Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-January 19, 2011, 73094-73095 [2010-29964]

Download as PDF 73094 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices attending the Informational Workshop and no later than 12:30 p.m. e.s.t. if you are attending the Town Hall Meeting so that you will be able to arrive promptly at the appropriate meeting. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • 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, setup, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meetings. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting(s). All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Seating capacity is limited to the first 250 registrants. Authority: Section 503 of Pub. L. 108–173. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 18, 2010. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2010–29989 Filed 11–26–10; 8:45 am] mstockstill on DSKH9S0YB1PROD with NOTICES BILLING CODE 4120–01–P VerDate Mar<15>2010 17:57 Nov 26, 2010 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3237–N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee— January 19, 2011 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. AGENCY: This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (‘‘Committee’’) will be held on Wednesday, January 19, 2011. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding the effects of Erythropoiesis Stimulating Agents (ESAs) on health outcomes in adult chronic kidney disease (CKD) patients (pre-dialysis and dialysis). 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 on Wednesday, January 19, 2011 from 7:30 a.m. until 4:30 p.m., Eastern Standard Time (EST). 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. EST, Monday, December 20, 2010. Once submitted, all 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., EST on Monday, December 20, 2010. 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 online at https://www.cms.gov/apps/ events/upcomingevents.asp? strOrderBy=1&type=3, or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 this notice by 5 p.m. EST, Wednesday, January 12, 2011. We will be broadcasting the meeting via Webinar. You must register for the Webinar portion of the meeting at https://webinar.cms.hhs.gov/ esamedcac119/event/registration.html by 5 p.m. EST, Thursday, January 13, 2011. 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., EST Friday, January 7, 2011. ADDRESSES: Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 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 January 19, 2011, public meeting of the Committee. During this meeting, the Committee will discuss the evidence that is currently available regarding the effects of Erythropoiesis Stimulating Agents (ESAs) on health outcomes in adult chronic kidney disease (CKD) patients (pre-dialysis and dialysis). Background information about this topic, including panel materials, is available at https:// www.cms.hhs.gov/center/coverage.asp. E:\FR\FM\29NON1.SGM 29NON1 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices We encourage the participation of appropriate organizations with expertise in the use of ESAs for treatment of anemia in adults with CKD including patients on dialysis and patients not on dialysis. mstockstill on DSKH9S0YB1PROD with NOTICES II. Meeting Format This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. The Committee may limit the number and duration of oral presentations to the 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 meetings registration process. While there is no registration fee, individuals must register to attend. You may register online at https:// www.cms.gov/apps/events/ upcomingevents.asp? strOrderBy=1&type=3 or by phone 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 government—issued photographic identification), 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. You must register for the Webinar portion of the meeting at https:// webinar.cms.hhs.gov/esamedcac119/ event/registration.html by the deadline listed in the DATES section of this notice. VerDate Mar<15>2010 17:57 Nov 26, 2010 Jkt 223001 73095 IV. Security, Building, and Parking Guidelines DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. Centers for Medicare & Medicaid Services 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 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: November 16, 2010. Barry M. Straube, CMS Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. 2010–29964 Filed 11–26–10; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Privacy Act of 1974; Report of New System of Records Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a New System of Records. AGENCY: In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new system of records (SOR) titled, ‘‘Medicare and Medicaid Electronic Health Record (EHR) Incentive Program National Level Repository’’ System No. 09–70–0587. The final rule for the Medicare and Medicaid EHR Incentive Program implements the provisions of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (Pub. L. 111–5). Specifically, Title IV of Division B of the Recovery Act amends Titles XVIII and XIX of the Social Security Act (the Act) by establishing incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) and Medicare Advantage (MA) Organizations participating in Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of certified electronic health record (EHR) technology. These Recovery Act provisions, together with Title XIII of Division A of the Recovery Act, may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act,’’ or the ‘‘HITECH Act.’’ The final rule specified the initial criteria EPs, eligible hospitals and CAHs, and MA Organizations must meet in order to qualify for an incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs, eligible hospitals and CAHs failing to demonstrate meaningful use of certified EHR technology beginning in 2015; and other program participation requirements. Also, the Office of the National Coordinator for Health Information Technology (ONC) issued a closely related final rule that specified the initial set of standards, implementation specifications, and certification criteria for certified EHR technology. ONC has also issued a separate final rule on the establishment of certification programs for health information technology (HIT). To register for the Medicare and Medicaid EHR Incentive Program, EPs, SUMMARY: E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73094-73095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29964]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3237-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--January 19, 2011

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, January 19, 2011. The 
Committee generally provides advice and recommendations concerning the 
adequacy of scientific evidence needed to determine whether certain 
medical items and services can be covered under the Medicare statute. 
This meeting will focus on the currently available evidence regarding 
the effects of Erythropoiesis Stimulating Agents (ESAs) on health 
outcomes in adult chronic kidney disease (CKD) patients (pre-dialysis 
and dialysis). 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 on Wednesday, 
January 19, 2011 from 7:30 a.m. until 4:30 p.m., Eastern Standard Time 
(EST).
    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. EST, Monday, December 20, 2010. Once submitted, all 
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., EST on Monday, December 20, 2010. 
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 online at https://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3, or by phone by contacting the 
person listed in the FOR FURTHER INFORMATION CONTACT section of this 
notice by 5 p.m. EST, Wednesday, January 12, 2011.
    We will be broadcasting the meeting via Webinar. You must register 
for the Webinar portion of the meeting at https://webinar.cms.hhs.gov/esamedcac119/event/registration.html by 5 p.m. EST, Thursday, January 
13, 2011.
    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., EST Friday, January 7, 2011.

ADDRESSES: Meeting Location: The meeting will be held in the main 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, 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 January 19, 
2011, public meeting of the Committee. During this meeting, the 
Committee will discuss the evidence that is currently available 
regarding the effects of Erythropoiesis Stimulating Agents (ESAs) on 
health outcomes in adult chronic kidney disease (CKD) patients (pre-
dialysis and dialysis). Background information about this topic, 
including panel materials, is available at https://www.cms.hhs.gov/center/coverage.asp.

[[Page 73095]]

We encourage the participation of appropriate organizations with 
expertise in the use of ESAs for treatment of anemia in adults with CKD 
including patients on dialysis and patients not on dialysis.

II. Meeting Format

    This meeting is open to the public. The Committee will hear oral 
presentations from the public for approximately 45 minutes. The 
Committee may limit the number and duration of oral presentations to 
the 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 meetings 
registration process. While there is no registration fee, individuals 
must register to attend. You may register online at https://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone 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 
government--issued photographic identification), 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.
    You must register for the Webinar portion of the meeting at https://webinar.cms.hhs.gov/esamedcac119/event/registration.html by the 
deadline listed in the DATES section of this notice.

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 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: November 16, 2010.
Barry M. Straube,
CMS Chief Medical Officer and Director, Office of Clinical Standards 
and Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-29964 Filed 11-26-10; 8:45 am]
BILLING CODE 4120-01-P
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