Weekly Legislative & Regulatory Round-up
Week of April 25 - May 1
| GAO reports |
Information Technology: Management and Oversight of Projects Totaling Billions of Dollars Need Attention GAO-09-624T, April 28, 2009
Health Resources and Services Administration: Many Underserved Areas Lack a Health Center Site, and Data Are Needed on Service Provision at Sites GAO-09-667T, April 30, 2009
VA Health Care: Challenges in Budget Formulation and Issues Surrounding the Proposal for Advance Appropriations GAO-09-664T, April 29, 2009
| OIG reports |
Monthly Recovery Update Report
Whistleblower Protections under the Recovery Act
Nationwide Review of Evaluation and Management Services Included in Eye and Ocular Adnexa Global Surgery Fees for Calendar Year 2005 (A-05-07-00077)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 898 |
4/24/09 |
BERNARD SANDERS(I-VT) |
A bill to amend the Social Security Act to provide grants and flexibility through demonstration projects for States to provide universal, comprehensive, cost-effective systems of health care coverage, with simplified administration; referred to the Committee on Finance. |
H.R. 2107 |
4/27/09 |
JACKIE SPEIER (D-CA) |
A bill to direct the Secretary of Health and Human Services to conduct a public education campaign on umbilical cord blood stem cells, and for other purposes; referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor. |
H.R. 2109 |
4/27/09 |
JACKIE SPEIER (D-CA) |
A bill to improve and enhance research and programs on childhood cancer survivorship, and for other purposes; referred to the Committee on Energy and Commerce. |
H.R. 2112 |
4/27/09 |
DONNA CHRISTENSEN (D-VI) |
A bill to establish a comprehensive interagency response to reduce lung cancer mortality in a timely manner; referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, and Veterans' Affairs. |
H.R. 2113 |
4/27/09 |
PHIL HARE (D-IL) |
A bill to require the Secretary of Labor to prescribe regulations requiring employers with more than one establishment and not fewer than 500 employees to report work-related deaths, injuries, and illnesses; referred to the Committee on Education and Labor. |
H.R. 2115 |
4/27/09 |
BARON HILL (D-IN) |
A bill to amend the Public Health Service Act to establish an Office of Men's Health; referred to the Committee on Energy and Commerce. |
H.R. 2124 |
4/27/09 |
EARL POMEROY (D-ND) |
A bill to extend subsections (c) and (d) of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Public Law 110-173) to provide for regulatory stability during the development of facility and patient criteria for long-term care hospitals under the Medicare Program, and for other purposes; referred to the Committee on Ways and Means. |
S. 914 |
4/27/09 |
ARLEN SPECTER (R-PA) |
A bill to establish an independent Cures Acceleration Network agency, to sponsor promising translational research to bridge the gap between laboratory discoveries and life-saving therapies, to reauthorize the National Institutes of Health, and for other purposes; referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 2137 |
4/28/09 |
MAXINE WATERS (D-CA) |
A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, the Internal Revenue Code of 1986, and title 5, United States Code, to require individual and group health insurance coverage and group health plans and Federal employees health benefit plans to provide coverage for routine HIV screening; referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor, Ways and Means, and Oversight and Government Reform. |
H.R. 2149 |
4/28/09 |
PATRICK KENNEDY (D-RI) |
A bill to authorize the Secretary of Health and Human Services to conduct activities to rapidly advance treatments for spinal muscular atrophy, neuromuscular disease, and other pediatric diseases, and for other purposes; referred to the Committee on Energy and Commerce. |
H.R. 2176 |
4/29/09 |
EARL POMEROY(D-ND) |
A bill to amend title XVIII of the Social Security Act to continue the ability of hospitals to supply a needed workforce of nurses and allied health professionals by preserving funding for hospital operated nursing and allied health education programs; referred to the Committee on Ways and Means. |
S. 935 |
4/30/09 |
KENT CONRAD (D-ND) |
A bill to extend subsections (c) and (d) of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Public Law 110-173) to provide for regulatory stability during the development of facility and patient criteria for long-term care hospitals under the Medicare program, and for other purposes; referred to the Committee on Finance. |
S. 947 |
4/30/09 |
BLANCHE LINCOLN (D-AR) |
A bill to amend title XVIII of the Social Security Act to provide for the treatment of certain physician pathology services under the Medicare program; to the Committee on Finance. |
S. 950 |
4/30/09 |
BLANCHE LINCOLN (D-AR) |
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 Finance. |
H.R. 2201 |
4/30/09 |
BRUCE BRALEY (D-IA) |
A bill to amend part B of title XVIII of the Social Security Act to provide a floor of 1.0 for the practice expense and for the work expense geographic practice cost indices (GPCI) under the Medicare Program; referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 2204 |
4/30/09 |
HENRY CUELLAR (D-TX) |
A bill to amend title XVIII of the Social Security Act to provide payment under part A of the Medicare Program on a reasonable cost basis for anesthesia services furnished by an anesthesiologist in certain rural hospitals in the same manner as payments are provided for anesthesia services furnished by anesthesiologist assistants and certified registered nurse anesthetists in such hospitals; referred to the Committee on Ways and Means. |
H.R. 2209 |
4/30/09 |
ALCEE HASTINGS (D-FL) |
A bill to amend titles XVI, XVIII, XIX, and XXI of the Social Security Act to remove limitations on Medicaid, Medicare, SSI, and SCHIP benefits for persons in custody pending disposition of charges; referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 2218 |
4/30/09 |
RON PAUL (R-TX) |
A bill to prohibit the use of Federal funds for any universal or mandatory mental health screening program; referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor. |
H.R. 2220 |
4/30/09 |
MIKE ROSS (D-AR) |
A bill to amend titles V and XIX of the Social Security Act to improve essential oral health care for lower-income individuals under the Maternal and Child Health Program and the Medicaid Program; referred to the Committee on Energy and Commerce. |
H.R. 2223 |
4/30/09 |
JOE SESTAK (D-PA) |
A bill to provide for nationwide expansion of the pilot program for national and State background checks on direct patient access employees of long-term care facilities or providers; referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Guidance Specifying the Technologies and Methodologies That
Render Protected Health Information Unusable, Unreadable, or
Indecipherable to Unauthorized Individuals for Purposes of the Breach
Notification Requirements Under Section 13402 of Title XIII (Health
Information Technology for Economic and Clinical Health Act) of the
American Recovery and Reinvestment Act of 2009; Request for Information
ACTION: Guidance and Request for Information.
SUMMARY: This document is guidance and a request for comments under
section 13402 of the Health Information Technology for Economic and
Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of
Division B of the American Recovery and Reinvestment Act of 2009 (ARRA)
(Pub. L. 111-5). ARRA was enacted on February 17, 2009. The HITECH Act
(the Act) at section 13402 requires the Department of Health and Human
Services (HHS) to issue interim final regulations within 180 days of
enactment to require covered entities under the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) and their business
associates to provide for notification in the case of breaches of
unsecured protected health information. For purposes of these
requirements, section 13402(h) of the Act defines ``unsecured protected
health information'' to mean protected health information that is not
secured through the use of a technology or methodology specified by the
Secretary in guidance, and requires the Secretary to issue such
guidance no later than 60 days after enactment and to specify within
the technologies and methodologies that render protected health
information unusable, unreadable, or indecipherable to unauthorized
individuals. Through this document, HHS is issuing the required
guidance and seeking public comment both on the guidance as well as the
breach notification provisions of the Act generally to inform the
future rulemaking and updates to the guidance.
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff: Technical Considerations for Pen, Jet, and Related Injectors
Intended for Use With Drugs and Biological Products; Availability
ACTION: Notice.
Food and Drug Administration
Computational Modeling for Cardiovascular Devices; Public
Workshop
ACTION: Notice of public workshop.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Request for Information Regarding the Paul Wellstone and Pete
Domenici Mental Health Parity and Addiction Equity Act of 2008
ACTION: Request for Information.
SUMMARY: This document is a request for comments regarding issues under
the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction
Equity Act of 2008 (MHPAEA). The Departments of Labor, Health and Human
Services (HHS), and the Treasury (collectively, the Departments) invite
public comments in advance of future rulemaking.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Updating the List of Hazardous Drugs for the NIOSH Alert:
Additions and Deletions to the NIOSH Hazardous Drug List
ACTION: Notice of draft document available for public comment.
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
announces the availability of the following draft document available
for public comment entitled ``Updating the List of Hazardous Drugs for
the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug
List.'' The document and instructions for submitting comments can be
found at http://www.cdc.gov/niosh/review/public/105a/.
Food and Drug Administration
Organ-Specific Warnings; Internal Analgesic, Antipyretic, and
Antirheumatic Drug Products for Over-the-Counter Human Use; Final
Monograph
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is issuing this final
rule to require important new organ-specific warnings and related
labeling for over-the-counter (OTC) internal analgesic, antipyretic,
and antirheumatic (IAAA) drug products. The new labeling informs
consumers about the risk of liver injury when using acetaminophen and
the risk of stomach bleeding when using nonsteroidal anti-inflammatory
drugs (NSAIDS). The new labeling is required for all OTC IAAA drug
products whether marketed under an OTC drug monograph or an approved
new drug application (NDA).
Emergency Care Coordination Center (ECCC)
ACTION: Notice.
Executive Summary
The Emergency Care Coordination Center (ECCC) is a new strategic
entity that is located within the Office of the Assistant Secretary for
Preparedness and Response (ASPR) at the Department of Health and Human
Services, in fulfillment of Homeland Security Presidential Directive
21 and in response to the following 2006 Institute of Medicine
Reports: Emergency Care for Children, Hospital-Based Emergency Care and
Emergency Medical Services: At the Crossroads. HHS recognizes that the
successful delivery of daily emergency care is a necessary foundation
for our nation's emergency preparedness efforts. Public health and
medical disaster readiness continue to be priorities for the U.S.
government (USG). Improving the resiliency, efficiency, effectiveness,
and capacity of daily hospital emergency medical care delivery will
strengthen the nation's state of readiness for public health
emergencies and disasters.
For further information, contact the Emergency Care Coordination
Center at ECCC@hhs.gov, or visit the Web site at: http://www.hhs.gov/
aspr/opeo/eccc/
Office of the National Coordinator for Health Information
Technology
ACTION: Notification of the Establishment of the HIT Policy Committee.
SUMMARY: This notice announces the establishment of the HIT Policy
Committee. The American Recovery and Reinvestment Act of 2009 (Pub. L.
111-5), section 13101, directs the establishment of the HIT Policy
Committee. The HIT Policy Committee (also referred to as the
``Committee'') is charged with recommending to the National Coordinator
a policy framework for the development and adoption of a nationwide
health information technology infrastructure that permits the
electronic exchange and use of health information as is consistent with
the Federal Health IT Strategic Plan and that includes recommendations
on the areas in which standards, implementation specifications, and
certification criteria are needed. The HIT Policy Committee is also
charged with recommending to the National Coordinator an order of
priority for the development, harmonization, and recognition of such
standards, specifications, and certification criteria.
Office of the National Coordinator for Health Information
Technology
ACTION: Notification of the Establishment of the HIT Standards
SUMMARY: This notice announces the establishment of the HIT Standards
Committee. The American Recovery and Reinvestment Act of 2009 (ARRA)
(Pub. L. 111-5), section 13101, directs the establishment of the HIT
Standards Committee. The HIT Standards Committee (also referred to as
the ``Committee'') is charged with making recommendations to the
National Coordinator on standards, implementation specifications, and
certification criteria for the electronic exchange and use of health
information for purposes of adoption, consistent with the
implementation of the Federal Health IT Strategic Plan, and in
accordance with policies developed by the HIT Policy Committee.
No relevant reports
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
DEPARTMENT OF LABOR
Employee Benefits Security Administration
Establishment of the Children's Health Insurance Program Working
Group and Request for Nominations for Members
ACTION: Notice.
SUMMARY: This notice announces the establishment of the Children's
Health Insurance Program Working Group and discusses the group's
purpose and charter. It also solicits nominations for members.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Inpatient Psychiatric Facilities Prospective
Payment System Payment Update for Rate Year Beginning July 1, 2009 (RY
2010)
ACTION: Notice; request for comments.
SUMMARY: This notice updates the payment rates for the Medicare
prospective payment system (PPS) for inpatient psychiatric hospital
services provided by inpatient psychiatric facilities (IPFs). These
changes are applicable to IPF discharges occurring during the rate year
beginning July 1, 2009 through June 30, 2010. We are also requesting
comments on the IPF PPS teaching adjustment and the market basket.
National Institutes of Health
Proposed Collection; Comment Request; Collection of Customer
Service, Demographic, and Smoking/Tobacco Use Information From NCI
Cancer Information Service (CIS) Clients (NCI)
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Food and Drug Administration
Draft Guidance for Industry on Label Comprehension Studies for
Nonprescription Drug Products; Availability
ACTION: Notice.
Office of the Secretary
Public Consultation Meeting of the Working Group on Strengthening
the Biosecurity of the United States
ACTION: Notice.
SUMMARY: The U.S. Department of Health and Human Services is hereby
giving notice that the Working Group on Strengthening the Biosecurity
of the United States will be holding a public consultation meeting. The
meeting is open to the public.
DATES: The Working Group on Strengthening the Biosecurity of the United
States will hold a public consultation meeting on May 13, 2009 from
8:30 a.m. to 5 p.m. EDT and May 14, 2009 from 8:30 a.m. to 3:15 p.m.
EDT.
ADDRESSES: The Hyatt Regency-Bethesda, 7400 Wisconsin Ave., Bethesda,
MD 20814. Phone (301) 657-1234.