Medicaid Implements Waivers for Certain Clinical Trial Coverage

Federal officials will allow flexibility to meet new clinical trial cost coverage requirements for Medicaid registrants, seeking to accommodate states where legislatures do not meet in time to make necessary rule changes.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that has been hailed by the American Society of Clinical Oncology (ASCO) and others. groups like a trial boost as well as critically ill patients who have lower incomes.


The mandate went into effect Jan. 1, but the Centers for Medicare & Medicaid Services (CMS) will allow implementation time accommodations for states that have yet to be able to make the legislative changes. necessary, wrote Dan Tsai, director of Medicaid. , in a letter of December 7. Tsai’s letter does not mention specific states. CMS did not immediately respond to a request for information on which states should request exemptions.

Medicaid has been a rare US insurance program in recent years that does not cover the costs of clinical trials. The Affordable Care Act of 2010 made this coverage mandatory for people in private insurance plans. The federal government decided in 2000 that Medicare would.

“A hidden opportunity”

A perspective article last May in the New England Journal of Medicine called Medicaid’s new mandate for clinical trials a “hidden opportunity,” referring to its genesis as an addition to a massive federal spending program enacted in December 2020.

In the article, Samuel Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and his coauthors noted that participation rates in clinical trials remain low for racial and ethnic minority groups, in part to due to lack of Medicaid coverage.

“For example, non-Hispanic white patients are nearly twice as likely as black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time. time, ”write Takvorian and his co-authors. “Inequalities in recruitment also manifested themselves during the COVID-19 pandemic, which disproportionately affected non-white patients, without their proportional representation in trials of COVID-19 therapies. “

In October, researchers at Arthur G. James Cancer Hospital and Ohio State University, Columbus published the results of a Retrospective study of stage I-IV patients pancreatic cancer who also found inequalities in registrations. Write in the Annals of Surgical Oncology, Mariam F. Eskander, MD, MPH, and the coauthors reported what they found by examining the charts of 1127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not register. They found that enrollment in trials increased over the study period, but not for black patients or patients on Medicaid.

Eskander said Medscape Medical News the new Medicaid policy will remove a major barrier to participation in clinical trials. Oncologist Eskander said she looked forward to helping more of her patients access experimental drugs and treatments.

But that may not be enough to attract more low-income people to these studies, said Eskander, who is now at Rutgers University. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as wide use of Medicaid non-urgent medical transport (NEMT) benefits.

“Some patients will be offered to enroll in clinical trials and others will accept, but I’m really concerned about the challenges low-income people face with things like transportation and absence from work,” he said. she declared.

Kerry Dooley Young is a freelance journalist based in Washington, DC. She is the Senior Subject Manager for Patient Safety Issues for the Association of Health Care Journalists. Young earlier covered health policy and the federal budget for the Congressional Quarterly / CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung .

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