Download iStent inject Medicare Claim Appeal Letter Template (NGS-Novitas)-0376T....[1934] UPDATED

August 15, 2022
{payerName}
ATTN: {payerDepartment}
Fax: {payerFax}
{payerAddressStreet1} {payerAddressStreet2}
{payerAddressCity}, {payerAddressState} {payerAddressZipCode}
Re: {activityLevel} Appeal for Claim Denial of CPT 0376T - Insertion of anterior segment
aqueous drainage device, without extraocular reservoir, internal approach, into the
trabecular meshwork, each additional device insertion
Patient’s Name: {patientName}
Patient’s ID Number: {patientMemberID}
Patient’s Date of Birth: {patientDOB}
Dates of Service: {dateOfService}
Claim number: {claimNumber}
Rendering Physician Name: {providerName}
Rendering Physician NPI: {providerNPI}
Return Phone:
Return Fax:
Dear Appeals Department:
I am writing to appeal the denied payment of the iStent inject® Trabecular Micro-Bypass which
is described by CPT® code 0191T Insertion of anterior segment aqueous drainage device,
without extraocular reservoir, internal approach, into the trabecular meshwork and 0376T Each
additional device insertion. A cataract procedure was also performed in conjunction of the
iStent inject: 66984 Extracapsular cataract removal with insertion of intraocular lens prosthesis
(1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or
phacoemulsification). // 66983 Intracapsular cataract extraction with insertion of intraocular
lens prosthesis (1 stage procedure). // 66982 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 in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or
primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental
stage.
In the denial dated {denialDate}, {payerName} stated that the service requested will not be
covered as a result of the following rationale:
“{denialRationale}”
I strongly disagree with this denial as this procedure was medically necessary given the
patient’s medical history and symptoms. The iStent inject Trabecular Micro-Bypass System
(Model G2-M-IS) contains two preloaded intra-ocular stents (micro-stents). Each of the two
iStent inject stents are preloaded in a single injector. Please see the attached package insert
and procedure steps for more details regarding the iStent inject Trabecular Micro-Bypass
System.
Note to the QIC Reviewer: Please be aware that in the Final Rule “70 FR 11472, Mar. 8, 2005,
Subpart 1 – Determination, Redeterminations, Reconsiderations, and Appeals Under Original
Medicare (Part A and Part B)”1 , Section 405.968 – for Conduct of a Reconsideration – the
following is stated:
“(2) QICs are not bound by LCDs, LMRPs, or CMS program guidance, such as program
memoranda and manual instructions, but give substantial deference to these policies if they
are applicable to a particular case. A QIC may decline to follow a policy, if the QIC determines,
either at a party's request or at its own discretion, that the policy does not apply to the facts
of the particular case.”
For your convenience, I have attached a copy of the specific section of the rule that is
described above.
The Novitas LCD L38223 for Micro-Invasive Glaucoma Surgery that considers CPT 0376T as not
medically necessary. The National Government Services (NGS) Local Coverage Determination
(LCD) L37244 for Micro-Invasive Glaucoma Surgery (MIGS) considers CPT 0376T as not
medically necessary. However, other MACs agree that the iStent inject’s 0376T is medically
necessary and not experimental or investigational.
Wisconsin Physician Services (MAC for Jurisdiction 5 and 8 – IA, KS, MO, NE, IN, and MI)
revised their LCD L35490 for Category III Codes considering both CPT 0191T and 0376T as
medically necessary procedures with an associated physician fee schedule. Also, Palmetto
GBA (MAC for Jurisdiction M – VA, WV, NC, and SC – and Jurisdiction J – AL, GA, TN) has
revised their LCD for Micro-Invasive Glaucoma Surgery (LCD L37531). The LCD L37531 is
effective beginning 02/10/2020. According to the related Local Coverage Article (LCA) A56866
for Billing and Coding, both CPT 0191T and 0376T are considered medically necessary.
1
Title 42: Public Health; Subpart I—Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare (Part A and
Part B): https://www.q2a.com/Portals/0/FR%20Appeals%202009%20PBreaks.pdf?ver=2017-03-02-085112-000
There are also Add-on Code Edits2 under CMS, those rules state add-on codes must be billed
with the appropriate primary procedure in order to be paid. CMS has categorized CPT 0376T
as a Type I add-on code3, which is defined as “A Type I add-on code has a limited number of
identifiable primary procedure codes. The CR lists the Type I add-on codes with their
acceptable primary procedure codes. A Type I add-on code, with one exception (99292), is
eligible for payment if one of the listed primary procedure codes is also eligible for payment
to the same practitioner for the same patient on the same date of service.”
It should be noted that CPT 0191T (the primary procedure) is eligible for payment per [MAC
NAME]’s Local Coverage Determination (LCD) [LCD#], for Micro-Invasive Glaucoma Surgery.
Therefore, the Type I add-on code 0376T should also be covered, as per the definition of a
Type I add-on code.
Failure to allow coverage for the iStent inject for this patient would limit our ability to
continue to offer this sight-saving, minimally-invasive procedure to Medicare beneficiaries,
which would create a discrepancy in coverage and treatment options available to Medicare
beneficiaries in the state of ______.
I respectfully request to have this claim denial overturned and cover this procedure as it was
a medically necessary treatment for my patient’s condition.
What follows is a brief summary of the patient’s history and condition which demonstrates that
the use of the treatment provided was not only medically necessary but an appropriate level of
care.
The patient is a {patientAge}-year-old {patientGender} who has been diagnosed with
{glaucomaDiagnosisCodeAndDescription}.
Glaucoma is the leading cause of blindness and is a progressive, chronic optic neuropathy in
which intraocular pressure (IOP) and other unknown factors contribute to damage of the optic
nerve and loss of retinal ganglion cells and their axons.4 Glaucoma is slowed and managed by
reducing IOP.
This patient’s pre-operative IOP reading was {IOPMeasurement} mmHg and in an attempt to
manage {patientGenderPossessivePronoun} condition, {patientGenderPersonalPronoun} was
prescribed the following medication:
Medication
«Medications_List»
Frequency
2
Add-on Code Edits: https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/Add-On-Code-Edits.html
Complete File of Add-on Code Edits for 04/01/2019 Implementation for Medicare:
https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/Downloads/Add-on-Code-Edits-04012019.zip
3
4
Preferred Practice Pattern: Primary Open-Angle Glaucoma. American Academy of Ophthalmology. October 2015
http://www.aaojournal.org/article/S0161-6420(15)01276-2/pdf. Accessed December 28, 2015
Section 1862(a)(1)(A) of the Social Security Act, states that items and services must be
established as safe and effective to be considered medically necessary. That is, the items and
services must be:
1) Consistent with the symptoms of diagnosis of the illness under treatment.
According to the FDA approval dated June 25, 2018, iStent inject is indicated for use in
conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult
patients with mild to moderate primary open-angle glaucoma (2018). My patient fits
this criterion as {patientGenderPersonalPronoun} has a diagnosis of
{glaucomaDiagnosis}. On {dateOfService}, {patientName} had a combination surgery
which included cataract surgery, as well as the insertion of two anterior segment micro
stent aqueous drainage devices. This procedure followed both the diagnosis and
treatment explicitly outlined by the FDA, thus the diagnosis and treatment are medically
necessary and appropriate.
2) Necessary for and consistent with, generally accepted professional medical standard of care
(e.g., not experimental).
The use of two stents is not experimental. On June 25, 2018 the FDA approved a device
that allows for implantation of two stents for commercial distribution.5
In this letter, I have included a clinical literature packet that summarizes the major
publications which demonstrate that use of two devices are a safe and effective strategy
for management of POAG by lowering IOP in patients undergoing cataract surgery. 6
3) Not furnished primarily for the convenience of the patient or of the provider or supplier.
The use of two stents is not a convenience item. The insertion of two stents improves
my ability to address a clinical diagnosis that, if uncorrected, will result in blindness. At
the same time two devices preserves my options for other more invasive procedures
should this disease continue to progress.
4) Furnished at the most appropriate level of care that can be provided safely and effective to
the patient.
In addition to the FDA letter there are a number of major publications demonstrating
the use of two stents to be safe and effective for the management of POAG. 0191T is
currently covered for the placement of one stent. With FDA approval I now have the
legal clearance to implant two stents thus improving outflow and control of this disease.
The benefits of the second stent are to improve outflow by increasing the access to
collector channels within the eye thus improving outflow.
Medication is expensive, associated with side effects, many patients have difficulty
complying with instructions and regimen, and/or may become immune to the
5
6
FDA Letter dated June 25, 2018
iStent inject US Technology Clinical Literature packet, June 2018
treatment. The use of one stent has been a standard of care in the treatment of
glaucoma for the last six years. The use of two stents has a demonstrable improvement
in reducing IOP over one stent.
The following summaries are of peer reviewed evidence supporting the safety and efficacy of
the iStent inject. Full copies of the published evidence are included with the clinical literature
packet. Attached to this submission as Exhibit A, is a summary of iStent inject peer reviewed
safety data. Attached to this submission as Exhibit B, is a summary of iStent inject peer
reviewed efficacy data. In terms of iStent inject recently published data that was not previously
available as part of the peer reviewed evidence, a summary of the studies is provided as
follows:

Samuelson et al. (2019)7 evaluated the safety and effectiveness of iStent inject in
combination with cataract surgery in patients with mild-to-moderate primary OAG
(387 patients in the iStent inject and cataract group, and 118 patients in the control
group). At 24 months, 76% of the iStent inject cohort vs. 62% of the cataract surgeryonly cohort had ≥ 20% unmedicated diurnal IOP reduction from medication without
washout baseline at 24 months post-surgery. Of the responders, 84% of the
treatment eyes and 67% of the control eyes were not using IOP medications at 23
months. Overall, clinically and statistically greater reductions in IOP without
medications were achieved after iStent inject implantation with cataract surgery vs.
cataract surgery alone, with excellent safety through two years.
iStent inject Pivotal Trial: A. Primary Effectiveness Results;
B. Secondary Effectiveness Results From Effectiveness Cohort
A
B
Abbreviation: DIOP, diurnal intraocular pressure. Source: Samuelson 2019.
7
Samuelson TW, Sarkisian Jr. SR, Lubeck DM, et al. Prospective, Randomized, Controlled Pivotal Trial of iStent inject Trabecular Micro-Bypass in
Primary Open-Angle Glaucoma and Cataract: Two-Year Results, Ophthalmology (2019), doi: https://doi.org/10.1016/j.ophtha.2019.03.006.

Guedes et al. (2019)8 reported on real world outcomes of the longitudinal
retrospective study evaluating performance and safety in consecutive eyes
implanted with either the iStent or iStent inject with concomitant cataract surgery
(73 eyes with OAG with iStent and iStent inject representing 38 and 35 eyes
respectively). Guedes concluded that there is a significant IOP and medication
reductions observed after iStent (implantation of a single stent) and iStent inject
(implantation of two stents) concomitant with cataract surgery, along with a trend
towards greater effectiveness and fewer adverse events with iStent inject:
o 38 eyes with iStent vs. 35 eyes with iStent inject. Baseline characteristics
were similar between groups:
 iStent (n=38) – Pre-op IOP of 16.5 mmHg on 1.8 medications
 iStent inject (n=35) – Pre-op IOP of 17.3 mmHg on 2.3 medications
o The author concludes there is a significant and safe IOP and medication
reductions observed after iStent and iStent inject concomitant with cataract
surgery, along with a trend towards greater effectiveness and fewer adverse
events with the iStent inject device.

8
Hengerer et al. (2018)9 examined real-world, prospective, single-surgeon data in 81
eyes with predominantly POAG and pseudoexfoliative glaucoma of which 32% had
previous glaucoma surgery and 56% were on ≥ 3 medications. At the 36-month postoperative time point (n = 41), mean IOP and medications were reduced by 37% and
68%, respectively, from baseline values. The proportion of eyes that achieved ≤ 18
mmHg was 100%. Furthermore, 54% of eye were medication-free, and only 2% of
eyes were on ≥ 3 medications. These observations provide practical evidence on the
sustainable beneficial effects of iStent inject combined with cataract surgery in
patients with various stages of glaucoma. The mean medication use was decreased
Guedes RAP, Gravina DM, Lake JC, et al. Intermediate Results of iStent or iStent inject Implantation Combined with Cataract Surgery in a RealWorld Setting: A Longitudinal Retrospective Study. Ophthalmol Ther. 2019 Mar;8(1):87-100.
9
Hengerer FH, Auffarth GU, Riffel C, et al. Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass
Stents with Phacoemulsification in Eyes with Various Types of Glaucoma. Ophthalmol Ther. 2018 Dec;7(2):405-415. doi: 10.1007/s40123-0180152-8.
from 2.5 to 0.8 medications at three years, a 68% reduction; and 74% of eyes were
using 0 or 1 medication compared to 21% pre-operatively.

Clement et al. (2019)10 performed a retrospective study of iStent inject implantation
with cataract surgery for patients with mild to advanced glaucoma (predominantly
primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or
ocular hypertension (OHT). Of the 290 eyes that underwent surgery, 165 eyes had
12-month outcomes reported, which resulted in IOP reduced by 23.2% (from 18.3
mmHg to 14.0 mmHg and mean number of medications decreased by 71.5% (from
1.65 to 0.47 medications). Moreover, at month 12, 76.4% of eyes were on zero
medications from 17.6% pre-operatively. Clement demonstrated that iStent inject
significantly and safely reduced medications and IOP in eyes with various types and
severities of glaucoma.
In closing, I respectfully submit that the information provided demonstrates medical necessity
and the treatment provided meets the criteria as outlined in Section 1862(a)(1)(A) of the Social
Security Act and thus qualifies for payment.
Thank you for the opportunity to submit this reconsideration.
Sincerely yours,
{providerName}
{siteName}
10
Clement CI, Howes F, Ioannidis AS, et al. One-year outcomes following implantation of second-generation trabecular micro-bypass stents in
conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study. Clinical
Ophthalmology 2019, 13: 491–499
{siteAddressStreet1} {siteAddressStreet2}
{siteAddressCity}, {siteAddressState} {siteAddressZipCode}
Enclosed:
1. Appeal Form
2. EOB
3. Medical Record
4. Operative Report
5. iStent inject Clinical Literature