CFR-2023-title45-vol2-sec147-210

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§ 147.210

45 CFR Subtitle A (10–1–23 Edition)

reconstructive surgery, rehabilitation
services, skilled nursing care, specialist, usual customary and reasonable (UCR), and urgent care; and
(ii) Such other terms as the Secretary determines are important to define so that individuals and employers
may compare and understand the
terms of coverage and medical benefits
(including any exceptions to those benefits), as specified in guidance.
(3) Appearance. A group health plan,
and a health insurance issuer, must
provide the uniform glossary with the
appearance specified by the Secretary
in guidance to ensure the uniform glossary is presented in a uniform format
and uses terminology understandable
by the average plan enrollee (or, in the
case of individual market coverage, an
average individual covered under a
health insurance policy).
(4) Form and manner. A plan or issuer
must make the uniform glossary described in this paragraph (c) available
upon request, in either paper or electronic form (as requested), within
seven business days after receipt of the
request.
(d) Preemption. For purposes of this
section, the provisions of section 2724
of the PHS Act continue to apply with
respect to preemption of State law.
State laws that conflict with this section (including a state law that requires a health insurance issuer to provide an SBC that supplies less information than required under paragraph (a)
of this section) are preempted.
(e) Failure to provide. A health insurance issuer or a non-federal governmental health plan that willfully fails
to provide information to a covered individual required under this section is
subject to a fine of not more than $1,000
as adjusted annually under 45 CFR part
102 for each such failure. A failure with
respect to each covered individual constitutes a separate offense for purposes
of this paragraph (e). HHS will enforce
these provisions in a manner consistent with §§ 150.101 through 150.465 of
this subchapter.
(f) Applicability to Medicare Advantage
benefits. The requirements of this section do not apply to a group health
plan benefit package that provides
Medicare Advantage benefits pursuant

to or 42 U.S.C. Chapter 7, Subchapter
XVIII, Part C.
(g) Applicability date. (1) This section
is applicable to group health plans and
group health insurance issuers in accordance with this paragraph (g). (See
§ 147.140(d), providing that this section
applies to grandfathered health plans.)
(i) For disclosures with respect to
participants and beneficiaries who enroll or re-enroll through an open enrollment period (including re-enrollees
and late enrollees), this section applies
beginning on the first day of the first
open enrollment period that begins on
or after September 1, 2015; and
(ii) For disclosures with respect to
participants and beneficiaries who enroll in coverage other than through an
open enrollment period (including individuals who are newly eligible for coverage and special enrollees), this section applies beginning on the first day
of the first plan year that begins on or
after September 1, 2015.
(2) For disclosures with respect to
plans, this section is applicable to
health insurance issuers beginning September 1, 2015.
(3) For disclosures with respect individuals and covered dependents in the
individual market, this section is applicable to health insurance issuers beginning with respect to SBCs issued for
coverage that begins on or after January 1, 2016.
[80 FR 34310, June 16, 2015, as amended at 81
FR 61581, Sept. 6, 2016]

§ 147.210 Transparency in coverage—
definitions.
(a) Scope and definitions—(1) Scope.
This section sets forth definitions for
the price transparency requirements
for group health plans and health insurance issuers in the individual and
group markets established in this section and §§ 147.211 and 147.212.
(2) Definitions. For purposes of this
section and §§ 147.211 and 147.212, the
following definitions apply:
(i) Accumulated amounts means:
(A) The amount of financial responsibility a participant, beneficiary, or enrollee has incurred at the time a request for cost-sharing information is
made, with respect to a deductible or
out-of-pocket limit. If an individual is

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Dept. of Health and Human Services

§ 147.210

enrolled in other than self-only coverage, these accumulated amounts
shall include the financial responsibility a participant, beneficiary, or enrollee has incurred toward meeting his
or her individual deductible or out-ofpocket limit, as well as the amount of
financial responsibility that all the individuals enrolled under the plan or
coverage have incurred, in aggregate,
toward meeting the other than selfonly deductible or out-of-pocket limit,
as applicable. Accumulated amounts
include any expense that counts toward a deductible or out-of-pocket
limit (such as a copayment or coinsurance), but exclude any expense that
does not count toward a deductible or
out-of-pocket limit (such as any premium payment, out-of-pocket expense
for out-of-network services, or amount
for items or services not covered under
the group health plan or health insurance coverage); and
(B) To the extent a group health plan
or health insurance issuer imposes a
cumulative treatment limitation on a
particular covered item or service
(such as a limit on the number of
items, days, units, visits, or hours covered in a defined time period) independent of individual medical necessity
determinations, the amount that has
accrued toward the limit on the item
or service (such as the number of
items, days, units, visits, or hours the
participant, beneficiary, or enrollee
has used within that time period).
(ii) Billed charge means the total
charges for an item or service billed to
a group health plan or health insurance
issuer by a provider.
(iii) Billing code means the code used
by a group health plan or health insurance issuer or provider to identify
health care items or services for purposes of billing, adjudicating, and paying claims for a covered item or service, including the Current Procedural
Terminology (CPT) code, Healthcare
Common Procedure Coding System
(HCPCS)
code,
Diagnosis-Related
Group (DRG) code, National Drug Code
(NDC), or other common payer identifier.
(iv) Bundled payment arrangement
means a payment model under which a
provider is paid a single payment for
all covered items and services provided

to a participant, beneficiary, or enrollee for a specific treatment or procedure.
(v) Copayment assistance means the financial assistance a participant, beneficiary, or enrollee receives from a prescription drug or medical supply manufacturer towards the purchase of a covered item or service.
(vi) Cost-sharing liability means the
amount a participant, beneficiary, or
enrollee is responsible for paying for a
covered item or service under the
terms of the group health plan or
health insurance coverage. Cost-sharing
liability
generally
includes
deductibles, coinsurance, and copayments, but does not include premiums,
balance billing amounts by out-of-network providers, or the cost of items or
services that are not covered under a
group health plan or health insurance
coverage.
(vii) Cost-sharing information means
information related to any expenditure
required by or on behalf of a participant, beneficiary, or enrollee with respect to health care benefits that are
relevant to a determination of the participant’s, beneficiary’s, or enrollee’s
cost-sharing liability for a particular
covered item or service.
(viii) Covered items or services means
those items or services, including prescription drugs, the costs for which are
payable, in whole or in part, under the
terms of a group health plan or health
insurance coverage.
(ix) Derived amount means the price
that a group health plan or health insurance issuer assigns to an item or
service for the purpose of internal accounting, reconciliation with providers
or submitting data in accordance with
the requirements of § 153.710(c) of this
subchapter.
(x) Enrollee means an individual who
is covered under an individual health
insurance policy as defined under section 2791(b)(5) of the Public Health
Service (PHS) Act.
(xi) Historical net price means the retrospective average amount a group
health plan or health insurance issuer
paid for a prescription drug, inclusive
of any reasonably allocated rebates,
discounts, chargebacks, fees, and any
additional price concessions received
by the plan or issuer with respect to

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§ 147.210

45 CFR Subtitle A (10–1–23 Edition)

the prescription drug. The allocation
shall be determined by dollar value for
non-product specific and product-specific rebates, discounts, chargebacks,
fees, and other price concessions to the
extent that the total amount of any
such price concession is known to the
group health plan or health insurance
issuer at the time of publication of the
historical net price in a machine-readable file in accordance with § 147.212.
However, to the extent that the total
amount of any non-product specific and
product-specific rebates, discounts,
chargebacks, fees, or other price concessions is not known to the group
health plan or health insurance issuer
at the time of file publication, then the
plan or issuer shall allocate such rebates, discounts, chargebacks, fees, and
other price concessions by using a good
faith, reasonable estimate of the average price concessions based on the rebates, discounts, chargebacks, fees, and
other price concessions received over a
time period prior to the current reporting period and of equal duration to the
current reporting period, as determined
under § 147.212(b)(1)(iii)(D)(3).
(xii) In-network provider means any
provider of any item or service with
which a group health plan or health insurance issuer, or a third party for the
plan or issuer, has a contract setting
forth the terms and conditions on
which a relevant item or service is provided to a participant, beneficiary, or
enrollee.
(xiii) Items or services means all encounters, procedures, medical tests,
supplies, prescription drugs, durable
medical equipment, and fees (including
facility fees), provided or assessed in
connection with the provision of health
care.
(xiv) Machine-readable file means a
digital representation of data or information in a file that can be imported
or read by a computer system for further processing without human intervention, while ensuring no semantic
meaning is lost.
(xv) National Drug Code means the
unique 10- or 11-digit 3-segment number
assigned by the Food and Drug Administration, which provides a universal
product identifier for drugs in the
United States.

(xvi) Negotiated rate means the
amount a group health plan or health
insurance issuer has contractually
agreed to pay an in-network provider,
including an in-network pharmacy or
other prescription drug dispenser, for
covered items and services, whether directly or indirectly, including through
a third-party administrator or pharmacy benefit manager.
(xvii) Out-of-network allowed amount
means the maximum amount a group
health plan or health insurance issuer
will pay for a covered item or service
furnished by an out-of-network provider.
(xviii) Out-of-network provider means
a provider of any item or service that
does not have a contract under a participant’s, beneficiary’s, or enrollee’s
group health plan or health insurance
coverage to provide items or services.
(xix) Out-of-pocket limit means the
maximum amount that a participant,
beneficiary, or enrollee is required to
pay during a coverage period for his or
her share of the costs of covered items
and services under his or her group
health plan or health insurance coverage, including for self-only and other
than self-only coverage, as applicable.
(xx) Plain language means written
and presented in a manner calculated
to be understood by the average participant, beneficiary, or enrollee.
(xxi) Prerequisite means concurrent
review, prior authorization, and steptherapy or fail-first protocols related
to covered items and services that
must be satisfied before a group health
plan or health insurance issuer will
cover the item or service. The term
prerequisite does not include medical
necessity determinations generally or
other forms of medical management
techniques.
(xxii) Underlying fee schedule rate
means the rate for a covered item or
service from a particular in-network
provider, or providers that a group
health plan or health insurance issuer
uses to determine a participant’s, beneficiary’s, or enrollee’s cost-sharing liability for the item or service, when
that rate is different from the negotiated rate or derived amount.
(b) [Reserved]
[85 FR 72305, Nov. 12, 2020]

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