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Asset Publisher
Treatment of Hyperhidrosis (Excluding Botox)
Policy Number: MP-086
Refer to pharmacy policy, PH-0238 Botox® (onabotulinumtoxinA) under "Provider-Administered Drug Policies (Excluding Oncology)” for Botulinum Toxin (Botox) treatments related to hyperhidrosis.
Latest Review Date: July 2024
Category: Therapy
POLICY:
Primary Focal Hyperhidrosis
The following treatments for primary focal hyperhidrosis may be considered medically necessary when there is documentation of functional impairment or medical conditions/complications related to the hyperhidrosis including but not limited to the following:
- acrocyanosis of the hands; or
- history of recurrent skin maceration with bacterial or fungal infections; or
- history of recurrent secondary infections; or
- history of persistent eczematous dermatitis in spite of medical treatments with topical dermatologic or systemic anticholinergic agents.
The specific treatments and additional criteria for coverage are listed below by body area.
Focal Regions
Axillary
The following treatments for the axillary may be considered medically necessary:
- Endoscopic transthoracic sympathectomy (ETS) and surgical excision of axillary sweat glands, if conservative treatment (i.e., aluminum chloride) has failed
The following treatments for the axillary are considered investigational:
- Axillary liposuction
- Iontophoresis
- Microwave treatment
- Radiofrequency ablation
Palmar
The following treatments for the palmar may be considered medically necessary:
- ETS, if conservative treatment (i.e., aluminum chloride) has failed
The following treatments of hyperhidrosis of the palmar focal region are considered investigational:
- Iontophoresis
- Microwave treatment
- Radiofrequency ablation
Plantar
The following treatments for the plantar focal region are considered investigational:
- Iontophoresis
- Lumbar sympathectomy
- Microwave treatment
- Radiofrequency ablation
Craniofacial
The following treatments for the craniofacial focal region may be considered medically necessary:
- Endoscopic transthoracic sympathectomy (ETS), if conservative treatment (i.e., aluminum chloride) has failed
The following treatments for the craniofacial focal region are considered investigational:
- Iontophoresis
- Microwave treatment
- Radiofrequency ablation
Secondary Hyperhidrosis
Secondary Gustatory Hyperhidrosis
The following treatments may be considered medically necessary for the treatment of severe gustatory hyperhidrosis:
- Surgical options (i.e., tympanic neurectomy), if conservative treatment has failed.
Other treatments of severe gustatory hyperhidrosis including but not limited to the following are considered investigational:
- Iontophoresis
DESCRIPTION OF PROCEDURE OR SERVICE:
Hyperhidrosis, or excessive sweating, can lead to impairments in psychologic and social functioning. Various treatments for hyperhidrosis are available, such as topical antiperspirant agents (eg, aluminum chloride 20% solution), oral medications, botulinum toxin, and surgical procedures.
Hyperhidrosis
Hyperhidrosis has been defined as excessive sweating, beyond a level required to maintain normal body temperature, in response to heat exposure or exercise. It can be classified as primary or secondary. Primary focal hyperhidrosis is idiopathic, typically involving the hands (palmar), feet (plantar), or axillae (underarms). Secondary hyperhidrosis can result from a variety of drugs (eg, tricyclic antidepressants, selective serotonin reuptake inhibitors) or underlying diseases/conditions (eg, febrile diseases, diabetes, menopause). Secondary hyperhidrosis is usually generalized or craniofacial sweating.
Secondary gustatory hyperhidrosis is excessive sweating on ingesting highly spiced foods. This trigeminovascular reflex typically occurs symmetrically on the scalp or face and predominately over the forehead, lips, and nose. Secondary facial gustatory hyperhidrosis occurs independently of the nature of the ingested food. This phenomenon frequently occurs after injury or surgery in the region of the parotid gland. Frey syndrome is an uncommon type of secondary gustatory hyperhidrosis that arises from injury to or surgery near the parotid gland resulting in damage to the secretory parasympathetic fibers of the facial nerve. After the injury, these fibers regenerate, and miscommunication occurs between them and the severed postganglionic sympathetic fibers that supply the cutaneous sweat glands and blood vessels. The aberrant connection results in gustatory sweating and facial flushing with mastication. Aberrant secondary gustatory sweating follows up to 73% of surgical sympathectomies and is particularly common after bilateral procedures.
The consequences of hyperhidrosis are primarily psychosocial. Symptoms such as fever, night sweats, or weight loss require further investigation to rule out secondary causes. Sweat production can be assessed with the Minor starch-iodine test, which is a simple qualitative measure to identify specific sites of involvement.
Treatment
A variety of therapies have been investigated for primary hyperhidrosis, including topical therapy with aluminum chloride, topical anticholinergic medications, oral anticholinergic medications, iontophoresis, intradermal injections of botulinum toxin, endoscopic transthoracic sympathectomy, and surgical excision of axillary sweat glands. Treatment of secondary hyperhidrosis focuses on treatment of the underlying cause, such as discontinuing certain drugs or hormone replacement therapy as a treatment of menopausal symptoms.
Iontophoresis uses electrical current to deliver medication transdermally. A charged ionic drug is placed on the skin with an electrode of the same charge, which drives the drug into the skin, with the purpose of achieving better penetration of the drug into underlying tissue. The benefits of this method would be an enhancement of treatment effects and a reduction in adverse events associated with systemic administration of the drug.
Botulinum toxin is a potent neurotoxin that blocks cholinergic nerve terminals, which prevents hyperstimulation of eccrine sweat glands that lead to excessive sweating. Therefore, intracutaneous injections have been investigated as a treatment of gustatory hyperhidrosis and focal primary hyperhidrosis, most frequently involving the axillae or palms. The drawback of this approach is the need for repeated injections, which have led some to consider surgical approaches.
Surgical treatment options include removal of the eccrine glands and/or interruption of the sympathetic nerves. Eccrine sweat glands produce an aqueous secretion, the overproduction of which is primarily responsible for hyperhidrosis. These glands are innervated by the sympathetic nervous system. Surgical removal has been performed in patients with severe isolated axillary hyperhidrosis.
Various surgical techniques of sympathectomy may also be tried. The second (T2) and third (T3) thoracic ganglia are responsible for palmar hyperhidrosis, the fourth (T4) thoracic ganglion controls axillary hyperhidrosis, and the first (T1) thoracic ganglion controls facial hyperhidrosis. Thoracic sympathectomy has been investigated as a potentially curative procedure, primarily for combined palmar and axillary hyperhidrosis that is unresponsive to nonsurgical treatments. While accepted as an effective treatment, sympathectomy is not without complications. In addition to the immediate surgical complications of pneumothorax or temporary Horner’s syndrome, compensatory sweating on the trunk generally occurs in a majority of patients, with different degrees of severity. Medical researchers have investigated whether certain approaches, e.g., T3 versus T4 sympathectomy, result in less compensatory sweating, but there remains a lack of consensus about which approach best minimizes the risk of this adverse effect. In addition, with lumbar sympathectomy for plantar hyperhidrosis, there has been concern about the risk of postoperative sexual dysfunction in both men and women.
Outcome Measures
The outcome of different surgical and medical treatment modalities is best assessed by using a combination of tools. Quantitative tools include gravimetry, evaporimetry, and the Minor starch iodine test. Qualitative assessment tools include general health surveys and hyperhidrosis-specific surveys. Of these, the Hyperhidrosis Disease Severity Scale (HDSS) has been found to have a good correlation to other assessment tools and to be practical in the clinical setting.
Refer to pharmacy policy, PH-0238 Botox® (onabotulinumtoxinA) under "Provider-Administered Drug Policies (Excluding Oncology)” for botulinum toxin (Botox) treatments related to hyperhidrosis.
KEY POINTS:
The most recent literature update was performed through April 26, 2024.
Summary of Evidence
Iontophoresis
For individuals who have primary focal hyperhidrosis (ie, axillary, palmar, plantar, craniofacial) who receive iontophoresis, the evidence includes a systematic review, a randomized controlled trial (RCT), and case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The RCT found that iontophoresis was less effective than botulinum toxin in the short-term treatment of palmar hyperhidrosis. Additional RCTs are needed comparing iontophoresis with sham or active treatment in patients with various types of primary focal hyperhidrosis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Microwave
For individuals who have primary focal hyperhidrosis (i.e., axillary, palmar, plantar, craniofacial) who receive microwave treatment, the evidence includes a systematic review, an RCT, and a case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The systematic review and RCT found a short-term benefit of microwave treatment in reducing hyperhidrosis, but also reported skin-related adverse events (eg, pain, altered sensation). Additional RCTs are needed comparing radiofrequency ablation with sham or active treatment in patients with various types of primary focal hyperhidrosis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have primary focal hyperhidrosis (i.e., axillary, palmar, plantar, craniofacial) who receive radiofrequency ablation, the evidence consists of a nonrandomized cohort study. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The cohort study, conducted in patients with palmar hyperhidrosis, found a higher cure rate in the surgery group than in the radiofrequency ablation group, and found a similar rate of compensatory sweating in both groups. RCTs are needed comparing radiofrequency ablation to sham or active treatment in patients with various types of primary focal hyperhidrosis. The evidence is insufficient to determine the effects of the technology on health outcomes.
Radiofrequency Ablation
For individuals who have primary focal hyperhidrosis (ie, axillary, palmar, plantar, craniofacial) who receive radiofrequency ablation (RFA), the evidence includes two small RCTs and a nonrandomized cohort study. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. One nonrandomized comparative study found RFA inferior to surgical sympathectomy for patients with severe bilateral palmar hyperhidrosis resistant to conservative treatment. Two small RCTs that compared RFA to botulinum toxin A in patients with palmar or axillary hyperhidrosis had conflicting results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Surgery
For individuals who have primary axillary hyperhidrosis who receive surgical excision of axillary sweat glands, the evidence consists of review articles. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The evidence has shown that excision is highly effective and this treatment is considered standard of care for this indication. The evidence is sufficient to determine qualitatively that the technology results in an improvement in the net health outcome.
For individuals who have primary axillary and palmar hyperhidrosis who receive endoscopic transthoracic sympathectomy, the evidence consists of several RCTs, a meta-analysis, and case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The meta-analysis found a high rate of clinical efficacy after endoscopic transthoracic sympathectomy, although the rate of postoperative compensatory sweating was substantial. Subsequent studies have supported these findings. The evidence is sufficient to determine qualitatively that the technology results in an improvement in the net health outcome.
For individuals who have primary plantar hyperhidrosis who receive lumbar sympathectomy, the evidence includes one RCT conducted at a single center in Brazil, case series, and a systematic review. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. Case series have reported high rates of clinical efficacy, but findings are inconclusive due to lack of control groups. The RCT was limited by its small sample size and lack of blinded outcome assessment. Moreover, there have been substantial rates of compensatory sweating and concerns about adverse events on sexual functioning. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Secondary Gustatory Hyperhidrosis
For individuals who have severe secondary gustatory hyperhidrosis who receive iontophoresis, the evidence consists of uncontrolled studies and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The systematic reviews did not identify any relevant RCTs; RCTs are needed to evaluate the safety and efficacy of these conditions for treatment of severe secondary gustatory hyperhidrosis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have severe secondary gustatory hyperhidrosis who receive tympanic neurectomy, the evidence consists of uncontrolled studies and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. This treatment is considered standard of care for this indication, and has high success rates, without need for repeated interventions. The evidence is sufficient to determine qualitatively that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
National Institute for Health and Care Excellence
The NICE (2017) stated that evidence is “inadequate in quantity and quality” on the use of transcutaneous microwave ablation for treatment of severe primary axillary hyperhidrosis.
The National Institute for Health and Care Excellence issued guidance in 2014 stating that there is sufficient evidence of the efficacy and safety of endoscopic thoracic sympathectomy (ETS) for primary facial blushing to support the use of the procedure.
The Institute also issued guidance in 2014 on endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb. The guidance stated that “current evidence on the efficacy and safety of endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb is adequate to support the use of this procedure.” Also: “Due to the risk of side effects, this procedure should only be considered in patients suffering from severe and debilitating primary hyperhidrosis that has been refractory to other treatments.”
For severe primary axillary hyperhidrosis, NICE issued guidance in 2017 on the use of transcutaneous microwave ablation. The guidance stated that there is inadequate evidence in both quantity and quality to evaluate the safety and efficacy of microwave ablation.
Society of Thoracic Surgeons
In 2011, the Society of Thoracic Surgeons published an expert consensus statement on the surgical treatment of hyperhidrosis. The document stated that endoscopic thoracic sympathectomy is the treatment of choice for patients with primary hyperhidrosis. It further recommended the following treatment strategies (with R referring to rib and the number to which rib):
- R3 interruption for palmar hyperhidrosis; an R4 interruption is also reasonable. The authors note a slightly higher rate of compensatory sweating with R3, but R3 is also more effective at treating hyperhidrosis.
- R4 or R5 interruption for palmar-axillary, palmar-axillary-plantar, or axillary hyperhidrosis alone; R5 interruption is also an option for axillary hyperhidrosis alone.
- R3 interruption for craniofacial hyperhidrosis without blushing; an R2 and R3 procedure is an option but may lead to a higher rate of compensatory sweating, and also increases the risk of Horner syndrome.
According to the statement, endoscopic thoracic sympathectomy has been recommended for patients with severe symptoms that cannot be managed with other therapies who meet the following criteria:
- Onset of hyperhidrosis at an early age (before 16 years)
- <25 years of age at time of surgery
- Body mass index <28 kg/m2
- No sweating during sleep
- No significant comorbidities
- Resting heart rate <55 beats per minute
U.S. Preventive Services Task Force Recommendations
Not applicable.
KEY WORDS:
botulinum toxin, treatment of hyperhidrosis, aluminum hydroxide, hexahydrate, Drysol, endoscopic sympathectomy, gustatory hyperhidrosis, hyperhidrosis, iontophoresis, sweating, excessive, sympathectomy, thoracic, thoracoscopic sympathectomy, tympanic neurectomy, miraDry System, microwave treatment for hyperhidroses, Dysport, Botox, Myobloc, Xeomin, Brella® Sweat Control Patch
APPROVED BY GOVERNING BODIES:
In January 2011, the miraDry® System (Miramar Labs, Inc.; Sunnydale, CA) was cleared by the FDA through the 510(k) process for treating primary axillary hyperhidrosis. This is a microwave device designed to heat tissue at the dermal-hypodermal interface, the location of the sweat glands. Treatment consists of two sessions of approximately one hour in duration. Sessions occur in a physician’s office and local anesthetic is used. The device is currently not approved for the treatment of palmar or plantar hyperhidrosis.
In 2023, the Brella® Sweat Control Patch (Candesant Biomedical, Inc.) was approved by the FDA through the 513(f)(2) de novo pathway for the treatment of primary axillary hyperhidrosis in adults. The patch is applied by a clinician and kept in place for up to 3 minutes, during which the patch's sodium layer creates heat after coming into contact with sweat, which leads to temporary inactivation of sweat glands.
BENEFIT APPLICATION:
Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan.
CURRENT CODING:
CPT codes:
32664 |
Thoracoscopy, surgical; with thoracic sympathectomy |
64818 |
Sympathectomy, lumbar |
69676 |
Tympanic neurectomy |
97033 |
Application of modality to one or more areas; iontophoresis, each 15 minutes |
HCPCS:
E1399 |
Durable medical equipment, miscellaneous |
REFERENCES:
- Baumgartner FJ, Reyes M, Sarkisyan GG et al. Thorascopic sympathicotomy for disabling palmar hyperhidrosis: A prospective randomized comparison between two levels. Ann Thorac Surg 2011; 92(6):2015-9.
- Cerfolio RJ, De Campos JR, Bryant AS et al. The Society of Thoracic Surgeons expert consensus for the surgical treatment of hyperhidrosis. Ann Thorac Surg 2011; 91(5):1642-1648.
- de Andrade Filho LO, Kuzniec S, Wolosker N et al. Technical Difficulties and Complications of Sympathectomy in the Treatment of Hyperhidrosis: An Analysis of 1731 Cases. Ann Vasc Surg. May 2013; 27(4):447-453.
- de Campos JRM, Lembranca L, Fukuda JM, et al. Evaluation of patients who underwent resympathectomy for treatment of primary hyperhidrosis. Interact Cardiovasc Thorac Surg. Nov 1 2017; 25(5):716-719.
- Deng B, Tan QY, Jiang YG et al. Optimization of sympathectomy to treat palmar hyperhidrosis: the systematic review and meta-analysis of studies published during the past decade. Surg Endosc 2011; 25(6):1893-1901.
- Dogruk Kacar S, Ozuguz P, Eroglu S et al. Treatment of primary hyperhidrosis with tap water iontophoresis in paediatric patients: a retrospective analysis. Cutan Ocul Toxicol. Dec 2014; 33(4):313-316.
- Food and Drug Administration. Approved risk evaluation and mitigation strategies. www.accessdata.fda.gov/scripts/cder/rems/index.cfm..
- Fukuda JM, Varella AYM, Teivelis MP, et al. Video-Assisted thoracoscopic sympathectomy for facial hyperhidrosis: the influence of the main site of complaint. Ann Vasc Surg. Jan 2018; 46:337-344.
- Glaser DA, Coleman WP, Fan LK et al. A randomized blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. Dermatol Surg 2012; 38(2):185-191.
- Grimalt R, Tordera PD and Callejas MA. Topical atropine sulfate for the treatment of axillary hyperhidrosis. J Cosmet Dermatol, December 2006; 5(4): 294-296. (Abstract)
- Hong HC, Lupin M, O'Shaughnessy KF. Clinical evaluation of a microwave device for treating axillary hyperhidrosis. Dermatol Surg 2012; 38(5):728-735.
- Hsu TH, Chen YT, Tu YK, et al. A systematic review of microwave-based therapy for axillary hyperhidrosis. J Cosmet Laser Ther. Oct 2017; 19(5):275-282.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Ishy A, de Campos JR, Wolosker N et al. Objective evaluation of patients with palmar hyperhidrosis submitted to two levels of sympathectomy: T3 and T4. Interact Cardiovasc Thorac Surg 2011; 12(4):545-548.
- Karamustafaoglu YA, Kuzucuoglu M, Yanik F, et al. 3-year follow-up after uniportal thoracoscopic sympathicotomy for hyperhidrosis: undesirable side effects. J Laparoendosc Adv Surg Tech A. Nov 2014; 24(11):782-785.
- Lembranca L, Wolosker N, de Campos JRM, et al. Videothoracoscopic sympathectomy results after oxybutynin chloride treatment failure. Ann Vasc Surg. Aug 2017; 43:283-287.
- Levit F. Treatment of hyperhidrosis by tap water iontophoresis. Cutis 1980; 26(2): 192-194.
- Li C, Wu F, Zhang Q, et al. Interventions for the treatment of Frey's syndrome. Cochrane Database Syst Rev. 2015; 3:CD009959.
- Lima SO, Santos RS, Moura AMM, et al. A systematic review and meta-analysis to evaluate the efficacy of lumbar sympathectomy for plantar hyperhidrosis. Int J Dermatol. Aug 2019; 58(8): 982-986.
- Loureiro Mde P, de Campos JR, Kauffman P, et al. Endoscopic lumbar sympathectomy for women: effect on compensatory sweat. Clinics (Sao Paulo). Apr 2008; 63(2): 189-96.
- McAleer MA, Collins P. A Study Investigating Patients' Experience of Hospital and Home Iontophoresis for Hyperhidrosis. J Dermatolog Treat. Aug 2014; 25(4):342-344.
- National Institute of Health and Care Excellence (NICE). Endoscopic thoracic sympathectomy for primary facial blushing [IPG480 ]. 2014; www.nice.org.uk/guidance/ipg480.
- National Institute of Health and Care Excellence (NICE). Endoscopic throacic sympathectomy for primary hyperhidrosis of the upper limb [IPG487]. 2014; www.nice.org.uk/guidance/ipg487..
- National Institute of Health and Care Excellence (NICE). Transcutaneous microwave ablation for severe primary axillary hyperhidrosis [IPG601 ]. 2017; www.nice.org.uk/guidance/ipg601.
- Obed D, Salim M, Bingoel AS, et al. Botulinum Toxin Versus Placebo: A Meta-Analysis of Treatment and Quality-of-life Outcomes for Hyperhidrosis. Aesthetic Plast Surg. Aug 2021; 45(4): 1783-1791.
- Purtuloglu T, Atim A, Deniz S et al. Effect of radiofrequency ablation and comparison with surgical sympathectomy in palmar hyperhidrosis. Eur J Cardiothorac Surg. Jun 2013; 43(6):e151-154.
- Smidfelt K, Drott C. Late results of endoscopic thoracic sympathectomy for hyperhidrosis and facial blushing. Br J Surg 2011; 98(12):1719-1724.
- Vasconcelos-Castro S, Soares-Oliveira M, Tuna T, et al. Thoracoscopic sympathotomy for palmar hyperhidrosis: How young is too young?. J Pediatr Surg. Nov 2020; 55(11): 2362-2365.
- Wade R, Rice S, Llewellyn A, et al. Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis. Health Technol Assess. Dec 2017; 21(80):1-280.
- Yuncu G, Turk F, Ozturk G et al. Comparison of only T3 and T3-T4 sympathectomy for axillary hyperhidrosis regarding treatment effect and compensatory sweating. Interact Cardiovasc Thorac Surg 2013; 17(2):263-267.
- Zhong Y, Zhu Y, Li J, et al. Efficacy and safety of radiofrequency ablation versus surgical sympathectomy in palmar hyperhidrosis. Sci Rep. Apr 01 2024; 14(1): 7620.
POLICY HISTORY:
Medical Policy Group, July 2004 (3)
Medical Policy Administration Committee, August 2004
Available for comment August 11-September 24, 2004
Medical Policy Group, January 2006 (1)
Medical Policy Administration Committee, January 2006
Available for comment January 28-March 13, 2006
Medical Policy Group, January 2008 (1)
Medical Policy Group, August 2009 (1)
Medical Policy Group, September 2009 (3)
Medical Policy Administration Committee, October 2009
Available for comment October 3-November 17, 2009
Medical Policy Group November 2009 (3)
Medical Policy Administration Committee, December 2009
Available for comment December 4, 2009-January 19, 2010
Medical Policy Administration Committee, November 2010
Available for comment November 4 – December 20, 2010
Medical Policy Group, April 2012 (3): 2012 Updates-Added Microwave to Policy Section, Updated Description, Key Points, Key Words & References
Medical Policy Administration Committee, May 2012
Available for comment May 10 through June 25, 2012
Medical Policy Panel, May 2013
Medical Policy Group, May 2013 (3): 2013 Updates – Added Radiofrequency Ablation as investigational to Policy Section for palmar surfaces; updated Key points, Approved by Governing Bodies & References
Available for comment May 22 through July 5, 2013
Medical Policy Group, October 2013 (3): Removed ICD-9 Diagnosis codes; no change to policy statement.
Medical Policy Panel, May 2014
Medical Policy Group, June 2014 (3): 2014 Updates to Description, Key Points & References; no change in policy statement
Medical Policy Group, January 2015 (1) Added PRIME link and effective date of 1/1/15 to policy section for direction of how to handle botulinum toxin treatment for hyperhidrosis on or after that date
Medical Policy Panel, May 2015
Medical Policy Group, July 2015 (3): 2015 Updates to Key Points & references; some clarifying info added to policy statement but no change in policy intent
Medical Policy Panel, May 2016
Medical Policy Group, May 2016 (7): Updates to Key Points, Key Words, and References. No change to policy statement.
Medical Policy Panel, April 2018
Medical Policy Group, June 2018 (7): Updates to Description, Key Points and References. Clarification to Policy Statement: radiofrequency ablation as a treatment of primary focal hyperhidrosis (i.e., axillary, palmar, plantar, craniofacial) is considered investigational. No change in policy intent.
Medical Policy Group, January 2019 (7): Update to Title. Removed information related to botulinum toxin. Refer to PH 102- Botulinum Toxin Policy Summary (Botox, Dysport, Myobloc, Xeomin) for botulinum toxin (Botox) treatments related to hyperhidrosis. Removed aluminum chloride from Policy Statement.
Medical Policy Panel, June 2019
Medical Policy Group, July 2019 (7): Updates to Key Points and References. Added CPT codes 64818 and 69676. No change to policy statement.
Medical Policy Panel, June 2020
Medical Policy Group, June 2020 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.
Medical Policy Panel, June 2021
Medical Policy Group, June 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to clarify “not medically necessary and investigational” verbiage, no change to policy intent.
Medical Policy Panel, June 2022
Medical Policy Group, June 2022 (5):Minor updates to Description, Key Points, and References. No change to Policy Statement.
Medical Policy Panel, June 2023
Medical Policy Group, June 2023 (5): Updates to Description, Key Points, Benefit Application, and References. No change to Policy statement.
Medical Policy Panel, July 2024
Medical Policy Group, July 2024 (5): Updates to Key Points, Key Words: Brella® Sweat Control Patch, Approved by Governing Bodies, and References. Current Coding section updated to remove the following codes as they are no longer applicable to this policy: 64650, 64653. Policy Statement updated to replace “not medically necessary” verbiage with “investigational.” No change to Policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.