MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Non-Pharmacologic Treatment of Rosacea

Number 2.01.519

Effective Date February 24, 2014

Revision Date(s) 02/10/14; 02/11/13; 02/14/12; 07/12/11; 08/10/10; 08/11/09; 11/11/08; 12/12/06; 02/14/06; 6/15/05

Replaces 2.01.71

Policy

Non-pharmacologic treatment of rosacea (to include laser, chemical peels, and surgical debulking) may be considered medically necessary only for those individuals who:

  • Have failed an adequate pharmacologic trial, defined as the use of 2 or more topicals and /or oral antibiotics for at least 6 months AND
  • Have developed complications of their disease and physical functional impairments, such as:
  • Recurrent and/or persistent bacterial infections that have failed multiple courses of antibiotics
  • Persistent open wounds, or localized skin hemorrhage with associated bloody drainage;
  • Rhinophyma with nasal obstruction, airway impairment or sinus infection.

In the absence of failure of conservative treatment and complications of the disease resulting in a physical functional impairment, non-pharmacologic treatment of rosacea is considered not medically necessary.

Related Policies

2.01.89

Laser Treatment of Onychomycosis

10.01.514

Cosmetic and Reconstructive Services

Policy Guidelines

N/A

Description

Rosacea is a chronic, inflammatory skin condition 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 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 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. Non-pharmacologic therapy has also been tried in patients who are intolerant of, or choose not 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).

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. This medical policy does not apply to Medicare Advantage.

Benefit Application

For the purposes of this policy, the following definitions apply:

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

Physical Functional Impairment: In this policy, 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

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 (e.g., 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.

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 non-pharmacologic treatments of rosacea. (1-3) 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 non-pharmacologic treatment in comparison with established pharmacologic therapies.

2005 Update

A literature search of the MEDLINE database was performed for the period of 2004 through October 2005. No additional studies were identified in the published medical literature that would prompt reconsideration of the policy statement, which remains unchanged.

2006 Update

A literature search of the MEDLINE database for the period of July 2005 through October 2006 identified reviews and a small retrospective study using laser-pulsed light, or photodynamic therapy for the treatment of rosacea. 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. (4) A recent Cochrane report described phototherapy as a common treatment for the vascular symptoms of rosacea; however, there were no high quality, randomized controlled trials available to systematically assess its efficacy. (5) 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 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) health information website (last updated in 2002) as a treatment option for red lines caused by dilated blood vessels or for rhinophyma. (6) Thus, although phototherapy either alone or in combination with aminolevulinic or methylaminolevulinic 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. Therefore, evidence to date is insufficient to change the policy statement: phototherapy and other non-pharmacological treatments for rosacea are considered to be investigational.

2007 Update

A literature search of the MEDLINE database for the period of November 2006 through January 2008 did not identify any comparative trials. A systematic review of rosacea treatments included 29 good to fair quality randomized controlled trials (RCT) on treatments for rosacea. (7) 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 non-pharmacological 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. (8, 9) There does not appear to be much research interest in non-pharmacologic treatment approaches; out of 15 publicly listed clinical trials no other non-pharmacologic treatments were listed. Evidence remains insufficient to evaluate the efficacy of non-pharmacologic treatments of rosacea. (9) Therefore, the policy statement is unchanged.

2008 Update

Bernstein and Kligman investigated the ability of a new generation high-energy 595 nm long pulse-duration pulsed-dye laser to improve rosacea. Twenty subjects were given 4 laser treatments at 4 week intervals. Improvement was determined by blinded evaluation of digital photographs and by the treating physicians’ subjective evaluation, before and 8 weeks following the final treatment. The average rosacea score as estimated by the treating physician was a statistically significant decrease from 2.7 to 1.4. The average rosacea score as estimated by the blinded physician observers scoring digital photographs was a statistically significant decrease from 2.3 to 1.4. Those subjects with the most severe rosacea score of 4.25 before treatment had the greatest improvement of 2.0 at the final follow-up visit. There was also an improvement in rosacea papules, with the average number of papules as 6.8 before treatment and 0.2 following the final treatment. The authors concluded that the high-energy, long pulse-duration pulsed-dye laser improved rosacea with a very favorable safety profile and less purpura than resulted from earlier generation pulsed-dye lasers.

Laser treatment of rosacea has shown significant improvement in its technology delivery over the past 10 years. Although high quality randomized controlled trials are lacking, there are a large number of good to fair randomized controlled trials and these studies have shown vascular laser therapy to be effective treatment for patients with extensive and symptomatic complications of their disease. Therefore, laser therapy may be considered medically necessary in the small subpopulation of rosacea patients for whom all other treatments have failed and patients have a resulting physical functional impairment.

2009 Update

A literature search of the MEDLINE database conducted from November 2008 through June 2009 did not identify any additional published studies that would prompt reconsideration of the policy statement, which remains unchanged.

2010 Update

A search of ClinicalTrials.gov identified one active trial evaluating a non-pharmacologic 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 is June 2010.

2011 Update

The clinical trial referenced above was completed in October 2010 but no results have been published.

A literature search from July 2009 through May 2011 did not identify any published studies which would prompt a change in the policy statement.

2012 Update

In 2011, van Zuuren and colleagues published a Cochrane review on interventions for rosacea (an update of a 2005 review). The systematic review identified 58 randomized controlled trials (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 non-pharmacologic treatments. In addition, as the authors noted, additional trials evaluating non-pharmacologic therapies should be a priority because they have the potential to treat symptoms on the face, which is highly desirable.

The literature on nonpharmacologic treatment of rosacea primarily consists of case series. 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. 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.

2013 Update

Practice Guidelines and Position Statements

A search of the National Guideline Clearinghouse database in October 2012 did not identify any guidelines or position statements from national organizations on the use of nonpharmacologic treatments for treating rosacea.

Medicare National Coverage

There is no national coverage determination.

Ongoing Clinical Trials

A search of the online clinicaltrials.gov database in January 2013 identified two non-comparative trials recruiting for an evaluation of the Luxe device and Ulthera system. Two other studies were complete but results have not been posted – one comparing azelaic acid with YAG laser (NCT01631656) and another comparing pulsed dye laser and YAG (NCT01529996).

2014 Update

Alam and colleagues published the results from their clinical trial reference above (NCT01529996).The 2013 double-blind study monitored 16 patients with erythematotelangiectatic rosacea. 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 post treatment. 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 to Nd:YAG (mean pain level, 3.1/10; p=0.003).

A 2013 systematic review addressed literature published through August 2011 on pulsed dye laser (PDL) treatment for a variety of inflammatory skin diseases.(2) The authors identified 52 articles on RCTs, observational studies and case series. Most studies addressed PDL treatment of psoriasis, acne vulgaris and lupus. There were only 2 articles on PDL treatment of rosacea, and neither of these included a control or comparison group. Both studies were on papulopustular rosacea.

References

  1. Blount BW, Pelletier AL. Rosacea: a common, yet commonly overlooked, condition. Am Fam Physician 2002; 66(3):435-40. Summary for patients in: Am Fam Physician. 2002 1; 66(3):442.
  2. Rebora A. The management of rosacea. Am J Clin Dermatol 2002; 3(7):489-96.
  3. 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.
  4. Schroeter CA, Haaf-von Below S, Neumann HA. Effective treatment of rosacea using intense pulsed light systems. Dermatol Surg 2005;31(10):1285-9.
  5. van Zuuren EJ, Graber MA, Hollis S, et al. Interventions for rosacea. Cochrane Database Sys Rev 2005;(3):CD003262.
  6. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). March 2005. (Accessed June 6, 2011.)
  7. van Zuuren EJ, Gupta AK, Gover MD, et al. Systematic review of rosacea treatments. J Am Acad Dermatol 2007; 56(1):107-15.
  8. Bryld LE, Jemec GB. Photodynamic therapy in a series of rosacea patients. J Eur Acad Dermatol Venereol 2007; 21(9):1199-202. Accessed January 30, 2014.
  9. Bernstein EF, Kligman A. Rosacea treatment using the new-generation, high-energy, 595 nm, long pulse-duration pulsed-dye laser. Lasers Surg Med. 2008;40(4):233-9.
  10. Neuhaus IM, Zane LT, Tope WD. Comparative efficacy of nonpurpuragenic pulsed dye laser and intense pulsed light for erythematotelangiectatic rosacea. Dermatol Surg 2009; 35(6):920-8.
  11. www.ClinicalTrials.gov. Accessed January 24, 2014.
  12. Van Zuuren EJ, Kramer S, Carter B et al. Interventions for rosacea. Cochrane Database Syst Rev 2011; (3):CD003262.
  13. 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.
  14. Blue Cross Blue Shield Association Medical Policy Reference Manual. Non-pharmacologic Treatment of Rosacea. Last review Dec 2013.
  15. 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 2013; 69(3):438-43.
  16. 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 2013; 69(4):609-15 e8.

Coding

Codes

Number

Description

CPT

15780

Dermabrasion; total face (e.g., for acne scarring, fine wrinkling, rhytids, general keratosis)

 

15781

segmental, face

 

15782

regional, other than face

 

15783

superficial, any site, (e.g. tattoo removal)

 

15788

Chemical peel, facial; epidermal

 

15789

dermal

 

15792

Chemical peel, nonfacial; epidermal

 

15793

dermal

 

17106

Destruction of cutaneous vascular proliferative lesions (e.g., laser technique); less than 10 sq cm

 

17107

10.0 to 50.0 sq cm

 

17108

over 50.0 sq cm

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

695.3

Rosacea

HCPCS

S8948

Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes

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

L71.0 - L71.9

Rosacea code range

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

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

 

Appendix

N/A

History

Date

Reason

02/08/05

Add to Medicine Section - New Policy. Held for notification, published 6/15/05.

02/14/06

Replace policy. Policy statement clarified with the removal of first sentence; last paragraph under Rationale also removed as they both referred to cosmetic. Policy will be reviewed again with BCBSA scheduled update.

02/22/06

Code updates. No other changes, effective date unchanged.

06/16/06

Update Scope and Disclaimer - No other changes.

12/12/06

Replace policy. Policy updated with literature review; references added; no change in policy statement.

7/10/07

Cross Reference Update - No other changes.

11/11/08

NEW PR Policy 2.01.519 - Policy updated with literature search. Policy statement regarding rosacea changed from investigational to medically necessary. Status changed from BC to PR. Replaces BC.2.01.71. References added.

08/11/09

Replace policy. Policy updated with literature review; no change in policy statement.

02/09/10

Cross Reference Update - No other changes.

08/10/10

Replace policy. Policy updated with literature review; references added. No change to the policy statement.

07/12/11

Replace policy. Policy updated with literature review. No change to the policy statement.

09/23/11

Related Policies updated; 10.01.514 added.

02/14/12

Replace policy. Policy updated with literature review. No change to the policy statement.

02/13/13

Replace policy. Policy updated with literature review. No change to the policy statement.

03/15/13

Update Related Policies. Remove 2.01.521 as it was archived.

07/16/13

Update Related Policies. Add 2.01.89.

12/03/13

Coding Update. Add ICD-10 codes.

02/24/14

Replace policy. Policy updated with literature review. No change to the policy statement. CPT codes 17000 – 17004 and 30117 – 30118 were provided for informational purposes only and have been removed from the policy. ICD-9 Diagnosis code 695.3 was also removed from the policy, as it is not utilized in adjudicating the policy.


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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