A new study of cancer drugs denied by Medicare Part D insurance plans found that more than one-fifth of denials were overturned upon review by a contracted reviewer. This suggests there are a considerable number of inappropriate denials.

The study, led by Youngmin Kwon, PhD, a postdoctoral research fellow in the Department of Health Policy at Vanderbilt Health, implemented natural language processing to analyze the text of second-level appeals of cancer drugs denied under Medicare Part D, the supplemental plans that cover prescription drugs. The study was published in JAMA Network Open.

“Cancer drugs are expensive, and their use is closely monitored and controlled by insurance plans. They also belong to a protected drug class in the Part D program, meaning that plans must cover all or nearly all of these drugs. While plans cannot broadly exclude coverage, they can deny coverage of drugs that are not deemed medically necessary,” Kwon said.

The most common reason for initial denials was “non-medically acceptable” indications, or drugs prescribed “off-label,” which generally means using a drug outside its formally approved indication by the Food and Drug Administration.

When treating cancer, prescription drugs are often combined or used for cancer types or populations that aren’t always specifically included in the FDA-approved labeled indication. To govern coverage of off-label use, Medicare relies on clinical compendia that summarize supporting clinical evidence or other peer-reviewed studies of medications prescribed off-label.

“Off-label prescribing is exceptionally common in oncology, especially for treating rare or treatment-resistant cancers. Because it does not follow the ‘standard’ treatment protocol, insurers may have a greater justification for heavily scrutinizing off-label use and refuse coverage,” Kwon said.

However, the study found that 88% of successful appeals for off-label use were for medically acceptable indications already supported by a Medicare-approved clinical compendium or peer-reviewed scientific literature, suggesting that many requests for acceptable off-label use may have been denied.

Further, appeals for off-label use were often denied due to clerical issues (72%), such as failure to include adequate documentation and supporting citations. This suggests that many coverage decisions may have been made purely on administrative grounds, rather than through a formal clinical review, Kwon said.

Among drugs prescribed on-label but that were initially denied for failing to follow the preapproval process, 60% were ultimately approved by reviewers, a higher rate of favorable review.

Kwon said these findings echo concerns that utilization management tools used by insurers, such as prior authorization, are imposing barriers to necessary and evidence-based care.

“Patients and their providers may face considerable administrative burden in the appeals process for coverage of drugs that could be lifesaving. A simple mishap, such as forgetting to attach a lab result or a supporting citation, could mean weeks of delay. This creates stress for patients and their care team and could even lead to worse health outcomes if care is substantially delayed.”

Kwon said the new findings can be helpful in ensuring that Medicare beneficiaries undergoing cancer treatment receive timely, high-quality medical care they need.

“Given the rapid adoption of AI into medical review processes, it will be important for Centers for Medicare & Medicaid Services and insurers offering Part D plans to continue to improve the coverage and appeals process for Medicare beneficiaries. For instance, reducing documentation burden for on-label therapies, while establishing clearer guidelines for determining effective off-label use by insurers, may go a long way in improving patients’ access to prescribed cancer drugs.”

The research was conducted in collaboration with researchers from the American Cancer Society, Emory University, the University of Pittsburgh and University of Hawai’i at Mānoa, and Wake Forest University.

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Many Medicare patients with advanced cancer receive potentially aggressive treatment at the expense of supportive care, according to a study that analyzed Medicare records. 

The study, published Feb. 21 in JAMA Health Forum, examined the quality of end-of-life care among 33,744 Medicare decedents. The study involved patients of diverse ethnic backgrounds age 66 or older who died from breast, prostate, pancreatic or lung cancers.  

Overall, claims records showed that 45% of the patients experienced potentially aggressive care (such as multiple acute care visits within days of death), while there was a low receipt of supportive care, such as palliative, hospice and advanced care planning in the last six months of life. While hospice care spiked to more than 70% during the month that death occurred, over 16% of patients spent less than three days in hospice care. Moreover, receipt of advanced care planning and palliative care remained below 25%. 

“Care at end-of-life continues to favor overtreatment despite considerable efforts to raise awareness about the harms of aggressive treatment in the last decade,” said Youngmin Kwon, PhD, a research fellow with the Department of Health Policy at Vanderbilt University Medical Center.  

Access to supportive care varied among demographic groups. Patients who were older, non-Hispanic white, had longer survival durations, or lived in rural areas, as well as areas with lower socioeconomic levels, were less likely to receive supportive care. 

“For dying patients and their caregivers, hospice is often considered the gold standard of end-of-life that can holistically manage care needs,” the authors noted. “The fact that a considerable portion did not use hospice care at all or entered into hospice care within three days of death suggests the potential benefits of hospice care were not realized for many patients.” 

The findings underscore the need for multifaceted efforts to optimize the quality of end-of-life care for cancer patients. 

 “Having clear and honest communication between patients, their caregivers and providers regarding disease prognosis and advanced planning is crucial,” said Kwon. “At the same time, policies to increase access to supportive care and ensure an adequate workforce of palliative care providers are necessary to address structural barriers to high-quality care.” 

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