The CLINICAL TREATMENT Act, HR 6836, was introduced by Representatives Gus Bilirakis (R-FL-12) and Ben Ray Lujan (D-NM-03) to guarantee coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition.
Medicaid insures nearly one-fifth of the U.S. population and is the only major payer that is not required by federal law to provide coverage of the routine care costs for participating in a clinical trial. Medicare has paid for these services since a 2000 National Coverage Decision. Private payers are required to provide coverage under the provisions of the Public Health Service Act section 2709, enacted as part of the Affordable Care Act.
Clinical trial participation benefits cancer patients in ways that go beyond the value of the research data generated within the trial, and clinical trials often provide individuals with cancer with their best clinical option.
Improving representation improves the validity of clinical research data and quality of new treatments. Medicaid serves a large portion of under-represented minorities and ethnicities that are not well represented in clinical trial enrollment. Failure to address the coverage barrier that Medicaid patients face could further exacerbate existing disparities and prevents researchers from obtaining optimal results in clinical trials.
Providing coverage for the routine costs of clinical trials is affordable for states as several studies have demonstrated a minimal effect on overall care costs. Because in most cases, this is coverage for care that patients would be receiving anyway. Routine care costs include the non-experimental costs of treating a patient who is participating in a clinical trial, such as physician visits and laboratory studies. The cost of the investigational device or drug would still be covered by the trial sponsor.
Take action today! Urge your Representative to cosponsor H.R. 6836 and urge your Senator to consider leading a Senate companion bill.