[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30041-30043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1340-N]
Medicare Program; Public Meeting in Calendar Year 2010 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 (including accompanying 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) 2011. The meeting provides a forum for interested parties to make
presentations and submit written comments on the new codes that will be
included in Medicare's Clinical Laboratory Fee Schedule for CY 2011,
which will be effective on January 1, 2011. 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 meeting.
DATES: Meeting Date: The public meeting is scheduled for Thursday, July
22, 2010 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 16, 2010.
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 16, 2010.
Deadline for Submission of Written Comments: Interested parties may
submit written comments on the proposed payment determinations by
September 24, 2010, 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)
requires 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) of the Act. Section 1833(h)(8)(A) of the Act states that
such new tests are any clinical diagnostic laboratory tests with
respect to which a new or substantially revised Healthcare Common
Procedures Coding System (HCPCS) code is assigned on or after January
1, 2005 (hereinafter referred to as, ``new test'' or ``new clinical
laboratory test''). Section 1833(h)(8)(B) of the Act sets forth the
methods for determining payment bases for new tests. 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
[[Page 30042]]
and recommendations (including accompanying 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
represent either 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) 2011 will be published on our
Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched upon publication
of this notice in the Federal Register.
Two methods are used to establish payment amounts for new tests
included in the CY 2011 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
to 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 to receive comments and recommendations (including
accompanying data on which recommendations are based) on the
appropriate payment basis for the specified list of new CPT codes 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 2011 Clinical
Laboratory Fee Schedule.
Presentations must be brief and accompanied by three written
copies. CMS recommends that presenters make copies available for
approximately 50 meeting participants, since CMS will not be providing
additional copies. Before the annual meeting on July 22, 2010,
presentations must also be electronically submitted to CMS on or before
July 2, 2010. Presentations should be sent via e-mail to Glenn McGuirk,
at [email protected]. Once the presentations are collected, CMS
will post them on the Clinical Laboratory Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched. Presenters should address the
following items:
New test code(s) and descriptor;
Test purpose and method;
Costs;
Charges; and
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 the CMS Web site by early September 2010 and can be accessed
at http://www.cms.hhs.gov/ClinicalLabFeeSched.
In addition, the summary on the CMS Web site will also include a
list of all comments received by August 6, 2010 (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 24, 2010, to the address specified in the ADDRESSES section
of this notice. Final payment determinations will be posted on our Web
site in October 2010. 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. We also refer readers to
the November 27, 2007 final rule (72 FR 66275 through 66280).
III. Registration Instructions
The Division of Ambulatory Services in CMS is coordinating the
public meeting registration. Beginning June 22, 2010, 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); 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. 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
[[Page 30043]]
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 such registrations 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)
Dated: May 7, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare
& Medicaid Services.
[FR Doc. 2010-12458 Filed 5-27-10; 8:45 am]
BILLING CODE 4120-01-P