IBM: No-go for genetic screening

IBM, the world’s largest computer maker, pledged Monday not to use genetic data to screen employees and applicants in what it said was the first such move by a major corporation to safeguard a new category of privacy.

International Business Machines Corp. (Research) also said it would refrain from using the data in determining eligibility for health care or benefits plans.

The pledge comes as Congress debates a proposed privacy bill that would bar health insurers and employers from discriminating against people with a genetic predisposition to disease.

Four years ago, railroad conglomerate 3Burlington Northern Santa Fe Corp. (Research) agreed to abstain from submitting its employees to genetic testing after it was sued by federal regulators.

“Genetic information comes pretty close to the essence of who you are, it’s something you can’t change,” IBM’s chief privacy officer, Harriet Pearson, told Reuters.

“It has nothing to do with your employment, how good your contributions are, how good of a team member you are, so making a policy statement in this case is the right thing to do,” she said.

IBM, based in Armonk, N.Y., employs more than 300,000 people worldwide.

The Genetic Alliance, a Washington-based patients advocacy group, called IBM’s policy “remarkable” and predicted it would spur other U.S. corporations to follow suit.

IBM shares rose 75 cents, or nearly 1 percent, to $81.25 trading Monday after Citigroup upgraded its rating on the company to “buy” from “hold.” IBM’s share price has dropped more than 17 percent this year.

I.B.M. to Put Genetic Data of Workers Off Limits

As concerns grow that genetic information could become a modern tool of discrimination, I.B.M. plans to announce a new work force privacy policy today.

I.B.M., the world’s largest technology company by revenue, is promising not to use genetic information in hiring or in determining eligibility for its health care or benefits plans. Genetics policy specialists and privacy rights groups say that the I.B.M. pledge to its more than 300,000 employees worldwide appears to be the first such move by a major corporation.

The new policy, which comes as Congress is considering legislation on genetic privacy, is a response to the growing trend in medical research to focus on a person’s genetic propensity for disease in hopes of tailoring treatments to specific medical needs.

Gene tests are not yet widespread, but start-up companies are already intent on developing a market for genetic testing and counseling. I.B.M. has a business stake in promoting genetic data gathering and processing, as a leading information technology company with a growing presence in the medical industry.

Research on genetics is already beginning to lead to improvements in health care. But polls have shown that Americans worry that gene tests and genetic profiling could be used to keep people deemed at genetic risk of certain diseases or conditions from getting jobs and health insurance. And there have already been instances of employers trying to use genetic data to workers’ detriment.

“What I.B.M. is doing is significant because you have a big, leadership company that is saying to its workers, ‘We aren’t going to use genetic testing against you,’ ” said Arthur L. Caplan, director of the Center for Bioethics at the University of Pennsylvania medical school.

“If you want a genomic revolution,” Mr. Caplan added, “then you better have policies, practices and safeguards that give people comfort and trust.”

In a handful of publicly disclosed cases, genetic data has been used without workers’ knowledge. Perhaps the best known involved a $2.2 million settlement in 2002 that the United States Equal Employment Opportunity Commission reached with the Burlington Northern and Santa Fe Railway Company. The government had sued, saying the railroad tested, or sought to test, 36 of its employees, using blood samples, without their knowledge or consent. According to testimony, the company performed the tests in the hopes of claiming that the workers’ arm injuries stemmed from a rare genetic condition instead of from work-related stress on muscles and nerves. The railroad denied that it violated the law, but agreed not to use genetic tests in future medical examinations.

The Genetic Alliance, a Washington coalition of patient advocacy groups, receives a few inquiries a week, said Sharon F. Terry, president and chief executive of the alliance. Some are complaints from people who have had trouble getting health insurance after they disclosed a genetic condition, while others come from people concerned about how employers might use any genetic information they might reveal in health forms.

“It is a problem already, and the prospect is that the problem will only grow,” Ms. Terry said. “That is why we need rules and practices from government and the private sector to prevent abuses.”

Congress has certainly taken notice of the issue. This year, the Senate passed a genetic information nondiscrimination bill, by a vote of 98 to 0, and the House is now considering similar legislation. Two years ago, after the Senate passed a genetic privacy act, the House never voted on the legislation. But House sponsors are more optimistic this time. Also, about 40 states have laws that address some aspect of genetic privacy and discrimination.

To some extent, the privacy provisions in existing statutes like the Health Insurance Portability and Accountability Act and disability and civil rights laws already address the issue. They include prohibitions against using personal medical information to discriminate against people in hiring and in providing health insurance. But the current laws tend to deal with the diseases or disabilities that people already have.

Some critics say the genetic privacy bill would deny insurers a means of measuring risk that would be available to the people they insure, allowing some people to take advantage of that information. For example, there is a strong genetic marker for the early onset of Alzheimer’s disease. A person could test for it privately, and then take out long-term care insurance.

Health insurers have expressed skepticism about the need for federal legislation to protect genetic privacy. They say that current federal and state laws are adequate, and that a new law could have the unintended effect of, say, preventing insurers from providing disease management programs to people who have tested positive for a genetic risk. But the industry’s big trade association, America’s Health Insurance Plans, has not lobbied against the Senate bill, according to Congressional staff members.

I.B.M. has become a big player in what is called information-based medicine, which relies on genetic information. The company’s involvement goes beyond the hardware and software often employed in such work. I.B.M. scientists and technology consultants are engaged in projects including research at the Mayo Clinic and a venture with the National Geographic Society to trace the genealogy of the world’s population.

The trends in scientific research and medicine, along with the questions I.B.M. has heard from outsiders and some of its employees about its handling of genetic information, all contributed to the decision to adopt a formal genetic privacy policy.

“The time is right,” explained Harriet Pearson, I.B.M.’s chief privacy officer. “The market and medical practice is moving in this direction – to gather and use genetic information.”

In an e-mail message to be sent to all I.B.M. employees today, Samuel J. Palmisano, I.B.M.’s chief executive, writes that the spread of gene-testing and genomic research is “enormously promising – but it also raises very significant issues, especially in the areas of privacy and security.”

Opinion polls have repeatedly showed that workers are leery of companies using genetic test information against them. For example, a poll in 2000 by the National Center for Genome Resources, a research group, found that 63 percent of workers would not take genetic tests if employers could get access to the results.

Genetic specialists regard I.B.M.’s move as a positive step and one that could help prod policy forward. But many also insist that a federal law would be the best protection.

In an article last month in The Journal of the American Medical Association, Dr. Francis S. Collins, director of the National Human Genome Research Institute, and Dr. Alan E. Guttmacher, the deputy director, wrote that “potential discrimination in health insurance or employment based on the results of genetic testing has been apparent for years and requires a national legislative solution.”

To Find a Doctor, Mine the Data

Now that millions of consumers are surfing the Web to research their own medical symptoms, many are taking the next step: comparison-shopping online for hospitals and doctors.
When Kirk Emerich, a bank executive in West Bend, Wis., needed knee surgery for a volleyball injury earlier this year, for example, he researched the local doctors and hospitals, using a Web site provided by his employer’s insurer, Humana. The comparative data included the number of patients that the hospitals treated annually and the complication rates after surgery.
“Both our hospitals were pretty good,” said Mr. Emerich, a senior vice president for West Bend Savings Bank. “But the doctor I ended up with had an edge: she was more focused on sports injuries.”
As their out-of-pocket health care expenses continue to grow – through rising medical costs, higher insurance premiums and heftier co-payments – many people are using consumer skills well honed by online research on everything from digital cameras to S.U.V.’s. And their employers and insurers, intent on getting the best value from their own health spending, are arming those consumers with increasingly detailed searchable databases.
The data come from medical records that insurers are pressing doctors and hospitals to provide, and in some cases from patient surveys.
“We believe American consumers should know as much about the medical care they receive as they do about the vehicles they purchase,” said Sharon Baldwin, a spokeswoman for General Motors, the nation’s largest private purchaser of health care. Next month, G.M. plans to brief its salaried employees about their health benefit options for 2006, and will provide online information to help them make choices.
So far, the various consumer databases, many available only to individuals enrolled in insurance plans, have some gaps.
“We’ve got terrific measurements information in some areas, but in other areas we don’t have good measurements at all,” said Dr. Carolyn Clancy, director of the federal Agency for Healthcare Research and Quality, which is working to standardize the way health care data are reported.
At this point, there is much more quality-of-care information available about hospitals than about individual doctors, except in nine states including Florida, Pennsylvania and Wisconsin that make statistics available on the numbers of procedures that surgeons perform.
And pricing information still tends to be scarce. But the databases can grow only more robust, now that the full weight of the health insurance industry is behind the trend and the federal government is beginning to wield its influence.
Anyone, insured or not, can now log on to the federal Department of Health and Human Services’ Web site called Hospital Compare (hospitalcompare.hhs.gov), which uses Medicare and Medicaid data to assess the track records of more than 4,000 hospitals around the country.
Want to know which hospitals in your city to go to for treating heart attacks or pneumonia? Log on to Hospital Compare, plug in the step-by-step particulars, and judge for yourself, based on criteria that include whether the hospitals provide appropriate medicines when patients are admitted and discharged.
The government also plans to begin reporting on complications after surgery and whether doctors and nurses make clear to patients how to take care of themselves after a hospital stay, said Dr. Mark B. McClellan, administrator of the federal Centers for Medicare and Medicaid.
Private health plans typically provide more comparative data than the federal Web site. Yesterday, Wellpoint, the nation’s largest commercial health insurer, announced that its 28 million members would be able to log on to an expanded list of health care information services. The service is to include software to help members compare their own potential costs under various health plans. Wellpoint began providing consumer information for comparing hospitals several years ago.
Vivian Johnson is a Wellpoint enrollee who works for the Banta Corporation, a national printing company. When she transferred to Lancaster, Pa., from Utah earlier this year, Ms. Johnson used a Wellpoint system to research doctors for herself and pediatricians for her 2-year-old daughter, Averie.
“I relied heavily on certain statistics,” Ms. Johnson said, like “how many patients the doctors treated, where they were located and in some cases feedback from consumers.”
Besides Wellpoint and Humana, most of the big insurance companies – including United Healthcare, Aetna and Cigna, as well as many state and regional Blue Cross and Blue Shield insurers – provide this type of information. One of the most recent to join the wave was Michigan Blue Cross and Blue Shield, which on Sept. 1 started offering online hospital and doctor comparisons to its 4.7 million members.
“The insurance carriers are all headed in this direction,” said Dale Whitney, corporate health and welfare manager for United Parcel Service, which offers plans from all the big national health insurers to its 328,000 employees across the country. “A lot of employers are trying to get people to say, ‘Yes, I have some responsibility to take care of my health.’ “
The raw material for the information on the Web systems is typically assembled from data that include medical payment claims, hospitals’ reports to Medicare and health care information from employers who belong to an alliance known as the Leapfrog Group.
Companies that collect and organize the information include Subimo, a privately held company that supplies data for Wellpoint and Michigan Blue Cross, among other insurers; HealthShare Technology, which was recently acquired by WebMD; and Health Grades, based in Golden, Colo.
In May, Wellpoint bought Lumenos, a data compiler. And last year, UnitedHealth Group bought Definity Health, a company that, like Lumenos, operates high-deductible health savings plans and provides comparative data for consumers.
The ability to compare costs is especially important for a growing number of employers seeking to interest their workers in high-deductible health savings plans that offer lower premiums at the onset but require plan members to assume more of the financial burden when they need care.
The Detroit auto companies, which spend billions of dollars annually on employee health benefits, are among the large employers considering making such plans an option. DaimlerChrysler said last week that it would offer a high-deductible plan along with online information about the quality and costs of certain doctors.
Specialists say that, so far, the sources of information are far from perfect. Data based on medical claims payments can be particularly sketchy and unreliable, said R. Heather Palmer, a professor of health policy and management at the Harvard School of Public Health. “The hope,” she said, “is that as we move toward electronic medical records, we will get data with more clinical detail.”
The data collecting companies make no claim of perfection. “In the absence of perfect information, we help equip people so they know what questions to ask to be smarter consumers of health care,” said Ann Mond Johnson, chief executive of Subimo, a five-year-old company based in Chicago.
Most specialists agree that improvements depend on achieving a standardized, computerized approach to collecting and assembling medical data at all levels, from big hospitals to small doctors’ offices – a long-range goal of the Bush administration.
Until information technology is more widely available, “it is extremely difficult to collect this information, and it is expensive,” said Charles N. Kahn III, president of the Federation of American Hospitals, a trade group of for-profit hospitals.
But others say that, technology questions aside, medical care providers need to be more forthcoming with information.
“For the last 15 years, the hospital industry has resisted public reporting,” said Dr. Mark D. Smith, president of the California Health Care Foundation, a nonprofit research organization. Doctors and hospitals are still reluctant, he said, “but they are increasingly comfortable with the inevitability and desirability of public reporting on performance.” He added, “It’s a huge improvement.”
The foundation has a Web site (calhospitals.org), which uses patient survey data to enable anyone to compare California hospitals within a county or metropolitan region on a wide range of performance criteria.
Margaret O’Kane, president of the National Committee for Quality Assurance, which certifies health plans, said the hospitals had a lot to answer for. “There are huge issues out there in the number of people being harmed by hospitals,” she said, referring to statistics indicating that tens of thousands of hospital patients die each year from avoidable medical errors.
Publishing more quality data can help change that. “No hospital wants to have data out there that makes them look like poor performers,” she said.
Mr. Kahn, of the hospitals federation, acknowledged that “consumer education is part of the future.” But, he added, “we are only at the beginning of knowing what information to collect to get a meaningful reflection of the quality of specific institutions.”
Even so, Mr. Emerich, who found his knee surgeon online, says the information already available is helpful. His operation turned out well. “I’m fully active, with no restrictions,” he said. But, he conceded, at age 42 it might be time to think about giving up volleyball.

Health Records Of Evacuees Go Online

The federal government is making medical information on Hurricane Katrina evacuees available online to doctors, the first time private records from various pharmacies and other health care providers have been compiled into centralized databases.
The data contain records from 150 Zip codes in areas hit by Katrina. Starting yesterday, doctors in eight shelters for evacuees could go to the Internet to search prescription drug records on more than 800,000 people from the storm-racked region.
Officials hope to soon add computerized records from Medicaid in Mississippi and Louisiana, Department of Veterans Affairs health facilities, laboratories and benefits managers.
The records are one step in reconstructing medical files on more than 1 million people disconnected from their regular doctors and drug stores. Officials fear that many medical records in the region, especially those that were not computerized, were lost to the storm and its aftermath.
Although the immediate focus is on urgent care for hurricane victims, participants in the effort say the disaster demonstrates a broader need to computerize individual health records nationwide and make them available throughout the medical system. Such a step could, for example, give emergency room doctors a way to quickly view medical histories for late-night accident victims.
Electronic health records are controversial among many privacy advocates, who fear the data could be exploited by hackers, companies or the government.
Ray Fowler, head of medical relief operations in Dallas, said “it was extremely scary” for doctors to have no records to rely on as thousands of evacuees poured off buses with serious injuries or infections.
Some patients had been on various medications before the hurricane, for conditions such as high blood pressure, but did not know what prescriptions they took, Fowler said.
Currently, roughly 8,000 people are in critical care shelters, while other seriously ill patients are being treated in hospitals outside the Gulf Coast region. But many of the 250,000 evacuees in various shelters also need medical attention.
“We think this could help save some lives,” said Dr. David J. Brailer, coordinator of health information technology for the Department of Health and Human Services, who is spearheading the effort.
The system took about 10 days to organize, with daily conference calls involving as many as 60 state and federal officials; emergency medical providers; insurance, pharmacy and medical-software company representatives; and government lawyers.
Participating pharmacies so far include CVS, Rite Aid, Albertsons, Walgreens and Wal-Mart. Expected to be added soon are Winn-Dixie, Kmart and Target.
Brailer said he was concerned throughout the process with privacy issues. Only medical personnel at the various shelters and hospitals treating evacuees will have access to the information.
Federal regulations do not require patient consent for their records to be shared for medical purposes. Companies or organizations that have such data must have formal agreements with each other before data can be exchanged, but the government said it would not enforce those rules while Katrina victims were in need, as long at the entities had verbal agreements to use the data for the relief effort.
States with more stringent regulations suspended their rules as well.
“We’ve been extremely cautious,” Brailer said. “There were a lot of things we could have done that we didn’t do.”
Brailer said in his original vision, the database program would end once evacuees are permanently resettled, either back in their home communities or elsewhere.
Others involved in the effort, however, already are discussing ways to enhance the system and create personal health records for those who might need to move frequently over the next several months. As constructed, the databases do not allow doctors to update the records with information on treatment provided in the shelters.
“We’re already preparing for a second wave of victims who have been in hotels but the money is running out,” Fowler said.
The Bush administration and the pharmaceutical and technology industries have long argued that standardized, individual electronic health records that can be shared and quickly viewed would improve care and cut costs.
Electronic records also would speed the way for patients seeing different specialists, switching doctors or moving frequently in an increasingly mobile society. And they could be used to identify medical inefficiencies in the public-health system, proponents argue.
Even before the hurricane hit, Brailer’s office was preparing to award contracts to create a “national architecture” for electronic records that every player in the medical system could use. The government is not mandating such a system nor will it operate it, Brailer said, but it wants to enable the private sector to do so.
On Monday, Health and Human Services Secretary Michael Leavitt named 16 people to a task force to advance the administration’s goal of bringing electronic health records to most Americans within 10 years.
None is from a recognized privacy organization, and privacy advocates worry that even beneficial efforts during an emergency can expand beyond the scope of the original crisis.
Sue A. Blevins, founder of the Institute for Health Freedom, a medical-policy think tank, said she supports emergency programs such as the Katrina databases. But she said that “many things are done during a crisis that society normally would not accept.”
Blevins opposes national electronic health records for individuals because the Bush Administration eliminated the right of patients to give consent before their health information could be shared under many circumstances.
“When you don’t give people the freedom to decide how much information they want to share . . . the only choice they have is to either lie or withhold the information when they want their privacy,” she said.
© 2005 The Washington Post Company

Katrina Shows Need to Computerize Records

One oncologist evacuated flooded New Orleans clutching a laptop computer with some patients’ records, another threw some paper charts in her truck on the way out. But for most of the 80 children with cancer in Dr. Joseph Mirro’s evacuee clinic, their parents’ memory of last treatments proved key to resuming therapy.

Hurricane Katrina destroyed or left inaccessible the medical records of untold numbers of people, focusing new attention on the need for computerized medicine – health records that follow patients, even if their doctors’ offices no longer exist – so a disaster doesn’t mean restarting care from scratch.

“There may not have been an experience that demonstrates, for me or the country, more powerfully the need for electronic health records … than Katrina,” Health and Human Services Secretary Mike Leavitt told The Associated Press on Monday.

“I saw physicians treating patients who were obviously ill and who were without sufficient information to make diagnoses.”

It’s an ongoing problem, as hurricane survivors move from triage care like that provided at the New Orleans airport, to federal shelters, to church shelters or private homes – seeing different volunteer doctors in each place who may provide different, even conflicting, care. What records of the temporary care they’re able to carry to the next doctor they see varies widely.

Leavitt’s office is developing two programs that he hopes will help soon:

-A database of prescription drug records from retail pharmacies and pharmaceutical benefits managers, for 90 days preceding the storm. Large drugstore chains keep such databases, meaning evacuees who bought their medicines at a single chain could get refills fairly easily. But many people buy medicine from more than one store or by mail, and a national database could provide harried health workers a one-stop check.

-A pilot project to generate electronic medical records of care provided in certain hurricane shelters.

Such a project can work: Leavitt saw one in action at Houston’s Astrodome, where within 48 hours of opening Texas hospital workers set up computer-generated records of evacuee care, including the results of laboratory tests beamed offsite for analysis.

The federal government’s goal is to give most Americans computerized medical records within 10 years. But it’s so expensive and technologically challenging that only a fraction of the nation’s doctors offer them now – meaning many patients in the hurricane-ravaged Gulf Coast will have to completely reconstruct their medical histories.

One bright exception: Even though the New Orleans VA Medical Center flooded, electronic medical records for 50,000 patients of that hospital and surrounding veterans’ outpatient clinics survived. On Sept. 1, a Department of Veterans Affairs computer specialist was airlifted from New Orleans carrying backup tapes of all the records, which by the next night had been re-entered into computers in Houston.

“Every single thing on that computer was saved,” said Charlie Gephart, records chief for the South-Central VA Healthcare Network.

Moreover, evacuees could access some of those records even at the height of the disaster, Gephart said. His office put patient prescriptions and other data tracked at a separate location onto a secure Web site as an interim solution.

But three weeks after Katrina hit, the lack of medical records remains a big obstacle in caring for most evacuees.

“A lot of people walk in and say, ‘I take a little blue pill,”’ without any idea what it was, said Dr. Bethany Gardiner, a pediatrician from Santa Barbara, Calif., who is treating evacuees in Baton Rouge, La.

Computerized records would have sped treatment decisions for those child cancer patients, said Mirro, chief medical officer of St. Jude Children’s Research Hospital in Memphis. Working out of Baton Rouge last week, when he couldn’t find the children’s also-evacuated doctors, he relied heavily on parents’ recall to piece together complicated chemotherapy plans.

“I honestly feel quite comfortable that the worst-case scenario is we delayed treatment” for some children, he said. But there was “a lot of flying by the seat of your pants to get it right.”

Just having records on a computer isn’t enough, Mirro stressed. His own hospital backs up the records on an out-of-town computer server plus tapes. If both servers are destroyed, it would take about two days to retrieve the tapes. He’s now wondering if even that’s enough.

“In a hurricane zone, you have to have multiple contingencies, and we will have to have more in the future,” said the VA’s Gephart.


Lauran Neergaard covers health and medical issues for The Associated Press in Washington. AP medical writer Marilynn Marchione in Milwaukee contributed to this report.

Commissioners Selected for American Health Information Community

HHS Secretary Mike Leavitt today selected 16 commissioners to serve on the American Health Information Community (the Community), a federally-chartered commission charged with advising the Secretary on how to make health information digital and interoperable. The work of the Community will help the country achieve the President’s goal of having most Americans using interoperable electronic health records within 10 years. Patients, doctors, hospitals and insurance companies will have access to vital and confidentiality-protected medical information immediately and efficiently, helping to reduce medical errors, improve quality, lower costs and eliminate paperwork hassle.

“The President has set a national goal to move health care from the paper age to the information age, and the American Health Information Community will help guide this transformation.” Secretary Leavitt said. “My aspiration is for the Community to provide stakeholders with a meaningful voice in a federal process that will ultimately shape health care for generations.”

Interoperability of health information is a shared goal among health care payers, providers, vendors and consumers. Myriad competitive interests have prevented a unified effort to achieve common standards and interoperability. As a result, health care has lagged behind other industries — like the banking, transportation, and retail trade — in realizing the benefits of modern information technology (IT).

“From nearly anywhere in the world, we can withdraw money from our bank accounts, pay bills, apply for a mortgage, book airline tickets and even order groceries online,” Secretary Leavitt said. “But, more often than not, we can’t share a X-ray digitally, from one hospital to another, even if they are on opposing street corners. Even worse, if a loved one is involved in a life-threatening accident, paramedics and emergency room doctors cannot quickly check their medical histories for even the most basic things like blood type or allergies. We can and must do better than this.”

The national strategy to confront this problem calls for federal agencies — that pay more than one third of all health care costs — to collaborate with private payers in developing and adopting an architecture, standards, certification process and a method of governance for ongoing implementation of health IT. Once the market has structure, patients, providers, medical professionals and vendors will innovate, create efficiencies and improve care.

Secretary Leavitt will chair the Community. In addition to the Secretary, commission membership includes the following:

  • Scott P. Serota, President and CEO, Blue Cross Blue Shield Association
  • Douglas E. Henley, M.D., Executive Vice President, American Academy of Family Physicians
  • Lillee Smith Gelinas, R.N., Chief Nursing Officer, VHA Inc.
  • Charles N. Kahn III, President, Federation of American Hospitals
  • Nancy Davenport-Ennis, CEO, National Patient Advocate Foundation
  • Steven S Reinemund, CEO and Chairman, PepsiCo
  • Kevin D. Hutchinson, CEO, SureScripts
  • Craig R. Barrett, Chairman, Intel Corporation
  • E. Mitchell Roob, Secretary, Indiana Family and Social Services Administration
  • Mark B. McClellan, M.D., Administrator, Centers for Medicare & Medicaid Services
  • Julie Louise Gerberding, M.D., Director, Centers for Disease Control and Prevention
  • Jonathan B. Perlin, M.D., Under Secretary for Health, Department of Veterans Affairs
  • William Winkenwerder Jr., M.D., Assistant Secretary of Defense, Department of Defense
  • Mark J. Warshawsky, Assistant Secretary for Economic Policy, Department of Treasury
  • Linda M. Springer, Director, Office of Personnel Management
  • Michelle O’Neill, Acting Under Secretary for Technology, Department of Commerce

“I have selected commissioners who represent key interests and have the broad support of their peers,” Secretary Leavitt said. “The Community will adhere to an aggressive timetable that focuses on the areas of critical need — such as adverse drug event reporting and bio-surveillance — as we get about the work of developing, setting and certifying standards.”

Dr. David Brailer, National Coordinator for Information Technology, added, “The Community will provide input and recommendations to HHS on how to make health information digital and interoperable, and assure that the privacy and security of that information is protected. The public-private nature of this group is designed to ensure that this nationwide transition to electronic health records — including common standards and interoperability — occurs in a smooth, market-led way.”

In addition to these commissioners, who will serve two-year terms, the Secretary will seek input from Advisors who will provide subject matter expertise on issues related to interoperability, adoption, privacy and security, and other matters identified by the Community. The federal members of the Community serve in their formal capacities as appointees within the federal system and not as individuals.

The first meeting of the Community is scheduled for Oct. 7, 2005 in Washington, D.C. The meeting is open to the public. Materials shared with the commissioners before and at the meeting, as well as minutes of the proceedings can be accessed online at www.hhs.gov/healthit.

Pricey Therapy

As Brooke Shields testifies in her recent memoir, into many a postpartum life a little rain must fall. And evidently, a little Tom Cruise as well: someone who tops off a struggling new mother’s depression with a downpour of judgment and misunderstanding. When Cruise blasted Shields on national television for using antidepressants to treat her postpartum depression, I thought, “Wow, he’d get along great with my health-insurance underwriters.” They slapped me with a five-year penalty of raised premiums because I sought help for depression following the birth of my daughter.

In July 2004, my husband and I applied for personal health insurance from Anthem Blue Cross and Blue Shield of Virginia. He had left his job to start his own company, and I was self-employed, so we began looking for family coverage while the COBRA clock ticked. Because I was blessed with lifelong health, the “medical information” page of my application was relatively brief. I listed a prescription for Clomid, a fertility drug I’d taken while trying to conceive my daughter, and a single appointment I’d had with a psychiatrist after she was born, regarding the possibility of postpartum depression.

Shortly after we submitted our paperwork to Anthem’s headquarters in Roanoke, the letters started arriving in our mailbox. My application was under review. More information was needed. Then another letter arrived. My husband and 9-month-old daughter had been approved for coverage at Level 1, the company’s best rating. I had been rejected. The reason: the psychiatrist appointment.

I contacted Anthem. The company could not deny me coverage because, as stated on my application, I metall the criteria of the federal statute that protects health-insurance coverage for workers and their families when they change or lose their jobs. A week later Anthem approved me at Level 4, its worst rating. My husband and daughter’s combined monthly premium was $237. Mine was $730.

During numerous calls to Anthem in the ensuing weeks, I learned that an indication of depression—including temporary postpartum depression—within a year of application sends a candidate down the Level 4 chute if legally she can’t be rejected outright. “You were on medication for your condition,” a representative noted during one of the calls. “It was a physician’s sample,” I explained, “and I discarded it after I learned the medication could pass into breast milk.” The representative was not swayed. “I can only go on what the doctor’s form says, and the form says Zoloft.”

Over the next three months I appealed Anthem’s decision. I argued that a single visit to a specialist should not be cause for charging an applicant the highest possible premium. Nor should taking a single pill of a medication that takes weeks to become effective be considered tantamount to receiving drug treatment. Trying to understand my low rating, I got a copy of the original form submitted to Anthem by the psychiatrist I’d seen. On the “diagnosis” line, she’d written “depression.” I asked her to send a follow-up letter. In it she explained that during our one appointment, I’d had “depressive symptoms” that had subsequently been resolved.

Nonetheless, Anthem twice denied my appeal. The identical rejection letters assured me of the “thorough review” of my case. But it was hard to have faith in that when the underwriters failed even to get my name right on the letters, addressing me by my husband’s last name after I’d told them in writing of the error. In the end, I had to opt for an inferior and yet more costly insurance policy, at $450 a month, than the one granted to my husband and daughter. After more calls to Anthem, I learned that the psychiatrist’s appointment would bar me from a Level 1 rating for five years. I later filed a complaint with the Virginia Bureau of Insurance, but the state found no wrongdoing on Anthem’s part. Insurers are free to establish their “own guidelines without regulatory interference,” as long as those guidelines apply to everyone.

I couldn’t believe, though, that taking an hour to meet with a professional about feeling overwhelmed and exhausted would brand me an insurance pariah. For the previous two years, I’d been singularly focused on staying healthy as I went through fertility treatments, carried my daughter in utero, endured a difficult labor that ended in an emergency Caesarean section, soothed her through three months of colic, and nursed her around the clock for nine months. While I was pregnant, I’d been bombarded with the message, “If you’re depressed, seek help!” Glossy magazine articles, doctor’s handouts, and childbirth classes depicted postpartum depression as both relatively common and treatable.

During the early weeks at home with my daughter, anxiety, fatigue, and loneliness defined my existence. Surely willpower could fix my sense of hopelessness, I reasoned at first. I was 35. I’d experienced hardship. But this was different. I’d never before forgotten the feeling of joy. I’d never been bereft of ideas about how to make things better.

Did I have “depression,” as the psychiatrist initially wrote on the Anthem form? Or did I have “depressive symptoms,” as she later clarified? In the shrouded world of insurance underwriting, these semantics seemed to determine my rating and premium. Yet I don’t think many doctors realize the power of their word choice. And the pregnancy articles failed to mention that entertaining the idea that I needed help for PPD—even once—would have far-reaching repercussions. No one explained that my $250 appointment with a psychiatrist would constitute a grave risk to an insurer and cost my family thousands of dollars in raised premiums. Or that my low health-insurance rating could also adversely affect the cost and benefits of other kinds of insurance, such as life and disability. The postpartum depression awareness campaign to which Shields laudably devotes herself has worked in part. But knowledge of PPD leads to another baffling and difficult condition: being punished for advocating for your health.

This past February, I became eligible for Anthem’s Level 3 coverage because a year had passed since my appointment with the psychiatrist. Still, my coverage continues to cost more than twice as much as my husband’s. I won’t be eligible for his Level 1 rating until 2009, and only then if no depression or other malady arises in the interim. To understand where our money is going, I Googled Larry Glasscock, Anthem’s CEO, and learned that the company’s “significant growth” reportedly grossed him upwards of $40 million in cash bonuses and stock awards in 2004.

Years ago, when I was in middle school, I used to draw braces on the gleaming white teeth of models in teen magazines. Since my struggle with postpartum depression, I like to conjure up my 12-year-old self, along with a splash of the late artist Jean-Michel Basquiat. In my fantasies, I swoop down on the piles of pregnancy journals in doctors’ offices, sail onto the sets of talk shows, and hover above the handouts given out in childbirth classes. When I come across the line, “If you’re depressed, seek help,” I write, with my can of orange spray paint, “BUT PAY FOR IT IN CASH.”

Whitney Morrill is an architect and writer living in Virginia. She’s currently working on a primer for new moms who might have PPD.

Medicare Law Prompts a Rush for Lobbyists

The new Medicare law has touched off explosive growth in lobbying by the health care industry, whose spending on advocacy here far exceeds that of consumer groups and other industries like defense and banking.
Almost every week the federal government issues new rules or guidelines to carry out the 2003 law, which provides a drug benefit starting in January. To keep track of the new rules and to decipher their meaning is a full-time job for hundreds of lawyers and lobbyists, who regularly seek changes advantageous to their clients.
With hundreds of billions of dollars at stake, health care providers, insurers, drug makers and pharmacies are continually trying to influence rules for the drug benefit and other initiatives authorized by the law.
“You see a real surge in health care lobbying because that’s where the money is,” said Frederick H. Graefe, a lobbyist for hospitals and makers of medical equipment. “Twenty years ago the defense industry was dominant and had the most lobbyists, the big players. Now it’s health care.”
Last year alone, the health care industry spent $325 million – more than any other sector – in its efforts to influence Congress and federal agencies, according to Political Money Line, a nonpartisan group that studies reports filed with Congress by lobbyists and their clients.
Drug companies led the way. They reported spending $86.9 million on lobbying last year, followed by hospitals with $55 million and doctors with $35.4 million.
Lobbying Congress nowadays often means persuading lawmakers to make telephone calls to Bush administration officials on behalf of clients concerned about specific issues, like the Medicare payment for a drug or a medical device.
The pinpoint focus of much lobbying is illustrated by the case of Lexapro, an antidepressant made by Forest Laboratories. The Bush administration has said that Medicare drug plans must cover “substantially all” antidepressants, but not necessarily Lexapro, a drug widely prescribed for depression and anxiety among older adults. Claudia Schlosberg, a lawyer with Blank Rome who represents Forest Laboratories, has been pressing Medicare officials to reverse that decision and has obtained letters from several members of Congress supporting the company’s position in favor of covering Lexapro.
“Every health care interest has a voice on Capitol Hill,” said Elizabeth J. Fowler, a lawyer who recently left the Democratic staff of the Senate Finance Committee to join a consulting firm. “What you lose in the process is consumer and beneficiary voices. We heard a lot more from industry interests than from beneficiaries.”
Chris Jennings, who became a lobbyist after serving as health policy coordinator for President Bill Clinton, said: “The proliferation of health care lobbyists produces specialization. The broader good is often lost as people focus on next year’s Medicare reimbursement rate for a specific group of health care providers, or a regulation to be issued next month.”
The health care industry is subject to pervasive federal regulation, and the government sets prices for many goods and services provided to the elderly under Medicare. But the Bush administration and the Republican majority in Congress are receptive to advice from the industry, including private insurers who will deliver the drug benefit.
“The success of the new Medicare law depends on a robust partnership between government and the private sector,” said Stacey Hughes, a partner in the lobbying firm established by former Senator Don Nickles, Republican of Oklahoma.
Health policy experts and officials said the growth of health care lobbying reflected several trends:
¶Congress earmarks more and more money each year for specific hospitals, medical schools and health care projects. Health care providers and local officials have a better chance to obtain such largess if they retain lobbyists to plump for their projects on Capitol Hill.
¶Lobbying has become more substantive. To buttress their arguments, lobbyists need data, cost estimates and economic analyses of health policy proposals. They retain expert consultants to prepare such reports.
¶Lobbyists have adopted many techniques of political campaigns. They hire pollsters and buy advertising to sway public opinion and pressure Congress.
¶Many lobbyists have carved a niche for themselves by focusing on one party, one house of Congress, one Congressional committee or a handful of influential lawmakers.
Carol A. McDaid, a health care lobbyist at Capitol Decisions, a subsidiary of the Van Scoyoc Companies, said, “It’s become so sophisticated that, in preparation for a critical vote, a big health care or pharmaceutical company will hire a different firm to lobby each key member of an important committee, like the Ways and Means Committee.”
The Pharmaceutical Research and Manufacturers of America reported spending $15.5 million on lobbying last year, while two of its members, Pfizer and Bristol-Myers Squibb, spent $5.6 million apiece and Johnson & Johnson spent $4.5 million.
Other heavyweight lobbies included the American Medical Association, which spent $18.5 million last year, and America’s Health Insurance Plans, which spent $5.6 million, about the same amount as the Blue Cross and Blue Shield Association.
By contrast, AARP, the lobby for older Americans, spent $8 million. The American Cancer Society spent $2.6 million, the American Heart Association spent $1 million and Families USA, the liberal group that calls itself a voice for health care consumers, reported spending $40,000.
Alan B. Mertz, president of the American Clinical Laboratory Association, said the advocacy budget for his group had more than tripled, to $2.5 million this year from $750,000 in 2002. “We had to beef up our advocacy to deal with threats to our Medicare reimbursement,” Mr. Mertz said, noting that Medicare payments for laboratory tests had been frozen through 2008.
Lobbyists said it made sense for their clients to pour money into lobbying because so much money was at stake. Health care accounts for more than 15 percent of the nation’s economy, and private insurers often look to Medicare as a guide in deciding what services to cover and how much to pay.
Moreover, the federal role is growing. Medicare and Medicaid will account for 37 percent of all spending on prescription drugs next year, up from 20 percent this year, said Stephen Heffler, an economist at the federal Centers for Medicare and Medicaid Services.
The Bush administration and the Congressional Budget Office say Medicare will spend more than $1 trillion on prescription drugs in the next 10 years, with outlays topping $100 billion a year after 2009.
Two linguistic changes show how health care lobbyists have emerged as a potent force. Lobbyists and trade associations, once seen as special interests, are now called “stakeholders,” with a legitimate claim to be heard in the policy-making process.
“Expanding coverage” used to mean providing health insurance to people who had none. But lobbyists now use the term in a different sense. When they speak of “coverage expansions,” they mean that Medicare should cover, or pay for, new technology like PET scans, implantable defibrillators and drug-coated stents to treat clogged arteries.
Political campaign contributions are frequently coordinated with lobbying campaigns. Lobbyists often hold fund-raisers at the request of members of Congress, as allowed by campaign finance laws. They are expected to contribute money from their own pockets and to raise money from clients.
“You increase your influence and access by doing fund-raisers,” said James C. Pyles, a lawyer and lobbyist for psychoanalysts and home care agencies. “If you’re not on the donor list, you don’t have much access.”
Ms. McDaid, who lobbies for hospitals and ambulance companies, said: “In the old days, the requests for political giving went mainly to your clients’ political action committees. Now health care lobbyists have to tithe personally. The bigger your client base, the more pressure there is to give. It’s not unusual for a lobbyist at a big firm to give $25,000 to $50,000 in personal contributions to Congressional candidates in a two-year election cycle.”
The growing prominence of health care issues on the national agenda has created an unquenchable demand for lobbyists. New issues include bioterrorism, stem cells, health information technology, the privacy of medical records, television advertising of prescription drugs and the importing of drugs from Canada.
Republicans are in demand at lobbying firms and trade associations, but so are knowledgeable Democrats.
John E. McManus, who formed his own lobbying firm after working for Republican members of the House Ways and Means Committee, received a total of $620,000 last year from the American Medical Association, the Advanced Medical Technology Association, the Pharmaceutical Research and Manufacturers of America and several drug companies, including Merck and Genentech. Mr. McManus can help them navigate the new Medicare law because, as a Congressional aide, he helped write it.
On the other side of the political spectrum, David H. Nexon, a health policy adviser to Senator Edward M. Kennedy for more than two decades, stepped down in February to become senior executive vice president of the Advanced Medical Technology Association, the lobby for makers of medical devices like Medtronic and Guidant.
Charles M. Brain, director of legislative affairs for President Clinton, reported that he got $240,000 last year for representing the Pharmaceutical Research and Manufacturers of America. Stephen J. Ricchetti, deputy chief of staff in the Clinton White House, lobbies for Eli Lilly & Company, Novartis and Pfizer.
Richard J. Pollack, executive vice president of the American Hospital Association, said health lobbying had become more partisan.
“We hire Republicans to lobby Republican members of Congress and Democrats to work Democratic offices,” Mr. Pollack said.
The Generic Pharmaceutical Association has retained Mr. Jennings and Mark W. Isakowitz to lobby for legislation to increase the use of generic drugs. As a White House aide, Mr. Jennings helped devise the Clinton plan for universal health insurance. As a lobbyist at the National Federation of Independent Business, Mr. Isakowitz, a Republican, helped defeat the Clinton plan.
As the costs of Medicare and Medicaid soar, federal prosecutors and members of Congress are investigating fraud and abuse with new zeal. Many health care companies find they need more lawyers and lobbyists to cope.
In a recent advertisement recruiting lawyers for its Washington office, Sidley Austin Brown & Wood, one of the nation’s largest law firms, said its health care practice had “experienced tremendous growth.”

Bush signs bill creating electronic prescription monitoring

President Bush signed into law a bill to create electronic monitoring programs to prevent the abuse of prescription drugs in all 50 states.
The new law creates a grant program for states to create databases and enhance existing ones in hopes of ending the practice of “doctor shopping” by drug abusers seeking multiple prescriptions. It would authorize $60 million for the program through fiscal 2010.
The bill, signed late Thursday at the president’s Crawford, Texas, ranch, was sponsored by Rep. Ed Whitfield, a Republican representing Kentucky’s 1st District.
Kentucky’s existing electronic prescription monitoring database, called KASPER – Kentucky All Schedule Prescription Electronic Reporting – would be eligible for enhancement grants under the bill. Establishing programs in adjacent states would help prevent abusers from crossing borders to get prescription drugs and then bring them back into Kentucky.
“It’s going to be a tremendous boost (for the Kentucky program) and be much more effective,” Whitfield told The Associated Press.
A July letter from the American Medical Association in support of the bill called prescription drug abuse “one of the fastest growing public health problems” in the United States. The letter cited a 2002 Substance Abuse and Mental Health Services Administration survey that estimated there were 6.2 million recreational prescription drugs users then.
The bill passed the House by voice vote and the Senate by unanimous consent in July.
Robert Benvenuti, inspector general of the Kentucky Cabinet for Health and Family Services, said he hadn’t seen full details of the new law yet. However, Benvenuti said he thought it was going to “be very positive” for Kentucky.
“If all states had the ability to tap into each others’ information we would know that that person is doctor shopping,” Benvenuti said. “It will allow states to see not only what’s going on in their states but what’s going on in other states.”
Nineteen states have existing programs that vary in effectiveness, Whitfield said. Illinois, which borders his western Kentucky district, has a program that only tracks Schedule II drugs, such as cocaine and oxycodone, leaving drugs such as codeine and the brand names Vicodin and Valium unreported, said John Halliwell, Whitfield’s legislative director.
Neighboring Tennessee and Indiana do not yet have such programs, Halliwell said.
Some federal money has been appropriated for state monitoring programs in the past on a limited basis. Those grants were administered by the Department of Justice, but this law will place the program under the Department of Health and Human Services instead.
“This is a health problem, and the Department of Health and Human Services is the most logical place to run a prescription drug program,” Whitfield said.
Some in Congress worry the law will invade privacy. “This bill lacks fundamental privacy protections, such as notifying patients if their information has been lost or stolen,” said Democratic Rep. Edward J. Markey of Massachusetts, whose amendment to add that notification to the bill was defeated in committee. “The lack of such safeguards virtually guarantees that this well-meaning effort to combat drug abuse will become a scandalous invasion of the privacy of innocent bystanders.”
Whitfield said his staff worked with Markey and others to address many of those privacy concerns, including requiring states to have standards for the protection of information and requiring states to establish penalties for the unauthorized use of data.
“If we feel like it’s being abused we would definitely take action,” Whitfield said.
Associated Press writer Joe Biesk in Frankfort, Ky., contributed to this story.

Medical software from feds could benefit big health care

Some IT managers at large health care organizations are delighted that the federal government plans to offer its electronic health records (EHR) software to small and midsize physician practices at a low cost. The move is expected to be a significant boon to the efforts of big providers to computerize patient records, the IT managers say.

While many hospitals and large physician practices have deployed EHR software for their patient bases, the systems won’t be fully effective unless physicians in smaller medical groups who refer patients for treatment automate their records as well.

The Centers for Medicare and Medicaid Services (CMS) expects to announce the distribution plans for its Vista-Office EHR software this month. The announcement, which has already been widely publicized [QuickLink 55837], was due to take place last week but didn’t materialize. Vista-Office has been in use at Veterans Affairs hospitals and clinics for more than 20 years.

Encouraging Adoption

The CMS will allow physicians to license Vista-Office for less than $3,000 for a five-doctor practice, according to a CMS spokesman. The move is designed to address one of the biggest barriers to the Bush administration’s goal of computerizing all patient records over the next decade: the lagging adoption rate among smaller practices.

“Vista is a good program, [and] if done correctly, there will be a level of ability to share records across regional health information organizations. It could prove to be a very effective tool for many of our small-practice, community-based M.D.s,” said John Hummel, CIO at Sutter Health in Sacramento, Calif. Sutter operates 27 hospitals in Northern California.

Any option that gets physicians to begin to computerize patient records is a good idea, said J. David Liss, vice president of government relations and strategic initiatives at NewYork-Presbyterian Healthcare System.

“Physicians who have rotated through VA hospitals love Vista — having all the patient data in one place is so compelling,” Liss said.

Hospitals and health systems could benefit from the government plan because historically, they capture the lion’s share of the benefits from EHRs: They get access to patient histories, while the physician practices that compile them bear most of the costs, said Eric Brown, an analyst at Forrester Research Inc.

As a result, large hospitals have a vested interest in making sure that all the physicians referring patients to them are using an EHR system, he said. Brown and others warned that the capital investment in electronic records often can be dwarfed by the training, implementation and configuration costs involved.

Vendors are ramping up to support physicians who will deploy Vista. In May, the not-for-profit organization WorldVista was awarded a contract by the CMS to provide training to vendors that will install the software.

Medsphere Systems Corp. in Aliso Viejo, Calif., will be offering Medsphere OpenVista, an open-source version of the government’s software that captures clinical, financial and administrative data. Medsphere will also be providing an ASP version of the software and services such as training, maintenance and support for Vista users, said Scott Shreeve, chief medical officer and co-founder of Medsphere.

Midland Memorial Hospital in Midland, Texas, will go live in December with its first clinical application based on Medsphere’s OpenVista. The hospital plans to use the technology to develop a comprehensive EHR system, said David Whiles, director of information systems at Midland.

“It is an extremely mature, very functionally rich electronic record,” he said. “It has been in place for 20-plus years, and it is not one of these new systems that vendors are offering, looking for alpha or beta partners.”

The OpenVista project will cost less than half of the upfront capital investment required for a commercial EHR product, Whiles said.