February 7, 2023
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: Division of Outpatient Care, Acting Director, David Rice
Baltimore MD 21244
RE: Pre-Proposed Rule CPL Recommendations for CY 2024
Dear Sir/Madam:
The American Association of Oral and Maxillofacial Surgeons (AAOMS) appreciates theopportunity to nominate procedures for addition to CMS’s Ambulatory Surgery Center Covered
Procedure List (ASC CPL) in advance of the CY 2024, Medicare Hospital Outpatient Prospective
Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule.
AAOMS represents more than 9,000 oral and maxillofacial surgeons in the United States.
AAOMS supports CMS’s overarching commitment to patient safety but wishes to emphasizethat evolving technology and treatment modalities have allowed for increasingly complex
procedures to be performed safely and efficiently across a wide range of care settings, including
ambulatory surgery centers. The AAOMS Committee on Healthcare Policy, Coding andReimbursement convened a special panel of surgeons with extensive experience performing
orthognathic surgery to evaluate whether certain oral and maxillofacial surgical procedures
meet the criteria for addition to the ASC CPL. The specialty panel reviewed each oral andmaxillofacial surgical procedure payable in the outpatient setting for CY 2023, assessing themerit of the exclusion from payment in the ASC through both a retrospective case log review
and a comprehensive search of current scientific literature and perioperative protocols fororthognathic surgery procedures. Through this process, the panel identified and reached anexpert consensus on the recommendation of four codes to the ASC CPL for CY 2024.
We hope to be able to work with CMS in the reconsideration of facility coverage for selectprocedures we believe not only meet the longstanding patient safety criteria but represent amechanism for increasing access to care in a safe and cost-effective way. AAOMS strongly
encourages the following procedures be added to the ambulatory surgery center coverage list:

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21193 Reconstruction of mandibular rami, horizontal, vertical, C, or L osteotomy;
without bone graft21194 Reconstruction of mandibular rami, horizontal, vertical, C, or L osteotomy; withbone graft (includes obtaining graft)
21195 Reconstruction of mandibular rami and/or body, sagittal split; without internal
rigid fixation
21196 Reconstruction of mandibular rami and/or body, sagittal split; with internal
rigid fixation

Due to the high vascularity of the maxillofacial and maxillomandibular regions, blood loss is ofprimary concern to the OMS when treatment planning and furnishing orthognathic surgicalprocedures. However, the AAOMS specialty panel concluded that patients undergoing theabove listed reconstructive procedures of the mandible experience minimal blood loss, with anaverage blood loss of 100cc or 100mL. This is consistent with Lee et al. that found the mean
intraoperative blood loss for a typical single-jaw orthognathic case, specifically either a sagittal
split ramus osteotomy (SSRO) or intraoral vertical ramus osteotomy (IVRO) ranges from 55 to
167mL and 82 to 104mL, respectively1. Chen et al. reported an average interoperative blood
loss of 105.9mL in patients undergoing bilateral vertical ramus osteotomy2. It is an exceedingly
rare instance, if ever, that a patient would need to remain hospitalized due to excessive bloodloss. Indeed, although Moenning et al. reported a slightly increased average blood loss of
176.6mL, in a study of 171 patients undergoing SSRO none required perioperative bloodtransfusion3.
The implementation of advanced clinical protocols in conjunction with orthognathic surgery,particularly the four procedures being recommended for coverage in the ASC have been shown
to improve patient outcomes by shortening length of stay, facilitating postoperative pain
control and decreasing the incidence of postsurgical complications including nausea andvomiting4. For example, the Enhanced Recovery After Surgery (ERAS) protocol has beenadopted across multiple specialties and represents a systematic, multimodal approach toimproving patient outcomes5. Integrating perioperative ERAS protocols for areas of the head,neck, face and jaws include considerations such as presurgical hydration, glycemic control,
patient mobilization and preemptive pain management. A retrospective study by Ferrara et al. 5
found the implementation of ERAS protocols led to a decrease in overall length of stay, allowing
for safe and effective same-day discharge for patients undergoing extensive bimaxillary or twojaw orthognathic surgery. The authors also cited a decrease in blood loss, as well as opioid use
based on implementation of the perioperative ERAS regiment5. A retrospective cohort study byStratton et al.4 including both single-jaw and double-jaw orthognathic surgeries found that astandardized ERAS protocol was effective in reducing postoperative nausea and vomiting aswell as opioid consumption in the postsurgical period.

Other factors have contributed to the mitigation of hemorrhage risk associated with certain
orthognathic surgical procedures, particularly those described by codes 21193, 21194, 21195and 21196. For instance, technique advancement has predominantly happened by way ofefficiencies from virtual surgical planning (VSP). This process allows surgeons to anticipate
issues intraoperatively, for example predicting bony interferences or the position of the inferior
alveolar nerve. VSP may also be used to provide custom plates for rigid internal fixation andosteotomy cutting guides. This translates to less surgical time and a decrease in intraoperative
blood loss.
It should be noted that each of the procedures being recommended for addition to the ASC CPL
are “core” procedures which oral and maxillofacial surgeons are trained to perform during theirresidency program at accredited institutions. Further, none of the other patient safety criteria
for exclusion from the ASC setting apply to the four mandibular procedures herein discussed. As
such, AAOMS recommends that these procedures be added to the ASC CPL. The attachedbibliography and cited references throughout support the premise that advancements inperioperative patient management and treatment protocols can be utilized to effectively
improve patient outcomes and divert complex surgical procedures from more resourceintensive sites of service to the ambulatory setting.
It is also critical to consider the clinical population of patients who undergo these services. Oraland maxillofacial surgeons are primary surgical providers of patient services associated with theabove listed codes. As such, we know relying exclusively on Medicare claims site-of-service
data to define procedure location skews the outcomes because the vast majority of theseservices are provided for patients who are not covered by Medicare, thus not part of theMedicare claims database. The flaw in this methodology is supported by the extremely low
frequency of many of these procedures in the Medicare population. The 9,000 fellows andmembers of AAOMS primarily perform these procedures in younger, non-disabled patients,
who are not representative of the typical Medicare or Medicaid population.
As a specialty society, we recognize that the CMS classification of ASC procedures dictates thepattern of coverage in the ASC industry, both for federally funded programs and commercialcarriers. The effect of coverage limitations on site of service for certain procedures inherently
limits the ability of specialty societies to produce substantiating data from commercial and/or
private payers that would more accurately represent the patients appropriately receiving these
services in places other than an inpatient setting or, in some cases, hospital outpatient
departments.
We respectfully request CMS to take a leadership position on this issue as place-of-service
restrictions driven by such coverage policies have the potential to severely limit reasonable
access to care and increase costs to the system without improving the quality of care provided.
It is the firm belief of AAOMS that the practitioner should not be restricted from utilizing an ASC
when a patient’s medical condition, age, or anesthetic requirement is best served byperforming the procedure in an ambulatory setting. Furthermore, AAOMS believes that,
especially after reviewing the CMS frequency data for these procedures, the exclusion of thesecodes would not translate into significant cost savings for the program. We also believe thatthe continued exclusion of these codes from the list of covered services could work to increase
costs by shifting those services which could be safely performed in the ASC to the more costlyhospital setting.
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 orpserpico@aaoms.org.
Sincerely,

Paul J. Schwartz, DMD
AAOMS President

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

Scott Talaga Scott.Talaga@cms.hhs.gov
Mitali Dayal Mitali.Dayal2@cms.hhs.gov

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References
1 Lee, K.T., Lin, S.S., Hsu, K.J., Tsai, C.Y., Lee, Y.H., Change, Y.J. and Wu, T.J. (2021).
Intraoperative blood loss and postoperative pain in the sagittal split ramus osteotomy andintraoral vertical ramus osteotomy: A literature review. BioMed Research International, 2021.
https://doi.org/10.1155/2021/4439867
2 Chen, H.S., Lai, S.S.T., Lee, K.T., Lee, H.E. and Hsu, K.J. (2013). Intraoperative blood loss during
an osteotomy of the bilateral vertical ramus. Journal of Dental Sciences, 9(3). 249-252.
https://doi.org/10.1016/j.jds.2013.04.008
3 Moenning, J. E., Bussard, D. A., Lapp, T. H., & Garrison, B. T. (1995). Average blood loss andthe risk of requiring perioperative blood transfusion in 506 orthognathic surgicalprocedures. Journal of Oral and Maxillofacial Surgery, 53(8), 880–883.
https://doi.org/10.1016/0278-2391(95)90273-2
4 Stratton, M., Waite, P.D., Powell, K.K., Scopel, M.M. and Kukreja, P. (2021). Benefits of theenhanced recovery after surgery pathway for orthognathic surgery. International Journal ofOral & Maxillofacial Surgery,51(2). 214-218. https://doi.org/10.1016/j.ijom.2021.04.008
5 Ferrara, J.T., Tehrany, G.M., Chen, Q., Sheinbaum, J., More-Marquez, J., Hernandez Conte, A.
and Rudikoff, A.G. (2022). Evaluation of an enhanced recovery after surgery protocol (ERAS) forsame-day discharge and reduction of opioid use following bimaxillary surgery. Journal of Oral &Maxillofacial Surgery,80(1). 38-46. https://doi.org/10.1016/j.joms.2021.07.002