(a) The formulary information required by §
21.3032 of this title (relating to
Formulary Disclosure Requirements for Individual Health Benefit Plans) must
include a summary titled "Summary of Formulary Benefits" that includes this
statement: "The information in this document is designed to help you understand
the prescription drug benefits offered under this plan and to compare these
benefits to those offered by other plans. Information contained in this summary
is designed to help you compare both the value and scope of formulary
benefits." The summary must also include, in the following order:
(1) Under the header, "How to Find
Information on the Cost of Prescription Drugs," a description of how a consumer
may use the plan's summary health plan document, formulary information, and
web-based tool, if applicable, to determine the cost sharing they may owe, and
an explanation that cost-sharing information reflects a consumer's share of the
cost excluding any deductible requirement, calculated using an estimate of the
full price of the drug, which is based on the plan's median or the actual cost
allowed amount at a given point in time.
(2) Under the header, "Formulary by Health
Benefit Plan," a chart that displays each formulary that applies to each
individual health benefit plan issued by the issuer and includes a direct
electronic link to the Summary of Benefits and Coverage for each individual
health plan listed. This chart may be limited to individual health benefit
plans being sold in the market in which the applicable health benefit plan is
issued.
(3) Under the header,
"Drugs by Cost-Sharing Tier," if the drug formulary is a multitier formulary, a
summary that displays the percent of drugs in each cost-sharing tier for all
drugs in the formulary.
(4) Under
the header, "How Prescription Drugs are Covered under the Plan":
(A) under a section titled, "Formulary
Composition," an explanation of the method the issuer uses to determine the
prescription drugs to be included in or excluded from the formulary, an
explanation of whether the formulary is open or closed, and a statement of how
often the issuer reviews the contents of the formulary.
(B) Under a section titled, "Right to
Appeal," an explanation that if a drug is not covered under the formulary, but
the enrollee's physician has determined that the drug is medically necessary,
the consumer has the right to appeal, consistent with §
21.3023 of this title (relating to
Nonformulary Prescription Drugs; Adverse Determination) and Insurance Code §
1369.056. A statement
of how cost sharing will be determined for drugs covered as a result of a
successful appeal.
(C) Under a
section titled, "Continuation of Coverage," an explanation of a consumer's
right to continued coverage for a prescription drug at the coverage level or
tier at which the drug was covered at the beginning of the plan year, until the
enrollee's plan renewal date, consistent with §
21.3022 of this title (relating to
Continuation of Benefits) and Insurance Code §
1369.055 and §
1369.0541.
(D) Under a section titled, "Off-Label Drug
Use," an explanation of how formulary drugs are covered under the plan,
including an explanation of coverage for off-label drug use.
(E) Under a section titled, "Cost Sharing,"
an explanation of how cost sharing is determined under the plan, including
whether a deductible applies to prescription drug coverage; how cost sharing
for prescription drugs counts towards the plan's deductible; how drugs are
categorized into each of the formulary tiers or cost-sharing levels, whether
the drug formulary is a multitier formulary; the difference between preferred
and nonpreferred drugs, if applicable; the difference in coverage for drugs
dispensed from in-network and out-of-network pharmacies; and the difference in
coverage for drugs dispensed in a retail pharmacy and a mail-order pharmacy, if
applicable.
(F) Under a section
titled, "Medical Management Requirements," an explanation of each type of
medical management requirement used by the individual health benefit plan,
including prior authorization, step therapy, or other protocol requirements
that limit access to prescription drugs, as applicable.