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HHS Letter Reiterates Expectations for Language Accessibility

On December 5, 2024, the US Department of Health and Human Services Office for Civil Rights issued a “Dear Colleague” letter reiterating obligations that covered entities have under the May 2024 final rule related to language access requirements under Section 1557 of the Affordable Care Act. Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in covered health programs and activities. The final rule strengthened many protections against discrimination in healthcare, including rules for providing language assistance to individuals with limited English proficiency (LEP) or disability. This Dear Colleague letter had the goal of outlining key requirements to ensure that covered entities provide meaningful language access to individuals in time for the June 5, 2025, deadline for full implementation.

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HHS, Labor, and Treasury Finalize Mental Health Parity Rule

On September 9, 2024, the US Departments of Health and Human Services , Labor, and the Treasury finalized a rule related to the Mental Health Parity and Addiction Equity Act. This rule introduces significant updates to mental health and substance use disorder benefits, ensuring parity with medical and surgical benefits. Key changes include enhanced protections against restrictive treatment limitations, clarified definitions, and new data evaluation requirements. These updates, effective from January 2025, are crucial for hospitals, health systems, and managed care providers.

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Plan Sponsors, Insurers, and the Landmark Mental Health Parity Final Rule

The US Departments of the Treasury, Labor, and Health and Human Services recently issued much-anticipated final regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). The newly issued final regulations update the 2013 final regulations principally to reflect the changes to MHPAEA enacted by the Consolidated Appropriations Act, 2021, which requires plans and issuers to formally analyze and compare nonquantitative treatment limitations as they apply to both mental health and substance use disorder benefits and medical/surgical benefits.

The changes in the final regulations largely take effect in 2025, with the effective date for some provisions delayed until 2026. Although the final regulations may face litigation challenges, considering the recent decision in Loper Bright Enterprises v. Raimondo, health plan sponsors should plan to comply by the quickly approaching deadlines.

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White House Launches ‘Time Is Money’ Initiative

On August 12, 2024, the Biden administration launched a new “Time Is Money” initiative, seeking to crack down on time-consuming and burdensome business processes.

The initiative includes a requirement for federal employee health plans to provide an online opportunity to submit claims. It also features an accompanying letter to health insurance CEOs from the heads of the US Department of Health and Human Services and US Department of Labor that challenges the CEOS to offer online claim submissions, deny claims only where appropriate, and provide clear steps to appeal decisions.

Read more about the initiative and other McDermott+ healthcare-related regulatory updates here.




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Federal Court Invalidates Key Part of HHS OCR Bulletin Regarding Application of HIPAA to Online Tracking Technologies

In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled that the US Department of Health and Human Services Office for Civil Rights exceeded its authority in certain respects in sub-regulatory guidance. The guidance concerned HIPAA’s application to cookies and other online tracking technologies on HIPAA-regulated entities’ unauthenticated webpages.

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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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Six Wishes for the Forthcoming Final Regulations Under MHPAEA

On July 1, 2024, the US Department of Labor (DOL) submitted final regulations to the Congressional Budget Office (CBO), implementing the Mental Health Parity and Addiction Equity Act (MHPAEA) as most recently amended by the Consolidated Appropriations Act, 2021 (CAA). 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 benefits (MH/SUD) and medical and surgical (M/S) benefits. Submission to the CBO is the last step in the process of issuing a binding, final rule. The agency ordinarily acts on these submissions within 90 days, but it is widely anticipated that the final rule will be issued sooner.

The final regulations implement proposed regulations issued in July 2023, which were widely commented on. Our previous content explaining the proposed regulations, including a series of blog posts commenting on the comments, is available here.

To call the proposed rule contentious is an understatement, and the stakes for group health plan sponsors that provide mental health benefits are significant. Many comments on the proposed regulations asked the regulators to withdraw the proposed rule and to reconsider the issue anew. While the chance of that happening was always remote, it is now clear that this is not going to happen. There will shortly be final regulations. Recognizing this to be the case, here are six items in the proposed regulations that we would like to see changed or clarified.

  1. Application of the Quantitative Testing Requirements to NQTLs

MHPAEA generally provides that financial requirements and treatment limitations imposed on MH/SUD benefits cannot be more restrictive than the predominant financial requirements and treatment limitations that apply to substantially all M/S benefits in a classification. The 2013 final regulations established the following classifications for this purpose: inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. “Treatment limitations” can be either quantitative treatment limitations (QTLs) (e.g., visit limits) or NQTLs (i.e., concurrent review). The rules for the testing of QTLs set out in the 2013 final regulations include detailed numerical standards, which have spawned a cottage industry for testing services.

The proposed regulations would impose quantitative testing requirements on NQTLs. This is at least modestly counterintuitive. It would also make an already complex testing rule materially more complicated. It is our hope that the DOL, US Department of Health and Human Services, and the US Department of the Treasury (the Departments) see fit to back away from this requirement.

  1. Mental Health Carve-Out Vendors

The proposed regulations establish a three-prong test that plans and issuers must pass to impose an NQTL in a classification. To qualify, an NQTL:

  • Must be no more restrictive when applied to MH/SUD benefits as compared to M/S benefits;
  • The plan or issuer must meet specified design and application requirements; and
  • The plan or issuer must collect, evaluate and consider the impact of relevant data on [...]

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HHS Final Section 1557 Nondiscrimination Regulations: Gender-Affirming Care and the Role of Carriers Under ASO Arrangements

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press releasefact sheetFAQs) reinterpreting Section 1557 of the Affordable Care Act, which 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. The rule, which has staggered effectivity dates starting on July 5, 2024, largely finalizes the policies as proposed in HHS’s August 2022 Notice of Proposed Rulemaking, including clarifying protections for gender-affirming care, as provided by group health plans, carriers and third-party administrators under administrative-services-only (ASO) arrangements.

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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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OCR Update on Tracking Technologies Provides Little Relief for HIPAA-Regulated Entities

On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” In releasing the 2024 update, OCR stated that its purpose was to “increase clarity for regulated entities and the public.” While the update appears to narrow the scope of what OCR considers to be HIPAA-protected health information (PHI) in the context of online tracking technologies, it largely reconfirms prior guidance in the 2022 bulletin and will likely have limited practical impact for HIPAA-covered entities and business associates that have already heeded the 2022 bulletin.

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