Text: HSB00242 Text: HSB00244 Text: HSB00200 - HSB00299 Text: HSB Index Bills and Amendments: General Index Bill History: General Index
PAG LIN
1 1 Section 1. LEGISLATIVE FINDINGS. The Iowa general
1 2 assembly finds and declares all of the following:
1 3 1. Third-party payors have denied payment for prescription
1 4 drugs that have been approved by the United States food and
1 5 drug administration, when the drugs are prescribed for uses
1 6 other than those stated on the marketing label approved by the
1 7 United States food and drug administration, while other
1 8 insurers with similar coverage terms do pay for off-label use.
1 9 Denial of payment for off-label uses interrupts necessary and
1 10 appropriate treatment for persons being treated for life-
1 11 threatening illnesses by competent, responsible medical
1 12 professionals.
1 13 2. The United States food and drug administration and the
1 14 United States department of health and human services
1 15 recognize the wide variety of effective uses of federally
1 16 approved drugs through off-label uses. Continuing medical
1 17 research has demonstrated effective, new uses of federally
1 18 approved drugs. Information on the appropriate off-label use
1 19 of federally approved drugs is obtained from compendia
1 20 published by the United States pharmacopeial convention or the
1 21 American society of hospital pharmacists. In addition,
1 22 scientific studies of off-label use of drugs published in
1 23 recognized peer-reviewed professional journals provide
1 24 information on appropriate off-label uses of drugs. The
1 25 federal Omnibus Budget Reconciliation Act of 1990 recognizes
1 26 these compendia and peer-reviewed literature as appropriate
1 27 sources for reimbursement.
1 28 3. The federal approval process for drugs is very
1 29 expensive and time-consuming. Use of federally approved drugs
1 30 for off-label uses provides efficacious drugs at a lower cost.
1 31 To require that all appropriate uses of a drug undergo
1 32 approval by the United States food and drug administration
1 33 would substantially increase the cost of drugs, and delay or
1 34 deny patients' ability to obtain medically effective
1 35 treatment. To require approval for all new uses would add to
2 1 the already rising cost of prescription drugs.
2 2 4. Reimbursement for off-label uses of federally approved
2 3 drugs is necessary to conform to the way in which appropriate
2 4 medical treatment is provided, to make needed drugs available
2 5 to patients, and to contain health care costs.
2 6 Sec. 2. NEW SECTION. 514C.141 COVERAGE FOR OFF-LABEL USE
2 7 OF PRESCRIPTION DRUGS.
2 8 1. For purposes of this section, unless the context
2 9 otherwise requires:
2 10 a. "Medical literature" means published scientific studies
2 11 published in any peer-reviewed national professional journal
2 12 of medicine.
2 13 b. "Standard reference compendia" means any of the
2 14 following:
2 15 (1) The United States pharmacopoeia drug information.
2 16 (2) The American hospital formulary service drug
2 17 information.
2 18 (3) Drugdex.
2 19 2. Notwithstanding section 514C.6, a policy or contract
2 20 providing for third-party payment or prepayment of health care
2 21 or medical expenses shall not exclude coverage for a
2 22 prescription drug for a particular use on the basis that the
2 23 drug is prescribed for a use that is different from the use
2 24 for which that drug has been approved for marketing by the
2 25 United States food and drug administration, provided that all
2 26 the following conditions have been met:
2 27 a. The drug is approved for use by the United States food
2 28 and drug administration.
2 29 b. The drug is prescribed by a licensed health care
2 30 provider, participating under the policy or contract, for
2 31 appropriate medical treatment.
2 32 c. The drug has been recognized for the medical treatment
2 33 for which it was prescribed by one of the following:
2 34 (1) The American hospital formulary service drug
2 35 information.
3 1 (2) The United States pharmacopoeia dispensing
3 2 information.
3 3 (3) One article from a major peer-reviewed medical journal
3 4 that presents data supporting the proposed off-label use or
3 5 uses as generally safe and effective unless there is clear and
3 6 convincing contradictory evidence presented in a major peer-
3 7 reviewed medical journal.
3 8 3. A participating health care provider, if requested by a
3 9 third-party payor, shall submit to the third-party payor
3 10 documentation as identified in subsection 1, paragraph "c".
3 11 4. Coverage for a drug pursuant to this section also
3 12 includes medically necessary services associated with the
3 13 administration of the drug.
3 14 5. This section applies to the following classes of third-
3 15 party payment provider contracts or policies delivered, issued
3 16 for delivery, continued, or renewed in this state on or after
3 17 January 1, 2000:
3 18 a. Individual or group accident and sickness insurance
3 19 providing coverage on an expense-incurred basis.
3 20 b. An individual or group hospital or medical service
3 21 contract issued pursuant to chapter 509, 514, or 514A.
3 22 c. An individual or group health maintenance organization
3 23 contract regulated under chapter 514B.
3 24 d. An individual or group Medicare supplemental policy,
3 25 unless the coverage required by this section pursuant to such
3 26 a policy is preempted by federal law.
3 27 e. An organized delivery system licensed by the director
3 28 of public health.
3 29 f. Any other entity engaged in the business of insurance,
3 30 risk transfer, or risk retention, which is subject to the
3 31 jurisdiction of the commissioner.
3 32 6. a. This section shall not be construed to alter
3 33 existing laws with regard to provisions limiting the coverage
3 34 of drugs that have not been approved by the United States food
3 35 and drug administration.
4 1 b. This section shall not be construed to require coverage
4 2 for experimental drugs not otherwise approved for any use by
4 3 the United States food and drug administration.
4 4 c. This section shall not reduce or limit coverage for
4 5 off-label use of drugs otherwise required by law or contract.
4 6 7. The commissioner shall create a panel of seven experts
4 7 to review off-label uses not included in any of the two
4 8 standard reference compendia or in the medical literature and
4 9 to give advice to the commissioner in such instances as to
4 10 whether a particular off-label use is medically appropriate.
4 11 The panel shall make such recommendations from time to time
4 12 and whenever a dispute about payment for an off-label use is
4 13 brought to the commissioner. The seven-member panel shall
4 14 include all of the following:
4 15 a. Three physicians licensed in this state as follows:
4 16 (1) One selected by the state medical oncology
4 17 association.
4 18 (2) One selected by the Iowa medical society.
4 19 (3) One selected by the American college of cardiology,
4 20 Iowa chapter.
4 21 b. Two licensed pharmacists selected by the Iowa pharmacy
4 22 association.
4 23 c. Two laypersons selected by the commissioner.
4 24 EXPLANATION
4 25 This bill creates new Code section 514C.14 which provides
4 26 that a policy or contract providing for third-party payment or
4 27 prepayment of health care or medical expenses shall not
4 28 exclude coverage for a prescription drug for a particular use
4 29 on the basis that the drug is prescribed for a use that is
4 30 different from the use for which that drug has been approved
4 31 for marketing by the United States food and drug
4 32 administration, if the drug is approved for use by the United
4 33 States food and drug administration; the drug is prescribed by
4 34 a licensed health care provider, participating under the
4 35 policy or contract, for appropriate medical treatment; and the
5 1 drug has been recognized for the medical treatment for which
5 2 it was prescribed by the American hospital formulary service
5 3 drug information, the United States pharmacopoeia dispensing
5 4 information, drugdex, or one article from a major peer-
5 5 reviewed medical journal that presents data supporting the
5 6 proposed off-label use or uses as generally safe and effective
5 7 unless there is clear and convincing contradictory evidence
5 8 presented in a major peer-reviewed medical journal. The bill
5 9 provides that such coverage also includes medically necessary
5 10 services associated with the administration of the drug.
5 11 The bill applies to third-party payment provider contracts
5 12 or policies delivered, issued for delivery, continued, or
5 13 renewed in this state on or after January 1, 2000.
5 14 LSB 2180HC 78
5 15 mj/cf/24
Text: HSB00242 Text: HSB00244 Text: HSB00200 - HSB00299 Text: HSB Index Bills and Amendments: General Index Bill History: General Index
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