Weekly Legislative & Regulatory Round-up

Week of May 30 - June 5

GAO reports

Influenza Pandemic: Continued Focus on the Nation's Planning and Preparedness Efforts Remains Essential GAO-09-760T

Hospital Emergency Departments: Crowding Continues to Occur, and Some Patients Wait Longer than Recommended Time Frames GAO-09-347

Information Technology: FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts GAO-09-523

Federal Employees Health Benefits Program: Enrollee Cost Sharing for Selected Specialty Prescription Drugs GAO-09-517

Indian Health Service: Millions of Dollars in Property and Equipment Continue to Be Lost or Stolen GAO-09-450

OIG reports

Review of Medicaid Outpatient Drug Expenditures in the State of New York for the Period October 1, 2003, Through September 30, 2005 (A-02-07-01028)

Medicare Part D Payments for Beneficiaries in Part A Skilled Nursing Facility Stays in 2006 (PDF) (OEI-02-07-00230)

Fraud and Abuse Safeguards for State Medicaid Nonemergency Medical Transportation Services (PDF) (OEI-06-07-00320)

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 1161	6/2/09	JEFF BINGAMAN (D-NM)	A bill to amend the Public Health Service Act to authorize programs to increase the number of nurse faculty and to increase the domestic nursing and physical therapy workforce, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
S. 1164	6/2/09	RUSS FEINGOLD (D-WI)	A bill to amend the Public Health Service Act to reauthorize the Automated Defibrillation in Adam's Memory Act; to the Committee on Health, Education, Labor, and Pensions.
S. 1165	6/2/09	RUSS FEINGOLD (D-WI)	bill to promote the development of health care cooperatives that will help businesses to pool the health care purchasing power of employers, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
H. Con. Res. 137	6/2/09	JERROLD NADLER (D-NY)	Concurrent resolution expressing the sense of the Congress that the lack of adequate housing must be addressed as a barrier to effective HIV prevention, treatment, and care, and that the United States should make a commitment to providing adequate funding for developing housing as a response to the AIDS pandemic; to the Committee on Financial Services.
S. 1169	6/3/09	KRISTEN GILLIBRAND (D-NY)	A bill to amend title 10, United States Code, to provide for the treatment of autism under TRICARE; to the Committee on Armed Services.
S. 1171	6/3/09	MARK PRYOR (D-AR)	A bill to amend title XVIII of the Social Security Act to restore State authority to waive the 35-mile rule for designating critical access hospitals under the Medicare Program; to the Committee on Finance.
S. 1174	6/3/09	MARIA CANTWELL (D-WA)	A bill to amend the Public Health Service Act and the Social Security Act to increase the number of primary care physicians and primary care providers and to improve patient access to primary care services, and for other services; to the Committee on Finance.
S. 1176	6/3/09	MARIA CANTWELL (D-WA)	A bill to amend the Public Health Service Act to promote and improve the allied health professionals; to the Committee on Health, Education, Labor, and Pensions.
S. 1177	6/3/09	HERB KOHL (D-WI)	A bill to improve consumer protections for purchasers of long-term care insurance, and for other purposes; to the Committee on Finance.
H.R. 2686	6/3/09	STEVE ISRAEL (D-NY)	A bill to amend title XVIII of the Social Security Act to provide for a Medicare Advantage benchmark adjustment for certain local areas with VA medical centers and for certain contiguous areas; to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
H.R. 2688		FRANK PALLONE (D-NJ)	A bill to amend title XIX of the Social Security Act to improve the State plan amendment option for providing home and community-based services under the Medicaid Program, and for other purposes; to the Committee on Energy and Commerce.
H.R. 2691		PETE STARK (D-CA)	A bill to provide assistance to adolescents and young adults with serious mental health disorders as they transition to adulthood; to the Committee on Energy and Commerce.
H.R. 2692		WILLIAM THORNBERRY (R-TX)	A bill to amend title XVIII of the Social Security Act to restore State authority to waive the 35-mile rule for designating critical access hospitals under the Medicare Program; to the Committee on Ways and Means.
H. Con. Res. 142		ELIJAH CUMMINGS (D-MD)	Concurrent resolution supporting National Men's Health Week; to the Committee on Oversight and Government Reform.
S. 1181		RON WYDEN (D-OR)	A bill to provide for a demonstration project to examine whether community-level public health interventions can result in lower rates of chronic disease for individuals entering the Medicare program; to the Committee on Finance.
S. 1185		JEFF BINGAMAN (D-NM)	A bill to amend titles XVIII and XIX of the Social Security Act to ensure that low-income beneficiaries have improved access to health care under the Medicare and Medicaid programs; to the Committee on Finance .
S. 1186		JEFF BINGAMAN (D-NM)	A bill to amend title XVIII of the Social Security Act to eliminate the in the home restriction for Medicare coverage of mobility devices for individuals with expected long-term needs; to the Committee on Finance.
S. 1188		JACK REED (D-RI)	A bill to amend the Public Health Service Act with respect to mental health services; to the Committee on Health, Education, Labor, and Pensions.
H.R. 2697		JANICE SCHAKOWSKY (D-IL)	A bill to amend title XIX of the Social Security Act to require Medicaid coverage of professional services of optometrists that are otherwise covered when furnished by a physician; to the Committee on Energy and Commerce.
H.R. 2698		GABRIELLE GIFFORDS (D-AZ)	A bill to improve and enhance the mental health care benefits available to veterans, to enhance counseling and other benefits available to survivors of veterans, and for other purposes; to the Committee on Veterans' Affairs.
H.R. 2699		GABRIELLE GIFFORDS (D-AZ)	A bill to improve the mental health care benefits available to members of the Armed Forces, to enhance counseling available to family members of members of the Armed Forces, and for other purposes; to the Committee on Armed Services, and in addition to the Committee on Veterans' Affairs.
H.R. 2700		LLOYD DOGGETT (D-TX)	A bill to amend part D of title XVIII of the Social Security Act to assist low-income individuals in obtaining subsidized prescription drug coverage under the Medicare prescription drug program by expediting the application and qualification process and by revising the resource standards used to determine eligibility for such subsidies, and for other purposes; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 2708		FRANK PALLONE (D-NJ)	A bill to amend the Indian Health Care Improvement Act to revise and extend that Act, and for other purposes; to the Committee on Natural Resources, and in addition to the Committees on Energy and Commerce, and Ways and Means.
H.R. 2716		JAVEIR BECERRA (D-CA)	A bill to amend title XIX of the Social Security Act to provide financial stability for seniors and people with disabilities through improvements in the Medicare Savings Program; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 2718		JIM COOPER (D-TN)	A bill to amend title XVIII of the Social Security Act to create a sensible infrastructure for delivery system reform by renaming the Medicare Payment Advisory Commission, making the Commission an executive branch agency, and providing the Commission new resources and authority to implement Medicare payment policy; to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.
H.R. 2726		STEVE ISRAEL (D-NY)	A bill to amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes; to the Committee on Energy and Commerce.
H.R. 2730		CAROLYN MCCARTHY (D-NY)	A bill to amend the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to eligible States for the purpose of reducing the student-to-school nurse ratio in public secondary schools, elementary schools, and kindergarten; to the Committee on Energy and Commerce.
H.R. 2731		CAROLYN MCCARTHY (D-NY)	A bill to fund comprehensive programs to ensure an adequate supply of nurses; to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor.

Federal Register notices

June 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Guidance for Industry on Providing Regulatory Submissions in

Electronic Format--Drug Establishment Registration and Drug Listing;

Availability

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a guidance for industry entitled ``Providing Regulatory

Submissions in Electronic Format--Drug Establishment Registration and

Drug Listing.'' This guidance document is designed to assist industry

(e.g., manufacturers, repackers, and relabelers) with the electronic

submission of drug establishment registration and drug listing

information.

Food and Drug Administration

Advisory Committee for Pharmaceutical Science and Clinical

Pharmacology; Notice of Meeting

ACTION: Notice.

Date and Time: The meeting will be held August 4, 2009, from 8 a.m.

to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727

Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-

589-5200.

Food and Drug Administration

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of

Meeting

ACTION: Notice.

Date and Time: The meeting will be held on June 26, 2009, from 8

a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, Maryland Ballrooms,

8727 Colesville Rd., Silver Spring, MD.

June 2

No relevant notices.

June 3

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Draft Guideline for Prevention of Catheter-Associated Urinary

Tract Infections 2008

ACTION: Notice of document availability and request for public comment.

SUMMARY: This notice is a request for review of and comment on the

Draft Guideline for Prevention of Catheter-Associated Urinary Tract

Infections 2008, available on the following Web site: http://

wwwnd.cdc.gov/publiccomments/. This document is for use by infection

prevention staff, healthcare epidemiologists, healthcare

administrators, nurses, other healthcare providers, and persons

responsible for developing, implementing, and evaluating infection

prevention and control programs for healthcare settings across the

continuum of care. The guideline updates and expands the 1981 Guideline

for Prevention of Catheter-associated Urinary Tract Infections.

DATES: Comments must be received on or before July 6, 2009.

Centers for Medicare & Medicaid Services

Medicare Program; Revisions to FY 2009 Medicare Severity-Long-

Term Care Diagnosis-Related Group (MS-LTC-DRG) Weights

ACTION: Interim final rule with comment period.

SUMMARY: This interim final rule with comment period implements revised

Medicare severity long-term care diagnosis-related group (MS-LTC-DRG)

relative weights for payment under the long-term care hospital (LTCH)

prospective payment system (PPS) for federal fiscal year (FY) 2009. We

are revising the MS-LTC-DRG relative weights for FY 2009 due to the

misapplication of our established methodology in the calculation of the

budget neutrality factor. The revised FY 2009 MS-LTC-DRG relative

weights are effective for the remainder of FY 2009 (that is, from June

3, 2009 through September 30, 2009).

DATES: Effective date: These regulations are effective on June 3, 2009.

Comment date: To be assured consideration, comments must be

received at one of the addresses provided below, no later than 5 p.m.,

June 29, 2009.

Centers for Medicare & Medicaid Services

Medicare Program; Proposed Rate Year (RY) 2010 Medicare Severity-

Long-Term Care Diagnosis-Related Group (MS-LTC-DRG) Relative Weights

and High-Cost Outlier Fixed-Loss Amount

ACTION: Proposed rule; supplemental.

SUMMARY: This supplemental proposed rule presents both proposed rate

year (RY) 2010 Medicare severity-long-term care diagnosis-related group

(MS-LTC-DRG) relative weights and a proposed RY 2010 high cost outlier

(HCO) fixed-loss amount based on the revised fiscal year (FY) 2009 MS-

LTC-DRG relative weights presented in an interim final rule with

comment period published elsewhere in this Federal Register.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on June 30, 2009.

Food and Drug Administration

Draft Guidance for Industry and Researchers on the Radioactive

Drug Research Committee: Human Research Without an Investigational New

Drug Application; Availability

ACTION: Notice.

Food and Drug Administration

Food and Drug Administration Transparency Task Force; Public

Meeting

ACTION: Notice of public meeting; request for comments.

SUMMARY: The Food and Drug Administration (FDA) is announcing a public

meeting to solicit recommendations from interested persons on ways in

which FDA can make useful and understandable information about FDA

activities and decisionmaking more readily available to the public.

Dates and Times: The public meeting will be held on June 24, 2009,

from 8 a.m. to 5 p.m. Persons interested in attending the meeting must

August 7, 2009.

Location: The public meeting will be held at the National

Transportation Safety Board (NTSB) Conference Center, 429 L'Enfant

Plaza, SW., Washington, DC 20594.

June 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Public Meeting of the Federal Coordinating Council on Comparative

Effectiveness Research

ACTION: Notice of public meeting.

DATES: The meeting, which is the third of three public meetings that

the Coordinating Council expects to convene, will be held on Wednesday,

June 10, 2009, from 12 p.m.-3 p.m. EDT.

ADDRESSES: The meeting will be held at the Embassy Suites Convention

Center, 900 10th St., NW., Washington, DC 20001. In addition, the

meeting will be Web cast and individuals may also participate by

audioconference.

Office of the National Coordinator for Health Information

Technology; HIT Policy Committee Meeting

ACTION: Announcement of meeting.

DATES: HIT Policy Committee meeting on June 16, 2009, from 10 a.m. to 1

p.m. [Eastern Time].

ADDRESSES: HIT Policy Committee Meeting, Hubert H. Humphrey Building

(200 Independence Avenue, SW., Washington, DC 20201), Conference Room

505A. Please bring photo ID for entry to a Federal building.

National Committee on Vital and Health Statistics

Meeting

Time and Date: June 10, 2009 9 a.m.-3:30 p.m., June 11, 2009 10

a.m.-1 p.m.

Place: National Center for Health Statistics, 3311 Toledo Road,

Hyattsville, MD 20782.

Status: Open.

June 5

No relevant notices.