May 28, 2008
 
A summary of daily news relevant to the federal workforce produced by the Partnership for Public Service.

1. FDA, Medicare to Form Early-Warning Drug Network 
2. Federal Diary: Lawmakers Question Duplicative Retiree Drug Coverage
3. Court Rules for Older Federal Workers in Discrimination Case
4. Survey: Many Government Contractors Unaware of 'Green' Technology  

FDA, Medicare to Form Early-Warning Drug Network

Los Angeles Times

By Ricardo Alonso-Zaldiva

 

Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced a joint venture Thursday that promises to improve prescription drug safety for all Americans, while potentially reducing wasteful spending on medications.

The Food and Drug Administration and Medicare agreed on rules for using information from Medicare's giant claims databases to create a computerized early-warning network for problems with medications and medical devices that come to light after they go on the market.

 

Though Medicare will not turn over individual patients' data to the FDA, the two agencies' computers will now be able to talk to each other, in effect, to pose and answer questions that may reveal potentially risky side effects in new drugs. Since pre-market testing usually involves a limited number of patients, serious problems sometimes become evident only after hundreds of thousands of people begin using a product.

The new system, called the Sentinel Initiative, will eventually include private insurers as well, to fill in information gaps about drugs that elderly patients don't use, such as contraceptives.

The FDA's current early-warning system is nowhere near as comprehensive as the new system is expected to be. It relies on self-reporting by drug makers, hospitals and doctors, and is believed to capture only 1% to 10% of problems. Since the elderly are the major consumers of medications, Medicare's trove of inpatient, outpatient and prescription plan data is considered particularly rich.

Health and Human Services Secretary Mike Leavitt compared the FDA's current safety system to "looking at the stars from your backyard with the naked eye." The new system will provide a precise telescope, he added, and "you will see the stars trying to send you messages."

Setting up the network will not entail any major new expense for technology, officials said. Instead, the main task involves getting data experts from both agencies to work together under a mutually agreed-on framework.

Sentinel could save money, said Kerry Weems, acting administrator of the U.S. Centers for Medicare and Medicaid Services, citing estimates that the cost of treating preventable drug reactions in the elderly is as high as $900 million a year.

"Our understanding of how well drugs work and how safe they are for the elderly or disabled has been limited," Weems said. "Clinical trials often exclude the very old, patients with multiple chronic conditions, and those taking multiple medications. Those cohorts comprise the vast majority of Medicare beneficiaries."

While collaboration between the FDA and Medicare sounds simple, it has taken years to bring this plan to fruition. The concept got a major push earlier in the Bush administration from Mark B. McClellan, who served as FDA commissioner and later as Medicare administrator. Congress included it in drug safety legislation passed last year.

The new system could shorten the time it takes to detect drug safety problems from years to months, McClellan said in an interview. "What will be possible with this broader framework will be much larger-scale analysis," he said. "It has the promise to detect potential problems far more quickly, and you can also learn about risks to particular groups of patients."

There has been relatively little criticism of the new approach.

However, privacy advocates are expected to scrutinize the rules for information-sharing between Medicare and the FDA, which will take effect in 30 days. And drug companies have expressed some concern, arguing that studies of large populations of patients in the real world are not as precise as controlled clinical trials, and could generate false alarms.

Janet Woodcock, who heads the FDA center that reviews new drugs, acknowledged that possibility but said the alternative was worse.

"We completely understand and agree that getting information in this way isn't as free of bias as what we get in a clinical trial," she said.

"However, in most cases, we don't have any way of getting this information at all right now."

The FDA is working on standards for interpreting the data, and Woodcock said she hoped that would reduce the chances of false alarms.

One of the major uses of the Sentinel network will be to address lingering doubts about new medications, Woodcock said.

For example, suppose that pre-approval clinical trials had raised suspicion that a new drug might pose a particular kind of risk, but not enough information could be gleaned from the trials to resolve the question with certainty.

In such a case, Woodcock said, the FDA would query the Medicare databases to see if patients who took the medication had bad reactions. The agency would get statistical answers, but no information on individual patients. However, public health agencies have authority under other federal laws to obtain private information in an investigation.

"Say we had a some hint or report that there was some adverse event that was distinctive," said Woodcock. "We could take that signal . . . and do a study. Though it wouldn't answer all the questions, it would provide a much better source of information, probably pretty rapidly."

 

Lawmakers Question Duplicative Retiree Drug Coverage

The Washington Post
By Stephen Barr
 
More than 200,000 federal retirees are enrolled in two government-sponsored prescription drug programs, and the duplicative coverage may cost more than $200 million annually, according to two House members.

The federal retirees are probably paying $60 million in unnecessary premiums, and taxpayers are providing $140 million in subsidies, Reps. Henry A. Waxman (D-Calif.) and Danny K. Davis (D-Ill.) wrote in a letter to Bush administration officials.

The prescription drug benefits are provided to federal retirees through the Federal Employees Health Benefits Program, or FEHBP, and Medicare Part D. Congress directed Medicare to coordinate benefits with other prescription drug plans, but Medicare and FEHBP "have not acted to require or ensure effective coordination of the drug benefits," Waxman and Davis wrote.

As a result, private insurance companies offering Medicare Part D coverage "appear to be reaping a $200 million windfall annually, paid for by the retirees and American taxpayers," they wrote.

Waxman chairs the House Oversight and Government Reform Committee, and Davis is chairman of the House federal workforce subcommittee. Both have jurisdiction over federal retirement benefits, including health-care coverage provided to civil service and postal retirees.

Their letter, dated May 12, went to Linda M. Springer, director of the Office of Personnel Management, and Kerry N. Weems, the acting administrator for the Centers for Medicare and Medicaid Services.

A spokeswoman for the OPM said the agency would not comment because a response was being prepared. CMS also is developing a response, a spokesman said.

In the letter, Waxman and Davis said briefings provided by the two agencies raised questions about whether taxpayer money was being wasted. Officials at the agencies, in discussions with the House committee, said there was almost no coordination between the two programs, the letter said.

For most federal retirees who are 65 and older, Medicare serves as the first payer on insurance claims. When Medicare added a prescription drug benefit in 2003, OPM officials said federal retirees didn't need to enroll in Part D and pay extra for prescription drug coverage because FEHBP benefits were better or equivalent to the coverage provided by Part D.

The OPM also said FEHBP and Medicare would coordinate drug benefits, but Waxman and Davis wrote, "this does not appear to be happening."

 

Court Rules for Older Federal Workers in Discrimination Case

The Associated Press 

 

The Supreme Court sided Tuesday with employees who faced retaliation after complaining about race and age discrimination in rulings that drew support from conservative and liberal justices.

The court, by a 7-2 vote, said a provision of the Civil Rights Act of 1866 covers claims of retaliation that follow complaints about discrimination on the basis of race.

In a 6-3 ruling, the court likewise held that the part of the major anti-age bias law covering federal employees also protects them from retaliation after complaining about discrimination.

Neither provision contains express prohibitions against retaliation.

But Justice Stephen G. Breyer, writing for the court in a case involving a black Cracker Barrel employee who was fired, said that previous Supreme Court decisions and Congressional action make clear that retaliation is covered.

The idea that a provision of the 1866 law, known as section 1981, "encompasses retaliation claims is indeed well embedded in the law," Justice Breyer said.

Business groups objected that the absence of an explicit prohibition on retaliation was significant and said employees should have to file suit under another law, Title VII of the Civil Rights Act of 1964. That law has a shorter deadline for filing suit and caps the amount of money that a successful plaintiff may recover.

The Bush administration was on the side of the workers.

The case grew out of the firing of a black associate manager at a Cracker Barrel restaurant in Bradley, Ill. The associate manager, Hedrick Humphries, asserted he was fired after he complained about race discrimination by other Cracker Barrel supervisors.

Mr. Humphries filed a lawsuit claiming both discrimination and retaliation. Both claims were dismissed by a federal judge and only the retaliation claim was appealed.

The United States Court of Appeals for the Seventh Circuit in Chicago said Mr. Humphries could pursue his retaliation claim under section 1981. The high court upheld the appeals court ruling.

In the age retaliation case, Justice Samuel Alito's majority opinion concluded that a Postal Service employee could pursue her lawsuit under the Age Discrimination in Employment Act.

The law does specifically bar reprisals against private sector employees who complain about discrimination. But it is silent as to federal workers. Justice Alito said the law indeed does apply to both categories of employees.

The case involves Myrna Gomez-Perez, a postal worker in Puerto Rico who asserted she was being discriminated against because of her age. Ms. Gomez-Perez, who was then 45, said that after she filed a complaint with the Equal Opportunity Employment Commission, she suffered a "series of reprisals" from her supervisors.

She sued under the Age Discrimination in Employment Act, claiming retaliation in violation of the law.

The United States Court of Appeals for the First Circuit in Boston upheld a lower court's dismissal. The Supreme Court reversed that ruling Tuesday.

The administration, which is backing workers in other age bias cases at the high court, said the Employment Act does not afford federal workers protection from retaliation. It said Congress could have extended protections to federal workers, but did not.

Justices Antonin Scalia and Clarence Thomas dissented. Chief Justice John Roberts joined them in the age bias case, but sided with the majority in the Cracker Barrel case.

Both decisions relied, in part, on a 2005 ruling that called retaliation another form of intentional, unlawful discrimination under Title IX, which bars sex discrimination in education. Title IX also does not explicitly talk about reprisals.

Survey: Many Government Contractors Unaware of 'Green' Technology

Washington Business Journal
By Tierney Plumb

Half of today's government work force appears unfamiliar with the concept of "green" information technology, according to a new survey.

Less than 20 percent of federal workers surveyed by 1105 Government Information Group said their organization has measurable goals or outcomes related to green technology initiatives and products.

"Although environmentalism and green business are on the minds of public sector professionals, and the general public, this survey indicates that only half of government employees are familiar with the concept," said Christina Condos, vice president of events for 1105 Government Information Group.

1105 Government Information Group, a provider of integrated information and media to government agencies, surveyed 268 public sector workers.

The group produced Tuesday's Green Computing Summit held at the Ronald Reagan Building in D.C., where members of the General Services Administration and the Department of Energy discussed ways to reduce energy use, carbon emission, and costs through such initiatives as the Energy Star and EPEAT programs.

The random survey sample came from Federal Computer Week and Government Computer News subscribing senior executives, program managers, and technical managers.