Weekly Legislative & Regulatory Round-up
Week of March 14 - 20
| GAO reports |
Health-Care-Associated Infections In Hospitals: Continuing Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections GAO-09-516T
Medicare and Medicaid Participating Facilities: CMS Needs to Reexamine Its Approach for Funding State Oversight of Health Care Facilities GAO-09-64
| OIG reports |
Comparison of Prices for Negative Pressure Wound Therapy Pumps (OEI-02-07-00660)
Follow-up Review of the Medicaid Drug Rebate Program in Ohio (A-04-08-07005)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 613 |
3/17/09 |
SAM BROWNBACK (R-KS) |
A bill to prohibit the use of Federal funds to approve certain biologics license applications by the Food and Drug Administration; to the Committee on Health, Education, Labor, and Pensions. |
S. 616 |
3/17/09 |
TOM HARKIN (D-IA) |
A bill to amend the Public Health Service Act to authorize medical simulation enhancement programs, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. |
S. 619 |
3/17/09 |
HARRY REID (D-NV) |
A bill to amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases; to the Committee on Health, Education, Labor, and Pensions. |
S. 621 |
3/17/09 |
RICHARD DURBIN (D-IL) |
A bill to amend the Public Health Service Act to coordinate Federal congenital heart disease research efforts and to improve public education and awareness of congenital heart disease, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. |
S. 623 |
3/17/09 |
JOHN ROCKEFELLER (D-WV) |
A bill to amend title I of the Employee Retirement Income Security Act of 1974, title XXVII of the Public Service Act, and the Internal Revenue Code of 1986 to prohibit preexisting condition exclusions in group health plans and in health insurance coverage in the group and individual markets; to the Committee on Health, Education, Labor, and Pensions. |
H.R. 1544 |
3/17/09 |
STEVE DRIEHAUS (D-OH) |
A bill to amend title 38, United States Code, to provide for unlimited eligibility for health care for mental illnesses for veterans of combat service during certain periods of hostilities and war; to the Committee on Veterans' Affairs |
H.R. 1548 |
3/17/09 |
ANNA ESHOO (D-CA) |
A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes; to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary. |
H.R. 1549 |
3/17/09 |
LOUISE MCINTOSH SLAUGHTER (D-NY) |
A bill to amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases; to the Committee on Energy and Commerce, and in addition to the Committee on Rules. |
H.R. 1558 |
3/17/09 |
JOE COURTNEY (D-CT) |
A bill to amend title I of the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to prohibit preexisting condition exclusions in group health plans and health insurance coverage in the group and individual markets; to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor. |
S. 628 |
3/18/09 |
KENT CONRAD (D-ND) |
A bill to provide incentives to physicians to practice in rural and medically underserved communities; to the Committee on the Judiciary. |
S. 631 |
3/18/09 |
HERB KOHL (D-WI) |
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; to the Committee on Finance. |
H.R. 1581 |
3/18/09 |
JANICE SCHAKOWSKY (D-IL) |
A bill to optimize the delivery of critical care medicine and expand the critical care workforce; to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture. |
S. 647 |
3/19/09 |
CHARLES GRASSLEY (R-IA) |
A bill to amend titles XVIII and XIX of the Social Security Act to improve the transparency of information on skilled nursing facilities and nursing facilities and to clarify and improve the targeting of the enforcement of requirements with respect to such facilities; to the Committee on Finance. |
S. 648 |
3/19/09 |
JEFF BINGAMAN (D-NM) |
A bill to amend title XVIII of the Social Security Act to establish a prospective payment system instead of the reasonable cost-based reimbursement method for Medicare-covered services provided by Federally qualified health centers and to expand the scope of such covered services to account for expansions in the scope of services provided by Federally qualified health centers since the inclusion of such services for coverage under the Medicare program; to the Committee on Finance. |
S. 652. |
3/19/09 |
PATTY MURRAY (D-WA) |
A bill to authorize the Secretary of Health and Human Services to make grants to community health coalitions to assist in the development of integrated health care delivery, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. |
S. 654. |
3/19/09 |
JIM BUNNING (R-KY) |
A bill to amend title XIX of the Social Security Act to cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate quality foot and ankle care; to the Committee on Finance. |
S. 660. |
3/19/09 |
ORRIN HATCH (R-UT) |
A bill to amend the Public Health Service Act with respect to pain care; to the Committee on Health, Education, Labor, and Pensions |
S. 662 |
3/19/09 |
KENT CONRAD (D-ND) |
A bill to amend title XVIII of the Social Security Act to provide for reimbursement of certified midwife services and to provide for more equitable reimbursement rates for certified nurse-midwife services; to the Committee on Finance. |
H.R. 1614 |
3/19/09 |
GENE GREEN (D-TX) |
A bill to authorize the Secretary of Health and Human Services to make grants to community health coalitions to assist in the development of integrated health care delivery, and for other purposes; to the Committee on Energy and Commerce. |
H.R. 1616 |
3/19/09 |
ELIOT ENGEL (D-NY) |
A bill to amend title XIX of the Social Security Act to permit States the option to provide Medicaid coverage for low-income individuals infected with HIV; to the Committee on Energy and Commerce. |
H.R. 1619 |
3/19/09 |
ALLYSON SCHWARTZ (D-PA) |
A bill to amend title I of the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to prohibit preexisting condition exclusions for children in group health plans and health insurance coverage in the group and individual markets; to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor, and Ways and Means. |
H.R. 1625 |
3/19/09 |
DIANA DEGETTE (D-CO) |
A bill to amend title XIX of the Social Security Act to cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate quality foot and ankle care; to the Committee on Energy and Commerce |
H.R. 1636 |
3/19/09 |
GERRY CONNOLLY (D-VA) |
A bill to amend titles XVIII and XIX of the Social Security Act with respect to the qualification of the director of food services of a Medicare skilled nursing facility or a Medicaid nursing facility; to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce. |
H.R. 1639 |
3/19/09 |
GABRIELLE GIFFORDS (D-AZ) |
A bill to amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to extend Federal reimbursement of emergency health services furnished to undocumented aliens; to the Committee on Energy and Commerce. |
H.R. 1642 |
3/19/09 |
JOHN LARSON (D-CT) |
A bill to provide loans and grants for fire sprinkler retrofitting in nursing facilities; to the Committee on Energy and Commerce. |
H.R. 1643 |
3/19/09 |
JOHN LEWIS (D-GA) |
A bill to amend title XVIII of the Social Security Act to establish a prospective payment system instead of the reasonable cost-based reimbursement method for Medicare-covered services provided by Federally qualified health centers and to expand the scope of such covered services to account for expansions in the scope of services provided by Federally qualified health centers since the inclusion of such services for coverage under the Medicare Program; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H. Res. 271 |
3/19/09 |
ALCEE HASTINGS (D-FL) |
A resolution recognizing the need to support the development and enforcement of a well-informed national long-term care strategy to solve the problems of cost, quality, and access to long-term care in the home and community, and the imperativeness of including long-term care in the comprehensive health care reform agenda; to the Committee on Energy and Commerce, and in addition to the Committees on Financial Services, Ways and Means, and Education and Labor. |
| Federal Register notices |
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, April 3, 2009, from 9 a.m.
to 3 p.m.
ADDRESSES: The meeting will be held at the Eisenberg Conference Center,
Agency for Healthcare Research and Quality, 540 Gaither Road,
Rockville, Maryland 20850.
DEPARTMENT OF DEFENSE
Office of the Secretary
Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in
Federal Procurement of Pharmaceuticals
ACTION: Final rule.
SUMMARY: Section 703 of the National Defense Authorization Act for
Fiscal Year 2008 (NDAA-08) states with respect to any prescription
filled on or after the date of enactment of the NDAA, the TRICARE
Retail Pharmacy Program shall be treated as an element of the DoD for
purposes of procurement of drugs by Federal agencies under section 8126
of title 38, United States Code (U.S.C.), to the extent necessary to
ensure pharmaceuticals paid for by the DoD that are provided by network
retail pharmacies under the program to eligible covered beneficiaries
are subject to the pricing standards in such section 8126. NDAA-08 was
enacted on January 28, 2008. The statute requires implementing
regulations. This final rule is to implement section 703 of the NDAA-
08.
DATES: Effective Date: This final rule is effective May 26, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 021
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 021'' (Recognition List Number: 021), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
ATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Secretary's Advisory Committee on Genetics, Health, and Society;
SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and
Society (SACGHS) is requesting public comments on a Draft Report to the
Secretary of Health and Human Services, ``Public Consultation Draft
Report on Gene Patents and Licensing Practices and Their Impact on
Patient Access to Genetic Tests'' (available at http://oba.od.nih.gov/
SACGHS/sacghs_public_comments.html).
A copy can also be obtained from the National Institutes of Health
(NIH) Office of Biotechnology Activities (OBA) by e-mailing
faunteroytd@od.nih.gov or calling 301-496-9838.
National Institutes of Health
Proposed Collection; Comment Request; Survey of NHLBI
Constituents' Health Information Needs and Preferred Formats
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 Heart, Lung and
Blood Institute (NHLBI), 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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Community-Acquired Bacterial
Pneumonia: Developing Drugs for Treatment; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Community-
Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' This
draft guidance informs industry of FDA's current thinking regarding the
overall development program and clinical trial designs for drugs to
support an indication for treatment of community-acquired bacterial
pneumonia (CABP). This draft guidance does not address the development
of drugs for other purposes or populations, such as treatment of
patients with hospital-acquired pneumonia or ventilator-associated
pneumonia. This draft guidance revises the draft guidance for industry
entitled ``Community-Acquired Pneumonia-Developing Antimicrobial Drugs
for Treatment'' published July 1998.