Electric Current Therapy (Iontophoresis) E/I ELECTRIC CURRENT THERAPY (IONTOPHORESIS) HS-237. Policy Number: HS-237. Original Effective Date: 1/9/2014

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Easy Choice Health Plan, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Inc. Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc. WellCare Health Insurance of Illinois, Inc. WellCare Health Plans of New Jersey, Inc. WellCare Health Insurance of Arizona, Inc. WellCare of Florida, Inc. WellCare of Connecticut, Inc. WellCare of Georgia, Inc. WellCare of Kentucky, Inc. WellCare of Louisiana, Inc. WellCare of New York, Inc. WellCare of South Carolina, Inc. WellCare of Texas, Inc. WellCare Prescription Insurance, Inc. Windsor Health Plan Windsor Rx Medicare Prescription Drug Plan Electric Current Therapy (Iontophoresis) E/I Policy Number: Original Effective Date: 1/9/2014 Revised Date(s): 4/3/2014; 4/2/2015 APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Clinical Coverage Guideline page 1

DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/providers/ccgs for list of current LOBs. BACKGROUND Electric Current Therapy (or Iontophoresis) is a method of transdermal local drug delivery using electrical current. A charged ionic drug is placed on the skin with an electrode of the same charge, allowing direct current to drive the drug into the skin. POSITION STATEMENT Applicable To: Medicaid All Markets Medicare All Markets Use of iontophoresis is considered medically necessary when part of physical or occupational therapy and is combined with another procedure code that extends treatment time to at least 8 minutes to qualify under the 8- minute rule. In addition, at least one of the following must be met: 1. Delivery of local anesthetic before emergent skin puncture or dermatological procedures to reduce pain associated with these procedures. 2. Intractable, disabling primary focal hyperhidrosis when all of the following are met: Member is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g., anti-cholinergics, beta-blockers, or benzodiazapines); AND, Topical aluminum chloride or other extra-strength anti-perspirants are ineffective or result in a severe rash. AND EITHER, Documentation in the medical record of significant disruption of professional and/or social life has occurred because of excessive sweating, including inability to perform age-appropriate activities of daily living; Condition is causing persistent or chronic cutaneous conditions (e.g., skin maceration, dermatitis, fungal infections, secondary microbial infections). 3. Iontophoretic administration of fentanyl for patient-controlled analgesia of acute post-operative pain. 4. Sweat test by pilocarpine iontophoresis for the diagnosis of cystic fibrosis. Clinical Coverage Guideline page 2

Use of iontophoresis is considered experimental and investigational due to insufficient evidence related to efficacy. Indications may include, but are not limited to: Administration of acetic acid for treating epicondylitis Administration of acetylcholine and sodium nitroprusside for assessing risk of development and progression of cardiovascular disease. Administration of non-steroidal anti-inflammatory drugs or corticosteroids for treating musculoskeletal disorders (e.g., patella-femoral pain syndrome). Administration of verapamil for treating Peyronie's disease. Administration of vitamin C for treating melasma. CODING Botulinum Toxin Covered CPT Codes 64650 Chemodenervation of eccrine glands; both axillae 64653 Chemodenervation of eccrine glands; other area(s) (e.g., scalp, face, neck), per day 97033 Iontophoresis, each 15 minutes Covered HCPCS Codes E1399 Durable medical equipment, miscellaneous [when specified as iontophoresis device for home use] J0585 Injection, onabotulinumtoxina, 1 unit J0586 Injection, abobotulinumtoxina, 5 units J0587 Injection, rimabotulinumtoxinb, 100 units J0588 Injection, incobotulinumtoxina, 1 unit Covered ICD-9 Diagnosis 705.21 Primary focal hyperhidrosis 705.22 Secondary focal hyperhidrosis 780.8 Generalized hyperhidrosis ICD-10 Diagnosis ICD-10-CM draft codes; effective 10/01/2014 L74.510-L74.519 Primary focal hyperhidrosis R61 Generalized hyperhidrosis When Services are Not Medically Necessary: For the procedure and diagnosis codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as not medically necessary. Sympathectomy Covered CPT Codes 00622 Anesthesia for procedures on thoracic spine and cord; thoracolumbar sympathectomy 32664 Thoracoscopy, surgical; with thoracic sympathectomy Covered ICD-9 Diagnosis Codes 705.21 Primary focal hyperhidrosis [specified as axillary or palmar] 705.22 Secondary focal hyperhidrosis [specified as axillary or palmar] 780.8 Generalized hyperhidrosis [specified as axillary or palmar] Clinical Coverage Guideline page 3

Covered ICD-10 Procedure 01BL3ZZ Excision of thoracic sympathetic nerve, percutaneous approach 01BL4ZZ Excision of thoracic sympathetic nerve, percutaneous endoscopic approach L74.510 Primary focal hyperhidrosis, axilla L74.512 Primary focal hyperhidrosis, palms When services are Not Medically Necessary: For the procedure and diagnosis codes listed above when criteria are not met or for the following diagnoses, or when the code describes a procedure indicated in the Position Statement section as not medically necessary. L74.511 Primary focal hyperhidrosis, face L74.519 Primary focal hyperhidrosis, unspecified R61 Generalized hyperhidrosis When services are Investigational and Not Medically Necessary: For the procedure codes listed above for the following diagnoses, or when the code describes a procedure indicated in the Position Statement section as not medically necessary. Covered ICD-9 Diagnosis Codes 705.21 Primary focal hyperhidrosis [specified as plantar] 705.22 Secondary focal hyperhidrosis [specified as plantar] 780.8 Generalized hyperhidrosis [specified as plantar] L74.513 Primary focal hyperhidrosis, soles Non-Covered CPT Codes 64520 Injection, anesthetic agent; lumbar or thoracic (paravertebral sympathetic) 64818 Sympathectomy, lumbar 64999 Unlisted procedure, nervous system [when specified as endoscopic lumbar sympathectomy] Non-Covered ICD-9 Diagnosis Codes 705.21 Primary focal hyperhidrosis [specified as plantar] 705.22 Secondary focal hyperhidrosis [specified as plantar] 780.8 Generalized hyperhidrosis [specified as plantar] Non-Covered ICD-10 Procedure Codes 01BN0ZZ Excision of lumbar sympathetic nerve, open approach 01BN3ZZ Excision of lumbar sympathetic nerve, percutaneous approach 01BN4ZZ Excision of lumbar sympathetic nerve, percutaneous endoscopic approach Non- L74.513 Primary focal hyperhidrosis, soles L74.519 Primary focal hyperhidrosis, unspecified R61 Generalized hyperhidrosis Non-Covered CPT Codes 15876-15879 Suction assisted lipectomy [includes codes 15876, 15877, 15878, 15879] 17999 Unlisted procedure, skin, mucous membrane and subcutaneous tissue [when specified as laser or microwave destruction or resection of subcutaneous sweat glands Clinical Coverage Guideline page 4

Non-Covered ICD-9 Procedure Codes 86.83 Size reduction plastic operation Non-Covered ICD-9 Diagnosis Codes 705.21 Primary focal hyperhidrosis 705.22 Secondary focal hyperhidrosis 780.8 Generalized hyperhidrosis Non-Covered ICD-10 Procedure Codes 0X040ZZ-0X044ZZ Alteration of right axilla [by approach; includes codes 0X040ZZ, 0X043ZZ, 0X044ZZ] 0X050ZZ-0X054ZZ Alteration of left axilla [by approach; includes codes 0X050ZZ, 0X053ZZ, 0X054ZZ] Non- L74.510-L74.519 Primary focal hyperhidrosis R61 Generalized hyperhidrosis *Current Procedural Terminology (CPT ) 2015 American Medical Association: Chicago, IL. REFERENCES 1. Iontophoresis for epicondylitis. Hayes Directory Web site. http://www.hayesinc.com. Published July 9, 2012 (archived September 6, 2013. Accessed March 16, 2015. 2. Ultrasound-enhanced transcutaneous drug delivery. Hayes Directory Web site. http://www.hayesinc.com. Published July 12, 2011 (archived August 9, 2012). Accessed March 16, 2015. MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS Date Action 4/2/2015 Approved by MPC. No changes. 4/3/2014 Approved by MPC. Included medically necessary criteria. 1/9/2014 Approved by MPC. New. Clinical Coverage Guideline page 5