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.