Government Executive - Authors - Kristen A. Lee

Health agencies again sound alarm on flu pandemic

Kristen A. Lee — Thu, 25 Jan 2007 00:00:00 -0500

Labor-HHS Appropriations Subcommittee Chairman Tom Harkin, D-Iowa, and ranking member Arlen Specter, R-Pa., expressed concern that failure to increase funding to the agencies might slow preparations for a pandemic. Specter said Congress' failure to make such funding a priority is "totally unacceptable."

In 2005, President Bush requested $7.1 billion in emergency supplemental funding for pandemic preparations, of which $6.1 billion has been appropriated. Harkin and Specter also lamented that public attention to a potential pandemic had waned.

Much of the hearing focused on H5N1 avian influenza, which has the potential to become a devastating pandemic due to its high mortality rate -- more than 50 percent -- and humans' lack of immunity to the disease.

"It's alarming we're not protected from it and it's alarming because it's so deadly," said CDC Director Julie Gerberding. To date, 269 human cases of avian flu have occurred in 10 countries, and 163 patients have died. The panelists stressed, however, that they cannot know if or when the avian flu will become a pandemic, or an epidemic that spreads over a large area.

The panelists, including National Institute of Allergy and Infectious Diseases Director Anthony Fauci, described their efforts to create a vaccine based on the currently circulating strain of the virus and to develop the infrastructure to quickly produce large quantities of a new vaccine once a pandemic strain has been identified.

The panelists said that research to develop a universal flu vaccine, which in theory could protect against all strains of influenza, is also progressing.

The agencies are working toward a goal of providing the entire population of the United States with a vaccine within six months of a pandemic outbreak, as well as to provide antivirals for 25 percent of the population.

The CDC is also working with states and local governments to help them prepare for their roles in the event of an outbreak, according to Gerberding. During the hearing, Harkin floated an idea of giving all Americans free flu shots, in part to create a platform for future vaccine distribution on a massive scale.

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Senator accuses FDA nominee of withholding information

Kristen A. Lee — Fri, 01 Dec 2006 00:00:00 -0500

This latest confrontation was prompted by von Eschenbach's written responses to questions submitted by Grassley during a Senate confirmation hearing. Grassley released those responses Thursday along with a critical statement: "The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government."

Specifically, Grassley accused von Eschenbach of failing to cooperate with the committee's investigation of the antibiotic Ketek. The investigation was sparked by allegations that the drug was approved by the FDA despite evidence that some clinical safety data was fraudulent.

In his response to a question about the agency's failure to cooperate with the investigation, von Eschenbach wrote that "disclosure of pre-decisional information would significantly compromise the ability of our staff to consider important public health and safety matters in an objective and independent setting."

Grassley also released a letter sent Wednesday to Health and Human Services Secretary Michael Leavitt, accusing the FDA and HHS of failing to provide all information requested by the committee.

"Selectively providing documents and access to executive agency officials pursuant to a Congressional subpoena cannot constitute compliance," Grassley wrote, noting that some relevant documents had been "'overlooked' or purposefully withheld."

Grassley requested a complete list of officials involved in the review or post-market surveillance of Ketek by Dec. 13. In an e-mailed statement, an FDA spokeswoman said, "We have worked diligently w/ Sen. Grassley's staff since April to provide them access to as much data and as many Agency personnel as possible, while remaining responsible stewards of the extraordinarily sensitive information we handle, as a regulatory agency in the Executive Branch."

Grassley announced his intention to block a Senate vote on von Eschenbach's nomination in a Nov. 16 letter to Majority Leader Bill Frist, R-Tenn., because of his "continued failure to comply with the Committee's subpoenas over the past six months."

A spokeswoman for Finance ranking member Max Baucus, D-Mont., who will become chairman in January, declined to comment on Grassley's criticisms of the nominee. Von Eschenbach, who was nominated to the position in March, faces additional hurdles to his confirmation.

Sens. David Vitter, R-La., and Jim DeMint, R-S.C., also have expressed their intentions to put a hold on the nomination. Vitter wants the FDA to legalize the importation of personal shipments of prescription drugs from Canada. DeMint said he objects to the sale of RU-486.

Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., lifted their early objections to von Eschenbach's confirmation in late August after the FDA agreed to allow over-the-counter sale of Plan B to women age 18 or older. The Health, Education, Labor and Pensions Committee approved Von Eschenbach's nomination by voice vote in September.

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Freshman Democrats include anti-terrorism expert

Megan Scully, Darren Goode, and Kristen A. Lee — Fri, 10 Nov 2006 00:00:00 -0500

Democrat Chris Carney, a former Pentagon senior adviser on intelligence and counter terrorism, beat incumbent Rep. Don Sherwood, R-Pa. Retired Vice Adm. Joseph Sestak, a 31-year career officer who handily beat embattled Rep. Curt Weldon, R-Pa., served in Afghanistan and Iraq, and worked during the Clinton administration on the National Security Council. And Tim Walz, a retired Army National Guard member who deployed to Italy in support of operations in Afghanistan, beat six-term incumbent GOP Rep. Gil Gutknecht of Minnesota.

Meanwhile, women continued to make gains in Congress, with at least 12 incoming freshmen and several more in undecided races. There were 67 women in the House this Congress, and there will be a net gain of at least four next year.

At least eight Democratic women will join the House freshman class, and only one will not return: Rep. Cynthia McKinney of Georgia, who lost in the primary. On the Republican side, four sitting GOP women in the House were defeated for re-election and a fifth -- Rep. Katherine Harris of Florida -- lost her Senate bid.

Women also garnered two new seats in the Senate, with the victories of Democrats Amy Klobuchar and Claire McCaskill, bringing the total to 16. All six female senators up for re-election won. Only two Republican women freshman were elected, for a net loss of at least three.

While the majority of freshmen have state legislative or other public service experience, there are several notable political outsiders. The Democrats include former NFL quarterback Heath Shuler of North Carolina., alternative newsweekly founder and columnist John Yarmuth of Kentucky, and physician Steve Kagen of Wisconsin.

The musical ear of Congress also arguably improved with the addition of Democrats John Hall, co-founder of the 1970s soft rock band Orleans, and Paul Hodes, who cut several albums with his wife as part of their two-member folk band Peggosus and earned a gig at the White House during the Clinton administration.

There were notable family ties as well:

-- Democrat John Sarbanes, son of retiring Sen. Paul Sarbanes, D-Md., won the open seat vacated by Rep. Benjamin Cardin, D-Md.
-- Republican Gus Bilirakis will replace his father, retiring Rep. Michael Bilirakis, R-Fla.
-- Florida Democrat Kathy Castor is the daughter of Betty Castor, who narrowly lost a 2004 Senate bid to now-Sen. Mel Martinez, R-Fla.
-- And Robert Casey Jr. is the eldest son of the late Pennsylvania Gov. Robert Casey Sr. The younger Casey defeated GOP Sen. Rick Santorum.

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House committee approves biodefense measure

Kristen A. Lee — Thu, 21 Sep 2006 00:00:00 -0400

The Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (H.R. 5533), expands on Project BioShield, which was signed into law two years ago.

The bill establishes a point of authority in the federal government -- the Biomedical Advanced Research and Development Authority -- to coordinate and facilitate efforts to develop countermeasures for bioterrorism or pandemic infectious diseases.

The legislation, which passed on voice vote, also authorizes $160 million in fiscal 2007 and fiscal 2008 for advanced research and development.

Rep. Anna Eshoo, D-Calif., who co-sponsored the legislation with Rep. Mike Rogers, R-Mich., cited the threat of avian influenza or another anthrax attack as reasons for the bill's passage.

House Energy and Commerce Health Subcommittee Chairman Nathan Deal, R-Ga., offered a substitute amendment that made technical changes to the bill. The manager's amendment also passed by voice vote.

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Subcommittee advances electronic health records bill

Kristen A. Lee — Thu, 14 Sep 2006 00:00:00 -0400

The Federal Family Health Information Technology Act of 2006 (H.R. 4859), which passed by voice vote, requires the federal government's Office of Personnel Management to require all insurance carriers to provide members of the Federal Employee Health Benefits Program (FEHBP) with two types of electronic health records.

The first type of record would contain information already tracked by carriers, such as hospital and physician visits, claims information and prescription drug records. The bill would require that the information be made available to FEHBP members within four years after the bill's enactment.

The bill also requires that carriers make personal electronic health records available to members. These records - which would contain personal health information such as medical history, symptoms and diet - are to be controlled by FEHBP members.

The bill stipulates that carriers must comply with the privacy regulations under the Health Insurance Portability and Accountability Act of 1996 in handling the electronic records.

House Government Reform Federal Workforce Subcommittee Chairman Jon Porter, R-Nev., who co-sponsored the legislation with William Lacy Clay, D-Mo., said that the bill would empower federal workers to have ownership over their own medical records. "The only person who doesn't know much about his own health care is the insure[d]," he said. He argued that failure to pass the legislation would allow "senseless deaths" through medical errors to continue.

In response to suggestions by the Government Accountability Office and subcommittee members, Porter offered a substitute amendment, which also passed by voice vote, making several adjustments to the original bill. The substitute requires carriers to offer grants and incentives to medical providers to implement interoperable health records. The grants would be funded by private donations to a trust fund managed by the Office of Personnel Management.

The substitute amendment also adds a provision mandating that carriers provide hard copies of these records to FEHBP members without access to the internet and allow those members to make changes. The amendment also requires that any savings that occur as a result from the implementation of electronic records translate into lower premiums for members.

Rep. Danny Davis, D-Ill., said that the bill did not include sufficient privacy protections. He raised concerns that FEHBP members could be coerced by insurance carriers into disclosing their personal records. Rep. Davis also called for a provision that would require carriers to notify an FEHBP member if his or her personal information has been improperly released.

House Government Reform ranking member Henry Waxman, D-Calif., who did not attend the debate, released a statement opposing the bill. He recommended that legislation wait until a Department of Health and Human Services task force on interoperability standards finishes its work.

Waxman also called for additional privacy provisions, including the assurance that FEHBP members can take legal action if there is a security breach involving their records.

Porter agreed to work on incorporating some of the Democratic recommendations into the bill. "I think some of these would be a real asset to final legislation," he said.

A full committee markup has not yet been scheduled. Porter wrote in a statement that Sen. Thomas Carper, D-Del., is leading an effort to write a similar bill in the Senate.

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Panel questions administration on Medicare data errors

Kristen A. Lee — Fri, 08 Sep 2006 00:00:00 -0400

The option was offered as a convenient way for individuals to pay Medicare premiums, but a number of computer glitches have made the system costly for the government and a headache for beneficiaries. About 4.5 million individuals have chosen to pay their premiums through Social Security. The problems affect approximately 150,000 of the beneficiaries.

The problem of the Medicare prescription drug coverage gap known as the "doughnut hole" was also addressed in the meeting. The doughnut hole is a gap in benefits that begins when an individual's drug expenses exceed $2,250 and only ends when catastrophic coverage takes over.

At a news conference following the meeting, McClellan said the number of people affected by the coverage gap this year will be lower than previous estimates. He did not offer an exact figure but said it was expected to be fewer than the 3 million individuals estimated in a recent Health Leadership Council study conducted by PriceWaterhouseCoopers.

As for the data-processing glitches, McClellan said the problems will be resolved by next month.

Senate Finance Chairman Charles Grassley, R-Iowa, said McClellan and Barnhart "demonstrated a good faith effort to solve those problems," adding, "I think we're working things out."

Finance ranking member Max Baucus, D-Mont., was more pessimistic. "I expect more problems like this down the road," he said, blaming the Bush administration for creating an "unnecessarily complicated" drug program.

The urgency to resolve the problems is increased by the upcoming open enrollment period, which begins Nov. 15. In addition, McClellan announced this week that he will leave the agency next month, and the administration has not announced his replacement.

The most recent problems followed on the heels of a widely publicized processing error that resulted in CMS erroneously sending refunds of drug benefit premiums to more than 230,000 Medicare beneficiaries. CMS was forced to apologize and request that the payments, which averaged $215 and totaled almost $50 million, be returned to the federal government. Beneficiaries also received a letter incorrectly stating that their premiums would no longer be deducted from their Social Security checks.

Finance Committee members expressed concern that the incorrect withholdings are a burden to constituents on fixed incomes. The problems affect some beneficiaries who are eligible for a low-income subsidy, with some of those low-income beneficiaries receiving reduced Social Security checks due to the error.

A spokesman for CMS said the number of low-income beneficiaries so affected is small.

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Senate panel OKs bill to establish Justice cold case offices

Kristen A. Lee — Fri, 04 Aug 2006 00:00:00 -0400

The bill, which passed by voice vote, was amended to authorize the inspectors general at federal law enforcement agencies to assign staff to investigate missing child cold cases.

The Unsolved Civil Rights Crime Act (S. 2679), sponsored by Sen. Jim Talent, R-Mo., and Chris Dodd, D-Conn., would establish an Unsolved Civil Rights Crime Investigative Office in the FBI's Civil Rights Unit to investigate unsolved civil rights-era cases that resulted in death.

The bill would also create an Unsolved Civil Rights Era Crimes Unit in the Justice Department's Civil Rights Division to prosecute cases in coordination with state and local officials based on the result of the investigation. Cases that investigators determine not to be murders would be referred to the Criminal Section of the Justice Department's Civil Rights Division.

The Justice Department unit would also be required to provide Congress with an annual status report on the cases under its jurisdiction.

The committee authorized a $5 million annual budget for each office and allocates a $1.5 million annual budget to the Justice Department's Community Relations Service to act as a liaison between law enforcement agencies and local communities affected by the investigations.

Talent said in a statement that his conversations with Alvin Sykes, president of the Emmett Till Justice Campaign, inspired the legislation. Till, a black teenager from Chicago, was brutally murdered in 1955 in Mississippi for allegedly whistling at a white woman.

An all-white jury acquitted the two white men indicted for the crime, who later confessed to the murder. The original defendants have since died, but the Justice Department reopened the case in 2004 in response to reports that others may have been involved in Till's death. The federal investigation was closed in 2005.

The successful prosecution of Edgar Ray Killen in 2005 for the 1964 murders of three Civil Rights workers -- Andrew Goodman, James Chaney and Michael Schwerner -- also drew the attention of Congress to unsolved civil rights-era cases.

"While we cannot bring back and make whole those who suffered and died at the hands of racists," said Dodd, "we can at least reaffirm our nation's commitment to seek the truth and make equal justice a reality."

An identical bill (H.R. 5236), sponsored by Reps. John Lewis, D-Ga., and Kenny Hulshof, R-Mo., has been referred to the House Judiciary Committee.

The committee approved a substitute amendment, introduced by Sen. Patrick Leahy, D-Vt., and John Cornyn, R-Texas, which incorporated the Missing Child Cold Case Review Act into the legislation. The amendment would amend the Crime Control Act of 1990 to authorize the inspectors general of federal law enforcement agencies to assign criminal investigators to work with the National Center for Missing and Exploited Children to investigate "cold cases" of missing children.

Current law prohibits inspectors general from activities outside of their statutory duties. The amendment would authorize investigators to collaborate with the National Center for Missing and Exploited Children on a voluntary basis.

"I understand that our inspectors general are eager to provide this assistance and I understand why," said Leahy. "These cases need to resolution. As parents and grandparent we all know that. What they need is legal authorization to be allowed to help. That is what my amendment provides."

At the request of the Justice Department, the substitute amendment also gave the Attorney General flexibility in distributing funds between the two civil rights crime offices and allows the Attorney General to allocate staff and resources to the offices based on the greatest geographical need. The amendment also added a 10-year sunset provision to the civil rights crime offices.

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