Latest Review Date: June 2024

Category: Vision                                                                 

POLICY:

Cataract removal surgery may be considered medically necessary when:

1. The individual's visual acuity is 20/50 (best corrected) or worse, as defined objectively, by Snellen visual acuity testing; AND
   • There is symptomatic impairment of visual function resulting in unsatisfactory ability to conduct activities of daily living (e.g., reading, viewing television, driving, meeting occupational/vocational expectations); AND
   • Individual history includes the individual's own assessment of impairment of functional status; AND
   • Individual has undergone an appropriate ophthalmologic evaluation; 
     OR
2. Cataract extraction is required to adequately diagnose or treat ophthalmologic disease, including but not limited to, diabetic retinopathy.

Implantation of Accommodative lenses (e.g., Crystalens®) is considered not medically necessary. 

Conventional/Accommodative Lenses:

A conventional intraocular lens may be considered a covered service when all of the criteria required in this policy statement is satisfied. 

For individuals who elect non-covered accommodative lenses, providers may bill the individual additional expenses associated with the insertion of accommodative lenses if the individual signs a waiver specific to non-coverage of accommodative lenses for the specific date of service the lens is inserted. Given that the intent of the multi-focal IOL, accommodating IOL and the Toric IOL is to obviate the need for reading glasses post-surgery, these IOLs are considered not medically necessary. 

Examples of accommodative lenses, including but not limited to, the following: AcrySof® Toric, AcrySof IQ Vivity Extended Vision Intraocular Lens, Crystalens®, Trulign®, ReZoom®, Tecnis® Multifocal, AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lenses to correct presbyopia, Clareon Vivity Extended Vision IOL

DESCRIPTION OF PROCEDURE OR SERVICE:

A cataract is defined by the American Academy of Ophthalmology (AAO) as a degradation of the optical quality of the crystalline lens that affects vision. This condition reduces the amount of incoming light and results in visual function deterioration. Most cataract development is related to aging, and it can occur in one or both eyes. Dysfunction related to this condition can range from minimal to extremely disabling for the affected individual.

Cataract removal surgery should be considered as a treatment when the cataract causes the affected individual severely limited ability to perform activity of daily living (ADLs). ADLs that are typically regarded important by an individual are the ability to read, view television, drive, or meet occupational/vocational expectations. An individual's tolerance of visual impairment is highly subjective and varies per personal perception. In addition to subjective indicators, there are objective indicators that should be evaluated when deciding that surgery is the appropriate treatment path for cataracts, such as Snellen visual acuity testing. Visual acuity should be recorded and considered in the context of the individual's visual impairment and other ocular findings.

Cataract removal surgery, while generally accepted as low risk, carries risk of complication (e.g.,capsular problems, dropped nucleus or lens fragments into vitreous, endophthalmitis, persistent corneal edema, etc.). The decision to perform this procedure should be carefully evaluated to determine that the risk does not outweigh the potential benefit. Cataracts only need to be removed when they cause significant vision loss and disruption to an individual's quality of life, or in the case of needing to properly visualize, treat, and monitor other ocular diseases such as glaucoma, macular degeneration, or diabetic retinopathy.

The intra-ocular lens (IOL) is a permanent plastic lens implanted inside the eye to replace the crystalline lens.  Dick (2005) stated that the potential clinical benefits of accommodative IOL technology for both cataract patients and refractive patients may place accommodative IOLs in a competitive position with multi-focal IOL technology. Given that the intent of the multi-focal IOL, accommodating IOL and the Toric IOL is to obviate the need for reading glasses post-surgery, these IOLs are considered not medically necessary. Standard IOLs meet an individual’s basic functional needs by replacing the native lens. 

Cataracts may be diagnosed with procedures included in the comprehensive ophthalmologic examination.  Cataracts may be seen on ophthalmoscopy as gray opacities in the lens.  Cataracts obscure the normal "red reflex" that is elicited by examining the dilated pupil with the ophthalmoscope held about 1 foot away.  Slit-lamp examination provides more details about the character, location, and extent of the opacity.

An appropriate preoperative evaluation should be performed prior to surgery. This generally includes, at minimum, a comprehensive ophthalmologic evaluation. It is also appropriate to identify any ocular comorbidities, high-risk ocular features, or systemic issues that could impact the performance and outcomes of surgery.

KEY POINTS:

This evidence review was created and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through June 11, 2024.

Summary of Evidence

Treatment outcomes that are the most crucial and relevant to the individual are improved visual function and quality of life. Well-designed studies consistently show that cataract removal surgery has a substantial positive impact on vision-dependent functioning. Numerous studies, as reported by the AAO, show that physical function, mental health, emotional well-being, safety, and overall quality of life can be positively impacted when visual function is satisfactory. The evidence is sufficient to prove that the technology has a positive effect on net health outcomes when significant and debilitating visual acuity compromise has been subjectively and objectively proven. Cataract removal surgery may be considered appropriate when the individual has been sufficiently educated on the disease process, treatment options, and it is mutually agreed upon between the individual and surgeon that the surgery will result in enhanced function.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The American Academy of Ophthalmology Preferred Practice Pattern Cataract and Anterior Segment Panel updated its guidelines for the use of cataract surgery in the adult eye in 2021 as below:

Indications for Surgery:

The primary indication for cataract surgery is a decline in visual function such that it no longer meets a patient’s visual needs and for which surgery provides a reasonable likelihood of improvement. Other indications for cataract removal include the following:

• There is clinically significant anisometropia in the presence of a cataract.
• A lens opacity interferes with optimal diagnosis or management of posterior segment pathology.
• A lens causes inflammation and related secondary glaucoma (phacolytic, lens particle, phacoantigenic).
• The lens induces primary angle closure or other forms of lens-related glaucoma.

Contraindications to Surgery

• Surgery for a cataract should not be performed under the following circumstances:
• Tolerable refractive correction provides vision that meets the patient’s needs and desires.
• Surgery is not expected to improve visual function and no other indication for lens removal exists.
• The patient cannot safely undergo surgery because of coexisting medical or ocular conditions.
• Appropriate postoperative care cannot be arranged.
• The patient or patient’s surrogate decision maker is unable to give informed consent for nonemergent surgery.

KEY WORDS:

Cataracts, visual function, visual acuity, intraocular lens (IOL), phacoemulsification, Crystalens®, accommodative IOL (AIOL), accommodative lens, AcrySof® IQ ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Tecnis® Multifocal Foldable Silicone and Acrylic Intraocular Lenses-P080010, Toric lens, ReZoom®, Tecnis® Multifocal,Clareon Vivity, Trulign

APPROVED BY GOVERNING BODIES:

Numerous intraocular lens implants have received FDA approval for implantation. FDA approval does not indicate medical necessity.

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

CURRENT CODING:

CPT codes:    

HCPCS Codes:      

Previous Coding:

CPT codes:

REFERENCES:

1. American Academy of Ophthalmology (AAO), Cataract/Anterior Segment Panel,. Cataract in the adult eye. Preferred Practice Pattern. San Francisco, CA: AAO; October 2016.
2. Aslam, T.M., Devlin, H., Dhillon, B. Use of Nd:  YAG laser capsulotomy, Surv Ophthalmol. 2003; 48(6): 594-612.
3. Baratz, K.H., Cook, B.E., Hodge, D.O. Probability of Nd:  YAG laser capsulotomy after cataract surgery in Olmsted County, Minnesota. Am J Ophthalmol 2001; 131(2): 161-166.
4. Day AC, Gore DM, Bunce C, Evans JR. Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery. Cochrane Database Syst Rev. 2016 Jul 8;7(7):CD010735. doi: 10.1002/14651858.CD010735.pub2. Update in: Cochrane Database Syst Rev. 2023 Jun 23;6:CD010735. 
5. Dick HB. Accommodative intraocular lenses: Current status. Curr Opin Ophthalmol. 2005;16(1):8-26.
6. Dole K, Baheti N, Deshpande R, Kulkarni S, Shetty R, Deshpande M. Comparative study of anatomical and functional recovery of eye along with patient satisfaction score after small-incision cataract surgery and phacoemulsification cataract surgery. Indian J Ophthalmol. 2022 Nov;70(11):3942-3947. doi: 10.4103/ijo.IJO_1614_22. 
7. Fogla R, Rao SK. Model eye for Nd:  YAG laser capsulotomy. J Cataract Refract Surg, 2000; 26(10): 1435-1437.
8. Gierek-Ciaciura S, Cwalina L, Bednarski L, Mrukwa-Kominek E. A comparative clinical study of the visual results between three types of multifocal lenses. Graefes Arch Clin Exp Ophthalmol. 2010;248(1):133-140.
9. Hantera MM, Hamed AM, Fekry Y, Shoheib EA. Initial experience with an accommodating intraocular lens: Controlled prospective study. J Cataract Refract Surg. 2010;36(7):1167-1172.
10. ICHOM (International Consortium for Health Outcomes Measurement). Standard set for cataract surgery. www.ichom.org/portfolio/cataracts/.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Keay L, Lindsley K, Tielsch J, et al. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2012;(3):CD007293.
13. Kessel L, Andresen J, Erngaard D, Flesner P, Tendal B, Hjortdal J. Indication for cataract surgery. Do we have evidence of who will benefit from surgery? A systematic review and meta-analysis. Acta Ophthalmol. 2016 Feb;94(1):10-20. doi: 10.1111/aos.12758. Epub 2015 Jun 3
14. Kramar A, Grabner G, Seyeddain O, et al. Multifocal versus monofocal IOLs:  No clear winner in small study, Cataract & Refractive Surgery Today Europe 2008; 16-18.
15. Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmology. 2015 Nov; 133(11):1247-1252.
16. Miller KM, Oetting TA, Tweeten JP, Carter K, Lee BS, Lin S, Nanji AA, Shorstein NH, Musch DC; American Academy of Ophthalmology Preferred Practice Pattern Cataract/Anterior Segment Panel. Cataract in the Adult Eye Preferred Practice Pattern. Ophthalmology. 2022 Jan;129(1):P1-P126. doi: 10.1016/j.ophtha.2021.10.006. Epub 2021 Nov 12.
17. National Institute for Health and Clinical Excellence (NICE). Implantation of multifocal (non-accommodative) intraocular lenses during cataract surgery. Interventional Procedure Guidance 264. London, UK: NICE; June 2008.
18. Shafer BM, McCabe C, Reiser H, Newsom TH, Berdahl J. The REVIVE Study: Long Term Outcomes of a Novel Non-Diffractive Extended Vision IOL versus Monofocal Control IOL. Clin Ophthalmol. 2022;16:3945-3950. Published 2022 Nov 28. doi:10.2147/OPTH.S390380
19. Vital MC, Jong KY, Trinh CE, Starck T, Sretavan D. Endothelial Cell Loss Following Cataract Surgery Using Continuous Curvilinear Capsulorhexis or Precision Pulse Capsulotomy. Clin Ophthalmol. 2023 Jun 16;17:1701-1708. doi: 10.2147/OPTH.S411454.
20. Zamora-de La Cruz D, Zuniga-Posselt K, Bartlett J, et al. Trifocal intraocular lenses versus bifocal intraocular lenses after cataract extraction among participants with presbyopia. Cochrane Database Syst Rev. 2020;6(6):CD012648.
21. Zhang ML, Hirunyachote P, Jampel H. Combined surgery versus cataract surgery alone for eyes with cataract and glaucoma. Cochrane Database Syst Rev. 2015;7:CD008671.

POLICY HISTORY:

Medical Policy Group, July 2004 (4)

Medical Policy Administration Committee, August 2004

Available for comment August 24-October 7, 2004

Medical Policy Group, April 2005 (2)

Medical Review Committee, May 2005

Medical Policy Administration Committee, May 2005

Available for comment May 9-June 22, 2005

Medical Policy Group, July 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment, July 30-September 12, 2005

Medical Policy Group, December 2005 (4)

Medical Policy Group, February 2009 (4)

Medical Policy Group, March 2011 (3); Updated effective date for Code Q1003

Medical Policy Group, September 2012 (3): Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, January 2018: (6): Updates to policy statement with no change in policy intent, Key Words and Coding section.

Medical Policy Group, December 2018: 2019 Annual Coding Update.  Added new CPT code 0514T.

Medical Policy Group, November 2019 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, Key Words (ReZoom®, Tecnis® multifocal), Coding (66830,66982,66985) and References. No change to policy intent.

Medical Policy Group, December 2019 (6) 2020 Annual coding update, Revised code 66984 to include “without endoscopic cyclophotocoagulation”.

Medical Policy Group, November 2020 (9): Updated Description for clarification purposes. Removed statement: "Experts state that cataract removal surgery should be performed on each eye separately and sufficient time be allowed for the first eye to heal before the second cataract removal is performed (an interval of 2 to 6 months is customary)." No change to policy statement or intent of coverage.

Medical Policy Group, August 2021 (9): Updated Description, Key Points, References. Policy statement verbiage updated for clarity and readability. No change to intent of coverage. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, July 2022 (9): Updated Description, Key Points, References. Updated policy statement verbiage made for clarity: “less than or equal to” replaced with “or worse”; “subjective” replaced with “objective”. No change to intent of coverage. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, November (9): Created previous coding section. Moved CPT code 0514T from current coding section to previous coding section. Code is deleted effective 12/31/22 due to coding update.

Medical Policy Group, July 2023 (9); Updated Key Points, Benefit Application and References. Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2024 (6): Updates to Description, Key Points, Key Words, Current Coding (+66987-66988, V2630-V2632) 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.