Weekly Legislative & Regulatory Round-up
Week of October 10 - 16
| GAO reports |
The Federal Government's Long-Term Fiscal Outlook: Fall 2009 Update GAO-10-137SP
VA Health Care: Ineffective Medical Center Controls Resulted in Inappropriate Billing and Collection Practices GAO-10-152T
| OIG reports |
Notice for Potential Monitors for Quality-of-Care Corporate Integrity Agreements: Federal Register
Monthly Recovery Act Report: September
Medicare Part D E-Prescribing Standards: Early Assessment Shows Partial Connectivity (OEI-05-08-00320)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
| S. 1773 | 10/13/09 | MARY LANDRIEU (D-LA) | A bill to amend title XVIII of the Social Security Act to provide for coverage of comprehensive cancer care planning under the Medicare Program and to improve the care furnished to individuals diagnosed with cancer by establishing a Medicare hospice care demonstration program and grant programs for cancer palliative care and symptom management programs, provider education, and related research; Referred to the Committee on Finance. |
| S. 1776 | 10/13/09 | DEBBIE STABENOW (D-MI) | A bill to amend title XVIII of the Social Security Act to provide for the update under the Medicare physician fee schedule for years beginning with 2010 and to sunset the application of the sustainable growth rate formula, and for other purposes; read the first time. |
| H.R. 3790 | 10/13/09 | KENDRICK MEEK (D-FL) | A bill to amend title XVIII of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS) in a budget neutral manner; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
| H.R. 3792 | 10/13/09 | FRANK PALLONE (D-NJ) | A bill to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS; Referred to the Committee on Energy and Commerce. |
| H.R. 3798 | 10/13/09 | STEVE ISRAEL (D-NY) | A bill to amend the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to eligible entities to train elementary and secondary school nurses on how to respond to a biological or chemical attack or an outbreak of pandemic influenza in a school building or on school grounds; Referred to the Committee on Energy and Commerce. |
| H.R. 3799 | 10/13/09 | HENRY JOHNSON (D-GA) | A bill to amend title XVIII of the Social Security Act to improve prescription drug coverage under Medicare part D and to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986, to improve prescription drug coverage under private health insurance, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor. |
| H. Con. Res. 198 | 10/13/09 | G.K. BUTTERFIELD (D-NC) | Concurrent resolution recognizing Pediatric Acquired Brain Injury as the leading cause of death and disability in the United States for children and young adults from birth until 25 years of age and endorsing the National Pediatric Acquired Brain Injury Plan to develop a seamless, standardized, evidence-based system of care universally accessible for all of these children, young adults, and their families, regardless of where they live in the country; Referred to the Committee on Energy and Commerce. |
| S. 1778 | 10/14/09 | JEANNE SHAHEEN (D-NY) | A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to generic drugs, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
| H.R. 3806 | 10/14/09 | JERRY MORAN (R-KS) | A bill to amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to extend and expand the Medicare rural community hospital demonstration program; Referred to the Committee on Ways and Means. |
| S. 1788 | 10/15/09 | AL FRANKEN (D-MN) | A bill to direct the Secretary of Labor to issue an occupational safety and health standard to reduce injuries to patients, direct-care registered nurses, and all other health care workers by establishing a safe patient handling and injury prevention standard, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
| S. 1790 | 10/15/09 | BYRON DORGAN (D-ND) | A bill to amend the Indian Health Care Improvement Act to revise and extend that Act, and for other purposes; Referred to the Committee on Indian Affairs. |
| S. 1793 | 10/15/09 | TOM HARKIN (D-IA) | An original bill to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS; Referred from the Committee on Health, Education, Labor, and Pensions; placed on the calendar. |
| H.R. 3822 | 10/15/09 | NATHAN DEAL (R-GA) | A bill to permit employers to provide contributions and assistance to certain employees who purchase individual health insurance; Referred to the Committee on Education and Labor, and in addition to the Committees on Energy and Commerce, and Ways and Means. |
| H.R. 3823 | 10/15/09 | NATHAN DEAL (R-GA) | A bill to amend titles XIX and XXI of the Social Security Act to make certain changes to the State Children's Health Insurance Program and the Medicaid Program; Referred to the Committee on Energy and Commerce. |
| H.R. 3826 | 10/15/09 | JUDY BIGGERT (R-IL) | A bill to amend title XVIII of the Social Security Act to provide payments under the Medicare Program to licensed health care practitioners for unscheduled telephone consultation services in the case that such payments are determined to be cost and quality effective; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
| H.R. 3830 | 10/15/09 | JEFF FORTENBERRY (R-NE) | A bill to direct the Secretary of Health and Human Services to develop an individual chronic disease prevention and wellness achievement matrix; Referred to the Committee on Energy and Commerce. |
| H.R. 3831 | 10/15/09 | JEFF FORTENBERRY (R-NE) | A bill to amend the American Recovery and Reinvestment Act of 2009 to eliminate the phase out of the Medicare hospice budget neutrality adjustment factor; Referred to the Committee on Ways and Means. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Reagents for Detection of Specific Novel
Influenza A Viruses
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 guidance on reagents for
detection of specific novel influenza A viruses.
DATES: Submit written or electronic comments on the collection of
information by December 14, 2009.
Office of the Secretary, HHS
Agency Information Collection Request. 60-Day Public Comment
Proposed Project: The Hospital Preparedness Program--Revision-OMB
No. 0990-0326-OS--Assistant Secretary for Preparedness and Response
(ASPR).
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: Children's Hospitals Graduate Medical Education
Payment Program (CHGME PP) (OMB No. 0915-0247)—Extension
DEPARTMENT OF HEALTH AND HUMAN SERIVCES
Food and Drug Administration
Advancing Clinical Development of Molecular and Other Diagnostic
Tests for Respiratory Tract Infections; Notice of Public Workshop
ACTION: Notice.
Date and Time: The public workshop will be held on November 12,
2009, from 8 a.m. to 6 p.m. and on November 13, 2009, from 8 a.m. to
4:30 p.m.
Location: The public workshop will be held at the Hilton Washington
DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD
20877. Seating is limited and available only on a first-come, first-
served basis.
Office of Inspector General (OIG)
ACTION: Notice for Potential Monitors for Quality-of-Care Corporate Integrity Agreements.
SUMMARY: The Office of Inspector General (OIG) is seeking to identify
potential organizations to monitor health care entities under quality-
of-care Corporate Integrity Agreements (CIA) with OIG. OIG is
interested in receiving information from organizations that believe
they have the capability to be monitors for quality-of-care CIAs. This
is not a request for proposals and does not commit OIG to select or
consider a particular organization to be a monitor. Any information
provided to OIG in response to this notice is strictly voluntary. The
Government will not pay for information submitted in response to this
notice.
DATES: Responses may be submitted on an ongoing basis.
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, November 13, 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.
Food and Drug Administration
Medical Devices; Plastic Surgery Devices; Classification of Wound
Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is classifying the
wound dressing with pDADMAC additive into class II (special controls).
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of a guidance document entitled ``Class II Special
Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl
Ammonium Chloride) (pDADMAC) Additive,'' which will serve as the
special control for this device type. The agency is classifying this
device type into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of these devices.
DATES: This final rule is effective November 16, 2009.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Detention and Banned Medical Devices
ACTION: Notice.
Food and Drug Administration
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Wound Dressing With Poly
(Diallyl Dimethyl Ammonium Chloride) Additive; Availability
ACTION: Notice.
Food and Drug Administration
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
ACTION: Notice.
Food and Drug Administration
Request for Nominations for Voting Members on Public Advisory
Panels or Committees
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee, certain device panels of the
Medical Devices Advisory Committee, the National Mammography Quality
Assurance Advisory Committee, and the Technical Electronic Products
Radiation Safety Standards Committee in the Center for Devices and
Radiological Health. Nominations will be accepted for current vacancies
and those that will or may occur through August 31, 2010.
DATES: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received at
least 6 months before the date of scheduled vacancies for each year, as
indicated in this notice.
Health Resources and Services Administration
Council on Graduate Medical Education; Notice of Meeting
Name: Council on Graduate Medical Education (COGME).
Dates and Times: November 18, 2009, 8:30 a.m.-4:45 p.m.,
November 19, 2009, 7:30 a.m.-4:15 p.m.
Place: Hilton Washington DC/Rockville Executive Meeting Center,
Regency Ballroom, 1750 Rockville Pike, Rockville, MD 20854,
Telephone: (301) 468-1100.
Status: The meeting will be open to the public.