Florida Senate - 2011 COMMITTEE AMENDMENT
Bill No. CS for SB 1736
Barcode 165656
LEGISLATIVE ACTION
Senate . House
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The Committee on Budget (Fasano) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 2714 - 2718
4 and insert:
5 3. For a prescribed drug billed as a 340B prescribed
6 medication rendered to all Medicaid-eligible individuals,
7 including claims for cost sharing for which the agency is
8 responsible, the claim must meet the requirements of the Deficit
9 Reduction Act of 2005 and the federal 340B program, and contain
10 a national drug code.
11
12 Delete lines 4006 - 4018
13 and insert:
14 Section 104. Subsection (23) and paragraph (a) of
15 subsection (54) of section 499.003, Florida Statutes, are
16 amended to read:
17 499.003 Definitions of terms used in this part.—As used in
18 this part, the term:
19 (23) “Health care entity” means a closed pharmacy or any
20 person, organization, or business entity that provides
21 diagnostic, medical, surgical, or dental treatment or care, or
22 chronic or rehabilitative care, but does not include any
23 wholesale distributor or retail pharmacy licensed under state
24 law to deal in prescription drugs. However, a blood
25 establishment is a health care entity that may engage in the
26 wholesale distribution of prescription drugs under s.
27 499.01(2)(g)1.c.
28 (54) “Wholesale distribution” means distribution of
29 prescription drugs to persons other than a consumer or patient,
30 but does not include:
31 (a) Any of the following activities, which is not a
32 violation of s. 499.005(21) if such activity is conducted in
33 accordance with s. 499.01(2)(g):
34 1. The purchase or other acquisition by a hospital or other
35 health care entity that is a member of a group purchasing
36 organization of a prescription drug for its own use from the
37 group purchasing organization or from other hospitals or health
38 care entities that are members of that organization.
39 2. The sale, purchase, or trade of a prescription drug or
40 an offer to sell, purchase, or trade a prescription drug by a
41 charitable organization described in s. 501(c)(3) of the
42 Internal Revenue Code of 1986, as amended and revised, to a
43 nonprofit affiliate of the organization to the extent otherwise
44 permitted by law.
45 3. The sale, purchase, or trade of a prescription drug or
46 an offer to sell, purchase, or trade a prescription drug among
47 hospitals or other health care entities that are under common
48 control. For purposes of this subparagraph, “common control”
49 means the power to direct or cause the direction of the
50 management and policies of a person or an organization, whether
51 by ownership of stock, by voting rights, by contract, or
52 otherwise.
53 4. The sale, purchase, trade, or other transfer of a
54 prescription drug from or for any federal, state, or local
55 government agency or any entity eligible to purchase
56 prescription drugs at public health services prices pursuant to
57 Pub. L. No. 102-585, s. 602 to a contract provider or its
58 subcontractor for eligible patients of the agency or entity
59 under the following conditions:
60 a. The agency or entity must obtain written authorization
61 for the sale, purchase, trade, or other transfer of a
62 prescription drug under this subparagraph from the State Surgeon
63 General or his or her designee.
64 b. The contract provider or subcontractor must be
65 authorized by law to administer or dispense prescription drugs.
66 c. In the case of a subcontractor, the agency or entity
67 must be a party to and execute the subcontract.
68 d. A contract provider or subcontractor must maintain
69 separate and apart from other prescription drug inventory any
70 prescription drugs of the agency or entity in its possession.
71 d.e. The contract provider and subcontractor must maintain
72 and produce immediately for inspection all records of movement
73 or transfer of all the prescription drugs belonging to the
74 agency or entity, including, but not limited to, the records of
75 receipt and disposition of prescription drugs. Each contractor
76 and subcontractor dispensing or administering these drugs must
77 maintain and produce records documenting the dispensing or
78 administration. Records that are required to be maintained
79 include, but are not limited to, a perpetual inventory itemizing
80 drugs received and drugs dispensed by prescription number or
81 administered by patient identifier, which must be submitted to
82 the agency or entity quarterly.
83 e.f. The contract provider or subcontractor may administer
84 or dispense the prescription drugs only to the eligible patients
85 of the agency or entity or must return the prescription drugs
86 for or to the agency or entity. The contract provider or
87 subcontractor must require proof from each person seeking to
88 fill a prescription or obtain treatment that the person is an
89 eligible patient of the agency or entity and must, at a minimum,
90 maintain a copy of this proof as part of the records of the
91 contractor or subcontractor required under sub-subparagraph e.
92 f.g. In addition to the departmental inspection authority
93 set forth in s. 499.051, the establishment of the contract
94 provider and subcontractor and all records pertaining to
95 prescription drugs subject to this subparagraph shall be subject
96 to inspection by the agency or entity. All records relating to
97 prescription drugs of a manufacturer under this subparagraph
98 shall be subject to audit by the manufacturer of those drugs,
99 without identifying individual patient information.
100
101 ================= T I T L E A M E N D M E N T ================
102 And the title is amended as follows:
103 Delete line 360
104 and insert:
105 activities; redefining the term “wholesale
106 distribution” to delete a provision requiring certain
107 entities to keep prescription drugs of the agency
108 separate from other drugs in their inventory; amending
109 s. 499.005, F.S.; clarifying