New York Codes, Rules and Regulations
Title 11 - INSURANCE
Chapter XXII
Part 452 - General Duties, Accountability, and Transparency Provision For Pharmacy Benefit Managers
Section 452.4 - Conflicts of interest
Universal Citation: 452 NY Comp Codes Rules and Regs ยง 452.4
Current through Register Vol. 46, No. 39, September 25, 2024
(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.
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