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SECOND REGULAR SESSION
HOUSE BILL NO. 2081
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE KEA THLEY .
4030H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o amend chapter 191, RSMo, by adding thereto one new section relating to the 340B drug
pricing program, with penalty provisions.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Chapter 191, RSMo, is amended by adding thereto one new section, to be
2 known as section 191.1064, to read as follows:
191.1064. 1. As used in this section, the following terms mean:
2 (1) "340B-cover ed entity":
3 (a) An entity described in 42 U.S.C. Section 256b(a)(4)(L) thr ough 42 U.S.C.
4 Section 256b(a)(4)(O) that:
5 a. Is authorized to participate in the federal 340B Drug Pricing Pr ogram under
6 Section 340B of the federal Public Health Service Act (42 U.S.C. Section 256b(a)(4));
7 and
8 b. Has a service addr ess in this state as of January first of the rep orting year;
9 and
10 (b) Any offsite outpatient facility affiliated under the 340B progra m with an
11 entity described in paragraph (a) of this subdivision;
12 (2) "340B pr ogram", the federal 340B Drug Pricing Pr ogram established under
13 42 U.S.C. Section 256b;
14 (3) "Charity car e", the unr eimbursed cost to a hospital of pr oviding, funding, or
15 otherwise financially supporting health car e services:
16 (a) T o a person classified by the hospital as financially indigent or medically
17 indigent on an inpatient or outpatient basis; and
EXPLANA TION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is
intended to be omitted from the law . Matter in bold-face type in the above bill is proposed language.
18 (b) T o financially indigent patients thr ough other nonprof it or public outpatient
19 clinics, hospitals, or health care organizations;
20 (4) "Department", the department of health and senior services;
21 (5) "Financially indigent", an uninsured or underinsured person who:
22 (a) A hospital accepts for care with no obligation or a discounted obligation to
23 pay for the services r ender ed;
24 (b) Qualifies for such car e based on a hospital's financial criteria and pr ocedur e
25 for determining whether a patient is eligible for charity car e, which shall include income
26 levels and means testing indexed to the federal poverty guidelines; and
27 (c) The hospital determines is eligible for such care under the hospital's
28 eligibility system either before or after health car e services ar e pr ovided;
29 (6) "Medically indigent", a person who:
30 (a) Receives or will re ceive medical or hospital bills, after payment by third-
31 party payers, that exceed a specified per centage of the person's annual gross income as
32 determined in accordance with the hospital's eligibility system;
33 (b) Is financially unable to pay the rem aining balance after payment by third-
34 party payers; and
35 (c) The hospital determines is eligible for assistance under the hospital's
36 eligibility system for charity car e either before or after health car e services are
37 pr ovided.
38 2. Befor e April first of each year , a 340B-cover ed entity shall r eport the following
39 information and transactions to the department concerning the 340B-covered entity's
40 participation in or participation on behalf of the 340B-covered entity in the federal 340B
41 pr ogram for the pr evious calendar year:
42 (1) The name of the 340B-cover ed entity;
43 (2) The service addr ess of the 340B-cover ed entity;
44 (3) The 340B pr ogram identification number of the 340B-cover ed entity;
45 (4) The designation of entity type, as specified in 42 U.S.C. Section 256b(a)(4), of
46 the 340B-covered entity;
47 (5) The aggrega te acquisition cost for all pr escription drugs obtained under the
48 340B pr ogram and dispensed or administer ed to patients;
49 (6) The aggrega te payment amount rec eived for all drugs obtained under the
50 340B pr ogram and dispensed or administer ed to patients;
51 (7) The aggr egate payment made to pharmacies under contract to dispense
52 drugs obtained under the 340B pr ogram;
53 (8) The number of claims for prescrip tion drugs described in subdivision (6) of
54 this subsection;
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55 (9) How the 340B-cover ed entity uses any savings fro m participating in the 340B
56 pr ogram, including the amount of savings used for the prov ision of charity car e,
57 community benefits, or a similar pro gram of pr oviding unr eimbursed or subsidized
58 health car e;
59 (10) The aggr egate payments made to any other entity that is not a 340B-cover ed
60 entity and is not a contract pharmacy as described in subdivision (7) of this subsection
61 for managing any aspect of the 340B-covered entity's 340B pr ogram;
62 (1 1) The aggre gate payment made for any other administering expense for the
63 340B pr ogram;
64 (12) The aggr egate number of prescrip tion drugs dispensed or administered to
65 patients for which a payment was repo rted under subdivision (6) of this subsection;
66 (13) The per centage of the 340B-covered entity's claims that were for
67 pr escription drugs obtained under the 340B prog ram;
68 (14) The number and percen tage of low-income patients of the 340B-cover ed
69 entity that were served by a sliding-fee scale for a pre scription drug dispensed or
70 administer ed under the 340B pr ogram;
71 (15) The 340B-cover ed entity's total operating costs;
72 (16) The 340B-cover ed entity's total costs for charity car e; and
73 (17) A copy of the 340B-cover ed entity's financial assistance policy for the
74 r eporting year .
75 3. The information requ ired to be repo rted under subdivisions (6) to (8) of
76 subsection 2 of this section shall, to the extent feasible, be repo rted by payer type,
77 including the following:
78 (1) Commer cial;
79 (2) Medicaid;
80 (3) Medicare; and
81 (4) Uninsur ed.
82 4. The data submitted in the r eports req uired under subsection 2 of this section
83 is confidential and is not available for public inspection.
84 5. Before November fifteenth of each year , the department shall pr epar e a report
85 that aggr egates the data submitted under subsection 2 of this section and:
86 (1) Submit the report to the general assembly in an electr onic format; and
87 (2) Post the r eport on the department's website.
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88 6. A 340B-covered entity that fails to prov ide the information req uired under
89 this section by the date re quir ed shall pay a fine of one thousand dollars per day that the
90 information is past due.
✔
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