Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 20, 2008, 36528-36529 [E8-14649]

Download as PDF 36528 Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices and impact on the effective and efficient administration of the Medicare program. In addition, if the cost incurred by the FI, RHHI, or carrier to meet its contractual requirements exceeds the amount that we find to be reasonable and adequate to meet the cost that must be incurred by an efficiently and economically operated FIs or carrier, these high costs may also be grounds for adverse action. VIII. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently the Office of Management and Budget need not review it under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). IX. Response to Comments Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are unable to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this notice, and, if we proceed with a subsequent document, we will respond to the comments in the section entitled as ‘‘Analysis of and Response to Public Comments Received on FY 2009 Criteria and Standards’’ of that document. Authority: Sections 1816(f), 1834(a)(12), and 1842(b) of the Social Security Act (42 U.S.C. 1395h(f), 1395m(a)(12), and 1395u(b)). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: May 16, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E8–14641 Filed 6–26–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services jlentini on PROD1PC65 with NOTICES [CMS–3201–N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee— August 20, 2008 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. AGENCY: VerDate Aug<31>2005 18:47 Jun 26, 2008 Jkt 214001 SUMMARY: This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (‘‘Committee’’) will be held on Wednesday, August 20, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the oncologic indications of 2-[F–18] Fluoro-D-Glucose (FDG) positron emission tomography (PET) for nine cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney). The panel will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The panel will also consider data generated under a current national coverage determination that provides coverage for PET for specified cancers when additional data are prospectively collected. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). DATES: Meeting Date: The public meeting will be held 7:30 a.m. until 4:30 p.m., d.s.t. on Wednesday, August 20, 2008. Deadline for Submission of Written Comments: Written comments must be received at the address specified in the ADDRESSES section of this notice by 5 p.m., d.s.t. on July 21, 2008. Once submitted, comments are final. Deadlines for Speaker Registration and Presentation Materials: The deadline to register to be a speaker, and to submit Powerpoint presentation materials and writings that will be used in support of an oral presentation, is 5 p.m., d.s.t. on Monday, July 21, 2008. Speakers may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentation materials must be received at the address specified in the ADDRESSES section of this notice. Deadline for All Other Attendees Registration: Individuals may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., d.s.t. on Wednesday, August 13, 2008. Deadline for Submitting a Request for Special Accommodations: Persons attending the meeting who are hearing PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 or visually impaired, or have a condition that requires special assistance or accommodations, are asked to contact the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5 p.m., d.s.t. Friday, August 8, 2008. ADDRESSES: Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244. Submission of Presentations and Comments: Presentation materials and written comments that will be presented at the meeting must be submitted via email to MedCACpresentations@cms.hhs.gov or by regular mail to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for MedCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, C1–09–06, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410–786–0309) or via e-mail at Maria.Ellis@cms.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background MedCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), provides advice and recommendations to CMS regarding clinical issues. (For more information on MCAC, see the December 14, 1998 Federal Register (63 FR 68780).) This notice announces the August 20, 2008, public meeting of the Committee. During this meeting, the Committee will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The Committee will focus on evidence regarding the use of FDG PET to inform the treating physician on cancer diagnosis, staging, detecting metastatic disease and detecting recurrence. Background information about this topic, including panel materials, will become available at https://www.cms.hhs.gov/coverage. II. Meeting Format This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 30 minutes. The Committee may limit the number and duration of oral presentations to the E:\FR\FM\27JNN1.SGM 27JNN1 Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices time available. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will be available on the following Web site prior to the meeting: https:// www.cms.hhs.gov/mcd/index_ list.asp?list_type=mcac. We require that you declare at the meeting whether you have any financial involvement with manufacturers (or their competitors) of any items or services being discussed. The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15-minute unscheduled open public session for any attendee to address issues specific to the topics under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS. jlentini on PROD1PC65 with NOTICES III. Registration Instructions CMS’ Coverage and Analysis Group is coordinating the meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver’s license), address, organization, telephone, fax number(s), and e-mail address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified the seating capacity has been reached. IV. Security, Building, and Parking Guidelines This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. VerDate Aug<31>2005 18:47 Jun 26, 2008 Jkt 214001 • Inspection, via metal detector or other applicable means of all persons brought entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, 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 presentation or to support a presentation. Note: 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 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: 5 U.S.C. App. 2, section 10(a). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: June 17, 2008. Barry M. Straube, Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. E8–14649 Filed 6–26–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1394–N] Medicare Program; Second SemiAnnual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—August 27–29, 2008 Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. AGENCY: SUMMARY: In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second semiannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 36529 Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel’s advice as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2009. DATES: Meeting Dates: We are scheduling the second semi-annual meeting in 2008 for the following dates and times: • Wednesday, August 27, 2008, 1 p.m. to 5 p.m. (e.d.t.) 1 • Thursday, August 28, 2008, 8 a.m. to 5 p.m. (e.d.t.) 1 • Friday, August 29, 2008, 8 a.m. to 12 noon (e.d.t.) 2 Deadlines Deadline for Hardcopy Comments/ Suggested Agenda Topics 5 p.m. (e.d.t.), Monday, August 4, 2008. Deadline for Hardcopy Presentations 5 p.m. (e.d.t.), Monday, August 4, 2008. Deadline for Attendance Registration 5 p.m. (e.d.t.), Wednesday, August 13, 2008. Deadline for Special Accommodations 5 p.m. (e.d.t.), Wednesday, August 13, 2008. Submission of Materials to the Designated Federal Officer (DFO): Because of staffing and resource limitations, we cannot accept written comments and presentations by FAX, nor can we print written comments and presentations received electronically for dissemination at the meeting. Only hardcopy comments and presentations can be reproduced for public dissemination. All hardcopy presentations must be accompanied by Form CMS–20017 (revised 01/07). The form is now available through the CMS Forms Web site. The Uniform Resource Locator (URL) for linking to this form is as follows: https://www.cms.hhs.gov/ cmsforms/downloads/cms20017.pdf. Presenters must use the most recent copy of CMS–20017 (updated 01/07) at the above URL. Additionally, presenters must clearly explain the action(s) that they are requesting CMS to take in the appropriate section of the form. They must also clarify their relationship to the organization that they represent in the presentation. 1 The times listed in this notice are approximate times; consequently, the meetings may last longer than listed in this notice—but will not begin before the posted times. 2 If the business of the Panel concludes on Thursday, August 28, 2008, there will be no Friday (August 29, 2008) meeting. E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36528-36529]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14649]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3201-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--August 20, 2008

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

-----------------------------------------------------------------------

SUMMARY: This notice announces that a public meeting of the Medicare 
Evidence Development & Coverage Advisory Committee (MedCAC) 
(``Committee'') will be held on Wednesday, August 20, 2008. The 
Committee generally provides advice and recommendations concerning the 
adequacy of scientific evidence needed to determine whether certain 
medical items and services are reasonable and necessary under the 
Medicare statute. This meeting will focus on the oncologic indications 
of 2-[F-18] Fluoro-D-Glucose (FDG) positron emission tomography (PET) 
for nine cancers (brain, cervical, small cell lung, ovarian, 
pancreatic, testicular, prostate, bladder, and kidney). The panel will 
review the scientific evidence of the impact of PET as part of a 
management strategy to improve patient-centered outcomes. The panel 
will also consider data generated under a current national coverage 
determination that provides coverage for PET for specified cancers when 
additional data are prospectively collected. The meeting will discuss 
the various kinds of evidence that are useful to support requests for 
Medicare coverage in this field. This meeting is open to the public in 
accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, 
section 10(a)).

DATES: Meeting Date: The public meeting will be held 7:30 a.m. until 
4:30 p.m., d.s.t. on Wednesday, August 20, 2008.
    Deadline for Submission of Written Comments: Written comments must 
be received at the address specified in the ADDRESSES section of this 
notice by 5 p.m., d.s.t. on July 21, 2008. Once submitted, comments are 
final.
    Deadlines for Speaker Registration and Presentation Materials: The 
deadline to register to be a speaker, and to submit Powerpoint 
presentation materials and writings that will be used in support of an 
oral presentation, is 5 p.m., d.s.t. on Monday, July 21, 2008. Speakers 
may register by phone or via e-mail by contacting the person listed in 
the FOR FURTHER INFORMATION CONTACT section of this notice. 
Presentation materials must be received at the address specified in the 
ADDRESSES section of this notice.
    Deadline for All Other Attendees Registration: Individuals may 
register by phone or via e-mail by contacting the person listed in the 
FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., 
d.s.t. on Wednesday, August 13, 2008.
    Deadline for Submitting a Request for Special Accommodations: 
Persons attending the meeting who are hearing or visually impaired, or 
have a condition that requires special assistance or accommodations, 
are asked to contact the Executive Secretary as specified in the FOR 
FURTHER INFORMATION CONTACT section of this notice no later than 5 
p.m., d.s.t. Friday, August 8, 2008.

ADDRESSES:
    Meeting Location: The meeting will be held in the main auditorium 
of the Centers for Medicare & Medicaid Services, 7500 Security Blvd, 
Baltimore, MD 21244.
    Submission of Presentations and Comments: Presentation materials 
and written comments that will be presented at the meeting must be 
submitted via e-mail to MedCACpresentations@cms.hhs.gov or by regular 
mail to the contact listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice by the date specified in the DATES section of 
this notice.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for 
MedCAC, Centers for Medicare & Medicaid Services, Office of Clinical 
Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone 
(410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    MedCAC, formerly known as the Medicare Coverage Advisory Committee 
(MCAC), provides advice and recommendations to CMS regarding clinical 
issues. (For more information on MCAC, see the December 14, 1998 
Federal Register (63 FR 68780).) This notice announces the August 20, 
2008, public meeting of the Committee. During this meeting, the 
Committee will review the scientific evidence of the impact of PET as 
part of a management strategy to improve patient-centered outcomes. The 
Committee will focus on evidence regarding the use of FDG PET to inform 
the treating physician on cancer diagnosis, staging, detecting 
metastatic disease and detecting recurrence. Background information 
about this topic, including panel materials, will become available at 
https://www.cms.hhs.gov/coverage.

II. Meeting Format

    This meeting is open to the public. The Committee will hear oral 
presentations from the public for approximately 30 minutes. The 
Committee may limit the number and duration of oral presentations to 
the

[[Page 36529]]

time available. Your comments should focus on issues specific to the 
list of topics that we have proposed to the Committee. The list of 
research topics to be discussed at the meeting will be available on the 
following Web site prior to the meeting: https://www.cms.hhs.gov/mcd/
index_list.asp?list_type=mcac.
    We require that you declare at the meeting whether you have any 
financial involvement with manufacturers (or their competitors) of any 
items or services being discussed.
    The Committee will deliberate openly on the topics under 
consideration. Interested persons may observe the deliberations, but 
the Committee will not hear further comments during this time except at 
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address 
issues specific to the topics under consideration. At the conclusion of 
the day, the members will vote and the Committee will make its 
recommendation(s) to CMS.

III. Registration Instructions

    CMS' Coverage and Analysis Group is coordinating the meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register by contacting the person listed in 
the FOR FURTHER INFORMATION CONTACT section of this notice by the 
deadline listed in the DATES section of this notice. Please provide 
your full name (as it appears on your state-issued driver's license), 
address, organization, telephone, fax number(s), and e-mail address. 
You will receive a registration confirmation with instructions for your 
arrival at the CMS complex or you will be notified the seating capacity 
has been reached.

IV. Security, Building, and Parking Guidelines

    This meeting will be held in a Federal government building; 
therefore, Federal security measures are applicable. We recommend that 
confirmed registrants arrive reasonably early, but no earlier than 45 
minutes prior to the start of the meeting, to allow additional time to 
clear security. Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means 
of all persons brought entering the building. We note that all items 
brought into CMS, whether personal or for the purpose of presentation 
or to support a presentation, 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 presentation or to support a presentation.

    Note: 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 30 to 45 
minutes prior to the convening of the meeting.

    All visitors must be escorted in areas other than the lower and 
first floor levels in the Central Building.

    Authority: 5 U.S.C. App. 2, section 10(a).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: June 17, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-14649 Filed 6-26-08; 8:45 am]
BILLING CODE 4120-01-P
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