Notices. Final notice

5,010 words·~23 min read·/register/2006/01/27/06-747

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4120-01-P 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® (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 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). 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 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 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 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 AMO Tecnis® 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. 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® 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, 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 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 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. 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 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 e-mail 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 e-mail 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 anti-cancer 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 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 recommend allowing additional time to clear security. In order to gain access to the building and grounds, individuals must present photographic identification to the Federal Protective Service or Guard Service personnel before being allowed entrance. Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all individuals entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration. Parking permits and instructions will be issued upon arrival. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: 5 U.S.C. App. 2, section 10(a). (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: December 12, 2005. Barry M. Straube, Acting Chief Medical Officer and Acting Director, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services. [FR Doc. E6-704 Filed 1-26-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-1328-N] Medicare Program; February 15, 2006 Town Hall Meeting on the Practice Expense Methodology Including the Proposal From the Physician Fee Schedule Proposed Rule for Calendar Year 2006 AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces a Town Hall meeting on our methodology for establishing practice expense

(PE)values for services paid under the physician fee schedule (PFS). The purpose of this meeting is to:

(1)Clarify our proposed revisions to the PE methodology contained in the PFS calendar year

(CY)2006 proposed rule; and

(2)receive comments and opinions from individuals of the medical community regarding ideas for the CY 2007 PFS proposed rule. This meeting is open to the public, but attendance is limited to space available. DATES: The Town Hall meeting is scheduled for Tuesday, February 15, 2006 from 1:30 p.m. to 4:30 p.m. e.s.t. ADDRESSES: The Town Hall meeting will be held at the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850 in the auditorium in the central building. *Meeting Registration:* Persons wishing to attend this meeting must register by contacting Debbie Cooley at Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail stop C4-03-06, Baltimore, MD 21244-1850, or, by FAX at 410-786-4490 to the attention of Debbie Cooley. Please include the name of the attendee and the organization he or she represents, if applicable. This information must be received by 5 p.m., e.s.t, on Friday, February 10, 2006. This meeting will be held in a Federal Government building, the Centers for Medicare and Medicaid Services; therefore, persons attending this meeting will be required to show a government-issued photo identification and a copy of their confirmation of registration for the meeting. Access may be denied to persons without proper identification. In planning your arrival time, we recommend allowing additional time to clear security. *Security measures include:* Inspection of vehicles, inside and out, at the entrance to the grounds; passing through a metal detector; and, the inspection of all items brought into the building. Laptops and other computer equipment must be registered with the security desk upon entry. Please note that CMS headquarters is a smoke-free complex. FOR FURTHER INFORMATION CONTACT: Debbie Cooley, (410)786-0007 or Dorothy Shannon, (410)786-3396. SUPPLEMENTARY INFORMATION: I. Background Since January 1, 1992, Medicare has paid for services of physicians and other practitioners under a physician fee schedule. This schedule sets payment rates for 7,000 services based on the resources used to provide those services and is updated annually. To construct the fee schedule, we assign values called relative value units

(RVUs)to each service. The total RVUs for a service are the sum of the work RVUs (which include the physician's time and effort); the practice expense RVUs (which cover expenses such as overhead, staff, and supplies); and the malpractice expense RVUs (which cover malpractice premiums). In the CY 2006 PFS proposed rule (70 FR 45764), we outlined our plans to revise the practice expense

(PE)methodology. There were three major parts to our proposal: 1. Changing from a “top-down” methodology for calculating direct PE to a “bottom-up” approach. Currently, on a specialty-specific basis, we derive a PE per physician hour from aggregate survey data, create a cost pool using Medicare utilization data, and then allocate the pool to all the services performed by the specialty. This methodology is complex, often not intuitive, and produces some PE values that can change significantly from year-to-year. The proposed bottom-up approach would use the sum of the typical resource costs for clinical staff, supplies, and equipment required for each service. These typical costs for each service would be determined based primarily on recommendations we reviewed and accepted from the American Medical Association's Relative Value Update Committee (RUC). We would then convert these costs into direct cost PE RVUs. We believe this methodology is easier to understand and more intuitive than the current top-down approach, and should also improve the stability of the PE RVUs over time. In addition, because most of the inputs that would be used in the bottom-up calculation have been approved by the multi-specialty RUC, the medical community has already agreed to their accuracy. 2. Accepting the supplementary PE surveys from seven specialties—allergy, dermatology, urology, gastrointestinal, cardiology, radiology, and radiation oncology—and using these in the calculation of indirect PE. 3. Calculating, on a code-specific basis, the higher of the current portion of the PE RVU for indirect costs (the indirect PE RVU) or the indirect PE RVU resulting from acceptance of the supplementary surveys. This proposal was to have the effect of mitigating the redistributive effects of accepting the seven supplementary surveys by ensuring that, before application of PE budget neutrality, the indirect PE RVUs for each service were no lower than the current indirect PE RVUs. In comments on the CY 2006 PFS proposed rule, commenters indicated that they did not understand the mechanics of our proposals and that there was not enough information for specialties to analyze them. Many commenters requested a 1-year delay in implementation of our proposals to allow time for CMS to provide further information and to give other specialties an additional opportunity to submit their own supplementary survey. After reviewing the CY 2006 PFS proposed rule comments, we determined that the proposal for revising the indirect PE was confusing to the public because the published PE values and impacts were incorrect. Therefore, in the CY 2006 PFS final rule (70 FR 70116), we withdrew the proposed PE revision for 2006 and used the 2005 PE RVUs for most services. The only exceptions were to price the codes that were new in 2006 and, as required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L 108-173), to use the new urology PE data in the calculation of the drug administration codes used by their specialty. As we indicated when we issued the CY 2006 PFS final rule (70 FR 70116), we intend to work with the medical community to ensure that any future proposals to change the PE methodology are understandable and informed by input from the medical community. As the initial step in this process, we are holding this Town Hall meeting to provide this opportunity. II. Meeting Format This meeting will begin with an overview of the objectives of the meeting along with an introduction of the topics to be discussed during the meeting which include: • Clarifying our efforts to revise the PE methodology in the CY 2006 PFS proposed rule which include: + The change from a “top-down” methodology for calculating direct PE to a “bottom-up” approach utilizing the direct cost inputs; + The use of the accepted supplementary PE surveys from the seven specialties in the calculation of indirect PE; + The intended method of obtaining the indirect PE values; and + The elimination of the nonphysician workpool and the related impacts. • A question and answer session that offers the meeting attendees an opportunity to clarify further the topics discussed. • Soliciting input from individual attendees on each facet of our methodology: direct PE, indirect PE, supplementary surveys, and nonphysician workpool. The comments provided during this meeting will assist us in the preparation of the physician fee schedule proposed rule for CY 2007. To provide a basis of understanding before the meeting we will be posting information concerning the PE methodology on our Web site at *http://www.cms.hhs.gov/PhysicianFeeSched/* . This information will include current PE values, examples for deriving PE values using the bottom-up methodology, and projected impacts of these revisions. We encourage individuals to familiarize themselves with this material before the meeting. Copies of this information will be available on the day of the meeting. Authority (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: January 19, 2006. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 06-747 Filed 1-26-06; 8:45 am]

Connectionstraces to 4

Traces to 4 documents

U.S. Code