LRB-4895/1
JPC&KRP:all
2023 - 2024 LEGISLATURE
December 6, 2023 - Introduced by Representatives Subeck, C. Anderson, J.
Anderson, Andraca, Bare, Billings, Clancy, Conley, Considine, Drake,
Emerson, Hong, Jacobson, Joers, Madison, Moore Omokunde, Neubauer,
Ortiz-Velez, Palmeri, Ratcliff, Riemer, Shankland, Shelton, Sinicki,
Stubbs and Haywood, cosponsored by Senators Hesselbein, Agard,
Carpenter, L. Johnson, Pfaff, Roys, Smith, Spreitzer, Taylor and Wirch.
Referred to Committee on Health, Aging and Long-Term Care.
AB748,1,7
1An Act to repeal 49.45 (18) (ag);
to renumber and amend 632.895 (6);
to
2amend 49.45 (18) (ac), 609.83 and 632.895 (6) (title); and
to create 20.145 (1)
3(a), 49.45 (18) (b) 8., 255.056 (2g), 450.085 (3), 601.31 (1) (nv), 601.31 (1) (nw),
4601.41 (13), 601.415 (14), 601.575, 632.863, 632.864, 632.865 (2m), 632.868,
5632.869 and 632.895 (6) (b) of the statutes;
relating to: health care costs
6omnibus, granting rule-making authority, making an appropriation, and
7providing a penalty.
Analysis by the Legislative Reference Bureau
Elimination of cost sharing for prescription drugs under the Medical
Assistance program
Under current law, certain persons who receive health services under the
Medical Assistance program, also known in this state as BadgerCare, are required
to contribute a cost-sharing payment to the cost of certain health services. This bill
eliminates all cost-sharing payments for prescription drugs under the Medical
Assistance program. The Medical Assistance program is a joint state and federal
program that provides health services to individuals who have limited financial
resources.
Cost-sharing cap on insulin
This bill prohibits every health insurance policy and governmental
self-insured health plan that cover insulin and impose cost sharing on prescription
drugs from imposing cost sharing on insulin in an amount that exceeds $35 for a
one-month supply. Current law requires every health insurance policy that provides
coverage of expenses incurred for treatment of diabetes to provide coverage for
specified expenses and items, including insulin. The required coverage under
current law for certain diabetes treatments other than insulin infusion pumps is
subject to the same exclusions, limitations, deductibles, and coinsurance provisions
of the policy as other covered expenses. The bill's cost-sharing limitation on insulin
supersedes the specification that the exclusions, limitations, deductibles, and
coinsurance are the same as for other coverage.
Fiduciary and disclosure requirements for pharmacy benefit managers
The bill imposes fiduciary and disclosure requirements on pharmacy benefit
managers. Pharmacy benefit managers contract with health plans that provide
prescription drug benefits to administer those benefits for the plans. They also have
contracts with pharmacies and pay the pharmacies for providing the drugs to the
plan beneficiaries.
The bill provides that a pharmacy benefit manager owes a fiduciary duty to a
plan sponsor. The bill also requires that a pharmacy benefit manager annually
disclose all of the following information to the plan sponsor:
1. The indirect profit received by the pharmacy benefit manager from owning
a pharmacy or service provider.
2. Any payments made to a consultant or broker who works on behalf of the plan
sponsor.
3. From the amounts received from drug manufacturers, the amounts retained
by the pharmacy benefit manager that are related to the plan sponsor's claims or
bona fide service fees.
4. The amounts received from network pharmacies and the amount retained
by the pharmacy benefit manager.
Reimbursements for certain 340B program entities
The bill prohibits any person from reimbursing certain entities that participate
in the federal drug pricing program, known as the 340B program, for a drug subject
to an agreement under the program at a rate lower than that paid for the same drug
to pharmacies that have a similar prescription volume. The bill also prohibits a
person from imposing any fee, charge back, or other adjustment on the basis of the
entity's participation in the 340B program. The entities covered by the prohibitions
under the bill are federally qualified health centers, critical access hospitals, and
grantees under the federal Ryan White HIV/AIDS program, as well as these entities'
pharmacies and any pharmacy with which any of the entities have contracted to
dispense drugs through the 340B program.
Drug repository program
Under current law, the Department of Health Services must maintain a drug
repository program under which persons may donate certain drugs or supplies that
may be used by other individuals identified by DHS by rule. The bill allows DHS to
partner with out-of-state drug repository programs. The bill also allows
out-of-state persons to donate to the drug repository program in Wisconsin, and
persons in Wisconsin to donate to participating drug repository programs in other
states. Further, the bill directs DHS to study and implement a centralized physical
drug repository program.
Value-based diabetes medication pilot project
The bill directs the Office of the Commissioner of Insurance to develop a pilot
project under which a pharmacy benefit manager and pharmaceutical manufacturer
are directed to create a value-based, sole-source arrangement to reduce the costs of
prescription diabetes medication. The bill allows OCI to promulgate rules to
implement the pilot project.
Pharmacist continuing education credits for volunteering at free and
charitable clinics
Under current law, a licensed pharmacist must renew his or her license every
two years. An applicant for renewal of a pharmacist license must submit proof that
he or she has completed 30 hours of continuing education within the two-year period
immediately preceding the date of his or her application. The bill allows pharmacists
to meet up to 10 hours of the continuing education requirement for each two-year
period by volunteering at a free and charitable clinic.
Prescription drug importation program
The bill requires the commissioner of insurance, in consultation with persons
interested in the sale and pricing of prescription drugs and federal officials and
agencies, to design and implement a prescription drug importation program for the
benefit of and that generates savings for Wisconsin residents. The bill establishes
requirements for the program, including all of the following:
1. The commissioner must designate a state agency to become a licensed
wholesale distributor or contract with a licensed wholesale distributor and to seek
federal certification and approval to import prescription drugs.
2. The program must comply with certain federal regulations and import from
Canadian suppliers only prescription drugs that are not brand-name drugs, have
fewer than four competitor drugs in this country, and for which importation creates
substantial savings.
3. The commissioner must ensure that prescription drugs imported under the
program are not distributed, dispensed, or sold outside of Wisconsin.
4. The program must have an audit procedure to ensure the program complies
with certain requirements specified in the bill.
Before submitting the proposed program to the federal government for
certification, the commissioner must submit the proposed program to the Joint
Committee on Finance for its approval.
Pharmacy benefits tool grants
The bill directs OCI to award grants in an amount of up to $500,000 in each
fiscal year to health care providers to develop and implement a tool that would allow
prescribers to disclose the cost of prescription drugs for patients. The tool must be
usable by physicians and other prescribers to determine the cost of prescription
drugs for their patients. Any health care provider that receives a grant to develop
and implement a patient pharmacy benefits tool is required to contribute matching
funds equal to at least 50 percent of the total grant awarded.
Prescription drug purchasing entity study
The bill requires OCI to conduct a study on the viability of creating or
implementing a state prescription drug purchasing entity.
Licensure of pharmacy services administrative organizations
The bill requires that a pharmacy services administrative organization (PSAO)
be licensed by OCI. Under the bill, a PSAO is an entity operating in Wisconsin that
does all of the following:
1. Contracts with an independent pharmacy to conduct business on the
pharmacy's behalf with a third-party payer.
2. Provides at least one administrative service to an independent pharmacy
and negotiates and enters into a contract with a third-party payer or pharmacy
benefit manager on the pharmacy's behalf.
The bill defines “independent pharmacy" to mean a licensed pharmacy
operating in Wisconsin that is under common ownership with no more than two other
pharmacies. “Administrative service” is defined to mean assisting with claims or
audits, providing centralized payment, performing certification in a specialized care
program, providing compliance support, setting flat fees for generic drugs, assisting
with store layout, managing inventory, providing marketing support, providing
management and analysis of payment and drug dispensing data, or providing
resources for retail cash cards. The bill defines “third-party payer” to mean an entity
operating in Wisconsin that pays or insures health, medical, or prescription drug
expenses on behalf of beneficiaries. The bill uses the current law definition of
“pharmacy benefit manager," which is an entity doing business in Wisconsin that
contracts to administer or manage prescription drug benefits on behalf of an insurer
or other entity that provides prescription drug benefits to Wisconsin residents.
To obtain the license required by the bill, a person must apply to OCI and
provide the contact information for the applicant and a contact person, evidence of
financial responsibility of at least $1,000,000, and any other information required by
the commissioner. Under the bill, the license fee is set by the commissioner, and the
term of a license is two years.
The bill also requires that a PSAO disclose to OCI the extent of any ownership
or control by an entity that provides pharmacy services; provides prescription drug
or device services; or manufactures, sells, or distributes prescription drugs,
biologicals, or medical devices. The PSAO must notify OCI within five days of any
material change in its ownership or control related to such an entity.
Licensure of pharmaceutical representatives
The bill requires a pharmaceutical representative to be licensed by OCI and to
display the pharmaceutical representative's license during each visit with a health
care professional. The bill defines “pharmaceutical representative” to mean an
individual who markets or promotes pharmaceuticals to health care professionals on
behalf of a pharmaceutical manufacturer for compensation.
The term of a license issued under the bill is one year, and the license is
renewable. The application to obtain or renew a license must include the applicant's
contact information, a description of the type of work in which the applicant will
engage, the license fee, an attestation that professional education requirements are
met, proof that any penalties and other fees are paid, and any other information
required by OCI. Under the bill, the license fee is set by the commissioner. The bill
requires the pharmaceutical representative to report, within four business days, any
change to the information provided on the application or any material change to the
pharmaceutical representative's business operations or other information required
to be reported under the bill.
The bill requires that a pharmaceutical representative complete a professional
education course prior to becoming licensed and to annually complete at least five
hours of continuing professional education courses. The coursework must include,
at a minimum, training in ethical standards, whistleblower protections, and the laws
and rules applicable to pharmaceutical marketing. The bill directs the commissioner
to regularly publish a list of courses that fulfill the education requirements. Under
the bill, a course provider must disclose any conflict of interest, and the courses may
not be provided by the employer of a pharmaceutical representative or be funded by
the pharmaceutical industry or a third party funded by the industry.
The bill requires that, no later than June 1 of each year, a pharmaceutical
representative report to OCI the pharmaceutical representative's total number of
contacts with health care professionals in Wisconsin, the specialties of those health
care professionals, the location and duration of each contact, the pharmaceuticals
discussed, and the value of any item provided to a health care professional. The bill
directs the commissioner to publish the information on OCI's website, without
identifying individual health care professionals.
The bill requires that a pharmaceutical representative, during each contact
with a health care professional, disclose the wholesale acquisition cost of any
pharmaceuticals discussed and the names of at least three generic prescription
drugs from the same therapeutic class.
The bill directs the commissioner to promulgate ethical standards for
pharmaceutical representatives. Additionally, the bill prohibits a pharmaceutical
representative from engaging in deceptive or misleading marketing of a
pharmaceutical product; using a title or designation that could reasonably lead a
licensed health care professional, or an employee or representative of such a
professional, to believe that the pharmaceutical representative is licensed to practice
in a health occupation unless the pharmaceutical representative holds a license to
practice in that health occupation; or attending a patient examination without the
patient's consent.
An individual who violates any of the requirements under this bill is subject to
a fine, and the individual's license may be suspended or revoked. An individual
whose license is revoked must wait at least two years before applying for a new
license.
Insulin safety net programs
The bill requires insulin manufacturers to establish a program under which
qualifying Wisconsin residents who are in urgent need of insulin and are uninsured
or have limited insurance coverage can be dispensed insulin at a pharmacy. Under
the program, if a qualifying individual in urgent need of insulin provides a pharmacy
with a form attesting that the individual meets the program's eligibility
requirements, specified proof of residency, and a valid insulin prescription, the
pharmacy must dispense a 30-day supply of insulin to the individual and may charge
the individual a copayment of no more than $35. The pharmacy may submit an
electronic payment claim for the insulin's acquisition cost to the manufacturer or
agree to receive a replacement of the same insulin in the amount dispensed.
The bill also requires that each insulin manufacturer establish a patient
assistance program to make insulin available to any qualifying Wisconsin resident
who, among other requirements, is uninsured or has limited insurance coverage and
whose family income does not exceed 400 percent of the federal poverty line. Under
the bill, an individual must apply to participate in a manufacturer's program. If the
manufacturer determines that the individual meets the program's eligibility
requirements, the manufacturer must issue the individual a statement of eligibility,
which is valid for 12 months and may be renewed. Under the bill, if an individual
with a statement of eligibility and valid insulin prescription requests insulin from
a pharmacy, the pharmacy must submit an order to the manufacturer, who must then
provide a 90-day supply of insulin at no charge to the individual or pharmacy. The
pharmacy may charge the individual a copayment of no more than $50. Under the
bill, a manufacturer is not required to issue a statement of eligibility if the individual
has prescription drug coverage through an individual or group health plan and the
manufacturer determines that the individual's insulin needs are better addressed
through the manufacturer's copayment assistance program. In such case, the
manufacturer must provide the individual with the necessary drug coupons, and the
individual may not be required to pay more than a $50 copayment for a 90-day
supply of insulin.
Under the bill, if the manufacturer determines that an individual is not eligible
for the patient assistance program, the individual may file an appeal with OCI. The
bill directs OCI to establish procedures for deciding appeals. Under the bill, OCI
must issue a decision within 10 days, and that decision is final.
The bill requires that insulin manufacturers annually report to OCI certain
information, including the number of individuals served and the cost of insulin
dispensed under the programs and that OCI annually report to the governor and the
legislature on the programs. The bill also directs OCI to conduct public outreach and
develop an information sheet about the programs, conduct satisfaction surveys of
individuals and pharmacies that participate in the programs, and report to the
governor and the legislature on the surveys by July 1, 2026. Additionally, the bill
requires that OCI develop a training program for health care navigators to assist
individuals in accessing appropriate long-term insulin options and maintain a list
of trained navigators.
The bill provides that a manufacturer that fails to comply with the bill's
provisions may be assessed a penalty of up to $200,000 per month of noncompliance,
which increases to $400,000 per month if the manufacturer continues to be in
noncompliance after six months and to $600,000 per month if the manufacturer
continues to be in noncompliance after one year. The bill's requirements do not apply
to manufacturers with annual insulin sales revenue in Wisconsin of no more than
$2,000,000 or to insulin that costs less than a specified dollar amount.
This proposal may contain a health insurance mandate requiring a social and
financial impact report under s. 601.423, stats.
Because this bill creates a new crime or revises a penalty for an existing crime,
the Joint Review Committee on Criminal Penalties may be requested to prepare a
report.
For further information see the state fiscal estimate, which will be printed as
an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB748,1
1Section 1
. 20.005 (3) (schedule) of the statutes: at the appropriate place, insert
2the following amounts for the purposes indicated:
-
See PDF for table ![PDF](https://docs.legis.wisconsin.gov/assets/image/file_acrobat.gif)
AB748,2
3Section 2
. 20.145 (1) (a) of the statutes is created to read:
AB748,7,54
20.145
(1) (a)
State operations. The amounts in the schedule for general
5program operations.