HHS’ Proposed New Anti-Discrimination Rule & What You Can Do to Comply with It

The COVID-19 pandemic exposed what had already been one of the worst kept secrets about society in America: the current healthcare system is inequitable and discriminates against minorities and other disadvantaged populations. Now, the Biden administration is aiming to turn a societal problem into a practical compliance challenge by proposing a wide-ranging rule to ban discrimination in health care. Here’s a briefing of what you need to know about the 308-page rule and its potential impact on you, along with a basic strategy you can deploy to battle discrimination in the telehealth context.  

The Section 1557 Controversy

Labs that discriminate in employment and provision of services risk liability under federal civil rights laws. In addition, Section 1557 of the Affordable Care Act (ACA) legislation adopted in 2010 bans health programs or facilities that receive federal funding from discriminating on the basis of race, color, national origin, sex, age, or disability. While the rule sounds fairly straightforward, its precise meaning and scope has become a legal and political battlefield.

The controversy really started heating up in May 2016 when the Obama administration issued a final rule interpreting Section 1557 expansively as also banning other grounds of discrimination not expressly listed in the ACA. Thus, for example, the rule interpreted the ban on “national origin” discrimination as protecting those with limited English proficiency (LEP) and the ban on “sex” discrimination as protecting gender identity and termination of pregnancy.

Critics cried foul and, in December 2016, a Texas federal court judge issued a nationwide injunction banning the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) from enforcing the gender identity and termination of pregnancy provisions of the final rule.

In June 2020, the Trump administration issued a new rule that wiped out major parts of the 2016 rule, including the broad definitions of classes protected from discrimination—including language stating that “sex” refers to a person’s genetic sex at birth—language access requirements, and enforcement provisions.

The 2020 rule spurred another round of litigation in federal district courts around the country, with the roles of defenders and challengers reversed. Most of these suits were put on hold when President Biden took office.

The ping ponging continued in May 2021, when HHS announced that it would interpret the Section 1557 ban on sex discrimination to include discrimination on the basis of sexual orientation and gender identity. And just as surely as night follows day, defenders of the 2020 rule filed new lawsuits challenging the HHS policy.

The New Proposed Rule

The next flashpoint came on July 25 when HHS issued a new Section 1557 proposed rule. Not surprisingly, the Biden rule is a lot like the Obama version, only more so, and a complete repudiation of the Trump revision. In addition to restoring the interpretation of “sex” discrimination as covering sexual orientation, gender identity, and pregnancy-related conditions, the new proposed rule would:

• Ban discrimination on the basis of a person’s marital, family, or parental status;
• Ban the use of algorithms based on race, color, national origin, sex, age, or disability for clinical decision-making;
• Ban discrimination in providing telehealth services;
• Extend Section 1557 to private health insurers and certain third-party administrators (TPAs);
• Extend Section 1557 to providers that receive payment via Medicare Part B;
• Reinstate and expand notice requirements designed to ensure access to language assistance, auxiliary aids, and services;
• Require labs and other covered entities to adopt new written policies and procedures to ensure compliance with Section 1557 and train their employees on those policies and procedures; and
• Require covered entities to post information about their Section 1557 compliance on their websites and at their physical facilities.

What Happens Next

The fate of the new Section 1557 proposed rule will be decided by federal courts and, ultimately, the 2024 presidential election—at least through 2028. But barring something dramatic like a new court injunction, the rule is likely to take effect sometime in early 2023.

The timetable: After fielding comments on the proposed rule through Sept. 24, HHS will post a final rule based on the feedback, which would take effect 60 days after it gets published in the Federal Register.

Impact & Compliance Strategy

You may very well need to develop and implement new Section 1557 written non-discrimination policies and procedures to keep your lab compliant. G2 Intelligence will help you do that when the final rule comes out. In the meantime, HHS has outlined a general strategy for preventing discrimination in the form of new guidance. While the guidance specifically addresses telehealth, the principles also apply to eliminating discrimination and ensuring accessibility in the broader patient communication context.

While it expands availability to health care, telehealth may also cause accessibility challenges for certain populations, the guidance notes, listing the following examples:

• People with visual impairments may be shut out if the web-based platform their doctor uses to schedule telehealth appointments doesn’t support screen reader software;
• Deaf persons who communicate via sign language interpreters may be shut out if their doctor’s video conferencing program doesn’t allow an interpreter to conference in from a separate location; and
• LEP persons may be shut out if they don’t get instructions on how to set up a telehealth appointment in their native language.  

“A healthcare provider’s failure to take appropriate action to ensure that care provided through telehealth is accessible can result in unlawful discrimination” under Section 1557 and other federal civil rights laws, the guidance warns. It then outlines three broad sets of measures that providers may have to take to avoid liability.

1. Provide Reasonable Accommodations for the Disabled

Federal and state discrimination laws require service providers to make “reasonable accommodations” for persons with disabilities to the point of undue hardship. Such accommodations may include “reasonable changes” to “policies, practices[,] or procedures, which may include providing additional support to patients when needed before, during[,] and after a virtual visit.” Examples:

• Giving a patient with an intellectual disability extra time before an appointment to become familiar with how the telehealth platform works;
• Using a platform that enables a support person or family member to join the consultation from a separate location; and
• Extending appointments to give disabled patients ample time to communicate and verify their comprehension of the physician’s diagnosis and instructions.

2. Communications Aids

The guidance suggests that providers must also be prepared to offer and furnish necessary communication aids and services at no cost to patients, depending on their needs and the nature, length, and complexity of the information communicated. The provider needs to work with individual patients to determine what best suits their requirements. Examples may include sign language interpreters and real-time captioning platforms for deaf and hard of hearing people, and audio captioning for those with vision impairments.

3. Avoiding LEP Discrimination

Echoing the policy set out in the proposed Section 1557 rule, the HHS guidance affirms that the ban on national origin discrimination applies to LEP persons. “Recipients of federal financial assistance must take reasonable steps to ensure meaningful access for LEP persons in all aspects of care, including telehealth services,” the guidance states. Such “reasonable steps” include providing “meaningful access” on information about telehealth availability, how appointments are scheduled, and how information is communicated during the appointment. Specifically, providers might have to offer and pay for language assistance services to ensure meaningful access. Examples:

• Including in emails or social media postings on scheduling telehealth appointments a short, non-English statement explaining to LEP persons how to get the information in a language they understand;
• Ensuring that telehealth platforms can support a telephone or video remote interpreter; and
• Providing an LEP patient a qualified interpreter and allowing the interpreter to join the telehealth session—providers shouldn’t rely on patients to bring their own interpreters, the guidance cautions, due to issues of confidentiality and potential conflicts of interest.