[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Notices]
[Pages 31620-31622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1441-N]
Medicare Program; Public Meeting in Calendar Year 2012 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 from the public on the appropriate basis for
establishing payment amounts for new or substantially revised
Healthcare Common Procedure Coding System (HCPCS) codes being
considered for Medicare payment under the clinical laboratory fee
schedule (CLFS) for calendar year (CY) 2013.
DATES: Meeting Dates: The public meeting is scheduled for Monday, July
16, 2012, from 9:00 a.m. to 5:00 p.m., and Tuesday, July 17, 2012, from
9:00 a.m. to 12:00 p.m. All times are Eastern Daylight Savings Time.
Deadline for Registration of Presenters: All presenters for the
public meeting must register by July 6, 2012.
Deadline for Written/Electronic Presentations: Written
presentations must also be electronically submitted to on or before
July 6, 2012.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5:00
p.m., on July 6, 2012.
Deadline for Submission of Written Comments: Interested parties may
submit written comments on the proposed payment determinations by
September 28, 2012, 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 tests are in accordance with
the procedures published in the Federal Register on November 23, 2001
(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 requires the
Secretary to ``establish by regulation procedures for determining the
basis for, and amount of, payment for any clinical diagnostic
laboratory test with respect to which a new or substantially revised
HCPCS code is assigned on or after January 1, 2005'' (hereinafter
referred to as, ``new test''). A code is considered to be
``substantially revised'' if ``there is a substantive change to the
definition of the test or procedure to which the code applies (such as
a new analyte or a new methodology for measuring an existing analyte-
specific test).'' (See section 1833(h)(8)(E)(ii) of the Act.)
Section 1833(h)(8)(B) of the Act sets forth the process for
determining the basis for, and the amount of, payment for new tests.
Section 1833(h)(8)(B)(i) and (ii) of the Act requires the Secretary
to--(1) ``make available to the public (through an Internet Web site
and other appropriate mechanisms)a list that includes any such test for
which establishment of a payment amount is being considered for a
year''; and (2) ``on the same day such list is made available, causes
to have published in the Federal Register 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 the tests on such list.'' The list of
codes for which the establishment of a payment amount under the CLFS is
being considered for CY 2013 is posted on our Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched.
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.
Two methods are used to establish payment amounts for new tests.
The first method called ``crosswalking'' 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
assigned to the local fee schedule amounts and the national limitation
amount of the existing test. Payment for the new test is made at the
lesser of the local fee schedule amount or the national limitation
amount. (See Sec. 414.508(a).)
The second method called ``gapfilling'' 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
carrier geographic area(s) for use in the first year. The carrier-
specific amounts are established for the new test code using 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. In the second year, the test code is paid at the
national limitation amount, which is the median of the carrier-specific
amounts. (See Sec. 414.508(b).)
II. Proposals in the CY 2013 Physician Fee Schedule Proposed Rule
We are following our process to determine the appropriate basis and
payment amount for new test codes under the CLFS for CY 2013. Some of
these tests are molecular pathology tests. Stakeholders in the
molecular pathology community continue to debate whether Medicare
should pay for molecular pathology tests under the CLFS or the
physician fee schedule (PFS). Medicare pays for clinical diagnostic
laboratory tests through the CLFS and for services that ordinarily
require physician work through the PFS. We believe that we would
benefit from additional public comments on whether these tests are
clinical diagnostic laboratory tests or whether they are services that
should be paid under the PFS. Therefore, we intend to solicit public
comments on this issue in the CY 2013 PFS proposed rule as well as
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public comment on pricing policies for these tests under the PFS. We
will make final decisions with respect to molecular pathology codes in
the CY 2013 PFS final rule with comment period, and we will post on our
Web site the final payment determinations for any codes paid under the
CLFS in November.
In addition, we intend to post our proposed determinations with
respect to the appropriate basis for establishing a payment amount
under the CLFS for each of these new test codes by September 28, 2012.
If we later decide, based on comments received in response to the
proposals set forth in the CY 2013 PFS proposed rule, that any of these
codes are not clinical diagnostic laboratory test codes, we will post
our final payment determinations only for the new test codes that we
determine are clinical diagnostic laboratory test codes that will be
paid under the CLFS. We intend to post these final payment
determinations in November (at the same time as the CY 2013 PFS final
rule with comment period is published).
Comments and recommendations on whether these codes represent
clinical diagnostic laboratory tests that should be paid under the CLFS
or services that should be paid under the PFS should be provided in
response to the proposals set forth in the CY 2013 PFS proposed rule.
For purposes of this public meeting, comments and recommendations
should be limited to the appropriate basis for establishing payment
amounts for the new test codes under the CLFS for CY 2013.
III. Format
Meeting Overview
This meeting to receive comments and recommendations (including
accompanying data on which recommendations are based) on the
appropriate payment basis for the new test codes contained on the
preliminary list is open to the public. The meeting provides a forum
for interested parties to make presentations and submit written
comments on new test 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 meeting. Comments submitted should
pertain to the payment basis for establishing a payment amount for the
new test codes posted on the CMS Web site.
Meeting Agenda and Instructions for Presenters
The on-site check-in for visitors will be held from 8:30 a.m., to
9:00 a.m., followed by opening remarks. Registered persons from the
public may discuss and recommend payment determinations for specific
new test codes for the CY 2013 CLFS.
Because of time constraints, presentations must be brief, lasting
no longer than 10 minutes, and must be accompanied by three written
copies. In addition, CMS recommends that presenters make copies
available for approximately 50 meeting participants, since additional
copies will not be provided. Written presentations must also be
electronically submitted to CMS on or before July 6, 2012. In the past,
the meeting was held on a single day. This year's meeting will be held
for an additional half day, extending the meeting to allow enough time
for everyone who is interested in presenting information in person to
be accommodated. However, presentation slots will be assigned on a
first-come, first-served basis. In the event that there is not enough
time for presentations by everyone who is interested in presenting, we
will gladly accept written presentations from those who were unable to
present due to time constraints. Presentations should be sent via email
to Glenn McGuirk, at [email protected]. Presenters should
address all of the following items:
New test code(s) and descriptor.
Test purpose and method.
Costs.
Charges.
A recommendation, with rationale, for one of the two
methods (cross-walking or gap-filling) for determining payment for new
tests.
Additionally, the presenters should provide the data on which their
recommendations are based. Written presentations from the public
meeting will be available upon request, via email, to Glenn McGuirk at
[email protected]. 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. We may request missing
information following the meeting in order to prevent a recommendation
from being considered incomplete.
Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, we will post our
proposed determinations with respect to the appropriate basis for
establishing a payment amount for each such code, an explanation of the
reasons for each determination, the data on which the determinations
are based, and a request for public written comments on the proposed
determinations on the CMS Web site by early September 2012. This Web
site can be accessed at http://www.cms.hhs.gov/ClinicalLabFeeSched. We
also will include a summary of all comments received by August 6, 2012
(15 business days after the meeting). Interested parties may submit
written comments on the proposed payment determinations by September
28, 2012, to the address specified in the ADDRESSES section of this
notice. Final payment determinations on new test codes to be included
for payment on the CLFS for CY 2013 will be posted on the CMS Web site
in November 2012 along with the rationale for each such determination,
the data on which the determinations are based, and responses to
comments and suggestions received from the public.
After the final payment determinations have been posted on the CMS
Web site, the public may request reconsideration of the basis for, and
amount of payment for, a new test as set forth in Sec. 414.509. (See
the November 27, 2007 final rule (72 FR 66275 through 66280).)
IV. Registration Instructions
The Division of Ambulatory Services in CMS is coordinating the
public meeting registration. Beginning June 18, 2012, registration may
be completed on-line at the following web address: http://www.cms.hhs.gov/ClinicalLabFeeSched. All the following information must
be submitted when registering:
Name.
Company name.
Address.
Telephone number(s).
Email address(es).
When registering, individuals who want to make a presentation must
also specify on which new 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.
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. Security, Building, and Parking Guidelines
The meeting will be held in a Federal government building;
therefore, Federal
[[Page 31622]]
security measures are applicable. In planning your arrival to the CMS
facility, we recommend allowing additional time to clear security.
Attendees should arrive between 8:15 a.m. and 8:30 a.m., in order to be
prompt for the 9:00 a.m. meeting. 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. (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.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 22, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-12982 Filed 5-25-12; 8:45 am]
BILLING CODE 4120-01-P