[Federal Register Volume 71, Number 102 (Friday, May 26, 2006)]
[Notices]
[Pages 30423-30424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7503]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1324-N]


Medicare Program; Public Meeting in Calendar Year 2006 for New 
Clinical Laboratory Tests for Payment Determinations

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

ACTION: Notice.

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SUMMARY: 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 2007, 
which will be effective on January 1, 2007. Discussion is directed 
toward 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 public meeting.

DATES: The public meeting announced in this notice is scheduled for 
Monday, July 17, 2006 from 10 a.m. to 3 p.m.

[[Page 30424]]


ADDRESSES: The public meeting will be held in the main auditorium of 
the central building of the Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244.

FOR FURTHER INFORMATION CONTACT: Anita Greenberg, (410) 786-4601.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 531(b) of the Medicare, Medicaid, and State Child Health 
Insurance Program 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, 
Ninth Revision, Clinical Modification (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) to the Act to require that we convene 
a public meeting to receive comments and recommendations (and data on 
which recommendations are based) for establishing payment amounts for 
new clinical laboratory tests.
    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 calendar year 2007 will be 
listed on our Web site http://www.cms.hhs.gov/ClinicalLabFeeSched on or 
after June 19, 2006.
    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 identify which tests to 
cross-walk.

II. Format

    This meeting is open to the public. For registration information, 
see section III. The on-site check-in for visitors will be held from 
9:30 a.m. to 10 a.m., followed by opening remarks. Registered persons 
from the public may discuss and recommend payment determinations for 
specific new CPT codes for the 2007 Clinical Laboratory Fee Schedule.
    The public meeting is intended to provide expert input on the 
nature of new clinical laboratory tests and receive recommendations to 
either cross-walk or gap-fill for payment. Decisions regarding payment 
for the newly created Physicians' Current Procedural Terminology (CPT) 
codes will not be made at this meeting. 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 8, 2006 and can be 
accessed at http://www.cms.hhs.gov/ClinicalLabFeeSched. In addition, 
the summary of the meeting will list additional comments received on or 
before 15 days after the meeting. The summary will also display our 
tentative payment determinations, and interested parties may submit 
written comments on the tentative payment determinations by September 
22, 2006 to the following address: Centers for Medicare & Medicaid 
Services (CMS), Center for Medicare Management, Mailstop: C4-07-07, 
7500 Security Boulevard, Baltimore, Maryland 21244-1850.
    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(s), the test purpose and method, costs 
and charges, and present a recommendation with rationale for one of two 
methods (cross-walking or gap-fill) for determining payment for new 
clinical laboratory codes.

III. Registration Instructions

    CMM is coordinating the meeting registration. Beginning June 19, 
2006, registration may be completed on-line at http://www.cms.hhs.gov/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. Individuals may also register by calling Anita Greenberg 
at (410) 786-4601. Registration Deadline: Individuals must register by 
July 12, 2006.

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 their 
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 each day.
    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 the 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.

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

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

    Dated: April 19, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E6-7503 Filed 5-25-06; 8:45 am]
BILLING CODE 4120-01-P