[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29863-29865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11269]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1646-N]
Medicare Program; Public Meeting on July 18, 2016 Regarding New
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the
Clinical Laboratory Fee Schedule for Calendar Year 2017
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 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) 2017. 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 Monday, July 18,
2016 from 9:00 a.m. to 3:00 p.m., Eastern Daylight Savings Time
(E.D.T.)
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 1, 2016 E.D.T.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5:00
p.m. on July 1, 2016 E.D.T.
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 in section
II. Format) for CY 2017 by early September 2016. Interested parties may
submit written comments on these determinations by early October, 2016,
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.)
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
[[Page 29864]]
establishment of a payment amount is being considered for a year and,
on the same day that the list is made available, causes to have
published a notice in the Federal Register 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) 2017 is posted on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. 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 code 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 billed amount, the local fee schedule
amount, or the national limitation amount. (See Sec. 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 area) 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: (1) Charges for the test and routine discounts to charges;
(2) resources required to perform the test; (3) payment amounts
determined by other payers; and (4) charges, payment amounts, and
resources required for other tests that may be comparable or otherwise
relevant. (See Sec. 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 on the proposed
determinations during the public comment period, the Secretary then
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 the CMS 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 2017.
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
2017 CLFS.
We note that the July 2016 Clinical Diagnostic Laboratory Tests
(CDLT) Advisory Panel meeting and the laboratory public meeting will be
a joint meeting this year, on July 18, 2016. The announcement for the
CDLT Advisory Panel meeting will be included in a separate Federal
Register notice.
Because of time constraints, presentations must be brief, lasting
no longer than 10 minutes, and must be accompanied by three written
copies. In addition, presenters should 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 1, 2016. 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 5 items:
(1) Reconsidered or new test codes and descriptor.
(2) Test purpose and method.
(3) Costs.
(4) Charges.
(5) Recommendation with rationale for one of the two bases
(crosswalking or gapfilling) for determining payment for reconsidered
and 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 regarding reconsidered and new
test codes that do not address the above five items for presenters may
be considered incomplete and may not be considered by CMS when making a
determination. However, we may request missing information following
the meeting to prevent a recommendation from being considered
incomplete.
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
2016. This Web site can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. We also will include a
summary of all comments received by August 8, 2016 (15 business
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days after the meeting). Interested parties may submit written comments
on the proposed determinations for new test codes or the preliminary
determinations for reconsidered codes by early October, 2016, 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 2017 and reconsidered codes will be posted on the CMS Web
site in November 2016, 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. 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 6,
2016, registration may be completed on-line at the following Web site:
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, 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 11, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-11269 Filed 5-12-16; 8:45 am]
BILLING CODE 4120-01-P