BlueCross and BlueShield of Montana Medical Policy/Codes
Nonpharmacologic Treatment of Rosacea
Chapter: Medicine: Treatments
Current Effective Date: July 18, 2013
Original Effective Date: December 18, 2009
Publish Date: July 18, 2013
Revised Dates: March 22, 2012
Description

Rosacea is a chronic, inflammatory skin condition that cannot be cured; the goal of treatment is symptom management. Nonpharmacologic treatments, including laser and light therapy, dermabrasion, and others, are proposed for patients who do not want to use or are unresponsive to pharmacologic treatments.

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 due to 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 (i.e., 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, CO2 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 multi-application platform laser device (Alma Lasers; Israel).

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross Blue Shield of Montana (BCBSMT) considers nonpharmacologic treatment of rosacea, including but not limited to laser and light therapy, dermabrasion, chemical peels, surgical debulking and electrosurgery, experimental, investigational and unproven.

Rationale

This policy was originally created in 2009 and was updated regularly with searches of peer reviewed literature. The following is a summary of the key literature.

Rosacea is progressive and chronic; while the clinical manifestations do not usually impact the physical health status of the patient, there may be psychological consequences from the most visually apparent symptoms (i.e., erythema, papules, pustules, telangiectasias) that can impact quality of life. It has been reported that rhinophyma may obstruct nasal passages in rare, severe cases. Rhinophyma has also been related to an increase in basal and squamous cell carcinoma. Yet there is insufficient evidence to demonstrate any association with or increase in carcinoma in patients with rosacea. 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.

One study from the Netherlands reported 77.8% long-term clearance (follow-up of 12–99 months) of telangiectasia in 60 randomly selected patients with facial rosacea who had been treated with intense pulsed light. (1) A recent Cochrane report, published in 2005, described phototherapy as a common treatment for the vascular symptoms of rosacea; however, there were no high-quality randomized controlled trials (RCTs) available to systematically assess its efficacy. (2) The report did find adequate evidence to conclude that topical metronidazole and azelaic acid are effective treatments for rosacea.

Laser surgery is listed on the updated National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) health information web site as a treatment option for red lines caused by dilated blood vessels or for rhinophyma. (3) Thus, although phototherapy either alone or in combination with aminolevulinic or methyl aminolevulinic acid appears to be an increasingly accepted and effective mode of treatment for rosacea and other skin disorders, there are no high-quality studies that compare this treatment approach with placebo or other topical therapies. In addition, standard practice guidelines for phototherapy have not been established.

Prior to 2006, numerous case reports and clinical trials (generally of small size) are contained in the published peer-reviewed literature, yet it is difficult to draw conclusions as to the effects of various nonpharmacologic treatments of rosacea. (4-7) While positive results have been reported in the appearance of rosacea with various ablation techniques, the outcome measures used are varied and subjective. In addition to the lack of objective and quantitative outcomes data, there is a lack of comparative data to determine the effectiveness of nonpharmacologic treatment in comparison with established pharmacologic therapies.

An additional literature search of the MedLine database for the period of November 2006 through January 2008 did not identify any comparative trials. (8, 9) A systematic review of rosacea treatments included 29 good to fair quality RCTs on treatments for rosacea. The primary outcome measures were patient’s self-assessment of rosacea and their perceived quality of life due to the psychological consequences of rosacea (e.g., shame, embarrassment, low self-esteem, anxiety, lack of confidence, depression). Secondary outcome measures in this report were physician-assessed changes in rosacea severity, physician’s global evaluation, time needed for improvement, and duration of remission. No studies of nonpharmacological treatments were considered to be of sufficient quality to be included in the review.

A single group from Europe is exploring the use of photodynamic therapy for rosacea. (10) There does not appear to be much research interest in nonpharmacologic treatment approaches, since out of 15 publicly listed clinical trials no other nonpharmacologic treatments were listed.

Summary

Evidence remains insufficient to evaluate the efficacy of nonpharmacologic treatments of rosacea. Therefore, nonpharmacologic treatment of rosacea is considered experimental,  investigational and unproven.

2011 Update

A search of peer reviewed literature through January 2011 identified clinical trial information. The following is a summary of the key literature.

Two randomized trials, both using split-face designs, on nonpharmacologic treatment for rosacea were identified. A 2009 study by Neuhaus and colleagues included patients, with moderate erythematotelangiectatic rosacea without active inflammatory papules and pustules, who were at least 18 years old and had not received previous treatment with a laser or light-based device, were not undergoing treatment with a photosensitizing agent and had not had changes to their medication in the past three months. (11) The study used a split-face design; 29 patients were randomly assigned to receive treatment with a pulsed dye laser (Vbeam, Candela Corp) on one side of the face and an intense pulsed light (Quantum, Lumenis) on the other side, and four patients each received either pulsed dye laser or intense pulsed lights on one side of the face and no treatment on the other. Laterality of treatment (right versus left side) was also randomly assigned. Patients underwent a total of three treatment sessions, four weeks apart and received their final evaluation four 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 pulsed dye laser and groups. Thus, we cannot conclude that one of these treatments is superior to the other. To determine whether both are effective or ineffective, studies with a control group are needed. In this study, there were significantly lower erythema and telangiectasia scores for both intense pulsed lights and pulsed dye laser treatment compared to control (p<0.01). However, the comparisons with no treatment included only four patients each and therefore these findings should be considered preliminary.

In 2010, Maxwell and colleagues published a split-face design study that included 14 patients with acne rosacea. The study evaluated the combination of laser treatment and a topical treatment. (12) All patients received six sessions of treatment with a 532 nm laser and a retinaldehyde-based topical application over three months on a randomly selected side of the face. The other side of the face served as the control. Eleven out 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 (i.e., close to the 50% expected by chance). This was a small study with drop-outs and involved limited collection of objective efficacy data.

Ongoing Clinical Trials

A search of ClinicalTrials.gov identified one active trial evaluating a nonpharmacologic treatment for rosacea. This is a single-blind, non-comparative study of combination therapy with calcium dobesilate and a pulsed dye laser and is currently recruiting patients. The final data collection date for the primary outcome measure was supposed to be June 2010. However, as of January 2011, patients continue to be recruited and no updated completion date has been posted.

Summary

The evidence to date remains insufficient to conclude that nonpharmacologic treatment for rosacea improves health outcomes. To date, two small, randomized, split-face design studies using laser therapy have been published; both report limited objective and quantitative outcomes data. In addition, there is a lack of RCTs comparing nonpharmacologic to pharmacologic treatments. Thus, the coverage position of the medical policy remains unchanged.

2013 Update

A search of peer reviewed literature through February 2013 identified clinical trial information. The following is a summary of the key literature.

In 2011, van Zuuren and colleagues published an updated Cochrane systematic review on interventions for rosacea. (13) The systematic review identified 58 RCTs that compared treatments to 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. The Cochrane review highlights the lack of evidence on light and laser therapy for treating rosacea, especially in comparison to nonpharmacologic treatments. In addition, as the authors noted, additional trials evaluating nonpharmacologic therapies should be a priority because they have the potential to treat symptoms on the face, which is highly desirable.

The current literature on nonpharmacologic treatment of rosacea primarily consists of case series. (14-16) One of the largest series was published in 2011 by Kassir and colleagues who reviewed the medical records from 102 patients with mild to severe rosacea. (15) All patients had their entire face treated with an intense pulsed light (IPL) system; the number of treatments and treatment parameters were individualized. Patients were evaluated pre-treatment and 1-2 weeks post-treatment. According to clinician assessment and photodocumentation, 80% of patients had reduced redness after treatment. Photodocumentation showed a 51% reduction in telangiectasias. The study did not include long-term follow-up.

Practice Guidelines and Position Statements

A search of the National Guideline Clearinghouse database in March 2013 did not identify any guidelines or position statements from national organizations on the use of nonpharmacologic treatments for treating rosacea.

Ongoing Clinical Trials

A search of the online Clinicaltrials.gov database was completed in March 2013. Of the 13 open comparative trials, there were no trials evaluating nonpharmacologic treatments for rosacea.

Summary

The evidence to date remains insufficient to conclude that nonpharmacologic treatment for rosacea improves health outcomes. There is limited evidence from case series report short-term improvements in redness and telangiectasias. As a result, there is a need for further larger RCTs comparing nonpharmacologic treatments to placebo controls and to pharmacologic treatments. Thus, nonpharmacologic treatments for rosacea remain experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
86.3, 695.3
ICD-10 Codes

L71.0, L71.1, L71.8, L71.9, 3E00XTZ, 0HD0XZZ, 0HD1XZZ, 0HD4XZZ, 0HD5XZZ, 0HD6XZZ, 0HD7XZZ, 0HD8XZZ, 0HDAXZZ, 0HDBXZZ, 0HDCXZZ, 0HDDXZZ, 0HDEXZZ, 0HDFXZZ, 0HDGXZZ, 0HDHXZZ, 0HDJXZZ, 0HDKXZZ, 0HDLXZZ, 0HDMXZZ, 0HDNXZZ, 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, 0HB0XZZ, 0HB1XZZ, 0HB4XZZ, 0HB5XZZ, 0HB6XZZ, 0HB7XZZ, 0HB8XZZ, 0HB9XZZ, 0HBAXZZ, 0HBBXZZ, 0HBCXZZ, 0HBDXZZ, 0HBEXZZ, 0HBFXZZ, 0HBGXZZ, 0HBHXZZ, 0HBJXZZ, 0HBKXZZ, 0HBLXZZ, 0HBMXZZ, 0HBNXZZ 

Procedural Codes: 15780, 15781, 15782, 15783, 15788, 15789, 15792, 15793, 17000, 17003, 17004, 17106, 17107, 17108, 30117, 30118
References
  1. Schroeter, C.A., Haaf-von Below, S., et al. Effective treatment of rosacea using intense pulsed light systems. Dermatologic Surgery (2005 October) 31(10):1285-9.
  2. van Zuuren, E.J., Graber, M.A., et al. Interventions for rosacea. Cochrane Database System Review (2005) (3):CD003262.
  3. NIAMS – Rosacea (2009 April) NIH Publication No. 09-5038. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Available at http://www.niams.nih.gov (accessed on 2011 January 21).
  4. Rebora, A. The management of rosacea. American Journal of Clinical Dermatology (2002) 3(7):489-96.
  5. Blount, B.W., and A.L. Pelletier. Rosacea: a common, yet commonly overlooked, condition. American Family Physician (2002 August 1) 66(3):435-40.
  6. Tan, S.R., and W.D. Tope. Pulsed dye laser treatment of rosacea improves erythema, symptomatology, and quality of life. Journal of the American Academy of Dermatology (2004 October) 51(4):592-9.
  7. van Zuuren, E.J., and M.A. Graber. The rigor of trials evaluating Rosacea treatments. Cutis (2005 March) 75(3 Supplement): 13-6; discussion 33-6.
  8. van Zuuren, E.J., Gupta, A.K., et al. Systematic review of rosacea treatment. Journal of the American Academy of Dermatology (2007 January) 56(1):107-15.
  9. Taub, A.F., and E.C. Devita. Successful treatment of erythematotelangiectatic rosacea with pulsed light and radiofrequency. Journal of Aesthetic Dermatology (2008 May) 1(1):37-40.
  10. Bryld, L.E., and G.B. Jemec. Photodynamic therapy in a series of rosacea patients. Journal of the European Academy of Dermatology (2007 October) 21(9):1199-202.
  11. Neuhasu, I.M., Zane, L.T., et al. Comparative efficacy of nonpurpuragenic pulsed dye laser and intense pulsed light for erythematotelangiectatic rosacea. Dermatologic Surgery (2009 June) 35(6):920-8.
  12. Maxwell, E.L., Ellis, D.A., et al. Acne rosacea: effectiveness of 532 nm laser on the cosmetic appearance of the skin. Journal of Otolaryngology Head and Neck Surgery (2010 June) 39(3):292-6.
  13. van Zuuren EJ, Kramer S, Carter B et al. Interventions for rosacea. Cochrane Database Syst Rev 2011; (3):CD003262.
  14. Bryld LE, Jemec GB. Photodynamic therapy in a series of rosacea patients. J Eur Acad Dermatol Venereol 2007; 21(9):1199-202.
  15. Kassir R, Kolluru A, Kassir M. Intense pulsed light for the treatment of rosacea and telangiectasias. J Cosmet Laser Ther 2011; 13(5):216-22.
  16. Tan SR, Tope WD. Pulsed dye laser treatment of rosacea improves erythema, symptomatology, and quality of life. J Am Acad Dermatol 2004; 51(4):592-9.
  17. Nonpharmacologic Treatment of Rosacea. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 December) Medicine 2.01.71.
History
March 2012  Policy updated with literature review through October 2011. Reference numbers 1 and 5 added; other references re-numbered or removed. Change in policy statement from Medically Necessary to Investigational.
April 2013 Policy formatting and language revised.  Policy statement unchanged.  Added cpt codes 15792 and 15793.
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Nonpharmacologic Treatment of Rosacea