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Weekly Legislative & Regulatory Round-up

Week of July 3 - 9, 2010

GAO reports

No relevent notices.

OIG reports

Review of Inpatient Rehabilitation Facilities’ Compliance With Medicare’s Transfer Regulation During Fiscal Years 2004 Through 2007 (A-04-09-00059)

Review of Medicaid Disproportionate Share Hospital Payment Distribution (A-07-09-04150)

Review of Coventry Health Care, Inc.’s 2007 Prescription Drug Event Data Elements Related to Yearend Reconciliation (A-03-09-00020)

Payments for Outpatient Infusion Therapy, Lithotripsy, and Blood Administration Services Provided at Providence Hospital, Washington, DC (A-03-10-10004)

Medicare Part B Carrier Payments for Neulasta Injections in the District of Columbia for Calendar Years 2004 Through 2007 (A-03-09-00016)

Comparison of Fourth-Quarter 2009 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2010 (PDF) (OEI-03-10-00350)  

Bills introduced

No bills introduced.

Federal Register notices

July 6

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Agency for Healthcare Research and Quality

Request for Nominations for Public Members: National Advisory Council for

Healthcare Research and Quality

ACTION: Notice.

Summary: The terms of seven current members of the National Advisory Council for Healthcare Research and Quality (the Council) will expire in November 2010.  To fill these positions in accordance with the legislative mandate establishing the Council, the Agency for Healthcare Research and Quality is seeking individuals who are distinguished: (1) In the conduct of research, the demonstration projects, and evaluations with respect to healthcare; (2) in the fields of health care quality research or health care improvement; (2) in the practice of medicine; (4) in other health professions; (5) in the fields of health care economics, information systems, law, ethics, business, or public policy; and (6) individuals who could represent the interests of patients and consumers of health care; and (7) the private health care sector.

Dates: Nominations should be received on or before 60 days after July 6, 2010.

 

Centers for Medicare & Medicaid Services

Medicaid Program: Premiums and Cost Sharing; Correction of final rule with comment period

ACTION: Correction

Summary: This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on May 28, 2010 entitled ‘‘Medicaid Program; Premiums and Cost Sharing.’’ The May 28, 2010, final rule revised a November 25, 2008, final rule entitled, ‘‘Medicaid Programs; Premiums and Cost Sharing’’ which addressed public comments received during reopened comment periods, and reflected relevant statutory changes made in the American Recovery and Reinvestment Act of 2009. The November 2008 document revised final rule implemented and interpreted section 1916A of the Social Security Act.

Effective Date: This correction document is effective July 1, 2010

 

July 7

No relevant notices

 

July 8

No relevant notices

 

July 9

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

[Docket No. FDA–2010–N–0316]

Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on

the continuation of a pilot project to evaluate the electronic collection of the 3500A Form for adverse events related to the use of medical products to obtain data from user   facilities participating in the Medical Product Safety Network (MedSun). Additionally, the electronic form will include hospital profile information and several other questions

related to the use of medical products. ate1 wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1

DATES: Submit either electronic or written comments on the collection of information by September 7, 2010.

ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the

docket number found in brackets in the heading of this document.

 

 

 

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