November 18, 2013 Via Facsimile@ Harry.Feliciano@PalmettoGBA.com Harry Feliciano, M.D., M.P.H. Palmetto G.B.A. (J1 MAC) PO Box 1437 Augusta, GA 30903-1437 Re: Proposed LCD ID# DL34336 - Epidural Steroid Injections Dear Dr. Feliciano: As part of the physician community, the American Academy of Physical Medicine and Rehabilitation (“AAPM&R”) appreciates the opportunity to provide our comments regarding the Proposed LCD ID # DL 34336 – Epidural Steroid Injections. Our principal recommendations are set forth below and are supported in the attached list of references. AAPM&R is the national medical society representing more than 9,000 physiatrists, physicians who are specialists in the field of physical medicine and rehabilitation and primarily focused on diagnosing and serving the needs of people with a wide range of disabilities and chronic conditions. Physiatrists treat adults and children with acute and chronic pain, persons who have experienced catastrophic events resulting in paraplegia, quadriplegia, traumatic brain injury, spinal cord injury, limb amputations, rheumatologic conditions, musculoskeletal injuries, and individuals with neurologic disorders or any other disease process that results in impairment and/or disability. With appropriate rehabilitation, many patients can regain significant function, live independently, and enjoy fulfilling lives. Most, if not all, of the AAPM&R members participate in the Medicare program. You may be aware that AAPM&R participates in a multi-specialty pain workgroup (MPW) involving 14 national specialty societies representing well over 100,000 physicians. MPW was created by a small group of Contractor Medical Directors who were reviewing services and LCDs ranging from Spinal Cord Stimulation to Epidural Steroid Injections and were in search of the best evidence supporting a given treatment for the Medicare population to assist in the definition of “best practices”. Noridian Healthcare Solutions Medical Directors, Bernice Hecker, MD and Gary Oakes, MD, identified the MPW participants. This MPW has made consensus recommendations for a number of potential LCDs involving pain-related procedures including lumbar epidural steroid injections. We believe those recommendations are very appropriate and the comments submitted here are consistent with the work and recommendations produced by that group. For clarification, lumbar epidural steroid injections are performed via three routes, interlaminar and caudal (CPT code 62311) or transforaminal (CPT codes 64483, 64484). Diagnostic lumbar spinal nerve root blocks (DSNRBs) are often used to evaluate radicular pain and guide surgical planning. DSNRBs are technically similar to a transforaminal ESI and are coded exactly the same with CPT codes 64483, 64484. These are unilateral codes so a “-50” modifier is appropriate if a bilateral approach is utilized at the same segmental level. CPT codes 64483 and 64484 have image-guidance (fluoroscopic or CT) bundled into the payment, however CPT code 62311 does not so therefore it is appropriate to bill CPT code 77003 with this code (62311) when fluoroscopic or CT guidance is utilized. Please note that although these procedures are often needed in an urgent or timely manner to treat patients suffering with severe pain, they are elective procedures that are best performed with image-guidance (fluoroscopic or CT). Contrast medium should be injected during epidural injection procedures to help decrease the potential complications associated with intravascular, subdural or intrathecal injections and to ensure the medication will reach the desired target. The exception to the use of contrast would be in patients with a significant history and/or at high risk for an adverse event if contrast material were used (e.g., contrast allergy). The reasons for not using contrast should be documented in the medical or procedure report. Therefore, we recommend, as did the MPW, that epidural steroid injections be performed with contrastenhanced image-guidance. The only reasonable exception to this would be in rare, emergent cases where access to imaging was not reasonably available. In these situations, the medical records should document the necessity to perform the injection without image-guidance. In addition, in certain situations it is appropriate to perform both a transforaminal ESI and a one level facet joint injection in the same setting. In patients suffering with radicular pain due to neuroforaminal or lateral recess stenosis caused by a facet synovial cyst, it is appropriate for the patient to receive both an ESI and facet injection. The ESI provides local anesthesia and treats the radiculitis. The subsequent facet injection is performed to rupture the facet cyst and decompress the involved segmental area and thereby avoid a more costly open surgical procedure. In these rare circumstances, a "-59" modifier should be added to the facet CPT code 64493 and the indication and medical necessity for performing both injections should be clearly documented in the procedure report and medical records. Further, the Academy recommends that the LCD includes an exception so that these two procedures can be performed for this specific indication. We additionally recommend that these procedures be performed by physicians who have been appropriately trained. We believe any LCD should be consistent with and refer to the CMS Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf). This document outlines that "reasonable and necessary" services are "ordered and/or furnished by qualified personnel." Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. In the interest of patient safety and quality of care, healthcare professionals who perform Epidural Steroid Injections are appropriately trained and/or credentialed by a formal residency/fellowship program and/ or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. If the practitioner works in a hospital facility at any time and/or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure and utilization of the required associated imaging modalities. Although most patients with back and radicular pain respond to 1-2 ESIs for an episode of radicular pain, some patients may require additional injections for a number of reasons including: • A relapse of pain that was previously responsive to an ESI; • A new radicular problem that is contralateral or at a different segmental level compared to the patient’s prior pain problem; • A patient who may not be a surgical candidate due to medical co-morbidities; or • A patient may require a Diagnostic Selective Nerve Root Block (DSNRB) for surgical planning. Likewise, a second therapeutic ESI may be appropriate in patients who did not respond to a first (prior) ESI, if a different approach or medication is utilized. Obviously, a DSNRB would also be appropriate in patients that failed 1-2 therapeutic ESIs in whom surgery is being considered. Although many other individual scenarios may present for any given patient, based on the above examples, we believe that at least 3 DSNRBS or therapeutic ESIs per 6 months (or 6 total/year), are appropriate in these types of situations and any LCD should accommodate this recommended frequency and potential utilization. Obviously, the medical necessity to perform additional injections should be documented in the medical record. In closing, AAPM&R appreciates the opportunity to provide our views on the proposed LCD -Epidural Steroid Injections, and we look forward to working with Palmetto G.B.A. to achieve resolution in each of the foregoing matters. We are available for further discussions on the proposed LCD. Please contact Suzanne Butler, J.D., AAPM&R Manager, Legislative Affairs at (847) 7376022, or email her at sbutler@aapmr.org with any questions. Sincerely, Phillip Bryant, DO Chair, American Academy of Physical Medicine and Rehabilitation’s Reimbursement & Policy Review Committee November 18, 2013 Harry Feliciano, M.D., M.P.H. Letter American Academy of Physical Medicine and Rehabilitation References Interlaminar and Caudal ESIs Ackerman WE 3rd, Ahmad M. The efficacy of lumbar epidural steroid injections in patients with lumbar disc herniations. Anesth Analg. 2007; 104:1217-22. Arden NK, Price C, Reading I, Stubbing J, Hazelgrove J, Dunne C, Michel M, Rogers P, Cooper C; WEST Study Group. A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: The WEST study. Rheumatology (Oxford). 2005; 44:1399-1406. Barre L, Lutz GE, Southern D, Cooper G. Fluoroscopically guided caudal epidural steroid injections for lumbar spinal stenosis: A retrospective evaluation of long term efficacy. Pain Physician. 2004; 7:187-93. 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