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DESCRIPTIONHyperhidrosis may be defined as excessive sweating, beyond a level required to maintain normal body temperature in response to heat exposure or exercise. Hyperhidrosis can be classified as either primary or secondary. Primary hyperhidrosis is idiopathic in nature, typically involving the hands (palmar), feet (plantar), or axillae. 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. Gustatory hyperhidrosis is an unusual iatrogenic cause of facial hyperhidrosis in response to hot or spicy foods, resulting from surgery to the parotid gland and subsequent aberrant regenerating parasympathetic fibers.
Frey’s syndrome is an uncommon type of secondary gustatory hyperhydrosis 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 mastication. Aberrant secondary gustatory sweating follows up to 73 percent of surgical sympathectomies and is particularly common after bilateral procedures.
The consequences of hyperhidrosis are primarily psychosocial in nature. Excessive sweating may be socially embarrassing (i.e., limiting the ability to shake hands) or interfere with certain professions. For example, palmar hyperhidrosis may preclude artwork, working with electrical components, or playing certain musical instruments. In addition, hyperhidrosis may require several changes of clothing a day; excessive sweating may also result in staining of clothing or shoes. 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 or tanning agents, iontophoresis, botulinum toxin, and endoscopic transthoracic sympathectomy and surgical excision of axillary sweat glands. Treatment of secondary hyperhydrosis focuses on treatment of the underlying cause, such as discontinuing certain drugs or hormone replacement therapy as a treatment of menopausal symptoms.
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 and iodine test. Qualitative assessment tools include general health surveys and hyperhydrosis -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.
Drysol™ (aluminum chloride [hexahydrate] 20% topical solution, Person and Covey, Inc.) is FDA approved as an astringent to be used as an aid in the management of hyperhidrosis (axillae, palmar, plantar, and craniofacial) available by prescription. In 2004, the U.S. Food and Drug Administration (FDA) approved OnabotulinumtoxinA (marketed as Botox) [formerly botulinum toxin type A] to treat primary axillary hyperhydrosis (severe underarm sweating) that cannot be managed by topical agents such as prescription (Drysol™) and over-the-counter (OTC) (i.e., Certain Dri® 12%) topical agents with aluminum chloride. A typical dosage would be intradermal injections of 50 units per axilla. Efficacy begins in about 7 to 10 days and lasts approximately 4 to 12 months. Contraindications to OnabotulinumtoxinA (Botox) toxin include infection at the proposed injection site(s), pregnancy, and lactation. OnabotulinumtoxinA (Botox) should be used with caution in patients with neuromuscular disorders (i.e., myasthenia gravis) and patients taking medications such as aminoglycosides, pencillamine, quinine, and calcium channel blockers. The safety and effectiveness has been established for patients 18 years and older. Botulinum toxin has also been investigated as a treatment of hyperhydrosis in body areas other than the axilla and for secondary gustatory hyperhydrosis.
The FDA completed a safety review of botulinum toxin products, which included OnabotulinumtoxinA (marketed as Botox) [formerly botulinum toxin type A] and RimabotulinumtoxinB (marketed as Myobloc) [formerly botulinum type B]. On July 31, 2009, the FDA approved the following revisions to the prescribing information:
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 2 sessions of approximately one hour in duration. Sessions occur in a physician’s office and local anesthetic is used.
POLICYPrimary Focal Hyperhidrosis
Primary focal hyperhidrosis is defined as excessive sweating induced by sympathetic hyperactivity in selected areas that is not associated with an underlying disease process. The most common locations are underarms (axillary hyperhidrosis), palms (palmar hyperhidrosis), soles (plantar hyperhidrosis) or face (craniofacial hyperhidrosis).
In the majority of patients, treatment of hyperhidrosis would be considered not medically necessary based on the lack of functional impairment or medical complications.
In a small subset of patients, treatment of primary hyperhidrosis may be considered medically necessary with the following medical complications:
* FDA approved indications
Secondary hyperhidrosis is excessive sweating that can be generalized or craniofacial sweating and may occur as a result of olfactory or gustatory stimuli, neurologic lesions, intrathoracic neoplasms, Raynaud’s disease and Frey’s syndrome.
Secondary Gustatory Hyperhidrosis
The following treatments would be considered medically necessary for the treatment of severe gustatory hyperhidrosis:
The following treatments are considered investigational as a treatment for severe gustatory hyperhidrosis including, but not limited to:
* FDA approved indication
Prior Authorization is required for Botox®.
Treatment of severe primary axillary hyperhidrosis with OnabotulinumtoxinA (Botox) is considered medically necessary after a consultation with a dermatologist, and prior authorization.
Refer to the Botox®(OnabotulinumtoxinA), Dysport®(AbobotulinumtoxinA), MYOBLOC®(RimabotulinumtoxinB), IncobotulinumtoxinA (Xeomin®) medical policy for other indications.
POLICY EXCEPTIONSFederal Employee Program may dictate that all FDA approved devices, drugs, or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESA multispecialty working group 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 at least 2 of the following features: bilateral and relatively symmetric sweating, impairment of daily activities, frequency of at least once per week, age at onset younger than 25 years, positive family history, and cessation of focal sweating during sleep.
In the hyperhidrosis disease severity scale, patients rate the severity of symptoms on a scale of 1-4:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/25/2004: Approved by Medical Policy Advisory Committee (MPAC)
4/29/2004: Code Reference section completed
9/9/2004: Policy statement "Treatment of hyperhidrosis with botulinum toxin is considered investigational and not medically necessary since it is not FDA approved for this indication." changed from investigational to medically necessary as follows: "Treatment of severe primary axillary hyperhidrosis with botulinum toxin is considered medically necessary after failed treatment using topical agents."; "The treatment of axillary hyperhidrosis is considered cosmetic and therefore not eligible for coverage." deleted, Code Reference section updated, ICD-9 diagnosis code 780.8 description revised and "Note" added covered table, HCPCS J0585 added covered table, non-covered table added, CPT code 15878, 17999, 97033 added non-covered table, ICD-9 procedure code 86.3, 86.83, 99.27 added non-covered table
11/18/2004: Reviewed by MPAC, Treatment of severe primary axillary hyperhidrosis with botulinum toxin is considered medically necessary after failed treatment using topical agents, consultation with a dermatologist, and prior authorization. Sources updated
5/5/2005: Code Reference section updated, ICD-9 diagnosis code 705.21 added with Note: "Use code 780.8 to report all forms of hyperhidrosis for dates of service prior to 10/1/2004. See POLICY statement for coverage information regarding the various forms of hyperhidrosis." ICD-9 diagnosis code 780.8 description "Hyperhidrosis (includes palmar hyperhidrosis, axillary hyperhidrosis, and primary hyperhidrosis)" revised to read "Generalized Hyperhidrosis" with a Note change from "See POLICY statement regarding the coverage of palmar, axillary, and primary hyperhidrosis added 9/9/2004" to "See POLICY statement regarding the coverage of the various types of hyperhidrosis"
3/14/2006: Coding updated. CPT4 2006 revisions added to policy
8/7/2006: Policy reviewed and policy statement re-written for clarification.
01/01/2009: Accredo preferred provider information removed. BCBSMS information added.
07/27/2009: Policy Description section updated for a clearer understanding of primary and secondary hyperhidrosis symptoms and treatments, Policy Statement section revised to add table with treatments considered medically necessary per region and treatments considered investigational per region for a clearer understanding of the intent of the policy, Policy Guidelines section updated to add features of hyperhidrosis, note added to HCPCS code J0585 under covered table, HCPCS code J0587 added to non covered table.
08/03/2010: Policy description updated to add new FDA information about the safety evaluation of botulinum toxin products and the new drug names established to reinforce individual potencies and prevent medication errors. Botulinum type A and botulinum B were changed to OnabotulinumtoxinA and RimabotulinumtoxinB, respectively, throughout the policy. Added links to related medical policy. FEP verbiage added to the Policy Exceptions section. Code Reference Section updated to add ICD-9 code 705.22 and J3490 to the Covered Codes table. Moved CPT code 17999 from non-covered to covered. Added 64818 and J0856 to the Non-covered Codes table. Revised the descriptions of J0585 and J0587. Added the FDA Web site to the Sources section.
08/03/2011: Policy reviewed; no changes.
05/07/2012: For clarity purposes, added "if a medically necessary medical complication listed above is present" to the table regarding treatments considered medically necessary for primary hyperhidrosis. Intent of policy statement unchanged.
07/12/2012: Microwave treatment added as investigational for primary focal hyperhidrosis.
11/06/2013: Radiofrequency ablation added as investigational for palmar hyperhidrosis. Clarified that OnabotulinumtoxinA (Botox) is considered investigational for palmar hyperhidrosis.
Hayes Medical Technology Directory
Patrick J. Lillis, MD, and William P. Coleman III, MD, Liposuction for Treatment of Axillary Hyperhidrosis, Dermatologic Clinics July 1990; Vol 8, No 3.; 479-482.
Strutton et al. US Prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: Results from a national survey. Journal of The
Hornberger et al. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. Journal of The
Hayes Alert, Vol VII, Number 8 – August 2004
www.fda.gov: Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc)
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Not Medically Necessary Codes