Weekly Legislative & Regulatory Round-up
Week of October 3 - 9
| GAO reports |
Medicaid: State and Federal Actions Have Been Taken to Improve Children's Access to Dental Services, but Gaps Remain GAO-09-723
Medicaid: State and Federal Actions Have Been Taken to Improve Children's Access to Dental Services, but More Can Be Done GAO-10-112T
| OIG reports |
Advisory Opinion 09-17 (concerning a joint venture to provide EMS and scheduled ambulance transportation services)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H. Res. 796 |
10/6/09 | JOHN SHADEGG (R-AZ) | A resolution expressing the sense of the House of Representatives that no American should be penalized for failing to purchase Government-mandated health coverage; Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary. |
S. 1760 |
10/7/09 | FRANK LAUTENBERG (D-NJ) | A bill to amend the Public Health Service Act with regard to research on asthma, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. |
S. 1762 |
10/7/09 | SAM BROWNBACK (R-KS) | A bill to amend the Public Health Service Act to expand and intensify programs of the National Institutes of Health and the Centers for Disease Control and Prevention with respect to translational research and related activities concerning Down syndrome, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 3741 |
10/7/09 | PETER HOEKSTRA (R-MI) | A bill to provide Federal matching funding for State insurance expenditures for high risk pools; Referred to the Committee on Energy and Commerce. |
H.R. 3754 |
10/7/09 | CAROLYN MCCARTHY (D-NY) | A bill to amend the Public Health Service Act with regard to research on asthma, and for other purposes; Referred to the Committee on Energy and Commerce. |
S. 1771 |
10/7/09 | ROBERT CASEY (D-PA) | A bill to authorize the Secretary of Health and Human Services to establish a program of grants to newly accredited allopathic medical schools for the purpose of increasing the supply of physicians; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 3776 |
10/8/09 | SAM GRAVES (R-MO) | A bill to amend the Internal Revenue Code of 1986 to provide a 100 percent deduction for the health insurance costs of individuals; Referred to the Committee on Ways and Means. |
H.R. 3778 |
10/8/09 | PAUL KANJORSKI (D-PA) | A bill to authorize the Secretary of Health and Human Services to establish a program of grants to newly accredited allopathic medical schools for the purpose of increasing the supply of physicians; Referred to the Committee on Energy and Commerce. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry and FDA Staff; the Scope of the
Prohibition Against Marketing a Tobacco Product in Combination With
Another Article or Product Regulated Under the Federal Food, Drug, and
Cosmetic Act; Availability
ACTION: Notice.
Food and Drug Administration
Food and Drug Administration Transparency Task Force; Public
Meeting; Request for Comments
ACTION: Notice of public meeting; request for comments.
SUMMARY: The Food and Drug Administration (FDA) is announcing a second
public meeting to discuss issues related to transparency at the agency.
The purpose of this public meeting is to receive detailed and in-depth
comments on three specific issues related totransparency at FDA.
DATES: The public meeting will be held on November 3, 2009, from 9 a.m.
to 3 p.m. Persons interested in attending and/or participating in the
meeting must register by 5 p.m. on October 27, 2009. Submit electronic
or written comments by November 6, 2009.
Office of the Secretary
Pandemic Influenza Vaccines--Amendment
ACTION: Notice of first amendment to the June 15, 2009 Republished
Declaration under the Public Readiness and Emergency Preparedness Act.
SUMMARY: Amendment to declaration issued on June 15, 2009 (74 FR 30294)
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C.
247d-6d) to provide targeted liability protections for pandemic
countermeasures to add provisions consistent with other declarations
issued under this authority that may facilitate vaccination campaigns,
and republication of the declaration to reflect the declaration in its
entirety, as amended.
DATES: The first amendment of the republished declaration issued on
June 15, 2009 is effective as of September 28, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 National Coordinator for Health Information
Technology
HIT Policy Committee's Information Exchange Workgroup Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on October 20, 2009, from 9
a.m. to 3 p.m. Eastern Time.
Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC.
Office of the Secretary
Renewal of Declaration Regarding Emergency Use of Doxycycline
Hyclate Tablets Accompanied by Emergency Use Information
ACTION: Notice.
Health Resources and Services Administration
National Advisory Council on Migrant Health; Notice of Meeting
Dates and Times: November 2, 2009, 8:30 a.m. to 5 p.m.; November
3, 2009, 8:30 a.m. to 5 p.m.
Place: Hilton Hotel, 1750 Rockville Pike, Rockville, Maryland
20852, Telephone: (301) 468-1100, Fax: (301) 468-0308.
Status: The meeting will be open to the public.
National Institutes of Health
Notice of Establishment of the Interagency Breast Cancer and
Environmental Research Coordinating Committee
SUMMARY: Pursuant to the Federal Advisory Committee Act, as amended (5
U.S.C. Appendix 2), the Director, National Institutes of Health (NIH),
announces the establishment of the Interagency Breast Cancer and
Environmental Research Coordinating Committee (Committee).
The Committee shall coordinate all efforts within the Department of
Health and Human Services to share and coordinate information on
existing research activities, and make recommendations to the Secretary
DHHS, the National Institutes of Health and other Federal agencies
regarding how to improve existing research programs.
Duration of this committee is two years from the date the Charter
is filed.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Changes to the Hospital Inpatient Prospective
Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates and
to the Long-Term Care Hospital Prospective Payment System and Rate Year
2010 Rates; Corrections
ACTION: Correction of final rules and interim final rule with comment
period.
SUMMARY: This document corrects technical errors and typographical
errors that appeared in the final rules and interim final rule with
comment period published in the Federal Register on August 27, 2009 entitled
``Medicare Program; Changes to the Hospital Inpatient Prospective
Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates and
to the Long-Term Care Hospital Prospective Payment System and Rate Year
2010 Rates.''
DATES: Effective Date: This correction document is effective October 2,
2009.
Applicability Date: This correction document is applicable to
discharges occurring on or after October 1, 2009.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Interim Final Rules Prohibiting Discrimination Based on Genetic
Information in Health Insurance Coverage and Group Health Plans
ACTION: Interim final rules with request for comments.
SUMMARY: This document contains interim final rules implementing
sections 101 through 103 of the Genetic Information Nondiscrimination
Act of 2008. These provisions prohibit discrimination based on genetic
information in health insurance coverage and group health plans.
DATES: Effective Date: These interim final regulations are effective on
December 7, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary; Office of Civil Rights
HIPAA Administrative Simplification: Standards for Privacy of
Individually Identifiable Health Information
ACTION: Proposed rule.
SUMMARY: The Department of Health and Human Services (HHS) proposes to
modify certain provisions of the ``Standards for Privacy of
Individually Identifiable Health Information'' (Privacy Rule), issued
under the Health Insurance Portability and Accountability Act of 1996
(HIPAA). The purpose of these proposed modifications is to implement
section 105 of Title I of the Genetic Information Nondiscrimination Act
of 2008 (GINA) regarding the privacy and confidentiality of genetic
information, as well as to make certain other changes to the HIPAA
Privacy Rule.
DATES: Comments on the proposed rule will be considered if we receive
them at the appropriate address, as provided below, no later than
December 7, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry and Food and Drug Administration Staff;
Implementation of Medical Device Establishment Registration and Device
Listing Requirements Established by the Food and Drug Administration
Amendments Act of 2007; Availability
ACTION: Notice.
SUMMARY: The purpose of this guidance is to explain recent changes in
the device registration and listing program to owner/operators and
official correspondents of device establishments and to help them
fulfill these new requirements.
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 (0MB) approve the proposed information collection
project: ``Medical Expenditure Panel Survey (MEPS) Household Component
and the MEPS Medical Provider Component through 2012.'' In accordance
with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public to comment on this proposed
information collection.
DATES: Comments on this notice must be received by November 9, 2009.
Agency for Healthcare Research and Quality
National Advisory Council for Healthcare Research and Quality:
Request for Nominations for Public Members
ACTION: Request for nominations for public members.
SUMMARY: Section 931 of the Public Health Service Act (PHS Act), 42
U.S.C. 299c, established a National Advisory Council for Healthcare
Research and Quality (the Council). The Council is to advise the
Secretary of HHS (Secretary) and the Director of the Agency for
Healthcare Research and Quality (AHRQ) on matters related to activities
of the Agency to improve the quality, safety, efficiency, and
effectiveness of health care for all Americans.
Seven current members' terms will expire in November 2009. To fill
these positions in accordance with the legislative mandate establishing
the Council, we are seeking individuals who are distinguished: (1) In
the conduct of research, demonstration projects, and evaluations with
respect to health care; (2) in the fields of health care quality
research or health care improvement; (3) in the practice of medicine;
(4) in other health professions; (5) in representing the private health
care sector (including health plans, providers, and purchasers) or
administrators of health care delivery systems; (6) in the fields of
health care economics, information systems, law, ethics, business, or
public policy; and (7) in representing the interests of patients and
consumers of health care. Individuals are particularly sought with
experience and success in activities specified in the summary above.
DATES: Nominations should be received on or before Friday, November 20,
2009.
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: Medicare Quality of Care Complaint Form
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: CY 2011 Bid
Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription
Drug Plans (PDP)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: CY 2011 Plan
Benefit Package (PBP) Software and Formulary Submission
3. 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
4. Type of Information Collection Request: New collection; Title of
Information Collection: Data Collection For Developing Outpatient
Therapy Payment Alternatives (DOTPA)
5. 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
Food and Drug Administration
Medical Devices; Immunology and Microbiology Devices;
Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay
ACTION: Final rule.
Food and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent
Extension; ENTEREG; U.S. Patent Nos. 5,250,542 and 5,434,171
ACTION: Notice.
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff; the Mammography Quality Standards Act Final Regulations:
Modifications and Additions to Policy Guidance Help System 13;
Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``The Mammography Quality
Standards Act Final Regulations: Modifications and Additions to Policy
Guidance Help System 13.'' This document is intended to
provide guidance to mammography facilities and their personnel. It
represents FDA's current thinking on the final regulations implementing
the Mammography Quality Standards Act of 1992 (MQSA). This guidance
document updates previous guidance. This draft guidance is not final
nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 7, 2010.
Food and Drug Administration
Guidances for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Documents: Respiratory Viral Panel
Multiplex Nucleic Acid Assay; and Testing for Human Metapneumovirus
Using Nucleic Acid Assays; and Testing for Detection and
Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic
Acid Assays; Availability
ACTION: Notice.
DATES: Submit written or electronic comments on the guidances at any
time. General comments on agency guidance documents are welcome at any
time.