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Anticipating the MHPAEA Final Regulations: A Word About Network Composition

If our trade and industry sources have it right, we could see final regulations implementing the Mental Health Parity and Addiction Equity Act (MHPAEA), as most recently amended by the Consolidated Appropriations Act, 2021 (CAA), any day now. Last week, we offered a wish list of things we would like to see modified or addressed once the rules become final. Our previous MHPAEA commentary is available here.

An August 1, 2024, letter from Viginia Foxx, chairwoman of the US House of Representatives Committee on Education and the Workforce, to the secretaries of the US Department of Health and Human Services (HHS) and the US Department of the Treasury (Treasury) and the acting secretary of the US Department of Labor (DOL) leads us to add one more item to our wish list. It relates to a subject that has been a major item of contention and the cause of considerable frustration in MHPAEA audits: network composition and adequacy.

The CAA added a requirement that plans and issuers perform and document comparative analyses of the design and application of nonquantitative treatment limitations (NQTLs) on mental health and substance use disorder (MH/SUD) benefits and medical and surgical (M/S) benefits. Nothing in the CAA modifies prior law relating to network composition or adequacy, however. MHPAEA generally requires that the application of NQTLs on MH/SUD benefits “in operation” be comparable and no more stringent than on M/S benefits. In the case of an audit, the DOL has analyzed diverse types of outcomes data, such as denial or reimbursement rates.

But – and this is critical – nothing in existing law requires comparability of outcomes. Indeed, the DOL’s self-compliance tool makes clear that disparate outcomes are not determinative of noncompliance, recognizing that the law requires only that the processes and standards used in applying the NQTL be comparable across MH/SUD and M/S benefits. Different outcomes can still be MHPAEA-compliant. An intervening FAQ (No. 7) suggests otherwise, saying that disparate outcomes raise a “red flag.” FAQs lack the force of law, however.

The proposed rules upend current law by making differences in outcomes a strong indicator of noncompliance or, in the case of network composition, a conclusive determination of noncompliance. Chairwoman Foxx criticizes this approach, saying that “This [ ] suggests that approval or denial rates in either a MH/SUD or M/S context are indicative of appropriateness.” This is in her view a flawed assumption. She also claims that the DOL, HHS and Treasury (the Departments) have exceeded their statutory authority in the matter. The DOL is in our experience applying this rule on audit as though the proposed rule is the law.

We express no opinion on whether the proposed rule comports with the statue. This is for the courts to decide. It’s no secret, however, that the Departments now face a higher bar in the wake of the US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo (wherein the Court overruled the [...]

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The Impact of the ACA 1557 Final Regulations on Gender-Affirming Care

Section 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age or disability, or any combination thereof, in a health program or activity, any part of which is receiving federal financial assistance.

On May 6, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services published final regulations (final regulations) implementing Section 1557 (Our summary and overview of the final regulations is available here.) Entities that are subject to Section 1557 (covered entities) include hospitals, health clinics, health insurance issuers, state Medicaid agencies and community health centers. While group health plans are not themselves covered entities unless they receive federal financial assistance (e.g., certain Medicare Part D programs and Employer Group Waiver Plans), carriers that provide administrative services to group health plans may themselves be covered entities if they receive federal financial assistance (e.g., by selling Medicare Advantage products).

Reversing prior law, the final regulations unambiguously prohibit categorical coverage exclusions or limitations for health services related to gender transition or other gender-affirming care. OCR finds support for this change in the US Supreme Court’s decision in Bostock v. Clayton County, which held that Title VII of the Equal Employment Act prohibits an employer from discriminating against an individual on the basis of sexual orientation. But prohibiting categorical coverage exclusions is not the same thing as requiring covered entities to provide access to gender-affirming care under all circumstances. There are limits; covered entities must not:

[D]eny or limit services based on gender identity or sex assigned at birth, adopt any policy of treating individuals differently on the basis of sex, including to the extent it prevents an individual from engaging in a health program or activity consistent with the individual’s gender identity, or deny or limit services sought for gender transition or other gender-affirming care based on sex assigned at birth or gender identity.

The provision would outlaw blanket bans on both gender-affirming care itself and on specific gender-affirming procedures (like facial feminization surgery). But it would also prohibit plans or carriers that qualify as covered entities from covering breast reconstruction for cancer treatment, or hormones to treat post-menopause symptoms, without also covering these procedures to treat gender dysphoria.

The final regulations do not interfere with individualized clinical judgment about the appropriate course of care for a patient. (The preamble makes further claims that OCR has a general practice of deferring to a clinician’s judgment about whether a particular service is medically appropriate for an individual, or whether the clinician has the appropriate expertise to provide care.) A provider’s belief that gender transition or other gender-affirming care can never be beneficial, or its compliance with a state or local law that reflects a similar judgment, is not a sufficient basis for a judgment that a health service is never clinically appropriate, however.

The 2016 final Section 1557 regulations were successfully challenged in Franciscan Alliance v. Burwell (N.D. [...]

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How Pending Fishing Boat Cases at the Supreme Court Could Rock the Benefits Plan Boat

If the US Supreme Court strikes down the established doctrine of significant judicial deference to certain government agency interpretations in two upcoming fishing boat cases, this decision could have ripple effects on employee benefit plan sponsors and fiduciaries. Such a decision would rock the boat and create more uncertainty in administering employee benefits.

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McDermott Submits Amicus Brief to the US Supreme Court in United Behavioral Health

On January 2, 2024, McDermott filed an amicus curiae brief on behalf of the ERISA Industry Committee (ERIC) and the United States Chamber of Commerce (Chamber) in United Behavioral Health v. David K., No. 23-586, in the US Supreme Court. The case presents two questions of broad public importance concerning the requirements under the Employee Retirement Income Security Act (ERISA) for denials of health benefits. But underlying the two questions is an even more fundamental Administrative Procedure Act (APA) issue: May a court, at the invitation of an agency in an amicus brief, effectively amend regulations by judicial fiat, providing the agency with an end run around the APA’s notice-and-comment rulemaking procedures?

The answer to that question should be an obvious no. But that is precisely what happened in the court of appeals in this case. After the plaintiffs filed their response brief, the US Department of Labor (DOL) filed an amicus brief urging a radically new interpretation of regulations the agency had promulgated to implement ERISA’s procedural protections. In essence, the DOL argued that its disability- and health-benefit regulations should be read to contain the same procedural requirements, despite clear regulatory language specifying that some requirements only apply in one context and not the other. The US Court of Appeals for the Tenth Circuit adopted the DOL’s position, decreeing a new regulatory requirement for health-benefit denials that the DOL, in dual 2015 and 2016 rulemakings, expressly considered and chose to adopt only for disability-benefit denials and not for health-benefit denials.

If not corrected by the Supreme Court, the decision will stand as an invitation to agencies to file amicus briefs in the courts of appeals, advocating for substantial changes to their regulations without the bother (or transparency) of APA rulemaking. When so much lawmaking today is undertaken by unaccountable federal bureaucrats, that is a deeply troubling prospect. ERIC and the Chamber supported the petition, explaining the legal and practical issues with the approach the DOL and Tenth Circuit mutually took. Agency interpretations that defy clear regulatory text are entitled to no deference because they are invalid (especially after the Court’s decision in Kisor v. Wilkie). Ignoring this basic proposition of administrative law undercuts the core values served by the APA, including transparency and accountability. Most directly, however, an agency’s decision to seek backdoor revisions to its rules through interpretations announced in litigation deprive the agency of the benefit of public comment that can provide critical data and analysis to inform the agency’s policymaking. Had the DOL engaged in notice and comment, as it should have done, commenters would have presented key distinctions between the disability- and health-benefit contexts; without that information, the DOL’s decision was not fully informed.

ERIC and the Chamber are frequent amici in cases concerning ERISA and the APA’s interpretation and requirements. While the Supreme Court grants only a tiny fraction of the petitions it receives each term, the amici are hopeful that this brief will help focus the Court’s attention on this [...]

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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

Register here.




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How Dobbs Has Changed the Data Privacy Landscape

Companies are taking a fresh look at their privacy policies in the wake of Dobbs v. Jackson Women’s Health Organization. According to this Law360 article, policymakers are putting more pressure on companies to tighten their restrictions on collecting and disclosing personal health and location data.

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From Clinic to Courtroom: Legislation and Litigation Limiting Prescription Practices

On April 20, 2023, McDermott’s Alden Bianchi was a speaker at the ERISA Industry Committee’s 2023 Annual Spring Policy Conference, which was held at the National Press Club in Washington, D.C. The panel in which he participated was entitled “From Clinic to Courtroom – Legislation and Litigation Limiting Prescription Practices,” and it covered three main topics: state regulation of telehealth; the regulation of specialty pharmacy supply chains and delivery measures (“brown bagging,” “white bagging” and “clear bagging”); and state-level efforts to regulate pharmacy benefit managers (PBMs) following the US Supreme Court’s 2020 Rutledge decision, which held that an Arkansas law regulating the costs of prescription drugs was not preempted by the Employee Retirement Income Security Act of 1974 (ERISA).

Here are some of the program’s key takeaways and predictions:

  • While telehealth is here to stay, the high cost of Medicare reimbursements presents an immediate barrier to widespread adoption, and the particulars of how telehealth will be regulated will be left largely to the states.
  • The battle over the delivery of specialty prescription drugs is heating up as PBMs seek to capture some of the margins previously available only to providers. State laws regulating pharmacies and pharmacists will be at the center of the battle, and future legislative efforts will likely be subject to challenge.
  • State legislatures have read the Rutledge decision broadly in ways that virtually guarantee a good deal of future litigation. It might take as long as a decade, and it may well take more than one trip to the Supreme Court before plans, issuers, providers, state legislators and regulators, and other stakeholders have a reliable understanding of the contours of ERISA preemption in the pharmacy context.

Accompanying this post are copies of Mr. Bianchi’s panel materials, including:




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OCR Issues Proposed Rule to Modify HIPAA Privacy Rule to Include Explicit Protections for Reproductive Healthcare

On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The Proposed Rule comes as a part of the Biden administration’s response to the US Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization.

The Proposed Rule would provide special protections for protected health information (PHI) related to reproductive healthcare. Following the Dobbs decision, many healthcare providers expressed concerns that PHI related to reproductive healthcare may be sought by state and local governments for use in criminal, civil or administrative investigations or proceedings. OCR noted that such compelled uses and disclosures of PHI could have a chilling effect on lawfully obtained healthcare and erode trust in confidential communications between a patient and provider. Additionally, providers could elect to leave out critical details from a patient’s medical record if they fear the information could later be used by a state or local government actor against the patient.

Stakeholders may submit comments on the proposed rule on or before June 16, 2023.

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What the Potential Shutdown of Biden’s Loan Forgiveness Plan Could Mean for Plan Sponsors

As the US Supreme Court deliberates on the Biden administration’s loan forgiveness plan, what is the recommended course of action for plan sponsors regarding student loan repayment programs? In this PLANSPONSOR article, McDermott Partner Jeffrey M. Holdvogt offers insight into student loan debt benefits through the Coronavirus Aid, Relief and Economic Security Act.

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