80 FR 59782 - Medicare, Medicaid, and Children's Health Insurance Programs; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on October 19, 2015
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 191 (October 2, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 191 (October 2, 2015)
| Page Range | 59782-59784 | |
| FR Document | 2015-25162 |
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)] [Notices] [Pages 59782-59784] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25162] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1657-N] Medicare, Medicaid, and Children's Health Insurance Programs; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on October 19, 2015 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the next meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday, October 19, 2015. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on issues related to clinical diagnostic laboratory tests. DATES: Meeting Date: The meeting of the Panel is scheduled to take place at CMS's headquarters in Baltimore, MD on Monday, October 19, 2015. beginning at 9:00 a.m., Eastern Daylight Time (EDT). The Panel will address issues relating to the CY 2016 clinical laboratory fee schedule (CLFS) preliminary determinations of new and [[Page 59783]] reconsidered test codes, as well as provide input on other CY2016 CLFS issues that are designated in the Panel's charter. Meeting Registration: The public may attend the meeting in-person, view via webcast, or listen via teleconference. Beginning Friday, October 2, 2015, and ending Tuesday, October 13, 2015 at 5:00 p.m. EDT, registration to attend the meeting in-person may be completed on-line at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On this Web page, under ``Related Links,'' double-click the ``Clinical Diagnostic Laboratory Tests FACA Panel Meeting Registration'' link and enter the required information. All the following information must be submitted when registering:Name. Company name. Address. Email addresses. Note: Participants who do not plan to attend the meeting in- person on October 19, 2015 should not register. No registration is required for participants who plan to view the meeting via webcast or listen via teleconference. Presenter Registration and Submission of Presentations and Comments We are interested in submitted comments or in person presentations at the meeting concerning the issues described in the SUPPLEMENTARY INFORMATION section of this notice and clarified in the agenda to be published approximately 2 weeks before the meeting. The comments and presentations should not address issues not before the Panel. The deadline to register to be a presenter and to submit written presentations for the meeting is 5:00 p.m. EDT, Tuesday, October 13, 2015. Presenters may register by email by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentations should be sent via email to the same person's email address. Meeting Location, Webcast, and Teleconference The meetings will be held in the Auditorium, CMS Central Office, 7500 Security Boulevard, Woodlawn, Maryland 21244-1850. Alternately, the public may either view the meetings via a webcast or listen by teleconference. During the scheduled meeting, webcasting is accessible online at http://cms.gov/live. Teleconference dial-in information will appear on the final meeting agenda, which will be posted on the CMS Web site when available at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. Meeting Format 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. on Monday, October 19, 2015. Following the opening remarks, the Panel will address any issues relating to the CY 2016 CLFS preliminary determinations of new and reconsidered test codes, as well as provide input on other CY 2016 CLFS issues that are designated in the Panel's charter. The Panel will hear oral presentations from the public for no more than 1 hour during each of two sessions. During session one, registered persons from the public may present recommendations on preliminary determinations of new and reconsidered codes for the CY 2016 CLFS. During session two, registered persons from the public may present recommendations on CLFS issues that are designated in the Panel's charter and outlined in the Agenda. ADDRESSES: Web site: For additional information on the Panel, please refer to our Web site at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal Official (DFO), Center for Medicare, Division of Ambulatory Services, CMS, 7500 Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244, 410-786-5723, email [email protected] or [email protected]. Press inquiries are handled through the CMS Press Office at (202) 690- 6145. SUPPLEMENTARY INFORMATION: I. Background The Advisory Panel on Clinical Diagnostic Laboratory Tests is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216 of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted April 1, 2014). The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (Secretary) to consult with an expert outside advisory panel, established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests. Such individuals may include molecular pathologists, clinical laboratory researchers, and individuals with expertise in laboratory science or health economics. The Panel will provide input and recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following: The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test; The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and Other aspects of the new payment system under section 1834A of the Act. A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014 Federal Register (79 FR 63919 through 63920). In the August 7, 2015 Federal Register (80 FR 47491), CMS announced membership appointments to the Panel along with the first public meeting date for the Panel, which was held on August 26, 2015. The Panel charter provides that panel meetings will be held up to four times annually. The Panel consists of 15 individuals and a Chair. The Panel Chair facilitates the meeting and the DFO or DFO's designee must be present at all meetings. II. Agenda The Agenda for the October 19, 2015, meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter: CY 2016 CLFS preliminary determinations of new and reconsidered test codes which were posted on September 25, 2015 on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html. Other CY 2016 CLFS issues designated in the Panel's charter and further described on our Agenda. A detailed Agenda will be posted approximately 2 weeks before the meeting, on the CMS Web site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. III. Meeting Attendance The Panel's meeting on October 19, 2015, is open to the public; however, [[Page 59784]] attendance is limited to space available. Priority will be given to those who pre-register and attendance may be limited based on the number of registrants and the space available. Persons wishing to attend this meeting, which is located on federal property, must register by following the instructions in the ``Meeting Registration'' section of this notice. A confirmation email will be sent to the registrants shortly after completing the registration process. IV. Security, Building, and Parking Guidelines The following are the security, building, and parking guidelines: Persons attending the meeting, including presenters, must be pre-registered and on the attendance list by the prescribed date. Individuals who are not pre-registered in advance may not be permitted to enter the building and may be unable to attend the meeting. Attendees must present a government-issued photo identification to the Federal Protective Service or Guard Service personnel before entering the building. Without a current, valid photo ID, persons may not be permitted entry to the building. Security measures include inspection of vehicles, inside and out, at the entrance to the grounds. All persons entering the building must pass through a metal detector. All items brought into CMS including personal items, for example, laptops and cell phones are subject to physical inspection. The public may enter the building 30 to 45 minutes before the meeting convenes each day. All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. The main-entrance guards will issue parking permits and instructions upon arrival at the building. V. Special Accommodations Individuals requiring special accommodations must include the request for these services during registration. VI. Panel Recommendations and Discussions The Panel's recommendations will be posted after the meeting on our Web site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. VIII. Copies of the Charter The Secretary's Charter for the Advisory Panel on Clinical Diagnostic Laboratory Tests is available on the CMS Web site at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice. IX. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: September 29, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015-25162 Filed 10-1-15; 8:45 am] BILLING CODE 4120-01-P
![59782 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
other aspect of this collection of comply with this requirement, CMS is Calendar Year (CY) 2005. The ASP data
information, including any of the publishing this notice that summarizes reporting requirements are specified in
following subjects: The necessity and the following proposed collection(s) of Section 1927 of the Act. The reported
utility of the proposed information information for public comment: ASP data are used to establish the
collection for the proper performance of 1. Type of Information Collection Medicare payment amounts. The
the agency’s functions; the accuracy of Request: Reinstatement of a previously reporting template was revised in CY
the estimated burden; ways to enhance approved collection; Title of 2011 in order to facilitate accurate
the quality, utility, and clarity of the Information Collection: Skilled Nursing collection of ASP data. An
information to be collected; and the use Facility (SNF) Prospective Payment accompanying user guide with
of automated collection techniques or System and Consolidated Billing; Use: instructions on the template’s use was
other forms of information technology to We are requesting approval of a also created and included an
minimize the information collection reinstatement of a Change of Therapy explanation of the data elements in the
burden. OMRA for Skilled Nursing Facilities template. Form Number: CMS–10110
(SNFs). As described in CMS–1351–F, (OMB Control Number: 0938–0921);
DATES: Comments on the collection(s) of we finalized the assessment effective
information must be received by the Frequency: Quarterly; Affected Public:
October 1, 2011. The SNFs are required Private sector (Business or other For-
OMB desk officer by November 2, 2015. to submit this assessment. The COT profits); Number of Respondents: 180;
ADDRESSES: When commenting on the OMRA is comprised of a subset of Total Annual Responses: 720; Total
proposed information collections, resident assessment information Annual Hours: 34,560. (For policy
please reference the document identifier developed for use by SNFs to satisfy a questions regarding this collection
or OMB control number. To be assured Medicare payment requirement. The contact Amy Gruber at 410–786–1542).
consideration, comments and burden associated with this is the SNF
recommendations must be received by Dated: September 29, 2015.
staff time required to complete the COT
the OMB desk officer via one of the OMRA, SNF staff time to encode the William N. Parham, III,
following transmissions: data, and SNF staff time spent in Director, Paperwork Reduction Staff, Office
OMB, Office of Information and transmitting the data. The SNFs are of Strategic Operations and Regulatory
Regulatory Affairs, Attention: CMS Desk required to complete a COT OMRA Affairs.
Officer, Fax Number: (202) 395–5806 or when a SNF resident was receiving a [FR Doc. 2015–25109 Filed 10–1–15; 8:45 am]
Email: OIRA_submission@omb.eop.gov. sufficient level of rehabilitation therapy BILLING CODE 4120–01–P
To obtain copies of a supporting to qualify for an Ultra High, Very High,
statement and any related forms for the High, Medium, or Low Rehabilitation
proposed collection(s) summarized in category and when the intensity of DEPARTMENT OF HEALTH AND
this notice, you may make your request therapy (as indicated by the total HUMAN SERVICES
using one of following: reimbursable therapy minutes (RTM)
Centers for Medicare & Medicaid
1. Access CMS’ Web site address at delivered, and other therapy qualifiers
such as number of therapy days and Services
http://www.cms.hhs.gov/
PaperworkReductionActof1995. disciplines providing therapy) changes [CMS–1657–N]
2. Email your request, including your to such a degree that it would no longer
address, phone number, OMB number, reflect the RUG–IV classification and Medicare, Medicaid, and Children’s
and CMS document identifier, to payment assigned for a given SNF Health Insurance Programs;
Paperwork@cms.hhs.gov. resident based on the most recent Announcement of the Advisory Panel
3. Call the Reports Clearance Office at assessment used for Medicare payment. on Clinical Diagnostic Laboratory
(410) 786–1326. The COT OMRA is a type of required Tests Meeting on October 19, 2015
FOR FURTHER INFORMATION CONTACT: PPS assessment which uses the same
item set as the End of Therapy (EOT) AGENCY: Centers for Medicare &
Reports Clearance Office at (410) 786– Medicaid Services (CMS), HHS.
1326. OMRA. Form Number: CMS–10387
(OMB Control Number: 0938–1140); ACTION: Notice.
SUPPLEMENTARY INFORMATION: Under the Frequency: Yearly; Affected Public:
Paperwork Reduction Act of 1995 (PRA) Private sector (Business or other For- SUMMARY: This notice announces the
(44 U.S.C. 3501–3520), federal agencies profits and Not-for-profit institutions); next meeting date of the Advisory Panel
must obtain approval from the Office of Number of Respondents: 15,421; Total on Clinical Diagnostic Laboratory Tests
Management and Budget (OMB) for each Annual Responses: 678,524; Total (the Panel) on Monday, October 19,
collection of information they conduct Annual Hours: 701,119. (For policy 2015. The purpose of the Panel is to
or sponsor. The term ‘‘collection of questions regarding this collection advise the Secretary of the Department
information’’ is defined in 44 U.S.C. contact Penny Gershman at 410–786– of Health and Human Services (DHHS)
3502(3) and 5 CFR 1320.3(c) and 6643). (the Secretary) and the Administrator of
includes agency requests or 2. Type of Information Collection the Centers for Medicare & Medicaid
requirements that members of the public Request: Reinstatement of a previously Services (CMS) (the Administrator) on
submit reports, keep records, or provide approved collection; Title of issues related to clinical diagnostic
information to a third party. Section Information Collection: Manufacturer laboratory tests.
3506(c)(2)(A) of the PRA (44 U.S.C. Submission of Average Sales Price DATES: Meeting Date: The meeting of the
mstockstill on DSK4VPTVN1PROD with NOTICES
3506(c)(2)(A)) requires federal agencies (ASP) Data for Medicare Part B Drugs Panel is scheduled to take place at
to publish a 30-day notice in the and Biologicals; Use: In accordance with CMS’s headquarters in Baltimore, MD
Federal Register concerning each Section 1847A of the Social Security on Monday, October 19, 2015. beginning
proposed collection of information, Act (the Act), Medicare Part B covered at 9:00 a.m., Eastern Daylight Time
including each proposed extension or drugs and biologicals not paid on a cost (EDT). The Panel will address issues
reinstatement of an existing collection or prospective payment basis are paid relating to the CY 2016 clinical
of information, before submitting the based on the average sales price (ASP) laboratory fee schedule (CLFS)
collection to OMB for approval. To of the drug or biological, beginning in preliminary determinations of new and
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![59784 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
attendance is limited to space available. • The public may enter the building that is, reporting, recordkeeping or
Priority will be given to those who pre- 30 to 45 minutes before the meeting third-party disclosure requirements.
register and attendance may be limited convenes each day. Consequently, there is no need for
based on the number of registrants and • All visitors must be escorted in review by the Office of Management and
the space available. areas other than the lower and first-floor Budget under the authority of the
Persons wishing to attend this levels in the Central Building. Paperwork Reduction Act of 1995 (44
meeting, which is located on federal • The main-entrance guards will U.S.C. 3501 et seq.).
property, must register by following the issue parking permits and instructions Dated: September 29, 2015.
instructions in the ‘‘Meeting upon arrival at the building. Andrew M. Slavitt,
Registration’’ section of this notice. A
confirmation email will be sent to the V. Special Accommodations Acting Administrator, Centers for Medicare
& Medicaid Services.
registrants shortly after completing the Individuals requiring special
[FR Doc. 2015–25162 Filed 10–1–15; 8:45 am]
registration process. accommodations must include the
BILLING CODE 4120–01–P
request for these services during
IV. Security, Building, and Parking
registration.
Guidelines
The following are the security, VI. Panel Recommendations and DEPARTMENT OF HEALTH AND
building, and parking guidelines: Discussions HUMAN SERVICES
• Persons attending the meeting, The Panel’s recommendations will be Administration for Children and
including presenters, must be pre- posted after the meeting on our Web site Families
registered and on the attendance list by at http://cms.gov/Regulations-
the prescribed date. andGuidance/Guidance/FACA/ Submission for OMB Review;
• Individuals who are not pre- AdvisoryPanelonClinicalDiagnostic Comment Request
registered in advance may not be LaboratoryTests.html.
permitted to enter the building and may Title: April 2016 Current Population
be unable to attend the meeting. VIII. Copies of the Charter Survey Supplement on Child Support.
• Attendees must present a The Secretary’s Charter for the OMB No.: 0970–0416.
government-issued photo identification Advisory Panel on Clinical Diagnostic Description: Collection of these data
to the Federal Protective Service or Laboratory Tests is available on the will assist legislators and policymakers
Guard Service personnel before entering CMS Web site at http://cms.gov/ in determining how effective their
the building. Without a current, valid Regulations-and-Guidance/Guidance/ policymaking efforts have been over
photo ID, persons may not be permitted FACA/AdvisoryPanelonClinical time in applying the various child
entry to the building. DiagnosticLaboratoryTests.html or you support legislation to the overall child
• Security measures include may obtain a copy of the charter by support enforcement picture. This
inspection of vehicles, inside and out, at submitting a request to the contact listed information will help policymakers
the entrance to the grounds. in the FOR FURTHER INFORMATION determine to what extent individuals on
• All persons entering the building CONTACT section of this notice. welfare would be removed from the
must pass through a metal detector. welfare rolls as a result of more
• All items brought into CMS IX. Collection of Information stringent child support enforcement
including personal items, for example, Requirements efforts.
laptops and cell phones are subject to This document does not impose Respondents: Individuals and
physical inspection. information collection requirements, households.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Child Support Survey ....................................................................................... 41,300 1 0.03 1,239
Estimated Total Annual Burden document in the Federal Register. the Administration for Children and
Hours: 1,239. Therefore, a comment is best assured of Families.
Additional Information: Copies of the having its full effect if OMB receives it
Robert Sargis,
proposed collection may be obtained by within 30 days of publication. Written
writing to the Administration for comments and recommendations for the Reports Clearance Officer.
Children and Families, Office of proposed information collection should [FR Doc. 2015–24972 Filed 10–1–15; 8:45 am]
Planning, Research and Evaluation, 370 be sent directly to the following: Office BILLING CODE 4184–01–P
L’Enfant Promenade SW., Washington, of Management and Budget, Paperwork
DC 20447, Attn: ACF Reports Clearance Reduction Project, Fax: 202–395–7285,
Officer. All requests should be
mstockstill on DSK4VPTVN1PROD with NOTICES
Email: OIRA_SUBMISSION@
identified by the title of the information OMB.EOP.GOV, Attn: Desk Officer for
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
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Document Created: 2015-12-15 08:45:24
Document Modified: 2015-12-15 08:45:24
| 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 C. McGuirk, Designated Federal Official (DFO), Center for Medicare, Division of Ambulatory Services, CMS, 7500 Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244, 410-786-5723, email [email protected] or [email protected] Press inquiries are handled through the CMS Press Office at (202) 690- 6145. | |
| FR Citation | 80 FR 59782 |
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