cp coolief cooled rf reimbursement guide rev april 2018 … · 2018-09-29 · dorsal rami exiting...

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REIMBURSEMENT GUIDE

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Page 1: CP COOLIEF Cooled RF Reimbursement Guide Rev April 2018 … · 2018-09-29 · dorsal rami exiting from the posterior sacral foramen at S1, S2, and S3. CPT® Codes: 64635: Destruction

REIMBURSEMENT GUIDE

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AVANOS* Pain Management Cooled RF Systems Reimbursement Guide

Table of Contents • Introduction ............................................................................ 2

• Reimbursement Hotline ............................................................. 3

• COOLIEF* TRANSDICAL* Disc Biacuplasty Cooled Radiofrequency .......... 3

• COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency ......................... 9

• COOLIEF* Cervical Cooled Radiofrequency ........................................ 18

• COOLIEF* Thoracic Cooled Radiofrequency.................................... 26

• COOLIEF* Lumbar Cooled Radiofrequency..................................... 33

• COOLIEF* Knee Cooled Radiofrequency ........................................ 38

• COOLIEF* Hip Cooled Radiofrequency .......................................... 45

• Appeals ...................................................................................... 51

• Appendix ............................................................................... 54

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 April 2018 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.

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Reimbursement Hotline To assist your office or facility, Avanos provides experienced reimbursement assistance for Coolief Cooled RF procedures through our consultant, The Reimbursement Group

(TRG). TRG provides physicians and hospital business staff with guidance to streamline the reimbursement process. The staff at TRG is experienced in working with URAC Standards and Patient Protection and Affordable Care Act criteria.

TRG’s certified medical coders, auditors, and nurse case managers are provided by Avanos to assist with your reimbursement needs, including:

• Filing pre-authorization requests for benefits on behalf of your patients • Answers to questions related to CPT and ICD-10 codes • Patient eligibility and benefits verification • Assistance with filing pre-service appeals and claim denials • Claim submission guidance • Peer-to-peer support

Reimbursement specialists are available Monday through Friday from 8:00 am to 8:00 pm EST. TRG can be reached at:

Phone: 1-855-779-6000 Fax: 224-433-5144 Email: [email protected]

Note: TRG is HIPAA compliant and can promptly answer your questions and begin working directly with your insurance carriers for your Coolief patients.

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

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Device Codes:

There are no specific 2018 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.

ICD-10-CM 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-10-CM 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-10-CM CODE DESCRIPTION

M51.36 Other intervertebral disc degeneration,lumbar region

M51.37 Other intervertebral disc degeneration,lumbosacral region

M51.36 Other intervertebral disc degeneration,lumbar region

M51.37 Other intervertebral disc degeneration,lumbosacral region

M46.47 Discitis, unspecified, lumbosacral region

M51.86 Other intervertebral disc disorders, lumbar region

M51.87 Other intervertebral disc disorders, lumbosacral region

M46.46 Discitis, unspecified, lumbar region

M54.5 Low back pain

M54.08 Panniculitis affecting regions of neck and back, sacral and sacrococcygeal region

M54.06 Panniculitis affecting regions of neck and back, lumbar region

M54.07 Panniculitis affecting regions of neck and back, lumbosacral region

M54.09 Panniculitis affecting regions of neck and back,multiple sites in spine region

M43.26 Fusion of spine,lumbar region

M43.27 Fusion of spine,lumbosacral region

M99.03 Segmental and somatic dysfuntion of lumbar region

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For a complete list of coding options and descriptions, consult the current ICD-10-CM manual.

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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.

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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.

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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 AVANOS* 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.)

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Sample Operative Note TRANSDISCAL RADIOFREQUENCY

Reference Material Only TRANSDISCAL RADIOFREQUENCY PATIENT:

MRN:

PREOPERATIVE DIAGNOSIS: POSTOPERATIVE DIAGNOSIS:

PROCEDURE: Radiofrequency ablation of the posterior and lateral annulus fibrosus

DATE OF PROCEDURE:

ANESTHESIA:

COMPLICATIONS:

CONSENT: A full description of the procedure was provided including benefits as well as possible complications. All questions were answered and informed consent was given and signed. ASA guidelines for fasting were verified prior to sedation.

PROCEDURE IN DETAIL The patient was brought into the procedure room and placed on the exam table in a comfortable prone position. A grounding pad was placed on the LEFT/RIGHT thigh. The lumbar spine was widely prepped with a chloraprep solution, allowed to air dry and draped in standard sterile surgical fashion. Local anesthesia was provided by mL of % delivered with a 25g needle.

Using intermittent fluoroscopy, a 17g 150mm radiofrequency introducer needle was placed at the planned anatomical targets with a perpendicular, extrapedicular approach inserting into the posterior annulus fibrosus. A second 17g 150mm introducer was placed contralateral to the first. The stylets were removed and two radiofrequency probes with 6mm active tips were inserted while ensuring the probes were extending from the introducers into the posterior annulus fibrosus.

Needle tip position of the probes were verified in the AP and lateral views. Radiofrequency energy was then delivered between the two probes in the annulus fibrosus at 50 degrees Celsius for 15 minutes. Tissue impedances were noted to be between 125-250 Ohms. A 2nd lesion on both the left and right side was performed at 80 degrees Celsius for 2 minutes and 30 seconds to cover the lateral border of the annulus without movement of the introducers/probes.

POST PROCEDURE EVALUATION: The patient tolerated the procedure well. After observation the patient was discharged with instructions and follow up. The patient was also provided contact information to call regarding any concerning symptoms or questions.

IMPRESSION: 1. Successful transdiscal radiofrequency ablation was performed without complication. 2. RTC in week(s). 3. Estimated Blood Loss: 4. Fluoroscopy time: seconds

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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 or XS (Medicare)

RF lesions at S2: 64640-59 or XS (Medicare)

RF lesions at S3: 64640-59 or XS (Medicare)

Note: For bilateral procedures, use Modifier-50

Services Reporting

CPT Modifiers provide additional information about the reported procedure. Many times the specific modifier may reflect actual reimbursement of services. CPT modifier may describe whether multiple procedures were performed, why that procedure was necessary, where the procedure was performed on the body, how many surgeons worked on the patient, and other information that may be critical to a claim’s status.

When reporting COOLIEF* sacroiliac thermal RF ablation services, the initial procedure should be reported without modifier. The second procedure, line item 2, can be reported with -59 modifier or XS (subset of modifier -59/Medicare) indicating that the treatment is being delivered to a new site/organ/nerve. The final procedure, line item 3, can also be reported with -59 modifier or XS (Medicare) indicating that this treatment is also being delivered to a new site/organ/nerve.

Check specific guidelines for reporting individual cases. Additional documentation may be required to support procedures reported with modifier-59 or XS. A complete list of all modifiers is available in the 2018 AMA CPT book and online on the Medicare website. See also sample below.

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Sample CPT/HCPCS Modifiers

Modifier Description

-22

Increased Procedural Services. When the work required to provide a service is significantly increased beyond the typical work required a modifier -22 may be appended. The documentation must support the increased services and the reasoning. (Examples include; increased time, technical difficulty, severity of patient condition, increased effort.)

-26 Professional Component. Some procedures have both a professional and technical component. When the modifier -26 is appended to the professional service the components may be paid separately per payor guidelines.

-50 Bilateral Procedure. When CPT codes are not identified as bilateral in the code description or parenthetical a modifier -50 may be appended when the procedure is performed bilaterally.

-51 Multiple Procedures. When more than one procedure is performed at the same session a modifier -51 is appended to additional procedures. It is not appended to codes listed as “add-on” codes.

-59 Distinct Procedural Service. Modifier -59 is used to report separate services that are distinct or independent and not normally reported together. Documentation must support the distinct service (Example; separate area of injury in extensive injuries)

Effective January 1, 2015 CMS has established four new modifiers to define specific subsets of the -59 modifier. Modifier -59 is still recognized but should not be used when a more descriptive modifier is available. The newly created -X{EPSU} modifiers are below.1

-XE Separate Encounter, A Service That Is Distinct Because It Occurred During A Separate Encounter

-XS Separate Structure, A Service That Is Distinct Because It Was Performed On A Separate Organ/Structure

-XP Separate Practitioner, A Service That Is Distinct Because It Was Performed By A Different Practitioner

-XU Unusual Non-Overlapping Service, The Use Of A Service That Is Distinct Because It Does Not Overlap Usual Components Of The Main Service

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 non- thermal 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.

1 MLN Matters®Number MM8863 http://cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8863.pdf (Accessed January 2018).

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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.”

Device Codes:

There are no specific 2018 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.

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ICD-10-CM 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-10-CM diagnostic codes may apply based on the patient’s diagnosis. The physician must always make the final determination of the appropriate diagnosis code.

ICD-10-CM CODE DESCRIPTION

G54.1 Lumbosacral plexus disorders

G54.4 Lumbosacral root disorders, not elsewhere classified

G54.8 Other nerve root and plexus disorders

G55 Nerve root and plexus compressions in diseases classified elsewhere

M25.551 Pain in right hip

M25.552 Pain in left hip

M45.0 Ankylosing spondylitis of multiple sites in spine

M45.7 Ankylosing spondylitis of lumbosacral region

M45.8 Ankylosing spondylitis sacral and sacrococcygeal region

M48.8X7 Other specified spondylopathies lumbosacral region

M48.8X8 Other specified spondylopathies sacral and sacrococcygeal region

M46.1 Sacroiliitis, not elsewhere classified

M47.817 Spondylosis without myelopathy or radiculopathy, lumbosacral region

M47.26 Other spondylosis with radiculopathy, lumbar region

M47.27 Other spondylosis with radiculopathy, lumbosacral region

M47.816 Spondylosis without myelopathy or radiculopathy, lumbar region

M47.896 Other spondylosis, lumbar region

M47.897 Other spondylosis, lumbosacral region

M54.5 Low back pain

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

M43.27 Fusion of spine, lumbosacral region

M43.28 Fusion of spine, sacral and sacrococcygeal region

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ICD-10-CM CODE DESCRIPTION M53.2X7 Spinal instabilities, lumbosacral region

M53.2X8 Spinal instabilities, sacral and sacrococcygeal region

M53.86 Other specified dorsopathies, lumbar region

M53.87 Other specified dorsopathies, lumbosacral region

M53.88 Other specified dorsopathies, sacral and sacrococcygeal region

M54.08 Panniculitis affecting regions of neck and back, sacral and sacrococcygeal region

M54.07 Panniculitis affecting regions of neck and back, lumbosacral region

M54.17 Radiculopathy, lumbosacral region

M99.04 Segmental and somatic dysfunction of sacral region

M99.05 Segmental and somatic dysfunction of pelvic region

Q76.2 Congenital spondylolisthesis

For a complete list of coding options and descriptions, consult the current ICD-10-CM manual.

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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.

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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.

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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.

The sacroiliac joint neurotomy procedure is performed using the AVANOS* COOLIEF* SINERGY* Sacroiliac Cooled RF Pain Management System. 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 AVANOS* 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.

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Sample Operative Note SINERGY SACROILIAC RADIOFREQUENCY

Reference Material Only

SINERGY SACROILIAC RADIOFREQUENCY PROCEDURE:

MRN:

PREOPERATIVE DIAGNOSIS: POSTOPERATIVE DIAGNOSIS:

PROCEDURE: 1. Radiofrequency Ablation of LT/RT L5 Dorsal Ramus and LT/RT L4 medial branch 2. Sacroiliac Joint Ablation - Lateral Branches of LT/RT S1, S2, S3

DATE OF PROCEDURE:

ANESTHESIA: MAC, Conscious Sedation, None

COMPLICATIONS: None

CONSENT: A full description of the procedure was provided including benefits as well as possible complications. All questions were answered and informed consent was given and signed. ASA guidelines for fasting were verified prior to sedation.

PROCEDURE IN DETAIL The patient was brought into the fluoroscopy suite and carefully assisted into the prone position on the fluoroscopy table and allowed to adjust to a position of comfort. A grounding pad was placed on the LEFT/RIGHT thigh. The low back and buttocks were widely prepped with a chloraprep solution, allowed to air dry and draped in standard sterile surgical fashion. Local anesthesia was provided by mL of % delivered with a 25 g needle.

PROCEDURE #1: Radiofrequency Ablation of Dorsal Ramus of L5, medial branch of L4. A 17g 75/100/150mm radiofrequency introducer needle was placed to the planned anatomic target, guided with intermittent fluoroscopy with a perpendicular approach, to terminally place at the LEFT/RIGHT sacral ala and the superior articular process at the transverse process for the LEFT/RIGHT L4 medial branch nerve. The stylets were removed and the radiofrequency probes with a 4mm active tip were then inserted. Needle tip position of the probes were verified in the AP, oblique, and lateral views. At each site, the medial branch nerve was stimulated at 2Hz to a maximum of 1-2volts determined to finalize safe needle and electrode placement. The patient was awake and responsive during this portion of the procedure. Each target was anesthetized with 1-2mL of % anesthesia for lesioning and then each target was lesioned at 80 degrees Celsius for 2 minutes and 30 seconds. Tissue impedences were noted to be between 250 and 500 Ohms.

PROCEDURE #2: Radiofrequency Ablation of S1, S2, S3 Lateral Branches Using the AP fluoroscopic view for visualization of the lateral PSFA as defined by the pre-placed 27-gauge Quincke needles, appropriate skin starting positions were defined. Using the PSFA as a “clock-face”, the positions were:

S1; Right = 1 o’clock, 3 o’clock and 5 o’clock S2; Right = 1 o’clock, 3 o’clock and 5 o’clock S3; Right = 1 o’clock, 5 o’clock

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Using fluoroscopic guidance, a 17g introducer needle was inserted sequentially onto the target positions described above until the introducer tip touched the bony surface of the sacrum. The stylet was withdrawn from the introducer and the radiofrequency probe with a 4 mm active tip was fully inserted into the introducer. A lateral view was obtained for standard reference. At each of the targets, needle placement was verified with the use of multi-planar fluoroscopy. The needle tip position was approximately 7 - 10mm lateral to the PSFA as determined by using an Epsilon ruler.

At each site, the lateral branch nerve was stimulated at 2 Hz to a maximum of 1-2 volts determined to finalize safe needle and electrode placement. The patient was awake and responsive during this portion of the procedure. Each target was anesthetized with 1-2 mL of % anesthesia for lesioning and then each target was lesioned at 80 degrees Celsius for 2 minutes and 30 seconds. Tissue impedences were noted to be between 250- 500 Ohms. At the conclusion of the lesioning the needles were removed and bandages placed over the needle placement sites and the patient returned to the supine position on a stretcher and transported to the recovery room without hemodynamic, neurologic, or allergic reactions. Fluoroscopic images were printed for hard copy recording and digitally archived.

FLUOROSCOPIC INTERPRETATION: Appropriate epidurogram obtained. Appropriate lesioning of the 10 targets noted.

POST PROCEDURE EVALUATION: The patient was comfortable in the recovery room. The patient is aware that pain may worsen before remitting and 4 – 6 weeks may be required prior to the onset of pain relief.

IMPRESSION: 1. Technically successful sacral lateral branch, lumbar dorsal ramus and L4 medial branch neurotomy for

denervation from L4-S3 on the LEFT/RIGHT without complication. 2. RTC in weeks. 3. Estimated Blood Loss: 4. Fluoroscopy time: seconds

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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 non- thermal 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 2018 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:

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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.

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ICD-10-CM 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-10-CM diagnostic codes may apply based on the patient’s diagnosis. The physician must always make the final determination of the appropriate diagnosis code.

ICD-10-CM CODE DESCRIPTION G24.3 Spasmodic torticollis

G89.4 Chronic pain syndrome

G50.1 Atypical face pain

G54.2 Cervical root disorders not elsewhere classified

M47.812 Spondylosis without myelopathy or radiculopathy, cervical region

M47.21 Other spondylosis with radiculopathy, occipito-atlanto-axial region

M47.22 Other spondylosis with radiculopathy, cervical region

M47.23 Other spondylosis with radiculopathy, cervicothoracic region

M47.811 Spondylosis without myelopathy or radiculopathy, occipito-atlanto-axial region

M47.813 Spondylosis without myelopathy or radiculopathy, cervicothoracic region

M47.891 Other spondylosis, occiiito-atlanto-axial region

M47.892 Other spondylosis, cervical region

M47.893 Other spondylosis, cervicothoracic region

M47.12 Other spondylosis with myelopathy, cervical region

M47.011 Anterior spinal artery compression syndromes, occipito-atlanto-axial region

M47.012 Anterior spinal artery compression syndromes, cervical region

M47.013 Anterior spinal artery compression syndromes, cervicothoracic region

M47.021 Vertebral artery compression syndromes, occipito-atlanto-axial region

M47.022 Vertebral artery compression syndromes, cervical region

M47.11 Other spondylosis with myelopathy, occipito-atlanto-axial region

M47.13 Other spondylosis with myelopathy, cervicothoracic region

M50.20 Other cervical disc displacement, unspecified cervical region

M50.21 Other cervical disc displacement, high cervical region

M50.22 Other cervical disc displacement, mid- cervical region

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ICD-10-CM CODE DESCRIPTION M50.23 Other cervical disc displacement, cervicothoracic region

M50.30 Other cervical disc degeneration, unspecified cervical region

M50.31 Other cervical disc degeneration, high cervical region

M50.32 Other cervical disc degeneration, mid- cervical region

M50.33 Other cervical disc degeneration, cervicothoracic region

M50.00 Cervical disc disorder with myelopathy, unspecified cervical region

M50.01 Cervical disc disorder with myelopathy, high cervical region

M50.02 Cervical disc disorder with myelopathy, mid-cervical region

M50.03 Cervical disc disorder with myelopathy, cervicothoracic region

M48.02 Spinal stenosis, cervical region

M48.01 Spinal stenosis, occipito-atlanto-axial region

M48.03 Spinal stenosis, cervicothoracic region

M99.21 Subluxation stenosis of neural canal of cervical region

M99.31 Osseous stenosis of neural canal of cervical region

M99.41 Connective tissue stenosis of neural canal of cervical region

M99.51 Intervertebral disc stenosis of neural canal of cervical regiion

M99.61 Osseous and subluxation stenosis of intervertebral foramina of cervical region

M99.71 Connective tissue and disc stenosis of intervertebral foramina of cervical region

M54.2 Cervicalgia

M54.12 Radiculopathy, cervical region

M54.13 Radiculopathy, cervicothoracic region

M50.10 Cervical disc disorder with radiculopathy, unspecified cervical region

M50.11 Cervical disc disorder with radiculopathy, high cervical region

M50.12 Cervical disc disorder with radiculopathy,mid-cervical region

M50.13 Cervical disc disorder with radiculopathy, cervicothoracic region

M54.11 Radiculopathy, occipito-atlanto-axial region

M53.82 Other specified dorsopathies, cervical region

M53.81 Other specified dorsopathies, occipito- atlanto-axial region

M53.83 Other specified dorsopathies, cervicothoracic region

M54.81 Occipital neuralgia

M54.03 Panniculitis affecting regions of neck and back, cervicothoracic region

M54.09 Panniculitis affecting regions of neck and back, multiple sites in spine

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ICD-10-CM CODE DESCRIPTION M80.08XA Age-related osteopororosis with current pathologiacl fracture,vertebra€, initial encounter for

fracture

M84.68XA Pathological fracture in other disease, other site, initial encounter for fracture

M48.51XA Collapsed verterbra, not elsewhere classified, occipito-atlanto-axial region, initial encounter for fracture

M48.52XA Collapsed verterbra, not elsewhere classified, cervical region, initial encounter for fracture

M48.53XA Collapsed verterbra, not elsewhere classified, cervicothoracic region, initial encounter for fracture

M80.88XA Other osteoporosis with current pathological fracture, vertebra€, initial encounter

M84.58XA Pathological fracture in neoplastic disease, other specified site, initial encounter

S13.4XXA Sprain of ligaments of cervical spine, initial encounter

S13.8XXA Sprain of joints and ligaments of other parts of neck, initial encounter

S16.1XXA Strain of muscle, fascia and tendon at neck level, initial encounter

S14.2XXA 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) • 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)

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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.

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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 AVANOS* 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.

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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 AVANOS* 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]

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Sample Operative Note CERVICAL RADIOFREQUENCY

Reference Material Only

CERVICAL 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

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-guage (50mm/75mm) insulated sharp radiofrequency introducer 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 radiofrequency lesion of the medial branch of C4 was then performed at 80 degrees Celsius 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.

IMPRESSION: 1. Successful bilateral C4, C5, and C6 cervical medial branch radiofrequency ablation. 2. Follow-up in 3 weeks to assess the efficacy of this procedure.

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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 non- thermal 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 2018 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:

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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.

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ICD-10-CM 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-10-CM diagnostic codes may apply based on the patient’s diagnosis. The physician must always make the final determination of the appropriate diagnosis code.

ICD-10-CM CODE DESCRIPTION

G54.3 Thoracic root disorders, not elsewhere classified

G54.8 Other nerve root and plexus disorders

G55 Nerve root and plexus compressios in diseases classified elsewhere

M45.0 Ankylosing spondylitis of multiple sites in spine

M45.3 Ankylosing spondylitis of cervicothoracic region

M45.4 Ankylosing spondylitis of thoracic region

M45.5 Ankylosing spondylitis of thoracolumbar region

M48.8X3 Other specified spondylopathies, cervicothoracic region

M48.8X4 Other specified spondylopathies, thoracic region

M48.8X5 Other specified spondylopathies, thoracolumbar region

M48.8X9 Other specified spondylopathies, site unspecified thoracolumbar region

M46.03 Spinal enthesopathy, cervicothoracic region

M46.94 Spinal enthesopathy, thoracic region

M46.05 Spinal enthesopathy, thoracolumbar region

M46.09 Spinal enthesopathy, multiple sites in spine

M47.814 Spondylosis without myelopathy or radiculopathy, thoracic region

M47.24 Other spondylosis with radiculopathy, thoracic region

M47.25 Other spondylosis with radiculopathy, thoracolumbar region

M47.815 Spondylosis without myelopathy or radiculopathy, thoracolumbar region

M47.894 Other spondylosis, thoracic region

M47.895 Other spondylosis, thoracolumbar region

M48.13 Ankylosing hyperostosis (Forestier), cervicothoracic region

M48.14 Ankylosing hyperostosis (Forestier), thoracic region

M48.15 Ankylosing hyperostosis (Forestier), thoracolumbar region

M48.19 Ankylosing hyperostosis (Forestier), multiple sites in spine

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ICD-10-CM CODE DESCRIPTION

M48.33 Traumatic spondylopathy, cervicothoracic region

M48.34 Traumatic spondylopathy, thoracic region

M48.35 Traumatic spondylopathy, thoracolumbar region

M96.1 Postlaminectomy syndrome, not elsewhere classified

M54.6 Pain in thoracic spine

M54.14 Radiculopathy, thoracic region

M54.15 Radiculopathy, thoracolumbar region

M51.14 Intervertebral disc disorders with radiculopathy, thoracic region

M51.15 Intervertebral disc disorders with radiculopathy, thoracolumbar region

M54.03 Panniculitis affecting regions of neck and back, cervicothoracic region

M54.04 Panniculitis affecting regions of neck and back, thoracic region

M54.05 Panniculitis affecting regions of neck and back, thoracolumbar region

M54.09 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.

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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.

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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 AVANOS* 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 AVANOS* 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

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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]

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Sample Operative Note THORACIC RADIOFREQUENCY

Reference Material Only

THORACIC RADIOFREQUENCY PATIENT:

MRN:

PREOPERATIVE DIAGNOSIS: POSTOPERATIVE DIAGNOSIS:

PROCEDURE:

1. T4 Medial Branch Radiofrequency Denervation 2. T5 Medial Branch Radiofrequency Denervation 3. T6 Medial Branch Radiofrequency Denervation

DATE OF PROCEDURE:

ANESTHESIA:

COMPLICATIONS:

CONSENT: A full description of the procedure was provided including benefits as well as possible complications. All questions were answered and informed consent was given and signed. ASA guidelines for fasting were verified prior to sedation.

PROCEDURE IN DETAIL The patient was brought into the procedure room and placed on the exam table in a comfortable prone position. A grounding pad was placed on the LEFT/RIGHT thigh. The thoracic region was widely prepped with a chloraprep solution, allowed to air dry and draped in standard sterile surgical fashion. Local anesthesia was provided by mL of % delivered with a 25g needle.

Using intermittent fluoroscopy, a 17g 75mm radiofrequency introducer needle was perpendicularly placed at the inferior lateral aspect of the transverse process of T4 and guided until bony contact was felt. The introducer was then guided to the final placement at the superolateral aspect of the Right T4 transverse process. The stylet was removed and a radiofrequency probe with a 5.5mm active tip was inserted. Needle tip position of the probe was verified in the AP, oblique and lateral views. The medial branch nerve was stimulated at 2Hz to a maximum of 1-2 volts to determine finalization of safe needle and electrode placement. A mixture consisting of was slowly injected and then the target was lesioned at 80 degrees Celsius for 2 minutes and 30 seconds. The identical protocol was then conducted at the T5 and T6 levels. Tissue impedances were noted to be between 150 and 500 Ohms at each site.

POST PROCEDURE EVALUATION: The patient tolerated the procedure well. After observation the patient was discharged with instructions and follow up. The patient was also provided contact information to call regarding any concerning symptoms or questions.

IMPRESSION: 1. Successful thoracic medial branch radiofrequency ablations were performed without complication. 2. RTC in week(s). 3. Estimated Blood Loss: 4. Fluoroscopy time: seconds

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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 non- thermal 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 single- use probe kit; however, it is at the payer’s discretion to provide additional reimbursement.

Coverage:

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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.

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ICD-10-CM 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-10-CM diagnostic codes may apply based on the patient’s diagnosis. The physician must always make the final determination of the appropriate diagnosis code.

ICD-10-CM CODE DESCRIPTION

G54.1 Lumbosacral plexus disorders

G54.4 Lumbosacral root disorders, not elsewhere classified

G54.8 Other nerve root and plexus disorders

G55 Nerve root and plexus compressions in diseases classified elsewhere

G57.01 Lesion of sciatic nerve,right lower limb

G57.02 Lesion of sciatic nerve, left lower limb

M25.551 Pain in right hip

M25.552 Pain in left hip

M46.00 Spinal enthesopathy, site unspecified

M46.06 Spinal enthesopathy, lumbar region

M46.07 Spinal enthesopathy, lumbosacral region

M46.09 Spinal enthesopathy, multiple sites in spine

M47.817 Spondylosis without myelopathy or radiculopathy, lumbosacral region

M47.26 Other spondylosis with radiculopathy, lumbar region

M47.27 Other spondylosis with radiculopathy, lumbosacral region

M47.816 Spondylosis without myelopathy or radiculopathy, lumbar region

M47.896 Other spondylosis, lumbar region

M47.897 Other spondylosis, lumbosacral region

M48.10 Ankylosing hyperostosis (Forestier), site unspecified

M48.16 Ankylosing hyperostosis (Forestier), lumbar region

M48.17 Ankylosing hyperostosis (Forestier), lumbosacral region

M48.19 Ankylosing hyperostosis (Forestier), multiple sites in spine

M48.36 Traumatic spondylopathy, lumbar region

M48.37 Traumatic spondylopathy, lumbosacral region

M96.1 Postlaminectomy syndrome, not elsewhere classified

M46.47 Discitis, unspecified, lumbosacral region

M51.86 Other intervertebral disc disorders, lumbar region

M51.87 Other intervertebral disc disorders, lumbosacral region

M46.46 Discitis, unspecified, lumbar region

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ICD-10-CM CODE DESCRIPTION

M48.06 Spinal stenosis, lumbar region

M48.07 Spinal stenosis, lumbosacral region

M99.23 Subluxation stenosis of neural canal of lumbar region

M99.33 Osseous stenosis of neural canal of lumbar region

M99.43 Connective tissue stenosis of neural canal of lumbar region

M99.53 Intervertebral disc stenosis of neural canal of lumbar regiion

M99.63 Osseous and subluxation stenosis of intervertebral foramina of lumbar region

M99.73 Connective tissue and disc stenosis of intervertebral foramina of lumbar region

M54.5 Low back pain

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

M54.16 Radiculopathy, lumbar region

M54.17 Radiculopathy, lumbosacral region

M51.16 Intervertebral disc disorders with radiculopathy, lumbar region

M51.17 Intervertebral disc disorders with radiculopathy, lumbosacral region

M54.89 Other dorsalgia

M43.27 Fusion of spine, lumbosacral region

M53.2X7 Spinal instabilities, lumbosacral region

M53.86 Other specified dorsopathies, lumbar region

M53.87 Other specified dorsopathies, lumbosacral region

M54.06 Panniculitis affecting regions of neck and back, lumbar region

M54.07 Panniculitis affecting regions of neck and back, lumbosacral region

M54.09 Panniculitis affecting regions of neck and back, multiple sites in spine

M43.8X9 Other specified deforming dorsopathies, site unspecified

M43.26 Fusion of spine, lumbar region

M43.27 Fusion of spine, lumbosacral region

M53.80 Other specified dorsopathies, site unspecified

M53.85 Other specified deforming dorsopathies, thoracolumbar region

M99.03 Segmental and somatic dysfunction of lumbar region

M99.04 Segmental and somatic dysfunction of sacral region

Q76.2 Congenital spondylolisthesis

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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 may be required by the patient’s insurance carrier.

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 lumbar medial branch neurotomy procedure.

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Sample Operative Note LUMBAR RADIOFREQUENCY

Reference Material Only

LUMBAR RADIOFREQUENCY PATIENT:

MRN:

PREOPERATIVE DIAGNOSIS: Lumbar Spondylosis

POSTOPERATIVE DIAGNOSIS: Lumbar Spondylosis

PROCEDURE: Radiofrequency Ablation of medial branches - RT L1 L2 L3 L4 L5 / LT L1 L2 L3 L4 L5

DATE OF PROCEDURE:

ANESTHESIA: MAC, Conscious Sedation, None

COMPLICATIONS: None

CONSENT: A full description of the procedure was provided including benefits as well as possible complications. All questions were answered and informed consent was given and signed. ASA guidelines for fasting were verified prior to sedation.

PROCEDURE IN DETAIL The patient was brought into the fluoroscopy suite and positioned into the prone position on the fluoroscopy table and allowed to adjust to a position of comfort. A grounding pad was placed on the LEFT/RIGHT thigh. The lumbar region was widely prepped with a chloraprep solution, allowed to air dry and draped in standard sterile surgical fashion. Local anesthesia was provided by mL of % delivered with a 25 g needle.

A 17g 75/100/150mm radiofrequency introducer needle was placed to the planned anatomic targets guided with intermittent fluoroscopy with a perpendicular approach to terminally place at the junction of the superior articular process and the transverse process of the LEFT/RIGHT L1 L2 L3 L4 L5 and the base of the sacral ala on the LEFT/RIGHT for the L5 medial branch nerve. The stylets were removed and radiofrequency probes with a 4mm active tip were then inserted. Needle tip position of the probes was verified in the AP, oblique, and lateral views. At each site, the medial branch nerve was stimulated at 2 Hz to a maximum 1-2 volts determined to finalize safe needle and electrode placement. The patient was awake and responsive during this portion of the procedure. Each target was anesthetized with 1-2 mL of % for anesthesia for lesioning and then each target was lesioned at 80 degrees Celsius for 2 minutes and 30 seconds. Tissue impedences were noted to be between 250 and 500 Ohms. Electrodes and needles were then removed and bandages placed over the needle placement sites, the patient then returned to the supine position on a stretcher and transported to the recovery room without hemodynamic, neurologic, or allergic reactions. Fluoroscopic images were printed for hard copy recording and digitally archived.

POST PROCEDURE EVALUATION: The patient was comfortable in the recovery room. The patient is aware that pain may worsen before remitting and 4 – 6 weeks may be required prior to the onset of pain relief.

IMPRESSION: 1. Technically successful LEFT/RIGHT L1 L2 L3 L4 L5 medial branch radiofrequency neurotomy for denervation

on the LEFT/RIGHT without complication. 2. RTC in weeks. 3. Estimated Blood Loss: 4. Fluoroscopy time: seconds

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COOLIEF* Knee Cooled Radiofrequency COOLIEF* Knee Cooled Radiofrequency is performed to treat the pain associated with chronic knee osteoarthritis (OA) through the use of an internally water-cooled radiofrequency probe to ablate the articular branches of the knee known as genicular nerves.

CPT Codes:

64640: Destruction by neurolytic agent, other peripheral nerve or branch

COOLIEF* Knee Cooled Radiofrequency is generally performed to ablate the superolateral genicular branch from the vastus lateralis, the superomedial genicular branch from the vastus medialis, and the inferomedial genicular branch from the saphenous nerve. An example of coding commonly used by physicians performing genicular neurotomy is listed below:

RF Lesion of superolateral genicular branch from the vastus lateral: 64640

RF Lesion of superomedial genicular branch from the vastus medialis: 64640-59 or XS (Medicare)

RF Lesion of inferomedial genicular branch from the saphenous nerve: 64640-59 or XS (Medicare)

Services Reporting

CPT Modifiers provide additional information about the reported procedure. Many times the specific modifier may reflect actual reimbursement of services. CPT modifier may describe whether multiple procedures were performed, why that procedure was necessary, where the procedure was performed on the body, how many surgeons worked on the patient, and other information that may be critical to a claim’s status.

When reporting COOLIEF* genicular thermal RF ablation services, as outlined in the previously studied protocol, three separate nerves are being ablated during the same intervention. As such, the initial procedure should be reported without modifier. The second procedure, line item 2, can be reported with -59 modifier or XS (subset of modifier -59/Medicare) indicating that the treatment is being delivered to a new site/organ/nerve. The final procedure, line item 3, can also be reported with -59 modifier or XS (Medicare) indicating that this treatment is also being delivered to a new site/organ/nerve.

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Check specific guidelines for reporting individual cases. Additional documentation may be required to support procedures reported with modifier-59 or XS. A complete list of all modifiers is available in the 2018 AMA CPT book and online on the Medicare website. See also sample below.

Sample CPT/HCPCS Modifiers

Modifier Description

-22

Increased Procedural Services. When the work required to provide a service is significantly increased beyond the typical work required a modifier -22 may be appended. The documentation must support the increased services and the reasoning. (Examples include; increased time, technical difficulty, severity of patient condition, increased effort.)

-26 Professional Component. Some procedures have both a professional and technical component. When the modifier -26 is appended to the professional service the components may be paid separately per payor guidelines.

-50 Bilateral Procedure. When CPT codes are not identified as bilateral in the code description or parenthetical a modifier -50 may be appended when the procedure is performed bilaterally.

-51 Multiple Procedures. When more than one procedure is performed at the same session a modifier -51 is appended to additional procedures. It is not appended to codes listed as “add-on” codes.

-59 Distinct Procedural Service. Modifier -59 is used to report separate services that are distinct or independent and not normally reported together. Documentation must support the distinct service (Example; separate area of injury in extensive injuries)

Effective January 1, 2015 CMS has established four new modifiers to define specific subsets of the -59 modifier. Modifier -59 is still recognized but should not be used when a more descriptive modifier is available. The newly created -X{EPSU} modifiers are below.2

-XE Separate Encounter, A Service That Is Distinct Because It Occurred During A Separate Encounter

-XS Separate Structure, A Service That Is Distinct Because It Was Performed on A Separate Organ/Structure

-XP Separate Practitioner, A Service That Is Distinct Because It Was Performed by A Different Practitioner

-XU Unusual Non-Overlapping Service, The Use of A Service That Is Distinct Because It Does Not Overlap Usual Components Of The Main Service

Device Codes:

There are no specific 2018 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.

2 MLN Matters®Number MM8863 http://cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8863.pdf (Accessed January 2018).

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ICD-10-CM Diagnosis Codes:

Following is a list of possible diagnosis codes which may support medical necessity for genicular neurotomy to treat the chronic pain caused by these conditions. This list is not intended to be an all-inclusive list. Other ICD-10 diagnostic codes may apply based on the patient’s diagnosis.

The physician must always make the final determination of the appropriate diagnosis code.

ICD-10-CM CODE DESCRIPTION

M17.10 Unilateral primary osteoarthritis, unspecified, knee

M17.0 Bilateral primary osteoarthritis of knee

M17.11 Unilateral primary osteoarthritis, right knee

M17.12 Unilateral primary osteoarthritis, left knee

M17.5 Other unilateral secondary osteoarthritis of knee

M17.2 Bilateral post-tarumatic osteoarthritis of knee

M17.30 Unliateral post-traumatic osteoarthritis, unspecified knee

M17.31 Unilateral post-traumatic osteoarthritis, right knee

M17.32 Unilateral post-traumatic osteoarthritis, left knee

M17.4 Other bilateral secondary osteoarthritis of knee

M12.561 Traumatic arthropathy, right knee

M12.562 Traumatic arthropathy, left knee

M13.169

M13.161 Monoarthritis, not elsewhere classified, right knee

M13.162 Monoarthritis, not elsewhere classified, left knee

M12.869 Other specific arthropathies, not elsewhere classified, unspecified knee

M07.661 Enteropathic arthropathies, right knee

M07.662 Enteropathic arthropathies, left knee

M07.669 Enteropathic arthropathies, unspecified knee

M12.861 Other specific arthropathies, not elsewhere classified, right knee

M12.862 Other specific arthropathies, not elsewhere classified, left knee

For a complete list of coding options and descriptions, consult the current ICD-10-CM manual.

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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 may be required by the patient’s insurance carrier.

Note: Medicare does not have a pre-authorization process. It is recommended that a potential patient 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 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 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 genicular neurotomy.

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Following is a sample letter of medical necessity for the genicular neurotomy 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-9 diagnosis code and description of procedure]. It is my clinical judgment that [Mr./Ms. Insert patient last name] is an ideal candidate for genicular neurotomy, and prior to scheduling this procedure I am seeking preauthorization and predetermination of benefits for my patient.

Patient History [Mr./Ms. Insert patient last 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 treatment efforts include: [indicate procedures, medications, and/or therapies attempted – include outcome of each treatment]. Despite these treatments and therapies, [Mr./Ms. Insert patient last 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, etc.]. The findings of these test results confirm my diagnosis of [insert patient diagnosis code] and support my request for treatment.

I am recommending a radiofrequency denervation procedure, genicular neurotomy, for the ablation of the articular branches of the knee known as the genicular nerves. The procedure involves the use of the COOLIEF* cooled radiofrequency probes to create targeted lesions at the superolateral genicular branch from the vastus lateralis; the superomedial genicular branch from the vastus medialis; and the inferomedial genicular branch from the saphenous nerve.

Because of the varied innervations of these nerves, large radiofrequency lesions are required to ensure complete ablation of each of these three separate nerves. Cooled RF technology allows a large volume of tissue to be heated [without excessively heating the tissue adjacent to the probe tip] compared to conventional radiofrequency electrodes.

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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, ASC]. 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]

Encl. [relevant diagnostic tests and results, patient’s pertinent medical history records, etc.]

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Sample Operative Note KNEE RADIOFREQUENCY

Reference Material Only

KNEE RADIOFREQUENCY

PROCEDURE:

1. Superolateral genicular branch from the vastus lateralis 2. Superomedial genicular branch from the vastus medialis 3. Inferomedial genicular branch from the saphenous nerve 4. (Optional) Terminal branch of the nerve vastus intermedius

DATE OF PROCEDURE:

ANESTHESIA:

COMPLICATIONS:

PROCEDURE IN DETAIL: Hx/PE/meds/allergies/applicable labs reviewed. No changes and no contraindications were found. Full description of the procedure was provided including benefits as well as possible complications including transient increased pain, stomach irritation, mood alteration, transient weakness or parasthesias as well as more serious nerve injury, bleeding, infection or allergic reaction. Informed consent was obtained and documented.

The patient was brought to the procedure room and placed on the exam table in a comfortable supine position. The place for needle placement was obtained by manual palpation with radiographic confirmation. The sterile field was prepared by chloroprep and sterile drapes. Local anesthesia superficial and deep was provided by local infiltration of .

A 17g 75/100/150mm radiofrequency introducer needle with a 4 mm active tip was placed overlying the Right/left knee joint and using fluoroscopic guidance the needle was advanced to a bony endpoint on the superiolateral portion of the femoral condyle of the Right/left knee. A second needle was advanced to a bony endpoint on the superiomedial portion of the femoral condyle. A third needle was then placed over the inferiomedial portion of the tibial condyle until a bony endpoint was met. Attempted aspiration yielded no blood. Lateral x-ray views showed all the needles at 50% depth of the femur and tibia. Motor stimulation was tested ad 2.0 volts with no leg movement. Images were saved in AP and lateral. A mixture consisting of was slowly injected. Then a radiofrequency ablation of each of the geniculate nerves were done at 80 degrees Celsius for 2 minutes and 30 seconds each. The needles were withdrawn. The patient tolerated the procedure well. After observation the patient was discharged with instructions and follow up. They were also provided contact information to call regarding any concerning symptoms or questions.

IMPRESSION: 1. Successful geniculate knee radiofrequency ablation was performed. 2. The patient was given prescription of 3. RTC in week(s).

This information cannot guarantee coverage or reimbursement for radiofrequency neurotomy and Avanos makes no other representations as to selecting codes for radiofrequency neurotomy or compliance with any other billing protocols or prerequisites. As with all claims, individual physicians and hospitals are responsible for exercising their independent clinical judgment in selecting the codes that most accurately reflect the patient’s condition and procedures performed for a patient. Physicians and hospitals should refer to current, complete, and authoritative publications such as AMA CPT lists or insurer policies for selecting codes and completing claims forms based on the care rendered to an individual patient, and may wish to contact individual carriers, fiscal intermediaries, or other third-party payers as needed.

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COOLIEF* Hip Cooled Radiofrequency COOLIEF* Hip Cooled Radiofrequency is performed to treat the pain associated with chronic hip joint pain of the hip through the use of an internally water-cooled radiofrequency probe to ablate the femoral and obturator nerves.

CPT Codes:

There are two coding options when performing hip neurotomy:

• 64640: Destruction by neurolytic agent, other peripheral nerve or branch

Obturator and femoral articular sensory branch neurotomy is generally performed to ablate the femoral and obturator nerves. If using CPT code 64640, an example of coding commonly used by physicians is listed below:

• RF Lesion of femoral nerve: 64640 • RF Lesion of obturator nerve: 64640-59 or XS (Medicare) • In addition, the physician can bill for fluoroscopic guidance using CPT code 77002-26.

Services Reporting

CPT Modifiers provide additional information about the reported procedure. Many times the specific modifier may reflect actual reimbursement of services. CPT modifier may describe whether multiple procedures were performed, why that procedure was necessary, where the procedure was performed on the body, how many surgeons worked on the patient, and other information that may be critical to a claim’s status.

When reporting COOLIEF* hip thermal RF ablation services, the initial procedure should be reported without modifier. The second procedure, line item 2, can be reported with -59 modifier or XS (subset of modifier -59/Medicare) indicating that the treatment is being delivered to a new site/organ/nerve.

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Check specific guidelines for reporting individual cases. Additional documentation may be required to support procedures reported with modifier-59 or XS. A complete list of all modifiers is available in the 2018 AMA CPT book and online on the Medicare website. See also sample below.

Sample CPT/HCPCS Modifiers

Modifier Description

-22

Increased Procedural Services. When the work required to provide a service is significantly increased beyond the typical work required a modifier -22 may be appended. The documentation must support the increased services and the reasoning. (Examples include; increased time, technical difficulty, severity of patient condition, increased effort.)

-26 Professional Component. Some procedures have both a professional and technical component. When the modifier -26 is appended to the professional service the components may be paid separately per payor guidelines.

-50 Bilateral Procedure. When CPT codes are not identified as bilateral in the code description or parenthetical a modifier -50 may be appended when the procedure is performed bilaterally.

-51 Multiple Procedures. When more than one procedure is performed at the same session a modifier -51 is appended to additional procedures. It is not appended to codes listed as “add-on” codes.

-59 Distinct Procedural Service. Modifier -59 is used to report separate services that are distinct or independent and not normally reported together. Documentation must support the distinct service (Example; separate area of injury in extensive injuries)

Effective January 1, 2015 CMS has established four new modifiers to define specific subsets of the -59 modifier. Modifier -59 is still recognized but should not be used when a more descriptive modifier is available. The newly created -X{EPSU} modifiers are below.3

-XE Separate Encounter, A Service That Is Distinct Because It Occurred During A Separate Encounter

-XS Separate Structure, A Service That Is Distinct Because It Was Performed On A Separate Organ/Structure

-XP Separate Practitioner, A Service That Is Distinct Because It Was Performed By A Different Practitioner

-XU Unusual Non-Overlapping Service, The Use Of A Service That Is Distinct Because It Does Not Overlap Usual Components Of The Main Service

Device Codes:

There are no specific 2018 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.

3 MLN Matters®Number MM8863 http://cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8863.pdf (Accessed January 2018).

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ICD-10 CM Diagnosis Codes:

Following is a list of possible diagnosis codes which may support medical necessity for hip neurotomy to treat the chronic pain caused by these conditions. This list is not intended to be an all-inclusive list. Other ICD-10-CM diagnostic codes may apply based on the patient’s diagnosis. The physician must always make the final determination of the appropriate diagnosis code.

ICD-10 CODE DESCRIPTION

M16.0 Bilateral primary osteoarthritis of hip

M16.11 Unilateral primary osteoarthritis, right hip

M16.12 Unilateral primary osteoarthritis, left hip

M16.7 Other unilateral secondary osteoarthritis of hip

M16.2 Bilateral osteoarthritis resulting from hip dysplasia

M16.30 Unilateral osteoarthritis resulting from hip dysplasia, unspecified hip

M16.31 Unilateral osteoarthritis resulting from hip dysplasia, right hip

M16.32 Unilateral osteoarthritis resulting from hip dysplasia, left hip

M16.4 Bilateral post-traumatic osteoarthritis of hip

M16.51 Unilateral post-traumatic osteoarthritis, right hip

M16.52 Unilateral post-traumatic osteoarthritis, left hip

M16.6 Other bilateral secondary osteoarthritis of hip

M12.551 Traumatic arthropathy, right hip

M12.552 Traumatic arthropathy, left hip

M13.851 Other specified arthritis, right hip

M13.852 Other specified arthritis, left hip

M13.0 Polyarthritis, unspecified

M13.151 Monoarthritis, not elsewhere classified, right hip

M13.152 Monoarthritis, not elsewhere classified, left hip

M07.651 Enteropathic arthropathies, right hip

M07.652 Enteropathic arthropathies,left hip

M12.851 Other specific arthropathies, not elsewhere classified, right hip

M12.852 Other specific arthropathies, not elsewhere classified, left hip

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ICD-10-CM CODE DESCRIPTION

M25.551 Pain in right hip

M25.552 Pain in left hip

R29.4 Clicking hip

M25.859 Other specified joint disorders, unspecified hip

M25.851 Other specified joint disorders, right hip

M25.852 Other specified joint disorders, left hip

M70.61 Trochanteric bursitis, right hip

M70.62 Trochanteric bursitis, left hip

M70.71 Other bursitis of hip, right hip

M70.72 Other bursitis of hip, left hip

M76.01 Gluteal tendinitis, right hip

M76.02 Gluteal tendinitis, left hip

M76.11 Psoas tendinitis, right hip

M76.12 Psoas tendinitis, left hip

M76.21 Iliac crest spur, right hip

M76.22 Iliac crest spur, left hip

M76.31 Iliotibial band syndrome, right leg

M76.32 Iliotibial band syndrome, left leg

For a complete list of coding options and descriptions, consult the current ICD-10-CM manual.

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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 may be required by the patient’s insurance carrier.

Note: Medicare does not have a pre-authorization process. It is recommended that a potential patient 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 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 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 Obturator and Femoral Articular Sensory Branch Neurotomy.

Following is a sample letter of medical necessity for the COOLIEF* Hip 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-9 diagnosis code and description of procedure]. It is my clinical judgment that [Mr./Ms. Insert patient last name] is an ideal candidate for hip neurotomy, and prior to scheduling this procedure I am seeking preauthorization and predetermination of benefits for my patient.

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Patient History [Mr./Ms. Insert patient last 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 treatment efforts include: [indicate procedures, medications, and/or therapies attempted – include outcome of each treatment]. Despite these treatments and therapies, [Mr./Ms. Insert patient last 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, etc.]. The findings of these test results confirm my diagnosis of [insert patient diagnosis code] and support my request for treatment.

I am recommending a radiofrequency denervation procedure, COOLIEF* Hip Cooled Radiofrequency, for the ablation of the femoral and obturator nerves. The procedure involves the use of the COOLIEF* cooled radiofrequency probes to create targeted lesions at the femoral nerve and the obturator nerve. Because of the varied innervations of these nerves, large radiofrequency lesions are required to ensure complete ablation of each of these two separate nerves. Cooled RF technology allows a large volume of tissue to be heated [without excessively heating the 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, ASC]. 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]

Encl. [relevant diagnostic tests and results, patient’s pertinent medical history records, etc.]

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Sample Operative Note HIP RADIOFREQUENCY

Reference Material Only

HIP RADIOFREQUENCY

PROCEDURE:

1. L/R articular branch of femoral nerve radiofrequency denervation 2. L/R articular branch of obturator nerve radiofrequency denervation

DATE OF PROCEDURE: ANESTHESIA: COMPLICATIONS:

PROCEDURE IN DETAIL: Hx/PE/meds/allergies/applicable labs reviewed. No changes and no contraindications were found. Full description of the procedure was provided including benefits as well as possible complications including transient increased pain, stomach irritation, mood alteration, transient weakness or parathesias as well as more serious nerve injury, bleeding, infection or allergic reaction. Informed consent was obtained and documented.

The patient was brought to the procedure room and placed on the exam table in a comfortable prone/supine position. The place for the needle placement was obtained by manual palpation with radiographic confirmation. The sterile field was prepared by and sterile drapes. Local anesthesia superficial and deep was provided by local infiltration of ml % and ml %.

Using fluoroscopic guidance, a 17g 150/100/75mm radiofrequency introducer needle with 4mm active tip was advanced to the anteromedial aspect of the extraarticular portion of the hip joint where the articular branch of the femoral nerve traverses until a bony endpoint is felt. Attempted aspiration yielded no blood. Motor testing was then performed with

volts and no lower extremity motor stimulation was observed. cc of % was injected through the RF needle. A radiofrequency lesion of the articular branch of the femoral nerve was then performed at 80 degrees Celsius for 2 min and 30 seconds. The needle was then withdrawn.

A second needle was placed and using fluoroscopic guidance the needle was advanced to the incisura of the acetabulum where the articular branch of the obturator nerve traverses until a bony endpoint was met. Attempted aspiration yielded no blood. Radiographs were made. Motor testing was then performed with volts and no lower extremity motor stimulation was observed. cc % was injected through the RF needle. A radiofrequency lesion of the articular branch of the obturator nerve was then performed at 80 degrees Celsius for 2 minutes and 30 seconds. The needle was then withdrawn.

The patient tolerated the procedure well. After observation the patient was discharged with instructions and follow up. They were also provided contact information to call regarding any concerning symptoms or questions.

IMPRESSION: 1. Successful radiofrequency ablations of the articular branches of the obturator and femoral nerves was performed. 2. Follow up in weeks to assess the efficacy of the procedure. 3. Estimated Blood Loss: 4. Disposition:

This information cannot guarantee coverage or reimbursement for COOLIEF* Cooled Radiofrequency neurotomy and Avanos, Inc. makes no other representations as to selecting codes for radiofrequency neurotomy or compliance with any other billing protocols or prerequisites. As with all claims, individual physicians and hospitals are responsible for exercising their independent clinical judgment in selecting the codes that most accurately reflect the patient’s condition and procedures performed for a patient. Physicians and hospitals should refer to current, complete, and authoritative publications such as AMA CPT lists or insurer policies for selecting codes and completing claims forms based on the care rendered to an individual patient, and may wish to contact individual carriers, fiscal intermediaries, or other third-party payers as needed.

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Appeals Facilities and physicians may encounter denied, pended, or underpaid claims for numerous reasons. Claims are usually pended or denied for five primary reasons:

• Administrative errors made by claims processors • Clerical errors made on claim forms • A determination by the payer that the procedure is not medically necessary • Patient not responding to payer’s request for information • Payer is requesting documentation to support the claim

Appealing Denied Claims:

If a claim is denied, we recommend careful review of the Explanation of Benefits (EOB) for an explanation or reason for the denial. If the EOB does not clearly explain the reason, immediately contact the payer and request an explanation of the denied claim. In those cases where a clerical error was made on the claim form, simply confirm the appropriate codes to use and resubmit a corrected claim form.

In other cases, payers may deny claims based on their determination of:

• A lack of medical necessity • A diagnosis code does not match with the CPT® code • A determination that the technology is considered investigational

In these cases, you should contact the payer and offer to provide additional information about the procedure (COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled RF, COOLIEF* SINERGY* Sacroiliac Cooled RF, COOLIEF* Thoracic Cooled RF or COOLIEF* Lumbar Cooled RF). You should ask the claims processor to specify what additional materials are required to reverse the original coverage determination.

Underpaid Claims:

If you feel your claim has been underpaid, contact the claims office identified on the patient’s EOB, and request a review of your claim. Claims may be underpaid for various reasons including:

• Low contractual agreement • Incorrect coding of the actual procedure(s) performed • Lack or misuse of appropriate modifier • Lack of supporting documentation

Each payer has its own review process, but in most cases, you will be asked to submit your request in writing. Once you determine what the process is, inquire as to where the request should be sent and to whom it should be directed.

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Claim Reversals:

According to a recent Medicare report, the following were listed as the top reasons claims were reversed at the appeal level:

• In 45% of the cases reversed, additional information, more detailed documentation of the patient’s condition, or proper diagnosis coding was supplied at the appeal level

• In 18% of the cases reversed, a Unique Identification Number (UPIN) was submitted or corrected at the appeal level

• In 18% of the cases reversed, a request for modifier change or addition to the claim was requested.

To avoid the frustration of claim denials and appeal processing, we suggest checking to be sure that the claim form contains all the required information. Claim submitters should verify that the correct UPIN number, procedure code and diagnosis have been indicated on the claim.

Incomplete or insufficient documentation of a patient’s medical condition could result in claim denial.

SAMPLE APPEAL LETTER [Date]

Attn: [Contact] usually the medical director

[Title]

[Name of Health Insurance Company] [Address]

[City, State, ZIP Code]

RE: Denial of [Specify Procedure] procedure [Patient Name] [Policy Number/Group Number/Patient ID#] [Date of Birth]

Dear [Name of Contact]:

I am writing to appeal, [name of insurance company]’s recent denial of benefits for my patient, [Patient Name] for treatment of [insert diagnosis] utilizing a procedure called

[Specify Procedure]. The denial states the procedure is investigational and I strongly dispute those findings. My recommended treatment, [Specify Procedure] has been successfully used in many cases.

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[Patient Name] has been thoroughly evaluated and has been diagnosed with [insert diagnosis]. Enclosed with this letter is the original documentation submitted and I request that you review the information again with particular attention to the patient’s history of [insert diagnosis] which has been ongoing since [include date of onset]. Numerous conservative attempts at treatment have been tried and failed, such as [include medical history, treatments tried, include conservative treatments and length of time].

Despite these attempts, [Patient Name] has received no 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 any other tests performed to confirm diagnosis].

Based on these findings and our previous attempts at conservative treatments, I believe it is medically necessary to move forward and schedule [Patient Name] for this procedure. I firmly believe that [Patient Name] is an excellent candidate for [Specify Procedure]. I request your immediate reconsideration of coverage for this procedure.

Thank you for your attention to this matter, and I look forward to your response. Please contact me if you have additional questions.

Sincerely,

[Physician’s Name]

[Physician’s Practice Name]

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Appendix 2018 COOLIEF* Cooled RF Quick Reference Table

COOLIEF* Knee Cooled Radiofrequency

COOLIEF* Hip Cooled Radiofrequency

COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency

COOLIEF* Cervical Cooled Radiofrequency

COOLIEF* Thoracic Cooled Radiofrequency

COOLIEF* Lumbar Cooled Radiofrequency

CPT Codes Diagnostic Injections

64450 (For each nerve)

64447 (femoral nerve) 64450 (obturator nerve)

64493 (L5 dorsal ramus) 64450 (S1 injection) 64450 (S2 injection) 64450 (S3 injection)

64490 (First facet joint) 64491 (2nd facet joint) 64492 (Each additional facet joint)

64490 (First facet joint) 64491 (2nd facet joint) 64492 (Each additional facet joint)

64493 (First facet joint) 64494 (2nd facet joint) 64495 (Each additional facet joint)

CPT Codes Radiofrequency Denervation

64640 (For each nerve)

64640 (For each nerve)

64635 (L5 dorsal ramus) 64640 (S1 denervations) 64640 (S2 denervations) 64640 (S3 denervations)

64633 (First facet joint) 64634 (Additional facet joints)

64633 (First facet joint) 64634 (Additional facet joints)

64635 (First facet joint) 64636 (Additional facet joints)

Modifiers Add -50 modifier for bilateral procedures Add -59 or XS (Medicare) modifier to CPT codes 64450 and 64640 for 2nd, 3rd, & 4th nerves

Add -50 modifier for bilateral procedures Add -59 or XS (Medicare) modifier to CPT code 64640 for 2nd nerve

Add -50 modifier for bilateral procedures Add -59 or XS (Medicare) modifier to CPT codes 64450 and 64640 (all levels)

Add -50 modifier for bilateral procedures

Add -50 modifier for bilateral procedures

Add -50 modifier for bilateral procedures

APC CODES 5442 (64450) 5443 (64640)

5441 (64447) 5442 (64450) 5443 (64640)

5443 (64693) 5442 (64450) 5431 (64635) 5443 (64640)

5443 (64490) 5431 (64633)

5443 (64490) 5431 (64633)

5443 (64493) 5431 (64635)

HCPCS Code HOPD: A4649 (Cooled RF Probe Kit)

HOPD: A4649 (Cooled RF Probe Kit)

HOPD: A4649 (Cooled RF Probe Kit)

HOPD: A4649 (Cooled RF Probe Kit)

HOPD: A4649 (Cooled RF Probe Kit)

HOPD: A4649 (Cooled RF Probe Kit)

Common ICD-10-CM Codes

M17.0 - M17.5 M25.561 - M25.562

M25.551 - M25.552 M16.0 - M16.6

M45.7 M45.8 M46.1 M47.27 M47.817 - M47.818 M47.27 M47.897 M54.30 - M54.32 M54.40 - M54.42 M54.5

M54.2 M47.11 - M47.13 M47.811 - M47.813

M54.6 M47.14 - M47.15 M47.814 - M47.815

M54.30 - M54.32 M54.40 - M54.42 M54.5 M54.89 M47.16 M47.817

Place of HOPD: 22 HOPD: 22 HOPD: 22 HOPD: 22 HOPD: 22 HOPD: 22

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COOLIEF* Knee Cooled Radiofrequency

COOLIEF* Hip Cooled Radiofrequency

COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency

COOLIEF* Cervical Cooled Radiofrequency

COOLIEF* Thoracic Cooled Radiofrequency

COOLIEF* Lumbar Cooled Radiofrequency

Service ASC: 24 ASC: 24 ASC: 24 ASC: 24 ASC: 24 ASC: 24

Notes Bill for fluorscopic guidance 77002-26 (Physician billing only) Subject to Multiple Procedure Discount

Bill for fluoroscopic guidance 77002-26 (Physician billing only) Subject to Multiple Procedure Discount

Fluoroscopic guidance included in CPT codes. No separate billing Subject to Multiple Procedure Discount

Fluoroscopic guidance included in CPT codes. No separate billing HOPD & ASC: Bill only for first facet joint using 64633 Subject to Multiple Procedure Discount

Fluoroscopic guidance included in CPT codes. No separate billing HOPD & ASC: Bill only for first facet joint using 64633 Subject to Multiple Procedure Discount

Fluoroscopic guidance included in CPT codes. No separate billing HOPD & ASC: Bill only for first facet joint using 64635 Subject to Multiple Procedure Discount

Information provided in this table is intended for reference only. Complete information can be found in the respective section of the COOLIEF* Cooled RF Reimbursement Guide. Providers are responsible for documentation and final selection of reported services. The Current Procedure Terminology, Version 4 (CPT-4) is copyrighted by the American Medical Association. The Healthcare Common Procedure Code Services (HCPCS) and other mapping rules are maintained by the Center for Medicare and Medicaid Services (CMS). Cooled RF Probe kit is not separately paid by Medicare. Payment by commercial payers varies per contract.

The intent of this table 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 claim submissions and reimbursement decisions. Each claim should be coded appropriately and supported with adequate documentation of the patient's medical record. The codes listed are examples of codes that may be appropriate for individual situations. These codes do not represent correct coding for all procedures involving our various COOLIEF* Cooled RF procedures.