Federal policy on clinical trial coverage must bring Medicaid up to speed with Medicare, private ACA counterparts
By Steve Lee, MD
The status of Medicaid remains firmly in the news, with ongoing political and legal questions regarding hot-button issues such as work requirements that have far-reaching implications on access to care. On the oncology front, Medicaid access made waves at the 2019 ASCO Annual Meeting, with an abstract meriting plenary session placement.
The Flatiron Health and Yale study analyzed electronic medical records of over 34,000 patients in the Flatiron database before and after the 2014 expansion of Medicaid via the Obama-era Patient Protection and Affordable Care Act (PPACA). Most notably, in the post expansion era, African Americans were as likely as their white counterparts to receive first line treatment within 30 days of diagnosis whereas prior to the expansion African Americans were 4.9 percentage points less likely to receive timely treatment. These findings suggest that political decisions which increase access to health coverage can improve the delivery of cancer care, particularly among underserved populations.
I have found this to be true in my former role as an oncologist at Bellevue Hospital Center in New York City. The flagship of New York City's municipal health system, Bellevue receives and treats patients with complex cancer diagnoses regardless of insurance or legal status. Through a unique partnership with New York University as well as its Perlmutter Cancer Center, an NCI-designated Comprehensive Cancer Center, my Bellevue patients had access to a diverse portfolio of clinical trials.
In other parts of the country, however, Medicaid expansion does not necessarily allow for enrollment and potential benefit from clinical trials. While Medicare and the vast majority of post-ACA private health insurance plans cover the routine costs of care for patients on clinical trials, these protections do not include Medicaid. Only twelve states independently cover these charges which would be incurred regardless of trial status - these include regular appointments, imaging, medications, and hospitalizations; study drugs and study-specific testing are typically covered by the trial sponsor. Interestingly, New York is not one of these twelve states, and they and 42.2 million Medicaid recipients in the other 37 states may not have access to potentially life-changing clinical trials.
In response, ASCO has teamed up with other patient advocacy organizations to support H.R. 913, the Clinical Treatment Act. With bipartisan co-sponsors including Rep. Ben Ray Lujan (D-NM) and Rep Gus Bilirakis (R-FL), the bill would bring Medicaid protections up to speed with its Medicare and ACA exchange counterparts. The Flatiron Health and Yale study highlights the promise and potential of reducing disparities through expanded Medicaid while enhancing Medicaid protections in the clinical trial space could lead to greater inclusion in clinical trials and subsequently foster more generalizable research findings.
While a step in the right direction, H.R. 913 does not promise a solution to all payment-related barriers to clinical trial enrollment. Despite health insurance coverage of medical costs, many patients face onerous out-of-pocket costs such as increased travel expenses and co-pays that restrict the ability to participate in clinical trials. Further, oncologists have found therapy hampered by restrictive prior authorizations and other red tape that can prevent enrollment in a clinically relevant timeframe. In response, ASCO convened a 2017 Roundtable to address the real patient-facing costs of clinical trial research, with policy recommendations. H.R. 913 has not yet received a budget score, though proponents suggest a minimal effect on total health care spending, as routine costs of care are likely to be incurred whether or not a patient is on a trial. After introduction in January 2019, the bill remains in Committee.
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