INTERVENTIONAL GLAUCOMAREIMBURSEMENT GUIDE1INTERVENTIONAL GLAUCOMAREIMBURSEMENT GUIDE
INDEX
Reimbursement Disclaimer

2

Indication Statements

3

iDose® TR Billing & Coding

4

iStent infinite® Billing & Coding

7

iStent inject® W Billing & Coding

10

iAccess® Precision Blade Billing & Coding

13

Sample Claim Forms

14

iStent infinite® Operative Note

17

Glaucoma FAQs

20

Glaukos Patient Services

23

REIMBURSEMENT DISCLAIMER
Glaukos provides this coding guide for informational purposes only and it is subject to change without notice. This guide is
not an affirmative instruction as to which codes and modifiers to use for a particular service, supply, procedure, or treatment
and does not constitute advice regarding coding, coverage, or payment for Glaukos products. It is the responsibility ofproviders, physicians, and suppliers to determine and submit appropriate codes, charges, and modifiers for products,
services, supplies, procedures, or treatment furnished or rendered. Providers, physicians, and suppliers should contact
their third-party payers for specific and current information on their coding, coverage, and payment policies. For further
detailed product information, including indications for use, contraindications, effects, precautions, and warnings, please
consult the product’s Instructions/Directions for Use (IFU/DFU) or Prescribing Information (PI) prior to use. The information
provided herein is without any other warranty or guarantee of any kind, expressed or implied, as to completeness, accuracy,
or otherwise. This information is intended only to help estimate Medicare payment rates and product costs. All rates shown
are national average Medicare rates and have not been adjusted for geographic variations in payment or other factors, suchas sequestration. Glaukos makes no guarantee of coverage or reimbursement.

Reimbursement
DisPM-US-1829 ©2024

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INDICATION STATEMENTS

iDose® TR (travoprost intracameral implant) 75 mcg is indicatedfor the reduction of intraocular pressure (IOP) in patients with
open angle glaucoma (OAG) or ocular hypertension (OHT).

The iStent infinite® Trabecular Micro-Bypass System Model iS3
is an implantable device intended to reduce the intraocularpressure (IOP) of the eye. It is indicated for use in adult patientswith primary open-angle glaucoma in whom previous medical
and surgical treatment has failed.

The iStent inject® W Trabecular Micro-Bypass System Model
G2-W is indicated for use in conjunction with cataract surgery
for the reduction of intraocular pressure (IOP) in adult patientswith mild to moderate primary open-angle glaucoma.

The Glaukos iAccess® Precision Blade is intended for use inophthalmic surgical procedures to manually cut trabecularmeshwork (TM) in pediatric and adult patients.

Indication
PM-US-1829 Statements
©2024

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BILLING AND CODING
iDose® TR
For an iDose® TR-specific reimbursement guide, please contact your Reimbursement
Liaison at gps@glaukos.com

iDose® TR is a procedure-based treatment that is administered by a healthcare provider in an outpatient setting.
OUTPATIENT SETTINGS MAY INCLUDE:•

Ambulatory Surgical Centers (ASCs)•

Hospital Outpatient Departments (HOPDs)•

Office-Based Settings

Some Medicare Advantage plans and commercial payers may require a prior authorization (PA) before covering iDose TR. If
appropriate, conducting a benefits verification can determine if individual plans require a PA or step therapy.
Medicare Fee-for-service (FFS) Part B covers 80% of iDose® TR cost
The majority of FFS beneficiaries have some type of supplemental coverage:
Approximately 89% of Medicare (FFS) beneficiaries have some formof supplemental insurance, which can help cover copays

41% of Medicare FFS beneficiaries have a Medigap planthat may help cover Part B coinsurance costs (20%)

Development of medical policies for treatments that are newly U.S. Food and Drug Administration (FDA) approved, such as
iDose® TR, typically occur in the months following approval. Always check with the patient’s payer to determine coveragerules.
CURRENT PROCEDURAL TERMINOLOGY (CPT)® * CODES FOR DRUG ADMINISTRATION SERVICES: CPT® is thecode set used to describe procedures and services performed by healthcare providers.
CPT® Category III CodeDescriptor

0660T

Implantation of anterior segment intraocular nonbiodegradable drug-eluting system,
internal approach

iDose TR Billing & Cod®
PM-US-1829 ©2024*CPT copyright 2023 American Medical Association. All rights reserved. CPT is a registered trademarkof the American Medical Association.

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BILLING AND CODING
iDose® TR Continued
DIAGNOSIS CODES: ICD-10-CM is the diagnosis code set used for all healthcare settings
for medical claims reporting.

ICD-10-CM

Descriptor

OPEN-ANGLE GLAUCOMA

ICD-10-CM

Descriptor

OCULAR HYPERTENSION

H40.10X

Unspecified open-angle glaucoma

H40.111

Primary open-angle glaucoma, right eye

H40.113

Primary open-angle glaucoma, bilateral

H40.119

Primary open-angle glaucoma, unspecified eye

H40.131

Pigmentary glaucoma, right eye

H40.132

Pigmentary glaucoma, left eye

H40.133

Pigmentary glaucoma, bilateral

H40.139

Pigmentary glaucoma, unspecified eye

H40.141

Capsular glaucoma with pseudoexfoliation oflens, right eye

For open-angle glaucoma codes, please add theappropriate seventh character to reflect the stage ofthe patient’s condition:

H40.142

Capsular glaucoma with pseudoexfoliation oflens, left eye
Capsular glaucoma with pseudoexfoliation oflens, bilateral
Capsular glaucoma with pseudoexfoliation oflens, unspecified eye

0 = stage unspecified,
1 = mild stage,
2 = moderate stage,
3 = severe stage,
4 = indeterminate stage.

H40.143
H40.149

ICD-10-CM=International Classification of Diseases, Tenth Revision,
Clinical Modification.

H40.051

Ocular hypertension, righteye

H40.052

Ocular hypertension, lefteye

H40.053

Ocular hypertension,bilateral

H40.059

Ocular hypertension,
unspecified eye

Please consult the ICD-10 codebook for more information.

HCPCS Codes: Claims for drugs that are physician-administered must be submitted with a HCPCS code when billed to a payer.

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BILLING AND CODING
iDose® TR Continued
The following code may be appropriate:
HCPCS CodeDescription

Place of Service

J7355

Injection, travoprost intracameral
ASC, HOPD, or Physician office
implant, 1 mcg

ASC = ambulatory surgical center; HCPCS=Healthcare Common Procedure Coding System;
HOPD = hospital outpatient department.

NATIONAL DRUG CODE:•

FDA-specified 10-Digit NDC (5-3-2 format) 25357-100-01•

11-Digit NDC (5-4-2 format) 25357-0100-01•

While the FDA provides NDCs as 10-digit codes, some payers may require an 11-digit format•

Converting the 10-digit NDC to an 11-digit NDC may be as simple as the payer requiring you to add a leading zero•Contact each payer for specific requirements, as they vary by payer

MEDICARE: Once a physician-administered drug, such as iDose TR, is established in the marketplace,reimbursement for ASCs, HOPDs, and physician offices will be based on ASP + 6%.*
COMMERCIAL PAYERS: Commercial payer reimbursement varies and is based on the contracted rate with the provider.
Review your contracts to understand your speci ic reimbursement rates.
MEDICAID: Medicaid reimbursement varies by state. Often, payment methodologies follow Medicare and are based on apercentage of ASP, wholesale acquisition cost (WAC), and AWP.

IMPORTANT SAFETY INFORMATIONCONTRADICATIONS: iDose TR is contraindicated in patients with active or suspected ocular or periocular infections,patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal
transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]),
patients with hypersensitivity to travoprost or to any other components of the product. WARNINGS AND PRECAUTIONS:
iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely
to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris
pigmentation is likely to be permanent. ADVERSE REACTIONS: In controlled studies, the most common ocular adverse
reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain,
ocular hyperaemia, and reduced visual acuity. Please see full Prescribing Information at https:// www.idosetrhcp.com/. You
are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also callGlaukos at 1-888-404-1644.

PM-US-1829 ©2024*Department of Health and Human Services. Office of Inspector General. Average sales prices: manufacturer reporting and CMS oversight. Accessed May 11, 2024.
www.oig.hhs.gov/oei/
reports/oei-03-08-00480.pdf. 30. Prescription Analytics. Key government pricing terms. August 2022. Accessed May 11, 2024. https://prescriptionanalytics.com/wpcontent/uploads/2022/11/Key-GP-Terms.pdf. Congressional Research Service. Medicare and budget sequestration. Accessed May
11, 2024. https://crsreports.congress.gov/product/pdf/R/R45106.
**2% sequestration (Medicare payment adjustment) continues until further notice.

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BILLING AND CODING
iStent infinite®
MEDICARE COVERAGE TIP: for procedures subject to claim-by-claim consideration,
the Medicare Administrative Contractor (MAC) may request medical records to assist
in the evaluation and pricing. This occurs only after receipt of the claim. Therefore,
providers who submit claims electronically should indicate that documentation isavailable upon request. For those providers that do not submit claims electronically,
documentation must accompany the claim.

DIAGNOSIS: The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is the coding
system used to report patient diagnoses. Diagnosis codes are used to document the indication for the procedure and may
include additional diagnoses of other clinical conditions applicable to a healthcare visit. It is up to the provider to determine
the appropriate diagnosis code(s) on the claim.
ICD-10-CM CodeDescriptor

H40.XXXX

Glaucoma

PROCEDURE: The following Current Procedural Terminology (CPT®) codes may be appropriate to describe the iStent
infinite® insertion procedure.
CPT Code

Descriptor

0671T

Insertion of anterior segment aqueous drainage device into the trabecular meshwork,without external reservoir, and without concomitant cataract removal, one or more

669891

Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage
procedure), manual or mechanical technique (eg, irrigation and aspiration or
phacoemulsification), complex, requiring devices or techniques not generally used inroutine cataract surgery (eg, iris expansion device, suture support for intraocular lens,or primary posterior capsulorrhexis) or performed on patients in the amblyogenic
development stage; with insertion of intraocular (eg, trabecular meshwork,supraciliary, suprachoroidal) anterior segment aqueous drainage device, without
extraocular reservoir, internal approach, one or more.

66991

Extracapsular cataract removal with insertion of intraocular lens prosthesis(1-stage procedure), manual or mechanical technique (eg, irrigation and aspirationor phacoemulsification); with insertion of intraocular (eg, trabecular meshwork,supraciliary, suprachoroidal) anterior segment aqueous drainage device, without
extraocular reservoir, internal approach, one or more.

Modifiers-LT (left side)-RT (right side)

if iStent infinite is completed with a cataract combination procedure 66989/66991, should be used in accordance with
documentation in the procedure operative note and corresponding medical documentation.

1®
iStentinfinite
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BILLING AND CODING
iStent infinite® Continued

NATIONAL UNADJUSTED MEDICARE PAYMENT RATES FOR 2024*
CPT Code

0671T

66989

66991

Descriptor

PhysicianPayment*

Ambulatory SurgicalCenter (ASC) Payment†

Hospital Outpatient
Department (HOPD)
Payment ‡Insertion of anterior segment aqueous drainage device
into the trabecular meshwork, without external reservoir,
and without concomitant cataract removal, one or more

Contractor
Priced$3,816$4,980APC 5493

Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure), manualor mechanical technique (eg, irrigation and aspirationor phacoemulsification), complex, requiring devices
or techniques not generally used in routine cataract
surgery (eg, iris expansion device, suture support for
intraocular lens, or primary posterior capsulorrhexis) or
performed on patients in the amblyogenic development
stage; with insertion of intraocular (eg, trabecularmeshwork, supraciliary, suprachoroidal) anterior
segment aqueous drainage device, without extraocularreservoir, internal approach, one or more

$831

$3,665$4,980APC 5493

Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure),
manual or mechanical technique (eg, irrigation andaspiration or phacoemulsification); without endoscopic
cyclophotocoagulation with insertion of intraocular(eg, trabecular meshwork, supraciliary, suprachoroidal)
anterior segment aqueous drainage device, without
extraocular reservoir, internal approach, one or more

$664

$3,733$4,980APC 5493*https://www.cms.gov/medicare/payment/fee-schedules/physician†
https://www.cms.gov/license/ama?file=/files/zip/2024-cn-addendum-aa-bb-dd1-dd2-ee-and-ff.zip‡
https://www.cms.gov/license/ama?file=/files/zip/2024-cn-opps-addendum-b-and-c.zip

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BILLING AND CODING
iStent infinite® Continued
DEVICE: Healthcare Common Procedure Coding System (HCPCS) codes are used, among
other things, to describe medical devices provided to patients. C-codes are HCPCS codes
established by the Centers for Medicare & Medicaid Services (CMS) for the Hospital
Outpatient Prospective Payment System (HOPPS) for use on Medicare claims for hospital
outpatient and ambulatory surgical center items and services. The following HCPCS codes
may be appropriate for reporting when iStent infinite® is used, and the number of service
units for the code reported may correspond to the number of stents deployed.

HCPCS CodeDescriptor

Revenue Codes

C1783

Ocular implant; aqueous drainage assist device

278

L8612

Aqueous shunt

278

IMPORTANT SAFETY INFORMATIONCONTRADICATIONS: The iStent infinite® is contraindicated in eyes with angle-closure glaucoma where the angle has notbeen surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital
anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge Weber Syndrome or any
other type of condition that may cause elevated episcleral venous pressure.
Please see additional Important Safety Information on last page and Instructions for Use (IFU) for a complete list ofcontraindications, warnings, precautions, and adverse events (AEs).

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BILLING AND CODING
iStent inject® W
COVERAGE: Prior authorization or Pre-certifications are highly recommended forcommercial payers. Medical policies are a component of coverage. A published feeschedule and/or presence of codes does not guarantee coverage. For questions regarding
coverage, please check with your Glaukos Reimbursement Liasion at gps@glaukos.com.

DIAGNOSIS: The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is the coding
system used to report patient diagnoses. In addition to the appropriate cataract diagnosis, the following possible ICD-10-CM
diagnosis codes may describe conditions that are consistent with the FDA-labeled indication for iStent inject® W:

ICD-10-CM CodeDescriptor

H40.1111

Primary Open-Angle Glaucoma, Right Eye, Mild Stage

H40.1112

Primary Open-Angle Glaucoma, Right Eye, Moderate Stage

H40.1121

Primary Open-Angle Glaucoma, Left Eye, Mild Stage

H40.1122

Primary Open-Angle Glaucoma, Left Eye, Moderate Stage

H40.1131

Primary Open-Angle Glaucoma, Bilateral, Mild Stage

H40.1132

Primary Open-Angle Glaucoma, Bilateral, Moderate StagePROCEDURE: The following possible CPT1 codes may be reported when insertion of an anterior segment aqueous drainage
device is performed in combination with cataract or complex cataract surgery.

CPT Code

Descriptor

Modifiers

66989

Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage
procedure), manual or mechanical technique (eg, irrigation and aspiration or
phacoemulsification), complex, requiring devices or techniques not generally used inroutine cataract surgery (eg, iris expansion device, suture support for intraocular lens,or primary posterior capsulorrhexis) or performed on patients in the amblyogenic
development stage; with insertion of intraocular (eg, trabecular meshwork,supraciliary, suprachoroidal) anterior segment aqueous drainage device, without
extraocular reservoir, internal approach, one or more.

-LT (left side) or -RT (right side)

66991

Extracapsular cataract removal with insertion of intraocular lens prosthesis(1-stage procedure), manual or mechanical technique (eg, irrigation and aspirationor phacoemulsification); with insertion of intraocular (eg, trabecular meshwork,supraciliary, suprachoroidal) anterior segment aqueous drainage device, without
extraocular reservoir, internal approach, one or more.

®
iStentinjectW Billing
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BILLING AND CODING
iStent inject® W Continued

NATIONAL UNADJUSTED MEDICARE CODING AND PAYMENT UPDATES FOR 2024*
PhysicianPayment*

Ambulatory SurgicalCenter (ASC) Payment†

Hospital Outpatient
Department (HOPD)
Payment ‡Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure), manualor mechanical technique (eg, irrigation and aspirationor phacoemulsification), complex, requiring devices ortechniques not generally used in routine cataract surgery(eg, iris expansion device, suture support for intraocularlens, or primary posterior capsulorrhexis) or performedon patients in the amblyogenic development stage;
with insertion of intraocular (eg, trabecular meshwork,supraciliary, suprachoroidal) anterior segment aqueous
drainage device, without extraocular reservoir, internal
approach, one or more

$831

$3,665$4,980APC 5493

Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure),
manual or mechanical technique (eg, irrigation andaspiration or phacoemulsification); without endoscopic
cyclophotocoagulation with insertion of intraocular(eg, trabecular meshwork, supraciliary, suprachoroidal)
anterior segment aqueous drainage device, without
extraocular reservoir, internal approach, one or more

$664

$3,733$4,980APC 5493

CPT Code

Descriptor

66989

66991

DEVICE: Healthcare Common Procedure Coding System (HCPCS) codes are used, among other things, to describe medical
devices provided to patients. C-codes are unique temporary HCPCS codes established by the Centers for Medicare &Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (HOPPS) for use on claims for hospital
outpatient and ambulatory surgical center items and services. Although other payers may also accept C-codes, they are notrequired to do so. The following HCPCS codes may be reported to describe iStent inject® W:

HCPCS CodeDescriptor

Revenue Code

C1783

Ocular implant; aqueous drainage assist
device0278, other implants

L8612

Aqueous shunt*https://www.cms.gov/medicare/payment/fee-schedules/physician†
https://www.cms.gov/license/ama?file=/files/zip/2024-cn-addendum-aa-bb-dd1-dd2-ee-and-ff.zip‡
https://www.cms.gov/license/ama?file=/files/zip/2024-cn-opps-addendum-b-and-c.zip
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BILLING AND CODING
iStent inject® W Continued

IMPORTANT SAFETY INFORMATIONCONTRADICATIONS: The iStent inject® W is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant,uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar
tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleralvenous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of theangle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper
placement of the stent and pose a hazard. MRI INFORMATION. The iStent inject W is MR-Conditional, i.e., the device
is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for
details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The
safety and effectiveness of the iStent inject W have not been established as an alternative to the primary treatmentof glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic
inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vasculardisorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes
without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or
unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents. ADVERSE EVENTS.
Common postoperative adverse events reported in the iStent inject® randomized pivotal trial included stent obstruction(6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention(5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%). CAUTION: Federal law restricts this device to saleby, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, andadverse events.

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BILLING AND CODING
iAccess® Precision Blade
INDICATION: The Glaukos iAccess® Precision Blade is intended for use inophthalmic surgical procedures to manually cut trabecular meshwork (TM) in
pediatric and adult patients.1

NATIONAL UNADJUSTED MEDICARE CODING AND PAYMENT UPDATES FOR 2024*
CPT® CodeDescriptor

Physician1Ambulatory Surgical Center (ASC)

Hospital Outpatient Department (HOPD)

65820

Goniotomy$803$2,045$3,874
APC 5492

IMPORTANT SAFETY INFORMATIONCONTRADICATIONS: The Glaukos iAccess Trabecular Trephine is contraindicated in eyes where there is poor visualization ofangle structures. WARNINGS/PRECAUTIONS: Physician training is required prior to use of the iAccess Trabecular Trephine,
including intraoperative gonioscopy. Do not use the Glaukos iAccess Trabecular Trephine if there is poor visualizationof angle structures. Improper visualization could result in damage to adjacent eye structures. Do not re-sterilize or reuse
the device as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative
adverse events. CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for acomplete list of instructions, contraindications, warnings, and precautions.

*https://www.cms.gov/medicare/payment/fee-schedules/physician
When performed in a facility (ASC or HOPD).

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iAccess
Precision
Blade

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SAMPLE CLAIM
FORMS
NOTE: These sample claim forms are for iStent infinite®. If support is needed for other form types, please contact theappropriate regional reimbursement liaison.

SAMPLE UB-04 FOR FACILITIESBOX 44
Report 0671T.

BOX 42
Append appropriate
revenue code per internalbilling policies andprocedures.

BOX 46
Append appropriate
number of service units.

BOX 44

BOX 63

For Medicare claims, report
the iStent infinite device
with HCPCS code C1783.
Non-Medicare payers may
require the use of L8612.

BOX 44
Append the appropriate
modifier (-LT or -RT).

Coverage and coding
requirements vary by payer.
A benefit verification andreview of the payer’s medical
policy prior to treatment isrecommended.

BOX 66
Report the appropriate
ICD-10 code for theprocedure.

SampleClaim
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SAMPLE CLAIMFORMS
SAMPLE CMS-1500 FOR FACILITIESBOX 21B
Report the appropriate
ICD-10 code specific to thepatient’s condition. See (A).

BOX 24D
Report 0671T.

BOX 24DFor commercial payers,
include HCPCS code L8612,
ocular implant, aqueous
drainage assist device. For
Medicare claims, do notreport a HCPCS code.

BOX 24D
Append the appropriate
modifier (-LT or -RT).

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SAMPLE CLAIMFORMS
SAMPLE CMS-1500 FOR PHYSICIANS

BOX 21B
Report the appropriate
ICD-10 code specific to
the patient’s condition. A
list of potential codes islocated on page 2.

BOX 24D
BOX 24D
Report 0671T.

PM-US-1829 ©2024

Append the appropriate
modifier (-LT or -RT).
Medicare no longer
requires -51 to indicate
multiple procedures.

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ISTENT INFINITE GOOD
DOCUMENTATION PRACTICES &PERI-OPERATIVE DOCUMENTATIONFOR MEDICAL NECESSITY
This resource packet is intended to assist providers in documenting medical necessity for iStent
infinite® Trabecular Micro-Bypass System Model iS3, first standalone trabecular micro-bypass
device to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma
uncontrolled by prior medical and surgical therapy.
DEFINING MEDICAL NECESSITY
Medicare and other third-party insurance payers provide coverage and payment of services and items
used in treatment based on what is considered medically necessary and reasonable. Medicare.gov
defines medical necessity as “services or supplies that are needed to diagnose or treat your medical
condition and that meet accepted standards of medical practice.”1
Upon receipt of a claim for services provided, Medicare and other payers may request additional
documentation to prove the medical necessity of treatment provided. The documentation to support
treatment should include:• a history of the patient’s condition,• testing used to diagnosis the illness or injury,• all current and previous medical and surgical interventions used to treat the condition,• failure of current and previous medical and surgical interventions, and• a treatment plan and expected outcomes.
Failure to comply with a payer’s request for additional medical records, or records that do notdemonstrate medical necessity, will likely result in non-coverage of the claim.
PRACTICE DOCUMENTATION & RESOURCES IMPORTANT TO PAYERS
To aid in supporting medical necessity for iStent infinite® this guide includes a sample operative note
which may be used to support medical necessity for reasonable care. Additional documents may
also support the medical documentation and claim for the beneficiary. These recommendations arefor informational purposes only and must be tailored to your own practice and the patient’s clinicalcondition.
•
•
•

1

Sample Language for Pre-Determination/Authorization, Requests for Medical Necessity, orClaim Additional Documentation Request (ADR), Appeal and/or Denial Template Letter
Chart Documentation Checklist, as provided by the payer correspondence
Medical Records | Rationale to support medical necessityo History & Physical (H&P)
o Pre-operative consultation reporto Operative Reporto Discharge/Expected Outcomes/Follow Up

https://www.medicare.gov/what-medicare-covers/part-b/what-medicare-part-b-covers.html

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iStentinfinite® Operative

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ISTENT INFINITE SAMPLEOPERATIVE NOTE
Operative notes should clearly identify the patient, the date of surgery, the surgeon and assistant,the preoperative and postoperative diagnoses, the procedure(s) performed and on which eye, theimplantable device used, the anesthesia and other pharmacotherapeutics used, and whether there
were any intraoperative complications. In addition, the notes should include a summary of thepatient’s glaucoma staging, including prior medications and failed surgical treatments.
Below is a brief example of operative notes for a standalone procedure using iStent infinite®
Practitioners should use their medical judgment and training to customize this sample to best reflect
the patient treated and procedure(s) performed.

Date of Surgery
Patient Name
SurgeonAssistant
Preoperative Diagnosis
Postoperative Diagnosis
Procedure(s) Performed
Device(s) Implanted
Anesthesia
Intraoperative Complications
Proposed target IOP (e.g., <20mmHg)

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ISTENT INFINITE OPERATIVE
NOTE, CONTINUED
Indications for Surgery: The patient had a history of open angle glaucoma and has failed prior
medical and surgical intervention. Additionally, report Visual Field Abnormality VF mean defect score,
Optic Nerve cup to disc ratio, as well as stage of glaucoma (ICD-10) (mild, moderate, severe).
Include detail regarding current medications, including previous medical and surgical therapy (laser
and incisional) [Include further detail about the medical and surgical treatments that have failed.]
Procedure: The patient was brought to the preoperative area and received topical anesthesia, thenwas brought to the operating room, prepped, and draped in the usual sterile ophthalmic manner. The
operative eye was identified.
A lid speculum was placed. The operating microscope was placed in the proper position for ideal
viewing. A clear corneal incision was made temporally. Miostat was instilled and viscoelastic wasinjected into the anterior chamber of the eye. The eye was examined and using a gonioscopy prism,
the angle was visualized and was open with the trabecular meshwork identified.
The conjunctiva was marked for iStent infinite® placement 2 clock hours apart for a total of 3 marksin the nasal angle. The first and second devices were implanted without complication and there wasimmediate blood reflux from Schlemm’s canal into the anterior chamber through the stents. The
injector handpiece was removed from the eye. The scope was adjusted and surgeons positioning
was adjusted to allow for the proper angle for injector entry into the anterior chamber. The patient’s
head was rotated to allow the best view upon visualizing the nasal angle with the goniolens. The
superonasal angle examined, then additional viscoelastic was instilled and the third stent was thenpositioned with the injector in the trabecular meshwork. There was some blood reflux present. All 3stents were visualized in the proper anatomical position.
Viscoelastic and residual blood were removed from the eye with irrigation. BSS was injected into thecorneal incisions for hydration, and they were confirmed to be sealed with a Weck-cel sponge witha well-formed anterior chamber and a reasonable intraocular pressure determined by palpation.
The patient received [postoperative medication regimen]. The patient left the operating room insatisfactory condition with no complications noted.

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HOW DO YOU CODE FOR THE REMOVAL OF AN ISTENT INJECT® & INFINITE®?
When an iStent is explanted, code 65920, Removal of implanted material, anterior segment of eye,
may be appropriate. Diagnosis code T85.698A, mechanical complication of implanted material, may
be appropriate.

HOW SHOULD PROVIDERS SET CHARGES FOR ISTENT INFINITE®?
Providers should use a charge setting methodology consistent across all payers.
Physicians should set charges taking into consideration the time, intensity, and resources utilized toprovide care.
Hospital outpatient departments should also set charges consistent with their usual and customary
protocol. All device costs should be accounted for when charges are set

ARE THERE ADDITIONAL DOCUMENTATION REQUIREMENTS FOR ISTENT INFINITE®?
Providers must always satisfy the payer’s medical necessity requirements. Accurate and complete
documentation is essential. Our Glaukos Reimbursement Liaison staff can assist you with obtaining
our Documenting to Support Medical Necessity Guide.
When payers begin to see claims for a new procedure, it is common for records to be requested.
First and foremost, there must be proper documentation, medical justification, and submission ofcomplete records to justify the procedure.

Glaucoma
FAQs
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IN THE RARE INSTANCE THAT AN ISTENT INFINITE PROCEDURE IS DISCONTINUED, WHATARE THE BILLING OPTIONS FOR THE PHYSICIAN AND THE ASC?
Medicare and non-Medicare payers may have differing policies for billing discontinued procedures.
Each payer’s guidelines should be reviewed and followed. Typically, Medicare billing would follow the
scenarios outlined in the chart below.
iStent infinite Procedure

Physician Billing Options

Provider decision….
Bill 0671T, modifier -53 (discontinued procedure)
Attempted, no stents
placedOnly one of two stents
placedCarefully document the procedure steps completed and reason for
discontinuing the procedure

ASC Billing Options

Bill 0671T -74 (discontinued
procedure)
Carefully document theprocedure steps completed
and reason for discontinuing
the procedure

Payer may adjust the procedure payment

Payer may adjust theprocedure payment

Bill 0671T as usual, no modifierBill 0671T, no modifier

NOTE: If a procedure is aborted or if a stent is unable to be implanted/surgery unable to becompleted for any reason, you are required to notify Medical Safety of the event—even if the event isunrelated to the device.

WHAT IF ISTENT INFINITE® IS PERFORMED AT THE SAME TIME AS CATARACT SURGERY?
If infinite is used with cataract surgery, CPT code 66989 or 66991 is appropriate with sufficient
documentation and medical necessity. Coding is not product specific; it’s based on anatomical
approach, structure, and the work involved to perform a procedure. Stent coding structure is basedon whether cataract surgery is performed or not. If stenting is performed standalone (i.e.,withoutcataract) the code 0671T is appropriate with sufficient documentation and medical necessity.
National Correct Coding Initiative (NCCI) edits exist disallowing coding 66989/66991 with cataract
66982/66984 codes.
Physician claims are subject to the multiple procedure payment reduction (MPPR). The highest
paying procedure would be paid at 100% and each lower valued service would be reduced by 50%.

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MULTIPLE PROCEDURE PAYMENT REDUCTION
The MPPR means that if a healthcare provider performs multiple procedures during a single patientencounter, Medicare (and many commercial insurers)
typically will pay “full price” for only the highest-valued procedure. The reason is explained in
Chapter 1 of the National Correct Coding Initiative (NCCI)* Policy Manual: most medical and surgicalprocedures include pre-procedure, intra-procedure, and post-procedure work. When multiple
procedures are performed at the same patient encounter, there is often overlap of the pre-procedureand post-procedure work. Payment methodologies for surgical procedures account for the overlap of
the pre-procedure and post-procedure work.

*https://www.cms.gov/files/document/medicare-ncci-policy-manual-2024-chapter-1.pdf

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