Weekly Legislative & Regulatory Round-up
Week of April 5 - 16, 2010
| GAO reports |
Fiscal Year 2011 Budget Request: U.S. Government Accountability Office GAO-10-574T
Human Capital: Status of Actions Needed to Improve the Timely and Accurate Delivery of Compensation and Medical Benefits to Deployed Civilians GAO-10-615T
| OIG reports |
Analysis of Improper Payments Identified During the Payment Error Rate Measurement Program Reviews in 2006 and 2007 (A-06-09-00079)
Medicare Payments for Medical Equipment and Supply Claims With Identical Referring Physician and Supplier National Provider Identifiers (PDF) (OEI-04-10-00110)
Review of the Hurricane Katrina Health-Care-Related Professional Workforce Supply Grant for the Greater New Orleans Area (A-06-08-00026)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 4993 |
4/13/10 |
ALLYSON SCHWARTZ (D-PA) |
A bill to amend title XVIII of the Social Security Act to ensure more timely access to home health services for Medicare beneficiaries under the Medicare Program; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce. |
H.R. 4995 |
4/13/10 |
RON PAUL (R-TX) |
A bill to restore the American people's freedom to choose the health insurance that best meets their individual needs by repealing the mandate that all Americans obtain government-approved health insurance; Referred to the Committee on Ways and Means, and in addition to the Committee on Education and Labor. |
H.R. 4999 |
4/13/10 |
SCOTT GARRETT (R-NJ) |
A bill to amend the Internal Revenue Code of 1986 to repeal the mandate that individuals purchase health insurance; Referred to the Committee on Ways and Means. |
S. 3199 |
4/14/10 |
OLYMPIA SNOWE (R-ME) |
A bill to amend the Public Health Service Act regarding early detection, diagnosis, and treatment of hearing loss; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 3201 |
4/14/10 |
MARK UDALL (D-CO) |
A bill to amend title 10, United States Code, to extend TRICARE coverage to certain dependents under the age of 26; Referred to the Committee on Armed Services. |
H.R. 5014 |
4/14/10 |
BOB FILNER (D-CA) |
A bill to clarify the health care provided by the Secretary of Veterans Affairs that constitutes minimum essential coverage; Referred to the Committee on Ways and Means. |
H.R. 5025 |
4/14/10 |
PATRICK KENNEDY (D-RI) |
A bill to amend the Public Health Service Act and the Social Security Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
SHAHEEN |
4/15/10 |
JEANNE SHAHEEN (D-NH) |
A bill to amend title XVIII of the Social Security Act to improve access to diabetes self-management training by designating certain certified diabetes educators as certified providers for purposes of outpatient diabetes self-management training services under part B of the Medicare Program; Referred to the Committee on Finance. |
S. 3216 |
4/15/10 |
CHARLES GRASSLEY (R-IA) |
A bill to amend title XVIII of the Social Security Act to ensure Medicare beneficiary access to physicians, to ensure equitable reimbursement under the Medicare program for all rural States, and to eliminate sweetheart deals for frontier States; Referred to the Committee on Finance. |
H.R. 5044 |
4/15/10 |
RON KLEIN (D-FL) |
A bill to provide for enhanced penalties to combat Medicare and Medicaid fraud, a Medicare data-mining system and biometric technology pilot program, and a GAO study on Medicare administrative contractors; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 5054 |
4/15/10 |
RANDY FORBES (R-VA) |
A bill to prohibit the Internal Revenue Service from hiring new employees to enforce the Federal Government's invasion into the health care lives of American citizens; Referred to the Committee on Ways and Means. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Neurological and Physical Medicine Devices; Designation of
Special Controls for Certain Class II Devices and Exemption From
Premarket Notification
ACTION: Proposed rule.
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices; Neurological and Physical Medicine Device
Guidance Documents; Availability
ACTION: Notice.
Food and Drug Administration
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 7 on
Dissolution Test General Chapter; Availability
ACTION: Notice.
Food and Drug Administration
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 9 on Tablet
Friability General Chapter; Availability
ACTION: Notice.
Food and Drug Administration
Memorandum of Understanding Between the Food and Drug
Administration, United States Department of Health and Human Services
and the Association of Minority Health Profession Schools, Inc.
ACTION: Notice.
Food and Drug Administration
Memorandum of Understanding Between the Food and Drug
Administration, United States Department of Health and Human Services
and the National Alliance for Hispanic Health
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator for Health Information
Technology
HIT Policy Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of change of location for meetings.
Date and Time: The meetings will be held on April 20, 2010, from 9
a.m. to 5 p.m./Eastern Time (the Meaningful Use Workgroup); and April
21, 2010, from 10 a.m. to 4 p.m./Eastern Time (HIT Policy Committee).
Location: The location for both meetings has changed to the
Renaissance Dupont Circle Hotel, 1143 New Hampshire Avenue, NW.,
Washington, DC. The hotel telephone number is 202-775-0800.
Indian Health Service
Tribal Management Grant Program; Announcement Type: New and
Competing Continuation Discretionary Funding Cycle for Fiscal Year 2011
I. Funding Opportunity Description:
The Indian Health Service (IHS) announces competitive grant
applications for the Tribal Management
Grant (TMG) Program. This program is authorized under 25 U.S.C. 450h(b)
and 25 U.S.C. 450h(e) of the Indian Self-Determination and Education
Assistance Act (ISDEAA), Public Law (Pub. L.) 93-638, as amended.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: National Health Service Corps Alumni Initiative—New
Health Resources and Service Administration
Advisory Committee on Interdisciplinary, Community-Based
Linkages; Notice for Request for Nominations
SUMMARY: The Health Resources and Services Administration (HRSA) is
requesting nominations to fill ten upcoming vacancies on the Advisory
Committee on Interdisciplinary, Community-Based Linkages (ACICBL).
DATES: The Agency must receive nominations on or before June 30, 2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Drug and Medical Device Forum on Food and Drug Administration
Drug and Device Requirements and Supplier Controls; Public Educational
Forum
ACTION: Notice of public educational forum.
SUMMARY: The Food and Drug Administration (FDA) Baltimore District, in
co-sponsorship with the Association of Food and Drug Officials (AFDO),
is announcing a public educational forum entitled ``Drugs & Medical
Device Supplier Management Forum.'' This 2-day public educational
forum, a component of AFDO's Annual Educational Conference, is intended
to provide information about FDA drug and device regulation to the
regulated industry.
Date and Time: The public educational forum will be held on Monday,
June 21, 2010, from 8 a.m. to 5 p.m. and Tuesday, June 22, 2010, from 8
a.m. to 5 p.m.
Location: The public educational forum will be held at the Sheraton
Norfolk Waterside Hotel, 777 Waterside Dr., Norfolk, VA 23510, 800-325-
3535, or 757-622-6664, FAX: 757-625-8271.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 10 on
Polyacrylamide Gel Electrophoresis General Chapter; Availability
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Developing Guidance on Naming, Labeling, and Packaging Practices
to Reduce Medication Errors; Public Workshop; Request for Comments
ACTION: Notice of public workshop; request for comments.
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Developing Guidance on Naming, Labeling, and
Packaging Practices to Reduce Medication Errors.'' The purpose of the
public workshop is to initiate constructive dialogue and information
sharing among regulators, researchers, the pharmaceutical industry,
health care organizations, health care professionals, and others from
the general public about the design of drug and therapeutic biologic
container labels, carton labeling, and product packaging, and practices
to develop proprietary names to reduce medication errors. The input
from this workshop will be used to develop draft guidance for industry
on practices for naming, labeling, and packaging of drugs and biologics
to reduce the potential for medication errors. FDA is also opening a
public docket to receive comments on this topic to assist in the
development of draft guidance.
DATES AND TIME: The public workshop will be held on Thursday and
Friday, June 24 and 25, 2010, from 8:30 a.m. to 5 p.m. each day.
Register to make a presentation at the workshop by May 25, 2010. See
section IV of this document for information on how to attend or present
at the meeting. Submit written or electronic comments to the docket by
July 23, 2010, to receive consideration.
No relevant notices.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Medical Loss Ratios; Request for Comments Regarding Section 2718
of the Public Health Service Act
ACTION: Request for information.
SUMMARY: This document is a request for comments regarding Section 2718
of the Public Health Service Act (PHS Act), which was added by Sections
1001 and 10101 of the Patient Protection and Affordable Care Act
(PPACA), Public Law 111-148, enacted on March 23, 2010. Section 2718 of
the PHS Act, among other provisions, requires health insurance issuers
offering individual or group coverage to submit annual reports to the
Secretary on the percentages of premiums that the coverage spends on
reimbursement for clinical services and activities that improve health
care quality, and to provide rebates to enrollees if this spending does
not meet minimum standards for a given plan year. Section 1562 of PPACA
also added section 715 of the Employee Retirement Income Security Act
of 1974 (ERISA) and section 9815 of the Internal Revenue Code of 1986
(the Code). These two sections effectively incorporate by reference
section 2718 and other amendments to title XXVII of the PHS Act. The
Departments of Health and Human Services (HHS), Labor, and the Treasury
(collectively, the Departments) invite public comments in advance of
future rulemaking.
DATES: Submit written or electronic comments by May 14, 2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Premium Review Process; Request for Comments Regarding Section
2794 of the Public Health Service Act
ACTION: Request for information.
SUMMARY: This document is a request for comments regarding Section 1003
of the Patient Protection and Affordable Care Act (PPACA), Pub. L. 111-
148, which added Section 2794 to the Public Health Service Act (the PHS
Act). Section 2794 of the PHS Act requires the Secretary to work with
States to establish an annual review of unreasonable rate increases, to
monitor premium increases and to award grants to States to carry out
their rate review process. The Department of Health and Human Services
(HHS) invites public comments in advance of future rulemaking.
DATES: Submit written or electronic comments by May 14, 2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Policy and Technical Changes to the Medicare
Advantage and the Medicare Prescription Drug Benefit Programs
ACTION: Final rule.
SUMMARY: This final rule makes revisions to the regulations governing
the Medicare Advantage (MA) program (Part C) and prescription drug
benefit program (Part D) based on our continued experience in the
administration of the Part C and D programs. The revisions strengthen
various program participation and exit requirements; strengthen
beneficiary protections; ensure that plan offerings to beneficiaries
include meaningful differences; improve plan payment rules and
processes; improve data collection for oversight and quality
assessment, implement new policies and clarify existing program policy.
DATES: Effective Date: These regulations are effective on June 7, 2010.
However, we note that because health and drug plans under the Part C
and D programs operate under contracts with CMS that are applicable on
a calendar year basis, the provisions will not be applicable prior to
contract year January 1, 2011, except where otherwise noted.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: HRSA AIDS Education and Training Centers Evaluation
Activities (OMB No. 0915-0281)—Revision
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: Scholarships for Disadvantaged Students Program (OMB
No. 0915-0149) Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Agency Information Collection Request; 30-Day Public Comment
Proposed Project: The Effect of Reducing Falls on Acute and Long-
Term Care Expenses OMB No. 0990-0308--Extension--Assistant Secretary
Planning Evaluation (ASPE).
Office of the Secretary
Agency Information Collection Request. 60-Day Public Comment
Proposed Project: Comprehensive Communication Campaign for HITECH
Act--OMB No. 0990-NEW-Office National Coordinator for Health
Information Technology (ONC).