National Medical Policy

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1 National Medical Policy Subject: Policy Number: Intradiscal Steroid Injections NMP481 Effective Date*: January 2005 Updated: August 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other X None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Intradiscal Steroid Injections Aug 15 1

2 Current Policy Statement Health Net, Inc. considers intradiscal steroid injections investigational. The published literature suggests both positive and negative results. Further research is being done to determine the safety and efficacy of injecting steroids directly into the disc. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes Lumbar intervertbral disc without myelopathy (disc herniation, radiculitis,extrusion, protrusion, prolapse, discogenic syndrome) Degeneration of lumbar or lumbosacral intervertebral disc Intervertebral disc disorder with myelopathy, lumbar region Other and unspecified disc disorder, lumbar region ICD-10 Codes M46.47 Discitis, unspecified, lumbosacral region M51.06 Intervertebral disc disorders with mylopathy, lumbar region M51.16 Intervertebral disc disorders with radiculopathy, lumbar region M51.36 Other intervertebral disc degeneration, lumbar region M51.86 Other intervertebral disc disorders, lumbar region CPT Codes Unlisted, spine procedure Unlisted, spine procedure HCPCS Codes N/A Scientific Rationale Update August 2015 There is an ongoing Clinical Trial on Intradiscal Steroid Injection for MODIC I Discopathy (PREDID) that is ongoing but not currently recruiting participants. The ClinicalTrials.gov Identifier is NCT , and it was last updated on June 4, The purpose of the study was to assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging. The hypothesis is delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy. The primary completion date is listed as May 2015, since this study was started in 2008, but it is not completed yet, and is now almost August Intradiscal Steroid Injections Aug 15 2

3 Scientific Rationale Update September 2011 There is no convincing evidence that intradiscal glucocorticoids are effective for low back pain. In patients with MRI evidence of degenerative disc disease and a positive response to discography, two trials found no difference between intradiscal steroid and control injection (saline or local anesthetic). A third trial found that in patients with degenerative disc disease who failed an epidural steroid injection, intradiscal steroid injection was superior to discography alone only in the subgroup of patients with inflammatory endplate changes on MRI. However, outcomes were not well defined in this trial and levels of statistical significance were poorly reported. Based on these trials, the American Pain Society guideline recommends against intradiscal glucocorticoid injection for chronic low back pain. The use of intradiscal steroid injections is also debated because intradiscal steroid may cause discitis, progression of disc degeneration, and calcification of the intervertebral disc. Scientific Rationale Update December 2010 Candido (2010) completed a retrospective observational report as the first attempt to quantify the overall rate of intradiscal injections during transforaminal epidural steroid injections and interlaminar lumbar epidural steroid injections. A retrospective analysis of 3 years of accrued data ( ) showed that 2412 transforaminal epidural steroid injections were performed at the 2 training institutions (Loyola University Medical Center and Northwestern University/Feinberg School of Medicine). There were 6 intradiscal (annular) injections of contrast, for a rate of 1:402. Over the same interval, 4723 lumbar epidural steroid injections were performed, with 1 intradiscal injection, for a rate of 1:4723. Cao et al. (2010) completed a double-blind, randomized, controlled, prospective clinical study, on 120 patients with discogenic low back pain and endplate Modic changes on magnetic resonance imaging (MRI) who received discography but were unwilling to accept surgical operation. Patients who received diagnostic discography for suspected degenerative discogenic low back pain were recruited, and divided into Groups A and B according to the type of Modic changes on MRI. Then, the patients in Groups A and B were randomized into three subgroups, respectively. Intradiscal injection of normal saline was performed in Subgroups A1 and B1, intradiscal injection of diprospan was performed in Subgroups A2 and B2, and intradiscal injection of a mixed solution of diprospan+songmeile (cervus and cucumis polypeptide) was performed in Subgroups A3 and B3. The clinical outcome of each patient was evaluated and recorded by using the VAS and ODI at 3 and 6 months after the procedure. The subgroups were comparable with respect to gender, age, pain, and percentage disability. Neither VAS pain scores nor Oswestry function scores of the patients within Group A had any improvement at 3 or 6 months after saline injection, but both of them improved significantly at the two time points after diprospan and diprospan+songmeile injection, respectively. Meanwhile, the latter two injection protocols led to no significant difference in pain relief and functional recovery. Similar results were obtained in patients within Group B. Furthermore, no difference of the improvement of VAS pain scores or Oswestry function scores was found between the patients within Group A and within Group B at different time points after various interventions. Intradiscal injection of corticosteroids could be a short-term alternative for discogenic low back pain patients with endplate Modic changes on MRI who were still unwilling to accept surgical operation when conservative treatment failed, however additional peer-reviewed randomized Intradiscal Steroid Injections Aug 15 3

4 controlled and comparative trials are necessary, to determine the safety, efficacy and long-term effects of intradiscal steroids for the treatment of discogenic lumbar pain. Scientific Rationale Initial Bertin et al (1990) reported their initial series of 30 cases of intradiscal injection of triamcinolone hexacetonide in the treatment of sciatica. The patients were monitored at months 1 and 3. The results were judged to be good in 36.6% of the cases, moderate in 36.6% and poor in 26.7% of the cases. They urged that larger series and double-blind studies are necessary to confirm the effectiveness of this modality of treatment. Koning et al (2001) tested intradiscal steroid therapy as an alternative to surgical intervention over the long term. A total of 85 consecutive patients were screened, who were treated in a one year period with intradiscal steroids for chronic low back pain and/or sciatica with normal neurological findings on examination. Patients considered as having clinical benefit from intradiscal steroid therapy and who did not experience a relapse of their complaints in the follow-up period were included for an assessment by questionnaire. An independent observer conducted a long-term follow-up assessment of the therapy by telephone interview. Two months following intradiscal steroid therapy, 43 of the 85 patients reported an improvement. One year after intradiscal steroid therapy, continuing pain relief occurred in 74% of the successfully treated patients and it decreased to 44% of the patients two years after treatment. 21% of patients obtained a good long-term effect (2 years or more). The researchers proposed that intradiscal steroid therapy can be a useful alternative for patients with low back syndromes not responding to conventional therapy. Simmons et al (1992) conducted a prospective, randomized, double-blind study to evaluate the clinical efficacy of intradiscal steroid injections. Criteria for entrance were one-level internal disc disruption or nonsequestered nuclear prolapse with or without sciatica and a positive pain response on awake discography. A total of 25 patients were randomly assigned to Treatment Group A (methylprednisolone, Depo- Medrol 80 mg/ml) or Treatment Group B (bupivacaine, Marcaine.5% 1.5 ml). Fourteen patients received Depo-Medrol, with 21% showing subjective improvement and 79% no improvement. Eleven patients received intradiscal Marcaine, with 9% showing clinical improvement and 91% no improvement. To quantify clinical response, a pain diagram grid score, a visual analog scale, and the Oswestry Pain Questionnaire were used before injection and days after injection. No statistically significant benefit was identified in the use of intradiscal steroids. Duquesnoy et al (1992) studied 92 patients with sciatica caused by intervertebral disc herniation who received intradiscal injections of triamcinolone hexacetonide. Although the first results at 6 months were encouraging, however, the results at 2 years' follow-up were mixed: 34 patients (36.9%) were satisfactory, 19 patients (20.6%) were poor, and 39 patients (42%) had to be operated upon within the 2 years. Moreover, calcifications were found in 19 out of 38 patients; they were of varying size, sometimes detected only at computerized tomography, and some of them appeared to produce symptoms. The authors surmised that, all things considered, the failure rates, the number of patients who required surgery and the occurrence of large and sometimes symptomatic calcifications make intradiscal injections of triamcinolone hexacetonide, and recommended that this treatment should be abandoned. Similarly, Menei et al (1991) reported three patients who Intradiscal Steroid Injections Aug 15 4

5 developed lesions of necrosis with granulomatous inflammatory reaction and bone metaplasia in the first year after intradiscal injection of triamcinolone hexacetonide. Ito et al (2001) followed 183 patients (498 discs) roentgenographically for a mean of 5 years to evaluate the occurrence of lumbar spinal canal ossification and calcification after triamcinolone intradiscal injection therapy. They found that the incidence and degree of ossification and calcification were significantly lower (3.8%) than those reported in previous studies, and a long time elapsed before ossification and calcification appeared or enlarged. They inferred that intradiscal injection of betamethasone did not appear to confer any incremental relative risk for lumbar spinal canal ossification and calcification based on review of follow-up roentgenographs Because previous studies have shown variable results, Khot et al (2004) published their prospective randomized study of the therapeutic effect of intradiscal steroid injection compared to a saline placebo in a total of 120 patients to determine whether intradiscal steroid injection influences the clinical outcome at 1 year in patients with chronic low back pain of discogenic origin. At 1 year after the procedure the patients were asked to report pain according to a visual analogue score and their Oswestry Disability Index was recorded. The primary outcome measure was determined as a percentage change in disability, and the secondary outcome measure was a change in the pain score. They found that there was no significant difference in the primary or secondary outcomes between the two groups. They concluded that intradiscal steroid injections do not improve the clinical outcome in patients with discogenic back pain compared with placebo. There is no solid scientific evidence that intradiscal steroid injections provide an alternative in the treatment of discogenic lumbar pain, with or without radicular symptoms. There are ongoing studies utilizing injection of chondroitin sulfate directly into the disc but current prospective investigations utilizing steroids directly injected into the disc are not being performed since that reported by Khot. There may be a place for this method of therapy in patients who fail lumbar epidural steroid injections and/or transforaminal epidural steroid injections, but this remains to be proven. Of grave concern are the reports of necrosis of the vertebral endplate, calcification of the nucleus, nuclear cellular degeneration and usage of these injections with the evidence available that they are potentially overtly dangerous. Review History January 2005 Medical Advisory Council July 2006 Update no revisions August 2007 Update no revisions December 2010 Update. Added Medicare Table. No revisions. September 2011 Update. Added Revised Medicare Table. No Revisions. August 2012 Update no revisions August 2013 Update no revisions. Codes updated. August 2014 Update no revisions August 2015 Update no revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. Manchikanti L, Staats PS, Singh V, et al. Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain. Pain Phys Intradiscal Steroid Injections Aug 15 5

6 2003;6:3-81. Accessed at: 2. AAOS Clinical Guideline on Low Back Pain/Sciatica (Acute) (Phases I and II) Support Document. 3. American Medical Association. Assessing & Treating Persistent Nonmalignant Pain: An Overview. Pain Management: Online Series. Continuing Medical Education Library. Chicago, IL: AMA; December References Update August Clinicaltrials.gov. Intradiscal Steroid Injection for MODIC I Discopathy (PREDID). ClinicalTrials.gov Identifier: NCT June Available at: tions&rank=1 References Update August Hong JH, Lee SM, Bae JH. Analysis of Inadvertent Intradiscal Injections during Lumbar Transforaminal Epidural Injection. Korean J Pain Apr;27(2): Hong JH, Kim SY, Huh B, Shin HH. Analysis of inadvertent intradiscal and intravascular injection during lumbar transforaminal epidural steroid injections: a prospective study. Reg Anesth Pain Med Nov-Dec;38(6): Lu Y, Guzman JZ, Purmessur D, et al. Nonoperative management of discogenic back pain: a systematic review. Spine (Phila Pa 1976) Jul 15;39(16): References Update August Berthelot JM, Le Goff B, Maugars Y. Side effects of corticosteroid injections: What's new? Joint Bone Spine Jul;80(4): References Update August Cao P, Jiang L, Zhuang C, et al. Spine J Feb;11(2): Epub 2010 Sep 20. Intradiscal injection therapy for degenerative chronic discogenic low back pain with end plate Modic changes References Update September Chou R. Subacute and chronic low back pain: Nonsurgical interventional treatment. UpToDate. March 25, 2011, updated Updated June 3, Goldman: Goldman's Cecil Medicine, 24th ed Saunders, An Imprint of Elsevier. Disorders of the Spine. Neck and Back Pain. References Update December Candido KD. Incidence of intradiscal injection during lumbar fluoroscopically guided transforaminal and interlaminar epidural steroid injections. Anesth Analg 1-MAY-2010; 110(5): Cao P, Jiang L, Zhuang C, et al. Intradiscal injection therapy for degenerative chronic discogenic low back pain with endplate Modic changes. The Spine Journal. September 20, Zhuang CY, Zhonghua YZ. Intradiscal interventional therapy for degenerative chronic discogenic low back pain with end-plate Modic changes. 22-SEP-2009; 89(35): Intradiscal Steroid Injections Aug 15 6

7 References Initial 1. Khot A, Bowditch M, Powell J, Sharp D. The use of intradiscal steroid therapy for lumbar spinal discogenic pain: a randomized controlled trial. Spine Nov 1;29(21): Ito S, Usui H, Maruyama K, Muro T. Roentgenographic evaluation of ossification and calcification of the lumbar spinal canal after intradiscal betamethasone injection. J Spinal Disord Oct;14(5): Riew KD, Yin Y, Gilula L, et al. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain. A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am 2000;82;11: Benmansour A, Filali K, Tijari A, et al. Acquired lumbar block vertebra. Was intradiscal injection of triamcinolone hexacetonide a contributing factor? Rev Rhum Engl Ed Jan;66(1): Aoki M, Kato F, Mimatsu K, Iwata H. Histologic changes in the intervertebral disc after intradiscal injections of methylprednisolone acetate in rabbits. Spine 1997;22:127-31;discussion Privat JM, Finiels PJ. Neurosurgical treatment of complications of intra-disk injections of triamcinolone hexacetonide. Value of a radio-clinical classification. Neurochirurgie 1997;43(4): Maigne JY, Aivaliklis A, Pfefer F. Results of sacroiliac joint double block and value of sacroiliac pain provocation tests in 54 patients with low back pain. Spine 1996;21: Dreyfuss P, Michaelsen M, Pauza K, McLarty J, Bogduk N. The value of medical history and physical examination in diagnosing sacroiliac joint pain. Spine 1996;21: Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine 1995;20: Duquesnoy B, Debiais F, Heuline A, et al. Unsatisfactory results of intradiscal injection of triamcinolone hexacetonide in the treatment of sciatica caused by intervertebral disk herniation. Presse Med Nov 14;21(38): Simmons JW, McMillin JN, Emery SF, Kimmich SJ. Intradiscal steroids. A prospective double-blind clinical trial. Spine Jun;17(6 Suppl):S Beltran Fabregat J. The intradiscal injection of triamcinolone hexacetonide: from alternative to abandonment. Med Clin (Barc) May 30;99(1): Menei P, Fournier D, Alhayek G, et al. Calcificated necrotic inflammatory granuloma after intradiscal injection of triamcinolone hexacetonide. Rev Rhum Mal Osteoartic Oct;58(9): Bertin P, Rochet N, Arnaud M, et al. Intradiscal injection of triamcinolone hexacetonide for acute, subacute, and chronic sciatica. Results at 3 months an open-prospectus study of 30 cases and review of the literature. Clin Rheumatol 1990;9: Menkes CJ, Vallee C, Giraudet-Le Quintrec JS. Calcification of the epidural space following an intradiscal injection of triamcinolone hexacetonide. Presse Med Oct 21;18(34):1707. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, Intradiscal Steroid Injections Aug 15 7

8 including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Intradiscal Steroid Injections Aug 15 8

9 Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Intradiscal Steroid Injections Aug 15 9