February 1, 2023
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-4201-P
P.O. Box 8013
Baltimore, MD 21244
Submitted online via www.regulations.gov
Re: File Code CMS-4201-P Medicare Program: Contract Year 2024 Policy and Technical Changes to theMedicare Advantage Program Proposed Rule
Dear Sir/Madam:
The American Association of Oral and Maxillofacial Surgeons (AAOMS) represents more than 9,000 oraland maxillofacial surgeons (OMSs) in the United States. AAOMS appreciates Agency efforts to increasetransparency in the prior authorization process under the Medicare Advantage program. On behalf ofour members, AAOMS is pleased to offer comment on the Contract Year 2024 Policy and TechnicalChanges to the Medicare Advantage Program Proposed Rule.
According to the Kaiser Family Foundation, in 2022 more than 28 million people, nearly half of all eligible
Medicare beneficiaries were enrolled in a Medicare Advantage plan 1. With projections to surpass the 50
percent threshold potentially as soon as this year, Agency efforts to clarify Medicare Advantage
coverage policies and better align decision-making processes with that of traditional Medicare areimperative both to ensure access to medically necessary healthcare services and mitigate administrative
burden on providers.
OMSs understand the important role oral health can have on a patient’s overall health. As theintegration of medicine and dentistry evolves, it is vital for CMS to implement policies that encourage
multidisciplinary engagement in healthcare, from the provision of services to the practices that defineand shape medical necessity determinations.
The development of internal coverage criteria should allow for draft policy review and public comment
When creating internal policies to guide medical necessity determinations, in the absence of fully
established Medicare coverage criteria, Medicare Advantage (MA) plans must make publicly available
Henry J. Kaiser Family Foundation. Medicare Advantage in 2022: Enrollment Update and Key Trends.
https://www.kff.org/medicare/issue-brief/medicare-advantage-in-2022-enrollment-update-and-key-trends/ Aug.
25, 2022. Accessed Jan. 1, 2023.
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the evidence, clinical data and rationale used in the development process. This is a fundamental step
towards increasing the transparency of coverage determinations, as well as providing much neededconsumer protection. However, CMS is not proposing to require that such internal coverage policies besubject to a draft policy review or public comment period, unlike both national and local coveragedeterminations.
The opportunity for interested parties and industry stakeholders to engage with CMS and/or Medicare
Administrative Contractors (MACs) has become an integral part of the Medicare program, helping tofacilitate the development of evidence-based policies that reflect current clinical practice. This process
allows specialty organizations to weigh in on key issues that may impact their membership and thepatient populations their members serve. It is also a mechanism for physicians and other specialists tooffer clinical and/or professional expertise on a particular procedure or condition, an opportunity they
may not have unless involved directly in the clinical research or development of treatment guidelines.
The OMS scope of practice straddles the line between medicine and dentistry. For example, medicationrelated osteonecrosis of the jaw (MRONJ) is a rare and complex condition that affects both the soft andhard tissues of the jaw and often requires a multimodal treatment approach, ranging from conservative
therapies to invasive surgical intervention. Certain services related to the treatment of MRONJ are
historically considered for payment under Medicare, when deemed medically appropriate andnecessary. However, there is an overall lack of fully established Medicare coverage policies andguidelines, in terms of both National and Local Coverage Determinations related to MRONJ. As OMSs
play an integral role in both the differential diagnosis and management of the condition, it is foreseeable
the development of internal coverage criteria related to this condition would be impactful to thespecialty of oral and maxillofacial surgery.
According to CMS, widely used treatment guidelines and high-quality clinical literature (e.g., randomized
controlled trials or cohort studies or all-or-none studies with clear results, published in a peer-reviewed
journal and specifically designed to answer the relevant clinical question, or large systematic reviews ormeta-analyses summarizing the literature of the specific clinical question published in a peer-reviewed
journal with clear and consistent results) must be used to develop internal coverage policies under theMedicare Advantage program, if finalized. AAOMS believes this to be an appropriate definition of“clinical literature”; however, we wish to acknowledge that a lack of “big data” on certain conditions,such as MRONJ may pose challenges in meeting this threshold. For instance, the published peerreviewed clinical data on MRONJ, including cohort studies and retrospective literature reviews typicallyconsist of small sample sizes which can increase the margin of error or prevent the findings from being
extrapolated, in certain circumstances. Despite ongoing specialty society research efforts, there is anabsence of standardized, widely accepted treatment protocols for MRONJ. These factors may impact
how data from MRONJ research is translated into clinical policy and practice. Therefore, a draft policy
review and comment period would allow specialty societies and practitioners with expertise in treating
certain conditions to provide insight and context to the existing data, which may be used to inform thedevelopment of meaningful and appropriate medical necessity criteria.
As such, AAOMS encourages CMS to extend the requirement for draft policy review and publiccomment period to any internal coverage criteria developed by Medicare Advantage organizations in
the absence of fully established Medicare coverage guidelines.

Medical necessity determinations should be performed by a provider of the same or similar specialty
relevant to the service(s) under review
AAOMS appreciates Agency efforts to apply the standard of “expertise appropriate for the specificservice at issue” to utilization management and policies and practices for Medicare Advantageorganizations. A provider's attestation that a service is medically necessary is an important considerationin the prior authorization process. Likewise, the party responsible for issuing a determination of medical
necessity is integral to ensuring the right care is provided in the right place at the right time. An adverse
benefit determination can limit beneficiary access to important and clinically appropriate healthcare
services, particularly when the decision is issued by a physician or other qualified healthcare
professional unfamiliar with or lacking expertise in the type of service(s) under medical necessity review.
Medicare defines medically necessary as "healthcare services or supplies needed to diagnose or treat anillness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine." Given
this, it stands to reason that a reviewer responsible for issuing a determination of medical necessity
must possess expert clinical knowledge of a diagnosis or condition, as well as knowledge of current
standards of care in the treatment of the condition to render an appropriate decision on patient care.
For example, an OMS submits a prior authorization request for the segmental resection of the mandible
for a Medicare Advantage enrollee with a differential diagnosis of stage 3 2 MRONJ of the lower jaw. In
this scenario, it is imperative for the reviewer to understand the nuances of the complex condition as
well as clinical best practices for disease management, including but not limited to the refractory natureof MRONJ and the necessity of timely intervention. A provider specializing in conditions of the head,neck, mouth, face and jaws – such as an oral and maxillofacial surgeon – would be best suited to issue a
medical necessity determination regarding such treatment. AAOMS believes the inclusion of OMSs
within utilization management processes for Medicare Advantage organizations is crucial to ensuring
access to clinically appropriate, medically necessary oral surgical services for all MA plan enrollees.
Therefore, AAOMS supports CMS’s proposal to require medical necessity and coverage decisions to beissued by physicians or other qualified healthcare professionals of the same or similar specialty
relevant to the service(s) under review.
Health IT limitations should not prevent providers from capitalizing on prior authorization process
improvements
AAOMS also appreciates Agency efforts to streamline utilization management processes including priorauthorization and to reduce the administrative burden placed on providers. Many of the proposedchanges encompass updated standards and processes for all interested parties, including providers.
Although an integral part of hospital systems and trauma teams, many OMSs are part of small practices
and therefore face unique challenges with respect to health IT and economies of scale. Outside of ourthose practicing in academic or institutional settings, many utilize dental/surgical practice management
software systems that lack certified electronic health record (EHR) technology capabilities, limiting
OMSs, as well as other dental specialists, from meaningful participation in electronic transactions anddata interchange process and quality payment programs. As this space evolves, OMSs and their staff
American Association of Oral and Maxillofacial Surgeons. Medication-Related Osteonecrosis of the Jaw – 2022
Update. https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf. 2022.
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must continue to utilize manual processes for healthcare transactions, such as prior authorization
requests. Given the current barriers to implementing certified EHR technology including cost and dental
software limitations with interoperability and prior authorization transactions, AAOMS would encourage
CMS to engage with industry stakeholders to improve current mechanisms involving the use of
proprietary payer portals for prior authorization transactions. Although the use of individualized portals
presents its own set of challenges, working to streamline the process may still help to mitigate some of
the administrative burden placed on providers who lack more advanced, technology-based solutions. To
this end, we encourage CMS to offer providers the flexibility to benefit from the proposed utilization
management process changes, such as prior authorization decision time frames and medical necessity
thresholds regardless of the mechanism used for the prior authorization request (e.g., manual processversus electronic transaction).
Thank you for your consideration of these comments. Please contact Patricia Serpico, Director, Health
Policy, Quality & Reimbursement with any questions at 800-822-6637, ext. 4394 or
pserpico@aaoms.org.
Sincerely,Paul J. Schwartz, DMD
AAOMS President

Joshua E. Everts, DDS, MD, FACS
Chair, AAOMS Committee on Healthcare Policy, Coding & Reimbursement