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Weekly Legislative & Regulatory Round-up

Week of March 28 - April 3

GAO reports

Methadone-Associated Overdose Deaths: Factors Contributing to Increased Deaths and Efforts to Prevent Them GAO-09-341

Health-Care-Associated Infections: HHS Action Needed to Obtain Nationally Representative Data on Risks in Ambulatory Surgical Centers GAO-09-213

 

OIG reports

No relevant reports

 

Bills introduced
Number/
Title
Date Introduced Sponsor Description

H.R. 1776

3/30/09

JASON ALTMIRE (D-PA)

A bill to amend title XVIII of the Social Security Act to expand the development of quality measures for inpatient hospital services, to implement a performance-based payment methodology for the provision of such services under the Medicare Program, and for other purposes; Referred to the Committee on Ways and Means.

S. 750

3/31/09

BARBARA BOXER (D-CA)

A bill to amend the Public Health Service Act to attract and retain trained health care professionals and direct care workers dedicated to providing quality care to the growing population of older Americans; Referred to the Committee on Health, Education, Labor, and Pensions.

S. 754

3/31/09

JOHN ROCKEFELLER (D-WV)

A bill to provide for increased Federal oversight of methadone treatment; Referred to the Committee on Health, Education, Labor, and Pensions.

H.R. 1809

3/31/09

PEDRO PIERLUISI (D-PR)

A bill to amend title 10, United States Code, to expand the geographical coverage of TRICARE Prime to include Puerto Rico and Guam; Referred to the Committee on Armed Services.

H.R. 1816

3/31/09

HOWARD BERMAN (D-CA)

A bill to amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer; Referred to the Committee on Energy and Commerce.

H.R. 1829

3/31/09

EARL POMEROY (D- ND)

A bill to amend title XVIII of the Social Security Act to authorize physical therapists to evaluate and treat Medicare beneficiaries without a requirement for a physician referral, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 1832

3/31/09

ROBERT WEXLER (D-FL)

A bill to amend part D of title XVIII of the Social Security Act to limit the increase in premium costs for beneficiaries under the Medicare prescription drug program to no more than the Social Security cost-of-living adjustment, and to direct the Secretary of Health and Human Services to negotiate lower prescription drug prices on behalf of Medicare beneficiaries; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

S. 767

4/1/09

HERBERT KOHL (D-WI)

A bill to amend the Public Health Service Act to provide grants or contracts for prescription drug education and outreach for healthcare providers and their patients; Referred to the Committee on Health, Education, Labor, and Pensions.

S. 769

4/1/09

BLANCHE LINCOLN (D-AR)

A bill to amend title XVIII of the Social Security Act to improve access to, and increase utilization of, bone mass measurement benefits under the Medicare part B program; Referred to the Committee on Finance.

S. 770

4/1/09

RICHARD DURBIN (D-IL)

A bill to amend titles V, XVIII, and XIX of the Social Security Act to promote cessation of tobacco use under the Medicare program, the Medicaid program, and the maternal and child health services block grant program; Referred to the Committee on Finance.

S. 776

4/1/09

ROBERT CASEY (D-PA)

A bill to assist in creating substantive culture change in long-term residential care by establishing a small house nursing home loan program to provide for the establishment, renovation, and construction of small house nursing homes; Referred to the Committee on Banking, Housing, and Urban Affairs.

H.R. 1844

4/1/09

LOIS CAPPS (D-CA)

A bill to amend title XVIII of the Social Security Act to provide for coverage of comprehensive cancer care planning under the Medicare Program and to improve the care furnished to individuals diagnosed with cancer by establishing a Medicare hospice care demonstration program and grants programs for cancer palliative care and symptom management programs, provider education, and related research; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 1850

4/1/09

DIANA DEGETTE (D-CO)

A bill to amend titles V, XVIII, and XIX of the Social Security Act to promote tobacco use cessation under the Medicare Program, the Medicaid Program, and the maternal and child health program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

H.R. 1859

4/1/09

FRANK PALLONE (D-NJ)

A bill to amend the Public Health Service Act to provide grants or contracts for prescription drug education and outreach for healthcare providers and their patients; Referred to the Committee on Energy and Commerce.

S. 790

4/2/09

JEFF BINGAMAN (D-NM)

A bill to improve access to health care services in rural, frontier, and urban underserved areas in the United States by addressing the supply of health professionals and the distribution of health professionals to areas of need; Referred to the Committee on Finance.

S. 792

4/2/09

BERNARD SANDERS (I-VT)

A bill to amend the Public Health Service Act to improve the National Program of Cancer Registries by expanding data collection and allowing data sharing for public health objectives, while preserving the confidentiality of patients, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.

S. 811

4/2/09

DANIEL INOUYE (D-HI)

A bill to amend the Public Health Service Act to promote mental and behavioral health services for underserved populations; Referred to the Committee on Health, Education, Labor, and Pensions.

 

Federal Register notices

 

March 30, 2009

 

No relevant notices.

 

March 31, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

 

Agency Information Collection Activities: Proposed Collection;

Comment Request

ACTION: Notice.

SUMMARY: This notice announces the intention of the Agency for

Healthcare Research and Quality (AHRQ) to request that the Office of

Management and Budget (OMB) allow information collection related to

implementation of the Patient Safety and Quality Improvement Act of

2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization

Certification for Initial Listing and Related Forms and a Patient

Safety Confidentiality Complaint Form.'' In accordance with the

Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites

the public to comment on this proposed information collection.

    This proposed information collection was previously published in

the Federal Register on January 27, 2009 and allowed 60 days for public

comment. No comments were received. The purpose of this notice is to

allow an additional 30 days for public comment.

 

Agency for Healthcare Research and Quality

 

Agency Information Collection Activities: Proposed Collection;

Comment Request

ACTION: Notice.

SUMMARY: This notice announces the intention of the Agency for

Healthcare Research and Quality (AHRQ) to request that the Office of

Management and Budget (OMB) approve the proposed information collection

project: ``CAHPS Field Test of Proposed Health Information Technology

Questions and Methodology.'' In accordance with the Paperwork Reduction

Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites

the public to comment on this proposed information collection.

 

Food and Drug Administration

 

Medical Devices; Technical Amendment

ACTION: Final rule; technical amendment.

SUMMARY: The Food and Drug Administration (FDA) is amending a medical

device regulation to correct a statutory reference to reflect the

current citation and to ensure accuracy and clarity in the agency's

regulations.

 

April 1, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

 

Agency Information Collection Activities: Proposed Collection;

Comment Request

ACTION: Notice.

SUMMARY: This notice announces the intention of the Agency for

Healthcare Research and Quality (AHRQ) to request that the Office of

Management and Budget (OMB) approve the proposed information collection

project: ``Assessing Organizational Responses to AHRQ's Health Literacy

Pharmacy Tools.'' In accordance with the Paperwork Reduction Act of

1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on

this proposed information collection.

    This proposed information collection was previously published in

the Federal Register on January 29th, 2009 and allowed 60 days for

public comment. No comments were received. The purpose of this notice

is to allow an additional 30 days for public comment.

 

Agency for Healthcare Research and Quality

 

Request for Nominations for AHRQ Study Section Members

ACTION: Request for nominations for public members.

SUMMARY: In accordance with Title IX of the Public Health Service Act,

the authorizing legislation for AHRQ and its grant and contract

regulations pertaining to Peer Review of Grant and Contracts 42 CFR

Part 67, applications submitted to the AHRQ will be evaluated using the

AHRQ peer review process to ensure a fair, equitable, and unbiased

evaluation of their scientific and technical merit. The initial peer

review of grant applications involves an assessment conducted by panels

of experts established to include pertinent scientific disciplines and

medical specialty areas. The confidential part of the peer review

meetings devoted to critical evaluations will be closed meetings in

accordance with section 10(d) of the Federal Advisory Committee Act as

amended (5 U.S.C., Appendix 2).

    AHRQ is seeking nominations to fill approximately 20 to 30 percent

of its study section membership, across the following study sections

 

April 2, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 

Draft Guidance for Industry: Somatic Cell Therapy for Cardiac

Disease; Availability.

ACTION: Notice.

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

availability of a draft document entitled ``Guidance for Industry:

Somatic Cell Therapy for Cardiac Disease'' dated March 2009. The draft

guidance document provides sponsors of cellular therapies for the

treatment of cardiac disease with recommendations on the design of

preclinical and clinical studies, and information that should be

submitted about the product delivery system. This guidance also

provides recommendations on the chemistry, manufacturing and controls

information to include in an investigational new drug application (IND)

for cardiac cellular therapy.

 

 

Health Resources and Services Administration

 

Advisory Committee on Heritable Disorders in Newborns and

Children

ACTION: Notice of Request for Nominations.

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

requesting nominations to fill two (2) vacancies on the Advisory

Committee on Heritable Disorders in Newborns and Children. The

Secretary of Health and Human Services (the Secretary, HHS) is

soliciting nominations for individuals with expertise either in ethics

or infectious diseases.

 

April 3, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

 

Medicaid Program; State Flexibility for Medicaid Benefit Packages

ACTION: Final rule; delay of effective date and reopening of comment

period.

SUMMARY: This action temporarily delays the effective date of the

December 3, 2008 final rule entitled, ``Medicaid Program: State

Flexibility for Medicaid Benefit Packages'' (73 FR 73694) until

December 31, 2009. In addition, this action reopens the comment period

on the policies set out in the December 3, 2008 final rule, and

specifically solicits comments on the effect of certain provisions of

the Children's Health Insurance Program Reauthorization Act of 2009.

 

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