[Federal Register: May 22, 2009 (Volume 74, Number 98)]
[Notices]
[Page 24017-24019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my09-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1407-N]
Medicare Program; Public Meeting in Calendar Year 2009 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 receive comments and
recommendations (and data on which recommendations are based) from the
public on the appropriate basis for establishing payment amounts for a
specified list of new Clinical Procedural Terminology (CPT) codes for
clinical laboratory tests in calendar year (CY) 2010. 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 CY 2010, which will be
effective on January 1, 2010. 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 Centers for Medicare & Medicaid
Services (CMS) meeting.
DATES: Meeting Date: The public meeting is scheduled for Tuesday, July
14, 2009 from 9 a.m. to 2 p.m., Eastern Standard Time (E.S.T.).
Deadline for Registration of Presenters: All presenters for the
public meeting must register by July 9, 2009.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5
p.m., E.S.T. on July 9, 2009, the final day of registration.
Deadline for Submission of Written Comments: Interested parties may
submit written comments on the proposed payment determinations by
September 18, 2009, to the address specified in the ADDRESSES section
of this notice.
ADDRESSES: The public meeting will be held in the main auditorium of
the central building of the Centers for Medicare & Medicaid Services
(CMS), 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
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) (Pub. L. 106-554)
required the Secretary to establish procedures for coding and payment
determinations for new clinical diagnostic laboratory tests under Part
B of title XVIII of the Social Security Act (the Act) that permit
public consultation 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.
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) of the Act, which sets forth the methods for determining
payment bases for new tests. Section 1833(h)(8)(A) of the Act states
that new tests are any clinical diagnostic laboratory tests with
respect to which a new or substantially revised health care common
procedures code (HCPCS) is assigned on or after January 1, 2005
(hereinafter referred to as, ``new test'' or ``new clinical laboratory
test''). Pertinent to this notice, section 1833(h)(8)(B)(i) and (ii) of
the Act requires the Secretary to make available to the public a list
that includes new tests for which establishment of a payment amount is
being considered for a year and, on the same day that the list is made
available, to publish in the Federal Register a notice of a meeting to
receive comments and recommendations (and data on which recommendations
are based) from the public on the appropriate basis for establishing
payment amounts for new tests. Section 1833(h)(8)(B)(iii) of the Act
requires that we convene a public meeting not less than 30 days after
publication of the notice in the Federal Register. These requirements
are codified at 42 CFR part 414, subpart G.
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 calendar year (CY) 2010 will be published on our
Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched when this notice
is published in the Federal Register.
Two methods are used to establish payment amounts for new tests
[[Page 24018]]
included in the CY 2010 Clinical Laboratory Fee Schedule. The first
method, called cross-walking, is used when a new test is determined to
be comparable 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 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 Part A and Part B Medicare
Administrative Contractor (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 the following
years. For each new clinical laboratory test code, a determination must
be made to either cross-walk or gap-fill.
II. Format
This meeting is open to the public. The on-site check-in for
visitors will be held from 8:30 a.m., E.S.T. to 9 a.m., E.S.T.,
followed by opening remarks. Registered persons from the public may
discuss and recommend payment determinations for specific new test
codes for the CY 2010 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
following:
New test code(s) and descriptor.
Test purpose and method.
Costs.
Charges.
Make a recommendation with rationale for one of two
methods (cross-walking or gap-fill) for determining payment for new
tests.
Additionally, the presenters should provide the data on which their
recommendations are based. Presentations that do not address the above
five items may be considered incomplete and may not be considered by
CMS when making a payment determination. CMS may request missing
information following the meeting in order to prevent a recommendation
from being considered incomplete.
A summary of the proposed new test codes and the payment
recommendations that are presented during the public meeting will be
posted on our Web site by early September 2009 and can be accessed at
http://www.cms.hhs.gov/ClinicalLabFeeSched.
In addition, the summary will list other comments received by July
29, 2009 (15 days after the meeting). The summary will also display our
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 proposed payment
determinations by September 18, 2009, to the address specified in the
ADDRESSES section of this notice. Final payment determinations will be
posted on our Web site in October 2009. Each determination will include
a rationale, data on which the determination is based, and 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
The Division of Ambulatory Services in CMS is coordinating the
public meeting registration. Beginning June 15, 2009, registration may
be completed on-line at the following Web address: http://
www.cms.hhs.gov/ClinicalLabFeeSched. The following information must be
submitted when registering:
Name.
Company name.
Address.
Telephone number(s).
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. Individuals must register by the date specified in the
DATES section of this notice.
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.
It is suggested that you arrive at the CMS facility between 8:15 a.m
and 8:30 a.m., E.S.T. so that you will be able to arrive promptly at
the meeting by 9 a.m., E.S.T. 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 8:15 a.m., E.S.T. (45 minutes before the convening of the
meeting).
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel. Persons without proper identification may be denied access
to the building.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support a
demonstration, 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 demonstration.
V. Special Accommodations
Individuals attending the 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. The deadline for registration is listed in the DATES
section of this notice.
VI. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
[[Page 24019]]
Dated: May 14, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-12030 Filed 5-21-09; 8:45 am]
BILLING CODE 4120-01-P