Weekly Legislative & Regulatory Round-up
Week of February 7 - 13
| GAO reports |
February 4, 2009
Estimated Temporary Medicaid Funding Allocations Related to Section
5001 of the American Recovery and Reinvestment Act
| OIG reports |
Follow-Up Audit of the Medicaid Drug Rebate Program in Alaska (A-09-08-00051)
Medicaid and Medicare Home Health Payments for Skilled Nursing and Home Health Aide Services(OEI-07-06-00641; 02/09)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 914 |
2/9/09 |
MICHAEL BURGESS (R-TX) |
A bill to amend title VII of the Public Health Service Act to establish a loan program for eligible hospitals to establish residency training programs; Referred to the Committee on Energy and Commerce. |
H.R. 916 |
2/9/09 |
GENE GREEN (D-TX) |
A bill to amend the Public Health Service Act to provide grants for the training of graduate medical residents in preventive medicine and public health; Referred to the Committee on Energy and Commerce |
S. 406 |
2/10/09 |
ARLEN SPECTER (R-PA) |
A bill to amend title XIX of the Social Security Act to provide Medicaid coverage of drugs prescribed for certain research study child participants; Referred to the Committee on Finance |
S. 408 |
2/10/09 |
DANIEL K. INOUYE (D-HI) |
A bill to amend the Public Health Service Act to provide a means for continued improvement in emergency medical services for children; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 936 |
2/10/09 |
EDOLPHUS TOWNS (D-NY) |
A bill to ensure the continued and future availability of lifesaving trauma health care in the United States and to prevent further trauma center closures and downgrades by assisting trauma centers with uncompensated care costs, core mission services, emergency needs, and information technology; Referred to the Committee on Energy and Commerce |
H.R. 956 |
2/10/09 |
MARCY KAPTUR (D-OH) |
A bill to expand the number of individuals and families with health insurance coverage, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, and Rules. |
H.R. 972 |
2/10/09 |
JOE WILSON (R-SC) |
A bill to amend title 10, United States Code, to eliminate the requirement that certain former members of the reserve components of the Armed Forces be at least 60 years of age in order to be eligible to receive health care benefits; Referred to the Committee on Armed Services. |
H.R. 978 |
2/11/09 |
JASON ALTMIRE (D-PA) |
A bill to recognize and clarify the authority of the States to regulate intrastate helicopter medical services pursuant to their authority over public health planning and protection, patient safety and protection, emergency medical services, the quality and coordination of medical care, and the practice of medicine within their jurisdictions; Referred to the Committee on Transportation and Infrastructure, and in addition to the Committee on Energy and Commerce. |
H.R. 995 |
2/11/09 |
JERROLD NADLER (D-NY) |
A bill to amend the Public Health Service Act and Employee Retirement Income Security Act of 1974 to require that group and individual health insurance coverage and group health plans provide coverage for annual screening mammography for women 40 years of age or older and for such screening and annual magnetic resonance imaging for women at high risk for breast cancer if the coverage or plans include coverage for diagnostic mammography for women 40 years of age or older; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor. |
H. Con. Res. 48 |
2/11/09 |
JANICE SCHAKOWSKY (D-IL) |
Concurrent resolution expressing the sense of Congress that national health care reform should ensure that the health care needs of women and of all individuals in the United States are met; Referred to the Committee on Energy and Commerce |
S. 421 |
2/12/09 |
ARLEN SPECTER (R-PA) |
A bill to impose a temporary moratorium on the phase out of the Medicare hospice budget neutrality adjustment factor; Referred to the Committee on Finance. |
S. 422 |
2/12/09 |
DEBBIE A. STABENOW (D-MI) |
A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diesases in women; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 423 |
2/12/09 |
DANIEL K. AKAKA (D-HI) |
A bill to amend title 38, United States Code, to authorize advance appropriations for certain medical care accounts of the Department of Veterans Affairs by providing two-fiscal year budget authority, and for other purposes; Referred to the Committee on Veterans' Affairs. |
H.R. 1011 |
2/12/09 |
GENE GREEN (D-TX) |
A bill to amend the Public Health Service Act with respect to mental health services; Referred to the Committee on Energy and Commerce. |
H.R. 1016 |
2/12/09 |
BOB FILNER (D-CA) |
A bill to amend title 38, United States Code, to provide advance appropriations authority for certain medical care accounts of the Department of Veterans Affairs, and for other purposes; Referred to the Committee on Veterans' Affairs |
H.R. 1021 |
2/12/09 |
GENE GREEN (D-TX) |
A bill to improve research, diagnosis, and treatment of musculoskeletal diseases, conditions, and injuries, to conduct a longitudinal study on aging, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Science and Technology. |
H.R. 1030 |
2/12/09 |
KEVIN BRADY (R-TX) |
A bill to direct the Secretary of Health and Human Services to encourage research and carry out an educational campaign with respect to pulmonary hypertension, and for other purposes; Referred to the Committee on Energy and Commerce |
H.R. 1031 |
2/12/09 |
MICHAEL BURGESS (R-TX) |
A bill to promote a better health information system; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. |
H.R. 1032 |
2/12/09 |
LOIS CAPPS (D-CA) |
A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women; Referred to the Committee on Energy and Commerce. |
H.R. 1033 |
2/12/09 |
STEPHEN COHEN (D-TN) |
A bill to amend the Immigration and Nationality Act with respect to temporary admission of nonimmigrant aliens to the United States for the purpose of receiving medical treatment, and for other purposes; Referred to the Committee on the Judiciary. |
H.R. 1038 |
2/12/09 |
MAZIE HIRONO (D-HI) |
A bill to amend part B of title XVIII of the Social Security Act to provide coverage for the shingles vaccine under the Medicare Program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. |
H.R. 1039 |
2/12/09 |
GINNY BROWN-WAITE (R-FL) |
A bill to encourage and enhance the adoption of interoperable health information technology to improve health care quality, reduce medical errors, and increase the efficiency of care; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 1051 |
2/12/09 |
JOHN TANNER (D-TN) |
A bill to amend title XVIII of the Social Security Act to extend and improve protections for sole community hospitals under the Medicare Program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker. |
| Federal Register notices |
No relevant reports.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Changes to the Competitive Acquisition of
Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS) by Certain Provisions of the Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA)
ACTION: Notice of proposed delay of effective date.
SUMMARY: In accordance with the memorandum of January 20, 2009 from the Assistant to the President and Chief of Staff, entitled ``Regulatory
Review,'' CMS is seeking public comment on a contemplated delay of 60
days in the effective date of the rule entitled ``Medicare Program;
Changes to the Competitive Acquisition of Certain Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain
Provisions of the Medicare Improvements for Patients and Providers Act
of 2008 (MIPPA),'' published in the Federal Register on January 16,
2009 (74 FR 2873). That rule implements certain MIPPA provisions that
delay implementation of Round 1 of the competitive bidding program;
requires CMS to conduct a second Round 1 competition (the ``Round 1
rebid'') in 2009; and mandates certain changes for both the Round 1
rebid and subsequent rounds of the program, including a process for
providing feedback to suppliers regarding missing financial
documentation and requiring contractors to disclose to CMS information
regarding subcontracting relationships.
Food and Drug Administration
Applications for Food and Drug Administration Approval to Market
a New Drug; Postmarketing Reports; Reporting Information About
Authorized Generic Drugs; Withdrawal
ACTION: Direct final rule; withdrawal.
SUMMARY: The Food and Drug Administration (FDA) published in the
Federal Register of September 29, 2008 (73 FR 56487), a direct final
rule amending its regulations to require that the holder of a new drug
application (NDA) submit certain information regarding authorized
generic drugs in an annual report to a central office in the agency.
The comment period closed December 15, 2008. FDA is withdrawing the
direct final rule because the agency received significant adverse
comment.
Food and Drug Administration
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.
Office of the Secretary
Findings of Scientific Misconduct
ACTION: Notice.
SUMMARY: Notice is hereby given that the Office of Research Integrity
(ORI) and the Assistant Secretary for Health have taken final action in
the following case:
Kazuhiro Tanaka, M.D., Ph.D., National Institute of Dental and
Craniofacial Research, National Institutes of Health: Based on the
report of an investigation conducted by the National Institutes of
Health (NIH) and additional analysis conducted by the Office of
Research Integrity (ORI) in its oversight review, the U.S. Public
Health Service (PHS) found that Dr. Kazuhiro Tanaka, former Visiting
Postdoctoral Fellow, Molecular Biology Section, Craniofacial
Developmental and Biology and Regeneration Branch (CDBRB), National
Institute of Dental and Craniofacial Research (NIDCR), NIH, engaged in
scientific misconduct in research supported by PHS funds from the
NIDCR, NIH Intramural Program.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Compliance With the Medical
Device User Fee and Modernization Act of 2002, as Amended: Prominent
and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly
``Reprocessed Single-Use Device Labeling'')
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Regulations.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements under which the
clinical investigation of the safety and effectiveness of unapproved
new drugs and biological products can be conducted.
Food and Drug Administration
Request for Nominations for Voting and Nonvoting Consumer
Representative Members on Public Advisory Committee and Panels
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting and nonvoting consumer representatives to serve
on the National Mammography Quality Assurance Advisory Committee
(NMQAAC) and certain devices panels of the Medical Devices Advisory
Committee in the Center for Devices and Radiological Health (CDRH).
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Changes to the Competitive Acquisition of
Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS) by Certain Provisions of the Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Medicare Evidence Development & Coverage
Advisory Committee; Cancellation of the March 18, 2009 Meeting and
Announcement of the June 17, 2009 Meeting
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
SUMMARY: This notice announces the cancellation of the March 18, 2009
public meeting of the Medicare Evidence Development & Coverage Advisory
Committee (MEDCAC) (``Committee'') that was published in the January
16, 2009 Federal Register (74 FR 3051 through 3053). This notice also
announces a public meeting on Wednesday, June 17, 2009.
DATES: Meeting date: The public meeting will be held on Wednesday, June
17, 2009 from 7:30 a.m. until 4:30 p.m., eastern daylight time
(e.d.t.).
Health Resources and Services Administration
Notice of Availability of Final Policy Guidance
ACTION: Final Agency Guidance and Response to Public Comments.
SUMMARY: HRSA is publishing a final Agency Guidance (``Policy
Information Notice'' (PIN) 2009-02), to describe the policy and
processes pertaining to requests from federally-funded health centers
to change the scope of their Federal project. The PIN, ``Specialty
Services and Health Centers'' Scope of Project,'' and the Agency's
``Response to Public Comments'' are available on the Internet at http:/
DATES: The effective date of this final Agency guidance is December 18,
2008.
Health Resources and Services Administration
Notice of Availability of Final Policy Guidance
ACTION: Final Guidance.
DATES: The effective date of this final Agency guidance is January 5,
2009.
SUMMARY: HRSA has issued Policy Information Notice (PIN) 2009-04,
``Revision to PIN 2003-21: Federally Qualified Health Center (FQHC)
Look-Alike Guidelines and Application,'' to announce a technical
revision to PIN 2003-21: FQHC Look-Alike Guidelines and Application,
issued on August 26, 2003. Both PINs are available on HRSA's Web site
at http://bphc.hrsa.gov/policy/#lookalikes.