GOLDEN VALLEY, Minn.—Preceptis Medical, Inc. announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized the creation of a new add-on G code to identify and reimburse costs associated with pediatric tympanostomy tube (ear tube) procedures performed in-office. As part of the CY2025 Medicare Physician Fee Schedule Final Rule, this important update significantly advances access to innovative, safe, and efficient in-office care for children requiring tympanostomy tubes and the use of tympanostomy tube delivery devices such as Preceptis Medical’s Hummingbird® Tympanostomy Tube System (Hummingbird® TTS).

The new code, effective January 1, 2025, offers a standardized mechanism for physicians to be reimbursed for the additional work and resources involved in performing tympanostomy procedures for children outside of the operating room.

HCPCS Code Details:

• Code: G0561
• Description: Tympanostomy with local or topical anesthesia and insertion of a ventilating tube when performed with tympanostomy tube delivery device, unilateral (List separately in addition to 69433)

Improved Access to Care and Patient Safety

Tympanostomy tube placement is one of the most common procedures performed on children in the United States¹. Ear tubes are placed to help treat ear infections and other ear conditions, with close to 1 million pediatric ear tube procedures performed annually in the United States². Traditionally, this procedure is performed in a hospital or surgical center operating room and requires general anesthesia. By using an FDA cleared tympanostomy tube delivery device, such as the Hummingbird® TTS, the procedure can now be safely and effectively performed in an office setting, helping pediatric patients avoid the risks and costs associated with operating room surgeries and general anesthesia exposure. Clinical study data demonstrates that 98% of pediatric patients successfully received ear tubes in the office using the Hummingbird® TTS, the procedure was tolerated by 100% of patients in an independent physician review, and the procedure had no reported serious adverse events³.

“The establishment of this new HCPCS code by CMS is a significant milestone for the adoption of pediatric in-office tympanostomy procedures,” shared Dr. Shelagh Cofer, Associate Professor of Otolaryngology at Mayo Clinic, “By expanding reimbursement, we are improving access to high-quality care for children and reducing a burden on families.”

Preceptis Medical’s Commitment to Pediatric Innovation, Supporting Providers, and Supporting Patients

Preceptis Medical developed the Hummingbird® TTS to enable ear tube placement in the ENT’s office with a single pass through the ear drum. The Hummingbird® TTS received its initial FDA Clearance for in-office use in children ages 6 months and older in 2020. Since that time, the Hummingbird® TTS has been used commercially in thousands of children at select sites across the United States⁴.

According to Steve Anderson, CEO of Preceptis Medical, “Pediatric-specific codes are very rare. The CMS issuance of an add-on G code for in-office pediatric ear tube procedures is an incredibly important milestone. CMS, the largest and most important health care insurer in the US, recognized the value of transitioning pediatric ear tube procedures from the operating room to the office, stating that office ear tube procedures are less invasive and can offer significant benefits such as reduction of risks associated with general anesthesia, quicker recovery, and improved access to care.”

The new add-on G code facilitates fair compensation to providers for the incremental work and practice expenses involved in performing pediatric tympanostomy procedures in-office. This will support the sustainability of in-office pediatric ear tubes and encourage broader access to the procedure.

“This is a very important step to providing equal access to in-office ear tube procedures for all children. We appreciate the thoughtful approach from CMS and the support the proposal received from other stakeholders, including the American Academy of Otolaryngology – Head and Neck Surgery,” said Joe Delgado, CFO and GM of Healthcare Services of Preceptis Medical. “Our goal is to make tympanostomy tube placement safer, less expensive, and more accessible, and this new code helps pave the way for that vision.”

Preceptis Medical offers a broad set of reimbursement and market access support services to help patients get treatment and to assist providers and payers with adoption of the new add-on G Code.

About Preceptis Medical

Founded in 2011, Preceptis Medical is an innovative medical technology company dedicated to providing less invasive ear tube procedure options for pediatric patients. The FDA-cleared Hummingbird® Tympanostomy Tube System (TTS) streamlines ear tube placement and addresses risks associated with pediatric general anesthesia use. The Hummingbird, indicated for use in patients 6 months of age and older, provides a simple and efficient option for ENTs and parents while reducing healthcare costs. For more information, please visit https://www.hummingbirdeartubes.com/

About CMS and the Medicare Physician Fee Schedule

The Centers for Medicare & Medicaid Services (CMS) is the federal agency responsible for administering the nation’s major healthcare programs including Medicare, Medicaid, and the Health Insurance Marketplace. The Medicare Physician Fee Schedule determines the reimbursement rates for healthcare services provided to Medicare beneficiaries. The inclusion of the new add-on G code in the CY2025 Final Rule reflects CMS’s ongoing effort to improve access to high-quality, safe, and less expensive care.

References:

1. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009;(11): 1–25
2. IBM Marketscan® Commercial Claims and Medicaid Database
3. FDA 510(k) files K200952 and K221254
4. Preceptis Medical, Data on File

Given that recurrent otitis media can expose children to hearing loss, delayed speech development and repeated antibiotic use, it is not at all surprising that ear tube insertion is the most common ambulatory procedure performed in the United States. But what if there was a way to insert ear tubes in children without going to the operating room? In this episode, host Dr. Ashley Agan speaks with Dr. Shelagh Cofer, pediatric otolaryngologist at the Mayo Clinic, about the Hummingbird Tympanostomy Tube (TTS) system.

MINNEAPOLIS, Minn. – (BUSINESS WIRE) – Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive ear tube procedure options for pediatric patients, announced today that children will have expanded access to the Hummingbird in-office ear tube procedure through a collaboration with one of the largest Medicaid payers in the United States.

This expanded coverage will help meet increased demand for ear tubes by alleviating operating room (OR) schedules and reducing delays in care for pediatric patients, resultant from the COVID-19 Pandemic. With one million children undergoing OR-based ear tube procedures annually¹, the pilot program shows promise to increase care access and address current health equity challenges encountered by Medicaid populations.

Pilot program participant, Dr. Paula Harmon, MD, MBA, FAAP of Pediatric Ear, Nose & Throat of Atlanta (PENTA) commented, “The Hummingbird device has allowed our practice the opportunity to address rising challenges facing pediatric patients due to OR scheduling constraints and healthcare access inequities.” Voted as a Top ENT Doctor in a national listing of Top Doctors in 2022, Harmon continued, “Our partnership with Preceptis Medical (makers of the Hummingbird TTS) and the Medicaid pilot program will help in our endeavor to remove healthcare disparities, a goal of PENTA since its inception.”

The FDA-cleared Hummingbird device uniquely combines the separate tools and steps performed in surgical ear tube procedures into a comprehensive, single-step process. Utilizing Preceptis Medical’s patented One-Pass® technology, ENT surgeons make an incision and deliver, position and place ear tubes with a single pass device in the office setting.

Available for use in children 6 months of age or older, the Hummingbird eliminates the need for general anesthesia and the OR, as the procedure only requires a topical numbing anesthetic. The Hummingbird, delivering a 98% success rate in clinical studies,² allows parents to be present during treatment and children to return to normal activities immediately following the procedure.

“We are thrilled to collaborate with one of the most respected, well-known managed care payers in the United States on this important initiative. This new partnership is critical as parental and provider demand rises for ear tube placement alternatives that do not involve general anesthesia,” stated Greg Mielke, Preceptis Medical’s Chief Commercial Officer. “The pilot program serves as a critical step in not only increasing healthcare access, but also in expanding coverage and commercial growth initiatives,” Mielke concluded.

To locate a Hummingbird provider, or to learn more about Preceptis Medical’s innovative technology, please visit. www.hummingbirdeartubes.com.

About Preceptis Medical

Founded in 2011, Preceptis Medical is an innovative medical technology company dedicated to providing less invasive ear tube procedure options for pediatric patients. The FDA-cleared Hummingbird® Tympanostomy Tube System (TTS) streamlines ear tube placement and addresses risks associated with pediatric general anesthesia use. The Hummingbird, safe for use in patients 6 months of age and older, provides a simple and efficient option for ENTs and parents while reducing healthcare costs.
Web: https://www.hummingbirdeartubes.com/

References

¹ IBM Marketscan® Commercial Claims and Medicaid Database.

² Truitt, TO, Kosko, JR, Nimmons, GL, et al. In‐office insertion tympanostomy tubes in children using single‐pass device. Laryngoscope Investigative Otolaryngology. 2021;1-7.

Media Contact

Leah Davidson, Sr. Director of Marketing
Preceptis Medical
763.568.7810
leah@preceptismedical.com

Ear infections are a common ailment for small children. In some cases, ear tubes are needed to help alleviate the infections. Thanks to Medical Alley company Preceptis Medical, there’s a new and innovative way for patients to receive ear tubes in just a matter of minutes and without anesthesia.

Listen to this episode of the Medical Alley Podcast as we chat with Dr. Ted Truitt of St. Cloud Ear, Nose & Throat Clinic to learn about Preceptis Medical’s Hummingbird TTS device and the difference he’s seen it make for patients and their families.

MAPLE GROVE, Minn.–(BUSINESS WIRE)—Preceptis Medical, Inc., an innovative medical technology company dedicated to providing less invasive options for pediatric patients, today announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children 6-24 months, this new labeling allows in-office procedures in all children six months and older.

The Hummingbird TTS uniquely combines the separate tools and steps performed in standard ear tube procedures into one comprehensive device. With the Hummingbird, otolaryngologists or ear, nose and throat specialists (ENTs) can now make an incision and deliver an ear tube using a single pass in the office environment. The device eliminates the need for fasting, general anesthesia, and an operating room – all with 98% success in the office setting.¹ The procedure requires only a topical anesthetic, and parents can be present with their child to provide further comfort.

“This device has been a gamechanger for patients and families. Having their child’s ear tubes placed in a quick office visit is comforting to parents, and they have been happy with the results. We look forward to offering this procedure to even more eligible patients,” said Dr. Nathan Page, pediatric otolaryngologist at Phoenix Children’s, one of the nation’s largest pediatric health care systems.

“When I first began working with the Preceptis team on the clinical study, my hope was that one day the Hummingbird would be available for all of my pediatric patients,” said Dr. Shelagh Cofer, Division Chair of Pediatric Otolaryngology at the Mayo Clinic. “I am proud to have been a part of the study and excited to see the culmination of years of work in this fully expanded label.”

Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone.² In-office ear tube placement using the Hummingbird can save thousands of dollars per patient by shifting the procedure from the operating room to the office setting.

“Our goal when we started Preceptis was to provide a safe, simple, and less expensive ear tube procedure option to all families. This final label expansion represents the work of many ENTs, clinical study coordinators, and team members, and I appreciate the trust parents put into Preceptis and our ENTs while participating in the study,” said Steve Anderson, Chief Executive Officer, Preceptis Medical.

“Parent and ENT feedback has been extremely positive, and we have seen ever increasing demand for the in-office ear tube procedure option as more parents, pediatricians, and ENTs become aware of the product,” shared Greg Mielke, Chief Commercial Officer for Preceptis. “We have also received strong support from the insurance community both locally and nationally, and this expanded label will increase patient access and improved health equity in our communities.”

Preceptis Medical has successfully completed its initial launch and plans to build on strong momentum and demand from parents and providers through a larger commercial launch to expand access to this option in the future.

About Preceptis Medical

Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The Hummingbird device was developed in partnership with leading pediatric ENTs to simplify ear tube procedures while reducing the risks associated with the use of general anesthesia in children. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs. The Hummingbird® Tympanostomy Tube System (TTS) is FDA 510(k) cleared for use in children 6 months and older. For more information, visit www.hummingbirdeartubes.com.

¹ FDA 510(k) files K200952 and K221254
² IBM Marketscan® Commercial Claims and Medicaid Database.

Contacts

Greg Mielke
Preceptis Medical
763.568.7810
Greg@preceptismedical.com

Publish Date: February, 2022

Objective: Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All these conditions are encompassed by the term otitis media (middle ear inflammation). This guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The guideline is intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals.

Purpose: The purpose of this clinical practice guideline update is to reassess and update recommendations in the prior guideline from 2013 and to provide clinicians with trustworthy, evidence-based recommendations on patient selection and surgical indications for managing tympanostomy tubes in children. In planning the content of the updated guideline, the guideline update group (GUG) affirmed and included all the original key action statements (KASs), based on external review and GUG assessment of the original recommendations. The guideline update was supplemented with new research evidence and expanded profiles that addressed quality improvement and implementation issues. The group also discussed and prioritized the need for new recommendations based on gaps in the initial guideline or new evidence that would warrant and support KASs. The GUG further sought to bring greater coherence to the guideline recommendations by displaying relationships in a new flowchart to facilitate clinical decision making. Last, knowledge gaps were identified to guide future research.

Methods: In developing this update, the methods outlined in the American Academy of Otolaryngology-Head and Neck Surgery Foundation’s “Clinical Practice Guideline Development Manual, Third Edition: A Quality-Driven Approach for Translating Evidence Into Action” were followed explicitly. The GUG was convened with representation from the disciplines of otolaryngology-head and neck surgery, otology, pediatrics, audiology, anesthesiology, family medicine, advanced practice nursing, speech-language pathology, and consumer advocacy.

Action statements: The GUG made strong recommendations for the following KASs: (14) clinicians should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea; (16) the surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion AND should educate families regarding the need for routine, periodic follow-up to examine the ears until the tubes extrude.The GUG made recommendations for the following KASs: (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months’ duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown); (2) clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties; (5) clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (6) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (7) clinicians should offer bilateral tympanostomy tube insertion in children with recurrent acute otitis media who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (8) clinicians should determine if a child with recurrent acute otitis media or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors; (10) the clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube; (12) in the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications; (13) clinicians should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement; (15) clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes.The GUG offered the following KASs as options: (4) clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life; (9) clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer; (11) clinicians may perform adenoidectomy as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) OR in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.

Publish Date: April 21, 2021

The position of the AAO-HNS is that tympanostomy tubes are safe and effective for managing otitis media in children who meet current guidelines for tube insertion [Rosenfeld 2013]. Although insertion of tympanostomy tubes in children is generally accomplished in the operating room under general anesthesia, insertion in the clinic in appropriately selected patients using shared decision making between clinicians and families can be appropriate.

Data published in Laryngoscope Investigative Otolaryngology show that in-office ear tube placement using the Hummingbird is safe, successful and well tolerated in young children

MAPLE GROVE, Minn.–(BUSINESS WIRE)–Preceptis Medical, Inc., a company dedicated to helping ENT surgeons improve how they care for children, today announced positive results from a prospective, multicenter study designed to assess in-office pediatric ear tube placement with the FDA-cleared Hummingbird Tympanostomy Tube System (TTS). Peer-reviewed results from the study were published in Laryngoscope Investigative Otolaryngology.

Outcomes from the study show that in-office ear tube, or tympanostomy tube (TT), placement with the Hummingbird device, in awake young children using only a topical anesthetic was safe, successful and well tolerated. The study enrolled 211 children age 6-24 months who were treated at 10 sites by 13 ENT investigators. TT placement was successfully and safely completed in the office setting in 99% of cases for this age group, with a median procedure time of less than five minutes for bilateral TT placement. Tolerability of the procedure was validated by assessments from the ENT surgeons and their staff members, as well as procedure reviews from independent clinicians. Additionally, a survey showed 97% of parents with children treated with the Hummingbird would recommend the procedure to other parents.¹

“Results from this study show the safety, tolerability and efficiency of in-office ear tube procedures using this novel approach,” said Shelagh Cofer, M.D., lead investigator of the study at the Mayo Clinic and senior author of the paper. “With a single-pass tympanostomy tube insertion device, ENT surgeons can now offer their patients a safe and fast ear tube procedure right from the convenience of their office. Children recover quickly and can return to normal activities immediately following the procedure.”

Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone.² These procedures are done under general anesthesia due to the limitations, potential risks, and pain associated with using standard surgical instruments to treat children. The Hummingbird TTS is a breakthrough pediatric technology that reduces trauma for patients and enables safe and efficient in-office TT placement for children. Further, the American Academy of Otolaryngology released a Position Statement supporting in-office TT placement in appropriate children.

“Interest from both parents and surgeons has been very strong, further reinforcing the unmet need and desire for alternative options to procedures performed in the operating room,” said Greg Mielke, Chief Commercial Officer, Preceptis Medical. “This novel approach could also significantly reduce overall healthcare costs associated with traditional ear tube insertion.”

About Preceptis Medical, Inc.

Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The Hummingbird device was developed in partnership with leading pediatric ENTs to simplify ear tube procedures while reducing the risks associated with the use of general anesthesia in children. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs. For more information, visit www.hummingbirdeartubes.com.

¹Truitt TO, et al. In‐office insertion tympanostomy tubes in children using single‐pass device. Laryngoscope Investigative Otolaryngology. February 2021 (epub).

²IBM Marketscan® Commercial Claims and Medicaid Database.

Contact:
Greg Mielke
greg@preceptismedical.com
763.568.7810

Media:
Jessica Stebing
Health+Commerce
260.336.6202
jstebing@healthandcommerce.com