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Potential Election Year Shakeup: Regulatory Implications of the Congressional Review Act

The Congressional Review Act (CRA) empowers Congress to act to invalidate regulations issued by federal agencies. These regulations include final rules, interim final rules and guidance documents. The CRA is most practically used by a new Congress to invalidate regulations issued by a previous administration and received within 60 legislative days of the previous Congress’ adjournment.

Should Republicans gain control of both chambers of Congress and the presidency, the 119th Congress could use the CRA to nullify certain Biden administration regulations. With federal elections looming later this year, this article reviews the CRA and how it might impact the current administration’s regulatory agenda.

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Healthcare Payors and Providers and AI Companies Voluntarily Commit to AI Principles

The Biden administration recently announced that 28 healthcare payors and providers intend to implement and adhere to voluntary commitments for the safe, secure and trustworthy development and deployment of artificial intelligence (AI) in healthcare. The signatory companies aligned around the FAVES principle—namely, that AI should lead to healthcare outcomes that are fair, appropriate, valid, effective and safe.

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What Does Landmark AI Executive Order Mean for Healthcare?

On October 30, 2023, the Biden administration released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI while highlighting many known risks of AI tools and systems. It directs a broad range of actions around new standards for AI that will impact many sectors, and it articulates eight guiding principles and priorities to govern the development and use of AI.

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The Proposed MHPAEA Regulations: A Comment on the Comments

In our last post, we considered some of the comment letters submitted in response to 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 comment period for the proposed regulations closed on October 17, 2023. Stakeholders submitted more than 7,500 comments. While we have not read them all, we’ve seen enough to discern the broad contours. There are those in favor, those opposed and those that take some middle ground with recommended modifications. Among the latter, the modifications run the gamut from trivial to substantive. One particular comment generally approving of the rule but urging modifications caught our attention. It was submitted by the Brookings Institution, and it offered the following (at least in our view) useful insights.

Heterogeneity of Mental Health/Substance Use Disorder (MH/SUD) Benefits Versus Medical/Surgical (M/S) Benefits

The comment explains that roughly 41% of M/S visits are for chronic conditions, which are less likely to be subject to concurrent review. In contrast, between 64% and 69% of MH/SUD visits focus on treatment of mood disorders, anxiety disorders, psychoses and personality disorders, i.e., chronic recurring conditions. The comment notes: “Even if all chronic visits in general medical practice were subject to concurrent review, any concurrent review for mental health or substance use disorder services would fail the ‘substantially all’ test.” (Emphasis added)

The comment recommends that the Departments consider a more fine-grained method of comparing the use of nonquantitative treatment limitations (NQTLs) between MH/SUD benefits and those for M/S benefits.

Schematic Representation of NQTLs (and Why This Matters)

The comment expresses concern over the depth of the analysis that is required for each NQTL. Page four provides a useful schematic that fleshes out the particulars. The schematic makes the point that a substantial amount of effort is involved in demonstrating compliance for a single NQTL. The steps include “identifying which services apply [ ], identifying factors considered in the design of the NQTL, identifying sources used to define these factors, and demonstrating that the NQTL is applied no more stringently to mental health and substance use disorder benefits than medical/surgical benefits.”

Moreover, all steps must be repeated for each additional NQTL. While even a casual review of the proposal would lead the reader with the sense that compliance would be a challenge, the use of the visual schematic drives the point home visually.

The Exception for Independent Professional Medical or Clinical Standards

The proposed rule identifies two exceptions to the NQTL requirements, the first of which is based on “Independent Professional Medical or Clinical Standards.” While there is a good deal of disagreement as to its proper scope and even its utility, the Brookings comment worries that “the language in the proposed rule also opens the door to regulatory gaming because it is overly broad.” According to the comment: “If the [...]

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Discerning Congressional Purpose from the Proposed MHPAEA Regulations Comment Letters

We continue 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 comment period for the proposed regulations closed on October 17, 2023, and one thing is clear: Stakeholders are divided not so much over particulars of the proposal but rather on the broad scope and reach of the rule. The is no doubt that the rule is intended to enact an overarching policy goal of the Biden administration. One need look no further than the administration’s July 25, 2023, fact sheet, which touts the administration’s “comprehensive national strategy to transform how mental health is understood, accessed, treated, and integrated in and out of health care settings.” Nor is there any doubt that the proposed rule is granular and prescriptive, as we previously explained.

While many of the comment letters address the particulars of the rule, certain high-profile comments ask whether it should be adopted at all. On one side are the providers (see the American Hospital Association’s comments, which offer a full-throated endorsement of the rule); on the other are the carriers (see AHIP’s comments, which claim the rule is vague and impossible to administer and calls for its withdrawal.)

If the final rule looks anything like the proposal, there will be a challenge, the particulars of which will likely include one central question: Is the final rule consistent with Congress’ intent in the matter? Dueling comments by the majority and minority members of the House of Representatives Committee on Education and the Workforce and (in the case of the minority) the Subcommittee on Health, Employment, Labor, and Pensions frame the question as follows:

Comment letter of Virginia Foxx, Chairwoman, Committee on Education and the Workforce

Citing MHPAEA’s legislative history, the majority claims that “Congress did not intend to include NQTLs [nonquantitative treatment limitations] when enacting the MHPAEA.” According to the comment letter, “the [MHPAEA] Committee report does not contain one mention of an NQTL.” (While the letter refers to the “Consolidated Appropriations Act, 2021 (CAA),” it does not attach any significance to that law’s requirement for plans and issuers to prepare and furnish on-demand reports detailing their NQTL compliance.) The majority also expresses its view that measuring and analyzing outcomes data is both impractical and exceeds the scope of the law. The majority is perplexed that the Departments believe they have the authority “to require plans to measure outcomes data stems from the statutory language.”

Comment letter of Bobby Scott, Ranking Member, Committee on Education and the Workforce, and Mark DeSaulnier, Ranking Member, Subcommittee on Health, Employment, Labor, and Pensions.

The minority’s comments welcome the proposed rules’ “emphasis on access to behavioral health care” and make the claim that the imposition of rules governing NQTLs is “entirely consistent with the statutory [...]

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Patients May Not Feel Benefits of Medicare Drug Price Negotiations

The Biden administration recently announced a list of Medicare-covered drugs that will be subject to price negotiations. The administration said the negotiations—a reality thanks to the Inflation Reduction Act—will benefit nearly nine million seniors.

However, according to this Insider article, some drug-policy analysts seem unconvinced by the administration’s claims.

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Webinar Replay: SECURE 2.0 and the Impacts of Employer Matching for Student Loan Payments

Student loan debt is set once again to impact millions of American workers. Fortunately, starting next year, employers will have new ways to help employees navigate student loan debt. Provisions of the SECURE 2.0 Act will allow employers to provide employer-matching contributions based on their employees’ qualified student loan repayments outside the plan.

In this webinar, McDermott’s Jeffrey M. Holdvogt and Teal N. Trujillo were joined by Tom Robertson C(k)P® of Graystone Consulting for a discussion exploring how organizations can provide this exciting new benefit to their workforces and leverage this important tool to increase employee satisfaction and retention.

Topics included:

  • Reasons why your organization should consider student loan debt/repayment benefits
  • Options available to employers to provide tax-advantaged benefits related to student loan debt and repayment
  • Key aspects of the SECURE 2.0 Act related to student loan repayment benefits as part of an employee retirement plan
  • Questions, challenges and tips for employers implementing a SECURE 2.0 student loan benefit in their retirement plans

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SECURE 2.0: The Impacts of Employer Matching for Student Loan Payments

Following the US Supreme Court’s rejection of substantial portions of the Biden administration’s plans for student loan debt relief, and with the end of the student loan repayment moratorium in sight, student loan debt is set once again to impact millions of American workers. Fortunately, starting next year, employers will have new ways to help employees navigate student loan debt. Provisions of the SECURE 2.0 Act will allow employers to provide employer-matching contributions based on their employees’ qualified student loan repayments outside the plan.

On September 12, 2023, join McDermott Will & Emery lawyers Jeffrey M. Holdvogt and Teal N. Trujillo as well as Tom Robertson C(k)P® of Graystone Consulting for a live webinar exploring how your organization can provide this exciting new benefit to your workforce and leverage it to increase employee satisfaction and retention.

Covered topics will include:

  • Reasons why your organization should consider student loan debt/repayment benefits
  • Options available to employers to provide tax-advantaged benefits related to student loan debt and repayment
  • Key aspects of the SECURE 2.0 Act related to student loan repayment benefits as part of an employee retirement plan
  • Questions, challenges and tips for employers implementing a SECURE 2.0 student loan benefit in their retirement plans

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DOL Wage Rule for Immigrants and H-1B Visa Holders Could Be History

The Biden administration may eliminate a US Department of Labor rule that would have modified how the US government sets prevailing wages for H-1B professionals and employment-based green card applicants, according to this Forbes article. The Trump administration originally sought to use the wage rule to make it more challenging for foreign-born scientists and engineers to seek employment.

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