| (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.
(b) Formulary information must include the summary
information required under subsection (a) of this section beginning
on the first page of the formulary document under the title, "Summary
of Formulary Benefits."
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