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Washington Highlights: November 10 , 2006

Democrats to Control House in 110th Congress

Democrats will control the House of Representatives for the first time since 1995, and several senior members of the House are poised to chair key committees of importance to academic medicine. At press time, the Democrats have won 230 seats, Republicans have won 196 seats, and 9 races are still undecided. Current House Minority Leader Nancy Pelosi (D-Calif.) will become the first woman Speaker of the House when the 110th Congress begins on Jan. 3, 2007.

The House Budget Committee will be chaired by Rep. John Spratt (D-S.C.), who has served as its ranking member since 1996. Rep. Dave Obey (D-Wis.) will take control of the House Appropriations Committee, which he briefly chaired from March 1994 to January 1995 and has served as ranking member since that time. Rep. John Dingell (D-Mich.), the senior member of the House, will regain control of the House Energy and Commerce Committee, which he chaired from 1981 to 1995. Rep. Charles Rangel (D-N.Y.) will chair the House Ways and Means Committee, becoming the committee's first New York City chair since Rep. Fernando Wood (D) in 1877-81. Rep. George Miller (D-Calif.), one of three remaining Democrats of the Watergate class of 1974 (the others are James Oberstar (D-Minn.) and Henry Waxman (D-Calif.)), will chair the Education and Workforce Committee.

Several committees important to academic medicine will undergo significant changes in their membership. The House Labor-HHS-Education Appropriations Subcommittee will lose three Republicans: Reps. Anne Northup (Ky.) and Don Sherwood (Pa.) both lost their House races, and Rep. Ernest Istook (Okla.) lost his bid to become Governor of Oklahoma.

The House Energy and Commerce Committee will lose at least six members. Rep. Michael Bilirakis (R-Fla.) is retiring; Rep. Charles Bass (R-N.H.) lost his House race; Rep. Sherrod Brown (D-Ohio) was elected to the Senate; Reps. Ted Strickland (D-Ohio) and C.L. "Butch" Otter (R-Idaho) were elected Governor of their states; and Rep. Jim Davis (D-Fla.) lost his race to become Governor.

The House Ways and Means Committee will lose at least nine members. Chairman Bill Thomas (R-Calif.) is retiring, Reps. Jim Nussle (R-Iowa) and Bob Beauprez (R-Colo.) lost their bids to become Governor, and Rep. Ben Cardin (D-Md.) was elected to the Senate. Five Republican Ways and Means members were defeated on Election Day: Clay Shaw (Fla.); Nancy Johnson (Conn.), who chaired the Health Subcommittee; J.D. Hayworth (Ariz.); Melissa Hart (Pa.); and Chris Chocola (Ind.).

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

Senate Outlook for 110th Congress

The Democratic Party will regain control of the Senate in the 110th Congress. Democrats and Independents (who will caucus with Democrats) will have 51 seats; Republicans will hold 49.

A total of 10 new Senators will join the 110th Congress. Four Senators - Mark Dayton (D-Minn.), Bill Frist (R-Tenn.), Jim Jeffords (I-Vt.), and Paul Sarbanes (D-Md.) - are retiring. They will be replaced by Amy Klobuchar (D-Minn.), Bob Corker (R-Tenn.), Bernard Sanders (I-Vt.), and Ben Cardin (D-Md.), respectively.

Six Republican incumbents were defeated on Tuesday: Sherrod Brown defeated Mike DeWine in Ohio; Bob Casey beat Rick Santorum in Pennsylvania; Claire McCaskill defeated Jim Talent in Missouri; Jon Tester beat Conrad Burns in Montana; Jim Webb defeated George Allen in Virginia; and Sheldon Whitehouse defeated Lincoln Chafee in Rhode Island.

DeWine served on both the Senate Appropriations and Health, Education, Labor, and Pensions (HELP) Committee. The HELP Committee also loses Frist and Jeffords. The Senate Finance Committee loses Frist, Santorum, and Jeffords.

It is anticipated the following Democrats will chair committees of interest to medical schools and teaching hospitals: Kent Conrad (N.D.) - Budget; Robert Byrd (W.Va.) - Appropriations; Max Baucus (Mont.) - Finance; and Edward Kennedy (Mass.) - HELP.

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

AAMC Comments on FDA Informed Consent Exception Draft Guidance

The AAMC Oct. 26 responded to the Food and Drug Administration's draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research. AAMC expressed strong support of the overall goal of the proposed guidance, namely to assist those conducting important research to improve the treatment of patients with critical illness and injury, while at the same time protecting the rights of human subjects. In its comment letter, AAMC affirmed its support of the comments of the Society for Academic Emergency Medicine (SAEM), a constituent organization of the AAMC, and the network of investigators supported by NIH National Institute of Neurological Disorders and Stroke for Neurological Emergencies Treatment Trials. These organizations noted that the proposed guidance does not address a number of important issues including:

  • special patient populations such as children;

  • the definition of "unsatisfactory or unproven" and the need for incremental risk assessment;

  • guidance for out of hospital research;

  • guidance for multi-center trials and the use of central IRBs;

  • defining the purpose and criteria for assessment of community consultation; and

  • defining the purpose and criteria for assessment of public notification.

AAMC joined SAEM in calling for a stakeholders' meeting to revisit the requirements of the Final Rule.

Information:
Howard Dickler, Director
AAMC Biomedical Health Sciences Research
hdickler@aamc.org
(202) 828-0567

AAMC Files Amicus Brief in FCA Case

The AAMC and several other associations Oct. 26 filed an amicus curiae brief in a case that will be heard by the U.S. Supreme Court in December. While the case, Rockville International Corporation v. United States ex rel. Stone, involves a Department of Energy contractor, the issue it raises is of utmost importance to health care providers: what is the standard that is used to determine whether a whistleblower is an "original source" as required under the False Claims Act (FCA).

While most circuit courts that have considered this issue imposed a rigorous standard, the Tenth Circuit did not. It required only that the relater have obtained knowledge of some of the background facts relevant to the claim. The amicus brief argues that "a clear, consistent, and strict 'original source' rule, applied in tandem with the [False Claims] Act's other gate keeping mechanisms, gives courts and defendants a powerful tool to identify and ward off illegitimate qui tam strike suits like those sometimes aimed at amici's members."

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490

CMS Releases 2007 OPPS Final Rule

The Centers for Medicare and Medicaid Services (CMS) Nov. 1 released on its website the calendar year (CY) 2007 Medicare Outpatient Prospective Payment System (OPPS) final rule, which includes a 3.4 percent inflation update in base payment rates for hospital outpatient services. After taking into account all the factors that affect the level of payments, CMS estimates that the average increase in payments for all hospitals will be 3.0 percent. The increase in payments for major teaching hospitals will be only 2.8 percent, lower than the increase for non-teaching hospitals (3.0 percent) and minor teaching hospitals (3.2 percent).

The final rule delayed the proposal to establish a hospital outpatient quality reporting payment program until 2009. CMS will not use the inpatient quality measures as a proxy for the outpatient setting and instead will use the additional time to develop appropriate measures for the outpatient setting.

In response to comments, CMS decided to reimburse hospitals for separately payable drugs and biologicals at 106 percent of the average sales price (ASP). This payment rate is the same as last year's payment rate. CMS had initially proposed to reduce the payment rate to 105 percent of ASP.

CMS is finalizing its proposal to create five new G-codes to describe hospital emergency visits provided in dedicated emergency departments that are subject to the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) but are not open 24 hours, 7 days a week. The final rule however, will not implement the proposed G-codes for clinic and emergency department visits that satisfy EMTALA requirement and are open 24 hours and for critical care services until national guidelines have been established. Commenters had urged CMS not to make this change, because of the administrative burden associated with incorporating new codes into their billing systems. Payment for clinic and emergency department visits will be made for five levels instead of the current three levels.

Information:
Jennifer Faerberg, Director, GME Track/Health Care Quality Liaison
AAMC Division of Health Care Affairs
jfaerberg@aamc.org
(202) 862-6221

Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498

NIH Panel Concludes Revisions to Animal Care Guide Are Unwarranted

The National Institutes of Health (NIH) Nov. 9 announced that a panel has "found no evidence to warrant revision the performance standards" of The Guide for the Care and Use of Laboratory Animals." The Guide was first published in 1963 and revised in 1965, 1968, 1972, 1978, 1985, and 1993. NIH solicited comments from the community earlier this year seeking advice on whether the Guide needed revision. The Public Health Service Policy on Humane Care and Use of Laboratory Animals incorporates by reference the latest issue of the Guide.

The panel charged with reviewing the comments did suggest that the Guide become a "living, web-based" document and that the appendix containing references be expanded and updated periodically. They also said that as information for a component of science increases, specialized reports may be advantageous.

Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059

Senators Call for Additional Health Funding

A bipartisan letter signed by 57 Senators was sent to the Senate leadership Oct. 27 asking for an additional $2 billion to be added to the FY 2007 Labor-HHS-Education spending bill. The letter, organized by Senators Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa), the chair and ranking member, respectively, of the Senate Labor-HHS-Education Appropriations Subcommittee, was sent to Senate Majority Leader Bill Frist (R-Tenn.) and Minority Leader Harry Reid (D-Nev.). The letter also was sent to Senators Thad Cochran (R-Miss.) and Robert C. Byrd (D-W.Va.), the chair and ranking member of the Senate Appropriations Committee.

The letter notes that in March 73 Senators voted for the Specter-Harkin amendment to the FY 2007 budget resolution (S.Con.Res. 83) to provide an additional $7 billion above the Administration's request for the Labor-HHS-Education bill to restore funding to the FY 2005 level [see Washington Highlights, March 17]. The letter states the appropriations bill approved by the Senate Appropriations Committee on July 20 falls $2 billion short of FY 2005, "effectively ignoring the intent of the Senate."

The letter continues, "At a time when the demand for job-training and education is critical to maintain America's competitiveness, and when the cost of health care and access to quality care are major issues for many Americans, we simply cannot afford to cut funding for health care and education. These cuts move our country in the wrong direction."

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525