Tuesday, 

August 3, 2010 

Book 3 of 3 Books 

Pages 46169–46836 

Part II—Continued 

Department of 

Health and Human 

Services 

Centers for Medicare and Medicaid 

42 CFR Parts 410, 416 and 419 

Medicare Program: Changes to the 

Hospital Outpatient Prospective Payment 

System and CY 2010 Payment Rates; 

Changes to the Ambulatory Surgical 

Center Payment System and CY 2010 

Payment Rates; Corrections; Final Rule, 

Notice, and Proposed Rule 

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46170 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 410, 411, 412, 413, 416, 

419, 482, and 489 

[CMS–1504–P] 

RIN 0938–AP82 

Medicare Program; Proposed Changes 

to the Hospital Outpatient Prospective 

Payment System and CY 2011 Payment 

Rates; Proposed Changes to the 

Ambulatory Surgical Center Payment 

System and CY 2011 Payment Rates; 

Proposed Changes to Payments to 

Hospitals for Certain Inpatient Hospital 

Services and for Graduate Medical 

Education Costs; and Proposed 

Changes to Physician Self-Referral 

Rules and Related Changes to 

Provider Agreement Regulations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the Medicare hospital outpatient 

prospective payment system (OPPS) to 

implement applicable statutory 

requirements and changes arising from 

our continuing experience with this 

system and to implement certain 

provisions of the Patient Protection and 

Affordable Care Act, as amended by the 

Health Care and Education 

Reconciliation Act of 2010 (Affordable 

Care Act). In this proposed rule, we 

describe the proposed changes to the 

amounts and factors used to determine 

the payment rates for Medicare hospital 

outpatient services paid under the 

prospective payment system. These 

proposed changes would be applicable 

to services furnished on or after January 

1, 2011. 

In addition, this proposed rule would 

update the revised Medicare ambulatory 

surgical center (ASC) payment system to 

implement applicable statutory 

requirements and changes arising from 

our continuing experience with this 

system and to implement certain 

provisions of the Affordable Care Act. In 

this proposed rule, we set forth the 

proposed applicable relative payment 

weights and amounts for services 

furnished in ASCs, specific HCPCS 

codes to which these proposed changes 

would apply, and other pertinent 

ratesetting information for the CY 2011 

ASC payment system. These proposed 

changes would be applicable to services 

furnished on or after January 1, 2011. 

This proposed rule also includes 

proposals to implement provisions of 

the Affordable Care Act relating to 

payments to hospitals for direct 

graduate medical education (GME) and 

indirect medical education (IME) costs; 

and new limitations on certain 

physician referrals to hospitals in which 

they have an ownership or investment 

interest. 

DATES: To be assured consideration, 

comments on all sections of this 

proposed rule must be received at one 

of the addresses provided in the 

ADDRESSES section no later than 5 p.m. 

EST on August 31, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1504–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1504– 

P, P.O. Box 8013, Baltimore, MD 21244– 

1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–1504– 

P, Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal Government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call the telephone number (410) 

786–7195 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Alberta Dwivedi, (410) 786–0378, 

Hospital outpatient prospective 

payment issues. 

Paula Smith, (410) 786–0378, 

Ambulatory surgical center issues. 

Michele Franklin, (410) 786–4533, 

and Jana Lindquist, (410) 786–4533, 

Partial hospitalization and community 

mental health center issues. 

James Poyer, (410) 786–2261, 

Reporting of quality data issues. 

Tzvi Hefter, (410) 786–4487, and IngJye Cheng, (410) 786–4548, Hospital 

preadmission services and direct 

graduate medical education and indirect 

medical education payments issues. 

Jacqueline Proctor, (410) 786–8852, 

Physician ownership and investment in 

hospitals issues. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244, on Monday 

through Friday of each week from 8:30 

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processing system would respond to the 

modifier by waiving the deductible for 

all surgical services on the same date as 

the diagnostic test. Coinsurance or 

copayment would continue to apply to 

the diagnostic test and to other services 

furnished in connection with, as a result 

of, and in the same clinical encounter as 

the screening test. 

2. Proposed Payment for Covered 

Ancillary Services 

a. Background 

Our final payment policies under the 

revised ASC payment system for 

covered ancillary services vary 

according to the particular type of 

service and its payment policy under 

the OPPS. Our overall policy provides 

separate ASC payment for certain 

ancillary items and services integrally 

related to the provision of ASC covered 

surgical procedures that are paid 

separately under the OPPS and provides 

packaged ASC payment for other 

ancillary items and services that are 

packaged under the OPPS. Thus, we 

established a final policy to align ASC 

payment bundles with those under the 

OPPS (72 FR 42495). 

Our ASC payment policies provide 

separate payment for drugs and 

biologicals that are separately paid 

under the OPPS at the OPPS rates, while 

we pay for separately payable radiology 

services at the lower of the MPFS nonfacility PE RVU (or technical 

component) amount or the rate 

calculated according to the ASC 

standard ratesetting methodology (72 FR 

42497). In all cases, ancillary items and 

services must be provided integral to the 

performance of ASC covered surgical 

procedures for which the ASC bills 

Medicare, in order for those ancillary 

services also to be paid. 

ASC payment policy for 

brachytherapy sources generally mirrors 

the payment policy under the OPPS. We 

finalized our policy in the CY 2008 

OPPS/ASC final rule with comment 

period (72 FR 42499) to pay for 

brachytherapy sources applied in ASCs 

at the same prospective rates that were 

adopted under the OPPS or, if OPPS 

rates were unavailable, at contractorpriced rates. Subsequent to publication 

of that rule, section 106 of the Medicare, 

Medicaid, and SCHIP Extension Act of 

2007 (Pub. L. 110–173) mandated that, 

for the period January 1, 2008 through 

June 30, 2008, brachytherapy sources be 

paid under the OPPS at charges adjusted 

to cost. Therefore, consistent with our 

final overall ASC payment policy, we 

paid ASCs at contractor-priced rates for 

brachytherapy sources provided in 

ASCs during that period of time. 

Beginning July 1, 2008, brachytherapy 

sources applied in ASCs were to be paid 

at the same prospectively set rates that 

were finalized in the CY 2008 

OPPS/ASC final rule with comment 

period (72 FR 67165 through 67188). 

Immediately prior to the publication of 

the CY 2009 OPPS/ASC proposed rule, 

section 142 of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (Pub. L. 110–275) 

amended section 1833(t)(16)(C) of the 

Act (as amended by section 106 of the 

Medicare, Medicaid, and SCHIP 

Extension Act of 2007, Pub. L. 110–173) 

to extend the requirement that 

brachytherapy sources be paid under 

the OPPS at charges adjusted to cost 

through December 31, 2009. Therefore, 

consistent with final ASC payment 

policy, ASCs continued to be paid at 

contractor-priced rates for 

brachytherapy sources provided integral 

to ASC covered surgical procedures 

during that period of time. 

Other separately paid covered 

ancillary services in ASCs, specifically 

corneal tissue acquisition and device 

categories with OPPS pass-through 

status, do not have prospectively 

established ASC payment rates 

according to the final policies of the 

revised ASC payment system (72 FR 

42502 and 42509; § 416.164(b)). Under 

the revised ASC payment system, 

corneal tissue acquisition is paid based 

on the invoiced costs for acquiring the 

corneal tissue for transplantation. As 

discussed in section IV.A.1. of this 

proposed rule, new pass-through device 

categories may be established on a 

quarterly basis, but currently there are 

no OPPS device pass-through categories 

that would continue for OPPS passthrough payment (and, correspondingly, 

separate ASC payment) in CY 2011. 

b. Proposed Payment for Covered 

Ancillary Services for CY 2011 

For CY 2011, we are proposing to 

update the ASC payment rates and make 

changes to ASC payment indicators as 

necessary to maintain consistency 

between the OPPS and ASC payment 

system regarding the packaged or 

separately payable status of services and 

the proposed CY 2011 OPPS and ASC 

payment rates. The proposed CY 2011 

OPPS payment methodologies for 

separately payable drugs and biologicals 

and brachytherapy sources are 

discussed in sections V. and VII. of this 

proposed rule, respectively, and we are 

proposing to set the CY 2011 ASC 

payment rates for those services equal to 

the proposed CY 2011 OPPS rates. 

Consistent with established ASC 

payment policy (72 FR 42497), the 

proposed CY 2011 payment for 

separately payable covered radiology 

services is based on a comparison of the 

CY 2011 proposed MPFS non-facility PE 

RVU amounts (we refer readers to the 

CY 2011 MPFS proposed rule) and the 

proposed CY 2011 ASC payment rates 

calculated according to the ASC 

standard ratesetting methodology and 

then set at the lower of the two 

amounts. Alternatively, payment for a 

radiology service may be packaged into 

the payment for the ASC covered 

surgical procedure if the radiology 

service is packaged under the OPPS. 

The payment indicators in Addendum 

BB indicate whether the proposed 

payment rates for radiology services are 

based on the MPFS nonfacility PE RVU 

amount or the ASC standard rate setting 

methodology, or whether payment for a 

radiology service is packaged into the 

payment for the covered surgical 

procedure (payment indicator ‘‘N1’’). 

Radiology services that we are 

proposing to pay based on the ASC 

standard ratesetting methodology are 

assigned payment indicator ‘‘Z2’’ 

(Radiology service paid separately when 

provided integral to a surgical 

procedure on ASC list; payment based 

on OPPS relative payment weight) and 

those for which the proposed payment 

is based on the MPFS non-facility PE 

RVU amount are assigned payment 

indicator ‘‘Z3’’ (Radiology service paid 

separately when provided integral to a 

surgical procedure on ASC list; payment 

based on MPFS non-facility PE RVUs). 

All covered ancillary services and 

their proposed payment indicators are 

listed in Addendum BB to this proposed 

rule. 

E. New Technology Intraocular Lenses 

(NTIOLs) 

1. Background 

In the CY 2007 OPPS/ASC final rule 

with comment period (71 FR 68176), we 

finalized our current process for 

reviewing applications to establish new 

active classes of new technology 

intraocular lenses (NTIOLs) and for 

recognizing new candidate intraocular 

lenses (IOLs) inserted during or 

subsequent to cataract extraction as 

belonging to a NTIOL class that is 

qualified for a payment adjustment. 

Specifically, we established the 

following process: 

• We announce annually in the 

Federal Register a document that 

proposes the update of ASC payment 

rates for the following calendar year, a 

list of all requests to establish new 

NTIOL classes accepted for review 

during the calendar year in which the 

proposal is published and the deadline 

for submission of public comments 

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regarding those requests. In accordance 

with section 141(b)(3) of Public Law 

103–432 and our regulations at 

§ 416.185(b), the deadline for receipt of 

public comments is 30 days following 

publication of the list of requests. 

• In the Federal Register document 

that finalizes the update of ASC 

payment rates for the following calendar 

year, we— 

° Provide a list of determinations 

made as a result of our review of all new 

class requests and public comments; 

and 

° Announce the deadline for 

submitting requests for review of an 

application for a new NTIOL class for 

the following calendar year. 

In determining whether a lens belongs 

to a new class of NTIOLs and whether 

the ASC payment amount for insertion 

of that lens in conjunction with cataract 

surgery is appropriate, we expect that 

the insertion of the candidate IOL 

would result in significantly improved 

clinical outcomes compared to currently 

available IOLs. In addition, to establish 

a new NTIOL class, the candidate lens 

must be distinguishable from lenses 

already approved as members of active 

or expired classes of NTIOLs that share 

a predominant characteristic associated 

with improved clinical outcomes that 

was identified for each class. 

Furthermore, in the CY 2007 OPPS/ASC 

final rule with comment period (71 FR 

68227), we finalized our proposal to 

base our determinations on 

consideration of the following factors 

set out at § 416.195: 

• The IOL must have been approved 

by the FDA and claims of specific 

clinical benefits and/or lens 

characteristics with established clinical 

relevance in comparison with currently 

available IOLs must have been approved 

by the FDA for use in labeling and 

advertising; 

• The IOL is not described by an 

active or expired NTIOL class; that is, it 

does not share the predominant, classdefining characteristic associated with 

improved clinical outcomes with 

designated members of an active or 

expired NTIOL class; and 

• Evidence demonstrates that use of 

the IOL results in measurable, clinically 

meaningful, improved outcomes in 

comparison with use of currently 

available IOLs. According to the statute, 

and consistent with previous examples 

provided by CMS, superior outcomes 

that we consider include the following: 

Æ Reduced risk of intraoperative or 

postoperative complication or trauma; 

Æ Accelerated postoperative recovery; 

Æ Reduced induced astigmatism; 

Æ Improved postoperative visual 

acuity; 

Æ More stable postoperative vision; 

and/or 

Æ Other comparable clinical 

advantages, such as— 

Æ Reduced dependence on other 

eyewear (for example, spectacles, 

contact lenses, and reading glasses); 

Æ Decreased rate of subsequent 

diagnostic or therapeutic interventions, 

such as the need for YAG laser 

treatment; 

Æ Decreased incidence of subsequent 

IOL exchange; and 

Æ Decreased blurred vision, glare, 

other quantifiable symptom or vision 

deficiency. 

For a request to be considered 

complete, we require submission of the 

information that is found in the 

guidance document entitled 

‘‘Application Process and Information 

Requirements for Requests for a New 

Class of New Technology Intraocular 

Lens (NTIOL)’’ posted on the CMS Web 

site at: http://www.cms.gov/ 

ASCPayment/08_

NTIOLs.asp#TopOfPage. 

As we stated in the CY 2007 OPPS/ 

ASC final rule with comment period (71 

FR 68180), there are three possible 

outcomes from our review of a request 

for establishment of a new NTIOL class. 

As appropriate, for each completed 

request for consideration of a candidate 

IOL into a new class that is received by 

the established deadline, one of the 

following determinations is announced 

annually in the final rule updating the 

ASC payment rates for the next calendar 

year: 

• The request for a payment 

adjustment is approved for the 

candidate IOL for 5 full years as a 

member of a new NTIOL class described 

by a new HCPCS code; 

• The request for a payment 

adjustment is approved for the 

candidate IOL for the balance of time 

remaining as a member of an active 

NTIOL class; or 

• The request for a payment 

adjustment is not approved. 

We also discussed our plan to 

summarize briefly in the final rule with 

comment period the evidence that we 

reviewed, the public comments, and the 

basis for our determinations in 

consideration of applications for 

establishment of a new NTIOL class. We 

established that when a new NTIOL 

class is created, we identify the 

predominant characteristic of NTIOLs in 

that class that sets them apart from other 

IOLs (including those previously 

approved as members of other expired 

or active NTIOL classes) and that is 

associated with improved clinical 

outcomes. The date of implementation 

of a payment adjustment in the case of 

approval of an IOL as a member of a 

new NTIOL class would be set 

prospectively as of 30 days after 

publication of the ASC payment update 

final rule, consistent with the statutory 

requirement. 

2. NTIOL Application Process for 

Payment Adjustment 

In CY 2007, we posted an updated 

guidance document to the CMS Web site 

to provide process and information 

requirements for applications requesting 

a review of the appropriateness of the 

payment amount for insertion of an IOL 

to ensure that the ASC payment for 

covered surgical procedures includes 

payment that is reasonable and related 

to the cost of acquiring a lens that is 

approved as belonging to a new class of 

NTIOLs. This guidance document can 

be accessed on the CMS Web site at: 

http://www.cms.gov/ASCPayment/

downloads/NTIOLprocess.pdf. 

We note that we have also issued a 

guidance document entitled ‘‘Revised 

Process for Recognizing Intraocular 

Lenses Furnished by Ambulatory 

Surgery Centers (ASCs) as Belonging to 

an Active Subset of New Technology 

Intraocular Lenses (NTIOLs).’’ This 

guidance document can be accessed on 

the CMS Web site at: http:// 

www.cms.gov/ASCPayment/Downloads/

Request_for_inclusion_in_current_

NTIOL_subset.pdf. 

This second guidance document 

provides specific details regarding 

requests for recognition of IOLs as 

belonging to an existing, active NTIOL 

class, the review process, and 

information required for a request to 

review. Currently, there is one active 

NTIOL class whose defining 

characteristic is the reduction of 

spherical aberration. We accept requests 

throughout the year to review the 

appropriateness of recognizing an IOL 

as a member of an active class of 

NTIOLs. That is, review of candidate 

lenses for membership in an existing, 

active NTIOL class is ongoing and not 

limited to the annual review process 

that applies to the establishment of new 

NTIOL classes. We ordinarily complete 

the review of such a request within 90 

days of receipt of all information that 

we consider pertinent to our review, 

and upon completion of our review, we 

notify the requestor of our 

determination and post on the CMS 

Web site notification of a lens newly 

approved for a payment adjustment as 

an NTIOL belonging to an active NTIOL 

class when furnished in an ASC. 

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3. Classes of NTIOLs Approved and 

New Requests for Payment Adjustment 

a. Background 

Since implementation of the process 

for adjustment of payment amounts for 

NTIOLs that was established in the June 

16, 1999 Federal Register, we have 

approved three classes of NTIOLs, as 

shown in the following table, with the 

associated qualifying IOLs to date: 

b. Request to Establish New NTIOL 

Class for CY 2010 and Deadline for 

Public Comment 

As explained in the guidance 

document on the CMS Web site, the 

deadline for each year’s requests for 

review of the appropriateness of the 

ASC payment amount for insertion of a 

candidate IOL as a member of a new 

class of NTIOLs is announced in the 

final rule updating the ASC and OPPS 

payment rates for that calendar year. 

Therefore, a request for review for a new 

class of NTIOLs for CY 2011 must have 

been submitted to CMS by March 8, 

2010, the due date published in the CY 

2010 OPPS/ASC final rule with 

comment period (74 FR 60621). We 

received one request for review to 

establish a new NTIOL class for CY 

2011 by the March 8, 2010 due date. A 

summary of this request follows. 

Requestor/Manufacturer: Alcon 

Laboratories, Inc. 

Lens Model Number: Acrysof®

Natural IOLs, Models: SN60WF, 

SN60AT, MN60MA, and MN60AC. 

Summary of the Request: Alcon 

Laboratories, Inc. (Alcon) submitted a 

request for CMS to determine that its 

Acrysof® Natural intraocular lenses 

meet the criteria for recognition as 

NTIOL and to concurrently establish a 

new class of NTIOLs for blue light 

filtering to improve driving safety under 

glare conditions, with these lenses as 

members. As part of its request, Alcon 

submitted descriptive information about 

the candidate IOLs as outlined in the 

guidance document that we make 

available on the CMS Web site for the 

establishment of a new class of NTIOLs, 

as well as information regarding 

approval of the candidate IOL by the 


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U.S Food and Drug Administration 

(FDA). This information included the 

approved labeling for the candidate 

lenses, a summary of the IOLs’ safety 

and effectiveness, a copy of the FDA’s 

approval notification, and instructions 

for their use. In addition, Alcon also 

submitted a number of studies in 

support of its claim that the blue light 

filtering design features of the candidate 

lenses would improve driving safety 

under glare conditions. We note that we 

have previously considered another 

candidate IOL for which ASC payment 

review was requested on the basis of 

blue light filtering properties. We 

discussed these lenses in the July 23, 

2004 and March 25, 2005 NTIOL 

proposed and final rules published in 

the Federal Register (69 FR 44029 and 

70 FR 15337, respectively). 

In its CY 2011 request, Alcon asserts 

that its request is based on new research 

and measurement technologies that 

demonstrate that the Acrysof® Natural 

IOLs with a blue light filtering 

chromophore filter light in a manner 

that approximates the human crystalline 

lens in the 400–475 nm blue light 

wavelength range to reduce glare that 

impairs the ability of the eye to 

differentiate objects from the 

background. Alcon further states that 

glare reduction can help beneficiaries 

avoid hazards that can be caused by 

glare. Alcon also states that at present, 

there are no active or expired NTIOL 

classes that describe IOLs similar to its 

IOL. 

We established in the CY 2007 OPPS/ 

ASC final rule with comment period 

that when reviewing a request for 

recognition of an IOL as an NTIOL and 

a concurrent request to establish a new 

class of NTIOLs, we would base our 

determination on consideration of the 

three major criteria that are outlined in 

the discussion above. We have begun 

our review of Alcon’s request to 

recognize its Acrysof® Natural IOLs as 

NTIOLs and concurrently establish a 

new class of NTIOLs. We are soliciting 

public comment on these candidate 

IOLs with respect to the established 

NTIOL criteria as discussed above. 

First, for an IOL to be recognized as 

an NTIOL we require that the IOL must 

have been approved by the FDA and 

claims of specific clinical benefits and/ 

or lens characteristics with established 

clinical relevance in comparison with 

currently available IOLs must have been 

approved by the FDA for use in labeling 

and advertising. We note that FDA 

approval for the candidate lens was 

granted in May 2007 and that Alcon 

provided FDA approval documentation, 

including a copy of the FDA’s approval 

notification, the FDA’s summary of the 

IOL’s safety and effectiveness, and the 

labeling approved by the FDA in its 

request for a new class of NTIOLs. The 

approved labels for the Alcon IOLs all 

state, ‘‘Alcon’s proprietary blue light 

filtering chromophore filters light in a 

manner that approximates the human 

crystalline lens in the 400–475 nm blue 

light wavelength range.’’ The FDA label 

does not otherwise reference specific 

clinical benefits or lens characteristics 

of blue light filtering on glare. We are 

interested in public comments on the 

specific clinical benefits or lens 

characteristics with established clinical 

relevance for the blue light filter effects 

on glare. Specifically, we are interested 

in public comments regarding the 

assertion that the specific blue light 

filter properties associated with the 

candidate IOLs improve driving safety 

via the reduction of glare. 

Second, we also require that the 

candidate IOL not be described by an 

active or expired NTIOL class; that is, it 

does not share the predominant, classdefining characteristic associated with 

improved clinical outcomes with 

designated members of an active or 

expired NTIOL class. As noted in the 

table above regarding active and expired 

NTIOL classes, since implementation of 

the NTIOL review process that was 

established in the June 16, 1999 Federal 

Register, we have approved three 

classes of NTIOLs: Multifocal and 

Reduction in Preexisting Astigmatism 

classes, both of which were created in 

2000 and expired in 2005, and the 

currently active Reduced Spherical 

Aberration class, which was created in 

2006 and will expire in 2011. The classdefining characteristic specific to IOLs 

that are members of these classes is 

evident in the name assigned to the 

class. For example, IOLs recognized as 

members of the reduced spherical 

aberration class are characterized by 

their aspheric design that results in 

reduced spherical aberration. We refer 

readers to the table above for 

information about the NTIOL classes 

that have been created since the 

implementation of the review process. 

Based on this information, the candidate 

lens may not be described by an active 

or expired NTIOL class. Its proposed 

class-defining characteristic and 

associated clinical benefits that were 

described in the submitted request, 

specifically the blue light filtering 

properties, may not be similar to the 

class-defining characteristics and 

associated benefits of the two expired 

NTIOL classes, the Multifocal and 

Reduction in Preexisting Astigmatism 

classes, or to the class-defining 

characteristic and associated benefits of 

the currently active Reduced Spherical 

Aberration class. We welcome public 

comments that address whether the 

proposed class-defining characteristic 

and associated clinical benefits of the 

candidate Alcon IOLs are described by 

the expired or currently active NTIOL 

classes. 

Third, our NTIOL evaluation criteria 

also require that an applicant submit 

evidence demonstrating that use of the 

IOL results in measurable, clinically 

meaningful, improved outcomes in 

comparison to use of currently available 

IOLs. We note that in the CY 2007 

OPPS/ASC final rule with comment 

period, we sought comments as to what 

constitutes currently available IOLs for 

purposes of such comparisons, and we 

received several comments in response 

to our solicitation (71 FR 68178). We 

agreed with commenters that we should 

remain flexible with respect to our view 

of ‘‘currently available lenses’’ for 

purposes of reviewing NTIOL requests, 

in order to allow for consideration of 

technological advances in lenses over 

time. For purposes of reviewing this 

request to establish a new NTIOL class 

for CY 2011, we believe that foldable, 

spherical, monofocal IOLs made of 

acrylic, silicone, or 

polymethylmethacrylate materials 

represent the currently available lenses 

against which the candidate NTIOL to 

establish a new class should be 

compared. The Alcon request asserts 

that the proprietary blue light filtering 

chromophore incorporated into the 

design of the candidate lenses and 

asserted associated benefits makes them 

different from IOLs that are currently 

available in the U.S. market. We are 

again seeking public comment on our 

view of ‘‘currently available lenses’’ for 

the purposes of this CY 2011 review. 

We reviewed the evidence submitted 

as part of the request, including two 

peer-reviewed articles and two related 

clinical studies. The first of the 

submitted articles discussed the effect of 

the candidate lenses on glare disability, 

while the second article discussed the 

effects of glare on driving in simulated 

driving conditions. The requestor also 

submitted data from two clinical studies 

directly related to the submitted articles 

discussed above. One cross sectional 

study with a planned sample size of 70 

subjects evaluated glare disability by 

comparing the candidate lenses against 

control lenses which did not include the 

blue light filtering chromophore. Results 

from this study suggest that subjects 

implanted with the applicant IOLs had 

significantly faster photostress recovery 

times than subjects who had control 

IOLs implanted without the blue light 

filtering chromophore. We note that this 

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cross sectional study is ongoing; 

consequently the preliminary results 

submitted with the request only reflect 

40 subjects from the planned total 

sample size. The requestor also 

submitted data from a second clinical 

study with a total sample size of 34 that 

evaluated the benefit of the blue light 

filtering chromophore on driving 

performance in patients implanted with 

the candidate IOLs compared to patients 

implanted with non blue light filtering 

IOLs. The results from this study 

suggested that incorporation of the 

yellow chromophore into the design of 

the candidate lenses reduce glare 

disability and thereby improve the 

ability of older drivers implanted with 

the candidate lenses to drive safely. 

Overall, the evidence submitted 

provides us with important information 

that is critical to our review of this 

request. However, in making our 

decision as to whether to establish a 

new class of NTIOL based on the 

primary characteristic of the candidate 

lenses, we are also interested in what 

other information the public can 

contribute related to the asserted 

benefits of the blue light filtering optic. 

Specifically, we are seeking public 

comment and relevant data on the 

following: 

• Are there other peer-reviewed data 

that would support or disprove the 

claims of clinical benefit made by the 

applicant? 

• The presented studies compare the 

blue filtering optic to clear IOLs, are 

there other IOLs or other clinical 

alternatives for reducing glare? 

• Is the sample size used in both 

studies sufficient considering all 

confounding variables including, but 

not limited to age, sex, race, time from 

surgery, status of eyes (which eye 

received the IOL or both eyes, for 

example) to conclude that a blue light 

filtering optic would reduce glare in the 

Medicare population? 

• What kind of study design would be 

appropriate to prove the claim of 

significant clinical benefit due to glare 

reduction on which the new class 

would be based? 

• Are the submitted data enough to 

clarify that the blue filtering optic is 

responsible for reduction in glare 

disability as asserted by applicant? 

We welcome public comments and 

relevant data specifically addressing 

whether use of the Alcon Acrysof® 

Natural IOLs result in measurable, 

clinically meaningful, improved 

outcomes in comparison with use of 

currently available IOLs. Additionally, 

in accordance with our established 

NTIOL review process, we are seeking 

public comments on all of the review 

criteria for establishing a new NTIOL 

class that would be based on the ability 

of the Acrysof® Natural IOLs to filter 

blue light and subsequently help 

beneficiaries avoid hazards that can be 

caused by glare while driving. All 

comments on this request must be 

received by September 2, 2010. The 

announcement of CMS’s determination 

regarding this request will appear in the 

CY 2011 OPPS/ASC final rule with 

comment period. If a determination of 

membership of the candidate lens in a 

new or currently active NTIOL class is 

made, this determination will be 

effective 30 days following the date that 

the final rule with comment period is 

published in the Federal Register. 

4. Proposed Payment Adjustment 

The current payment adjustment for a 

5-year period from the implementation 

date of a new NTIOL class is $50. In the 

CY 2007 OPPS/ASC final rule with 

comment period, we revised 

§ 416.200(a) through (c) to clarify how 

the IOL payment adjustment is made 

and how an NTIOL is paid after 

expiration of the payment adjustment, 

and made minor editorial changes to 

§ 416.200(d). For CY 2008, CY 2009, and 

CY 2010, we did not revise the payment 

adjustment amount, and we are not 

proposing to revise the payment 

adjustment amount for CY 2011 in light 

of our limited experience with the 

revised ASC payment system, 

implemented initially on January 1, 

2008. 

5. Proposed ASC Payment for Insertion 

of IOLs 

In accordance with the final policies 

of the revised ASC payment system, for 

CY 2011, payment for IOL insertion 

procedures is established according to 

the standard payment methodology of 

the revised payment system, which 

multiplies the ASC conversion factor by 

the ASC payment weight for the surgical 

procedure to implant the IOL. CY 2011 

ASC payment for the cost of a 

conventional lens is packaged into the 

payment for the associated covered 

surgical procedures performed by the 

ASC. The HCPCS codes for IOL 

insertion procedures were included in 

Table 53 below, and their proposed CY 

2011 payment rates may be found in 

Addendum AA to this proposed rule. 


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