By Averitt H.B. No. 2061 Line and page numbers may not match official copy. Bill not drafted by TLC or Senate E&E. A BILL TO BE ENTITLED 1-1 AN ACT 1-2 relating to insurance coverage for off-label uses of federal Food 1-3 and Drug Administration approved 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 21.53H to read as follows: 1-7 Art. 21.53H. COVERAGE FOR OFF-LABEL USES OF FDA-APPROVED 1-8 DRUGS 1-9 Sec. 1. DEFINITIONS. In this article: 1-10 (1) "Contraindication" means the potential for, or the 1-11 occurrence of, an undesirable alteration of the therapeutic effect 1-12 of a given prescription because of the presence, in the patient for 1-13 whom it is prescribed, of a disease condition or the potential for, 1-14 or the occurrence of, a clinically significant adverse effect of 1-15 the drug on the patient's disease condition. 1-16 (2) "FDA" means the federal Food and Drug 1-17 Administration. 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 which points out its cause, diagnosis, 2-1 course of treatment, or prognosis. 2-2 (5) "Peer-reviewed medical literature" means published 2-3 scientific studies in any peer-reviewed national professional 2-4 journal. 2-5 (6) "Standard reference compendia" means any of the 2-6 following: 2-7 (A) The United States Pharmacopoeia-Drug 2-8 Information; 2-9 (B) The American Medical Association Drug 2-10 Evaluations; or 2-11 (C) The American Hospital Formulary Service Drug 2-12 Information. 2-13 Sec. 2. SCOPE OF ARTICLE. (a) This article applies to a 2-14 health benefit plan that provides coverage for drugs and that: 2-15 (1) provides benefits for medical or surgical expenses 2-16 incurred as a result of a health condition, accident, or sickness, 2-17 including: 2-18 (A) an individual, group, blanket, or franchise 2-19 insurance policy or insurance agreement, a group hospital service 2-20 contract, or an individual or group evidence of coverage that is 2-21 offered by: 2-22 (i) an insurance company; 2-23 (ii) a group hospital service corporation 2-24 operating under Chapter 20 of this code; 2-25 (iii) a fraternal benefit society 3-1 operating under Chapter 10 of this code; 3-2 (iv) a stipulated premium insurance 3-3 company operating under Chapter 22 of this code; or 3-4 (v) a health maintenance organization 3-5 operating under the Texas Health Maintenance Organization Act 3-6 (Chapter 20A, Vernon's Texas Insurance Code); or 3-7 (B) to the extent permitted by the Employee 3-8 Retirement Income Security Act of 1974 (29 U.S.C. Section 1001 et 3-9 seq.), a health benefit plan that is offered by: 3-10 (i) a multiple employer welfare 3-11 arrangement as defined by Section 3, Employee Retirement Income 3-12 Security Act of 1974 (29 U.S.C. Section 1002); 3-13 (ii) any other entity not licensed under 3-14 this code or another insurance law of this state that contracts 3-15 directly for health care services on a risk-sharing basis, 3-16 including an entity that contracts for health care services on a 3-17 capitation basis; or 3-18 (iii) another analogous benefit 3-19 arrangement; or 3-20 (2) is offered by an approved nonprofit health 3-21 corporation that is certified under Section 5.01(a), Medical 3-22 Practice Act (Article 4495b, Vernon's Texas Civil Statutes), and 3-23 that holds a certificate of authority issued by the commissioner 3-24 under Article 21.52F of this code. 3-25 (b) This article does not apply to: 4-1 (1) a plan that provides coverage: 4-2 (A) only for a specified disease or other 4-3 limited benefit; 4-4 (B) only for accidental death or dismemberment; 4-5 (C) for wages or payments in lieu of wages for a 4-6 period during which an employee is absent from work because of 4-7 sickness or injury; 4-8 (D) as a supplement to liability insurance; 4-9 (E) for credit insurance; 4-10 (F) only for dental or vision care; or 4-11 (G) only for indemnity for hospital confinement; 4-12 (2) a small employer health benefit plan written under 4-13 Chapter 26 of this code; 4-14 (3) a Medicare supplemental policy as defined by 4-15 Section 1882(g)(1), Social Security Act (42 U.S.C. Section 1395ss); 4-16 (4) workers' compensation insurance coverage; 4-17 (5) medical payment insurance issued as part of a 4-18 motor vehicle insurance policy; or 4-19 (6) a long-term care policy, including a nursing home 4-20 fixed indemnity policy, unless the commissioner determines that the 4-21 policy provides benefit coverage so comprehensive that the policy 4-22 is a health benefit plan as described by Subsection (a) of this 4-23 section. 4-24 Sec. 3. MINIMUM STANDARDS OF COVERAGE. (a) A health 4-25 benefit plan that provides coverage for drugs shall provide for any 5-1 drug prescribed to treat enrollees with chronic, disabling, or 5-2 life-threatening illnesses so long as the drug: 5-3 (1) has been approved by the FDA for at least one 5-4 indication; 5-5 (2) is supported by clinical research that appears in 5-6 peer-reviewed medical literature for that indication; or 5-7 (3) is supported or accepted in one of the standard 5-8 reference compendia. 5-9 (b) Coverage of the drug required by this section shall also 5-10 include medically necessary services associated with the 5-11 administration of the drug. 5-12 (c) A drug use that is covered under this section shall not 5-13 be denied coverage based on a "medical necessity" requirement 5-14 except for reasons that are unrelated to the legal status of the 5-15 drug use. 5-16 (d) This section shall not be construed to require coverage 5-17 for experimental drugs not otherwise approved for any indication by 5-18 the FDA. 5-19 (e) This section shall not be construed to require coverage 5-20 for a drug when the FDA has determined its use to be 5-21 contraindicated for treatment of the current indication. 5-22 SECTION 2. This Act takes effect September 1, 1999, and 5-23 applies only to a health benefit plan that is delivered, issued for 5-24 delivery, or renewed on or after January 1, 2000. A health benefit 5-25 plan that is delivered, issued for delivery, or renewed before 6-1 January 1, 2000, is governed by the law as it existed immediately 6-2 before the effective date of this Act, and that law is continued in 6-3 effect for that purpose. 6-4 SECTION 3. The importance of this legislation and the 6-5 crowded condition of the calendars in both houses create an 6-6 emergency and an imperative public necessity that the 6-7 constitutional rule requiring bills to be read on three several 6-8 days in each house be suspended, and this rule is hereby suspended.