(a) To place a drug on a maximum allowable cost list, a pharmacy benefits manager must ensure that the drug meets all of the following requirements:
(1) It is listed as “A” or “B” rated in the most recent version of the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, or has an “NR” or “NA” rating or a similar rating by a nationally recognized reference.
(2) It is generally available for purchase by pharmacies in this State from national or regional wholesalers.
(3) It is not obsolete, temporarily unavailable, or listed on a drug shortage list as in shortage.
(4) If it is manufactured by more than 1 manufacturer, the drug is available for purchase by a contracted pharmacy, including a contracted retail pharmacy, in this State from a wholesale distributor with a permit in this State.
(5) If it is manufactured by only 1 manufacturer, the drug is generally available for purchase by a contracted pharmacy, including a contracted retail pharmacy, in this State from at least 2 wholesale distributors with a permit in this State.
(b) A pharmacy benefits manager engaging in maximum allowable cost pricing must do all of the following:
(1) Make available to each network provider at the beginning of the term of the network provider’s contract, and upon renewal of the contract, the sources utilized to determine the maximum allowable cost pricing.
(2) Provide a process for a network pharmacy provider to readily access the most recent maximum allowable cost specific to that provider in an electronic format as updated in accordance with the requirements of this section.
(3) Review and update maximum allowable cost price information at least once every 7 business days and update the information when there is a modification of maximum allowable cost pricing.
(4) Ensure that dispensing fees are not included in the calculation of maximum allowable cost.
(5) On the next day after a pricing information update under paragraph (b)(3) of this section, use the updated pricing information in calculating the payments made to all contracted pharmacies.
(6) Maintain a procedure to eliminate products from the maximum allowable cost list as necessary to do all of the following:
a. Remain consistent with price changes.
b. Remove from the maximum allowable cost list a drug that no longer meets the requirements of subsection (a) of this section.
c. Reflect the most recent availability of drugs in the marketplace.
80 Del. Laws, c. 245, § 1; 82 Del. Laws, c. 115, § 2.
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