SECTION 21.2441. Four-Step Analysis of Nonquantitative Treatment Limitations

(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.

Source Note: The provisions of this §21.2441 adopted to be effective September 7, 2021, 46 TexReg 5571