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NASS ESI Cov Recs - SIS Comments · PDF file 4. Compressive lesions of the spinal cord, conus medullaris or cauda equina: a. Progressive neurological deficits manifesting as myelopathy,

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Text of NASS ESI Cov Recs - SIS Comments · PDF file 4. Compressive lesions of the spinal cord, conus...

  • Spine Intervention Society (SIS) (Formerly International Spine Intervention Society)

    120 E. Ogden Avenue, Suite 202 Hinsdale, IL 60521 630.203.2252 SpineIntervention.org

    March 18, 2019

    Jeffery C. Wang, MD via Email to [email protected] President North American Spine Society 7075 Veterans Blvd Burr Ridge, IL 60527

    Dear Dr. Wang:

    On behalf of the Spine Intervention Society (SIS), a multi-specialty association of more than 2,800 physicians dedicated to the development and promotion of the highest standards for the practice of interventional procedures in the diagnosis and treatment of pain, thank you for the opportunity to share our comments regarding the proposed coverage policy recommendations for epidural steroid injections (ESI). We have reviewed the draft coverage policy recommendations and wish to commend the North American Spine Society (NASS) on the draft. There are several suggestions included below that we wish to highlight for consideration. In addition, we have incorporated our comments and additional specific suggestions via tracked changes made in the attachment.

    METHODOLOGY § Suggest removing “and non-conflicted” as it refers to experience and expertise of

    authors. With the intended audience largely being payers, unless the individuals who developed the document neither perform ESI nor rely on ESI for the treatment of their patients, they are seen as conflicted.

    SCOPE AND CLINICAL INDICATIONS § Suggest adding electrodiagnostic testing to item 4 as it relates to findings

    consistent with the correlative region of nerve involvement.

    PROCEDURAL REQUIREMENTS, UTILIZATION, AND RESTRICTIONS § When referring to the recommendations endorsed by the Multisociety Pain

    Workgroup (MPW) regarding the safe use initiative, we recommend including the language verbatim from the Rathmell article. Edits have been made to several of the recommendations that slightly alter their meaning.

    § While we agree that ESIs should only be performed by well-trained physicians that have undergone appropriate medical training, this is not one of the MPW’s recommendations. It is still appropriate to include, but should be removed from the MPW recommendations list.

    § Preferred nomenclature to refer to “particulate-free steroid” is “nonparticulate steroid”. This is consistent with the MPW recommendations.

  • Page 2 of 2

    § In item (g) under the MPW recommendations, the statement reflects the opposite of what is intended and should read, “The risks of using particulate steroid in the thoracic and cervical spine likely outweigh the benefits of durability.” Please correct.

    § Item (l) under the MPW recommendations indicates that, “If sedation is required…” Rarely would sedation be “required” for ESIs. Please change the statement to read, “If light sedation is used”. Again, the original wording of the MPW recommendations has been changed here significantly altering the meaning in this case.

    Again, we would like to commend NASS on the draft coverage recommendations and thank you for considering our comments and suggestions. If you have any questions, please do not hesitate to contact Belinda Duszynski, Senior Director of Policy and Practice, at [email protected]

    Sincerely,

    Timothy P. Maus, MD President Spine Intervention Society

  • Introduction North American Spine Society (NASS) coverage policy recommendations are intended to assist payers and members by proactively defining appropriate coverage positions. Historically, NASS has provided comment on payer coverage policy upon request. However, in considering coverage policies received by the organization, NASS believes proactively examining medical evidence and recommending credible and reasonable positions may be to the benefit of both payers and members in helping achieve consensus on coverage before it becomes a matter of controversy. This coverage recommendation reflects the best available data as of 08/01/18; information and data available after 08/01/18 is thus not reflected in this recommendation and may warrant deviations from this recommendation, if appropriate.

    Methodology The coverage policies put forth by NASS use an evidence-based approach to spinal care when possible. In the absence of strict evi- dence-based criteria, policies reflect the multidisciplinary experience and expertise of the authors in order to reflect reasonable standard practice indications in the United States.

    NASS Coverage Policy Methodology

    Background Information Epidural steroid injections (ESIs) can be performed via a transforaminal (TF), interlaminar (IL), or caudal approach. Every approach re- quires the use of fluoroscopic or computerized tomography (CT) guidance to enhance safety and efficacy. There are rare exceptions (eg, pregnancy) where image guidance may pose greater risk than benefit. Insufficient safety and efficacy data exist around ultrasound guid- ance for any ESI approach for NASS to recommend for coverage of this alternative technique.

    Scope and Clinical Indications Therapeutic ESIs are indicated for the treatment of radicular or referred pain* in which 2 of 4 of the following criteria are met:

    1. The pain is severe enough to cause a degree of functional and/or vocational impairment or disability. 2. Pain duration of at least four weeks, and/or inability to tolerate or failure to respond to four weeks of noninvasive care**. 3. Objective findings of radiculopathy or scleratomal referred pain pattern are present and documented on examination. 4. Advanced imaging (CT or magnetic resonance imaging [MRI]) or electrodiagnostic testing demonstrate a correlative

    region of nerve involvement.

    * Lumbar referred pain is defined by having pain radiating to the buttock and/or leg, and would include conditions such as neurogenic claudication. Cervical referred pain is defined by having pain radiating into the shoulder, periscapular area and/or upper arm. While these diagnoses clearly include several potential anatomic pain generators, it is a common inclusion criterion for research studies1,2 and in clinical practice where the precise pain generator can be in question. In these cases, an ESI may offer diagnostic and therapeutic benefits.

    ** The majority of acute back, neck and radicular pain will improve over 4 weeks. It is therefore reasonable to recommend a trial of less invasive treatments for 4 weeks for those that have not already demonstrated pain beyond the normal natural history. Appropriate nonsurgical, noninjection treatments should be considered and documented in notes along with a rationale demonstrating that benefits of interventional treatment outweigh risks. Exceptions to waiting 4 weeks exist but should be carefully documented and should be reviewed on a case-by-case basis. These include, but are not limited to:

    1. At least moderate to severe pain, with functional loss at work and/or home. 2. Pain unresponsive to outpatient medical management. 3. Inability to tolerate nonsurgical, noninjection care due to coexisting medical condition(s) (eg, cardiac disease) or severe pain. 4. Prior successful injection therapy for the same condition that achieved greater than 50% pain relief with documented function-

    al improvement, reduced impairment or decrease in analgesic medication.

    Diagnostic selective nerve root blocks (DSNRBs) use a small amount of anesthetic via a transforaminal approach to anesthetize a specific spinal nerve. DSNRBs are used to evaluate a patient’s anatomical level and/or source of radicular pain. They are often used in surgical planning and decision-making. Documentation of pre- and postinjection assessment of the pain to fully record the degree of relief on a visual analog or numeric rating scale (VAS or NRS, respectively) with objective provocative testing is required.

    SIS� 3/6/2019 10:38 AM Comment [1]: Not sure “non-conflicted” is accurate. Any physician who performs or relies on the performance of ESIs can be seen as having a conflict. Would omit. SIS� 3/6/2019 10:37 AM

    Deleted: and non-SI SIS 3/6/2019 10:40 AM

    Deleted: to delivering an epidural spinal injection (ESI)

    SIS� 3/13/2019 3:40 PM Formatted: Body Text, Justified, Indent: Left: 0.5", Space Before: 0.05 pt, No bullets or numbering, Tabs:Not at 1.01" + 1.01"

    SIS 3/13/2019 3:39 PM Deleted: following diagnoses with qualifying criteria, when appropriate:... [1]

    SIS 3/13/2019 3:40 PM Formatted: Numbered + Level: 2 + Numbering Style: 1, 2, 3, ... + Start at: 1 + Alignment: Left + Aligned at: 1.15" + Indent at: 1.4"

    SIS� 3/11/2019 12:19 PM Deleted:

    SIS 3/11/2019 12:19 PM Deleted: s

    SIS 3/6/2019 10:41 AM Deleted:

    SIS 3/6/2019 10:42 AM

    Deleted: four

    Deleted: It is known that the SIS 3/13/2019 3:18 PM Comment [2]: If using numerals, use consistently throughout SIS� 3/6/2019 10:43 AM

    SIS 3/6/2019 10:44 AM Deleted: ,

    SIS� 3/6/2019 10:49 AM Deleted: . The following must be documented:

  • © 2014-2019 North American Spine Society. All rights reserved.

    Contraindications to ESIs and DSNRBs ESIs and DSNRBs are NOT indicated in cases that do not fulfill the above criteria. Of note, ESIs are not indicated in the following sce- narios:

    1. Axial or non-specific pain without radiating pain (unless it involves a nerve root that does not refer to a limb): a. Rad

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