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SF 2284

as introduced - 88th Legislature (2013 - 2014) Posted on 03/18/2014 09:45am

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health; setting requirements for the designation of specialty drugs and
the filling of specialty drug prescriptions; allowing retail community pharmacies
to fill mail-order prescriptions; placing limits on the use of maximum allowable
cost pricing; proposing coding for new law in Minnesota Statutes, chapter 151.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [151.71] DEFINITIONS.
new text end

new text begin (a) For purposes of sections 151.71 to 151.74, the following definitions apply.
new text end

new text begin (b) "Health plan" has the meaning provided in section 62Q.01, subdivision 3.
new text end

new text begin (c) "Health plan company" has the meaning provided in section 62Q.01, subdivision
4.
new text end

new text begin (d) "Managed care organization" has the meaning provided in section 62Q.01,
subdivision 5.
new text end

new text begin (e) "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.
new text end

Sec. 2.

new text begin [151.72] SPECIALTY DRUGS.
new text end

new text begin Subdivision 1. new text end

new text begin Designation of specialty drugs. new text end

new text begin (a) The Board of Pharmacy, in
consultation with the commissioner of human services and the formulary committee
established under section 256B.0625, subdivision 13e, shall specify the prescription drugs
that may be considered specialty drugs by a pharmacy benefit manager under this section.
In specifying the prescription drugs that may be considered specialty drugs, the board
shall take into account whether:
new text end

new text begin (1) the prescription drug is used to treat a patient with a complex, chronic, or rare
medical condition that is progressive, can be debilitating or fatal if left untreated or
undertreated, or for which there is no known cure, including but not limited to multiple
sclerosis, hepatitis C, cystic fibrosis, some cancers, HIV, and rheumatoid arthritis;
new text end

new text begin (2) the prescription drug is not generally stocked at community retail pharmacies;
new text end

new text begin (3) the prescription drug has special handling, storage, inventory, or distribution
requirements; and
new text end

new text begin (4) patients receiving the prescription drug require complex education and
maintenance, including but not limited to complex dosing, intensive monitoring, and
clinical oversight.
new text end

new text begin (b) The board shall publish in the State Register, every six months, a list of the
prescription drugs that the board has designated as specialty drugs.
new text end

new text begin (c) For purposes of this section, "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.
new text end

new text begin Subd. 2. new text end

new text begin Requirements for pharmacy benefit managers. new text end

new text begin (a) If a pharmacy benefit
manager intends to designate certain prescription drugs as specialty drugs on a formulary,
the pharmacy benefits manager shall designate only prescription drugs that are on the list
of specialty drugs published by the board under subdivision 1.
new text end

new text begin (b) A pharmacy benefit manager shall allow any licensed pharmacy or licensed
pharmacist in the state to fill a prescription for a specialty drug at the specialty pharmacy
rate, if the pharmacy or pharmacist:
new text end

new text begin (1) has a contract with the pharmacy benefit manager;
new text end

new text begin (2) has the specialty drug in inventory or has ready access to the specialty drug; and
new text end

new text begin (3) 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.
new text end

new text begin (c) A pharmacy benefit manager shall reimburse the pharmacy or pharmacist for
a specialty drug at the same rate that it 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.
new text end

Sec. 3.

new text begin [151.73] FILLING MAIL ORDER PRESCRIPTIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following definitions
apply.
new text end

new text begin (b) "Covered individual" means an individual receiving prescription drug coverage
under a health plan, as defined in section 62Q.01, subdivision 3, through a pharmacy benefit
manager, or through an employee benefit plan established or maintained by a plan sponsor.
new text end

new text begin (c) "Mail-order pharmacy" means a pharmacy licensed under this chapter that:
new text end

new text begin (1) has the primary business of receiving prescription drug orders by mail or
electronic transmission;
new text end

new text begin (2) dispenses prescribed drugs to patients through the use of mail or a private
delivery service; and
new text end

new text begin (3) primarily consults with patients by mail or electronic means.
new text end

new text begin (d) "Plan sponsor" has the meaning provided in section 151.61, subdivision 4.
new text end

new text begin (e) "Retail community pharmacy" means a pharmacy that is open to the public,
serves walk-in customers, and allows individuals to whom a prescription drug is being
dispensed the opportunity to consult with a pharmacist face-to-face.
new text end

new text begin Subd. 2. new text end

new text begin Requirements for pharmacy benefit managers. new text end

new text begin (a) 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:
new text end

new text begin (1) any mail-order pharmacy; or
new text end

new text begin (2) any retail community pharmacy that is part of the network of pharmacies
offered to the plan sponsor or by the pharmacy benefit manager, if the pharmacy agrees
to dispense the prescription drug for a price that is substantially the same as the price
offered to a mail-order pharmacy.
new text end

new text begin (b) A pharmacy benefit manager may not impose cost-sharing or other requirements
on a covered individual who elects to fill a prescription at a retail community pharmacy
that is part of the network of pharmacies served by the pharmacy benefit manager 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 a mail-order pharmacy.
new text end

new text begin (c) A pharmacy benefit manager shall use the same pricing benchmarks, indices,
and formulas, and the same prescription drug codes, when reimbursing pharmacies under
this section, regardless of whether the pharmacy is a mail-order pharmacy or a retail
community pharmacy.
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, pharmacists, and plan sponsors
entered into or renewed on or after that date.
new text end

Sec. 4.

new text begin [151.74] MAXIMUM ALLOWABLE COST PRICING.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following definitions
apply.
new text end

new text begin (b) "Maximum allowable cost" means:
new text end

new text begin (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
new text end

new text begin (2) any similar reimbursement amount that is used by a pharmacy benefit manager to
reimburse pharmacies for multiple-source drugs.
new text end

new text begin (c) "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.
new text end

new text begin (d) "Therapeutically equivalent" means the drug is identified as therapeutically
or pharmaceutically equivalent or "A" rated by the United States Food and Drug
Administration.
new text end

new text begin Subd. 2. new text end

new text begin Limits on use of maximum allowable cost pricing. new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin Subd. 3. new text end

new text begin Notice requirements for use of maximum allowable cost pricing. new text end

new text begin A
pharmacy benefit manager shall disclose to a pharmacy with which it has contracted:
new text end

new text begin (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
new text end

new text begin (2) at least once every seven business days, the maximum allowable cost pricing
index or maximum allowable cost rates used by the pharmacy benefit manager, provided
in a readily accessible and useable format that retains a record of index or rate changes.
new text end

new text begin Subd. 4. new text end

new text begin Contesting a rate. new text end

new text begin A pharmacy benefit manager shall establish a 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:
new text end

new text begin (1) become effective on the date on which the pharmacy initiated proceedings under
this subdivision; and
new text end

new text begin (2) apply to all pharmacies in the pharmacy network served by the pharmacy benefit
manager.
new text end

new text begin Subd. 5. new text end

new text begin Patient data. new text end

new text begin (a) A pharmacy benefit manager must adhere to the criteria
specified in this subdivision when handling personally identifiable utilization and claims
data or other sensitive patient data.
new text end

new text begin (b) A pharmacy benefit manager shall notify the health plan sponsor if it intends
to sell, lease, or rent utilization or claims data for individuals covered by the health plan
sponsor that the pharmacy benefit manager possesses. A pharmacy benefit manager shall
notify the health plan sponsor 30 days before selling, leasing, or renting utilization or claims
data, and provide the health 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 health plan sponsor.
new text end

new text begin (c) 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. A pharmacy benefit manager shall not initially contact covered individuals
without the written permission of the health plan sponsor, and must obtain the written
permission of the covered individual for any ongoing contact with the individual.
new text end

new text begin (d) 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, in writing, to fill a particular prescription at the pharmacy
owned by the pharmacy benefit manager.
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, pharmacists, and plan sponsors
entered into or renewed on or after that date.
new text end