N.Y. Comp. Codes R. & Regs. tit. 11 § 452.4

Current through Register Vol. 46, No. 43, October 23, 2024

Section 452.4 - Conflicts of interest

(a) Any of following activities, policies, practices, contracts, or arrangements shall be considered potential conflicts of interest for purposes of Public Health Law section 280-a(2)(e) and therefore the following information shall be disclosed to a health plan, upon written request by the health plan, within 30 days of such request:

(1) Where there is a difference in the amount charged to the health plan for a prescription drug's ingredient cost or dispensing fee and the amount the pharmacy benefit manager reimburses a pharmacy for the same prescription drug's ingredient cost or dispensing fee:

(i) the pharmacy benefit manager shall disclose to the health plan the actual total reimbursement amounts for each drug the pharmacy benefit manager paid to each network pharmacy after all direct and indirect administrative and other fees that have been retrospectively charged to the pharmacies are applied; and

(ii) the pharmacy benefit manager shall disclose to the health plan the actual total reimbursement amounts for each drug the pharmacy benefit manager pays each and every pharmacy benefit manager's owned or affiliated mail order or specialty pharmacy after all direct and indirect administrative and other fees have been retrospectively charged to the pharmacies are applied;

(2) Where the pharmacy benefit manager or any owned or affiliated entity receives any renumeration, including, any rebates, fees, discounts, reimbursements, payments, or other funds received by the pharmacy benefit manager from a manufacturer for a prescription drug, where such renumeration is not fully passed through to the health plan:

(i) the pharmacy benefit manager shall disclose to the health plan the total dollar amount and percentage of all rebates, fees, discounts, reimbursements, payments, or other funds received from any manufacturer by the pharmacy benefit manager for each drug on the pharmacy benefit manager's formularies, including any rebates, fees, discounts, reimbursements, payments, or other funds paid to or received from an owned or affiliated entity, which includes any rebate aggregator or group purchasing organization; and

(ii) the pharmacy benefit manager shall also disclose its relationship with each rebate aggregator or group purchasing organization, including whether and how the rebate aggregator or group purchasing organization is owned or affiliated with the pharmacy benefit manager;

(3) Where the pharmacy benefit manager has any ownership interest in, or affiliation with, any retail, specialty, or mail order pharmacy, including in-network pharmacies and out-of-network pharmacies, the pharmacy benefit manager shall disclose to the health plan:

(i) each and every ownership interest in, or affiliation with, each and every retail, specialty, or mail order pharmacy that claims were paid to by the pharmacy benefit manager on behalf of the health plan in the past calendar year;

(ii) the total dollar amount and the percentage of total claims that were paid to each owned or affiliated pharmacy by the pharmacy benefit manager on behalf of the health plan in the past calendar year; and

(iii) the total dollar amount and the percentage of total claims that were paid to non-affiliated pharmacies by the pharmacy benefit manager on behalf of the health plan in the past calendar year;

(4) Where the pharmacy benefit manager solicits or incentivizes, either directly or indirectly, any covered individual to use a pharmacy benefit manager-owned or affiliated dispensing entity, including a pharmacy benefit manager-owned or affiliated retail pharmacy, specialty pharmacy, mail order pharmacy or other dispensing entity in lieu of a non-pharmacy benefit manager-affiliated pharmacy, the pharmacy benefit manager shall disclose to the health plan:

(i) each and every communication made by the pharmacy benefit manager to each and every covered individual that could be seen by a reasonable person as a solicitation or incentivization to that covered individual to utilize a pharmacy benefit manager-owned or affiliated dispensing entity;

(ii) the contents of each and every communication that was made by the pharmacy benefit manager to each and every covered individual that could be seen by a reasonable person as a solicitation or incentivization to that covered individual to use a pharmacy benefit manager-owned or affiliated dispensing entity;

(iii) the method by which, and the number of times, each and every communication was made by the pharmacy benefit manager to each and every covered individual that could be seen by a reasonable person as a solicitation or incentivization to that covered individual to use a pharmacy benefit manager-owned or affiliated dispensing entity; and

(iv) any communications by a pharmacy benefit manager to any covered individual that mentions a pharmacy benefit manager's wholly owned pharmacy in any way;

(5) Where the prescription of a claim originating in one pharmacy is transferred to another pharmacy that the pharmacy benefit manager has an ownership interest in or affiliation with, the pharmacy benefit manager shall disclose to the health plan:

(i) each claim originating in a pharmacy where a prescription was transferred for any reason to another pharmacy that the pharmacy benefit manager has an ownership interest in or affiliation with;

(ii) to and from which pharmacy the prescription was transferred;

(iii) whether the pharmacy benefit manager contacted the covered individual, prescriber, or both in an effort to promote the transfer or obtain the prescription;

(iv) the reason why the prescription was transferred; and

(v) if the prescription was transferred for any reason related to a prior authorization, whether efforts were made to obtain the prior authorization at the originating pharmacy, and if so, whether the prescription was still transferred and the reason for the transfer;

(6) Where the pharmacy benefit manager conducts audits of pharmacies, the pharmacy benefit manager shall disclose to the health plan:

(i) each pharmacy for which the pharmacy benefit manager has conducted an audit in the past 12 months;

(ii) the number of audits that were or are currently being conducted on each individual pharmacy;

(iii) whether such pharmacy is owned or affiliated with the pharmacy benefit manager or whether such pharmacy is an independently owned pharmacy; and

(iv) the amount of any and all monetary fees of any kind paid to the pharmacy benefit manager in connection with such audit for each pharmacy as well as the reasons for the fees for each pharmacy;

(7) Where the pharmacy benefit manager or any entity owned or affiliated with the pharmacy benefit manager is responsible for managing, coordinating, or facilitating, in whole or in part, any program that restricts in any way a manufacturer's contributions to copay discount cards or copay coupons from applying to the health plan's beneficiaries' cost-sharing requirements under the health plan, the pharmacy benefit manager shall disclose to the health plan:

(i) the name of the entity responsible for managing, coordinating, or facilitating, in whole or in part, any program that restricts in any way a manufacturer's contributions to copay discount cards from applying to the health plan's cost-sharing requirements under the plan;

(ii) the relationship between the pharmacy benefit manager and the entity managing, coordinating, or facilitating, in whole or in part, any program that restricts in any way a manufacturer's contributions to copay discount cards from applying to the health plan's cost-sharing requirements under the plan; and

(iii) the percentage or amount of the manufacturer's contributions to copay discount cards or copay coupons applies to the health plan's beneficiaries' cost-sharing requirements under the plan;

(8) Where the pharmacy benefit manager or any entity owned or affiliated with the pharmacy benefit manager shares any data obtained from a non-affiliated pharmacy with the pharmacy benefit manager's own or affiliated pharmacy or pharmacies, the pharmacy benefit manager shall disclose to the health plan:

(i) how the non-affiliated pharmacy data was obtained from the pharmacy; and

(ii) the precise data obtained from the non-affiliated pharmacy that the pharmacy benefit manager shares with the pharmacy benefit managers' own affiliated pharmacy or pharmacies; and

(9) Where the health plan reasonably views any other activity, policy, practice, contract, or arrangement of the pharmacy benefit manager not otherwise listed above as directly or indirectly presenting a conflict of interest with the pharmacy benefit manager's relationship with or obligation to the health plan, the pharmacy benefit manager shall disclose such activity, policy, practice, contract, or arrangement to the health plan upon request by the health plan.

N.Y. Comp. Codes R. & Regs. Tit. 11 § 452.4

Adopted New York State Register July 12, 2023/Volume XLV, Issue 28, eff. 7/12/2023