Current through Reg. 50, No. 13; March 28, 2025
(a) Four-step analysis. An issuer must
complete the four-step analysis detailed in this section for each NQTL
contained in the plan documents for each plan. An issuer must report its NQTL
analyses separately for each applicable classification or subclassification,
using the classification worksheets as described in subsection (b) of this
section.
(b) Step 1. Within the
NQTL template, in the worksheet titled "NQTL Summary," an issuer must identify
each NQTL that applies to MH/SUD or medical/surgical benefits covered by the
plan, including, but not limited to, those identified in §
21.2439 of this title (relating to
Nonquantitative Treatment Limitations Generally).
(1) Within the NQTL Summary worksheet, an
issuer must identify, for each NQTL listed:
(A) whether the NQTL does or does not apply
to benefits categorized as:
(i)
medical/surgical benefits; and
(ii)
MH/SUD benefits; and
(B)
whether the NQTL does or does not apply to the following classifications and
subclassifications:
(i) in-network
inpatient;
(ii) out-of-network
inpatient;
(iii) in-network
outpatient, including, if applicable:
(I)
in-network outpatient - office; and
(II) in-network outpatient - all
other;
(iv)
out-of-network outpatient, including, if applicable:
(I) out-of-network outpatient - office;
and
(II) out-of-network outpatient
- all other;
(2) Within the NQTL template, in each
classification or subclassification worksheet, an issuer must provide the
specific plan document terms, coverage terms, or other relevant terms regarding
the NQTL.
(3) Within the NQTL
template, in each classification or subclassification worksheet, an issuer must
list all MH/SUD and medical/surgical covered benefits to which each NQTL
applies, and:
(A) assign covered benefits to
classifications using a comparable methodology across medical/surgical benefits
and MH/SUD benefits;
(B) use the
same categorization and classification of a given covered benefit for both its
QTL and NQTL analyses;
(C) analyze
the NQTLs separately for MH/SUD and medical/surgical benefits;
(D) analyze each NQTL separately if a covered
benefit includes multiple components (such as outpatient and prescription drug
classifications), and each component is subject to a different type of NQTL
(such as prior authorization and limits on treatment dosage or duration);
and
(E) describe how the
requirements for each NQTL are implemented, who makes the decisions, and what
the decision maker's qualifications are.
(c) Step 2. Within the NQTL template, in each
classification or subclassification worksheet, an issuer must identify each
factor considered in the design and application of the NQTL. Illustrative
examples of factors are provided in the NQTL template.
(1) If only certain benefits are subject to
an NQTL (such as meeting a fail-first protocol or requiring preauthorization),
issuers must have information available to substantiate how the applicable
factors were used to apply the specific NQTL to medical/surgical and MH/SUD
benefits.
(2) An issuer must
document whether any factors were given more weight than others and the reasons
for doing so, including evaluating the specific data used in the determination
(if any).
(d) Step 3.
Within the NQTL template, in each classification or subclassification
worksheet, an issuer must identify the sources (including any processes,
strategies, or evidentiary standards) used to define the factors identified in
Step 2 to design and apply the NQTL. Illustrative examples of sources of
factors are provided in the NQTL template.
(1)
If an issuer uses these sources of factors, they must apply them comparably to
MH/SUD and medical/surgical benefits.
(2) Evidentiary standards and processes that
an issuer relies on may include any evidence that the issuer considers in
developing its medical management techniques, including recognized medical
literature and professional standards and protocols (such as comparative
effectiveness studies and clinical trials), and published research
studies.
(3) If there is any
variation in the application of a guideline or standard being relied on by the
issuer, an issuer must explain the process and factors relied on for
establishing that variation.
(4) If
an issuer relies on any experts, the issuer must describe the experts'
qualifications and whether the expert evaluations in setting recommendations
for both MH/SUD and medical/surgical conditions are comparable.
(5) When identifying the sources of the
factors considered in designing the NQTL, an issuer must identify any threshold
at which each factor will implicate the NQTL. For example, if high cost is
identified as a factor used in designing a prior authorization requirement, the
issuer would identify and explain:
(A) the
threshold dollar amount at which prior authorization will be required for any
benefit;
(B) the data used to
determine the benefit is "high cost"; and
(C) how, if at all, the amount that is to be
considered "high cost" is different for MH/SUD benefit as compared with
medical/surgical benefits, and how the issuer justifies this
difference.
(6) The NQTL
template includes examples of how factors identified based on evidentiary
standards may be defined to set applicable thresholds for NQTLs.
(e) Step 4. Within the NQTL
template, in each classification or subclassification worksheet, an issuer must
provide a comparative analysis demonstrating that the processes, strategies,
evidentiary standards, and other factors used to apply the NQTL to MH/SUD
benefits, as written and in operation, are comparable to and are applied no
more stringently than the processes, strategies, evidentiary standards, and
other factors used to apply the NQTL to medical/surgical benefits. Examples of
methods and analyses an issuer could use to substantiate that factors,
evidentiary standards, and processes are comparable are included in the NQTL
template. When applicable, the comparability analysis must:
(1) demonstrate any methods, analyses, or
other evidence used to determine that any factor used, evidentiary standard
relied upon, and process employed in developing and applying the NQTL are
comparable and applied no more stringently to MH/SUD benefits and
medical/surgical benefits;
(2) if
utilization review is conducted by different entities or individuals for
medical/surgical and MH/SUD benefits, identify the measures in place to ensure
comparable application of utilization review policies to the NQTL;
(3) identify any consequences or penalties
that apply to the benefits when the NQTL requirement is not met, such as a
reduction in benefits if not preauthorized; and
(4) demonstrate compliance both as written
and in operation by:
(A) identifying all
exception processes available and when they may be applied;
(B) identifying how much discretion is
allowed in applying the NQTL and whether such discretion is afforded comparably
for processing MH/SUD benefit claims and medical/surgical benefits
claims;
(C) identifying who makes
denial determinations and whether the decision makers have comparable expertise
with respect to MH/SUD and medical/surgical benefits;
(D) performing and documenting an audit to
check sample claims to assess how several NQTLs operate in practice, and
whether written processes are correctly carried out;
(E) determining and documenting average
denial rates and appeal overturn rates for concurrent review, and assessing the
parity between these rates for MH/SUD benefits and medical/surgical benefits;
and
(F) demonstrating that there
are not arbitrary or discriminatory differences in how the issuer applies
underlying processes and strategies to NQTLs with respect to medical/surgical
benefits versus MH/SUD benefits.