the 5-25 constitutional rule requiring bills to be read on three several 5-26 days in each house be suspended, and this rule is hereby suspended.