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Senate Committee Reports Health Bills
On July 20, the Senate Committee on Health, Education, Labor, & Pensions
(HELP) reported S. 1418, the Wired for Healthcare Technology Act, and
S. 1420, the Medical Device User Fee Stabilization Act.
S. 1418, sponsored by HELP Committee Chair Michael
Enzi (R-WY), ranking member Ted Kennedy (D-MA), and a bipartisan group
of 19 other senators,
would amend the Public Health Service Act to do the following:
• establish in HHS an Office of the National Coordinator of Health Information
Technology to head a program for developing a nationwide, interoperable
healthcare technology system with key patient privacy provisions;
• require the HHS secretary to establish a public-private
American Health Information Collaborative to advise on these activities,
including
the establishment of standards and the coordination of all federal
spending;
• authorize grants to non-profit hospitals,
physician practices, and others, as well as grants to states to make
loans for purchase and
operation of information technology, and;
• authorize grants to help incorporate information technology education
in medical training curricula.
Many of the activities either required or authorized under the legislation
are under way through HHS programs, so this legislation, in large measure,
could – if enacted – reinforce the importance of those
programs.
S. 1420 makes several changes to address some technical
problems identified in the Medical Device User Fee program. In addition,
the bill would place an 8.5% cap on increases in device user fees.
The bill is believed to be widely supported by the device industry
and FDA, and is expected to pass relatively easily and be enacted quickly.
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Energy & Commerce Committee Reports Health Bills
On July 20, the House Energy & Commerce Committee reported a number
of health-related bills, some or all of which potentially could be
considered on the House floor next week.
H.R. 3205, the Patient Safety and Quality Improvement
Act, addresses concerns about medical errors. It is a bipartisan bill
by Reps. Mike
Bilirakis (R-FL), Nathan Deal (R-GA), Henry Waxman (D-CA), and Sherrod
Brown (D-OH) that would establish patient safety organizations to
collect and analyze information to understand the nature of medical
errors and how to prevent them; provide limited liability protections
so healthcare providers will not be concerned about reporting for fear
of malpractice claims, and establish a patient safety database. Concerns
about protection of patient privacy had been expressed by Waxman when
an earlier version of the bill was discussed by the health subcommittee.
Waxman’s support indicates these concerns were addressed in the
version of the bill the committee reported.
H.R. 2355, the Health Care Choice Act by Reps. John
Shadegg (R-AZ) and other Republican members, would allow companies
to sell health
insurance in states other than the one in which they are located. However,
companies must follow the regulations of the state designated as the “primary” one
regulating the company’s insurance products.
H.R. 3204, the State High Risk Pool Funding Extension
Act by Reps. John Shadegg (R-AZ) and Ed Towns (D-NY), would authorize
grants to
states to operate high risk pools to expand availability of health
insurance within the state.
H.R. 1132, the National All Schedules Prescription
Electronic Reporting Act by Reps. Ed Whitfield (R-KY), Frank Pallone
(D-NJ), Charlie Norwood
(R-GA) and Ted Strickland (D-OH), is a compromise bill, incorporating
components from legislation introduced earlier by the four members.
Its purpose is to establish grant programs to help states initiate
or operate statewide prescription drug monitoring programs focusing
on abuse, diversion and mis-prescribing of controlled substances such
as opiate pain relieving medication. States currently with programs
in place have done such things as establish databases to help prevent “doctor
shopping” and “prescription mills.” The legislation
originally stemmed from concerns about widespread abuse and diversion
of Oxycontin.
In addition, the committee reported two resolutions,
one to recognize the work of America’s Blood Centers (H.Res.
220) and one to encourage the Centers for Medicare and Medicaid Services
(CMS) to continue, for
an additional year, the current demonstration program to reimburse
for quality cancer care.
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Stem Cell Vote in the Senate Uncertain
The possibility of a Senate floor vote next week on
stem cell legislation is uncertain following intense discussion this
week. In a new twist,
Senate Labor-HHS appropriations subcommittee Chair Arlen Specter (R-PA)
threatened Thursday to attach his bill to the FY06 Labor-HHS appropriations
bill. While Specter has made similar threats before, he
appears to be considering this a real possibility. At risk is a Bush
veto of the entire spending bill.
Specter raised the amendment possibility after talks
with Senate Majority Leader Bill Frist (R-TN) to bring Specter’s
version of the May House-passed bill to the floor for a straight vote
stalled.
Recent
discussions to include this bill in a series of six floor votes on
and restricted expansion of current stem cell policy and anti-cloning
legislation have raised concerns this would siphon votes away from
the Specter bill.
House leaders and the White House oppose the House bill, sponsored
by Reps. Michael Castle (R-DE) and Diana DeGette (D-CO).
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Senate Addresses Health Information
Technology
This week the Senate HELP Committee passed “The
Wired for Health Care Quality Act,” S. 1418 by a voice vote.
The bill would award demonstration grants to health professions centers
and academic health
centers to integrate health information technology into clinical education.
Also this week, the Senate Budget Committee held a
hearing on "Health
Information Technology: The Federal Role and Budget Implications," with
HHS Secretary Mike Leavitt as the sole witness. He said while health
IT is about lowering costs, making fewer mistakes and providing better
healthcare, it is also about ensuring the U.S. is prepared for bioterrorism
and pandemic threats. Leavitt said HHS is funding a lot of adaptation
of
IT systems and many models throughout the country. It is key to have
a combined focus on establishing national standards and learning from
other systems. Through all of this, he noted confidentiality, privacy
and security needs to be secured.
From his opening statement to his response to almost
every question, Leavitt emphasized that a “laser focus” needs
to be on interoperability. He said a clear strategy for achieving interoperability
has been established
that involves setting up an interoperable system for numerous government
agencies which provide 46% of the nation’s healthcare (including
Medicare, Medicaid and the Veterans Administration). Establishing this
set of common standards will move the market.
Yet Sen. Debbie Stabenow (D-MI) was critical of Leavitt’s “laser
focus” on interoperability, saying programs need to move forward.
By waiting for immediate interoperability we are risking lives, she
said.
Sen. Kent Conrad (D-ND) requested Leavitt’s office produce a
report within 30 days on the CDC’s ability to communicate in
real time with major healthcare facilities across the United States.
Return to top Crawford
Confirmed As FDA Head
The Senate this week confirmed acting Food & Drug
Administration Commissioner Lester M. Crawford as the permanent head
of the agency.
While the final vote was 78 to 16, it has been a contentious five months
since President Bush nominated Crawford.
Sens. Hillary Clinton (D-NY) and Patty Murray (D-WA)
held up the nomination over concerns about FDA’s lack of action
to convert the Plan B emergency contraceptive product to over-the-counter
status. However
last week Health & Human Services Secretary Mike Leavitt sent a letter
to Committee Chair Mike Enzi (R-WY) with a written assurances
FDA will decide by Sept. 1 whether to allow sale of the drug without
a doctor's prescription.
Another issue resolved prior to the vote was a hold
placed by Sen. Tom Coburn (R-OK). Coburn objected to FDA having not
changed
the labeling on condom packages to reflect potential risks of when
they may fail, as required by a 2000 law.
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NIH Changes Proposed
This week the House Energy & Commerce Committee
held a hearing on reauthorization of the National Institutes of Health
(NIH) with NIH Director Elias A. Zerhouni, M.D. as the sole witness.
Under the draft legislation released by a House committee this week,
proposed changes to NIH would provide the NIH director with authority
to decide the agency’s federal spending priorities and the power
to reorganize the agency's 27 institutes and centers.
"I see great wisdom in what the committee is proposing," Zerhouni
told the committee. But Zerhouni did not fully endorse the proposal,
noting many details had to be filled in.
Committee Chair Joe Barton (R-TX) said NIH reauthorization is
a major goal this year. His draft legislation would not immediately
reduce the number of institutes and centers at NIH. Instead it proposes
to consolidate them into two major divisions -- one containing the
institutes that focus on specific diseases or organs, and the other
containing those that focus more on basic research. It would then be
up to the NIH director -- with input from others -- to decide how the
money should be distributed.
Rep. Tammy Baldwin (D-WI) was concerned about programs being pitted
against each other for available funding. Zerhouni said he does
not want a zero-sum game, but a common fund for common good. Language
that limits the number of institutes does not concern him since NIH
growth has been haphazard and driven by factors other than science.
Focusing on the grant process, Zerhouni advocated for complete preservation
of the NIH peer review process. He cited continued reliance on those
closest to the research forming policy and having outside oversight.
Rep. Mike Bilirakis (R-FL) criticized these as subjective standards;
Zerhouni said the wisdom of Congress is it has stayed out of
the
peer review process.
It is still uncertain how the Senate would approach reauthorization.
The $28-billion agency was last authorized by Congress in 1993.
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Montana Judge Halts R-CALF/Border Hearing
A Montana federal judge this week cancelled a July
27 trial date for opening arguments in the lawsuit brought by R-CALF
against
the federal government over Canadian live cattle imports.
This occurred In the wake of a unanimous federal appeals court ruling overturning
U.S. District Judge Richard Cebull’s temporary injunction to close the
Canadian-U.S. border to live cattle imports.
The judge cancelled the trial start, saying he would await the formal opinion
of the 9th U.S. Circuit Court of Appeals. After study the opinion, “this
court will determine whether further hearings are necessary,” the judge
wrote in his order.
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Johanns Warns Japan on Beef Sales - Again
U.S. Agriculture Secretary Mike Johanns again warned Japanese authorities
last week that Congress is losing patience with the continuing delays in resuming
beef trade, speculating that when Congress returns from its August recess it
could turn to trade issues involving Japan’s 19-month ban on U.S. beef
imports.
The House and Senate are both discussing anti-Japan resolutions
that could impose sanctions on Japan if beef trade doesn’t resume. Johanns’ comments
were made to his counterpart, Japanese Ag Minister Yoshinobu Shimamura, in
a sideline conversation during WTO ministerial meetings in Dalian, China.
Return to top CA Assembly to Debate “BSE Tested” Labeling Bill
A bill to allow cattle owners to test their own animals for
BSE, then market and label the beef as “BSE tested,” was introduced
this week by California state Sen. Michael Machado. SB 905, Machado said, would
allow consumers who are willing to pay for the extra testing to receive the
assurance the label implies. It’s questionable if the bill, if enacted,
could be enforced since USDA could preempt state laws on testing.
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Chile Lifts Ban on U.S. Beef
The government of Chile said it will resume purchases of U.S. beef and beef
products from animals under 30 months of age, Secretary of Agriculture Mike
Johanns announced this week. In 2003, Chile purchased $5.3 million in beef
and beef products.
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Lugar Wants EPA to Speed Up Soybean Rust Fungicide Approvals
Former Senate Agriculture Committee chair Sen. Richard Lugar
(R-IN) told EPA Administrator Steve Johnson this week he’s concerned
about the time lag in agency approval of 18 pending applications for fungicides
to be used to
fight Asian soybean rust in the event of a broad U.S. outbreak. Lugar’s
comments were prompted by a USDA report of a fresh outbreak of rust in Mississippi
and Alabama reported by USDA last week.
While Lugar’s concerns went to approvals pending for
the state of Indiana, his letter to Johnson represents congressional concerns
over the broad implications
of an inadequate fungicide stockpile to fight the potentially devastating soybean
disease.
A number of products have been EPA approved using Section
18 emergency exemption authority under FIFRA. Lugar also sent a letter to USDA
urging the
department to work with EPA on a stockpile of fungicides and quickly moving
those supplies to soybean rust “hotspots.” He also talked about
proactive steps to avoid interference in soybean trade.
In addition, Lugar asked USDA to clarify “recommended management practices” necessary
for a farmer to qualify for federal crop insurance for soybean rust. Lugar
wants to see specific guidelines issued by the department.
Return to top Energy, Highway Conferences Rushing to Complete By August
With an eye towards the Senate being nearly consumed with
Supreme Court confirmation hearings, House and Senate conferees on reauthorizing
the federal highway program
and crafting an omnibus energy package vow to work through weekends and late
into the night to get agreements before the August recess.
Highway conferees, who earlier were confident they could hammer out a conference
report and pass it this week, instead wound up joining their colleagues to
pass the 10th extension of existing federal highway and urban commuter/transport
programs. Again, conferees are stuck on how to disperse among the states federal
dollars for highway funding, hours of service, environmental reviews of federal
highway projects and other issues. Senate conferees said they were close to
a deal until Rep. Tom DeLay (R-TX) put on the table a new set of demands, including
items beneficial to Texas. Conferees are also trying to pare back the cost
of the highway package to avoid a threatened veto by President Bush.
On energy, conferees said they’d work through the weekend
in hopes of getting a deal by the end of July so as to meet President Bush’s
deadline of signing an energy package by August 1. Sticking points include
MTBE liability protection. House Energy & Commerce Committee Chair Rep.
Joe Barton (R, TX) finally unveiled a long-promised compromise plan on MTBE
liability that would grant protection in exchange for an $11.43-billion trust
fund to clean up MTBE-contaminated sites. Both MTBE refiners and the federal
government would contribute to the fund, which would be an extension of the
Leaking Underground Storage Tank Trust Fund with an added state matching portion,
Barton said. Senate opponents want the larger trust fund to help clean up polluted
waters caused by MTBE leaks from underground storage tanks. In return for the
trust fund contribution, MTBE refiners would get immunity from lawsuits filed
after Sept. 5, 2003, except for lawsuits filed by state attorneys general.
Confereesalso agreed to extend daylight savings for extra month – three
weeks earlier in the spring and a week later in the fall – beginning
in March, 2007, pending a study by the Department of Energy on savings. Farm
groups oppose the extension.
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Corn Prices Will Rise “Significantly” Under 8-Billion Gallon RFS
Corn prices “may rise significantly” if a “substantial” Renewable
Fuels Standard (RFS) becomes law, USDA Chief Economist Keith Collins said during
testimony on the impact of the RFS on production agriculture in the House Agriculture
Committee this week.
With an 8-billion gallon RFS, demand for corn for ethanol will increase by
about 685 million bushels for crop years 2006-2013, Collins estimated, kicking
the price of corn about 8% higher. By 2013, the RFS will push the corn price
up 30 cents per bushel or 12%.
The RFS mandates how much alternative fuel – ethanol
and biodiesel– oil refiners must blend yearly with their diesel and
gasoline through 2012. The House passed a 5-billion gallon mandate; the Senate
pushed
the mandate to 8 billion
gallons.
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House CAFTA Vote to Follow China Trade Vote
House leadership this week confirmed the full House will consider separately
a vote on alleged Chinese trade abuses prior to taking up the vote on the Central
American Free Trade Agreement (CAFTA) before Congress recesses for the month
of August. And while the sugar industry has not given up its opposition to
CAFTA, it appears House opposition centers more on labor and environmental
protections than on the price of sugar.
U.S. Special Trade Representative Ambassador Rob Portman told the Inter-American
Development Bank this week of $20 million in federal money available to assist
CAFTA nations to train judges in labor courts, conduct labor inspections, worker
education and several other labor-related actions.
The Administration is working to get fence-sitting Democrats
to come over to the “aye” side of the CAFTA vote by pledging the labor
improvements. A major break came this week when House Democrat leadership agreed
not to hold their members to a party-line vote. Some senior Democrats see this
move as critical to House approval of the controversial trade pact.
At a press conference this week, groups in opposition to CAFTA, including
the National Farmers Union (NFU), heard Rep. Charlie Melancon (D-LA) warn farm
state legislators that if CAFTA passes, farmers who are hurt by the deal “will
seek retribution.”
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Federal Animal Health Agency Recommended By Science Panel
With the threat of BSE, avian influenza and foot and mouth disease (FMD),
consolidating all federal animal health authority under one high-ranking federal
department to coordinate among federal, state and private sectors could be
the most efficient way of protecting livestock and poultry production in the
U.S., the National Research Council (NRC) said this week.
NRC, a council of the National Academy of Sciences (NAS), said the current
federal animal health and environmental protection system is “too convoluted” at
a time when industry is vulnerable to disease and bioterrorism. More than 200
different federal offices, seven Cabinet departments and “hundreds of
state and local agencies” share responsibility for regulating U.S. animal
health, NRC said.
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New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.1418
Sen. Mike Enzi (R-WY) introduced a bill to enhance the adoption of
a nationwide interoperable health information technology system.
S.1422
A bill offered by Sen. Chuck Hagel (R-NE) seeks to reduce human exposure
to mercury through vaccines.
H.C.R.213
Rep. John Dingell (D-MI) with 89 cosponsors offered a resolution on
the “vital role of Medicare in the health care system of our
Nation over the last 40 years.”
H.C.R.215
Rep. Henry Waxman (D-CA) with 88 cosponsors offered a resolution on
the “importance of Medicaid in the health care system of our
Nation.”
H.R.5
Rep. Phil Gingrey (R-GA) offered legislation on medical malpractice
liability reform.
H.R.3331
A bill proposed by Rep. Brad Miller ((D-NC) would “provide funding
to enable institutions of higher education to establish a grant program
to bridge the gap between laboratory discovery and commercially viable
research.”
H.R.3359
Rep. John Conyers (D-MI) offered legislation on medical malpractice
liability reform.
H.R.3369
Rep. Nita Lowey (D-NY) proposed a bill with respect to preparation
for an influenza pandemic, including an avian influenza pandemic.
H.R.3378
Legislation introduced by Rep. Brian Baird (D-WA) would provide comprehensive
reform regarding medical malpractice.
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