Coverage Policy Manual
Policy #: 2012001
Category: Radiology
Initiated: January 2012
Last Review: February 2024
  Functional Anesthetic Discography

Description:
Functional anesthetic discography is a diagnostic procedure that involves injecting an anesthetic agent directly into a spinal disc. Proponents suggest functional anesthetic discography can be used to confirm the presence of injured discs as the source of the patient’s back pain symptoms. According to the manufacturer, functional anesthetic discography is designed to diagnose and potentially treat back pain caused by degenerative disc disease. Although techniques may vary, under light sedation and x-ray guidance, a small catheter is inserted into the suspected disc and anchored in place with a small balloon. After recovering from light sedation, the patient is asked to engage in physical activity to reproduce pain. Local anesthetic is then injected in the disc believed to be causing the patient’s pain. Reduction in pain is considered diagnostic. If the injection into a specific disc relieves the patient's back pain, the disc can be further evaluated to determine additional treatment options. If the test does not relieve the patient's pain, the physician can investigate other possible causes of pain.
 
The FAD™ System (originally developed by InnoSpine, Inc., Palo Alto, CA, and later acquired by Kyphon Inc., Sunnyvale, CA) received 510(k) approval through the U.S. Food and Drug Administration (FDA) in April 2005 (FDA, K043500) as a Class II device. According to the FDA, the intended use of the system is to deliver either a single dose or continuous administration of radiopaque contrast, local anesthetics, and/or saline solution to the intradiscal space. In April 2007 the Discyphor Catheter System (Kyphon, Inc., Sunnyvale, CA), a more recent update to the FAD System, was cleared by the FDA.
 
There is no specific CPT or HSPCS code that describes functional anesthetic discography. The service should be billed with an unlisted code, CPT 64999.

Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Functional anesthetic discography to diagnose or treat back pain does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, functional anesthetic discography to diagnose or treat back pain is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
There are no randomized controlled trials comparing functional anesthetic discography to other forms of imaging for back pain thought to be due to degenerative disc disease. No published reports of improvements in health outcomes due to functional anesthetic discography were identified.
 
Study of Disc Anesthesia for the Preoperative Diagnosis of Chronic Lower Back Pain (SODA), an industry sponsored, nonrandomized, open label trial has been completed but results have not been published (NCT00443781).
 
Alamin, Kim and Agarwal, in 2011, in an online journal, published results of a prospective clinical series, 52 patients, in an academic spinal surgical practice. These patients had chronic low back pain presumed discogenic in origin. A standard pressure controlled provocative discography (PD) was done, followed by (in positive cases or in patients with clinical features and imaging studies felt to be highly suggestive of symptomatic disc degeneration) the FAD test and assessment or response to the injection of a low dose of local anesthetic into the disc during a position productive of the patient’s typical pain. Discordant results were noted in 46% of patients in the series with 26% of those patients having a positive PD and negative FAD test. The authors concluded further studies are needed to demonstrate the clinical utility of the test.
 
2013 Update
This policy is being updated with a literature review through January 2013. There was no new literature identified that would prompt a change in the coverage statement.
 
2014 Update
This policy is being updated with a literature review through January 2014. There was no new literature identified that would prompt a change in the coverage statement.
 
2015 Update
This policy was reviewed and a literature search was conducted using the MEDLINE database. There was no new information identified that would prompt a change in the coverage statement.
 
The American Society of Interventional Pain Physicians’ updated evidence-based guidelines for interventional techniques in chronic spinal pain states that the evidence for lumbar functional anesthetic discography is limited (Manchikanti, 2013).
 
2016 Update
A literature search was conducted through December 2015 using the MEDLINE database. No new randomized controlled trials or ongoing clinical trials were identified. There was no new information identified that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through January 2018. There was no new information that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through January 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
64999Unlisted procedure, nervous system

References: Alamin TF, Kim MJ, Agarwal V.(2011) Provocative lumbar discography verus functional anesthetic discography: a comparison of the results of tow different diagnostic techniques in 52 patients with chronic low back pain. Spine J, 2011; 11:756-65.

Manchikanti L, Abdi S, Atluri S, et al.(2013) An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: Guidance and recommendations. Pain Physician. 2013;16(2 Suppl):S49-S283.

Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain (SODA) . http://www.clinicaltrial.gov/ct2/show/NCT00443781?term=discography&rank=2; accessed 9/30/2011.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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