Government Executive - Authors - Julie Rovner

What’s it really like to be HHS secretary? Three who’ve done it spill the beans

Julie Rovner and Emmarie Huetteman — Sat, 24 Jun 2023 14:29:17 -0400

As the nation’s top health official and leader of one of the federal government’s largest departments, the secretary of Health and Human Services makes life-or-death decisions every day that affect millions of Americans.

But not all important work is serious.

One former HHS secretary, Kathleen Sebelius, recalled a highlight of her tenure: recording a public service message with “Sesame Street.” “The Elmo commercial was to teach kids how to sneeze,” she said. “We were trying to spread good health habits.”

The script called for Sebelius to ask her co-star to “bend your elbow and sneeze into your arm.”

“Elmo has no elbow,” the beloved red Muppet replied, veering off script. So, Sebelius said, they swapped roles: “Elmo taught me how to sneeze.”

Her story punctuated a rare, intimate conversation Wednesday with three HHS secretaries, past and present — and across party lines. Secretary Xavier Becerra, the agency’s current leader, joined Sebelius, who worked under then-President Barack Obama from 2009 to 2014, and Alex Azar, who worked under then-President Donald Trump from 2018 to 2021. Their candid discussion took place at Aspen Ideas: Health, part of the Aspen Ideas Festival, about the job each of them held.

The panel discussion, taped in Aspen, Colorado, before a standing room-only crowd, was hosted as a live episode of KFF Health News’ weekly policy news podcast, “What the Health?,” and is now available to stream.

Becerra, Azar, and Sebelius spoke not only about the common bullet point on their resumes, but also about their shared understanding of what it means to lead the agency at a time when health is at the front of American minds — and in the crosshairs of American politics. Becerra and Azar have led HHS during the covid-19 pandemic, and Sebelius was in charge during the implementation of the Affordable Care Act.

They offered frank and at times strikingly similar perspectives on leading a department with more than 80,000 employees; a budget of more than $1.5 trillion; and an agenda most often set by outside events or their boss at 1600 Pennsylvania Ave.

Azar, who described fielding “two to five” daily phone calls from Trump, which could come at nearly any hour, said he started his days huddling with senior staff “to discuss what could hit us in the face today.”

“The White House is not a patient place,” said Becerra, who described losing 11 twin towers’ worth of Americans to covid-19 every day when he took the reins. “They want answers quickly.”

“It truly is life and death at HHS,” Becerra added. “The gravity, it hits you. And it’s nonstop.”

The panel offered some behind-closed-doors takes on today’s top issues, including the bruising fights over skyrocketing drug prices under Trump and ACA contraceptive coverage under Obama.

Deciding which “hills do you die on” was Azar’s top challenge as HHS secretary, he said. “When do you fight and when do you not fight with, say, the White House?” He pointed to his push to eliminate drugmaker rebates paid to health plans and pharmacy benefit managers, which drugmakers and others have criticized for driving up drug costs.

“I left a lot of blood on the field of battle just to try to outlaw pharmaceutical rebates,” he said.

All three secretaries agreed that one of the least understood but most important aspects of the department’s work happens outside the United States, performing what Sebelius called “soft diplomacy.” While many countries are loath to welcome officials from the State Department or the military, “they welcome health professionals,” she said. “They welcome the opportunity to learn.”

Asked what they felt unprepared for when they got the job, Azar — who had worked at HHS previously as general counsel then deputy secretary — replied: “The Trump administration.”

Coming from the administration of former President George W. Bush and later a stint as president of the U.S. division of the drugmaker Eli Lilly, Azar said he was “used to certain processes and ways people interact.” Working in the Trump administration, “it was different.”

The atypical assembly of current and former political appointees also offered a chance for some unusually friendly banter.

Becerra noted that one reason he was familiar with HHS programs was because he had filed numerous lawsuits challenging the agency’s actions when he was attorney general of California.

“Oh, he sued me a lot,” Azar quipped, as the group laughed. “Becerra v. Azar, all over the place.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Collins’ Skillful Piloting Helped NIH Steer Clear of Political Minefields

Julie Rovner, KFF Health News — Thu, 07 Oct 2021 12:30:56 -0400

It’s remarkable that the reputation of the National Institutes of Health has remained mostly intact through the covid-19 pandemic, even as other federal science agencies, including the Food and Drug Administration and Centers for Disease Control and Prevention, have come under partisan fire.

That is in no small part due to NIH’s soft-spoken but politically astute director, Dr. Francis Collins. The motorcycle-riding, guitar-playing Collins announced Tuesday he will step down by the end of the year from his job as chief of the research agency, having served more than a dozen years under three presidents.

“No single person should serve in the position too long,” said Collins in a statement, and “it’s time to bring in a new scientist to lead the NIH into the future.” Collins, 71, said he plans to return to his lab at the National Human Genome Research Institute, which he led for 15 years, from 1993 to 2008. Under his leadership, the institute successfully mapped the human genome, and Collins helped shepherd through Congress legislation to protect the privacy of individuals’ genetic information.

The big question now is not just who will fill Collins’ big shoes at NIH, but whether the agency can maintain its status as a political favorite among members of both parties. Under Collins’ stewardship, NIH’s budget has increased by more than a third during a time of mostly flat federal health budgets, and political interference with biomedical research has been, if not nonexistent, at least mostly off the front pages. That’s in sharp contrast to the CDC, whose handling of the pandemic has drawn plenty of criticism under both Presidents Donald Trump and Joe Biden, and the FDA, which tallied its own covid missteps and remains without a nominated commissioner nearly 10 months into the new administration.

While Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, has maintained a much higher profile than Collins and also courted controversy, most of that flak did not redound to NIH as a whole.

President Joe Biden praised Collins, calling him “one of the most important scientists of our time.” Noting Collins’ work on the human genome and his help launching the Obama administration’s work on precision medicine, the Brain Initiative and the National Cancer Moonshot effort, Biden said, “Millions of people will never know Dr. Collins saved their lives.”

Accolades for Collins flowed in from the scientific community as soon as news of his impending departure was announced. “For more than a decade Dr. Collins has provided exemplary leadership and stewardship as head of the NIH,” said the American Cancer Society Cancer Action Network.

And the praise from politicians was distinctly bipartisan. Sen. Richard Burr (R-N.C.) said in a statement that Collins “led the NIH capably and admirably, leaving it better prepared to meet the challenges of the 21st century.” House Majority Leader Steny Hoyer was no less effusive, calling Collins “one of our country’s greatest public servants, having spent his career working to improve the health of all Americans and promoting cutting-edge research that extends our understanding of the human body and how to heal it.”

It is notable that the relative lack of controversy during Collins’ tenure has been the exception, not the rule, for NIH over the past half-century. Starting in the 1970s, every biomedical advance, from in vitro fertilization to fetal tissue and stem cell research to the cloning of Dolly the sheep resulted in intense political fights and blaring headlines.

In the late 1990s, Republicans led by then-House Speaker Newt Gingrich decided to make science funding a priority and spearheaded a doubling of NIH’s budget, an effort Democrats happily joined. But after that doubling, a stagnant NIH budget caused cutbacks in university research, creating controversy of its own, which Collins had to manage.

Controversy comes with the territory. “Anytime there’s controversy in science, NIH is going to be involved,” said Mary Woolley, president and CEO of Research!America, a science funding advocacy group.

What has set Collins apart, said Woolley, is his ability to communicate to transcend that controversy, “both in ways unexpected, like singing and riding motorcycles, and more traditional ways,” like dealing with lawmakers.

Dr. Ross McKinney, chief scientific officer for the Association of American Medical Colleges, agreed. “He’s just done a dynamite job at being effective at communicating with both sides,” he said. “He’s good with scientists, he’s personally Christian and religious, so he can speak to that side, as well.”

Both Woolley and McKinney said they are confident there are plenty of good candidates to lead NIH, although neither would name any. But McKinney said he hopes the NIH doesn’t end up with a void at the top like the FDA. “I think the FDA precedent is concerning,” he said.

Still, Woolley said, Collins is leaving the NIH in good shape. “The next leader will benefit from what he has done,” she said.

HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN’s chief Washington correspondent, Julie Rovner, who has covered health care for more than 30 years.

Subscribe to KHN's free Morning Briefing.

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Why Doesn’t Medicare Cover Services So Many Seniors Need?

Julie Rovner, KFF Health News — Thu, 12 Aug 2021 11:00:00 -0400

Sorry, Joe Namath. Despite what you keep saying in those TV ads, under Medicare, seniors are not “entitled to eliminate copays and get dental care, dentures, eyeglasses, prescription drug coverage, in-home aides, unlimited transportation and home-delivered meals, all at no additional cost.” But if Democratic lawmakers in Congress have their say, seniors could soon be entitled to some of those services.

Namath’s commercial is hawking private Medicare Advantage plans, which frequently do offer benefits traditional Medicare does not — in exchange for being limited to certain doctors and hospitals. “Traditional” Medicare does not cover many benefits used overwhelmingly by its beneficiaries, including most vision, dental and hearing care, and drug coverage is available only by purchasing a separate insurance plan — Medicare Part D.

But Democrats in the House and Senate plan to try to change that as soon as this fall. On Monday, Senate Majority Leader Chuck Schumer released an outline of a coming budget bill that includes a directive to the Senate Finance Committee to expand Medicare “to include dental, vision, hearing benefits.” The catch — all the Democrats in the Senate and almost all in the House will have to agree on the entire budget bill for it to become law.

Still, that raises a question about Medicare: Why has it taken so long to add such obviously needed benefits?

As with almost everything to do with the U.S. health system, the answer is complicated, and a combination of policy and politics.

“Medicare is the kind of program where you’d expect the benefits would be expanded over and over again. It’s popular, and benefits expansions poll well,” said Jonathan Oberlander, a professor of health policy at the University of North Carolina-Chapel Hill and author of the book “The Political Life of Medicare.” “It’s one of the great puzzles of Medicare politics: why benefit expansions have been so rare.”

In fact, in the 56 years since Medicare became law, only a few benefits have been added to the package, which was created to emulate a 1965 Blue Cross/Blue Shield plan. During the 1980s and ’90s some preventive care was added, like pneumonia vaccines and mammograms. Republicans spearheaded the addition of prescription drug coverage in 2003, when they controlled both Congress and the White House. But they decided to make that coverage separate from the program’s traditional benefit package.

Other efforts to expand benefits have not gone so well. In 1988, a bipartisan effort in Congress produced the Medicare Catastrophic Coverage Act, which would have added drug coverage to traditional Medicare and also would have plugged a hole: the fact that there is no limit on the amount patients can be charged for their share of covered services. That law, however, was repealed just a year later after seniors rebelled against being asked to foot most of the bill for the new benefits via a new income “surtax.” Today, Medicare beneficiaries still face the risk of unlimited expenses.

Medicare is funded by a combination of money paid directly to the government from paychecks and taxes paid by working Americans and their employers. That brings us to another big reason Medicare’s benefit package hasn’t been beefed up more — the cost of the current program.

“When Medicare was created, its architects assumed expansion, both in terms of population and in terms of benefits later,” said Oberlander. “They didn’t anticipate the shift in American politics to the right, and they didn’t anticipate that Medicare would be labeled a fiscal problem and that policymakers would be more concerned with avoiding the next trust fund shortfall than expanding benefits.”

Indeed, in the ’80s and ’90s, Medicare spending was more often restrained than expanded. A series of budget reconciliation bills trimmed millions of dollars out of Medicare — usually at the expense of payment to doctors, hospitals and other health providers.

As the years wore on, Medicare has remained popular, but it has grown less generous than most private insurance policies. Many Medicare patients, however, have been able to find supplemental coverage to fill in what Medicare does not cover, through private “Medigap” policies, employer-provided retiree plans or Medicaid for those with low incomes. Increasingly popular in recent years have been those Medicare managed-care plans, now known as Medicare Advantage, that were first authorized in 1982 and often provide extra benefits for members.

All of that “has taken some of the pressure off” lawmakers to expand the program, Oberlander said. And a final reason that vision, hearing and dental care have not been added to standard Medicare is that they are far from the most critical gaps in Medicare’s benefit package.

For example, Medicare does not cover long-term custodial care — the sort of non-nursing, personal care that provides assistance in activities of daily living such as bathing, dressing, eating, getting in or out of a bed or chair, using the bathroom or preparing food. Custodial care tends to be both very expensive ($50,000 to $100,000 a year or more) and needed by a large number of beneficiaries, particularly after age 80. Efforts over the years to create a government long-term care benefit have been largely unsuccessful. A very limited program, the CLASS Act, was part of the Affordable Care Act in 2010 but was repealed before it could take effect because its financing was deemed insufficient. President Joe Biden has called for Congress to include billions of dollars for caregiving in the infrastructure package Democrats will work on this fall.

Also, as previously mentioned, traditional Medicare includes no limits on patient cost sharing — the percentage or amount of a medical bill that a beneficiary must pay. Its basic hospital benefit runs out after 90 days, and the 20% coinsurance (the percentage patients are responsible for) on outpatient care runs indefinitely.

So why are dental, vision and hearing coverage on the front burner now as lawmakers consider beefing up the program? Part may be self-serving for lawmakers tasked with appropriating funds. All three benefits “are less expensive than [adding] nursing home” coverage, said Oberlander.

But a big part is politics. On the campaign trail, Biden promised to lower Medicare’s eligibility age from 65 to 60. “Medicare for All” advocates like Senate Budget Committee Chair Bernie Sanders (I-Vt.) pledged to try to do the same, and lowering the eligibility age is included in the outline Schumer shared with Senate Democrats as an option.

But lowering the eligibility age is vehemently opposed by hospitals and other health providers, who fear they will lose money if people currently covered by higher-paying private insurance are covered by Medicare instead. That makes benefits expansion the much easier choice for Congress.

That is not saying it will happen. The Congressional Budget Office said the vision, hearing and dental benefits included in a bill passed by the House in 2019 would have cost an estimated $358 billion over 10 years. But this is the closest the benefits have gotten to enactment since Medicare’s inception.

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Medicare beneficiaries sent empty envelopes

Emily Heil and Julie Rovner — Wed, 08 Jun 2005 00:00:00 -0400

After its first mass-mailing late last month -- part of a complicated effort to reach 4.7 million low-income beneficiaries -- the Centers for Medicare and Medicaid Services received several calls about errors in the mailings.

"CMS has become aware that, in some cases, the intended recipients of the letters received empty envelopes," stated a Medicare posting on a drug-benefit listserve. "We believe this is a very limited problem and a random one that is not concentrated in any given state."

A Medicare spokesman said Tuesday that the number of such envelopes may be small, and called it an "apparently very tiny problem." But the posting noted that even if only one-tenth of one percent of the envelopes mailed had problems, 6,000 people would be affected.

The spokesman also noted that the letters were being sent to those who will be automatically enrolled in a drug-benefit plan -- people eligible for both Medicare and Medicaid known as "dual eligibles" -- and that the mailings were intended only to inform them about the new benefit. Medicare will be contacting those people again in the fall.

But the mishap underscores the difficulty that Medicare faces in reaching out to a notoriously hard-to-reach community: poor seniors. Medicare is relying on a small army of partners, including community groups, the AARP and the Access to Benefits Coalition, to help them get the message out to beneficiaries.

Dual-eligibles get the most help in paying for their drugs under the new benefit, and they will be randomly enrolled in a plan unless they choose one themselves. But education also is important for regular Medicare beneficiaries, most of whom will not be automatically enrolled in a plan. If seniors do not elect a drug plan by the middle of 2006, they might be penalized.

Meanwhile, CMS Administrator Mark McClellan visited a House GOP leadership meeting on Capitol Hill Tuesday to brief lawmakers about Medicare's plan to educate seniors about the new drug benefit and to coordinate efforts to promote it.

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FCC asked to investigate agencies' video news releases

Julie Rovner and Drew Clark — Thu, 17 Mar 2005 00:00:00 -0500

Clips of videos created by federal agencies have been broadcast frequently on local news programs without reference to the fact that they were produced by the government, according to press reports.

"Certain broadcasters are editing government-created VNRs to make it appear as if such information is the result of independent news-gathering," Inouye said in a letter sent Tuesday to the FCC and released Wednesday.

He added that it "seems to violate FCC rules requiring attribution for the airing of 'any political broadcast matter' or 'the discussion of a controversial issue of public importance.' "

Asked about the practice at a Wednesday news conference, President Bush said: "There is a Justice Department opinion that says these pieces are within the law so long as they're based upon facts, not advocacy. And I expect our agencies to adhere to that ruling, to that Justice Department opinion."

But he added: "I think it would be helpful if local stations then disclosed to their viewers that this was based upon a factual report and they chose to use it. But evidently in some cases that's not the case."

Health and Human Servics Secretary Mike Leavitt defended his agency's use of video news releases that are not clearly identified as government productions, despite a Government Accountability Office opinion that such communications violate a ban on propaganda.

At a Senate Labor-HHS Appropriations Subcommittee hearing, Leavitt said educating 41 million Medicare beneficiaries about the new prescription drug benefit that begins next year "is a very big challenge" and the department would use whatever means available to communicate needed information.

He said "we will follow guidance of our legal counsel," which differs from that of the GAO.

Labor-HHS Appropriations Subcommittee ranking member Tom Harkin, D-Iowa, got Leavitt to agree to provide the subcommittee with the budget for public relations, including contracts with public relations firms. The videos that GAO found inappropriate last year were produced by outside contractors.

Harkin said he did not object so much to the department producing such videos, but to the fact that they were not clearly identified as government-produced.

"We send out letters and information all the time," he said. "But at least we sign our names. Shouldn't HHS sign this stuff?"

Said Leavitt, who was not at the department during last year's flap over the Medicare information, "That seems like a logical approach."

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Panel chief calls for streamlining NIH structure

Julie Rovner — Thu, 17 Mar 2005 00:00:00 -0500

Zerhouni's appearance before the panel's Health Subcommittee was in anticipation of the first reauthorization for NIH since 1993, which Barton said he hoped to have ready for the House floor in the next two to three months.

"We've been working on reauthorizing NIH longer than some of us have been in Congress," noted Energy and Commerce Health Subcommittee Chairman Nathan Deal, R-Ga.

Barton said the agency's growth "has resulted in an almost random collection of structures in which largely independent institutes and centers are tasked to advance research programs not in cooperation with one another but according to diseases, organ systems or stage of life in which they specialize." While the 27 institutes sometimes work together, he said, "it defies reason to believe they will produce the efficiencies that can be achieved by a logically unified structure."

Barton envisions giving the NIH director more authority -- something Zerhouni readily agreed would help -- as well as streamlining its budget.

Congress has created more than 60 separate research programs, and appropriators fund 26 separate line items. Instead, Barton said Congress should consider "budget clusters" within NIH. He also suggested "a new, more transparent reporting system," to replace frequent congressional mandates for reports on specific diseases.

Zerhouni agreed that NIH must reorganize. With no change, he said, "the cost of practicing medicine ... will become unsustainable." The 21st century, he said, must become a time when doctors intervene before illness strikes, rather than after symptoms appear. But that will require research across institutes, he said.

"Right now we have a hand with 27 fingers, but I'm not sure the palm is as strong as it ought to be," he said.

Zerhouni is proposing an Office of Portfolio Analysis and Strategic Initiatives that he said would look agencywide to identify gaps or redundancies in research.

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Witnesses spar over FDA's effectiveness on drug safety

Julie Rovner — Thu, 03 Mar 2005 00:00:00 -0500

But a top FDA official said the agency already is moving to correct lapses that led to the withdrawal of the painkiller Vioxx last year after it was linked to increased risk of heart attack and stroke.

Health, Education, Labor and Pensions Committee Chairman Mike Enzi, R-Wyo., and ranking member Edward Kennedy, D-Mass., are working on legislation regarding FDA's approval process, although aides said there is no timeline for its completion. In the meantime, witnesses had plenty of suggestions.

"I have thought about this a great deal, and I do believe there's a crisis" in the FDA's approval process, testified Raymond Woosley, a professor of medicine and pharmacology at the University of Arizona. "Only 109 scientists monitor the safety data from over 3,000 prescription drugs. Where a complete system of drug safety surveillance is needed, the FDA is forced to rely on its voluntary reporting system for adverse events," he said.

Bruce Psaty, professor of Medicine and Epidemiology at the University of Washington, agreed. "Your committee did good work correcting the drug lag" by passing the Prescription Drug User Fee Act in 1992, which sped up the drug approval process, he said. "But now we have a safety lag."

FDA Acting Deputy Commissioner for Operations Janet Woodcock said agency officials already spend half their time on safety issues, and that new information about drug dangers "is not a cause for dismay" but rather evidence of medical progress.

"Our approval process is the strongest it's ever been," she said. If the agency took only safety into account, "We wouldn't have any drugs because all of them have risks."

Woodcock also said the agency is taking steps to combat allegations of "intellectual bias" that might lead FDA officials who approved a drug to disregard later evidence of safety problems. She said safety boards outside the agency are a bad idea. Surveillance of drugs "is a continuum between pre-market and post-market" activities, she said, and the same people should be involved.

Woodcock also said she is less concerned about direct-to-consumer advertising, which has been blamed for millions of patients taking Vioxx who did not really need it, than about the level of direct-to-physician marketing done by drug companies. "That has more impact on doctors' prescribing practices than direct-to-consumer ads," she said.

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Gingrich calls for 'virtual public health service'

Julie Rovner — Thu, 15 Jul 2004 00:00:00 -0400

"Paper kills," Gingrich told the House Government Reform Technology Subcommittee. "Paper prescriptions kill. Paper records kill. And if there's a public health emergency, paper will kill a lot of people," he said.

Gingrich said the nation needs to create "a virtual public health service" that ties together literally every health facility. In the case of a major nuclear event, he said, officials would need to mobilize every nursing home and long-term care facility as well as every veterinarian's office, "because all the downtown hospitals will be gone."

The federal government's main responsibility, Gingrich said, is to set standards for systems to be able to communicate with each other.

Otherwise, he said, "it will be like the beginning of the railroad era, where you had to change trains at every state line" because the tracks were different sizes.

Gingrich also said that the federal government should commit 1 percent of health spending toward improving health information technology. "If you did that, within three to four years you'd be in a different world," he said, with not only fewer medical errors and better data for research, but also lower costs.

"I can't understate the importance of forcing [the Congressional Budget Office] and [the Office of Management and Budget] to calculate what we're wasting now" with paper-based records systems. "It's inconceivable" that moving to electronic systems will not save money, he said.

Other witnesses at the hearing said the federal government is making slow progress toward more electronic-based records. "The federal government is taking a leadership role in setting a national strategy and implementing standards," said GAO's David Powner. But implementing those standards, he said, "remains a work in progress."

Richard Weisman, director of Florida's poison information center, testified about what happens when health facilities cannot communicate during a crisis.

After anthrax was discovered at the Florida offices of American Media International in 2001, he said, it took 36 hours for the Centers for Disease Control and Prevention to provide a fact sheet to his facility, well after panicked patients began showing up at physicians' offices and hospitals around South Florida.

"Not knowing if this valuable fact sheet was going to get to the emergency room physicians, we faxed the document to every emergency department. We subsequently learned that only half of hospitals ever received the fact sheet from the CDC and 10 percent never received the copy we faxed to the ER," he said in his statement.

CDC's Claire Broome told the subcommittee the federal government's new Public Health Information Network should address those difficulties.

The network's goal, she said, is for state and local health departments, clinical care facilities, federal agencies, public health laboratories, and law enforcement agencies all to be able to communicate with each other "in real time."

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Lawmaker weighs bill to address NIH conflicts of interest

Julie Rovner — Thu, 08 Jul 2004 00:00:00 -0400

An investigation of NIH has uncovered cases of questionable awards and speaking fees given to scientists involved in grant-making and the extensive use of a federal law that allows higher salaries for temporary employees. After a series of discussions, NIH Director Elias Zerhouni is making changes, Greenwood said, including barring awards to scientists involved in the grant-making process.

These changes also include forbidding some scientists from serving on corporate boards or owning stock in drug or biotechnology companies, and increasing public disclosure of their outside income. Greenwood said he wants to remove existing salary caps and "let it go to market rate" but with an open and transparent system.

"I want to set up a system in which you ought to be able to pay people what you need to get them," he said.

Finding a vehicle for such legislation could be difficult. The obvious place would be an NIH reauthorization bill, which Energy and Commerce Committee Chairman Joe Barton, R-Texas, has said he wants this year.

"So would I," said Greenwood. "I'd like to fly, too. But I don't think it's going to happen."

He said an NIH bill faces not only a fight over embryonic stem cell research but also "people will want to play the 'don't study sex' game," a reference to social conservatives' questioning of some NIH grants.

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NIH under fire for alleged conflicts of interest

Julie Rovner — Thu, 13 May 2004 00:00:00 -0400

At that hearing, Energy and Commerce Oversight and Investigations Subcommittee Chairman Jim Greenwood, R-Pa., accused lawyers from the Health and Human Services Department of "slow-rolling" subcommittee requests for information about scientists accepting consulting contracts or other forms of compensation from drug and biotechnology companies.

Greenwood said the practice -- which in many, if not most, cases is legal -- amounts to a "swivel chair" rather than a revolving door, but one that threatens the agency's appearance of impartiality.

Greenwood said since subcommittee investigators have not yet received the specific information requested from HHS about amounts scientists have received, he will ask drug companies themselves to provide it. HHS officials say in many cases, scientists are not required to disclose their outside arrangements to the agency.

That is likely to end, said Energy and Commerce Chairman Joe Barton, R-Texas, who noted NIH has not been formally reauthorized in more than a decade, and he intends to try to rectify that this year.

In the meantime, he said, NIH is going to cooperate with the investigation. "They can cooperate cooperatively or we will make them cooperate coercively," Barton said.

Democrats were equally angry at reports some NIH scientists have taken hundreds of thousands of dollars from private firms over the past decade, and recent efforts to rein in the practice have produced only modest proposals for change.

"It appears the leadership of NIH may have fallen victim to a disease itself, and that disease is greed," said Oversight and Investigations Subcommittee ranking member Peter Deutsch, D-Fla.

NIH Director Elias Zerhouni, who appeared before the panel for the first time since the investigation was launched, defended the steps he has taken, including creation of a new NIH Ethics Advisory Committee to oversee outside activities.

But he defended the need to allow NIH employees to continue to receive outside income, so the agency recruit and retain the best scientific minds and to further NIH activities.

"Collaborations with the nongovernmental research community are vital, not only for understanding and advancing science, but for translating our knowledge into actual medical practice and treatment," he said.

Zerhouni said banning all outside activities "would be bad for science, unfair to the employees and ultimately hinder our efforts to improve the nation's health."

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HHS chief unveils electronic medical records initiative

Julie Rovner — Fri, 07 May 2004 00:00:00 -0400

"We need to get it done, and we need to get it done now," Thompson said at an HHS-sponsored information technology summit attended by health system leaders and technology company representatives.

Thompson said a good information technology system "could save our economy, conservatively, $140 billion a year. That's 10 percent of what we spend right now [on health care]."

At the summit, Thompson announced that the international health group HL7 has approved standards and a model for an electronic health record, which he termed "a critical first step" toward development of an "interoperable" system that will let different health facilities talk to each other.

Thompson also announced that copies of "SNOMED CT," a standardized electronic medical vocabulary program HHS has licensed from the American College of Pathologists, will be available for free from the National Library of Medicine.

Helping the health care system find ways to collect and share information electronically is one of the few areas of significant bipartisan agreement in Congress this year.

In an interview with health reporters Wednesday, Sen. Hillary Rodham Clinton, D-N.Y., called legislation to help facilitate the transition "a no-brainer. The health care system is the least savvy and technologically advanced of our sectors."

At the HHS summit, House Ways and Means Health Subcommittee Chairwoman Nancy Johnson, R-Conn., said development of an information technology infrastructure is critical to the nation's ability to realize the cost-saving potential of things like disease management.

Having a system that protects privacy, yet is able to transmit needed information "is the key to whether the health care system moves forward or back," Johnson said.

Former House Speaker Newt Gingrich challenged those attending the summit -- and federal officials -- to move aggressively. "Grow what already exists. Don't spend 10 years inventing the future," he said.

Gingrich suggested that incoming Medicare beneficiaries who receive "welcome to Medicare" physicals starting in 2005 also be given electronic medical records.

"We should never have a 'Welcome to Medicare' physical that's paper-based," he said.

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Ex-Medicare chiefs say agency managers face massive task

Julie Rovner — Thu, 08 Apr 2004 00:00:00 -0400

"This is a very tight squeeze," Gail Wilensky, who ran Medicare in the first Bush administration, told the Senate Governmental Affairs Government Management Subcommittee. "Controversial regulations are very difficult to deal with." She responded to panel members' complaints about the length of the period between passage of the law and the start of the drug benefit by pointing out that "corporate America does not have to go through the Administrative Procedures Act process."

The Clinton administration's Medicare chief, Nancy-Ann Min DeParle, said that she was also concerned about the regulatory process, but that she was even more worried about some of the actions that would need to occur once the regulations were written -- including the bidding process for plans and beneficiary education. "There are a lot of details that will have to be final when [beneficiaries] get that piece of paper in the mail" in October 2005, she said.

Both Wilensky and DeParle warned about a continuing "brain drain" at the Centers for Medicare and Medicaid Services. An estimated 30 percent of its senior career employees are eligible to retire, said Government Management Subcommittee Chairman George Voinovich, R-Ohio, and in the last three years, a quarter of its career executives have left.

DeParle added that while the Senate should be commended for its quick confirmation of Mark McClellan to head the agency, she remained worried about the impending departure of Health and Human Services Secretary Tommy Thompson, who has announced he will leave after the November election. When she was struggling to implement the more than 400 separate changes imposed by the 1997 Balanced Budget Act, DeParle said, "I relied heavily upon Secretary [Donna] Shalala's judgment and especially her support in marshaling the resources of the department to get things done."

Michael McMullan, a career CMS employee, who is overseeing implementation of the new drug discount cards, acknowledged in her testimony that the new law would require the agency to acquire expertise it currently lacks -- including hiring personnel who understand pharmacy benefits management and disease management, as well as information technology personnel "experienced with the types of payment systems contemplated by the law." McMullan added that the agency "is making good headway" with the enormous task before it.

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HHS chief requests probe of Medicare employee's allegations

Julie Rovner — Wed, 17 Mar 2004 00:00:00 -0500

In a hastily scheduled, hour-long briefing with reporters, Thompson said he has asked the HHS inspector general to investigate allegations made late last week by Chief Medicare Actuary Richard Foster that former Medicare Administrator Thomas Scully threatened to fire him if he shared the administration's higher estimates for the Medicare bill with members of Congress.

Thompson also said he is planning to release those estimates to the numerous Congress members who have been asking for them. "They are being accumulated now," he said.

But he also defended his department's actions as completely proper and lashed out at Democrats who are suggesting otherwise. "I think [the new Medicare law] is going to be very well received, but right now it's being demagogued by everyone who can," Thompson said.

Thompson also took the offensive in regard to a "video news release" sent out by the department as part of its effort to educate the public about the new law. The VNR includes a fully produced segment narrated by Karen Ryan, who HHS officials called "a freelance journalist, not an actor," as was suggested in a story Monday in the New York Times. The VNR's production company, Home Front Communications, said it had hired her to read a script prepared by the government.

The General Accounting Office announced Monday night it is examining the videos to determine if they violate a federal ban on the use of taxpayer funds for propaganda. An earlier GAO examination of HHS television ads and a flier for beneficiaries found they contained "omissions" but were not so political as to be illegal.

At the briefing, HHS Assistant Secretary for Public Affairs Kevin Keane showed a strikingly similar video produced in 1999 by the Clinton administration on its plan "to strengthen and modernize Medicare," which also included a fully narrated segment. "It's much more overt than anything we have done," said Thompson.

Keane said with regard to the GAO inquiry, "We have a box of tapes from the previous administration we'll be submitting."

Thompson took pains to distance himself from the colorful and often outspoken Scully, who has left the department to take a job in the private sector.

As to Scully's refusal to let Foster share his estimates with Congress, Thompson said, "I have no restrictions on his dealing with members of Congress. Tom Scully did, but Tom Scully is no longer here."

When asked if he should have supervised Scully more closely, Thompson replied: "You all know Tom Scully. Do you think that would have been possible?"

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Despite 'omissions,' GAO says HHS Medicare ads are legal

Julie Rovner — Thu, 11 Mar 2004 00:00:00 -0500

The GAO undertook the legal analysis at the request of nine House and Senate Democrats, who said the ads were so misleading they violated a ban on tax-funded "publicity and propaganda."

GAO disagreed, although it noted the department has already changed some misleading references in the print materials and pointedly criticized running one of the ads in the newspaper Roll Call. "There are any number of more effective vehicles to communicate with members of Congress, and at less cost, than advertising in a newspaper," the analysis said.

GAO agreed with Democrats that the campaign fails to note such key details as the fact that beneficiaries will have to pay for the new "drug discount cards," and premiums will be raised for those who fail to sign up for drug coverage when it first becomes available to them. It found the theme of the campaign -- "Same Medicare. More Benefits" -- "may appear as an attempt to persuade the public to the administration's point of view regarding the newly enacted benefit."

At the same time, though, "the publicity or propaganda prohibition ... does not bar materials that may have some political content or express support for a particular view," GAO concluded.

HHS Secretary Tommy Thompson hailed the decision. "We're going to keep providing seniors with fact-based information on the new benefits under Medicare and give them straight answers to their questions," he said in a statement.

Senate Majority Leader Bill Frist, R-Tenn., also praised the findings. "This opinion clearly shows that HHS is following the spirit and letter of the law by providing seniors critical information," Frist said.

Democrats, however, continued to urge HHS to pull the ads. "Although the GAO report does not find the Medicare advertising campaign to be technically illegal, it recognizes that the ads are full of errors and omissions," said Health, Education, Labor and Pensions ranking member Edward Kennedy, D-Mass. "It's obvious that Medicare funds are being misused to pay for TV ads designed to highlight the president's defective Medicare bill."

Sen. Frank Lautenberg, D-N.J., said, "Legal loopholes aside, Secretary Thompson needs to pull these misleading ads now."

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House chair calls for cuts in unauthorized programs

Julie Rovner — Thu, 11 Mar 2004 00:00:00 -0500

Barton said a preliminary staff analysis has found that 93 health programs are currently being funded by appropriators without a formal authorization. "I don't think that's a responsible practice," he told the hearing's lone witness, Health and Human Services Secretary Tommy Thompson. "From my perspective, programs without authorizations should not receive the same funding priority" as other programs, Barton said.

Among the programs whose authorizations have lapsed are major portions of the National Institutes of Health, the Centers for Disease Control and Prevention, much of the Health Resources and Services Administration and parts of the Indian Health Service. Some programs, like the Title X family planning program, have not been reauthorized since the 1980s.

Thompson said he agreed that the programs "should be reauthorized -- in a systematic way."

While appropriators and GOP leaders in the House and Senate have been discussing trimming the budget by cracking down on unauthorized programs, Energy and Commerce Democrats were surprised that Barton would add his voice to the effort.

"I don't know what he's thinking," said Rep. Henry Waxman, D-Calif. "We'd be slitting our throats by saying 'Don't fund these programs we haven't gotten around to reauthorizing.' "

Public health programs "are all underfunded to begin with," said Energy and Commerce Health Subcommittee ranking member Sherrod Brown, D-Ohio. "President Bush's tax cuts have made it very hard to fund health programs."

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Medicare nomination may stall over drug 'reimportation'

Julie Rovner — Wed, 25 Feb 2004 00:00:00 -0500

Speaking Tuesday at a summit of governors and members of Congress who support allowing U.S. citizens to buy cheaper drugs from Canada and other countries that control prices, Dorgan said he wanted to know "what's going on over at the FDA" on the issue. Until he does, McClellan's nomination "is going to spend awhile" in the Senate, he said.

McClellan, President Bush's White House health policy adviser before taking over at FDA in late 2002, is popular on Capitol Hill. Bipartisan approval by the Finance Committee, which will consider the nomination, greeted the announcement last week that he would be appointed to head CMS.

McClellan is considered a steady hand both politically and substantively, something the agency needs as it implements last year's massive Medicare law.

But another bipartisan, bicameral group of reimportation advocates considers McClellan an enemy because of his uncompromising opposition on safety grounds to opening the closed U.S. regulatory system for drugs -- a position his predecessors also held.

"I can understand why we are fighting the drug companies," said Wisconsin Democratic Gov. Jim Doyle, who announced at the meeting that his state would expand the Web site it has set up to facilitate the purchase of Canadian drugs. "But I cannot understand why we are fighting the federal government."

If Dorgan follows through on his threat to delay the nomination, it will be déjà vu for McClellan: Sen. Jeff Bingaman, D-N.M., briefly held up his nomination to run FDA after a spat between Bingaman and HHS Secretary Tommy Thompson over Thompson's withdrawal of support for a Bingaman bill to make pregnant women, rather than fetuses, eligible for the State Children's Health Insurance Program.

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HHS Secretary to release original report on health disparities

Julie Rovner — Wed, 11 Feb 2004 00:00:00 -0500

Thompson said at a hearing of the House Ways and Means Committee that some individuals in the department "took it upon themselves to rewrite" the first annual National Healthcare Disparities Report. HHS released the report in December in what legislators charged was a censored fashion. "A mistake was made and it's going to be rectified," said Thompson.

Eight House members, led by Government Reform ranking member Henry Waxman, D-Calif., complained to Thompson in January that the report was "yet another example of the administration's manipulation of science to fit its political goals."

A study by Waxman's Government Reform Committee staff found, "HHS substantially altered the conclusions of its scientists on health disparities."

For example, in a June 2003 draft, the report "found 'significant inequality' in health care in the United States, called healthcare disparities 'national problems,' emphasized that these disparities are 'pervasive in our healthcare system,' and found that the disparities carry a significant 'personal and societal price.' The final version of the report, however, contains none of these conclusions."

According to the analysis, the final version of the report eliminated nearly all mention of the word 'disparity,' cutting 28 of 30 references in the 'key findings' section.

An HHS spokesman could not say exactly when the report would be released. Senate Majority Leader Bill Frist, R-Tenn., is expected to unveil his health disparities bill later this week.

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Dems launch new attacks on HHS Medicare education program

Julie Rovner — Fri, 06 Feb 2004 00:00:00 -0500

A request to GAO from seven Senate and House Democrats says the television ad being run by HHS "is so simplified that it does not provide any meaningful information to beneficiaries. In addition, the lack of detail about the changes in Medicare will mislead beneficiaries to make erroneous conclusions about the benefits that will be available to them."

The requesters -- led by Sen. Frank Lautenberg, D-N.J., who asked GAO last month to look into the appropriateness of the flyer Medicare is sending to all 41 million beneficiaries -- now want GAO to investigate why print ads are running in newspapers like Roll Call, whose readers probably are not Medicare beneficiaries, and the appropriateness of HHS having hired media firms that are also handling President Bush's re-election campaign.

On the Senate floor Thursday afternoon, Health, Education, Labor and Pensions ranking member Edward Kennedy, D-Mass., said he already knows why the campaign has been structured as it has. "There is no purpose for these advertisements except to convince senior citizens that the Medicare bill is good for them. They are nothing more than propaganda for the Bush re-election campaign, using $23 million of senior citizens' own money," said Kennedy, referring to the combined cost of running the ads and mailing the flyer.

Separately, five House Democrats, led by Rep. Rosa DeLauro, D-Conn., are asking the HHS inspector general to investigate the appropriateness of the campaign, including whether the contracts for the ads were competitively bid, if the campaign "follows the norm for a traditional public-service announcement" and why the campaign is running two years before the drug benefit is set to begin.

"We are concerned that this effort is a blatant misuse of taxpayer funds for political purposes and that the administration will be using its own campaign operatives to place the ads," the members wrote.

Republicans, however, said Democrats were complaining to keep the issue alive. "I don't think [the complaints are] legitimate," Senate Finance Committee Chairman Chuck Grassley, R-Iowa, said in an interview with CongressDaily reporters.

"You've got to get the information out," said Grassley. The advertising campaign is needed, he said, to educate people who might be eligible for a low-income benefit associated with drug discount cards starting in June. Since participation is voluntary and seniors must decide soon whether they will participate in the new program, the advertising is an important use of Medicare dollars, Grassley said.

Emily Heil contributed to this report.

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Medicare chief defends job-hunting activity

Julie Rovner — Thu, 04 Dec 2003 00:00:00 -0500

"I am a lawyer, and I spent a lot of time making sure I followed every ethical guideline," Scully told reporters in a conference call Wednesday afternoon.

Scully said he was told by the Health and Human Services Department general counsel that: "I was a model citizen. I did this by the book." And the frequently thin-skinned Scully said a New York Times story suggesting a "bidding war" for his services was unfair. "What really irritates me is that I followed the rules absolutely to the 'T.' For somebody to suggest other than that is absolutely outrageous," he said.

Scully also said that while he has not yet formally been offered any of the jobs he has been discussing, he thinks it unlikely he will return to lobbying in any case, and would prefer "to spend more time on the business and policy side of health care."

Scully said he personally would like to stick around at the helm of CMS while the huge job of implementing the massive Medicare bill gets underway, "but I lost a family vote of 4-1."

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Lawmakers blast proposal to overhaul Public Health Service corps

Julie Rovner — Thu, 13 Nov 2003 00:00:00 -0500

Here is what most people don't know about the U.S. surgeon general: He (or she) heads one of the nation's seven uniformed services, the Commissioned Corps of the Public Health Service.

Originally limited to physicians when the nation's first surgeon general, John Maynard Woodworth, founded it in the late 1800s, today the corps comprises approximately 6,000 health professionals, including physicians, dentists, nurses, veterinarians, engineers, pharmacists, bench scientists, dieticians, therapists and health service officers. Members of the corps serve in every agency of the U.S. Public Health Service, including the National Institutes of Health, Centers for Disease Control and Prevention, FDA and Indian Health Service, as well as "on detail" to state and local governments.

For years, about 30 percent of corps members volunteered to be "deployable," or ready to pick up and serve if needed to help with natural or human-made public health emergencies. Members of the corps were dispatched most recently to southern California, to help when wildfires burned through an estimated 750,000 acres over two weeks, causing $2.5 billion in damage and killing more than 20 people.

But in the wake of the Sept. 11, 2001, terrorist attacks and the bioterror threat, HHS Secretary Tommy Thompson wants the corps to be more like the Army or the Navy and less like the group of middle-aged health professionals and bench scientists it has become in recent years. In July, Thompson announced a major overhaul that he said "will forge the Commissioned Corps into a more highly trained, fully deployable force that is prepared to respond to emergency situations."

Among the proposed changes are scholarships to bring more practitioners to medically underserved areas, but also new physical fitness requirements and a system "designed to bring the status of the Commissioned Corps to 100 percent deployability by the end of 2005." Subsequent details also would transfer most supervisory duties for the corps away from the surgeon general to the HHS assistant secretary for health.

While no one has suggested that an overhaul of the corps is a bad idea, the specifics have prompted many complaints, including some from within an administration usually known for keeping its policy differences quiet. FDA Commissioner Mark McClellan, a former White House health adviser, wrote Thompson to complain that if the proposal takes effect, his agency's effectiveness "could be seriously negatively affected" by discouraging expert scientists from joining the corps, and by making the agency reluctant to employ corps members "who might be called away at a moment's notice."

House Government Reform Committee ranking member Henry Waxman, D-Calif., has been less measured in his criticism, calling the proposals "unwise and unfair" and a "bait and switch" for current corps members, some of whom "may suffer from chronic diseases; others may have family obligations that prevent deployment."

In the end, says Waxman, the proposal could make the corps less ready, as the best and brightest opt for the private sector instead. "A more gradual approach would achieve your objective without draining needed scientific expertise from the government or mistreating employees," Waxman wrote Thompson last August.

At a Government Reform Committee hearing on the issue last month, two former surgeons general, C. Everett Koop and Julius Richmond, added their voices to those expressing doubts. Koop said the proposal does not take enough account of the fact that corps members have "day jobs [that] are critically important, whether they are clinicians on a remote Indian reservation or assigned as an epidemiologist or researcher at the CDC."

Richmond was among several who said physical fitness requirements should match a corps member's job requirements. "Had we held to arbitrary standards" when he served as a flight surgeon in World War II, Richmond told the panel, "we would have lost much valuable person-power."

Both of the former vice admirals said the surgeon general should retain leadership of the corps. "It violates any sound principles of management to propose an Office of Commissioned Corps force management to assume functions that the surgeon general has had historically," Richmond testified.

Current Surgeon General Richard Carmona tried to reassure critics the overhaul remains a work-in-progress and insisted the transformation could take place "without disadvantaging any current members of the Corps." But although he said, "No officer will be disadvantaged for promotion by physical fitness standards in the 2004 promotion cycle," he made no promises beyond that.

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NIH chief seeks overhaul, but lawmakers offer own plans

Julie Rovner — Thu, 02 Oct 2003 00:00:00 -0400

The director of the National Institutes of Health tried Thursday to sell his overhaul plans for the agency during a joint hearing of the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees. But as usual when it comes to one of the most politically popular federal programs, members of Congress have some agenda items of their own.

NIH Chief Elias Zerhouni thanked the committee members for doubling the agency's budget over the past five years. He noted that the increase has resulted in some tangible and immediate benefits, including identifying the cause of Severe Acute Respiratory Syndrome "in record time."

But Zerhouni said the rapid pace of scientific advance has rendered outmoded NIH's "silo" structure, in which individual institutes and centers receive separate funding. "Often research done in one institute eventually finds its greatest application in the mission of another, illustrating both the convergence of science and its unpredictability," Zerhouni said. He cited as an example the cancer drug Gleevec, originally developed for heart disease.

Zerhouni's "road map" for the agency calls for more cross-institute, multi-disciplinary research initiatives, and a change in the way clinical research is conducted "to more quickly translate discoveries into practice." Harold Varmus, Zerhouni's predecessor who now heads New York's Memorial-Sloan Kettering Cancer Center, called for even more radical changes. Charging that the "proliferation" of new NIH institutes and centers "threatens the capacity of the agency to seize important opportunities and undermines the ability of the NIH director to lead," he called for fusing the agency's 27 institutes into five large units, with a sixth, "NIH Central," to be headed by the director himself.

Members, however, made it clear they have other priorities for NIH- particularly after bestowing such largesse on it over the past half decade. "With the dramatically increasing budget, it is also important to ensure that the American people get the most out of this massive investment of resources," said House Energy and Commerce Health Subcommittee Chairman Michael Bilirakis, R-Fla.

Energy and Commerce Chairman Billy Tauzin, R-La., who missed the start of the hearing after being called to the White House to consult on the energy bill, offered a statement in which he said Congress "may want to consider establishing a system of greater transparency of NIH research activities to guarantee that NIH is held accountable for taxpayer investments."

Democrats, for their part, decried the small size of the increase proposed for fiscal 2004. "Even with the increases provided by the Senate," said Health, Education, Labor and Pensions ranking member Edward Kennedy, D-Mass., "the number of new [research] grants would actually decrease by 75."

And Energy and Commerce ranking member John Dingell, D-Mich., complained about efforts to "outsource" some of NIH's functions. "Are we serving science, or are we serving a privatization ideology?" Dingell asked. "Outsourcing is an instrument of fear, and successful organizations do not use fear as their primary management tool," he said.

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Study suggests NIH could benefit from reorganization

Julie Rovner — Tue, 29 Jul 2003 00:00:00 -0400

"NIH has never been administratively reorganized in any substantial way, only added on to, despite vast changes in the landscape of science and the nation's health concerns during the last half century," said the report, ordered by Congress as part of the fiscal 2001 Labor-HHS appropriations bill.

Among the IoM's top recommendations is one to create a formal process to consider changes to NIH's organizational structure. That process should be used, said the IoM committee, to consider two mergers-one between the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism, whose missions overlap substantially; and another between the National Institute of General Medical Sciences and the National Human Genome Research Institute. The latter institutes both focus on basic research.

The IoM panel, chaired by Harold Shapiro of Princeton University, also suggested several changes in the way NIH is led. It recommends that the NIH director be appointed to a six-year term, with a second six-year term possible, and that he or she be given authority to hire, fire and review annually the individual institute directors, who are currently appointed by the HHS secretary.

The panel recommends that Congress order the NIH director to "lead a trans-NIH planning process to identify major crosscutting issues and their associated research and training opportunities and to generate a small number of major multi-year, but time-limited, research programs." Such trans-NIH research could consume 10 percent or more of NIH's budget within five years.

The committee also recommended that the director be given a "special projects" budget, initially $100 million, but rising to as much as $1 billion "to fund risky cutting-edge research that offers a high potential payoff for society in terms of cures or improved medical treatment."

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House approves 'Bioshield' bill, but industry remains concerned

Julie Rovner — Thu, 17 Jul 2003 00:00:00 -0400

The House overwhelmingly approved a bill Wednesday to implement President Bush's "Project Bioshield." But the measure, which passed the House 421-2, remains stalled in the Senate, and the industry group representing those at whom it is aimed said its members still are not totally satisfied with either version.

The bill would provide up to $5.6 billion over the next 10 years to guarantee a market to private firms that develop diagnostic tests, treatments and vaccines to combat germs most likely to be used by bioterrorists. These include smallpox, anthrax, plague, Ebola virus and botulinum toxin. It also would authorize the HHS secretary to allow use of vaccines, drugs or treatments not yet approved by FDA in emergency situations.

House members on the floor praised both the product and the process by which three committees-Energy and Commerce, Government Reform and Homeland Security-worked out their differences on the measure.

"This legislation is the product of a good-faith, bipartisan process," said Energy and Commerce Health Subcommittee ranking member Sherrod Brown, D-Ohio.

Government Reform Chairman Tom Davis, R-Va., echoed the concerns of many that if the United States were the subject of a bioterrorist attack, "the need would be great, and it would be immediate," yet few modern tests or treatments exist for many of the most likely weapons.

But Gillian Woollett of the Biotechnology Industry Organization, whose members are considered most likely to use the new incentives, said while much progress has been made, "we're still in the 'yes, if' mode."

Specifically, Woollett said, firms remain concerned about possible liability issues, as well as prohibitions on "secondary" uses for the products.

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Study says feds' health plan falters as Medicare reform model

Julie Rovner — Fri, 30 May 2003 00:00:00 -0400

The Federal Employees Health Benefits Plan, touted by President Bush and many in Congress as a "model" for Medicare reform, might not necessarily work as well as many expect if the health program for the elderly and disabled were remade along its lines, according to a study released Friday.

"FEHBP, like any private plan, costs more than Medicare," the study's author, policy analyst Mark Merlis, said at a briefing sponsored by the Kaiser Family Foundation. At the same time, Merlis said that making coverage available, particularly in rural areas, remains a challenge even for FEHBP.

For example, while FEHBP purports to have six nationwide plans, in Lebanon, Kan., (the geographic center of the lower 48 states) only two of those plans had in-network primary care doctors located within an hour's drive. "It's not easy to put together multiple competing networks that would be national in scope," Merlis said.

Responding to the paper, Marilyn Moon of the Urban Institute said that many backers of making Medicare more like the health plan for federal workers think if that happens, "poof, extra benefits will appear." But she said the reason the FEHBP offers better benefits than Medicare is not necessarily its structure and that there is no way increasing private competition in Medicare can save enough money to shore up the program for the oncoming baby boom generation.

"If we want prescription drugs in Medicare, we're going to have to pay for them," Moon said. Stuart Butler of the Heritage Foundation, a longtime backer of making Medicare more like FEHBP, disagreed that Merlis' evidence "highlighted the difficulties" of making such a transition.

To the contrary, Butler said, Medicare's glaring lack of a drug benefit or an out-of-pocket spending cap highlights the "difficulties of developing a government-run system." Butler also suggested that Merlis' estimate that FEHBP plans spend between 7 percent and 15 percent on administration, while Medicare spends only about 2 percent, is not necessarily a point in Medicare's favor. As one of a large group of analysts from across the ideological spectrum who signed a petition a few years ago noting that Congress was providing too little to Medicare officials to run the program, Butler said, "It is not intuitively obvious that the low administrative spending on Medicare is necessarily a good thing."

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Senators offer plan to cover reservists' healthcare costs

Julie Rovner — Tue, 20 May 2003 00:00:00 -0400

An unlikely alliance including Senate Minority Leader Tom Daschle, D-S.D., and Sens. Lindsey Graham, R-S.C., Hillary Rodham Clinton, D-N.Y., and Patrick Leahy, D-Vt., Tuesday announced a joint effort to come up with a way to better provide health coverage to members of the military reserves and the National Guard and their families.

"This is an issue every one of us hears about every week at home," said Clinton of National Guard members and reservists who either lack insurance in their everyday lives, or lose their family's coverage when they are called up. "This is a bipartisan coalition you may never see again, so enjoy it," cracked Graham, who was himself called to active duty during the first Persian Gulf War.

Daschle Monday night offered a version of the proposal as an amendment to the fiscal 2004 Defense authorization bill. It would make all members of the Guard and Army Reserve and their families eligible for TRICARE, the military's health insurance program, with the federal government paying the same share it pays for workers in the Federal Employee Health Benefits Plan.

It would also help pay to keep private coverage for families when the head of the family is mobilized. The Senate Tuesday afternoon approved, 85-10, a compromise version of the measure Daschle said merged his plan with Graham's proposal. Graham's original plan would have funneled more families into TRICARE, at a lower cost for the families, but a higher one for the government.

The agreement used Graham's more generous government contribution, but kept Daschle's provision allowing a subsidy for families that elect to keep their private coverage. "Not only will it make health care more affordable for Reserve and Guard members and their families, but it will help recruitment efforts and reduce the chance that a Guard or Reserve unit could not deploy because too many of its members had health problems," Daschle said.

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