12
1 Clinical Policy Title: Glaucoma testing Clinical Policy Number: CCP.1285 Effective Date: February 1, 2017 Initial Review Date: January 18, 2017 Most Recent Review Date: January 8, 2019 Next Review Date: January 2020 Related policies: CCP.1140 Canaloplasty and viscocanalostomy in treatment of glaucoma CCP.1040 Telehealth ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of glaucoma testing to be clinically proven and, therefore, medically necessary when the following criteria are met (American Academy of Ophthalmology Glaucoma Panel, 2010; European Glaucoma Society, 2008): There is concern for the presence of glaucoma based on concurrent disease, family history or ethnicity and age (e.g., diabetes, a family history of glaucoma, African American age 50 years or older, or Hispanic American age 65 years or older). The covered person presents to an eye-care professional for specialty evaluation and management of eye-related complaints (e.g., visual field defect). The covered person carries an eye-related diagnosis (e.g., glaucoma) requiring periodic follow-up and management. Limitations: Policy contains: Genetic testing. Glaucoma testing. Optical coherence tomography. Tonometry.

Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

1

Clinical Policy Title: Glaucoma testing Clinical Policy Number: CCP.1285 Effective Date: February 1, 2017

Initial Review Date: January 18, 2017

Most Recent Review Date: January 8, 2019

Next Review Date: January 2020

Related policies:

CCP.1140 Canaloplasty and viscocanalostomy in treatment of glaucoma

CCP.1040 Telehealth

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers the use of glaucoma testing to be clinically proven and, therefore,

medically necessary when the following criteria are met (American Academy of Ophthalmology

Glaucoma Panel, 2010; European Glaucoma Society, 2008):

There is concern for the presence of glaucoma based on concurrent disease, family history

or ethnicity and age (e.g., diabetes, a family history of glaucoma, African American age 50

years or older, or Hispanic American age 65 years or older).

The covered person presents to an eye-care professional for specialty evaluation and

management of eye-related complaints (e.g., visual field defect).

The covered person carries an eye-related diagnosis (e.g., glaucoma) requiring periodic

follow-up and management.

Limitations:

Policy contains:

Genetic testing.

Glaucoma testing.

Optical coherence tomography.

Tonometry.

Page 2: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

2

AmeriHealth Caritas considers the use of routine glaucoma screening of the general population to be

investigational/experimental and, therefore, not medically necessary.

AmeriHealth Caritas considers the use of glaucoma testing to be investigational/experimental and,

therefore, not medically necessary where the following apply:

Testing is conducted with an unproven instrument of measurement (e.g., genetic testing for

glaucoma).

Testing is conducted with an unproven technique or clinical art (e.g., corneal hysteresis,

multi-focal visual evoked potentials, ocular blood flow tonometry, ocular Doppler blood flow

analysis, continuous monitoring of intraocular pressure).

All other uses of glaucoma testing are not medically necessary (U.S. Preventive Services Task Force,

2013).

Alternative covered services:

Routine in-network primary and eye- specialty health care provider evaluation and management.

Background

Glaucoma is a painless, symptomless condition that can cause blindness. With one exception, narrow-

angle glaucoma, it is associated with increased intraocular pressure within the eye. Inside the eye, fluid

is constantly being manufactured and has to drain from inside the eye. High eye pressure is always

related to some increased resistance or obstruction of the normal outflow of the intraocular fluid. The

chronic sustained high eye pressure leads to degenerative optic neuropathy, loss of retinal ganglion cells

and axons, and ultimately to blindness if not treated.

Glaucoma is a noncurable disease, and all humans are at risk. Open-angle glaucoma, its most common

form, has no symptoms, increasing the importance of early detection. An estimated three million

Americans have the disease, but only half are aware of it. About 120,000 Americans are blind from

glaucoma. African Americans are 15 times more likely to be visually impaired, and six to eight times

more likely to be blind from glaucoma than American Caucasians (Glaucoma Research Foundation,

2017a). A family history of glaucoma increases risk of the disorder by four to nine times (Glaucoma

Research Foundation, 2017b).

Children (typically under age one) and adults may develop glaucoma. Testing for early detection is

recommended for adults under age 40 (every two to four years), ages 40 to 54 (every one to three

years), ages 55 to 64 (every one to two years), and after age 65 (every six to 12 months). In general,

glaucoma testing is performed with hand-held instruments or during a slit-lamp examination in the

outpatient setting. Traditional approaches to glaucoma testing include:

Tonometry.

Page 3: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

3

Gonioscopy.

Ophthalmoscopy.

Perimetry.

Pachymetry (Glaucoma Research Foundation, 2017c).

A more recent technology to perform glaucoma testing is optical coherence tomography, a digital-

imaging technique that produces accurate and detailed reproductions of the retina and optic nerve. It is

very useful for assessing retinal nerve fiber layers and evaluating the optic nerve. With optical

coherence tomography, eye specialists can determine the severity of damage from glaucoma and

monitor treatment. Similar useful technologies include scanning laser ophthalmoscopy and scanning

laser polarimetry.

It has been suggested that the causes of glaucoma may be related to defects in the genome, and a body

of information is emerging to support this theory. Genetic linkage reports have acknowledged a

common gene mutation which explains a tiny segment of glaucoma incidence. On a daily basis, genome-

wide association studies are finding more genes associated with glaucoma but even when incorporated

into rigorous family history analyses are unable to explain more than a fraction of the heritable cases of

the condition.

Glaucoma is treated using multiple approaches, all of which aim to reduce intraocular pressure. One

approach is eye drops. Medications, used singly or in combination, include alpha agonists, beta blockers,

carbonic anhydrase inhibitors, cholinergics (miotics), and prostaglandin analogs. Procedures include

selective laser trabeculoplasty, other laser surgeries, and incisional surgery (Glaucoma Research

Foundation, 2017d).

Searches

AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality and other evidence-based practice centers.

The Centers for Medicare & Medicaid Services.

We conducted searches on November 8, 2018. Search terms were: “glaucoma testing” and “glaucoma

screening.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes

and greater precision of effect estimation than in smaller primary studies. Systematic

reviews use predetermined transparent methods to minimize bias, effectively treating the

review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Page 4: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

4

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency

studies — which also rank near the top of evidence hierarchies.

Findings

Guidelines for glaucoma testing are bound to the traditional methods of diagnosis (Ou, 2011). The

American Academy of Ophthalmology (2010) and South East Asia Glaucoma Interest Group (2008)

guidelines require direct visualization of pathologic findings to unilateral or bilateral optic disc/retinal

nerve fiber layers and the visual fields to have defects for a confirming diagnosis. The European

Glaucoma Society (2008) guidelines are less rigid, with more options on a menu that includes but is not

limited to optic disc or retinal nerve fiber layer defects, and glaucomatous visual field defects. It is also

the only guideline to define a quantitative threshold for diagnosis (i.e., an untreated peak intraocular

pressure >21 mmHg). Both societies endorse computer-based image analysis such as optical coherence

tomography.

A preferred practice pattern from the American Academy of Ophthalmology (2016) includes information

on screening, along with diagnosis and treatment, updating the Academy’s 2010 version.

An assessment of the value of screening of the general population for glaucoma from the U.S.

Preventive Services Task Force (2013) found no direct evidence on the benefits of screening, and

inadequate evidence that screening for or treatment of increased intraocular pressure or early

asymptomatic primary open-angle glaucoma reduces the number of persons who will develop impaired

vision or health-related quality of life. However, the Task Force found convincing evidence that

treatment of intraocular pressure and early glaucoma detection reduces the number of persons who

develop small, clinically unnoticeable visual field defects and that treatment of early asymptomatic

primary open-angle glaucoma decreases the number of persons whose visual field defects worsen.

Standard automated perimetry has commonly been used to diagnose glaucoma. The procedure has

limits, as retinal ganglion cell loss precedes defects detected by the test. Perimetry is also prone to inter-

test variability making the evaluation of disease progression problematic. New devices for glaucoma

screening have been developed (Turalba, 2010).

An early systematic review from the United Kingdom documented glaucoma screening tests with a

specificity rate of 85 percent or higher, but no single test was most accurate. Lack of randomized

controlled trials was cited as a limit in assessing outcomes of screening. The study recommended

screening for high-risk persons, but not the entire population (Burr, 2008).

Another systematic review from the United Kingdom of 40 studies (n=48,000) assessed nine tests,

although most were reported by only a few studies. No clear patterns of sensitivity and specificity

emerged, data were deemed of limited quality, and the review could not identify a superior test

(Mowatt, 2008).

Page 5: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

5

The Agency for Healthcare Research and Quality reviewed 83 studies on the accuracy of glaucoma

screening tests. Sensitivities and specificities varied by device. No evidence was found linking glaucoma

screening with visual field loss, visual impairment, optic nerve damage, intraocular pressure, or patient-

reported outcomes, despite improvements in screening devices (Ervin, 2012).

An expert panel in Sweden conducted a systematic review of 106 studies (n=16,260 eyes, assigned as

cases and controls) assessing accuracy of confocal scanning laser ophthalmoscopy, optical coherence

tomography, and scanning laser polarimetry (as used by the GDx device) for diagnosing glaucoma in

people who are at risk. In persons referred by primary eye care, such as in those who have already

undergone some functional or anatomic testing by optometrists, the best measures would miss 30

percent of cases (sensitivity 70 percent), and would incorrectly refer five percent without glaucoma

(specificity 95 percent). Accuracy was relatively consistent by device ( Michelessi, 2015; Swedish Council

on Health Technology Assessment, 2015).

A meta-analysis of relatively new techniques of glaucoma testing searched 2,474 articles. The greatest

accuracy was found with frequency doubling technology (diagnostic odds ratio 57.7) followed by blue on

yellow perimetry (46.7), optical coherence tomography (41.8), GDx (32.4), and Heidelberg retina

tomography (17.8) (Ahmed, 2016). A meta-analysis of 86 articles determined odds ratios for detecting

glaucoma calculated that odds ratios for detection were 29.5 for optical coherence tomography, 18.6 for

GDx, and 13.9 for Heidelberg retinal tomography (Fallon, 2017).

A study of 943 subjects referred from the community to hospital eye services for glaucoma compared

various devices. The Heidelberg retinal tomography had relatively high sensitivity and specificity for its

Moorfield’s regression analysis (87.0 and 63.9) and its glaucoma probability score (81.5 and 67.7).

Optical coherence tomography had similar sensitivity and specificity (76.9 and 78.5), while GDx had a

very low sensitivity and very high specificity 35.1 and 97.2) (Azuara-Blanco, 2016).

A meta-analysis of 150 studies included 16,104 glaucomatous and 11,543 normal control eyes. A

comparison of five optical coherence tomography devices that test for glaucoma (Zeiss Stratus, Zeiss

Cirrus, Heidelberg Spectralis and Optovue RTVue, and Topcon 3D-OCT) found that each had similar

classification capability (Kansal, 2018).

Teleglaucoma is a method of detecting the disease, using stereoscopic digital imaging to take ocular

images, which are transmitted electronically to an ocular specialist. A systematic review of 45 studies

concluded teleglaucoma was more specific and less sensitive than in-person examination, and more

likely to detect the disease than through in-person testing. The pooled estimates of sensitivity and

specificity through teleglaucoma were 83.2 percent and 79.0 percent (Thomas, 2014).

There is no conclusive medical evidence that genetic testing for glaucoma is impactful in influencing

treatment outcomes or reducing glaucoma-related blindness yet. The scientific research for a link

between genetics and glaucoma is an emerging body of work ( Al-Shahrani, 2016; Khawaja, 2016; Liu,

2016; Mauri, 2016; Verma, 2016) with numerous threads that may be interwoven into a coherent

Page 6: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

6

diagnostic and treatment approach in the future, but are not sufficiently understood at present to

create hard and fast statements regarding their diagnostic utility or therapeutic potential. As such, these

methods are not included in any contemporary specialty-society or international health-body guidelines

on the diagnosis and treatment of glaucoma.

A cost-effectiveness review of 20 studies determined that teleophthalmology screening programs for

glaucoma (two of the 20 studies) are effective compared to in-person evaluations, which underlines the

importance of expanding screening into underserved populations such as those in rural areas

(Sharafeldin, 2018).

Policy updates:

In December, 2017, we added a total of four guidelines/other and 10 peer-reviewed references to this

policy.

In November, 2018, we added two guidelines/other and two peer-reviewed publications to the

reference list, and deleted one peer-reviewed reference.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Fallon (2017)

Accuracy of diagnosing

glaucoma, by device

Key points:

Meta-analysis of 86 articles on ability to detect glaucoma.

Odds ratios for detecting glaucoma were 29.5 for optical coherence tomography, 18.6

for GDx, and 13.9 for Heidelberg retinal tomography.

Optical coherence tomography is most accurate means of testing.

Ahmed (2016)

Accuracy of diagnosing

glaucoma, relatively new

devices

Key points:

Meta-analysis of relatively new techniques of glaucoma testing searched 2,474 articles

Diagnostic odds ratio were frequency doubling technology 57.7, exceeding blue on

yellow perimetry 46.7, optical coherence tomography 41.8, GDx 32.4, and Heidelberg

retina tomography 17.8.

Frequency doubling technology is most accurate means of testing, but several devices

have high accuracy.

Michelessi (2015)

Accuracy of diagnosing

glaucoma by device,

sensitivity and specificity

Key points:

Systematic review of 106 studies (n=16,260 eyes), assigned to cases and controls

Goal was to assess accuracy of confocal scanning laser ophthalmoscopy, optical

coherence tomography, and scanning laser polarimetry (as used by the GDx device) for

diagnosing glaucoma in people who are at risk.

In persons referred by primary eye care, such as in those who have already undergone

Page 7: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

7

Citation Content, Methods, Recommendations

some functional or anatomic testing by optometrists, the best measures would miss 30

percent of cases (sensitivity 70 ), and would incorrectly refer five percent without

glaucoma (specificity 95%).

Accuracy was relatively consistent by device.

Ou (2011)

A critical appraisal and

comparison of the quality

and recommendations of

glaucoma clinical practice

guidelines

Key points:

All published guidelines on glaucoma testing recommend slit-lamp biomicroscopy with

stereoscopic visualization of the optic nerve, as well as direct ophthalmoscopy.

European Glaucoma Society defines a threshold of 21 mm intraocular pressure peak in

the untreated eye as diagnosis of primary open-angle glaucoma.

American Academy of Ophthalmology Glaucoma Panel and South East Asia Glaucoma

Interest Group guidelines do not define an intraocular pressure requirement in the

diagnosis of primary open-angle glaucoma.

American Academy of Ophthalmology Glaucoma Panel and European Glaucoma

Society guidelines address age of onset; South East Asia Glaucoma Interest Group

does not.

American Academy of Ophthalmology Glaucoma Panel and South East Asia Glaucoma

Interest Group guidelines specify that primary open-angle glaucoma can only be

diagnosed in the absence of other causes.

American Academy of Ophthalmology Glaucoma Panel, European Glaucoma Society,

and South East Asia Glaucoma Interest Group require different descriptions of optic

nerve findings:

o American Academy of Ophthalmology Glaucoma Panel requires only minimal

documentation of neuropathy.

o The European Glaucoma Society guidelines illustrate various optic nerve

findings with drawings and detailed text.

o South East Asia Glaucoma Interest Group guidelines not only provide

descriptive guidelines on detecting glaucomatous optic neuropathy but also

include an appendix with illustrative optic nerve photographs (non-

stereoscopic).

American Academy of Ophthalmology and European Glaucoma Society recommend

stereoscopic disc photography or computer-based image analysis (e.g., optical

coherence tomography) of the optic nerve and retinal nerve fiber layer.

References

Professional society guidelines/other:

American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern. Primary Open-Angle

Glaucoma. San Francisco, CA: American Academy of Ophthalmology; 2010: 1–35.

American Academy of Ophthalmology. Preferred Practice Pattern: Primary Open-Angle Glaucoma. San

Francisco CA: American Academy of Ophthalmology, 2016. https://www.aaojournal.org/article/S0161-

6420(15)01276-2/pdf. Accessed November 8, 2018.

Page 8: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

8

European Glaucoma Society. Terminology and Guidelines for Glaucoma. 3rd ed. Savona, Italy: European

Glaucoma Society; 2008:1– 4.5.3.6.

Glaucoma Research Foundation. Glaucoma Facts and Stats. San Francisco CA: Glaucoma Research

Foundation, last reviewed October 29, 2017a. https://www.glaucoma.org/glaucoma/glaucoma-facts-

and-stats.php. Accessed November 8, 2018.

Glaucoma Research Foundation. Are You at Risk for Glaucoma? San Francisco CA: Glaucoma Research

Foundation, last reviewed October 29, 2017b. https://www.glaucoma.org/glaucoma/are-you-at-risk-for-

glaucoma.php. Accessed November 8, 2018.

Glaucoma Research Foundation. Five Common Glaucoma Tests. San Francisco CA: Glaucoma Research

Foundation, last reviewed October 29, 2017c. https://www.glaucoma.org/glaucoma/diagnostic-

tests.php. Accessed November 8, 2018.

Glaucoma Research Foundation. Care and Treatment. San Francisco CA: Glaucoma Research Foundation,

last reviewed October 29, 2017d. https://www.glaucoma.org/treatment. Accessed November 8, 2018.

South East Asia Glaucoma Interest Group. Asia Pacific Glaucoma Guidelines. 2nd ed. Sydney, Australia:

South East Asia Glaucoma Interest Group; 2008:1–101.

Swedish Council on Health Technology Assessment (SCHTA). Open-angle glaucoma: diagnosis, follow-up,

and treatment. A systematic literature review. Pub Med Health, last updated 2015. Tests for imaging the

optic nerves and its fibres for diagnosing glaucoma.

https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0080834/. Accessed November 8, 2018.

U.S. Preventive Services Task Force. Screening for glaucoma: U.S. Preventive Services Task Force

recommendation statement. Ann Intern Med. 2013;159(7):484-489. Doi: 10.7326/0003-4819-159-6-

201309170-00686.

Peer-reviewed references:

Ahmed S, Khan Z, Si F, et al. Summary of glaucoma diagnostic testing accuracy: An evidence-based meta-

analysis. J Clin Med Res. 2016;8(9):641-649. Doi: 10.14740/jocmr2643w.

Al-Shahrani H, Al-Dabbagh N, Al-Dohayan N, et al. Association of the methylenetetrahydrofolate

reductase (MTHFR) C677T polymorphism with primary glaucoma in Saudi population. BMC

Ophthalmology. 2016;16(1):156. Doi: 10.1186/s12886-016-0337-7.

Azuara-Blanco A, Banister K, Boachie C, et al. Automated imaging technologies for the diagnosis of

glaucoma: a comparative diagnostic study for the evaluation of the diagnostic accuracy, performance as

Page 9: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

9

triage tests and cost-effectiveness (GATE study). Health Technol Assess. 2016;20(8):1-168. Doi:

10.3310/hta20080.

Burr JM, Mowatt G, Hernandez R, et al. The clinical effectiveness and cost-effectiveness of screening for

open angle glaucoma: a systematic review and economic evaluation. Health Technol Assess.

2007;11(41)1-190. PMID: 17927922.

Ervin AM, Boland MV, Myrowitz EH, et al (eds.). Screening for glaucoma: comparative effectiveness

[Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. Report No.: 12-

EHC037-EF. AHRQ Comparative Effectiveness Reviews.Agency for Healthcare Research and Quality

website. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/glaucoma-screening_research.pdf.

Accessed November 8, 2018.

Fallon M, Valero O, Pazos M, Anton A. Diagnostic accuracy of imaging devices in glaucoma: A meta-

analysis. Surv Ophthalmol. 2017;62(4):446 461. Doi: 10.1016/j.survophthal.2017.01.001.

Kansal V, Armstrong JJ, Pintwala R, Hutnik C. Optical coherence tomography for glaucoma diagnosis: An

evidence based meta-analysis. PLoS One. 2018;13(1):e0190621. Doi: 10.1371/journal.pone.0190621.

Khawaja AP, Cooke Bailey JN, Kang JH, et al. Assessing the association of mitochondrial genetic variation

with primary open-angle glaucoma using gene-set analyses. Invest Ophthal Vis Science.

2016;57(11):5046 5052. Doi: 10.1167/iovs.16-20017.

Liu Y, Bailey JC, Helwa I, et al. A common variant in MIR182 is associated with primary open-angle

glaucoma in the NEIGHBORHOOD consortium. Invest Ophthal Vis Science. 2016;57(10):4528 4535. Doi:

10.1167/iovs.16-19688.

Mauri L, Uebe S, Sticht H, et al. Expanding the clinical spectrum of COL1A1 mutations in different forms

of glaucoma. Orphanet Journal of Rare Diseases. 2016;11:108. Doi: 10.1186/s13023-016-0495-y.

Michelessi M, Lucenteforte E, Oddone F, et al. Optic nerve head and fibre layer imaging for diagnosing

glaucoma. Cochrane Database Syst Rev. 2015 Nov 30;(11):CD008803. doi:

10.1002/14651858.CD008803.pub2.

Mowatt G, Burr JM, Cook JA, et al. Screening tests for detecting open-angle glaucoma: systematic review

and meta-analysis. Invest Ophthalmol Vis Sci. 2008;49(12):5373 5385. Doi: 10.1167/iovs.07-1501.

Ou Y, Goldberg I, Migdal C, et al. A critical appraisal and comparison of the quality and

recommendations of glaucoma clinical practice guidelines. Ophthalmology 2011;118:1017–1023. Doi:

10.1016/j.ophtha.2011.03.038.

Page 10: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

10

Sharafeldin N, Kawaguchi A, Sundaram A, et al. Review of economic evaluations of teleophthalmology

as a screening strategy for chronic eye disease in adults. Br J Ophthalmol. 2018;102(11):1485-1491. Doi:

10.1136/bjophthalmol-2017-311452.

Turalba AV, Grosskreutz C. A review of current technology used in evaluating visual function in

glaucoma. Semin Ophthalmol. 2010;25(5-6):309-316. Doi: 10.3109/08820538.2010.518898.

Thomas SM, Jeyeraman MM, Hodge WG, Hutnik C, Costella J, Malvankar-Mehta MS. The effectiveness of

teleglaucoma versus in-patient examination for glaucoma screening: a systematic review and meta-

analysis. PLoS One. 2014;9(12):e113779. Doi: 10.1371/journal.pone.0113779.

Verma SS, Cooke Bailey JN, Lucas A, et al. Epistatic gene-based interaction analyses for glaucoma in

eMERGE and NEIGHBOR consortium. Myers AJ, ed. PLoS Genetics. 2016;12(9):e1006186. Doi:

10.1371/journal.pgen.1006186.

Centers for Medicare & Medicaid Services National Coverage Determinations:

No National Coverage Determinations identified as of the writing of this policy; however, coverage of

glaucoma testing is covered by Medicare Part B when:

The covered person is at high risk (e.g., diabetes, a family history of glaucoma, African

American and age 50 or older, or Hispanic American and age 65 or older).

Medicare.gov. Glaucoma tests. Medicare.gov website: https://www.medicare.gov/coverage/glaucoma-

tests.html. Accessed November 8, 2018.

Local Coverage Determinations:

No Local Coverage Determinations identified as of the writing of this policy; however, a local coverage

article regarding glaucoma screening states:

Medicare coverage of glaucoma screenings was implemented with the Benefits

Improvement and Protection Act of 2000.

A glaucoma screening is defined to include:

o A dilated eye examination with an intraocular pressure measurement.

o A direct ophthalmoscopy examination or a slit-lamp biomicroscopic examination.

Medicare covers glaucoma screening for the following persons considered to be at high risk

for developing this disease:

o Individuals with diabetes mellitus.

o Individuals with a family history of glaucoma.

o African Americans age 50 or over.

o Hispanics Americans age 65 or older.

Glaucoma screening frequency limitations and payment information:

Page 11: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

11

o Medicare pays for this service annually (i.e., at least 11 full months must have

passed following the month in which the last Medicare-covered glaucoma screening

examination was performed).

Services rendered more frequently than allowed under this screening benefit may require

that the beneficiary be given an Advance Beneficiary Notice.

o The beneficiary will pay 20 percent as the copayment or coinsurance after meeting

the yearly Part B deductible.

Medical record documentation requirements:

o Medical record documentation to support that the beneficiary is a member of one

of the high risk groups, as defined above.

Documentation must support one of the screening defined:

o A dilated eye examination with intraocular pressure measurement and direct

ophthalmoscopic examination, or a slit-lamp biomicroscopic examination.

Local coverage article: A53495 glaucoma screening.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is

not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and

bill accordingly.

CPT code Description Comments

92100 Serial tonometry with multiple measurements of ocular pressure over an extended period of time, with interpretation and report the same day

Single episode tonometry is a component of the ophthalmological service or E/M service

92133 Scanning computerized ophthalmic diagnostic imaging, posterior segment, with interpretation and report unilateral or bilateral; optic nerve

92134 Scanning computerized ophthalmic diagnostic imaging, posterior segment, with interpretation and report unilateral or bilateral; retina

ICD 10 code Description Comments

E08-E13.9 Diabetes mellitus

H40.00-H42 Glaucoma

Z13.0 Encounter for screening for diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

Z83.511 Family history of glaucoma

HCPCS Level II code

Description Comments

G0117 Glaucoma screening for high risk patients furnished by an optometrist or ophthalmologist

G0118 Glaucoma screening for high risk patient furnished under the direct supervision

Page 12: Clinical Policy Title: Glaucoma testing · reflective of evidence-based medicine at the time of review. ... Routine in-network primary and eye- specialty health care provider evaluation

12

HCPCS Level II code

Description Comments

of an optometrist or ophthalmologist