COOLIEF* COOLED RADIOFREQUENCY REIMBURSEMENT GUIDE Revised 06/2016
HALYARD* Pain Management Cooled RF Systems Reimbursement Guide Table of Contents Introduction... 2 COOLIEF* TRANSDICAL* Disc Biacuplasty Cooled Radiofrequency... 3 COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency... 8 COOLIEF* Cervical Cooled Radiofrequency... 15 COOLIEF* Thoracic Cooled Radiofrequency...23 COOLIEF* Lumbar Cooled Radiofrequency...29 COOLIEF* Knee Cooled Radiofrequency...33 COOLIEF* Hip Cooled Radiofrequency...40 Appeals...46 Introduction This reimbursement guide provides basic information regarding coding and coverage to assist you and your facility in obtaining reimbursement for our COOLIEF* Cooled RF procedures, which include: COOLIEF* TRANSDICAL* Disc Biacuplasty Cooled Radiofrequency COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency COOLIEF* Cervical Cooled Radiofrequency COOLIEF* Thoracic Cooled Radiofrequency COOLIEF* Lumbar Cooled Radiofrequency COOLIEF* Knee Cooled Radiofrequency COOLIEF* Hip Cooled Radiofrequency Information contained in this reimbursement guide is derived from a variety of sources as of September 2015 and is intended for general information only. The intent of this guide is to assist providers in accurately obtaining coverage and reimbursement for healthcare services. It is not intended to increase or maximize reimbursement by any payer. Providers assume full responsibility for all claims submissions and reimbursement decisions. Each claim should be coded appropriately and supported with adequate documentation of the patient s medical record. The codes listed in the guide are examples of codes that may be appropriate for individual situations. These codes do not represent correct coding for all procedures involving our various cooled RF technologies. 2
COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled Radiofrequency The disc biacuplasty procedure uses the COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled Radofrequency. This procedure is performed to treat patients with chronic discogenic pain and contained herniated discs through a bipolar approach using internally water-cooled radiofrequency probes to coagulate and deactivate nerves while decompressing disc material. CPT Codes: 22899: Unlisted procedure, spine OR 64999: Unlisted procedure, nervous system 77003: Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures Device Codes: There are no specific HCPCS codes (C Code or pass-through code) for the disc biacuplasty probe kit. The miscellaneous surgical supply code, A4649, can be used to bill for the single-use probe kit; however, it is at the payer s discretion to provide additional reimbursement. Coverage: To support the use of an unlisted procedure code, a prior authorization from the payer is recommended. 3
ICD-9/ICD-10 Diagnosis Codes: Following is a list of possible diagnosis codes which may support medical necessity for the disc biacuplasty procedure to treat the chronic pain caused by these medical conditions. This list is not intended to be an all-inclusive list. Other ICD-9 diagnostic codes may apply based on the patient s diagnosis. The physician must always make the final determination of the appropriate diagnosis code. CPT is a Registered Trademark of the American Medical Association. All rights reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained in this guide. The AMA assumes no responsibility for consequences attributable to or related to any use or interpretation of any information or views contained or not contained in this guide. ICD-9 CODE 722.52 722.6 722.93 DESCRIPTION Degeneration of lumbar or lumbosacral intervertebarl disc Degeneration of intervertebral disc, site uinspecified Other and unspecified disc disorder of lumbar region ICD-10 CODE M51.36 M51.37 M51.36 M51.37 DESCRIPTION Other intervertebral disc degeneration,lumbar region Other intervertebral disc degeneration,lumbosacral region Other intervertebral disc degeneration,lumbar region Other intervertebral disc degeneration,lumbosacral region M46.47 Discitis, unspecified, lumbosacral region M51.86 M51.87 Other intervertebral disc disorders, lumbar region Other intervertebral disc disorders, lumbosacral region M46.46 Discitis, unspecified, lumbar region 724.2 Lumbago M54.5 Low back pain 724.8 Other symptoms referable to the back M54.08 M54.06 M54.07 M54.09 Panniculitis affecting regions of neck and back, sacral and sacrococcygeal region Panniculitis affecting regions of neck and back, lumbar region Panniculitis affecting regions of neck and back, lumbosacral region Panniculitis affecting regions of neck and back,multiple sites in spine region 724.9 Other unspecified back disorders M43.26 Fusion of spine,lumbar region 739.3 Nonallopathic lesions of lumbar region, not elsewhere classified M43.27 Fusion of spine,lumbosacral region M99.03 Segmental and somatic dysfuntion of lumbar region For a complete list of coding options and descriptions, consult the current ICD-10-CM manual. 4
Pre-Authorization Process: Once a candidate has been identified, medical necessity has been established, and a Waiver of Financial Liability has been signed by the patient, a pre-authorization request should be submitted to the patient s insurance carrier prior to performing the disc biacuplasty procedure. Note: Medicare does not have a pre-authorization process. It is recommended that a potential patient who is covered by Medicare sign an ABN (Advanced Beneficiary Notice). When submitting a pre-authorization request, the following steps should be taken: Place a call to the payer to verify insurance benefits and determine if a pre-authorization is required. Provide the payer with the patient s diagnosis and the appropriate CPT code If a pre-authorization is required, documentation to support medical necessity will be required, which should be included in the letter of medical necessity (LOMN): Patient s brief medical history Physician s exam findings Copies of pertinent reports (MRIs, CT scans, etc) Alternative treatments previously tried How the activities of daily life are being impacted by the medical condition Duration of the diagnosis Identification of the site of service (office, ASC, or hospital outpatient) Note: Payers base their decisions on medical necessity, as well as benefits, therefore we encourage you to make a strong case for the patient s particular medical need for the disc biacuplasty procedure. 5
Following is a sample letter of medical necessity for the COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled Radiofrequency procedure to assist you in drafting a pre-authorization request. SAMPLE LETTER OF MEDICAL NECESSITY [Date] Attn: [Contact] usually the medical director [Title] [Name of Health Insurance Company] [Address] [City, State, ZIP Code] RE: Treatment authorization request for [Patient Name] [Policy Number/Group Number/Patient ID#] [Date of Birth] Dear [Name of Contact] / [To Whom It May Concern]: I am writing on behalf of my patient, [name of patient], to document the medical necessity of performing the COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled Radiofrequency procedure. [Mr./Mrs./Ms.] [Patient s last name] has been suffering from chronic discogenic pain for [xx] months. [Mr./Mrs./Ms.] [Patient s last name] s medical history and treatment information for chronic discogenic pain is as follows: List previous conservative treatment(s) done on the patient (including use of drugs such as analgesics, opioids, anti-inflammatory drugs; physiotherapy; steroid injections) and their outcome(s) Despite these attempts, [Mr./Mrs./Ms.] [Patient s last name] has received minimal relief from symptoms and is currently [describe patient s current condition and how activities of daily life are affected]. I have included the results of tests which indicate [list findings from CT, MRI, etc., and attach any other tests performed to confirm diagnosis]. Due to the unsuccessful outcome(s) of previous treatment(s), I am of the medical opinion that [Mr./Mrs./Ms.] [Patient s last name] would benefit from a procedure called COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled Radiofrequency. This procedure is medically necessary to treat [Mr./Mrs./Ms.] [Patient s last name] for chronic discogenic pain. My recommended treatment has been successfully used in many cases. 6
I am recommending a procedure called intervertebral disc biacuplasty at the [Specify Level] levels to ablate the nociceptors and nerve fibers that are responsible for discogenic pain within the degenerated disc. The procedure involves the use of the COOLIEF* Cooled RF System. The COOLIEF* Cooled RF System in combination with the HALYARD* COOLIEF* Pain Management Generator uses a bipolar approach with internally water-cooled radiofrequency probes to coagulate and deactivate nerves while decompressing disc material and aims to treat symptomatic patients with discogenic pain and contained herniated discs. [Mr./Mrs./Ms.] [Patient s last name] quality of life is diminished as the pain severely interferes with his/her work, family and the community activities he [she] would normally be involved in. This procedure will be performed [Date] at [Facility] pending the authorization of this request. Please confirm this procedure will be covered for [Mr./Mrs./Ms.] [Patient s last name] based on medical necessity. Contact me by phone at or by fax if you have any questions. Thank you for your attention to this matter, and I look forward to your response. Sincerely, [Physician s Name] [Physician s Practice Name] Encl. (relevant diagnostic test(s) and result(s), patient s pertinent medical history records etc.) 7
COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency is designed to treat patients with chronic sacroiliac joint pain. This treatment utilizes an internally water-cooled radiofrequency probe to ablate the dorsal ramus of L5 and the lateral branches of the dorsal rami exiting from the posterior sacral foramen at S1, S2, and S3. CPT Codes: 64635: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); lumbar or sacral, single facet joint 64640: Destruction by neurolytic agent; other peripheral nerve or branch RF denervation in the sacroiliac region is commonly done at L5, S1, S2, and S3 levels. Physicians who currently perform RF denervation procedure in the sacroiliac region commonly use the following approach in coding: RF lesion at L5/S1 facet joint: 64635 RF lesions at S1: 64640-59 RF lesions at S2: 64640-59 RF lesions at S3: 64640-59 Note: For bilateral procedures, use Modifier-50 Effective January 1, 2016 the AMA added guidelines for the facet joint denervation CPT codes (64633, 64634, 64635 and 64636) that state that these codes should not be used for nonthermal facet joint denervation including chemical, low-grade thermal energy (< 80 degrees Celsius), or any form of pulsed radiofrequency. Note: The Cooled RF Temp (default setting of 60 degrees C) displayed on the COOLIEF* Cooled RF Generator refers to the cooled electrode temperature and does not reflect the surrounding tissue temperature. The heat generated from the radiofrequency energy produces thermal energy with average maximum tissue temperature greater than 80 degrees C. According to the AMA, as published in the CPT Assistant, December 2009: To differentiate between the work when performing sacral nerve destruction of S1, S2, S3, and S4, each individually separate peripheral nerve root neurolytic block is reported as destruction of a peripheral nerve, using code 64640, Destruction by neurolytic agent; other peripheral nerve or branch. In this instance, code 64640 is reported four times. It is suggested that Modifier 59, Distinct Procedural Service, be appended as well. 8
Device Codes: There are no specific HCPCS codes (C Code or pass-through code) for the SInergy* probe kit. The miscellaneous surgical supply code, A4649, can be used to bill for the single-use probe kit; however, it is at the payer s discretion to provide additional reimbursement. Coverage: Coverage for RF denervation to treat sacroiliac joint pain varies significantly between payers. As a result, a prior authorization from the payer is recommended. 9
ICD-9/ICD-10 Diagnosis Codes: Following is a list of possible diagnosis codes which may support medical necessity for the COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency Treatment to treat the chronic pain caused by these medical conditions. This list is not intended to be an all-inclusive list. Other ICD-9 diagnostic codes may apply based on the patient s diagnosis. The physician must always make the final determination of the appropriate diagnosis code. ICD-9 CODE DESCRIPTION ICD-10 CODE DESCRIPTION 353.1 Lumbosacral plexus lesions G54.1 Lumbosacral plexus disorders 353.4 Lumbosacral root lesions, not elsewhere classified G54.4 Lumbosacral root disorders, not elsewhere classified 353.8 Other nerve root and plexus disorder G54.8 Other nerve root and plexus disorders 719.45 Pain in joint, pelvic region and thigh M25.551 Pain in right hip G55 720.O Ankylosing spondylitis M45.0 M25.552 Pain in left hip M45.7 M45.8 M48.8X7 M48.8X8 Nerve root and plexus compressions in diseases classified elsewhere Ankylosing spondylitis of multiple sites in spine Ankylosing spondylitis of lumbosacral region Ankylosing spondylitis sacral and sacrococcygeal region Other specified spondylopathies lumbosacral region Other specified spondylopathies sacral and sacrococcygeal region 720.2 Sacroilitis M46.1 Sacroiliitis, not elsewhere classified 721.3 Lumbosacral spondylosis without myelopathy M47.817 M47.26 M47.27 M47.816 Spondylosis without myelopathy or radiculopathy, lumbosacral region Other spondylosis with radiculopathy, lumbar region Other spondylosis with radiculopathy, lumbosacral region Spondylosis without myelopathy or radiculopathy, lumbar region M47.896 Other spondylosis, lumbar region M47.897 Other spondylosis, lumbosacral region 724.2 Lumbago M54.5 Low back pain 724.3 Sciatica M54.30 Sciatica, unspecified side M54.31 Sciatica, right side M54.32 Sciatica, left side M54.40 Lumbago with sciatica, unspecified side M54.41 Lumbago with sciatica, right side M54.42 Lumbago with sciatica, left side 724.6 Disorders of the sacrum M43.27 Fusion of spine, lumbosacral region M43.28 Fusion of spine, sacral and sacrococcygeal region 10
ICD-9 CODE DESCRIPTION ICD-10 CODE M53.2X7 M53.2X8 DESCRIPTION Spinal instabilities, lumbosacral region Spinal instabilities, sacral and sacrococcygeal region M53.86 Other specified dorsopathies, lumbar region M53.87 M53.88 724.8 Other symptoms referable to the back M54.08 739.4 Nonallopathic lesions of sacral region, not elsewhere classified M54.07 Other specified dorsopathies, lumbosacral region Other specified dorsopathies, sacral and sacrococcygeal region Panniculitis affecting regions of neck and back, sacral and sacrococcygeal region Panniculitis affecting regions of neck and back, lumbosacral region M54.17 Radiculopathy, lumbosacral region M99.04 M99.05 Segmental and somatic dysfunction of sacral region Segmental and somatic dysfunction of pelvic region 756.12 Cogenital spondylolisthesis Q76.2 Congenital spondylolisthesis For a complete list of coding options and descriptions, consult the current ICD-10-CM manual. 11
Pre-Authorization Process: Once a candidate has been identified, medical necessity has been established, and a Waiver of Financial Liability has been signed by the patient, a pre-authorization request should be submitted to the patient s insurance carrier prior to performing the COOLIEF* SINERGY* Sacroiliac Cooled RF Treatment. Note: Medicare does not have a pre-authorization process. It is recommended that a potential patient that is covered by Medicare sign an ABN (Advanced Beneficiary Notice). When submitting a pre-authorization request, the following steps should be taken: Place a call to the payer to verify insurance benefits and determine if a pre-authorization is required. Provide the payer with the patient s diagnosis and the appropriate CPT code If a pre-authorization is required, documentation to support medical necessity will be required which should be included in the letter of medical necessity (LOMN): Patient s brief medical history Physician s exam findings Copies of pertinent reports (MRIs, CT scans, etc) Alternative treatments previously tried How the activities of daily life are being impacted by the medical condition Duration of the diagnosis Identification of the site of service (office; ASC; or hospital outpatient) Note: Payers base their decisions on medical necessity, as well as benefits; therefore we encourage you to make a strong case for the patient s particular medical need for the sacroiliac joint neurotomy procedure. 12
Following is a sample letter of medical necessity for the COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency procedure to assist you in drafting a pre-authorization request. SAMPLE LETTER OF MEDICAL NECESSITY [Date] Attn: [Contact] usually the medical director [Title] [Name of Health Insurance Company] [Address] [City, State, ZIP Code] RE: Treatment authorization request for [Patient Name] [Policy Number/Group Number/Patient ID#] [Date of Birth] Dear [Name of Contact] / [To Whom It May Concern]: I am writing on behalf of my patient, [name of patient], to document the medical necessity of sacroiliac joint neurotomy procedure. [Mr./Mrs./Ms.] [Patient s last name] has been suffering from chronic pain associated with the sacroiliac joint complex for [xx] months. [Mr./Mrs./Ms.] [Patient s last name] s medical history and treatment information for chronic pain associated with the sacroiliac joint complex is as follows: List previous conservative treatment(s) done on the patient (including use of drugs such as analgesics, opioids, anti-inflammatory drugs; physiotherapy; steroid injections) and their outcome(s) Despite these attempts, [Mr./Mrs./Ms.] [Patient s last name] has received minimal relief from symptoms and is currently [describe patient s current condition and how activities of daily life are affected]. I have included the results of tests which indicate [list findings from CT, MRI, etc., and attach any other tests performed to confirm diagnosis]. Due to the unsuccessful outcome(s) of previous treatment(s), I am of the medical opinion that [Mr./Mrs./Ms.] [Patient s last name] would benefit from a procedure called sacroiliac joint neurotomy. This procedure is medically necessary to treat [Mr./Mrs./Ms.] [Patient s last name] for chronic pain associated with the sacroiliac joint complex. My recommended treatment has been successfully used in many cases. 13
The sacroiliac joint neurotomy procedure is performed using the HALYARD* COOLIEF* SINERGY* Sacroiliac Cooled RF Pain Management System. The The COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency Treatment is comprised of COOLIEF* SINERGY* Probe Kit, COOLIEF* SINERGY* Introducer, Pain Management Pump Unit and Cable, Pain Management Tube kit, Dispersive Electrode and Connecting Cable. This system is used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in the nervous tissue. The procedure ablates the dorsal ramus of L5 that runs along the sacral ala and the lateral branches of the dorsal rami exiting from posterior sacral foramen at S1, S2 and S3. These nerves are known to innervate the sacroiliac joint and are responsible for the pain associated with sacroiliac joint syndrome. Because of the complex, varied and diffuse innervations in the sacroiliac region, large radiofrequency lesions are required to ensure complete ablation of the nervous tissue. A cooled probe allows a sufficiently large volume of tissue to be heated without excessively heating tissue adjacent the probe tip. In summary, sacroiliac joint neurotomy procedure using the HALYARD* COOLIEF* SINERGY* Sacroiliac Cooled RF Pain Management System is necessary and reasonable for [Mr./Mrs./ Ms.] [Patient s last name] s medical condition. Based on the diagnostic results, I firmly believe that [Mr./Mrs./Ms.] [Patient s last name] is an excellent candidate for this procedure and I request you to consider a prompt approval for this procedure. Thank you for your attention to this matter, and I look forward to your response. Sincerely, [Physician s Name] [Physician s Practice Name] Encl. (relevant diagnostic test(s) and result(s), patient s pertinent medical history records etc. Note: This information is not intended to serve as specific advice on how to code, bill, or charge for any service. It is always the provider s responsibility to determine appropriate codes. You may wish to contact your local payer for interpretation of appropriate codes and coverage policies. CPT is a registered trademark of the American Medical Association. CPT codes 2005 American Medical Association. All rights reserved. 14
COOLIEF* Cervical Cooled Radiofrequency COOLIEF* Cervical Cooled Radiofrequency is designed to treat the pain associated with cervical Z-joint through the use of an internally water-cooled radiofrequency probe to ablate the medial branches coursing over the superolateral aspect of the transverse process of the cervical spine. CPT Codes: 64633: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); cervical or thoracic, single facet joint 64634: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); cervical or thoracic, each additional facet joint Cervical medial branch neurotomy procedures are commonly performed at levels from C3 to C7. An example of coding commonly used by physicians performing cervical medial branch neurotomy is listed below: RF lesion at C 3/4 facet joint: 64633 RF lesion at C 4/5 facet joint: 64634 RF lesion at C 5/6 facet joint: 64634 Note: For bilateral procedures, use Modifier-50 Effective January 1, 2016 the AMA added guidelines for the facet joint denervation CPT codes (64633, 64634, 64635 and 64636) that state that these codes should not be used for nonthermal facet joint denervation including chemical, low-grade thermal energy (< 80 degrees Celsius), or any form of pulsed radiofrequency. Note: The Cooled RF Temp (default setting of 60 degrees C) displayed on the COOLIEF* Cooled RF Generator refers to the cooled electrode temperature and does not reflect the surrounding tissue temperature. The heat generated from the radiofrequency energy produces thermal energy with average maximum tissue temperature greater than 80 degrees C. Device Codes: There are no specific HCPCS codes (C Code or pass-through code) for the COOLIEF* Probe Kit. The miscellaneous surgical supply code, A4649, can be used to bill for the single-use probe kit; however, it is at the payer s discretion to provide additional reimbursement. Coverage: Most commercial payers and medicare provide coverage for RF Denervation to treat cervical facet joint pain. Requirements and limitations will vary between payers. Please check with the patient s insurance for their specific coverage policy on RF Denervation for cervical facet. 15
ICD-9/ICD-10 Diagnosis Codes: Following is a list of possible diagnosis codes which may support medical necessity for RF denervation of cervical facet nerves to treat the chronic pain caused by these medical conditions. This list is not intended to be an all-inclusive list. Other ICD-9 diagnostic codes may apply based on the patient s diagnosis. The physician must always make the final determination of the appropriate diagnosis code.icd-9-cm ICD-9 CODE DESCRIPTION ICD-10 CODE DESCRIPTION 333.83 Spasmodic torticollis/cervical dystonia G24.3 Spasmodic torticollis 338.4 Chronic pain syndrome G89.4 Chronic pain syndrome 350.2 Atypical face pain G50.1 Atypical face pain 353.2 Cervical root lesions not elsewhere classified G54.2 721.O Cervical spondylosis without myelopathy M47.812 M47.21 M47.22 M47.23 M47.811 M47.813 M47.891 721.1 Cervical spondylosis with myelopathy M47.12 722.O Displacement of cervical intervertebral disc without myelopathy Cervical root disorders not elsewhere classified Spondylosis without myelopathy or radiculopathy, cervical region Other spondylosis with radiculopathy, occipito-atlanto-axial region Other spondylosis with radiculopathy, cervical region Other spondylosis with radiculopathy, cervicothoracic region Spondylosis without myelopathy or radiculopathy, occipito-atlanto-axial region Spondylosis without myelopathy or radiculopathy, cervicothoracic region Other spondylosis, occiiito-atlanto-axial region M47.892 Other spondylosis, cervical region M47.893 Other spondylosis, cervicothoracic region M47.011 M47.012 M47.013 M47.021 M47.022 M47.11 M47.13 M50.20 M50.21 M50.22 Other spondylosis with myelopathy, cervical region Anterior spinal artery compression syndromes, occipito-atlanto-axial region Anterior spinal artery compression syndromes, cervical region Anterior spinal artery compression syndromes, cervicothoracic region Vertebral artery compression syndromes, occipito-atlanto-axial region Vertebral artery compression syndromes, cervical region Other spondylosis with myelopathy, occipito-atlanto-axial region Other spondylosis with myelopathy, cervicothoracic region Other cervical disc displacement, unspecified cervical region Other cervical disc displacement, high cervical region Other cervical disc displacement, midcervical region 16
ICD-9 CODE 722.4 722.71 DESCRIPTION Degeneration of cervical intervertebral disc Intervertebral disc disorder with myelopathy cervical region ICD-10 CODE M50.23 M50.30 M50.31 M50.32 M50.33 M50.00 M50.01 M50.02 M50.03 DESCRIPTION Other cervical disc displacement, cervicothoracic region Other cervical disc degeneration, unspecified cervical region Other cervical disc degeneration, high cervical region Other cervical disc degeneration,midcervical region Other cervical disc degeneration, cervicothoracic region Cervical disc disorder with myelopathy, unspecified cervical region Cervical disc disorder with myelopathy, high cervical region Cervical disc disorder with myelopathy, mid-cervical region Cervical disc disorder with myelopathy, cervicothoracic region 723.O Spinal stenosis in cervical region M48.02 Spinal stenosis, cervical region M48.01 Spinal stenosis, occipito-atlanto-axial region M48.03 Spinal stenosis, cervicothoracic region M99.21 M99.31 M99.41 M99.51 M99.61 M99.71 723.1 Cervicalgia M54.2 Cervicalgia Subluxation stenosis of neural canal of cervical region Osseous stenosis of neural canal of cervical region Connective tissue stenosis of neural canal of cervical region Intervertebral disc stenosis of neural canal of cervical regiion Osseous and subluxation stenosis of intervertebral foramina of cervical region Connective tissue and disc stenosis of intervertebral foramina of cervical region 723.4 Radiculopathy neuritis cervical/brachial M54.12 Radiculopathy, cervical region M54.13 Radiculopathy, cervicothoracic region M50.10 M50.11 M50.12 M50.13 723.8 Occipital neuralgia M53.82 Cervical disc disorder with radiculopathy, unspecified cervical region Cervical disc disorder with radiculopathy, high cervical region Cervical disc disorder with radiculopathy,mid-cervical region Cervical disc disorder with radiculopathy, cervicothoracic region M54.11 Radiculopathy, occipito-atlanto-axial region M53.81 M53.83 Other specified dorsopathies, cervical region Other specified dorsopathies, occipitoatlanto-axial region Other specified dorsopathies, cervicothoracic region M54.81 Occipital neuralgia 17
724.8 Facet syndrome- lumbar, cervical, thoracic M54.03 M54.09 733.13 Compression fracture (vertebral) M80.08XA M84.68XA M48.51XA M48.52XA M48.53XA M80.88XA M84.58XA 847.O Neck sprain S13.4XXA S13.8XXA S16.1XXA 953.O Injury to cervical nerve root S14.2XXA Panniculitis affecting regions of neck and back, cervicothoracic region Panniculitis affecting regions of neck and back, multiple sites in spine Age-related osteopororosis with current pathologiacl fracture,vertebra, initial encounter for fracture Pathological fracture in other disease, other site, initial encounter for fracture Collapsed verterbra, not elsewhere classified, occipito-atlanto-axial region, initial encounter for fracture Collapsed verterbra, not elsewhere classified, cervical region, initial encounter for fracture Collapsed verterbra, not elsewhere classified, cervicothoracic region, initial encounter for fracture Other osteoporosis with current pathological fracture, vertebra, initial encounter Pathological fracture in neoplastic disease, other specified site, initial encounter Sprain of ligaments of cervical spine, initial encounter Sprain of joints and ligaments of other parts of neck, initial encounter Strain of muscle, fascia and tendon at neck level, initial encounter Injury of nerve root of cervical spine, initial encounter For a complete list of coding options and descriptions, consult the current ICD-10-CM manual. Pre-Authorization Process: Once a candidate has been identified, medical necessity has been established, and a Waiver of Financial Liability has been signed by the patient, a pre-authorization request should be submitted to the patient s insurance carrier prior to performing the COOLIEF* Cervical Cooled Radiofrequency Treatment. Note: Medicare does not have a pre-authorization process. It is recommended that a potential patient that is covered by Medicare sign an ABN (Advanced Beneficiary Notice). When submitting a pre-authorization request, the following steps should be taken: Place a call to the payer to verify insurance benefits and determine if a pre-authorization is required. Provide the payer with the patient s diagnosis and the appropriate CPT code If a pre-authorization is required, documentation to support medical necessity will be required which should be included in the letter of medical necessity (LOMN): Patient s brief medical history Physician s exam findings Copies of pertinent reports (MRIs, CT scans, etc) 18
Alternative treatments previously tried How the activities of daily life are being impacted by the medical condition Duration of the diagnosis Identification of the site of service (office; ASC; or hospital outpatient) Note: Payers base their decisions on medical necessity, as well as benefits, therefore we encourage you to make a strong case for the patient s particular medical need for the cervical medial branch neurotomy procedure. 19
Following is a sample letter of medical necessity for the COOLIEF* Cervical Cooled Radiofrequency procedure to assist you in drafting a pre-authorization request. SAMPLE LETTER OF MEDICAL NECESSITY [Date] [Payer Address] Re: [Insert patient name and subscriber number] Dear [Medical Director]: Please consider this letter a request for preauthorization of benefits to treat my patient, [insert patient name], who suffers from [insert patient ICD-10-CA diagnosis code and description of procedure]. It is my clinical judgment that [Mr./Ms. insert patient last name] is an ideal candidate for radiofrequency (RF) denervation in the cervical region utilizing the HALYARD* COOLIEF* Cervical Cooled RF Pain Management System, and prior to scheduling this procedure I am seeking preauthorization and predetermination of benefits for my patient. Patient History [Mr./Ms. insert patient name] presented to me with complaints of [insert detailed patient history with description of patient s current condition including diagnosis, length of time problem has existed, current/ ongoing complaints, and level of impairment. Describe functional impairments, and how the patient s condition has impacted his/her activities of daily life.] Previous interventional treatment efforts include: [indicate procedures, medications, and/or therapies attempted include outcome of each treatment]. Despite these treatments and therapies, [Mr./Ms. insert patient name] has experienced no significant relief from [insert specific symptoms here]. A problem-focused history and exam was performed as well as [indicate scans, MRIs, X-rays, nerve blocks etc]. The findings of these test results confirm my diagnosis of [insert patient diagnosis code] and support my request for treatment. 20
Proposed Treatment I am recommending a radiofrequency denervation procedure for the ablation of medial branch nerves in the cervical region. The procedure involves the use of the HALYARD* COOLIEF* Cervical Cooled RF Pain Management System to create targeted lesions at the medial branches of the cervical dorsal rami. These nerves are known to innervate the cervical zygapophysial joints (z-joints) and are associated with cervical z-joint pain. Because of the varied innervations in the cervical region, large radiofrequency lesions are required to ensure complete ablation of the nervous tissue. Cooled RF technology utilized by the COOLIEF* Cervical Cooled RF Pain Management System allows a large volume of tissue to be heated (without excessively heating tissue adjacent to the probe tip) compared to conventional radiofrequency electrodes. This procedure will be performed on [indicate anticipated date of procedure] at [indicate site of service and name of facility where the procedure will be performed physician office, outpatient hospital]. Please confirm if there are any restrictions on performing this procedure in this setting. Please confirm this procedure will be covered for [insert patient name] based on medical necessity. Please contact me at [insert phone number] if you have any questions. Sincerely, [Doctor signature] Dr. [doctor name] 21
COOLIEF* CERVICAL COOLED RADIOFREQUENCY PATIENT NAME: MRN: PHYSICIAN: PREOPERATIVE DIAGNOSIS: POSTOPERATIVE DIAGNOSIS: PROCEDURE: 1. C3 facet joint radiofrequency denervation 2. C4 facet joint radiofrequency denervation 3. C5 facet joint radiofrequency denervation DATE OF PROCEDURE: ANESTHESIA: MAC COMPLICATIONS: None ESTIMATED BLOOD LOSS: Minimal Sample Operative Note COOLIEF* CERVICAL COOLED RADIOFREQUENCY Reference Material Only PROCEDURE IN DETAIL: informed consent was given and signed informed consent document was obtained. A full description of the procedure was provided including benefits, as well as possible complications including transient increased pain, short term tremulusness, headaches, stomach irritation, mood alteration, as well as more uncommon nerve injury, bleeding, infection or allergic reaction The patient was brought to the operating room and placed on the exam table in a comfortable prone position. The place for the needle placement was obtained by manual palpation as well as radiographic confirmation. The sterile field was prepped by chlorhexidine and sterile drapes. Local anesthesia, both superficial and deep was provided by local infiltration of 8 ml Lidocaine 1%. Using fluoroscopic guidance, a 17-gauge (50mm/75mm) insulated sharp radiofrequency needle with a 2 mm active tip was placed overlying the right C4 cervical vertebra from the posterior approach and was advanced until bony contact was felt with the articular pillar. The needle was walked off the pillar, maintaining contact with the bone. Attempted aspiration revealed no blood or cerebrospinal fluid. Radiographs were then made in AP and lateral. Motor testing was then performed with 2.0 volts and no upper extremity motor stimulation was observed. 1 cc of the 5ml Lidocaine was injected through the RF needle. A thermal radiofrequency lesion of the medial branch of C4 was then performed at an average maximum tissue temperature greater than 80 degrees C for 2 minutes and 30 seconds. The same procedure was repeated for bilateral C5 and C6 medial branches. The patient tolerated the procedure well. He was taken to recovery in good condition. He was provided with instructions as to what to expect. He was also provided with contact information and instructed to call regarding any concerning symptoms or questions. Registered Trademark or Trademark of Halyard Health, Inc. and its affiliates. 2015 HYH. All rights reserved. w ww.halyardhealth.com For more information, call 1-800-524-3577 22
COOLIEF* Thoracic Cooled Radiofrequency COOLIEF* Thoracic Cooled Radiofrequency is designed to treat the pain associated with thoracic Z-joint through the use of an internally water-cooled radiofrequency probe to ablate the medial branches coursing over the superolateral aspect of the transverse process of the thoracic spine. CPT Codes: 64633: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); cervical or thoracic, single facet joint 64634: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); cervical or thoracic, each additional facet joint Thoracic medial branch neurotomy procedures are commonly performed at levels from T1 to T12. An example of coding commonly used by physicians performing thoracic medial branch neurotomy is listed below: RF lesion at T3-4 facet joint: 64633 RF lesion at T4-5 facet joint: 64634 RF lesion at T5-6 facet joint: 64634 Note: For bilateral procedures, use Modifier-50 Effective January 1, 2016 the AMA added guidelines for the facet joint denervation CPT codes (64633, 64634, 64635 and 64636) that state that these codes should not be used for nonthermal facet joint denervation including chemical, low-grade thermal energy (< 80 degrees Celsius), or any form of pulsed radiofrequency. Note: The Cooled RF Temp (default setting of 60 degrees C) displayed on the COOLIEF* Cooled RF Generator refers to the cooled electrode temperature and does not reflect the surrounding tissue temperature. The heat generated from the radiofrequency energy produces thermal energy with average maximum tissue temperature greater than 80 degrees C. Device Codes: There are no specific HCPCS codes (C Code or pass-through code) for the COOLIEF* Probe Kit. The miscellaneous surgical supply code, A4649, can be used to bill for the single-use probe kit; however, it is at the payer s discretion to provide additional reimbursement. Coverage: Coverage for RF denervation to treat thoracic facet joint pain varies significantly between payers. As a result, a prior authorization from the payer is recommended. 23
ICD-9/ICD-10 Diagnosis Codes: Following is a list of possible diagnosis codes which may support medical necessity for RF denervation of thoracic facet nerves to treat the chronic pain caused by these medical conditions. This list is not intended to be an all-inclusive list. Other ICD-9 diagnostic codes may apply based on the patient s diagnosis. The physician must always make the final determination of the appropriate diagnosis code. ICD-9 CODE 353.3 DESCRIPTION Thoracic root lesions, not elsewhere classified ICD-10 CODE G54.3 DESCRIPTION Thoracic root disorders, not elsewhere classified 353.8 Other nerve root and plexus disorder G54.8 Other nerve root and plexus disorders G55 720.O Ankylosing spondylitis M45.0 M45.3 Nerve root and plexus compressios in diseases classified elsewhere Ankylosing spondylitis of multiple sites in spine Ankylosing spondylitis of cervicothoracic region M45.4 Ankylosing spondylitis of thoracic region M45.5 M48.8X3 M48.8X4 M48.8X5 M48.8X9 Ankylosing spondylitis of thoracolumbar region Other specified spondylopathies, cervicothoracic region Other specified spondylopathies, thoracic region Other specified spondylopathies, thoracolumbar region Other specified spondylopathies, site unspecifiedthoracolumbar region 720.1 Spinal enthesopathy M46.03 Spinal enthesopathy, cervicothoracic region 721.2 Thoracic spondylosis without myelopathy M47.814 M46.94 Spinal enthesopathy, thoracic region M46.05 Spinal enthesopathy, thoracolumbar region M46.09 Spinal enthesopathy, multiple sites in spine M47.24 M47.25 M47.815 721.6 Ankylosing vertebral hyperostosis M48.13 Spondylosis without myelopathy or radiculopathy, thoracic region Other spondylosis with radiculopathy, thoracic region Other spondylosis with radiculopathy, thoracolumbar region Spondylosis without myelopathy or radiculopathy, thoracolumbar region M47.894 Other spondylosis, thoracic region M47.895 Other spondylosis, thoracolumbar region M48.14 M48.15 M48.19 Ankylosing hyperostosis (Forestier), cervicothoracic region Ankylosing hyperostosis (Forestier), thoracic region Ankylosing hyperostosis (Forestier), thoracolumbar region Ankylosing hyperostosis (Forestier), multiple sites in spine 24
ICD-9 CODE DESCRIPTION ICD-10 CODE 721.7 Traumatic spondylopathy M48.33 722.82 Postlqaminectomy syndrome, thoracic region DESCRIPTION Traumatic spondylopathy, cervicothoracic region M48.34 Traumatic spondylopathy, thoracic region M48.35 M96.1 Traumatic spondylopathy, thoracolumbar region Postlaminectomy syndrome, not elsewhere classified 724.1 Pain in thoracic spine M54.6 Pain in thoracic spine 724.4 Thoracic or lumbosacral neuuritis or radiculitis, unspecified M54.14 Radiculopathy, thoracic region M54.15 Radiculopathy, thoracolumbar region M51.14 M51.15 724.8 Other symptoms referable to the back M54.03 729.2 Unspecified neuralgia, neuritis, and radiculitis M54.04 M54.05 M54.09 Intervertebral disc disorders with radiculopathy, thoracic region Intervertebral disc disorders with radiculopathy, thoracolumbar region Panniculitis affecting regions of neck and back, cervicothoracic region Panniculitis affecting regions of neck and back,thoracic region Panniculitis affecting regions of neck and back,thoracolumbar region Panniculitis affecting regions of neck and back,multiple sites in spine M79.2 Neuralgia and neuritis, unspecified For a complete list of coding options and descriptions, consult the current ICD-10-CM manual. 25
Pre-Authorization Process: Once a candidate has been identified, medical necessity has been established, and a Waiver of Financial Liability has been signed by the patient, a pre-authorization request should be submitted to the patient s insurance carrier prior to performing the COOLIEF* Thoracic Cooled Radiofrequency procedure. Note: Medicare does not have a pre-authorization process. It is recommended that a potential patient that is covered by Medicare sign an ABN (Advanced Beneficiary Notice). When submitting a pre-authorization request, the following steps should be taken: Place a call to the payer to verify insurance benefits and determine if a pre-authorization is required. Provide the payer with the patient s diagnosis and the appropriate CPT code If a pre-authorization is required, documentation to support medical necessity will be required which should be included in the letter of medical necessity (LOMN): Patient s brief medical history Physician s exam findings Copies of pertinent reports (MRIs, CT scans, etc) Alternative treatments previously tried How the activities of daily life are being impacted by the medical condition Duration of the diagnosis Identification of the site of service (office; ASC; or hospital outpatient) Note: Payers base their decisions on medical necessity, as well as benefits, therefore we encourage you to make a strong case for the patient s particular medical need for the thoracic medial branch neurotomy procedure. 26
Following is a sample letter of medical necessity for the COOLIEF* Thoracic Cooled Radiofrequency procedure to assist you in drafting a pre-authorization request. SAMPLE LETTER OF MEDICAL NECESSITY [Date] [Payer Address] Re: [Insert patient name and subscriber number] Dear [Medical Director]: Please consider this letter a request for preauthorization of benefits to treat my patient, [insert patient name], who suffers from [insert patient ICD-10-CA diagnosis code and description of procedure]. It is my clinical judgment that [Mr./Ms. insert patient last name] is an ideal candidate for radiofrequency (RF) denervation in the thoracic region utilizing the HALYARD* COOLIEF* Thoracic Cooled RF Pain Management System, and prior to scheduling this procedure I am seeking preauthorization and predetermination of benefits for my patient. Patient History [Mr./Ms. insert patient name] presented to me with complaints of [insert detailed patient history with description of patient s current condition including diagnosis, length of time problem has existed, current/ ongoing complaints, and level of impairment. Describe functional impairments, and how the patient s condition has impacted his/her activities of daily life.] Previous interventional treatment efforts include: [indicate procedures, medications, and/or therapies attempted include outcome of each treatment]. Despite these treatments and therapies, [Mr./Ms. insert patient name] has experienced no significant relief from [insert specific symptoms here]. A problem-focused history and exam was performed as well as [indicate scans, MRIs, X-rays, nerve blocks etc]. The findings of these test results confirm my diagnosis of [insert patient diagnosis code] and support my request for treatment. Proposed Treatment I am recommending a radiofrequency denervation procedure for the ablation of medial branch nerves in the thoracic region. The procedure involves the use of the HALYARD* COOLIEF* Thoracic Cooled RF Pain Management System to create targeted lesions at the medial branches of the thoracic dorsal rami. These nerves are known to innervate the thoracic zygapophysial 27
joints (z-joints) and are associated with thoracic z-joint pain. Because of the varied innervations in the thoracic region, large radiofrequency lesions are required to ensure complete ablation of the nervous tissue. Cooled RF technology utilized by the COOLIEF* Thoracic Cooled RF Pain Management System allows a large volume of tissue to be heated (without excessively heating tissue adjacent to the probe tip) compared to conventional radiofrequency electrodes. This procedure will be performed on [indicate anticipated date of procedure] at [indicate site of service and name of facility where the procedure will be performed physician office, outpatient hospital]. Please confirm if there are any restrictions on performing this procedure in this setting. Please confirm this procedure will be covered for [insert patient name] based on medical necessity. Please contact me at [insert phone number] if you have any questions. Sincerely, [Doctor signature] Dr. [doctor name] 28
COOLIEF* Lumbar Cooled Radiofrequency The COOLIEF* Lumbar Cooled Radiofrequency is designed to treat the pain associated with lumbar Z-joint pain through the use of an internally water-cooled radiofrequency probe to ablate the medial branches coursing over the base of the superior articular process of the lumbar spine. CPT Codes: 64635: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); lumbar or sacral, single facet joint 64636: Destruction by neurolytic agent, paravertebral facet joint nerve(s); (Fluoroscopy or CT); lumbar or sacral, each additional facet joint Lumbosacral medial branch neurotomy procedures are commonly performed at levels from L1 to L5. An example of coding commonly used by physicians performing lumbar medial branch neurotomy is listed below: RF lesion at L3-4 facet joint: 64635 RF lesion at L4-5 facet joint: 64636 RF lesion at L5/S1 facet joint: 64636 Note: For bilateral procedures, use Modifier-50 Effective January 1, 2016 the AMA added guidelines for the facet joint denervation CPT codes (64633, 64634, 64635 and 64636) that state that these codes should not be used for nonthermal facet joint denervation including chemical, low-grade thermal energy (< 80 degrees Celsius), or any form of pulsed radiofrequency. Note: The Cooled RF Temp (default setting of 60 degrees C) displayed on the COOLIEF* Cooled RF Generator refers to the cooled electrode temperature and does not reflect the surrounding tissue temperature. The heat generated from the radiofrequency energy produces thermal energy with average maximum tissue temperature greater than 80 degrees C. Device Codes: There are no specific HCPCS codes (C Code or pass-through code) for the COOLIEF* Probe Kit. The miscellaneous surgical supply code, A4649, can be used can be used to bill for the singleuse probe kit; however, it is at the payer s discretion to provide additional reimbursement. Coverage: Most commercial payers and Medicare provide coverage for RF denervation to treat lumbar facet joint pain. Requirements and limitations will vary between payers. Please check with the patient s insurance for their specific coverage policy on RF denervation for lumbar facet nerves. 29
ICD-9/ICD-10 Diagnosis Codes: Following is a list of possible diagnosis codes which may support medical necessity for RF denervation of lumbar facet nerves to treat the chronic pain caused by these medical conditions. This list is not intended to be an all-inclusive list. Other ICD-9 diagnostic codes may apply based on the patient s diagnosis. The physician must always make the final determination of the appropriate diagnosis code. ICD-9 CODE DESCRIPTION ICD-10 CODE DESCRIPTION 353.1 Lumbosacral plexus lesions G54.1 Lumbosacral plexus disorders 353.4 Lumbosacral root lesions, not elsewhere classified G54.4 Lumbosacral root disorders, not elsewhere classified 353.8 Other nerve root and plexus disorder G54.8 Other nerve root and plexus disorders G55 Nerve root and plexus compressions in diseases classified elsewhere 355.O Lesion of sciatic nerve G57.01 Lesion of sciatic nerve,right lower limb G57.02 Lesion of sciatic nerve, left lower limb 719.45 Pain in joint, pelvic region and thigh M25.551 Pain in right hip M25.552 Pain in left hip 720.1 Spinal enthesopathy M46.00 Spinal enthesopathy, site unspecified 721.3 Lumbosacral spondylosis without myelopathy M46.06 Spinal enthesopathy, lumbar region M46.07 Spinal enthesopathy, lumbosacral region M46.09 Spinal enthesopathy, multiple sites in spine M47.817 M47.26 M47.27 M47.816 721.6 Ankylosing vertebral hyperostosis M48.10 Spondylosis without myelopathy or radiculopathy, lumbosacral region Other spondylosis with radiculopathy, lumbar region Other spondylosis with radiculopathy, lumbosacral region Spondylosis without myelopathy or radiculopathy, lumbar region M47.896 Other spondylosis, lumbar region M47.897 Other spondylosis, lumbosacral region M48.16 M48.17 M48.19 Ankylosing hyperostosis (Forestier), site unspecified Ankylosing hyperostosis (Forestier), lumbar region Ankylosing hyperostosis (Forestier), lumbosacral region Ankylosing hyperostosis (Forestier), multiple sites in spine 721.7 Traumatic spondylopathy M48.36 Traumatic spondylopathy, lumbar region 722.83 722.93 Postlaminectomy syndrome, lumbar region Other and unspecified disc disorder, lumbar region M48.37 M96.1 Traumatic spondylopathy, lumbosacral region Postlaminectomy syndrome, not elsewhere classified M46.47 Discitis, unspecified, lumbosacral region M51.86 M51.87 Other intervertebral disc disorders, lumbar region Other intervertebral disc disorders, lumbosacral region M46.46 Discitis, unspecified, lumbar region 30