[Federal Register Volume 60, Number 194 (Friday, October 6, 1995)]
[Notices]
[Pages 52396-52403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24835]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-797-PN]
RIN 0938-AG65
Medicare Program; Limitations on Medicare Coverage of Cataract
Surgery
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed notice.
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SUMMARY: This notice announces the Medicare program's proposal to
define medical necessity with respect to Medicare coverage of
preoperative testing for cataracts, cataract surgery, and Nd:YAG
capsulotomy.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on
December 5, 1995.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: BPD-797-PN, P.O. Box 26688,
Baltimore, MD 21207.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue SW.,
Washington, DC 20201, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code BPD-797-PN. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
For comments that relate to information collection requirements,
mail a copy of comments to: Allison Herron Eydt, HCFA Desk Officer,
Office of Information and Regulatory Affairs, Room 10235, New Executive
Office Building, Washington, DC 20503.
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 512-1800 or by faxing to (202) 512-
2250. The cost for each copy is $8. As an alternative, you can view and
photocopy the Federal Register document at most libraries designated as
Federal Depository Libraries and at many other public and academic
libraries throughout the country that receive the Federal Register.
FOR FURTHER INFORMATION CONTACT: Karen McVearry, (410) 786-4643.
SUPPLEMENTARY INFORMATION:
I. Background
A. Medicare Program Description
The Medicare program was established by the Congress in 1965
through the enactment of title XVIII of the Social Security Act (the
Act). This program provides payment for certain medical services and
supplies for persons 65 years of age and over, certain disabled
persons, and beneficiaries with end-stage renal disease.
While Medicare does cover many health care costs, the program was
not designed to pay for every type of medical care for its
beneficiaries. Section 1862(a)(1)(A) of the Act prohibits Medicare
payment for any expenses incurred for items or services that are not
reasonable and necessary for the diagnosis or treatment of an illness
or injury or to improve the functioning of a malformed body member.
Longstanding Medicare policy has interpreted the term ``reasonable
and necessary'' to mean that an item or service is safe and effective,
not experimental or investigational, and generally accepted in the
medical community. We have used various methods for seeking medical and
scientific opinion in determining whether a health care technology is
reasonable and necessary. These methods have included, at one time or
another, the use of the Office of Health Technology Assessment (OHTA),
a unit of the Agency for Health Care Policy and Research (AHCPR) within
the Public Health Service (PHS), and various forms of consultation and
liaison with national medical associations and groups along with
carrier medical directors, our central office staff physicians, and PHS
representatives.
In developing this proposal for a national coverage policy
concerning preoperative testing, cataract removal surgery, and
postoperative issues, we
[[Page 52397]]
carefully considered cataract practice guidelines developed by a
private-sector panel of experts under the auspices of AHCPR (referenced
in this notice as the ``Expert Panel'') as well as findings from
several other studies discussed in this notice.
The following studies are those that we considered:
Cataract Management Guideline Panel, Cataract in Adults:
Management of Functional Impairment, Clinical Practice Guideline Number
4, Rockville, MD, U.S. Department of Health and Human Services, PHS,
AHCPR, AHCPR Publication Number 93-0542, February 1993. (Throughout
this notice, this study will be referred to as the Clinical Practice
Guideline). In addition to the Clinical Practice Guideline, AHCPR also
published as companion pieces a Patient's Guide (AHCPR Publication
Number 93-0544) and Management of Cataracts in Adults, Quick Reference
Guide for Clinicians Number 4 (AHCPR Publication Number 93-0543).
(Copies of the guidelines may be obtained from the AHCPR Publications
Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907; its toll free
telephone number is 1-800-358-9295.)
American College of Eye Surgeons, Outpatient Ophthalmic
Surgery Society, Society for Excellence in Eye Care, and Society for
Geriatric Ophthalmology, Guidelines for Cataract Practice, Bellevue,
WA, McIntyre Eye Clinic and Surgical Center, February 1993. (Copies of
the guidelines may be obtained from the McIntyre Eye Clinic and
Surgical Center, 1920-116th Avenue NE., Bellevue, WA 98004; its toll
free telephone number is 1-800-822-0199. Its fax number is 1-206-646-
5914.)
General Accounting Office (GAO), Program Evaluation and
Methodology Division, Cataract Surgery, (GAO/PEMD-93-14 Cataract
Surgery, B-239626, April 20, 1993. (Copies of the GAO study may be
obtained from the following address: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. The telephone
number is 1-202-512-1800. The fax number is 1-202-512-2250.)
U.S. Department of Health and Human Services, Office of
Inspector General (OIG), Outpatient Surgery--Medical Necessity and
Quality of Care (OEI-09-88-01000, 1991). (Copies of the OIG study may
be obtained from the following address: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. The telephone
number is 1-202-512-1800. The fax number is 1-202-512-2250.)
B. Medicare Coverage of Cataract Surgery
A cataract is an opacification, or clouding, of the eye's lens that
usually occurs as a part of the aging process. This condition affects
about 50 percent of Americans between the ages of 65 and 75, and
approximately 70 percent of people over 75. Not all cataracts require
surgical removal. The presence of a cataract does not always produce a
noticeable or functional impairment. Thus, cataract surgery is
generally considered to be elective.
When cataract surgery is performed, the opacified lens is removed
from the eye. Extracapsular extraction and phacoemulsification are
cataract removal procedures. The extracapsular procedure is done by
making an incision in the eye and removing the anterior portion of the
capsule. In addition, the nucleus and lens cortex are also extracted,
leaving behind the posterior capsule. Phacoemulsification cataract
removal is a modification of the extracapsular procedure. In
phacoemulsification, the nucleus of the cataract is fragmented by a
probe through ultrasonic frequency while simultaneously aspirating the
fragments from the eye. In most cases, an intraocular lens is then
implanted in the treated eye. The Expert Panel reviewed medical
literature and prepared guidelines based on that review, which revealed
that these surgeries appear to be equally effective in restoring
vision. Adequate data are not available to determine if one technique
is more effective than the other in reducing or eliminating functional
impairment due to the cataract.
Section 35-9 of the Medicare Coverage Issues Manual (HCFA-Pub. 6),
``Phacoemulsification Procedure--Cataract Extraction,'' states that
phacoemulsification is an acceptable procedure for the removal of
cataracts. Therefore, the Medicare program covers reasonable and
necessary services furnished in connection with this procedure, as well
as for extracapsular extractions.
Although Medicare presently does not have a national coverage
policy that specifies the exact parameters for determining coverage of
cataract surgery, there are guidelines for the coverage of presurgery
cataract diagnostic evaluations in Medicare Coverage Issues Manual
section 35-44, ``Use of Visual Tests Prior to and General Anesthesia in
Cataract Surgery.'' Medicare currently covers one comprehensive eye
examination and an A-scan and, if medically justified, a B-scan. (These
scans use sonar to study structures that are not directly visible. They
are used to determine the appropriate pseudophakic power of the
intraocular lens. For most cases involving a simple cataract, a
diagnostic ultrasound A-scan is used. For patients with a dense
cataract, a diagnostic ultrasound B-scan may be used.) These ultrasound
scans are billed and paid for separately from the comprehensive eye
examination because they are separate procedures with their own
Physicians' Current Procedural Terminology (CPT) codes. (Tests
performed that have separate CPT codes are not included as part of the
service reported under ``evaluation and management'' codes. Thus, A-
scans and B-scans cannot be included in the payment for the
comprehensive eye examination.)
Section 50-38 of the Medicare Coverage Issues Manual sets forth
Medicare's current policy on endothelial cell photography. This test is
used to determine the endothelial cell count, which is a predictor of
success of ocular surgery or certain other ocular procedures. Section
50-38 states that this test may be covered in certain circumstances but
that, if the test is performed as part of a presurgical examination for
cataract surgery, coverage for the test is available only as part of
the comprehensive eye examination. In this circumstance, therefore,
separate payment is not made.
This notice proposes to continue this policy of limiting coverage
of diagnostic testing performed before cataract surgery to a
comprehensive eye examination, an A-scan, and, if medically necessary,
a B-scan. Thus, Medicare's policy of not providing additional or
separate coverage for other preoperative tests unless there is another
diagnosis in addition to cataracts would be continued.
Currently, Medicare does not have a national coverage policy that
specifically addresses the following tests:
Contrast sensitivity testing, which is designed to measure
the amount of contrast required to detect a specific stimulus.
Glare testing, which attempts to reproduce the symptom of
glare in cataract patients and to quantify the amount of visual
impairment it causes by comparing acuity with and without a bright
light source directed by the eye.
Potential vision testing, which is designed to determine
whether patients with obviously impaired vision have the potential to
see well following cataract surgery.
[[Page 52398]]
C. Rationale for This Notice: Clinical Studies and Other Evaluations
In reviewing Medicare's cataract removal policy, we have reviewed
the Expert Panel's Clinical Practice Guideline as well as the findings
of the Guidelines for Cataract Practice, the GAO study, and the OIG
study.
1. Findings From the Expert Panel
Through the sponsorship of AHCPR in PHS, the Clinical Practice
Guideline was published in February 1993. In sponsoring development of
this guideline, AHCPR convened an interdisciplinary panel of private-
sector experts made up of ophthalmologists, nurses, optometrists,
internists, a family physician, a psychiatrist, an anesthesiologist, a
clinical social worker, and a patient representative. The panel first
undertook an extensive and comprehensive interdisciplinary review of
the field to define the existing knowledge base and to evaluate
critically the assumptions and common wisdom in the field of cataract
care. Next, the panel developed and initiated a peer review of the
guideline drafts and field reviews with intended users in clinical
sites. Finally, comments from these reviews were assessed and used in
the development of the final guidelines.
The Expert Panel included the following findings concerning
preoperative testing, cataract removal surgery, and postoperative
issues in its guidelines.
a. Preoperative Testing. The Clinical Practice Guideline found
inadequate scientific evidence to support the use of most preoperative
tests in deciding whether cataract surgery is medically appropriate.
These preoperative tests include contrast sensitivity testing, glare
testing, potential vision testing, and specular photographic microscopy
(referred to in this proposed notice as endothelial cell photography).
Contrast Sensitivity Testing
The guidelines state that, at this time, there is inadequate
evidence that contrast sensitivity testing provides information, beyond
the information obtained through a patient's history and an ocular
examination, that is useful for the determination of whether a patient
would benefit from cataract surgery.
Glare Testing
The report of the Expert Panel indicates that there is inadequate
evidence that glare testing provides useful information beyond that
found in a patient's history and an eye examination. This testing,
however, may be useful for corroborating glare symptoms in a small
percentage of cataract patients who complain of glare, yet measure good
Snellen acuity (a standard method of measuring visual accuracy during
an eye examination) in office testing. Even in these patients, a
positive glare test does not determine whether surgery should be
recommended.
Potential Vision Testing
Regarding potential vision testing (PVT), the Expert Panel found
that adequate evidence is lacking as to whether PVT can assist the
ophthalmologist in predicting the outcome of cataract surgery.
Endothelial Cell Photography
The Expert Panel found that there is currently no evidence or
rationale to support the use of endothelial cell photography on all
patients who have cataracts in order to predict the response of the
cornea to cataract surgery.
Other Preoperative Tests
Other preoperative tests were also reviewed by the Expert Panel.
The panel concluded that the following tests are not indicated as part
of the preoperative workup for cataract surgery unless specific
circumstances justify them and unless the justification is documented
in the patient's chart:
--Formal visual fields, which refers to the entire area that can be
seen without shifting the gaze.
--Fluorescein angiography, which is a process in which dye is used to
assess adequate circulation in the blood vessels of the eye.
--External photography, which is a photograph of the external portion
of the eye and lens.
--Corneal pachymetry, which is a procedure that quantifies and monitors
changes in the thickness of the central cornea.
--B-scan ultrasonography, defined earlier in this notice.
--Specialized color vision tests, which are done to determine the
functional ability of the macula and optic nerve.
--Tonography, which records changes in intraocular pressure produced by
the constant application of a known weight on the globe of the eye,
reflecting the facility of outflow of the aqueous humor from the
anterior chamber.
--Electrophysiologic tests, which test the organic functions of the eye
by means of electrical current.
The Expert Panel's report indicates that most of the preoperative
tests reviewed by the panel provide inadequate scientific evidence to
support the need for surgery. Thus, the Expert Panel concluded that
these tests do not predict the benefits a patient may experience from
the surgery or negative outcomes of the surgery. The Expert Panel found
inadequate evidence to support the use of these tests in most cases to
determine the need for cataract removal surgery. The Expert Panel also
found that ``special circumstances'' often necessitate the use of these
preoperative tests.
b. Cataract Removal Surgery. The guidelines also found that surgery
usually is not necessary solely because a cataract is present. The
Expert Panel found that the decision to have cataract surgery should be
based on several factors, such as a complete patient history and an
ocular examination, and an evaluation of the effect of the cataract on
the patient's visual and overall function, after assessing the
patient's visual needs, and after a thorough consideration of the
potential risks associated with the surgery. The Expert Panel believes
that cataract surgery should be considered if--
The individual is afflicted with visual disability that
results in functional impairment, taking into special consideration the
circumstances of the one-eyed patient;
The individual suffers from a lens-induced disease (such
as phacomorphic glaucoma or phacolytic glaucoma); or
The individual has an ocular condition that requires
cataract extraction in order to be adequately diagnosed or treated.
Functional impairment means that the cataract causes a reduction in
visual function that significantly interferes with the person's ability
to participate in everyday activities and infringes on the person's
autonomy. Management of the cataract should be determined primarily on
the basis of the patient's overall visual function and needs, a
complete medical history, an eye examination, and the person's
understanding of the risks and benefits of cataract surgery. The Expert
Panel concluded that cataract surgery performed solely for improving
vision should not be performed if the patient does not want surgery; if
glasses or visual aids provide satisfactory functional vision; if the
patient's lifestyle is not compromised; or if the patient is medically
unfit for cataract removal surgery. Whether the patient's lifestyle is
compromised because of the cataract is a decision made by the patient
and reached through subjective criteria. In addition, the physician
should assist in assessing the patient's visual needs as well as
informing the patient of the potential risks associated with the
cataract removal surgery. The
[[Page 52399]]
patient must decide whether the cataract infringes on his or her
ability to carry out needed or desired activities. Therefore, it is the
patient along with the physician who must determine whether the visual
disability caused by the cataract is significant enough to warrant
surgery.
The panel reviewed situations in which cataract surgery is
indicated for both eyes. The panel concluded that indications for
cataract removal surgery are the same as those for the first eye.
Therefore, the same subjective and objective criteria used to determine
the need for cataract removal in the first eye should also be used in
the evaluation of the second eye. According to the panel, visual
acuity, stereopsis, and visual field are all enhanced by binocular
vision. These facts strongly support the potential benefit of cataract
removal surgery on the second eye.
At this time, there appear to be no scientific data indicating the
optimal time interval for surgically removing a cataract in the second
eye. The panel strongly emphasized, however, that cataract removal
surgery not be performed on both eyes at the same time. The panel
warned that surgery on both eyes during the same procedure runs the
risk of catastrophic consequences if there are unrecognized problems
with unsterile instruments or materials used during the procedure.
In summary, the Expert Panel believes the goal of cataract
treatment is to maintain or restore autonomy through appropriate
treatment in order to remove the disability. In addition, the panel
also asserts that the purpose of cataract surgery is to reduce and,
ideally, alleviate functional impairment caused by the cataract. If a
patient does not have to compromise everyday activities because of the
cataract, the surgery is usually unnecessary. The panel considers
surgery necessary only when the cataract has progressed to the point
that the person's vision is functionally impaired to a level that
infringes on the person's lifestyle.
c. Postoperative Issues. Opacification of the posterior, or back,
lens capsule is a consequence of modern cataract surgery. As the
cloudiness increases, the patient's vision is adversely affected. This
opacification can lead to functional impairment. The most common
technique for treating posterior capsular opacification (PCO) is Nd:YAG
capsulotomy, also referred to as YAG or laser capsulotomy. This
technique uses a laser to make a hole in the central part of the
posterior lens to improve vision.
The Expert Panel lists indications for Nd:YAG capsulotomy in its
Clinical Practice Guideline that include subjective, objective, and
educational criteria. Nd:YAG capsulotomy is considered appropriate and
justified when the ability to carry out needed and desired activities
is impaired. The eye examination confirms the diagnosis of PCO and
excludes other ocular causes of functional impairment, and also
confirms that the patient has been educated about the risks and
benefits of laser surgery to the posterior capsule.
The Expert Panel found no justification for Nd:YAG capsulotomy to
be scheduled at the same time the patient is scheduled for cataract
removal surgery, or when the cataract removal is performed. The Expert
Panel noted that Nd:YAG capsulotomy should never be performed
prophylactically because there is no predictable time at which this
procedure may be necessary. The Clinical Practice Guideline reports
that Nd:YAG capsulotomy is seldom needed before 3 months have elapsed
following cataract surgery, and that Nd:YAG capsulotomy carries its own
risks. Although PCO is common, it varies in severity and does not
always necessitate surgery. It is rare that opacification is severe
enough to require Nd:YAG capsulotomy within 3 months of cataract
surgery, and it is uncommon within the first 6 months after cataract
surgery. The Expert Panel asserts that less than 25 percent of those
having cataract surgery have Nd:YAG capsulotomy done within 2 years of
surgery. The Expert Panel found Nd:YAG capsulotomy to be a highly
successful procedure. However, justification for Nd:YAG capsulotomy
should be well documented in the patient's record.
2. Findings From the Guidelines for Cataract Practice
Another study on cataract removal was issued at approximately the
same time that the AHCPR-sponsored Clinical Practice Guideline was
published. The additional study is entitled Guidelines for Cataract
Practice and was completed by a cooperative committee composed of
members of the leadership of several clinical ophthalmic surgeon
organizations. These guidelines represent a consensus of highly
experienced surgeons who have been personally involved in the
development of cataract surgical removal techniques, the treatment of
patients, and the education of other ophthalmic surgeons.
a. Preoperative Testing. The Guidelines for Cataract Practice, like
the Clinical Practice Guideline, states that before the decision to
have cataract surgery is made, full information regarding the correct
diagnosis of the cataract and the prognosis for return of visual
function following the anticipated treatment must be obtained. The
patient's medical history should be carefully evaluated including how
the cataract presently affects the patient's ability to function
normally. In other words, these guidelines support the Expert Panel's
findings that functional impairment of the patient should be weighed
heavily before deciding whether to have cataract removal surgery.
In addition, the Guidelines for Cataract Practice states that
preoperative testing may be of some use in determining the presence of
a cataract, as well as the presence of other ocular diseases. Several
preoperative tests that are discussed in the Expert Panel's findings
are also addressed in the Guidelines for Cataract Practice. Three
specific tests are discussed in detail by both studies. These tests are
contrast sensitivity testing, glare testing, and endothelial cell
photography.
Contrast Sensitivity Testing
Contrast sensitivity is a measure of the contrast level required
for detection of a specified size of a test object. This test
quantitatively reveals decreased perception of low contrast objects.
Although the Guidelines for Cataract Practice indicates that contrast
sensitivity has been shown to be an indication of the need of
recognition of visual targets for those dealing with rapidly moving
test targets, the Expert Panel's guidelines state only that there is
inadequate evidence as to whether this test will indicate either the
presence or severity of a cataract or a prognosis for improvement
following cataract removal surgery.
Glare Testing
Glare testing measures the effect of simulated glare on vision
function. Disabling glare is often an indication that a cataract has
developed. But, the Guidelines for Cataract Practice found that using
glare testing as a diagnostic tool may be effective only if the patient
complains of glare in situations when visual function would otherwise
be considered satisfactory. If visual function is decreased in normal
lighting conditions, glare testing adds little to the diagnostic
evaluation. Although glare testing may indicate the presence of a
cataract, the test does not measure the severity of the cataract or the
prognosis for improvement after cataract surgery. Thus, this test does
not show that cataract removal surgery is medically necessary.
[[Page 52400]]
Endothelial Cell Photography
Endothelial cell photography may be done before an intraocular
operation because the corneal endothelium is particularly sensitive to
the trauma of the surgery. This test is used to measure and record the
evaluation of corneal endothelial cells. Patients with a preoperative
reduction of their endothelial cell density are unusually sensitive to
the trauma of surgery and may not maintain adequate visual functions
following surgery. The Guidelines for Cataract Practice found that
endothelial cell photography is useful in these cases to predict
unusual surgical risks because low endothelial cell density may not be
accurately predicted by patient history or examination. However, the
Guidelines for Cataract Practice also found that many patients of low
endothelial cell density can be identified through the patient's
medical history and clinical examination.
Other Tests
In addition to contrast sensitivity, glare testing, and endothelial
cell photography, the Guidelines for Cataract Practice discusses other
preoperative tests. The Guidelines for Cataract Practice states that
these additional tests may be of some use in the diagnosis and
prognosis of cataract removal. The Guidelines for Cataract Practice
suggests that patients with ocular diseases other than cataracts would
benefit from additional preoperative testing because these tests would
protect the patient from disappointing results if the cataract is not
the major cause of visual impairment. Some of these additional tests
are also discussed in AHCPR-sponsored Clinical Practice Guideline. In
addition to the tests previously mentioned, both studies discuss B-scan
ultrasonography, corneal pachymetry, the electrophysiological test,
external photography, fluorescein angiography, formal visual fields,
the specialized color vision test, and tonography.
b. Cataract Surgery. Regarding the treatment of cataracts, the
findings from the Guidelines for Cataract Practice are similar to those
in the Expert Panel's guidelines. The Guidelines for Cataract Practice
agrees with the Expert Panel's guidelines, which state that the goal of
cataract removal surgery for the purpose of functional rehabilitation
is improvement of visual function. Surgery should be performed for the
purpose of reducing or eliminating functional impairment caused by the
cataract.
The Guidelines for Cataract Practice concurs with the Expert
Panel's findings that surgery generally is not necessary solely because
the cataract is present. Both guidelines list similar reasons why a
patient may choose not to have surgery. These reasons include:
The patient does not desire surgery.
Glasses or visual aids provide functional vision
satisfactory to the patient's needs and desires.
The patient's lifestyle is not compromised.
The patient is known to be medically unfit for safe
surgical intervention.
The Guidelines for Cataract Practice generally supports the Expert
Panel's findings regarding surgical removal of a cataract in the second
eye. The guidelines concludes that surgery on the second eye is
justified in order to restore binocular vision. In addition, the
subjective and objective criteria used to determine the necessity of
cataract removal for the first eye must also be fulfilled before
performing the same procedure on the second eye.
While the Guidelines for Cataract Practice agrees that cataract
removal generally should not be performed on both eyes during the same
procedure, additional findings contend that some clinical circumstances
may exist that would require consideration of operating on both eyes
simultaneously. For example, a patient who has poor general health and
multiple medical conditions may be a candidate for dual cataract
removal because of the high risk involved in anesthetizing the patient
twice. It is suggested that whenever possible, however, cataract
removal surgery be performed on each eye separately and that sufficient
time be allowed for the first eye to heal before the second cataract
removal is performed.
The Expert Panel's guidelines and the Guidelines for Cataract
Practice both agree that the decision to have cataract surgery should
be left to the patient after all appropriate counseling has been
provided.
c. Postoperative Issues. The Guidelines for Cataract Practice, like
the Expert Panel's findings, indicates that PCO frequently occurs after
cataract removal surgery. Nd:YAG laser capsulotomy was found to be the
most commonly performed procedure to relieve PCO. Management of
functional impairment due to PCO is similar to the management of the
procedure that removes the cataract. Findings from the Guidelines for
Cataract Practice also are consistent with the Expert Panel's
guidelines that Nd:YAG capsulotomy should not be performed or scheduled
at the same time cataract removal is performed. Both studies assert
that routine or prophylactic posterior capsulotomy is not appropriate.
3. Findings from GAO
In April 1993, GAO issued a report on cataract surgery. GAO's
findings support the Expert Panel's assertion that the mere presence of
a cataract does not necessitate the surgical removal of the cataract.
GAO set up a study to determine how many cataract surgeries were
performed unnecessarily. GAO hypothesized that the four States
(California, Massachusetts, Pennsylvania, and Texas) from their survey
on eye symptoms and functional impairment before and after surgery were
not unrepresentative of current practice and applied the permissive
criterion that surgery is considered inappropriate if the patient
reported no functional impairment. The study revealed that by using the
criterion of functional impairment, 6 percent of the respondents'
surgeries were inappropriate. GAO further calculated that every 1
percent of cataract surgeries represented approximately $34 million in
expenditures for Medicare. Under this scenario, GAO concluded that
Medicare spent $204 million in 1991 for inappropriate cataract surgery.
This is a conservative estimate considering that, in that same year,
1.35 million cataract surgeries were performed for which the Medicare
program alone spent $3.4 billion. GAO theorized that if the number of
inappropriate surgeries could be reduced, Medicare would not only save
a great deal of money, but the quality of care for individuals with
cataracts would improve.
4. Findings from OIG
The OIG's study, Outpatient Surgery--Medical Necessity and Quality
of Care (OEI-09-88-01000, 1991), found that high-volume
ophthalmologists (those who earn at least $1 million annually) are more
likely to perform medically unnecessary surgeries and provide poor or
questionable care than non-high-volume ophthalmologists.
II. Provisions of the Proposed Notice
The findings from the Expert Panel regarding cataract surgery and
postoperative issues are supported by information found in the
Guidelines for Cataract Practice. The GAO study concluded that there
are substantial numbers of inappropriate cataract surgeries, while the
OIG study found that high-volume ophthalmologists are more likely to
perform medically unnecessary surgeries and provide poor or
questionable care than non-high-volume ophthalmologists.
[[Page 52401]]
After evaluating these findings, we are proposing to adopt the
following policies:
Medicare would maintain its policy of paying only for a
comprehensive eye examination or brief/intermediate examination as well
as an A-scan and, if medically necessary, a B-scan before cataract
surgery if the patient's only diagnosis is cataracts. We believe
coverage of the B-scan is justified because this is a necessary
diagnostic test for a patient who has a dense cataract rather than a
simple cataract, which can be tested with an A-scan.
Thus, Medicare would include payment for tests such as contrast
sensitivity, glare testing, and potential vision testing in the payment
for the comprehensive eye examination performed before cataract surgery
if the patient's only diagnosis is cataracts. Additional or separate
payment for these tests would not be allowed if the only diagnosis is
cataracts. Also, when there is a diagnosis in addition to cataracts, we
would require that the medical need for these tests be documented in
the patient's medical record whenever they are performed.
Medicare would cover cataract surgery only for individuals
who desire the surgery; who are medically fit for the surgery; and
whose lifestyle is compromised by functional impairment because of the
cataract, as documented in the patient's medical record. Medicare would
not consider cataract surgery reasonable and necessary if glasses could
satisfactorily correct the condition; if the patient's lifestyle was
not compromised; or, if surgery was performed solely because a cataract
was present. Medicare would also cover cataract surgery for individuals
who suffer from lens-induced disease and ocular conditions requiring
clear media.
The Expert Panel's guidelines strongly emphasized that
clinical studies have revealed that there is the potential for great
risk if cataract removal is performed on both eyes during the same
procedure. As a result, the Expert Panel found that cataract removal be
performed on each eye during separate procedures and sufficient time be
allowed for the first eye to heal before cataract removal is performed
on the second eye. If extraordinary medical circumstances exist in
which it may be dangerous or life-threatening for the patient to
undergo anesthesia twice, a single procedure may be considered.
Medicare coverage extends to both sets of circumstances.
Medicare would cover Nd:YAG capsulotomy only if this
procedure is performed subsequent to cataract surgery and is found to
be medically necessary. Namely, Nd:YAG capsulotomy would be covered
when it is reasonable and medically necessary to remedy functional
impairment due to opacification following cataract surgery, as
documented in detail in the patient's record. Medicare would not cover
Nd:YAG capsulotomy if this procedure is performed or scheduled
concurrently with cataract removal surgery.
III. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and if we proceed with a subsequent document,
we will respond to the comments in the preamble to that document.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, agencies are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Therefore, we are soliciting public comment on each of these issues
for the information collection requirements discussed below.
The information collection requirements concern written
documentation in the patient's medical record of the necessity of
cataract surgery. The record must state that the individual desires the
surgery, is medically fit for the surgery, and the lifestyle of the
individual is compromised by functional impairment because of the
cataract; or, the individual suffers from lens-induced disease and
ocular conditions requiring clear media. The information collection
requirements also concern written documentation in the patient's
medical record of the necessity of Nd:YAG capsulotomy. The record must
state that this procedure is performed subsequent to cataract surgery
and is found to be medically necessary to remedy a documented
functional impairment because of opacification following cataract
surgery. Physicians, specifically ophthalmologists, would provide the
information. Public reporting burden for this collection of information
is estimated to be 166,666 hours per year based on an average of 5
minutes per service for a total of approximately 2 million services
furnished in 1994.
These reporting and recordkeeping requirements are not effective
until they have been approved by OMB. A notice will be published in the
Federal Register when approval is obtained.
Organizations and individuals desiring to submit comments on the
information collection and recordkeeping requirements should direct
them to HCFA, OFHR, MPAS, C2-27-17, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850 and to the OMB official whose name appears in the
ADDRESSES section of this preamble.
V. Regulatory Impact Analysis
A. Regulatory Flexibility Act
Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612), we prepare a regulatory flexibility analysis unless the
Secretary certifies that a notice would not have a significant economic
impact on a substantial number of small entities. For purposes of the
RFA, all ophthalmologists, ambulatory surgical centers (ASCs), and
hospitals are considered to be small entities.
We are preparing a regulatory impact analysis because we anticipate
that a majority of the ophthalmologists who perform cataract surgery
would be affected by recommendations contained in this notice. The
following discussion describes what we know about the impact of this
proposed notice on affected entities and is intended to fulfill the
requirements of the RFA.
1. Background
The effect of a cataract on vision can range from minimal to
catastrophic. In most cases, surgical removal of the obscured natural
lens, usually combined with the insertion of an artificial lens
implant, is the only treatment option available. In recent years, the
vast majority of these operations have been performed either in a
hospital outpatient department or in a Medicare-
[[Page 52402]]
certified ASC. The GAO report, Cataract Surgery, discussed earlier in
this notice, mentions that the Medicare program paid for more than 1.8
million outpatient cataract surgeries in 1991. Our payment data
indicate that these surgeries cost the Medicare program in excess of
$3.4 billion.
The information in the GAO report, issued in April 1993, was based
on a random sample survey of 1,964 Medicare patients living in four
States who had undergone cataract surgery. Usable responses were
obtained from 76 percent of the sample. About 75 percent of the
responding Medicare patients reported one or more substantial
functional impairments affecting their ability to drive, read, or watch
television before their cataract surgery. If the criterion for surgery
is that any level of problem with either symptoms or functions (even
those the patient considers slight) is sufficient to warrant surgery,
responses to the GAO survey show that few surgeries (2.5 percent) were
inappropriate. If the criterion is functional impairment, then 6
percent of the respondents' surgeries could be considered
inappropriate.
The GAO report stated that the data from the four States did not
allow them to make generalizations regarding the likely levels of
questionable cataract surgery in the nation as a whole. However, to get
some sense of the financial importance reducing this surgery could
have, GAO: (1) Hypothesized that the four States in the survey were not
unrepresentative of current practice; (2) applied the permissive
criterion that, for the surgery to be considered inappropriate, a
patient must have reported no functional impairment; and (3) calculated
that every 1 percent of cataract surgeries represented approximately
$34 million in expenditures for the Medicare program as a whole. Under
the outlined scenario, GAO reported that Medicare spent approximately
$200 million in 1991 for inappropriate cataract surgery.
2. Effects on Expenditures
We believe that the provisions of this notice would facilitate
savings. First, by reaffirming existing coverage for preoperative
tests, we eliminate or reduce any confusion about this matter. Medicare
would continue to pay for a comprehensive eye examination and an A-scan
and, if medically necessary, a B-scan if the patient's only diagnosis
is cataracts. Payment for additional preoperative tests would be
considered as part of the payment for the comprehensive eye
examination. Additional or separate payment would not be allowed for
tests other than the comprehensive eye examination, A-scan, and, if
medically necessary, a B-scan if the patient's only diagnosis is
cataracts.
Second, we believe that savings would result from a reduction of
unnecessary cataract-removal surgeries. We do not have our own estimate
determining to what degree cataract surgery is performed
inappropriately or the effect this notice would have on reducing
inappropriate cataract surgery. However, the GAO report estimated that
6 percent of the respondents' surgeries could be considered
inappropriate.
Medicare would cover cataract removal surgery only if specific
indications for the surgery are fulfilled. The group that may be most
affected by the inclusion of these indications would be high-volume
ophthalmologists. In its 1991 report, as discussed earlier in this
notice, OIG stated that high-volume ophthalmologists (those who earn at
least $1 million annually) perform almost twice the rate of medically
unnecessary surgery and questionable care as non-high-volume
ophthalmologists.
Third, we believe there would be a decline overall in the number of
Nd:YAG capsulotomies performed as a result of requiring physicians to
document in the patient's medical record that the patient suffers from
functional impairment due to PCO before performing or scheduling the
surgery. Since we are proposing to redefine what constitutes medical
necessity for Nd:YAG capsulotomy, we believe the frequency the
procedure is performed prophylactically (sometimes within 3 months
following cataract surgery) would be drastically reduced, resulting in
additional savings.
We cannot estimate the value of any savings we anticipate as a
result of this notice because we lack information. Savings would depend
upon our ability to generate payment edits that would help us enforce
the proposed coverage policy.
3. Effects on Providers
Cataract surgery performed to redress functional impairment due to
cataract in the adult is the most common surgical procedure performed
on Americans age 65 and over. As a result, cataract surgery is a
significant item in the Medicare budget. The extent that
ophthalmologists would be affected by this notice would depend upon the
extent that they perform cataract surgery on Medicare beneficiaries
that would not conform to the medical necessity criteria proposed in
this notice. All ophthalmologists who treat Medicare beneficiaries,
especially those who perform a high volume of cataract procedures,
would be required to review their methods of evaluating patients before
surgery. Also, ophthalmologists would be required to review their
criteria for performing surgery to ensure that they perform surgery
only on those Medicare patients who have a functional impairment
resulting from the effect of the cataract that compromises the
patient's lifestyle and for whom glasses do not satisfactorily correct
the condition. Under the provisions of this notice, the
ophthalmologists must document in the patient's record any impairment
requiring cataract surgery.
Because the policies we are proposing reflect some of the findings
stated in the guidelines, which were developed by an interdisciplinary
private sector Expert Panel under the sponsorship of AHCPR, we
anticipate that the guidelines would be acceptable to those physicians
furnishing services to Medicare beneficiaries. Most ophthalmologists
are already documenting to some extent the need for cataract surgery in
patients' records; however, this notice would impose additional
requirements on ophthalmologists. We believe that any decrease in the
number of tests and procedures that would result due to a change in
Medicare policy would primarily affect ophthalmologists performing a
high volume of cataract-related procedures on Medicare beneficiaries.
The GAO findings describe a situation in which Medicare expenditures
could be reduced and the quality of services furnished by
ophthalmologists could be enhanced at the same time.
In recent years, the vast majority of cataract surgery procedures
have been performed either in a hospital outpatient department or in a
free-standing ASC. Cataract procedures are performed approximately
twice as often in a hospital outpatient department as in an ASC. A
facility that specializes in eye procedures would be affected to a
greater extent if the number of cataract surgery procedures is reduced
than a facility that handles a wider range of surgical procedures.
B. Rural Hospital Impact Statement
Section 1102(b) of the Act requires the Secretary to prepare a
regulatory impact analysis if a notice may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of
[[Page 52403]]
a Metropolitan Statistical Area and has fewer than 50 beds.
This notice would have little direct effect on payments to rural
hospitals since this rule would recommend coverage changes that would
affect primarily ophthalmologists, ASCs, and hospital outpatient
surgery departments. Very few small rural hospitals would have an
outpatient surgery department.
We are not preparing an analysis for section 1102(b) of the Act
since we have determined, and the Secretary certifies, that this notice
would not result in a significant impact on the operations of a
substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
(Sections 1861 and 1862 of the Social Security Act (42 U.S.C. 1395x
and 1395y))
(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare
Supplementary Medical Insurance)
Dated: May 7, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: June 30, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-24835 Filed 10-5-95; 8:45 am]
BILLING CODE 4120-01-P