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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When colorectal adenomas — polyps that can develop into colon cancer — are removed during a colonoscopy, patients look for guidance about when to have another colonoscopy to look for new growths.

Current surveillance guidelines emphasize polyp characteristics, but a new study led by Vanderbilt Health researchers demonstrates that demographic factors also influence colorectal adenoma recurrence. Their findings, reported in the journal JAMA Network Open, underscore the need for surveillance strategies that factor in polyp characteristics and population-specific risk profiles, as well as variation over time.

Colorectal cancer is the second most common cause of cancer-related death in the United States, according to the National Cancer Institute. Removing precancerous polyps during colonoscopy procedures significantly reduces the burden of colorectal cancer. But about 30% of patients who have a colorectal adenoma removed will develop recurrent adenomas, putting them at increased risk for developing cancer.

“The current guidelines for surveillance after polyp removal stratify recurrence risk primarily based on polyp characteristics including size, histology and number,” said Xingyi Guo, PhD, associate professor of Medicine in the Division of Epidemiology and co-corresponding author of the new study. “The guidelines universally neglect demographic variables such as race, sex, family history, age and obesity, and may therefore be inadequately addressing population heterogeneity in recurrence risk and timing.”

The researchers, led by Guo and co-corresponding author Zhijun Yin, PhD, associate professor of Biomedical Informatics, conducted a retrospective cohort study using Vanderbilt Health electronic health records for about 3.5 million patients.

They identified a study group of 59,667 adult patients who had an initial colonoscopy with polyp removal between January 1990 and July 2024, and up to 25 years of follow-up. About 29.5% of the patients experienced adenoma recurrence within five years.

The researchers evaluated associations between recurrence and demographic variables: race and ethnicity, sex, obesity (body mass index greater than 30), family history of colorectal cancer or polyps, and age at time of initial adenoma (younger than 50 versus 50 and older). They examined associations with adenoma features including histology, size, number and dysplasia (abnormal cell structure).

Among their notable findings:

• High-grade dysplasia had the largest association with early (less than five years) adenoma recurrence, but not with mid- (five to 10 years) or late-term (10 or more years) recurrence.
• Villous histology exhibited a biphasic pattern: an early elevation and late-term resurgence in recurrence risk.
• Obesity conferred persistent risk across all surveillance intervals.
• Female patients with high-risk adenomas had marked late-term risk, exceeding male patients.
• Colorectal adenoma recurrence demonstrated distinct heterogeneity over time, rather than constant risk.

The researchers noted that the study cohort’s predominantly non-Hispanic white population (87.2%) may limit generalizability of the findings, and other factors that could affect risk like socioeconomic status and lifestyle exposures (e.g., tobacco and alcohol use, physical activity and diet) were not consistently available in health records and could not be included in the analysis.

“Our findings suggest that both histopathologic and demographic factors show time-dependent associations with adenoma recurrence, supporting a shift toward dynamic and individualized surveillance strategies,” Yin said.

Usman Ayub Awan, PhD, epidemiology postdoctoral fellow, and Qingyuan Song, PhD, computer science and biomedical informatics graduate student, are co-first authors of the JAMA Network Open study. Guo, Yin and Wanqing Wen, MD, MPH, research professor of Medicine in the Division of Epidemiology, are co-senior authors of the study. The research was supported by the National Cancer Institute (grants R01CA297582 and R01CA269589).

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Aimal Khan, MD, assistant professor of Surgery at Vanderbilt University Medical Center, noticed the puzzled or anxious expressions of patients trying to fully comprehend what he was saying during preoperative consultations, so he devised visual aids — three-dimensional models of the lower digestive tract. 

The 3D models allowed patients to easily distinguish the ascending colon from the sigmoid colon, along with other parts of the digestive system. Patients could actually see where the surgery would occur, and Khan noticed that they asked more questions, felt more confident and seemed less anxious.  He devised a study to determine whether his personal observations were scientifically valid. 

The study, which was published June 3 in JAMA Network Open, determined that the 3D models made patients feel they played a bigger role in decision-making and that their anxiety levels decreased. 

The patients were scheduled for partial or complete colon and/or rectal resections for colorectal cancer, diverticulitis or inflammatory disease. Fifty-one patients participated in the study with 28 receiving consultations using the 3D models and 23 receiving conventional consultations. The patients in the 3D arm of the study reported a significantly higher involvement in shared decision-making and significantly reduced anxiety levels compared to the other patients. 

Khan and five other Vanderbilt surgeons conducted the study from March 2022 to June 2023.  

“Using 3D models during consultations allowed our patients to truly visualize their surgery, which not only empowered them to take an active role in decision-making but also significantly eased their anxiety. This approach has the potential to transform how we communicate complex information to our patients. We are currently working with surgeons from other specialties, including thoracic surgery, ENT and surgical oncology, to validate these findings in a multicenter randomized trial,” Khan said. 

The findings are important because other studies have shown that improvements in shared decision-making are associated with reduced hospital stays, lower health care utilization, improvement in patient-reported health outcomes and fewer emergency department visits.  

The 3D models used in the study were developed in collaboration with the Department of Radiology. The modular designs, which were made with 3D printing, allowed each segment of the colon and rectum to be magnetically detached and reattached. 

To the knowledge of the study’s authors, this is the first randomized clinical trial to compare the effectiveness of a 3D-printed model with usual care on colorectal surgery patients’ involvement in decision-making, anxiety and education. 

Other Vanderbilt researchers who authored the study are Danish Ali, MD, Shannon McChesney, MD, Michael Hopkins, MD, Molly Ford, MD, Roberta Muldoon, MD, Timothy Geiger, MD, MMHC, Alexander Hawkins, MD, MPH, Georgina Sellyn, MA, Hillary Samaras, RN, and Dann Martin, MD, MS.

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