Weekly Legislative & Regulatory Round-up

Week of June 19 - 25, 2010

GAO reports

No relevant notices.

OIG reports

Nationwide Review of Inpatient Rehabilitation Facilities’ Transmission of Patient Assessment Instruments for Calendar Years 2006 and 2007 (A-01-09-00507)

Health Resources and Services Administration’s Bureau of Clinician Recruitment and Service – Internal Control Review of the Process for Awarding American Recovery and Reinvestment Act Fund (A-03-09-00372)

Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials (PDF) (OEI-01-08-00510)

Medicare Part B Services During Non-Part A Nursing Home Stays: Enteral Nutrition Therapy (PDF) (OEI-06-07-00090)

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
H.R. 5570	06/22/2010	Upton, Fred (R-MI)	A bill to provide that no funds are authorized to be appropriated to the Internal Revenue Service to expand its workforce in order to implement, enforce, or otherwise carry out either the Patient Protection and Affordable Care Act or the Health Care and Education Reconciliation Act of 2010; Referred to the Committee on Ways and Means.
H.R. 5588	06/23/2010	Schrader, Kurt (D-OR)	A bill to amend title XVIII of the Social Security Act to provide for additional opportunities to enroll under part B of the Medicare Program, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
S. 3527	06/24/2010	Brown, Sherrod (D-OH)	A bill to amend title XVIII of the Social Security Act to ensure access to chest radiography (x-ray) services that use Computer-Aided Detection for the purpose of early detection of lung cancer; Referred to the Committee on Finance
H.R. 5593	06/24/2010	Sutton, Betty (D-OH)	A bill to amend title XVIII of the Social Security Act to provide for timely access to post-mastectomy items under Medicare; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5597	06/24/2010	Matsui, Doris (D-CA)	A bill to establish a Medicare patient IVIG access demonstration project; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.
H. Res. 1476	06/24/2010	Chu, Judy (D-CA)	A resolution supporting and recognizing the achievements of the family planning services programs operating under title X of the Public Health Service Act; Referred to the Committee on Energy and Commerce.
H. Res. 1477	06/24/2010	Kildee, Dale (D-MI)	A resolution expressing support for the designation of May as Ehlers-Danlos Syndrome Awareness Month to increase the knowledge of this little-known, potentially fatal, genetic disease; Referred to the Committee on Energy and Commerce.
H. Res. 1478	06/24/2010	Lee, Barbara (D-CA)	A resolution supporting the goals and ideals of National HIV Testing Day, and for other purposes; Referred to the Committee on Energy and Commerce.

Federal Register notices

tices

June 21

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: ``Avoiding Readmissions in Hospitals Serving Diverse

Patients.'' In accordance with the Paperwork Reduction Act, 44 U.S.C.

3501-3520, AHRQ invites the public to comment on this proposed

information collection.

DATES: Comments on this notice must be received by August 20, 2010.

Proposed Project: Avoiding Readmissions in Hospitals Serving Diverse Patients

Food and Drug Administration

Authorization of Emergency Use of Certain In Vitro Diagnostic

Devices; Availability

ACTION: Notice.

Indian Health Service

American Indians Into Medicine; Notice of Competitive Grant

Applications for American Indians Into Medicine Program

Application Deadline: July 21, 2010.

Funding Opportunity Description: The Indian Health Service (IHS) is accepting competitive grant applications for the American Indians into Medicine Program. This program is authorized under the authority of 25 U.S.C. 1616g (a), Indian Health Care Improvement Act, Public Law 94-437, as amended by

Public Law 111-148.

Purpose: The purpose of the Indians into Medicine Program (INMED) is to

augment the number of Indian health professionals serving Indians by

encouraging Indians to enter the health professions and removing the

multiple barriers to their entrance into the IHS and private practice

among Indians.

June 22

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus

Erythematosus--Developing Medical Products for Treatment; Availability

ACTION: Notice.

Food and Drug Administration

Guidance for Industry on Systemic Lupus Erythematosus--Developing

Medical Products for Treatment; Availability

ACTION: Notice.

June 23

No relevant notices

June 24

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; Medical Devices: Current Good Manufacturing Practice

Quality System Regulations

ACTION: Notice.

Food and Drug Administration

Medical Devices; Availability of Safety and Effectiveness

Summaries for Premarket Approval Applications

ACTION: Notice.

Office of the National Coordinator for Health Information

Technology Establishment of the Temporary Certification Program for Health

Information Technology

ACTION: Final rule.

SUMMARY: This final rule establishes a temporary certification program

for the purposes of testing and certifying health information

technology. This final rule is established under the authority granted

to the National Coordinator for Health Information Technology (the

National Coordinator) by section 3001(c)(5) of the Public Health

Service Act (PHSA), as added by the Health Information Technology for

Economic and Clinical Health (HITECH) Act. The National Coordinator

will utilize the temporary certification program to authorize

organizations to test and certify Complete Electronic Health Records

(EHRs) and/or EHR Modules, thereby making Certified EHR Technology

available prior to the date on which health care providers seeking

incentive payments available under the Medicare and Medicaid EHR

Incentive Programs may begin demonstrating meaningful use of Certified

EHR Technology.

DATES: These regulations are effective June 24, 2010. The incorporation

by reference of certain publications listed in the rule is approved by

the Director of the Federal Register as of June 24, 2010.

Health Resources and Services Administration

Legislative Changes to Primary Care Loan Program Authorized Under

Title VII of the Public Health Service Act

ACTION: Notice.

SUMMARY: On March 23, 2010, President Obama signed into law the

Affordable Care Act (ACA), Public Law 111-148. Section 5201 of the ACA

changes the Primary Care Loan (PCL) program by: (1) Reducing the number

of years for the primary health care service requirement; (2) lowering

the interest rate for service default; and (3) eliminating the HHS

requirement that parental financial information be submitted for

independent students.

Health Resources and Services Administration

Recruitment of Sites for Assignment of National Health Service

Corps (NHSC) Personnel Obligated Under the NHSC Scholarship Program

ACTION: General notice.

June 25

Food and Drug Administration

Guidance for Industry and Food and Drug Administration Staff; In

Vitro Diagnostic Studies--Frequently Asked Questions; Availability

ACTION: Notice.

Health Resources and Services Administration

Legislative Changes to Nursing Student Loan Program Authorized

Under Title VIII of the Public Health Service Act

ACTION: Notice.