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On July 25, 2022, the Department of Health and Human Services issued a new Proposed regulation (Later Published In the Federal Register on August 4) Section 1557 of the Affordable Care Act (ACA) prohibits discrimination in certain health programs and activities based on race, color, place of birth, sex, age, or disability. The comment period closes on October 3.
This proposed rule is a broad and significant amendment to the implementing regulations of section 1557. Rather, it looks at two sections that specifically impact digital health, particularly as new additions to the section 1557 rulemaking history—namely, the extension of section 1557 to “clinical algorithms” and telehealth services.
Scope of the proposed regulation
The proposed rule applies broadly to both payers and providers.
- HHS proposes to apply section 1557 to: (1) each health program or activity that receives from HHS; (2) each health program or activity administered by HHS; and (3) each program or activity administered by an entity under title I of the ACA (eg, exchanges).
- HHS proposes to define a “health program or activity” broadly to include, among other things, the provision of health care services to health education for health care professionals.
- HHS proposed to broadly define “federal financial assistance” to include grants, loans, and other federal assistance.
For payers, as proposed, section 1557 applies to health plans, Medicare Advantage organizations, Medicare Part D plan sponsors, and Medicaid managed care organizations. Additionally, because Section 1557 applies to the organization rather than to a specific product, insurers must comply across all lines of business, even when serving as a third-party administrator for a self-insured employer plan.
For providers, as proposed, Section 1557 would apply if they received federal financial assistance through participation in Medicare or Medicaid. Specifically, for the first time, HHS proposed to include Medicare Part B, meaning that providers receiving payment for outpatient services under Part B must comply with Section 1557.
Addition of “Clinical Algorithm”.
For the first time, HHS proposed to apply section 1557 to covered entities that use “clinical algorithms” in their decision-making. “Clinical algorithms,” as proposed, “can include tools used to guide healthcare decision-making and range from flowcharts and clinical guidelines to complex computer algorithms, decision-support interventions, and models.” While covered entities are not responsible for clinical algorithms they did not create, they are responsible for “any decisions made in reliance” on such tools.
As proposed, clinical algorithms include a wide range of tools that inform clinical decision making. More clarity is needed on the scope of instruments that HHS intends to include in the proposed rule. For example, as proposed, “clinical algorithms” would seem to include all modern digital tools used in clinical settings, where covered entities are widely used as clinical decision support tools. It provides helpful clarity on artificial intelligence and machine learning, clinical decision support software (both instrumental and non-instrumental), and software-as-a-medical-device compliance with Food and Drug Administration guidance.
The proposed rule provides selected examples where the use of clinical algorithms has resulted in bias. As such, HHS emphasizes at several points in the introduction that clinical algorithms should be used to replace, not supplement, clinical judgment. However, further clarity is needed regarding the scope of “any decisions made in confidence” that remain ambiguous in the proposed rule. Moreover, more clarity is needed on the closely related concept – which is not defined in the proposed rule – of what “complementary” means as opposed to replacement clinical decisions, as the intended uses of such devices can vary widely and influence them. Clinical judgment in biased ways.
Increasing telehealth services
Also, for the first time, HHS proposed to apply Section 1557 to covered entities in the delivery of telehealth services. As proposed, HHS refers to this as an “affirmative obligation” that requires covered entities not to discriminate in their health programs and provision of telehealth services. HHS defines telehealth as already defined by Health Resources Services Administration, which includes a variety of technologies, such as live video and store and delivery methods.
However, more clarity is needed from HHS regarding other embedded virtual care technologies that may be connected to telehealth, but are usually handled separately. For example, remote patient monitoring and mobile health applications are both briefly mentioned in the examples, but not in the definition discussion. As another example, telemedicine administration is not mentioned, but is a separate part of the recent Centers for Medicare and Medicaid Services.
HHS provides several examples of disparities in access to telehealth services based on race or disability that result in discrimination. As proposed, to ensure compliance, covered entities must account for the provision of telehealth services, the process of making telehealth appointments, and communications regarding telehealth appointments. Under the proposed legislation, this would include, for example, appropriate aids and services for people with disabilities and language assistance for individuals with limited English proficiency.
Many covered entities may comply with these proposed requirements under existing operating policies. However, once completed, covered entities should closely revisit these policies, especially to include payments under Medicare Part B. For new entrants in the telehealth services market, however, these requirements may result in additional operating costs.
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