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Weekly Legislative & Regulatory Round-up

Week of January 16 - 22, 2010

GAO reports

Medicaid and CHIP: Enrollment, Benefits, Expenditures, and Other Characteristics of State Premium Assistance Programs GAO-10-258R

Medicare Advantage: CMS Assists Beneficiaries Affected by Inappropriate Marketing but Has Limited Data on Scope of Issue GAO-10-36

OIG reports

Review of Early Intervention Services Costs Claimed by New Jersey to the Medicaid Program (A-02-07-01053)

Review of Ryan White Title II Funding in Maryland (A-03-08-00551)

A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices (PDF) (OEI-03-08-00490)

Outlier Average Manufacturer Prices in the Federal Upper Limit Program (PDF) (OEI-03-07-00740)

Review of the Centers for Disease Control and Prevention’s Compliance With Appropriations Laws and Acquisition Regulations—Contractor A (A-04-08-01059)

Bills introduced
Number/
Title
Date Introduced Sponsor Description

H.R. 4473

1/20/10

KURT SCHRADER (D-OR)

A bill to amend title XVIII of the Social Security Act to establish an extended special enrollment period for individuals to enroll in part B of Medicare; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

S. 2942

1/21/10

MARK PRYOR (D-AR)

A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology program; to the Committee on Health, Education, Labor, and Pensions.

H.R. 4500

1/21/10

THADDEUS MCCOTTER (R-MI)

A bill to rescind unobligated appropriations and repeal certain health care-related provisions in the American Recovery and Reinvestment Act of 2009 for purposes of reducing the national debt; to the Committee on Appropriations, and in addition to the Committees on Energy and Commerce, and Science and Technology.

H. Res. 1033

1/21/10

DAVE REICHERT (R-WA)

A resolution expressing support for designation of April 2010 as ``National Autism Awareness Month'' and supporting efforts to devote new resources to research into the causes and treatment of autism and to improve training and support for individuals with autism and those who care for individuals with autism; to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor.

 

Federal Register notices

January 19

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Office of the Secretary

National Biodefense Science Board: Notification of Public

Teleconference

ACTION: Notice.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the

Department of Health and Human Services (HHS) is hereby giving notice

that the National Biodefense Science Board (NBSB) will hold a

teleconference meeting. The meeting is open to the public. Pre-

registration is NOT required, however, individuals who wish to

participate in the public comment session should e-mail NBSB@HHS.GOV to

RSVP.

DATES: The meeting will be held on February 10, 2010 from 2 p.m. to 4

p.m. ET.

 

January 20

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

Draft Guidance for Industry and Food and Drug Administration

Staff; Heart Valves -- Investigational Device Exemption (IDE) and

Premarket Approval (PMA) Applications; Availability

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of the draft guidance document entitled ``Heart Valves --

Investigational Device Exemption (IDE) and Premarket Approval (PMA)

Applications.'' This draft guidance document describes FDA's

recommendations about investigational device exemption and premarket

approval applications for heart valves. This draft guidance document is

not final, nor is it in effect at this time.

 

January 21

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

International Conference on Harmonisation; Guidance on M3(R2)

Nonclinical Safety Studies for the Conduct of Human Clinical Trials and

Marketing Authorization for Pharmaceuticals; Availability

ACTION:  Notice.

 

 

January 22

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Advisory Panel on Medicare

Education; Cancellation of the February 3, 2010 Meeting and

Announcement of the March 31, 2010 Meeting

ACTION: Notice of meeting.

SUMMARY: This notice announces the cancellation of the meeting of the

Advisory Panel on Medicare Education (the Panel) that was published in

the December 18, 2009 Federal Register (74 FR 67240-67241). This notice

also announces a public meeting on March 31, 2010. 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, March 31, 2010 from 8:30 a.m. to 3

p.m., eastern daylight time (e.d.t.).

Deadline for Meeting Registration, Presentations and Comments:

Wednesday, March 24, 2010, 5 p.m., e.d.t.

Deadline for Requesting Special Accommodations: Wednesday, March

17, 2010, 5 p.m., e.d.t.

 

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Practicing Physicians Advisory

Council, March 8, 2010

ACTION: Notice.

SUMMARY: This notice announces a quarterly meeting of the Practicing

Physicians Advisory Council (the Council). The Council will meet to

discuss certain proposed changes in regulations and manual instructions

related to physicians' services, as identified by the Secretary of

Health and Human Services. This meeting is open to the public.

DATES: Meeting Date: Monday, March 8, 2010, from 8:30 a.m. to 5 p.m.,

eastern standard time (e.s.t.).

ADDRESSES: Meeting Location: The meeting will be held in the

Multipurpose Room, at the CMS Single Site campus, 7500 Security

Boulevard, Baltimore, MD 21244.

 

Office of the Secretary

2009 HHS Poverty Guidelines Extended Until March 1, 2010

ACTION: Notice.

SUMMARY: This notice advises that, pursuant to section 1012 of the

Department of Defense Appropriations Act, 2010, the 2009 Department of

Health and Human Services (HHS) poverty guidelines will remain in

effect until updated 2010 poverty guidelines are published, which shall

not take place before March 1, 2010.

DATES:  Effective Date: Date of publication.

 

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Proposed Project: Advanced Education Nursing Traineeship (AENT) and

Nurse Anesthetist Traineeship (NAT) (OMB No. 0915-0305) [Extension]

 

Health Resources and Services Administration

National Advisory Committee on Rural Health and Human Services;

Notice of Meeting

Dates and Times: February 17, 2010, 1 p.m.-5 p.m.

February 18, 2010, 9 a.m.-5 p.m.

February 19, 2010, 9 a.m.-10:30 a.m.

Place: The Sofitel Lafayette Square, 806 15th Street, NW.,

Washington, DC, 20005, Phone: 202-730-8800.

Status: The meeting will be open to the public.

 

Health Resources and Services Administration

Ryan White HIV/AIDS Part C Early Intervention Services (EIS)

Program

ACTION: Notice of Non-competitive Replacement Award.

SUMMARY: The Health Resources and Services Administration (HRSA) is

issuing a non-competitive replacement award to the Orange County Health

Department, Orlando, Florida, that will ensure continuity of Part C,

Early Intervention Services (EIS), HIV/AIDS care and treatment services

to women, infants, and children without disruption from Orlando Health

Incorporated's HUG-ME Program, in Orange County and the surrounding

areas.

 

National Institutes of Health

NIH Consensus Development Conference on Vaginal Birth After

Cesarean: New Insights; Notice

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