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H. B. No. 384 As Passed by the HouseAs Passed by the House
128th General Assembly | Regular Session | 2009-2010 |
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Cosponsors:
Representatives Balderson, Boyd, Chandler, Daniels, Derickson, Dolan, Domenick, Evans, Fende, Garland, Hackett, Hagan, Harris, Harwood, Heard, Letson, Lundy, Newcomb, Pillich, Sears, Ujvagi, Weddington, Batchelder, Belcher, Blair, Book, Boose, Brown, Burke, Carney, Celeste, Coley, Combs, DeBose, DeGeeter, Driehaus, Dyer, Foley, Gardner, Garrison, Gerberry, Goyal, Grossman, Hall, Hite, Hottinger, Lehner, Luckie, Mandel, Mecklenborg, Okey, Otterman, Patten, Phillips, Pryor, Reece, Sayre, Skindell, Slesnick, Snitchler, Stewart, Uecker, Wachtmann, Williams, B., Winburn, Yuko, Zehringer
A BILL
To amend sections 1751.66 and 3923.60 of the Revised
Code to use the compendia adopted by the United
States Department of Health and Human Services to
determine whether an insurer may exclude coverage
for off-label drug usage.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 1751.66 and 3923.60 of the Revised
Code be amended to read as follows:
Sec. 1751.66. (A) No individual or group
health insuring
corporation policy, contract, or agreement that
provides coverage
for prescription drugs shall limit or exclude
coverage for any
drug approved by the United States food and
drug administration on
the basis that the drug has not been approved
by the United States
food and drug
administration for the treatment of the particular
indication
for which the drug has been prescribed, provided the
drug has
been recognized as safe and effective for treatment of
that
indication in one or more of the standard medical reference
compendia specified in division
(B)(1) of this section adopted by
the United States department of
health and human services under
42 U.S.C. 1395x (t)(2), as
amended, or in
medical literature that
meets the criteria specified in division
(B)(2) of this section.
(B)(1) The compendia accepted for purposes of division
(A) of
this section are the following:
(a) The "AMA drug evaluations," a publication of the
American
medical association;
(b) The "AHFS (American hospital formulary
service) drug
information," a publication of the
American society of health
system pharmacists;
(c) "Drug information
for the health care provider," a
publication of the
United States pharmacopoeia convention.
(2) Medical literature may be accepted for purposes of
division (A) of this section
only if all of the following apply:
(a)(1) Two articles from
major peer-reviewed professional
medical journals have
recognized, based on scientific or medical
criteria, the drug's
safety and effectiveness for treatment of the
indication for
which it has been prescribed;
(b)(2) No article from a
major peer-reviewed professional
medical journal has concluded,
based on scientific or medical
criteria, that the drug is unsafe
or ineffective or that the
drug's safety and effectiveness
cannot be determined for the
treatment of the indication for
which it has been prescribed;
(c)(3) Each article meets
the uniform requirements for
manuscripts submitted to biomedical
journals established by the
international committee of medical
journal editors or is published
in a journal specified by the
United States department of health
and human services
pursuant to Section 1861(t)(2)(B) of the
"Social Security Act," 107 Stat. 591
(1993), 42 U.S.C. 1395
(x)(t)(2)(B), as amended, as accepted
peer-reviewed medical
literature.
(C) Coverage of a drug
required by division (A) of
this
section includes medically necessary services associated
with the
administration of the drug.
(D) Division
(A) of this section shall not
be construed to
do any of the following:
(1) Require coverage for any drug if the
United
States food
and drug
administration has determined its use to be
contraindicated for
the treatment of the particular indication for
which the drug
has been prescribed;
(2) Require coverage for experimental drugs not approved
for
any indication by the
United
States food and drug
administration;
(3) Alter any law with regard to provisions limiting the
coverage of drugs that have not been approved by the
United
States
food and drug
administration;
(4) Require reimbursement or coverage for any drug not
included in the drug formulary or list of covered drugs
specified
in a health insuring corporation contract;
(5) Prohibit a health insuring corporation from limiting
or
excluding coverage of a drug, provided that the decision to
limit
or exclude coverage of the drug is not based primarily on
the
coverage of drugs required by this section.
(E) This section applies
only to health insuring
corporation
policies, contracts, and
agreements that are described
in
division
(A) of this section and that
are delivered, issued for
delivery, or renewed in this state on
or after July 1, 1997.
Sec. 3923.60. (A) Notwithstanding section 3901.71 of the
Revised Code, no group or individual policy of sickness and
accident insurance that provides coverage for prescription drugs
shall limit or exclude coverage for any drug approved by the
United States food and drug administration on the basis that the
drug has not
been
approved by the United States food and drug
administration for
the treatment of the particular
indication for
which the drug
has been prescribed, provided the drug has been
recognized as
safe and effective for treatment of that
indication
in one or more of the standard
medical reference compendia
specified in division (B)(1) of
this section adopted by the United
States department of health and
human services under 42 U.S.C.
1395x (t)(2), as amended, or in medical
literature that meets the
criteria specified in division
(B)(2) of
this section.
(B)(1) The compendia accepted for
purposes of division (A) of
this section are the following:
(a) The "AMA drug evaluations," a publication of the
American
medical association;
(b) The "AHFS (American hospital formulary
service) drug
information," a publication of the American society of
health
system pharmacists;
(c) "Drug information for the health care
provider," a
publication of the United States pharmacopeia
convention.
(2) Medical literature may be accepted for
purposes of
division (A) of this section only if all of the following
apply:
(a)(1) Two articles from major peer-reviewed professional
medical journals have recognized, based on
scientific or medical
criteria, the drug's safety and effectiveness for
treatment of the
indication for which it has been prescribed;
(b)(2) No article from a major
peer-reviewed professional
medical journal
has concluded, based on scientific or medical
criteria,
that the drug is unsafe or ineffective or that the
drug's safety
and effectiveness cannot be determined for the
treatment of the
indication for which it has been prescribed;
(c)(3) Each article meets the uniform
requirements for
manuscripts submitted to biomedical journals
established by the
international committee of medical journal
editors or is published
in a journal specified by the United
States department of health
and human services pursuant to
section 1861(t)(2)(B) of the
"Social Security Act," 107 Stat. 591
(1993), 42 U.S.C.
1395x(t)(2)(B), as amended, as acceptable
peer-reviewed medical
literature.
(C) Coverage of a drug required by division (A) of this
section includes medically necessary services associated with the
administration of the drug.
(D) Division (A) of this section shall not be construed to
do
any of the following:
(1) Require coverage for any drug if the United States
food
and drug administration has determined its use to be
contraindicated for the treatment of the
particular indication for
which the drug has been prescribed;
(2) Require coverage for experimental drugs not
approved for
any indication by the United States food and drug
administration;
(3) Alter any law with regard to provisions limiting the
coverage of drugs that have not been approved by the United
States
food and drug administration;
(4) Require
reimbursement or coverage for any drug not
included in the drug
formulary or list of covered drugs specified
in a policy of
sickness and accident insurance;
(5) Prohibit a
policy of sickness and accident insurance from
limiting or
excluding coverage of a drug, provided that the
decision to
limit or exclude coverage of the drug is not based
primarily on
the coverage of drugs required by this section.
(E) This section, as amended, applies
only to policies of
sickness and
accident insurance that are described in division (A)
of this
section and that are delivered, issued for delivery, or
renewed
in this state on or after the effective date of this
amendment.
Section 2. That existing sections 1751.66 and 3923.60 of the
Revised Code are hereby repealed.
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