[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Notices]
[Pages 33825-33826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1402-N]


Medicare Program; Public Meeting in Calendar Year 2008 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 2009, 
which will be effective on January 1, 2009. 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 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 14, 2008 from 9 
a.m. to 2 p.m., Eastern Standard Time (EST).

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: Glenn McGuirk, (410) 786-5723.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA), Public Law 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), Public Law 108-173, 
added section 1833(h)(8)(B)(iii) of the Act to require that we convene 
a public meeting not less than 30 days after publication of this notice 
in the Federal Register to receive comments and recommendations (and 
data on which recommendations are based) for establishing payment 
amounts for new clinical laboratory tests.
    A newly created Current Procedural Terminology (CPT) code can 
either represent a refinement or modification of existing test methods, 
or a substantially new test method. The preliminary list of newly 
created CPT codes for the calendar year (CY) 2009 will be published on 
our Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched 
approximately mid-June 2008.
    Two methods are used to establish payment amounts for tests paid on 
the clinical laboratory fee schedule. 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 the related existing national 
limitation amount. Payment for the new test code is made at the lesser 
of the local fee schedule amount or the 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 or A/B MAC to determine a payment amount for its 
geographic area(s) for use in the first year. These determinations are 
based on the following sources of information (if available): Charges 
for the test and routine discounts to charges; resources required to 
perform the test; payment amounts determined by other payers; and 
charges, payment amounts, and resources required for other tests that 
may be comparable or otherwise relevant. 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 cross-walk.

II. Format

    This meeting is open to the public. The on-site check-in for 
visitors will be held from 8:30 a.m. to 9 a.m., followed by opening 
remarks. Registered persons from the public may discuss and recommend 
payment determinations for specific new CPT codes for the CY 2009 
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--
(1) new test code(s) and descriptor; (2) the test purpose and method; 
(3) costs; (4) charges; and (5) make a recommendation with rationale 
for one of two methods (cross-walking or gap-fill) for determining 
payment for new clinical laboratory codes. Additionally, the presenters 
should provide the data on which their recommendations are based. 
Presentations that do not address the five items may be considered 
incomplete and may not be considered by CMS when making a payment 
determination. CMS may request

[[Page 33826]]

missing information following the meeting in order to prevent a 
recommendation from being considered incomplete.
    A summary of the proposed new codes and the payment recommendations 
that are presented during the public meeting will be posted on our Web 
site by early September 2008 and can be accessed at http://www.cms.hhs.gov/ClinicalLabFeeSched.
    In addition, the summary will list other comments received by July 
29, 2008 or 15 days after the meeting. The summary will also display 
CMS' proposed payment determinations, an explanation of the reasons for 
each determination, and the data on which the determinations are based. 
Interested parties may submit written comments on the tentative payment 
determinations by September 19, 2008 to the address specified in the 
ADDRESSES section of the summary. Final payment determinations will be 
posted on our Web site during October 2008 together with the rationale 
for each determination, the data on which the determinations are based, 
responses to comments, and suggestions received from the public.
    After the final payment determinations have been posted on our Web 
site, the public may request reconsideration of the payment 
determinations as set forth in 42 CFR 414.509. See also 72 FR 66275 
through 66280.

III. Registration Instructions

    We are coordinating the public meeting registration. Beginning June 
16, 2008, 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 on which new clinical laboratory test code(s) they will be 
presenting comments. A confirmation will be sent upon receipt of the 
registration.
    Registration Deadline: Individuals must register by July 9, 2008.

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 not be able 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.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance Program; and No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: May 29, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-13097 Filed 6-12-08; 8:45 am]
BILLING CODE 4120-01-P