Medicare Program; Approval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers, 4586-4589 [E6-1049]

Download as PDF 4586 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices rmajette on PROD1PC67 with NOTICES requirements; and ability to provide us with the necessary data for validation. Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization’s complete application, a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from our receipt of a completed application to publish approval or denial of the application. The purpose of this proposed notice is to inform the public of our ¨ consideration of the TUV Healthcare ¨ Specialists’ (TUVHS’) request to become a national accreditation organization for hospitals. This notice also solicits public comment on the ability of ¨ TUVHS requirements to meet or exceed the Medicare CoPs for hospitals. III. Evaluation of Deeming Authority Request ¨ On December 2, 2005, the TUV ¨ Healthcare Specialists (TUVHS) submitted all the necessary materials to enable us to make a determination concerning its request for approval as a deeming organization for hospitals. Under section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accreditation organizations), ¨ our review and evaluation of TUVHS will be conducted in accordance with, but not necessarily limited to, the following factors: ¨ • The equivalency of TUVHS’ standards for hospitals as compared with our comparable hospital CoPs. ¨ • TUVHS’ survey process to determine the following: —The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. ¨ —The comparability of TUVHS’ processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. ¨ —TUVHS’ processes and procedures for monitoring providers or suppliers found out of compliance with ¨ TUVHS’ program requirements. These monitoring procedures are used only ¨ when TUVHS identifies noncompliance. If noncompliance is identified through validation reviews, the survey agency monitors corrections as specified at § 488.7(d). ¨ —TUVHS’ capacity to report deficiencies to the surveyed facilities and respond to the facility’s plan of correction in a timely manner. ¨ —TUVHS’ capacity to provide us with electronic data in ASCII comparable VerDate Aug<31>2005 15:17 Jan 26, 2006 Jkt 208001 code, and reports necessary for effective validation and assessment of the organization’s survey process. ¨ —The adequacy of TUVHS’ staff and other resources, and its financial viability. ¨ —TUVHS’ capacity to adequately fund required surveys. ¨ —TUVHS’ policies with respect to whether surveys are announced or unannounced. ¨ —TUVHS’ agreement to provide us with a copy of the most current ac creditation survey together with any other information related to the survey as we may require (including corrective action plans). DEPARTMENT OF HEALTH AND HUMAN SERVICES IV. Collection of Information Requirements SUMMARY: In this final notice we respond to public comments on our September 30, 2005 notice with comment period and announce our decision concerning an application submitted by Advanced Medical Optics (AMO) to adjust the Medicare payment amounts for certain intraocular lenses (IOLs) on the basis that they are new technology intraocular lenses (NTIOLs). This is the third of three statutorily required Federal Register documents. On May 27, 2005, we published a notice in the Federal Register entitled ‘‘Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)’’ (70 FR 30731) that solicited interested parties to submit requests for review of the appropriateness of the payment amount for an IOL furnished by an ambulatory surgical center. On September 30, 2005, we published a notice with comment period entitled ‘‘Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)’’ (70 FR 57297) acknowledging timely receipt of one application. In this final notice, we announce our decision to approve the NTIOL application submitted by Advanced Medical Optics (AMO) for Tecnis (model numbers Z9000, Z9001, and Z9003). EFFECTIVE DATE: This notice is effective on February 27, 2006. FOR FURTHER INFORMATION CONTACT: Michael Lyman, (410) 786–6938. SUPPLEMENTARY INFORMATION: This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). V. Response to Public Comments and Notice Upon Completion of Evaluation Because of the large number of comments 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 proposed notice. Upon completion of our evaluation, including evaluation of comments received as a result of this proposed notice, we will publish a final notice in the Federal Register responding to the public comments and announcing the result of our evaluation. VI. Executive Order 12866 Statement In accordance with the provisions of Executive Order 12866, this proposed notice was not reviewed by the Office of Management and Budget. Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: January 20, 2006. Mark B. McClellan, Administrator, Centers for Medicare and Medicaid Services. [FR Doc. 06–748 Filed 1–26–06; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Centers for Medicare and Medicaid Services [CMS–3144–FN] 0938–ZA49 Medicare Program; Approval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final notice. AGENCY: I. Background On October 31, 1994, the Social Security Act Amendments of 1994 (SSAA 1994) (Pub. L. 103–432) were enacted. Section 141(b)(1) of SSAA 1994 required us to develop and implement E:\FR\FM\27JAN1.SGM 27JAN1 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices a process under which interested parties may request a review of the appropriateness of the payment amount for intraocular lenses furnished by ASCs under section 1833(i)(2)(A)(iii) of the Social Security Act (the Act) on the basis that those lenses constitute a class of new technology intraocular lenses. On June 16, 1999, we published a final rule in the Federal Register entitled ‘‘Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers’’ (64 FR 32198), which added subpart F to 42 CFR part 416. The June 16, 1999 final rule established a process for adjusting payment amounts for NTIOLs furnished by ambulatory surgical centers (ASCs), defined the terms relevant to the process, and established an initial flat rate payment adjustment of $50 for IOLs that we determine are NTIOLs. The payment adjustment applies for a 5-year period that begins when we recognize a payment adjustment for the first IOL in a new class of technology, as explained below. Any subsequent IOLs having the same characteristics as the first IOL recognized for a payment adjustment will receive the same adjustment for the remainder of the 5-year period established by the first recognized NTIOL. In accordance with the payment review process specified in § 416.185, after July 16, 2002, the $50 adjustment amount can be modified through proposed and final rulemaking in connection with ASC services. To date, we have made no changes to the payment amount and have opted not to change the adjustment for calendar year 2005 (CY 2005). rmajette on PROD1PC67 with NOTICES II. NTIOL Applications Submitted for Calendar Year 2005 On May 27, 2005 we published a notice in the Federal Register entitled ‘‘Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)’’ (70 FR 30731) that solicited interested parties to submit requests for review of the appropriateness of the payment amount for an IOL furnished by an ambulatory surgical center. In response to the May 27, 2005 notice, we received one timely request for review: 1. Manufacturer: Advanced Medical Optics (AMO); Model Numbers: Tecnis (model numbers Z9000, Z9001, and Z9003). Tecnis Models Z9000 and Z9001 are made from silicone material. The Tecnis Model Z9003 is made from acrylic material. All three lenses provide the same functionality, differing VerDate Aug<31>2005 15:17 Jan 26, 2006 Jkt 208001 only in material. Accordingly, we are treating these lenses as the same lens. On September 30, 2005 we published in the Federal Register a notice with comment period entitled ‘‘Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers (ASCs)’’ (70 FR 57297) acknowledging timely receipt of one application. III. Criteria and Process for NTIOL Determination We will classify an IOL as an NTIOL if the lens meets the definition of a ‘‘new technology IOL’’ in § 416.180, which incorporates section 141(b)(2) of SSAA 1994. Under that section, a ‘‘new technology IOL’’ is defined as ‘‘an IOL that CMS determines has been approved by the FDA for use in labeling and advertising the IOL’s claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.’’ The process we use for evaluating requests for NTIOL designation and reviewing the appropriateness of the payment amount for a NTIOL furnished by ASCs is described in our regulations at part 416, subpart F and in the September 30, 2005 Federal Register notice. This process includes— • Publishing a public notice in the Federal Register identifying requirements and the deadline for submitting a request; • Processing requests to review the appropriateness of the payment amount for an IOL; • Compiling a list of the requests we receive that identify the IOL manufacturer, IOL model number under review, name of the requester, and a summary of the request for review of the appropriateness of the IOL payment amount; • Publishing an annual public notice in the Federal Register that lists the requests and provides for a public comment period; • Reviewing the information submitted with the applicant’s request for review, and requesting confirmation from the FDA about labeling applications that have been approved on the IOL model under review. We also request the FDA’s recommendations as to whether or not the IOL model submitted represents a new class of PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 4587 technology that sets it apart from other IOLs. Using a baseline of the date of the last determination of a new class of IOLs, the FDA states an opinion based on proof of superiority over existing lenses of the same type of material or over lenses providing specific clinical advantages and superiority over existing IOLs as described in the preceding paragraph; • Determining which lenses meet the criteria to qualify for the payment adjustment based on clinical data and evidence submitted for review, the FDA’s analysis, public comments on the lenses, and other available information; • Designating a type of material or a predominant characteristic of an NTIOL that sets it apart from other IOLs to establish a new class; • Publishing a notice in the Federal Register announcing the IOLs that we have determined are ‘‘new technology’’ IOLs. These NTIOLs qualify for a $50 payment adjustment (or other amount announced through notice and comment rulemaking); and • Adjusting payments effective 30 days after the publication of the final notice announcing our determinations described in the preceding paragraph of this section. In accordance with our NTIOL application review procedures, we asked the FDA to review the AMO application to determine whether the manufacturer’s claims of specific clinical advantages and superiority over existing IOLs had been approved for labeling and advertising purposes. Our regulations require the FDA’s approval of a requestor’s claims for advertising and labeling in order for an IOL to be classified as a NTIOL. IV. Analysis of and Responses to Public Comments We received 12 timely public comments in response to the September 30, 2005 notice with comment period on the NTIOLs under review. Eleven were from ophthalmologists in support of NTIOL status for the Tecnis lenses. One comment was received from another manufacturer who makes an IOL with similar aspheric optic design characteristics. The comments we received and our responses are as follows: Comments: The commenting ophthalmologists strongly supported NTIOL designation for the Tecnis lenses. Most of these commenters reported positive experiences from patients in whom they implanted the Tecnis lenses during cataract surgery. The commenters reported improved contrast vision, reduced overall ocular spherical aberration, improved E:\FR\FM\27JAN1.SGM 27JAN1 4588 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices functional vision, and significantly better contrast sensitivity and contrast acuity. One stated that surgeons should not use substandard lenses when better lenses are available. Another commenter provided a research article concluding the Tecnis lens provided improved visual acuity and functional acuity contrast testing compared to conventional spherical silicone and acrylic IOLs. This article had been previously submitted by AMO in its 2004 and 2005 calendar year NTIOL submissions. We also received a comment supporting NTIOL status for the Tecnis lenses that suggested they be classified as ‘‘Aspheric Optic’’ NTIOLs. The commenter also requested that one of its IOL products having aspheric optic design characteristics, as well as an IOL of another manufacturer, be placed in this newly created ‘‘Aspheric Optic’’ NTIOL class. We agree with the commenters in their support of the Tecnis lenses. We do not agree with the comment that the Tecnis lenses be classified as ‘‘Aspheric Optic’’ NTIOLs. NTIOL classes are defined by clinical outcomes which provide benefits to Medicare beneficiaries. The two previously created NTIOL classes are ‘‘Multifocal’’ and ‘‘Reduction in Preexisting Astigmatism.’’ We disagree with the commenter’s suggestion to create a new ‘‘Aspheric Optic’’ NTIOL class as this class would not be based upon clinical outcome. We recommend that the commenter who claimed that one of its IOLs has aspheric optic design characteristics submit an application with evidence showing clinical benefits of its lenses during the 2006 NTIOL application period. We appreciate all commenters’ interest in the NTIOL process. V. NTIOL Decision—Approval of Advanced Medical Optics Application Tecnis rmajette on PROD1PC67 with NOTICES AMO Lenses; Models Z9000, Z9001, and Z9003 In CY 2004, AMO applied for NTIOL designation for the Tecnis lenses. As part of the 2004 NTIOL review, CMS requested FDA review of AMO’s NTIOL application. FDA’s review confirmed that the clinical trial performed by AMO demonstrated that results under several conditions tested were statistically significantly better with the Tecnis lens than with the control acrylic IOL. However, we denied AMO’s CY 2004 NTIOL application for the Tecnis lenses due to the lack of evidence that the Tecnis design improvements provided clinical benefits to patients. VerDate Aug<31>2005 15:17 Jan 26, 2006 Jkt 208001 AMO resubmitted its NTIOL request in CY 2005 and provided additional information on the clinical relevance of reduced postoperative spherical aberration and increased contrast sensitivity. In the CY 2005 application, AMO provided additional peerreviewed published studies, a metaanalysis, and a justification of the choice of comparator lens, none of which were included in the CY 2004 application. To demonstrate clinical superiority, AMO submitted journal articles and AMO-sponsored research reporting improved functional vision resulting from compensation for corneal spherical aberration. We reviewed the additional literature submitted by AMO in its CY 2005 application and found it to be acceptable and supportive of our requirements. AMO claims the Tecnis IOLs create a new class of IOLs compensating for corneal spherical aberration. AMO states this improves contrast sensitivity, functional performance, and especially safer night driving. Based on the additional information from AMO, CMS approves AMO’s claims of clinical advantages and superiority of the Tecnis IOL for ocular spherical aberrations and simulated night driving. We find the AMO Tecnis Lenses Models Z9000, Z9001, and Z9003 meet the NTIOL definition and are to be given the new NTIOL classification of Reduced Spherical Aberration. VI. Collection of Information Requirements Because the requirements referenced in this final notice will not affect 10 or more persons on an annual basis, this notice does not impose any information collection and record keeping requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. VII. Regulatory Impact Statement We have examined the impacts of this notice as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995(Pub. L. 104–4) and Executive Order 13132. Executive Order 12866, (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We have determined that this final notice is not a major rule. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined that this final notice will not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a regulation 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 604 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 a Core-Based Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined that this final notice will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This final notice will have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State, local, or tribal governments, preempts State law, or otherwise has Federalism implications. Since this final notice does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this final notice E:\FR\FM\27JAN1.SGM 27JAN1 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices was not reviewed by the Office of Management and Budget. Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: January 9, 2006. Mark B. McClellan, Administrator, Centers for Medicare and Medicaid Services. [FR Doc. E6–1049 Filed 1–25–06; 4:00 pm] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3162–N] Medicare Program; Meeting of the Medicare Coverage Advisory Committee—March 30, 2006 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. rmajette on PROD1PC67 with NOTICES AGENCY: SUMMARY: This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. The charter also permits the MCAC to develop recommendations about other specific issues of Medicare coverage. This meeting concerns authoritative drug compendia that may be used in determining the medically accepted indications of drugs and biologicals used in an anti-cancer chemotherapeutic regimen under Part B of the Medicare program. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). DATES: The public meeting will be held on Thursday, March 30, 2006 from 7:30 a.m. until 4:30 p.m. e.s.t. Deadlines: Deadline for Presentations and Comments: Written comments and presentations must be received by February 27, 2006, 5 p.m., e.s.t. Deadline for Registration To Attend Meeting: For security reasons, individuals wishing to attend this meeting must register by close of business on March 23, 2006. Special Accommodations: Persons attending the meeting who are hearing VerDate Aug<31>2005 15:17 Jan 26, 2006 Jkt 208001 or visually impaired, or have a condition that requires special assistance or accommodations, are asked to notify the Executive Secretary by March 23, 2006 (see FOR FURTHER INFORMATION CONTACT). ADDRESSES: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244. FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, Executive Secretary, by telephone at 410–786–2881 or by email at Michelle.Atkinson@cms.hhs.gov. Web site: You may access up-to-date information on this meeting at http:// www.cms.hhs.gov/FACA/ 02_MCAC.asp#TopOfPage. Presentations and Comments: Interested persons may present data, information, or views orally or in writing on issues pending before the Committee. Please submit written comments to Michelle Atkinson, by email at Michelle.Atkinson@cms.hhs.gov or by mail to the Executive Secretary for MCAC, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C1–09–06, Baltimore, MD 21244. SUPPLEMENTARY INFORMATION: I. Background On December 14, 1998, we published a notice in the Federal Register (63 FR 68780) to describe the Medicare Coverage Advisory Committee (MCAC), which provides advice and recommendations to us about clinical issues. This notice announces a public meeting of the Committee. Meeting Topic: The Committee will discuss evidence and hear presentations and public comments regarding the desired characteristics of published authoritative compendia that may be used by CMS to determine the medically accepted indications of drugs and biologicals employed in an anticancer chemotherapeutic regimen under Part B of the Medicare program, section 1861(t)(2) of the Social Security Act. Background information about this topic, including panel materials, is available on the Internet at http:// www.cms.hhs.gov/coverage/. II. Procedure This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. The Committee may limit the number and duration of oral presentations to the time available. If you wish to make formal presentations, you must notify PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 4589 the Executive Secretary named in the FOR FURTHER INFORMATION CONTACT section and submit the following by the Deadline for Presentations and Comments date listed in the DATES section of this notice: a brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and a written copy of your presentation. Your presentation should consider the questions we have posed to the Committee and focus on the issues specific to the topic. The questions will be available on our Web site at http:// www.cms.hhs.gov/FACA/ 02_MCAC.asp#TopOfPage. We require that you declare at the meeting whether or not you have any financial involvement with manufacturers of any items or services being discussed (or with their competitors). After the public and CMS presentations, the Committee will deliberate openly on the topic. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15 minute unscheduled open public session for any attendee to address issues specific to the topic. At the conclusion of the day, the members will vote, and the Committee will make its recommendation. III. Registration Instructions The Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting Maria Ellis at 410–786– 0309, mailing address: Coverage and Analysis Group, OCSQ; Centers for Medicare & Medicaid Services; 7500 Security Blvd, Mailstop: C1–09–06; Baltimore, MD 21244, or by e-mail at Maria.Ellis@cms.hhs.gov. Please provide your name, address, organization, telephone and fax number, and e-mail address. You will receive a registration confirmation with instructions for your arrival at the CMS complex. You will be notified if the seating capacity has been reached. This meeting is located on Federal property; therefore, for security reasons, any individuals wishing to attend this meeting must register by close of business on March 23, 2006. IV. Security, Building, and Parking Guidelines This meeting will be held in a Federal Government building; therefore, Federal security measures are applicable. In planning your arrival time, we E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Notices]
[Pages 4586-4589]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-3144-FN]
0938-ZA49


Medicare Program; Approval of Adjustment in Payment Amounts for 
New Technology Intraocular Lenses Furnished by Ambulatory Surgical 
Centers

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: In this final notice we respond to public comments on our 
September 30, 2005 notice with comment period and announce our decision 
concerning an application submitted by Advanced Medical Optics (AMO) to 
adjust the Medicare payment amounts for certain intraocular lenses 
(IOLs) on the basis that they are new technology intraocular lenses 
(NTIOLs).
    This is the third of three statutorily required Federal Register 
documents. On May 27, 2005, we published a notice in the Federal 
Register entitled ``Medicare Program; Calendar Year 2005 Review of the 
Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70 
FR 30731) that solicited interested parties to submit requests for 
review of the appropriateness of the payment amount for an IOL 
furnished by an ambulatory surgical center. On September 30, 2005, we 
published a notice with comment period entitled ``Medicare Program; 
Calendar Year 2005 Review of the Appropriateness of Payment Amounts for 
New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory 
Surgical Centers (ASCs)'' (70 FR 57297) acknowledging timely receipt of 
one application. In this final notice, we announce our decision to 
approve the NTIOL application submitted by Advanced Medical Optics 
(AMO) for Tecnis[supreg] (model numbers Z9000, Z9001, and Z9003).

EFFECTIVE DATE: This notice is effective on February 27, 2006.

FOR FURTHER INFORMATION CONTACT: Michael Lyman, (410) 786-6938.

SUPPLEMENTARY INFORMATION: 

I. Background

    On October 31, 1994, the Social Security Act Amendments of 1994 
(SSAA 1994) (Pub. L. 103-432) were enacted. Section 141(b)(1) of SSAA 
1994 required us to develop and implement

[[Page 4587]]

a process under which interested parties may request a review of the 
appropriateness of the payment amount for intraocular lenses furnished 
by ASCs under section 1833(i)(2)(A)(iii) of the Social Security Act 
(the Act) on the basis that those lenses constitute a class of new 
technology intraocular lenses.
    On June 16, 1999, we published a final rule in the Federal Register 
entitled ``Adjustment in Payment Amounts for New Technology Intraocular 
Lenses Furnished by Ambulatory Surgical Centers'' (64 FR 32198), which 
added subpart F to 42 CFR part 416. The June 16, 1999 final rule 
established a process for adjusting payment amounts for NTIOLs 
furnished by ambulatory surgical centers (ASCs), defined the terms 
relevant to the process, and established an initial flat rate payment 
adjustment of $50 for IOLs that we determine are NTIOLs. The payment 
adjustment applies for a 5-year period that begins when we recognize a 
payment adjustment for the first IOL in a new class of technology, as 
explained below. Any subsequent IOLs having the same characteristics as 
the first IOL recognized for a payment adjustment will receive the same 
adjustment for the remainder of the 5-year period established by the 
first recognized NTIOL. In accordance with the payment review process 
specified in Sec.  416.185, after July 16, 2002, the $50 adjustment 
amount can be modified through proposed and final rulemaking in 
connection with ASC services. To date, we have made no changes to the 
payment amount and have opted not to change the adjustment for calendar 
year 2005 (CY 2005).

II. NTIOL Applications Submitted for Calendar Year 2005

    On May 27, 2005 we published a notice in the Federal Register 
entitled ``Medicare Program; Calendar Year 2005 Review of the 
Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70 
FR 30731) that solicited interested parties to submit requests for 
review of the appropriateness of the payment amount for an IOL 
furnished by an ambulatory surgical center. In response to the May 27, 
2005 notice, we received one timely request for review:
    1. Manufacturer: Advanced Medical Optics (AMO); Model Numbers: 
Tecnis[supreg] (model numbers Z9000, Z9001, and Z9003). Tecnis[supreg] 
Models Z9000 and Z9001 are made from silicone material. The 
Tecnis[supreg] Model Z9003 is made from acrylic material. All three 
lenses provide the same functionality, differing only in material. 
Accordingly, we are treating these lenses as the same lens.
    On September 30, 2005 we published in the Federal Register a notice 
with comment period entitled ``Medicare Program; Calendar Year 2005 
Review of the Appropriateness of Payment Amounts for New Technology 
Intraocular Lenses Furnished by Ambulatory Surgical Centers (ASCs)'' 
(70 FR 57297) acknowledging timely receipt of one application.

III. Criteria and Process for NTIOL Determination

    We will classify an IOL as an NTIOL if the lens meets the 
definition of a ``new technology IOL'' in Sec.  416.180, which 
incorporates section 141(b)(2) of SSAA 1994. Under that section, a 
``new technology IOL'' is defined as ``an IOL that CMS determines has 
been approved by the FDA for use in labeling and advertising the IOL's 
claims of specific clinical advantages and superiority over existing 
IOLs with regard to reduced risk of intraoperative or postoperative 
complication or trauma, accelerated postoperative recovery, reduced 
induced astigmatism, improved postoperative visual acuity, more stable 
postoperative vision, or other comparable clinical advantages.''
    The process we use for evaluating requests for NTIOL designation 
and reviewing the appropriateness of the payment amount for a NTIOL 
furnished by ASCs is described in our regulations at part 416, subpart 
F and in the September 30, 2005 Federal Register notice.
    This process includes--
     Publishing a public notice in the Federal Register 
identifying requirements and the deadline for submitting a request;
     Processing requests to review the appropriateness of the 
payment amount for an IOL;
     Compiling a list of the requests we receive that identify 
the IOL manufacturer, IOL model number under review, name of the 
requester, and a summary of the request for review of the 
appropriateness of the IOL payment amount;
     Publishing an annual public notice in the Federal Register 
that lists the requests and provides for a public comment period;
     Reviewing the information submitted with the applicant's 
request for review, and requesting confirmation from the FDA about 
labeling applications that have been approved on the IOL model under 
review. We also request the FDA's recommendations as to whether or not 
the IOL model submitted represents a new class of technology that sets 
it apart from other IOLs. Using a baseline of the date of the last 
determination of a new class of IOLs, the FDA states an opinion based 
on proof of superiority over existing lenses of the same type of 
material or over lenses providing specific clinical advantages and 
superiority over existing IOLs as described in the preceding paragraph;
     Determining which lenses meet the criteria to qualify for 
the payment adjustment based on clinical data and evidence submitted 
for review, the FDA's analysis, public comments on the lenses, and 
other available information;
     Designating a type of material or a predominant 
characteristic of an NTIOL that sets it apart from other IOLs to 
establish a new class;
     Publishing a notice in the Federal Register announcing the 
IOLs that we have determined are ``new technology'' IOLs. These NTIOLs 
qualify for a $50 payment adjustment (or other amount announced through 
notice and comment rulemaking); and
     Adjusting payments effective 30 days after the publication 
of the final notice announcing our determinations described in the 
preceding paragraph of this section.
    In accordance with our NTIOL application review procedures, we 
asked the FDA to review the AMO application to determine whether the 
manufacturer's claims of specific clinical advantages and superiority 
over existing IOLs had been approved for labeling and advertising 
purposes. Our regulations require the FDA's approval of a requestor's 
claims for advertising and labeling in order for an IOL to be 
classified as a NTIOL.

IV. Analysis of and Responses to Public Comments

    We received 12 timely public comments in response to the September 
30, 2005 notice with comment period on the NTIOLs under review. Eleven 
were from ophthalmologists in support of NTIOL status for the 
Tecnis[supreg] lenses. One comment was received from another 
manufacturer who makes an IOL with similar aspheric optic design 
characteristics. The comments we received and our responses are as 
follows:
    Comments: The commenting ophthalmologists strongly supported NTIOL 
designation for the Tecnis[supreg] lenses. Most of these commenters 
reported positive experiences from patients in whom they implanted the 
Tecnis[supreg] lenses during cataract surgery. The commenters reported 
improved contrast vision, reduced overall ocular spherical aberration, 
improved

[[Page 4588]]

functional vision, and significantly better contrast sensitivity and 
contrast acuity. One stated that surgeons should not use substandard 
lenses when better lenses are available. Another commenter provided a 
research article concluding the Tecnis[supreg] lens provided improved 
visual acuity and functional acuity contrast testing compared to 
conventional spherical silicone and acrylic IOLs. This article had been 
previously submitted by AMO in its 2004 and 2005 calendar year NTIOL 
submissions.
    We also received a comment supporting NTIOL status for the 
Tecnis[supreg] lenses that suggested they be classified as ``Aspheric 
Optic'' NTIOLs. The commenter also requested that one of its IOL 
products having aspheric optic design characteristics, as well as an 
IOL of another manufacturer, be placed in this newly created ``Aspheric 
Optic'' NTIOL class.
    We agree with the commenters in their support of the Tecnis[supreg] 
lenses. We do not agree with the comment that the Tecnis[supreg] lenses 
be classified as ``Aspheric Optic'' NTIOLs. NTIOL classes are defined 
by clinical outcomes which provide benefits to Medicare beneficiaries. 
The two previously created NTIOL classes are ``Multifocal'' and 
``Reduction in Preexisting Astigmatism.'' We disagree with the 
commenter's suggestion to create a new ``Aspheric Optic'' NTIOL class 
as this class would not be based upon clinical outcome. We recommend 
that the commenter who claimed that one of its IOLs has aspheric optic 
design characteristics submit an application with evidence showing 
clinical benefits of its lenses during the 2006 NTIOL application 
period. We appreciate all commenters' interest in the NTIOL process.

V. NTIOL Decision--Approval of Advanced Medical Optics Application

AMO Tecnis[supreg] Lenses; Models Z9000, Z9001, and Z9003

    In CY 2004, AMO applied for NTIOL designation for the 
Tecnis[supreg] lenses. As part of the 2004 NTIOL review, CMS requested 
FDA review of AMO's NTIOL application. FDA's review confirmed that the 
clinical trial performed by AMO demonstrated that results under several 
conditions tested were statistically significantly better with the 
Tecnis[supreg] lens than with the control acrylic IOL. However, we 
denied AMO's CY 2004 NTIOL application for the Tecnis[supreg] lenses 
due to the lack of evidence that the Tecnis[supreg] design improvements 
provided clinical benefits to patients.
    AMO resubmitted its NTIOL request in CY 2005 and provided 
additional information on the clinical relevance of reduced 
postoperative spherical aberration and increased contrast sensitivity. 
In the CY 2005 application, AMO provided additional peer-reviewed 
published studies, a meta-analysis, and a justification of the choice 
of comparator lens, none of which were included in the CY 2004 
application. To demonstrate clinical superiority, AMO submitted journal 
articles and AMO-sponsored research reporting improved functional 
vision resulting from compensation for corneal spherical aberration. We 
reviewed the additional literature submitted by AMO in its CY 2005 
application and found it to be acceptable and supportive of our 
requirements.
    AMO claims the Tecnis[supreg] IOLs create a new class of IOLs 
compensating for corneal spherical aberration. AMO states this improves 
contrast sensitivity, functional performance, and especially safer 
night driving. Based on the additional information from AMO, CMS 
approves AMO's claims of clinical advantages and superiority of the 
Tecnis[supreg] IOL for ocular spherical aberrations and simulated night 
driving.
    We find the AMO Tecnis[reg] Lenses Models Z9000, Z9001, and Z9003 
meet the NTIOL definition and are to be given the new NTIOL 
classification of Reduced Spherical Aberration.

VI. Collection of Information Requirements

    Because the requirements referenced in this final notice will not 
affect 10 or more persons on an annual basis, this notice does not 
impose any information collection and record keeping requirements that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995.

VII. Regulatory Impact Statement

    We have examined the impacts of this notice as required by 
Executive Order 12866 (September 1993, Regulatory Planning and Review), 
the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-
354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 
1995(Pub. L. 104-4) and Executive Order 13132.
    Executive Order 12866, (as amended by Executive Order 13258, which 
merely reassigns responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We have determined that this final notice is not a major rule. The RFA 
requires agencies to analyze options for regulatory relief of small 
businesses. For purposes of the RFA, small entities include small 
businesses, nonprofit organizations, and government agencies. Most 
hospitals and most other providers and suppliers are small entities, 
either by nonprofit status or by having revenues of $6 million to $29 
million in any 1 year. Individuals and States are not included in the 
definition of a small entity. We are not preparing an analysis for the 
RFA because we have determined that this final notice will not have a 
significant economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a regulation 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 604 
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 a Core-
Based Statistical Area and has fewer than 100 beds. We are not 
preparing an analysis for section 1102(b) of the Act because we have 
determined that this final notice will not have a significant impact on 
the operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. That threshold 
level is currently approximately $120 million. This final notice will 
have no consequential effect on State, local, or tribal governments or 
on the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it publishes a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State, 
local, or tribal governments, preempts State law, or otherwise has 
Federalism implications. Since this final notice does not impose any 
costs on State or local governments, the requirements of E.O. 13132 are 
not applicable.
    In accordance with the provisions of Executive Order 12866, this 
final notice

[[Page 4589]]

was not reviewed by the Office of Management and Budget.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program).

    Dated: January 9, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare and Medicaid Services.
 [FR Doc. E6-1049 Filed 1-25-06; 4:00 pm]
BILLING CODE 4120-01-P