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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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Gender-Affirming Benefits: Best Practices for Group Health Plans

Group health plan sponsors, third-party administrators and other health plan service providers must navigate a shifting legal landscape as they determine how to offer gender-affirming benefits, including whether − and to what extent − group health plans must cover gender-affirming medical or surgical treatments, especially regarding minors. In this On the Subject, we discuss recent legal developments impacting gender-affirming care and approaches to group health plan coverage.

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Mental Health Parity, Quantitative Treatment Limitations, Employee Assistance Plans and the End of the COVID-19 Emergency

The Biden administration has announced its intention to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our series introduction for more information). Among other things:

  • The NE and the PHE modified the rules governing financial requirements and quantitative treatment limitations under the Mental Health Parity and Addiction Equity Act (MHPAEA). The end of the NE and the PHE will require modifications to group health plans’ and health insurance issuers’ MHPAEA testing as it relates to financial requirements and quantitative treatment limits. The NE and the PHE also affect the design and operation of some employee assistance plans (EAPs).
  • The NE and the PHE allowed plan sponsors to expand coverage under excepted benefit EAPs in certain respects without risking their status as the Health Insurance Portability and Accountability Act (HIPAA)-excepted benefits.

MHPAEA 

MHPAEA requires that the financial requirements (such as coinsurance and copays) and quantitative treatment limits (such as visit limits) imposed on mental health or substance use disorder (MH/SUD) benefits cannot be more restrictive than the predominant financial requirements and treatment limitations that apply to substantially all medical/surgical benefits in a particular benefit classification. During the public health emergency period, group health plans and health insurance issuers were permitted to disregard certain items and services related to testing for the detection of SARS-CoV-2, the virus that causes COVID-19, when performing the “substantially all” and “predominant” tests. Absent this relief, the costs of covering COVID-19 testing items and services without cost-sharing would be the amounts allocated to medical/surgical benefits, thereby putting group health plans and health insurance issuers at risk of running afoul of MHPAEA quantitative treatment limits.

From and after the end of the PHE, group health plans and health insurance issuers must include the cost of covering COVID-19 tests, either diagnostic or over-the-counter, or testing-related services, when calculating MHPAEA quantitative treatment limits.

Action Items: Employers should revisit their MHPAEA compliance testing to ensure that the coverage of COVID-19 tests is properly accounted for in applying the relevant quantitative treatment limits. There is, however, no longer a requirement that a group health plan or health insurance issuer cover these services without charge.

EMPLOYEE ASSISTANCE PLANS

The end of the NE and the PHE could have various impacts on EAPs depending on the specific plan design. Employers may, for example, see a spike in the need for mental health support that could be met through EAP services. While the pandemic may be winding down, the mental health impacts of the past three years may continue for by many employees. Employers may need to continue to offer mental health services and resources through their EAPs, and potentially explore expanding mental health services through an EAP or otherwise, to support employees who are struggling with anxiety, depression or other mental health issues related to the pandemic.

Particular attention is required in the case of excepted benefit EAPs. Excepted benefit EAPs do not provide minimum essential coverage for Affordable Care [...]

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Safe Harbor Issued for Reporting Healthcare Prices Under Transparency Rules

The US Departments of Labor, Health and Human Services, and the Treasury recently released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting provisions of the Affordable Care Act (ACA). The FAQs were released to provide clarity on the required drug price disclosures identified in the Transparency in Coverage final rule (the Rule) issued on October 29, 2020. As described in this SHRM article, employers are responsible for making sure that these disclosures are ready and available.

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Agencies Issue Final Employer Healthcare Price Transparency Rule

On October 29, 2020, the US Departments of Health and Human Services, Labor, and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth requirements for group health plans and health insurance issuers to disclose cost-sharing information upon request to participants, as well as additional pricing information to the general public.

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A Momentary Victory for the ACA: Federal Judge Issues a Nationwide Injunction against Trump Administration’s Contraceptive Coverage Carve Outs

On January 14, 2019, US District Judge Wendy Beetlestone in the US District Court for the Eastern District of Pennsylvania issued a nationwide preliminary injunction blocking the Trump administration’s carveouts to the Affordable Care Act’s (ACA) contraceptive coverage mandate. One day prior, US District Judge Haywood Gilliam in the US District Court for the Northern District of California issued a more limited injunction blocking the same carve outs from taking effect in 13 states plus the District of Columbia.

On October 6, 2017, the Trump administration issued rules that are the subject of these two decisions. The rules would have allowed employers to raise religious and moral objections to avoid the ACA’s requirement that contraceptive coverage be provided without cost sharing under their group health plans. Under the ACA, certain contraceptive products and services are included in the list of preventive services that must be covered by most group health plans without cost sharing. The available exemptions to this rule were limited.

Judge Beetlestone reasoned that the loss of contraceptive coverage would have resulted in “significant” and “proprietary harm” to the states by causing increased use of state-funded contraceptive services, along with increased costs associated with unintended pregnancies. Without the preliminary injunction, the Trump administration’s rules would have gone into effect on January 14, 2019. The preliminary injunction does not permanently block the rules, but rather it stops the rules from going into effect while legal challenges are being pursued. Judge Beetlestone indicated that she is likely to invalidate the rules, stating that the US Departments of Health and Human Services, Labor and Treasury exceeded the scope of their authority under the ACA by issuing the carve outs.

Charnae Supplee, a law clerk in the Firm’s Washington, DC office, also contributed to this post. 




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Fridays with Benefits Webinar | Mental Health Parity and Compliance Complexities

New proposed guidance on mental health parity issued last month spotlights the complexities of these rules. Join us for out next Fridays with Benefits webinar on June 1 as Jacob M. Mattinson and Judith Wethall discuss the impact these rules will have on group health plans and how to determine if your plan complies. Find out about recent litigation and agency enforcement actions.

Friday, June 1st, 2018
10:00 – 10:45 am PDT
11:00 – 11:45 am MDT
12:00 – 12:45 pm CDT
1:00 – 1:45 pm EDT

Register now.  




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Government Shutdown Pushes Back Cadillac Tax

On January 22, 2018, Congress passed an interim funding bill to end the three-day government shutdown that also pushed back the effective date of the Affordable Care Act’s controversial “Cadillac Tax.”  The Cadillac Tax imposes an excise tax on group health plans that provide benefits in excess of certain thresholds.  The new legislation pushes the effective date back an additional two years to January 1, 2022.




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21st Century Cures Act: Small Employer Changes under the Affordable Care Act

President Obama has signed the 21st Century Cures Act, Pub. L. No. 114-225 (Dec. 13, 2016). As we previously mentioned, the new legislation permits small employers (those that are not considered applicable large employers under the Affordable Care Act (ACA)) to maintain general-purpose stand-alone Health Reimbursement Arrangements (HRAs) if they do not offer a group health plan to any of their employees. Stand-alone HRAs were not permitted based on ACA guidance. Annual benefits under these new HRAs cannot exceed an indexed maximum of $4,950 per year ($10,000 if family members are covered), must be funded solely by employer contributions (employee contributions are not permitted), and can only be used for the reimbursement of Internal Revenue Code §213(d) medical care expenses.




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Implementation Date for New Summary of Benefits and Coverage Template

The U.S. Departments of Treasury, Labor, and Health and Human Services (the Departments) recently issued new guidance regarding the intended timeframe for the use of the new summary of benefits and coverage (SBC) template and instructions, an updated uniform glossary and other associated materials.

Background

The Affordable Care Act (ACA) generally requires group health plans and health insurance issuers offering group or individual health insurance coverage to provide an SBC to participants and beneficiaries. The Departments issued revised final regulations governing the SBC requirement on June 16, 2015, and published a proposed new SBC template on February 26, 2016. Comments on the proposed template and associated documents are due by March 28, 2016.

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