MEDICAL POLICY

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APPENDIX
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Treatment of Hyperhidrosis

Number 8.01.519

Effective Date July 8, 2013

Revision Date(s) 07/08/13; 07/10/12; 05/10/11; 04/13/10; 05/12/09; 04/08/08; 06/12/07; 03/08/05; 06/08/04; 03/09/04; 09/12/03; 11/12/02; 09/07/99

Replaces 8.01.19

Policy

Primary Focal Hyperhidrosis

Treatment of primary (focal) hyperhidrosis may be considered medically necessary when 1 or more of the following medical complications are present:

  • Acrocyanosis of the hands
  • History of persistent eczematous dermatitis in spite of medical treatments with topical dermatological or systemic anticholinergic agents
  • History of recurrent secondary infections
  • History of recurrent skin maceration with bacterial or fungal infections

Focal Regions

Treatments that may be considered

Medically Necessary

(if a medical complication from the above list is present)

Treatments Considered Investigational

(but not limited to):

Axillary

  • aluminum chloride 20% solution*
  • botulinum toxin type A products* (if not adequately managed with topical agents, in patients 18 years old and older)
  • endoscopic transthoracic sympathectomy [ETS] if conservative treatment has failed (i.e., aluminum chloride or botulinum toxin, individually and in combination)
  • surgical excision of axillary sweat glands, if conservative treatment has failed (i.e., aluminum chloride or botulinum toxin, individually and in combination)
  • iontophoresis
  • axillary liposuction
  • microwave treatment

Palmar

  • aluminum chloride 20% solution*
  • botulinum toxin type A products (if not adequately managed with topical agents, in patients 18 years and older)
  • endoscopic transthoracic sympathectomy (ETS), if conservative treatment has failed (i.e., aluminum chloride or botulinum toxin type A, individually and in combination)
  • iontophoresis
  • RimabotulinumtoxinB
  • microwave treatment
  • radiofrequency ablation

Plantar

  • aluminum chloride 20% solution*
  • botulinum toxin type A (if not adequately managed with topical agents)
  • iontophoresis
  • lumbar sympathectomy
  • microwave treatment

Craniofacial

  • aluminum chloride 20% solution*
  • botulinum toxin type A products (if not adequately managed with topical agents)
  • endoscopic transthoracic sympathectomy (ETS), if conservative treatment has failed (i.e., aluminum chloride)
  • iontophoresis
  • microwave treatment

*FDA approved indication.

Ongoing/repeat treatments may be considered medically necessary to maintain improvements in physical function.

Treatment of primary (focal) hyperhidrosis is considered not medically necessary in the absence of physical functional impairment or medical complications associated with the condition.

Secondary Hyperhidrosis

Treatment of secondary gustatory hyperhidrosis may be considered medically necessary when 1 or more of the following medical complications are present:

  • Diabetic neuropathies
  • Encephalitis
  • Frey’s syndrome
  • Herpes zoster parotitis
  • Parotid abscess
  • Syringomyelia

Treatments that may be considered Medically Necessary

(if a medical complication from the above list is present for severe gustatory hyperhidrosis)

Treatments considered Investigational (but not limited to):

  • aluminum chloride 20% solution*
  • botulinum toxin type A
  • surgical options, if conservative treatment has failed (i.e. tympanic neurectomy)
  • iontophoresis

*FDA approved indication.

Treatment of secondary gustatory hyperhidrosis is considered not medically necessary in the absence of physical functional impairment or medical complications associated with the condition.

Related Policies

5.01.512

Botulinum Toxin

Policy Guidelines

A multispecialty working group (1) defines primary focal hyperhidrosis as a condition that is characterized by visible, excessive sweating of at least 6 months’ duration without apparent cause and with 2 or more of the following features:

  • age at onset younger than 25 years old
  • bilateral and relatively symmetric sweating
  • focal sweating stops during sleep
  • frequency of at least once per week
  • impairment of daily activities
  • positive family history of focal hyperhidrosis

To evaluate the severity of hyperhidrosis, the Hyperhidrosis Disease Severity Scale (HDSS) questionnaire (2) provides a quantitative measure of severity and impact on daily life before and after treatment. Patients use the following questions in the HDSS to rate their symptom severity:

  1. My underarm sweating is never noticeable and never interferes with my daily activities.
  2. My underarm sweating is tolerable but sometimes interferes with my daily activities.
  3. My underarm sweating is barely tolerable and frequently interferes with my daily activities.
  4. My underarm sweating is intolerable and always interferes with my daily activities.

Scoring: 1:mild, 2:moderate, 3-4:severe

Iontophoresis device HCPCS code

There are no specific HCPCS codes for the durable medical equipment [DME] used for iontophoresis therapy. The following nonspecific code may be used:

E1399 Durable medical equipment, miscellaneous

Botulinum toxin HCPCS codes

HCPCS codes

Trade Name

New Drug Name

Old Drug Name

J0585 – I unit

Botox

onabotulinumtoxinA

Botulinum toxin type A

J0586 – 5 units

Dysport

abobotulinumtoxinA

Botulinum toxin type A

J0587 – 100 units

Myobloc

rimabotulinumtoxinB

Botulinum toxin type B

J0588 – 1 unit

Xeomin

incobotulinumtoxinA

Botulinum toxin type A

Botulinum toxin products are unique biologic agents and are not interchangeable with each other. Not all of the botulinum toxin products listed are indicated for treatment of hyperhidrosis (See Regulatory Status).

Note: This policy provides medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Unique clinical circumstances may warrant individual consideration, based on a review of applicable medical records.

Description

Hyperhidrosis, or excessive sweating, can lead to impairments in psychological and social functioning. Various treatments for hyperhidrosis are available, such as topical agents, oral systemic medications, iontophoresis, botulinum toxin injections, and surgical procedures.

Background

Hyperhidrosis may be 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 either primary or secondary. Primary focal hyperhidrosis is idiopathic in nature, typically involving the hands (palmar), feet (plantar), or axillae (underarms). Secondary hyperhidrosis can result from a variety of drugs, such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), or underlying diseases/conditions, such as febrile diseases, diabetes mellitus, or 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 scalp or face and predominately over forehead, lips, and nose. Secondary facial gustatory sweating, in contrast, is usually asymmetrical and 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’s 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 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 chewing. 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 in nature. 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.

A variety of therapies have been investigated for primary hyperhidrosis, including topical therapy with aluminum chloride, 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.

Topical iontophoresis (the use of an electric current to introduce various ions through the skin) is a long-standing treatment of palmar or plantar hyperhidrosis and recently adapted for axillary hyperhidrosis. The mechanism of action is not precisely known, but is thought to be related to plugging of the sweat gland pores. The U.S. Food and Drug Administration (FDA) regulates iontophoresis devices via the 510(k) process.

In tap water iontophoresis (TWI) treatment, the patient places his/her hands or feet into a tap water bath that contains two electrodes, or positions an electrode device in the armpit(s). A small electric current passes through the electrodes. Patients are treated for 20-30 minutes, with treatments every 2 to 3 days for 5 to 10 sessions before an effect is observed. After euhirdosis is achieved, maintenance therapy may consist of treatment every 1-4 weeks after initial therapy. Iontophoresis is primarily used for focal palmo-plantar hyperhidrosis, since the hands and feet are the easiest body parts to submerge in water.

Botulinum toxin is a potent neurotoxin that blocks cholinergic nerve terminals; symptoms of botulism include cessation of 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. Various surgical techniques of thoracic sympathectomy have been investigated as a curative procedure, primarily for combined palmar and axillary hyperhidrosis that is unresponsive to non-surgical 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 side effect. In addition, with lumbar sympathectomy for plantar hyperhidrosis, there has been concern about the risk of post-operative sexual dysfunction in men and women.

The outcome of different surgical and medical treatment modalities is best assessed by using a combination of tools. Quantitative tools include gravimetry, evaporimetry, and Minor's 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.

Regulatory Status

Drysol™ (aluminum chloride [hexahydrate] 20% topical solution, Person and Covey, Inc.) is an astringent, available by prescription, approved by the U.S. Food and Drug Administration (FDA) to aid in the management of hyperhidrosis in the axillae (underarms), palmar (palms of hands), plantar (bottom of feet), and craniofacial (head and face) areas.).

In 2004 the FDA approved botulinum toxin type A (Botox®) to treat primary axillary hyperhidrosis (severe underarm sweating) that cannot be managed by topical agents. In 2009, this product was renamed to OnabotulinumtoxinA.

Other FDA-approved botulinum toxin products include:

  • 2000: RimabotulinumtoxinB, marketed as Myobloc® (Solstice Neurosciences)
  • 2009: AbobotulinumtoxinA, marketed as Dysport® (Medicis Pharmaceutical Corporation, Scottsdale, AZ)
  • 2010: IncobotulinumtoxinA, marketed as Xeomin® (Merz Pharmaceuticals)

Not all of these botulinum toxin products are indicated for treatment of hyperhidrosis.

On July 31, 2009, the FDA approved the following revisions to the prescribing information of botulinum toxin products:

  • A Boxed Warning highlighting the possibility of experiencing potentially life-threatening distant spread of toxin effect from injection site after local injection.
  • A Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide to help patients understand the risk and benefits of botulinum toxin products.
  • Changes to the established drug names to reinforce individual potencies and prevent medication errors. The potency units are specific to each botulinum toxin product, and the doses or units of biological activity cannot be compared or converted from one product to any other botulinum toxin product. The new established names reinforce these differences and the lack of interchangeability among products.

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 U.S. Food and Drug Administration (FDA) regulates iontophoresis devices via the 510(k) process. Some machines are only for use by professionals in the office setting. Two devices, commercially available by prescription for home use, are the Drionic® device (General Medical Co., Los Angeles, CA) and the Fisher™ MD-1a Galvanic Unit (R.A. Fischer Co., Northridge, CA.).

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

For the purposes of this policy, the following terms are defined below:

Cosmetic: In this policy, cosmetic services are those which are primarily intended to preserve or improve appearance. Cosmetic surgery is performed to reshape normal structures of the body in order to improve the patient’s appearance or self-esteem.

Physical Functional Impairment: In this policy, physical functional impairment means a limitation from normal (or baseline level) of physical functioning that may include, but is not limited to, problems with ambulation, mobilization, communication, respiration, eating, swallowing, vision, facial expression, skin integrity, distortion of nearby body parts or obstruction of an orifice. The physical functional impairment can be due to structure, congenital deformity, pain, or other causes. Physical functional impairment excludes social, emotional and psychological impairments or potential impairments.

Reconstructive Surgery: In this policy, reconstructive surgery refers to surgeries performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. It is generally performed to improve function.

Rationale

The most recent literature search of the Medline database was performed for the period April 2012 through May 2013. Following is a summary of the key literature to date:

Aluminum Chloride

Topical products are the first line of therapy in treating primary (focal) hyperhidrosis. Aluminum chloride, like other metallic salts, exerts its anhidrotic effect by obstructing the distal sweat ducts within the acrosyringium by facilitating the formation of a precipitate. Common side effects usually limit the efficacy of the modality to mild cases of hyperhidrosis. For those patients who respond to antiperspirants, long-term use can sometimes result in degeneration of the eccrine unit and resolution of the localized hyperhidrosis. Drysol & Xerac AC are brand names for topical aluminum chloride solution available by prescription. Aluminum chloride is predominantly used to treat axillary hyperhidrosis, however additional indications include use on the hands, feet and scalp.

Iontophoresis

Iontophoresis became recognized as a practical approach in the treatment of hyperhidrosis in 1968. No large randomized trials have been performed, but several smaller trials (n=3–112) suggest significant benefit with 81.2% of patients having a positive result after 8 treatments. (2) Most iontophoretic systems use direct current (DC) although alternating current (AC) can also be used or AC with DC offset (AC⁄DC). Lesser side effects are associated with devices that use AC⁄DC. Frequent side effects of treatment include irritation, dry, peeling, and cracked skin at the treatment site, especially in the axillary area.

Case series include a 2013 study from Ireland with 28 patients. (5) Patients received a minimum of 9 treatments over 21 days in a clinical setting. Twenty of the 25 patients (80%) for whom data were available after hospital administration of tap water iontophoresis reported a moderate or great amount of improvement in symptoms and a moderate or great improvement in quality of life (according to a Disease Life Quality Index). After the initial course of treatment, 13 patients chose to purchase a home iontophoresis device. Eight of the 13 (62%) reported that home iontophoresis was ‘much less effective’ than hospital treatment. No other outcomes e.g., symptom improvement, were reported following home use.

Summary

After topical aluminum chloride, iontophoresis is a second line treatment for palmar or plantar hyperhidrosis, but is frequently too irritating for regular use in the axilla.

Botulinum toxin type A

A considerable body of published literature addresses botulinum toxin injection for the treatment of axillary and palmar hyperhidrosis and substantiates the efficacy of this treatment. (4-15) Studies include multiple randomized placebo-controlled trials evaluating Botox, a botulinum toxin type A product. In addition, another botulinum toxin A product, Dysport, has been evaluated in RCTs for treatment of axillary hyperhidrosis (13) and palmar hyperhidrosis (11). Moreover, a small RCT published in 2007 compared Botox and Dysport and found similar levels of efficacy and safety with the two products. (5)

One of the larger RCTs was published in 2007. (14) This study was an industry-sponsored multicenter double-blind, placebo-controlled efficacy and safety study of botulinum toxin type A in patients with persistent bilateral primary axillary hyperhidrosis. Enrollment criteria included a resting sweat production of at least 50 mg/axilla in 5 minutes and a rating of 3 or 4 (underarm sweating barely tolerable or intolerable, and frequently or always interferes with daily activities) on the Hyperhidrosis Disease Severity Scale (HDSS). A total of 322 patients were randomized to receive 50 U, or 75 U of Botox or placebo. Retreatment after 4 weeks was allowed in subjects with at least 50 mg of sweat (per axilla) over 5 minutes and an HDSS score of 3 or 4. Following the first injection, 75% of subjects in the Botox groups showed at least a 2-point improvement in the HDSS, compared with 25% of subjects in the placebo group. Sweat production decreased by 87% (75 U), 82% (50 U), and 33% (vehicle). (Similar results were obtained in patients requiring a second treatment.) The median duration of effect was 197, 205, and 96 days (75 U, 50 U, and vehicle, respectively). Seventy-eight percent of subjects (252) completed the 52-week study; 96 of 110 (87%) in the 75-U group, 83 of 104 (80%) in the 50-U group, and 73 of 108 (68%) in the control group. Intent-to-treat analysis at 52 weeks showed a responder rate (greater than 2-point improvement on the HDSS) for 54 (49%) subjects in the 75-U group, 57 (55%) in the 50-U group, and 6 (6%) in the placebo group. Injection-site pain was reported in about 10% of all groups, with a mean duration of 2.4 days (10-day maximum).

No placebo-controlled RCTs were identified evaluating the safety and efficacy of the newest formulation of botulinum toxin A, Xeomin. In 2010, Dressler published a double-blind RCT from Germany comparing Xeomin to Botox for treating primary axillary hyperhidrosis. (16) Forty-six patients with bilateral axillary hyperhidrosis and a previously stable Botox treatment for at least 2 years received 50 MU of Botox in one axilla and 50 MU Xeomin in the other axilla. All patients completed the study. A total of 41 of 46 (89%) patients reported the therapeutic effect as excellent and 5 (11%) as good. The mean reported duration of therapeutic effect was 3.2 months. According to patient self-report in structured interviews, there were no side-to-side differences in therapeutic effect including onset latency, extent and duration and no differences in injection site pain. Moreover, clinical examination did not identify any side-to-side differences in the diffuse sweating pattern.

There is less evidence in support of botulinum toxin type A for treating plantar hyperhidrosis. No RCTs or large uncontrolled studies were identified; most published studies are case reports or small case series.

The evidence evaluating botulinum toxin A use for gustatory hyperhidrosis as a result of Frey’s syndrome includes noncontrolled or nonrandomized studies, all showing favorable treatment outcomes. The patient inclusion criteria were variable across the studies and case reports; ages varied (16 to 87 years); patients had undergone varied types of parotid surgery (i.e., bilateral, partial); not all studies documented gustatory sweating with Minor’s starch test as part of the patient screening.

Summary

Multiple RCTs support the efficacy and safety of botulinum toxin A for treating severe axillary and palmar hyperhidrosis. There is a lack of RCTs on use of botulinum toxin A for plantar hyperhidrosis and gustatory hyperhidrosis.

Botulinum toxin type B

There was one placebo-controlled randomized trial on botulinum toxin B (Myobloc) for treating primary axillary hyperhidrosis and one on palmar hyperhidrosis. Both studies were by Baumann and colleagues and were published in 2005; neither discussed whether patients had failed previous treatments for hyperhidrosis. The study on axillary hyperhidrosis included 20 participants; they received subcutaneous injections of Myobloc (2,500 U or 0.5 mL per axilla) (n=15) or placebo (n=5). (17) Patients who received placebo were offered Myobloc at subsequent injections. One patient in the placebo group did not return for follow-up and another responded to placebo and did not return for a subsequent Myobloc injection. Data were available on Myobloc efficacy for the remaining 18 participants (15 in the initial Myobloc group and 3 crossovers). There was a statistically significant improvement in axillary hyperhidrosis according to patient and physician subjective assessment from baseline (before receiving an active injection) to Day 30. Details on the efficacy outcomes were not reported. The mean length of time to return to baseline levels of sweating in these 18 patients was 151 days (range 66 to 243 days). Sixteen participants reported 61 adverse events over the course of the study. Five of 61 adverse events (8.2%) were determined to be definitely related to the study; 4 axillary bruising events and 1 instance of pain at the injection site. Eleven adverse events (18%) were determined to be probably related to study treatment; dry eyes (n=3), dry mouth (n=5) and indigestion (n=3). Flu-like symptoms were reported by 6 of 20 patients (30%); however, the study period coincided with flu season. Note that the authors did not compare the active treatment and placebo groups in their analysis.

The RCT on Myobloc for treatment of palmar hyperhidrosis included 20 participants with excessive palmar sweating. Fifteen participants received injections of Myobloc (50,000 U per palm) and 5 received placebo. (18) Nonresponders were offered an injection of Myobloc at day 30. At day 30, the two quality-of-life measures were significantly higher in the Myobloc group compared to the control group. However, there was not a statistically significant difference in efficacy in the physician analysis of the palmar iodine starch test at day 30 (p=0.56). No further details were provided on the efficacy outcome measures described above. The mean duration of action according to self-report in 17 patients (15 in the initial treatment group and 2 who crossed-over from the placebo group) was 3.8 months (range, 2.3 to 4.9 months). Participants were asked about specific adverse events. Eighteen of 20 (90%) reported dry mouth/throat, 12 (60%) reported indigestion, 12 (60%) reported excessively dry hands, 12 (60%) reported muscle weakness, and 10 (50%) reported decreased grip strength. Both studies by Baumann and colleagues were limited by a small sample sizes and limited or no comparative data.

A small randomized trial by Frasson and colleagues in Italy that compared botulinum toxin type A and type B for treating axillary hyperhidrosis was published in 2011. (17) This study included 10 patients with idiopathic focal axillary hyperhidrosis that was unresponsive to other non-surgical treatments. Patients received 50 U botulinum toxin A in one axilla and 2,500 U botulinum toxin B in the contralateral axilla. Gravimetry was performed at baseline and follow-up as an objective measurement of sweat production. In addition, the sweat area was photographed. At each follow-up point, the decrease in sweat weight from baseline was significantly greater on the botulinum toxin B side compared to the botulinum toxin A side. For example, after 1 month, the sweat weight in 5 minutes was 13% of the baseline value on the botulinum toxin A side and 4% of the baseline value on the botulinum toxin B side (p=0.049). By 6 months, the sweat weight returned to 91% of baseline on the botulinum toxin A side and 56% of baseline weight on the botulinum toxin B side (p=0.02). Findings were similar for sweating area. All patients tolerated injections of botulinum toxin types A and B well and none reported systemic adverse effects. The authors commented that this study used a higher dosage of botulinum toxin B than previous studies.

Summary

There are few RCTs evaluating botulinum toxin type B for treating hyperhidrosis. One small RCT did not clearly demonstrate the efficacy of botulinum toxin type B in patients with palmar hyperhidrosis. Two RCTs support the efficacy of this treatment for patients with axillary hyperhidrosis.

Microwave treatment

A 2012 RCT evaluated a microwave device for treating hyperhidrosis. (18) This device applies microwave energy to superficial skin structures with the intent of inducing thermolysis of the eccrine and apocrine sweat glands. This industry-sponsored double-blind study randomized 120 adults with primary axillary hyperhidrosis in a 2-to-1 ratio to active (n=81) or sham (n=39) treatment. Treatment consisted of 2 sessions, separated by approximately 2 weeks. Patients who responded adequately after 1 session or declined further treatment did not need to undergo the second session and a third procedure was allowed within 30 days for participants who still had a high level of sweating after 2 sessions. All patients in the sham group had 2 sessions. In the active treatment group, 11 individuals (9%) had only 1 session and 10 (8%) had a third procedure. The primary efficacy endpoint was a score of 1 (underarm sweating never noticeable) or 2 (underarm sweating tolerable) on the Hyperhidrosis Disease Severity Scale at the 30-day follow-up; HDSS score at 6 months was a secondary outcome. A total of 101/120 (84%) completed the study. At 30 days, 89% of the active treatment group and 54% of the sham group had an HDSS score of 1 or 2; p<0.001. At 6 months, 67% of the active treatment group and 44% of the sham group had an HDSS score of 1 or 2; the difference between groups remained statistically significant, p=0.02. Unblinding occurred at 6 months. Twelve-month data were available for the active treatment group only; 69% reported an HDSS score of 1 or 2. There were 45 procedure-related adverse events in 23 (28%) of the active treatment group and 5 (13%) of the sham group. The most frequently reported adverse event was altered sensation; no serious adverse events were reported. Compensatory sweating was reported by 2 individuals in each group and had a mean duration of 52 days. The authors noted that study data provided an opportunity to identify areas for improvement of the treatment protocol including waiting longer between treatments and using a higher dose of energy at the second session.

A 2012 industry-sponsored case series reported on 31 patients with primary axillary hyperhidrosis who were treated with microwave therapy using the miraDry system. (19) All patients had an HDSS score of 3 or 4 at baseline. The primary efficacy outcome, the proportion of patients whose HDSS decreased to 1 or 2 was 28 (90%) at 6 months and 12 months after treatment. Longer-term skin-related side effects (that all resolved over time) were altered sensation in the skin of the axillae (65% of patients, median duration, 37 days) and palpable bumps under the skin of the axillae (71% of patients, median duration, 41 days).

Summary

A single RCT and case series provides insufficient evidence that microwave treatment improves the health outcome for primary focal hyperhidrosis. This RCT reports short term benefit of microwave treatment in reducing hyperhidrosis, but also reports a high rate of skin-related side effects such as pain and altered sensation. Additional controlled studies with long-term follow-up in the treatment and control groups, a longer period of blinding and a consistent treatment protocol are needed to confirm the efficacy of this treatment, and to better define the risk/benefit ratio.

Radiofrequency ablation

A 2013 study evaluated radiofrequency ablation as a treatment option for patients with severe bilateral palmar hyperhidrosis resistant to conservative treatment. (20) The study was conducted in Turkey and retrospectively reviewed outcomes after radiofrequency ablation (n-48) or transthoracic sympathectomy (n=46). Patients were no randomized to treatment group. After the mean of 15 months follow-up, palmar hydrosis was absent in 36 patients (75%) in the radiofrequency ablation group and 44 patients (96%) in the surgery group. The difference in outcomes was statistically significant between groups, favoring the surgical intervention, p<0.01. Six patients in each group reported moderate or severe compensatory sweating (p+0.78).

Summary

One non-randomized comparative study represents insufficient evidence on radiofrequency ablation as a treatment of hyperhidrosis. In this single available study, radiofrequency ablation was found to be inferior to surgical sympathectomy.

Surgical interventions

Tympanic neurectomy for gustatory hyperhidrosis

Review articles by Clayman et al. (21) and de Bree et al. (22) describe the various medical and surgical treatments for Frey’s syndrome. Tympanic neurectomy is described as a treatment for Frey’s syndrome, with satisfactory control reported in 82% of patients. In addition, this surgical treatment is generally definitive without a need for repeated interventions.

Sweat gland excision for primary focal hyperhidrosis

Surgery may involve removal of the subcutaneous sweat glands without removal of any skin, limited excision of skin, and removal of surrounding subcutaneous sweat glands, or a more radical excision of skin and subcutaneous tissue en bloc. (23) Depending on the completeness of surgical excision, the treatment is effective in 50–95% of patients.

Transthoracic sympathectomy for primary focal hyperhidrosis

Several RCTs and one meta-analysis have compared different approaches to surgery; there were no sham-controlled RCTs. In 2011, Deng and colleagues published a meta-analysis of data from RCTs and observational studies published to 2010 evaluating thoracoscopic sympathectomy for patients with palmar hyperhidrosis. (24) The authors pooled outcome data from different approaches to sympathectomy, i.e., single-ganglia blockage (T2, T3, or T4), and multi-ganglia blockage (T2-3, T2-4, or T3-4). (Note: T refers to rib). Based on these analyses, they concluded that T3 (11 studies) and T3-4 (2 studies) had the “best” clinical efficacy i.e., postoperative resolution of symptoms. The T3 approach resulted in a 97.9% pooled efficacy rate, and the T3-4 approach resulted in a 100% pooled efficacy rate. In the studies for which data were available, the pooled rate of postoperative compensatory sweating was 40% after T3 surgery. Data on compensatory sweating after T3-4 surgery was only available from one study with 60 patients; a pooled analysis could not be performed.

Subsequent RCTs have also compared levels of sympathectomy. A 2011 study by Baumgartner and colleagues included 121 patients with disabling palmoplantar hyperhidrosis. (25) Patients were randomized to receive bilateral sympathectomy over T2 (n=61 patients) or T3 (n=60 patients). Six of 121 (5%) patients, 3 in each group, were considered treatment failures i.e., had recurrent palmar sweating to a bothersome level. There were no significant differences between groups in the reported subjective change in plantar or axillary sweating after surgery. At 6 months, the mean level of compensatory sweating (0 to 10 severity scale) was 4.7 (SD=2.7) for the T2 group and 3.8 (SD=2.8) for the T3 group (p=not significant). Similarly, at 1 year, the mean severity rating of compensatory sweating was 4.7 (SD=2.5) in the T2 group and 3.7 (SD=2.8) in the T3 group; p=0.09. Another study was published by Ishy and colleagues in Brazil in which surgery at the T3 and T4 levels was compared. (26) This study included 20 patients with palmar hyperhidrosis. All patients experienced complete bilateral remission of palmary sweating after 1 year of follow-up. The level of compensatory sweating did not differ significantly between groups at 1 week, 1 month or 6 months but at 1 year there was a significantly higher rate in the T3 compared to the T4 group (20/20, 100% in the T3 group and 15/20, 75% in the T4 group, p=0.47).

There is also a large amount of data from case series on transthoracic sympathectomy for treating primary focal hyperhidrosis (27-32) Case series generally report high success rates for palmar and axillary hyperhidrosis, although there are potential adverse effects, most commonly compensatory sweating.

For example, in 2010, Wait and colleagues published a retrospective analysis of prospectively collected data on patients who underwent bilateral thoracoscopic sympathectomy for hyperhidrosis. (31) Data were available on 322 of 348 (93%) of patients who underwent surgery. Patients’ previous use of nonsurgical hyperhidrosis treatments was not reported. Complete resolution of symptoms was experienced by 300 of 301 (99.7%) with palmar hyperhidrosis, 136 of 186 (73%) with axillary hyperhidrosis, 27 of 30 (90%) with craniofacial hyperhidrosis, and 19 of 197 (9.6%) with plantar hyperhidrosis. Compensatory sweating was reported by a total of 201 of 322 (62%) patients. The compensatory sweating was severe in 20 (6.2%) of patients and mild or moderate in 181 (56.2%) of patients. It is worth noting that thoracoscopic sympathectomy was performed in some cases of plantar hyperhidrosis and that there was a low rate of success. In addition, when reporting rates of compensatory sweating, the authors did not distinguish between mild and moderate levels of symptoms, although these could have different clinical implications for the patient.

In 2011, Smidfelt and Drott in Sweden reported on long term outcomes after transthoracic sympathectomy (32) Of 3015 patients who had been treated with endoscopic thoracic sympathectomy for hyperhidrosis and/or facial blushing, 1700 (56%) responded to a written survey after a mean of 14.6 (SD=2.4) years. The most common indications for surgery were palmar hyperhidrosis (n=795 47%) and facial blushing (n=536, 32%). A total of 85.1% of respondents reported that they had a satisfactory and lasting effect of the surgery. Sweating and/or blushing recurred and was considered a problem in 8.1% and 6.9% reported no initial effect or a poor effect. No or insignificant compensatory sweating was reported by 425 (25.6%) respondents. Compensatory sweating was considered troublesome by 299 (17.6%), annoying by 409 (24.1%), severe by 367 (21.6%) and incapacitating by 190 (11.2%). Nearly half of the patients who underwent surgery did not respond to the survey; their outcomes may have been different from those of study respondents.

A 2013 series reported on complications after thoracic sympathectomy in 1731 patients with palmar, axillary or craniofacial hyperhidrosis. (33) Thirty days after surgery, 1531 (88.4%) of patients reported compensatory sweating. Among the 1531 patients, compensatory sweating was mild in 473 (31%) moderate in 642 (42%) and severe in 416 (27%). Gustatory sweating was reported by 334 of the 1731 (19%) patients.

Summary

RCTs and a meta-analysis of RCTs support the efficacy of transthoracic sympathectomy at various levels for palmar and axillary hyperhidrosis. These data are complemented by case series which have found high efficacy rates, but also high rates of compensatory sweating for these conditions. There is insufficient evidence in support of transthoracic sympathectomy for treating plantar hyperhidrosis; case series found lower rates of efficacy for plantar compared to axillary or palmar hyperhidrosis, and there are concerns for side effects in sexual functioning.

Endoscopic lumbar sympathectomy for primary plantar hyperhidrosis

No RCTs were identified but several case series were identified. A 2009 series by Rieger and colleagues from Austria evaluated surgery results in 90 patients (59 men, 31 women with severe plantar hyperhidrosis). (34) Thirty-seven patients (41%) had only plantar hyperhidrosis, and 53 (59%) had plantar and palmar hyperhidrosis. All patients had previously used other treatments including topical aluminum chloride therapy. There were a total of 178 procedures–90 on the right-side and 88 on the left side. The technique involved resecting a segment of the sympathetic trunk between the third and fourth lumbar bodies together with the ganglia (L3 and/or L4). After a mean follow-up of 24 months (range: 3 to 45), hyperhidrosis was eliminated in 87 of 90 patients (97%). Postoperative neuralgia occurred in 38 (42%) patients between the 7th and 8th day. The pain lasted less than 4 weeks in 11 patients, 1-3 months in 19 patients, 4-12 months in 5 patients, and more than 12 months in 3 patients. Three men reported temporary sexual symptoms; one was incapable of ejaculation for 2 months. None of the women reported postoperative sexual dysfunction.

In 2010, Reisfeld reported on results of a U.S.-based study from a specialized hyperhidrosis clinic in which bilateral endoscopic lumbar sympathectomy was performed in 63 patients with focal plantar hyperhidrosis. (35) There were 13 (21%) male patients and 50 (79%) female patients. A clamping method was used in which clamps were placed at L3 (46.6%), L4 (52.4%), and L2 in one case. There was a learning curve with this procedure, and 5 early cases had to be converted to an open procedure. Fifty-six (89%) of the patients had previously undergone some form of thoracic sympathectomy, and all had tried conservative measures. After a mean follow-up of 7 months, all patients considered their plantar hyperhidrosis symptoms to be “cured” or “improved;” 97% reported “cure.” All of the patients with previous thoracic sympathectomy had some degree of compensatory sweating. After lumbar sympathectomy, 51 of the 56 patients (91%) reported that their compensatory sweating was unchanged. In the 7 patients who did not have a previous thoracic sympathectomy, 1 reported mild and 6 reported moderate compensatory sweating. The authors stated that no sexual problems were reported by the male patients, and they did not discuss possible sexual problems among the female patients.

It is worth noting, that in contrast to earlier concerns about this procedure being associated with risks of permanent sexual dysfunction in men and women, the recent case series did not find any instances of permanent sexual dysfunction. A 2004 review from a multi-specialty working group on hyperhidrosis stated that lumbar sympathectomy is not recommended for plantar hyperhidrosis because of associated sexual dysfunction; this article did not cite any data documenting sexual dysfunction. (1) To date, there are very few studies on endoscopic lumbar sympathectomy for focal plantar hyperhidrosis and no comparative studies.

Summary

There are insufficient data supporting the safety and efficacy of lumbar sympathectomy for treating primary plantar hyperhidrosis.

Conclusion

There is insufficient evidence on the efficacy and safety of microwave treatment for treating hyperhidrosis and on radiofrequency ablation for palmar hyperhidrosis. There is evidence from randomized trials that botulinum toxin improves the net health outcome for patients with axillary hyperhidrosis and evidence that botulinum toxin A products improve the net health outcome for palmar hyperhidrosis. Due to the limited number of studies and high rates of adverse effects, there is insufficient evidence that botulinum toxin B improves the net health outcome for patients with primary palmar hyperhidrosis

Data from randomized controlled trials and observational studies show high rates of efficacy of endoscopic transthoracic sympathectomy for primary focal hyperhidrosis, with the exception of plantar hyperhidrosis. However, there are high rates of compensatory hyperhidrosis which should be considered in the treatment decision. There are insufficient data to draw conclusions on the efficacy of endoscopic lumbar sympathectomy in patients with primary plantar hyperhidrosis.

Practice Guidelines and Position Statements

In 2011, an expert consensus statement on the surgical treatment of hyperhidrosis was published by a task force of the Society of Thoracic Surgeons. (36) The document states that endoscopic thoracic sympathectomy is the treatment of choice for patients with primary hyperhidrosis. They further recommend 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 an 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’s syndrome.

In 2008, the American Academy of Neurology (AAN) created guidelines for use of botulinum neurotoxin for the treatment of autonomic disorders and pain. (37) These guidelines include the following recommendations for botulinum toxin injection as a treatment of hyperhidrosis:

  • Should be offered as a treatment option to patients with axillary hyperhidrosis (Level A).
  • Should be considered as a treatment option for palmar hyperhidrosis and drooling (Level B).
  • May be considered for gustatory sweating (Level C).

References

  1. Hornberger J, Grimes K, Naumann M et al; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dematol 2004; 51(2):274-86.
  2. Hoorens, I, Ongenae,K. Primary focal hyperhidrosis: current treatment options and a step-by-step approach. Journal of the European Academy of Dermatology and Venereology, 2012 26(1): 1–8.
  3. Solish N, Bertucci V, Dansereau A et al; Canadian Hyperhidrosis Advisory Committee. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg 2007; 33(8):908-23.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Iontophoresis for Medical Indications. TEC Assessments 2003; Volume 18, Tab 3.
  5. McAleer MA, Collins P. A Study Investigating Patients’ Experience of Hospital and Home Iontophoresis for Hyperhidrosis. J Dermatolog Treat 2013 [Epub ahead of print].
  6. Schnider P, Binder M, Auff E et al. Double-blind trial of botulinum A toxin for the treatment of focal hyperhidrosis of the palms. Br J Dermatol 1997; 136(4):548-52.
  7. Talarico-Filho S, Mendonça DO, Nascimento M et al. A double-blind, randomized, comparative treatment of two type A botulinum toxins in the treatment of primary axillary hyperhidrosis. Dermatol Surg 2007; 33(1 Spec. No.):S44-S50.
  8. Naumann M, Hofmann U, Bergmann I et al. Focal hyperhidrosis: effective treatment with intracutaneous botulinum toxin. Arch Dermatol 1998; 134(3):301-4.
  9. Naumann MK, Hamm H, Lowe NJ. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial. Br J Dermatol 2002; 147(6):1218-26.
  10. Naumann M, Lowe NJ, Kumar CR et al. Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study. Arch Dermatol 2003; 139(6):731-6.
  11. Campanati A, Penna L, Guzzo T et al. Quality-of-life assessment in patients with hyperhidrosis before and after treatment with botulinum toxin: results of an open-label study. Clin Ther 2003; 25(1):298-308.
  12. Lowe NJ, Yamauchi PS, Lask GP et al. Efficacy and safety of botulinum toxin type A in the treatment of palmar hyperhidrosis: a double-blind, randomized, placebo-controlled study. Dermatol Surg 2002; 28(9):822-7.
  13. Saadia D, Voustianiouk A, Wang AK et al. Botulinum toxin type A in primary palmar hyperhidrosis: randomized, single-blind, two-dose study. Neurology 2001; 57(11):2095-9.
  14. Naumann M, Lowe NJ. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. BMJ 2001; 323(7313):596-9.
  15. Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med 2001; 344(7):488-93.
  16. Lowe NJ, Glaser DA, Eadie N et al; North American Botox in Primary Axillary Hyperhidrosis Clinical Study Group. Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety. J Am Acad Dermatol 2007; 56(4):604-11.
  17. Flanagan KH, King R, Glaser DA. Botulinum toxin type a versus topical 20% aluminum chloride for the treatment of moderate to severe primary focal axillary hyperhidrosis. J Drugs Dermatol 2008; 7(3):221-7.
  18. Dressler D. Comparing Botox and Xeomin for axillar hyperhidrosis. J Neural Transm 2010; 117(3):317-9.
  19. Baumann L, Slezinger A, Halem M et al. Pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for treatment of axillary hyperhidrosis. Int J Dermatol 2005; 44(5):418-24.
  20. Baumann L, Slezinger A, Halem M et al. Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis. Dermatol Surg 2005: 31(3):263-70.
  21. Frasson E, Brigo F, Acler M et al. Botulinum toxin type A vs Type B for axillary hyperhidrosis in a case series of patients observed for 6 months. Arch Dermatol 2011; 147(1):122-3.
  22. 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):185-91.
  23. Hong HC, Lupin M, O’Shaughnessy KF. Clinical evaluation of a microwave device for treating axillary hyperhidrosis. Dermatol Surg 2012; 38(5):728-35.
  24. Purtuloglu T, Atim A, Deniz D et al. Effect of radiofrequency ablation and comparison with surgical sympathectomy in palmar hyperhidrosis. Eur J Cardiothorac Surg 2013 [Epup ahead of print].
  25. Clayman MA, Clayman SM, Seagle MB. A review of the surgical and medical treatment of Frey syndrome. Ann Plast Surg 2006; 57(5):581-4.
  26. de Bree R, van der Waal I, Leemans CR. Management of Frey syndrome. Head Neck 2007; 29(8):773-8.
  27. Hafner J, Beer GM. Axillary sweat gland excision. Curr Probl Dermatol 2002; 30:57-63.
  28. 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; 25:1893-901.
  29. 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.
  30. 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):545-8.
  31. Gossot D, Galetta D, Pascal A et al. Long-term results of endoscopic thoracic sympathectomy for upper limb hyperhidrosis. Ann Thorac Surg 2003; 75(4):1075-9.
  32. Han PP, Gottfried ON, Kenny KJ et al. Biportal thoracoscopic sympathectomy: surgical techniques and clinical results for the treatment of hyperhidrosis. Neurosurgery 2002; 50(2):306-12.
  33. Leseche G, Castier Y, Thabut G et al. Endoscopic transthoracic sympathectomy for upper limb hyperhidrosis: limited sympathectomy does not reduce postoperative compensatory sweating. J Vasc Surg 2003; 37(1):124-8.
  34. Lin TS, Kuo SJ, Chou MC. Uniportal endoscopic thoracic sympathectomy for treatment of palmar and axillary hyperhidrosis: analysis of 2000 cases. Neurosurgery 2002; 51(5 suppl):84-7.
  35. Wait SD, Killory BD, Lekovic GP et al. Thoracoscopic sympathectomy for hyperhidrosis: analysis of 642 procedures with special attention to Horner’s syndrome and compensatory hyperhidrosis. Neurosurgery 2010; 67(3):652-7.
  36. Smidfelt K, Drott C. Late results of endoscopic thoracic sympathectomy for hyperhidrosis and facial blushing. Br J Surg 2011; 98(12):1719-24.
  37. 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 2013 [Epub ahead of print].
  38. Rieger R, Pedevilla S, Pochlauer S. Endoscopic lumbar sympathectomy for plantar hyperhidrosis. Br J Surg 2009; 96(12):1422-8.
  39. Reisfeld R. Endoscopic lumbar sympathectomy for focal plantar hyperhidrosis using the clamping method. Surg Laparosc Endosc Percutan Tech 2010; 20(4):231-6.
  40. 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):1642-8.
  41. Naumann M, So Y, Argoff CE et al; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 70(19):1707-14. Available online at: http://www.guideline.gov/content.aspx?id=12948&search=botulinum+neurotoxin. Last accessed June 11, 2013.
  42. BlueCross BlueShield Association Medical Policy Reference Manual, Treatment of Hyperhidrosis. Medical Policy Reference Manual, Policy No. 8.01.19, 2013

Coding

Codes

Number

Description

CPT

32664

Thoracoscopy, surgical; with thoracic sympathectomy

 

64650

Chemodenervation of eccrine glands; both axillae

 

64653

Other area(s) (e.g., scalp, face, neck), per day

 

64809

Sympathectomy, thoracolumbar

 

64818

Sympathectomy, lumbar

 

95923

Testing of autonomic nervous system function; sudomotor, including 1 or more of the following: quantitative sudomotor axon reflex test (QSART), silastic sweat imprint, thermoregulatory sweat test, and changes in sympathetic skin potential

 

97033

Application of a modality to 1 or more areas; iontophoresis, each 15 minutes

ICD-9 Procedure

99.27

Iontophoresis

ICD-9 Diagnosis

705.21

Primary focal hyperhidrosis

 

705.22

Secondary focal hyperhidrosis

 

780.8

Generalized Hyperhidrosis

HCPCS

J0585

Injection, onabotulinumtoxinA, 1 unit

 

J0586

Injection, abobotulinumtoxinA, 5 units

 

J0587

Injection, rimabotulinumtoxinB, 100 units

 

J0588

Injection, incobotulinumtoxinA, 1 unit

 

J3490

Unclassified drugs (may be used to report aluminum chloride 20%)

ICD-10-CM
(effective 10/01/14)

L74.510-L74.519

Focal hyperhidrosis code range

 

L74.52

Secondary focal hyperhidrosis

 

R61

Generalized hyperhidrosis

ICD-10-PCS
(effective 10/01/14)

015L4ZZ

Surgical, peripheral nervous system, destruction, sympathetic nerve, percutaneous endoscopic

 

01BK3ZZ, 015L4ZZ

Surgical, peripheral nervous system, excision, head and neck sympathetic nerve, code by approach (percutaneous or percutaneous endoscopic)

Type of Service

Medicine / Surgery

 

Place of Service

Inpatient Outpatient

 

Appendix

N/A

History

Date

Reason

09/07/99

Add to Therapy Section - New Policy

11/12/02

Replace Policy - Policy reviewed without literature review; new review date only.

09/12/03

Replace Policy - Policy updated regarding iontophoresis as a treatment for hyperhidrosis based on 2003 TEC Assessment; policy statement revised to indicate that this is considered investigational (previously considered medically necessary). Policy changed from “AR” to “BC.”

03/09/04

Replace Policy - Policy revised regarding surgical treatments of axillary hyperhidrosis; surgical excision considered medically necessary, axillary liposuction considered investigational.

06/08/04

Replace Policy - Correction to policy statement to remove surgical excision of axillary sweat glands from investigative statement in Policy Section.

03/08/05

Replace Policy - Policy updated with literature search; policy statement unchanged.

02/06/06

Codes updated - No other changes.

06/02/06

Disclaimer and Scope updates - No other changes.

06/12/07

New PR Policy - Policy replaces BC.8.01.19. In the treatment of primary hyperhidrosis, treatment is considered medically necessary when physical functional impairment exists; and cosmetic when no physical functional impairment is present; axillary liposuction is considered investigational. Botox is indicated as medically necessary treatment for secondary gustatory hyperhidrosis. Definitions of physical functional impairment, cosmetic and reconstructive surgery added to Benefit Application section.

11/12/07

Code updated - CPT code 89230 deleted as directed by RPIW 11/8/07.

04/08/08

Replace Policy - Policy statement regarding aluminum chloride, iontophoresis, botulinum toxin, endoscopic transthoracic sympathectomy and surgical excision of axillary sweat glands changed from “cosmetic” to “not medically necessary” when there is no physical functional impairment. Description, Rationale and Reference sections updated.

05/12/09

Replace Policy - Policy updated with literature search; no change to policy statement. References added.

08/11/09

Code update - 68409 & 64818 added, no other changes.

12/08/09

Code Update - 89230 added back to policy.

02/09/10

Code Update - New 2010 code added.

04/13/10

Replace Policy - Policy updated with literature search; no change to policy statement.

11/15/10

Codes Updated - Additional J Codes added.

05/10/11

Replace Policy - Policy updated with literature search; no change to policy statement. Reference added.

07/10/12

Replace policy. An extensive reformatting of policy statement was done to mirror the layout of Blue Cross Policy 8.01.19 Treatment of Hyperhidrosis. Added Microwave treatment as investigational for primary focal hyperhidrosis. The Description and Rationale sections have been updated. Reference 2 replaced. Added CPT 69676 tympanic neurectomy and 97033 application of modality iontophoresis. Added ICD-9 procedure 99.27 Iontophoresis, added J3490 unclassified drugs, J0588 Injection, incobotulinumtoxinA, 1 unit.

10/09/12

Update Coding Section – ICD-10 codes are now effective 10/01/2014.

07/08/13

Replace policy. Policy statement has addition of radiofrequency ablation as investigational for treatment of palmer hyperhidrosis. Rationale updated based on a literature review through May 2013. References 4, 19, 20 and 32 added; other references renumbered or removed. Some policy sections reformatted for readability. Policy statement changed as noted.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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