CHAPTER 20. REIMBURSEMENT FOR OFF LABEL DRUG TREATMENT

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 thecommissioner 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 biologicthat 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 anaccident 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 adrug for indications other than those stated in the labeling approvedby 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 DrugInformation.
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 organizationthat provides coverage for drugs may not exclude coverage of a

covered drug for a particular indication on the grounds that the drughas not been approved by the federal Food and Drug Administrationfor the particular indication if any of the following conditions aremet:
        (1) The drug is recognized for treatment of the indication in atleast one (1) standard reference compendium.
        (2) The drug is recommended for that particular type of cancerand found to be safe and effective in formal clinical studies, theresults of which have been published in a peer reviewedprofessional medical journal published in the United States orGreat 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 chapterunder 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 drugsnot 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 andDrug Administration has determined the drug's use to becontraindicated.
        (2) Require coverage for an experimental drug not approved forany indication by the federal Food and Drug Administration.
        (3) Alter any other law limiting the coverage of drugs that havenot been approved by the federal Food and DrugAdministration.
As added by P.L.277-1993(ss), SEC.120.