New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy

The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible for Medicaid in April 2022. The letter expands upon coverage options for pediatric patients. However, a year has passed with no further updates on this letter or Medicaid beneficiaries enrolling in clinical trials. How can your institution best prepare for this change and what can you expect for the future?

Background

In 2001, Medicare released the national coverage determination (NCD) 310.1. This NCD provided guidance to not only Medicare beneficiaries, but also all private insurers on what items and services are deemed eligible for coverage. This resource has become a staple for all institutions conducting industry, federally funded, or investigator-initiated trials (IITs). Yet, coverage for pediatric patients or those receiving Medicaid coverage was not described until 2022.

What We Know

Much of the 2022 Medicaid letter aligns with the determinations in NCD 310.1, outlining routine costs in clinical trials. To be eligible for Medicaid coverage, a study must be deemed a qualifying clinical trial. The study must be performed to prevent, detect, or treat any serious or life-threatening disease or condition. In addition, trials must either be funded by a federally funded cooperative group, have an investigational new drug (IND) exemption issued by the FDA, or include a drug otherwise exempt from requiring an IND.

Routine costs include any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participating in the qualifying clinical trial. These assessments include any cost otherwise covered outside the scope of the study as per the patient’s routine care. These routine services may also include items required solely for the provision of the investigational item or service, such as the administration of an investigational drug.

Items and services not covered under the new mandatory Medicaid benefit include the investigational item itself, items/services not otherwise covered outside of the trial’s scope, and assessments solely performed for data collection or research purposes.

What We Don’t Know

A key question for research sites and institutions is how current NCDs and local coverage determinations (LCDs) further affect coverage. Pediatric patients often have a greater need to run additional testing compared to the adult patient population.

A laboratory test, such as thyroid-stimulating hormone (TSH), may be limited in an adult cancer study due to restrictions from NCD 190.22. However, a pediatric patient may indicate this due to their impacted and ever-developing endocrine system.

Research site and institution feedback shows these assessments are routinely covered for Medicaid beneficiaries, but further support from CMS is needed to ensure coverage.

Next Steps

Currently, individual states continue to review the plan and make appropriate legislative changes to account for this new Medicaid clinical trial policy. Research studies involving Medicaid beneficiaries continue to run, leaving the research industry in a state of limbo. Until further information is available, following the guidance from established Medicare policies on clinical trial coverage is the best recommendation.

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