Integration of Medically Necessary Prevention, Treatment, and Monitoring of Oncologic-related Oral, Dental, and Craniofacial Complications

Center for Clinical Research
Division of Extramural Research

Goal

The objective of this initiative is to encourage translational and clinical research that advances the integration of medically necessary oral, maxillofacial, and medical approaches to reduce dental, oral, and craniofacial (DOC)-related complications among oncology patients. This initiative also promotes research that builds new evidence aligned with recent changes in Medicare policies to reduce coverage gaps in dental services inextricably linked to the clinical success of medical oncology services.

Background

Despite the overall decrease in cancer rates over the past decade, over 40% (2 out of 5) of Americans will be diagnosed with cancer of any site at some point during their lifetime. Each year over 17 million U.S. children and adults live daily with cancer [1], and 18 million Americans are cancer survivors [2]. The 133 million Americans who experience cancer in their lifetime receive medically necessary care. Oral health care is an integral component of medically necessary care for oncology patients. Systemic cancer treatments, such as chemotherapy, immunotherapy, and transplantation, and localized targeted head and neck cancer treatments, such as surgery, radiotherapy, or proton therapy are associated with DOC complications, which vary depending on treatment type and a patient’s pre-existing conditions, such as medical co-morbidities and active dental disease. Complications may include spread of oral infections, altered dental and craniofacial growth, osteoradionecrosis, neuromuscular impairment, persistent neuropathic pain, salivary hypofunction, dysgeusia, dysphagia, painful ulcerations, fibrosis, and mucositis. In turn, DOC complications may lead to additional hazards, such as poorer nutrition, ab ingestis pneumonia or asphyxia. Oro-dental disease can interfere with or halt medically necessary urgent care, leading to reduced cancer treatment efficacy and increased risks, such as malignancy spread or recurrence, increased risk of systemic complications, and decreased survival [3]. Importantly, novel treatments, such as immune checkpoint inhibitors, may result in severe debilitating effects [4]. Treatment-related toxicity along the entire oral and gastrointestinal tract may require additional interventions, lengthen hospital stays or lead to unnecessary emergency visits, hospital admissions or readmissions, increasing health care costs and patient burden. The ongoing medical and dental separation exacerbates health inequities. Recognizing this gap, the recent Centers for Medicare & Medicaid Services (CMS) 2023 and 2024 Final Rules specifically address critically necessary inpatient and outpatient dental coverage delivered through coordinated medical and dental care for oncology patients [5,6].

Over the next decade, the number of cancer survivors is projected to increase by 24.4% to nearly 23 million Americans. Furthermore, the number of people who currently live 5 or more years after their cancer diagnosis is nearly 70% and projected to increase 30%, to over 16.3 million [2]. Thus, there is an urgent need to minimize complications from oncologic management, and fully integrate necessary dental and medical care to preserve lifelong function and quality of life. 

Gaps and Opportunities

Prevention, detection, and control of DOC-related complications is a clinical priority for practitioners and their oncology patients, who may live decades after the initial cancer diagnosis and require ongoing management of cancer complications. Thus, this initiative prioritizes understudied approaches to minimize DOC-related complications in oncology patients across the lifespan. This timely initiative also promotes research to build new evidence alongside the implementation of new CMS policies aimed at closing medically necessary dental coverage gaps [7]. This initiative differs from and complements other successful initiatives aimed at prevention, detection, and treatment of head and neck cancers, such as the recently launched AHEAD initiative. This initiative aligns with NIDCR’s strategic priorities #1, 2, and 3 [8]. Importantly, this initiative directly responds to the 2024 Senate Labor Health and Human Services Appropriation Bill (S2624), which states that dental care is integral to the medical management of numerous diseases and medical conditions and that the lack of medically necessary oral health care heightens the risk of costly medical complications … The Committee urges NIH to fund additional research in this area and conduct trials to determine which oral care interventions are most effective for improving medical management and reducing the prevalence of malignant oral cancers, … and lowering hospitalization and emergency department admission rates... [9].

The current NIDCR portfolio includes a limited selection of active grants in this area: side effects detected by magnetic resonance imaging (2), pain (10), infections (2), personalized toxicity risk prediction and surgical planning (3), salivary gland dysfunction (3), bone regeneration (1), or multiple complications (3). Three of these studies are clinical trials.

Specific Areas of Interest

Examples of studies include, but are not limited to:

• Investigations of personalized dental treatment practices prior to oncologic treatment to minimize oral sequelae (e.g., optimal pre-radiation timing of dental extractions among diabetic patients to minimize DOC complications and time to treatment initiation [TTI]).
• Monitoring and treatment of DOC complications of cancer patients with comorbidities (e.g., cancer survivors on bisphosphonates, or with concurrent immune or metabolic disorders).
• Novel organ at risk (OAR) sparing methods (e.g., target dose heterogeneity approaches to minimize sequelae of the alveolar bone, oral mucosa, parotid gland, and vascular or neuromuscular tissues).
• Comparison of meaningful medical and dental care coordination approaches to prevent oral complications during oncologic management and follow-up (e.g., care coordination for patients with periodontal disease and metastatic disease receiving bone modifying agents) in hospital or primary care settings, or among institutionalized patients.
• Integration of approaches that strengthen the continuity of care of cancer patients as they transition from inpatient to outpatient primary medical and dental care, particularly in limited resource settings, to reduce oro-dental-related emergency visits and hospital readmissions.
• Novel oral, dental, and maxillofacial surgical planning, reconstruction, and rehabilitation approaches performed as part of comprehensive oncologic patient management to reduce physical and functional sequelae (e.g., edentulism, implant-based reconstruction, bone and skin grafting, trismus, improvement of mandibular range of motion and orofacial pain).
• Development, validation, and integration of risk assessment algorithms, clinical practice workflows or techniques for early detection and surveillance of oral complications among patients undergoing oncologic treatment (e.g., AI-assisted detection of dental infections in neutropenic patients).
• Natural history studies of poorly understood DOC complications (e.g., assessing risk factors and progression of DOC growth and development complications in pediatric oncology patients).
• Comparative safety and efficacy studies of novel, experimental or combination oncologic therapies and DOC complications (e.g., mRNA-based, immune checkpoint inhibitors, CAR T-cell, or tumor-infiltrating lymphocytes).
• Implementation research to understand barriers and facilitators to adoption and implementation of prevention, treatment, and surveillance of DOC-related complications in cancer patients.
• Analyses of integrated medical and dental electronic health records to support clinical studies development and implementation to reduce oral complications among oncology patients.
• Methodological research to improve the consistency and accuracy of clinical research outcomes of oral complications studies among oncology patients.
• Controlled research studies to test the effectiveness of different dental care protocols prior to or during chemotherapy to improve clinical guidelines.

References

1. National Cancer Institute (NCI), Surveillance, Epidemiology, and End Results Program. NCI cancer stats facts: Cancer of any site [Internet]. Accessed 2024 Jun 21.
2. NCI, Division of Cancer Control and Population Sciences, Office of Cancer Survivorship. Statistics and graphs. Accessed 2024 Jun 21.
3. Murphy CT, Galloway TJ, Handorf EA, Egleston BL, Wang LS, Mehra R, et al. Survival impact of increasing time to treatment initiation for patients with head and neck cancer in the United States. J Clin Oncol. 2016 Jan 10;34(2): 169-178. Epub 2015 Nov 30. doi: 10.1200/JCO.2015.61.5906.
4. Elad S, Yarom N, Zadik Y. Immunotherapy-related oral adverse effects: Immediate sequelae, chronicity and secondary cancer. Cancers (Basel). 2023 Sep 28;15(19):4781. doi: 10.3390/cancers15194781.
5. Centers for Medicare & Medicaid Services. CMS-1784-F [Internet].
6. Centers for Medicare & Medicaid Services. MLN Matters: Medicare physician fee schedule final rule summary: CY 2024 [Internet]. MM13452.
7. 7. Hickam DH, Gordon CJ, Armstrong CE, Coen MJ, Paynter R, Helfand M. The efficacy of dental services for reducing adverse events in those receiving chemotherapy for cancer [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2023 Jul. doi: 10.23970/AHRQEPCRAPIDDENTALCANCER.
8. National Institutes of Health, National Institute of Dental and Craniofacial Research. NIDCR strategic plan 2021‒2026. Bethesda (MD): National Institutes of Health; 2021.
9. United States Committee on Appropriations. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2024. p. 96.