38.2-3407.5 - Denial of benefits for certain prescription drugs prohibited.

§ 38.2-3407.5. Denial of benefits for certain prescription drugs prohibited.

A. Each (i) insurer proposing to issue individual or group accident andsickness insurance policies providing hospital, medical and surgical or majormedical coverage on an expense incurred basis, (ii) corporation providingindividual or group accident and sickness subscription contracts, and (iii)health maintenance organization providing a health care plan for health careservices, whose policy, contract or plan, including any certificate orevidence of coverage issued in connection with such policy, contract or plan,includes coverage for prescription drugs, whether on an inpatient basis,outpatient basis, or both, shall provide in each such policy, contract, plan,certificate, and evidence of coverage that such benefits will not be deniedfor any drug approved by the United States Food and Drug Administration foruse in the treatment of cancer on the basis that the drug has not beenapproved by the United States Food and Drug Administration for the treatmentof the specific type of cancer for which the drug has been prescribed,provided the drug has been recognized as safe and effective for treatment ofthat specific type of cancer in any of the standard reference compendia.

B. Each (i) insurer proposing to issue individual or group accident andsickness insurance policies providing hospital, medical and surgical or majormedical coverage on an expense-incurred basis, (ii) corporation providingindividual or group accident and sickness subscription contracts, and (iii)health maintenance organization providing a health care plan for health careservices, whose policy, contract or plan, including any certificate orevidence of coverage issued in connection with such policy, contract or plan,includes coverage for prescription drugs, whether on an inpatient basis,outpatient basis, or both, shall provide in each such policy, contract, plan,certificate, and evidence of coverage that such benefits will not be deniedfor any drug prescribed to treat a covered indication so long as the drug hasbeen approved by the United States Food and Drug Administration for at leastone indication and the drug is recognized for treatment of the coveredindication in one of the standard reference compendia or in substantiallyaccepted peer-reviewed medical literature.

C. For the purposes of subsections A and B:

"Peer-reviewed medical literature" means a scientific study published onlyafter having been critically reviewed for scientific accuracy, validity, andreliability by unbiased independent experts in a journal that has beendetermined by the International Committee of Medical Journal Editors to havemet the Uniform Requirements for Manuscripts submitted to biomedicaljournals. Peer-reviewed medical literature does not include publications orsupplements to publications that are sponsored to a significant extent by apharmaceutical manufacturing company or health carrier.

"Standard reference compendia" means:

1. American Hospital Formulary Service Drug Information;

2. National Comprehensive Cancer Network's Drugs & Biologics Compendium; or

3. Elsevier Gold Standard's Clinical Pharmacology.

D. Coverage, as described in subsections A and B, includes medicallynecessary services associated with the administration of the drug.

E. Subsections A and B shall not be construed to do any of the following:

1. Require coverage for any drug if the United States Food and DrugAdministration has determined its use to be contraindicated for the treatmentof the specific type of cancer or indication for which the drug has beenprescribed;

2. Require coverage for experimental drugs not otherwise approved for anyindication by the United States Food and Drug Administration;

3. Alter any law with regard to provisions limiting the coverage of drugsthat have not been approved by the United States Food and Drug Administration;

4. Create, impair, alter, limit, modify, enlarge, abrogate, or prohibitreimbursement for drugs used in the treatment of any other disease orcondition; or

5. Require coverage for prescription drugs in any contract, policy or planthat does not otherwise provide such coverage.

F. The provisions of this section shall not apply to short-term travel, oraccident-only policies, or to short-term nonrenewable policies of not morethan six months' duration.

G. The provisions of subsection A are applicable to contracts, policies orplans delivered, issued for delivery or renewed in this Commonwealth on andafter July 1, 1994, and the provisions of subsection B are applicable tocontracts, policies or plans delivered, issued for delivery or renewed inthis Commonwealth on and after July 1, 1997.

(1994, c. 374; 1997, c. 656; 2010, c. 443.)