Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 58405 

given day by using the traditional 

alcoholism therapy based on clinical 

experience and intuition, with little 

rigorous validation of their effectiveness 

(http://health.nih.gov/topic/Alcoholism/ 

SubstanceAbuse). About 18% of 

American adults have anxiety disorders 

(www.nimh.nih.gov). More than 40 

million Americans suffer from chronic, 

long-term sleep disorders, and an 

additional 20 million report sleeping 

problems occasionally (http:// 

www.adaa.org). 

Inventors: Juan J. Marugan, Ke Liu, 

Samarjit Patnaik, Noel T. Southall, Wei 

Zheng (all with NHGRI); Markus Heilig 

(NIAAA). 

Related Publication: N Cannella et al. 

Persistent increase of alcohol-seeking 

evoked by neuropeptide S: An effect 

mediated by the hypothalamic 

hypocretin system. 

Neuropsychopharmacology. 2009 Aug; 

34(9): 2125–2134. [PubMed: 19322167]. 

Patent Status: U.S. Provisional 

Application No. 61/328,900 filed 28 Apr 

2010 (HHS Reference No. E–041–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Steve Standley, 

PhD; 301–435–4074; 

sstand@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIH Chemical Genomics Center 

(NCGC), NHGRI, NIH is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize these NPSR antagonist 

small molecule compounds for various 

therapeutic uses including treatment of 

neuropsychiatric disorders and alcohol 

and drug addiction. Please contact Dr. 

Juan J. Marugan at 

maruganj@mail.nih.gov for more 

information. 

A Rapid, Peripheral Blood Gene 

Expression Biomarker Panel for 

Diagnosis of Acute Ischemic Stroke 

Description of Invention: There are 

presently no rapid, accurate diagnostic 

procedures or methods that can be used 

to determine whether a patient has 

suffered an acute ischemic stroke (AIS). 

Current technologies for diagnosis of 

AIS are limited by speed and resources 

as well as inaccuracy and generally 

require a high level of training to 

interpret the results for medical 

technicians. In contrast, this invention 

may lead to the development of a rapid 

and accurate clinical diagnostic kit that 

would require very little training for 

proper use and could be used in the 

field or the emergency room setting. 

Scientists at the National Institutes of 

Health have discovered that expression 

levels of a set of nine genes may be used 

as biomarkers for diagnosis of AIS as 

well as outcome prediction. These 

biomarkers may be rapidly identified 

using peripheral whole blood and may 

form the basis of a rapid and accurate 

clinical point of care diagnostic kit. 

Further, if validation is positive, this 

technology may enable rapid differential 

diagnosis between acute ischemic stroke 

and hemorrhagic stroke, transient 

ischemic attack, or any pathology 

mimicking a stroke. Not only can this be 

used to identify stroke earlier in the 

course of treatment, this panel may also 

help to better characterize stroke 

subtype, and identify new pathways for 

stroke treatment. This is important as 

the only FDA approved treatment for 

acute ischemic stroke is tissue 

plasminogen activator (tPA) and tPA 

must not be given to hemorrhagic stroke 

patients since it could increase 

intracranial bleeding. To effectively 

treat AIS, tPA must be administered 

intravenously within 3–4 hours of 

known stroke onset. Because the 

differential diagnosis of AIS versus 

hemorrhagic stroke is difficult without 

specialized imaging equipment such as 

a CT scan with contrast or an MRI 

image, only a small percentage of stroke 

patients (3–5%) are ever given tPA. So, 

a rapid and accurate clinical diagnostic 

kit based on this invention would have 

a profound public health benefit and 

likely a large commercial potential. 

Applications: 

• A rapid and accurate clinical 

diagnostic kit for acute ischemic stroke. 

• Differentiation between acute 

ischemic stroke and a hemorrhagic 

stroke, transient ischemic attack, or any 

pathology mimicking a stroke. 

• Aid in the prediction of outcome 

and identify new pathways for ischemic 

stroke treatment. 

Advantages: Faster, more accurate, 

and requires less training than currently 

available diagnostic procedures. 

Development Status: Clinical 

Validation Pilot Study: Whole blood 

was collected in a clinical setting and 

gene expressions were subsequently 

profiled. 

Market: Every year, about 795,000 

people in the United States have a 

stroke, and about 675,000 of those 

strokes are ischemic. In 2006, 137,000 

people in the United States died of 

stroke (http://www.cdc.gov/stroke/). 

Inventors: Taura L. Barr (NINR), Maria 

Del Mar Matarin Jimenez (NIA), Steven 

J. Warach (NINDS), Andrew B. 

Singleton (NIA), Jinhui Ding (NIA), 

Allissa A. Dillman (NIA), Mark P. 

Cookson (NIA), Yvette Conley 

(University of Pittsburgh). 

Publication: Barr, T.L.; Conley, Y.; 

Ding, J.; Dillman, A.; Warach, S.; 

Singleton, A.; Matarin, M. Genomic 

biomarkers and cellular pathways of 

ischemic stroke by RNA gene expression 

profiling; Neurology, Volume 75(11), 14 

September 2010, pp 1009–1014. 

Patent Status: U.S. Provisional 

Application No. 61/307,233 filed 23 Feb 

2010 (HHS Reference No. E–023–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jeffrey Clark Klein, 

PhD; 301–594–4697; 

kleinjc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NINR is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize a point of care test for 

ischemic stroke diagnostics and 

outcome prediction. Please contact Dr. 

Taura Barr at 304–293–0503 or 

barrt@mail.nih.gov for more 

information. 

Dated: September 20, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–23957 Filed 9–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7019–N] 

Medicare Program; Meeting of the 

Advisory Panel on Medicare 

Education, October 13, 2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

meeting of the Advisory Panel on 

Medicare Education (the Panel) in 

accordance with the Federal Advisory 

Committee Act. The Panel advises and 

makes recommendations to the 

Secretary of Health and Human Services 

and the Administrator of the Centers for 

Medicare & Medicaid Services on 

opportunities to enhance the 

effectiveness of consumer education 

strategies concerning the Medicare 

program. This meeting is open to the 

public. 

DATES: Meeting Date: Wednesday, 

October 13, 2010 from 1 p.m. to 4 p.m., 

eastern daylight time (e.d.t.). 


srobinson on DSKHWCL6B1PROD with NOTICES
58406 Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 

Deadline for Meeting Registration and 

Comments: Wednesday, October 6, 

2010, 5 p.m., e.d.t. 

Deadline for Requesting Special 

Accommodations: Wednesday, October 

6, 2010, 5 p.m., e.d.t. 

ADDRESSES: Meeting Location: The 

October 13, 2010 meeting will be a 

‘‘virtual meeting’’ using Adobe Acrobat 

Connect Pro Meeting, a Web 

conferencing product that allows users 

to conduct live meetings and 

presentations over the Internet. The 

audio portion is also available via 

telephone conferencing. 

Meeting Registration: The meeting is 

open to the public, but attendance is 

limited to the telephone lines available. 

Persons wishing to attend this meeting 

must register at http:// 

www.blsmeetings.net/H1714-4. 

Meeting Presentations, Written 

Comments, and Special 

Accommodations: Jennifer Kordonski, 

Designated Federal Official (DFO), 

Division of Forum and Conference 

Development, Office of External Affairs, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Mailstop S1–13–05, Baltimore, MD 

21244–1850 or contact Ms. Kordonski 

via e-mail at 

Jennifer.Kordonski@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Kordonski, (410) 786–1840. 

Please refer to the CMS Advisory 

Committees’ Information Line (1–877– 

449–5659 toll free)/(410–786–9379 

local) or the Internet (http:// 

www.cms.hhs.gov/FACA/04_APME.asp) 

for additional information and updates 

on committee activities. Press inquiries 

are handled through the CMS Press 

Office at (202) 690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background and Meeting Agenda 

Section 9(a)(2) of the Federal 

Advisory Committee Act authorizes the 

Secretary of Health and Human Services 

(the Secretary) to establish an advisory 

panel if the Secretary determines that 

the panel is ‘‘in the public interest in 

connection with the performance of 

duties imposed * * * by law.’’ Such 

duties are imposed by section 1804 of 

the Social Security Act (the Act), 

requiring the Secretary to provide 

informational materials to Medicare 

beneficiaries about the Medicare 

program, and section 1851(d) of the Act, 

requiring the Secretary to provide for 

‘‘activities * * * to broadly disseminate 

information to [M]edicare beneficiaries 

* * * on the coverage options provided 

under [Medicare Advantage] in order to 

promote an active, informed selection 

among such options.’’ 

The Panel is also authorized by 

section 1114(f) of the Act (42 U.S.C. 

1311(f)) and section 222 of the Public 

Health Service Act (42 U.S.C. 217a). The 

Secretary signed the charter establishing 

this Panel on January 21, 1999 (64 FR 

7899, February 17, 1999) and approved 

the renewal of the charter on January 21, 

2009 (74 FR 13442, March 27, 2009). 

The Panel advises and makes 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

opportunities to enhance the 

effectiveness of consumer education 

strategies concerning the Medicare 

program. 

The goals of the Panel are as follows: 

• To provide recommendations on 

the development and implementation of 

a national Medicare education program 

that describes benefit options under 

Medicare. 

• To enhance the Federal 

government’s effectiveness in informing 

the Medicare consumer. 

• To make recommendations on how 

to expand outreach to vulnerable and 

underserved communities, including 

racial and ethnic minorities, in the 

context of a national Medicare 

education program. 

• To assemble an information base of 

best practices for helping consumers 

evaluate benefit options and build a 

community infrastructure for 

information, counseling, and assistance. 

The current members of the Panel are: 

Stephen P. Fera, M.B.A., Vice President, 

Social Mission Programs, Independence 

Blue Cross; Richard C. Frank, M.D., 

Director, Cancer Research, Whittingham 

Cancer Center; Cathy C. Graeff, R.Ph., 

M.B.A., Partner, Sonora Advisory 

Group; Carmen R. Green, M.D., 

Professor, Anesthesiology and Associate 

Professor, Health, Management, and 

Policy, University of Michigan; Cindy 

Hounsell, J.D., President, Women’s 

Institute for a Secure Retirement; Kathy 

Hughes, Vice Chairwoman, Oneida 

Nation; Gail Hunt, President and Chief 

Executive Officer, National Alliance for 

Caregiving; Warren Jones, M.D., 

F.A.A.F.P., Executive Director, 

Mississippi Institute for Improvement of 

Geographic Minority Health; Sandy 

Markwood, Chief Executive Officer, 

National Association of Area Agencies 

on Aging; David W. Roberts, 

M.P.A.,Vice President, Government 

Relations, Healthcare Information and 

Management System Society; Julie 

Boden Schmidt, M.S., Associate Vice 

President, Training and Technical 

Assistance, National Association of 

Community Health Centers; Rebecca P. 

Snead, Chief Executive Officer and 

Executive Vice President, National 

Alliance of State Pharmacy Associations 

and APME Chair; Donna Yee, PhD, 

Chief Executive Officer, Asian 

Community Center of Sacramento 

Valley; Deeanna Jang, Policy Director, 

Asian and Pacific Islander American 

Health Forum; Andrew Kramer, M.D., 

Professor of Medicine, Division of 

Health Care Policy and Research, 

University of Colorado, Denver; and 

John Lui, PhD, M.B.A., Executive 

Director, Stout Vocational 

Rehabilitation Institute. 

The agenda for the October 13, 2010 

meeting will include the following: 

• Recap of the previous (June 22, 

2010) meeting. 

• Subgroup Committee Work 

Summary. 

• Medicare Outreach and Education 

Strategies. 

• Public Comment. 

• Listening Session with CMS 

Leadership. 

• Next Steps. 

Individuals or organizations that wish 

to make a 5-minute oral presentation on 

an agenda topic should submit a written 

copy of the oral presentation to the DFO 

at the address listed in the ADDRESSES

section of this notice by the date listed 

in the DATES section of this notice. The 

number of oral presentations may be 

limited by the time available. 

Individuals not wishing to make a 

presentation may submit written 

comments to the DFO at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

II. Virtual Meeting Participation 

Information and Instructions 

A. Software Requirements 

Software to participate in a Connect 

Pro meeting only requires that you have 

an Internet connection, a Web browser, 

and Adobe Flash Player Version 8 or 

later to attend a Web conference. 

Connect Pro supports nearly any 

operating system including Windows, 

Macintosh, Linux, and Solaris, as well 

as the most widely used browsers 

including Internet Explorer, Firefox, and 

Safari. 

B. Participation in an Acrobat Connect 

Pro Meeting 

1. Pre-Meeting Computer Testing 

It is recommended that you test your 

computer prior to attending a meeting. 

You can do this by going to: https:// 

admin.adobe.acrobat.com/common/ 

help/en/support/meeting_test.htm. The 

connection test checks your computer to 

make sure all system requirements are 

met. If you pass the first three steps of 

the test, then you are ready to 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 58407 

participate in a meeting. If you do not 

pass the connection test, perform the 

suggested actions and run the test again. 

2. Joining the Meeting 

Registrants will receive an e-mail 

invitation with meeting access 

information prior to meeting. When the 

meeting date and time arrive, click on 

the link or enter the URL into your Web 

browser. The meeting login screen 

appears. Select ‘‘Enter as a Guest,’’ type 

in your first and last name, and click 

‘‘Enter Room.’’ The meeting launches in 

your browser. 

To access the audio portion of the 

meeting please dial 1–888–469–0694 

and enter passcode 1995616. If you 

should have difficulties accessing the 

meeting please contact Syreeta Jones via 

phone at 1–301–577–0244 ext. 4900 or 

via e-mail at sjones@blseamon.com. 

Authority: Sec. 222 of the Public Health 

Service Act (42 U.S.C. 217a) and sec. 10(a) 

of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) 

and 41 CFR 102–3). 

(Catalog of Federal Domestic Assistance 

Program No. 93.733, Medicare—Hospital 

Insurance Program; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 9, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–23312 Filed 9–23–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4143–N] 

Medicare Program; Medicare Appeals; 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2011 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

annual adjustment in the amount in 

controversy (AIC) threshold amounts for 

Administrative Law Judge (ALJ) 

hearings and judicial review under the 

Medicare appeals process. The 

adjustment to the AIC threshold 

amounts will be effective for requests 

for ALJ hearings and judicial review 

filed on or after January 1, 2011. The 

2011 AIC threshold amounts are $130 

for ALJ hearings and $1,300 for judicial 

review. 

DATES: Effective Date: This notice is 

effective on January 1, 2011. 

FOR FURTHER INFORMATION CONTACT: Liz 

Hosna (Katherine.Hosna@cms.hhs.gov), 

(410) 786–4993. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1869(b)(1)(E) of the Social 

Security Act (the Act), as amended by 

section 521 of the Medicare, Medicaid, 

and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA), 

established the AIC threshold amounts 

for ALJ hearing requests and judicial 

review at $100 and $1,000, respectively, 

for Medicare Part A and Part B appeals. 

Section 940 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA), 

amended section 1869(b)(1)(E) of the 

Act to require the AIC threshold 

amounts for ALJ hearings and judicial 

review to be adjusted annually. The AIC 

threshold amounts are to be adjusted, as 

of January 2005, by the percentage 

increase in the medical care component 

of the consumer price index for all 

urban consumers (U.S. city average) for 

July 2003 to July of the year preceding 

the year involved and rounded to the 

nearest multiple of $10. Section 

940(b)(2) of the MMA provided 

conforming amendments to apply the 

AIC adjustment requirement to 

Medicare Part C (Medicare Advantage 

‘‘MA’’) appeals and certain health 

maintenance organization and 

competitive health plan appeals. Health 

care prepayment plans are also subject 

to MA appeals rules, including the AIC 

adjustment requirement. Section 101 of 

the MMA provides for the application of 

the AIC adjustment requirement to 

Medicare Part D appeals. 

A. Medicare Part A and Part B Appeals 

The statutory formula for the annual 

adjustment to the AIC threshold 

amounts for ALJ hearings and judicial 

review of Medicare Part A and Part B 

appeals, set forth at section 

1869(b)(1)(E) of the Act, is included in 

the applicable implementing 

regulations, 42 CFR Part 405, Subpart I, 

at § 405.1006(b). The regulations require 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) to publish changes to the AIC 

threshold amounts in the Federal 

Register (§ 405.1006(b)(2)). In order to 

be entitled to a hearing before an ALJ, 

a party to a proceeding must meet the 

AIC requirements at § 405.1006(b). 

Similarly, a party must meet the AIC 

requirements at § 405.1006(c) at the time 

judicial review is requested for the court 

to have jurisdiction over the appeal 

(§ 405.1136(a)). 

B. Medicare Part C (Medicare 

Advantage) Appeals 

Section 940(b)(2) of the MMA applies 

the AIC adjustment requirement to Part 

C (MA) appeals by amending section 

1852(g)(5) of the Act. The implementing 

regulations for Medicare Part C appeals 

are found at 42 CFR Part 422, Subpart 

M. Specifically, § 422.600 and § 422.612 

discuss the AIC threshold amounts for 

ALJ hearings and judicial review. 

Section 422.600 grants any party to the 

reconsideration, except the MA 

organization, who is dissatisfied with 

the reconsideration determination, a 

right to an ALJ hearing as long as the 

amount remaining in controversy after 

reconsideration meets the threshold 

requirement established annually by the 

Secretary. Section 422.612 states that 

any party, including the MA 

organization, may request judicial 

review if, in part, the AIC meets the 

threshold requirement established 

annually by the Secretary. 

C. Health Maintenance Organizations, 

Competitive Medical Plans, and Health 

Care Prepayment Plans 

Section 1876(c)(5)(B) of the Act states 

that the annual adjustment to the AIC 

dollar amounts set forth in section 

1869(b)(1)(E) of the Act applies to 

certain beneficiary appeals within the 

context of health maintenance 

organizations and competitive medical 

plans. The applicable implementing 

regulations for Medicare Part C appeals 

are set forth in 42 CFR Part 422, Subpart 

M, and as discussed above, apply to 

these appeals. The Medicare Part C 

appeals rules also apply to health care 

prepayment plan appeals. 

D. Medicare Part D (Prescription Drug 

Plan) Appeals 

The annually adjusted AIC threshold 

amounts for ALJ hearings and judicial 

review that apply to Medicare Parts A, 

B, and C appeals also apply to Medicare 

Part D appeals. Section 101 of the MMA 

added section 1860D–4(h)(1) of the Act 

regarding Part D appeals. This statutory 

provision requires a prescription drug 

plan sponsor to meet the requirements 

set forth in sections 1852(g)(4) and (g)(5) 

of the Act, in a similar manner as MA 

organizations. As noted above, the 

annually adjusted AIC threshold 

requirement was added to section 

1852(g)(5) of the Act by section 

940(b)(2)(A) of the MMA. The 

implementing regulations for Medicare 

Part D appeals can be found at 42 CFR 

Part 423, Subpart M and Subpart U. The 

regulations impart at § 423.562(c) that, 


srobinson on DSKHWCL6B1PROD with NOTICES