On October 3, 2022, the HIV+Hepatitis Policy Institute (HIV+Hep) joined seventy other patient organizations, including the Autoimmune Association and JDRF, in a comment letter outlining how the Section 1557 nondiscrimination in healthcare proposed rule can improve patient access to prescription drugs.
In the comment letter – written on behalf of patients living with complex conditions such as HIV, autoimmune diseases, cancer, lupus, and diabetes – the patient groups collectively expressed their strong support for “meaningful steps to improve upon current regulations to ensure that people are not discriminated against in healthcare. In several instances, you have proposed to restore protections that had been included in the past but later withdrawn. In other instances, you have provided further clarity on what constitutes discrimination. In any instance, we emphasize that the law and whatever is finalized in regulation must be strictly enforced.”
The comment letter covers six specific areas: the scope of proposed nondiscrimination regulations; proposed discrimination through benefit design; proposed discrimination through excessive utilization management; discrimination of copay accumulator adjustment programs; potential discrimination of value assessments; and the need for enforcement.
The groups praised HHS for focusing on discrimination in benefit design, including coverage, exclusions, and limitations of benefits as well as prescription drug formularies and cost sharing. The groups specifically referred to HHS’ intent to apply nondiscrimination in benefit design “indirect mechanisms that affect the implementation of a benefit design within the covered entity’s control, such as utilization management practices, provider reimbursement, contracting out to third party-contractors such as PBMs.”
Additionally, the groups support the proposed rule’s concept of the potential discriminatory nature of value assessments in deciding healthcare coverage, including value assessments that use methods to calculate value that penalize individuals or groups based on age or disability. In the comment letter, the groups mentioned quality-adjusted life-years (QALYs) and how they are fundamentally discriminatory towards patients with chronic diseases. The letter states that “Because these groups may not ever be able to reach a completely healthy state, their overall gains from the lens of the QALY are lower, and treatments are accordingly wrongly assigned lower value… Since Section 1557 bans discrimination on the basis of age and disability, we believe the use of QALYs in health programs and activities should be prohibited.”
Further, the groups believe that excessive utilization management techniques employed by issuers and PBMs (i.e., prior authorization and step therapy) limit access to prescription drugs and constitutes potential discrimination. The proposed rule refers to certain utilization management techniques as “standard industry practices,” it also notes that they must be “applied in a neutral, non-discriminatory manner” and that “excessive use or administration of utilization management tools that target a particular condition” might violate Section 1557.
“While the Biden administration has prioritized the importance of nondiscrimination in healthcare, too often we have witnessed insurers that continue to discriminate against people, particularly those who experience serious health conditions, but no action is taken at either the state or federal levels,” said Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute. “While we are very supportive of the proposed rule, we urge HHS and states to devote the necessary resources to investigate complaints and benefit design that can lead to discrimination and take the proper enforcement against violators.”