Weekly Legislative & Regulatory Round-up
Week of November 28 - December 4
| GAO reports |
Hurricane Katrina: Federal Grants Have Helped Health Care Organizations Provide Primary Care, but Sustaining Services Will Be a Challenge GAO-10-273T
Disaster Assistance: Improvements in Providing Federal Disaster Case Management Services Could Help Agencies Better Assist Victims GAO-10-278T
| OIG reports |
Top HHS Management and Performance Challenges: FY 2009 (PDF)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 4161 | 12/1/09 |
LOUISE SLAUGHTER (D-NY) |
A bill to amend the Public Health Service Act to authorize the National Institute of Environmental Health Sciences to develop multidisciplinary research centers regarding women's health and disease prevention, and for other purposes; Referred to the Committee on Energy and Commerce. |
S. 2828 | 12/3/09 |
JOHN KERRY (D-MA) |
A bill to amend the Public Health Service Act to authorize the National Institute of Environmental Health Sciences to conduct a research program on endocrine disruption, to prevent and reduce the production of, and exposure to, chemicals that can undermine the development of children before they are born and cause lifelong impairment to their health and function, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
S. 2833 | 12/3/09 |
JACK REED (D-RI) |
A bill to provide adjusted Federal medical assistance percentage rates during a transitional assistance period; Referred to the Committee on Finance. |
H.R. 4190 | 12/3/09 |
JIM MORAN (D-VA) |
A bill to amend the Public Health Service Act to authorize the National Institute of Environmental Health Sciences to conduct a research program on endocrine disruption, to prevent and reduce the production of, and exposure to, chemicals that can undermine the development of children before they are born and cause lifelong impairment to their health and function, and for other purposes; Referred to the Committee on Energy and Commerce. |
H.R. 4199 | 12/3/09 |
G.K. BUTTERFIELD (D-NC) |
A bill to ensure patient choice in pharmacies by regulating pharmacy benefit managers and to establish a program to improve access to prescription drugs for certain individuals; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
H.R. 4204 | 12/3/09 |
PATRICK KENNEDY (D-RI) |
A bill to establish national centers of excellence for the treatment of depressive and bipolar disorders; Referred to the Committee on Energy and Commerce. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicaid Program; Coverage for Rehabilitative Services;
Withdrawal
ACTION: Withdrawal of proposed rule.
SUMMARY: This document withdraws a proposed rule that was published in
the Federal Register on August 13, 2007. The proposed rule discussed
our proposal to amend the definition of Medicaid ``rehabilitative
services.'' It also clarified the broad general language of the current
regulation to ensure that rehabilitative services are provided in a
coordinated manner, are limited to rehabilitative purposes, and are
furnished by qualified providers.
DATES: Effective November 23, 2009, the proposed rule published on
August 13, 2007 (72 FR 45201) is withdrawn.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
FY 2010 Special Diabetes Program for Indians Community-Directed
Grant Program
Announcement Type: New/Competing Continuation.
No relevant notices.
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: ``Spreading Techniques to Radically Reduce Antibiotic
Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or
MRSA).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 350
1-3520, AHRQ invites the public to comment on this proposed information
collection.
DATES: Comments on this notice must be received by January 25, 2010.
Centers for Medicare & Medicaid Services
Medicare Program; Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2010
ACTION: Final rule with comment period.
SUMMARY: This final rule with comment period implements changes to the
physician fee schedule and other Medicare Part B payment policies to
ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services. It also implements
or discusses certain provisions of the Medicare Improvements for
Patients and Providers Act of 2008. (See the Table of Contents for a
listing of the specific issues addressed in this rule.)
This final rule with comment period also finalizes the calendar
year (CY) 2009 interim relative value units (RVUs) and issues interim
RVUs for new and revised codes for CY 2010. In addition, in accordance
with the statute, it announces that the update to the physician fee
schedule conversion factor is -21.2 percent for CY 2010, the
preliminary estimate for the sustainable growth rate for CY 2010 is -
8.8 percent, and the conversion factor (CF) for CY 2010 is $28.4061.
DATES: Effective Dates: With the exception of the provisions of Sec.
414.68 and Sec. 414.210(e)(5), this final rule is effective on January
1, 2010. The provisions of Sec. 414.68 are effective on October 30,
2009, and the provisions of Sec. 414.210(e)(5) are effective on July
1, 2010.
Comment Date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on December 29, 2009.
Centers for Medicare & Medicaid Services
Medicare Program; Solicitation of Independent Accrediting
Organizations To Participate in the Advanced Diagnostic Imaging
Supplier Accreditation Program
ACTION: Notice.
SUMMARY: This notice announces to independent accreditation
organizations an opportunity to submit applications to participate in
the advanced diagnostic imaging supplier accreditation program as a
designated accreditation organization. Advanced diagnostic imaging
accreditation is required for suppliers furnishing the technical
component (TC) of advanced diagnostic imaging services. This notice
contains information on accreditation application guidelines for CMS
approval of suppliers who furnish the TC of advanced diagnostic imaging
services.
DATES: Applications will be considered for the January 1, 2010
designation deadline if received at the address, provided in the
ADDRESSES section of this notice, no later than 5 p.m. eastern standard
time (e.s.t.) on December 1, 2009.
Food and Drug Administration
Organ-Specific Warnings; Internal Analgesic, Antipyretic, and
Antirheumatic Drug Products for Over-the-Counter Human Use; Final
Monograph; Technical Amendment
ACTION: Final rule; technical amendment.
SUMMARY: The Food and Drug Administration (FDA) is amending a final
rule that appeared in the Federal Register of April 29, 2009 (74 FR
19385) (as amended in the Federal Register of June 30, 2009 (74 FR
31177). The final rule requires important new organ-specific warnings
and related labeling for over-the-counter (OTC) internal analgesic,
antipyretic, and antirheumatic (IAAA) drug products. The new labeling
informs consumers about the risk of liver injury when using
acetaminophen and the risk of stomach bleeding when using nonsteroidal
anti-inflammatory drugs (NSAIDs). This document is intended to clarify
some provisions in the final rule which may be unclear. Specifically,
this document addresses how blister cards can be labeled to comply with
the new required labeling, clarifies the length of time that the ``See
new warnings'' flag is required to appear in the labeling, and provides
some optional wording to clarify the liver injury warning on OTC
acetaminophen products containing multiple active ingredients.
DATES: Effective Date: This final rule is effective April 29, 2010.
Compliance Date: The compliance date for all products subject to
this final rule, including products with annual sales less than
$25,000, is April 29, 2010.
Food and Drug Administration
Guidance for Industry on Residual Solvents in Drug Products
Marketed in the United States; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Residual Solvents in
Drug Products Marketed in the United States.'' On July 1, 2008, the
United States Pharmacopeia (USP) published a new test requirement for
the control of residual solvents, General Chapter <467> ``Residual
Solvents,'' which replaced USP General Chapter <467> ``Organic Volatile
Impurities.'' The change affects all compendial drug products marketed
in the United States. This guidance reflects FDA's recommendations on
how to comply with those USP changes.
DATES: Submit written or electronic comments on agency guidances at any
time.
Office of the Secretary, Office of Public Health and Science, Office of Disease
Prevention and Health Promotion
ACTION: Notice of meeting.
Announcement of Meeting of the Secretary's Advisory Committee on
National Health Promotion and Disease Prevention Objectives for 2020
SUMMARY: The U.S. Department of Health and Human Services (HHS)
announces the next federal advisory committee meeting regarding the
national health promotion and disease prevention objectives for 2020.
This meeting will be open to the public and will be held online via
WebEx software.
DATES: The Committee will meet on December 11, 2009 from 1:30 p.m. to
4:30 p.m. Eastern Standard Time (EST).
ADDRESSES: The meeting will be held online, via WebEx software. For
detailed instructions about how to make sure that your windows computer
and browser is set up for WebEx, please visit the ``Secretary's
Advisory Committee'' Web page of the Healthy People Web site at: http:/
/www.healthypeople.gov/hp2020/advisory/default.asp.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Approval of the Accreditation
Commission for Health Care for Deeming Authority for Hospices
ACTION: Final notice.
SUMMARY: This final notice announces our decision to approve the
Accreditation Commission for Health Care (ACHC) for recognition as a
national accreditation program for hospices seeking to participate in
the Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective November 27, 2009
through November 27, 2013.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Approval of the Application by
the Joint Commission for Continued Deeming Authority for Hospitals
ACTION: Final notice.
SUMMARY: This final notice announces the approval of a deeming
application from the Joint Commission for continued recognition as a
national accreditation program for hospitals that request participation
in the Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective July 15, 2010
through July 15, 2014.
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Conditional Approval of
Application by the American Association for Accreditation of Ambulatory
Surgery Facilities for Continued Deeming Authority for Ambulatory
Surgical Centers
ACTION: Final notice.
SUMMARY: This final notice announces our decision to conditionally
approve, with a 180 day probationary period, the American Association
for Accreditation of Ambulatory Surgery Facilities (AAAASF) for
continued recognition as a national accreditation program for
ambulatory surgical centers seeking to participate in the Medicare or
Medicaid programs.
DATES: Effective Date: This final notice is effective on November 27,
2009 through November 27, 2012, with a 180-day probationary period
beginning November 27, 2009 through May 26, 2010.
Centers for Medicare & Medicaid Services
Medicare Program; Town Hall Meeting on the Fiscal Year 2011
Applications for New Medical Services and Technologies Add-on Payments
and Informational Workshop on the Application Process and Criteria for
New Medical Services and Technologies Add-on Payments
ACTION: Notice of meeting.
SUMMARY: This notice announces a Town Hall meeting to discuss fiscal
year (FY) 2011 applications for add-on payments for new medical
services and technologies under the hospital inpatient prospective
payment system (IPPS). Interested parties are invited to this meeting
to present their comments, recommendations, and data regarding whether
the FY 2011 new medical services and technologies applications meet the
substantial clinical improvement criterion.
Additionally, this notice announces an Informational Workshop for
all interested parties on the application process and criteria for new
medical services and technologies under the IPPS and on the outpatient
prospective payment system (OPPS) transitional pass-through payment for
drugs, biologicals, and devices and new technology Ambulatory Payment
Classification (APC) assignment for new services application processes.
DATES: Meeting Date: The Town Hall meeting and the Informational
Workshop announced in this notice will be held on Wednesday, February
10, 2010. The Informational Workshop will begin at 9 a.m., and check-in
will begin at 8:30 a.m. eastern daylight time (e.d.t.). The Town Hall
meeting will begin at 1 p.m. e.d.t. and check-in will begin at 12:30
p.m. e.d.t.
Office of the Secretary
Federal Financial Participation in State Assistance Expenditures;
Federal Matching Shares for Medicaid, the Children's Health Insurance
Program, and Aid to Needy Aged, Blind, or Disabled Persons for October
1, 2010 through September 30, 2011
ACTION: Notice.
SUMMARY: The Federal Medical Assistance Percentages (FMAP) and Enhanced
Federal Medical Assistance Percentages (eFMAP) for Fiscal Year 2011
have been calculated pursuant to the Social Security Act (the Act).
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicaid Program: State Flexibility for Medicaid Benefit Packages
and Premiums and Cost Sharing
ACTION: Final rule.
SUMMARY: This final rule temporarily delays the effective date of the
November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and
Cost Sharing'' and the December 3, 2008 final rule entitled, ``Medicaid
Program; State Flexibility for Medicaid Benefit Packages'' until July
1, 2010.
DATES: Effective Date: This action is effective December 31, 2009. The
effective date of the rule amending 42 CFR part 440 published in the
December 3, 2008 Federal Register (73 FR 73694) is delayed until July
1, 2010. The effective date of the rule amending 42 CFR parts 447 and
457 published in the November 25, 2008 Federal Register (73 FR 71828)
is delayed until July 1, 2010.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Reconciliation of State Invoice and Prior Quarter Adjustment Statement;
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Home Health Agency Survey and Deficiencies Report, Home Health
Functional Assessment Instrument and Supporting Regulations in 42 CFR
488.26 and 442.30.
3. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Dental Provider and Benefit Information Posted on Insure Kids Now!
Website.
4. Type of Information Collection Request: New Collection; Title of
Information Collection: State Medicaid HIT Plan and Templates for
Implementation of Section 4201 of ARRA; Form Number: CMS-10292
(OMB: 0938-NEW).
5. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Electronic Funds Transfer Authorization Agreement.
6. Type of Information Collection Request: Reinstatement without
change of a currently approved collection; Title of Information
Collection: Medicare Integrity Program Organizational Conflict of
Interest Disclosure Certificate and Supporting Regulations at 42 CFR
421.300-421.316.
Centers for Medicare & Medicaid Services
Medicare Program; Solicitation of Independent Accrediting
Organizations To Participate in the Advanced Diagnostic Imaging
Supplier Accreditation Program; Correction
ACTION: Correction notice.
SUMMARY: This document corrects a technical error in the notice
entitled ``Medicare Program; Solicitation of Independent Accrediting
Organizations to Participate in the Advanced Diagnostic Imaging
Supplier Accreditation Program'' which was posted for public inspection
by the Office of the Federal Register on October 30, 2009, and
published in the Federal Register on November 25, 2009.
Centers for Medicare & Medicaid Services
Medicare Program; Meeting of the Medicare Evidence Development
and Coverage Advisory Committee
ACTION: Notice of meeting.
SUMMARY: This notice announces that a public meeting of the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC)
(``Committee'') will be held on Wednesday, January 27, 2010. The
Committee generally provides advice and recommendations concerning the
adequacy of scientific evidence needed to determine whether certain
medical items and services can be covered under the Medicare statute.
This meeting will focus on the sufficiency of currently available
evidence to determine whether the results of pharmacogenomic testing
affect health outcomes of patients with cancer when used as a guide for
certain drug treatments. This meeting is open to the public in
accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2,
section 10(a)).
DATES: Meeting date: The public meeting will be held on Wednesday,
January 27, 2010 from 7:30 a.m. until 4:30 p.m., Eastern Standard Time
(E.S.T.).
Deadline for Submission of Written Comments: Written comments must
be received at the address specified in the ADDRESSES section of this
notice by 5 p.m., E.S.T. on December 28, 2009. Once submitted all
comments are final.
Office of the National Coordinator for Health Information
Technology; HIT Policy Committee's NHIN Workgroup Meeting; Notice of
Meeting
ACTION: Notice of meeting.
Name of Committee: HIT Policy Committee's Nationwide Health
Information Network (NHIN) Workgroup.
Date and Time: The meeting will be held on December 16, 2009, from
10 a.m. to 5 p.m./Eastern Time.
Location: The OMNI Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC. The hotel telephone number is 202-234-0700. The meeting
will be available via Webcast; visit http://healthit.hhs.gov for
instructions on how to listen via telephone or Web.
Office of the National Coordinator for Health Information
Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Name of Committee: HIT Standards Committee.
Date and Time: The meeting will be held on December 18, 2009, via
telephone conference call, from 9 a.m. to 2 p.m./Eastern Time. Members
of the public should call 1-877-705-6006; confirmation code ``HIT
Standards Committee meeting.'' To listen via computer, no sooner than
10 minutes prior to the meeting, please go to: http://
altarum.na3.acrobat.com/HITstandards.
Office of the National Coordinator for Health Information
Technology; HIT Policy Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Name of Committee: HIT Policy Committee.
Date and Time: The meeting will be held on December 15, 2009, from
9 a.m. to 5 p.m./Eastern Time.
Location: The Washington Marriott Hotel, 22nd and M Streets, NW.,
Washington, DC. The hotel telephone number is 202-872-1500.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
May 31, 2007, FDA announced the availability of a draft guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products,'' explaining the process that would be used to make product-
specific BE recommendations available to the public on FDA's Web site.
The BE recommendations identified in this notice were developed using
the process described in that guidance.
DATES: Submit written or electronic comments on the draft and revised
draft product-specific BE recommendations listed in this notice by
February 1, 2010.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: The Health Education Assistance Loan (HEAL) Program:
Forms (OMB No. 0915-0043 Extension)
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: National Health Service Corps Travel Request
Worksheet (OMB No. 0915-0278)—Extension
No relevant notices.
No relevant notices.
No relevant notices.