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Weekly Legislative & Regulatory Round-up

Week of January 23 - 29, 2010

GAO reports

Patient Safety Act: HHS Is in the Process of Implementing the Act, So Its Effectiveness Cannot Yet Be Evaluated GAO-10-281

Electronic Health Records: DOD and VA Interoperability Efforts Are Ongoing; Program Office Needs to Implement Recommended Improvements GAO-10-332

Emergency Preparedness: State Efforts to Plan for Medical Surge Could Benefit from Shared Guidance for Allocating Scarce Medical Resources GAO-10-381T

OIG reports

Monthly Recovery Act Report: December

Comparison of Second-Quarter 2009 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Fourth Quarter 2009 (PDF) (OEI-03-09-00640)

Comparison of Fourth-Quarter 2008 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2009 (PDF) (OEI-03-09-00340)

Comparison of First-Quarter 2009 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third Quarter 2009 (PDF) (OEI-03-09-00490)

Bills introduced
Number/
Title
Date Introduced Sponsor Description

H. Res. 1039

1/26/10

CHRISTOPHER LEE (R-NY)

A resolution supporting the goals and ideals of American Heart Month and National Wear Red Day; to the Committee on Oversight and Government Reform.

S. 2958

1/26/10

ROBERT MENENDEZ (D-NJ)

A bill to provide funding and incentives for caregiver support and long-term care assistance; to the Committee on Finance.

H. Con. Res. 233

1/27/10

BARBARA LEE (D-CA)

Concurrent resolution supporting the goals and ideals of National Black HIV/AIDS Awareness Day; to the Committee on Energy and Commerce.

S. 2964

 

CHARLES GRASSLEY (R-IA)

A bill to amend title XVIII, XIX, and XXI of the Social Security Act to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes; to the Committee on Finance.

 

Federal Register notices

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: ``Collection of Information for Agency for Healthcare Research

and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and

Systems (CAHPS) Health Plan Survey Comparative Database.'' 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 March 26, 2010.

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Disease Control and pvention

Healthcare Infection Control Practices Advisory Committee

(HICPAC); Meeting notice

Times and Dates: 9 a.m.-5 p.m., February 11, 2010. 9 a.m.-12

p.m., February 12, 2010.

Place: CDC, Global Communications Center, Building 19,

Auditorium B3, 1600 Clifton Road, NE., Atlanta, Georgia 30333.

Status: Open to the public, limited only by the space available.

 

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: Detailed Notice

of Discharge (DND).

2. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Important

Message from Medicare (IM)

3. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Recovery Act--

Reporting Requirements for States Under FMAP Increase and TMA

Provisions

4. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: State Plan p-

print implementing Section 6087 of the Deficit Reduction Act: Optional

Self-Direction Personal Assistance Services (PAS) Program (Cash and

Counseling); Form Number: CMS-10234 (OMB: 0938-1024)

 

Office of the National Coordinator for Health Information

Technology

Office of the National Coordinator for Health Information

Technology; HIT Policy Committee's Workgroup Meetings; Notice of

Meetings

ACTION: Notice of meetings.

Date and Time: The HIT Policy Committee Workgroups will hold the

following public meetings during February 2010: February 3rd Privacy &

Security Policy Workgroup, 3 to 4:30 p.m./Eastern Time; February 9th

Strategic Plan Workgroup, 9 to 12 p.m./Eastern Time; February 11th

Adoption/Certification Workgroup, 2 to 5 p.m./Eastern Time; February

12th Meaningful Use Workgroup, 11 to 1 p.m./Eastern Time; February 16th

NHIN Workgroup, 10 to 2 p.m./Eastern Time; February 19th Privacy &

Security Policy Workgroup, 2 to 4 p.m./Eastern Time; and February 26th

Strategic Plan Workgroup, 9 to 12 p.m./Eastern Time.

 

Office of the National Coordinator for Health Information

Technology

Office of the National Coordinator for Health Information

Technology; HIT Standards Committee's Workgroup Meetings; Notice of

Meetings

ACTION: Notice of meetings.

Date and Time: The HIT Standards Committee Workgroups will hold the

following public meetings during February 2010: February 18th Privacy &

Security Workgroup, 10 a.m. to 12 p.m./Eastern Time; and February 23rd

Clinical Operations Vocabulary Workgroup 9 a.m. to 4 p.m./Eastern Time.

 

Indian Health Service

Request for Public Comment: 30-Day Proposed Information

Collection: Indian Health Service Customer Satisfaction Survey

ACTION: Notice.

Proposed Collection: Title: 0917-NEW, ``Indian Health Service
Customer Satisfaction Survey.''

January 26

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare & Medicaid Services

Medicare Program; Approval of Independent Accrediting

Organizations To Participate in the Advanced Diagnostic Imaging

Supplier Accreditation Program

ACTION: Notice.

SUMMARY: This notice announces our approval of the following three

national accreditation organizations to accredit suppliers seeking to

furnish the technical component (TC) of advanced diagnostic imaging

services under the Medicare program: the American College of Radiology

(ACR); the Intersocietal Accreditation Commission (IAC); and The Joint

Commission (TJC).

 

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Medicare Evidence Development

and Coverage Advisory Committee, March 24, 2010

ACTION: Notice of meeting.

DATES: Meeting date: Wednesday, March 24, 2010 from 7:30 a.m. until

4:30 p.m., eastern daylight time (e.d.t.).

 

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; Export of Medical Devices-Foreign Letters of Approval

ACTION: Notice.

 

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; General Licensing Provisions: Biologics License

Application, Changes to an Approved Application, Labeling, Revocation

and Suspension, Postmarketing Studies Status Reports, and Forms FDA

356h and 2567

ACTION: Notice.

 

January 27

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Disease Control and pvention

Proposed Data Collections Submitted for Public Comment and

Recommendations

Proposed Project: pvention Research Centers Program National Evaluation Reporting

System--Revision--National Center for Chronic Disease pvention and

Health Promotion (NCCDPHP), Centers for Disease Control and pvention

(CDC).

 

Centers for Disease Control and pvention

Proposed Data Collections Submitted for Public Comment and

Recommendations

Proposed Project: Development and Testing of an HIV pvention Intervention Targeting

Black Bisexually-Active Men--new--National Center for HIV/AIDS, Viral

Hepatitis, STD and TB pvention (NCHHSTP), Centers for Disease Control

and pvention (CDC).

 

Centers for Disease Control and pvention

Proposed Data Collections Submitted for Public Comment and

Recommendations

Proposed Project: pvalence Survey of Healthcare Associated Infections (HAIs) and

Antimicrobial Use in U.S. Acute Care Hospitals--New--National Center

for Emerging and Zoonotic Infectious Diseases (NCEZID) (proposed),

Centers for Disease Control and pvention (CDC).

 

Centers for Disease Control and pvention

Notice of National Conversation on Public Health and Chemical

Exposures Leadership Council Conference Call

Time and Date: 1 p.m.-3 p.m., Friday, January 29, 2010.

Location: Teleconference.

Status: The public is invited to listen to the meeting by phone,

see ``contact for additional information'' below.

 

Centers for Disease Control and prevention

Notice of Public Meeting

The Centers for Disease Control and prevention (CDC), Food and Drug

Administration (FDA), and National Institutes of Health (NIH) announce

a public meeting to obtain public comment on ``A Public Health Action

Plan to Combat Antimicrobial Resistance (Part I: Domestic Issues)''.

Time and Date: 12-1:30 p.m. EST, February 3, 2010.

Place: Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda,

Maryland 20814 (One Bethesda Metro Center).

Status: Open to the public, limited only by the space available.

 

Centers for Disease Control and pvention

Task Force on Community pventive Services

Notice of public meeting

Name: Task Force on Community pventive Services meeting.

Times and Dates: 8 a.m.-5:30 p.m. EST, February 17, 2010; 8 a.m.-1

p.m. EST, February 18, 2010.

Place: Centers for Disease Control and pvention, 2500 Century

Parkway, Atlanta, Georgia 30345.

Status: Open to the public, limited only by space available.

 

Food and Drug Administration

Draft Guidance for Industry on Assessment of Abuse Potential of

Drugs; Availability

ACTION:  Notice.

 

Food and Drug Administration

Guidance for Industry on the Use of Mechanical Calibration of

Dissolution Apparatus 1 and 2--Current Good Manufacturing Practice;

Availability

ACTION: Notice.

 

Food and Drug Administration

The Neurological Devices Panel of the Medical Devices Advisory

Committee; Notice of Meeting

ACTION:  Notice.

Date and Time: The meeting will be held on March 12, 2010, from 8

a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,

and D, 620 Perry Pkwy., Gaithersburg, MD.

 

Food and Drug Administration

Strengthening the Center for Devices and Radiological Health's

510(k) Review Process; Public Meeting; Request for Comments

ACTION:  Notice of public meeting; request for comments.

 

Health Resources and Services Administration

Ryan White HIV/AIDS Program Part D--Coordinated HIV Services and

Access to Research for Women, Infants, Children, and Youth

ACTION: Notice of non-competitive replacement award.

SUMMARY: The Health Resources and Services Administration (HRSA) is

issuing a non-competitive replacement award from the pvious grantee,

Orlando Health, Incorporated's HUG-ME Program, to the Orange County

Health Department, Orlando, Florida, that will ensure continuity of

Part D HIV/AIDS care and treatment services without disruption to HIV/

AIDS-infected women, infants and children in Orange County and the

surrounding areas.

 

January 28

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Health Resources and Services Administration

National Practitioner Data Bank for Adverse Information on

Physicians and Other Health Care Practitioners: Reporting on Adverse

and Negative Actions

ACTION: Final rule.

SUMMARY: This final rule revises existing regulations under sections

401 through 432 of the Health Care Quality Improvement Act of 1986,

governing the National Practitioner Data Bank for Adverse Information

on Physicians and Other Health Care Practitioners, to incorporate

statutory requirements under section 1921 of the Social Security Act,

as amended by section 5(b) of the Medicare and Medicaid Patient and

Program Protection Act of 1987 (MMPPPA), and as amended by the Omnibus

Budget Reconciliation Act of 1990 (OBRA).

DATES: This rule is effective March 1, 2010.

 

January 9

 

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: Extension of a currently

approved collection; Title of Information Collection: End Stage Renal

Disease Death Notification Public Law 95-292; 42 CFR 405.2133, 45 CFR

5-5b; 20 CFR Parts 401 and 422E

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

1. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Eligibility Error

Rate Measurement in Medicaid and the Children's Health Insurance

Program.

 

President's Advisory Council for Faith-Based and Neighborhood

Partnerships

Meeting announcement

Times and Dates: Tuesday, February 2nd from 4-6 p.m. EST and

Thursday, February 4th from 4-6 p.m. EST.

Place: Meetings will be held via conference call. Please contact

Mara Vanderslice for call-in information and further details at

mvanderslice@who.eop.gov.

Status: Open to the public, limited only by the space available.

Conference call line will be available.

 

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