As Introduced

129th General Assembly
Regular Session
2011-2012
H. B. No. 218


Representative Hottinger 

Cosponsors: Representatives Grossman, Stebelton, Carey, Blair, Buchy, Blessing, Ruhl, Maag 



A BILL
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


BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

       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 specified in division (B)(1) of this sectionadopted by 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)(2) of this section.20

       (B)(1) The compendia accepted for purposes of division (A) of 21
this section are the following:22

       (a) The "AMA drug evaluations," a publication of the American 23
medical association;24

       (b) The "AHFS (American hospital formulary service) drug 25
information," a publication of the American society of health 26
system pharmacists;27

       (c) "Drug information for the health care provider," a 28
publication of the United States pharmacopoeia convention.29

       (2) Medical literature may be accepted for purposes of 30
division (A) of this section only if all of the following apply:31

       (a)(1) Two articles from major peer-reviewed professional 32
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

       (b)(2) No article from a major peer-reviewed professional 36
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

       (c)(3) Each article meets the uniform requirements for 41
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
specified in division (B)(1) of this sectionadopted by the United 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)(2) of this section.87

       (B)(1) The compendia accepted for purposes of division (A) of 88
this section are the following:89

       (a) The "AMA drug evaluations," a publication of the American 90
medical association;91

       (b) The "AHFS (American hospital formulary service) drug 92
information," a publication of the American society of health 93
system pharmacists;94

       (c) "Drug information for the health care provider," a 95
publication of the United States pharmacopeia convention.96

       (2) Medical literature may be accepted for purposes of 97
division (A) of this section only if all of the following apply:98

       (a)(1) Two articles from major peer-reviewed professional 99
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

       (b)(2) No article from a major peer-reviewed professional 103
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

       (c)(3) Each article meets the uniform requirements for 108
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