Broad Coalition Urges Congress to Include CLINICAL TREATMENT Act in Healthcare Extenders Package

Bipartisan CLINICAL TREATMENT ACT would ensure clinical trial coverage for Medicaid patients
February 18, 2020

On February 18, 106 organizations representing patients, providers, medical researchers, survivors, and families joined together to urge Congress to include the bipartisan CLINICAL TREATMENT Act (H.R. 913) in the upcoming ‘must pass’ healthcare extenders package, which is expected to pass this spring. 

The CLINICAL TREATMENT Act would guarantee coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition. Nearly 20 percent of Americans receive their health insurance coverage through Medicaid. However, unlike Medicare and private and commercial payers, Medicaid is not federally required to cover routine care costs (like physician visits and laboratory studies) for clinical trials. Without the guarantee of coverage, many Medicaid beneficiaries with life-threatening conditions do not have the latest technological and scientific advancements as a treatment option.

“Clinical trials often provide patients with the best--and perhaps only--treatment option for their disease,” said Monica Bertagnolli, MD, FACS, FASCO, Chair of the Association for Clinical Oncology, an affiliated professional organization of the American Society of Clinical Oncology. “Without fair coverage, patients with Medicaid are being excluded from potentially life-saving clinical trials. This is a simple fix, and one that should be addressed by Congress as soon as possible.” 

H.R. 913 Would Have Little to No Impact on Medicaid Budget

Since routine costs only include the non-experimental costs of treating a patient who is participating in a clinical trial, adoption of H.R. 913 would have little to no impact on the overall cost to Medicaid programs. Routine care costs are part of standard care for all patients and would be incurred whether or not a patient participates in a clinical trial. The cost of any investigative drug or device would continue to be covered by the trial sponsor. 

This makes the CLINICAL TREATMENT Act a strong candidate for inclusion in the healthcare extender package, which extends certain ‘must pass' programs before they are set to expire on May 22, 2020. 

Bill Would Improve Quality of Clinical Research, Reduce Health Disparities

Passing the CLINICAL TREATMENT Act could also help improve the validity of clinical research data. Medicaid insures a large portion of people from under-represented minority and ethnic groups who are not well represented in clinical trial enrollment. Lack of participation in clinical trials from the Medicaid population means these patients are not reflected in the outcome of the clinical research. Improving the representation of this group would improve the validity of clinical research data and the quality of new treatments – delivering better cures to all patients. In addition, covering routine costs of clinical trials for patients with Medicaid coverage could help to reduce health disparities and ensure all patients have access to the high-quality, high-value cancer care.

H.R. 913 was introduced by Representative Ben Ray Luján (D-NM) and Representative Gus Bilirakis (R-FL) and currently has 28 cosponsors representing both parties. 

Among the 106 organizations backing the bill are the Association for Clinical Oncology, the American Medical Association, the American Heart Association, and the American Cancer Society Cancer Action Network. 

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