[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Notices]
[Page 33825-33826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn08-65]
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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