[Federal Register Volume 69, Number 104 (Friday, May 28, 2004)]
[Notices]
[Pages 30658-30659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1266-N]


Medicare Program; Public Meeting in Calendar Year 2004 for New 
Clinical Laboratory Tests Payment Determinations

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

ACTION: Notice of meeting.

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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 individuals 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 2005 that 
will be effective on January 1, 2005. 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 largely performed by the CPT Editorial 
Panel and will not be discussed at the CMS meeting.

DATES: The public meeting is scheduled for Monday, July 26, 2004 from 
10 a.m. to 4 p.m., e.s.t.

ADDRESSES: The meeting will be held at the Centers for Medicare & 
Medicaid Services (CMS) Auditorium located at 7500 Security Boulevard, 
Baltimore, Maryland 21244.
    Registration: Registration Procedures: Beginning June 28, 2004 
registration may be completed on-line at http://www.cms.hhs.gov/paymentsystems. The following information must be submitted when 
registering: name, company name, address, telephone number, and e-mail 
address. When registering, individuals who want to make a presentation 
must also specify for 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 
22, 2004. If on-line registration is not used, individuals may register 
by phone at (410) 786-4601 or fax to the attention of Anita Greenberg 
at (410) 786-0169.

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

SUPPLEMENTARY INFORMATION:

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. The procedures and public 
meeting announced in this notice for new clinical laboratory tests are 
in accordance with the procedures published to implement section 531(b) 
of BIPA in the Federal Register at 66 FR 58743 on November 23, 2001. 
Also, section 942(b) of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003, Pub. L. 108-173, amended section 
1833(h)(8)(B)(iii) of 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. The public meeting is intended to provide 
expert input on the nature of new clinical laboratory tests and receive 
recommendations to either crosswalk 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 10, 2004 
and can be accessed at http://www.cms.hhs.gov/paymentsystems. The 
summary will also display our tentative payment determinations, and 
interested parties may submit written comments on the tentative payment 
determinations by September 24, 2004 to the address specified in the 
summary.

II. Presentations

    This meeting is open to the public. The on-site check-in for 
visitors will be held from 9:30 a.m. to 10 a.m., followed by opening 
remarks. Registered presenters may discuss and recommend payment 
determinations for specific new CPT codes for the 2004 Clinical 
Laboratory Fee Schedule. 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 2004 will be listed at the following Web site http://www.cms.hhs.gov/paymentsystems on or after June 28, 2004.
    Oral presentations must be brief, and must be accompanied by three 
written

[[Page 30659]]

copies. Presenters may also make copies available for approximately 50 
meeting participants. Presenters must address the new test code(s) and 
descriptor, the test purpose and method, costs, charges, and a 
recommendation with rationale for one of two methods (crosswalking or 
gap-fill) for determining payment for new clinical laboratory codes. 
The first method, called crosswalking, 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 crosswalk or to gap-
fill, and, if crosswalking is appropriate, to know what tests to which 
to crosswalk.

III. General Information

    The meeting will be held in a Federal government building; 
therefore, Federal security measures are applicable. In order to gain 
access to the building and grounds, participants must bring a 
government-issued photo identification and a copy of their registration 
confirmation. Security measures include inspection of vehicles, at 
entrance to the grounds, and the requirement for persons to pass 
through a metal detector when entering the building. All items brought 
to CMS, whether personal or for the purpose of demonstration or to 
support a presentation, are subject to inspection.
    Special Accommodation: Persons attending the meeting who are 
hearing or visually impaired and have special requirements, or who have 
a condition that requires special assistance, must provide this 
information upon registering for the meeting.

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

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

    Dated: May 10, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-11240 Filed 5-27-04; 8:45 am]
BILLING CODE 4120-01-P