Preceptis Medical Announces New CMS HCPCS Code for Pediatric Tympanostomy Procedures

GOLDEN VALLEY, Minn.--(BUSINESS WIRE)--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