PRINTER'S NO. 873
No. 784 Session of 2001
INTRODUCED BY BEBKO-JONES, BELARDI, YOUNGBLOOD, C. WILLIAMS,
WASHINGTON, WALKO, TRELLO, DALEY, COY, COSTA, CORRIGAN,
LAUGHLIN, READSHAW, ORIE, JAMES, HORSEY, HENNESSEY, THOMAS,
TANGRETTI, MELIO, BELFANTI, MANDERINO, SCRIMENTI, SOLOBAY,
STEELMAN, HARHAI, GEORGE AND FREEMAN, FEBRUARY 20, 2001
REFERRED TO COMMITTEE ON INSURANCE, FEBRUARY 20, 2001
AN ACT
1 Requiring health insurance providers which furnish coverage for
2 prescription drugs to extend coverage to off-label use of
3 drugs; and imposing a penalty.
4 The General Assembly of the Commonwealth of Pennsylvania
5 hereby enacts as follows:
6 Section 1. Short title.
7 This act shall be known and may be cited as the Off-label Use
8 of Drugs Coverage Act.
9 Section 2. Definitions.
10 The following words and phrases when used in this act shall
11 have the meanings given to them in this section unless the
12 context clearly indicates otherwise:
13 "Commissioner." The Insurance Commissioner of the
14 Commonwealth.
15 "Department." The Insurance Department of the Commonwealth.
16 "Health insurance." Any policy, contract or plan which
17 provides medical coverage on an expense-incurred service or
1 prepaid basis or an employee welfare benefit plan issued or
2 subject to any of the following laws:
3 (1) The act of May 17, 1921 (P.L.682, No.284), known as
4 The Insurance Company Law of 1921.
5 (2) The act of December 29, 1972 (P.L.1701, No.364),
6 known as the Health Maintenance Organization Act.
7 (3) The act of May 18, 1976 (P.L.123, No.54), known as
8 the Individual Accident and Sickness Insurance Minimum
9 Standards Act.
10 (4) The act of December 14, 1992 (P.L.835, No.134),
11 known as the Fraternal Benefit Societies Code.
12 (5) 40 Pa.C.S. Ch. 61 (relating to hospital plan
13 corporations) or 63 (relating to professional health services
14 plan corporations).
15 (6) The Employee Retirement Income Security Act of 1974
16 (P.L. 93-406, 88 Stat. 829).
17 "Medical literature." A peer-reviewed, national medical or
18 scientific journal.
19 "Off-label use of drugs." Prescribing a drug for treatment
20 of a condition other than a condition specifically approved for
21 treatment by the Food and Drug Administration.
22 "Secretary." The Secretary of Health of the Commonwealth.
23 "Standard reference compendia." The American Medical
24 Association Drug Evaluation, the American Hospital Formulary
25 Service Drug Information or the United States Pharmacopeia Drug
26 Information.
27 Section 3. Coverage for off-label use of drugs required.
28 Health insurance which provides coverage for prescription
29 drugs may not exclude coverage of a drug for a particular
30 indication on the grounds that the drug has not been approved by
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1 the Food and Drug Administration for that indication if the drug
2 is recognized for treatment of the indication in one of the
3 standard reference compendia or in medical literature.
4 Section 4. Review of off-label uses of drugs.
5 The secretary shall appoint a panel of eight qualified
6 medical experts to review off-label uses of drugs not included
7 in the standard reference compendia or medical literature. The
8 panel shall advise the commissioner whether a particular off-
9 label use is medically appropriate and shall make
10 recommendations regarding payment of off-label use.
11 Section 5. Enforcement.
12 The department shall enforce the provisions of this act.
13 Section 6. Penalty.
14 A provider of health insurance that violates this act shall
15 be subject to a civil penalty of $1,000.
16 Section 19. Construction of act.
17 Nothing in this act shall be construed to require coverage
18 for experimental drugs not otherwise approved for any indication
19 by the Food and Drug Administration.
20 Section 20. Effective date.
21 This act shall take effect in 60 days.
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