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MP 2.01.71 Non-Pharmacologic Treatment of Rosacea

Medical Policy    
Section
Medicine 
Original Policy Date
11/9/04
Last Review Status/Date
Reviewed with literature search/12:2014
Issue
12:2014
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

Rosacea is characterized by episodic erythema, edema, papules, and pustules that occur primarily on the face but may also be present on the scalp, ears, neck, chest, and back. On occasion, rosacea may affect the eyes. Patients with rosacea have a tendency to flush or blush easily. Since rosacea causes facial swelling and redness, it is easily confused with other skin conditions, such as acne, skin allergy, and sunburn.

Rosacea affects mostly adults with fair skin between the ages of 20 and 60 years and is more common in women, but often most severe in men. Rosacea is not life-threatening, but if not treated, may lead to persistent erythema, telangiectasias, and rhinophyma (hyperplasia and nodular swelling and congestion of the skin of the nose). The etiology and pathogenesis of rosacea is unknown but may be a result of both genetic and environmental factors. Some of the theories as to the causes of rosacea include blood vessel disorders, chronic Helicobacter pylori infection, demodex folliculorum (mites), and immune system disorders.

While the clinical manifestations of rosacea do not usually impact the physical health status of the patient, there may be psychological consequences from the most visually apparent symptoms (ie, erythema, papules, pustules, telangiectasias) that can impact quality of life. Rhinophyma, an end-stage of chronic acne, has been associated with obstruction of nasal passages and basal cell carcinoma in rare, severe cases. The probability of developing nasal obstruction or basal or squamous cell carcinoma with rosacea is not sufficiently great to warrant preventive removal of rhinophymatous tissue.

While rosacea cannot be eliminated, treatment can be effective to relieve its signs and symptoms. Treatment may include oral and topical antibiotics, isotretinoin, beta-blockers, clonidine, and anti-inflammatories. Patients are also instructed on various self-care measures such as avoiding skin irritants and dietary items thought to exacerbate acute flare-ups. To reduce visible blood vessels, treat rhinophyma, reduce redness, and improve appearance, various techniques have been used such as laser and light therapy, dermabrasion, chemical peels, surgical debulking, and electrosurgery. Nonpharmacologic therapy has also been tried in patients who cannot tolerate or do not want to use pharmacologic treatments. The various lasers used include low-powered electrical devices and vascular light lasers to remove telangiectasias, co 2 lasers to remove unwanted tissue from rhinophyma and reshape the nose, and intense pulsed lights that generate multiple wavelengths to treat a broader spectrum of tissue.

Regulatory Status

Several laser and light therapy systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for a variety of dermatologic indications, including rosacea. For example, rosacea is among the indications for the Candela® pulse dye laser system (Candela Corp., Wayland, MA), the Lumenis® One Family of Systems intense pulsed light component (Lumenis Inc., Santa Clara, CA), and the Harmony® XL multiapplication platform laser device (Alma Lasers, Israel). 


Policy

Nonpharmacologic treatment of rosacea, including but not limited to laser and light therapy, dermabrasion, chemical peels, surgical debulking and electrosurgery, is considered investigational.


Policy Guidelines

No applicable information


Benefit Application
BlueCard/National Account Issues

Some state or federal mandates (e.g., FEP) prohibit Plans from denying technologies approved by the U.S. Food and Drug Administration (FDA) as investigational. In these instances, Plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone.

Plans may wish to examine specific contract language regarding the definitions of cosmetic services to determine whether contract or benefit exclusions may apply to the treatment of rosacea. Please refer to policy No. 10.01.09 for further discussion on cosmetic/reconstructive services.


Rationale

This policy was originally created in 2004 and was updated regularly with searches of the MEDLINE database. The most recent literature review was performed through October 14, 2014. Following is a summary of the key literature to date.

Nonpharmacologic Treatments of Rosacea

Randomized controlled trials (RCTs) are crucial in determining the efficacy of nonpharmacologic treatment of rosacea and whether or not treatment improves the net health outcome. Ideally, RCTs would compare nonpharmacologic treatments with a placebo or a pharmacologic treatment. Where RCTs are lacking, nonrandomized comparative studies provide some evidence for efficacy but are limited by potential selection bias because patients may be preferentially selected for one treatment over another by disease severity or other clinical factors. Uncontrolled trials and case series offer little useful evidence on the efficacy of nonpharmacologic treatments. This review focuses on RCTs and systematic reviews of RCTs.

Systematic Reviews

In 2011, a Cochrane systematic review was published by van Zuuren et al on a variety of interventions for rosacea.(1) The systematic review identified 58 RCTs that compared treatments with placebo or a different intervention in adults with clinically diagnosed moderate to severe rosacea. The investigators identified only 1 trial on light therapy and 1 trial on laser therapy, and the trials did not compare these interventions with pharmacologic treatments or placebo controls. The remainder of the RCTs evaluated pharmacologic treatments.

Other systematic reviews included RCTs, as well as uncontrolled studies. In 2014, Wat et al identified 9 studies on the efficacy of intense pulsed light (IPL) for treating rosacea.(2) Two of the studies were controlled (left-right comparisons), and the remainder were uncontrolled, including 1 case report. A 2013 systematic review addressed pulsed dye laser (PDL) and identified 2 uncontrolled studies on PDL for treatment of rosacea.(3) None of the systematic reviews pooled the findings of studies on nonpharmacologic treatment of rosacea. Findings of the published systematic reviews highlight the shortage of RCTs on light and laser therapy for treating rosacea.

Randomized Controlled Trials

Several randomized trials on nonpharmacologic treatment for rosacea, as well as a small nonrandomized comparative study, all of which used split-faced designs, were identified.(4-8) Most compared 2 types of lasers, and none used a placebo control or used a pharmacologic treatment as the comparison intervention. No RCTs evaluating dermabrasion, chemical peels, surgical debulking, or electrosurgery for treating rosacea were identified. Representative RCTs are described briefly next.

A 2013 double-blind study by Alam et al studied 16 patients with erythematotelangiectatic rosacea.(4) Participants received PDL treatment on a randomly selected side of the face and neodymium-yttrium aluminum garnet (Nd:YAG) laser treatment on the other side. Treatments occurred at monthly intervals for 4 months. Fourteen of the 16 patients (88%) completed the study and were included in the analysis. The primary study outcome was the percent difference in facial redness (according to spectrophotometer measurements) from baseline to posttreatment. There was a mean difference in redness of 8.9% after PDL and a mean difference of 2.5% after Nd:YAG group; the difference between groups was statistically significant (p=0.02). Pain ratings, however, were significantly higher with PDL (mean pain level, 3.9/10)
compared with Nd:YAG (mean pain level, 3.1/10; p=0.003).

In 2010, Maxwell et al reported on 14 patients who had acne rosacea.(5) The study evaluated the combination of laser treatment and a topical treatment. All patients received 6 sessions of treatment with a 532 nm laser and a retinaldehyde-based topical application over 3 months on a randomly selected side of the face. The other side of the face served as a no-treatment control. Eleven of 14 patients (79%) completed the study. At the end of the treatment period, blinded evaluators could correctly identify the treated side of the face 47% of the time (ie, close to the 50% expected by chance). This was a small study with dropouts and involved limited collection of objective efficacy data.

A 2009 study by Neuhaus et al included patients with moderate erythematotelangiectatic rosacea without active inflammatory papules and pustules.(6) Twenty-nine patients were randomly assigned to receive treatment with a PDL on 1 side of the face and IPL on the other side, and 4 patients each received either PDL or IPL on 1 side of the face and no treatment on the other. Laterality of treatment (right vs left side) was also randomly assigned. Patients underwent a total of 3 treatment sessions, 4 weeks apart and received their final evaluation 4 weeks after the third treatment. Outcomes included an overall erythema score and overall telangiectasia score graded by a blinded observer and patient self-report of symptoms. Only p values, not actual scores were reported. There were no significant differences in outcomes between the PDL and IPL groups. Thus, we cannot conclude that one of these treatments is superior to the other. In this study, there were significantly lower erythema and telangiectasia scores for both IPL and PDL treatment compared with control (p<0.01). However, the comparisons with no treatment included only 4 patients each, and therefore these findings should be considered preliminary.

Summary of Evidence

The evidence to date remains insufficient to conclude that nonpharmacologic treatment for rosacea improves health outcomes. Several small randomized split-face design studies using light or laser therapy have been published, but none of had a comparison group of patients receiving a placebo or pharmacologic treatment and therefore do not offer useful evidence on the efficacy of nonpharmacologic treatment compared with alternative treatment options. There is a need for additional RCTs comparing nonpharmacologic treatments with placebo controls and with pharmacologic treatments. Thus, nonpharmacologic treatments for rosacea are considered investigational.

Practice Guidelines and Position Statements
No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References:

 

  1. Van Zuuren EJ, Kramer S, Carter B, et al. Interventions for rosacea. Cochrane Database Syst Rev 2011(3):CD003262.
  2. Wat H, Wu DC, Rao J, et al. Application of intense pulsed light in the treatment of dermatologic disease: a systematic review. Dermatol Surg. Apr 2014;40(4):359-377. PMID 24495252
  3. Erceg A, de Jong EM, van de Kerkhof PC, et al. The efficacy of pulsed dye laser treatment for inflammatory skin diseases: a systematic review. J Am Acad Dermatol. Oct 2013;69(4):609-615 e608. PMID 23711766
  4. Alam M, Voravutinon N, Warycha M, et al. Comparative effectiveness of nonpurpuragenic 595-nm pulsed dye laser and microsecond 1064-nm neodymium:yttrium-aluminum-garnet laser for treatment of diffuse facial erythema: A double-blind randomized controlled trial. J Am Acad Dermatol. Sep 2013;69(3):438-443. PMID 23688651
  5. Maxwell E, Ellis DA, Manis H. Acne rosacea: effectiveness of 532 nm laser on the cosmetic appearance of the skin. J Otolaryngol Head Neck Surg. 2010;39(3):292-296.
  6. Neuhaus IM, Zane LT, Tope WD. Comparative efficacy of nonpurpuragenic pulsed dye laser and intense pulsed light for erythematotelangiectatic rosacea. Dermatol Surg. Jun 2009;35(6):920-928. PMID 19397667
  7. Salem SA, Abdel Fattah NS, Tantawy SM, et al. Neodymium-yttrium aluminum garnet laser versus pulsed dye laser in erythemato-telangiectatic rosacea: comparison of clinical efficacy and effect on cutaneous substance (P) expression. J Cosmet Dermatol. Sep 2013;12(3):187-194. PMID 23992160
  8. Karsai S, Roos S, Raulin C. Treatment of facial telangiectasia using a dual-wavelength laser system (595 and 1,064 nm): a randomized controlled trial with blinded response evaluation. Dermatol Surg. May 2008;34(5):702-708. PMID 18318728
     

Codes

Number

Description

CPT 15780, 15781, 15782, 15783 Dermabrasion, face code range
  15788, 15789, 15792, 15793 Chemical peel code range
  17000, 17003, 17004 Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), all benign or premalignant lesions (e.g., actinic keratoses) other than skin tags or cutaneous vascular proliferative lesions code range
  17106, 17107, 17108 Destruction of cutaneous vascular proliferative lesions (e.g., laser technique) code range
  30117 Excision or destruction (e.g., laser), intranasal lesion; internal approach
  30118 Excision or destruction (e.g., laser), intranasal lesion; external approach (lateral rhinotomy)
ICD-9 Procedure 86.3 Other local excision or destruction of lesion or tissue of skin and subcutaneous tissue; destruction of skin by cauterization, cryosurgery, fulguration or laser beam
ICD-9 Diagnosis   Investigational for all relevant diagnoses
  695.3 Rosacea 
HCPCS    
ICD-10-CM (effective 10/1/15)   Investigational for all relevant diagnoses
  L71.0-L71.9 Rosacea code range
ICD-10-PCS (effective 10/1/15)   ICD-10-PCS codes are only used for inpatient services.
  3E00XTZ Administration, physiological systems and anatomical regions, introduction, skin and mucous membranes, external, destructive agent
  0HD0XZZ, 0HD1XZZ, 0HD4XZZ, 0HD5XZZ, 0HD6XZZ, 0HD7XZZ, 0HD8XZZ, 0HDAXZZ, 0HDBXZZ, 0HDCXZZ, 0HDDXZZ, 0HDEXZZ, 0HDFXZZ, 0HDGXZZ, 0HDHXZZ, 0HDJXZZ, 0HDKXZZ, 0HDLXZZ, 0HDMXZZ, 0HDNXZZ Surgical, skin and breast, extraction, external, code by body part
  0H50XZD, 0H50XZZ, 0H51XZD, 0H51XZZ, 0H54XZD, 0H54XZZ, 0H55XZD, 0H55XZZ, 0H56XZD, 0H56XZZ, 0H57XZD, 0H57XZZ, 0H58XZD, 0H58XZZ, 0H59XZD, 0H59XZZ, 0H5AXZD, 0H5AXZZ, 0H5BXZD, 0H5BXZZ, 0H5CXZD, 0H5CXZZ, 0H5DXZD, 0H5DXZZ, 0H5EXZD, 0H5EXZZ, 0H5FXZD, 0H5FXZZ, 0H5GXZD, 0H5GXZZ, 0H5HXZD, 0H5HXZZ, 0H5JXZD, 0H5JXZZ, 0H5KXZD, 0H5KXZZ, 0H5LXZD, 0H5LXZZ, 0H5MXZD, 0H5MXZZ, 0H5NXZD, 0H5NXZZ, 0H5QXZZ, 0H5RXZZ Surgical, skin and breast, destruction, external, single or multiple, code by body part
  0HB0XZZ, 0HB1XZZ, 0HB4XZZ, 0HB5XZZ, 0HB6XZZ, 0HB7XZZ, 0HB8XZZ, 0HB9XZZ, 0HBAXZZ, 0HBBXZZ, 0HBCXZZ, 0HBDXZZ, 0HBEXZZ, 0HBFXZZ, 0HBGXZZ, 0HBHXZZ, 0HBJXZZ, 0HBKXZZ, 0HBLXZZ, 0HBMXZZ, 0HBNXZZ Surgical, skin and breast, excision, external, code by body part
Type of Service Medicine  
Place of Service Outpatient  

Index
Rosacea, Treatment of
Laser Treatment, Rosacea


Policy History

Date Action Reason
11/09/04 Add to Medicine section New policy; literature review through September 2004
12/14/05 Replace policy Policy updated with literature search; no change in policy statement; reference number 3 added.
12/12/06 Replace policy Policy updated with literature search; reference numbers 4-6 added; no change in policy statement
4/09/08 Replace policy Policy updated with literature search; reference numbers 7-9 added; Rationale section edited; no change in policy statement
12/10/09 Replace policy Literature review update through October 2009; reference numbers 9 and 10 added (previous reference number 9 removed); no change in policy statement
12/09/10 Replace policy Policy updated with literature review through October 2010. Rationale extensively re-written; references re-ordered and selected older references were removed. Reference number 7 added. No change in policy statement.
12/08/11 Replace policy Policy updated with literature review through October 2011. Reference numbers 1 and 5 added; other references re-numbered or removed. No change in policy statement
12/13/12 Replace Policy
Policy updated with literature review through October 2012. No change in policy statement.
12/12/13 Replace policy Policy updated with literature review through October 25, 2013. Reference numbers 2, 3, 6, and 11 added; other references renumbered or removed. No change in policy statement.
12/11/14 Replace policy Policy updated with literature review through October 14, 2014. References 2 and 8 added. No change in policy statement.