Wisconsin 2023-2024 Regular Session

Wisconsin Assembly Bill AB748 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	LRB-4895/1
2	2	JPC&KRP:all
3	3	2023 - 2024 LEGISLATURE
4	4	2023 ASSEMBLY BILL 748
5	5	December 6, 2023 - Introduced by Representatives SUBECK, C. ANDERSON, J.
6	6	ANDERSON, ANDRACA, BARE, BILLINGS, CLANCY, CONLEY, CONSIDINE, DRAKE,
7	7	EMERSON, HONG, JACOBSON, JOERS, MADISON, MOORE OMOKUNDE, NEUBAUER,
8	8	ORTIZ-VELEZ, PALMERI, RATCLIFF, RIEMER, SHANKLAND, SHELTON, SINICKI,
9	9	STUBBS and HAYWOOD, cosponsored by Senators H ESSELBEIN, AGARD,
10	10	CARPENTER, L. JOHNSON, PFAFF, ROYS, SMITH, SPREITZER, TAYLOR and WIRCH.
11	11	Referred to Committee on Health, Aging and Long-Term Care.
12	12	*AUTHORS SUBJECT TO CHANGE*
13	13	AN ACT to repeal 49.45 (18) (ag); to renumber and amend 632.895 (6); to
14	14	amend 49.45 (18) (ac), 609.83 and 632.895 (6) (title); and to create 20.145 (1)
15	15	(a), 49.45 (18) (b) 8., 255.056 (2g), 450.085 (3), 601.31 (1) (nv), 601.31 (1) (nw),
16	16	601.41 (13), 601.415 (14), 601.575, 632.863, 632.864, 632.865 (2m), 632.868,
17	17	632.869 and 632.895 (6) (b) of the statutes; relating to: health care costs
18	18	omnibus, granting rule-making authority, making an appropriation, and
19	19	providing a penalty.
20	20	Analysis by the Legislative Reference Bureau
21	21	Elimination of cost sharing for prescription drugs under the Medical
22	22	Assistance program
23	23	Under current law, certain persons who receive health services under the
24	24	Medical Assistance program, also known in this state as BadgerCare, are required
25	25	to contribute a cost-sharing payment to the cost of certain health services. This bill
26	26	eliminates all cost-sharing payments for prescription drugs under the Medical
27	27	Assistance program. The Medical Assistance program is a joint state and federal
28	28	program that provides health services to individuals who have limited financial
29	29	resources.
30	30	1
31	31	2
32	32	3
33	33	4
34	34	5
35	35	6
36	36	7 - 2 -2023 - 2024 Legislature LRB-4895/1
37	37	JPC&KRP:all
38	38	ASSEMBLY BILL 748
39	39	Cost-sharing cap on insulin
40	40	This bill prohibits every health insurance policy and governmental
41	41	self-insured health plan that cover insulin and impose cost sharing on prescription
42	42	drugs from imposing cost sharing on insulin in an amount that exceeds $35 for a
43	43	one-month supply. Current law requires every health insurance policy that provides
44	44	coverage of expenses incurred for treatment of diabetes to provide coverage for
45	45	specified expenses and items, including insulin. The required coverage under
46	46	current law for certain diabetes treatments other than insulin infusion pumps is
47	47	subject to the same exclusions, limitations, deductibles, and coinsurance provisions
48	48	of the policy as other covered expenses. The bill's cost-sharing limitation on insulin
49	49	supersedes the specification that the exclusions, limitations, deductibles, and
50	50	coinsurance are the same as for other coverage.
51	51	Fiduciary and disclosure requirements for pharmacy benefit managers
52	52	The bill imposes fiduciary and disclosure requirements on pharmacy benefit
53	53	managers. Pharmacy benefit managers contract with health plans that provide
54	54	prescription drug benefits to administer those benefits for the plans. They also have
55	55	contracts with pharmacies and pay the pharmacies for providing the drugs to the
56	56	plan beneficiaries.
57	57	The bill provides that a pharmacy benefit manager owes a fiduciary duty to a
58	58	plan sponsor. The bill also requires that a pharmacy benefit manager annually
59	59	disclose all of the following information to the plan sponsor:
60	60	1. The indirect profit received by the pharmacy benefit manager from owning
61	61	a pharmacy or service provider.
62	62	2. Any payments made to a consultant or broker who works on behalf of the plan
63	63	sponsor.
64	64	3. From the amounts received from drug manufacturers, the amounts retained
65	65	by the pharmacy benefit manager that are related to the plan sponsor's claims or
66	66	bona fide service fees.
67	67	4. The amounts received from network pharmacies and the amount retained
68	68	by the pharmacy benefit manager.
69	69	Reimbursements for certain 340B program entities
70	70	The bill prohibits any person from reimbursing certain entities that participate
71	71	in the federal drug pricing program, known as the 340B program, for a drug subject
72	72	to an agreement under the program at a rate lower than that paid for the same drug
73	73	to pharmacies that have a similar prescription volume. The bill also prohibits a
74	74	person from imposing any fee, charge back, or other adjustment on the basis of the
75	75	entity's participation in the 340B program. The entities covered by the prohibitions
76	76	under the bill are federally qualified health centers, critical access hospitals, and
77	77	grantees under the federal Ryan White HIV/AIDS program, as well as these entities'
78	78	pharmacies and any pharmacy with which any of the entities have contracted to
79	79	dispense drugs through the 340B program.
80	80	Drug repository program
81	81	Under current law, the Department of Health Services must maintain a drug
82	82	repository program under which persons may donate certain drugs or supplies that - 3 -2023 - 2024 Legislature
83	83	LRB-4895/1
84	84	JPC&KRP:all
85	85	ASSEMBLY BILL 748
86	86	may be used by other individuals identified by DHS by rule. The bill allows DHS to
87	87	partner with out-of-state drug repository programs. The bill also allows
88	88	out-of-state persons to donate to the drug repository program in Wisconsin, and
89	89	persons in Wisconsin to donate to participating drug repository programs in other
90	90	states. Further, the bill directs DHS to study and implement a centralized physical
91	91	drug repository program.
92	92	Value-based diabetes medication pilot project
93	93	The bill directs the Office of the Commissioner of Insurance to develop a pilot
94	94	project under which a pharmacy benefit manager and pharmaceutical manufacturer
95	95	are directed to create a value-based, sole-source arrangement to reduce the costs of
96	96	prescription diabetes medication. The bill allows OCI to promulgate rules to
97	97	implement the pilot project.
98	98	Pharmacist continuing education credits for volunteering at free and
99	99	charitable clinics
100	100	Under current law, a licensed pharmacist must renew his or her license every
101	101	two years. An applicant for renewal of a pharmacist license must submit proof that
102	102	he or she has completed 30 hours of continuing education within the two-year period
103	103	immediately preceding the date of his or her application. The bill allows pharmacists
104	104	to meet up to 10 hours of the continuing education requirement for each two-year
105	105	period by volunteering at a free and charitable clinic.
106	106	Prescription drug importation program
107	107	The bill requires the commissioner of insurance, in consultation with persons
108	108	interested in the sale and pricing of prescription drugs and federal officials and
109	109	agencies, to design and implement a prescription drug importation program for the
110	110	benefit of and that generates savings for Wisconsin residents. The bill establishes
111	111	requirements for the program, including all of the following:
112	112	1. The commissioner must designate a state agency to become a licensed
113	113	wholesale distributor or contract with a licensed wholesale distributor and to seek
114	114	federal certification and approval to import prescription drugs.
115	115	2. The program must comply with certain federal regulations and import from
116	116	Canadian suppliers only prescription drugs that are not brand-name drugs, have
117	117	fewer than four competitor drugs in this country, and for which importation creates
118	118	substantial savings.
119	119	3. The commissioner must ensure that prescription drugs imported under the
120	120	program are not distributed, dispensed, or sold outside of Wisconsin.
121	121	4. The program must have an audit procedure to ensure the program complies
122	122	with certain requirements specified in the bill.
123	123	Before submitting the proposed program to the federal government for
124	124	certification, the commissioner must submit the proposed program to the Joint
125	125	Committee on Finance for its approval.
126	126	Pharmacy benefits tool grants
127	127	The bill directs OCI to award grants in an amount of up to $500,000 in each
128	128	fiscal year to health care providers to develop and implement a tool that would allow
129	129	prescribers to disclose the cost of prescription drugs for patients. The tool must be - 4 -2023 - 2024 Legislature LRB-4895/1
130	130	JPC&KRP:all
131	131	ASSEMBLY BILL 748
132	132	usable by physicians and other prescribers to determine the cost of prescription
133	133	drugs for their patients. Any health care provider that receives a grant to develop
134	134	and implement a patient pharmacy benefits tool is required to contribute matching
135	135	funds equal to at least 50 percent of the total grant awarded.
136	136	Prescription drug purchasing entity study
137	137	The bill requires OCI to conduct a study on the viability of creating or
138	138	implementing a state prescription drug purchasing entity.
139	139	Licensure of pharmacy services administrative organizations
140	140	The bill requires that a pharmacy services administrative organization (PSAO)
141	141	be licensed by OCI. Under the bill, a PSAO is an entity operating in Wisconsin that
142	142	does all of the following:
143	143	1. Contracts with an independent pharmacy to conduct business on the
144	144	pharmacy's behalf with a third-party payer.
145	145	2. Provides at least one administrative service to an independent pharmacy
146	146	and negotiates and enters into a contract with a third-party payer or pharmacy
147	147	benefit manager on the pharmacy's behalf.
148	148	The bill defines “independent pharmacy" to mean a licensed pharmacy
149	149	operating in Wisconsin that is under common ownership with no more than two other
150	150	pharmacies. “Administrative service” is defined to mean assisting with claims or
151	151	audits, providing centralized payment, performing certification in a specialized care
152	152	program, providing compliance support, setting flat fees for generic drugs, assisting
153	153	with store layout, managing inventory, providing marketing support, providing
154	154	management and analysis of payment and drug dispensing data, or providing
155	155	resources for retail cash cards. The bill defines “third-party payer” to mean an entity
156	156	operating in Wisconsin that pays or insures health, medical, or prescription drug
157	157	expenses on behalf of beneficiaries. The bill uses the current law definition of
158	158	“pharmacy benefit manager," which is an entity doing business in Wisconsin that
159	159	contracts to administer or manage prescription drug benefits on behalf of an insurer
160	160	or other entity that provides prescription drug benefits to Wisconsin residents.
161	161	To obtain the license required by the bill, a person must apply to OCI and
162	162	provide the contact information for the applicant and a contact person, evidence of
163	163	financial responsibility of at least $1,000,000, and any other information required by
164	164	the commissioner. Under the bill, the license fee is set by the commissioner, and the
165	165	term of a license is two years.
166	166	The bill also requires that a PSAO disclose to OCI the extent of any ownership
167	167	or control by an entity that provides pharmacy services; provides prescription drug
168	168	or device services; or manufactures, sells, or distributes prescription drugs,
169	169	biologicals, or medical devices. The PSAO must notify OCI within five days of any
170	170	material change in its ownership or control related to such an entity.
171	171	Licensure of pharmaceutical representatives
172	172	The bill requires a pharmaceutical representative to be licensed by OCI and to
173	173	display the pharmaceutical representative's license during each visit with a health
174	174	care professional. The bill defines “pharmaceutical representative” to mean an
175	175	individual who markets or promotes pharmaceuticals to health care professionals on
176	176	behalf of a pharmaceutical manufacturer for compensation. - 5 -2023 - 2024 Legislature
177	177	LRB-4895/1
178	178	JPC&KRP:all
179	179	ASSEMBLY BILL 748
180	180	The term of a license issued under the bill is one year, and the license is
181	181	renewable. The application to obtain or renew a license must include the applicant's
182	182	contact information, a description of the type of work in which the applicant will
183	183	engage, the license fee, an attestation that professional education requirements are
184	184	met, proof that any penalties and other fees are paid, and any other information
185	185	required by OCI. Under the bill, the license fee is set by the commissioner. The bill
186	186	requires the pharmaceutical representative to report, within four business days, any
187	187	change to the information provided on the application or any material change to the
188	188	pharmaceutical representative's business operations or other information required
189	189	to be reported under the bill.
190	190	The bill requires that a pharmaceutical representative complete a professional
191	191	education course prior to becoming licensed and to annually complete at least five
192	192	hours of continuing professional education courses. The coursework must include,
193	193	at a minimum, training in ethical standards, whistleblower protections, and the laws
194	194	and rules applicable to pharmaceutical marketing. The bill directs the commissioner
195	195	to regularly publish a list of courses that fulfill the education requirements. Under
196	196	the bill, a course provider must disclose any conflict of interest, and the courses may
197	197	not be provided by the employer of a pharmaceutical representative or be funded by
198	198	the pharmaceutical industry or a third party funded by the industry.
199	199	The bill requires that, no later than June 1 of each year, a pharmaceutical
200	200	representative report to OCI the pharmaceutical representative's total number of
201	201	contacts with health care professionals in Wisconsin, the specialties of those health
202	202	care professionals, the location and duration of each contact, the pharmaceuticals
203	203	discussed, and the value of any item provided to a health care professional. The bill
204	204	directs the commissioner to publish the information on OCI's website, without
205	205	identifying individual health care professionals.
206	206	The bill requires that a pharmaceutical representative, during each contact
207	207	with a health care professional, disclose the wholesale acquisition cost of any
208	208	pharmaceuticals discussed and the names of at least three generic prescription
209	209	drugs from the same therapeutic class.
210	210	The bill directs the commissioner to promulgate ethical standards for
211	211	pharmaceutical representatives. Additionally, the bill prohibits a pharmaceutical
212	212	representative from engaging in deceptive or misleading marketing of a
213	213	pharmaceutical product; using a title or designation that could reasonably lead a
214	214	licensed health care professional, or an employee or representative of such a
215	215	professional, to believe that the pharmaceutical representative is licensed to practice
216	216	in a health occupation unless the pharmaceutical representative holds a license to
217	217	practice in that health occupation; or attending a patient examination without the
218	218	patient's consent.
219	219	An individual who violates any of the requirements under this bill is subject to
220	220	a fine, and the individual's license may be suspended or revoked. An individual
221	221	whose license is revoked must wait at least two years before applying for a new
222	222	license. - 6 -2023 - 2024 Legislature LRB-4895/1
223	223	JPC&KRP:all
224	224	ASSEMBLY BILL 748
225	225	Insulin safety net programs
226	226	The bill requires insulin manufacturers to establish a program under which
227	227	qualifying Wisconsin residents who are in urgent need of insulin and are uninsured
228	228	or have limited insurance coverage can be dispensed insulin at a pharmacy. Under
229	229	the program, if a qualifying individual in urgent need of insulin provides a pharmacy
230	230	with a form attesting that the individual meets the program's eligibility
231	231	requirements, specified proof of residency, and a valid insulin prescription, the
232	232	pharmacy must dispense a 30-day supply of insulin to the individual and may charge
233	233	the individual a copayment of no more than $35. The pharmacy may submit an
234	234	electronic payment claim for the insulin's acquisition cost to the manufacturer or
235	235	agree to receive a replacement of the same insulin in the amount dispensed.
236	236	The bill also requires that each insulin manufacturer establish a patient
237	237	assistance program to make insulin available to any qualifying Wisconsin resident
238	238	who, among other requirements, is uninsured or has limited insurance coverage and
239	239	whose family income does not exceed 400 percent of the federal poverty line. Under
240	240	the bill, an individual must apply to participate in a manufacturer's program. If the
241	241	manufacturer determines that the individual meets the program's eligibility
242	242	requirements, the manufacturer must issue the individual a statement of eligibility,
243	243	which is valid for 12 months and may be renewed. Under the bill, if an individual
244	244	with a statement of eligibility and valid insulin prescription requests insulin from
245	245	a pharmacy, the pharmacy must submit an order to the manufacturer, who must then
246	246	provide a 90-day supply of insulin at no charge to the individual or pharmacy. The
247	247	pharmacy may charge the individual a copayment of no more than $50. Under the
248	248	bill, a manufacturer is not required to issue a statement of eligibility if the individual
249	249	has prescription drug coverage through an individual or group health plan and the
250	250	manufacturer determines that the individual's insulin needs are better addressed
251	251	through the manufacturer's copayment assistance program. In such case, the
252	252	manufacturer must provide the individual with the necessary drug coupons, and the
253	253	individual may not be required to pay more than a $50 copayment for a 90-day
254	254	supply of insulin.
255	255	Under the bill, if the manufacturer determines that an individual is not eligible
256	256	for the patient assistance program, the individual may file an appeal with OCI. The
257	257	bill directs OCI to establish procedures for deciding appeals. Under the bill, OCI
258	258	must issue a decision within 10 days, and that decision is final.
259	259	The bill requires that insulin manufacturers annually report to OCI certain
260	260	information, including the number of individuals served and the cost of insulin
261	261	dispensed under the programs and that OCI annually report to the governor and the
262	262	legislature on the programs. The bill also directs OCI to conduct public outreach and
263	263	develop an information sheet about the programs, conduct satisfaction surveys of
264	264	individuals and pharmacies that participate in the programs, and report to the
265	265	governor and the legislature on the surveys by July 1, 2026. Additionally, the bill
266	266	requires that OCI develop a training program for health care navigators to assist
267	267	individuals in accessing appropriate long-term insulin options and maintain a list
268	268	of trained navigators. - 7 -2023 - 2024 Legislature
269	269	LRB-4895/1
270	270	JPC&KRP:all
271	271	ASSEMBLY BILL 748
272	272	The bill provides that a manufacturer that fails to comply with the bill's
273	273	provisions may be assessed a penalty of up to $200,000 per month of noncompliance,
274	274	which increases to $400,000 per month if the manufacturer continues to be in
275	275	noncompliance after six months and to $600,000 per month if the manufacturer
276	276	continues to be in noncompliance after one year. The bill's requirements do not apply
277	277	to manufacturers with annual insulin sales revenue in Wisconsin of no more than
278	278	$2,000,000 or to insulin that costs less than a specified dollar amount.
279	279	This proposal may contain a health insurance mandate requiring a social and
280	280	financial impact report under s. 601.423, stats.
281	281	Because this bill creates a new crime or revises a penalty for an existing crime,
282	282	the Joint Review Committee on Criminal Penalties may be requested to prepare a
283	283	report.
284	284	For further information see the state fiscal estimate, which will be printed as
285	285	an appendix to this bill.
286	286	The people of the state of Wisconsin, represented in senate and assembly, do
287	287	enact as follows:
288	288	SECTION 1. 20.005 (3) (schedule) of the statutes: at the appropriate place, insert
289	289	the following amounts for the purposes indicated:
290	290	2023-24 2024-25
291	291	20.145 Insurance, office of the commissioner of
292	292	(1) SUPERVISION OF THE INSURANCE INDUSTRY
293	293	(a)State operations GPR A -0- 500,000
294	294	SECTION 2. 20.145 (1) (a) of the statutes is created to read:
295	295	20.145 (1) (a) State operations. The amounts in the schedule for general
296	296	program operations.
297	297	SECTION 3. 49.45 (18) (ac) of the statutes is amended to read:
298	298	49.45 (18) (ac) Except as provided in pars. (am) to (d), and subject to par. (ag),
299	299	any person eligible for medical assistance under s. 49.46, 49.468, or 49.47, or for the
300	300	benefits under s. 49.46 (2) (a) and (b) under s. 49.471, shall pay up to the maximum
301	301	1
302	302	2
303	303	3
304	304	4
305	305	5
306	306	6
307	307	7
308	308	8
309	309	9
310	310	10
311	311	11
312	312	12 - 8 -2023 - 2024 Legislature LRB-4895/1
313	313	JPC&KRP:all
314	314	SECTION 3 ASSEMBLY BILL 748
315	315	amounts allowable under 42 CFR 447.53 to 447.58 for purchases of services provided
316	316	under s. 49.46 (2). The service provider shall collect the specified or allowable
317	317	copayment, coinsurance, or deductible, unless the service provider determines that
318	318	the cost of collecting the copayment, coinsurance, or deductible exceeds the amount
319	319	to be collected. The department shall reduce payments to each provider by the
320	320	amount of the specified or allowable copayment, coinsurance, or deductible. No
321	321	provider may deny care or services because the recipient is unable to share costs, but
322	322	an inability to share costs specified in this subsection does not relieve the recipient
323	323	of liability for these costs.
324	324	SECTION 4. 49.45 (18) (ag) of the statutes is repealed.
325	325	SECTION 5. 49.45 (18) (b) 8. of the statutes is created to read:
326	326	49.45 (18) (b) 8. Prescription drugs.
327	327	SECTION 6. 255.056 (2g) of the statutes is created to read:
328	328	255.056 (2g) The department may partner with out-of-state drug repository
329	329	programs. The department may authorize a medical facility or pharmacy that elects
330	330	to participate in the drug repository program to receive drugs or supplies from out
331	331	of state, and the department may authorize an out-of-state entity that participates
332	332	in a partner out-of-state drug repository program to receive drugs or supplies from
333	333	Wisconsin.
334	334	SECTION 7. 450.085 (3) of the statutes is created to read:
335	335	450.085 (3) An applicant for renewal of a license under s. 450.08 (2) (a) may
336	336	count, for purposes of the continuing education requirement under sub. (1), up to 10
337	337	hours spent as a volunteer at a free and charitable clinic approved by the board.
338	338	SECTION 8. 601.31 (1) (nv) of the statutes is created to read:
339	339	1
340	340	2
341	341	3
342	342	4
343	343	5
344	344	6
345	345	7
346	346	8
347	347	9
348	348	10
349	349	11
350	350	12
351	351	13
352	352	14
353	353	15
354	354	16
355	355	17
356	356	18
357	357	19
358	358	20
359	359	21
360	360	22
361	361	23
362	362	24 - 9 -2023 - 2024 Legislature
363	363	LRB-4895/1
364	364	JPC&KRP:all
365	365	SECTION 8
366	366	ASSEMBLY BILL 748
367	367	601.31 (1) (nv) For issuing or renewing a license as a pharmaceutical
368	368	representative under s. 632.863, an amount to be set by the commissioner by rule.
369	369	SECTION 9. 601.31 (1) (nw) of the statutes is created to read:
370	370	601.31 (1) (nw) For issuing or renewing a license as a pharmacy services
371	371	administrative organization under s. 632.864, an amount to be set by the
372	372	commissioner by rule.
373	373	SECTION 10. 601.41 (13) of the statutes is created to read:
374	374	601.41 (13) VALUE-BASED DIABETES MEDICATION PILOT PROJECT. The
375	375	commissioner shall develop a pilot project to direct a pharmacy benefit manager, as
376	376	defined in s. 632.865 (1) (c), and a pharmaceutical manufacturer to create a
377	377	value-based, sole-source arrangement to reduce the costs of prescription medication
378	378	used to treat diabetes. The commissioner may promulgate rules to implement this
379	379	subsection.
380	380	SECTION 11. 601.415 (14) of the statutes is created to read:
381	381	601.415 (14) PATIENT PHARMACY BENEFITS TOOL. (a) From the appropriation
382	382	under s. 20.145 (1) (a), beginning in the 2024-25 fiscal year, the office shall award
383	383	grants in a total amount of up to $500,000 each fiscal year to health care providers
384	384	to develop and implement a tool for prescribers to disclose the cost of prescription
385	385	drugs for patients. The tool must be usable by physicians and other prescribers to
386	386	determine the cost of prescription drugs for their patients.
387	387	(b) Any health care provider that receives a grant under par. (a) shall contribute
388	388	matching funds equal to at least 50 percent of the grant amount awarded.
389	389	SECTION 12. 601.575 of the statutes is created to read:
390	390	601.575 Prescription drug importation program. (1) IMPORTATION
391	391	PROGRAM REQUIREMENTS. The commissioner, in consultation with persons interested
392	392	1
393	393	2
394	394	3
395	395	4
396	396	5
397	397	6
398	398	7
399	399	8
400	400	9
401	401	10
402	402	11
403	403	12
404	404	13
405	405	14
406	406	15
407	407	16
408	408	17
409	409	18
410	410	19
411	411	20
412	412	21
413	413	22
414	414	23
415	415	24
416	416	25 - 10 -2023 - 2024 Legislature LRB-4895/1
417	417	JPC&KRP:all
418	418	SECTION 12 ASSEMBLY BILL 748
419	419	in the sale and pricing of prescription drugs and appropriate officials and agencies
420	420	of the federal government, shall design and implement a prescription drug
421	421	importation program for the benefit of residents of this state, that generates savings
422	422	for residents, and that satisfies all of the following:
423	423	(a) The commissioner shall designate a state agency to become a licensed
424	424	wholesale distributor or to contract with a licensed wholesale distributor and shall
425	425	seek federal certification and approval to import prescription drugs.
426	426	(b) The program shall comply with relevant requirements of 21 USC 384,
427	427	including safety and cost savings requirements.
428	428	(c) The program shall import prescription drugs from Canadian suppliers
429	429	regulated under any appropriate Canadian or provincial laws.
430	430	(d) The program shall have a process to sample the purity, chemical
431	431	composition, and potency of imported prescription drugs.
432	432	(e) The program shall import only those prescription drugs for which
433	433	importation creates substantial savings for residents of this state and only those
434	434	prescription drugs that are not brand-name drugs and that have fewer than 4
435	435	competitor prescription drugs in the United States.
436	436	(f) The commissioner shall ensure that prescription drugs imported under the
437	437	program are not distributed, dispensed, or sold outside of this state.
438	438	(g) The program shall ensure all of the following:
439	439	1. Participation by any pharmacy or health care provider in the program is
440	440	voluntary.
441	441	2. Any pharmacy or health care provider participating in the program has the
442	442	appropriate license or other credential in this state.
443	443	1
444	444	2
445	445	3
446	446	4
447	447	5
448	448	6
449	449	7
450	450	8
451	451	9
452	452	10
453	453	11
454	454	12
455	455	13
456	456	14
457	457	15
458	458	16
459	459	17
460	460	18
461	461	19
462	462	20
463	463	21
464	464	22
465	465	23
466	466	24 - 11 -2023 - 2024 Legislature
467	467	LRB-4895/1
468	468	JPC&KRP:all
469	469	SECTION 12
470	470	ASSEMBLY BILL 748
471	471	3. Any pharmacy or health care provider participating in the program charges
472	472	a consumer or health plan the actual acquisition cost of the imported prescription
473	473	drug that is dispensed.
474	474	(h) The program shall ensure that a payment by a health plan or health
475	475	insurance policy for a prescription drug imported under the program reimburses no
476	476	more than the actual acquisition cost of the imported prescription drug that is
477	477	dispensed.
478	478	(i) The program shall ensure that any health plan or health insurance policy
479	479	participating in the program does all of the following:
480	480	1. Maintains a formulary and claims payment system with current information
481	481	on prescription drugs imported under the program.
482	482	2. Bases cost-sharing amounts for participants or insureds under the plan or
483	483	policy on no more than the actual acquisition cost of the prescription drug imported
484	484	under the program that is dispensed to the participant or insured.
485	485	3. Demonstrates to the commissioner or a state agency designated by the
486	486	commissioner how premiums under the plan or policy are affected by savings on
487	487	prescription drugs imported under the program.
488	488	(j) Any wholesale distributor importing prescription drugs under the program
489	489	shall limit its profit margin to the amount established by the commissioner or a state
490	490	agency designated by the commissioner.
491	491	(k) The program may not import any generic prescription drug that would
492	492	violate federal patent laws on branded products in the United States.
493	493	(L) The program shall comply with tracking and tracing requirements of 21
494	494	USC 360eee and 360eee-1, to the extent practical and feasible, before the
495	495	prescription drug to be imported comes into the possession of this state's wholesale
496	496	1
497	497	2
498	498	3
499	499	4
500	500	5
501	501	6
502	502	7
503	503	8
504	504	9
505	505	10
506	506	11
507	507	12
508	508	13
509	509	14
510	510	15
511	511	16
512	512	17
513	513	18
514	514	19
515	515	20
516	516	21
517	517	22
518	518	23
519	519	24
520	520	25 - 12 -2023 - 2024 Legislature LRB-4895/1
521	521	JPC&KRP:all
522	522	SECTION 12 ASSEMBLY BILL 748
523	523	distributor and fully after the prescription drug to be imported is in the possession
524	524	of this state's wholesale distributor.
525	525	(m) The program shall establish a fee or other mechanism to finance the
526	526	program that does not jeopardize significant savings to residents of this state.
527	527	(n) The program shall have an audit function that ensures all of the following:
528	528	1. The commissioner has a sound methodology to determine the most
529	529	cost-effective prescription drugs to include in the program.
530	530	2. The commissioner has a process in place to select Canadian suppliers that
531	531	are high quality, high performing, and in full compliance with Canadian laws.
532	532	3. Prescription drugs imported under the program are pure, unadulterated,
533	533	potent, and safe.
534	534	4. The program is complying with the requirements of this subsection.
535	535	5. The program is adequately financed to support administrative functions of
536	536	the program while generating significant cost savings to residents of this state.
537	537	6. The program does not put residents of this state at a higher risk than if the
538	538	program did not exist.
539	539	7. The program provides and is projected to continue to provide substantial cost
540	540	savings to residents of this state.
541	541	(2) ANTICOMPETITIVE BEHAVIOR. The commissioner, in consultation with the
542	542	attorney general, shall identify the potential for and monitor anticompetitive
543	543	behavior in industries affected by a prescription drug importation program.
544	544	(3) APPROVAL OF PROGRAM DESIGN; CERTIFICATION. No later than the first day of
545	545	the 7th month beginning after the effective date of this subsection .... [LRB inserts
546	546	date], the commissioner shall submit to the joint committee on finance a report that
547	547	includes the design of the prescription drug importation program in accordance with
548	548	1
549	549	2
550	550	3
551	551	4
552	552	5
553	553	6
554	554	7
555	555	8
556	556	9
557	557	10
558	558	11
559	559	12
560	560	13
561	561	14
562	562	15
563	563	16
564	564	17
565	565	18
566	566	19
567	567	20
568	568	21
569	569	22
570	570	23
571	571	24
572	572	25 - 13 -2023 - 2024 Legislature
573	573	LRB-4895/1
574	574	JPC&KRP:all
575	575	SECTION 12
576	576	ASSEMBLY BILL 748
577	577	this section. The commissioner may not submit the proposed program to the federal
578	578	department of health and human services unless the joint committee on finance
579	579	approves the proposed program. Within 14 days of the date of approval by the joint
580	580	committee on finance of the proposed program, the commissioner shall submit to the
581	581	federal department of health and human services a request for certification of the
582	582	approved program.
583	583	(4) IMPLEMENTATION OF CERTIFIED PROGRAM. After the federal department of
584	584	health and human services certifies the prescription drug importation program
585	585	submitted under sub. (3), the commissioner shall begin implementation of the
586	586	program, and the program shall be fully operational by 180 days after the date of
587	587	certification by the federal department of health and human services. The
588	588	commissioner shall do all of the following to implement the program to the extent the
589	589	action is in accordance with other state laws and the certification by the federal
590	590	department of health and human services:
591	591	(a) Become a licensed wholesale distributor, designate another state agency to
592	592	become a licensed wholesale distributor, or contract with a licensed wholesale
593	593	distributor.
594	594	(b) Contract with one or more Canadian suppliers that meet the criteria in sub.
595	595	(1) (c) and (n).
596	596	(c) Create an outreach and marketing plan to communicate with and provide
597	597	information to health plans and health insurance policies, employers, pharmacies,
598	598	health care providers, and residents of this state on participating in the program.
599	599	(d) Develop and implement a registration process for health plans and health
600	600	insurance policies, pharmacies, and health care providers interested in participating
601	601	in the program.
602	602	1
603	603	2
604	604	3
605	605	4
606	606	5
607	607	6
608	608	7
609	609	8
610	610	9
611	611	10
612	612	11
613	613	12
614	614	13
615	615	14
616	616	15
617	617	16
618	618	17
619	619	18
620	620	19
621	621	20
622	622	21
623	623	22
624	624	23
625	625	24
626	626	25 - 14 -2023 - 2024 Legislature LRB-4895/1
627	627	JPC&KRP:all
628	628	SECTION 12 ASSEMBLY BILL 748
629	629	(e) Create a publicly accessible source for listing prices of prescription drugs
630	630	imported under the program.
631	631	(f) Create, publicize, and implement a method of communication to promptly
632	632	answer questions from and address the needs of persons affected by the
633	633	implementation of the program before the program is fully operational.
634	634	(g) Establish the audit functions under sub. (1) (n) with a timeline to complete
635	635	each audit function every 2 years.
636	636	(h) Conduct any other activities determined by the commissioner to be
637	637	important to successful implementation of the program.
638	638	(5) REPORT. By January 1 and July 1 of each year, the commissioner shall
639	639	submit to the joint committee on finance a report including all of the following:
640	640	(a) A list of prescription drugs included in the prescription drug importation
641	641	program under this section.
642	642	(b) The number of pharmacies, health care providers, and health plans and
643	643	health insurance policies participating in the prescription drug importation program
644	644	under this section.
645	645	(c) The estimated amount of savings to residents of this state, health plans and
646	646	health insurance policies, and employers resulting from the implementation of the
647	647	prescription drug importation program under this section reported from the date of
648	648	the previous report under this subsection and from the date the program was fully
649	649	operational.
650	650	(d) Findings of any audit functions under sub. (1) (n) completed since the date
651	651	of the previous report under this subsection.
652	652	(6) RULEMAKING. The commissioner may promulgate any rules necessary to
653	653	implement this section.
654	654	1
655	655	2
656	656	3
657	657	4
658	658	5
659	659	6
660	660	7
661	661	8
662	662	9
663	663	10
664	664	11
665	665	12
666	666	13
667	667	14
668	668	15
669	669	16
670	670	17
671	671	18
672	672	19
673	673	20
674	674	21
675	675	22
676	676	23
677	677	24
678	678	25 - 15 -2023 - 2024 Legislature
679	679	LRB-4895/1
680	680	JPC&KRP:all
681	681	SECTION 13
682	682	ASSEMBLY BILL 748
683	683	SECTION 13. 609.83 of the statutes is amended to read:
684	684	609.83 Coverage of drugs and devices. Limited service health
685	685	organizations, preferred provider plans, and defined network plans are subject to ss.
686	686	632.853, 632.861, and 632.895 (6) (b), (16t), and (16v).
687	687	SECTION 14. 632.863 of the statutes is created to read:
688	688	632.863 Pharmaceutical representatives. (1) DEFINITIONS. In this section:
689	689	(a) “Health care professional” means a physician or other health care
690	690	practitioner who is licensed to provide health care services or to prescribe
691	691	pharmaceutical or biologic products.
692	692	(b) “Pharmaceutical” means a medication that may legally be dispensed only
693	693	with a valid prescription from a health care professional.
694	694	(c) “Pharmaceutical representative” means an individual who markets or
695	695	promotes pharmaceuticals to health care professionals on behalf of a pharmaceutical
696	696	manufacturer for compensation.
697	697	(d) “Wholesale acquisition cost” means the most recently reported
698	698	manufacturer list or catalog price for a brand-name or generic drug available to
699	699	wholesalers or direct purchasers in the United States, before application of
700	700	discounts, rebates, or reductions in price.
701	701	(2) LICENSURE. (a) No individual may act as a pharmaceutical representative
702	702	in this state without being licensed by the commissioner as a pharmaceutical
703	703	representative under this section. In order to obtain a license, the individual shall
704	704	apply to the commissioner in the form and manner prescribed by the commissioner.
705	705	The term of a license issued under this paragraph is one year and is renewable. The
706	706	application to obtain or renew a license shall include all of the following information:
707	707	1
708	708	2
709	709	3
710	710	4
711	711	5
712	712	6
713	713	7
714	714	8
715	715	9
716	716	10
717	717	11
718	718	12
719	719	13
720	720	14
721	721	15
722	722	16
723	723	17
724	724	18
725	725	19
726	726	20
727	727	21
728	728	22
729	729	23
730	730	24 - 16 -2023 - 2024 Legislature LRB-4895/1
731	731	JPC&KRP:all
732	732	SECTION 14 ASSEMBLY BILL 748
733	733	1. The applicant's full name, residence address and telephone number, and
734	734	business address and telephone number.
735	735	2. A description of the type of work in which the applicant will engage.
736	736	3. The fee under s. 601.31 (1) (nv).
737	737	4. An attestation that the applicant meets the professional education
738	738	requirements under sub. (3).
739	739	5. Proof that the applicant has paid any assessed penalties and fees.
740	740	6. Any other information required by the commissioner.
741	741	(b) The pharmaceutical representative licensed under par. (a) shall report, in
742	742	writing, to the commissioner any change to the information submitted on an
743	743	application under par. (a) or any material change to the pharmaceutical
744	744	representative's business operations or to any information provided under this
745	745	section. The pharmaceutical representative shall make the report no later than 4
746	746	business days after the change or material change occurs.
747	747	(c) A pharmaceutical representative licensed under par. (a) shall display the
748	748	pharmaceutical representative's license during each visit with a health care
749	749	professional.
750	750	(3) PROFESSIONAL EDUCATION REQUIREMENTS. (a) In order to become initially
751	751	licensed under sub. (2) (a), a pharmaceutical representative shall complete a
752	752	professional education course as determined by the commissioner. A pharmaceutical
753	753	representative shall, upon request, provide the commissioner with proof of the
754	754	coursework's completion.
755	755	(b) In order to renew a license under sub. (2) (a), a pharmaceutical
756	756	representative shall complete a minimum of 5 hours of continuing professional
757	757	1
758	758	2
759	759	3
760	760	4
761	761	5
762	762	6
763	763	7
764	764	8
765	765	9
766	766	10
767	767	11
768	768	12
769	769	13
770	770	14
771	771	15
772	772	16
773	773	17
774	774	18
775	775	19
776	776	20
777	777	21
778	778	22
779	779	23
780	780	24 - 17 -2023 - 2024 Legislature
781	781	LRB-4895/1
782	782	JPC&KRP:all
783	783	SECTION 14
784	784	ASSEMBLY BILL 748
785	785	education courses. A pharmaceutical representative shall, upon request, provide the
786	786	commissioner with proof of the coursework's completion.
787	787	(c) The professional education coursework required under pars. (a) and (b) shall
788	788	include training in ethical standards, whistleblower protections, laws and rules
789	789	applicable to pharmaceutical marketing, and other subjects that the commissioner
790	790	may identify by rule.
791	791	(d) The commissioner shall regularly designate courses that fulfill the
792	792	requirements under this subsection and publish a list of the designated courses.
793	793	(e) The professional education coursework required under this subsection may
794	794	not be provided by the employer of a pharmaceutical representative or be funded, in
795	795	any way, by the pharmaceutical industry or a 3rd party funded by the
796	796	pharmaceutical industry. A provider of a course designated under par. (d) shall
797	797	disclose any conflict of interest.
798	798	(4) DISCLOSURE TO COMMISSIONER. (a) No later than June 1 of each year, a
799	799	pharmaceutical representative licensed under sub. (2) (a) shall provide to the
800	800	commissioner, in the manner prescribed by the commissioner, all of the following
801	801	information from the previous calendar year:
802	802	1. The total number of times the pharmaceutical representative contacted
803	803	health care professionals in this state and the specialties of the health care
804	804	professionals contacted.
805	805	2. For each contact with a health care professional in this state, the location and
806	806	duration of the contact, the pharmaceuticals for which the pharmaceutical
807	807	representative provided information, and the value of any item, including a product
808	808	sample, compensation, material, or gift, provided to the health care professional.
809	809	1
810	810	2
811	811	3
812	812	4
813	813	5
814	814	6
815	815	7
816	816	8
817	817	9
818	818	10
819	819	11
820	820	12
821	821	13
822	822	14
823	823	15
824	824	16
825	825	17
826	826	18
827	827	19
828	828	20
829	829	21
830	830	22
831	831	23
832	832	24 - 18 -2023 - 2024 Legislature LRB-4895/1
833	833	JPC&KRP:all
834	834	SECTION 14 ASSEMBLY BILL 748
835	835	(b) The commissioner shall publish the information received under par. (a) on
836	836	the commissioner's website in a manner in which individual health care
837	837	professionals are not identifiable by name or other identifiers.
838	838	(5) DISCLOSURE TO HEALTH CARE PROFESSIONALS. During each contact with a
839	839	health care professional, a pharmaceutical representative licensed under sub. (2) (a)
840	840	shall disclose the wholesale acquisition cost of any pharmaceutical for which the
841	841	pharmaceutical representative provides information and the names of at least 3
842	842	generic prescription drugs from the same therapeutic class or, if 3 are not available,
843	843	as many as are available for prescriptive use.
844	844	(6) ETHICAL STANDARDS. The commissioner shall promulgate rules that contain
845	845	ethical standards for pharmaceutical representatives and shall publish the ethical
846	846	standards on the commissioner's website. A pharmaceutical representative licensed
847	847	under sub. (2) (a) shall comply with the ethical standards contained in the rules and
848	848	may not do any of the following:
849	849	(a) Engage in deceptive or misleading marketing of a pharmaceutical,
850	850	including the knowing concealment, suppression, omission, misleading
851	851	representation, or misstatement of a material fact.
852	852	(b) Use a title or designation that could reasonably lead a licensed health care
853	853	professional, or an employee or representative of a licensed health care professional,
854	854	to believe that the pharmaceutical representative is licensed to practice medicine,
855	855	nursing, dentistry, optometry, pharmacy, or other similar health occupation in this
856	856	state unless the pharmaceutical representative holds that license to practice.
857	857	(c) Attend a patient examination without the patient's consent.
858	858	1
859	859	2
860	860	3
861	861	4
862	862	5
863	863	6
864	864	7
865	865	8
866	866	9
867	867	10
868	868	11
869	869	12
870	870	13
871	871	14
872	872	15
873	873	16
874	874	17
875	875	18
876	876	19
877	877	20
878	878	21
879	879	22
880	880	23 - 19 -2023 - 2024 Legislature
881	881	LRB-4895/1
882	882	JPC&KRP:all
883	883	SECTION 14
884	884	ASSEMBLY BILL 748
885	885	(7) ENFORCEMENT. (a) Any individual who violates this section shall be fined
886	886	not less than $1,000 nor more than $3,000 for each offense. Each day of continued
887	887	violation constitutes a separate offense.
888	888	(b) The commissioner may suspend or revoke the license of a pharmaceutical
889	889	representative who violates this section. A suspended or revoked license may not be
890	890	reinstated until the pharmaceutical representative remedies all violations related
891	891	to the suspension or revocation and pays all assessed penalties and fees. A
892	892	pharmaceutical representative whose license is revoked for any cause may not be
893	893	issued a license under sub. (2) (a) until at least 2 years after the date of revocation.
894	894	(c) A health care professional who meets with a pharmaceutical representative
895	895	who does not display the pharmaceutical representative's license or share the
896	896	information required under sub. (5) may report the pharmaceutical representative
897	897	to the commissioner.
898	898	(8) RULES. The commissioner may promulgate rules to implement this section.
899	899	SECTION 15. 632.864 of the statutes is created to read:
900	900	632.864 Pharmacy services administrative organizations . (1)
901	901	DEFINITIONS. In this section:
902	902	(a) “Administrative service” means any of the following:
903	903	1. Assisting with claims.
904	904	2. Assisting with audits.
905	905	3. Providing centralized payment.
906	906	4. Performing certification in a specialized care program.
907	907	5. Providing compliance support.
908	908	6. Setting flat fees for generic drugs.
909	909	7. Assisting with store layout.
910	910	1
911	911	2
912	912	3
913	913	4
914	914	5
915	915	6
916	916	7
917	917	8
918	918	9
919	919	10
920	920	11
921	921	12
922	922	13
923	923	14
924	924	15
925	925	16
926	926	17
927	927	18
928	928	19
929	929	20
930	930	21
931	931	22
932	932	23
933	933	24
934	934	25 - 20 -2023 - 2024 Legislature LRB-4895/1
935	935	JPC&KRP:all
936	936	SECTION 15 ASSEMBLY BILL 748
937	937	8. Managing inventory.
938	938	9. Providing marketing support.
939	939	10. Providing management and analysis of payment and drug dispensing data.
940	940	11. Providing resources for retail cash cards.
941	941	(b) “Independent pharmacy" means a pharmacy operating in this state that is
942	942	licensed under s. 450.06 or 450.065 and is under common ownership with no more
943	943	than 2 other pharmacies.
944	944	(c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
945	945	(d) “Pharmacy services administrative organization” means an entity
946	946	operating in this state that does all of the following:
947	947	1. Contracts with an independent pharmacy to conduct business on the
948	948	independent pharmacy's behalf with a 3rd-party payer.
949	949	2. Provides at least one administrative service to an independent pharmacy
950	950	and negotiates and enters into a contract with a 3rd-party payer or pharmacy benefit
951	951	manager on behalf of the independent pharmacy.
952	952	(e) “Third-party payer” means an entity, including a plan sponsor, health
953	953	maintenance organization, or insurer, operating in this state that pays or insures
954	954	health, medical, or prescription drug expenses on behalf of beneficiaries.
955	955	(2) LICENSURE. (a) No person may operate as a pharmacy services
956	956	administrative organization in this state without being licensed by the commissioner
957	957	as a pharmacy services administrative organization under this section. In order to
958	958	obtain a license, the person shall apply to the commissioner in the form and manner
959	959	prescribed by the commissioner. The application shall include all of the following:
960	960	1. The name, address, telephone number, and federal employer identification
961	961	number of the applicant.
962	962	1
963	963	2
964	964	3
965	965	4
966	966	5
967	967	6
968	968	7
969	969	8
970	970	9
971	971	10
972	972	11
973	973	12
974	974	13
975	975	14
976	976	15
977	977	16
978	978	17
979	979	18
980	980	19
981	981	20
982	982	21
983	983	22
984	984	23
985	985	24
986	986	25 - 21 -2023 - 2024 Legislature
987	987	LRB-4895/1
988	988	JPC&KRP:all
989	989	SECTION 15
990	990	ASSEMBLY BILL 748
991	991	2. The name, business address, and telephone number of a contact person for
992	992	the applicant.
993	993	3. The fee under s. 601.31 (1) (nw).
994	994	4. Evidence of financial responsibility of at least $1,000,000.
995	995	5. Any other information required by the commissioner.
996	996	(b) The term of a license issued under par. (a) shall be 2 years from the date of
997	997	issuance.
998	998	(3) DISCLOSURE TO THE COMMISSIONER. (a) A pharmacy services administrative
999	999	organization licensed under sub. (2) shall disclose to the commissioner the extent of
1000	1000	any ownership or control of the pharmacy services administrative organization by
1001	1001	an entity that does any of the following:
1002	1002	1. Provides pharmacy services.
1003	1003	2. Provides prescription drug or device services.
1004	1004	3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical
1005	1005	devices.
1006	1006	(b) A pharmacy services administrative organization licensed under sub. (2)
1007	1007	shall notify the commissioner in writing within 5 days of any material change in its
1008	1008	ownership or control relating to an entity described in par. (a).
1009	1009	(4) RULES. The commissioner may promulgate rules to implement this section.
1010	1010	SECTION 16. 632.865 (2m) of the statutes is created to read:
1011	1011	632.865 (2m) FIDUCIARY DUTY AND DISCLOSURES TO HEALTH BENEFIT PLAN
1012	1012	SPONSORS. (a) A pharmacy benefit manager owes a fiduciary duty to the health
1013	1013	benefit plan sponsor to act according to the health benefit plan sponsor's instructions
1014	1014	and in the best interests of the health benefit plan sponsor.
1015	1015	1
1016	1016	2
1017	1017	3
1018	1018	4
1019	1019	5
1020	1020	6
1021	1021	7
1022	1022	8
1023	1023	9
1024	1024	10
1025	1025	11
1026	1026	12
1027	1027	13
1028	1028	14
1029	1029	15
1030	1030	16
1031	1031	17
1032	1032	18
1033	1033	19
1034	1034	20
1035	1035	21
1036	1036	22
1037	1037	23
1038	1038	24 - 22 -2023 - 2024 Legislature LRB-4895/1
1039	1039	JPC&KRP:all
1040	1040	SECTION 16 ASSEMBLY BILL 748
1041	1041	(b) A pharmacy benefit manager shall annually provide, no later than the date
1042	1042	and using the method prescribed by the commissioner by rule, the health benefit plan
1043	1043	sponsor all of the following information from the previous calendar year:
1044	1044	1. The indirect profit received by the pharmacy benefit manager from owning
1045	1045	any interest in a pharmacy or service provider.
1046	1046	2. Any payment made by the pharmacy benefit manager to a consultant or
1047	1047	broker who works on behalf of the health benefit plan sponsor.
1048	1048	3. From the amounts received from all drug manufacturers, the amounts
1049	1049	retained by the pharmacy benefit manager, and not passed through to the health
1050	1050	benefit plan sponsor, that are related to the health benefit plan sponsor's claims or
1051	1051	bona fide service fees.
1052	1052	4. The amounts, including pharmacy access and audit recovery fees, received
1053	1053	from all pharmacies that are in the pharmacy benefit manager's network or have a
1054	1054	contract to be in the network and, from these amounts, the amount retained by the
1055	1055	pharmacy benefit manager and not passed through to the health benefit plan
1056	1056	sponsor.
1057	1057	SECTION 17. 632.868 of the statutes is created to read:
1058	1058	632.868 Insulin safety net programs. (1) DEFINITIONS. In this section:
1059	1059	(a) “Manufacturer" means a person engaged in the manufacturing of insulin
1060	1060	that is self-administered on an outpatient basis.
1061	1061	(b) “Navigator" has the meaning given in s. 628.90 (3).
1062	1062	(c) “Patient assistance program” means a program established by a
1063	1063	manufacturer under sub. (3) (a).
1064	1064	(d) “Pharmacy" means an entity licensed under s. 450.06 or 450.065.
1065	1065	1
1066	1066	2
1067	1067	3
1068	1068	4
1069	1069	5
1070	1070	6
1071	1071	7
1072	1072	8
1073	1073	9
1074	1074	10
1075	1075	11
1076	1076	12
1077	1077	13
1078	1078	14
1079	1079	15
1080	1080	16
1081	1081	17
1082	1082	18
1083	1083	19
1084	1084	20
1085	1085	21
1086	1086	22
1087	1087	23
1088	1088	24 - 23 -2023 - 2024 Legislature
1089	1089	LRB-4895/1
1090	1090	JPC&KRP:all
1091	1091	SECTION 17
1092	1092	ASSEMBLY BILL 748
1093	1093	(e) “Urgent need of insulin" means having less than a 7-day supply of insulin
1094	1094	readily available for use and needing insulin in order to avoid the likelihood of
1095	1095	suffering a significant health consequence.
1096	1096	(f) “Urgent need safety net program” means a program established by a
1097	1097	manufacturer under sub. (2) (a).
1098	1098	(2) URGENT NEED SAFETY NET PROGRAM. (a) Establishment of program. No later
1099	1099	than July 1, 2024, each manufacturer shall establish an urgent need safety net
1100	1100	program to make insulin available in accordance with this subsection to individuals
1101	1101	who meet the eligibility requirements under par. (b).
1102	1102	(b) Eligible individual. An individual shall be eligible to receive insulin under
1103	1103	an urgent need safety net program if all of the following conditions are met:
1104	1104	1. The individual is in urgent need of insulin.
1105	1105	2. The individual is a resident of this state.
1106	1106	3. The individual is not receiving public assistance under ch. 49.
1107	1107	4. The individual is not enrolled in prescription drug coverage through an
1108	1108	individual or group health plan that limits the total cost sharing amount, including
1109	1109	copayments, deductibles, and coinsurance, that an enrollee is required to pay for a
1110	1110	30-day supply of insulin to no more than $75, regardless of the type or amount of
1111	1111	insulin prescribed.
1112	1112	5. The individual has not received insulin under an urgent need safety net
1113	1113	program within the previous 12 months, except as allowed under par. (d).
1114	1114	(c) Provision of insulin under an urgent need safety net program. 1. In order
1115	1115	to receive insulin under an urgent need safety net program, an individual who meets
1116	1116	the eligibility requirements under par. (b) shall provide a pharmacy with all of the
1117	1117	following:
1118	1118	1
1119	1119	2
1120	1120	3
1121	1121	4
1122	1122	5
1123	1123	6
1124	1124	7
1125	1125	8
1126	1126	9
1127	1127	10
1128	1128	11
1129	1129	12
1130	1130	13
1131	1131	14
1132	1132	15
1133	1133	16
1134	1134	17
1135	1135	18
1136	1136	19
1137	1137	20
1138	1138	21
1139	1139	22
1140	1140	23
1141	1141	24
1142	1142	25 - 24 -2023 - 2024 Legislature LRB-4895/1
1143	1143	JPC&KRP:all
1144	1144	SECTION 17 ASSEMBLY BILL 748
1145	1145	a. A completed application, on a form prescribed by the commissioner that shall
1146	1146	include an attestation by the individual, or the individual's parent or legal guardian
1147	1147	if the individual is under the age of 18, that the individual meets all of the eligibility
1148	1148	requirements under par. (b).
1149	1149	b. A valid insulin prescription.
1150	1150	c. A valid Wisconsin driver's license or state identification card. If the
1151	1151	individual is under the age of 18, the individual's parent or legal guardian shall meet
1152	1152	this requirement.
1153	1153	2. Upon receipt of the information described in subd. 1. a. to c., the pharmacist
1154	1154	shall dispense a 30-day supply of the prescribed insulin to the individual. The
1155	1155	pharmacy shall also provide the individual with the information sheet described in
1156	1156	sub. (8) (b) 2. and the list of navigators described in sub. (8) (c). The pharmacy may
1157	1157	collect a copayment, not to exceed $35, from the individual to cover the pharmacy's
1158	1158	costs of processing and dispensing the insulin. The pharmacy shall notify the health
1159	1159	care practitioner who issued the prescription no later than 72 hours after the insulin
1160	1160	is dispensed.
1161	1161	3. A pharmacy that dispenses insulin under subd. 2. may submit to the
1162	1162	manufacturer, or the manufacturer's vendor, a claim for payment that is in
1163	1163	accordance with the national council for prescription drug programs' standards for
1164	1164	electronic claims processing, except that no claim may be submitted if the
1165	1165	manufacturer agrees to send the pharmacy a replacement of the same insulin in the
1166	1166	amount dispensed. If the pharmacy submits an electronic claim, the manufacturer
1167	1167	or vendor shall reimburse the pharmacy in an amount that covers the pharmacy's
1168	1168	acquisition cost.
1169	1169	1
1170	1170	2
1171	1171	3
1172	1172	4
1173	1173	5
1174	1174	6
1175	1175	7
1176	1176	8
1177	1177	9
1178	1178	10
1179	1179	11
1180	1180	12
1181	1181	13
1182	1182	14
1183	1183	15
1184	1184	16
1185	1185	17
1186	1186	18
1187	1187	19
1188	1188	20
1189	1189	21
1190	1190	22
1191	1191	23
1192	1192	24 - 25 -2023 - 2024 Legislature
1193	1193	LRB-4895/1
1194	1194	JPC&KRP:all
1195	1195	SECTION 17
1196	1196	ASSEMBLY BILL 748
1197	1197	4. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the
1198	1198	application form described in subd. 1. a.
1199	1199	(d) Eligibility of certain individuals. An individual who has applied for public
1200	1200	assistance under ch. 49 but for whom a determination of eligibility has not been made
1201	1201	or whose coverage has not become effective or an individual who has an appeal
1202	1202	pending under sub. (3) (c) 4. may access insulin under this subsection if the
1203	1203	individual is in urgent need of insulin. To access a 30-day supply of insulin, the
1204	1204	individual shall attest to the pharmacy that the individual is described in this
1205	1205	paragraph and comply with par. (c) 1.
1206	1206	(3) PATIENT ASSISTANCE PROGRAM. (a) Establishment of program. No later than
1207	1207	July 1, 2024, each manufacturer shall establish a patient assistance program to
1208	1208	make insulin available in accordance with this subsection to individuals who meet
1209	1209	the eligibility requirements under par. (b). Under the patient assistance program,
1210	1210	the manufacturer shall do all of the following:
1211	1211	1. Provide the commissioner with information regarding the patient assistance
1212	1212	program, including contact information for individuals to call for assistance in
1213	1213	accessing the patient assistance program.
1214	1214	2. Provide a hotline for individuals to call or access between 8 a.m. and 10 p.m.
1215	1215	on weekdays and between 10 a.m. and 6 p.m. on Saturdays.
1216	1216	3. List the eligibility requirements under par. (b) on the manufacturer's
1217	1217	website.
1218	1218	4. Maintain the privacy of all information received from an individual applying
1219	1219	for or participating in the patient assistance program and not sell, share, or
1220	1220	disseminate the information unless required under this section or authorized, in
1221	1221	writing, by the individual.
1222	1222	1
1223	1223	2
1224	1224	3
1225	1225	4
1226	1226	5
1227	1227	6
1228	1228	7
1229	1229	8
1230	1230	9
1231	1231	10
1232	1232	11
1233	1233	12
1234	1234	13
1235	1235	14
1236	1236	15
1237	1237	16
1238	1238	17
1239	1239	18
1240	1240	19
1241	1241	20
1242	1242	21
1243	1243	22
1244	1244	23
1245	1245	24
1246	1246	25 - 26 -2023 - 2024 Legislature LRB-4895/1
1247	1247	JPC&KRP:all
1248	1248	SECTION 17 ASSEMBLY BILL 748
1249	1249	(b) Eligible individual. An individual shall be eligible to receive insulin under
1250	1250	a patient assistance program if all of the following conditions are met:
1251	1251	1. The individual is a resident of this state.
1252	1252	2. The individual, or the individual's parent or legal guardian if the individual
1253	1253	is under the age of 18, has a valid Wisconsin driver's license or state identification
1254	1254	card.
1255	1255	3. The individual has a valid insulin prescription.
1256	1256	4. The family income of the individual does not exceed 400 percent of the
1257	1257	poverty line as defined and revised annually under 42 USC 9902 (2) for a family the
1258	1258	size of the individual's family.
1259	1259	5. The individual is not receiving public assistance under ch. 49.
1260	1260	6. The individual is not eligible to receive health care through a federally
1261	1261	funded program or receive prescription drug benefits through the U.S. department
1262	1262	of veterans affairs, except that this subdivision does not apply to an individual who
1263	1263	is enrolled in a policy under Part D of Medicare under 42 USC 1395w-101 et seq. if
1264	1264	the individual has spent at least $1,000 on prescription drugs in the current calendar
1265	1265	year.
1266	1266	7. The individual is not enrolled in prescription drug coverage through an
1267	1267	individual or group health plan that limits the total cost sharing amount, including
1268	1268	copayments, deductibles, and coinsurance, that an enrollee is required to pay for a
1269	1269	30-day supply of insulin to no more than $75, regardless of the type or amount of
1270	1270	insulin needed.
1271	1271	(c) Application for patient assistance program. 1. An individual may apply to
1272	1272	participate in a patient assistance program by filing an application with the
1273	1273	manufacturer that established the patient assistance program, the individual's
1274	1274	1
1275	1275	2
1276	1276	3
1277	1277	4
1278	1278	5
1279	1279	6
1280	1280	7
1281	1281	8
1282	1282	9
1283	1283	10
1284	1284	11
1285	1285	12
1286	1286	13
1287	1287	14
1288	1288	15
1289	1289	16
1290	1290	17
1291	1291	18
1292	1292	19
1293	1293	20
1294	1294	21
1295	1295	22
1296	1296	23
1297	1297	24
1298	1298	25 - 27 -2023 - 2024 Legislature
1299	1299	LRB-4895/1
1300	1300	JPC&KRP:all
1301	1301	SECTION 17
1302	1302	ASSEMBLY BILL 748
1303	1303	health care practitioner if the practitioner participates in the patient assistance
1304	1304	program, or a navigator included on the list under sub. (8) (c). A health care
1305	1305	practitioner or navigator shall immediately submit the application to the
1306	1306	manufacturer. Upon receipt of an application, the manufacturer shall determine the
1307	1307	individual's eligibility under par. (b) and, except as provided in subd. 2., notify the
1308	1308	individual of the determination no later than 10 days after receipt of the application.
1309	1309	2. If necessary to determine the individual's eligibility under par. (b), the
1310	1310	manufacturer may request additional information from an individual who has filed
1311	1311	an application under subd. 1. no later than 5 days after receipt of the application.
1312	1312	Upon receipt of the additional information, the manufacturer shall determine the
1313	1313	individual's eligibility under par. (b) and notify the individual of the determination
1314	1314	no later than 3 days after receipt of the requested information.
1315	1315	3. Except as provided in subd. 5., if the manufacturer determines under subd.
1316	1316	1. or 2. that the individual is eligible for the patient assistance program, the
1317	1317	manufacturer shall provide the individual with a statement of eligibility. The
1318	1318	statement of eligibility shall be valid for 12 months and may be renewed upon a
1319	1319	determination by the manufacturer that the individual continues to meet the
1320	1320	eligibility requirements under par. (b).
1321	1321	4. If the manufacturer determines under subd. 1. or 2. that the individual is not
1322	1322	eligible for the patient assistance program, the manufacturer shall provide the
1323	1323	reason for the determination in the notification under subd. 1. or 2. The individual
1324	1324	may appeal the determination by filing an appeal with the commissioner that shall
1325	1325	include all of the information provided to the manufacturer under subds. 1. and 2.
1326	1326	The commissioner shall establish procedures for deciding appeals under this
1327	1327	subdivision. The commissioner shall issue a decision no later than 10 days after the
1328	1328	1
1329	1329	2
1330	1330	3
1331	1331	4
1332	1332	5
1333	1333	6
1334	1334	7
1335	1335	8
1336	1336	9
1337	1337	10
1338	1338	11
1339	1339	12
1340	1340	13
1341	1341	14
1342	1342	15
1343	1343	16
1344	1344	17
1345	1345	18
1346	1346	19
1347	1347	20
1348	1348	21
1349	1349	22
1350	1350	23
1351	1351	24
1352	1352	25 - 28 -2023 - 2024 Legislature LRB-4895/1
1353	1353	JPC&KRP:all
1354	1354	SECTION 17 ASSEMBLY BILL 748
1355	1355	appeal is filed, and the commissioner's decision shall be final. If the commissioner
1356	1356	determines that the individual meets the eligibility requirements under par. (b), the
1357	1357	manufacturer shall provide the individual with the statement of eligibility described
1358	1358	in subd. 3.
1359	1359	5. In the case of an individual who has prescription drug coverage through an
1360	1360	individual or group health plan, if the manufacturer determines under subd. 1. or 2.
1361	1361	that the individual is eligible for the patient assistance program but also determines
1362	1362	that the individual's insulin needs are better addressed through the use of the
1363	1363	manufacturer's copayment assistance program rather than the patient assistance
1364	1364	program, the manufacturer shall inform the individual of the determination and
1365	1365	provide the individual with the necessary coupons to submit to a pharmacy. The
1366	1366	individual may not be required to pay more than the copayment amount specified in
1367	1367	par. (d) 2.
1368	1368	(d) Provision of insulin under a patient assistance program. 1. Upon receipt
1369	1369	from an individual of the eligibility statement described in par. (c) 3. and a valid
1370	1370	insulin prescription, a pharmacy shall submit an order containing the name of the
1371	1371	insulin and daily dosage amount to the manufacturer. The pharmacy shall include
1372	1372	with the order the pharmacy's name, shipping address, office telephone number, fax
1373	1373	number, email address, and contact name, as well as any days or times when
1374	1374	deliveries are not accepted by the pharmacy.
1375	1375	2. Upon receipt of an order meeting the requirements under subd. 1., the
1376	1376	manufacturer shall send the pharmacy a 90-day supply of insulin, or lesser amount
1377	1377	if requested in the order, at no charge to the individual or pharmacy. The pharmacy
1378	1378	shall dispense the insulin to the individual associated with the order. The insulin
1379	1379	shall be dispensed at no charge to the individual, except that the pharmacy may
1380	1380	1
1381	1381	2
1382	1382	3
1383	1383	4
1384	1384	5
1385	1385	6
1386	1386	7
1387	1387	8
1388	1388	9
1389	1389	10
1390	1390	11
1391	1391	12
1392	1392	13
1393	1393	14
1394	1394	15
1395	1395	16
1396	1396	17
1397	1397	18
1398	1398	19
1399	1399	20
1400	1400	21
1401	1401	22
1402	1402	23
1403	1403	24
1404	1404	25 - 29 -2023 - 2024 Legislature
1405	1405	LRB-4895/1
1406	1406	JPC&KRP:all
1407	1407	SECTION 17
1408	1408	ASSEMBLY BILL 748
1409	1409	collect a copayment from the individual to cover the pharmacy's costs for processing
1410	1410	and dispensing in an amount not to exceed $50 for each 90-day supply of insulin.
1411	1411	The pharmacy may not seek reimbursement from the manufacturer or a 3rd-party
1412	1412	payer.
1413	1413	3. The pharmacy may submit a reorder to the manufacturer if the individual's
1414	1414	eligibility statement described in par. (c) 3. has not expired. The reorder shall be
1415	1415	treated as an order for purposes of subd. 2.
1416	1416	4. Notwithstanding subds. 2. and 3., a manufacturer may send the insulin
1417	1417	directly to the individual if the manufacturer provides a mail-order service option,
1418	1418	in which case the pharmacy may not collect a copayment from the individual.
1419	1419	(4) EXCEPTIONS. (a) This section does not apply to a manufacturer that shows
1420	1420	to the commissioner's satisfaction that the manufacturer's annual gross revenue
1421	1421	from insulin sales in this state does not exceed $2,000,000.
1422	1422	(b) A manufacturer may not be required to make an insulin product available
1423	1423	under sub. (2) or (3) if the wholesale acquisition cost of the insulin product does not
1424	1424	exceed $8, as adjusted annually based on the U.S. consumer price index for all urban
1425	1425	consumers, U.S. city average, per milliliter or the applicable national council for
1426	1426	prescription drug programs' plan billing unit.
1427	1427	(5) CONFIDENTIALITY. All medical information solicited or obtained by any
1428	1428	person under this section shall be subject to the applicable provisions of state law
1429	1429	relating to confidentiality of medical information, including s. 610.70.
1430	1430	(6) REIMBURSEMENT PROHIBITION. No person, including a manufacturer,
1431	1431	pharmacy, pharmacist, or 3rd-party administrator, as part of participating in an
1432	1432	urgent need safety net program or patient assistance program may request or seek,
1433	1433	or cause another person to request or seek, any reimbursement or other
1434	1434	1
1435	1435	2
1436	1436	3
1437	1437	4
1438	1438	5
1439	1439	6
1440	1440	7
1441	1441	8
1442	1442	9
1443	1443	10
1444	1444	11
1445	1445	12
1446	1446	13
1447	1447	14
1448	1448	15
1449	1449	16
1450	1450	17
1451	1451	18
1452	1452	19
1453	1453	20
1454	1454	21
1455	1455	22
1456	1456	23
1457	1457	24
1458	1458	25 - 30 -2023 - 2024 Legislature LRB-4895/1
1459	1459	JPC&KRP:all
1460	1460	SECTION 17 ASSEMBLY BILL 748
1461	1461	compensation for which payment may be made in whole or in part under a federal
1462	1462	health care program, as defined in 42 USC 1320a-7b (f).
1463	1463	(7) REPORTS. (a) Annually, no later than March 1, each manufacturer shall
1464	1464	report to the commissioner all of the following information for the previous calendar
1465	1465	year:
1466	1466	1. The number of individuals who received insulin under the manufacturer's
1467	1467	urgent need safety net program.
1468	1468	2. The number of individuals who sought assistance under the manufacturer's
1469	1469	patient assistance program and the number of individuals who were determined to
1470	1470	be ineligible under sub. (3) (c) 4.
1471	1471	3. The wholesale acquisition cost of the insulin provided by the manufacturer
1472	1472	through the urgent need safety net program and patient assistance program.
1473	1473	(b) Annually, no later than April 1, the commissioner shall submit to the
1474	1474	governor and the chief clerk of each house of the legislature, for distribution to the
1475	1475	legislature under s. 13.172 (2), a report on the urgent need safety net programs and
1476	1476	patient assistance programs that includes all of the following:
1477	1477	1. The information provided to the commissioner under par. (a).
1478	1478	2. The penalties assessed under sub. (9) during the previous calendar year,
1479	1479	including the name of the manufacturer and amount of the penalty.
1480	1480	(8) ADDITIONAL RESPONSIBILITIES OF COMMISSIONER. (a) Application form. The
1481	1481	commissioner shall make the application form described in sub. (2) (c) 1. a. available
1482	1482	on the office's website and shall make the form available to pharmacies and health
1483	1483	care providers who prescribe or dispense insulin, hospital emergency departments,
1484	1484	urgent care clinics, and community health clinics.
1485	1485	1
1486	1486	2
1487	1487	3
1488	1488	4
1489	1489	5
1490	1490	6
1491	1491	7
1492	1492	8
1493	1493	9
1494	1494	10
1495	1495	11
1496	1496	12
1497	1497	13
1498	1498	14
1499	1499	15
1500	1500	16
1501	1501	17
1502	1502	18
1503	1503	19
1504	1504	20
1505	1505	21
1506	1506	22
1507	1507	23
1508	1508	24 - 31 -2023 - 2024 Legislature
1509	1509	LRB-4895/1
1510	1510	JPC&KRP:all
1511	1511	SECTION 17
1512	1512	ASSEMBLY BILL 748
1513	1513	(b) Public outreach. 1. The commissioner shall conduct public outreach to
1514	1514	create awareness of the urgent need safety net programs and patient assistance
1515	1515	programs.
1516	1516	2. The commissioner shall develop and make available on the office's website
1517	1517	an information sheet that contains all of the following information:
1518	1518	a. A description of how to access insulin through an urgent need safety net
1519	1519	program.
1520	1520	b. A description of how to access insulin through a patient assistance program.
1521	1521	c. Information on how to contact a navigator for assistance in accessing insulin
1522	1522	through an urgent need safety net program or patient assistance program.
1523	1523	d. Information on how to contact the commissioner if a manufacturer
1524	1524	determines that an individual is not eligible for a patient assistance program.
1525	1525	e. A notification that an individual may contact the commissioner for more
1526	1526	information or assistance in accessing ongoing affordable insulin options.
1527	1527	(c) Navigators. The commissioner shall develop a training program to provide
1528	1528	navigators with information and the resources necessary to assist individuals in
1529	1529	accessing appropriate long-term insulin options. The commissioner shall compile
1530	1530	a list of navigators that have completed the training program and are available to
1531	1531	assist individuals in accessing affordable insulin coverage options. The list shall be
1532	1532	made available on the office's website and to pharmacies and health care
1533	1533	practitioners who dispense and prescribe insulin.
1534	1534	(d) Satisfaction surveys. 1. The commissioner shall develop and conduct a
1535	1535	satisfaction survey of individuals who have accessed insulin through urgent need
1536	1536	safety net programs and patient assistance programs. The survey shall ask whether
1537	1537	the individual is still in need of a long-term solution for affordable insulin and shall
1538	1538	1
1539	1539	2
1540	1540	3
1541	1541	4
1542	1542	5
1543	1543	6
1544	1544	7
1545	1545	8
1546	1546	9
1547	1547	10
1548	1548	11
1549	1549	12
1550	1550	13
1551	1551	14
1552	1552	15
1553	1553	16
1554	1554	17
1555	1555	18
1556	1556	19
1557	1557	20
1558	1558	21
1559	1559	22
1560	1560	23
1561	1561	24
1562	1562	25 - 32 -2023 - 2024 Legislature LRB-4895/1
1563	1563	JPC&KRP:all
1564	1564	SECTION 17 ASSEMBLY BILL 748
1565	1565	include questions about the individual's satisfaction with all of the following, if
1566	1566	applicable:
1567	1567	a. Accessibility to urgent-need insulin.
1568	1568	b. Adequacy of the information sheet and list of navigators received from the
1569	1569	pharmacy.
1570	1570	c. Helpfulness of a navigator.
1571	1571	d. Ease of access in applying for a patient assistance program and receiving
1572	1572	insulin from the pharmacy under the patient assistance program.
1573	1573	2. The commissioner shall develop and conduct a satisfaction survey of
1574	1574	pharmacies that have dispensed insulin through urgent need safety net programs
1575	1575	and patient assistance programs. The survey shall include questions about the
1576	1576	pharmacy's satisfaction with all of the following, if applicable:
1577	1577	a. Timeliness of reimbursement from manufacturers for insulin dispensed by
1578	1578	the pharmacy under urgent need safety net programs.
1579	1579	b. Ease in submitting insulin orders to manufacturers.
1580	1580	c. Timeliness of receiving insulin orders from manufacturers.
1581	1581	3. The commissioner may contract with a nonprofit entity to develop and
1582	1582	conduct the surveys under subds. 1. and 2. and to evaluate the survey results.
1583	1583	4. No later than July 1, 2026, the commissioner shall submit to the governor
1584	1584	and the chief clerk of each house of the legislature, for distribution to the legislature
1585	1585	under s. 13.172 (2), a report on the results of the surveys under subds. 1. and 2.
1586	1586	(9) PENALTY. A manufacturer that fails to comply with this section may be
1587	1587	assessed a penalty of up to $200,000 per month of noncompliance, with the maximum
1588	1588	penalty increasing to $400,000 per month if the manufacturer continues to be in
1589	1589	1
1590	1590	2
1591	1591	3
1592	1592	4
1593	1593	5
1594	1594	6
1595	1595	7
1596	1596	8
1597	1597	9
1598	1598	10
1599	1599	11
1600	1600	12
1601	1601	13
1602	1602	14
1603	1603	15
1604	1604	16
1605	1605	17
1606	1606	18
1607	1607	19
1608	1608	20
1609	1609	21
1610	1610	22
1611	1611	23
1612	1612	24 - 33 -2023 - 2024 Legislature
1613	1613	LRB-4895/1
1614	1614	JPC&KRP:all
1615	1615	SECTION 17
1616	1616	ASSEMBLY BILL 748
1617	1617	noncompliance after 6 months and increasing to $600,000 per month if the
1618	1618	manufacturer continues to be in noncompliance after one year.
1619	1619	SECTION 18. 632.869 of the statutes is created to read:
1620	1620	632.869 Reimbursement to federal drug pricing program participants.
1621	1621	(1) In this section:
1622	1622	(a) “Covered entity” means an entity described in 42 USC 256b (a) (4) (A), (D),
1623	1623	(E), (J), or (N) that participates in the federal drug pricing program under 42 USC
1624	1624	256b, a pharmacy of the entity, or a pharmacy contracted with the entity to dispense
1625	1625	drugs purchased through the federal drug pricing program under 42 USC 256b.
1626	1626	(b) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
1627	1627	(2) No person, including a pharmacy benefit manager and 3rd-party payer,
1628	1628	may do any of the following:
1629	1629	(a) Reimburse a covered entity for a drug that is subject to an agreement under
1630	1630	42 USC 256b at a rate lower than that paid for the same drug to pharmacies that are
1631	1631	not covered entities and have a similar prescription volume to that of the covered
1632	1632	entity.
1633	1633	(b) Assess a covered entity any fee, charge back, or other adjustment on the
1634	1634	basis of the covered entity's participation in the federal drug pricing program under
1635	1635	42 USC 256b.
1636	1636	SECTION 19. 632.895 (6) (title) of the statutes is amended to read:
1637	1637	632.895 (6) (title) EQUIPMENT AND SUPPLIES FOR TREATMENT OF DIABETES; INSULIN.
1638	1638	SECTION 20. 632.895 (6) of the statutes is renumbered 632.895 (6) (a) and
1639	1639	amended to read:
1640	1640	632.895 (6) (a) Every disability insurance policy which that provides coverage
1641	1641	of expenses incurred for treatment of diabetes shall provide coverage for expenses
1642	1642	1
1643	1643	2
1644	1644	3
1645	1645	4
1646	1646	5
1647	1647	6
1648	1648	7
1649	1649	8
1650	1650	9
1651	1651	10
1652	1652	11
1653	1653	12
1654	1654	13
1655	1655	14
1656	1656	15
1657	1657	16
1658	1658	17
1659	1659	18
1660	1660	19
1661	1661	20
1662	1662	21
1663	1663	22
1664	1664	23
1665	1665	24
1666	1666	25 - 34 -2023 - 2024 Legislature LRB-4895/1
1667	1667	JPC&KRP:all
1668	1668	SECTION 20 ASSEMBLY BILL 748
1669	1669	incurred by the installation and use of an insulin infusion pump, coverage for all
1670	1670	other equipment and supplies, including insulin or any other prescription
1671	1671	medication, used in the treatment of diabetes, and coverage of diabetic
1672	1672	self-management education programs. Coverage Except as provided in par. (b),
1673	1673	coverage required under this subsection shall be subject to the same exclusions,
1674	1674	limitations, deductibles, and coinsurance provisions of the policy as other covered
1675	1675	expenses, except that insulin infusion pump coverage may be limited to the purchase
1676	1676	of one pump per year and the insurer may require the insured to use a pump for 30
1677	1677	days before purchase.
1678	1678	SECTION 21. 632.895 (6) (b) of the statutes is created to read:
1679	1679	632.895 (6) (b) 1. In this paragraph:
1680	1680	a. “Cost sharing” means the total of any deductible, copayment, or coinsurance
1681	1681	amounts imposed on a person covered under a policy or plan.
1682	1682	b. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).
1683	1683	2. Every disability insurance policy and self-insured health plan that covers
1684	1684	insulin and imposes cost sharing on prescription drugs may not impose cost sharing
1685	1685	on insulin in an amount that exceeds $35 for a one-month supply of insulin.
1686	1686	3. Nothing in this paragraph prohibits a disability insurance policy or
1687	1687	self-insured health plan from imposing cost sharing on insulin in an amount less
1688	1688	than the amount specified under subd. 2. Nothing in this paragraph requires a
1689	1689	disability insurance policy or self-insured health plan to impose any cost sharing on
1690	1690	insulin.
1691	1691	SECTION 22.0Nonstatutory provisions.
1692	1692	1
1693	1693	2
1694	1694	3
1695	1695	4
1696	1696	5
1697	1697	6
1698	1698	7
1699	1699	8
1700	1700	9
1701	1701	10
1702	1702	11
1703	1703	12
1704	1704	13
1705	1705	14
1706	1706	15
1707	1707	16
1708	1708	17
1709	1709	18
1710	1710	19
1711	1711	20
1712	1712	21
1713	1713	22
1714	1714	23 - 35 -2023 - 2024 Legislature
1715	1715	LRB-4895/1
1716	1716	JPC&KRP:all
1717	1717	SECTION 22
1718	1718	ASSEMBLY BILL 748
1719	1719	(1) CENTRALIZED DRUG REPOSITORY. The department of health services shall
1720	1720	study and implement a centralized physical drug repository program under s.
1721	1721	255.056.
1722	1722	(2) PRESCRIPTION DRUG IMPORTATION PROGRAM. The commissioner of insurance
1723	1723	shall submit the first report required under s. 601.575 (5) by the next January 1 or
1724	1724	July 1, whichever is earliest, that is at least 180 days after the date the prescription
1725	1725	drug importation program is fully operational under s. 601.575 (4). The
1726	1726	commissioner of insurance shall include in the first 3 reports submitted under s.
1727	1727	601.575 (5) information on the implementation of the audit functions under s.
1728	1728	601.575 (1) (n).
1729	1729	(3) PRESCRIPTION DRUG PURCHASING ENTITY. During the 2023-2025 fiscal
1730	1730	biennium, the office of the commissioner of insurance shall conduct a study on the
1731	1731	viability of creating or implementing a state prescription drug purchasing entity.
1732	1732	SECTION 23.0Effective date.
1733	1733	(1) COST-SHARING CAP ON INSULIN. The treatment of ss. 609.83 and 632.895 (6)
1734	1734	(title), the renumbering and amendment of s. 632.895 (6), and the creation of s.
1735	1735	632.895 (6) (b) take effect on the first day of the 4th month beginning after
1736	1736	publication.
1737	1737	(END)
1738	1738	1
1739	1739	2
1740	1740	3
1741	1741	4
1742	1742	5
1743	1743	6
1744	1744	7
1745	1745	8
1746	1746	9
1747	1747	10
1748	1748	11
1749	1749	12
1750	1750	13
1751	1751	14
1752	1752	15
1753	1753	16
1754	1754	17
1755	1755	18
1756	1756	19