CHAPTER 20. REIMBURSEMENT FOR OFF LABEL DRUG TREATMENT - Indiana Statutes

IC 27-8-20
     Chapter 20. Reimbursement for Off Label Drug Treatment

IC 27-8-20-1
"Commissioner" defined
     Sec. 1. As used in this chapter, "commissioner" refers to the commissioner of the department of insurance.
As added by P.L.277-1993(ss), SEC.120.

IC 27-8-20-2
"Drug" defined
     Sec. 2. As used in this chapter, "drug" means a drug or biologic that is used in an anticancer chemotherapeutic regimen.
As added by P.L.277-1993(ss), SEC.120.

IC 27-8-20-3
"Insurance policy" defined
     Sec. 3. As used in this chapter, "insurance policy" means an accident and sickness policy (as defined in IC 27-8-5-1).
As added by P.L.277-1993(ss), SEC.120.

IC 27-8-20-4
"Off label use" defined
     Sec. 4. As used in this chapter, "off label use" means the use of a drug for indications other than those stated in the labeling approved by the federal Food and Drug Administration.
As added by P.L.277-1993(ss), SEC.120.

IC 27-8-20-5
"Health maintenance organization" defined
     Sec. 5. As used in this chapter, "health maintenance organization" has the meaning set forth in IC 27-13-1-19.
As added by P.L.277-1993(ss), SEC.120. Amended by P.L.26-1994, SEC.19.

IC 27-8-20-6
"Standard reference compendium" defined
     Sec. 6. As used in this chapter, "standard reference compendium" means any of the following:
        (1) The United States Pharmacopeia Drug Information.
        (2) The American Medical Association Drug Evaluations.
        (3) The American Hospital Formulary Service Drug Information.
As added by P.L.277-1993(ss), SEC.120.

IC 27-8-20-7
Exclusion of coverage for drugs not approved by the FDA; limitations
     Sec. 7. An insurance policy or a health maintenance organization that provides coverage for drugs may not exclude coverage of a

covered drug for a particular indication on the grounds that the drug has not been approved by the federal Food and Drug Administration for the particular indication if any of the following conditions are met:
        (1) The drug is recognized for treatment of the indication in at least one (1) standard reference compendium.
        (2) The drug is recommended for that particular type of cancer and found to be safe and effective in formal clinical studies, the results of which have been published in a peer reviewed professional medical journal published in the United States or Great Britain.
As added by P.L.277-1993(ss), SEC.120. Amended by P.L.26-1994, SEC.20.

IC 27-8-20-8
Enforcement of chapter
     Sec. 8. The commissioner has the authority to enforce this chapter under the provisions of IC 27-1-3-19, IC 27-9, and IC 27-13.
As added by P.L.277-1993(ss), SEC.120. Amended by P.L.26-1994, SEC.21.

IC 27-8-20-9
Drugs not requiring coverage; drug's use contraindicated; experimental drugs; alteration of laws limiting coverage on drugs not approved by the FDA
     Sec. 9. This chapter does not do any of the following:
        (1) Require coverage for any drug when the federal Food and Drug Administration has determined the drug's use to be contraindicated.
        (2) Require coverage for an experimental drug not approved for any indication by the federal Food and Drug Administration.
        (3) Alter any other law limiting the coverage of drugs that have not been approved by the federal Food and Drug Administration.
As added by P.L.277-1993(ss), SEC.120.