| (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;
(v) emergency care; or
(vi) prescription drugs.
(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.
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