Latest Review Date: May 2024

Category:  Vision

POLICY:

Transpupillary Thermotherapy for the treatment of choroidal neovascularization secondary to ocular conditions, including but not limited to Age-Related Macular Degeneration, is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Transpupillary thermotherapy uses infrared laser light administered by a modified diode laser to photocoagulate choroidal neovascularization tissue in individuals with wet age-related macular degeneration. The infrared radiation heat source gently targets the choroidal lesion is intended to limit damage to overlying retinal pigment epithelium, and as such is suggested as an alternative to standard focal laser photocoagulation. Healthy ocular tissue may be damaged, but generally the damage is limited to the site of treatment. Transpupillary thermotherapy is typically performed in the office or clinical outpatient setting under local anesthesia.

Age-Related Macular Degeneration

Age-related macular degeneration (AMD), a deterioration of the central portion of the retina, is the chief cause of severe and irreversible loss of vision in the United States. The risk of AMD increases with age, and usually affects people 60 years of age and older. Because the macula is the central portion of the retina, advanced AMD often leads to irreversible loss of the ability to read, recognize faces, and drive.

There are 2 forms of late AMD:

• the atrophic form
• the neovascular, exudative form

The atrophic form does not involve leakage of blood or serum; hence, it is called "dry" AMD.  The neovascular, exudative form includes serous or hemorrhagic detachment of retinal pigment epithelium and choroidal neovascularization, which lead to leakage and scarring; hence it is called "wet" AMD.

Choroidal Neovascularization

Choroidal Neovascularization, also known as CNV, involves the growth of new blood vessels that originate from the choroid through a break in the Bruch membrane into the sub-retinal pigment epithelium or sub retinal space. Choroidal neovascularization is a major cause of visual loss.  The symptoms of choroidal neovascularization include a distortion or waviness of central vision or a gray/black/void spot in the central vision. The condition is typically painless. The standard treatment of choroidal neovascularization is anti–vascular endothelial growth factor therapy.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through May 14, 2024.

Summary of Evidence

Results of studies evaluating the use of transpupillary thermotherapy for the prevention or control of choroidal neovascularization lesions in individuals with age-related macular degeneration do not provide sufficient evidence to conclude that transpupillary thermotherapy improves loss of vision due to age-related macular degeneration. Studies of TTT for treatment of choroidal neovascularization reported in the peer-reviewed medical literature are limited to retrospective analysis of uncontrolled case series and small, uncontrolled, short-term pilot studies. Further studies are needed using well-designed randomized control trials. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Evidence on transpupillary thermotherapy for treatment of choroidal neovascularization is limited. The available studies comparing transpupillary thermotherapy with sham have not shown benefit of this procedure. Although trials comparing transpupillary thermotherapy to photodynamic therapy show similar outcomes, there may be an increase in adverse events with transpupillary thermotherapy. Based on weak study designs, there is insufficient evidence to conclude that transpupillary thermotherapy is safe and/or effective for treating other conditions. Further study is needed using well-designed randomized control trials. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The American Academy of Ophthalmology 2019, updated in 2022, preferred practice pattern document for age-related macular degeneration states that thermal laser photocoagulation surgery is no longer recommended for subfoveal choroidal neovascularization (CNV) treatment.

The National Institute for Health and Care Excellence

In 2016, the National Institute for Health and Care Excellence concluded that clinical evidence on the safety and efficacy of transpupillary thermotherapy for age-related macular degeneration was inadequate for transpupillary thermotherapy to be used without special arrangement for consent and for audit or research.

KEY WORDS:

Transpupillary thermotherapy (TTT), choroidal neovascularization (CNV), age-related macular degeneration (ARMD), AMD

APPROVED BY GOVERNING BODIES:

Ophthalmic lasers are regulated by the FDA as Class II devices and many lasers have been approved via the 510(k) approval process. Ophthalmic laser systems that have received 510(k) marketing clearance for transpupillary thermotherapy include, but are not limited to:

• IRIS Medical® OcuLight® SLx (IREDIEX Corp.)
• Nidek DC-3000 laser diode photocoagulator (Nidek, Inc.)

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.  

CURRENT CODING:

CPT codes:

REFERENCES:

1. Agurto-Rivera R, Diaz-Rubio J, Torres-Bernal L et al. Intravitreal triamcinolone with transpupillary therapy for subfoveal choroidal neovascularization in age related macular degeneration. A randomized controlled pilot study [ISRCTN74123635]. BMC Ophthalmol 2005; 5:27.
2. Algvere PV, Libert C, Lindgarde G et al. Transpupillary thermotherapy of predominantly occult choroidal neovascularization in age-related macular degeneration with 12 months follow-up. Acta Ophthalmol Scand 2003; 81(2):110-7.
3. American Academy of Ophthalmology. ONE® Network. Preferred practice pattern Guidelines. Age-related macular degeneration. 2019. Available at: www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp.
4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). TEC special report: current and evolving strategies in the treatment of age-related macular degeneration. TEC Assessments 2005; Volume 20, Tab 11.
5. Chakravarthy U, Soubrane G, Bandello F, et al. Evolving European guidance on the medical management of neovascular age related macular degeneration. Br J Ophthalmol. 2006;90(9):1188-1196.
6. Currie ZI, Rennie IG, Talbot JF. Retinal vascular changes associated with transpupillary thermotherapy for choroidal melanomas. Retina. 2000;20(6):620-626.
7. Dunaief J. What is Choroidal Neovascularization? Macular Degeneration Research. Published on July 8, 2021. Available at: www.brightfocus.org/macular/article/what-choroidal-neovascularization.
8. Gustavsson C, Agardh E. Transpupillary thermotherapy for occult subfoveal choroidal neovascularization: a 1-year, prospective randomized pilot study. Acta Ophthalmol Scand 2005; 83(2):148-53.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. Kawamura R, Ideta H, Hori H et al. Transpupillary thermotherapy for atypical central serous chorioretinopathy. Clin Ophthalmol 2012; 6:175-9.
11. Kumar A, Prakash G, Singh RP. Transpupillary thermotherapy for idiopathic subfoveal choroidal neovascularization. Acta Ophthalmol Scand 2004; 82(2):205-8.
12. Kwon HJ, Kim M, Lee CS et al. Treatment of serous macular detachment associated with circumscribed choroidal hemangioma. Am J Ophthalmol 2012; 154(1):137-45 e1.
13. Lihteh W, Dahl A et al. Choroidal Neovascularization (CNV). Drugs & Diseases. Ophthalmology. Available at: emedicine.medscape.com/article/1190818.
14. Mason JO 3rd, Colagross CC, Feist RM, et al. Risk factors for severe vision loss immediately after transpupillary thermotherapy for occult subfoveal choroidal neovascularization. Ophthalmic Surg Lasers Imaging 2008; 39(6):460-5.
15. Mitamura Y, Kubota-Taniai M, Okada K et al. Comparison of photodynamic therapy to transpupillary thermotherapy for polypoidal choroidal vasculopathy. Eye. 2009 Jan; 23(1):67-72.
16. Myint K, Armbrecht AM, Mon S et al. Transpupillary thermotherapy for the treatment of occult CNV in age-related macular degeneration: a prospective randomized controlled pilot study. Acta Ophthalmol Scand 2006; 84(3):328-32.
17. Nagpal M, Nagpal K, Sharma S et al. Transpupillary thermotherapy for treatment of choroidal neovascularization secondary to age-related macular degeneration in Indian eyes. Indian J Ophthalmol 2003; 51(3):243-50.
18. National Institute for Health and Care Excellence (NICE). Transpupillary thermotherapy for age-related macular degeneration. May 2004.
19. Newsom, R.S.B., et al.  Transpupillary thermotherapy (TTT) for the treatment of choroidal neovascularization, Br J Ophthalmol, 2001; 85: 173-178.
20. Nowak MS, Jurowski P, Grzybowski A et al. A prospective study on different methods for the treatment of choroidal neovascularization. The efficacy of verteporfin photodynamic therapy, intravitreal bevacizumab and transpupillary thermotherapy in patients with neovascular age-related macular degeneration. Med Sci Monit 2012; 18(6):CR374-80.
21. Odergren A, Algvere PV, Seregard S and Kvanta A.  A prospective randomized study on low-dose transpupillary thermotherapy verus photodynamic therapy for neovascular age-related macular degeneration.  Br J Ophthalmol, June 2008; 92(6): 757-761.
22. Odergren A, Algvere PV, Seregard S, et al.  Vision-related function after low-dose transpupillary thermotherapy versus photodynamic therapy for neovascular age-related macular degeneration. Acta Ophthalmol 2010; 88(4):426-30.
23. Peyman G, Tsipursky M, Gohel P et al. Regression of peripapillary choroidal neovascularization after oscillatory transpupillary thermotherapy and anti-VEGF pharmacotherapy. Eur J Ophthalmol 2011; 21(2):162-72.
24. Rougier MB, Francois L, Fourmaux E et al. Complications and lack of benefit after transpupillary thermotherapy for occult choroidal neovascularization: 1-year results. Retina 2005; 25(6):784-8.
25. Soderberg AC, Algvere PV, Hengstler JC et al. Combination therapy with low-dose transpupillary thermotherapy and intravitreal ranibizumab for neovascular age-related macular degeneration: a 24-month prospective randomised clinical study. Br J Ophthalmol 2012; 96(5):714-8.
26. Tewari HK, Prakash G, Azad RV, et al.  A pilot trial for comparison of photodynamic therapy and transpupillary thermotherapy for the management of classic subfoveal choroidal neovascularization secondary to age-related macular degeneration.  Indian J Ophthalmol 2007; 55: 277-281.
27. Thach AB, Sipperley JO, Dugel PU et al. Large-spot size transpupillary thermotherapy for the treatment of occult choroidal neovascularization associated with age-related macular degeneration. Arch Ophthalmol 2003; 121(6):817-20.
28. Zhang X, Zhu X, Wang D, et al.  Low-power transpupillary thermotherapy combined with intravitreal triamcinolone acetonide for subfoveal choroidal neovascularization.  Ophthalmic Res 2007; 39(4): 241-242.

POLICY HISTORY:

Medical Policy Group, November 2002

Medical Policy Administration Committee, November 2002

Available for comment December 18, 2002-February 3, 2003

Medical Policy Group, November 2003

Medical Policy Group, November 2005 (1)

Medical Policy Group, November 2007 (1)

Medical Policy Group, February 2009 (1)

Medical Policy Group, February 2010 (1): Key Points added

Medical Policy Group, December 2010; 2011 Code updates

Medical Policy Group, June 2011; Updated Key Points & References

Medical Policy Group, February 2012 (1): Update to Description, Key Points and References related to MPP update; no change in policy statement.

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3): Update to Title, Description, Policy Statement clarification – secondary conditions, Key Points and References

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (1): Update to Key Points and References; no change to policy statement;

Medical Policy Group: January 2015: Active policy, but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, July 2019 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References. No change to policy intent.

Medical Policy Group, March 2021 (9): Updates to Description, Key Points, Approved by Governing Bodies, References. Policy statement updated to remove “not medically necessary,” no change to policy intent. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, April 2022 (9): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Description, Key Points.

Medical Policy Group, April 2023 (9): Reviewed by consensus. Updates to Key Points and Benefit Application. No change to policy statement. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2024 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.