## 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


### 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


### 46351 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Proposed Rules

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 OPPSrates 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 categoriesthat 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


### 46352 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Proposed Rules

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, itdoes 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.


### 46353 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Proposed Rules

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


### 46354 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Proposed Rules

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, itdoes 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 in2006 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


### 46355 Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Proposed Rules

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.