Weekly Legislative & Regulatory Round-up

Week of June 5 - 11, 2010

GAO reports

Review of the Quarterly Medicaid Statement of Expenditures for the Medical Assistance Program in Tennessee (A-04-09-04040)

Review of New Hampshire’s Compliance With the American Recovery and Reinvestment Act of 2009 Medicaid Eligibility Requirements (A-01-10-00002)

Review of American Recovery and Reinvestment Act of 2009 Medicaid Eligibility Requirements in Minnesota (A-05-10-00014)

Updated FY 2010 Recovery Act Implementation and Work Plan (xls)

Review of Florida’s Developmental Disabilities Medicaid Administrative Claiming Costs for the Period October 1, 2003, Through September 20, 2006 (A-04-07-00028)

Nationwide Review of Medicare Part A Emergency Department Adjustments for Inpatient Psychiatric Facilities During Calendar Years 2006 and 2007 (A-01-09-00504)

OIG reports

Advisory Opinion 10-07 (PDF)
(concerning a nonprofit, tax-exempt, charitable organization’s proposal to provide assistance with cost-sharing obligations to financially needy individuals, including Medicare and Medicaid beneficiaries, diagnosed with certain specified diseases)

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3479	06/10/11	Kay Hagan (D-NC)	A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to establish and implement a birth defects prevention, risk reduction, and public awareness program; Referred to the Committee on Health, Education, Labor, and Pensions.

Federal Register notices

June 7

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Health and Nutrition Examination Survey (NHANES) DNA

Samples: Guidelines for Proposals To Use Samples and Cost Schedule

ACTION: Notice.

Office of the Secretary

Medicaid Program: Proposed Implementation of Section 614 of the

Children's Health Insurance Program Reauthorization Act of 2009 for

Adjustments to the Federal Medical Assistance Percentage for Medicaid

Federal Matching Funds

ACTION: Notice with comment period.

SUMMARY: For purposes of Title XIX (Medicaid) of the Social Security

Act, the Federal Medical Assistance Percentage (FMAP), defined in

section 1905(b) of the Social Security Act, for each state beginning

with fiscal year 2006 is subject to adjustment pursuant to section 614

of the Children's Health Insurance Program Reauthorization Act of 2009

(CHIPRA), Public Law 111-3. Section 614 provides for a recalculation of

the FMAP disregarding identifiable significantly disproportionate

employer pension or insurance fund contributions for a state. These

contributions, when counted, increase state personal income and, by

operation of the statutory formula to calculate the FMAP, would

decrease the FMAP for the state. This notice announces the proposed

methodology that the U.S. Department of Health and Human Services will

use to determine the need for, and amount of, any such recalculation of

the FMAP for a state.

DATES: Comment Date: To be assured consideration, comment must be

received at the address provided below, no later than 5 p.m. EST on

July 7, 2010.

June 8

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Prescription Drug User Fee Act; Meetings on Reauthorization;

Request for Notification of Stakeholder Intention to Participate

ACTION: Notice; request for notification of participation.

Food and Drug Administration

Issues in the Development of Medical Products for the Prophylaxis

and/or Treatment of Acute Antibody Mediated Rejection in Kidney

Transplant Recipients; Public Workshop

ACTION: Notice of public workshop.

Office of the National Coordinator for Health Information

Technology

HIT Standards Committee; Notice and Publication of

Committee Recommendations to the National Coordinator for Health

Information Technology

ACTION: Notice of committee recommendations and invitation for public

input.

SUMMARY: This notice publishes recommendations made by the HIT

Standards Committee (Committee) at its public meeting on April 28,

2010, and invites public input on the recommendations at the

Committee's next meeting on June 30, 2010. The Committee is a federal

advisory committee to the Office of the National Coordinator for Health

Information Technology (ONC).

June 9

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.

3501-3520, AHRQ invites the public to comment on this proposed

information collection.

DATES: Comments on this notice must be received by July 9, 2010.

Health Resources and Services Administration

Discretionary Grant Program

ACTION: Notice of Noncompetitive Program Extension Supplemental Awards.

SUMMARY: HRSA will be issuing non-competitive supplemental funding

under the Maternal Child and Health Bureau's Family to Family Health

Information Centers Program. This will provide feasible time for the

Maternal and Child Health Bureau (MCHB) to align fiscal resources and

programmatic goals as outlined in changes that emerged as a result of

enactment of the Patient Protection and Affordable Care Act (Pub. L.

111-148) with the least disruption to the States, communities, and

constituencies that currently receive assistance and services from

these grantees.

Health Resources and Services Administration

Health Center Program

ACTION: Notice of Noncompetitive Replacement Awards to Albany Area

Primary Health Care, Inc.

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

be transferring Health Center Program (section 330 of the Public Health

Service Act) Community Health Center (CHC), Increased Demand for

Services (IDS), and Capital Improvement Program (CIP) funds originally

awarded to Unadilla Health Care Center, Inc., to Albany Area Primary

Health Care, Inc., to ensure the provision of critical primary health

care services to underserved populations in Dooly County, Georgia.

June 10

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;

Corrections

ACTION: Correction of final rule.

SUMMARY: This document corrects technical and typographical errors in

the final rule that appeared in the April 15, 2010 Federal Register

entitled ``Medicare Program; Policy and Technical Changes to the

Medicare Advantage and the Medicare Prescription Drug Benefit

Programs.''

DATES: Effective Date: This correction notice is effective June 7,

2010.

Food and Drug Administration

Food and Drug Administration Modernization Act of 1997:

Modifications to the List of Recognized Standards, Recognition List

Number: 024

ACTION: Notice.

June 11

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Notice of Meeting

In accordance with section 10(d) of the Federal Advisory Committee

Act (5 U.S.C., Appendix 2), announcement is made of a Health Care

Policy and Research Special Emphasis Panel (SEP) meeting.

Substantial segments of the upcoming SEP meeting listed below will

be closed to the public in accordance with the Federal Advisory

Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C.

552b(c)(6). Grant applications for the OS ARRA: Clinically-Enhanced

State Data for Analysis for CE Impact (R01) applications are to be

reviewed and discussed at this meeting.

SEP Meeting on: OS ARRA: Clinically-Enhanced State Data for

Analysis for CE Impact (R01).

Date: July 2, 2010. (Open on July 2 from 8 a.m. to 8:15 a.m. and

closed for the remainder of the meeting.)

Place: Hyatt Regency Bethesda Hotel, 7400 Wisconsin Avenue, 1

Bethesda Metro Center, Conference Room TBD, Bethesda, MD 20814.

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

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

approved collection; Title of Information Collection: Application for

Prescription Drug Plans (PDP); Application for Medicare Advantage

Prescription Drug (MA-PD)--CY 2012; Application for Cost Plans to Offer

Qualified Prescription Drug Coverage; Application for Employer Group

Waiver Plans to Offer Prescription Drug Coverage; Service Area

Expansion Application for Prescription Drug Coverage

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

approved collection; Title of Information Collection: Part C Medicare

Advantage Application and 1876 Cost Plan Expansion Application--CY

2012.

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Procedure for Hospitals Seeking

To Enter Into an Agreement With a Different Organ Procurement

Organization Following an 1138(a)(2) Waiver

ACTION: Notice.

SUMMARY: This notice announces the procedures that will be used when a

hospital, that has previously been granted a waiver under sections

1138(a)(2) of the Social Security Act (the Act), seeks to enter into an

agreement with a different Organ Procurement Organization (OPO). The

procedures are modeled after the public process required by 1138(a)(2)

of the Act. The process affords the public an opportunity to comment on

the proposed change and to submit information and material with respect

to whether the change is likely to increase organ donation and will

assure equitable treatment for patients in both affected OPO service

areas.

DATES: Effective Date: This notice is effective June 11, 2010.

Food and Drug Administration

Guidance for Industry on Bioequivalence Recommendations for

Specific Products; Availability

ACTION: Notice.

Food and Drug Administration

Indexing Structured Product Labeling for Human Prescription Drug

and Biological Products; Request for Comments

ACTION: Notice; request for comments.

Food and Drug Administration

Antibacterial Resistance and Diagnostic Device and Drug

Development Research for Bacterial Diseases; Public Workshop

ACTION: Notice of public workshop.

Dates and Times: The public workshop will be held on July 26, 2010,

from 8 a.m. to 5:30 p.m. and on July 27, 2010, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Crowne Plaza

Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited

and available only on a first-come, first-served basis.

Office of the Secretary, Office of Public Health and Science

Meeting of the Presidential Advisory Council on HIV/AIDS

ACTION: Notice.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.

Department of Health and Human Service (DHHS) is hereby giving notice

that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a

meeting. The meeting will be conducted as a telephone conference call.

The meeting will be open to the public through a conference call phone

number.

DATES: The meeting will be on June 29, 2010 from 4 p.m. to

approximately 5 p.m. EST.

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Proposed Project: Federally Qualified Health Centers (FQHC) Application

Forms: (OMB No. 0915-0285)—Revisions