Minnesota Legislature
HF 1872
1st Engrossment - 88th Legislature (2013 - 2014) Posted on 03/10/2014 03:34pm
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A bill for an act
relating to health; setting requirements for the use of maximum allowable cost
pricing; setting requirements for the designation of specialty drugs and the filling
of specialty drug prescriptions; allowing community/outpatient and long-term
care pharmacies to fill mail-order or extended days supply prescriptions; setting
requirements for the use of pharmacy utilization and claims data; proposing
coding for new law in Minnesota Statutes, chapter 151.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1.
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[151.71] DEFINITIONS.
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new text begin Subdivision 1. new text end
new text begin Applicability. new text end
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For purposes of sections 151.71 to 151.75, the
following definitions apply.
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new text begin Subd. 2. new text end
new text begin Community/outpatient pharmacy. new text end
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"Community/outpatient pharmacy"
has the meaning provided in Minnesota Rules, part 6800.0100, subpart 2.
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new text begin Subd. 3. new text end
new text begin Covered individual. new text end
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"Covered individual" means an individual receiving
prescription drug coverage under a health plan through a pharmacy benefit manager, or
through an employee benefit plan established or maintained by a plan sponsor.
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new text begin Subd. 4. new text end
new text begin Extended days supply. new text end
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"Extended days supply" means a medication
supply greater than the quantity considered by the health plan to be a one-month supply.
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new text begin Subd. 5. new text end
new text begin Health care provider. new text end
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"Health care provider" has the meaning provided in
section 62J.03, subdivision 8, except the term also includes nursing homes.
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new text begin Subd. 6. new text end
new text begin Health plan. new text end
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"Health plan" has the meaning provided in section 62Q.01,
subdivision 3.
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new text begin Subd. 7. new text end
new text begin Health plan company. new text end
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"Health plan company" has the meaning provided
in section 62Q.01, subdivision 4.
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new text begin Subd. 8. new text end
new text begin Long-term care pharmacy. new text end
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"Long-term care pharmacy" has the meaning
provided in Minnesota Rules, part 6800.0100, subpart 4.
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new text begin Subd. 9. new text end
new text begin Mail-order pharmacy. new text end
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"Mail-order pharmacy" means a pharmacy
licensed under this chapter that:
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(1) has the primary business of receiving prescription drug orders by mail or
electronic transmission;
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(2) dispenses prescribed drugs to patients through the use of mail or a private
delivery service; and
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(3) primarily consults with patients by mail or electronic means.
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new text begin Subd. 10. new text end
new text begin Managed care organization. new text end
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"Managed care organization" has the
meaning provided in section 62Q.01, subdivision 5.
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new text begin Subd. 11. new text end
new text begin Maximum allowable cost. new text end
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"Maximum allowable cost" means:
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(1) a maximum reimbursement amount for a group of therapeutically and
pharmaceutically equivalent multiple-source drugs that are listed in the most recent edition
of the Approved Drug Products with Therapeutic Equivalence Evaluations published by
the United States Food and Drug Administration or that may be substituted in accordance
with section 151.21; or
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(2) any similar reimbursement amount that is used by a pharmacy benefit manager to
reimburse pharmacies for multiple-source drugs.
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new text begin Subd. 12. new text end
new text begin Nationally available. new text end
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"Nationally available" means that all pharmacies
in Minnesota can purchase the drug, without limitation, from regional or national
wholesalers, and that the product is not obsolete or temporarily unavailable.
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new text begin Subd. 13. new text end
new text begin Pharmacy. new text end
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"Pharmacy" has the meaning provided in section 151.01,
subdivision 2.
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new text begin Subd. 14. new text end
new text begin Pharmacy benefit manager. new text end
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"Pharmacy benefit manager" means an
entity that contracts with pharmacies on behalf of a health plan, state agency, health plan
company, managed care organization, or other third-party payor to provide pharmacy
benefit services or administration.
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new text begin Subd. 15. new text end
new text begin Plan sponsor. new text end
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"Plan sponsor" has the meaning provided in section
151.61, subdivision 4.
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new text begin Subd. 16. new text end
new text begin Specialty drug. new text end
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"Specialty drug" means a prescription drug that requires
special handling, special administration, unique inventory management, a high level of
patient monitoring, or more intense patient support than conventional therapies. For
purposes of medical assistance, specialty drug means specialty pharmacy products defined
under section 256B.0625, subdivision 13e, paragraph (e).
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new text begin Subd. 17. new text end
new text begin Therapeutically equivalent. new text end
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"Therapeutically equivalent" means the
drug is identified as therapeutically or pharmaceutically equivalent or "A" rated by the
United States Food and Drug Administration or that may be substituted in accordance
with section 151.21.
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Sec. 2.
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[151.72] MAXIMUM ALLOWABLE COST PRICING.
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new text begin Subdivision 1. new text end
new text begin Limits on use of maximum allowable cost pricing. new text end
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(a) A pharmacy
benefit manager may not place a prescription drug on a maximum allowable cost pricing
index or create for a prescription drug a maximum allowable cost rate until after the
six-month period of generic exclusivity, and only if the prescription drug has three or more
nationally available and therapeutically equivalent drugs, including the brand product.
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(b) A pharmacy benefit manager shall remove a prescription drug from a maximum
allowable cost pricing index, or eliminate the maximum allowable cost rate, if the criterion
related to the number of nationally available and therapeutically equivalent drugs in
paragraph (a) cannot be met due to changes in the national marketplace for prescription
drugs. The removal of the drug or elimination of the rate must be made in a timely manner.
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new text begin Subd. 2. new text end
new text begin Notice requirements for use of maximum allowable cost pricing. new text end
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A
pharmacy benefit manager shall disclose to a pharmacy with which it has contracted,
through the term of the contract:
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(1) at the beginning of each calendar year, the basis of the methodology and
the sources used to establish the maximum allowable cost pricing index or maximum
allowable cost rates used by the pharmacy benefit manager; and
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(2) the maximum allowable cost pricing index or maximum allowable cost rates
used by the pharmacy benefit manager, updated at least once every seven calendar days
and provided in a readily accessible and searchable format that retains a record of index
or rate changes and includes, at a minimum, the drug name, drug strength, dosage form,
maximum allowable cost price, at least one national drug code for each product the
maximum allowable cost price applies to, and a network identifier.
new text end
new text begin Subd. 3. new text end
new text begin Contesting a rate. new text end
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A pharmacy benefit manager shall establish a written
procedure by which a pharmacy may contest a maximum allowable cost pricing index or
maximum allowable cost rate. The procedure established must require a pharmacy benefit
manager to respond to a pharmacy that has contested a pricing index or rate within 15
calendar days. If the pharmacy benefit manager changes the pricing index or rate, the
change must:
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(1) become effective on the date on which the pharmacy initiated proceedings under
this subdivision; and
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(2) apply to all pharmacies in the pharmacy network served by the pharmacy benefit
manager.
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new text begin EFFECTIVE DATE. new text end
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This section is effective August 1, 2014, and applies to
pharmacy benefit manager contracts with pharmacies and pharmacists entered into or
renewed on or after that date.
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Sec. 3.
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[151.73] SPECIALTY DRUGS.
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new text begin Subdivision 1. new text end
new text begin Designation of specialty drugs. new text end
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A pharmacy benefit manager may
designate certain prescription drugs as specialty drugs on a formulary.
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new text begin Subd. 2. new text end
new text begin Filling specialty drug prescriptions. new text end
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If a pharmacy benefit manager
designates certain prescription drugs as specialty drugs on the formulary, the pharmacy
benefit manager shall allow a covered individual to fill a prescription for a specialty drug
at any willing pharmacy, if the pharmacy or pharmacist:
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(1) has the specialty drug in inventory or has ready access to the specialty drug;
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(2) is capable of complying with any special handling, special administration,
inventory management, patient monitoring, patient education and maintenance, and any
other patient support requirements for the specialty drug; and
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(3) accepts the same rate that the pharmacy benefit manager applies to other
pharmacies or pharmacists for filling a prescription for that specialty drug.
new text end
new text begin EFFECTIVE DATE. new text end
new text begin
This section is effective August 1, 2014, and applies to
pharmacy benefit manager contracts with pharmacies and pharmacists entered into or
renewed on or after that date.
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Sec. 4.
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[151.74] MAIL ORDER OR EXTENDED DAYS SUPPLY
PRESCRIPTIONS.
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new text begin Subdivision 1. new text end
new text begin Filling prescriptions. new text end
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A pharmacy benefit manager that is under
contract with, or under the control of, a plan sponsor shall permit a covered individual to
fill a prescription at any pharmacy willing to meet the payment rate, terms, and conditions
of the plan's mail order or extended days supply network.
new text end
new text begin Subd. 2. new text end
new text begin Cost-sharing. new text end
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A pharmacy benefit manager may not impose cost-sharing
or other requirements on a covered individual who elects to fill a prescription at a
community/outpatient pharmacy or long-term care pharmacy that has accepted the terms
and conditions of the plan's mail order or extended days supply network, that are different
from the cost-sharing or other requirements that the pharmacy benefit manager imposes on
a covered individual who elects to fill a prescription at any mail-order pharmacy.
new text end
new text begin Subd. 3. new text end
new text begin Pharmacy reimbursement. new text end
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A pharmacy benefit manager shall use
the same pricing benchmarks, indices, and formulas when reimbursing pharmacies
under this section, regardless of whether the pharmacy is a mail-order pharmacy, a
community/outpatient pharmacy, or a long-term care pharmacy.
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new text begin EFFECTIVE DATE. new text end
new text begin
This section is effective August 1, 2014, and applies to
pharmacy benefit manager contracts with pharmacies, pharmacists, and plan sponsors
entered into or renewed on or after that date.
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Sec. 5.
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[151.75] PATIENT DATA.
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new text begin Subdivision 1. new text end
new text begin Requirement. new text end
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A pharmacy benefit manager shall adhere to the
criteria specified in this section when handling personally identifiable utilization and
claims data or other sensitive patient data.
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new text begin Subd. 2. new text end
new text begin Notification. new text end
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A pharmacy benefit manager shall notify the plan sponsor if
it intends to sell, lease, or rent utilization or claims data for individuals covered by the
plan sponsor that the pharmacy benefit manager possesses. A pharmacy benefit manager
shall notify the plan sponsor 30 days before selling, leasing, or renting utilization or claims
data, and provide the plan sponsor with the name of the potential purchaser of the data and
information on the expected use. A pharmacy benefit manager shall not sell, lease, or rent
utilization or claims data without written approval from the plan sponsor.
new text end
new text begin Subd. 3. new text end
new text begin Opt out for individuals. new text end
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The pharmacy benefit manager must also allow
each individual covered by a health plan the opportunity to opt out of the sharing of
utilization or claims data for that individual for marketing purposes.
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new text begin Subd. 4. new text end
new text begin Data transmission to pharmacies. new text end
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A pharmacy benefit manager shall not
transmit any personally identifiable utilization or claims data to a pharmacy owned by a
pharmacy benefit manager, unless the patient has voluntarily elected to fill that particular
prescription at the pharmacy owned by the pharmacy benefit manager.
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new text begin Subd. 5. new text end
new text begin Clinical use. new text end
new text begin
Nothing in this section is intended to limit the sharing of
data between health care providers for treatment purposes.
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new text begin EFFECTIVE DATE. new text end
new text begin
This section is effective August 1, 2014, and applies to
pharmacy benefit manager contracts with pharmacies, pharmacists, and plan sponsors
entered into or renewed on or after that date.
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Sec. 6.
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[151.76] APPLICABILITY.
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Sections 151.71 to 151.75 do not apply to the medical assistance and MinnesotaCare
programs.
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