Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  
 **History/Background and/or General Information  
  
** Cataracts occur frequently as a progressive, age-related disease that is
the leading cause of blindness in the U.S. and accounts for 50% of visual
impairment over the age of 40. Cataracts are the leading cause of treatable
blindness among African Americans age 40 and older. 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 (e.g.,
nuclear, cortical, subcapsular [anterior and posterior], and mixed).  
  
Cataracts can lead to blurred or distorted vision, glare problems, color
vision defects, and a decline of contrast sensitivity and depth perception.
These impairments lead to loss of balance, less independent mobility, falls,
injuries, increased mortality risk, and decreased mental well-being. This
raises more concern for the elderly population due to underlying systemic
comorbidities. Visual function plays a major role in physical performance,
mental well-being, and mobility for the elderly.1 Risk factors for cataracts
include diabetes mellitus, family history, hypertension, ionizing radiation,
myopia, obesity, smoking, ultraviolet-B light exposure, long-term topical,
systemic, or oral corticosteroid use, prior intraocular surgery, and lower
level education.  
  
Improving visual function and quality of life have increased the demand for
cataract surgery. Since there are no pharmacologic treatments to eliminate
cataracts, cataract surgery is the primary management of significant visual
impairment.1 Due to the different types of cataracts, the decision-making
process for cataract surgery can be complex in determining the appropriate
treatment, technique, devices, and complications to consider. 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 intraocular
lens (IOL) implantation.1  
  
In consideration for cataract surgery, cataract patients must have an
impairment of visual function due to cataract(s) resulting in the decreased
ability to carry out activities of daily living such as reading, viewing
television, driving or meeting occupational or vocational expectations. This
LCD provides medically reasonable and necessary indications for both routine
and complex cataract surgery. Coverage will be based upon documentation that
supports medical necessity and therefore covered by Medicare when one or more
of the covered indications are present.  
  
 **Covered Indications  
  
** Cataract Surgery will be considered medically reasonable and necessary when
one or more of the following indications are present:

  1. Visual function no longer meets the patient's needs based on visual acuity, visual impairment, and potential for functional benefits.2
  2. Visual Impairment and function are not correctable by glasses or other non-surgical measures.3
  3. The patient has undergone a preoperative examination that documents the following:

  *     * Inability to function satisfactorily due to visual impairment while performing various Activities of Daily Living.1,2
    * Confirmation that cataract is causing the visual impairment or other ocular or systemic conditions.1 
    * Cataract is causing unacceptable glare, polyopia, or reduced quality of vision.1-3

  4. There is clinically significant anisometropia in the presence of a cataract.1,2
  5. The lens opacity interferes with optimal diagnosis or management of posterior segment conditions.1,2
  6. The lens causes inflammation or secondary glaucoma (phacolysis, phaco-anaphylaxis).1,2
  7. There is worsening angle closure (phacomorphic glaucoma) due to increase in size of the crystalline lens.1,2
  8. A significant cataract is present in a patient who will be undergoing concurrent surgery in the same eye, such as a trabeculectomy or a corneal transplant when the surgeon deems that the decreased morbidity of single stage surgery is of significant benefit over surgery on separate dates.1,2

Please refer to NCD 10.1-Use of Visual Tests Prior to and General Anesthesia
During Cataract Surgery for information on pre surgery evaluations.  
  
**Complex cataract surgery** :  
  
 **Indications:**

Complex cataract surgery will be considered medically reasonable and necessary
when there is one of the following:

  1. A miotic pupil that will not dilate sufficiently4 requirng the use of a mechanical iris expansion device (Iris retractors through four additional incisions, Beehler expansion device, or Malyugin ring) to adequately visualize the lens in the posterior chamber of the eye.4
  2. Pre-existing zonular weakness requiring use of capsular tension rings or segments or intraocular suturing of the intraocular lens.5 
  3. Pediatric cataract surgery, intraoperatively difficult because of an anterior capsule that is more difficult to tear, cortex that is more difficult to remove needing a primary posterior capsulotomy or capsulorrhexis.
  4. Mature cataract requiring dye for visualization of capsulorrhexis.

Refer to CMS IOM Pub. 100-04, _Medicare Claims Processing Manual_ , Chapter
32, Section 120, for CMS guidelines on IOL insertion benefit following
cataract surgery.

**Limitations  
  
** The following are considered contraindicators to surgery for visually
impairing cataract and are not considered medically reasonable and necessary:

  1. Tolerable refractive correction that provides vision and meets the patient's needs and desires.2
  2. The patient's lifestyle is not compromised by the cataract and they are able to perform activities of daily living.1,2
  3. The patient cannot safely undergo surgery because of coexisting medical or ocular conditions.1,2
  4. Surgery is not expected to improve visual function, or no other indication for lens removal exists.1,2  

**Provider Qualifications**

Services will be considered medically reasonable and necessary when all
aspects of care are within the scope of practice of the provider's
professional licensure, when performed according to the supervision
requirements per state scope of practice laws, and when all procedures are
performed by appropriately trained providers in the appropriate setting.

**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.

The content of this LCD is supported through an evidence-based literature
search of articles and publications through PubMed. We identified articles
based on a key word search for: indications for complex cataract surgery,
miotic pupil or small pupil in complex cataract surgery, and pseudoexfoliation
in complex cataract surgery. The literature search was filtered to find
articles within 5-10 years, with one exception where an article dated back to
2001. Filters also included full text articles, clinical trials, randomized
controlled trials, and systematic reviews. Below is a summary of evidence to
support the medically reasonable and necessary indications for Cataract
Extraction (Including Complex Cataract Surgery) and explanation of
limitations.  
  
Michalska-Malecka, et al3 conducted a study at University Hospital No. 5 of
the Medical University of Silesia between 2008-2009. In this retrospective
study, Michalaska-Malecka and his colleagues 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 Intraocular pressure
(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. Michalaska-Malecka states, "Little evidence has been found to
support the hypothesis that age alone is a risk factor for phaco-cataract
surgery for intraoperative complications."11  
  
Bargoud et al4 and colleagues conducted a retrospective, observational cohort
study with the aim to see whether complex cataract surgery using the
phacoemulsification technique and a mechanical iris expansion device (iris
hooks, Kuglen hooks, and Malyugin rings) will lower IOP for patients with
glaucoma. Bargoud4 mentions the importance of this study in glaucoma patients
with the modifiable risk factor of increased IOP. However, a significantly
higher proportion of patients with glaucoma have been found to have smaller
pupils compared with similar control groups, and on patients who underwent
cataract surgery, they require iris manipulation and pupil expansion more
frequently. This study was conducted at the University Hospital in Newark, New
Jersey of surgeries from 2008-2016. The study was comprised of two groups: the
primary open angle closure group and the control group that included patients
without primary open-angle glaucoma (POAG) who underwent phacoemulsification
with intraoperative mechanical pupillary expansion. Thirty-seven eyes from the
31 glaucoma patients (5 with mature cataracts) and 29 eyes from the 28 control
patients (3 with mature cataracts) were included in the study and met the
inclusion criteria. The other eyes in both groups had non-mature cataracts.
Inclusion criteria focused on eyes that were diagnosed with POAG and had no
prior incisional surgery for 1 year or 1 year after. Exclusion criteria
included 1. eyes that had no confirmed glaucoma diagnosis, 2. had non-POAG
types of glaucoma such as neovascular, uveitic, or chronic angle closure, 3.
prior incisional glaucoma surgery, 4. eyes that had a phacoemulsification that
was combined with another surgery and pupillary expansion devices was not
confirmed from the operative report, and 5. had a vitrectomy, anterior chamber
intraocular lens, and/or sulcus placement or conversion to large incisional
surgery. The POAG group was significantly older than the control group at the
time of surgery (72.5 10.2 versus 65.3 11.5 years old; p = 0.01). However,
there were no significant differences in the proportions of hypertension,
diabetes, or hyperlipidemia between the control and the POAG group. The study
shows an increase 15.0  4.6 to 15.9  3.5 in IOP in the POAG group while the
control group shows a decrease 14.1  3.6 to 11.9  3.9 at 12 months
postoperative. Throughout the follow up period the control group showed
significant decrease in IOP while the POAG group showed a significant decrease
in mean antiglaucoma medication burden with improvement in visual acuity in
both groups, more specifically the control group. More complications were
noted in the POAG group than the control group. Complex cataract surgery did
not decrease the IOP in patients with primary open angle glaucoma. However, it
did improve visual acuity and reduced medication burden in the POAG group.
Complex cataract surgery did, however, decrease IOP in patients without POAG
and improve visual acuity. This study shows that complex cataract surgery,
such as phacoemulsification with intraoperative mechanical pupillary expansion
is useful in improvements of cataracts and glaucoma.  
  
Miyoshi5 and colleagues conducted a retrospective study to assess the effects
of using the capsular tension ring (CTR) on the surgical outcomes of toric and
multifocal IOLs in eyes with zonular instability. A total of 55 eyes from 43
patients (70.7  10.3 years old) were included who were high risk for zonular
instability that included pseudoexfoliation, shallow anterior chamber, high
myopia, phacodonesis, or unstable zonules. A total of 55 eyes from 43 patients
(70.7  10.3 years old) were included in this retrospective study undergoing
phacoemulsification and IOL implantation using CTR on toric and multifocal
IOLs. These eyes were at high risk for zonular instability that included
pseudoexfoliation, shallow anterior chamber, high myopia, phacodonesis, or
unstable zonules. The Toric IOL group had 9 eyes with CTR and 22 eyes without
CTR while the multifocal IOL had 9 eyes with CTR and 15 eyes without CTR. No
history of ocular surgery other than cataract removal was reported. The
exclusion criteria included any eyes that experienced intraoperative
complications affecting the IOL stability, except for zonular instability. One
surgeon performed all cases using a standard technique of phacoemulsification
through a 2.4-mm temporal clear corneal incision. Patients were followed up
for 3 months. Manifest refraction, refractive astigmatism, visual acuity, and
degree of IOL decentration and tilt were measured using swept-source anterior
segment optical coherence tomography. Axis misalignment of Toric IOLs was also
evaluated. Results show that the decentration and axis misalignment of the
Toric group was smaller with the CTR than without (p = 0.037), better visual
acuity with CTR than without, and a smaller axis misalignment with CTR (p =
0.037). Although the multifocal group prevented IOL tilt, manifested better
visual acuity with CTR than without (p = 0.021), and had a smaller degree of
tilt in CTR than without (p = 0.025), the follow up period was longer with
CTR. There were a few limitations in this study to include a random assignment
of eyes to CTR or non-CTR by the judgement of the surgeon, the follow-up
period was significantly longer in the multifocal IOL without CTR group than
the multifocal IOL with CTR group, measurements of wave-front aberration were
not conducted in this study, and no evaluation was done on the multifocal
Toric IOLs. Overall, the end results show that the outcome of Toric IOLs co-
implantation of CTR significantly reduce decentration and toxic axis
misalignment that improves uncorrected and corrected visual acuity
postoperatively. In multifocal IOLs, the combined use of CTR significantly
prevented IOL tilt and resulted in better uncorrected visual acuity. This
study shows that CTR is a useful device to improve surgical outcomes of
premium IOL in eyes at high risk of compromised zonular integrity.  
  
Vazquez-Ferreiro6 and colleagues conducted a systematic review and meta-
analysis to evaluate the association pseudoexfoliation syndrome has on IOL
dislocation 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 to
include 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? 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.  
  
**Society Evidence**  
  
According to the American Academy of Ophthalmology (AAO) 2011 et al,2 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 IOP after
phacoemulsification cataract surgery in patients with or without glaucoma.
Alternatives to cataract surgery and management of cataract are very few.
Chang (2011), displays 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 BCVA scores,
increased visual acuity, and were overall satisfied with the results of their
surgery and improvement in quality of life. The AAO mentions, "the ASCRS
National Cataract Database reported that at 3 months postoperatively 85.5% of
all patients had a 20/40 or better BCVA, 57.2% of patients had 20/25 or better
postoperative BCVA, and 74.6% of patients were within  D of target spherical
equivalent. In studies of phacoemulsification cataract surgery performed by
ophthalmology residents, the reported range of patients with postoperative
BCVA of 20/40 or better was 80% to 91%." The only major potentially eye-
threatening complications of cataract surgery are infectious endophthalmitis,
toxic anterior segment syndrome (TASS), intraoperative suprachoroidal
hemorrhage, cystoid macular edema (CME), retinal detachment, persistent
corneal edema, and IOL dislocation. 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. Same-day bilateral
cataract surgery is pending more evidence for safety and other concerns.  
  
According to the AAO 2016 et al,1 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 African Americans age 40 and older. Lower
level education has been added as one of the risk factors of cataracts. 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. In order 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 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 BCVA 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.  
  
The American College of Surgeons National Surgical Quality Improvement
Program, the Geriatrics Healthcare Professionals, the American Geriatrics
Society, and the John A. Hartford Foundation, have partnered to develop a
geriatric assessment and guidelines for preoperative management. In a 2010
study, seventy percent of the patients over 60 years old lacked the decision-
making capacity and over half of that population were required to make
decisions about their treatment and final days of life. Preoperative treatment
can sometimes require fasting, antibiotic prophylaxis, venous thromboembolism
prophylaxis, and medication management, in which, proper planning and
coordinating are required. Risk for falls are prevalent in the elderly
population. Fall prevention was significantly reduced and found to include
supervised exercises, environmental elements, assistive technology, and
knowledge interventions according to a 2010 Cochrane review. In addition to
preventing some of these age-related complications discussed above, reduction
of cost and length of hospital stay, reduced risk of mortality, increased
likelihood of discharge to home, improved care transitions, and improved
patient satisfaction and functional status at discharge are some of the key
components addressed in the guidelines for the geriatrics models of care.7

The evidence of literature supports that cataract surgery, including complex
surgery, is a safe and effective procedure improving visual acuity and
enhancing quality of life in adults and the elderly population with few
intraoperative and postoperative complications.1-3 The most frequent
complication following cataract surgery in the very elderly population is
posterior capsule tear without vitreous loss and corneal decompression
according to Michalska.3 Olson and Chang, mention the only major potentially
eye-threatening complications of cataract surgery are infectious
endophthalmitis, TASS, intraoperative suprachoroidal hemorrhage, CME, retinal
detachment, persistent corneal edema, and IOL dislocation.1,2  
  
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 al8 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,3 the BCVA scores improved in 100 out of the 122 patients
(82%) with senile cataracts postoperative and at follow up. Lastly, in a
retrospective, observational cohort study, complex cataract surgery did not
decrease the intraocular pressure in patients with POAG. However, it did
improve visual acuity and reduced medication burden in the POAG group. Complex
Cataract surgery did, however, decrease IOP in patients without primary open
angle glaucoma and improved visual acuity.4  
  
Societies such as the AAO, the 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.9 Based on the literature, limited
coverage will be provided for cataract surgery, including complex cataract
surgery as outlined in the LCD.