Washington Highlights: September
21, 2007
Legislation
Seeks to Extend Moratorium on Medicaid Rules
Contents
Prior Issues
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Reps. Eliot Engel (D-N.Y.)
and Sue Myrick (R-N.C.) Sept. 14 introduced legislation (H.R.
3533) to extend by one year the moratorium related to the May 29 Medicaid
final rule on cost limits/units of government and the May 23 Medicaid proposed
rule on graduate medical education payments [see Washington
Highlights, May 25]. Without
congressional action, the current moratorium expires May 27, 2008.
According
to H.R. 3533 ("The Public and Teaching Hospital Preservation Act"),
publication of the May 29 final rule and May 23 proposed rule "was not anticipated
by Congress and undermines the intent of the moratorium passed by Congress."
It adds that "extension of the moratorium is necessary to effectuate Congressional
intent." The legislation also states that implementation of the rule on graduate
medical education payments "would force billions of dollars in payment reductions
to teaching hospitals, thus hampering the ability ... to provide essential services
including the education of the next generation of medical professionals despite
a shortage of medical professionals."
As of Sept. 20, H.R. 3533 had
20 additional bipartisan cosponsors: Reps. Tim Bishop (D-N.Y.), Mary Bono (R-Calif.),
Lois Capps (D-Calif.), Stephen Cohen (D-Tenn.), John Conyers (D-Mich.), Joe Crowley
(D-N.Y.), Gene Green (D-Texas), John Hall (D-N.Y.), Alcee Hastings (D-Fla.), Robin
Hayes (R-N.C.), Maurice Hinchey (D-N.Y.), Nita Lowey (D-N.Y.), Carolyn Maloney
(D-N.Y.), Jim Matheson (D-Utah), James McGovern (D-Mass.), Gerald McNerney (D-Calif.),
Michael McNulty (D-N.Y.), Jerrold Nadler (D-N.Y.), Ileana Ros-Lehtinen (R-Fla.),
and Edolphus Towns (D-N.Y.).
On Sept. 11, Rep. Henry Waxman (D-Calif.) and
Sen. Jeff Bingaman (D-N.M.) introduced joint resolutions (H.J.
Res. 49/S.J.
Res. 18) expressing "congressional disapproval" of the May 29 Medicaid
final rule on cost limits/units of government. As of Sept. 20, the Senate measure
had 22 cosponsors: Sens. Evan Bayh (D-Ind.), Sherrod Brown (D-Ohio), Robert Byrd
(D-W.Va.), Maria Cantwell (D-Wash.), Bob Casey (D-Penn.), Hillary Clinton (D-N.Y.),
Thad Cochran (R-Miss.), Russ Feingold (D-Wis.), Dianne Feinstein (D-Calif.), John
Kerry (D-Mass.), Mary Landrieu (D-La.), Blanche Lincoln (D-Ark.), Patty Murray
(D-Wash.), Bill Nelson (D-Fla.), Barack Obama (D-Ill.), Mark Pryor (D-Ark.), John
Rockefeller (D-W.Va.), Ken Salazar (D-Colo.), Bernie Sanders (I-Vt.), Debbie Stabenow
(D-Mich.), Jon Tester (D-Mont.), and Sheldon Whitehouse (D-R.I.). H.J. Res. 49
had no cosponsors.
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
SCHIP Veto Threat Continues While Republicans
Offer Legislation to Extend Current Funding Levels
President Bush Sept.
20 called on Congress to pass a "clean, temporary extension of the current
[State Children's Health Insurance Program (SCHIP)] that I can sign" before
the program expires on Sept. 30. His remarks came as House and Senate Democrats
moved closer to an SCHIP reauthorization agreement reportedly based on the Senate-passed
H.R. 976 [see Washington Highlights,
Aug. 3]. The President has repeatedly promised to veto the Senate SCHIP package
because it increases taxes and encourages families to choose "government
run health care" over private coverage.
President Bush criticized
Congress for waiting until SCHIP "is just about to expire" to "score
political points in Washington." Senate Finance Committee Chair Max Baucus
(D-Mont.) responded with a press
release urging the President to "drop his threat to block this help for
kids" and work with Congress "for a real renewal" of the program.
The Baucus press release reported that the House and Senate were "coming
together on a real renewal and improvement" of SCHIP before it expires. Similarly,
a press
statement by House Energy and Commerce Health Subcommittee Chair Frank Pallone
(D-N.J.) reported that Congress would pass final legislation to reauthorize the
program before Sept. 30. Ranking Member Charles Grassley (R-Iowa) also was "disappointed"
by the President's reaction and advised that a bipartisan compromise is necessary.
House Republican leaders Sept.
19 reiterated support for a Presidential veto. Seeking to assure that both parties have "ample
time" to act in a "more responsible fashion," the Republicans also
have introduced legislation (H.R. 3584) to extend current SCHIP authorization
levels for 18 months. In a Sept. 19 letter to Speaker of the House Nancy Pelosi (D-Calif.), House Minority Leader
John Boehner (R-Ohio) and Minority Whip Roy Blunt (R-Mo.) urged her to schedule
a vote on the bill "so partisan politics does not push this program into
further peril as September 30 approaches." However, also on Sept. 19, a group
of 17 House Republicans sent a letter to Speaker Pelosi stating that they "would be supportive of consideration
of the Senate SCHIP bill."
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Opponents Seek Nullification of New SCHIP
Mandates
Sens. Ted Kennedy (D-Mass.), Gordon Smith (R-Ore.), John Rockefeller
(D-W.Va.), Olympia Snowe (R.-Maine), Robert Menendez (D-N.J.), and John Kerry
(D-Mass.) Sept. 12 introduced bipartisan legislation (S.
2049) to nullify the Aug. 17 requirements regarding State Children's Health
Insurance Program (SCHIP) expansions [see Washington
Highlights, Sept. 7]. The legislation
(which applies to any state plan amendment/waiver expanding SCHIP income eligibility
levels) also prohibits promulgation or implementation of any requirement, rule,
or provision "that is similar to any requirement in the August 17, 2007 letter."
Cosponsors of S. 2049 include Sens. Claire McCaskill (D-Mo.) and Bob Casey (D-Pa.).
Upon introduction of the bill, Sen. Smith described the new requirements as "unrealistic
standards."
Similarly, 30 governors signed a Sept. 17 bipartisan letter to Secretary of Health and Human Services Michael Leavitt opposing the new SCHIP
mandates. The governors (from N.Y., Calif., Iowa, Wash., N.J., Mich., Kan., Ohio,
Ill., Conn., Okla., N.H., Ore., Ariz., N.M., Pa., Del., La., Vt., Ark., Maine,
Colo., S.D., Wyo., Mass., Md., R.I., W.Va., P.R., and V.I.) call for immediate
rescission of the requirements. Explaining that they are "deeply troubled"
by the "mandates that limit state flexibility," the governors state
that the new rules "undermine the foundation of the state-federal partnership
upon which SCHIP was built."
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Congress Approves FDA Compromise
Both
the House and Senate have approved a comprehensive legislative package to reauthorize
drug industry user fees, provide greater incentives for pediatric drug testing,
and require reporting of clinical trial results. The House passed the measure
Sept. 19, 405-7, under suspension of the rules, while the Senate passed it by
unanimous consent the following day.
The final legislation (H.R.
3580) reflects a compromise between House and Senate bills to reauthorize
various programs at the Food and Drug Administration (FDA) [see Washington
Highlights, July 13]. The measure
reauthorizes through FY 2012 the Prescription Drug User Fee Amendments (PDUFA)
and the Medical Device User Fee Amendments (MDUFA), which expire Sept. 30, and
includes a number of provisions intended to improve drug safety.
Also included
in the bill is a provision expanding the ClinicalTrials.gov data bank at the Library
of Medicine to include registry information for clinical trials of all drugs,
biologics, and devices, as well as results information for clinical trials of
approved products. The compromise measure does not require that submitted information
conform to the International Clinical Trials Registry Platform data set of the
World Health Organization, as required in both the House- (H.R.
2900) and Senate-passed (S.
1082) bills. However, the measure does direct the Secretary of Health and
Human Services to "consider the status of the consensus data elements set
for reporting clinical trial results of the World Health Organization." According
to a summary prepared by the House Committee on Energy and Commerce, the compromise also
directs the Secretary to expand the data bank further to include unapproved products
and additional data elements through rulemaking.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
OMB Releases Risk Assessment
Memorandum
The White House's Office of Management and Budget (OMB) and
Office of Science and Technology Policy (OSTP) released a Sept. 19 memorandum announcing that OMB was retracting its proposed guidelines on risk assessment
issued in 2006. The National Academies of Sciences had strongly criticized
the proposed guidelines, which would have set standards for federal regulatory
and science agencies tasked with assessing health, environmental, and other risks,
as being too restrictive and setting requirements beyond what the current state-of-art
could justify. The AAMC criticized the guidelines as potentially constraining the ability of public health
officials to make timely decisions and communications on the basis of available
risk information. The OMB/OSTP memorandum reinforces a 1995 policy guiding risk
assessment and updates the Administration's policy at some length, including citations
to more recent reforms such as the Information Quality Guidelines.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
NIH Awards Second Round of CTSA
Funding
The National Institutes of Health (NIH) Sept. 18 announced it has
expanded its clinical and translational research consortium, adding another 12
academic health centers to the original group of 12 named last October. The participating
institutions, funded through Clinical and Translational Science Awards (CTSAs),
will work to translate research rapidly into prevention strategies and clinical
treatments for patients. When fully implemented in 2012, 60 institutions will
belong to the consortium. The following academic health centers received new funding
awards: Case Western Reserve University; Emory University/Morehouse School of
Medicine; Johns Hopkins University; University of Chicago; University of Iowa;
University of Michigan; University of Texas Southwestern Medical Center; University
of Washington; University of Wisconsin; Vanderbilt University/Meharry Medical
College; Washington University in St. Louis; and Weill Cornell Medical College/Hunter
College. According to NIH, total funding for these new awards will be approximately
$574 million over a 5-year budget period.
A third funding opportunity for
CTSAs has been announced. Applications are due Nov. 7.
Information:
Howard Dickler, Director
AAMC Biomedical Health Sciences Research
hdickler@aamc.org
(202) 828-0567
Report Addresses Rate of SCHIP "Crowd-Out"
The
Centers for Medicare and Medicaid Services (CMS) Sept. 19 released the "National
Evaluation of the State Children's Health Insurance Program," a report examining SCHIP's impact on coverage and access to care. The report also reviews
the effectiveness of outreach initiatives and the substitution of SCHIP for private
coverage ("crowd-out"). While the CMS report states that "some
amount of substitution is unavoidable," it explains that various data sources
and methodologies "yield wide ranging estimates" on the magnitude of
crowd-out. Population-based studies indicate a substitution rate of up to 56 percent,
while enrollee-based studies that exclude "involuntary loss of coverage"
(e.g., divorce, job loss) show a rate of up to 15 percent. The Congressional Budget
Office estimates that the House- and Senate-passed SCHIP reauthorization bills
would produce a crowd-out rate of 33 percent, prompting veto threats from President
Bush.
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
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