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To amend sections 1751.66 and 3923.60 of the Revised | 1 |
Code to use the compendia adopted by the United | 2 |
States Department of Health and Human Services to | 3 |
determine whether an insurer may exclude coverage | 4 |
for off-label drug usage. | 5 |
Section 1. That sections 1751.66 and 3923.60 of the Revised | 6 |
Code be amended to read as follows: | 7 |
Sec. 1751.66. (A) No individual or group health insuring | 8 |
corporation policy, contract, or agreement that provides coverage | 9 |
for prescription drugs shall limit or exclude coverage for any | 10 |
drug approved by the United States food and drug administration on | 11 |
the basis that the drug has not been approved by the United States | 12 |
food and drug administration for the treatment of the particular | 13 |
indication for which the drug has been prescribed, provided the | 14 |
drug has been recognized as safe and effective for treatment of | 15 |
that indication in one or more of the standard medical reference | 16 |
compendia | 17 |
the United States department of health and human services under 42 | 18 |
U.S.C. 1395x(t)(2), as amended, or in medical literature that | 19 |
meets the criteria specified in division (B) | 20 |
(B) | 21 |
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division (A) of this section only if all of the following apply: | 31 |
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medical journals have recognized, based on scientific or medical | 33 |
criteria, the drug's safety and effectiveness for treatment of the | 34 |
indication for which it has been prescribed; | 35 |
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medical journal has concluded, based on scientific or medical | 37 |
criteria, that the drug is unsafe or ineffective or that the | 38 |
drug's safety and effectiveness cannot be determined for the | 39 |
treatment of the indication for which it has been prescribed; | 40 |
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manuscripts submitted to biomedical journals established by the | 42 |
international committee of medical journal editors or is published | 43 |
in a journal specified by the United States department of health | 44 |
and human services pursuant to Section 1861(t)(2)(B) of the | 45 |
"Social Security Act," 107 Stat. 591 (1993), 42 U.S.C. 1395 | 46 |
(x)(t)(2)(B), as amended, as accepted peer-reviewed medical | 47 |
literature. | 48 |
(C) Coverage of a drug required by division (A) of this | 49 |
section includes medically necessary services associated with the | 50 |
administration of the drug. | 51 |
(D) Division (A) of this section shall not be construed to do | 52 |
any of the following: | 53 |
(1) Require coverage for any drug if the United States food | 54 |
and drug administration has determined its use to be | 55 |
contraindicated for the treatment of the particular indication for | 56 |
which the drug has been prescribed; | 57 |
(2) Require coverage for experimental drugs not approved for | 58 |
any indication by the United States food and drug administration; | 59 |
(3) Alter any law with regard to provisions limiting the | 60 |
coverage of drugs that have not been approved by the United States | 61 |
food and drug administration; | 62 |
(4) Require reimbursement or coverage for any drug not | 63 |
included in the drug formulary or list of covered drugs specified | 64 |
in a health insuring corporation contract; | 65 |
(5) Prohibit a health insuring corporation from limiting or | 66 |
excluding coverage of a drug, provided that the decision to limit | 67 |
or exclude coverage of the drug is not based primarily on the | 68 |
coverage of drugs required by this section. | 69 |
(E) This section applies only to health insuring corporation | 70 |
policies, contracts, and agreements that are described in division | 71 |
(A) of this section and that are delivered, issued for delivery, | 72 |
or renewed in this state on or after July 1, 1997. | 73 |
Sec. 3923.60. (A) Notwithstanding section 3901.71 of the | 74 |
Revised Code, no group or individual policy of sickness and | 75 |
accident insurance that provides coverage for prescription drugs | 76 |
shall limit or exclude coverage for any drug approved by the | 77 |
United States food and drug administration on the basis that the | 78 |
drug has not been approved by the United States food and drug | 79 |
administration for the treatment of the particular indication for | 80 |
which the drug has been prescribed, provided the drug has been | 81 |
recognized as safe and effective for treatment of that indication | 82 |
in one or more of the standard medical reference compendia | 83 |
84 | |
States department of health and human services under 42 U.S.C. | 85 |
1395x(t)(2), as amended, or in medical literature that meets the | 86 |
criteria specified in division (B) | 87 |
(B) | 88 |
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division (A) of this section only if all of the following apply: | 98 |
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medical journals have recognized, based on scientific or medical | 100 |
criteria, the drug's safety and effectiveness for treatment of the | 101 |
indication for which it has been prescribed; | 102 |
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medical journal has concluded, based on scientific or medical | 104 |
criteria, that the drug is unsafe or ineffective or that the | 105 |
drug's safety and effectiveness cannot be determined for the | 106 |
treatment of the indication for which it has been prescribed; | 107 |
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manuscripts submitted to biomedical journals established by the | 109 |
international committee of medical journal editors or is published | 110 |
in a journal specified by the United States department of health | 111 |
and human services pursuant to section 1861(t)(2)(B) of the | 112 |
"Social Security Act," 107 Stat. 591 (1993), 42 U.S.C. | 113 |
1395x(t)(2)(B), as amended, as acceptable peer-reviewed medical | 114 |
literature. | 115 |
(C) Coverage of a drug required by division (A) of this | 116 |
section includes medically necessary services associated with the | 117 |
administration of the drug. | 118 |
(D) Division (A) of this section shall not be construed to do | 119 |
any of the following: | 120 |
(1) Require coverage for any drug if the United States food | 121 |
and drug administration has determined its use to be | 122 |
contraindicated for the treatment of the particular indication for | 123 |
which the drug has been prescribed; | 124 |
(2) Require coverage for experimental drugs not approved for | 125 |
any indication by the United States food and drug administration; | 126 |
(3) Alter any law with regard to provisions limiting the | 127 |
coverage of drugs that have not been approved by the United States | 128 |
food and drug administration; | 129 |
(4) Require reimbursement or coverage for any drug not | 130 |
included in the drug formulary or list of covered drugs specified | 131 |
in a policy of sickness and accident insurance; | 132 |
(5) Prohibit a policy of sickness and accident insurance from | 133 |
limiting or excluding coverage of a drug, provided that the | 134 |
decision to limit or exclude coverage of the drug is not based | 135 |
primarily on the coverage of drugs required by this section. | 136 |
(E) This section, as amended, applies only to policies of | 137 |
sickness and accident insurance that are described in division (A) | 138 |
of this section and that are delivered, issued for delivery, or | 139 |
renewed in this state on or after the effective date of this | 140 |
amendment. | 141 |
Section 2. That existing sections 1751.66 and 3923.60 of the | 142 |
Revised Code are hereby repealed. | 143 |