Weekly Legislative & Regulatory Round-up
Week of March 21 - 27
| GAO reports |
March 26, 2009
Human Subjects Research: Undercover Tests Show the Institutional Review
Board System Is Vulnerable to Unethical Manipulation
GAO-09-448T
March 24, 2009
Private Health Insurance: 2008 Survey Results on Number and Market Share of
Carriers in the Small Group Health Insurance Market
GAO-09-363R
March 23, 2009
State Children's Health Insurance Program: CMS Should Improve Efforts to
Assess whether SCHIP Is Substituting for Private Insurance
GAO-09-252
Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class GAO-09-245
| OIG reports |
03-25-2009
Review of Health Resources and Services Administration Grant Closeout
Procedures (A-02-07-02008)
03-24-2009
An Open Letter to Health Care Providers (PDF)
03-23-2009
Driving for Quality in Acute Care: A Board of Directors Dashboard --
Government-Industry Roundtable (PDF)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 671 |
3/23/09 |
BLANCHE LINCOLN (D-AR) | A bill to amend title XVIII of the Social Security Act to provide for the coverage of marriage and family therapist services and mental health counselor services under part B of the Medicare program, and for other purposes; Referred to the Committee on Finance. |
S. 677 |
3/24/09 |
JOHN ENSIGN (R-NV) | A bill to amend title XVIII of the Social Security Act to require wealthy beneficiaries to pay a greater share of their premiums under the Medicare prescription drug program; Referred to the Committee on Finance. |
S. 688 |
3/24/09 |
OLYMPIA SNOWE (R-ME) | A bill to require that health plans provide coverage for a minimum hospital stay for mastectomies, lumpectomies, and lymph node dissection for the treatment of breast cancer and coverage for secondary consultations; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 1678 |
3/24/09 |
MARY BONO MACK (R-CA) | A bill to amend the Internal Revenue Code of 1986 to allow a bad debt deduction to doctors to partially offset the cost of providing uncompensated care required to be provided under amendments made by the Emergency Medical Treatment and Labor Act; Referred to the Committee on Ways and Means. |
H.R. 1680 |
3/24/09 |
MICHAEL ARCURI (D-NY) | A bill to authorize the Secretary of Health and Human Services to make grants to promote professional retrofit installation of fire alarm detection systems and other fire detection and prevention technologies in nursing homes, hospice facilities, and other appropriate facilities; Referred to the Committee on Energy and Commerce. |
H.R. 1691 |
3/24/09 |
ROSA DELAURO (D-CT) | A bill to require that health plans provide coverage for a minimum hospital stay for mastectomies, lumpectomies, and lymph node dissection for the treatment of breast cancer and coverage for secondary consultations; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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. 1693 |
3/24/09 |
BART GORDON (D-TN) | A bill to amend title XVIII of the Social Security Act to provide for the coverage of marriage and family therapist services and mental health counselor services 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, 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. Con. Res. 78 |
3/24/09 |
TAMMY BALDWIN (D-WI) | Concurrent resolution expressing the support of the Congress regarding the need to facilitate State innovation in national health care reform; Referred to the Committee on Energy and Commerce. |
S. 693 |
3/25/09 |
TOM HARKIN (D-IA) | A bill to amend the Public Health Service Act to provide grants for the training of graduate medical residents in preventive medicine; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 698 |
3/25/09 |
RUSS FEINGOLD (D-WI) | A bill to ensure the provision of high-quality health care coverage for uninsured individuals through State health care coverage pilot projects that expand coverage and access and improve quality and efficiency in the health care system; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 700 |
3/25/09 |
JEFF BINGAMAN (D-NM) | A bill to amend title II of the Social Security Act to phase out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits, to eliminate the waiting period for individuals with life-threatening conditions, and for other purposes; Referred to the Committee on Finance. |
S. 701 |
3/25/09 |
JOHN KERRY (D-MA) | A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG); Referred to the Committee on Finance. |
S. 702 |
3/25/09 |
CHARLES GRASSLEY (R-IA) | A bill to amend the Internal Revenue Code of 1986 to allow long-term care insurance to be offered under cafeteria plans and flexible spending arrangements and to provide additional consumer protections for long-term care insurance; Referred to the Committee on Finance. |
S. 703 |
3/25/09 |
BERNARD SANDERS (I-VT) | A bill to provide for health care for every American and to control the cost and enhance the quality of the health care system; Referred to the Committee on Finance. |
H.R. 1699 |
3/25/09 |
JASON ALTMIRE (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 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. 1706 |
3/25/09 |
BOBBY RUSH (D-IL) | A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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. 1708 |
3/25/09 |
GENE GREEN (D-TX) | A bill to amend title II of the Social Security Act to phase out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits, to eliminate the waiting period for individuals with life-threatening conditions, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and Transportation and Infrastructure, 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. A bill to amend the Public Health Service Act with respect to the protection of human subjects in research; Referred to the Committee on Energy and Commerce. |
H.R. 1715 |
3/25/09 |
DIANA DEGETTE (D-CO) | A bill to amend the Public Health Service Act with respect to the protection of human subjects in research; Referred to the Committee on Energy and Commerce. |
H.R. 1718 |
3/25/09 |
RON KIND (D-WI) | A bill to amend the Internal Revenue Code of 1986 to treat amounts paid for umbilical cord blood banking services as medical care expenses; Referred to the Committee on Ways and Means. |
H.R. 1723 |
3/25/09 |
FORTNEY STARK (D-CA) | A bill to provide for a paid family and medical leave insurance program, and for other purposes; Referred to the Committee on Education and Labor, and in addition to the Committees on Oversight and Government Reform, and 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. 1725 |
3/25/09 |
CHRIS VAN HOLLEN (D-MD) | A bill to amend title XIX of the Social Security Act to require, at the option of a State, drug manufacturers to pay rebates to State prescription drug discount programs as a condition of participation in a rebate agreement for outpatient prescription drugs under the Medicaid Program; Referred to the Committee on Energy and Commerce. |
S. 712 |
3/26/09 |
RUSS FEINGOLD (D-WI) | A bill to amend title XVIII of the Social Security Act to improve the Medicare program for beneficiaries residing in rural areas; Referred to the Committee on Finance. |
S. 716 |
3/26/09 |
DEBBIE STABENOW (D-MI) | A bill to amend title XVIII of the Social Security Act to preserve care for ventilator-dependent patients; Referred to the Committee on Finance. |
S. 717 |
3/26/09 |
EDWARD KENNEDY (D-MA) | A bill to modernize cancer research, increase access to preventative cancer services, provide cancer treatment and survivorship initiatives, and for other purposes; Referred to the Committee on Health, Education , Labor, and Pensions. |
S. 725 |
3/26/09 |
JEFF BINGAMAN (D-NM) |
A bill to amend the Internal Revenue Code of 1986 to allow self-employed individuals to deduct health insurance costs in computing self-employment taxes; Referred to the Committee on Finance. |
S. 726 |
3/26/09 |
CHARLES SCHUMER (D-NY) |
A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 731 |
3/26/09 |
BEN NELSON (D-NE) |
A bill to amend title 10, United States Code, to provide for continuity of TRICARE Standard coverage for certain members of the Retired Reserve; Referred to the Committee on Armed Services. |
S. 733 |
3/26/09 |
PATTY MURRAY (D-WA) |
A bill to ensure the continued and future availability of life saving 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, and emergency needs; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 1745 |
3/26/09 |
TIM MURPHY (R-PA) |
A bill to amend the Public Health Service Act to provide liability protections for volunteer practitioners at health centers under section 330 of such Act; Referred to the Committee on Energy and Commerce. |
H.R. 1765 |
3/26/09 |
DORIS MATSUI (D-CA) |
A bill to amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps 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 |
| Federal Register notices |
No relevant reports
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Exploratory Research with People Living with Lung Cancer--New--
Division of Cancer Prevention and Control (DCPC), National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
National Institutes of Health
Public Comment Session for Cancer Patients' CAM Information Needs
Comment Period
ACTION: Request for public comment.
SUMMARY: In compliance with the provisions of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public
comments on proposed data collection projects, the National Institutes
of Health (NIH), National Cancer Institute (NCI) 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
Centers for Disease Control and Prevention
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Sexually Transmitted Disease (STD) Morbidity Surveillance--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Food and Drug Administration
Center for Biologics Evaluation and Research eSubmitter Pilot
Evaluation Program for Source Plasma Establishments
ACTION: Notice.
SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is announcing an invitation to
participate in a pilot evaluation program for CBER's eSubmitter Program
(eSubmitter). CBER's eSubmitter has been customized as an automated
biologics license application (BLA) and BLA supplement (BLS) submission
system for blood and blood components. Participation in the pilot
program is open to blood establishments that collect Source Plasma. The
pilot program is intended to provide industry and CBER regulatory
review staff the opportunity to evaluate the eSubmitter system and
determine if it facilitates the BLA/BLS submission process. The purpose
of this notice is to invite blood establishments that collect Source
Plasma to submit a request to CBER if they are interested in
participating in this pilot program.
Food and Drug Administration
Draft Guidance for Industry: Use of Serological Tests to Reduce
the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood
and Blood Components for Transfusion and Human Cells, Tissues, and
Cellular and Tissue-Based Products; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry: Use
of Serological Tests to Reduce the Risk of Transmission of Trypanosoma
cruzi Infection in Whole Blood and Blood Components for Transfusion and
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)''
dated March 2009. The draft guidance document notifies establishments
that manufacture Whole Blood and blood components intended for use in
transfusion, and establishments that make eligibility determinations
for donors of HCT/Ps about FDA approval of a biologics license
application for an enzyme-linked immunosorbent assay (ELISA) test
system for the detection of antibodies to Trypanosoma cruzi (T. cruzi).
The draft guidance also notifies establishments that make donor
eligibility determinations for HCT/P donors that FDA has determined T.
cruzi to be a relevant communicable disease under current regulations.
In addition, the guidance provides recommendations for using a licensed
test for antibodies to T. cruzi to test individual human donors,
including donors of Whole Blood and blood components for transfusion
and HCT/P donors (living and cadaveric (non-heart beating)), for
antibodies to T. cruzi in plasma and serum samples. The guidance
document does not apply to Source Plasma.
Food and Drug Administration
Developing a Consolidated Pediatric Rheumatology Observational
Registry; Public Workshop
ACTION: Notice of public workshop; request for comments.
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Developing a Consolidated Pediatric Rheumatology
Observational Registry.'' This 2-day public workshop is intended to
seek constructive input from key stakeholders in the pediatric
rheumatology community, the pharmaceutical industry and the public to
explore the value and feasibility of developing a consolidated
pediatric rheumatology observational registry.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicaid Program; Premiums and Cost Sharing
ACTION: Final rule; delay of effective date and reopening of comment
SUMMARY: This action temporarily delays the effective date of the
November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and
Cost Sharing'' (73 FR 71828) until December 31, 2009. In addition, this
action reopens the comment period on the policies set out in the
November 25, 2008 final rule, and specifically solicits comments on the
effect of certain provisions of the American Recovery and Reinvestment
Act of 2009.
Centers for Medicare & Medicaid Services
Medicare Program; Surety Bond Requirement for Suppliers of
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS); Correcting Amendment
ACTION: Final rule; correcting amendment.
SUMMARY: This correcting amendment corrects a technical error in the
amendatory instructions of the regulations text in the final rule
entitled ``Medicare Program; Surety Bond Requirement for Suppliers of
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS)'' published in the January 2, 2009 Federal Register (74 FR
166). In that final rule, we implemented section 1834(a)(16)(B) of the
Social Security Act (the Act) requiring certain Medicare suppliers of
durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)
to furnish CMS with a surety bond. In addition, in the January 2, 2009
final rule, we responded to public comments on the August 1, 2007
proposed rule (72 FR 42001). The effective date for the January 2, 2009
final rule was March 3, 2009.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Approval of the Joint Commission
for Continued Deeming Authority for Hospices
ACTION: Final notice.
SUMMARY: This final notice announces the approval of a deeming
application from the Joint Commission for continued recognition as a
national accreditation program for hospices that request participation in the Medicare or Medicaid programs.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--October Through December 2008
ACTION: Notice.
SUMMARY: This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from October 2008 through December 2008, relating to the
Medicare and Medicaid programs. This notice provides information on
national coverage determinations (NCDs) affecting specific medical and
health care services under Medicare. Additionally, this notice
identifies certain devices with investigational device exemption (IDE)
numbers approved by the Food and Drug Administration (FDA) that
potentially may be covered under Medicare. This notice also includes
listings of all approval numbers from the Office of Management and
Budget for collections of information in CMS regulations and a list of
Medicare-approved carotid stent facilities. Included in this notice is
a list of the American College of Cardiology's National Cardiovascular
Data registry sites, active CMS coverage-related guidance documents,
and special one-time notices regarding national coverage provisions.
Also included in this notice is a list of National Oncologic Positron
Emissions Tomography Registry sites, a list of Medicare-approved
ventricular assist device (destination therapy) facilities, a list of
Medicare-approved lung volume reduction surgery facilities, a list of
Medicare-approved clinical trials for fluorodeoxyglucose positron
emissions tomography for dementia, and a list of Medicare-approved
bariatric surgery facilities.
Section 1871(c) of the Social Security Act requires that we publish
a list of Medicare issuances in the Federal Register at least every 3
months. Although we are not mandated to do so by statute, for the sake
of completeness of the listing, and to foster more open and transparent
collaboration efforts, we are also including all Medicaid issuances and
Medicare and Medicaid substantive and interpretive regulations
(proposed and final) published during this 3-month time frame.
Centers for Medicare & Medicaid Services
Medicare Program; Request for Nominations for Members for the
Medicare Evidence Development & Coverage Advisory Committee
ACTION: Notice.
SUMMARY: This notice announces a request for nominations for
consideration for membership on the Medicare Evidence Development &
Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC
advises the Secretary of the Department of Health and Human Services
(the Secretary) and the Administrator of the Centers for Medicare &
Medicaid Services on whether medical items and services are
``reasonable and necessary'' and therefore eligible for coverage under
Title XVIII of the Social Security Act.
We are requesting nominations for both voting and nonvoting members
to serve on the MEDCAC. Nominees are selected based upon their
individual qualifications and not as representatives of professional
associations or societies. We have a special interest in ensuring that
women, minority groups, and physically challenged individuals are
adequately represented on the MEDCAC. Therefore, we encourage
nominations of qualified candidates from these groups.
The MEDCAC reviews and evaluates medical literature, reviews
technology assessments, and examines data and information on the
effectiveness and appropriateness of medical items and services that
are covered or eligible for coverage under Medicare.
Centers for Medicare & Medicaid Services
Medicare, Medicaid, and CLIA Programs; Approval of the American
Osteopathic Association as a CLIA Accreditation Organization
ACTION: Notice.
SUMMARY: This notice announces CMS' grant of deeming authority to the
American Osteopathic Association (AOA) under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
the requirements of the AOA accreditation process are equal to or more
stringent than the CLIA condition level requirements, and that the AOA
has met the requirements of CMS. Consequently, laboratories that are
voluntarily accredited by the AOA and continue to meet the AOA
requirements will be deemed to meet the CLIA condition level
requirements for laboratories and therefore are not subject to routine
inspection by State survey agencies to determine their compliance with
Federal requirements. They are, however, subject to Federal validation
and complaint investigation surveys conducted by CMS or its designee.