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SECOND REGULAR SESSION
SENATE BILL NO. 1213
103RD GENERAL ASSEMBLY
INTRODUCED BY SENATOR NICOLA.
3819S.02I KRISTINA MARTIN, Secretary
AN ACT
To amend chapter 191, RSMo, by adding thereto one new section relating to the 340B drug
program.
Be it enacted by the General Assembly of the State of Missouri, as follows:
Section A. Chapter 191, RSMo, is amended by adding thereto 1
one new section, to be known as section 191.1067, to read as 2
follows:3
191.1067. 1. As used in this section, the following 1
terms mean: 2
(1) "340B covered entity" or "covered entity", an 3
entity described in 42 U.S.C. Section 256b(a)(4) that: 4
(a) Is authorized to participate in the federal 340B 5
Drug Pricing Program under Section 340B of the federal 6
Public Health Service Act, 42 U.S.C. Section 256b(a)(4), and 7
has a service address in this state as of January first of 8
the reporting year; or 9
(b) Any offsite outpatient facility affiliated under 10
the 340B program with an entity described in this 11
subdivision; 12
(2) "340B program" or "340B drug pricing program", the 13
federal 340B Drug Pricing Program established under 42 14
U.S.C. Section 256b; 15
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(3) "Charity care", the unreimbursed cost to a covered 16
entity of providing, funding, or otherwise financially 17
supporting health care services: 18
(a) To a person classified by the covered entity as 19
financially indigent or medically indigent on an inpatient 20
or outpatient basis; or 21
(b) To financially indigent patients through other 22
nonprofit or public outpatient clinics, hospitals, or health 23
care organizations; 24
(4) "Financially indigent", an uninsured or 25
underinsured person who is accepted for care with no 26
obligation or a discounted obligation to pay for the 27
services rendered based on the covered entity's financial 28
criteria and procedures used to determine if a patient is 29
eligible for charity care, provided that the criteria and 30
procedures include income levels and means testing indexed 31
to the federal poverty guidelines. A covered entity may 32
determine that a person is financially or medically indigent 33
under the covered entity's eligibility system after health 34
care services are provided; 35
(5) "Medically indigent", a person whose medical bills 36
after payment by third-party payers exceed a specified 37
percentage of the patient's annual gross income as 38
determined in accordance with the covered entity's 39
eligibility system, and who is financially unable to pay the 40
remaining bill. 41
2. Before April first of each year, a 340B covered 42
entity shall report to the department of health and senior 43
services the following information and transactions 44
concerning the 340B covered entity's participation in, or 45
participation on behalf of the 340B covered entity in, the 46
federal 340B program for the previous calendar year: 47
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(1) The 340B covered entity's: 48
(a) Name; 49
(b) Service address; 50
(c) 340B program identification number; and 51
(d) Designation of entity type as specified in 42 52
U.S.C. Section 256b(a)(4); 53
(2) The aggregate acquisition cost for all 54
prescription drugs obtained under the 340B program and 55
dispensed or administered to patients; 56
(3) The aggregate payment amount received for all 57
drugs obtained under the 340B program and dispensed or 58
administered to patients; 59
(4) The aggregate payment made to pharmacies under 60
contract to dispense drugs obtained under the 340B program; 61
(5) The number of claims for prescription drugs 62
described in subdivision (3) of this subsection; 63
(6) How the 340B covered entity uses any savings from 64
participating in the 340B program, including the amount of 65
savings used for the provision of charity care, community 66
benefits, or a similar program of providing unreimbursed or 67
subsidized health care; 68
(7) The aggregate payments made to any other entity 69
that is not a 340B covered entity and is not a contract 70
pharmacy, as described in subdivision (4) of this 71
subsection, for managing any aspect of the 340B covered 72
entity's utilization of the 340B program; 73
(8) The aggregate payment made for any other 74
administering expense for the 340B program; 75
(9) The aggregate number of prescription drugs 76
dispensed or administered to patients for which a payment 77
was reported under subdivision (3) of this subsection; 78
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(10) The percentage of the 340B covered entity's 79
claims that were for prescription drugs obtained under the 80
340B program; 81
(11) The number and percentage of low income patients 82
of the 340B covered entity that were served by a sliding fee 83
scale for a prescription drug dispensed or administered 84
under the 340B program; 85
(12) The 340B covered entity's total operating costs; 86
(13) The 340B covered entity's total costs for charity 87
care; and 88
(14) A copy of the 340B covered entity's financial 89
assistance policy for the reporting year. 90
3. The information required to be reported under 91
subdivisions (3) to (5) of subsection 2 of this section 92
shall, to the extent feasible, be reported by payer type, 93
including the following: 94
(1) Commercial; 95
(2) Medicaid or MO HealthNet; 96
(3) Medicare; and 97
(4) Uninsured. 98
4. The data submitted in the reports required under 99
subsection 2 of this section shall be closed records under 100
chapter 610. 101
5. Before November fifteenth of each year, the 102
department of health and senior services shall prepare a 103
report that aggregates the data submitted under subsections 104
2 and 3 of this section, shall provide the report to the 105
general assembly in electronic format, and shall publish the 106
report on the department's publicly accessible website. 107
6. A 340B covered entity that fails to provide the 108
information required under subsection 2 or 3 of this section 109
by the date required in this section shall be subject to a 110
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civil penalty of one thousand dollars per day the 111
information is past due. 112
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