1.1.................... moves to amend H.F. No. 1872 as follows:
1.2Delete everything after the enacting clause and insert:
1.3 "Section 1.
[151.71] DEFINITIONS.
1.4 Subdivision 1. Applicability. For purposes of sections 151.71 to 151.75, the
1.5following definitions apply.
1.6 Subd. 2. Community/outpatient pharmacy. "Community/outpatient pharmacy"
1.7has the meaning provided in Minnesota Rules, part 6800.0100, subpart 2.
1.8 Subd. 3. Covered individual. "Covered individual" means an individual receiving
1.9prescription drug coverage under a health plan through a pharmacy benefit manager, or
1.10through an employee benefit plan established or maintained by a plan sponsor.
1.11 Subd. 4. Extended days supply. "Extended days supply" means a medication
1.12supply greater than the quantity considered by the health plan to be a one-month supply.
1.13 Subd. 5. Health care provider. "Health care provider" has the meaning provided in
1.14section 62J.03, subdivision 8, except the term also includes nursing homes.
1.15 Subd. 6. Health plan. "Health plan" has the meaning provided in section 62Q.01,
1.16subdivision 3.
1.17 Subd. 7. Health plan company. "Health plan company" has the meaning provided
1.18in section 62Q.01, subdivision 4.
1.19 Subd. 8. Long-term care pharmacy. "Long-term care pharmacy" has the meaning
1.20provided in Minnesota Rules, part 6800.0100, subpart 4.
1.21 Subd. 9. Mail-order pharmacy. "Mail-order pharmacy" means a pharmacy
1.22licensed under this chapter that:
1.23(1) has the primary business of receiving prescription drug orders by mail or
1.24electronic transmission;
1.25(2) dispenses prescribed drugs to patients through the use of mail or a private
1.26delivery service; and
1.27(3) primarily consults with patients by mail or electronic means.
2.1 Subd. 10. Managed care organization. "Managed care organization" has the
2.2meaning provided in section 62Q.01, subdivision 5.
2.3 Subd. 11. Maximum allowable cost. "Maximum allowable cost" means:
2.4(1) a maximum reimbursement amount for a group of therapeutically and
2.5pharmaceutically equivalent multiple-source drugs that are listed in the most recent edition
2.6of the Approved Drug Products with Therapeutic Equivalence Evaluations published by
2.7the United States Food and Drug Administration or that may be substituted in accordance
2.8with section 151.21; or
2.9(2) any similar reimbursement amount that is used by a pharmacy benefit manager to
2.10reimburse pharmacies for multiple-source drugs.
2.11 Subd. 12. Nationally available. "Nationally available" means that all pharmacies
2.12in Minnesota can purchase the drug, without limitation, from regional or national
2.13wholesalers, and that the product is not obsolete or temporarily unavailable.
2.14 Subd. 13. Pharmacy. "Pharmacy" has the meaning provided in section 151.01,
2.15subdivision 2.
2.16 Subd. 14. Pharmacy benefit manager. "Pharmacy benefit manager" means an
2.17entity that contracts with pharmacies on behalf of a health plan, state agency, health plan
2.18company, managed care organization, or other third-party payor to provide pharmacy
2.19benefit services or administration.
2.20 Subd. 15. Plan sponsor. "Plan sponsor" has the meaning provided in section
2.21151.61, subdivision 4.
2.22 Subd. 16. Specialty drug. "Specialty drug" means a prescription drug that requires
2.23special handling, special administration, unique inventory management, a high level of
2.24patient monitoring, or more intense patient support than conventional therapies. For
2.25purposes of medical assistance, "specialty drug" means specialty pharmacy products
2.26defined under section 256B.0625, subdivision 13e, paragraph (e).
2.27 Subd. 17. Therapeutically equivalent. "Therapeutically equivalent" means the
2.28drug is identified as therapeutically or pharmaceutically equivalent or "A" rated by the
2.29United States Food and Drug Administration or that may be substituted in accordance
2.30with section 151.21.
2.31 Sec. 2.
[151.72] MAXIMUM ALLOWABLE COST PRICING.
2.32 Subdivision 1. Limits on use of maximum allowable cost pricing. (a) A pharmacy
2.33benefit manager may not place a prescription drug on a maximum allowable cost pricing
2.34index or create for a prescription drug a maximum allowable cost rate until after the
3.1six-month period of generic exclusivity, and only if the prescription drug has three or more
3.2nationally available and therapeutically equivalent drugs, including the brand product.
3.3(b) A pharmacy benefit manager shall remove a prescription drug from a maximum
3.4allowable cost pricing index, or eliminate the maximum allowable cost rate, if the criterion
3.5related to the number of nationally available and therapeutically equivalent drugs in
3.6paragraph (a) cannot be met due to changes in the national marketplace for prescription
3.7drugs. The removal of the drug or elimination of the rate must be made in a timely manner.
3.8 Subd. 2. Notice requirements for use of maximum allowable cost pricing. A
3.9pharmacy benefit manager shall disclose to a pharmacy with which it has contracted,
3.10through the term of the contract:
3.11(1) at the beginning of each calendar year, the basis of the methodology and
3.12the sources used to establish the maximum allowable cost pricing index or maximum
3.13allowable cost rates used by the pharmacy benefit manager; and
3.14(2) at least once every seven calendar days, the maximum allowable cost pricing
3.15index or maximum allowable cost rates used by the pharmacy benefit manager, provided
3.16in a readily accessible and searchable format that retains a record of index or rate changes
3.17and includes, at a minimum, the drug name, drug strength, dosage form, maximum
3.18allowable cost price, at least one national drug code for each product the maximum
3.19allowable cost price applies to, and a network identifier.
3.20 Subd. 3. Contesting a rate. A pharmacy benefit manager shall establish a written
3.21procedure by which a pharmacy may contest a maximum allowable cost pricing index or
3.22maximum allowable cost rate. The procedure established must require a pharmacy benefit
3.23manager to respond to a pharmacy that has contested a pricing index or rate within 15
3.24calendar days. If the pharmacy benefit manager changes the pricing index or rate, the
3.25change must:
3.26(1) become effective on the date on which the pharmacy initiated proceedings under
3.27this subdivision; and
3.28(2) apply to all pharmacies in the pharmacy network served by the pharmacy benefit
3.29manager.
3.30EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
3.31pharmacy benefit manager contracts with pharmacies and pharmacists entered into or
3.32renewed on or after that date.
3.33 Sec. 3.
[151.73] SPECIALTY DRUGS.
3.34 Subdivision 1. Designation of specialty drugs. A pharmacy benefit manager may
3.35designate certain prescription drugs as specialty drugs on a formulary.
4.1 Subd. 2. Filling specialty drug prescriptions. If a pharmacy benefit manager
4.2designates certain prescription drugs as specialty drugs on the formulary, the pharmacy
4.3benefit manager shall allow a covered individual to fill a prescription for a specialty drug
4.4at any willing pharmacy, if the pharmacy or pharmacist:
4.5(1) has the specialty drug in inventory or has ready access to the specialty drug;
4.6(2) is capable of complying with any special handling, special administration,
4.7inventory management, patient monitoring, patient education and maintenance, and any
4.8other patient support requirements for the specialty drug; and
4.9(3) accepts the same rate that the pharmacy benefit manager applies to other
4.10pharmacies or pharmacists for filling a prescription for that specialty drug.
4.11EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
4.12pharmacy benefit manager contracts with pharmacies and pharmacists entered into or
4.13renewed on or after that date.
4.14 Sec. 4.
[151.74] MAIL ORDER OR EXTENDED DAYS SUPPLY
4.15PRESCRIPTIONS.
4.16 Subdivision 1. Filling prescriptions. A pharmacy benefit manager that is under
4.17contract with, or under the control of, a plan sponsor shall permit a covered individual to
4.18fill a prescription at any pharmacy willing to meet the payment rate, terms, and conditions
4.19of the plan's mail order or extended days supply network.
4.20 Subd. 2. Cost-sharing. A pharmacy benefit manager may not impose cost-sharing
4.21or other requirements, on a covered individual who elects to fill a prescription at a
4.22community/outpatient pharmacy or long-term care pharmacy that has accepted the terms
4.23and conditions of the plan's mail order or extended days supply network, that are different
4.24from the cost-sharing or other requirements that the pharmacy benefit manager imposes on
4.25a covered individual who elects to fill a prescription at any mail-order pharmacy.
4.26 Subd. 3. Pharmacy reimbursement. A pharmacy benefit manager shall use
4.27the same pricing benchmarks, indices, and formulas when reimbursing pharmacies
4.28under this section, regardless of whether the pharmacy is a mail-order pharmacy, a
4.29community/outpatient pharmacy, or a long-term care pharmacy.
4.30EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
4.31pharmacy benefit manager contracts with pharmacies, pharmacists, and plan sponsors
4.32entered into or renewed on or after that date.
4.33 Sec. 5.
[151.75] PATIENT DATA.
5.1 Subdivision 1. Requirement. A pharmacy benefit manager shall adhere to the
5.2criteria specified in this section when handling personally identifiable utilization and
5.3claims data or other sensitive patient data.
5.4 Subd. 2. Notification. A pharmacy benefit manager shall notify the plan sponsor if
5.5it intends to sell, lease, or rent utilization or claims data for individuals covered by the
5.6plan sponsor that the pharmacy benefit manager possesses. A pharmacy benefit manager
5.7shall notify the plan sponsor 30 days before selling, leasing, or renting utilization or claims
5.8data, and provide the plan sponsor with the name of the potential purchaser of the data and
5.9information on the expected use. A pharmacy benefit manager shall not sell, lease, or rent
5.10utilization or claims data without written approval from the plan sponsor.
5.11 Subd. 3. Opt out for individuals. The pharmacy benefit manager must also allow
5.12each individual covered by a health plan the opportunity to opt out of the sharing of
5.13utilization or claims data for that individual.
5.14 Subd. 4. Data transmission to pharmacies. A pharmacy benefit manager shall not
5.15transmit any personally identifiable utilization or claims data to a pharmacy owned by a
5.16pharmacy benefit manager, unless the patient has voluntarily elected to fill a particular
5.17prescription at the pharmacy owned by the pharmacy benefit manager.
5.18 Subd. 5. Clinical use. Nothing in this section is intended to limit the sharing of
5.19data between health care providers for treatment purposes.
5.20EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
5.21pharmacy benefit manager contracts with pharmacies, pharmacists, and plan sponsors
5.22entered into or renewed on or after that date.
5.23 Sec. 6.
[151.76] APPLICABILITY.
5.24Sections 151.71 to 151.75 do not apply to the medical assistance and MinnesotaCare
5.25programs."
5.26Delete the title and insert:
5.28relating to health; setting requirements for the use of maximum allowable cost
5.29pricing; setting requirements for the designation of specialty drugs and the filling
5.30of specialty drug prescriptions; allowing community/outpatient and long-term
5.31care pharmacies to fill mail-order or extended days supply prescriptions; setting
5.32requirements for the use of pharmacy utilization and claims data;proposing
5.33coding for new law in Minnesota Statutes, chapter 151."