[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26264-26266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1623-N]
Medicare Program; Public Meeting on July 16, 2015 Regarding New
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the
Clinical Laboratory Fee Schedule for Calendar Year 2016
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 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) 2016. This meeting also provides a forum for those who
submitted certain reconsideration requests regarding final
determinations made last year on new test codes and for the public to
provide comment on the requests.
DATES: Meeting Date: The public meeting is scheduled for Thursday, July
16, 2015 from 9:00 a.m. to 3:00 p.m., Eastern Daylight Savings Time.
Deadline for Registration of Presenters and Submission of
Presentations: All presenters for the public meeting must register and
submit their presentations electronically to Glenn McGuirk at
[email protected] by July 2, 2015.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5:00
p.m. on July 2, 2015.
Deadline for Submission of Written Comments: We intend to publish
our proposed determinations for new test codes and our preliminary
determinations for reconsidered codes (as described below) for CY 2016
by early September 2015. Interested parties may submit written comments
on these determinations by early October, 2015 to the address specified
in the ADDRESSES section of this notice or electronically to Glenn
McGuirk at [email protected] (the specific date for the
publication of these determinations on the CMS Web site, as well as the
deadline for submitting comments regarding these determinations will be
published on the CMS Web site).
ADDRESSES: The public meeting will be held in the main auditorium of
the Centers for Medicare & Medicaid Services (CMS), Central Building,
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 of the Department of Health and Human Services
(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 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 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
Healthcare Common Procedure Coding System (HCPCS) code is assigned on
or after January 1, 2005 (hereinafter referred to as ``new tests''). 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).
[[Page 26265]]
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.
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 any such test for which establishment of a payment amount is
being considered for a year and, on the same day that the list is made
available, cause to have published in the Federal Register notice of a
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 the tests on
such list. This list of codes for which the establishment of a payment
amount under the clinical laboratory fee schedule (CLFS) is being
considered for calendar year (CY) 2016 is posted on the CMS Web site at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html. Section
1833(h)(8)(B)(iii) of the Act requires that we convene the 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 bases of payment are used to establish payment amounts for new
tests. The first basis called ``crosswalking,'' is used when a new test
is determined to be comparable to an existing test code, multiple
existing test codes, or a portion of an existing test code. The new
test code is assigned 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 42 CFR 414.508(a).)
The second basis called ``gapfilling,'' is used when no comparable
existing test is available. When using this method, instructions are
provided to each Part A and Part B Medicare Administrative Contractor
(MAC) to determine a payment amount for its Part B geographic areas for
use in the first year. The contractor-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. (See 42 CFR
414.508(b) and Sec. 414.509 for more information regarding the
gapfilling process.)
Under section 1833(h)(8)(B)(iv) of the Act, the Secretary, taking
into account the comments and recommendations (and accompanying data)
received at the public meeting, develops and makes available to the
public a list of proposed determinations with respect to the
appropriate basis for establishing a payment amount for each 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. Under section 1833(h)(8)(B)(v) of the
Act, taking into account the comments received during the public
comment period, the Secretary develops and makes available to the
public a list of final determinations of final payment amounts for new
test codes along with the rationale for each determination, the data on
which the determinations are based, and responses to comments and
suggestions received from the public.
After the final determinations have been posted on our Web site,
the public may request reconsideration of the basis and amount of
payment for a new test as set forth in Sec. 414.509. Pertinent to this
notice, those requesting that CMS reconsider the basis for payment or,
for crosswalking, reconsider the payment amount as set forth in Sec.
414.509(a) and (b)(1) may present their reconsideration requests at the
following year's public meeting provided that the requestor made the
request to present at the public meeting in the written reconsideration
request. For purposes of this notice, we refer to these codes as the
``reconsidered codes.'' The public may comment on the reconsideration
requests. (See the November 27, 2007 CY 2008 Physician Fee Schedule
final rule with comment period (72 FR 66275 through 66280) for more
information on these procedures.)
II. Format
We are following our usual process, including an annual public
meeting to determine the appropriate basis and payment amount for new
and reconsidered test codes under the CLFS for CY 2016.
This meeting is open to the public. 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 make
recommendations for specific new and reconsidered test codes for the CY
2016 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 CMS will not
be providing additional copies. Written presentations must be
electronically submitted to CMS on or before July 2, 2015. 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, CMS 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]. For reconsidered and new test codes,
presenters should address all of the following items:
Reconsidered or new test code(s) and descriptor.
Test purpose and method.
Costs.
Charges.
A recommendation with rationale for one of the two bases
(crosswalking or gapfilling) for determining payment for new tests, or
a recommendation with rationale for changing the basis or payment
amount, as applicable, for reconsidered 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 regarding reconsidered and new
test codes that do not address the above five items may be considered
incomplete and may not be considered by CMS when making a
determination.
Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, we intend to post
our proposed determinations with respect to the appropriate basis for
establishing a payment amount for each new test code and our
preliminary determinations with respect to the reconsidered codes along
with an explanation of the reasons for each determination, the data on
which the determinations are based, and a request for public written
comments on these determinations on the CMS Web site by early September
2015. This Web site can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html. We also will include a summary of all
comments received by August 6, 2015 (15 business days after the
meeting). Interested parties may submit written comments
[[Page 26266]]
on the proposed determinations for new test codes or the preliminary
determinations for reconsidered codes by early October, 2015, to the
address specified in the ADDRESSES section of this notice or
electronically to Glenn McGuirk at [email protected] (the
specific date for the publication of the determinations on the CMS Web
site, as well as the deadline for submitting comments regarding the
determinations will be published on the CMS Web site). Final
determinations for new test codes to be included for payment on the
CLFS for CY 2016 and reconsidered codes will be posted on our Web site
in November 2015, along with the rationale for each determination, the
data which the determinations are based, and responses to comments and
suggestions received from the public. The final determinations with
respect to reconsidered codes are not subject to further
reconsideration. With respect to the final determinations for new test
codes, the public may request reconsideration of the basis and amount
of payment as set forth in Sec. 414.509.
III. Registration Instructions
The Division of Ambulatory Services in the CMS Center for Medicare
is coordinating the public meeting registration. Beginning June 8,
2015, registration may be completed on-line at the following Web
address: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. All the
following information must be submitted when registering:
Name.
Company name.
Address.
Telephone numbers.
Email addresses.
When registering, individuals who want to make a presentation must
also specify for which new test codes 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., so that you will be able to arrive promptly at the
meeting by 9:00 a.m. 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.
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 that information upon registering
for the meeting. The deadline for registration is listed in the DATES
section of this notice.
Dated: April 7, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-11026 Filed 5-6-15; 8:45 am]
BILLING CODE 4120-01-P