Local Coverage Determination (LCD)

Visual Electrophysiology Testing

L36831

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36831
Original ICD-9 LCD ID
Not Applicable
LCD Title
Visual Electrophysiology Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36831
Original Effective Date
For services performed on or after 03/16/2017
Revision Effective Date
For services performed on or after 10/17/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/29/2016
Notice Period End Date
02/14/2017
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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR Section 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter).

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract

VEP/VER - The visual evoked response (VER) and visual evoked potential (VEP) evaluate the visual nervous system pathways from the eyes to the occipital cortex of the brain. By measuring the function of the entire visual pathway, it helps to separate eye disease from central nervous system defects. VER/VEP involves stimulation of the retina and optic nerve with a shifting checkerboard pattern or flash method. This external visual stimulus causes measurable electrical activity in neurons within the visual pathways. The VER is recorded by electroencephalography electrodes located over the occiput producing a characteristic waveform. Abnormalities may be seen in a variety of pathologic processes involving the optic nerve and its radiations. Pattern-shift VER is a highly sensitive means of documenting lesions in the visual system.

ERG - The full field electroretinogram (ERG) is used to detect loss of retinal function or distinguish between retinal and optic nerve lesions. ERG measures the electrical activity generated by neural and non-neuronal cells in the retina in response to a light stimulus. ERGs are usually obtained using electrodes embedded in a corneal contact lens, or a thin wire inside the lower eyelid, which measure a summation of retinal electrical activity at the corneal surface. The International Society for Clinical Electrophysiology of Vision (ISCEV) introduced minimum standards for the ERG in 1989. The ERG helps to distinguish retinal degeneration and dystrophies. Multi-focal electroretinography (mfERG) is a higher resolution form of ERG, enabling assessment of ERG activity in small areas of the retina. Pattern ERG (PERG) to assess retinal ganglion cell (RGC) function in glaucoma is being investigated.

Indications of Coverage

Visual Evoked Potentials or Responses (VEPs/VERs)

  1. Confirm diagnosis of multiple sclerosis when clinical criteria are inconclusive
  2. Evaluate diseases of the optic nerve, such as:
    1. Optic neuritis
    2. Ischemic optic neuropathy
    3. Toxic amblyopias
    4. Nutritional amblyopias
    5. Neoplasms compressing the anterior visual pathways
    6. Optic nerve injury or atrophy
    7. Malingering/functional vision loss (to rule out)
  3. Monitor the visual system during optic nerve (or related) surgery (monitoring of short-latency evoked potential studies).

Electroretinography (ERG)

  1. To diagnose loss of retinal function or distinguish between retinal lesions and optic nerve lesions:
    1. Toxic retinopathies, including those caused by intraocular metallic foreign bodies and Vigabatrin
    2. Diabetic retinopathy
    3. Ischemic retinopathies including central retinal vein occlusion (CRVO), branch vein occlusion (BVO), and sickle cell retinopathy
    4. Autoimmune retinopathies such as Cancer Associated Retinopathy (CAR), Melanoma Associated Retinopathy (MAR), and Acute Zonal Occult Outer Retinopathy (AZOOR)
    5. Retinal detachment
    6. Assessment of retinal function after trauma, especially in vitreous hemorrhage, dense cataracts, and other conditions where the fundus cannot be visualized photoreceptors; absent b-wave indicates abnormality in the bipolar cell region.
    7. Retinitis pigmentosa and related hereditary degenerations
    8. Retinitis punctata albescens
    9. Leber's congenital amaurosis
    10. Choroideremia
    11. Gyrate atrophy of the retina and choroid
    12. Goldman-Favre syndrome
    13. Congenital stationary night blindness
    14. X-linked juvenile retinoschisis
    15. Achromatopsia
    16. Cone dystrophy
    17. Disorders mimicking retinitis pigmentosa
    18. Usher Syndrome
  2. To detect chloroquine (Aralen) and hydroxychloroquine (Plaquenil) toxicity (mfERG) per AAO guidelines (10).

VEP/ERG in Glaucoma

A 2011 report by the AAO on “Assessment of Visual Function in Glaucoma” noted that while VEP and ERG, as objective measures of visual function, provided testing free of patient input, issues prevent their adoption for glaucoma management (1). It concluded that advances in technology have yet to produce definitive guidance on the diagnosis of glaucoma or its progression over time and that further research on an objective measure of visual function is needed.

Since then several studies (2-5) have investigated the use of VEP and ERG technology to differentiate between normal healthy eyes and eyes with early to advanced visual field loss resulting from glaucoma. The authors indicated that VEP and ERG may allow earlier diagnosis of glaucoma. However, NGS has determined that without larger studies, AAO’s 2011 conclusion, that these technologies have yet to produce definitive guidance on the diagnosis of glaucoma or its progression over time, remains. This was also the conclusion of a 2013 study which prospectively monitored progressive changes of RGC function in early glaucoma using PERG (6). The authors concluded that further follow-up is required to determine whether PERG losses are predictors of future visual field loss.

Neither of the 2015 AAO Preferred Practice Guidelines, “Primary Open-Angle Glaucoma Suspect” or “Primary Open-Angle Glaucoma,” mention VEP or ERG as diagnostic tools (7,8). Also, the UpToDate review on “Open-angle glaucoma: Epidemiology, clinical presentation, and diagnosis,” likewise omits reference to either test (9).

There remain no verified guidelines for normal vs abnormal that would be easily applicable to an individual patient. NGS, therefore, considers the use of VEP or ERG for either glaucoma diagnosis or management investigational.

Limitations

Testing shall be performed by physicians who have evidence of knowledge, training, and expertise to perform and interpret these tests. This training and expertise must have been acquired within the framework of an accredited school, residency or fellowship program.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information
  1. Jampel HD, Singh K, Lin SC, et al. Assessment of visual function in glaucoma: A report by the American Academy of Ophthalmology. Ophthalmology. 2011;118(5):986-1002.
  2. Horn FK, Kaltwasser C, Jünemann AG, et al. Objective perimetry using a four-channel multifocal VEP system: correlation with conventional perimetry and thickness of the retinal nerve fibre layer. Br J Ophthalmol. 2012;96(4):554-559.
  3. Pillai C, Ritch R, Derr P, Gonzalez A, Kopko Cox L, Siegfried J, Liebmann JM, Tello C. Sensitivity and specificity of short-duration transient visual evoked potentials (SD-tVEP) in discriminating normal from glaucomatous eyes. Invest Ophthalmol Vis Sci. 2013;54(4):2847-2852.
  4. Banitt MR, Ventura LM, Feuer WJ, et al. Progressive loss of retinal ganglion cell function precedes structural loss by several years in glaucoma suspects. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):2346-52.
  5. Jafarzadehpour E, Radinmehr F, Pakravan M, Mirzajani A, Yazdani S. Pattern Electroretinography in Glaucoma Suspects and Early Primary Open Angle Glaucoma. J Ophthalmic Vis Res. 2013;8(3):199-206.
  6. Ventura LM, Golubev I, Feuer WJ, Porciatti V. Pattern electroretinogram progression in glaucoma suspects. J Glaucoma. 2013;22:219–225.
  7. American Academy of Ophthalmology (AAO), Glaucoma Panel. Primary Open-Angle Glaucoma Suspect. Preferred Practice Pattern. San Francisco, CA: AAO; 2015. Accessed 8/24/16 http://www.aaojournal.org/article/S0161-6420(15)01278-6/pdf.
  8. American Academy of Ophthalmology (AAO), Glaucoma Panel. Primary Open-Angle Glaucoma. Preferred Practice Pattern. San Francisco, CA: AAO; 2015. Accessed 8/24/16 http://www.aaojournal.org/article/S0161-6420(15)01276-2/pdf.
  9. Jacobs DS. Open-angle glaucoma: Epidemiology, clinical presentation, and diagnosis. UpToDate Inc., Waltham, MA. Last accessed 8/24/16.
  10. Marmor MF, Kellner U, Lai TY, Melles RB, Mieler WF, American Academy of Ophthalmology. Recommendations on screening for Chloroquine and Hydroxychloroquine retinopathy (2016 Revision). Ophthalmology. 2016 Jun;123(6):1386-1394.
  11. Aetna policy #0854 Electroretinography. Last accessed 8/30/16. http://www.aetna.com/cpb/medical/data/800_899/0854.html
  12. BCBS FL policy #01-92000-28 Electroretinography. Last accessed 12/12/16. http://mcgs.bcbsfl.com/?doc=Electroretinography
  13. Anthem policy CG-MED-50. Visual, Somatosensory and Motor Evoked Potentials. Last accessed 8/30/16. https://www.anthem.com/medicalpolicies/guidelines/gl_pw_c160720.htm
  14. Noridian LCD Sensory Evoked Potentials & Intraoperative Neurophysiology Monitoring (L34072).
  15. Novitas LCD Neurohysiology Evoked Potentials (NEPs) (L34975).
  16. Cahaba LCD Medicine: Neurohysiology Evoked Potentials (NEPs) (L34266).
  17. American Optometric Association (AOA), Optometric Clinical Practice Guideline. Care of the Patient with Primary Angle Closure Glaucoma. St. Louis, MO:1994.
  18. American Optometric Association (AOA), Optometric Clinical Practice Guideline. Care of the Patient with Open Angle Glaucoma. St. Louis, MO:2011.
  19. Aetna policy #0181 Evoked Potential Studies. Last accessed 12/12/2016. http://www.aetna.com/cpb/medical/data/100_199/0181.html
  20. International Society for Clinical Electrophysiology of Vision (VISCEV): A Guide To Procedures. Visual Eelectrodiagnostics A Guide To Procedures. Accessed 12/12/2016.
    http://www.iscev.org/standards/proceduresguide.html.
  21. Bach M, Unsoeld AS, Philippin H. Pattern ERG as an early glaucoma indicator in ocular hypertension: a long-term, prospective study. Invest Ophthalmol Vis Sci. 2006;47:4881–4887.
  22. Bode SF, Jehle T, Bach M. Pattern electroretinogram in glaucoma suspects: new findings from a longitudinal study. Invest Ophthalmol Vis Sci. 2011;52:4300–4306.
  23. Ventura LM, Feuer WJ, Porciatti V. Progressive loss of retinal ganglion cell function is hindered with IOP-lowering treatment in early glaucoma. Invest Ophthalmol Vis Sci. 2012:53(2):659–663.
  24. Karaskiewicz J, Penkala K, Mularczyk M, Lubinski W. Evaluation of retinal ganglion cell function after intraocular pressure reduction measured by pattern electroretinogram in patients with primary open-angle glaucoma. Doc Ophthalmol. 2017:134:89–97.
  25. Ventura LM, Porciatti V. Restoration of retinal ganglion cell function in early glaucoma after intraocular pressure reduction: a pilot study. Ophthalmology. 2005;112:20–27.
  26. Ventura LM, Sorokac N, De Los Santos R, Feuer WJ, Porciatti V. The relationship between retinal ganglion cell function and retinal nerve fiber thickness in early glaucoma. Invest Ophthalmol Vis Sci. 2006; 47:3904–3911.
  27. Nebbioso M, Gregorio FD, Prencipe L, Pecorella I. Psychophysical and electrophysiological testing in ocular hypertension. Optom Vis Sci. 2011;88:E928–E939.
  28. Uva MG, DiPietro M, Longo A, Lauretta K, Reibaldi M, Reibaldi A. Pattern ERG and RNFL thickness in hypertensive eyes with normal blue-yellow visual field. Graefes Arch Clin Exp Ophthalmol. 2013;251:839–845.
  29. Parisi V, Centofanti, M, Ziccardi L, et al. Treatment with citicoline eye drops enhances retinal function and neural conduction along the visual pathways in open angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2015;253:1327–1340.
  30. Amarasekera DC, Resende AF, Waisbourd M, et al. Steady-state pattern electroretinogram and short-duration transient visual evoked potentials in glaucomatous and healthy eyes. Clin Exp Ophthalmol. 2017.
  31. A Prospective, Longitudinal Study to Evaluate the Function of the Retina and Visual Pathways in Glaucoma Patients Using PERG. NCT03330574. https://clinicaltrials.gov/show/NCT03330574.
  32. Observational/Prospective Study for Benchmarking the Management of Glaucoma With Selective Laser Trabeculoplasty (SLT) or Trabecular Stent Bypass Microsurgery, Using the Diopsys Visual Evoked Potential/Pattern ERG Protocols. NCT02594280. https://clinicaltrials.gov/show/NCT02594280.
Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/17/2019 R7

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A57060. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
01/01/2019 R6

Based on the 2019 annual CPT/HCPCS update, CPT code 92275 has been deleted and replaced with CPT codes 92273 and 92274 and they have been added to the "CPT/HCPCS Codes" section Group 1. CPT code 0509T has also been added to the "CPT/HCPCS Codes" section Group 1. CPT codes 92273, 92274 and 0509T have been added to the Group 2 code list in the “ICD-10 Codes that Support Medical Necessity” section of the LCD.

  • Revisions Due To CPT/HCPCS Code Changes
02/01/2018 R5

Based on a reconsideration request to provide coverage of pattern electroretinogram (PERG) testing for glaucoma, references have been added to the LCD. No changes were made in coverage. 

DATE (02/01/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Reconsideration Request
01/01/2018 R4

Based on the 2018 annual CPT/HCPC update, the description for CPT code 95930 has been revised.

DATE (01/01/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2017 R3

Based on the annual ICD-10-CM update, the following ICD-10-CM codes have been deleted from Group 1: H54.0, H54.11, H54.12, H54.2, H54.41, H54.42, H54.51 and H54.52 and replaced with: H54.0X33, H54.0X34, H54.0X35, H54.0X43, H54.0X44, H54.0X45, H54.0X53, H54.0X54, H54.0X55, H54.1131, H54.1132, H54.1141, H54.1142, H54.1151, H54.1152, H54.1213, H54.1214, H54.1215, H54.1223, H54.1224, H54.1225, H54.2X11, H54.2X12, H54.2X21, H54.2X22, H54.413A, H54.414A, H54.415A, H54.42A3, H54.42A4, H54.42A5, H54.511A, H54.512A, H54.52A1 and H54.52A2. The descriptors for ICD-10-CM codes S04.31A-S04242S have been changed. 

DATE (10/01/2017): At this time, the 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
03/16/2017 R2

Based on two reconsideration requests to provide coverage of electroretinogram (ERG) and pattern electroretinogram (PERG) testing for glaucoma – March 2017, references have been added to the LCD. No changes were made in coverage.  

DATE (08/01/2017): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Reconsideration Request
03/16/2017 R1 ICD-10-CM codes H47.521, H47.522, H53.011-H53.013, H53.021 – H53.023 and H53.031 – H53.033 have been added to the Group 1 code list for CPT code 95930.
  • Provider Education/Guidance
N/A

Associated Documents

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Updated On Effective Dates Status
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