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.