A cataract is a degradation of the optical quality of the crystalline lens
that affects vision. Cataracts cause an opacity or cloudiness in the lens of
the eye(s) which blocks the passage of light through the lens.6

Cataracts occur frequently as a progressive age-related disease and is the
leading cause of blindness worldwide of all ethnic and racial backgrouds.6
More than half of all Americans age 80 or older either have cataracts or have
had surgical treatment of cataracts.2 Cataract is the leading cause of visual
impairment among Americans of all studied ethnic and racial backgrounds.3 The
number of people in the United States with cataracts is expected to double
from 24.4 million to approximately 50 million in the next 30 years.2,6 Most
cataract development is related to aging, and it can occur in one or both
eyes. As part of the aging process, the lens increases in thickness and weight
causing hardening and compression on the nucleus eventually developing a
yellow-brown color that changes the transparency of the lens. Cataracts have
several different types that have their own anatomical location, pathology,
and risk factors which increases with each decade of life starting around age
40.6 Risk factors that can increase cataract development may include smoking,
ultraviolet  radiation exposure, complications of diabetes, and drug and/or
alcohol use.2

Medicare coverage for cataract extraction, and cataract extraction with
intraocular lens implant, is based on services that are reasonable and
medically necessary for the treatment of beneficiaries with cataract(s). This
policy defines coverage and describes criteria necessary to justify the
performance of cataract extraction(s).

**Coverage Indications**

Cataract extraction is considered medically necessary when one (or more) of
the following conditions or circumstances exists, and are clearly documented
in the medical record:

  * The patient's visual function is not correctable with a tolerable change in glasses or contact lenses; and
  * When 1 or more concomitant ocular diseases are present that potentially affect visual function (e.g., macular degeneration or diabetic retinopathy), the medical record should indicate that cataract is believed to be significantly contributing to the patient's visual impairment; and
  * The cataract is determined to have a significant negative impact to the patient's visual function in the presence of other eye disease(s) including, but not limited to macular degeneration or diabetic retinopathy, and
  * The patient is not able to carry out activities of daily living including but not limited to reading, viewing television, driving, or meeting occupational or recreational needs; or
  * An unimpeded view of the fundus is mandatory for proper monitoring or treatment of patients with concomitant intraocular diseases including, but not limited to diabetic retinopathy, open angle glaucoma or intraocular tumor; or
  * The cataract interferes with the performance of vitreoretinal surgery, as in the case of proliferative vitreoretinopathy, complicated retinal detachments, and severe proliferative diabetic retinopathy; or
  * There is a high probability of accelerating cataract progression resulting from concomitant or subsequent procedure (e.g., pars plana vitrectomy, iridocyclectomy, procedure for ocular trauma) and treatments such as external beam irradiation; or
  * Intolerable anisometropia or aniseikonia uncorrectable with glasses or contact lenses that exists because of lens extraction in the first eye (despite satisfactorily corrected monocular visual acuity).

**Coverage Limitations**

Second Eye Surgery  
Should a significant cataract also be present in the second eye, surgery is
generally not performed in both eyes at the same time because of the potential
for bilateral visual loss. In the more common situation where surgery is
performed sequentially in the other eye on separate days for bilateral
visually symptomatic cataracts, the appropriate interval between the first-eye
surgery and second-eye surgery is influenced by several factors:

  * The patient's visual needs,
  * The patient's preferences,
  * Visual function in the second eye,
  * The medical and refractive stability of the first eye,
  * The need to restore binocular vision and resolve anisometropia,
  * Allow an adequate interval of time to elapsed to evaluate and treat early postoperative complications in first eye, such as endophthalmitis; and/or
  * Logistical and travel considerations of the patient.

The patient and the ophthalmologist should discuss the benefits, risks, need,
and timing of second-eye surgery when they have had the opportunity to
evaluate the results of surgery on the first eye, considering the above
factors.

If the decision to perform cataract extraction in both eyes is made prior to
the first (sequential) cataract extraction, the documentation must support the
medical necessity for each procedure to be performed.

If bilateral cataract extraction is performed on both eyes, on the same date
of service, known as Immediate Sequential Bilateral Cataract Surgery, the
medical record must document the rationale, and that the patient has been
apprised of the risks and benefits of the procedure and available
alternatives.

Complex Cataract Surgery  
The billing of Complex Cataract Surgery is intended to differentiate the extra
work performed during the intraoperative or postoperative periods in a subset
of cataract operations. It is not related to the surgeon's perception of the
surgical difficulty. The use of this code is governed by the need to employ
devices or techniques not generally required/utilized in routine cataract
surgery.

For example:

  * A miotic pupil which will not dilate sufficiently to allow adequate visualization of the lens in the posterior chamber of the eye and requires the insertion of 4 iris retractors through 4 additional incisions, Beehler pupil dilator or similar expansion device, a sector iridectomy with subsequent suture repair of iris sphincter, synechiolysis using papillary stretch maneuvers, or sphincterotomies created with scissors.
  * The presence of a disease state that produces lens support structures that are abnormally weak or absent. This requires the need to support the lens implant with permanent intraocular sutures and/or a capsular support ring (approved by the FDA) to allow placement of an intraocular lens.
  * Pediatric cataract surgery may be more difficult intraoperatively because of an anterior capsule which is more difficult to tear, cortex which is more difficult to remove, and the need for a primary posterior capsulotomy (capsulorhexis).
  * Extraordinary work may occur during the postoperative period. This is the case with pediatric cases mentioned above and very rarely when there is extreme postoperative inflammation and pain.

**Visual Acuity**

The Snellen visual acuity chart is an excellent way of measuring distance
refractive error (e.g. myopia, hyperopia, astigmatism) in healthy eyes, and is
in wide clinical use. However, testing only with high contrast letters viewed
in dark room conditions will underestimate the functional impairments caused
by some cataracts in common real life situations such as day or nighttime
glare conditions, poor contrast environments or reading, halos and starbursts
at night, and impaired optical quality causing monocular diplopia and
ghosting.

While a single arbitrary objective measure might be desirable a specific
Snellen visual acuity alone can neither rule in, nor rule out the need for
surgery. It should be recorded and considered in the context of the patient's
visual impairment and other ocular findings.6

According to the American Academy of Ophthalmology (AAO) 2021 et al,6 cataract
surgery is primarily recommended for visual function that no longer meets the
patient's needs and should be considered based on visual acuity, visual
impairment, and potential for functional benefits. The preoperative evaluation
should not be solely based on a visual Snellen exam, but to include an
ophthalmic evaluation, patient-centered visual function exams and
questionnaires, and patient education about treatment options prior to
consent. The AAO has set characterizations to ensure that improved visual
function, physical function, and mental health is restored after cataract
surgery. Cataract surgery is also known to decrease intraocular pressure (IOP)
after phacoemulsification cataract surgery in patients with or without
glaucoma. Alternatives to cataract surgery and management of cataract are very
few. Miller, et al6 display outcomes from studies that prove cataract surgery
to be effective when considered in the AAO's practice patterns for cataract
surgery guidelines. Across the studies mentioned, patients have improved
corrected distance visual acuity (CDVA) scores, increased visual acuity, and
were overall satisfied with the results of their surgery and improvement in
quality of life. The only major potentially eye-threatening complications of
cataract surgery are infectious endophthalmitis, toxic anterior segment
syndrome (TASS), toxic posterior segment syndrome (TPSS), suprachoroidal
hemorrhage, cystoid macular edema (CME), persistent corneal edema, IOL
dislocation, secondary glaucoma, diplopia, and blindness those these
complications are rare. Comparing studies have shown that patients who receive
cataract surgery in both eyes have greater functional improvement than those
that had surgery in one eye. Although bilateral cataract surgery is
beneficial, if both eyes show significant indications for it, determining the
appropriate time interval between the first eye surgery and the second eye
surgery is complex and influenced by several factors.

According to the AAO 2021 et al,6 symptomatic cataract is a surgical disease
and the standard of care in cataract surgery in the U.S. is a small-incision
phacoemulsification with foldable IOL implantation. Cataracts are the leading
cause of treatable blindness among all races worldwide. The risk of developing
cataracts increases beginning at age 40. As part of the aging process, the
lens increases in thickness and weight causing hardening and compression on
the nucleus. The lens eventually develops a yellow-brown color that changes
the transparency. To confirm that a cataract is causing the visual impairment
rather than another ocular or systemic condition, a comprehensive evaluation
should be conducted. Cataract surgery is the primary management of significant
visual impairment. The complexity of cataract surgery requires special
training, clinical experience, and judgment that are necessary to evaluate the
medical, ocular, and psychosocial factors used to determine the
appropriateness and timing of surgery. There are no pharmacologic treatments
to eliminate cataracts. Visual function plays a major role in physical
performance, mental and emotional well-being, and mobility for the elderly.
Visual impairment increases the risk for falls and hip fractures in the
elderly. Improved vision can reduce the fear of falling, which is one of the
listed outcomes for characterized improvement in mental health and emotional
well-being in the elderly. The indications, contraindications, and
complications for cataract surgery are the same. Multiple studies that were
used for the AAO's preferred practice pattern show that CDVA scores improved,
over 90% of patients, postoperatively, had improved visual acuity and
improvement in VF-14 scores, and that the strongest preoperative indicator for
visual function improvement is the glare disability test at low and medium
spatial frequencies. Overall, cataract surgery is safe and effective for young
adults and the elderly population. It reaches its goal of improving visual
function and enhancing quality of life. The preferred practice patterns set by
AAO, have clear guidelines that are suited to promote optimal health and a
clear path of treating adult cataract patients. While studies in Canada,
Europe and other parts of the world have recently emerged supporting the
safety and efficacy of same-day bilateral cataract surgery, more studies are
needed in the US with attention to the serious risk of bilateral blindness due
to endophthalmitis or TASS.

Vazquez-Ferreiro5 and colleagues conducted a systematic review and meta-
analysis to evaluate the association pseudoexfoliation syndrome has on IOL
after having phacoemulsification cataract surgery. The aim was to identify
pseudoexfoliation as a risk factor for IOL dislocation and explore other
related factors from the surgery. Two reviewers performed a systematic search
of several cohort studies, case-control studies and clinical trials. Included
in this analysis were PubMed MEDLINE, Embase, Web of Science, Cochrane, and
Lilacs database. All resources were used for searches specific to IOL
dislocation in patients with and without pseudoexfoliation syndrome who had
undergone phacoemulsification. The meta-analysis of this review included 2
questions of interest: 1.) Do patients with pseudoexfoliation syndrome have a
clinically relevant increased risk of late IOL dislocation compared with
patients without this syndrome? and 2.) Can the risk of late lens IOL
dislocation in patients with pseudoexfoliation be reduced using hooks,
retractors, rings, or other devices to reduce incision size? Inclusion
criteria focused on articles that provided enough data with which to calculate
odds ratios (ORs) and corresponding confidence intervals (CIs) for IOL
dislocation. A few specific data that were extracted for this analysis to
mention are sample size, study setting, study population, use of hooks or
retractors, type of cataract, study design, etc. A total of 859 articles were
retrieved and only 14 articles met the inclusion criteria. All were cohort
studies, excluding one that was a case-control study. Only 2 studies were from
the United States. The overall OR for IOL dislocation was 6.02 (95% CI: 3.70;
9.79), with a p < 0.0001 suggest that patients with pseudoexfoliation are very
prone to IOL dislocation. A reduction in IOL dislocation in patients with
pseudoexfoliation syndrome was not noticeable, however there was no
significant increase in the ORs throughout the different quarters. The odds of
IOL dislocation in patients with pseudoexfoliation was slightly increased
using hooks or retractors. It was also suggested that a mild effect for time
on overall risk, improvements in techniques, and reduction of incision sizes
have reduced the risk of IOL dislocation. The findings suggest that there is a
high risk for late IOL dislocation in patients with pseudoexfoliation syndrome
after phacoemulsification cataract surgery. Suggestions point to larger
incision sizes and the use of hooks and retractors during surgery as a
contributing factor to the increased high risk of IOL dislocation. More
studies are suggested to assess the long-term effects and if improvements to
techniques will change the variables.

Flaxman, et al conducted a systematic review and meta-analysis of published
and unpublished population-based data from 1980 to 2014 to determine causes of
vision impairment and blindness.1 They searched online data bases (MEDLINE
from Jan 1, 1946, and Embase from Jan 1, 1974, and the WHO Library Database)
identifying population-based distance vision impairment data studies published
prior to July 8, 2014. Using the 21 Global Burden of Disease regions they
estimated causes of visual impairment over time by age and geographical area.
Using a Bayesian hierarchical modelling approach, and the Stan Modelling
approach, they fitted 6 separate mixed-effects models for cataract, glaucoma,
age-related macular degeneration, diabetic retinopathy, corneal opacity, and
other. A total of 288 studies of nearly 4 million participants were identified
contributing data from 98 countries. The authors determined in 2015 the
leading causes of moderate to severe vision impairment was uncorrected
refractive error and cataract and among the global population the leading
cause of blindness was cataract. They noted that by 2020 the number of people
affected by cataract causing vision impairment would increase from 52.6
million to 57.1 million and blindness caused by cataract would increase from
12.6 million to 13.4 million. The findings of the study support that cataract
and uncorrected refractive error combined contributed to more than half of
blindness and over 75% of vision impairment in adults 50 years or older with
women being affected more than men. While there are several limitations to
this study and determining causation, they reported that a large scale-up of
eye care provision to cope with the increasing numbers of people affected by
vision loss and blindness is needed to address avoidable vision loss.

Michalska-Malecka, et al4 conducted a study at University Hospital No. 5 of
the Medical University of Silesia between 2008-2009. In this retrospective
study, the authors set out to investigate the effectiveness and safety of
cataract surgery and IOL implantation for patients aged 90 years or older (43
men and 79 women). Patients considered for the study had significant bilateral
cataracts causing visual impairment not correctable by glasses, best corrected
visual acuity (BCVA) score worse than 0.7, an unacceptable glare, polyopia, or
overall reduced vision quality due to cataracts. As this study focuses on the
very elderly population, Michalska-Malecka noted that coexisting systemic
disorders, patient cooperation during surgery, higher incidence of hard
nucleus, smaller pupil size and high rate of pseudoexfoliation syndrome make
it difficult to perform cataract surgery. Individuals that were excluded from
the study were those that were under the age of 90, had a BCVA score of 0.7 or
greater, a baseline endothelial cell density of less than 1,500 cells/mm,
uncontrolled glaucoma, and physical or mental disability that would make it
difficult to perform the surgery. According to Michalska-Malecka, cataracts
are one of the most frequent reasons for visual impairment around the world.
As cataracts and its visual impairment reduces quality of life,
phacoemulsification surgery and extracapsular cataract extraction have proven
to be effective with increasing visual acuity. In this study,
phacoemulsification was performed on 113 of 122 eyes and extracapsular
cataract extraction (ECCE) was performed on 9 of 122 eyes. Visual acuity was
increased after the first postoperative day, 3 months, and 6 months after
surgery. The BCVA scores improved in 100 out of the 122 patients (82%) with
senile cataracts from this study. Visual acuity results remained the same in
20 of the patients and decreased in 2 of the patients because of co-existing
age-related macular degeneration (AMD). The IOP in patients with or without
glaucoma were shown to have little to no postoperative differences than
preoperatively. Patients with glaucoma had a significant difference in IOP,
postoperatively, while the patients without glaucoma had no difference. These
results show that cataract surgery is safe and effective in the treatment of
senile cataracts in the very elderly population.

Congden, et al conducted an analysis of data collected from major population-
based studies in the United States (US), and, where appropriate, Australia,
Barbados, and Western Europe.3 The goal was to take data since 1990 of those
age 40 and older affected by cataract, pseudophakia/aphakia, and prior
cataract surgery applied to US Census data in 2000, to determine an estimate
of pervasiveness of cataract on the US population in 2020. They separately
prepared data on black, white, and Hispanic people beginning at age 40. They
estimated prevalence in 5-year intervals based on cataract, prior cataract
surgery, blindness, and low vision due to cataract. They estimated that 20.5
million Americans over 40 years of age have cataract in either eye, and over 6
million have pseudophakia/aphakia with women have a notably higher rate of
cataract over men. Inclusion criteria focused on studies that provided enough
data with which to calculate odds ratios (ORs) and corresponding confidence
intervals (CIs) Results of this study show a significant prevalence in both
white and black persons for cataract development ( _P_ <.001 for both, _X 2_
test). Woman had a higher rate of cataract in both black and white populations
with an overall OR among blacks of 1.75 (95% CI, 1.18-2.56) and whites of 1.35
(95%CI 1.23-1.49). White males had a significantly higher rate of cataract
(OR=1.09, 95% CI 1.02-1.16) than black males. The also noted that
pseudophakia/aphakia was more significantly more prevalent in Hispanic
persons. They concluded that the rate of prevalence of cataract and
pseudophakia/aphakia in Americans would dramatically rise by 2020 to over 39
million combined.

Primary angle-closure glaucoma is a leading cause of irreversible blindness
around the world. In the early stages of disease, the intraocular pressure
(IOP) is raised without visual loss. In patients with glaucoma, cataract is
also common due to changes that occur as the eye ages. A cataract that is
growing in the anterior-posterior dimension narrows the anatomical gap between
the iris and the cornea. Cataract extraction opens this angle and can
alleviate intraocular pressure.

Cheng et al conducted a retrospective review on 26 eyes of 19 patients over a
17-year period with angle closure glaucoma (AGC) who received regular visual
field (VF) examination and uncomplicated phacoemulsification with intraocular
lens (IOL) implantation.9 VF tests using the Humphrey Field Analyzer were
completed every 6 months. The mean follow up period was 5.14  3.31 years and
5.97  2.35 years, respectively. The VF rate of progression, visual acuity
(VA), IOP, and number of patients needing glaucoma medication before and after
cataract surgery were compared. While this retrospective study and small
sample size are a limitation, they concluded that after cataract surgery,
there was significant improvement in IOP, VA, and a decrease in the number of
glaucoma medications used.

Sakai et al set out to investigate the long-term outcomes of cataract surgery
in patients with primary angle closure disease (PACD).10 This retrospective
case series reviewed the medical records of 87 patients with PACD. They
included only patients with a minimum follow up period of 10 years. They were
broken into 3 categories, patient with primary angle closure glaucoma (PACG),
primary angle closure (PAC), and primary angle closure suspect (PACS). All
eyes included in the study had experienced standard phacoemulsification and
IOL implantation. They compared IOP, number of glaucoma eye drops being used,
additional need for glaucoma treatment, VF progression, and progression to
glaucoma. Among the 87 patients, 39 had PACG, 26 had PAC, and 22 had PACS.
Almost half of the PACG group required additional glaucoma treatment, and 6
required surgery. Only 3 patients in the PAC group required additional
glaucoma medication. There was no difference in mean IOP at 10 years among the
3 groups and all had significantly decreased from baseline. They concluded
that cataract surgery has a long-term effect on reducing IOP in patient s with
PACD.

Senthil et al conducted a randomized controlled trial of a total of 70
patients with PACG.11 Out of those 70 patients, 33 patients had
phacoemulsification (Phaco) and 37 patients had phacotrabeculectomy (PT). They
defined PACG as non-visible posterior trabecular meshwork in at least 180
degrees of the angle on an indentation gonioscopy, raised IOP of >21 mm Hg, or
requiring eye drops or systemic medication that lowers the IOP <21 mm Hg with
glaucomatous optic disk damage, and corresponding defect in the VF. They
excluded patients with previous trabeculectomy surgery or documented
progression in the last year, and those where glaucoma was not a primary
diagnosis. Primary outcome measure was achieving an IOP of >/= 6 mmHg and </=
21 mmHg without antiglaucoma medications in both the groups after 1 year and
at last follow up. Secondary outcome measure was the speed of regaining VA,
number of antiglaucoma medications, mean IOP and obstacles in the 2 groups.

The overall success probability of the primary outcome measure between the 2
groups was 67.5% in the PT group and 66.6% in the Phaco group. This improved
even more to 78% at 1 year in the PT group, and 80% in the Phaco group with
the numbers decreasing slightly in both groups over 2 to 5 years.
Postoperative VA greatly improved in both groups but were significantly better
in the Phaco group initially, however similar in both groups at final follow
up. The authors concluded that there was faster visual recovery, with
comparable IOP control and VF stability in patients with phacoemulsification
vs. trabeculectomy in medically controlled PACG eyes with cataract.

The evidence of literature supports that cataract surgery is a safe and
effective procedure in adults and the elderly population. Cataract surgery
improved visual acuity, improves driving safety, and quality of life in the
elderly population with few intraoperative and postoperative complications.6
The most frequent complication following cataract surgery in the very elderly
population is posterior capsule tear without vitreous loss and corneal
decompression.4

Across the studies, patients have shown postoperative improvements in visual
acuity, intraocular pressure, and function abilities. In a small prospective
study conducted by Dunman et al7 Berg Balance Scale scores, Tinetti Gait test
scores, and Tinetti Balance test scores, for functional balance all increased
postoperatively after 1 month. In a retrospective study conducted by
Michalska-Malecka,4 the BCVA scores improved in 100 out of the 122 patients
(82%) with senile cataracts postoperative and at follow up.

Societies such as the AAO, Ophthalmology Variation Analysis Committee: Optimum
Physician Alliance, the American Society of Cataract and Refractive Surgery,
and the European Society of Cataract & Refractive Surgeons are all in support
of cataract surgery, including complex cataract surgery for its safe and
effective methods of treatment for cataract and other ocular diseases.

More studies are needed to determine the safety between simultaneous or
sequential bilateral cataract surgery.8 Based on the literature; limited
coverage will be provided for cataract surgery as outlined in the LCD.

While phacoemulsification is not a first line treatment for PACD, literature
supports that cataract extraction can offer moderate, although temporary
improvement in IOP and VA. We received additional documentation from a
provider for clear lens extraction for treatment of PACD, but that literature
was not included as it was out of the scope of this LCD.