80 FR 26264 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 88 (May 7, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 88 (May 7, 2015)
| Page Range | 26264-26266 | |
| FR Document | 2015-11026 |
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)] [Notices] [Pages 26264-26266] From the Federal Register Online [www.thefederalregister.org] [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
![26264 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
EXHIBIT 2—ESTIMATED COST BURDEN FOR THE 2015 LONGITUDINAL SURVEY
Number of Total Average hourly Total cost
Form name respondents burden hours wage rate* burden
Prescreener Questionnaire .......................................................................... 4,326 389 $30.95 $12,040
Establishment Questionnaire ....................................................................... 2,078 790 30.95 24,451
Plan Questionnaire ...................................................................................... 2,078 524 30.95 16,218
Total ...................................................................................................... 8,482 1,703 na $52,709
* Based upon the mean hourly wage for Compensation, Benefits, and Job Analysis Specialists occupation code 13–1141, at http://www.bls.gov/
oes/current/oes131141.htm (U.S. Department of Labor, Bureau of Labor Statistics.)
Request for Comments SUMMARY: This notice announces a ADDRESSES: The public meeting will be
In accordance with the Paperwork public meeting to receive comments and held in the main auditorium of the
Reduction Act, comments on AHRQ’s recommendations (including Centers for Medicare & Medicaid
information collection are requested accompanying data on which Services (CMS), Central Building, 7500
with regard to any of the following: (a) recommendations are based) from the Security Boulevard, Baltimore,
whether the proposed collection of public on the appropriate basis for Maryland 21244–1850.
information is necessary for the proper establishing payment amounts for new FOR FURTHER INFORMATION CONTACT:
performance of AHRQ health care or substantially revised Healthcare Glenn McGuirk, (410) 786–5723.
research and information dissemination Common Procedure Coding System SUPPLEMENTARY INFORMATION:
functions, including whether the (HCPCS) codes being considered for
Medicare payment under the clinical I. Background
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of laboratory fee schedule (CLFS) for Section 531(b) of the Medicare,
burden (including hours and costs) of calendar year (CY) 2016. This meeting Medicaid, and SCHIP Benefits
the proposed collection(s) of also provides a forum for those who Improvement and Protection Act of
information; (c) ways to enhance the submitted certain reconsideration 2000 (BIPA) (Pub. L. 106–554) requires
quality, utility, and clarity of the requests regarding final determinations the Secretary of the Department of
information to be collected; and (d) made last year on new test codes and for Health and Human Services (the
ways to minimize the burden of the the public to provide comment on the Secretary) to establish procedures for
collection of information on requests. coding and payment determinations for
respondents, including the use of DATES: Meeting Date: The public new clinical diagnostic laboratory tests
automated collection techniques or meeting is scheduled for Thursday, July under Part B of title XVIII of the Social
other forms of information technology. 16, 2015 from 9:00 a.m. to 3:00 p.m., Security Act (the Act) that permit public
Comments submitted in response to Eastern Daylight Savings Time. consultation in a manner consistent
this notice will be summarized and with the procedures established for
Deadline for Registration of Presenters
included in the Agency’s subsequent implementing coding modifications for
and Submission of Presentations: All
request for OMB approval of the International Classification of Diseases
presenters for the public meeting must
proposed information collection. All (ICD–9–CM). The procedures and public
register and submit their presentations
comments will become a matter of meeting announced in this notice for
electronically to Glenn McGuirk at
public record. new tests are in accordance with the
Glenn.McGuirk@cms.hhs.gov by July 2,
procedures published on November 23,
Dated: April 27, 2015. 2015.
2001 in the Federal Register (66 FR
Sharon B. Arnold, Deadline for Submitting Requests for 58743) to implement section 531(b) of
Deputy Director, AHRQ. Special Accommodations: Requests for BIPA.
[FR Doc. 2015–10981 Filed 5–6–15; 8:45 am] special accommodations must be Section 942(b) of the Medicare
BILLING CODE 4160–90–P received no later than 5:00 p.m. on July Prescription Drug, Improvement, and
2, 2015. Modernization Act of 2003 (MMA) (Pub.
Deadline for Submission of Written L. 108–173) added section 1833(h)(8) of
DEPARTMENT OF HEALTH AND Comments: We intend to publish our the Act. Section 1833(h)(8)(A) of the Act
HUMAN SERVICES proposed determinations for new test requires the Secretary to establish by
codes and our preliminary regulation procedures for determining
Centers for Medicare & Medicaid determinations for reconsidered codes the basis for, and amount of, payment
Services (as described below) for CY 2016 by for any clinical diagnostic laboratory
early September 2015. Interested parties test with respect to which a new or
[CMS–1623–N] may submit written comments on these substantially revised Healthcare
determinations by early October, 2015 Common Procedure Coding System
Medicare Program; Public Meeting on to the address specified in the (HCPCS) code is assigned on or after
July 16, 2015 Regarding New and ADDRESSES section of this notice or January 1, 2005 (hereinafter referred to
Reconsidered Clinical Diagnostic
mstockstill on DSK4VPTVN1PROD with NOTICES
electronically to Glenn McGuirk at as ‘‘new tests’’). A code is considered to
Laboratory Test Codes for the Clinical Glenn.McGuirk@cms.hhs.gov (the be substantially revised if there is a
Laboratory Fee Schedule for Calendar specific date for the publication of these substantive change to the definition of
Year 2016 determinations on the CMS Web site, as the test or procedure to which the code
AGENCY: Centers for Medicare & well as the deadline for submitting applies (such as, a new analyte or a new
Medicaid Services (CMS), HHS. comments regarding these methodology for measuring an existing
determinations will be published on the analyte-specific test). (See section
ACTION: Notice.
CMS Web site). 1833(h)(8)(E)(ii) of the Act).
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![26266 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
on the proposed determinations for new by 9:00 a.m. Individuals who are not requires that States and Territories
test codes or the preliminary registered in advance will not be submit monthly case-level data on the
determinations for reconsidered codes permitted to enter the building and will children and families receiving direct
by early October, 2015, to the address be unable to attend the meeting. The services under the Child Care and
specified in the ADDRESSES section of public may not enter the building earlier Development Fund (CCDF). The
this notice or electronically to Glenn than 8:15 a.m. (45 minutes before the implementing regulations for the
McGuirk at Glenn.McGuirk@ convening of the meeting). statutorily required reporting are at 45
cms.hhs.gov (the specific date for the Security measures include the CFR 98.70 and 98.71. Case-level reports,
publication of the determinations on the following: submitted quarterly or monthly (at
CMS Web site, as well as the deadline • Presentation of government-issued grantee option), include monthly
for submitting comments regarding the photographic identification to the sample or full population case-level
determinations will be published on the Federal Protective Service or Guard data. The data elements to be included
CMS Web site). Final determinations for Service personnel. Persons without in these reports are represented in the
new test codes to be included for proper identification may be denied ACF–801. ACF uses disaggregate data to
payment on the CLFS for CY 2016 and access to the building. determine program and participant
reconsidered codes will be posted on • Interior and exterior inspection of characteristics as well as costs and
our Web site in November 2015, along vehicles (this includes engine and trunk levels of child care services provided.
with the rationale for each inspection) at the entrance to the This provides ACF with the information
determination, the data which the grounds. Parking permits and necessary to make reports to Congress,
determinations are based, and responses instructions will be issued after the address national child care needs, offer
to comments and suggestions received vehicle inspection. technical assistance to grantees, meet
from the public. The final • Passing through a metal detector performance measures, and conduct
determinations with respect to and inspection of items brought into the research.
reconsidered codes are not subject to building. We note that all items brought Consistent with the recent
further reconsideration. With respect to to CMS, whether personal or for the reauthorization of the CCDBG statute,
the final determinations for new test purpose of demonstration or to support ACF requests extension of the ACF–801
codes, the public may request a demonstration, are subject to including a number of changes and
reconsideration of the basis and amount inspection. We cannot assume clarifications to the reporting
of payment as set forth in § 414.509. responsibility for coordinating the requirements and instructions as set
receipt, transfer, transport, storage, set- forth below.
III. Registration Instructions up, safety, or timely arrival of any • Homeless Status: Section
The Division of Ambulatory Services personal belongings or items used for 658K(a)(1)(B)(xi) of the CCDBG Act now
in the CMS Center for Medicare is demonstration or to support a requires States to report whether
coordinating the public meeting demonstration. children receiving assistance under this
registration. Beginning June 8, 2015, subchapter are homeless children.
V. Special Accommodations • Child Disability: ACF proposes to
registration may be completed on-line at
the following Web address: http:// Individuals attending the meeting add a new data element indicating
www.cms.gov/Medicare/Medicare-Fee- who are hearing or visually impaired whether or not each child receiving
for-Service-Payment/ and have special requirements, or a services is a child with a disability, in
ClinicalLabFeeSched/ condition that requires special part to track State implementation of
index.html?redirect=/ assistance, should provide that priority for services requirements at
ClinicalLabFeeSched/. All the following information upon registering for the section 658E(c)(3)(B) of the CCDBG Act
information must be submitted when meeting. The deadline for registration is (which includes children with special
registering: listed in the DATES section of this notice. needs as defined by the State).
• Name. Dated: April 7, 2015.
• Military Status: ACF proposes to
• Company name. add a new data element to the ACF–801
Andrew M. Slavitt,
• Address. Acting Administrator, Centers for Medicare
to determine the family’s status related
• Telephone numbers. & Medicaid Services.
to military service.
• Email addresses. • Family Zip Code and Provider Zip
[FR Doc. 2015–11026 Filed 5–6–15; 8:45 am] Code: ACF proposes to add zip codes to
When registering, individuals who
want to make a presentation must also BILLING CODE 4120–01–P both the family and the provider records
specify for which new test codes they to identify the communities where
will be presenting comments. A CCDF families and providers are
DEPARTMENT OF HEALTH AND located, in part to support
confirmation will be sent upon receipt
HUMAN SERVICES implementation of sections
of the registration. Individuals must
register by the date specified in the Administration for Children and 658E(a)(2)(M) and 658E(a)(2)(Q) of the
DATES section of this notice. Families CCDBG Act that require States to
address the supply and access to high-
IV. Security, Building, and Parking quality child care services for certain
Guidelines Proposed Information Collection
Activity; Comment Request areas and populations.
The meeting will be held in a Federal • Quality of Child Care Providers:
Proposed Projects
mstockstill on DSK4VPTVN1PROD with NOTICES
government building; therefore, Federal The existing ACF–801 allows States
security measures are applicable. In Title: Child Care Quarterly Case several ways of reporting information on
planning your arrival time, we Record Report—ACF–801. the quality of each child’s provider(s)—
recommend allowing additional time to OMB No.: 0970–0167. including: Quality Rating and
clear security. It is suggested that you Description: Section 658K of the Child Improvement System (QRIS)
arrive at the CMS facility between 8:15 Care and Development Block Grant participation and rating, accreditation
a.m. and 8:30 a.m., so that you will be (CCDBG) Act (42 U.S.C. 9858, as status, State pre-K standards, and other
able to arrive promptly at the meeting amended by Public Law 113–186) State-defined quality measure. To date,
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Document Created: 2015-12-16 07:50:14
Document Modified: 2015-12-16 07:50:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Glenn McGuirk, (410) 786-5723. | |
| FR Citation | 80 FR 26264 |
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