Delaware Code Title 18 Sec. 3323A – Requirements for maximum allowable cost pricing
(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 United States Food and Drug Administration’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, with whom the pharmacy has an existing relationship.
(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.
Terms Used In Delaware Code Title 18 Sec. 3323A
- Contract: A legal written agreement that becomes binding when signed.
- Contracted pharmacy: means a pharmacy that participates in the network of a pharmacy benefits manager through a contract with a pharmacy benefits manager, a pharmacy services administration organization, or a group purchasing organization. See Delaware Code Title 18 Sec. 3321A
- Drug shortage list: means a list of drug products listed on the federal Food and Drug Administration's Drug Shortages website. See Delaware Code Title 18 Sec. 3321A
- Maximum allowable cost: means the maximum amount that a pharmacy benefits manager will reimburse a pharmacist or pharmacy for the cost of a multi-sourced drug, medical product, or device. See Delaware Code Title 18 Sec. 3321A
- Maximum allowable cost list: means the multi-source generic drugs, medical products, and devices for which a maximum allowable cost has been established by a pharmacy benefits manager or a purchaser. See Delaware Code Title 18 Sec. 3321A
- Pharmacy: means as defined under § 2502 of Title 24. See Delaware Code Title 18 Sec. 3321A
- Pharmacy benefits manager: means as defined under § 3302A of this title. See Delaware Code Title 18 Sec. 3321A
- State: means the State of Delaware; and when applied to different parts of the United States, it includes the District of Columbia and the several territories and possessions of the United States. See Delaware Code Title 1 Sec. 302
- United States: includes its territories and possessions and the District of Columbia. See Delaware Code Title 1 Sec. 302
(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; 83 Del. Laws, c. 256, § 3;