As Reported by the House Insurance Committee

128th General Assembly Regular Session 2009-2010

H. B. No. 384

Representative Bolon 

Cosponsors: Representatives Balderson, Boyd, Chandler, Daniels, Derickson, Dolan, Domenick, Evans, Fende, Garland, Hackett, Hagan, Harris, Harwood, Heard, Letson, Lundy, Newcomb, Pillich, Sears, Ujvagi, Weddington 

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A BILL

To amend sections 1751.66 and 3923.60 of the Revised

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Code to use the compendia adopted by the United

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States Department of Health and Human Services to

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determine whether an insurer may exclude coverage

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for off-label drug usage.

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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	18
42 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	52
do 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	71
division (A) of this section and that are delivered, issued for	72
delivery, 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