Response to Comments: Scanning Computerized Ophthalmic Diagnostic Imaging

Multiple comments were received expressing concerns about limiting the use of SCODI based on the proposed draft criteria and/or definitions of mild, moderate, and advanced/severe glaucoma staging. Commenters stated that many were subjective, vague, or not consistent with the American Academy of Ophthalmology (AAO) current 2015 Primary Open-Angle Glaucoma (POAG) Preferred Practice Pattern (PPP) guidelines. 

The contractor is appreciative of the comments received. After review, the LCD will be revised to remove the criteria and/or definitions of mild, moderate, and advanced/severe glaucoma stages. It is expected that current AAO POAG PPP guidelines for glaucoma staging will be utilized by the provider.  These guidelines state that the severity of glaucoma damage can be estimated as mild, moderate, severe, or indeterminate and include definitions of each.

Multiple comments were submitted in support of coverage of SCODI for severe/advanced stage glaucoma. Literature was submitted for review and consideration.

The contractor is appreciative of the comments and literature received. After review, the LCD will be revised to allow coverage for severe/advanced stage glaucoma.

A couple of comments were received requesting coverage for “unspecified” and “indeterminate” stage glaucoma. Commenters requested that the classification be retained for “indeterminate” stage glaucoma as adopted by the AAO and American Glaucoma Society (AGS).

Thank you for your comments. There is coverage for indeterminate stage glaucoma diagnoses in the section of the policy titled “ICD-10 Codes that Support Medical Necessity”. Coverage in the final policy will include the glaucoma stages that are recognized by the AAO and AGS as follows: mild stage, moderate stage, indeterminate stage, and severe stage. The final policy will not include coverage for unspecified stage glaucoma. With the implementation of ICD-10 coding, it is expected that providers code the diagnosis to the highest level of specificity. The medical record must support the use of the selected ICD-10-CM code(s).

A couple of comments were received pertaining to limitation #2: “SCODI is considered not medically reasonable and necessary when performed to provide additional confirmatory information regarding a diagnosis which has already been determined. Documentation should support that the SCODI test result was used for establishing a diagnosis or for therapeutic purposes.” A commenter provided an example of when SCODI would be used to provide confirmatory information in a newly diagnosed glaucoma patient confirmed by visual field and optic nerve examination. The commenter went on to state that a baseline examination must be performed and established. This may well confirm the diagnosis and though it may not guide initial therapy, it is necessary to guide future therapy. The commenter stated that this should be allowed and reimbursed.

Thank you for your comments. The LCD will be revised such that SCODI will be considered medically reasonable and necessary to establish a diagnosis, to establish a baseline prior to treatment, or for monitoring purposes.

Numerous comments were received regarding non-coverage of CPT code 92132 (Scanning computerized ophthalmic diagnostic imaging, anterior segment, with interpretation and report, unilateral or bilateral). Many commenters indicated that the technology is invaluable and provides information that is not available with traditional gonioscopy. Most commenters stated that gonioscopy is considered the gold standard for anterior segment angle and that this is not a substitution, but noted that there are limitations to that procedure.  One commenter stated that anterior segment OCT generally serves no useful purpose over slit lamp and gonioscopy and should be non-covered with exceptions. Literature was submitted for review. Specific ICD-10 codes were requested as well as examples of uses were also submitted.

The contractor is appreciative of the comments, literature, and suggestions received.  The overwhelming majority of commenters agreed that the use of anterior segment SCODI, although rare, has exceptions that should be covered. After review, the contractor agrees that in some situations, SCODI may be a useful tool to examine the structures in the anterior segment of the eye. The LCD will be revised to add limited coverage for anterior segment SCODI (CPT code 92132). There will also be frequency parameters outlined in the “Utilization Guidelines” section for CPT code 92132. After finalization, the LCD reconsideration process may be utilized for consideration of additional requests with submission of supporting literature.

Multiple comments were received concerned with the following statement: “Fundus photography (CPT code 92250) and SCODI (CPT code 92133 or 92134-optical coherence tomography or OCT) are generally mutually exclusive of one another in that a provider would use one technique or the other to evaluate fundal disease.” Several commenters stated that SCODI and fundus photography provide very different information and that the techniques are complimentary. Examples were provided of when both technologies are appropriate.  One commenter indicated that fundus photography and SCODI is bundled on same day by CCI, therefore the paragraph is not necessary.

This statement was taken in part from the National Correct Coding Initiative (NCCI) Coding Policy Manual for Medicare Services, Chapter XI Medicine Evaluation and Management Services CPT Codes 90000 – 99999, Section G, Ophthalmology, Effective January 1, 2017. The contractor agrees that there are clinical scenarios where both techniques may be medically reasonable and necessary on the ipsilateral eye. The provider is not precluded from performing both on the same eye on the same day. However, frequent reporting of these services together may trigger focused medical review. Should both services be performed, as stated in the “Documentation Requirements” section of the LCD, the medical record documentation must clearly indicate the rationale which supports the medical necessity for performing the fundus photography and posterior segment SCODI on the same day on the same eye. Documentation should also reflect how the test results were used in the patient’s plan of care.

Multiple comments were received regarding a limitation on the use of SCODI and visual field (VF) tests on the same day for patients with moderate glaucomatous damage. Commenters indicate that VF should be allowed on the same day as OCT. There should not be any requirement to wait 3 months between the tests or limit the VF to 2 per year. Several commenters stated that each test provides different information that is complementary in determining progression of glaucoma. Performance of one of these tests should not preclude performing the other for a given period of time.

Thank you for your comments. The contractor agrees and will remove this limitation from the final policy.

A comment was received stating that the covered indications should include the following diagnoses: all glaucoma diagnoses with severe stage, optic neuritis due to demyelinating diseases, Anterior Ischemic Optic Neuropathy (AION), various other optic neuropathies such as ethambutol toxicity and optic disc drusen. No specific ICD-10 diagnoses codes were submitted.

Thank you for your comment. The contractor agrees to provide coverage for severe stage glaucoma in the final policy. Covered indications include conditions affecting the optic nerve. After finalization, the LCD reconsideration process may be utilized for consideration of additional requests for specific diagnoses codes with submission of supporting literature.

A comment was received stating that there are infrequent retinal diseases and conditions that should be included for coverage of CPT code 92134 such as cystoid macular edema and epiretinal membrane formation. There were no specific ICD-10 diagnoses codes requested.

Thank you for your comment. The requested conditions, while not specifically stated in the “Covered Indications” section of the policy, are included in the “ICD-10 Codes that Support Medical Necessity” section of the policy. There is coverage for Cystoid macular edema following cataract surgery (ICD-10 codes H59.031-H59.033) and Puckering of macula (ICD-10 codes H35.371-H35.373) for CPT code 92134 in the Group 3 codes of “ICD-10 Codes that Support Medical Necessity” section of the policy. After finalization, the LCD reconsideration process may be utilized for consideration of additional requests for specific diagnoses with submission of supporting literature.

A comment was received that there is no mention of the use of retinal OCT for several important surgical treatments and that OCT is required either to diagnose prior to surgery or to monitor following surgery.

Thank you for your comment. Surgical treatment for retinal conditions is not excluded from retinal OCT coverage. It would fall under the “Covered Indications” section of the policy for the “evaluation and treatment” of patients with conditions affecting the optic nerve or retinal disease and macular abnormalities.

A comment was received regarding incomplete information in the “General Information” section of the draft. 

Thank you for your comment.  After consideration, the “General Information” section will be revised appropriately. This revision does not change coverage. 

Multiple comments were received pertaining to the proposed utilization guideline limit for CPT code 92134 of no more than one (1) exam per month to manage the patient with retinal conditions undergoing active intravitreal drug treatment. Commenters stated that a more frequent use of retinal OCT should be allowed if there has been a significant change in vision for any patient, to allow each eye to be tested at separate intervals within the month, or to evaluate response to anti-VEGF treatment.  

Thank you for your comments. There was no literature submitted showing that testing each eye separately within the month improves long-term health outcomes over once a month bilateral eye testing for those receiving intravitreal drug treatment. The SCODI CPT codes describe a unilateral or bilateral study. Although there are exceptions that may require more frequent testing, these should be rare. The rationale for exceeding the frequency parameters as defined in the LCD must be documented in the medical record. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

A few comments were received pertaining to the proposed utilization guideline limit for CPT code 92134 of no more than one (1) exam every 2 months to manage the patient with retinal disease (that is not undergoing active treatment). Commenters stated that this limit is reasonable in most cases. However, certain conditions may require it more often. A commenter provided examples of the advantages of noninvasive OCT scanning over fluorescein angiography and requested that providers not be limited from using OCT when medically necessary. A commenter also recommended adding clarification that the first bullet is for those not undergoing active treatment (for a retinal condition) to distinguish it from the second bullet which is for those undergoing active treatment.

Thank you for your comments and recommendations. Although there are exceptions that may require more frequent testing for retinal conditions, these should be rare. The rationale for exceeding the frequency parameters as defined in the LCD must be documented in the medical record. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD. The contractor agrees to add clarification to the first bullet in the utilization guidelines for retinal conditions not undergoing active treatment. 

A couple of comments were received opposed to the proposed draft utilization guideline limit of four scans per year for the scope of retinal problems.

Thank you for your comments. The LCD does not limit four scans per year for management of retinal conditions. The request for additional testing (greater than four per year) for retinal conditions does not apply to the proposed utilization guideline limits as stated in the draft policy which are already greater than four per year except for CQ and/or HCQ annual monitoring. Please refer to the “Utilization Guidelines” section of the LCD, CPT code 92134, for retinal related frequency parameters.

A few comments were received pertaining to the proposed utilization guideline limit for CPT code 92133 stating that the frequency limitations in the draft for CPT code 92133 are not consistent with efficacious glaucoma management nor are they consistent with the limitations established for CPT code 92134. Commenters stated that the guidelines for retinal conditions (CPT code 92134) indicate the frequency limitation is based on the nature of the disease, treatment plan, and outcome. The same principles should be applied to CPT code 92133 in glaucoma management. More frequent than 2 tests per year may be needed for the case of rapidly progressing glaucoma, escalating ocular hypertension – especially from secondary causes, or in cases where progression is detected by another modality and a new baseline must be established.

Thank you for your comments. Although there are exceptions that may require more frequent testing for glaucoma, these should be rare. The rationale for exceeding the frequency parameters as defined in the LCD must be documented in the medical record. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

A comment was received pertaining to the current reimbursement restrictions when billing for both optic nerve (CPT code 92133) and retina (CPT code 92134) on the same visit. Many patients have both a macular indication for the scan (requiring the retina scan) and also require an optic nerve scan at the same visit to follow their glaucoma.

These restrictions are not implemented at a Local Medicare Administrative Contractor (MAC) level. Local coverage determinations (LCDs) do not determine CPT codes that may be reported in conjunction with another CPT code. That information would be located in the CMS National Correct Coding Initiative (NCCI) manual. LCDs do not replace payment policy rules, regulations, or coding manuals. The content of the CMS National Correct Coding Initiative (NCCI) manual is not developed or modified by Medicare Administrative Contractors (MACs). This comment does not pertain to the content of the draft LCD. Thank you for your comment.