New Proposed MHPAEA Rule Builds on NQTL Comparative Evaluation Requirements

On July 25, 2023, the U.S. Departments of Labor, Treasury, and Well being and Human Companies (the “Tri-Companies”) launched lengthy awaited proposed laws (the “Proposed Rule”) and a Technical Launch, which collectively suggest new necessities for comparative analyses of nonquantitative therapy limitations (“NQTL”) beneath the Psychological Well being Parity and Habit Fairness Act of 2008 (“MHPAEA”).  On the identical day, the Tri-Companies launched their annual report back to Congress on implementation of MHPAEA, as required beneath the Consolidated Appropriations Act, 2021 (“CAA 2021”). 

The Tri-Companies are soliciting feedback on the Proposed Rule, which will probably be due sixty days after the Proposed Rule’s forthcoming publication within the Federal Register, in addition to feedback on the Technical Launch, due on October 2, 2023. 

The Proposed Rule

The Proposed Rule supplies further clarification relating to the requirements the Tri-Companies will apply in reviewing NQTL comparative analyses beneath MHPAEA.  A lot of this builds on requirements already utilized – both expressly or tacitly – by the Tri-Companies when reviewing comparative analyses submitted thus far.

Probably the most vital developments within the Proposed Rule are:

1. Requirement for Outcomes Information – The Proposed Rule now explicitly acknowledges that knowledge evaluation is necessary for NQTL comparative analyses to show “comparability and stringency in operation.” Earlier MHPAEA steerage acknowledged that “comparable or dissimilar outcomes between [mental health and substance use disorder (“MH/SUD”)] advantages and medical/surgical [(“M/S”)] advantages … are NOT determinative of compliance,” however famous that disparate outcomes may very well be a “warning signal” of “potential operational parity noncompliance.” The brand new Proposed Rule makes clear that evaluation of “related knowledge” is now a required a part of a comparative evaluation.
   Though the Proposed Rule doesn’t particularly outline “related knowledge,” it states that related knowledge consists of, however shouldn’t be restricted to, the quantity and proportion of claims denials and another knowledge required by state regulation or personal accreditation requirements.  As well as, as a part of the Proposed Rule’s deal with community adequacy, related knowledge for NQTLs associated to community composition requirements consists of, however shouldn’t be restricted to, in-network and out-of-network utilization charges, community adequacy metrics, and supplier reimbursement charges.  The Technical Launch particularly solicits feedback on how these classes of knowledge ought to be thought-about in NQTL analyses relating to community adequacy.If the related knowledge demonstrates “materials variations” between entry to MH/SUD advantages as in comparison with M/S advantages, “the variations will probably be thought-about a robust indicator” that the plan violates MHPAEA, and the plan should “take affordable motion to deal with the variations in entry as vital” and doc the motion taken.  The Proposed Rule then creates a “particular rule” for related knowledge for NQTLs associated to community composition, which states that “materials variations” between entry to MH/SUD advantages and M/S advantages are violations, in operation, of MHPAEA.  Nevertheless, the Proposed Rule additionally solicits feedback on what circumstances may “correctly mitigat[e] materially totally different entry” knowledge.
2. Making use of the “predominant” and “considerably all” checks to NQTLs – The Proposed Rule brings the NQTL necessities extra carefully consistent with the statutory MHPAEA requirement by making use of to NQTLs the “predominant” and “considerably all” checks which were used for quantitative therapy limitations (“QTLs”). Particularly, the Proposed Rule would now require that an NQTL for MH/SUD advantages can’t be extra restrictive, as written or in operation, than the predominant (most frequent) NQTL utilized to considerably all (two-thirds) M/S advantages in the identical classification.  The “predominant” and “considerably all” checks will probably be measured for NQTLs equally to how they’re measured for QTLs.
3. Comparability in Design and Software of NQTLs – The Proposed Rule makes clear that processes, evidentiary requirements, or different components for MH/SUD advantages have to be corresponding to, and utilized no extra stringently, than these for M/S advantages in each design and utility. This idea was already implicit within the assessment of “as written” and “in operation” MHPAEA compliance, however it’s now much more categorical within the Proposed Rule.
4. Requirements Per Usually Acknowledged Requirements of Care – Whereas the Proposed Rule retains flexibility within the requirements utilized, the Proposed Rule makes clear that, in distinguishing MH/SUD and M/S advantages, plans and issuers should apply requirements according to typically acknowledged impartial requirements of present medical observe.
5. Particular Description, Definition, and Software of Components, Sources, and Evidentiary Requirements – The Proposed Rule clarifies the development in Tri-Company enforcement towards requiring larger specificity in definition of things, sources, and evidentiary requirements, together with requiring in comparative analyses particular descriptions of thresholds utilized, how and by whom selections are made, and circumstances that warrant deviation from these requirements.
6. Tight Timelines – The Tri-Companies suggest to codify in regulation the tight deadlines they’ve been making use of for requests for plan comparative analyses – particularly, that not more than 10 enterprise days will probably be allowed to offer comparative analyses or responses to insufficiency letters, and that extensions will probably be restricted and left to the discretion of the enforcement company.
7. Disclosures of Non-Compliance – The Proposed Rule additionally for the primary time supplies steerage on the content material required for disclosures to members if a plan receives a last dedication of non-compliance with MHPAEA. Such disclosures should embody a disclosure that the plan is non-compliant, a abstract of corrective modifications and an evidence of how the beneficiary can get a declare re-processed.  Additionally, the Proposed Rule permits the Tri-Companies to direct the plan or issuer to not impose the NQTL until and till the plan and issuer demonstrates compliance or cures the violation.

Technical Launch

The Tri-Companies issued their Technical Launch concurrently with the general public inspection model of the Proposed Rule to set out further rules and solicit particular feedback relating to the usage of knowledge in comparative analyses relating to community adequacy, in addition to a “potential enforcement protected harbor” for community adequacy measurement beneath MHPAEA.

Constructing on the Proposed Rule, the Technical Launch notes that the Tri-Companies think about 4 classes of community adequacy-related knowledge to be notably related: out-of-network utilization charges; the proportion of in-network suppliers “actively submitting claims;” time and distance to entry community suppliers; and reimbursement charges. The Tri-Companies have solicited feedback on how precisely these knowledge classes ought to be thought-about in comparative analyses.

Moreover, the Technical Launch famous that the Tri-Companies “intend to create an enforcement protected harbor with respect to NQTLs associated to community composition for plans and issuers that meet or exceed specified data-based requirements recognized in future steerage.”  Though this is able to be the primary enforcement protected harbor of its type, the community knowledge referred to as for within the Technical Launch seemingly may very well be tough to measure and monitor.  The Tri-Companies famous that the safe-harbor standards may embody requirements associated to the classes of knowledge beforehand discovered to be related, however the Tri-Companies didn’t present any concrete steerage as to what these standards could also be. They solely famous that the yet-to-be-developed standards would set a “excessive bar” and could be evaluated and up to date on an ongoing foundation.

Annual Report back to Congress

The Tri-Companies’ annual report to Congress on MHPAEA enforcement additionally supplies helpful guideposts for plans.  For one, the report notes that between February 2021 and July 2022, the Departments of Labor and Well being and Human Companies:

1. issued greater than 200 letters requesting comparative analyses for 740 NQTLs;
2. issued greater than 170 letters figuring out insufficiencies in comparative analyses for greater than 330 NQTLs;
3. issued almost 70 preliminary determinations discovering that greater than 90 NQTLs violated MHPAEA; and
4. issued 8 last dedication letters discovering that 10 NQTLs violated MHPAEA.

The Tri-Companies noticed that “many comparative analyses remained poor, even after a number of insufficiency letters,” indicating that the Departments of Labor and Well being and Human Companies stay lively of their enforcement, and that plans that fail to have comparative analyses on the prepared achieve this at their peril.

The Tri-Companies additionally offered perception into areas of specific danger and enforcement.  These embody:

1. “Impermissible exclusions,” which the Tri-Companies outlined to imply “exclusions of ABA remedy to deal with autism spectrum dysfunction, medication-assisted therapy and medicines for opioid dysfunction, urine drug testing . . . , and dietary counseling to deal with psychological well being circumstances similar to consuming issues”;
2. NQTLs associated to community adequacy, notably supplier community composition and participation requirements; and
3. Prior authorization and concurrent assessment necessities, together with “exclusions of particular therapies for sure circumstances within the prescription drug classification.”

Upcoming Regulatory Exercise

As plans proceed to digest and touch upon the Proposed Rule, Technical Launch, and annual report, further steerage from the Tri-Companies may additionally be within the works.  The day after the Proposed Rule was launched for public inspection, the Division of Labor’s Assistant Secretary for Advantages Safety acknowledged, throughout an American Bar Affiliation webinar, that the Division was engaged on extra steerage relating to NQTL analyses.  The Proposed Rule, Technical Launch, and annual report, and potential further forthcoming steerage show that MHPAEA compliance and enforcement stay entrance of thoughts for regulators and plans alike.