Florida Senate - 2010 SB 2300
By Senator Altman
24-00452A-10 20102300__
1 A bill to be entitled
2 An act relating to health care facilities; amending s.
3 395.002, F.S.; redefining the term “accrediting
4 organization” as used in ch. 395, F.S., relating to
5 hospitals and other licensed facilities, to include
6 other accrediting organizations that have been
7 approved by the Federal Government for purposes of the
8 Medicare program; amending s. 499.003, F.S.;
9 redefining the term “wholesale distribution” as it
10 relates to the sale, purchase, or trade of a
11 prescription drug from certain eligible entities to a
12 contract provider or its subcontractor; providing an
13 effective date.
14
15 Be It Enacted by the Legislature of the State of Florida:
16
17 Section 1. Subsection (1) of section 395.002, Florida
18 Statutes, is amended to read:
19 395.002 Definitions.—As used in this chapter:
20 (1) “Accrediting organizations” means the Joint Commission
21 on Accreditation of Healthcare Organizations, the American
22 Osteopathic Association, the Commission on Accreditation of
23 Rehabilitation Facilities, and the Accreditation Association for
24 Ambulatory Health Care, Inc., and other accrediting
25 organizations that have been approved by the Federal Government
26 for purposes of the Medicare program.
27 Section 2. Paragraph (a) of subsection (53) of section
28 499.003, Florida Statutes, is amended to read:
29 499.003 Definitions of terms used in this part.—As used in
30 this part, the term:
31 (53) “Wholesale distribution” means distribution of
32 prescription drugs to persons other than a consumer or patient,
33 but does not include:
34 (a) Any of the following activities, which is not a
35 violation of s. 499.005(21) if such activity is conducted in
36 accordance with s. 499.01(2)(g):
37 1. The purchase or other acquisition by a hospital or other
38 health care entity that is a member of a group purchasing
39 organization of a prescription drug for its own use from the
40 group purchasing organization or from other hospitals or health
41 care entities that are members of that organization.
42 2. The sale, purchase, or trade of a prescription drug or
43 an offer to sell, purchase, or trade a prescription drug by a
44 charitable organization described in s. 501(c)(3) of the
45 Internal Revenue Code of 1986, as amended and revised, to a
46 nonprofit affiliate of the organization to the extent otherwise
47 permitted by law.
48 3. The sale, purchase, or trade of a prescription drug or
49 an offer to sell, purchase, or trade a prescription drug among
50 hospitals or other health care entities that are under common
51 control. For purposes of this subparagraph, “common control”
52 means the power to direct or cause the direction of the
53 management and policies of a person or an organization, whether
54 by ownership of stock, by voting rights, by contract, or
55 otherwise.
56 4. The sale, purchase, trade, or other transfer of a
57 prescription drug from or for any federal, state, or local
58 government agency or any entity eligible to purchase
59 prescription drugs at public health services prices pursuant to
60 Pub. L. No. 102-585, s. 602 to a contract provider or its
61 subcontractor for eligible patients of the agency or entity
62 under the following conditions:
63 a. The agency or entity must obtain written authorization
64 for the sale, purchase, trade, or other transfer of a
65 prescription drug under this subparagraph from the State Surgeon
66 General or his or her designee.
67 b. The contract provider or subcontractor must be
68 authorized by law to administer or dispense prescription drugs.
69 c. In the case of a subcontractor, the agency or entity
70 must be a party to and execute the subcontract.
71 d. A contract provider or subcontractor must maintain
72 separate and apart from other prescription drug inventory any
73 prescription drugs of the agency or entity in its possession.
74 d.e. The contract provider and subcontractor must maintain
75 and produce immediately for inspection all records of movement
76 or transfer of all the prescription drugs belonging to the
77 agency or entity, including, but not limited to, the records of
78 receipt and disposition of prescription drugs. Each contractor
79 and subcontractor dispensing or administering these drugs must
80 maintain and produce records documenting the dispensing or
81 administration. Records that are required to be maintained
82 include, but are not limited to, a perpetual inventory itemizing
83 drugs received and drugs dispensed by prescription number or
84 administered by patient identifier, which must be submitted to
85 the agency or entity quarterly.
86 e.f. The contract provider or subcontractor may administer
87 or dispense the prescription drugs only to the eligible patients
88 of the agency or entity or must return the prescription drugs
89 for or to the agency or entity. The contract provider or
90 subcontractor must require proof from each person seeking to
91 fill a prescription or obtain treatment that the person is an
92 eligible patient of the agency or entity and must, at a minimum,
93 maintain a copy of this proof as part of the records of the
94 contractor or subcontractor required under sub-subparagraph d.
95 e.
96 f.g. In addition to the departmental inspection authority
97 set forth in s. 499.051, the establishment of the contract
98 provider and subcontractor and all records pertaining to
99 prescription drugs subject to this subparagraph shall be subject
100 to inspection by the agency or entity. All records relating to
101 prescription drugs of a manufacturer under this subparagraph
102 shall be subject to audit by the manufacturer of those drugs,
103 without identifying individual patient information.
104 Section 3. This act shall take effect July 1, 2010.
105