HHS Proposes Rules Prohibiting Discriminatory Health Care-Related Activities
On August 3, 2022, President Biden signed an Executive Order directing the Secretary of the US Department of Health and Human Services (HHS) to “consider all appropriate actions to advance the prompt understanding of and compliance with Federal nondiscrimination laws by health care providers that receive Federal financial assistance,” including nondiscrimination against persons seeking access to reproductive services. The following day, HHS published in the Federal Register a notice of proposed rulemaking (Proposed Rule) implementing Section 1557 of Title I of the Patient Protection and Affordable Care Act (Section 1557), which prohibits discrimination in certain health-related programs and activities based on race, color, national origin, sex, age, or disability. Among other things, in alignment with the Biden Executive Order, the Proposed Rule would clarify that discrimination “on the basis of sex” includes discrimination based on a patient’s pregnancy or related conditions, including with respect to termination of pregnancy. The Proposed Rule also would impose anti-discrimination requirements on providers of telehealth, the use of algorithms to make health care-related decisions, and the offering of medical diagnostic equipment.
HHS is inviting comments on the Proposed Rule, which would apply broadly to federally assisted health insurance programs and health care providers (Covered Entities), until October 3, 2022.
The ACA was enacted in 2010 to make health care more accessible and affordable. Section 1557 seeks to further that goal by prohibiting discrimination based on race, color, national origin, sex, age, or disability in a health program or activity, any part of which is receiving federal financial assistance, any program or activity that is administered by an Executive Agency, or any entity established under Title I of the ACA or its amendments. HHS previously sought to implement Section 1557 through regulations published in 2016 (2016 Rule), but was judicially enjoined from doing so with respect to the 2016 Rule’s interpretation that discrimination on the “basis of sex” includes discrimination based on “gender identity” or “termination of pregnancy,”1 including through an order enjoining HHS from interpreting or enforcing Section 1557 in a way that would require the plaintiffs challenging the rule to perform or provide insurance coverage for abortion or gender transition services.2 This decision is currently being appealed.
In 2020, HHS promulgated a new rule (2020 Rule), rescinding significant portions of the 2016 Rule, including the definition of “on the basis of sex.” Shortly after HHS published the 2020 Rule, litigants in numerous district courts challenged the 2020 Rule and sought to enjoin HHS from repealing certain provisions, including the 2016 Rule’s definition of “on the basis of sex.” HHS now seeks to revise the 2020 Rule to reinstate certain regulatory requirements to protect individuals from health care discrimination. Among other things, the Proposed Rule will:
- reinstate the same nondiscrimination standards to all administered health programs and activities;
- clarify the application of Section 1557’s nondiscrimination requirements to health insurance issuers;
- align sex discrimination regulatory requirements with recent Federal court decisions;
- clarify that discrimination “on the basis of sex” includes pregnancy or related conditions, including pregnancy termination;
- require Covered Entities to have Section 1557 policies and staff training;
- require Covered Entities to provide notice of the availability of language assistance services and auxiliary aids and services;
- prohibit Covered Entities from discriminating against individuals based on clinical algorithms;
- clarify the process for raising conscience and religious freedom objections; and
- clarify that nondiscrimination requirements apply to health programs and activities provided through telehealth services.
Below, we discuss and summarize the provisions of the Proposed Rule related to telehealth, the use of clinical algorithms, and abortion services.
Clarification That Nondiscrimination Requirements Apply to Telehealth Services
The Proposed Rule is the first iteration of HSS’s implementation of Section 1557 to address telehealth services. As emphasized in its discussion of the Proposed Rule, HHS is proposing to include telehealth services largely in recognition of the vastly increased reliance on telehealth during the COVID-19 pandemic. Telehealth services have expanded rapidly to include the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health, and health administration. Remote technologies, such as videoconferencing, websites, and online portals are now also widely used as a means to obtain diagnostic tests.
HHS has observed that the increased use of remote communication technologies has created new access barriers for certain individuals, including those with disabilities. Telehealth platforms often lack the ability to incorporate third-party services such as real-time captioning or screen reading software, and often do not consider usability or compatibility. Thus, individuals with disabilities may have difficulties accessing or navigating certain websites or portals.
To address these issues, the Proposed Rule clarifies that Covered Entities may not discriminate in their delivery of health programs and activities through telehealth services. Covered entities must ensure their telehealth services are accessible to individuals with disabilities unless doing so would result in undue financial or administrative burdens.
HHS is seeking comments on whether the Proposed Rule should include a provision requiring Covered Entities to comply with specific accessibility standards. HHS is also interested in comments regarding accessibility challenges individuals have faced with respect to telehealth services and recommendations on how to supplement and improve the current telehealth accessibility standards. Commentors are encouraged to “consider the range of technology available for accessing telehealth, including user-friendly design, as well as security and privacy requirements (for example, when using public Wi-Fi access).”3
Application of Nondiscrimination Rules to the Use of Clinical Algorithms
The Proposed Rule also includes, unlike prior iterations of HHS’ Section 1557 rulemakings, a prohibition on discrimination in the use of clinical algorithms in decision making. For purposes of the Proposed Rule, “clinical algorithms” are “tools used to guide health care decision-making and can range from flowcharts and clinical guidelines to complex computer algorithms, decision support interventions, and models.”4 Such tools may be used by hospitals, providers, and payers to screen, predict risk, diagnose, plan, allocate resources, or aid in clinical decision making.
In discussing its decision to address these tools in the Proposed Rule, HHS cited to “recent research demonstrating the prevalence of clinical algorithms that may result in discrimination.”5 For example, because race and ethnicity are often included as input variables, algorithmic outputs are often adjusted based on race and ethnicity. This practice, which is referred to as “race correction” or “race norming,” results in less favorable treatment of certain patients when compared to others. Other types of discriminatory practices may include clinical algorithms that penalize patients for diminished long-term life expectancy or include categorial exclusions of certain types of disabilities.
Covered Entities would be responsible under the Proposed Rule not only for ensuring nondiscrimination in clinical algorithms they themselves develop, but also for preventing discrimination in the use of any such algorithm regardless of whether the Covered Entity had a role in its design. Under the Proposed Rule, if HHS receives an allegation of discrimination, it will conduct a fact-specific analysis of the allegation. The analysis will take into account, among other things, what decisions and actions were taken by the Covered Entity in reliance on the clinical algorithm and the measures the entity took to ensure its decisions and actions resulting from its use of the clinical algorithm were not discriminatory.
HHS is seeking a wide range of comments regarding the clinical algorithm provisions, including whether they are appropriately limited to clinical algorithms or whether additional forms of automated decision making, such as artificial intelligence and machine learning, should be included. Additionally, HHS has requested comments regarding whether the clinical algorithm provisions should be more specific, such as by including actions Covered Entities may take to mitigate potential discriminatory outcomes or types of practices that Covered Entities may use to ensure clinical algorithms are not discriminatory. HHS has further requested comments regarding the types of clinical algorithms currently in use, information related to how they are used and whether they are more prevalent in certain health settings over others, and how to identify and mitigate discrimination caused using clinical algorithms.
Clarification That Discrimination on the Basis of Sex Includes Discrimination Based on Pregnancy-Related Conditions
As noted, the Proposed Rule clarifies that “[d]iscrimination on the basis of sex includes, but is not limited to, discrimination on the basis of . . . pregnancy or related conditions.” According to HHS, the inclusion of pregnancy or related conditions “is consistent with the longstanding interpretation of sex discrimination under Title IX, including the Department’s Title IX implementing regulations.”6
To supplement this definition, HHS is considering including a section specifically addressing discrimination on the basis of pregnancy or related conditions. HHS notes that although the 2016 Rule included actions related to pregnancy, false pregnancy, and termination of pregnancy within the actions deemed to be taken “on the basis of sex,” the 2016 Rule did not include a stand-alone provision prohibiting discrimination based on pregnancy-related conditions. Additionally, the 2020 Rule did not address discrimination on the basis of pregnancy-related conditions and further did not define “on the basis of sex.” Thus, the 2020 Rule did not specifically prohibit discrimination based on pregnancy-related conditions.
Under the Proposed Rule, Covered Entities must still comply with the provisions in the Title IX regulations, which expressly prohibit discrimination based on pregnancy-related conditions, including termination of pregnancy. Although the 2020 Rule did not address discrimination on the basis of pregnancy, it did prohibit discrimination on any grounds prohibited under Title IX. Thus, according to HHS, including a stand-alone provision addressing pregnancy related conditions does not deviate from the 2016 and 2020 Rules.
HHS is seeking comments on whether it would be beneficial to include a section in the planned regulations specifically prohibiting discrimination on the basis of pregnancy-related conditions and clarifying that discrimination on the basis of pregnancy-related conditions is a form of sex-based discrimination. HHS is also inviting comments on how the Supreme Court’s recent decision in Dobbs v. Jackson Women’s Health Organization may impact Section 1557 and the implementing regulations. Additionally, given the Dobbs decision, HHS is interested in discussing alternative approaches to ensure nondiscriminatory access to health care.
HHS has made clear that it intends to restore and strengthen existing anti-discrimination protections for individuals through the Proposed Rules. Given the breadth of the Proposed Rule’s application, and, among other things, its implications for the use of new technologies to interact with patients and to make decisions about their care, and for the legality of denying or refusing insurance coverage for certain sex- or gender-related health care services, Covered Entities would be well-served to consider submitting comments on the Proposed Rule, particularly in those areas where HHS has indicated it would welcome input. HHS is expected to issue a final rule later this year after the close of the notice-and-comment period.
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Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928 (N.D. Tex. 2019).
Franciscan All., Inc. v. Becerra, 553 F. Supp. 3d 316 (N.D. Tex. 20201), amended, No. 7:16-cv-00180-O, 2021 WL 6774686 (N.D. Tex. Oct. 1, 2021), appeal pending, No. 21-11174 (5th Cir. Nov. 21, 2021).
Notice of Proposed Rulemaking at 191.