Weekly Legislative & Regulatory Round-up
Week of June 6 - 12
| GAO reports |
VA Health Care: Overview of VA's Capital Asset Management GAO-09-686T
| OIG reports |
Semiannual Report: October through March FY 2009 (PDF)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 1201 |
6/8/09 |
JEFF BINGAMAN (D-NM) |
A bill to amend title XVIII of the Social Security Act to include costs incurred by the Indian Health Service, a Federally qualified health center, an AIDS drug assistance program, certain hospitals, or a pharmaceutical manufacturer patient assistance program in providing prescription drugs toward the annual out of pocket threshold under part D of the Medicare program; Referred to the Committee on Finance. |
S. 1204 |
6/8/09 |
PATTY MURRAY (D-WA) |
A bill to amend the Department of Veterans Affairs Health Care Programs Enhancement Act of 2001 to require the provision of chiropractic care and services to veterans at all Department of Veterans Affairs medical centers, and for other purposes; Referred to the Committee on Veterans' Affairs. |
S. 1206 |
6/8/09 |
SHERROD BROWN (D-OH) |
A bill to establish and carry out a pediatric specialty loan repayment program; to the Committee on Health, Education, Labor, and Pensions. |
H.R. 2744 |
6/8/09 |
LAURA RICHARDSON (D-CA) |
A bill to prohibit discrimination in Federal assisted health care services and research programs on the basis of sex, race, color, national origin, sexual orientation, gender identity, or disability status; Referred to the Committee on Energy and Commerce. |
H.R. 2753 |
6/8/09 |
MARION BERRY (D-AR) |
A bill to delay the implementation of new Medicare hospital geographic wage reclassification criteria until the Secretary of Health and Human Services issues a proposal to revise the hospital wage index classification system that addresses certain considerations; Referred to the Committee on Ways and Means. |
H.R. 2754 |
6/8/09 |
LOIS CAPPS (D-CA) |
A bill to amend the Public Health Service Act to establish the Nurse-Managed Health Clinic Investment program, and for other purposes; Referred to the Committee on Energy and Commerce. |
H.R. 2758 |
6/8/09 |
RON KIND (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 Energy and Commerce, and in addition to the Committee on Ways and Means. |
S. 1213 |
6/9/09 |
MAX BAUCUS (D-MT) |
A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Patient-Centered Outcomes Research Trust Fund, and for other purposes; Referred to the Committee on Finance. |
S. 1217 |
6/9/09 |
DEBBIE STABENOW (D-MI) |
A bill to amend title XIX of the Social Security Act to improve and protect rehabilitative services and case management services provided under Medicaid to improve the health and welfare of the nation's most vulnerable seniors and children; Referred to the Committee on Finance. |
S. 1218 |
6/9/09 |
ROBERT MENENDEZ (D-NJ) |
A bill to amend title XVIII of the Social Security Act to preserve access to urban Medicare-dependent hospitals; Referred to the Committee on Finance. |
S. 1220 |
6/9/09 |
ARLEN SPECTER (D-PA) |
A bill to require that certain complex diagnostic laboratory tests performed by an independent laboratory after a hospital outpatient encounter or inpatient stay during which the specimen involved was collected shall be treated as services for which payment may be made directly to the laboratory under part B of title XVIII of the Social Security Act; Referred to the Committee on Finance. |
S. 1221 |
6/9/09 |
ARLEN SPECTER (D-PA) |
A bill to amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price; Referred to the Committee on Finance. |
H.R. 2773 |
6/9/09 |
EARL BLUMENAUER (D-OR) |
A bill to amend title XVIII of the Social Security Act to cover transitional care services to improve the quality and cost effectiveness of care under the Medicare Program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 2774 |
6/9/09 |
DEBORAH HALVORSON (D-IL) |
A bill to amend title 38, United States Code, to make permanent the extension of the duration of Servicemembers' Group Life Insurance coverage for totally disabled veterans; Referred to the Committee on Veterans' Affairs. |
H.R. 2777 |
6/9/09 |
RUSH HOLT (D-NJ) |
A bill to include costs incurred by the Indian Health Service, a federally qualified health center, an AIDS drug assistance program, certain hospitals, or a pharmaceutical manufacturer patient assistance program in providing prescription drugs toward the annual out of pocket threshold under part D of title XVIII of the Social Security Act and to provide a safe harbor for assistance provided under a pharmaceutical manufacturer patient assistance program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 2778 |
6/9/09 |
JESSE JACKSON (D-IL) |
A bill to amend the Public Health Service Act to redesignate the National Center on Minority Health and Health Disparities as the National Institute for Minority Health and Health Disparities, and for other purposes; Referred to the Committee on Energy and Commerce. |
H.R. 2784 |
6/10/09 |
WILLIAM THORNBERRY (R-TX) |
A bill to establish a loan repayment program for qualifying physicians and nurse practitioners participating in the Medicare Program; Referred to the Committee on Energy and Commerce. |
H.R. 2785 |
6/10/09 |
WILLIAM THORNBERRY (R-TX) |
A bill to reduce the amount of paperwork and improve payment policies for health care services, to prevent fraud and abuse through health care provider education, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 2786 |
6/10/09 |
WILLIAM THORNBERRY (R-TX) |
A bill to amend the Internal Revenue Code of 1986 to improve the ability of medical professionals to practice medicine and provide quality care to patients by providing a tax deduction for patient bad debt; Referred to the Committee on Ways and Means. |
H.R. 2787 |
6/10/09 |
WILLIAM THORNBERRY (R-TX) |
A bill to provide grants to States for health care tribunals, and for other purposes; Referred to the Committee on the Judiciary. |
H.R. 2804 |
6/10/09 |
GENE GREEN (D-TX) |
A bill to amend title XXI of the Social Security Act to require 12-month continuous coverage under the State Children's Health Insurance Program; Referred to the Committee on Energy and Commerce. |
H.R. 2805 |
6/10/09 |
GENE GREEN (D-TX) |
A bill to amend title XIX of the Social Security Act to require 12-month continuous coverage for children under Medicaid; Referred to the Committee on Energy and Commerce. |
H.R. 2810 |
6/10/09 |
DORIS MATSUI (D-CA) |
A bill to amend the Public Health Service Act to establish various programs for the recruitment and retention of public health workers and to eliminate critical public health workforce shortages in Federal, State, local, and tribal public health agencies and health centers; Referred to the Committee on Energy and Commerce. |
H.R. 2816 |
6/10/09 |
JOHN TIERNEY (D-MA) |
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 Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, and Oversight and Government Reform. |
S. 1235 |
6/11/09 |
MARY LANDRIEU (D-LA) |
A bill to amend the Public Health Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require that group and individual health insurance coverage and group health plans provide coverage for treatment of a minor child's congenital or developmental deformity or disorder due to trauma, infection, tumor, or disease; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 1236 |
6/11/09 |
DIANNE FEINSTEIN (D-CA) |
A bill to amend title XVIII of the Social Security Act to transition to the use of metropolitan statistical areas as fee schedule areas for the physician fee schedule in California under the Medicare program; Referred to the Committee on Finance. |
S. 1239 |
6/11/09 |
JEFF BINGAMAN (D-NM) |
A bill to amend section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 1240 |
6/11/09 |
JIM DEMINT (R-SC) |
A bill to provide for the reform of health care, the Social Security system, the tax code for individuals and business, and the budget process; Referred to the Committee on Finance. |
S. 1249 |
6/11/09 |
AMY KLOBUCHAR (D-MN) |
A bill to amend title XVIII of the Social Security Act to create a value indexing mechanism for the physician work component of the Medicare physician fee schedule; Referred to the Committee on Finance. |
S. 1251 |
6/11/09 |
MARK WARNER (D-VA) |
A bill to amend title XVIII of the Social Security Act to provide for advanced illness care management services for Medicare beneficiaries, and for other purposes; Referred to the Committee on Finance. |
S. 1256 |
6/11/09 |
MARIA CANTWELL (D-WA) |
A bill to amend title XIX of the Social Security Act to establish financial incentives for States to expand the provision of long-term services and supports to Medicaid beneficiaries who do not reside in an institution, and for other purposes; Referred to the Committee on Finance. |
S. 1257 |
6/11/09 |
MARIA CANTWELL (D-WA) |
A bill to amend the Social Security Act to build on the aging network to establish long-term services and supports through single-entry point systems, evidence based disease prevention and health promotion programs, and enhanced nursing home diversion programs; Referred to the Committee on Finance. |
H.R. 2820 |
6/11/09 |
SAM FARR (D-CA) |
A bill to amend title XVIII of the Social Security Act to transition to the use of metropolitan statistical areas as fee schedule areas for the physician fee schedule in California under the Medicare Program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 2824 |
6/11/09 |
DONNA CHRISTENSEN (D-VI) |
A bill to enhance the conduct and support of federally funded comparative effectiveness research relating to health care, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Armed Services, and Veterans' Affairs. |
H.R. 2829 |
6/11/09 |
ANDRE CARSON (D-IN) |
A bill to ensure prompt access to supplemental security income, social security disability, and medicaid benefits for persons released from certain public institutions; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker. |
H.R. 2830 |
6/11/09 |
JOE COURTNEY (D-CT) |
A bill to amend title 38, United States Code, to direct the Secretary of Veterans Affairs to give priority to unemployed veterans in furnishing hospital care, medical services, and nursing home care to certain veterans assigned to priority level 8; Referred to the Committee on Veterans' Affairs. |
H.R. 2831 |
6/11/09 |
KATHY DAHLKEMPER (D-PA) |
A bill to amend the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to require the option of extension of dependent coverage for unmarried, uninsured children under 30 years of age under group health plans and under group and individual health insurance coverage; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor. |
H.R. 2833 |
6/11/09 |
KEITH ELLISON (D-MN) |
A bill to require a minimum loss ratio for 90 percent for health insurance coverage offered through an insurance exchange; Referred to the Committee on Energy and Commerce. |
H.R. 2840 |
6/11/09 |
JOHN SARBANES (D-MD) |
A bill to amend titles XIX and XXI of the Social Security Act to ensure payment under Medicaid and the State Children's Health Insurance Program for covered items and services furnished by school-based health clinics; Referred to the Committee on Energy and Commerce. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
May 31, 2007, FDA announced the availability of a draft guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products'' explaining the process that would be used to make product-
specific BE recommendations available to the public on FDA's Web site.
The BE recommendations identified in this notice were developed using
the process described in that guidance. Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of final product-
specific BE recommendations.
DATES: Submit written or electronic comments on the draft and revised
draft product-specific BE recommendations listed in this notice by
September 8, 2009.
Food and Drug Administration
Final Guidances for Industry Describing Product-Specific
Bioequivalence Recommendations; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of final product-specific bioequivalence (BE)
recommendations. The recommendations provide product-specific guidance
on the design of BE studies to support abbreviated new drug
applications (ANDAs). In the Federal Register of May 31, 2007, FDA
announced the availability of a draft guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' explaining the
process that would be used to make product-specific BE recommendations
available to the public on FDA's Web site. The BE recommendations
identified in this notice were developed using the process described in
that guidance. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of additional draft and revised draft
product-specific BE recommendations.
DATES: Submit written or electronic comments on agency guidances at
any time.
Food and Drug Administration
Guidance for Industry on Medication Guides--Adding a Toll-Free
Number for Reporting Adverse Events; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Medication Guides--
Adding a Toll-Free Number for Reporting Adverse Events.'' Beginning
July 1, 2009, manufacturers of prescription drug products approved
under the Federal Food, Drug, and Cosmetic Act (the act) that are
required to have a Medication Guide must add a verbatim statement to
their Medication Guides containing FDA's toll-free number for reporting
side effects. These manufacturers are also required to report to FDA
that they have complied with this requirement. This guidance explains
what statement to add to Medication Guides, where to add it, and how to
notify the agency that such a statement has been added.
DATES: Submit written or electronic comments on agency guidances at any
time.
Health Resources and Services Administration
Maternal Child Health Bureau, Healthy Start Eliminating
Disparities in Perinatal Health
ACTION: Notice of Non-competitive Supplemental Funding to Northern
Manhattan Perinatal Partnership.
SUMMARY: The Health Resources and Services Administration (HRSA) is
issuing non-competitive supplemental funding under the Maternal Child
Health Bureau, Healthy Start Eliminating Disparities in Perinatal
Health program to ensure that the Northern Manhattan Perinatal
Partnership (NMPP), the primary provider of prenatal services in
Central Harlem, can continue to provide much needed services to help
stem the rise in and ultimately reduce the Infant Mortality Rate (IMR)
in the affected service area.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
International Conference on Harmonisation; Guidance on Q8(R1)
Pharmaceutical Development; Addition of Annex; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q8(R1) Pharmaceutical
Development.'' The guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The ICH Q8(R1)
guidance includes the previously published parent guidance entitled
``Q8 Pharmaceutical Development'' (Q8 parent guidance) (71 FR 29344;
May 22, 2006) and a newly added annex. The annex provides
further clarification of key concepts outlined in the Q8 parent
guidance and describes the principles of quality by design (QbD). The
annex is intended to show how concepts and tools (e.g., design space)
outlined in the Q8 parent guidance could be put into practice by the
applicant for all dosage forms.
DATES: Submit written or electronic comments on agency guidances at any
time.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator for Health Information
Technology; HIT Standards Committee
ACTION: Announcement of meeting.
SUMMARY: This notice announces the second meeting of the HIT Standards
Committee in accordance with the Federal Advisory Committee Act (Pub.
L. No. 92-463, 5 U.S.C., App.).
DATES: June 23, 2009, from 9 a.m. to 12 p.m. [Eastern]
ADDRESSES: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC 20008, Diplomat Ballroom.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Draft Guideline for Prevention of Catheter-Associated Urinary
Tract Infections 2008 [Correction]
The notice ``Draft Guideline for Prevention of Catheter-Associated
Urinary Tract Infections 2008,'' was published in the Federal Register
on June 3rd, 2009, (Vol. 74 FR No. 105).
This notice is corrected as follows: On page 26704 first column, under
SUMMARY, the Web site should read: http://wwwn.cdc.gov/publiccomments/.
Office of the Secretary, Office of Public Health and Science, Office of Disease
Prevention and Health Promotion
National Health Promotion and Disease Prevention Objectives for 2020
ACTION: Notice of meeting.
SUMMARY: The U.S. Department of Health and Human Services (HHS)
announces the next Federal advisory committee meeting regarding the
national health promotion and disease prevention objectives for 2020.
This meeting will be open to the public and will be held online via
WebEx software.
DATES: The Committee will meet on July 10, 2009 from 2 p.m. to 4 p.m.
Eastern Daylight Time (EDT).
ADDRESSES: The meeting will be held online, via WebEx software. For
detailed instructions about how to make sure that your windows computer
and browser is set up for WebEx, please visit the ``Secretary's
Advisory Committee'' Web page of the Healthy People Web site at: http:/
/www.healthypeople.gov/hp2020/advisory/default.asp
No relevant notices.