To whom it may concern: 

We are writing to request an update to your Sleep Apnea medical policy to identify K1027, which describes an oral device used to reduce upper airway collapsibility without a mechanical hinge and the related healthcare services, as a covered treatment for beneficiaries diagnosed with Obstructive Sleep Apnea (“OSA”). 

Introduced by the Centers for Medicare and Medicaid Services (“CMS”) in October 2021, K1027 represents a clinically and scientifically proven treatment for OSA patients. Its coverage is critical to improving access to care. American Academy of Dental Sleep Medicine (“AADSM”) guidelines state: “an Oral appliance mechanism is not limited to a fixed mechanical hinge,” and that, “a number of nonhinged devices have demonstrated efficacy.” Statements made in the American Academy of Sleep Medicine’s (“AASM”) guideline for Oral Appliance Therapy (“OAT”) imply the benefits of covering nonhinged devices: “A qualified dentist will be able to screen for many problems and choose and/or build the OA with features to minimize the side effects of the therapy.” 

OSA is a highly prevalent disease linked with significant comorbidity, quality of life and economic consequences if not treated. OSA affects approximately one in twelve adults in the United States, according to the American Academy of Sleep Medicine (AASM). Untreated OSA is associated with serious health risks, including hypertension, cardiovascular disease, and reduced quality of life due to excessive daytime sleepiness. Oral appliance therapy (“OAT”) is a well-established, evidence-based alternative to continuous positive airway pressure (“CPAP”) therapy, particularly for patients who are CPAP-intolerant, or prefer a less invasive option.

HCPCS code K1027 was established to acknowledge innovations in dental sleep medicine, specifically for custom-fabricated oral appliances without a fixed mechanical hinge. Unlike the previously established code E0486, which requires a mechanical hinge, K1027 accommodates innovative designs, which leverage precision manufacturing and digital workflows to enhance patient comfort, durability and symptom alleviation. Studies have shown that non-hinged appliances are effective, and K1027 reflects the need for broader reimbursable options to meet diverse patient needs.

Coverage of K1027 is essential for the following reasons:

• Expanded Treatment Options: The availability of K1027 alongside E0486 allows clinicians to tailor treatments to individual patient anatomies and preferences, to improve outcomes and patient acceptance.
  
  
• Improved Patient Satisfaction: Devices under K1027 may enhance patient comfort through precise fit and advanced biocompatible materials, increasing the likelihood of consistent nightly use.
  
  
• Evolving Insurance Trends: Recent data indicates that many insurance plans already cover K1027, suggesting growing acceptance of this code.

To ensure optimal patient care, we urge you to include HCPCS code K1027 in your covered services for OSA treatment. Inclusion will better align coverage with relevant sleep medicine academy guidelines and facilitate access to innovative, FDA-cleared oral appliances that are engineered to enhance patient outcomes. For verification of approved devices, I recommend consulting the Pricing, Data Analysis, and Coding (PDAC) contractor’s product classification list at DMEPDAC.com, which currently verifies 23 appliances for K1027.

Thank you for considering this request. 

Sincerely,

[signatories] 

 
References

·       Journal of Dental Sleep Medicine. (2019). Definition of an Effective Oral Appliance for the Treatment of Obstructive Seep Apnea and Snoring: An Update for 2019.

·       Journal of Clinical Sleep Medicine. (2015) Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015

·       Dental Sleep Practice. (2024). Oral appliance billing — info on the new code. Retrieved from dentalsleeppractice.com.

·       Dental Sleep Practice. (2021). New OAT oral appliance therapy medical billing code issued for the treatment of OSA (K1027).

·       Nierman Practice Management. (2024). Should We Use the New 'K' Code for Oral Appliances for Obstructive Sleep Apnea?

·       Decisions in Dentistry. (2021). New OAT oral appliance therapy medical billing code issued for the treatment of OSA (K1027).

·       Vranjes N, Santucci G, Schulze K, Kuhns D, Khai A. Assessment of potential tooth movement and bite changes with a hardacrylic sleep appliance: A 2-year clinical study. J Dent Sleep Med. 2019;6(2). https://www.aadsm.org/docs/jdsm.4.10.19.o2.pdf 

·       Ioerger P, Afshari A, Hentati F, Strober W, Kallogjeri D, Ju YE, Piccirillo JF. Mandibular Advancement vs Combined Airway and Positional Therapy for Snoring: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):572-579. doi: 10.1001/jamaoto.2024.1035. PMID: 38780959; PMCID: PMC11117146.

·       Ryser AS, Sabol J, Handel S, Walworth P, Dimalanta W, et al. (2024) Soldier Preference in Mandibular Advancement Devices in Patients Who Brux. J Dent Oral Epidemiol 4(2): doi https://doi.org/10.54289/JDOE2400110

·       Mosca, E.V.; Bruehlmann, S.; Zouboules, S.M.; Chiew, A.E.; Westersund, C.; Hambrook, D.A.; Jahromi, S.A.Z.; Grosse, J.; Topor, Z.L.; Charkhandeh, S.; et al. In-Home Mandibular Repositioning during Sleep Using MATRx plus Predicts Outcome and Efficacious Positioning for Oral Appliance Treatment of Obstructive Sleep Apnea. J. Clin. Sleep Med. 2022, 18, 911–919. [Google Scholar] [CrossRef] [PubMed]

·       Kang, R.S.; Knowles, S.; Dekow, M. The Success of Oral Appliance Therapy Based on Symptom-Driven Titration. Mil. Med. 2022, 189, 620–626. [Google Scholar] [CrossRef] [PubMed]

·       Knowles, S.; Dekow, M.; Williamson, M.L. Oral Appliances for OSA Treatment: Meeting the Quadruple Aim. Mil. Med. 2021, 188, e718–e724. [Google Scholar] [CrossRef] [PubMed]

·       Sall, E.; Smith, K.; Desai, A.; Carollo, J.A.; Murphy, M.T.; Kim, S.; Liptak, L.A. Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly from a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea. Cureus 2023, 15, e50107. [Google Scholar] [CrossRef] [PubMed]

·       Vanderveken, O.M.; Van Daele, M.; Verbraecken, J.; Braem, M.J.; Dieltjens, M. Comparative analysis of two custom-made mandibular advancement devices with varied designs for treating moderate to severe obstructive sleep apnea. Sleep Med. 2024, 117, 95–98. [Google Scholar] [CrossRef]

·       Liptak, L.A.; Sall, E.; Kim, S.; Mosca, E.; Charkhandeh, S.; Remmers, J.E. Different Oral Appliance Designs Demonstrate Different Rates of Efficacy for the Treatment of Obstructive Sleep Apnea: A Review Article. Bioengineering 2025, 12, 210. https://doi.org/10.3390/bioengineering12020210

·       Benjafield, A.V.; Ayas, N.T.; Eastwood, P.R.; Heinzer, R.; Ip, M.S.M.; Morrell, M.J.; Nunez, C.M.; Patel, S.R.; Penzel, T.; Pépin, J.-L.; et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: A literature-based analysis. Lancet Respir. Med. 2019, 7, 687–698. [Google Scholar] [CrossRef] [PubMed]

·       VA/DOD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF CHRONIC INSOMNIA DISORDER AND OBSTRUCTIVE SLEEP APNEA 2025. Available Online: https://www.healthquality.va.gov/guidelines/CD/insomnia/I-OSA-CPG_2025-Guildeline_final_20250422.pdf (Accessed on May 13, 2025).

·       CHEST (2024). COMPARATIVE EFFECTIVENESS OF CPAP AND MANDIBULAR ADVANCEMENT DEVICE (MAD) THERAPY ON SLEEP APNEA-SPECIFIC HYPOXIC BURDEN (SASHB) IN OSA PATIENTS [Scientific Abstract] https://www.sciencedirect.com/science/article/pii/S0012369224044957