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Code § 4980D and Violations of the NQTL Analysis Requirement Under the Proposed MHPAEA Regulations

This post continues our investigation of proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and Human Services and the Treasury (the Departments). Our previous MHPAEA content is available here.

The proposed regulations establish a formal structure for how the Departments will enforce the requirement that plans and issuers comply with their obligations to provide a nonquantitative treatment limitation (NQTL) analysis on request. The structure includes the following steps:

  • Plans and health insurance issuers must provide the NQTL analysis within 10 business days of receipt of the request.
  • If the Departments determine that the NQTL analysis is deficient, upon notification, the plan/issuer has 10 business days to furnish any additional information to the Departments.
  • If the Departments determine that the NQTL analysis is deficient, plans/issuers must also undertake corrective actions and resubmit to the Departments a compliant NQTL analysis no later than 45 calendar days after notification of a noncompliant NQTL analysis.
  • If the plan or issuer remains out of compliance following the 45-calendar-day corrective action period, the plan or issuer must notify the plan participants of the plan’s/issuer’s noncompliance within seven calendar days of the receipt of the final determination of noncompliance.
  • The plan or issuer must also provide a copy of the notice to the Department of Labor or Health and Human Services, any service provider involved in the claims process and any fiduciary responsible for deciding benefit claims within the same seven calendar days.

These are not the only remedies or sanctions, however. Internal Revenue Code (Code) Section 4980D generally imposes a nondeductible excise tax of $100 per day per affected individual for failure to comply with Code Chapter 100, group health plan requirements. Noncompliant plans must self-report the Section 4980D excise tax on Form 8928. MHPAEA amends the Code, the Employee Retirement Income Security Act and the Public Health Service Act. The provisions amending the Code are in Section 9812, which is in Chapter 100. Thus, Code Section 4980D applies to violations of MHPAEA, including the requirement to prepare and provide NQTL analyses upon request.

According to a 2023 report to Congress, the Department of Labor alone sent some 182 requests, none of which were initially compliant. Shouldn’t all these plans (and many others) be self-reporting violations and paying excise taxes under Section 4980D? The proposed regulation takes up 117 pages of the Federal Register. Section 4980D is mentioned only once in a footnote. The accompanying text says merely that “plan sponsors are generally responsible for ensuring compliance and could, in certain circumstances, be liable for penalties for any violations.”

The application of Section 4980D to MHPAEA is an area that would benefit from regulatory attention and, hopefully, relief. For example, penalties should not at least in our view be enforced against plan sponsors acting in good faith whose NQTL analyses are initially deficient but are brought into compliance.

A Look into House Efforts on Hospital and Health Plan Price Transparency

In the 118th Congress, the US House of Representatives is keenly interested in healthcare price transparency. Three House committees—Energy and Commerce, Ways and Means, and Education and the Workforce—each approved legislation that would advance price transparency objectives. Generally, these bills seek to codify (or modify) the requirements around hospital and health plan price transparency as previously implemented by the Centers for Medicare & Medicaid Services.

While there are many similarities between the three bills, the committees and House leadership will need to negotiate certain key differences before a bill is brought to the House floor for a vote. It remains unclear which of the competing bills might get a vote.

This +Insight examines the hospital and health plan transparency provisions of these primary pieces of legislation and compares them with current regulations.

Read full analysis.

Texas District Court Overturns Portions of the IDR Process

On August 3, 2023, the US District Court for the Eastern District of Texas ruled on the implementation of the No Surprises Act in Texas Medical Association, et al. v. US Department of Health and Human Services, et al. (TMA IV).

In TMA IV, the plaintiffs challenged two things:

  1. The increased administrative fee to participate in the independent dispute resolution (IDR) process. Providers asserted that the fee made participating in IDR for small-value claims cost-prohibitive.
  2. The US Departments of the Treasury, Labor, and Health and Human Services (the Departments) rules regarding batching, which providers claimed made it difficult to batch related claims for resolution in a single arbitration proceeding.

The court found that the Departments violated the Administrative Procedure Act when they raised the IDR administrative fee from $50 to $350 for 2023 and established batching rules that did not allow providers to batch claims together in the IDR process. The court said that the changes were substantive and should have gone through notice and comment rulemaking. Ultimately, the court vacated both policies nationwide.

As a result, the IDR fee will return to $50 (for now). The batching rules are also vacated until the Departments go through rulemaking, resulting in a temporary suspension of the IDR portal. The Departments are working on a proposed rule that will likely include some batching policies.

The Departments can appeal this decision, as they did for TMA II.

The “Meaningful Benefit” Requirement for NQTLs Under the Proposed MHPAEA Regulations

In previous posts, we reported on proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments). More recently, we turned our attention to the treatment of non-quantitative treatment limitations (NQTLs), i.e., non-numeric benefit coverage limits that must be no more restrictive for mental health and substance use disorder (MH/SUD) benefits than for medical surgical (M/S) benefits. This blog post focuses on the proposed regulations’ “meaningful benefit” requirement.

Current law contains the now familiar rule that says if a plan (or health insurance issuer) provides MH/SUD benefits in any classification, those benefits must be provided in every classification in which M/S benefits are provided. (“Classifications” for this purpose include inpatient, out-of-network; inpatient, in-network; outpatient, out-of-network; outpatient, in-network; emergency care and prescription drugs.) But current law says nothing about which MH/SUD benefits must be provided in any classification. A plan or issuer might, for example, be able to comply by offering a single limited benefit for MH/SUD disorders or conditions in one or more classifications.

The proposed regulations add a requirement that plans and issuers must provide “meaningful benefits” for the treatment of MH/SUD disorders or conditions. While the term “meaningful benefit” is not defined, the proposed regulations offer two examples:

Autism Spectrum Disorder (ASD)

A plan that covers treatment for ASD, including outpatient, out-of-network developmental evaluations, but excludes all other benefits for outpatient treatment for ASD, including applied behavior analysis (ABA). (ABA therapy is one of the primary treatments for children with ASD.) The plan covers the full range of outpatient treatments and treatment settings for medical conditions and surgical procedures when provided on an out-of-network basis. The failure to cover ABA therapy violates the “meaningful benefits” requirement in the outpatient, out-of-network classification.

Eating Disorders

A plan covers diagnosis and treatment for eating disorders but specifically excludes coverage for nutrition counseling to treat eating disorders, including in the outpatient, in-network classification. (Nutrition counseling is one of the primary treatments for eating disorders.) The plan generally provides benefits for the primary treatments for medical conditions and surgical procedures in the outpatient, in-network classification. The exclusion of coverage for nutrition counseling results in the failure of the “meaningful benefits” requirement for the treatment of eating disorders in the outpatient, in-network classification.

The Departments invite comments on how to define “meaningful benefits” and on whether there might be other potential alternatives. Would it be more practical, for example, to require plans and issuers to provide “substantial coverage” of MH/SUD benefits or benefits for the “primary or most common or frequent types of treatment for a covered condition or disorder” in each classification in which M/S are provided? Violations of the “meaningful benefits” requirement would, under the proposal, constitute an MHPAEA parity violation, which would allow the Department of Labor to order the plan or issuer not to impose the NQTL unless (and until) the plan or issuer demonstrates compliance.

Takeaways from a Recent COBRA Notice Class Action Settlement

There has been a flurry of class action lawsuits and settlements relating to the deficiency of required election notices under the Consolidated Omnibus Budget Reconciliation Act (COBRA). The notices provide employees and their beneficiaries who participate in an employer’s group health plan with the option to elect to continue their coverage following a COBRA qualifying event. A recent class action lawsuit illustrates the stakes and provides some valuable lessons.

Read more here.

The ‘Data Evaluation Requirement’ for NQTLs Under the Newly Proposed MHPAEA Regulations

Last week’s post examined the “no more restrictive” requirement that would apply to non-quantitative treatment limitations (NQTLs) set out in recently proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). (Our description of the proposed regulations is available here.) The proposed regulations deal principally with NQTLs, which are non-numeric benefit coverage limits that must be no more restrictive for mental health and substance use disorder (MH/SUD) benefits than for medical surgical (M/S) benefits. We previously claimed that “if adopted in final form [the proposed regulations] would vastly complicate compliance by group health plans and health insurance issuers with an already challenging set of mental health parity rules.” Our views have not changed.

The proposed regulations would, if adopted, impose a series of new requirements on NQTLs that include a “data evaluation requirement.” This new requirement would provide that the plan or issuer designing and applying an NQTL collect and evaluate relevant data to assess the impact of the NQTL on access to MH/SUD and M/S benefits. The plan or issuer would also consider whether the NQTL, in operation, complies with the mental health parity rules. The specific type, form, and manner of data collection and evaluation will be the subject of future guidance. (A technical release accompanied the proposed regulations, described here, which invites comment and suggests a possible, narrow safe harbor.)

The proposed regulations establish two new network-related rules governing NQTLs:

  • For NQTLs not involving network composition, a material difference in the metrics/data gathering for the NQTL as applied to MH/SUD and M/S benefits would be considered a strong indicator of a violation.
  • For NQTLs involving network composition, a violation is deemed to occur if the relevant data shows material differences in access to in-network MH/SUD benefits as compared to in-network M/S benefits.

The proposed regulations would make compliance depend on outcomes. This position represents a significant shift in, if not an outright reversal of, existing law. Under the 2013 final MHPAEA regulations, outcomes are not determinative of compliance. Rather, comparability turns on the application of processes, strategies, evidentiary standards and other design-based factors. Compliance under current law thus turns on an examination of inputs, not outcomes. While the proposed regulations include exceptions for professional medical/clinical standards and for standards to detect fraud, waste and abuse, the preamble to the proposed regulations advises that “these exceptions should be narrowly tailored.”

States Amend Professional Practice Standards to Incorporate Telehealth

Numerous states—including Wisconsin, Illinois, Kentucky and Oklahoma—have been busy finalizing rulemaking and legislation that create or amend professional practice standards to incorporate telehealth. What have these states been up to over the last month?

Learn more here.

Guarding the Gateway: Florida Tightens Grip on Electronic Health Records Storage

In May 2023, the Florida Legislature amended the Florida Electronic Health Records Exchange Act to add a provision regarding the security and storage of patient information. It took effect on July 1, 2023. To ensure compliance, Florida healthcare providers should review where their electronic patient information is physically maintained.

Read more here.

The ‘No More Restrictive’ Requirement for NQTLs Under the Proposed MHPAEA Regulations

We previously reported on proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). If adopted in final form, these regulations would vastly complicate compliance by group health plans and health insurance issuers with an already challenging set of mental health parity rules.

The proposed regulations deal principally with non-quantitative treatment limitations (NQTLs), i.e., non-numeric benefit coverage limits that must be no more restrictive for mental health and substance use disorder (MH/SUD) benefits than for medical surgical (M/S) benefits. Examples of NQTLs include prior authorization requirements, concurrent review, standards for provider admission, Rx formulary design, and fail-first policies or step therapy protocols.

The proposed regulations set out new requirements on NQTLs that include a three-part test consisting of a “no more restrictive” requirement, a “design and application” requirement and a “data evaluation requirement.” There is also a new meaningful benefit requirement, under which plans and issuers must provide meaningful benefits for MH/SUD treatment where the plan also provides a corresponding M/S benefit. With perhaps the exception of the “design and application” requirement, each of these requirements represents a major new compliance obligation on the part of plans and issuers.

This blog post focuses on the “no more restrictive” requirement. Future posts will examine the other requirements.

MHPAEA regulates aggregate lifetime and annual dollar limits, financial requirements, and treatment limitations. (The Affordable Care Act bars lifetime and annual dollar limits on essential health benefits (EHBs). Under MHPAEA, plans and issuers may not be able to impose lifetime and annual dollar limits on MH/SUD benefits that are not EHBs.) Treatment limitations are subdivided into quantitative treatment limitations (QTLs) (e.g., number of days or visits covered) and NQTLs.

The 2013 final MHPAEA regulations apply numerical standards testing to financial requirements and QTLs. These final regulations also adopted six classifications of benefits for this purpose: inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. To comply, a financial requirement or QTL imposed on an MH/SUD benefit must be no more restrictive than the predominant financial requirement or QTL that applies to substantially all M/S benefits in a classification. For this purpose:

  • Substantially all” means that the financial limitation or QTL applies to at least two-thirds of all M/S benefits in the classification; and
  • “Predominant” means the level of financial requirement or QTL that applies to more than one-half of the M/S benefits in the relevant classification.

The 2013 final regulations largely rely on a subjective analysis of the processes, strategies, evidentiary standards, and other factors used in the application of NQTLs. The proposed regulations retain this subjective standard and layer on a quantitative “no more restrictive” requirement. As proposed, NQTLs would be subject to numerical standards testing similar to the current law testing that applies to financial requirements and NQTLs. While the “substantially all” prong would not change, some minor modifications would be made to the “predominant” prong. Under the proposed regulations, when testing NQTLs, the term “predominant” [...]

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Digital Health and the Direction of AI in Healthcare

What is the current state of digital health? Where will artificial intelligence (AI) see the most growth and adoption in healthcare? And what are the key AI issues most relevant to healthcare providers?

In this TripleTree article, Alya Sulaiman offers her perspective on some of the essential AI questions facing the digital health space.

Access the article.




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