The clinical research as a care option movement gains steam as outgoing POTUS worked with Washington elected officials to insert into the COVID-19 relief bill some mission-critical support for clinical research. Now state Medicaid plans can cover the patient costs of various medical services and products associated with the delivery of such routine medical services associated with a clinical trial. Effective as of 2022, the Medicaid beneficiary will have far more access to participate in clinical trials. In areas such as oncology, this can be life-saving. The intent of the law was to some extent harmonize access to clinical research across payer ecosystems (e.g. Medicare, commercial, Veterans, etc.).
Writing for Foley Hoag in JDSupra, Thomas Barker, JD, shares that the new law treats ”routine patient costs for items and services furnished in connection with a qualifying clinical trials” as a “Medicaid covered benefit.” Of course, not everything may be covered and some elements are options, such as dental services, but actual “routine trial costs will be a mandatory benefit.”
Barker suggests two definitions are (1) routine patient costs which includes…
“coverage of any item or service providing during the clinical trial, including items or services designed to prevent, diagnose, monitor or treat complications resulting from the participation in the trial to the extent those items or services treat complications resulting from the participation in the trial to the extent those items or service would otherwise be covered under the state plan outside of a trial.”
Foley Hoag’s Barker provides an example associated with a blood test used to measure the effectiveness of a drug suppressing a viral pathogen. While the investigational drug is not covered, nor is data collection and other such costs, (this is often provided no cost via the sponsor) the blood test would be covered by Medicaid.
The next definition (2) focuses on what the definition is of a “qualifying clinical trials.” That is a study that the Medicaid law kicks in and the patient’s relevant bills are covered by Medicaid. Here it’s described as “Conducted in relation to the prevention, detection, or treatment of any serious or life-threatening disease or condition.” Moreover, the study must be “approved, conducted or supported” via one of the key government research or health authorities such as the National Institutes of Health, Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services or an alliance of one or more of these agencies including the Department of Defense or Veterans Affairs. Non-governmental research institutes could also support the study.
Call to Action: Follow the link to the JDSupra piece and check out the new law here.