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Weekly Legislative & Regulatory Round-up

Week of July 25 - 31

GAO reports

Centers for Medicare & Medicaid Services: CMS Should Develop an Agencywide Policy for Translating Medicare Documents into Languages Other Than English
GAO-09-752R, July 30, 2009

Electronic Health Records: DOD and VA Efforts to Achieve Full Interoperability Are Ongoing; Program Office Management Needs Improvement
GAO-09-775, July 28, 2009

Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to Be Addressed
GAO-09-909T, July 29, 2009

OIG reports

Part B Services During Non-Part A Nursing Home Stays: Durable Medical Equipment (PDF)
(OEI-06-07-00100)

Accuracy of Drug Categorizations for Medicaid Rebates (PDF)
(OEI-03-08-00300)

Bills introduced
Number/
Title
Date Introduced Sponsor Description

H.R. 3340

7/24/09

TIMOTHY JOHNSON (R-IL)

A bill to establish a Medicare Chronic Care Rapid Learning Network to develop and apply improved practices in care management for Medicare beneficiaries with multiple chronic conditions; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3354

7/27/09

F. JAMES SENSENBRENNER (R-WI)

A bill to amend the Internal Revenue Code of 1986 to repeal the 7.5 percent threshold on the deduction for medical expenses; Referred to the Committee on Ways and Means.

S. 1521

7/28/09

AMY KLOBUCHAR (D-MN)

A bill to amend titles XVIII and XIX of the Social Security Act to require provider payments under Medicare and Medicaid to be made through direct deposit or electronic funds transfer (EFT) at insured depository institutions; Referred to the Committee on Finance.

S. 1522

7/28/09

DAVID VITTER (R-LA)

A bill to amend title XVIII of the Social Security Act to stabilize and modernize the provision of partial hospitalization services under the Medicare program, and for other purposes; Referred to the Committee on Finance.

H.R. 3356

7/28/09

SAM JOHNSON (R-TX)

A bill to amend title XVIII of the Social Security Act to clarify the use of private contracts by Medicare beneficiaries for professional services and to allow individuals to choose to opt out of the Medicare part A benefits; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.

H.R. 3361

7/28/09

CHARLES BOUSTANY (R-LA)

A bill to provide a process for public comment and Medicare Evidence Development & Coverage Advisory Committee review of certain Medicare national coverage determinations, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3365

7/28/09

BOB FILNER (D-CA)

A bill to provide Medicare payments to Department of Veterans Affairs medical facilities for items and services provided to Medicare-eligible veterans for non-service-connected conditions; Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and Veterans' Affairs.

H.R. 3369

7/28/09

PATRICK J. MURPHY (D-CA)

A bill to amend titles XVIII and XIX of the Social Security Act to require provider and supplier payments under Medicare and Medicaid to be made through direct deposit or electronic funds transfer (EFT) at insured depository institutions; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3372

7/29/09

TOM PRICE (R-GA)

A bill to establish Medicare performance-based quality measures, to establish an affirmative defense in medical malpractice actions based on compliance with best practices guidelines, and to provide grants to States for administrative health care tribunals; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3374

7/29/09

ADAM SMITH (D-WA)

A bill to provide for a demonstration project relating to the impact of health information technology on chronic disease management under the Medicare and Medicaid programs; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3391

7/29/09

LYNN JENKINS (R-KS)

A bill to allow for the continuation of critical access hospital designation for certain hospitals in geographic areas experiencing population growth; Referred to the Committee on Ways and Means.

H.R. 3400

7/30/09

TOM PRICE (R-GA)

A bill to provide for incentives to encourage health insurance coverage, and for other purposes; Referred Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, the Judiciary, Rules, the Budget, and Appropriations.

H.R. 3418

7/30/09

BRAD ELLSWORTH (D-IN)

A bill to amend part D of title XVIII of the Social Security Act to apply the exceptions process for tiered formulary drugs to specialty tier drugs; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H.R. 3422

7/30/09

STEVE KING (R-IA)

A bill to amend title XVIII of the Social Security Act to make temporary improvements to the Medicare inpatient payment adjustment for low-volume hospitals, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.

H.R. 3430

7/30/09

LINDA T. SANCHEZ (D-CA)

A bill to establish a Medicare DSH pilot program under which participants shall establish collaborative care networks to reduce the use of emergency departments, inpatient and other expensive resources of hospitals and other providers and provide more comprehensive and coordinated care to low-income individuals, including those without health insurance coverage, and to establish a Collaborative Care Network Center; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.

 

Federal Register notices

July 27, 2009

No relevant notices.

 

July 28, 2009

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Announcement of Meeting of the Secretary's Advisory Committee on

National Health Promotion and Disease Prevention Objectives for 2020

ACTION: Notice of meeting.

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.

 

 

July 29, 2009

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Information Collection Request. 30-Day Public Comment

Request

Proposed Project: Standards for Privacy of Individually

Identifiable Health Information and Supporting Regulations.

 

 

Food and Drug Administration

 

Applications for Food and Drug Administration Approval To Market

a New Drug; Postmarketing Reports; Reporting Information About

Authorized Generic Drugs

ACTION:  Final rule.

SUMMARY:  The Food and Drug Administration (FDA) is amending its

regulations to require that the holder of a new drug application (NDA)

submit certain information regarding authorized generic drugs in an

annual report. We are taking this action as part of our implementation

of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

FDAAA requires that FDA publish a list of all authorized generic drugs

included in an annual report since 1999, and that the agency update the

list quarterly.

DATES:  This final rule is effective January 25, 2010.

 

Food and Drug Administration

Guidance for Industry: Nucleic Acid Testing To Reduce the

Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived

Products; Availability

ACTION: Notice.

 

 

July 30, 2009

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

International Conference on Harmonisation; Draft Guidance on E16

Genomic Biomarkers Related to Drug Response: Context, Structure, and

Format of Qualification Submissions; Availability

ACTION:  Notice.

 

Food and Drug Administration

Guidance for Industry on Drug-Induced Liver Injury: Premarketing

Clinical Evaluation; Availability

ACTION: Notice.

 

Health Resources and Services Administration

Family-To-Family Health Information Center Program

ACTION: Notice of noncompetitive replacement award to Colorado Non-

Profit Development Center.

 

 

July 31, 2009

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Medicare Parts C

and D Universal Audit Guide

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Medicare

Disproportionate Share Adjustment Procedures and Criteria and

Supporting Regulations in 42 CFR 412.106: Use: Section 1886(d)(5)(F) of

the Social Security Act established the Medicare disproportionate share

adjustment (DSH) for hospitals, which provides additional payment to

hospitals that serve a disproportionate share of the indigent patient

population. This payment is an add-on to the set amount per case CMS

pays to hospitals under the Medicare Inpatient Prospective Payment

System (IPPS).

 

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.

 

Office of the National Coordinator for Health Information

Technology

ACTION: Notice of meeting.

Name of Committee: HIT Standards Committee.

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