New to iovera°?
On iovera.com, click on the Contact Us link for more information. Pacira BioSciences, Inc. has developed a large network of experienced providers who can give you more information. The PITT Training Center, located in Tampa, provides opportunities for continuing education and hands-on training with the iovera° device.
iovera° provides sustained relief of OA and TKA pain, decreasing the need for chronic adjuvant medications such as opioids.1,2 While traditional pain management options serve a purpose, many patients are happy to avoid the side effects associated with narcotic use to control pain.
Mechanism of Action
iovera° temporarily freezes nerves in the pain-signaling pathway, providing patients with pain relief for up to 90 days.1
No, iovera° causes second-degree Wallerian degeneration, which means that nerves regain function over time without fear of irreversible nerve destruction or painful neuromas.3
No, the effect of iovera° does not cause permanent nerve damage to the exterior nerve structure. It causes second-degree Wallerian degeneration, which means that nerves regain function over a period of time. This allows for successful pain relief with minimal-to-no risk of neuritis.3
Dasa et al, in a single-site retrospective study of 100 patients where 50 patients in the treatment group received iovera˚ and 50 in the control group did not, demonstrated that patients treated with iovera˚ before TKA had a shorter length of stay and decreased opioids prescribed compared with a standard of care treatment group.2
We continue to be fueled by studies that demonstrate the value of iovera°, as well as countless real-world success stories that range from decreased or eliminated opioid consumption and a faster road to rehabilitative therapy, to discharge on the same day of surgery.2
With iovera°, patients can expect up to 3 months of relief from OA pain.1
Treatment with iovera° is minimally painful. After the area is numbed, treatment is virtually painless.
Yes, clinical studies have shown that treatment with iovera° can significantly decrease the need for opioids post-TKA.2
Most patients treated with iovera° report significant relief of OA knee pain.1 In fact, iovera° allows many of these patients to delay TKA. For patients who do undergo surgery, iovera° has been shown to provide significant pain relief and a decreased need for opioids.2
After proper training, health care staff beyond the surgeon or anesthesiologist can administer treatment with iovera° if state regulations allow.
Yes, it can. In principle, any sensory peripheral nerve that can be blocked with local anesthetic can potentially be treated with iovera°. For example, it can be used for deep genicular blocks for chronic OA knee pain. Always be aware of adjacent nerves that could be within the cryogenic freeze zone when considering the use of iovera° for a specific nerve block.
Cost and coverage
Pacira BioSciences, Inc., has a dedicated reimbursement hotline to help determine the reimbursement policies in your region. As with most procedures, iovera° treatment reimbursement may vary; however, using specific provided codes can improve payment and reimbursement for the services rendered.
Pacira BioSciences, Inc., has a mission to provide high-quality, low-cost, opioid-sparing alternatives for physicians and patients. The costs associated with the iovera° treatment system are not prohibitive, and individualized capital investment conversations can help ensure that all patients receive the highest quality care.
General reimbursement information
Dedicated specialists are available to:
- Provide the applicable codes, the reimbursement amount or fee schedule, and the specific coding requirements (eg, bill per mg for EXPAREL® (bupivicaine liposome injectable suspension) or applicable CPT code depending on nerves being treated with iovera°)
- Assist with reviewing operative reports to ensure medical necessity is captured and applicable CPT codes are submitted for claim submission and with denials, including reviewing redacted Explanation of Benefits (EOBs)/denial letters to review the denial reason and work with customer in using and/or completing appeal letters
- Fulfill requests for coding education primer and for premeetings with customer and customer staff as part of iovera° assessment or as part of implementation process
- Research commercial payers policy regarding cryoneurolysis and iovera° and provide links to content
As you know, you will base iovera° use on your clinical determination of which nerves need to be treated and not on reimbursement.
We are unable to talk about pricing and reimbursement in the same discussion. We are, however, permitted to discuss various pricing and contracting options for iovera° unrelated to reimbursement. We can also review reimbursement associated with iovera° based on your clinical judgment about which nerves will be treated.
The professional component rates of CPT 64640 and 64624 in RVUs for Medicare are the same for either an MD or a DO. However, billing for Physician Assistant (PA) services is handled differently throughout the country. Generally, Medicare will defer to state laws regarding billing for PAs. Some private carriers want the PA credentialed, much like the doctors. Other private carriers will advise the client to bill the service or procedure under the supervising physician’s National Provider Identifier. Some carriers don’t recognize PAs at all and generally prefer the doctor’s provider number only. There are other issues, depending upon the state and carrier.
Please direct PA-related questions to our Reimbursement Helpline for assistance.
The specific site of care should be noted (eg, office, operating room, postanesthesia care unit, etc) in your operative note.
If the procedure is performed in a hospital outpatient department (HOPD) vs an office, but both are in the same building, the site of care listed should represent the specific area of the building where the procedure is performed.
The Medicare guidelines do not definitively state whether there is a limit on how many times a year you can bill CPT 64624. The procedure needs to be supported by medical necessity, including comprehensive clinical documentation with specific nerves being treated and the diagnosis code. Please be aware, this documentation does not guarantee reimbursement. We recommend that you contact our Reimbursement Helpline to review the situation prior to performing the treatment.
Unless there is a contract that includes bundling of procedures, the facility fee would apply to the CPT codes for the iovera° treatments and the TKA CPT code. The ICD-10-CM diagnosis code does not affect whether a CPT is captured in an outpatient setting.
It’s important to be aware that the global period for CPT 64640 and 64624 is 10 days. This may impact the TKA reimbursement if the iovera° treatments and TKA are performed on the same day.
Please contact our Reimbursement Helpline to review the specific situation for appropriate guidance and support.
If the documentation indicates that the AFCN and ISN are being treated, this would be considered 2 separate nerves. If the deep genicular nerves are being treated, it would be considered 1 nerve.
The total RVUs would be based on the RVUs specific to the work component:
Based on the 3 nerves treated, the work RVUs would be 6.46 work RVUs. It’s also possible that you may have contracts with hospitals that may have different RVUs assigned than the Medicare RVUs. Please see the Coding and Medication Guide for more information.
Although cryoneurolysis CPT codes applicable for iovera° treatments are not bundled into the TKA code by Medicare, there is no guarantee of reimbursement for both procedures on the same date of service.
The global period for CPT 64640 and CPT 64624 is 10 days, which is counted as day 1 for the date of service (DOS) plus 10 days, for a total period of 11 days. This should be the time frame between the iovera° treatment(s) and the TKA. We would not definitively advise you that both procedures cannot be performed on the same date of service, but doing so may result in a denial for either the iovera° treatment(s) or the TKA. Modifiers may also be needed to bill these procedures on the same day. Commercial payer policies vary.
We recommend that you contact our Reimbursement Helpline in advance to further discuss the situation and obtain guidance.
Yes, superficial genicular nerves and deep genicular nerves can be treated in 1 session. As noted in the iovera° Coding and Reimbursement Guide, use CPT 64640 for the superficial nerves treated and CPT 64624 for deep genicular nerves (superolateral, superomedial, and inferomedial).
Modifier 51 may be required, and some commercial payers may require Modifier 59. 64624 should be listed first since it has the highest RVU. Billing both 64624 and 64640 will result in applying multiple procedure billing rules depending on the number of nerves treated using CPT 64640.
Our dedicated reimbursement specialists at the Reimbursement Helpline are happy to provide additional support and assistance.
The Medicare guidelines do not definitively state whether there is a limit on how many times a year you can bill CPT 64640. The procedure needs to be supported by medical necessity, including comprehensive clinical documentation with specific nerves being treated and the diagnosis code. Please be aware, this documentation does not guarantee reimbursement. We recommend that you contact our Reimbursement Helpline to review the situation prior to performing the treatment.
In general, Medicare Advantage plans follow Medicare coverage rules. Medicare Advantage plans are considered Medicare Part C, which includes what is covered in Medicare Parts A and B.
iovera° reimbursement varies across commercial payers and may evolve with time as evidenced by updates on their policies. In addition, some commercial payers have reimbursement policies that vary by state.
Yes, the reimbursement rates provided in the iovera° Coding and Reimbursement Guide represent Medicare’s national average rates. Your biller or administrator is likely to be familiar with their local Medicare entity, commonly known as their fiscal intermediary or Medicare Administrator Contractor (MAC), and can access your local market information. However, if your staff are not familiar with how to proceed or would like additional support, our dedicated reimbursement specialists can be reached through our Reimbursement Helpline for assistance.
You may contact the Reimbursement Helpline at 855-793-9727 or email@example.com. If you prefer, your iovera° representative can ask the helpline team to contact you at a convenient time or send you an email to initiate contact.
References: 1. Radnovich R et al. Osteoarthritis Cartilage. 2017;25(8):1247-1256. 2. Dasa V et al. Knee. 2016;23(3):523-528. 3. Ilfeld BM et al. Br J Anaesth. 2017;119(4):703-706.