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Weekly Legislative & Regulatory Round-up

Week of June 20 - 26

GAO reports

Federal Tort Claims Act: Information Related to Implications of Extending Coverage to Volunteers at HRSA-Funded Health Centers GAO-09-693R 

Medicaid: Source of Screening Affects Women's Eligibility for Coverage of Breast and Cervical Cancer Treatment in Some States GAO-09-384 

Prescription Drugs: Overview of Approaches to Control Prescription Drug Spending in Federal Programs GAO-09-819T

 

OIG reports

No relevant reports.

 

Bills introduced
Number/
Title
Date Introduced Sponsor Description

S. 1307

6/19/09

RUSS FEINGOLD (D-WI)

A bill to amend part C of title XVIII of the Social Security Act with respect to Medicare special needs plans and the alignment of Medicare and Medicaid for dually eligible individuals, and for other purposes; Referred to the Committee on Finance.

H.R. 2962

6/19/09

JACKIE SPEIER (D-CA)

A bill to amend title XVIII of the Social Security Act to exclude certain advanced diagnostic imaging services from the in-office ancillary services exception to the prohibition on physician self-referral; Referred  to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 2975

6/19/09

JOHN CAMPBELL (R-CA)

A bill to improve the medical care by reducing the excessive burden imposed by the civil liability system on the health care delivery system; Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce.

H.R. 2987

6/19/09

LINDA T. SÁNCHEZ (D-CA)

A bill to amend the Public Health Service Act to ensure sufficient resources and increase efforts for research at the National Institutes of Health relating to Alzheimer's disease, to authorize an education and outreach program to promote public awareness and risk reduction with respect to Alzheimer's disease (with particular emphasis on education and outreach in Hispanic populations), and for other purposes; Referred to the Committee on Energy and Commerce.

S. 1315

6/22/09

BILL NELSON (D-FL)

A bill to amend the Federal Food, Drug, and Cosmetic Act to define the term ``first applicant'' for purposes of filing an abbreviated application for a new drug; Referred to the Committee on Health, Education, Labor, and Pensions.

H.R. 3000

6/23/09

BARBARA LEE (D-CA)

A bill to establish a United States Health Service to provide high quality comprehensive health care for all Americans and to overcome the deficiencies in the present system of health care delivery; Referred  to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor.

H.R. 3001

6/23/09

TAMMY BALDWIN (D-WI)

A bill to address the health disparities experienced by lesbian, gay, bisexual, and transgender Americans, to eliminate the barriers they face in accessing quality health care, and to ensure that good health and well-being is accessible to all; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, the Judiciary, Ways and Means, Oversight and Government Reform, House Administration, Education and Labor, Veterans' Affairs, Transportation and Infrastructure, Intelligence (Permanent Select), and Foreign Affairs.

H.R. 3002

6/23/09

JOHN BOEHNER (R-OH)

A bill to protect all patients by prohibiting the use of data obtained from comparative effectiveness research to deny coverage of items or services under Federal health care programs and to ensure that comparative effectiveness research accounts for advancements in personalized medicine and differences in patient treatment response; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3003

6/23/09

LOIS CAPPS (D-CA)

A bill to amend the Public Health Service Act to establish the School-Based Health Clinic program, and for other purposes; Referred to the Committee on Energy and Commerce.

S. 1334

6/24/09

KIRSTEN GILLIBRAND (D-NY)

A bill to amend the Public Health Service Act to extend and improve protections and services to individuals directly impacted by the terrorist attack in New York City on September 11, 2001, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.

H.R. 3024

6/24/09

MIKE ROSS (D-AR)

A bill to amend title XVIII of the Social Security Act to provide Medicare beneficiaries greater choice with regard to accessing hearing health services and benefits; Referred  to the Committee on Energy and Commerce, and in ad

H.R. 3030

6/24/09

TIM WALZ (D-MN)

A bill to establish pilot projects under the Medicare Program to provide incentives for home health agencies to utilize home monitoring and communications technologies; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.

S. 1352

6/25/09

CHRISTOPHER DODD (D-CT)

A bill to provide for the expansion of Federal efforts concerning the prevention, education, treatment, and research activities related to Lyme and other tick-borne diseases, including the establishment of a Tick-Borne Diseases Advisory Committee; Referred to the Committee on Health, Education, Labor, and Pensions.

S. 1355

6/25/09

JOHN BARRASSO (R-WY)

A bill to amend title XVIII of the Social Security Act to improve access to health care for individuals residing in underserved rural areas and for other purposes; Referred  to the Committee on Finance.

S. 1380

6/25/09

JOHN ROCKEFELLER (D-WV)

A bill to amend title XVIII of the Social Security Act to create a sensible infrastructure for delivery system reform by renaming the Medicare Payment Advisory Commission, making the commission an executive branch agency, and providing the Commission new resources and authority to implement Medicare payment policy; Referred  to the Committee on Finance.

S. 1278

6/17/09

JOHN ROCKEFELLER (D-WV)

A bill to establish the Consumers Choice Health Plan, a public health insurance plan that provides an affordable and accountable health insurance option for consumers; Referred to the Committee on Finance.

S. 1384

6/25/09

BENJAMIN CARDIN (D-MD

A bill to amend title XVIII of the Social Security Act to provide a senior housing facility plan option under the Medicare Advantage program; Referred to the Committee on Finance.

 

Federal Register notices

June 22

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Agency for Healthcare Research and Quality

Meeting of the National Advisory Council for Healthcare Research

and Quality

ACTION: Notice of public meeting.

DATES: The meeting will be held on Friday, July 24, 2009, from 9 a.m.

to 3 p.m.

ADDRESSES: The meeting will be held in Room 800, Hubert H. Humphrey

Building, 200 Independence Avenue, SW., Washington, DC 20201.

 

Centers for Medicare & Medicaid Services

Medicaid Program; Home and Community-Based Services (HCBS)

Waivers

ACTION: Advance notice of proposed rulemaking.

SUMMARY: This advance notice of proposed rulemaking announces the

intention of CMS to publish proposed amendments to the regulations

implementing Medicaid home and community-based services waivers under

section 1915(c) of the Social Security Act and solicits advance public

comments on the merits of providing States the option to combine or

eliminate the existing three permitted waiver targeting groups, and on

the most effective means to define home and community.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on August 21, 2009.

 

DEPARTMENT OF DEFENSE

TRICARE; Coverage of National Cancer Institute (NCI) Sponsored

Phase I Studies

ACTION: Proposed rule.

SUMMARY: This proposed rule adds coverage of National Cancer Institute

(NCI) sponsored Phase I studies for certain beneficiaries. The NCI

sponsored clinical treatment trials are conducted in a series of steps

called phases. Phase I trials are the first studies conducted in

people. They evaluate how a new drug should be given (by mouth,

injected into the blood, or injected into the muscle), how often, and

what dose is safe.

DATES: Written comments received at the address indicated below by

August 21, 2009 will be accepted.

 

June 23

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare and Medicaid Services

Emergency Clearance: Public Information Collection Requirements

Submitted to the Office of Management and Budget (OMB)

Type of Information Collection Request: New collection; Title of

Information Collection: State Collection and Reporting of Dental

Provider and Benefit Package Information.

 

Centers for Medicare & Medicaid Services

Notice of Hearing: Reconsideration of Disapproval of Washington

State Plan Amendment (SPA) 08-019

ACTION: Notice of Hearing.

SUMMARY: This notice announces an administrative hearing to be held on

August 4, 2009, at the CMS Seattle Regional Office, 2201 Sixth Avenue,

MS/RX-43, Seattle, Washington 98121, to reconsider CMS' decision to

disapprove Washington SPA 08-019.

 

June 24

 

No relevant notices.

 

June 25

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Agency for Healthcare Research and Quality

Request for Tools and Methods Used by Small- and Medium-Sized

Practices for Analyzing and Redesigning Workflows Either Before or

After Health Information Technology Implementation

ACTION: Notice of request for information.

SUMMARY: This notice announces the intention of the Agency for

Healthcare Research and Quality (AHRQ) to request information from (1)

small- and medium-sized practices about how they study or redesign

their workflow, including information on the use of tools and methods

for studying workflow, and (2) others (e.g., experts, vendors,

professional associations) that have developed, implemented and used

tools and methods for studying workflow in the context of health IT

implementation and use. Workflow is defined as the way work is

performed and patient-related information is communicated within small-

and medium-sized practices and between those practices and external

organizations such as community pharmacies and local hospitals. It is

our understanding that there is currently no standard description of

workflows for care processes that can be used to guide decisions of

where and how to incorporate health information technology. This

Request for Information is part of a three-pronged effort to scan the

environment, the literature and knowledgeable and interested parties to

produce a useful list of resources that may assist small- and medium-

sized medical practices and clinics to consider the utility and

potential effectiveness of incorporating health IT into the way they

practice and communicate patient information. The responses to this

request for information will be considered for reference and possible

incorporation into an electronic toolkit to be made available on the

Internet to assist small- and medium-sized practices in analyzing or

redesigning workflow either before or after implementation of one or

more health IT applications. All responses to this request for

information are voluntary.

 

Office of the Secretary

Pandemic Influenza Vaccines--Amendment

Authority:  42 U.S.C. 247d-6d.

ACTION: Notice of third amendment to the January 26, 2007 Declaration

under the Public Readiness and Emergency Preparedness Act, and

Republication of the Declaration, as Amended.

SUMMARY: Amendment to declaration pursuant to section 319F-3 of the

Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted

liability protections for pandemic countermeasures based on the Acting

Secretary's determination, under section 319F-3(b) of the Act, that the

risk that the spread of H1N1 swine influenza viruses (now known as 2009

H1N1 Influenza A, or 2009 H1N1 influenza) and resulting disease

constitutes a public health emergency; and republication of the

declaration to reflect the declaration in its entirety, as amended.

 

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: HRSA/Bureau of Primary Health Care Capital

Improvement Program Application Electronic Health Records (EHR)

Readiness Checklist (OMB No. 0915-0325)--Extension

 

June 26

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

1. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Information

Collection Requirements Referenced in HIPAA title I for the Individual

Market

2. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Information

Collection Requirements in HIPAA title I for the Group Market

 

Centers for Medicare & Medicaid Services

 

Agency Information Collection Activities: Proposed Collection;

Comment Request

Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Conditions of

Certification for Rural Health Clinics and Supporting Regulations

 

Centers for Medicare & Medicaid Services

 

Medicare and Medicaid Programs; Application by the Joint

Commission for Continued Deeming Authority for Hospitals

ACTION: Proposed notice.

SUMMARY: This proposed notice acknowledges the receipt of a deeming

application from the Joint Commission for continued recognition as a

national accrediting organization for hospitals that wish to

participate in the Medicare or Medicaid programs. The statute requires

that we publish within 60 days of receipt of an organization's complete

application, a notice that identifies the national accrediting body

making the request, describes the nature of the request, and provides

at least a 30-day public comment period.

 

Centers for Medicare & Medicaid Services

 

Medicare and Medicaid Programs; Approval of the Joint

Commission's Continued Deeming Authority for Critical Access Hospitals

ACTION: Final Notice of Removal of Conditional Probationary Status.

SUMMARY: Based on our review and observations, we have determined that

the Joint Commission's accreditation standards for critical access

hospitals (CAHs) meet or exceed our requirements. Therefore, this final

notice announces our decision to approve without condition the Joint

Commission's request for continued recognition as a national

accreditation program for CAHs seeking to participate in the Medicare

or Medicaid programs.

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