By Averitt H.B. No. 2061
76R10736 AJA-F
A BILL TO BE ENTITLED
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 SECTION 2. This Act takes effect September 1, 1999, and
4-25 applies only to a health benefit plan that is delivered, issued for
4-26 delivery, or renewed on or after January 1, 2000. A health benefit
4-27 plan that is delivered, issued for delivery, or renewed before
5-1 January 1, 2000, is governed by the law as it existed immediately
5-2 before the effective date of this Act, and that law is continued in
5-3 effect for that purpose.
5-4 SECTION 3. The importance of this legislation and the
5-5 crowded condition of the calendars in both houses create an
5-6 emergency and an imperative public necessity that the
5-7 constitutional rule requiring bills to be read on three several
5-8 days in each house be suspended, and this rule is hereby suspended.