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Medicare Program; Public Meeting in Calendar Year 2007 for New Clinical Laboratory Tests Payment Determinations

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Centers for Medicare & Medicaid Services (CMS), HHS.




This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2008, which will be effective on January 1, 2008. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is performed by the CPT Editorial Panel and will not be discussed at the CMS meeting.


The public meeting is scheduled for Monday, July 16, 2007 from 10 a.m. to 2 p.m.


The public meeting will be held in the main auditorium of the central building of the Centers for Medicare & Medicaid Services (CMS) located at 7500 Security Boulevard, Baltimore, Maryland 21244.

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Anita Greenberg, (410) 786-4601.

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I. Background

Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Pub. L. 106-554, mandated procedures that permit public consultation for payment determinations for new clinical laboratory tests under Part B of title XVIII of the Social Security Act (the Act) in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases (ICD-9-CM). The procedures and public meeting announced in this notice for new clinical laboratory tests are in accordance with the procedures published on November 23, 2001 in the Federal Register (66 FR 58743) to implement section 531(b) of BIPA. Also, section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108-173, added section 1833(h)(8)(B)(iii) of the Act, which required that we establish by regulation procedures for determining the basis for, and amount of, payment for new clinical laboratory tests. In the calendar year (CY) 2007 physician fee schedule final rule (71 FR 69701 through 69704), we adopted new 42 CFR subpart G regarding payment for new clinical diagnostic laboratory tests. Under 42 CFR 414.506, we annually convene a meeting that includes representatives of CMS officials involved in determining payment amounts to receive individual comments and recommendations (and data on which the recommendations are based).

A newly created CPT code can either represent a refinement or modification of existing test methods, or a substantially new test method. The newly created CPT codes for the calendar year 2007 will be listed at the web site​ClinicalLabFeeSched on or after June 18, 2007.

The first method, called cross-walking, is used when a new test is determined to be similar to an existing test, multiple existing test codes, or a portion of an existing test code. The new test code is then assigned the related existing local fee schedule amounts and resulting national limitation amount. The second method, called gap-filling, is used when no comparable, existing test is available. When using this method, instructions are provided to each Medicare carrier to determine a payment amount for its geographic area(s) for use in the first year, and the carrier-specific amounts are used to establish a national limitation amount for following years. For each new clinical laboratory test code, a determination must be made to either cross-walk or to gap-fill, and, if cross-walking is appropriate, to know which tests to cross-walk.

II. Meeting Format

This meeting is open to the public. The on-site check-in for visitors will be held from 9:30 to 10 a.m., followed by opening remarks. Registered individuals may discuss and recommend payment determinations for specific new CPT codes for the 2008 Clinical Laboratory Fee Schedule.

Oral presentations must be brief, and must be accompanied by three written copies. Presenters may also make copies available for approximately 50 meeting participants. Presenters should address the new test code(s) and descriptor, the test purpose and method, costs, charges, and make a recommendation with rationale for using one of two methods (cross-walking or gap-fill) for determining payment for new clinical laboratory codes. Presentations that do not address the six items may be considered incomplete and not considered by CMS when making a payment determination. We will request missing information following the meeting in order to prevent a recommendation from being considered incomplete.

A summary of the new codes and the payment recommendations that are presented during the public meeting will be posted on our Web site by September 7, 2007 and can be accessed at​ClinicalLabFeeSched. In addition, the Start Printed Page 29331summary will list other comments received on or before 15 days after the meeting, or August 1, 2007. The summary will also display CMS' tentative payment determinations, and interested individuals may submit written comments on the tentative payment determinations by September 21, 2007 to the address specified in the summary.

III. Registration Instructions

We are coordinating the public meeting registration. Beginning June 18, 2007 registration may be completed on-line at​ClinicalLabFeeSched. The following information must be submitted when registering: Name; company name; address; telephone number(s); and E-mail address(es).

When registering, individuals who want to make a presentation must also specify which new clinical laboratory test code(s) they will be presenting. A confirmation will be sent upon receipt of the registration.

Registration Deadline: Individuals must register by July 11, 2007.

IV. Security, Building, and Parking Guidelines

The 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, participants must bring a government-issued photo identification and a copy of your written meeting registration confirmation. Persons without proper identification may be denied access to the building.

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.

Security measures also include inspection of vehicles, inside and out at the entrance to the grounds. In addition, all persons 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 presentation, are subject to inspection.

V. Special Accommodations

Individuals attending a meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should provide the information upon registering for the meeting.

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Authority: Section 1102, 1833(h), and 1871 of the Social Security Act (42 U.S.C. 1302, 42 U.S.C. 13951, and 42 U.S.C. 1395hh)

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(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

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Dated: March 22, 2007.

Leslie V. Norwalk,

Acting Administrator, Centers for Medicare & Medicaid Services.

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[FR Doc. E7-9525 Filed 5-24-07; 8:45 am]