February 6, 2024
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: Dental Recommendations for CY 2025 Review
Submitted via MedicarePhysicianFeeSchedule@cms.hhs.gov
Re: Dental Recommendations for CY 2025 Review
Dear Sir/Madam:
The American Association of Oral and Maxillofacial Surgeons (AAOMS) represents more than 9,000 oral
and maxillofacial surgeons (OMSs) in the United States. OMSs specialize in the diagnosis and treatment
of disease, injury and defects of both hard and soft tissues of the mouth, face and jaws. Oral andmaxillofacial surgery is a surgical specialty of dentistry and one of the few dental specialties whosemembers routinely perform Medicare-covered procedures. As such, our members have extensive
experience with the Medicare program.
AAOMS recognizes the Centers for Medicare & Medicaid Services’ (CMS) initiative to extend Medicare
coverage for necessary dental services that address oral and dental complications in patients following
the direct treatment of head and neck cancer. Patients frequently present with complications extending
three years or more post-treatment, not only for head and neck cancers but also for other cancer types.
Additionally, a comparable trend may be seen in patients experiencing complications following antiresorptive drug therapy, for non-cancer-related conditions.
In light of these findings, we offer further information and literature to assist CMS in its evaluation ofdental service provisions during the post-treatment period for head and neck cancer patients, including
evidence to support the extension of coverage for specific dental services up to five years for those whohave received radiotherapy. Coverage may also be extended to include dental services for complications
arising from bisphosphonate therapy, which is used in the management of both cancerous and noncancerous conditions. This expanded coverage for certain dental services is crucial for addressing thebroader spectrum of oral health complications associated with various Medicare-covered treatments.
Establishment of a minimum coverage duration of two years for necessary dental services in the posttreatment period for head and neck cancer, extended to a minimum of five years following
radiotherapy
As noted previously, AAOMS supports CMS’ decision to extend Medicare coverage for certain dental
services to address oral or dental complications following the direct treatment of head and neck cancer

(HNC). We also appreciate CMS' consideration of the comprehensive research and evidence fromstakeholders, in shaping this policy. This action reflects the agency's dedication to a policy-making
process that is both evidence-based and collaborative.
We acknowledge CMS' assessment, as informed by evidence from various commenters, that most oralcomplications following HNC treatment are likely to occur within the first 24 months after completing
direct treatment. However, we interpret the current evidence and literature as supporting theprovision of Medicare coverage for a minimum of two years, with the understanding that somepatients may require dental or oral healthcare beyond this period due to delayed or late-onsetcomplications.
It's important to recognize that the timeline for the emergence of oral or dental complications posttreatment is not uniformly linear and can significantly vary among patients. For instance, a patient who
has received radiation therapy to the head or neck may still face a considerable risk forosteoradionecrosis of the jaw (ORN) even a decade after treatment, especially if dental extractions orother invasive oral surgical procedures are required. While the risks for “de novo” or spontaneous ORN
and other common oral toxicities might have a specific time frame for what is considered typical interms of manifestation, the actual occurrence of these complications can vary widely. This variability
may be influenced, at least in part, by the unique healthcare needs of the individual patient.
Patients who have undergone treatment for HNC are perpetually at risk for oral or dental complications,although their specific risk significantly vary based on the treatment modality employed. For instance,
radiation therapy, with its unique mechanism of injury, tends to cause specific types of oral
complications, such as xerostomia (dry mouth), mucositis, osteoradionecrosis and an increased risk ofdental caries, due to its direct impact on salivary glands and oral mucosa 1. In contrast,
chemotherapeutic modalities, with different mechanisms, often lead to a distinct set of complications,
including alterations in taste, increased susceptibility to oral infections and mucosal sensitivity 2.
As noted in previous comments, radiotherapy plays a significant role in the treatment of head and neckcancer with approximately 80 percent of all HNC patients receiving radiotherapy at least once during thecourse of their disease 3. Osteoradionecrosis or ORN is a recognized late toxicity in patients who havereceived radiotherapy for head and neck malignancies 4.Therefore, CMS may wish to consider extending
coverage for specific dental services in the post-treatment period for these patients. There is evidence
Sroussi, H.Y., Epstein, J.B., Bensdoun, R.J., Saunders, D.P., Lalla, R.V., Migliorati, C.A., Heaivilin, N. and Zumsteg,Z.S. (2017). Common oral complications of head and neck cancer radiation therapy: mucositis, infections, salivachange, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer
Medicine,6(12). 298-2931. http://doi.org/10.1002/cam4.1221
2PDQ® Supportive and Palliative Care Editorial Board. PDQ Oral Complications of Chemotherapy and Head/NeckRadiation. Bethesda, MD: National Cancer Institute. Updated October 21, 2022. Available at:https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oral-complications-hp-pdq.Accessed
January 30, 2024. [PMID: 26389320]
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Strojan, P., Hutcheson, K.A., Eisbruch, A., Beitler, J.J., Langendijk, J.A., Lee, A.W.M., Corry, J., Mendenhall, W.M,Smee, R., Rinaldo, A. and Ferlito, A. (2017). Treatment of late sequelae after radiotherapy for head and neckcancer. Cancer Treatment Reviews,59. 79-92. https://dx.doi.org/10.1016/j.ctrv.2017.07.003
4Caparrotti, F., Huang, S.H., Lu, L., Bratman, S.V., Ringash, J., Bayley, A., Cho, J., Giuliani, M., Kim, J., Waldron, J.,
Hansen, A., Tong, L., Xu, W., O’Sullivan, B., Wood, R., Goldstein, D. and Hope, A. (2017). Osteoradionecrosis of themandible in patients with oropharyngeal carcinoma treated with intensity-modulated radiotherapy.
Cancer,123(19). 3691-3700. http://doi.org/10.1002/cncr.30803
12to support Medicare coverage for dental services necessary to address oral or dental complications
arising from radiotherapy, extending for a minimum of five years post direct treatment. The five-yeartime frame for post-radiation complications, especially osteoradionecrosis, is based on an understandingof the delayed onset of radiation-related complications.
Specifically, Caparrotti et al.4 studied 1,196 patients with oropharyngeal carcinoma, finding that,
although the incidence of ORN is relatively low among patients treated with intensity-modulated
radiotherapy (IMRT), it escalates over time. Specifically, the study reports an actuarial rate of ORN of 3
percent at one year, 5 percent at three years and 7 percent at five years post-treatment. Given thatoropharyngeal carcinoma is the most prevalent site for squamous cell malignancy in the head and neckregion4, and IMRT is the standard form of treatment4, the long-term impact on the mandible issignificant. These effects may not become apparent until several years after treatment, as Caparrotti etal. have indicated.
This evidence supports a more extended coverage timeframe than initially proposed by CMS. A five-year
minimum coverage period is more aligned with the literature's findings, reflecting the typicalprogression and risk factors associated with these complications.
Establishment of a minimum coverage duration of two years for necessary dental services in the posttreatment period for cancer patients treated with anti-resorptive therapy, including bone-modifying
agentsAs noted previously, AAOMS supports CMS’ 2024 initiative to cover dental services necessary for theidentification, diagnosis and treatment of oral or dental infections before or during Medicare-covered
anti-resorptive therapy for cancer patients. However, it is important to acknowledge that medicationrelated osteonecrosis of the jaw (MRONJ), a serious and debilitating condition, is a known risk
associated with anti-resorptive therapy, including the use of bone-modifying agents 5. This therapy, often
used in the management of cancer, can interfere with the bone remodeling process, potentially leading
to the death of bone tissue in the jaw5. MRONJ often manifests as pain, swelling, infection and exposedbone in the jaw area5.
In consultation with our panel of experts, we have identified clinical evidence suggesting a potential fordelayed onset of MRONJ in certain cancer patients. Oral and maxillofacial surgeons have observed cases
where patients sought treatment for dental complications up to three years post-treatment, especiallyin those with multiple myeloma and metastatic bone lesions. This is supported by a prospective cohort
study which found that the risk of zoledronic acid, a bisphosphonate derivative, causing osteonecrosis of
the jaw in people with cancer in their bones increases in the years following treatment6. Specifically, onepercent after a year of being on the drug, two percent after two years and three percent after threeyears.

American Association of Oral and Maxillofacial Surgeons. (2022). Medication-related osteonecrosis of the Jaw2022 update (position paper). Available at:https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf

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This observation aligns with findings from Van Poznak et al. 6, a prospective cohort study of 3,491
people. The study revealed an increasing risk of osteonecrosis of the jaw associated with zoledronicacid, a bisphosphonate derivative, in patients with bone-involved cancers. Specifically, the cumulative
incidence was found to be about 1 percent after one year of medication use, 2 percent after two years
and approximately 3 percent after three years. We note this study is not specific to HNC but ratherincludes patients with bone metastases from a solid tumor, multiple myeloma and other malignant
neoplasms for which IV bisphosphonate has clinical indications in the treatment of metastatic bonedisease. Van Poznak et al. identified the predominant cancer types in their study as breast, prostate andlung, with 423 participants (12.1 percent) categorized as having “other neoplasms.” The authorsconcluded that the risk of MRONJ increases over time post-treatment and is influenced by severalfactors, including the patient’s oral health, the type of cancer and the frequency of dosing. Thishighlights the multifactorial nature of MRONJ risk, underscoring the importance of individualized
assessment and management, as well as an extended window of Medicare coverage for cancer patients
receiving anti-resorptive therapy, including treatment with bone-modifying agents.
For cancer patients undergoing dental extractions or similar invasive oral surgeries post-treatment, asystematic literature review by Schwech et al. 7 highlights a significantly elevated risk of developing
MRONJ. Specifically, the review indicates that patients treated with high-dose bisphosphonate anddenosumab face a risk nearly five times higher of developing MRONJ following tooth extraction.
Furthermore, the study notes that the occurrence of MRONJ can manifest up to three years after theextraction.
The development of MRONJ becomes increasingly likely with prolonged exposure to anti-resorptive
therapies. Notably, the impact of bisphosphonate medications can linger for an extended period.
Furthermore, concomitant medical issues and their associated treatments can intensify these risks overtime. Current literature supports the extension of Medicare coverage to include certain dental
services furnished post-anti-resorptive therapy, when used in the treatment of cancer for at least twoyears following treatment. CMS may consider this coverage be maintained for at least two years posttreatment to adequately address the potential delayed onset and progression of MRONJ in cancer
patients treated with anti-resorptive therapy, including bone-modifying agents.
Extension of Medicare coverage at a minimum duration of two years for dental services post-antiresorptive therapy in non-cancer patients
AAOMS recognizes the significant strides CMS has made towards covering dental services to addressoral or dental complications in the context of anti-resorptive therapy for cancer patients. The literature
supports extending this consideration to non-cancer patients undergoing similar treatments. MRONJ, acritical concern linked with anti-resorptive therapies including bone-modifying agents, poses risks
irrespective of the underlying condition – cancerous or non-cancerous.

Van Poznak, C.H., Unger, J.M., Darke, A.K., Moinpour, C., Bagramian, R.A., Schubert, M.M., Hansen, L.K., Floyd,J.D., Dakhil, S.R., Lew, D.L., Wade, J.L., Fisch, M.J., Henry, L., Hershman, D.L., and Gralow, J. (2021). Association ofosteonecrosis of the jaw with zoledronic acid treatment for bone metastases in patients with cancer. JAMA
Oncology,7(2). 246-254. http://doi.org/10.1001/jamaoncol.2020.6353
7Schwech, N., Nilsson, J., and Gabre, P. (2023). Incidence and risk factors for medication-related osteonecrosis
after tooth extraction in cancer patients – A systematic review. Clinical and Experimental Dental Research,9(1). 5565. http://doi.org/10.1002/cre2.698
64Clinical evidence and expert consultations suggest that the delayed onset of MRONJ is not exclusive tocancer therapies. In other words, MRONJ can occur irrespective of the underlying condition for which
the medication is prescribed. The risk factors, such as prolonged exposure to bisphosphonates andaccompanying medical treatments, are also prevalent in non-cancer patients receiving anti-resorptive
therapy. This is corroborated by studies like those conducted by Van Poznak et al.6 and Schwech et al.7,
which, although focused on cancer patients, provide insight into the extended risk period for MRONJ
associated with bisphosphonate use.
However, we recognize the risk associated with MRONJ development is statistically higher in cancer
patients than non-cancer patients5. While Schwech et al. underscores that cancer patients treated withhigh-dose bisphosphonate and denosumab face a statistically higher risk of developing MRONJ following
dental extractions, it is essential to recognize that the severity of this condition in non-cancer patientscan be equally significant. The occurrence of MRONJ, as indicated by Schwech et al., can manifest up to
three years post-extraction, highlighting the prolonged risk period irrespective of the underlying medicalcondition.
This acknowledgment suggests similar dental and oral treatment approaches for both cancer and noncancer patients affected by MRONJ. Despite the variance in statistical risk, the potential severity andimpact on quality of life in non-cancer patients may warrant the same level of attention and access tocomprehensive dental care as provided to those with cancer. Therefore, CMS may wish to consider auniform approach in extending Medicare coverage for necessary dental services post-treatment for all
patients at risk of MRONJ, regardless of their cancer status.
Given the shared risk profile between cancer and non-cancer patients treated with these therapies,
CMS may consider a similar extension of Medicare coverage for necessary dental services posttreatment. Specifically, CMS may consider extending coverage for dental services necessary toaddress oral or dental complications post-anti-resorptive therapy, including bone-modifying agents,
for a minimum duration of two years for non-cancer patients, aligning with the proposed coverage forcancer patients. This approach ensures a comprehensive and equitable treatment plan for all individuals
at risk of MRONJ, regardless of their primary diagnosis.
Lastly, there is an inextricable risk of the development for severe dental and oral complications, such as
ORN/MRONJ, in patients who have undergone the specific treatments for which Medicare has
permitted coverage and payment for linked dental services. Once patients receive these treatments,
they are perpetually at risk for developing such complications.
The provision of dental services is not merely adjunct but is fundamentally linked to the management ofthe Medicare-covered medical condition. However, the manifestation of dental or oral complications
following these medically invasive procedures often occurs outside the immediate treatment window.
This delayed onset may call for reconsideration or reassessment of the current Medicare coverage toensure that it aligns with the long-term healthcare needs of these patients.

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Thank you for your consideration of these comments. Please contact Patricia Serpico, AAOMS Directorof Health Policy, Quality & Reimbursement, with any questions at 800-822-6637, ext. 4394 or
pserpico@aaoms.org.
Sincerely,

Mark A. Egbert, DDS, FACSAAOMS President

Adam S. Pitts, DDS, MD, FACS
Chair, AAOMS Committee on Healthcare Policy, Coding & Reimbursement

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