The iovera° System received 510K clearance from the U.S. Food and Drug Administration (FDA) for the iovera° device on January 10, 2013. It is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue.
The iovera° system’s “1×90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. (K123516, K133453, K142866, K161835, K173763).
The iovera° handheld device delivers a controlled dosage of liquid nitrous oxide to the closed-end probes of the Smart Tip, which is then applied to specific targeted nerves. As this highly pressurized liquid travels from the handpiece to the Smart Tip, it undergoes a phase change becoming very cold, drawing in heat energy from the surrounding tissue and forming a precise zone of cold at the targeted nerve. The gaseous nitrous oxide returns into the handpiece, leaving nothing behind in the body. This precise cold treatment causes a reversible nerve block based on a process called Wallerian degeneration. Pain is relieved as the signal is not able to conduct along the sensory nerves until the axon is regenerated. The nerve axon regenerates at a rate of 1-2mm per day, which provides a predictable indicator for restoration of nerve function.1
Cryoneurolysis has been used clinically for decades to provide temporary pain relief.2 A large body of clinical work and commercial use over the past 35 years demonstrates relief for patients with various types of pain including, but not limited to, post-herpetic neuralgia,3,4 neuroma,5 intractable facial,6-10 temporomandibular joint,11 post-thoracotomy,12 intercostal,13 and perineal pain.1 These reports have demonstrated pain relief ranging from a couple of months to a few years.7,9 Generally, no sedation is used so the patient can assist in identifying the site of pain and the location of the target nerve(s). Because peripheral nerve function is disrupted due to the destruction of the axon and myelin sheath, the desired result is safe and effective, providing pain relief until the nerve(s) regenerates.
Information provided on Coding & Reimbursement Considerations is presented for illustrative purposes only and does not constitute coding, reimbursement or legal advice. It is always the provider’s responsibility to determine the medical necessity and proper site of service for the procedure, and to submit appropriate codes, charges and modifiers for services rendered. We recommend providers consult with payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters to ensure they submit accurate and appropriate claims for services. The information included here is gathered from third-party sources and is subject to change without notice as a result of complex and frequently-changing laws, regulations, rules and policies.
Payer coverage and payment policies will vary and should be verified by the provider prior to treatment and billing. The coding options listed within this guide are not intended to be an all-inclusive list of potential codes. We recommend consulting relevant coding manuals and guidance for appropriate coding options. Pacira does not promote the use of its products outside of their FDA-cleared label.
Coding, Coverage and Reimbursement Considerations
Codes provide a uniform language for describing the services performed by healthcare providers. The actual selection of codes depends upon details documented in the patient’s medical record. It is the sole responsibility of the healthcare provider to correctly prepare patient claims. The following information is shared solely for informational and educational purposes.
Physician’s Professional Component
Before preparing a claim, healthcare providers are encouraged to review the American Medical Association (AMA)’s instructions for coding “Destruction by Neurolytic Agent (e.g., chemical, thermal, electrical or radiofrequency)” section in CPT 2018. Contingent upon the patient’s chief complaint and physical examination, the CPT® code 64640, has been confirmed by the AMA for treatment of peripheral nerves in the knee. This code has also been confirmed to be appropriate for the management of osteoarthritis by the The American Academy of Orthopaedic Surgeons (AAOS) Coding Coverage & Reimbursement Committee.*
Healthcare providers may ask about thermal destruction of specific peripheral nerves.Providers are encouraged to review AMA’s instruction for use of other somatic nerves, such as but not limited to:
CMS CPT 2018 Non-facility RVUs
CMS CY2018 Total Facility RVUs
Destruction by neurolytic agent, trigeminal nerve;
supraorbital, infraorbital, mental, or inferior alveolar branch
Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale
Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale under radiologic monitoring
Destruction by neurolytic agent, intercostal nerve
Destruction by neurolytic agent; plantar common digital nerve
Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint
Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional facet joint
Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, single facet joint
Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional facet joint
Other peripheral nerve or branch
Source: Centers for Medicare and Medicaid Services. Medicare Physician Fee Schedule CY2018.
Standard off-the-shelf nerve stimulator may be used in applications where precise nerve location is desired.
*Copies of the correspondence from the AMA and AAOS are available upon request.
Facility’s Technical Component
Facility coding and reimbursement is influenced by the site of service for the primary procedure, patient’s chief complaint, associated comorbidities, payer mix and contract terms. Healthcare providers are encouraged to review their payer policies for peripheral nerve blocks and preemptive analgesia related to medically necessary conditions, such as but not limited to:
ICD-10 Diagnostic Codes
Pain in joint
Facility (if Applicable)
#5443; Level III Nerve Injection
$135.72 (for first nerve/branch)
$96.12 (for first nerve/branch)
Primary citation: CMS 2018 final fee schedules, based on a 2018 Conversion Factor of $35.9996.
Depending upon a facility’s payer contracts, Materials Managers may also want to report the iovera° probe with a Level II HCPCS supply code, such as but not limited to A4649 (Surgical supply; miscellaneous) or C2618 (Probe/needle cryoablation).
- Evans, P. J., J. W. Lloyd and T. M. Jack (1981). “Cryoanalgesia for intractable perineal pain.” J R Soc Med 74(11): 804-809.
- Ilfeld, B. M., Preciado, J. & Trescot, A. M. Novel Cryoneurolysis Device for the Treatment of Sensory and Motor Peripheral Nerves. Expert Rev. Med. Devices, 2016. 13(8): p. 713-725.
- Trescot, A. M. (2003). “Cryoanalgesia in interventional pain management.” Pain Physician 6(3): 345-360.
- Calandria, L. (2011). “Cryoanalgesia for post-herpetic neuralgia: a new treatment.” Int J Dermatol 50(6): 746-750.
- Hodor, L., K. Barkal and L. D. Hatch-Fox (1997). “Cryogenic denervation of the intermetatarsal space neuroma.” J Foot Ankle Surg 36(4): 311-314.
- Barnard, D., J. Lloyd and J. Evans (1981). “Cryoanalgesia in the management of chronic facial pain.” J Maxillofac Surg 9(2): 101-102.
- Nally, F. F. (1984). “A 22-year study of paroxysmal trigeminal neuralgia in 211 patients with a 3-year appraisal of the role of cryotherapy.” Oral Surg Oral Med Oral Pathol 58(1): 17-23.
- Zakrzewska, J. M. (1987). “Cryotherapy in the management of paroxysmal trigeminal neuralgia.” J Neurol Neurosurg Psychiatry 50(4): 485-487.
- Zakrzewska, J. M. and F. F. Nally (1988). “The role of cryotherapy (cryoanalgesia) in the management of paroxysmal trigeminal neuralgia: a six year experience.” Br J Oral Maxillofac Surg 26(1): 18-25.
- Zakrzewska, J. M. (1991). “Cryotherapy for trigeminal neuralgia: a 10 year audit.” Br J Oral Maxillofac Surg 29(1): 1-4.
- Sidebottom, A. J., E. C. Carey and A. K. Madahar (2011). “Cryoanalgesia in the management of intractable pain in the temporomandibular joint: a five-year retrospective review.” Br J Oral Maxillofac Surg 49(8): 653-656.
- Moore, W., D. Kolnick, J. Tan and H. S. Yu (2010). “CT guided percutaneous cryoneurolysis for post thoracotomy pain syndrome: early experience and effectiveness.” Acad Radiol 17(5): 603-606.
- Byas-Smith, M. G. and A. Gulati (2006). “Ultrasound-guided intercostal nerve cryoablation.” Anesth Analg 103(4): 1033-1035.