82_FR_27823 82 FR 27708 - Medicare Program; Public Meeting on July 31, 2017 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2018

82 FR 27708 - Medicare Program; Public Meeting on July 31, 2017 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 82, Issue 115 (June 16, 2017)

Page Range27708-27710
FR Document2017-12544

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) 2018. 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. The Clinical Diagnostic Laboratory Test (CDLT) Advisory Panel will participate in this meeting by gathering information and asking questions to presenters on July 31, 2017, and will hold a public meeting on August 1, 2017 to discuss matters of the Panel and make recommendations regarding the test codes presented at the CLFS public meeting. In the event the CLFS public meeting needs to extend to August 1, 2017, the CDLT Advisory Panel will convene its public meeting immediately following the CLFS public meeting, rather than starting at 9:00 a.m. Eastern Daylight Savings Time (E.D.T.) as currently planned.

Federal Register, Volume 82 Issue 115 (Friday, June 16, 2017)
[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Notices]
[Pages 27708-27710]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1668-N]


Medicare Program; Public Meeting on July 31, 2017 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2018

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) 2018. 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.
    The Clinical Diagnostic Laboratory Test (CDLT) Advisory Panel will 
participate in this meeting by gathering information and asking 
questions to presenters on July 31, 2017, and will hold a public 
meeting on August 1, 2017 to discuss matters of the Panel and make 
recommendations regarding the test codes presented at the CLFS public 
meeting. In the event the CLFS public meeting needs to extend to August 
1, 2017, the CDLT Advisory Panel will convene its public meeting 
immediately following the CLFS public meeting, rather than starting at 
9:00 a.m. Eastern Daylight Savings Time (E.D.T.) as currently planned.

DATES: Meeting Date: The CLFS public meeting is scheduled for Monday, 
July 31, 2017 from 9:00 a.m. to 5:00 p.m., E.D.T. If needed, the 
meeting will resume on Tuesday, August 1, 2017, beginning at 9:00 a.m. 
E.D.T.
    Deadline for Registration of Presenters and Submission of 
Presentations: All presenters for the CLFS public meeting must register 
and submit their presentations electronically to our CLFS dedicated 
email box, [email protected], by July 14, 2017 at 
5:00 p.m. E.D.T.
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than 5:00 
p.m. E.D.T. on July 14, 2017.
    Deadline for Submission of Written Comments: Written comments 
regarding the presentations must be received by August 11, 2017 at 5:00 
p.m. E.D.T. (10 days after the meeting). We intend to publish our 
proposed determinations for new test codes and our preliminary 
determinations for reconsidered codes (as described later in this 
notice in section II. ``Format'') for CY 2018 by early September 2017. 
Comments in response to the preliminary determinations will be due by 
early October 2017. Interested parties should submit all written 
comments on presentations and preliminary determinations to the address 
specified in the ADDRESSES section of this notice or electronically to 
our CLFS dedicated email box, [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 CLFS 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) 
required 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) (now, ICD-10-CM). The procedures 
and clinical laboratory fee schedule (CLFS) 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 for 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 and 
42 CFR 414.502).
    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 
prior to Calendar Year (CY) 2018 (Beginning January 1, 2018, payments 
for tests will be set in accordance with the methodologies specified in 
section 1834A of the Act.). Pertinent to this notice, sections 
1833(h)(8)(B)(i) and (ii) of the Act require 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, 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 CLFS is 
being considered for CY 2018 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

[[Page 27709]]

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. 
For a new CDLT that is assigned a new or significantly revised code 
before January 1, 2018, 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 amounts, or the national limitation 
amount. (See Sec.  414.508(a)(1)).
    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. In the first year, for a new CDLT that is 
assigned a new or substantially revised code before January 1, 2018, 
the contractor-specific amounts are established 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. In the second year, the test code is 
paid at the national limitation amount. (See Sec.  414.508(a)(2)).
    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 CLFS 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 
the payment amount as set forth in Sec.  414.509(a) and (b), may 
present their reconsideration requests at the following year's CLFS 
public meeting provided the requestor made the request to present at 
the CLFS 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 codes under the CLFS for CY 2018.
    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. E.D.T., followed by 
opening remarks. Registered persons from the public may discuss and 
make recommendations for specific new and reconsidered codes for the CY 
2018 CLFS.
    As stated in the SUMMARY section of this notice, the Clinical 
Diagnostic Laboratory Test (CDLT) Advisory Panel will participate in 
the CLFS public meeting by gathering information and asking questions 
to presenters on July 31, 2017, and will hold a public meeting on 
August 1, 2017 to discuss matters of the Panel and make recommendations 
regarding the test codes presented at the CLFS public meeting. The 
announcement for the CDLT Advisory Panel meeting is 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 14, 2017. Presentation slots will be 
assigned on a first-come, first-served basis. In the event there is not 
enough time for presentations by everyone who is interested in 
presenting, CMS will accept written presentations from those who were 
unable to present due to time constraints. Presentations should be sent 
via email to our CLFS dedicated email box, 
[email protected]. In addition, individuals may 
also submit requests after the CLFS public meeting to obtain electronic 
versions of the presentations. Requests for electronic copies of the 
presentations post public meeting should be sent via email to our CLFS 
dedicated email box, noted above.
    We are standardizing the presentation format for the CLFS public 
meeting. As a result, this year we are requiring presenters to submit 
all presentations using a standard PowerPoint template that is 
available on the CMS Web site, at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html, under the ``Meeting Notice and 
Agenda'' heading.
    For reconsidered and new codes, presenters should address all of 
the following five items:
    (1) Reconsidered or new 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. 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. We may, however, 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 CLFS 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 
2017. This Web site can be accessed at http://www.cms.gov/Medicare/
Medicare-Fee-for-Service-

[[Page 27710]]

Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. 
Interested parties may submit written comments on the preliminary 
determinations for new and reconsidered codes by early October 2017, to 
the address specified in the ADDRESSES section of this notice or 
electronically to our CLFS dedicated email box, 
[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 2018 and reconsidered 
codes will be posted on the CMS Web site in November 2017, 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 CLFS public meeting registration. Beginning June 
19, 2017, and ending July 14, 2017, registration may be completed on-
line at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. On this 
Web page, under the heading ``Meeting Notice, Registration and 
Agenda,'' you will find a link entitled ``Register for CLFS Annual 
Meeting.'' Click this link and enter the required information. 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.
    If not attending the CLFS public meeting in person, the public may 
view the meeting via webcast or listen by teleconference. During the 
public meeting, webcasting is accessible online at http://cms.gov/live. 
Teleconference dial-in information will appear on the final Panel 
meeting agenda, which will be posted on the CMS Web site when available 
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/.

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. 
We suggest that you arrive at the CMS facility between 8:15 a.m. and 
8:30 a.m. E.D.T., so that you will be able to arrive promptly at the 
meeting by 9:00 a.m. E.D.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.D.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 that information upon registering 
for the meeting. The deadline for registration is listed in the DATES 
section of this notice.

    Dated: June 2, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-12544 Filed 6-15-17; 8:45 am]
 BILLING CODE 4120-01-P



                                                27708                           Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices

                                                number: 0938–0287); Frequency:                          Daylight Savings Time (E.D.T.) as                      under Part B of title XVIII of the Social
                                                Occasionally; Affected Public: State,                   currently planned.                                     Security Act (the Act) that permit public
                                                Local, or Tribal Governments; Number                    DATES: Meeting Date: The CLFS public                   consultation in a manner consistent
                                                of Respondents: 54; Total Annual                        meeting is scheduled for Monday, July                  with the procedures established for
                                                Responses: 27; Total Annual Hours: 81.                  31, 2017 from 9:00 a.m. to 5:00 p.m.,                  implementing coding modifications for
                                                (For policy questions regarding this                    E.D.T. If needed, the meeting will                     International Classification of Diseases
                                                collection contact Stuart Goldstein at                  resume on Tuesday, August 1, 2017,                     (ICD–9–CM) (now, ICD–10–CM). The
                                                410–786–0694.)                                          beginning at 9:00 a.m. E.D.T.                          procedures and clinical laboratory fee
                                                   Dated: June 13, 2017.                                  Deadline for Registration of Presenters              schedule (CLFS) public meeting
                                                William N. Parham, III,                                 and Submission of Presentations: All                   announced in this notice for new tests
                                                                                                        presenters for the CLFS public meeting                 are in accordance with the procedures
                                                Director, Paperwork Reduction Staff, Office
                                                of Strategic Operations and Regulatory                  must register and submit their                         published on November 23, 2001 in the
                                                Affairs.                                                presentations electronically to our CLFS               Federal Register (66 FR 58743) to
                                                [FR Doc. 2017–12539 Filed 6–15–17; 8:45 am]             dedicated email box, CLFS_Annual_                      implement section 531(b) of BIPA.
                                                                                                        Public_Meeting@cms.hhs.gov, by July                       Section 942(b) of the Medicare
                                                BILLING CODE 4120–01–P
                                                                                                        14, 2017 at 5:00 p.m. E.D.T.                           Prescription Drug, Improvement, and
                                                                                                          Deadline for Submitting Requests for                 Modernization Act of 2003 (MMA) (Pub.
                                                DEPARTMENT OF HEALTH AND                                Special Accommodations: Requests for                   L. 108–173) added section 1833(h)(8) of
                                                HUMAN SERVICES                                          special accommodations must be                         the Act. Section 1833(h)(8)(A) of the Act
                                                                                                        received no later than 5:00 p.m. E.D.T.                requires the Secretary to establish by
                                                Centers for Medicare & Medicaid                         on July 14, 2017.                                      regulation procedures for determining
                                                Services                                                  Deadline for Submission of Written                   the basis for, and amount of, payment
                                                                                                        Comments: Written comments regarding                   for any clinical diagnostic laboratory
                                                [CMS–1668–N]                                                                                                   test for which a new or substantially
                                                                                                        the presentations must be received by
                                                Medicare Program; Public Meeting on                     August 11, 2017 at 5:00 p.m. E.D.T. (10                revised Healthcare Common Procedure
                                                July 31, 2017 Regarding New and                         days after the meeting). We intend to                  Coding System (HCPCS) code is
                                                Reconsidered Clinical Diagnostic                        publish our proposed determinations for                assigned on or after January 1, 2005
                                                Laboratory Test Codes for the Clinical                  new test codes and our preliminary                     (hereinafter referred to as ‘‘new tests’’).
                                                Laboratory Fee Schedule for Calendar                    determinations for reconsidered codes                  A code is considered to be substantially
                                                Year 2018                                               (as described later in this notice in                  revised if there is a substantive change
                                                                                                        section II. ‘‘Format’’) for CY 2018 by                 to the definition of the test or procedure
                                                AGENCY: Centers for Medicare &                          early September 2017. Comments in                      to which the code applies (such as, a
                                                Medicaid Services (CMS), HHS.                           response to the preliminary                            new analyte or a new methodology for
                                                ACTION: Notice.                                         determinations will be due by early                    measuring an existing analyte-specific
                                                                                                        October 2017. Interested parties should                test). (See section 1833(h)(8)(E)(ii) of the
                                                SUMMARY:   This notice announces a                                                                             Act and 42 CFR 414.502).
                                                public meeting to receive comments and                  submit all written comments on
                                                                                                        presentations and preliminary                             Section 1833(h)(8)(B) of the Act sets
                                                recommendations (including                                                                                     forth the process for determining the
                                                accompanying data on which                              determinations to the address specified
                                                                                                                                                               basis for, and the amount of, payment
                                                recommendations are based) from the                     in the ADDRESSES section of this notice
                                                                                                                                                               for new tests prior to Calendar Year (CY)
                                                public on the appropriate basis for                     or electronically to our CLFS dedicated
                                                                                                                                                               2018 (Beginning January 1, 2018,
                                                establishing payment amounts for new                    email box, CLFS_Annual_Public_
                                                                                                                                                               payments for tests will be set in
                                                or substantially revised Healthcare                     Meeting@cms.hhs.gov (the specific date
                                                                                                                                                               accordance with the methodologies
                                                Common Procedure Coding System                          for the publication of these
                                                                                                                                                               specified in section 1834A of the Act.).
                                                (HCPCS) codes being considered for                      determinations on the CMS Web site, as
                                                                                                                                                               Pertinent to this notice, sections
                                                Medicare payment under the clinical                     well as the deadline for submitting
                                                                                                                                                               1833(h)(8)(B)(i) and (ii) of the Act
                                                laboratory fee schedule (CLFS) for                      comments regarding these
                                                                                                                                                               require the Secretary to make available
                                                calendar year (CY) 2018. This meeting                   determinations, will be published on                   to the public a list that includes any
                                                also provides a forum for those who                     the CMS Web site).                                     such test for which establishment of a
                                                submitted certain reconsideration                       ADDRESSES: The CLFS public meeting                     payment amount is being considered for
                                                requests regarding final determinations                 will be held in the main auditorium of                 a year and, on the same day that the list
                                                made last year on new test codes and for                the Centers for Medicare & Medicaid                    is made available, causes to have
                                                the public to provide comment on the                    Services (CMS), Central Building, 7500                 published a notice in the Federal
                                                requests.                                               Security Boulevard, Baltimore,                         Register of a meeting to receive
                                                  The Clinical Diagnostic Laboratory                    Maryland 21244–1850.                                   comments and recommendations
                                                Test (CDLT) Advisory Panel will                         FOR FURTHER INFORMATION CONTACT:                       (including accompanying data on which
                                                participate in this meeting by gathering                Glenn McGuirk, (410) 786–5723.                         recommendations are based) from the
                                                information and asking questions to                     SUPPLEMENTARY INFORMATION:                             public on the appropriate basis for
                                                presenters on July 31, 2017, and will                                                                          establishing payment amounts for the
                                                hold a public meeting on August 1, 2017                 I. Background                                          tests on such list. This list of codes for
                                                to discuss matters of the Panel and make                   Section 531(b) of the Medicare,                     which the establishment of a payment
                                                recommendations regarding the test                      Medicaid, and SCHIP Benefits
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                                                               amount under the CLFS is being
                                                codes presented at the CLFS public                      Improvement and Protection Act of                      considered for CY 2018 is posted on the
                                                meeting. In the event the CLFS public                   2000 (BIPA) (Pub. L. 106–554) required                 CMS Web site at http://www.cms.gov/
                                                meeting needs to extend to August 1,                    the Secretary of the Department of                     Medicare/Medicare-Fee-for-Service-
                                                2017, the CDLT Advisory Panel will                      Health and Human Services (the                         Payment/ClinicalLabFeeSched/
                                                convene its public meeting immediately                  Secretary) to establish procedures for                 index.html?redirect=/Clinical
                                                following the CLFS public meeting,                      coding and payment determinations for                  LabFeeSched/. Section 1833(h)(8)(B)(iii)
                                                rather than starting at 9:00 a.m. Eastern               new clinical diagnostic laboratory tests               of the Act requires that we convene the


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                                                                                Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices                                           27709

                                                public meeting not less than 30 days                    determinations are based, and responses                presentations by everyone who is
                                                after publication of the notice in the                  to comments and suggestions received                   interested in presenting, CMS will
                                                Federal Register. These requirements                    from the public.                                       accept written presentations from those
                                                are codified at 42 CFR part 414, subpart                  After the final determinations have                  who were unable to present due to time
                                                G.                                                      been posted on the CMS Web site, the                   constraints. Presentations should be
                                                   Two bases of payment are used to                     public may request reconsideration of                  sent via email to our CLFS dedicated
                                                establish payment amounts for new                       the basis and amount of payment for a                  email box, CLFS_Annual_Public_
                                                tests. The first basis, called                          new test as set forth in § 414.509.                    Meeting@cms.hhs.gov. In addition,
                                                ‘‘crosswalking,’’ is used when a new test               Pertinent to this notice, those requesting             individuals may also submit requests
                                                code is determined to be comparable to                  that CMS reconsider the basis for                      after the CLFS public meeting to obtain
                                                an existing test code, multiple existing                payment or the payment amount as set                   electronic versions of the presentations.
                                                test codes, or a portion of an existing                 forth in § 414.509(a) and (b), may                     Requests for electronic copies of the
                                                test code. For a new CDLT that is                       present their reconsideration requests at              presentations post public meeting
                                                assigned a new or significantly revised                 the following year’s CLFS public                       should be sent via email to our CLFS
                                                code before January 1, 2018, the new                    meeting provided the requestor made                    dedicated email box, noted above.
                                                test code is assigned the local fee                     the request to present at the CLFS                        We are standardizing the presentation
                                                schedule amounts and the national                       public meeting in the written                          format for the CLFS public meeting. As
                                                limitation amount of the existing test.                 reconsideration request. For purposes of               a result, this year we are requiring
                                                Payment for the new test is made at the                 this notice, we refer to these codes as                presenters to submit all presentations
                                                lesser of the billed amount, the local fee              the ‘‘reconsidered codes.’’ The public                 using a standard PowerPoint template
                                                schedule amounts, or the national                       may comment on the reconsideration                     that is available on the CMS Web site,
                                                limitation amount. (See § 414.508(a)(1)).               requests. (See the November 27, 2007                   at https://www.cms.gov/Medicare/
                                                   The second basis, called ‘‘gapfilling,’’             CY 2008 Physician Fee Schedule final                   Medicare-Fee-for-Service-Payment/
                                                is used when no comparable existing                     rule with comment period (72 FR 66275                  ClinicalLabFeeSched/Laboratory_
                                                test is available. When using this                      through 66280) for more information on                 Public_Meetings.html, under the
                                                method, instructions are provided to                    these procedures).                                     ‘‘Meeting Notice and Agenda’’ heading.
                                                each Part A and Part B Medicare                                                                                   For reconsidered and new codes,
                                                Administrative Contractor (MAC) to                      II. Format
                                                                                                                                                               presenters should address all of the
                                                determine a payment amount for its Part                    We are following our usual process,                 following five items:
                                                B geographic area for use in the first                  including an annual public meeting to                     (1) Reconsidered or new codes and
                                                year. In the first year, for a new CDLT                 determine the appropriate basis and                    descriptor.
                                                that is assigned a new or substantially                 payment amount for new and                                (2) Test purpose and method.
                                                revised code before January 1, 2018, the                reconsidered codes under the CLFS for                     (3) Costs.
                                                contractor-specific amounts are                         CY 2018.                                                  (4) Charges.
                                                established using the following sources                    This meeting is open to the public.                    (5) Recommendation with rationale
                                                of information, if available: (1) Charges               The on-site check-in for visitors will be              for one of the two bases (crosswalking
                                                for the test and routine discounts to                   held from 8:30 a.m. to 9:00 a.m. E.D.T.,               or gapfilling) for determining payment
                                                charges; (2) resources required to                      followed by opening remarks.                           for reconsidered and new tests.
                                                perform the test; (3) payment amounts                   Registered persons from the public may                    Additionally, the presenters should
                                                determined by other payers; and (4)                     discuss and make recommendations for                   provide the data on which their
                                                charges, payment amounts, and                           specific new and reconsidered codes for                recommendations are based.
                                                resources required for other tests that                 the CY 2018 CLFS.                                      Presentations regarding reconsidered
                                                may be comparable or otherwise                             As stated in the SUMMARY section of                 and new test codes that do not address
                                                relevant. In the second year, the test                  this notice, the Clinical Diagnostic                   the above five items for presenters may
                                                code is paid at the national limitation                 Laboratory Test (CDLT) Advisory Panel                  be considered incomplete and may not
                                                amount. (See § 414.508(a)(2)).                          will participate in the CLFS public                    be considered by CMS when making a
                                                   Under section 1833(h)(8)(B)(iv) of the               meeting by gathering information and                   determination. We may, however,
                                                Act, the Secretary, taking into account                 asking questions to presenters on July                 request missing information following
                                                the comments and recommendations                        31, 2017, and will hold a public meeting               the meeting to prevent a
                                                (and accompanying data) received at the                 on August 1, 2017 to discuss matters of                recommendation from being considered
                                                CLFS public meeting, develops and                       the Panel and make recommendations                     incomplete.
                                                makes available to the public a list of                 regarding the test codes presented at the                 Taking into account the comments
                                                proposed determinations with respect to                 CLFS public meeting. The                               and recommendations (and
                                                the appropriate basis for establishing a                announcement for the CDLT Advisory                     accompanying data) received at the
                                                payment amount for each code, an                        Panel meeting is included in a separate                CLFS public meeting, we intend to post
                                                explanation of the reasons for each                     Federal Register notice.                               our proposed determinations with
                                                determination, the data on which the                       Because of time constraints,                        respect to the appropriate basis for
                                                determinations are based, and a request                 presentations must be brief, lasting no                establishing a payment amount for each
                                                for public written comments on the                      longer than 10 minutes, and must be                    new test code and our preliminary
                                                proposed determinations. Under section                  accompanied by three written copies. In                determinations with respect to the
                                                1833(h)(8)(B)(v) of the Act, taking into                addition, presenters should make copies                reconsidered codes along with an
                                                account the comments received on the                    available for approximately 50 meeting                 explanation of the reasons for each
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                                                proposed determinations during the                      participants, since CMS will not be                    determination, the data on which the
                                                public comment period, the Secretary                    providing additional copies. Written                   determinations are based, and a request
                                                then develops and makes available to                    presentations must be electronically                   for public written comments on these
                                                the public a list of final determinations               submitted to CMS on or before July 14,                 determinations on the CMS Web site by
                                                of final payment amounts for new test                   2017. Presentation slots will be assigned              early September 2017. This Web site can
                                                codes along with the rationale for each                 on a first-come, first-served basis. In the            be accessed at http://www.cms.gov/
                                                determination, the data on which the                    event there is not enough time for                     Medicare/Medicare-Fee-for-Service-


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                                                27710                           Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices

                                                Payment/ClinicalLabFeeSched/                            at http://cms.gov/live. Teleconference                   Dated: June 2, 2017.
                                                index.html?redirect=/Clinical                           dial-in information will appear on the                 Seema Verma,
                                                LabFeeSched/. Interested parties may                    final Panel meeting agenda, which will                 Administrator, Centers for Medicare &
                                                submit written comments on the                          be posted on the CMS Web site when                     Medicaid Services.
                                                preliminary determinations for new and                  available at http://www.cms.gov/                       [FR Doc. 2017–12544 Filed 6–15–17; 8:45 am]
                                                reconsidered codes by early October                     Medicare/Medicare-Fee-for-Service-                     BILLING CODE 4120–01–P
                                                2017, to the address specified in the                   Payment/ClinicalLabFeeSched/
                                                ADDRESSES section of this notice or                     index.html?redirect=/Clinical
                                                electronically to our CLFS dedicated                    LabFeeSched/.                                          DEPARTMENT OF HEALTH AND
                                                email box, CLFS_Annual_Public_                                                                                 HUMAN SERVICES
                                                Meeting@cms.hhs.gov (the specific date                  IV. Security, Building, and Parking
                                                for the publication of the determinations               Guidelines                                             Administration for Children and
                                                on the CMS Web site, as well as the                                                                            Families
                                                                                                          The meeting will be held in a Federal
                                                deadline for submitting comments                        government building; therefore, Federal
                                                regarding the determinations, will be                                                                          Submission for OMB Review;
                                                                                                        security measures are applicable. In                   Comment Request
                                                published on the CMS Web site). Final
                                                                                                        planning your arrival time, we
                                                determinations for new test codes to be                                                                           Title: Health Profession Opportunity
                                                                                                        recommend allowing additional time to
                                                included for payment on the CLFS for                                                                           Grant (HPOG) program: Third Follow-
                                                                                                        clear security. We suggest that you
                                                CY 2018 and reconsidered codes will be                                                                         Up Data Collection.
                                                                                                        arrive at the CMS facility between 8:15
                                                posted on the CMS Web site in                                                                                     OMB No.: 0970–0394.
                                                                                                        a.m. and 8:30 a.m. E.D.T., so that you
                                                November 2017, along with the                                                                                     Description: The Administration for
                                                                                                        will be able to arrive promptly at the
                                                rationale for each determination, the                                                                          Children and Families (ACF), U.S.
                                                                                                        meeting by 9:00 a.m. E.D.T. Individuals
                                                data on which the determinations are                                                                           Department of Health and Human
                                                                                                        who are not registered in advance will
                                                based, and responses to comments and                                                                           Services (HHS) is proposing data
                                                                                                        not be permitted to enter the building
                                                suggestions received from the public.                                                                          collection activities as part of the Health
                                                                                                        and will be unable to attend the
                                                The final determinations with respect to                                                                       Profession Opportunity Grant (HPOG)
                                                reconsidered codes are not subject to                   meeting. The public may not enter the
                                                                                                        building earlier than 8:15 a.m. E.D.T.                 program. The proposed data collection
                                                further reconsideration. With respect to                                                                       activities are for the Impact Study of the
                                                the final determinations for new test                   (45 minutes before the convening of the
                                                                                                        meeting).                                              first round of HPOG grants (HPOG-
                                                codes, the public may request                                                                                  Impact). The goal of HPOG-Impact is to
                                                reconsideration of the basis and amount                   Security measures include the                        evaluate the effectiveness of approaches
                                                of payment as set forth in § 414.509.                   following:                                             used by 20 of the 27 non-tribal HPOG
                                                III. Registration Instructions                            • Presentation of government-issued                  grantees to provide TANF recipients
                                                                                                        photographic identification to the                     and other low-income individuals with
                                                   The Division of Ambulatory Services                                                                         opportunities for education, training,
                                                                                                        Federal Protective Service or Guard
                                                in the CMS Center for Medicare is                                                                              and advancement within the healthcare
                                                                                                        Service personnel. Persons without
                                                coordinating the CLFS public meeting                                                                           field. It is also intended to evaluate
                                                                                                        proper identification may be denied
                                                registration. Beginning June 19, 2017,                                                                         variation in participant impact that may
                                                                                                        access to the building.
                                                and ending July 14, 2017, registration                                                                         be attributable to different HPOG
                                                may be completed on-line at http://                       • Interior and exterior inspection of
                                                                                                        vehicles (this includes engine and trunk               program components and models.
                                                www.cms.gov/Medicare/Medicare-Fee-                                                                                HPOG-Impact is one project within
                                                for-Service-Payment/Clinical                            inspection) at the entrance to the
                                                                                                        grounds. Parking permits and                           the broader portfolio of research that the
                                                LabFeeSched/index.html?redirect=/                                                                              ACF Office of Planning, Research and
                                                ClinicalLabFeeSched/. On this Web                       instructions will be issued after the
                                                                                                        vehicle inspection.                                    Evaluation (OPRE) is utilizing to assess
                                                page, under the heading ‘‘Meeting                                                                              the success of career pathways programs
                                                Notice, Registration and Agenda,’’ you                    • Passing through a metal detector                   and models. This strategy includes a
                                                will find a link entitled ‘‘Register for                and inspection of items brought into the               multi-pronged research and evaluation
                                                CLFS Annual Meeting.’’ Click this link                  building. We note that all items brought               approach for the HPOG program to
                                                and enter the required information. All                 to CMS, whether personal or for the                    better understand and assess the
                                                the following information must be                       purpose of demonstration or to support                 activities and their results as well as the
                                                submitted when registering:                             a demonstration, are subject to                        Pathways for Advancing Careers and
                                                   • Name.                                              inspection. We cannot assume
                                                   • Company name.                                                                                             Education (PACE) project. In order to
                                                                                                        responsibility for coordinating the                    maximize learning across the portfolio,
                                                   • Address.                                           receipt, transfer, transport, storage, set-
                                                   • Telephone numbers.                                                                                        survey development for the HPOG and
                                                                                                        up, safety, or timely arrival of any
                                                   • Email addresses.                                                                                          PACE baseline and follow-up surveys
                                                   When registering, individuals who                    personal belongings or items used for                  has been coordinated, and the majority
                                                want to make a presentation must also                   demonstration or to support a                          of the data elements collected in these
                                                specify which new test codes they will                  demonstration.                                         surveys are similar. (See OMB Control
                                                be presenting comments. A                               V. Special Accommodations                              #0970–0397 for PACE data collection.)
                                                confirmation will be sent upon receipt                                                                            Four data collection efforts have been
                                                                                                           Individuals attending the meeting                   approved for HPOG research: One for
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                                                of the registration. Individuals must
                                                register by the date specified in the                   who are hearing or visually impaired                   approval of a Performance Reporting
                                                DATES section of this notice.                           and have special requirements, or a                    System (PRS) (approved September
                                                   If not attending the CLFS public                     condition that requires special                        2011); a second for collection of
                                                meeting in person, the public may view                  assistance, should provide that                        baseline data (approved October 2012);
                                                the meeting via webcast or listen by                    information upon registering for the                   a third for a follow-up survey of
                                                teleconference. During the public                       meeting. The deadline for registration is              participants administered
                                                meeting, webcasting is accessible online                listed in the DATES section of this notice.            approximately 15 months after random


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Document Created: 2017-06-16 00:52:22
Document Modified: 2017-06-16 00:52:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesMeeting Date: The CLFS public meeting is scheduled for Monday, July 31, 2017 from 9:00 a.m. to 5:00 p.m., E.D.T. If needed, the meeting will resume on Tuesday, August 1, 2017, beginning at 9:00 a.m. E.D.T.
ContactGlenn McGuirk, (410) 786-5723.
FR Citation82 FR 27708 

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