ProPublica: Health & Science

GAO Investigating Medicare Auditors

2008-08-22T15:15:00-05:00

by Sharona Coutts

We wrote yesterday about the new Medicare fraud scandal, and how agency officials allegedly pressured their private auditors to use questionable accounting methods, resulting in figures that greatly underestimated the extent of false and unsupported claims for medical equipment.

The information comes from a draft inspector general's report detailed in the New York Times.

While the report focused on just medical equipment fraud, the company that did the audits, AdvanceMed, actually has many more contracts with the Centers for Medicare and Medicaid Services (CMS), for similar projects to do with tracking down false and undocumented medical claims.

The Government Accountability Office told us they've begun investigating one of those other projects.

The Medicare Recovery Audit Contractor (RAC) program, which "employs private companies on a contingent-fee basis to identify and recover improper over and under-payments of Medicare funds," started as a pilot in 2003 and was extended in 2006.

The program ran into difficulties since contractors hired to detect fraud were allegedly using unqualified personnel and inconsistent methods. In mid-July, five congressmen wrote to the GAO complaining about the program and requesting an investigation.

GAO spokeswoman Kathy King told us few details about the inquiry are available at this stage because it is so new, but that the investigation will look at "the changes that CMS has implemented from the pilot program to the permanent program."

AdvanceMed was not one of the primary RAC contractors, but they did work as "validation contractors" on the project. Neither the GAO, nor the offices of the congressmen who requested the GAO report knew exactly what that role entailed, and AdvanceMed's Kaye would not comment.

AdvanceMed calls itself "one of the most successful companies in the Medicare Integrity Program," and it won last year's "Investigation of the Year Award" from the national Health Care Anti-Fraud Association.

In promoting the award, the company wrote: "Identifying and combating fraud, waste and abuse in the nation’s Medicare program is necessary in protecting our elderly population from unscrupulous health care providers who deliberately endanger patients’ lives to cheat the system."

AdvanceMed's Web site lists six projects on Medicare fraud, operating in 23 states. CMS is their most important client, according to AdvanceMed's head of operations, Phyllis Kaye.

Kaye wouldn't comment on the GAO investigation, nor on the allegations that CMS ordered her company to use incorrect accounting methods. (According to the Times, the inspector general's report said such an order might violate the law.)

"We are asked by CMS to refer all requests to them," she told ProPublica. "When you get a request from your client, that's what you do."

Medicare Scandal: Who Audits the Auditor?

2008-08-21T17:49:00-05:00

by Sharona Coutts

The New York Times got its hands on a draft inspector general's report that purportedly says Medicare officials pressured the agency's private sector auditors to ignore government accounting rules in a way that masked billions of dollars in potential fraud.

The fraud and unsupported spending relate to false claims for expensive medical equipment, like motored wheelchairs, which were delivered to some people who didn't need them and didn't ask for them, and whose doctors didn't request them.

Every time a manufacturer delivers a powered wheelchair, they can bill Medicare $2,500 and pocket the money. All those wheelchairs and other medical gadgets added up to $2.8 billion in taxpayer money that couldn't be properly accounted for, according to the Times.

One puzzling aspect of the story surrounds Medicare's private contractor, AdvanceMed, and why its auditors allegedly buckled to bureaucratic pressure. Though the firm estimated only about 7.5 percent of equipment claims might be fraudulent, the IG said nearly a third were tainted.

Sen. Charles E. Grassley, R-Iowa, said Congress might now investigate AdvanceMed.

Well, we've done a little investigating ourselves.

Turns out that AdvanceMed is a wholly owned subsidiary of technology giant, Computer Sciences Corporation. The company won last year's "Large Business of the Year" award from the Treasury Department.

CSC is a major government contractor: During the last five years, the company won $16 billion worth of federal work. In many contracts, there is either limited or no competitive bidding, according to USASpending.gov, which tracks federal spending.

AdvanceMed has received scant media scrutiny, despite being a major player in the government's bid to clean up fraud in the $456 billion Medicare program. Here's a link to the company's Web site, where you'll see that it has projects in more than 20 states.

AdvanceMed says it "performs a wide range of forensic functions in an effort to assure that taxpayer dollars are protected and that the Medicare and Medicaid programs maintain the highest degree of integrity."

Congress has tried to crack down on Medicare fraud for years with mixed results. In 2003, it launched a pilot program in five states "to detect and correct improper payments." One state was California, where doctors complained that the government's auditor -- not AdvanceMed -- used unqualified personnel and inconsistent standards.

Nevertheless, in 2006, Congress made the program permanent and ordered it extended to all 50 states by 2010.

We've put in calls to AdvanceMed's media office, and we'll let you know if and when we hear back.

U.S. AIDS Program Funds Questionable Drugmaker

2008-08-14T12:01:00-05:00

by Alexandra Andrews

Millions of taxpayer dollars have gone to an Indian pharmaceutical company under investigation by the FDA and the Justice Department for allegedly producing substandard drugs. Not only are some of these drugs sold in the U.S., but they are also bought and distributed throughout the world as a part of President Bush's AIDS initiative.

The President's Emergency Plan for AIDS Relief (PEPFAR) was established in 2003 to tackle the global AIDS crisis. PEPFAR is overseen by the U.S. Global AIDS Coordinator, Ambassador Mark R. Dybul, who reports directly to the Secretary of State.

On July 30, President Bush signed a five-year extension of PEPFAR, prompting the Wall Street Journal to note ($) that much of the $131 million in funding is spent (PDF) on generic drugs. This is a marked departure from PEPFAR's early -- and heavily criticized -- practice of purchasing only expensive, patent-protected, name-brand drugs.

Last year, PEPFAR allocated $9 million of those funds to Ranbaxy, India's largest pharmaceutical company, for its generic antiretroviral drugs (ARVs), which inhibit the growth of HIV/AIDS. In 2007 alone, more than 1.8 million packages of Ranbaxy-produced ARVs were delivered to the 15 most affected countries where PEPFAR concentrates its efforts.

Yet throughout 2006 and 2007, while Ranbaxy profited from PEPFAR funding and supplied millions of ARVs to AIDS patients, the FDA was investigating allegations that the company's generic ARVs might be of substandard quality.

The FDA first uncovered quality problems at a Ranbaxy plant in India in February 2006; four months later, it sent a warning letter to the company citing irregular markings on its generic ARVs taken from distribution warehouses in Uganda and Nigeria.

Now the Justice Department alleges that Ranbaxy submitted bogus data to the FDA in order to conceal the fact that its drug-manufacturing process violated FDA standards. A motion (PDF) filed on June 7 by the U.S. Attorney's Office in Maryland alleges that the company has engaged in a "pattern of systemic fraudulent conduct."

No formal charges have been brought against the company yet. Neither Ranbaxy's lawyer nor its spokesman have returned e-mails or phone calls.

Despite these serious allegations, Ranbaxy remains on the FDA's list of generic ARVs approved for PEPFAR, which the report refers to as the "most updated approvals."

How those drugs maintained their approval status and continued to be purchased through PEPFAR is not exactly clear. Last month, Rep. John Dingell (D-MI), chairman of the House Committee on Energy and Commerce, opened an investigation in order to find out.

An FDA spokesman declined to comment on why this drug is still being sold in the U.S. But he did explain that the FDA is not involved in the purchase or distribution of the drugs through PEPFAR. "We only expedite the approval process," he said. "Another agency pulls the trigger."

According to a spokeswoman at the Office of the Global AIDS Coordinator (OGAC), that task falls to the U.S. Embassy in each target country. "They put together a 'country operational plan' at the beginning of each fiscal year that describes how they're going to spend that year's funding," she said. When asked specifically about Ranbaxy drugs, she referred questions to the FDA.

But it isn't clear whether the U.S. Embassies were told of the Ranbaxy investigation or any potential adulteration of its ARVs. A spokesman at the Office of Global Health Affairs, a division of the Department of Health and Human Services, thought the FDA might have sent out an alert. But the spokesman at the FDA had never heard of that alert, adding, "FDA's only public comment at this time is to acknowledge that Ranbaxy is under investigation."

PEPFAR's management is widely dispersed –- it has seven primary implementing agencies –- which may explain some of the confusion over whether the embassies were notified. But even a spokesman for the program most directly involved with the embassies' drug purchases, the USAID-administered Supply-Chain Management System, did not know if the embassies had been notified about the Ranbaxy investigation.

The U.S. Embassies in Kenya, Nigeria and Uganda -- the countries that purchased the most Ranbaxy ARVs in 2007 -- did not respond to e-mails.

Coming This Week…

2008-08-04T16:22:00-05:00

by Matt Townsend

Monday, Aug. 4

The Seventh International AIDS Conference began Sunday and runs through Friday. You can follow the events here via live webcasts. During Sunday's opening ceremonies, United Nations Secretary General Ban Ki-moon called attention to the increase in AIDS cases among gay men.

Tuesday, Aug. 5

The Government Accountability Office plans to release a financial report on the Iraqi government's budget. The GAO recently released reports on Iraq reconstruction progress (PDF) and oversight (PDF).

Wednesday, Aug. 6

1:45 p.m. -- The American Enterprise Institute hosts a forum called "The Collapse of the World Trade Organization (WTO) Doha Round Trade Talks: Implications and Future Options." The featured speaker will be Warren Maruyama, the general counsel for the Office of the United States Trade Representative. Video will be posted after the event.

Friday, Aug. 8

12 p.m. -- On the day of the opening ceremonies for the Beijing Olympics, the Center for American Progress hosts an event on "Sports Doping and the Dawn of the Age of Enhancement" that will feature bioethicist Arthur L. Caplan. Video will be posted after the event.

Bush Administration Tries To Slow Workplace Toxin Rules

2008-07-23T16:18:00-05:00

by Robert Lewis

As the Washington Post reported this morning, the Department of Labor is trying to push through a rule that, health and safety experts say, would make it harder to protect workers from exposure to hazardous chemicals and toxins:

The agency did not disclose the proposal, as required, in public notices of regulatory plans that it filed in December and May. The text of the proposed rule has not been made public, but according to sources briefed on the change and to an early draft obtained by The Washington Post, it would call for reexamining the methods used to measure risks posed by workplace exposure to toxins.

In response to the Post's article, Congressman George Miller (D-CA) and Senator Edward Kennedy (D-MA) sent a letter to Labor Secretary Elaine Chao demanding information on the "secret" rule.

As the Post notes, rules are typically done by "agency officials [consulting] with staff members, lawyers and outside experts." But in this case, the Post says, the proposal did not go through the normal process and instead was drafted by a "political deputy in Labor's office of the assistant secretary for policy."

Celeste Monforton, a researcher at the George Washington University School of Public Health and former OSHA and MSHA employee, first flagged the proposed Department of Labor rule on July 8, in a blog post. At that time the only indication was a brief nine word description on the White House Office of Management and Budget's Web site. (Monforton also offered more commentary, and criticism of the proposal, in a blog post today.)

The current flap isn't the first time the Bush administration has come under scrutiny for slowing the safety rulemaking process. In March 2008 the Government Accountability Office released a report blasting the Environmental Protection Agency for failing to "routinely complete timely, credible assessments." At the Department of Labor itself, as the Post reported, the Bush administration has adopted "only one major health rule for a chemical in the workplace, and it did so under a court order."

The Department of Labor did not respond to requests for comment. If they do, we'll update the story. We're also trying to get the draft proposal itself. (The Post said it "obtained" the proposal but hasn't posted it.)

UPDATE 7/23: We've gotten a copy of the draft. We're looking it over now, but our source has asked us not to post the full draft for fear it could identify the person who leaked it.

UPDATE II 7/23: The Department of Labor got back to us.

The Democrats' claim of "secret" rulemaking is "very speculative," David James, the assistant secretary for public affairs said. If the Office of Managment and Budget approves the draft rule, it will be submitted to the federal register and opened to the public for comment.

"If they want to criticize the department over what's in the proposal, they'll have plenty of opportunity to do so," James said.

He wouldn't comment on any specifics in the draft or confirm details in the Post's story because of a departmental policy not to discuss rules under review.

VA’s Disjointed Accounting System Likely Misses Out on Billions

2008-07-21T11:01:00-05:00

by Matt Townsend

The Department of Veterans Affairs covers care connected to military service, but if a veteran has private health insurance that can pay for care not connected to a service disability, the VA can bill the insurer. Although the VA has more than doubled its collections from insurers since the mid-1990s, a little-noticed Government Accountability Office report recently found that the VA likely missed out on billions of dollars from insurers because of a disorganized, disjointed accounting system.

The GAO audited 18 of the 153 medical centers in the VA system and found $290 million in unbilled services from documentation, coding and billing errors and other reasons. The GAO also cited more than $1 billion in medical costs that the VA couldn’t give valid reasons for why they weren’t billed. And in a random sampling of 260 bills from across the entire system to third-party insurers, the GAO found that the VA collected only 47 percent of the money. (The GAO also probed VA’s collection methods in 1999 and 2004.)

“In the private sector, billing is their lifeblood," said Christopher Needham, senior legislative associate for the Veterans of Foreign Wars. "At the VA, there are no standardized procedures [for billing and collecting]."

Since a law in 1996 increased eligibility and access to VA services, the number of patients the VA serves has grown by nearly 50 percent, to 5.6 million last year. That growth has brought in higher-income veterans who have private health insurance and the potential for a lot more collections. But because VA facilities have their own billing methods, no one can estimate how much money could be collected.

"That's a collection question that we get asked a lot," said Stephanie Mardon, the deputy at the VA’s chief business office for revenue operations. "It's a challenge to determine the upper threshold."

A major hurdle for the VA has been that it was never created with a complex billing system in mind. The VA only began billing insurance companies in 1986 and that was on a small scale.

"It's not something we've been at for 30 years," added Mardon. "That's certainly why we strive to continue to improve businesses' processes."

One of the bright spots for the VA in the report was the performance of eight medical centers in the audited group that had their billing done at a consolidated patient account center (CPAC), which employed a contractor to train government employees to use private sector business practices. The CPAC, a pilot program started in 2005, does the billing for the eight centers at one location and had better collection rates and more accountability for the billing process.

A bill now being considered in the House of Representatives would create seven more CPACs in the next five years. The bill passed the Veterans Affairs committee last week. It has yet to be introduced in the Senate. As it stands, the CPAC audited by the GAO is the only one in operation.

Exploring the AMA’s History of Discrimination

2008-07-16T11:22:00-05:00

by Jonathan Sidhu

Last Thursday, the American Medical Association apologized for its history of discrimination against African-American physicians. The apology comes on the heels of a JAMA paper published ($) by a panel of independent experts, which among other things detailed how the AMA worked to close down African-American medical schools. We spoke with one of the paper's authors, Harriet A. Washington, who last year also won the National Book Critics Circle Award for "Medical Apartheid," a history of medical experimentation on black Americans.

Note: This is an edited transcript of the conversation.

What did the AMA apologize for?

The AMA apologized to black physicians specifically for a history of systematic exclusion of black physicians from the AMA and its constituent societies. In order to join the AMA for most of its history, you had to belong to a local medical society. Many of those local medical societies were closed to black physicians, particularly in the South. And this condition persisted right up to the civil rights era. The AMA countenanced this -- it refused to interfere or penalize those societies.

The AMA has also apologized for other decisions it made that marginalized black patients and physicians.

Why was the JAMA paper pursued now? And could you tell me about the process of putting together this historical inquiry?

In 2005, John Nelson, then-president of the AMA, visited the National Medical Association [which represents African-American physicians]. He gave a speech, and during that speech, he apologized personally. Now, because the AMA is a democracy, he could not presumed to be speaking for all of the AMA, but of course he was also AMA president.

However, the AMA could not issue an apology without going through certain procedures. And being scientists and physicians who are wedded to the concept of evidence-based medicine, they also would need documentation.

John Nelson wanted this history looked into, and yet he also understood it should not be the AMA that did the historical discovery -- that it should be independent experts. And I can say that since 2005, when we began writing the paper, we were given utterly free hand.

What was the actual mandate the AMA gave you in pursuing this paper?

That’s probably most indicative of their hands-off stance: they didn’t give us a mandate. They asked us to look into the history of black physicians and the American Medical Association. And it was we who decided how to form the paper, and it was we who decided that we wanted to submit it for publication.

Could you summarize the key findings of the paper?

Overall, the really important finding is that we took several signal events that not only dramatically illustrated the sort of bias and the sort of discrimination practice, but some of them had pretty clearly traceable long-term effects.

The AMA was founded in 1847. Shortly after the Civil War, black physicians tried to join it. They attended the annual meeting and tried to get seated as delegates and were rebuffed. And the reason given by the AMA, after the fact was, "We did not seat you because you come from groups and schools that admit women and that admit irregular practitioners."

But there were also representatives from other groups that included these kinds of irregular practitioners in their fold. They only castigated the black physicians.

And after refusing them admission, they went on to pass an addendum to their code of ethics indicating that they don’t practice racial discrimination, and that their only basis for excluding people was scientific accuracy and practice codes.

So, not only did they discriminate against the black physicians, but then they exonerated themselves for having done so.
Then you look a bit farther in the future, and you find that in 1910, the American Medical Association commissioned a report of all medical schools. They were very interested in lowering the number of physicians. They wanted to raise the professional stature of physicians, and they wanted to do that by exclusion. They commissioned Abraham Flexner to go to every medical school in the U.S. and Canada and make an assessment -- basically which medical schools should and should not be encouraged to continue. When Flexner did this, he deemed every black medical school substandard and recommended they all be closed, except for two, Howard and Meharry.

And he also went beyond that to stipulate that black physicians should only treat black patients, that black physicians should have their roles curtailed. And he warned that an essentially untrained Negro bearing an MD label is dangerous. So he looked on all black physicians with a jaundiced eye.

His recommendations were prophetic. All the black schools except for Howard and Meharry closed -- they could not attract funding any longer because of the damning indictment of them. And black physicians were indeed kept from specialties like surgery. They were kept from research.

This report was singlehandedly responsible for not only drastically lowering the number of black MDs but also for deranging the image of black MDs in the eyes of not only the white population in the U.S. but also the black population of the U.S.
Finally, during the civil rights era, things came to a head. We were seeing open warfare between black and white physicians. Black physicians picketed AMA meetings. Black physicians pushed legislation that AMA doctors were visiting Congress trying to get annulled. Black physicians wanted Medicare and Medicaid passed. But white physicians and the AMA, in particular, were damning it as "socialized medicine."

Black doctors who attended an AMA meeting in Atlanta were arrested by the police because the AMA luncheon was being held in a segregated cafeteria. When the AMA was asked for comment, they did not defend them. The AMA simply stressed the importance of adhering to the laws of the land. And of course segregation was the law of the land.

What sorts of responsibilities does the AMA have to correct the injustices it has committed?

The first important thing the organization has had to do it’s already done: and that is an apology. The apology is very important partly for cathartic reasons. It’s really important if you’re going to gain the trust of black physicians and black patients, to openly admit that you are divorcing yourself from the policies of the past. And that’s been done.

A few other things have also been done. There’s a commission to end health care disparities. It’s a multi-pronged attempt. They are pursuing research, legislation and changes in political practice, trying to end racial health disparities that are haunting the country.

For the future, what’s going to be very important, in my opinion, is for there to be efforts to recruit and retain black physicians not only in medical school but also in specialty practice.

Do you see the AMA serving as a model for other institutions and organizations in grappling with similar histories?

Well, I can certainly hope it will. It seems to me that there has been a trend of organizations making apologies for terrible behavior of the past. Of course, the key is for these apologies to be the prelude to real action. Words are very important sometimes -- in this case I think the words are very important -- but we will need to see more activity as well.

Big Pharma Limits Small Gifts to Doctors

2008-07-10T14:46:00-05:00

by Jonathan Sidhu

The U.S. pharmaceutical industry has announced a revised code of conduct for its dealings with health providers, reports today’s Wall Street Journal ($). While the voluntary code will ban giving pens, mugs and other small gifts to doctors, it won’t curb some of the more controversial and lucrative financial connections between doctors and drug companies.

The New York Times reports:

But the code provides no definite limits on the millions of dollars spent on speaking and consulting arrangements that drug makers have forged with tens of thousands of doctors. Nor does it ban the routine provision of office breakfasts and lunches, or the occasional invitation to educational dinners at fancy restaurants.

The move by the Pharmaceutical Research and Manufacturers of America, the industry’s trade group, comes amid increased scrutiny of the dealings between doctors and the pharmaceutical industry.

Sen. Chuck Grassley (R-IA) is sponsoring legislation that would require researchers to disclose fully any financial connections to drug companies. But one of the more striking examples he cited as illustrating the need for such legislation is in dispute.

Two weeks ago, Grassley asserted in a letter in the Congressional Record that a prominent Stanford University psychiatrist, Alan Schatzberg, did not fully reveal his financial interest in a company that manufactures one of the drugs he is investigating. Grassley contended that Schatzberg, in a disclosure statement to Stanford, said he held shares worth "over $100,000" in Corcept Pharmaceuticals, which produces an anti-psychotic drug called mifepristone.

Public filings with the Securities and Exchange Commission show that Schatzberg held more than 2 million shares of the stock with a value, as of June 12, of over $6 million. Schatzberg is the principal investigator of a National Institute of Health-sponsored study of mifepristone.

Stanford shot back with a letter that questions the factual basis of Grassley’s assertions. The university said that after Schatzberg filed his form, further questions were raised and the researcher disclosed in writing to Stanford officials the "actual value" of his Corcept stock. "Based on our extensive investigation to date, we believe that Dr. Alan Schatzberg, a member of the medical school faculty, has fully complied with the University’s rigorous conflict of interest policy," says a statement issued by the university. A spokesman for Grassley could not be reached late Thursday.

This isn't the first time Grassley has examined impropriety in financial dealings between researchers and the pharmaceutical industry. Last month he revealed that top child psychiatrists at Harvard University received millions in consultation fees from drug makers and didn’t disclose such dealings. Previously he reported that a University of Cincinnati psychiatrist received more than $100,000 from Astra Zeneca while studying an anti-psychotic medication manufactured by the firm.

Currently, the National Institute of Health requires researchers to disclose to their universities any “significant financial interest” that may affect the objectivity of their research studies. But the responsibility of evaluating such conflicts rests primarily with those institutions — not the NIH.

The NIH defines significant financial interest as a $10,000 payment or a 5 percent stake in an entity.

The institutions, which do much of their policing internally, must file the financial disclosures with the NIH and certify that their policies are consistent with NIH guidelines. But it is unclear if the NIH follows up on the disclosures. A January 2008 Department of Health and Human Services report found that the NIH could not provide an accurate count of financial disclosures between 2004 and 2006. The report also found that the financial disclosures often do not explicitly identify the actual conflict.

Update/Correction: This post initially erred in describing a disclosure statement filed with Stanford University by Dr. Alan Schatzberg. The researcher told the university that his holdings in a pharmaceutical company whose drug he was studying were valued at "over" $100,000. The post did not include a full account of the university's response to statements by Sen. Charles Grassley. Stanford said that after filing his disclosure form, Schatzberg told the university his stock was worth more than $6 million.

Report: Governments and Aid Agencies Overlook Disabled Refugees

2008-06-23T16:56:00-05:00

by Sheri Fink

In the chaos of disaster and war, governments and aid agencies have largely overlooked the needs of the estimated 2.5-3.5 million displaced persons worldwide who are disabled, according to a report released today by the Women's Commission for Refugee Women and Children and co-funded by the United Nations High Commissioner for Refugees.

"They've been so invisible to us," Dale Buscher, director of the Commission's protection program, told ProPublica. "Because of the lack of accessibility in many of these settings, these people are often housebound, so we haven't had a clear indication of how many people with disabilities are out there. When they're invisible and you don't have appropriate mechanisms for identifying them, you don't recognize the need."

Representatives of the Commission visited five countries and consulted with aid officials in several others. They found numerous problems, including:

refugee camps where toilets, shelters and health facilities were inaccessible for people with mobility and sensory impairments
refugee registration drives that missed counting people with disabilities
exclusion of people with disabilities from income generation programs, vocational training programs, and decision-making activities for their communities.

In war-torn Darfur, elderly people and people with disabilities were left out of food aid distributions, leading to malnutrition and health problems. Awareness of the needs of displaced persons living in urban environments was generally even poorer than in refugee camps. However the researchers reported a few positive findings - many children with disabilities were attending primary school in refugee camps, and some received additional support and rehabilitation services.

The Women's Commission has produced a resource kit (pdf) to give humanitarian workers concrete guidance on how to better include those with disabilities in their programs.

Although the report focuses on foreign countries, its message is equally applicable to disaster preparedness and response in America: When crisis strikes, those who most need assistance will often have the hardest time accessing it. Too often, they have been overlooked.

FDA Failing on Food Safety, Needs Money

2008-06-13T11:43:00-05:00

by Joaquin Sapien

As the Food and Drug Administration continues its investigation on the source of salmonella-tainted tomatoes that have sickened 228 people across the U.S., a Government Accountability Office report released yesterday noted that the FDA has failed to implement a November 2007 food protection plan designed to stop such outbreaks before they begin. Key senators had actually pushed to fund the plan, but the FDA was initially unresponsive.

The same month that the food safety plan was released, the FDA's Science Board concluded that the administration lacked the staff and financial resources to implement it, saying that the plan would require an increase of $128 million in fiscal year 2009 alone. Yet despite the need, FDA chief Andrew von Eschenbach at first refused to tell Congress what he would need to implement the plan. It was only after a plea from Sen. Arlen Specter (R-PA) asking the commissioner how much money he wanted to "protect the public's health" that Eschenbach reversed his stance, and requested $275 million.

On Monday, Health and Human Services Secretary Michael Leavitt announced a formal request to include an additional $275 million for the FDA's fiscal year 2009 budget. Frustrated that this money would not get into the FDA's hand for another year, Specter wrote a letter to Leavitt, stating this "submission undermines the work we have been doing to obtain these additional dollars on an expedited basis." Specter's initial offer would have gotten the FDA the money by the end of September.

As The Wall Street Journal reported on its health blog, the FDA may have been reluctant to initially tell Congress exactly how much money was needed because of an obscure Office of Management Budget rule that prohibits a federal agency from publicly disagreeing with the President's budget request.