Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Form

. Coblation is a patented process which causes molecules in body fluids to become highly energized and converted into a gas at low temperatures, purportedly minimizing damage to surrounding tissues.15 This process is used in surgical instrumentation to destruct small segments of a tendon or connective tissue supposedly to stimulate blood vessel development and healing of damaged tissue.
Examples of US Food & Drug Administration (FDA) approved coblation surgical instruments include, but may not be limited to, the Topaz MicroDebrider and the Werewolf Coblation System.

Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 2 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Extracorporeal shock wave therapy (ESWT) is a nonsurgical treatment that involves the delivery of acoustic shock waves to musculoskeletal areas of the body (commonly the epicondyle, shoulder or heel) with the goal of reducing pain and promoting healing of the affected soft tissue. The acoustic waves are theorized to reduce inflammation, break up scar tissue and stimulate tissue healing. ESWT is performed on an outpatient basis and may utilize local anesthesia to numb the area targeted for treatment. ESWT is intended as a noninvasive alternative to surgical treatment in a selected individual who has failed conventional medical therapy. Additional types of ESWT include: • Extracorporeal pulse activation therapy (EPAT) or radial wave therapy is another type of ESWT that uses waves of pressure to transform kinetic energy into radially expanding shock waves. It is purported to be an alternative to focused ESWT and can address larger treatment areas.
• Pulse Acoustic Cellular Expression therapy (PACE) is a proprietary type of ESWT for use as an adjunct to standard wound care in an adult with a diabetic foot ulcer lasting longer than 30 days. An example of a FDA-approved PACE device is the dermaPACE.
Percutaneous ultrasonic ablation combines the use of ultrasound imaging and a minimally invasive pen-like surgical instrument that uses ultrasonic energy to visualize, cut and remove diseased or damaged tissue in an individual with chronic tendinopathies. An example of a FDA-approved ultrasonic ablation surgical instrument is the Tenex Health TX system. This procedure is frequently referred to as percutaneous needle tenotomy, percutaneous tenotomy or percutaneous fasciotomy.
For information regarding coblation, ESWT and percutaneous ultrasonic ablation for plantar fasciitis, please refer to Plantar Fasciitis Treatments Medical Coverage Policy. For information regarding erectile dysfunction and ESWT, please refer to Erectile Dysfunction and Peyronie's Disease Treatments Medical Coverage Policy. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.

Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 3 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Coverage Determination Humana members may NOT be eligible under the Plan for any form of ESWT (eg, focused, high energy, low energy, radial, EPAT, PACE) for any indications including, but may not be limited to: • Delayed or nonunion of fractures; OR • Epicondylitis; OR • Soft tissue injuries including, but may not be limited to, the following: o Achilles tendinopathy; OR o Greater trochanteric pain syndrome; OR o Patellar tendinopathy; OR o Rotator cuff tendinopathy; OR • Soft tissue wounds; OR • Stress fractures This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. Humana members may NOT be eligible under the Plan for the treatment of any musculoskeletal indications with the following therapies: • Coblation therapy (eg, Topaz MicroDebrider or Werewolf Coblation System); OR • Percutaneous ultrasonic ablation (also referred to as percutaneous needle tenotomy, percutaneous tenotomy or percutaneous fasciotomy) (eg, Tenex) These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.

Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 4 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Background Additional information about delayed or nonunion fractures, epicondylitis, greater trochanteric pain syndrome, tendinopathies or soft tissue wounds may be found from the following websites: • American Academy of Orthopaedic Surgeons • American College of Foot and Ankle Surgeons • National Institute of Arthritis and Musculoskeletal and Skin Diseases • National Library of Medicine
Medical Alternatives Alternatives to coblation, ESWT and percutaneous ultrasonic ablation include, but may not be limited to, the following: • Home exercises • Immobilization • Night splints
• Orthotics (please refer to Orthotics Medical Coverage Policy) • Padding and/or taping • Physical therapy (please refer to Physical Therapy and Occupational Therapy
Medical Coverage Policy) Physician consultation is advised to make an informed decision based on an individual’s health needs.
Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.

Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 5 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. CPT® Code(s) Description Comments 20999 Unlisted procedure, musculoskeletal system, general 29999 Unlisted procedure, arthroscopy CPT® Category III Code(s) 0101T 0102T 0512T 0513T HCPCS Code(s) Description Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; initial wound Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; each additional wound (List separately in addition to code for primary procedure) Not Covered if used to report any procedure outlined in Coverage Determination section Not Covered if used to report any procedure outlined in Coverage Determination section Comments Not Covered Not Covered Not Covered Not Covered Description Comments No code(s) identified References

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   Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 6 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

9. ClinicalKey. Weinlein JC. Delayed union and nonunion of fractures. In: Azar F, T, Beaty J. Campbell’s Operative Orthopaedics. 14th ed. Elsevier; 2021:3192- 3116.e.8. https://www.clinicalkey.com. Accessed August 4, 2023. ECRI Institute. Clinical Evidence Assessment. Extracorporeal shock wave therapy for chronic lateral hip pain. https://www.ecri.org. Published November 11, 2020. Accessed August 4, 2023. ECRI Institute. Clinical Evidence Assessment. Tenex Health TX system (Tenex Health, Inc.) for treating chronic tendinopathy. https://www.ecri.org. Published May 22, 2013. Updated March 31, 2021. Accessed August 4, 2023. ECRI Institute. Clinical Evidence Assessment. Werewolf flow 50 coblation wand (Smith & Nephew, Inc.) for arthroscopic hip surgery. https://www.ecri.org. Published June 1, 2023. Accessed August 4, 2023. ECRI Institute. Hotline Response (ARCHIVED). Extracorporeal shockwave therapy for treating shoulder tendonitis. https://www.ecri.org. Published July 17, 2006. Updated August 7, 2013. Accessed August 10, 2021. ECRI Institute. Product Brief (ARCHIVED). Werewolf coblation system (Smith & Nephew, Inc.) for anterior cruciate ligament reconstruction. https://www.ecri.org. Published March 1, 2020. Accessed July 20, 2022. Hayes, Inc. Evidence Analysis Research Brief. Percutaneous ultrasonic tenotomy (Tenex Health TX System) for treatment of nonelbow and non- achilles tendinopathy. https://evidence.hayesinc.com. Published March 9, 2023. Accessed August 9, 2023. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Percutaneous ultrasound guided tenotomy for hip pain. https://evidence.hayesinc.com. Published January 30, 2020. Accessed July 20, 2022.

10. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Tenex Health TX Procedure (Tenex Health Inc.) for treatment of tendinopathies. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.

    Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 7 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. https://evidence.hayesinc.com. Published February 26, 2020. Accessed July 20, 2022.

11. Hayes, Inc. Emerging Technology Report (ARCHIVED). dermaPACE system for diabetic foot ulcers. https://evidence.hayesinc.com. Published January 22, 2019. Accessed August 9, 2023.
12. Hayes, Inc. Evolving Evidence Review. Percutaneous ultrasound guided tenotomy (Tenex Health TX) for treatment of elbow tendinopathy. https://evidence.hayesinc.com. Published January 10, 2022. Updated April 3, 2023. Accessed August 8, 2023.
13. Hayes, Inc. Evolving Evidence Review. Tenex (Tenex Health TX) percutaneous ultrasonic tenotomy system to treat achilles tendinopathy. https://evidence.hayesinc.com. Published October 26, 2021. Accessed August 4, 2023.
14. Hayes, Inc. Health Technology Assessment. Extracorporeal shock wave therapy for calcific tendonitis of the shoulder. https://evidence.hayesinc.com. Published August 5, 2022. Accessed August 9, 2023.
15. Hayes, Inc. Health Technology Brief (ARCHIVED). Topaz MicroDebrider (ArthroCare Corp.) for treatment of tendon disorders of the lower extremities.
    https://evidence.hayesinc.com. Published April 8, 2011. Updated March 29, 2013. Accessed August 4, 2023.
16. Hayes, Inc. Health Technology Brief (ARCHIVED). Topaz MicroDebrider (ArthroCare Corp.) for treatment of tendon disorders of the upper extremities.
    https://evidence.hayesinc.com. Published March 31, 2011. Updated March 29, 2013. Accessed August 4, 2023.

17. Hayes, Inc. Medical Technology Directory (ARCHIVED). Extracorporeal shock wave therapy for chronic lateral epicondylitis of the elbow. https://evidence.hayesinc.com. Published August 22, 2005. Updated August 13, 2009. Accessed August 9, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.

    Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 8 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

18. Hayes, Inc. Medical Technology Directory (ARCHIVED). Extracorporeal shock wave therapy for tendonitis of the rotator cuff. https://evidence.hayesinc.com. Published August 22, 2005. Updated August 6, 2009. Accessed August 9, 2023.
19. MCG Health. Extracorporeal shockwave therapy, musculoskeletal. 27th edition. https://www.mcg.com. Accessed August 9,2023.
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22. UpToDate, Inc. Elbow tendinopathy (tennis and golf elbow). https://www.uptodate.com. Updated July 2023. Accessed August 11, 2023.
23. UpToDate, Inc. Management of diabetic foot ulcers. https://www.uptodate.com. Updated July 2023. Accessed August 11, 2023.
24. UpToDate, Inc. Overview of stress fractures. https://www.uptodate.com. Updated July 2023. Accessed August 11, 2023.
25. UpToDate, Inc. Overview of the management of overuse (persistent) tendinopathy. https://www.uptodate.com. Updated July 2023. Accessed August 11, 2023.
26. UpToDate, Inc. Rotator cuff tendinopathy. https://www.uptodate.com. Updated July 2023. Accessed August 11, 2023.

27. US Food & Drug Administration (FDA). 510(k) summary: Tenex health TX1 tissue removal system. https://www.fda.gov. Published March 20, 2013. Accessed September 12, 2018. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.

    Ablation Techniques and Extracorporeal Shock Wave Therapy for Musculoskeletal Indications and Soft Tissue Wounds Effective Date: 08/24/2023 Revision Date: 08/24/2023 Review Date: 08/24/2023 Policy Number: HUM-0379-021 Page: 9 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

28. US Food & Drug Administration (FDA). 510(k) summary: Topaz EZ MicroDebrider coblation. https://www.fda.gov. Published June 10, 2014. Accessed December 1, 2014.
29. US Food & Drug Administration (FDA). 510(k) summary: Werewolf coblation system. https://www.fda.gov. Published June 24, 2021. Accessed August 10, 2023.
30. US Food & Drug Administration (FDA). De novo summary: dermaPACE system. https://www.fda.gov. Published December 28, 2017. Accessed September 14, 2018. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.