[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29330-29331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1546-N]


Medicare Program; Public Meeting in Calendar Year 2007 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 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.

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

ADDRESSES: 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.

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, 
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 http://www.cms.hhs.gov/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 http://www.cms.hhs.gov/ClinicalLabFeeSched. In addition, the

[[Page 29331]]

summary 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 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.
    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.

    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)

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

    Dated: March 22, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E7-9525 Filed 5-24-07; 8:45 am]
BILLING CODE 4120-01-P