HHS Section 504 QALYs Comments

November 13, 2023 

The Honorable Xavier Becerra 

Secretary 

U.S. Department of Health and Human Services 

200 Independence Avenue, S.W. Washington, D.C. 20201 

Re: Nondiscrimination on the Basis of Disability Proposed Rule Section 504 of the Rehabilitation Act of 1973

Dear Ms. Barkoff:

I am writing on behalf of HealthHIV & The National Coalition for LGBTQ Health in response to the Notice of Proposed Rulemaking: Older Americans Act Regulations, RIN Number 0985–AA17.

As background, HealthHIV is a national non-profit working with healthcare organizations, communities, and providers to advance effective HIV, HCV, STI and LGBTQI+ health care, harm reduction and health equity through education and training, technical assistance and capacity building, advocacy, communications, and health services research and evaluation.

HealthHIV leads the HealthHCV initiative, the National Center for Health Care Capacity Building, and the National Coalition for LGBTQ Health.

The National Coalition for LGBTQ Health (“Coalition”), administered by HealthHIV, is committed to improving the health and well-being of lesbian, gay, bisexual, transgender and intersex + (LGBTQI+)  individuals through federal and local advocacy, education, and research. The Coalition strives to address the entire LGBTQI+ community, including individuals of every sexual orientation, gender, gender identity, race, ethnicity, and age regardless of disability, income, education, and geography. The Coalition is an initiative of HealthHIV, a national nonprofit focused on health equity.

In short, both champion the rights and well-being of LGBTQI+ individuals, while further emphasizing the distinctive and syndemic needs of those living with HIV. 

Summary: In the context of HIV treatment and prevention, as well as primary and secondary immunodeficiencies, the proposed rule implementing Section 1557 of the Affordable Care Act by the U.S. Department of Health and Human Services (HHS) is pivotal. This rule, calling for public feedback on healthcare value assessments, must meticulously avoid discrimination based on race, color, national origin, sex, age, or disability. Patient advocacy organizations nationwide have advocated for prohibiting value assessment methods that inadvertently disadvantage specific groups, particularly in crucial areas like treatment coverage and pricing. This is especially crucial in HIV care, where equitable access to antiretroviral therapies (ART) and preventive measures like pre-exposure prophylaxis (PrEP) is vital. The construction of measures like quality-adjusted life-years (QALY) and the EQ-5D, often used in these assessments, requires careful consideration to prevent biases that may devalue treatments for populations like the elderly or those with disabilities, a concern also relevant for individuals with immunodeficiencies. It’s imperative for HHS to ensure that these value assessments are inclusive, avoiding ableist methodologies and acknowledging the diverse needs within the HIV community and those with immunodeficiencies. The final rule should enable policymakers to discern whether a value assessment used for coverage decisions employs discriminatory methods, thereby advocating for healthcare practices that are more inclusive and equitable.

Expanded

In response to the proposed rule implementing Section 1557 of the Affordable Care Act, the U.S. Department of Health and Human Services (HHS) has sought public feedback on the application of value assessments in healthcare decision-making. This request specifically addresses concerns that clinical algorithms used by covered entities must not result in discrimination based on race, color, national origin, sex, age, or disability. In reaction,  we are pressing the Office for Civil Rights to formulate a rule that prohibits value assessment methods that inadvertently penalize individuals or groups based on these protected characteristics, especially within areas such as utilization management, formulary design, price negotiations, and alternative payment models. This push aims to ensure equitable access to care and the affordability of essential treatments.

The problem of discrimination in value assessment extends beyond merely the issue of life extension. The construction of metrics, including the quality-adjusted life-years (QALY) and similar measures, are susceptible to inherent biases. For instance, calculations like life years lost (LYL) require estimations of life expectancy at the point of treatment. However, if the data source for one disease comprises older individuals or more people with disabilities or chronic conditions than the source for another disease, it could result in biased weightings of potential life year gains, affecting the evaluation of treatments’ value.

This issue highlights the need for value assessment methods to align with the National Institutes of Health (NIH) efforts to eliminate ableism. For example, measures like the equal value of life year gained (evLYG) may not adequately value medications that primarily improve quality of life, which is often a crucial consideration for individuals with disabilities. The evLYG, like the QALY, has been criticized for its inability to fully capture the value of life-extension and quality of life improvements. The NIH’s recent initiatives to understand how ableism contributes to health disparities and to modify its mission statement to eliminate ableist language are steps in the right direction. These efforts reflect a broader move towards valuing diverse experiences and needs in healthcare, particularly for people with disabilities.

Utility weights used in value assessments, such as the EQ-5D, have also come under scrutiny. These measures often fall short in capturing the nuanced experiences of patients, particularly those with disabilities. The EQ-5D, for instance, might devalue the quality of life for non-ambulatory individuals by using standards that equate walking with a higher quality of life. This approach overlooks the full spectrum of health-related quality of life impacts and fails to align with patient-driven perspectives, as emphasized by the U.S. Food and Drug Administration (FDA) in their guidance on patient-reported outcome (PRO) measures.

In conclusion, the proposed rule by HHS presents an opportunity to reevaluate how value assessments in healthcare are conducted, particularly to ensure they do not perpetuate discrimination or ableism. It is crucial for these assessments to consider a broad range of patient experiences and needs, moving away from traditional methods that may undervalue the lives and experiences of people with disabilities. The final rule should enable policymakers to discern whether a value assessment used for coverage decisions employs discriminatory or ableist methods, thereby advocating for more inclusive and equitable healthcare practices.

From the perspective of HIV disease treatment and prevention care—and through the lens of primary immunodeficiencies and secondary or acquired immunodeficiencies—the proposed rule implementing Section 1557 of the Affordable Care Act by the U.S. Department of Health and Human Services (HHS) is a critical step towards ensuring equitable healthcare for all, particularly for those living with or at risk for HIV. This rule, which seeks feedback on value assessments in healthcare decision-making, must be carefully crafted to avoid discrimination based on race, color, national origin, sex, age, or disability.

1. Necessity of Non-Discriminatory Value Assessments in HIV Care:

In the realm of HIV treatment and prevention, value assessments are pivotal. These assessments influence decisions on which treatments are covered, how they are priced, and how they are made accessible to patients. Historically, communities most affected by HIV, including racial and ethnic minorities, the LGBTQ+ community, and those living in poverty, have faced systemic healthcare barriers. Therefore, it’s crucial that value assessments do not perpetuate these disparities but instead promote equitable access to life-saving HIV treatments and preventive measures.

2. Impact on HIV Treatment Accessibility and Affordability:

Over 80 organizations have already urged HHS to ban value assessment methods that disadvantage specific groups, particularly in utilization management and pricing. This is vital in the context of HIV care, where access to antiretroviral therapies (ART) and preventive measures like pre-exposure prophylaxis (PrEP) should be based on clinical need and efficacy, not biased value assessments that could restrict access based on discriminatory criteria.

3. Risk of Biased Metrics in Life Extension Measures:

In HIV care, the quality of life and life extension are paramount. Measures like the quality-adjusted life-years (QALY) must be employed carefully to avoid biases that undervalue treatments for certain populations. For instance, a biased life expectancy estimate could lead to undervaluing ART’s effectiveness in older or disabled HIV-positive individuals. Such discrepancies can directly affect the types of treatments funded and accessible to various subgroups within the HIV community.

4. Alignment with NIH’s Efforts to Eliminate Ableism:

Value assessment methods should be consistent with the NIH’s efforts to combat ableism. HIV treatment and prevention strategies must value the life and quality of life for all, including people with disabilities. Measures like the EQ-5D, often used in these assessments, must be scrutinized to ensure they do not adopt ableist standards in evaluating treatment outcomes.

5. Inclusive Approach in Value Assessment:

It is crucial for HHS to adopt a proposed rule that acknowledges the risk of discrimination in broader value assessments. Such assessments should not classify people with disabilities, or those from minority communities disproportionately affected by HIV, as inferior in any aspect of healthcare, whether it be in life extension or quality-of-life improvement.

As we continue to combat HIV, ensuring equitable treatment and prevention access is paramount. The proposed rule by HHS presents an opportunity to reevaluate and reshape healthcare value assessments, ensuring they are inclusive, non-discriminatory, and effectively serve the diverse needs of the HIV community. It is imperative that these assessments fully recognize and value the lives and health outcomes of all individuals, regardless of their background or health status. This approach is not just a matter of policy compliance but a fundamental necessity in our ongoing fight against the HIV epidemic—and our friends with primary immunodeficiencies and secondary or acquired immunodeficiencies.

Conclusion

The proposed rule by the U.S. Department of Health and Human Services (HHS) offers a crucial opportunity to revisit and reform healthcare value assessments, with the goal of ensuring they are inclusive and unbiased, particularly in the context of HIV treatment and prevention. This initiative is vital not only for policy adherence but also as a key element in the ongoing fight against HIV, including for individuals with primary and secondary immunodeficiencies. The rule aims to transform value assessments to be more encompassing and sensitive to the varied experiences and needs of patients, including those with disabilities. It seeks to prevent discriminatory or ableist practices in healthcare decision-making, advocating for a more inclusive and equitable approach in evaluating healthcare treatments and their accessibility. The outcome should guide policymakers in determining the fairness and inclusivity of value assessments in healthcare coverage decisions.

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