Weekly Legislative & Regulatory Round-up
Week of December 12 - 18
| GAO reports |
Biosurveillance: Developing a Collaboration Strategy Is Essential to Fostering Interagency Data and Resource Sharing GAO-10-171, December 18, 2009
Veterans Health Administration: Inadequate Controls over Miscellaneous Obligations Increase Risk over Procurement Transactions GAO-10-307
Veterans Health Administration: Inadequate Controls over Miscellaneous Obligations Increase Risk over Procurement Transactions GAO-10-307T
Influenza Pandemic: Monitoring and Assessing the Status of the National Pandemic Implementation Plan Needs Improvement GAO-10-73
| OIG reports |
CDC’s Ethics Program for Special Government Employees on Federal Advisory Committees (PDF) (OEI-04-07-00260)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 4313 |
12/15/09 |
DON YOUNG (R-AK) |
A bill to amend Part B of title XVIII of the Social Security Act to eliminate the sunset for reimbursement for services furnished by certain Indian hospitals and clinics; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 4371 |
12/16/09 |
CHARLES GONZALEZ (D-TX) |
A bill to amend title XVIII of the Social Security Act to continue using 2009 Medicare practice expense relative value units for certain cardiology services; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 4373 |
12/16/09 |
ALCEE HASTINGS (D-FL) |
A bill to amend title XVIII of the Social Security Act to stabilize and modernize the provision of partial hospitalization services under the Medicare Program, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce. |
H.R. 4383 |
12/16/09 |
JIM MARSHALL (D-GA) |
A bill to amend the Public Health Service Act and title XIX of the Social Security Act to provide for a screening and treatment program for prostate cancer in the same manner as is provided for breast and cervical cancer; Referred to the Committee on Energy and Commerce. |
H.R. 4390 |
12/16/09 |
SCOTT MURPHY (D-NY) |
A bill to amend title XI of the Social Security Act to provide for enhanced program and provider protections under the Medicare, Medicaid, and Children's Health Insurance programs; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 4404 |
12/16/09 |
MAXINE WATERS (D-CA) |
A bill to amend the Public Health Service Act to authorize grants to provide treatment for diabetes in minority communities; Referred to the Committee on Energy and Commerce. |
| Federal Register notices |
No relevant notices.
No relevant notices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Notice of Meeting: Secretary's Advisory Committee on Genetics,
Health, and Society
The meeting will be held from 8:30 a.m. to approximately 5:30 p.m. on Thursday,
February 4, 2010, and from 8 a.m. to approximately 3 p.m. on Friday,
February 5, 2010, at the Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC 20008. The meeting will be open to the public with
attendance limited to space available. The meeting also will be Web
cast.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
International Conference on Harmonisation; Draft Guidance on
Addendum to International Conference on Harmonisation S6; Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1);
Availability
ACTION: Notice.
Food and Drug Administration
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 11 on
Capillary Electrophoresis General Chapter; Availability
ACTION: Notice.
Food and Drug Administration
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 12 on
Analytical Sieving General Chapter; Availability
ACTION: Notice.
Food and Drug Administration
Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance and Good Clinical Practices; Public Workshop
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) Florida District, in
cosponsorship with The Society of Clinical Research Associates, Inc.
(SoCRA), is announcing a public workshop entitled ``FDA Clinical Trial
Requirements, Regulations, Compliance and GCP.'' This 2-day public
workshop is intended to provide information about FDA clinical trial
requirements to the regulated industry.
Date and Time: The public workshop will be held on Wednesday, March
3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8
a.m. to 4:35 p.m.
Location: The public workshop will be held at The Wyndham Orlando
Resort, 8001 International Dr., Orlando, FL 32819, 407-351-2420.
Centers for Disease Control and Prevention
Total Inward Leakage Requirements for Respirators
ACTION: Notice of proposed rulemaking; extension of comment period.
SUMMARY: The Centers for Disease Control and Prevention (CDC) is
extending to March 29, 2010, the comment period for the notice of
proposed rulemaking by the National Institute for Occupational Safety
and Health (NIOSH) of CDC, entitled ``Total Inward Leakage Requirements
for Respirators,'' published in the Federal Register on Friday, October
30, 2009 (74 FR 56141). In the notice of proposed rulemaking, CDC
requested comments by December 29, 2009. The Agency is taking this
action in response to requests for an extension to allow interested
parties additional time to submit comments.
DATES: Comments: The public comment period is extended by 90 days, from
December 29, 2009, as established in the proposed rule of October 30,
2009 (74 FR 56141). All written comments must be received on or before
March 29, 2010.
Health Resources and Services Administration
Health Center Program
ACTION: Notice of noncompetitive replacement awards to Regional Health
SUMMARY: The Health Resources and Services Administration (HRSA) will
be transferring Health Center Program (section 330 of the Public Health
Service Act) New Access Point (NAP) and Increased Demand for Service
(IDS) funds originally awarded to Trover Health System to Regional
Health Care Affiliates to ensure the provision of critical primary
health care services to underserved populations in Webster and McLean
Counties, Kentucky.
Health Resources and Services Administration
National Vaccine Injury Compensation Program; List of Petitions
Received
ACTION: Notice.
SUMMARY: The Health Resources and Services Administration (HRSA) is
publishing this notice of petitions received under the National Vaccine
Injury Compensation Program (``the Program''), as required by Section
2112(b)(2) of the Public Health Service (PHS) Act, as amended. While
the Secretary of Health and Human Services is named as the respondent
in all proceedings brought by the filing of petitions for compensation
under the Program, the United States Court of Federal Claims is charged
by statute with responsibility for considering and acting upon the
petitions.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: New Collection; Title of
Information Collection: State Plan Amendment Template for the Option to
Cover Certain Children and Pregnant Women Lawfully residing in U.S.
2. Type of Information Collection Request: New collection; Title of
Information Collection: State Plan Amendment Templates for Additional
State Plan Option for Providing Premium Assistance under Title XIX and
XXI.
3. Type of Information Collection Request: New collection; Title of
Information Collection: Program Evaluation of the Eighth and Ninth
Scope of Work Quality Improvement Organization Program.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
Comment Request
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Intermediate Care
Facility (ICF) for the Mentally Retarded (MR) or Persons with Related
Conditions Survey Report Form and Supporting Regulations
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Organ Procurement
Organization's (OPO's) Health Insurance Benefits Agreement and
Supporting Regulations at 42 CFR 486.301-486.348.
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Services
Participation Report.
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: State Health
Insurance Assistance Program (SHIP) Client Contact Form, Public and
Media Form, and Resource Report Form; Form Number: CMS-10028
(OMB: 0938-0850)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: End Stage Renal
Disease (ESRD) Medical Information Facility Survey; Form Number: CMS-
2744 (OMB: 0938-0447).
6. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Notification of
Fiscal Intermediaries and CMS of co-located Medicare providers and
Supporting Regulations in 42 CFR 412.22 and 412.533.
7. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Examination and
Treatment for Emergency Medical Conditions and Women in Labor (EMTALA).
8. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Evaluation of the
Medicare National Competitive Bidding Program for DME.
9. Type of Information Collection Request: New collection; Title of
Information Collection: Information Collection Requirements and
Supporting Information for Chronic Kidney Disease Surveys under the 9th
Scope of Work.
Centers for Medicare & Medicaid Services
Medicaid Program and Children's Health Insurance Program; Model
of Interstate Coordinated Enrollment and Coverage Process for Low-
Income Children
ACTION: Notice with comment.
SUMMARY: This notice requests comments to assist in the development of
a model process for the coordination of enrollment, retention, and
coverage for low-income Medicaid and Children's Health Insurance
Program eligible children as required under the Children's Health
Insurance Program Reauthorization Act (CHIPRA) of 2009. CHIPRA requires
this model process to be developed by August 4, 2010 and the Secretary
is required to submit a Report to Congress describing additional steps
or authority needed to make further improvements to coordinate the
enrollment, retention, and coverage under CHIP and Medicaid of low-
income children who frequently change their State of residence.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on January 19, 2010.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--July Through September 2009
ACTION: Notice.
SUMMARY: This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from July 2009 through September 2009, 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 tomogrogphy for dementia, and a list of Medicare-approved
bariatric surgery facilities.
Centers for Medicare & Medicaid Services
Medicare Program; First Semi-Annual Meeting of the Advisory Panel
on Ambulatory Payment Classification Groups--February 17-19, 2010
ACTION: Notice.
SUMMARY: This notice announces the first semi-annual meeting of the
Advisory Panel on Ambulatory Payment Classification (APC) Groups (the
Panel) for 2010. The purpose of the Panel is to review the APC groups
and their associated weights and to advise the Secretary of the
Department of Health and Human Services (DHHS) (the Secretary) and the
Administrator of the Centers for Medicare & Medicaid Services (CMS)
(the Administrator) concerning the clinical integrity of the APC groups
and their associated weights. We will consider the Panel's advice as we
prepare the proposed and final rules that would update the hospital
Outpatient Prospective Payment System (OPPS) for CY 2011.
DATES: Meeting Dates: We are scheduling the first semi-annual meeting
in 2010 for the following dates and times:
Wednesday, February 17, 2010, 1 p.m. to 5 p.m. eastern
standard time (e.s.t.) \1\
Thursday, February 18, 2010, 8 a.m. to 5 p.m. (e.s.t.)
Friday, February 19, 2010, 8 a.m. to 12 noon (e.s.t.)
Centers for Medicare & Medicaid Services
Medicare Program; Meeting of the Advisory Panel on Medicare
Education, February 3, 2010
ACTION: Notice of meeting.
SUMMARY: This notice announces a meeting of the Advisory Panel on
Medicare Education (the Panel) in accordance with the Federal Advisory
Committee Act. The Panel advises and makes recommendations to the
Secretary of Health and Human Services and the Administrator of the
Centers for Medicare & Medicaid Services on opportunities to enhance
the effectiveness of consumer education strategies concerning the
Medicare program. This meeting is open to the public.
DATES: Meeting Date: Wednesday, February 3, 2010 from 8:30 a.m. to 3
p.m., eastern standard time (e.s.t.).
Deadline for Meeting Registration, Presentations and Comments:
Wednesday, January 27, 2010, 5 p.m., e.s.t.
Deadline for Requesting Special Accommodations: Wednesday, January
20, 2009, 5 p.m., e.s.t.
ADDRESSES: Meeting Location: Hilton Washington Hotel Embassy Row, 2015
Massachusetts Avenue, NW., Washington, DC 20036, (202) 265-6800.
Centers for Medicare & Medicaid Services
Medicare Program; Physician Quality Reporting Initiative (PQRI):
Listening Session-February 2, 2010.
ACTION: Notice of meeting.
SUMMARY: This notice announces a listening session to discuss the
Physician Quality Reporting Initiative (PQRI).
DATES: Meeting Date: The listening session will be held on Tuesday,
February 2, 2010 from 10 a.m. until 4:30 p.m. Eastern Standard Time
(E.S.T).
Meeting Registration and Request for Special Accommodations
Deadline: Registration opens on Monday, December 21, 2009. For security
reasons, registration must be completed no later than 5 p.m. E.S.T. on
Wednesday, January 27, 2010. Requests for special accommodations must be
received by 5 p.m. E.S.T. on Wednesday, January 27, 2010.
Food and Drug Administration
Incorporation of New Science Into Regulatory Decisionmaking
Within the Center for Devices and Radiological Health; Public Meeting;
Request for Comments
ACTION: Notice of public meeting; request for comments.
The purpose of the public meeting is to identify strategies and means
for incorporating new science into the regulatory decisionmaking
process within the agency's Center for Devices and Radiological Health
(CDRH).
Dates and Time: The public workshop will be held on February 9,
2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting
must register by 5 p.m. on February 3, 2010.
Location: The public meeting will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.