[Federal Register: May 27, 2005 (Volume 70, Number 102)]
[Notices]               
[Page 30734-30735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my05-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1293-N]

 
Medicare Program; Public Meeting in Calendar Year 2005 for New 
Clinical Laboratory Tests 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 2006, 
which will be effective on January 1, 2006. 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 further discussed at the CMS meeting.

DATES: The public meeting is scheduled for Monday, July 18, 2005, from 
10 a.m. to 4 p.m., e.d.t.

ADDRESSES: The meeting will be held in the auditorium at the Centers 
for Medicare & Medicaid Services, located at 7500 Security Boulevard, 
Baltimore, Maryland 21244.

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 (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, 
amends 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 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 website by September 8, 2005 and can be 
accessed at http://www.cms.hhs.gov/suppliers/clinlab. The summary will 

also display our tentative payment determinations, and interested 
parties may submit written comments on the tentative payment 
determinations by September 23, 2005, to the address specified in the 
summary.

II. Registration

    Registration Procedures:
    Beginning June 20, 2005, registration may be completed on-line at 
http://www.cms.hhs.gov/suppliers/clinlab. To register by telephone 

contact Anita Greenberg at (410) 786-4601. 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

[[Page 30735]]

of the registration. Individuals may also register by calling Anita 
Greenberg at (410) 786-4601. Registration Deadline: Individuals must 
register by July 14, 2005.

III. 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 persons from the public may discuss and recommend 
payment determinations for specific new CPT codes for the 2005 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 2005 will be listed at the Web site http://www.cms.hhs.gov/suppliers/clinlab
 on or after June 20, 2005.

    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 a 
recommendation with rationale for one of two methods (cross-walking or 
gap-fill) for determining payment for new clinical laboratory codes.
    The first method, called cross-walking, 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 what tests to which 
to cross-walk.

IV. Security, Building, and Parking Guidelines

    The meetings are 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 
government-issued photo identification and a copy of your written 
meeting registration confirmation. Persons without proper 
identification may be denied access.
    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. 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 presentation.
    Parking permits and instructions are issued upon arrival by the 
guards at the main entrance.
    All visitors must be escorted in areas other than the lower and 
first-floor levels in the Central Building.

V. Special Accommodations

    Individuals attending a meeting who are hearing or visually 
impaired and have special requirements, or a condition that requires 
special assistance or accommodations, must provide this information 
when 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).

    Dated: May 12, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-10263- 5-26-05; 8:45 am]
BILLING CODE 4120-01-P