Text: HF02160 Text: HF02162 Text: HF02100 - HF02199 Text: HF Index Bills and Amendments: General Index Bill History: General Index
PAG LIN
1 1 Section 1. NEW SECTION. 514C.21 COVERAGE FOR OFF-LABEL
1 2 USE OF PRESCRIPTION DRUGS.
1 3 1. For the purposes of this section, unless the context
1 4 otherwise requires:
1 5 a. "FDA" means the United States food and drug
1 6 administration.
1 7 b. "Off-label" means the use of an FDA-approved drug for
1 8 an indication that is not included in the approved labeling.
1 9 c. "Peer-reviewed medical literature" means published
1 10 scientific studies in any peer-reviewed national professional
1 11 medical journal.
1 12 d. "Standard reference compendium" means any of the
1 13 following:
1 14 (1) The American hospital formulary service drug
1 15 information.
1 16 (2) The American medical association drug evaluation.
1 17 (3) The United States pharmacopeia drug information.
1 18 2. Notwithstanding section 514C.6, a policy or contract
1 19 providing for third-party payment or prepayment of health care
1 20 or medical expenses that provides benefits for prescription
1 21 drugs shall include a provision for the payment of off-label
1 22 prescription drugs, if all of the following conditions are
1 23 met:
1 24 a. The drug is approved for use by the United States food
1 25 and drug administration.
1 26 b. The drug is prescribed by a licensed health care
1 27 provider, participating under the policy or contract, for
1 28 appropriate medical treatment.
1 29 c. The drug has been recognized for the medical treatment
1 30 for which the drug is prescribed in at least one standard
1 31 reference compendium or in at least one article from peer-
1 32 reviewed medical literature.
1 33 3. Coverage for a prescription drug under this section
1 34 also includes medically necessary services associated with the
1 35 administration of the drug.
2 1 4. This section shall not be construed to require any of
2 2 the following:
2 3 a. Coverage for any experimental drug not otherwise
2 4 approved for the proposed use by the United States food and
2 5 drug administration.
2 6 b. Coverage for any disease, condition, service, or
2 7 treatment that is excluded from coverage.
2 8 5. This section shall not be construed to reduce or limit
2 9 coverage for off-label use of drugs otherwise required by law
2 10 or contract.
2 11 6. If requested by a third-party payor, a participating
2 12 health care provider shall submit documentation as described
2 13 in subsection 2, paragraph "c".
2 14 7. This section applies to the following classes of third-
2 15 party payment provider contracts or policies delivered, issued
2 16 for delivery, continued, or renewed in this state on or after
2 17 January 1, 2003:
2 18 a. Individual or group accident and sickness insurance
2 19 providing coverage on an expense-incurred basis.
2 20 b. An individual or group hospital or medical service
2 21 contract issued pursuant to chapter 509, 514, or 514A.
2 22 c. An individual or group health maintenance organization
2 23 contract regulated under chapter 514B.
2 24 d. An individual or group Medicare supplemental policy,
2 25 unless the coverage required by this section pursuant to such
2 26 a policy is preempted by federal law.
2 27 e. An organized delivery system licensed by the director
2 28 of public health.
2 29 f. Any other entity engaged in the business of insurance,
2 30 risk transfer, or risk retention, which is subject to the
2 31 jurisdiction of the commissioner.
2 32 Sec. 2. NEW SECTION. 514C.22 OVERRIDING FORMULARY
2 33 RESTRICTIONS.
2 34 1. Notwithstanding section 514C.6, a policy or contract
2 35 providing for third-party payment or prepayment of health care
3 1 or medical expenses that provides benefits for prescription
3 2 drugs shall include a provision that allows a prescribing
3 3 licensed health care provider to override any formulary
3 4 restrictions if the health care provider determines that the
3 5 prescription drug prescribed is medically necessary for the
3 6 benefit of the patient. The procedure for overriding the
3 7 formulary may include peer review, but shall not impose
3 8 additional administrative requirements on the prescribing
3 9 health care provider.
3 10 EXPLANATION
3 11 This bill provides that a policy or contract providing for
3 12 third-party payment or prepayment of health care or medical
3 13 expenses that provides benefits for prescription drugs shall
3 14 include a provision for the payment of off-label prescription
3 15 drugs, if the drug is approved for use by the United States
3 16 food and drug administration (FDA); the drug is prescribed by
3 17 a licensed health care provider, participating under the
3 18 policy or contract, for appropriate medical treatment; and the
3 19 drug has been recognized for the medical treatment for which
3 20 it was prescribed in at least one standard reference
3 21 compendium or in at least one article from peer-reviewed
3 22 medical literature. Required coverage for a prescription drug
3 23 also includes medically necessary services associated with the
3 24 administration of the drug. The bill does not require
3 25 coverage for any experimental drug not otherwise approved by
3 26 the FDA for the proposed use or coverage for any disease,
3 27 condition, service, or treatment that is excluded from
3 28 coverage. The bill is not to be construed to reduce or limit
3 29 coverage for off-label use of drugs otherwise required by law
3 30 or contract. The bill provides that if a third-party payor
3 31 requests, the participating health care provider who
3 32 prescribes the off-label drug is to submit documentation that
3 33 the drug has been recognized for the medical treatment for
3 34 which it was prescribed in at least one standard reference
3 35 compendium or in at least one article from peer-reviewed
4 1 medical literature.
4 2 The required coverage applies to third-party payment
4 3 provider contracts or policies delivered, issued for delivery,
4 4 continued, or renewed in this state on or after January 1,
4 5 2003, that include individual or group accident and sickness
4 6 insurance providing coverage on an expense-incurred basis; an
4 7 individual or group hospital or medical service contract
4 8 issued pursuant to Code chapter 509, 514, or 514A; an
4 9 individual or group health maintenance organization contract
4 10 regulated under Code chapter 514B; an individual or group
4 11 Medicare supplemental policy, unless the coverage required by
4 12 this section pursuant to such a policy is preempted by federal
4 13 law; an organized delivery system licensed by the director of
4 14 public health; and any other entity engaged in the business of
4 15 insurance, risk transfer, or risk retention, which is subject
4 16 to the jurisdiction of the commissioner.
4 17 The bill also provides that a policy or contract providing
4 18 for third-party payment or prepayment of health care or
4 19 medical expenses that provides benefits for prescription drugs
4 20 shall include a provision that allows a prescribing licensed
4 21 health care provider to override any formulary restrictions if
4 22 the health care provider determines that the prescription drug
4 23 prescribed is medically necessary for the benefit of the
4 24 patient. The bill provides that the procedure for overriding
4 25 the formulary may include peer review but is not to impose
4 26 additional administrative requirements on the prescribing
4 27 health care provider.
4 28 LSB 5502HH 79
4 29 pf/sh/8
Text: HF02160 Text: HF02162 Text: HF02100 - HF02199 Text: HF Index Bills and Amendments: General Index Bill History: General Index
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