Text: SF00422 Text: SF00424 Text: SF00400 - SF00499 Text: SF 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. "Off-label" means the use of a drug approved by the
1 6 United States food and drug administration for an indication
1 7 that is not included in the approved labeling.
1 8 b. "Peer-reviewed medical literature" means published
1 9 scientific studies in any peer-reviewed national professional
1 10 medical journal.
1 11 c. "Standard reference compendium" means any of the
1 12 following:
1 13 (1) The American hospital formulary service drug
1 14 information.
1 15 (2) The American medical association drug evaluation.
1 16 (3) The United States pharmacopoeia drug information.
1 17 2. Notwithstanding section 514C.6, a policy or contract
1 18 providing for third-party payment or prepayment of health care
1 19 or medical expenses that provides benefits for prescription
1 20 drugs shall include a provision for the payment of off-label
1 21 prescription drugs, if all of the following conditions are
1 22 met:
1 23 a. The drug is approved for use by the United States food
1 24 and drug administration.
1 25 b. The drug is prescribed by a licensed health care
1 26 provider, participating under the policy or contract, for
1 27 appropriate medical treatment.
1 28 c. The drug has been recognized for the medical treatment
1 29 for which the drug is prescribed in at least one standard
1 30 reference compendium or in at least one article from peer-
1 31 reviewed medical literature.
1 32 3. Coverage for a prescription drug under this section
1 33 also includes medically necessary services associated with the
1 34 administration of the drug.
1 35 4. This section shall not be construed to require any of
2 1 the following:
2 2 a. Coverage for any experimental drug not otherwise
2 3 approved for the proposed use by the United States food and
2 4 drug administration.
2 5 b. Coverage for any disease, condition, service, or
2 6 treatment that is excluded from coverage.
2 7 5. This section shall not be construed to reduce or limit
2 8 coverage for off-label use of drugs otherwise required by law
2 9 or contract.
2 10 6. If requested by a third-party payor, a participating
2 11 health care provider shall submit documentation as described
2 12 in subsection 2, paragraph "c".
2 13 7. This section applies to the following classes of third-
2 14 party payment provider contracts or policies delivered, issued
2 15 for delivery, continued, or renewed in this state on or after
2 16 January 1, 2004:
2 17 a. Individual or group accident and sickness insurance
2 18 providing coverage on an expense-incurred basis.
2 19 b. An individual or group hospital or medical service
2 20 contract issued pursuant to chapter 509, 514, or 514A.
2 21 c. An individual or group health maintenance organization
2 22 contract regulated under chapter 514B.
2 23 d. An individual or group Medicare supplemental policy,
2 24 unless the coverage required by this section pursuant to such
2 25 a policy is preempted by federal law.
2 26 e. An organized delivery system licensed by the director
2 27 of public health.
2 28 f. Any other entity engaged in the business of insurance,
2 29 risk transfer, or risk retention, which is subject to the
2 30 jurisdiction of the commissioner.
2 31 Sec. 2. NEW SECTION. 514C.22 OVERRIDING FORMULARY
2 32 RESTRICTIONS.
2 33 Notwithstanding section 514C.6, a policy or contract
2 34 providing for third-party payment or prepayment of health care
2 35 or medical expenses that provides benefits for prescription
3 1 drugs shall include a provision that allows a prescribing
3 2 licensed health care provider to override any formulary
3 3 restrictions if the health care provider determines that the
3 4 prescription drug prescribed is medically necessary for the
3 5 benefit of the patient. The procedure for overriding the
3 6 formulary may include peer review, but shall not impose
3 7 additional administrative requirements on the prescribing
3 8 health care provider.
3 9 EXPLANATION
3 10 This bill provides that a policy or contract providing for
3 11 third-party payment or prepayment of health care or medical
3 12 expenses that provides benefits for prescription drugs shall
3 13 include a provision for the payment of off-label prescription
3 14 drugs, if the drug is approved for use by the United States
3 15 food and drug administration (FDA); the drug is prescribed by
3 16 a licensed health care provider, participating under the
3 17 policy or contract, for appropriate medical treatment; and the
3 18 drug has been recognized for the medical treatment for which
3 19 it was prescribed in at least one standard reference
3 20 compendium or in at least one article from peer-reviewed
3 21 medical literature. Required coverage for a prescription drug
3 22 also includes medically necessary services associated with the
3 23 administration of the drug. The bill does not require
3 24 coverage for any experimental drug not otherwise approved by
3 25 the FDA for the proposed use or coverage for any disease,
3 26 condition, service, or treatment that is excluded from
3 27 coverage. The bill is not to be construed to reduce or limit
3 28 coverage for off-label use of drugs otherwise required by law
3 29 or contract. The bill provides that if a third-party payor
3 30 requests, the participating health care provider who
3 31 prescribes the off-label drug is to submit documentation that
3 32 the drug has been recognized for the medical treatment for
3 33 which it was prescribed in at least one standard reference
3 34 compendium or in at least one article from peer-reviewed
3 35 medical literature.
4 1 The required coverage applies to third-party payment
4 2 provider contracts or policies delivered, issued for delivery,
4 3 continued, or renewed in this state on or after January 1,
4 4 2004, that include individual or group accident and sickness
4 5 insurance providing coverage on an expense-incurred basis; an
4 6 individual or group hospital or medical service contract
4 7 issued pursuant to Code chapter 509, 514, or 514A; an
4 8 individual or group health maintenance organization contract
4 9 regulated under Code chapter 514B; an individual or group
4 10 Medicare supplemental policy, unless the coverage required by
4 11 this section pursuant to such a policy is preempted by federal
4 12 law; an organized delivery system licensed by the director of
4 13 public health; and any other entity engaged in the business of
4 14 insurance, risk transfer, or risk retention, which is subject
4 15 to the jurisdiction of the commissioner.
4 16 The bill also provides that a policy or contract providing
4 17 for third-party payment or prepayment of health care or
4 18 medical expenses that provides benefits for prescription drugs
4 19 shall include a provision that allows a prescribing licensed
4 20 health care provider to override any formulary restrictions if
4 21 the health care provider determines that the prescription drug
4 22 prescribed is medically necessary for the benefit of the
4 23 patient. The bill provides that the procedure for overriding
4 24 the formulary may include peer review but is not to impose
4 25 additional administrative requirements on the prescribing
4 26 health care provider.
4 27 LSB 2753XS 80
4 28 pf/sh/8.1
Text: SF00422 Text: SF00424 Text: SF00400 - SF00499 Text: SF Index Bills and Amendments: General Index Bill History: General Index
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