Weekly Legislative & Regulatory Round-up
Week of May 15 - 21, 2010
| GAO reports |
Agency for Toxic Substances and Disease Registry: Policies and Procedures for Preparing Public Health Products Should Be Strengthened GAO-10-741T
Agency for Toxic Substances and Disease Registry: Policies and Procedures for Public Health Product Preparation Should Be Strengthened GAO-10-449
Centers for Disease Control and Prevention: An Appropriate Methodology Is Needed for Determining Administrative Costs Attributable to the Agency for Toxic Substances and Disease Registry GAO-10-610R
Nonprofit Sector: Treatment and Reimbursement of Indirect Costs Vary among Grants, and Depend Significantly on Federal, State, and Local Government Practices GAO-10-477
| OIG reports |
Most Medicaid Children in Nine States Are Not Receiving All Required Preventive Screening Services (PDF) (OEI-05-08-00520)
Performance Data for the Senior Medicare Patrol Projects: May 2010 Performance Report (PDF) (OEI-02-10-00100)
Excluded Medicaid Providers: Analysis of Enrollment (PDF) (OEI-09-08-00330)
Review of the Department of Health & Human Services’ Limited Data-Quality Reviews of Information Reported by Recipients of Recovery Act Funds (A-09-10-01001)
Updated OIG Guidance on IRO Independence and Objectivity (PDF)
- Prior Frequently Asked Questions Related to IRO Independence (PDF) (temporarily re-posted)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 5324 |
05/18/2010 |
DAVIS, SUSAN (D-CA) |
A bill to provide for extension of COBRA continuation coverage until coverage is available otherwise under either an employment-based health plan or through an American Health Benefit Exchange under the Patient Protection and Affordable Care Act; Referred to the Committee on Education and Labor, and in addition to the Committees on Energy and Commerce, and Ways and Means. |
H.R. 5335 |
05/18/2010 |
MARSHALL, JIM (D-GA) |
A bill to amend the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to eligible local educational agencies for the purpose of reducing the student-to-nurse ratio in public elementary and secondary schools; Referred to the Committee on Energy and Commerce. |
S. 3393 |
05/20/2010 |
BROWN, SHERROD (D-OH) |
A bill to provide for extension of COBRA continuation coverage until coverage is available otherwise under either an employment-based health plan or through an American Health Benefit Exchange under the Patient Protection and Affordable Care Act; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 5354 |
05/20/2010 |
ENGEL, ELIOT (D-NY) |
A bill to establish an Advisory Committee on Gestational Diabetes, to provide grants to better understand and reduce gestational diabetes, and for other purposes; Referred to the Committee on Energy and Commerce. |
H.R. 5364 |
05/20/2010 |
STUPAK, BART (D-MI) |
A bill to amend title XIX of the Social Security Act to require States to provide oral health services to aged, blind, or disabled individuals under the Medicaid Program, and for other purposes; Referred to the Committee on Energy and Commerce. |
| Federal Register notices |
No relevant notices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
Comment Request
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Coordination of
Benefits between Part D Plans and Other Prescription Coverage
Providers.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Participating Physician or Supplier Agreement; Form No.: CMS-460
(OMB 0938-0373)
3. Type of Information Collection Request: New collection; Title of
Information Collection: Survey to Inform the Children's Health
Insurance Program (CHIP) National Outreach & Education Campaign; Form
No.: CMS-10318 (OMB 0938-New).
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. 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
2. 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).
Food and Drug Administration
Request for Comment on Implementation of the Family Smoking
Prevention and Tobacco Control Act; Extension of Comment Period
ACTION: Advance notice of proposed rulemaking; extension of comment
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Invitation to Manufacturers and Distributors to
Voluntarily Submit Final Product Labeling and Information
Electronically for all Devices Cleared by the Food and Drug
Administration for Home Use; Notice of Pilot Program
ACTION: Notice.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: Data Collection Tool for State Offices of Rural
Health Grant Program
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
HRSA Telehealth Outcome Measures (OMB No. 0915-0311)—Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Solicitation of Written Comments on Draft HHS Strategic Framework
on Multiple Chronic Conditions
ACTION: Notice.
DATES: Comments on the HHS Interagency Workgroup on Multiple Chronic
Conditions draft strategic framework should be received no later than
5:30 p.m. on June 18, 2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance
for the Agency for Healthcare Research and Quality.'' In accordance
with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the
public to comment on this proposed information collection.
DATES: Comments on this notice must be received by July 19, 2010.
Food and Drug Administration
Draft Guidance for Industry, Third Parties and Food and Drug
Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit
Report Submission Program; Availability
ACTION: Notice.
Health Resources and Services Administration
Part C Early Intervention Services Grant Under the Ryan White
HIV/AIDS Program
ACTION: Notice of Non-competitive Award of Part C Funds for the Rural
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
FDA Transparency Initiative: Draft Proposals for Public Comment
Regarding Disclosure Policies of the U.S. Food and Drug Administration;
Availability
ACTION: Notice of availability; request for comments.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Responsibility of Applicants for Promoting Objectivity in
Research for Which Public Health Service Funding Is Sought and
Responsible Prospective Contractors
ACTION: Notice of proposed rulemaking.
SUMMARY: The Department of Health and Human Services (HHS or the
Department) and the HHS Public Health Service (PHS), proposes to amend
its regulations on the Responsibility of Applicants for Promoting
Objectivity in Research for which PHS Funding is Sought and Responsible
Prospective Contractors. Since the promulgation of the regulations in
1995, biomedical and behavioral research and the resulting interactions
among Government, research institutions, and the private sector have
become increasingly complex. This complexity, as well as a need to
strengthen accountability, have led to the proposal of amendments that
would expand and add transparency to investigator disclosure of
significant financial interests, enhance regulatory compliance and
effective institutional oversight and management of investigators'
financial conflicts of interests, as well as NIH's compliance
oversight.
DATES: Comments must be received on or before July 20, 2010 in order to
ensure we will be able to consider the comments when preparing the
final rule.