HB 0161 2003
1	A bill to be entitled
2	An act relating to prescription drugs; creating s.
3	409.960, F.S.; providing a popular name; creating s.
4	409.962, F.S.; creating “The LifeSaver Rx Program”;
5	providing purpose of the program; creating s. 409.964,
6	F.S.; providing definitions; creating s. 409.966, F.S.;
7	providing that the Secretary of Health Care Administration
8	shall operate the LifeSaver Rx Program as a state
9	pharmaceutical assistance program to provide discounts to
10	participants for prescription drugs covered by a rebate
11	agreement; providing that the secretary shall negotiate
12	discount prices or rebates for prescription drugs from
13	manufacturers or labelers; providing that the Agency for
14	Health Care Administration shall contract with
15	participating retail pharmacies to deliver discounted
16	prices to program participants; providing factors to be
17	considered in negotiating discounts or rebates; providing
18	for quarterly calculation of discounts; creating s.
19	409.968, F.S.; providing for calculation of payment by
20	program participants and the agency; requiring
21	participating retail pharmacies in the state to charge the
22	rate allowable under the Medicaid program for prescription
23	drugs sold to program participants; providing for rate of
24	reimbursement of participating retail pharmacies; creating
25	s. 409.970, F.S.; providing requirements for program
26	eligibility; requiring the Agency for Health Care
27	Administration to establish enrollment procedures;
28	providing for an annual enrollment fee; providing for use
29	of enrollment fees and rebates from drug manufacturers;
30	creating s. 409.972, F.S.; providing for operation of the
31	program; authorizing the Board of Pharmacy to adopt
32	certain rules; creating s. 409.974, F.S.; providing
33	procedure for resolution of discrepancies in rebate
34	amounts; creating s. 409.976, F.S.; requiring an annual
35	report; creating s. 409.978, F.S.; authorizing
36	coordination with other programs; creating s. 409.980,
37	F.S.; authorizing the agency to adopt rules; creating s.
38	409.982, F.S.; authorizing the agency to seek certain
39	waivers; providing a specified contribution by the agency
40	toward the cost of prescription drugs purchased by program
41	participants; providing severability; providing an
42	appropriation; providing an effective date.
43
44	Be It Enacted by the Legislature of the State of Florida:
45
46	Section 1. Section 409.960, Florida Statutes, is created
47	to read:
48	409.960 Popular name.--Sections 409.960-409.982 shall be
49	known by the popular name "LifeSaver Rx Program."
50	Section 2. Section 409.962, Florida Statutes, is created
51	to read:
52	409.962 LifeSaver Rx Program established; findings;
53	purpose.--
54	(1) It is the finding of the Legislature that
55	approximately one in four residents of Florida have no
56	prescription drug insurance coverage or wholly inadequate
57	prescription drug insurance coverage. These uninsured residents
58	pay excessive prices for prescription drugs, far higher prices
59	than are paid by managed care organizations, insurance
60	companies, and the Federal Government for the same medicines and
61	dosages. In many cases, these excessive drug prices have the
62	effect of denying residents access to medically necessary care,
63	thereby threatening their health and safety. Many Florida
64	residents require repeated doctor or medical clinic
65	appointments, having become sicker because they could not afford
66	to purchase the prescription drugs prescribed for them. Many
67	residents are admitted to or treated at hospitals each year
68	because they cannot afford the prescription drugs that could
69	have prevented the need for hospitalization. Many others enter
70	expensive institutional care settings because they cannot afford
71	the necessary prescription drugs that could have supported them
72	outside of an institution. In each of these circumstances, state
73	medical assistance programs, including the Medicaid program,
74	literally pay the price. One major reason uninsured residents
75	pay such high prices for prescription drugs is that, unlike
76	insured residents, they have no prescription benefits manager
77	negotiating a fair price with drug companies on their behalf.
78	State government currently provides prescription drugs and acts
79	as a prescription benefit manager through a variety of health
80	plans and assistance programs and, in 2001, the Legislature
81	expanded the state's role in negotiating better prescription
82	drug prices for Medicaid. State government is the only agent
83	that, as a practical matter, can play an effective role as a
84	market participant on behalf of all residents who are uninsured
85	or underinsured. The state can and should act as a prescription
86	benefit manager, negotiating drug rebates and using these funds
87	to reimburse retail pharmacies for offering lower drug prices.
88	(2) Recognizing that the state already acts as a
89	prescription benefit manager for a variety of health plans and
90	assistance programs, including the Medicaid program, the
91	LifeSaver Rx Program is established within the Agency for Health
92	Care Administration. The purpose of the program is to expand
93	Medicaid eligibility for prescription drug benefits only, at a
94	level that does not exceed available funding, thereby providing
95	prescription drug coverage to new populations by expanding the
96	state's role as a participant in the prescription drug
97	marketplace, negotiating rebates from drug companies, and using
98	the funds from such rebates to make prescription drugs more
99	affordable to Florida residents. Each program participant shall
100	receive a discount toward the purchase of all prescription drugs
101	that are covered by the Florida Medicaid program. The
102	Legislature finds that such a program will improve public health
103	and welfare, promote the economic strength of our society, and
104	substantially benefit state health assistance programs,
105	including the Medicaid program.
106	Section 3. Section 409.964, Florida Statutes, is created
107	to read:
108	409.964 Definitions.--As used in this act, unless the
109	context otherwise indicates, the term:
110	(1) "Agency" means the Agency for Health Care
111	Administration.
112	(2) "Labeler" means an entity or person that receives
113	prescription drugs from a manufacturer or wholesaler and
114	repackages those drugs for later retail sale and that has a
115	labeler code from the federal Food and Drug Administration under
116	21 C.F.R. s. 207.20 (1999).
117	(3) "Manufacturer" means a manufacturer of prescription
118	drugs and includes a subsidiary or affiliate of a manufacturer.
119	(4) "Participating retail pharmacy" means a retail
120	pharmacy or other business licensed to dispense prescription
121	drugs in this state that:
122	(a) Participates in the state Medicaid program; or
123	(b) Agrees to participate in the LifeSaver Rx Program.
124	(5) "Program" means the LifeSaver Rx Program.
125	(6) "Secretary" means the Secretary of Health Care
126	Administration or the secretary's designee.
127	(7) "Qualified resident" means an uninsured resident of
128	the state who has obtained from the agency a LifeSaver Rx
129	Program enrollment card.
130	Section 4. Section 409.966, Florida Statutes, is created
131	to read:
132	409.966 Prescription drug discounts; negotiation of
133	discounts or rebates; calculation of discounts.--The secretary
134	shall operate the program as a state pharmaceutical assistance
135	program under 42 U.S.C. s. 1396r-8(c)(1)(C)(i)(III) to provide
136	discounts to participants for prescription drugs covered by a
137	rebate agreement.
138	(1) The secretary shall negotiate discount prices or
139	rebates for prescription drugs from drug manufacturers and
140	labelers for the program. Using sums from negotiated rebates,
141	the agency shall contract with participating retail pharmacies
142	to deliver discounted prices to program participants.
143	(2) In negotiating discount or rebate terms, the secretary
144	shall take into consideration:
145	(a) The rebate calculated under the Medicaid rebate
146	program pursuant to 42 U.S.C. s. 1396r-8;
147	(b) The price provided to eligible entities under 42
148	U.S.C. s. 256b; and
149	(c) Any other available information on prescription drug
150	prices, discounts, and rebates.
151	(3) The secretary may consider any supplemental rebate
152	negotiated pursuant to s. 409.912(38)(a)7.
153	(4) The drug discounts received by program participants
154	shall be calculated by the secretary on a quarterly basis.
155	Section 5. Section 409.968, Florida Statutes, is created
156	to read:
157	409.968 Discounted prices for program participants.--
158	(1) Each program participant’s payment shall be equal to
159	the Medicaid allowable charge for the prescription minus the
160	payment made by the agency. The payment made by the agency shall
161	include the estimated manufacturer rebate plus the state subsidy
162	of 2 percent per prescription as provided under this act and the
163	federal matching share for the state general revenue
164	contribution.
165	(2) A participating retail pharmacy shall charge the
166	Medicaid allowable rate for prescription drugs sold to
167	participants in the program.
168	(3) The participating retail pharmacy shall be reimbursed
169	by the agency at the agency's manufacturer estimated rebate
170	amount.
171	(4) The program as established in s. 409.962 is not an
172	entitlement.
173	Section 6. Section 409.970, Florida Statutes, is created
174	to read:
175	409.970 Program eligibility.--
176	(1) An individual is eligible to participate in the
177	program if he or she:
178	(a) Is a resident of the state;
179	(b) Is 65 years of age or older and is a Medicare
180	participant;
181	(c) Has a net family income at or below 300 percent of the
182	federal poverty level;
183	(d) Has exhausted all third-party prescription coverage;
184	and
185	(e) Requests to be enrolled in the program.
186	(2) An individual is ineligible to participate in the
187	program if he or she is eligible for assistance under the
188	state's Medicaid program.
189	(3) The agency shall establish simple procedures for
190	enrolling program participants. Such procedures shall include
191	the assessment of an annual enrollment fee of up to $50 per
192	enrollee. The agency shall undertake outreach efforts to build
193	public awareness of the program and maximize enrollment by
194	eligible residents. Revenues generated from program enrollment
195	fees and rebates from drug manufacturers shall be used for, but
196	not be limited to, offsetting state costs to administer the
197	program, the purchase of prescription drugs, and any public
198	awareness campaigns.
199	Section 7. Section 409.972, Florida Statutes, is created
200	to read:
201	409.972 Program operation.--
202	(1) The Board of Pharmacy, as created by s. 465.004, in
203	consultation with the agency, is authorized to adopt rules
204	pursuant to ss. 120.536(1) and 120.54 requiring disclosure by
205	participating retail pharmacies to program participants of the
206	amount of savings provided as a result of the program. Such
207	rules must protect information that is proprietary in nature.
208	(2) Participating retail pharmacies shall be paid in
209	advance for program discounts or shall be reimbursed by the
210	agency on a weekly or biweekly basis, in accordance with
211	contracts between the agency and such businesses.
212	(3) The agency shall collect from the participating retail
213	pharmacies utilization data necessary to calculate the amount of
214	the rebate from the manufacturer or labeler. The agency shall
215	protect the confidentiality of all information subject to
216	confidentiality protection under the laws of this state or
217	federal laws, rules, or regulations.
218	Section 8. Section 409.974, Florida Statutes, is created
219	to read:
220	409.974 Discrepancies in rebate amounts.--Discrepancies in
221	rebate amounts must be resolved using the process established in
222	this section.
223	(1) If there is a discrepancy in the manufacturer's or
224	labeler's favor between the amount claimed by a participating
225	retail pharmacy and the amount rebated by the manufacturer or
226	labeler, the agency, at the agency's expense, may hire a
227	mutually agreed-upon independent auditor. If a discrepancy still
228	exists following the audit, the manufacturer or labeler shall
229	justify the reason for the discrepancy or make payment to the
230	agency for any additional amount due.
231	(2) If there is a discrepancy against the interest of the
232	manufacturer or labeler in the information provided by the
233	agency to the manufacturer or labeler regarding the
234	manufacturer's or labeler's rebate, the manufacturer or labeler,
235	at the manufacturer's or labeler's expense, may hire a mutually
236	agreed-upon independent auditor to verify the accuracy of the
237	data supplied to the agency. If a discrepancy still exists
238	following the audit, the agency shall justify the reason for the
239	discrepancy or refund the manufacturer or labeler.
240	(3) Following the completion of procedures established in
241	subsection (1) or subsection (2), the agency, the manufacturer,
242	or the labeler may request a hearing. Hearings shall be
243	conducted pursuant to ss. 120.569 and 120.57. Supporting
244	documentation must accompany the request for a hearing.
245	Section 9. Section 409.976, Florida Statutes, is created
246	to read:
247	409.976 Report.--The agency shall provide a report on the
248	enrollment and financial status of the program to the Governor,
249	the President of the Senate, and the Speaker of the House of
250	Representatives by the second week in January each year.
251	Section 10. Section 409.978, Florida Statutes, is created
252	to read:
253	409.978 Coordination with other programs.--The secretary
254	shall combine drug pricing negotiations to maximize drug rebates
255	when the secretary determines that the combination of such
256	negotiations is beneficial to both the LifeSaver Rx Program and
257	another state program, including the state Medicaid program.
258	Section 11. Section 409.980, Florida Statutes, is created
259	to read:
260	409.980 Rulemaking.--The agency is authorized to adopt
261	rules pursuant to ss. 120.536(1) and 120.54 to implement the
262	provisions of this act. Such rules shall include eligibility
263	requirements, limits on participation, benefit limitations, a
264	requirement for generic drug substitution, and other program
265	parameters comparable to those of the Medicaid program.
266	Section 12. Section 409.982, Florida Statutes, is created
267	to read:
268	409.982 Waivers.--The agency shall seek any waivers of
269	federal law, rule, or regulation necessary to implement the
270	provisions of this act.
271	Section 13.The agency shall contribute 2 percent toward
272	the cost of each prescription purchased by the program
273	participant.
274	Section 14.The Legislature shall appropriate from the
275	General Revenue Fund to the Agency for Health Care
276	Administration an amount that is sufficient to implement the
277	provisions of this act.
278	Section 15.If any provision of this act or the
279	application thereof to any person or circumstance is held
280	invalid, the invalidity shall not affect other provisions or
281	applications of the act which can be given effect without the
282	invalid provision or application, and to this end the provisions
283	of this act are declared severable.
284	Section 16. This act shall take effect upon becoming a
285	law.
286