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Archive for April, 2009

The Latest Headlines…

Wednesday, April 29th, 2009

Headlines for the Week of April 22-29, 2009:

Here are links to the current news in life, legal and healthcare.  If you find stories that you think should be included please email me at epeterson@mediconnect.net, or leave a comment on the blog. If you would like to receive this as an RSS Feed, click on the “subscribe link” at the top of this page.

Thanks.

04/29/09 WSJ.com: Swine Flu Moves Toward Pandemic Level
04/29/09 WSJ.com: Aetna Reports Slight Profit Increase
04/28/09 Reuters.com: U.S. Senate Approves Health Chief amid Flu Fears
04/27/09 Reuters.com: Experts Identify Genes Linked to Chronic Diseases
04/27/09 Newsinferno.com: Hepatitis Outbreak at Atlantic City Hospital
04/27/09 Newsinferno.com: Yamaha Rhino Victims in West Virginia File Lawsuits
04/27/09 USAToday.com: Alfalfa Sprout Warning Issued
04/27/09 WHO: 40 Confirmed Swine Flu Cases in United States
04/24/09 WSJ.com: Number of Malpractice Suits Falls 41% in Pennsylvania
04/24/09 Newsinferno.com: Tobacco Replacement Products Linked to Mouth Cancer
04/23/09 BusinessWeek.com: The Dubious Promise of Digital Medicine
04/23/09 Newsinferno.com: Super Poligrip, Fixodent Users Warned of Neuropathy
04/22/09 CNN.com: FDA to allow Morning-After Pill over the counter for 17-year-olds
04/22/09 Newsinferno.com: Salmonella Sickens Scores of Students at Massachusetts School
04/22/09 Newsinferno.com: North Carolina Sees First Chinese Drywall Lawsuit
04/22/09 Newsinferno.com: Fixodent Denture Cream in Zinc Poisoning Lawsuits
04/20/09 Reuters.com: Stressed Americans Postpone Healthcare
04/21/09 USAToday.com: Mayo Clinic backs new personal health record site

U.S. Senate Approves Health Chief Amid Flu Fears

Tuesday, April 28th, 2009

WASHINGTON (Reuters) - The U.S. Senate on Tuesday confirmed Kansas Governor Kathleen Sebelius as health secretary, filling a crucial spot in President Barack Obama’s cabinet amid growing fears of a possible swine flu pandemic.

The Senate voted 65-31 for Sebelius, brushing back Republican opposition to her support for abortion rights. Sebelius was tapped by Obama to lead his push to overhaul the U.S. healthcare system.

But Sebelius will take office as U.S. health officials rush to prepare for a possible widespread outbreak of a new strain of flu that has killed scores of people in Mexico and sickened at least 64 in the United States.

The confirmation of Sebelius allows Obama to fill the last open seat in his cabinet. Democrats said the swine flu outbreak made it all the more important to end the delay in filling that pivotal position.

“It is essential for the health of the nation, that president Obama has in place and the nation has in place, a strong secretary of health and human services to make sure that our federal efforts on this potential pandemic are ably coordinated,” said Democratic Senator Mark Warner.

The Sebelius nomination had been delayed by Republicans opposed to her support for abortion rights and a failure to initially report the full extent of her campaign contributions from a doctor who performs abortions.

Sebelius, a former insurance commissioner, will lead Obama’s push to enact by the end of this year an overhaul of the $2.5 trillion U.S. healthcare industry, one of the main political goals of his administration.

The Dubious Promise of Digital Medicine

Monday, April 27th, 2009

GE, Google, and others, in a stimulus-fueled frenzy, are piling into the business. But electronic health records have a dubious history
By Chad Terhune, Keith Epstein and Catherine Arnst

Neal Patterson likens the current scramble in health information technology to the 19th century land rush that opened his native Oklahoma to homesteaders. Cerner (CERN), the large medical vendor Patterson heads, is jockeying for new business spurred by a $19.6 billion federal initiative to computerize a health system buried in paper. “It’s a beautiful opportunity for us,” the CEO says.

The billions in taxpayer funds—part of the $787 billion economic stimulus—also have energized tech titans General Electric (GE), Intel (INTC), and IBM (IBM), all of which are challenging Cerner and other traditional medical suppliers. Microsoft (MSFT) and Google (GOOG) aim to put medical records in the hands of patients via the Web. Wal-Mart (WMT) is teaming with computer maker Dell (DELL) and digital vendor eClinicalWorks to sell information technology to doctors through Sam’s Club stores.

Under the federal stimulus program enacted in February, hospitals can seek several million dollars apiece for tech purchases over the next five years. Individual physicians can receive up to $44,000. These carrots should encourage the proliferation of technology that will computerize physician orders, automate dispensing of drugs, and digitally store patient records. If providers participate broadly, those files are supposed to be accessible no matter where a consumer goes for treatment. President Barack Obama says the changes will improve care, eliminate errors, and eventually save billions of dollars a year. There’s also a stick: The federal government will cut Medicare reimbursement for hospitals and medical practices that don’t go electronic by 2015.

The incentives are working. R. Andrew Eckert, CEO of tech provider Eclipsys, says one client, a 250-bed hospital that shelved a software order in the fall after losing $50 million in the stock market, has reinstated the order. The move is “100% due to the stimulus,” says Eckert (who won’t name the hospital). Brandon Savage, chief medical officer at GE’s health unit, says his company’s technology will leapfrog the competition by not just replacing paper but also guiding doctors to the best, least-costly treatments.

In Washington, where partisan bickering over how to revive the economy flares on several fronts, sweet consensus reigns on health-tech spending. Congressional Republicans sound just as enthusiastic as the White House. Encouraged by former House Speaker Newt Gingrich, now an influential industry consultant, lawmakers cheer electronic records as a business-based remedy for much that ails medical care.

HIGH COST, QUESTIONABLE QUALITY
That rare agreement, however, is obscuring the checkered history of computerized medical files and drowning out legitimate questions about their effectiveness. Cerner, based in Kansas City, Mo., and other industry leaders are pushing expensive systems with serious shortcomings, some doctors say. The high cost and questionable quality of products currently on the market are important reasons why barely 1 in 50 hospitals has a comprehensive electronic records system, according to a study published in March in the New England Journal of Medicine. Only 17% of physicians use any type of electronic records.

Hospitals and medical practices that plugged in early have experienced pricey setbacks and serious computer errors.
Suddenly dumping more money on hospitals, which will then funnel the cash to tech vendors, won’t necessarily improve the situation, say many doctors and administrators.

Studies have shown that some large networks, such as the Veterans Administration and the Kaiser Permanente system, based in Oakland, Calif., have used electronic records to help cut costs and improve care. But so far there’s little conclusive evidence that computerizing all of medicine will yield significant savings. And improvements to patient care may be modest. An analysis of four years of Medicare data published in March in the scholarly journal Health Affairs found only marginal improvement in patient safety due to electronic records—specifically, the avoidance of two infections a year at the average U.S. hospital. “Health IT’s true value remains uncertain,” wrote Stephen Parente and Jeffrey McCullough, researchers at the University of Minnesota.

Part of the problem stems from a fundamental tension. Info tech companies want to sell mass-produced software. But officials at large hospitals say such systems, once installed, require time-consuming and costly customization. The alterations often make it difficult for different hospitals and medical offices to share data—a key goal. Meantime, the health IT industry has successfully lobbied against government oversight.

“Most big health IT projects have been clear disasters,” says Dr. David Kibbe, senior technology adviser to the American Academy of Family Physicians. “This [digital push] is a microcosm for health-care reform….Will the narrow special interests win out over the public good?”

OVERLOOKING RED FLAGS
Britain’s experience shows that technology alone doesn’t offer an automatic advantage. An $18.6 billion initiative to digitize Britain’s government-run health system is four years behind schedule because of software snafus and vendor troubles. Few British doctors have been able to use electronic records, and there’s little proof that they have saved money or helped patients. “There is a belief that technology solves all of our problems,” says Ross Koppel, a sociologist at the University of Pennsylvania School of Medicine. “[But] more data does not equate to better medical care.”

Administration officials insist they are proceeding cautiously and will learn from any missteps. But red flags raised by doctors and researchers haven’t gotten much attention in Washington, in part because the health-tech industry has forged strong ties to the President, his top medical advisers, and Republican heavyweights such as Gingrich.

Nancy-Ann DeParle, the new White House health-reform czar, recently stepped down after eight years as a member of Cerner’s board of directors. A former administrator of Medicare and Medicaid during the Clinton Administration, DeParle worked from 2006 through 2008 as a managing director at CCMP Capital Advisors, a private equity firm that invests in health-care businesses. She has sold shares in Cerner for about $950,000 and is disposing of investments related to CCMP, according to the White House.

DeParle declined to comment. Obama spokeswoman Linda Douglass says DeParle will delegate any decisions related to Cerner to a subordinate. “She is not going to be involved in implementing health IT,” Douglass adds. Cerner CEO Patterson says DeParle’s ascension won’t benefit his company, which had $1.7 billion in revenue in 2008. “I think that actually works to our disadvantage,” he argues. “I’m not sure I’ll even be able to talk with her now.”

Glen Tullman, CEO of Allscripts-Misys (MDRX) Healthcare Solutions, a big Chicago vendor to doctors, became acquainted with Obama when he ran for the Senate in 2004. The pair worked out at the same Chicago gym and occasionally played basketball. At that time, Tullman gave Obama a personal demonstration of his company’s software at Allscripts’ headquarters and went on to serve on Obama’s Presidential campaign finance committee. ”

I feel fortunate that before he became President we had the opportunity to help him better understand the value of electronic health records as a necessary condition to fixing health care,” Tullman says.

Shortly after the stimulus became law two months ago, Tullman and Gingrich hosted a Webcast for thousands of hospital officials and doctors promoting the financial incentives. Since then, Tullman has worked with a client, the University of South Florida Health system in Tampa, to seek $15 million in stimulus money to hire 130 e-health “ambassadors” who would pass out free samples of Allscripts’ prescribing software to physicians. If the funding comes through, the $50,000-a-year representatives would receive a two-week training course from Allscripts, though the marketers otherwise are supposed to be independent of the company.

“This is all about getting doctors moving and considering an electronic health record,” Tullman says. “The market is so big, we will get our fair share.” U.S. Representative Kathy Castor, a Tampa Democrat, is helping. She has brought the Allscripts proposal to the attention of officials at the U.S. Health & Human Services Dept. whose job it is to dole out the tech incentives. Castor says the program will create good jobs during a recession.

Allscripts’ rivals want their share, too. Lobbyists for McKesson (MCK), a large medical supplier based in San Francisco that already generates $3 billion a year in health technology sales, are distributing a position paper to members of Congress and Administration officials that could help steer stimulus dollars toward the company. The document, reviewed by BusinessWeek, addresses the definition of “meaningful use” of electronic records. That is the standard Congress set for hospitals and doctors seeking incentive money; it is now up to the Obama Administration to refine the term. The McKesson paper urges a requirement that recipients “build on existing technologies”—language that could favor products of McKesson and other established vendors.

Dr. David Blumenthal, the new head of health tech at HHS, will play a big role in fine-tuning this language. Formerly director of the Institute for Health Policy at Harvard Medical School, he declined to comment. HHS spokesman Nicholas Papas says: “Health IT has the potential to save the federal government more than $12 billion over 10 years, improve the quality of care, and make our health-care system more efficient. We have work to do to achieve this potential… and we will ensure that everyone has a seat at the table.” McKesson says it’s just trying to speed the process. “Our big message is: ‘Please do this quickly. Uncertainty creates a slowdown,’ ” says Ann Richardson Berkey, senior vice-president for government strategy.

There are potential benefits to patients and taxpayers if the promise of electronic medical records can be fulfilled. In theory, a computer screen can supplant reams of paper and offer instant access to patient histories, dangerous drug interactions, and allergies. Treatment of diabetes, cancer, and other illnesses can be tracked more effectively.

SPIKES IN PHARMACY ERRORS
Geisinger Health System in Danville, Pa., wanted all that when it spent $35 million to purchase and install software from Epic Systems, a large vendor in Verona, Wis. But in June 2005, during a pilot run of a computerized order-entry system at Geisinger’s flagship medical center, errors began appearing at a rate of several a week in the hospital’s psychiatric unit. “The pharmacy would interpret an order as one drug at one dosage, and the patients were ordered the wrong medications at different dosages,” recalls Jean Adams, a nurse in charge of the IT team. Fortunately, astute staffers discovered the problem after a few weeks and began verifying the computer drug orders using the phone. Full implementation of the Epic system was put on hold. Adams says Geisinger traced the trouble to incompatibility between a common pharmacy database and Epic’s system.
Epic CEO Judith Faulkner says the episode at Geisinger, and similar incidents at other hospitals, taught her company that physician orders and pharmacy records cannot use distinct technologies. “It doesn’t work when you mix and match vendors,” Faulkner says. “It has to be one system, or it can be dangerous for patients.”

To resolve its problem, Geisinger spent an additional $2 million on fixes that took 18 months, according to Dr. James M. Walker, the hospital chain’s chief health information officer. An internist and former minister, Walker is one of health technology’s best-known advocates. Tech boosters frequently cite Geisinger as an illustration of IT’s sunny future. But Walker concedes that the stimulus-fueled rush to adopt existing technology could cause other providers to suffer through expensive fixes with potentially harmful consequences for patients. Vendors such as Epic, Walker says, sell relatively rudimentary electronic tools and expect hospitals and doctors to assure accuracy and safety. “This can be very tricky,” Walker adds. “A lot of us are trying to say: ‘Look, let’s slow down.’ ”

NO WAY TO REPORT PROBLEMS
The Joint Commission, a nonprofit group that inspects and accredits 15,000 health-care organizations, has expressed similar caution. The commission, based in Oakbrook Terrace, Ill., issued a warning in December about problems with complex health-tech systems. It cited one U.S. pharmaceutical database that found 43,372 medication mistakes, or about 25% of the total reported in 2006, involved computer technology. The problems included flaws in data entry, inadequate software, and confusing screens.

Koppel, the researcher at Penn, has sounded some of the loudest alarms. In 2005 he published a study in The Journal of the American Medical Association that examined an Eclipsys system at the university’s academic hospital. He found that use of computers introduced 22 new types of medication errors. His goal was to discover why young medical interns make so many errors. He hypothesized that long hours were to blame. To his surprise, the problems stemmed mostly from software installed to prevent mistakes.

Eclipsys CEO Eckert says Koppel’s study examined a technology that has been updated. “The industry has grown up,” he says. “There are months of testing by the client and us before someone activates a system.”

When health technology fails for one medical provider, there is no central mechanism for reporting problems to others who use it. The federal government collects and disseminates this kind of information on drugs and medical devices. But tech contracts routinely bar medical providers from disclosing systemic flaws. Koppel contends this is unethical and risky: “We need to collect what we know and head off [any potential] tragedy.”

Companies counter that confidentiality agreements protect their proprietary technology and that privacy laws prevent disclosure of patient and physician information without consent. “To the extent we are required to report information, or are allowed to, we would, of course, like to do that,” says Allscripts CEO Tullman. He compares the skeptics of health info tech to doctors who questioned the introduction of the stethoscope in the 19th century: “There have been Luddites in every industry.”

Disputes over health-tech failures are often resolved in private, making them difficult to sort out. Seattle Children’s Hospital sued Eclipsys in 2002, claiming the company missed installation deadlines and failed to fix software errors. This resulted in “sizeable cost overruns and delays,” the suit alleged. Eclipsys and the hospital reached a confidential settlement in 2003. A spokeswoman for Eclipsys says “isolated problems in Seattle don’t reflect our company’s overall success. Every vendor in the industry has had accounts with implementation issues.”

“That was a bad marriage,” says Dr. Mark Del Beccaro, chief medical information officer at Seattle Children’s Hospital. “It taught us to get a better prenuptial agreement next time.” The hospital turned to Cerner for a new system, but Del Beccaro soon became troubled by incidents of children suffering medication overdoses despite alerts from Epic CEO Judith Faulkner says the episode at Geisinger, and similar incidents at other hospitals, taught her company that physician orders and pharmacy records cannot use distinct technologies. “It doesn’t work when you mix and match vendors,” Faulkner says. “It has to be one system, or it can be dangerous for patients.”

To resolve its problem, Geisinger spent an additional $2 million on fixes that took 18 months, according to Dr. James M. Walker, the hospital chain’s chief health information officer. An internist and former minister, Walker is one of health technology’s best-known advocates. Tech boosters frequently cite Geisinger as an illustration of IT’s sunny future. But Walker concedes that the stimulus-fueled rush to adopt existing technology could cause other providers to suffer through expensive fixes with potentially harmful consequences for patients. Vendors such as Epic, Walker says, sell relatively rudimentary electronic tools and expect hospitals and doctors to assure accuracy and safety. “This can be very tricky,” Walker adds. “A lot of us are trying to say: ‘Look, let’s slow down.’ ”

NO WAY TO REPORT PROBLEMS
The Joint Commission, a nonprofit group that inspects and accredits 15,000 health-care organizations, has expressed similar caution. The commission, based in Oakbrook Terrace, Ill., issued a warning in December about problems with complex health-tech systems. It cited one U.S. pharmaceutical database that found 43,372 medication mistakes, or about 25% of the total reported in 2006, involved computer technology. The problems included flaws in data entry, inadequate software, and confusing screens.

Koppel, the researcher at Penn, has sounded some of the loudest alarms. In 2005 he published a study in The Journal of the American Medical Association that examined an Eclipsys system at the university’s academic hospital. He found that use of computers introduced 22 new types of medication errors. His goal was to discover why young medical interns make so many errors. He hypothesized that long hours were to blame. To his surprise, the problems stemmed mostly from software installed to prevent mistakes.

Eclipsys CEO Eckert says Koppel’s study examined a technology that has been updated. “The industry has grown up,” he says. “There are months of testing by the client and us before someone activates a system.”

When health technology fails for one medical provider, there is no central mechanism for reporting problems to others who use it. The federal government collects and disseminates this kind of information on drugs and medical devices. But tech contracts routinely bar medical providers from disclosing systemic flaws. Koppel contends this is unethical and risky: “We need to collect what we know and head off [any potential] tragedy.”

Companies counter that confidentiality agreements protect their proprietary technology and that privacy laws prevent disclosure of patient and physician information without consent. “To the extent we are required to report information, or are allowed to, we would, of course, like to do that,” says Allscripts CEO Tullman. He compares the skeptics of health info tech to doctors who questioned the introduction of the stethoscope in the 19th century: “There have been Luddites in every industry.”

Disputes over health-tech failures are often resolved in private, making them difficult to sort out. Seattle Children’s Hospital sued Eclipsys in 2002, claiming the company missed installation deadlines and failed to fix software errors. This resulted in “sizeable cost overruns and delays,” the suit alleged. Eclipsys and the hospital reached a confidential settlement in 2003. A spokeswoman for Eclipsys says “isolated problems in Seattle don’t reflect our company’s overall success. Every vendor in the industry has had accounts with implementation issues.”

“That was a bad marriage,” says Dr. Mark Del Beccaro, chief medical information officer at Seattle Children’s Hospital. “It taught us to get a better prenuptial agreement next time.” The hospital turned to Cerner for a new system, but Del Beccaro soon became troubled by incidents of children suffering medication overdoses despite alerts from the Cerner software.
He asked the doctors involved whether they had seen the alerts onscreen. “They told me, ‘I get so many alerts, I click through [them],’ ” Del Beccaro says. “They do become mind-numbing.”

“Alert fatigue” is a common concern at hospitals. The Joint Commission, in its December bulletin, warned about doctors and nurses overriding them and impairing patient safety. At Seattle Children’s, Del Beccaro says, it took considerable effort to reduce online warnings. “There are definitely times Cerner could be more responsive to our problems, but we are pretty happy with them,” he says.

Children’s National Medical Center in Washington, D.C., has had a similar experience. In 2006 doctors and nurses there say they discovered an eightfold increase in dosage errors for high-risk medications. They attributed the trend to a Cerner system installed six months earlier. The mistakes were caught, and no patients were harmed, according to the center. But the hospital reverted to a process using paper notes. “I felt betrayed by a system I was supposed to trust,” says Cherise Aldridge, a neonatal intensive-care nurse.

For three years, Cerner has resisted making adjustments to its software, which cost the Children’s Center $30 million, says Linda Talley, the hospital’s director of nursing systems. Today nurses use the Cerner network in combination with one assembled by the hospital’s tech department. Nurses retype drug dosages, babies’ weights, and other information from the Cerner computer into the homemade system to double-check how much medicine to administer. This time-consuming process has brought the dosage-error rate back down, says Talley. But she warns that other hospitals use the Cerner system without a backstop like the one her institution cobbled together.

Dick Flanigan, a senior vice-president at Cerner, says the company responds swiftly to requests for improvements and is “absolutely focused on making systems as safe and effective as possible.” There are divergent opinions as to which technology works best, he adds. Cerner has developed a more expensive system that uses bar codes for medication and is capable of better integrating a wide array of data, he says. “We are flexible on this, and at times we incorporate what is done by the client.” CEO Patterson adds that hospitals “are much safer [with Cerner technology] than without it.”

The company faced more questions over its technology at the University of Pittsburgh Medical Center (UPMC). In 2005 researchers there found that at the university’s Children’s Hospital, patient deaths more than doubled, to 6.6% of intensive-care admissions, in the five months following the installation of a computerized order-entry system. The research on child patient deaths at the University of Pittsburgh found a “direct association between [computerized records] and increased mortality,” according to an article published in December 2005 in the medical journal Pediatrics. Digital technology slowed treatment in several ways, the researchers concluded. One example: Doctors and nurses in the intensive-care unit were accustomed to ordering medications and tests while a sick child was en route to the hospital. The Cerner system required that orders be submitted only when the patient arrived, costing crucial time. The authors of the Pediatrics article acknowledged that their work clashed with other studies showing that digitization decreases errors and shortens hospital stays.

G. Daniel Martich, chief medical information officer at UPMC, says the Pediatrics study was flawed. Factors other than the installation of computers, such as the centralization of pharmacy services, also disrupted care, he emphasizes. The problems identified in the 2005 paper have all been resolved, Martich adds. “There were workflow issues,” he says. “We learned the hard way because we were pioneers.” Over the long run, he says, technology has helped decrease mortality rates and cut medication errors in half at Children’s Hospital since 2003 .

CURSORY PRODUCT TESTING
Cerner CEO Patterson says the 2005 Pittsburgh study “certainly got our attention” and prompted an internal review. But that inquiry and others since have found no pattern of ill effects, he says. ”
We have more clients doing more orders than anybody,” Patterson says. “If I had a systemic problem, you’d be reading about it on the front page.”

The U.S. Food & Drug Administration has been considering whether to regulate health technology in the manner it oversees medication and implants. That decision now falls to the Obama Administration, which faces opposition from industry groups arguing that additional red tape would impede adoption of helpful technology.

Companies are lobbying the Administration to keep product-testing and standard-setting within the sole jurisdiction of a nonprofit body called the Certification Commission for Healthcare Information Technology. Founded in 2004 with industry money and grants from nonprofits, CCHIT has received $2.5 million a year under a contract with the federal government. The other half of CCHIT’s $5 million budget comes from fees paid by companies.

Mark Leavitt, chairman of CCHIT, is a former tech vendor. He sold his electronic health-records company to GE (GE) in 2002 and later became chief medical officer of the Healthcare Information & Management Systems Society, a trade group in Chicago. Seven of the CCHIT’s 19 voting members work for vendors or for-profit tech consulting firms. “We try to strike a fair balance between medical providers and vendors,” Leavitt says. “People need to trust what we do.”

But another commissioner at the CCHIT, Michael L. Kappel, the senior vice-president for government and industry relations at McKesson Technology Solutions, acknowledges that preserving purely private-sector oversight will be tough in the wake of the financial crisis. “I’m having a hard time with this issue because people read about these financial companies, and there is a feeling that government lacks enough regulation,” Kappel says. But regulating health info tech “is a recipe for disaster,” he adds. “I am very sensitive to criticism that [CCHIT] is vendor-dominated. That couldn’t be further from the truth.”

Blumenthal, the new Obama health-tech chief, declined to comment on CCHIT. But in an article published this month in the New England Journal of Medicine, he said the body needs to set stricter standards: “Many certified [electronic health records] are neither user-friendly nor designed to meet [the stimulus law's] ambitious goal of improving quality and efficiency in the health-care system.”

Sharona Hoffman, a professor of law and bioethics at Case Western Reserve University in Cleveland, says CCHIT’s product testing, typically completed in a single day, isn’t rigorous enough. In an article last December in the Harvard Journal of Law & Technology, she and a co-author faulted the group for telling vendors the testing scenarios in advance and for not conducting ongoing monitoring. Without better oversight, she argues, hospitals and doctors probably will not spend their stimulus money wisely.

Barry Hendrix, a primary-care physician in Paragould, Ark., says he paid dearly for just such a mistake, wasting $100,000 on an electronic records system. “It was a complete disaster,” he says of the equipment he bought from NextGen in 2005 and abandoned within months. The system generated patient notes with stray asterisks and other gibberish, he says, and it didn’t work properly with NextGen’s billing software. Hendrix says he couldn’t get technical support from the company or its authorized reseller. NextGen, a unit of Quality Systems (QSII) in Horsham, Pa., counters that Hendrix is a rare exception among thousands of loyal customers. It adds that it has terminated the reseller that served him.

Hendrix, however, has advice for doctors looking to go electronic: “Never believe a slick salesman.”

The Latest Headlines…

Wednesday, April 22nd, 2009

Headlines for the Week of April 15-22, 2009:

Here are links to the current news in life, legal and healthcare.  If you find stories that you think should be included please email me at epeterson@mediconnect.net, or leave a comment on the blog. If you would like to receive this as an RSS Feed, click on the “subscribe link” at the top of this page.

Thanks.

04/22/09 Newsinferno.com: Salmonella Sickens Scores of Students at Massachusetts School

04/22/09 Newsinferno.com: North Carolina Sees First Chinese Drywall Lawsuit

04/22/09 Newsinferno.com: Fixodent Denture Cream in Zinc Poisoning Lawsuits

04/20/09 Reuters.com: Stressed Americans Postpone Healthcare

04/21/09 USAToday.com: Mayo Clinic backs new personal health record site

04/21/09 Newsinferno.com: South Dakota Urology Clinic Exposed Patients to Diseases

04/20/09 Newsinferno.com: Crocs Lawsuit Raises Concerns about Shoes, Escalators

04/20/09 Newsinferno.com: Parkinson Linked to Pesticides

04/20/09 Newsinferno.com: Several HIV Cases Linked to One VA Clinic

04/17/09 Newsinferno.com: Alzheimer’s Patients on Atypical Antipsychotics Experience “Significant” Weight Gain 

04/15/09 Reuters.com: Experts Identify Compound that May Fight Bird Flu           

04/15/09 Newsinferno.com: Tainted Castor Oil in Cosmetics Causing Concern

04/14/09 Reuters.com: $10 Million Prize to Transform U.S. Healthcare

04/14/09 Newsinferno.com: Mirapex, Other Parkinson’s Disease Drugs Linked to Compulsive Gambling, Hypersexuality

The Doctor of the Future

Monday, April 20th, 2009

By Chuck Salter, Fast Company Magazine

Cost, access, quality — the prognosis for American health care may look grim, but innovation is the cure. The medicine of tomorrow is being born today.

In March, President Obama identified “the biggest threat to our nation’s balance sheet.” Not major banks on the brink of insolvency. Not paralyzed credit markets. Not a bailout tab in the trillions. The biggest threat, he warned, “by a wide margin,” is “the skyrocketing price of health care.”

Health care accounts for $1 in every $6 spent in the United States — and costs are climbing at twice the rate of inflation. Every year, an estimated 1.5 million families lose their homes because of medical bills. Although we have the world’s most expensive health-care system, 24 countries have a longer life expectancy and 34 have a lower infant-mortality rate, according to the latest United Nations report.

But some physicians and surgeons have been quietly rethinking and reinventing medicine for the 21st century. Often collaborating with innovative companies, these pioneers are experimenting with cutting-edge technologies, from software to robots, that have the power to revolutionize the medical landscape — producing better outcomes, lower costs, broader access, and greater convenience. And advances on a far greater scale could emerge from the stimulus package and the $634 billion the Obama administration proposes to invest in health-care reform; the much-discussed expansion of electronic medical records (see Why Electronic Health Records Are Worth the Hype–and the Price) is just the beginning. As these breakthroughs come together, they will change the world for patients, doctors, insurers, regulators — all of us.

The doctor of the future will see you. Now.

“This is a $2.4 trillion industry run on handwritten notes,” says 33-year-old Dr. Jay Parkinson. “We’re using 3,000-year-old tools to deliver health care in the richest country on the planet.” His prescription: a Facebook-like platform that uses technology, from IM to video chat, to restore the traditional doctor-patient relationship that has been lost in today’s high-pressure, high-volume, eight-minute-appointment practice model, which is often blamed for the shortage of primary-care physicians.

Parkinson, fresh from residencies in pediatrics and preventive medicine and a master’s in public health from Johns Hopkins, started a virtual practice in 2007, in Williamsburg, a Brooklyn, New York, neighborhood known for its heavy concentration of artists, bloggers, and bushy beards. He had a Web site and a blog, of course. He made house calls and conducted same-day e-visits. He accepted PayPal, but not insurance. Three hundred patients signed up in the first three months.

And then, he says, sounding more like a perpetually amazed surfer than a medical rebel, “I blew up on Gawker, man.” Through some photographer buddies, the gossip site discovered Parkinson and proclaimed, “Williamsburg’s Hipster Doctor Will Diagnose You Via IM.” In the accompanying photo, he wore a stethoscope draped casually across his shoulders like a scarf, white jeans, and a white shirt with one too many buttons unbuttoned, as snarky commentators observed. Gothamist, Yahoo, and The Washington Post jumped on the story.

The publicity caught the attention of Nathaniel Findlay, the CEO of Canadian software company Myca Health. A veteran of six startups as well as $91 billion Cardinal Health, he was leading a team building a secure portal to do what Parkinson had cobbled together using multiple applications like Google Calendar. The Myca project had begun with Don Jones, who runs the health and life-sciences group at Qualcomm. Jones had worked on one of the first electronic-medical-records efforts in the 1990s and was eager to expand the wireless company’s mobile activities into telemedicine. After his team developed the technical requirements for such a platform, he contacted Myca to build it. Findlay then persuaded Parkinson to serve as chief concept officer to ensure a doctor-friendly application.

On a recent morning in Williamsburg, Parkinson demonstrates the latest version of the Myca Platform, which launches this summer. It’s part electronic medical record, part practice-management system, and part social-networking site, complete with profiles and photos of doctors and patients, all in a secure environment that complies with federal privacy standards.

If you’re a patient, your profile shows your medical team — a primary-care physician and any specialists you’ve chosen, perhaps from the experts listed on your primary-care physician’s profile. To make an appointment, you look at a doctor’s schedule, select a time slot of at least a half hour and the type of appointment (in-person, video, or IM), and fill out a text box describing your ailment so the doctor can start thinking about treatment. Typically, follow-ups are e-visits. A timeline dotted with icons representing previous appointments lets you review the doctor’s comments, read the IM thread, watch the video of an earlier electronic house call, or link to test results.

“You can rate a visit, comment on it, share it,” Parkinson says. “Is that innovative? Man, I don’t know. It’s paying attention to what’s awesome about Flickr and then doing it.”

For the doctor, the platform is an intuitive tool for managing his time — there are lists of upcoming appointments and prescription-refill requests — and communicating with patients and other physicians more quickly and directly. One feature provides a health snapshot, the top conditions treated that week locally, statewide, or nationally. Another allows doctors to organize patients by condition and email them as a group about new treatments. “I’m a big fan of Craig Newmark [of Craigslist],” says Parkinson. “Create something useful and get out of the way. I have no idea what people are going to come up with.”

The first practice that will employ the portal is Hello Health, a more polished, three-doctor version of Parkinson’s early practice. “Think of Hello Health as a Mac and the Myca Platform as Intel, the stuff running inside,” says Parkinson, who is never at a loss for a tech analogy. There’s no receptionist, so doctors greet patients as they arrive. The clientele skews young. Half have insurance, and it’s their responsibility to file for reimbursement. So far, very few insurers cover a wide range of e-visits, but the number is growing.

Insurance is, in fact, both a challenge for Parkinson’s vision — and, perhaps, an industry that could be transformed by the kind of medicine made possible by the Myca Platform. Doctors using the platform set their own fees, and Myca takes a cut of each transaction. At Hello Health, patients pay a $35 monthly subscription fee and $100 to $200 an hour for online or office visits. Brief email queries are free. Doctors at other practices who adopt the Myca Platform may charge less than their usual rates, since online appointments slash overhead. The sweet spot for this business model right now, Parkinson says, is the “invincibles,” as health-care types call young, healthy people who forgo high monthly insurance premiums; instead, they pay doctors directly and buy relatively inexpensive high-deductible policies for emergencies.

About 2,000 doctors have inquired about joining, says Myca’s Findlay. He maintains there’s no shortage of companies looking for health-care options for employees that could eliminate lost productivity through absenteeism or waiting in a doctor’s office. “The genie is out of the bottle,” he says. “People want it. We just have to figure out how to do it properly.”

One of the paradoxes of modern medicine is that it demands continual innovation yet often resists change. This is particularly true for highly complex surgeries, such as open-heart operations. After all, the traditional procedure works. Why change it? But Dr. Douglas Murphy, 59, a cardiac surgeon at St. Joseph’s Hospital in Atlanta, has led the way in repairing the heart’s mitral valve robotically, using Intuitive Surgical’s da Vinci Surgical System. The procedure has proven more effective, quicker to do, and dramatically less invasive. Now he’s on a mission to make it more widely adopted, providing a model for both high-tech surgery and remote medical education.

Murphy’s achievements in the operating room are nothing short of miraculous to the rest of us. Instead of cutting the sternum and splitting open the chest, one of the more violent operations performed on the body, he inserts long, slender instruments, including a robotic camera, through a few fingertip-size incisions. Slipping the tremor-free instruments between the ribs, he’s able to slice and enter the heart. “It’s like building a ship in a bottle,” he says. The camera gives him a three-dimensional, high-definition view (and magnification up to 10 times stronger than the human eye). The small size of the incisions nearly eliminates the risk of infection; there hasn’t been one in 750 surgeries.

“Traditional heart surgery has always been a mixed blessing,” Murphy says. “Sure, it’s life-saving, but it takes you two or three months to recover. The heart recovers in a couple of hours. But the body takes much longer. With robotic surgery, the patient is out of the hospital in less than half the time and recovered in three weeks. I’m talking back to playing golf or tennis.”

Why isn’t robotic cardiac surgery already the treatment of choice? Murphy estimates that it takes 100 cases to learn to perform it efficiently, and there’s no immediate financial incentive to do that since the reimbursement is the same. That means few surgeons — let alone other members of the surgical team — can afford to travel and observe an expert in action. What’s necessary, Murphy realized, is robot college.

So earlier this year, his hospital launched the International College of Robotic Surgery, the first such remote facility with a cardiac focus. Murphy and his colleagues teach via a secure Internet site. Tuition runs as high as $100,000 for a comprehensive package that includes more than 30 presentations, live video feeds of operations, proctoring, and sessions tailored to each role on the surgical team — surgeon, surgical assistant, nurse, anesthesiologist, and so on. “There are review sections, checklists, a section I call ‘Things I wish I hadn’t done,’” Murphy says. “We’ve documented 750 cases on video, so I can show it all — the great examples, what’s routine, what’s not routine. They get the know-how of the first 100 cases before they do their first.”

Murphy, who performed heart transplants before moving into less-invasive surgeries, teaches repair of the mitral valve — a flap in the heart’s upper chamber that can become leaky, leading to congestive heart failure. The optimal treatment is repairing the existing valve, but in nearly half of all nonrobotic procedures, surgeons install an artificial replacement, a considerably more expensive process. With robotics’ 3-D magnification, Murphy is able to repair more than 90%. Dr. Sudhir Srivastava, who joined St. Joseph’s from the University of Chicago Medical Center this year, teaches an even rarer robotic procedure: coronary bypass surgery on a beating heart.

Currently, hospitals around the world have more than 1,100 da Vinci systems, at a cost of $1 million to $1.7 million apiece. Using them more for cardiac procedures makes sense both medically and economically. The demand is there: Murphy has a two-month waiting list, with patients from all over. St. Joseph’s, which has five da Vincis, has grown its total annual robotics-surgery revenue to $25.5 million from scratch in six years. And the need for less-invasive measures is expected to increase as the population ages, because traditional surgery is too traumatic for the elderly.

“We’re toward the end of our careers, and we decided that rather than grind out more cases, we wanted to teach this worldwide,” says Murphy. “Every major metropolitan area should have one or two teams that are proficient in this.”

Last year, robotic surgery using the da Vinci system, the only one with FDA approval for soft-tissue surgery, reached a milestone: More than half of the 80,000 prostate removals in the United States were performed by surgeons manipulating robotic metallic arms instead of wielding scalpels in their own hands. A total of 136,000 operations involved da Vinci robots, a 60% increase from 2007. This revolution in the OR is likely to pick up speed as surgeons like Murphy and Srivastava perfect new robotic procedures — and exploit telemedicine technology to share that knowledge efficiently.
In theory, the more doctors learn about the body, the better basis they have for figuring out what’s wrong with you. In reality, they can’t keep up with the flood of new information. In neurology alone, the number of identified disorders has more than doubled in 10 years, to more than 1,800, the majority extremely rare. True, doctors as a community know more, but what any individual knows constitutes a smaller portion of medical information overall. What if physicians could use technology to tap their peers’ expertise to make quicker, more accurate diagnoses?

Dr. Michael Segal, 54, a renowned pediatric neurologist in Chestnut Hill, Massachusetts, has been working on this problem off and on for 20 years. The result: SimulConsult, a sophisticated online crowd-sourcing tool for identifying neurological disorders that demonstrates the potential of the Web to transform the way all kinds of diseases are diagnosed. Doctors enter a patient’s symptoms and test results, and the software produces likely diagnoses and the probability for each.

“It’s like having a group of more- experienced physicians helping with every diagnosis,” says Dr. Viveck Baluja, a resident in pediatric neurology and developmental medicine and a fellow at Baltimore’s Kennedy Krieger Institute. “The people inputting data about the diseases are experts in this field.”

Segal recognized the need for such a tool as a resident in the 1980s, when he spent hours poring through books and looking at every possible unusual disease for one particularly perplexing patient. “The problem is that textbooks are arranged so if you know the disease, they tell you the symptoms or lab results,” he says. “But patients come to us in the opposite way, with findings that we need to put together in a story to reach a diagnosis.”

SimulConsult works the way a physician does. It produces an initial diagnosis based on information from experts with a wealth of experience, then prompts the doctor to consider other pertinent tests and findings. For example, if a physician enters information about a teenager with a history of attention-deficit-hyperactivity disorder, an abnormal electrocardiogram, and bouts of weakness, SimulConsult asks about recent salt intake. “Most clinicians would not flag such information as relevant,” says Segal, but sodium has been known to trigger those symptoms in patients with a neurological syndrome known as hypokalemic periodic paralysis. Says Baluja: “There are thousands of outliers. The problem isn’t in the disease itself. It’s in the subtle variations of disease. The details matter.”

In 1997, Segal went part-time at Harvard Medical School, where he had been an award-winning researcher, to found SimulConsult. The firm didn’t begin generating revenue until this year; the tool was more of a puzzle he wanted to solve than a way to make money. Last year, in hopes of expanding, he hired a CEO, got his first ads, and secured an initial round of funding from an angel investor; eventually, he plans to charge a subscription fee for access to more detailed information. “This is typical of a lot of medical innovations,” says David Williams, a health-care consultant in Boston and informal adviser to Segal. “There’s a long incubation from basic R&D to commercialized product.”

Segal began by offering the database free to pediatric neurologists. Now primary-care physicians make up 20% of users, a development that should increase its impact. If SimulConsult helps generalists make correct diagnoses early on, that means fewer visits to the wrong specialists and unnecessary tests, greatly reducing costs and accelerating appropriate treatment.

Most significantly, more users would lead to more findings and a richer, more valuable diagnostic tool. “I think we will discover that many diseases that we thought were rare,” says Segal, “will turn out to have been just rarely recognized.”

It’s this ability to expand and harness knowledge that makes cutting-edge information technology such a powerful driver of the emerging health-care revolution. Professional tools like SimulConsult, Isabel, and Diagnosaurus can improve care and control costs. Sites such as PatientsLikeMe, which connects people with similar conditions, help them understand their health and may promote compliance with treatment. Physicians, not surprisingly, complain about patients who try to diagnose themselves after logging onto the symptom search engine Medgle. But the end result is to deepen communication, both among doctors and between physicians and their patients. Everyone will be smarter for it.
The call came after hours. A 36-year-old woman had arrived at the ER in Big Rapids, Michigan, with an apparent stroke. Omar Qahwash, a neurosurgeon at St. Joseph Mercy Oakland in Pontiac, outside Detroit, rushed to have a look. In the quiet of his bedroom, he flipped open his laptop and transported himself 197 miles away.

Although Mecosta County Medical Center, an 82-bed facility in Big Rapids (population: 10,849), doesn’t have a stroke specialist, it has the next best thing: the RP-7, a 5-foot-tall “remote presence” robot made by InTouch Health of Santa Barbara, California. Using a stubby joystick, Qahwash, 34, zoomed the two-way camera to review the patient’s chart and CT scan. Then, parking the robot at the woman’s bedside, he asked several questions, carefully studying her responses. To the patient, he was a face on the machine’s 15-inch monitor.

She hadn’t had a stroke, Qahwash concluded. The immediate and expert assessment avoided a needless helicopter transfer to Detroit, which would have cost several thousand dollars. If it had been a stroke, Qahwash was on hand to direct treatment.

The uneven distribution of specialists is a significant problem for the U.S. health-care system. While some large cities arguably have too many specialists, small cities and rural areas generally have too few. This deficit is especially acute in cases where rapid, expert diagnosis and treatment are the most critical. Some of the most powerful medical advances are those that address this growing manpower crisis. One cost-effective way to extend expertise is leading-edge telemedicine.

Consider stroke, the third leading cause of death in the United States and the No. 1 cause of long-term disability. Only 23% of county hospitals offer neurological services. The shortage is expected to worsen during the next 20 years as aging baby boomers live longer than previous generations. So St. Joseph Mercy, part of Trinity Health, a $6.3 billion nonprofit with 44 hospitals and a few hundred outpatient facilities, has established the Michigan Stroke Network, the largest such network in the country. St. Joseph spends $2 million a year to lease 33 robots that stand at the ready in 31 hospitals across the state.

Time is of the essence with strokes. Most are caused by clots that reduce blood flow to the brain. A clot-busting drug approved by the FDA in 1996 — tissue plasminogen activator (tPA), also known as “brain Drano” — can work wonders, but only with certain strokes and, in most cases, only within three hours of onset. (In other cases, tPA can make things worse.) The remote robot increases the chances of treating a patient effectively. Nationally, about 5% of stroke victims get tPA; in 2007, 80% of eligible patients in the stroke network did. On average, it takes just seven minutes for a network hospital to get a neurologist or neurosurgeon on-site via robot. As the specialist assesses the patient, other members of the team prepare for helicopter transport, just in case.

The RP-7, which some hospitals humanize with a lab coat, ID badge, and name, looks odd — even comical — with the bottom-heavy build of a vacuum cleaner and a flat-screen monitor for a head. (It comes with sounds effects, too, including Arnold Schwarzenegger saying, “I’ll be back.”) But patients don’t seem to mind the machine. “They’re relieved that they have a specialist at their bedside,” says Connie Parliament, supervisor of the stroke network. “They’re used to driving two hours to see someone.”

The robot “isn’t a panacea,” says Jack Weiner, St. Joseph president and CEO, “but it is the kind of technology that significantly reduces health-care costs.” With a robot, leased for about $7,000 a month, a community hospital can offer the expertise of a neurologist it couldn’t otherwise afford ($500,000 a year and up, says Weiner). That means more stroke victims walk out of the hospital, avoiding bills of $250,000 or more for months of rehab. “We think the insurance companies benefit,” says Weiner, “but they are not willing to support the program yet.” He wants more departments to use the robots. At St. Joseph, for example, ICU specialists make robot rounds from home before going to bed, which can prevent a late-night call. St. Alphonsus Regional Medical Center, a Trinity hospital in Boise, Idaho, uses eight units to provide neonatal, cardiology, mental health, and other services to rural facilities. And there, the revenue covers leasing costs.

Like the Myca Platform, the robots are just one example of an advanced technology that seems impersonal but actually enables doctors to be more hands-on; in a Twitter and Facebook world, screen-to-screen face time can build relationships with patients. And like SimulConsult and the robotic college’s remote learning, they encourage professional connections that dramatically enhance care. Together, innovations like these are beginning to free U.S. medicine from the strictures that have given us the world’s costliest health care, but not the best health care.

Think what happens when you put these things together. You can see your doctor immediately without wasting time in a waiting room. A robust database helps your physician make more accurate diagnoses. Advances in robotics cut your recovery time after surgery — and could even lead to operations assisted by remote experts. This is the vision of the medical system of tomorrow. And it’s emerging today.

“You get into medicine because you want to take care of people,” says a 39-year-old general practitioner in a traditional practice in Philadelphia. “But then you discover it’s not a fulfilling profession anymore.” Which is why he recently decided to leave the “hamster wheel” of rushing between patients all day without a break. He’s following Parkinson’s lead and opening a Hello Health practice with the Myca Platform. Just what the health-care system ordered: one more doctor of the future.

Why Electronic Health Records are Worth the Hype–and the Price

Monday, April 20th, 2009

By: Ellen McGirt

The push for electronic medical records has stirred controversy — but their potential is immeasurable
If you’ve been having trouble reaching your doctor lately, maybe you should try hanging out in the blogosphere. The prospect of a $19.2 billion investment in electronic medical records (EMRs) — the always controversial, not-so-new thing that is supposed to deliver better health care and lower costs — has driven docs to step into a new digital divide. Some lament product features about EMRs they’ve known (It won’t print. I have to constantly reboot); others get philosophical about the future of medicine (What about privacy?).

Doctors can debate, but it looks as if EMRs are here to stay. The American Recovery and Reinvestment Act states that every American should be provided an electronic medical record by 2014. The Obama administration is looking to speed the transition by providing financial incentives, up to $65,000 apiece to eligible physicians, starting in 2011.

At the most basic, EMRs are digital documentation of a doctor’s visit, including patient histories, exam notes, tests ordered, drugs prescribed, and any results. Some systems check for drug interactions, access X-rays, or deliver a prompt when a patient has not had a flu shot. “The preventive aspects alone have saved millions of dollars and thousands of hospitalizations,” says Dr. Steve Zeitzew, an orthopedic surgeon at the Veterans Administration West Los Angeles Healthcare Center.

So far, only 17% of doctors use even a basic EMR, and so far, most have had little reason to try. The average primary-care physician, earning, say, $110,000 a year, has no time to research the right EMR system from the 160 certified products out there, and less time to learn how to use it. “The hardware and software will cost you some $50,000,” says health-care-IT guru Dr. John Halamka — he’s CIO and dean for technology at Harvard Medical School and chairman of the New England Health Electronic Data Interchange Network, among other roles — “then 25% of your productivity will disappear as you implement it, patients will complain, and half your office will quit.” Worse, if the system does work, the doctor makes less money. “A doctor doesn’t get paid for illness she prevents,” says Halamka. Cough up money for an MRI machine and the first time you use it, “you get $1,000.” Cough up the $50,000 for an EMR system and you get nothing but headaches.

The dream of interoperable EMRs, which would create a mass database where we can detect epidemics and study drug interactions, has yet to be realized. Financial incentives from the government and private insurers may help, but there are other hurdles to overcome. Here are three places to begin.

TEACH THE DOCTORS WELL

Asking doctors to do this on their own is a recipe for disaster. Halamka applauds the regional health-care-IT centers that are outlined in the stimulus bill — “SWAT teams,” as he calls them. “Vendors,” he says, “are good at creating products, but not good at implementation, or workflow, or practice reengineering.” He cites regional public-private hybrids in Massachusetts and in New York City that have helped deploy hundreds of EMRs.

TAKE OPEN SOURCE SERIOUSLY

The VA’s VistA clinical software system, available for free under the Freedom of Information Act, has been a shining example of how EMRs can work. The VA relies on technology developed in-house, so iteration can be slow, but several modified versions exist for non-VA applications. A faster-track solution may be on the horizon. A recent meeting of WorldVistA, a not-for-profit group of VistA developers and fans, focused on creating an open-source collaboration model — think Mozilla’s Firefox — to make the platform a real alternative to privately developed systems, one to be shared freely.

REALIGN INCENTIVES

The fundamental problem is that doctors get paid for service, not wellness. The ideal is to find real patterns in health, safety, and wellness in EMRs, and reward accordingly. That requires the widespread adoption of a truly interconnected system that doesn’t quite exist yet. Even in the widely used VA EMR system, some data are recorded and shared, and some aren’t. Once we solve that problem, it will take the determination of all parties — including the government, through reform to Medicare and Medicaid — to put in place a new way of paying doctors and health systems.

An Open Letter to the New National Coordinator for Health IT - Untying HITECH’s Gordian Knot: Part 1

Friday, April 17th, 2009

KibbeB&WjpgCongratulations to David Blumenthal on being named National Coordinator for Health Information  Technology (ONCHIT). Dr. Blumenthal will be the person most responsible for the rules and distribution of the American Recovery and Reinvestment Act’s (ARRA) nearly $20 billion allocation, referred to as HITECH, designated to support physician and hospital adoption of health information technologies that can improve care.

The job is fraught with difficulties, which Dr. Blumenthal has readily acknowledged. His recent New England Journal of Medicine (NEJM) Perspective, “Stimulating the Adoption of Health Information Technology,” is a concise, clear and honest appraisal of two of these challenges, namely how to interpret and act upon the key terms used in the legislation, “meaningful use” and “certified EHR technology.” Dr. Blumenthal gets to the heart of the matter by identifying the tasks on which the National Coordinator’s success will most depend, and which will foster the greatest controversy.

The country needs Dr. Blumenthal to succeed. The issues are complex and, with huge ideological and financial stakes involved, politically charged.

 

Even so, we believe there are straightforward ways to help physicians and hospitals take advantage of this opportunity to use health IT to improve care. This article is the first of a series in which we’ll try to disentangle the Gordian knot of inter-related issues embedded in HITECH. Below we identify six issues. Then we address the first.

A defining paragraph in Dr. Blumenthal’s NEJM article offers his vision of the problem:

….[M]uch will depend on the federal government’s skill in defining two critical terms: “certified EHR” and “meaningful use.” ONCHIT currently contracts with a private organization, the Certification Commission for Health Information Technology [CCHIT], to certify EHRs as having the basic capabilities the federal government believes they need. But many certified EHRs are neither user-friendly nor designed to meet HITECH’s ambitious goal of improving quality and efficiency in the health care system. Tightening the certification process is a critical early challenge for ONCHIT. Similarly, if EHRs are to catalyze quality improvement and cost control, physicians and hospitals will have to use them effectively. That means taking advantage of embedded clinical decision supports that help physicians take better care of their patients. By tying Medicare and Medicaid financial incentives to “meaningful use,” Congress has given the administration an important tool for motivating providers to take full advantage of EHRs, but if the requirements are set too high, many physicians and hospitals may rebel — petitioning Congress to change the law or just resigning themselves to forgoing incentives and accepting penalties. Finally, realizing the full potential of HIT depends in no small measure on changing the health care system’s overall payment incentives so that providers benefit from improving the quality and efficiency of the services they provide. Only then will they be motivated to take full advantage of the power of EHRs.

Here are issues that, to develop rules that can make the most of emerging Health IT trends, deserve clarification:

  1. The term “electronic health record” (EHR) is unclear and imprecise, especially given the wide-ranging tools that can be used to manage health information in electronic format. Before developing rules that will guide our use of these tools, a clearer definition is essential.
  2. In thinking about health IT, it is useful to separate health data from the applications used to manage health data. Separating them is critical to better understanding the role of standards, certification and the criteria used to validate physicians’ and hospitals’ claims on HITECH’s incentive funds.
  3. In a certification process, the appropriate scope of “basic [EHR] capabilities” should be limited to the critical few. Given constraints on time and resources and the “meaningful uses” that Congress wishes to promote, does it make sense to require a large package of features or a more limited set of basic capabilities?
  4. How should the certification process be structured to ensure fairness, flexibility and openness to innovation? Does the current certification process meet these criteria?
  5. The roles patients and consumers might play in any determination of “meaningful use” are important, but are left on HITECH’s sidelines. How can health IT policy enhance the patient’s health care experience and participation?
  6. Will the incentive payments envisioned by HITECH actually encourage implementation of EHR technologies, and result in improvements in patient care quality? Or are better mechanisms available that can systemically improve care?

1. Definitions

First, let’s admit that there is no precise, universally-accepted meaning for “EHR.” 

The term sometimes refers to medical records themselves, digital files containing a person’s health data and information.  We believe this is what both Presidents Bush and Obama intended for the meaning when they have stated that all Americans should have their own electronic medical records.   Individuals should be able to access their health information in electronic formats (of which there are many), and not just in paper records. Patients with their own EHRs can access them, give viewing permission to others, download them to computers or cell phones, and use software applications to manage and transfer the records in digital formats.

However, EHR may also mean a software application - like Intuit’s Quicken for financial management or Microsoft Office for business productivity - used by doctors, nurses, and staff in a medical practice, hospital or other clinical setting. (EMR, for “electronic medical record,” was an earlier term for this same class of software, now less used.) EHR software is typically utilized for creating, storing and managing a patient’s care-related and billing data.  Dr. Blumenthal uses this meaning in the passage above; EHRs are certifiable software programs that have “capabilities.”  We might also point out that EHR software for ambulatory care is very different from EHR software used in hospitals.

Unfortunately, many people have come to believe that a specific class of EHR software is required to consume and utilize the EHRs that are digital health records. But this is completely inaccurate.  Many types of technologies can be used to manage digital records.  If, for example, your electronic health record is a discharge summary written by a physician in Microsoft Word or PDF - two very common digital file format standards for text documents - you could use any number of word processing software programs to view that EHR, including some that are open source and/or free.  Google Health, Microsoft HealthVault and WorldDoc store health records electronically for retrieval or updating by patients and the professionals or institutions that care for them. Even data that are digitally formatted in less publicly familiar standards, such as DICOM for radiological images and XML for structured medication or lab data, do not require an EHR application. Many types of software - personal health record applications (PHRs), image viewing programs, e-Prescribing applications, and even web browsers - can be used to create, consume, store, manage, and then transmit these data successfully. Each of these software programs, alone or in combination, deserves to be considered an EHR technology, by virtue of the fact that its main purpose is to handle electronic health records.

Further, the Certification Commission for Health Information Technology (CCHIT), initiated by the Health Information Management Systems Society (HIMSS), later re-organized as a non-profit and contracted by ONC while David Brailer was the the National Coordinator, insists that EHR software products must: a) include hundreds of features and functions, based on a model of such software that many would term “comprehensive,” and;  b) be supplied by a single vendor.  This EHR definition prohibits CCHIT certification for many simpler, less feature-rich, and less expensive EHR applications. It also prevents end-users from assembling EHR software from components from separate vendors and submitting this for CCHIT certification.

The upshot is that the term “EHR” is no longer very useful. It creates more confusion than it resolves. This is more than a quibble. One can never be certain what EHR refers to: health data in electronic format; a technology that is designed to handle electronic health records in some fashion; an EHR software program that has fewer or different features and functions than those required by CCHIT, or one that has been assembled from compatible modules; or a CCHIT-certified, comprehensive software application from a single vendor whose product has been accepted by CCHIT.

It is not necessary to accept this confusion. Ever-expanding technological options, more than anything else, have made the term EHR obsolete. However, we think clarity is especially important now, as we face the challenge of setting rules to determine who will and will not qualify for ARRA/HITECH funding. If the language we use to define key terms is arbitrary, capricious, biased or simply out-of-date, the guidance we follow will fail to be fair or, more importantly, in our national best interest.

So, in an effort to reach the appropriate level of clarity, we suggest that “EHR technology” replace the terms EMR or EHR in ONCHIT’s lexicon. The term would be defined as:

“An information technology tool, such as a software program or application, that is used to create, consume, manage or transport health data in electronic or digital form.

This definition is very broad, allowing many different kinds of technologies to qualify as meaningfully useful — required by HHS and ONC — and without requiring features and functions that are not useful. For the market to work and to encourage optimal innovation that can benefit all Americans, it is important to allow recognition and certification of single function applications that can mix-and-match with others, as well as more comprehensive packages, according to the needs, the budget, and customers’ capacity to adopt. A first step is to create clarity in the language used to describe these tools.

Nancy-Ann DeParle’s Definition of “Public” Health Insurance

Friday, April 17th, 2009

insuranceSo what is this “public” insurance plan that President Obama has been talking about, anyway?

When Obama was on the campaign trail, he pushed the idea of giving consumers the chance to choose among both private and publicly sponsored health-insurance options. The idea has caused some consternation among insurers, who worry such a public plan would have an unfair advantage with the heft of the government behind it. Another question is whether the new public plan would pay doctors at the same rates that Medicare does — rates many doctors feel are too low.

In a media briefing hosted by the Kaiser Family Foundation today, Nancy-Ann DeParle, who’s running the new White House Office of Health Reform, was asked for her own definition of the term. Her response:

A public plan is something that’s sponsored by the government, and therefore has very low or almost nonexistent administrative costs, compared to others. It doesn’t have the need to have brokers out selling; it wouldn’t have the need to have a lot of costs and profits, the way private plans would. So it has that advantage. It could operate by the same rules that all the other plans do; it could have payments rates that are very similar. Or it could have payment rates that are the same as Medicare — that’s one idea that’s been used. So there are various ways of looking at it.

DeParle then said one model might be the plans that are offered to state employees. They’re government-sponsored and tend to be less expensive, but they’re often operated by private companies, she said. Another model is Medicare, she added.

When it comes to differences on how to construct such a plan or how much it would pay, “there are ways of bridging that gap,” DeParle said. Some folks on the left, including Howard Dean, are trying to make sure Obama doesn’t give up the idea altogether.

The Latest Headlines…

Thursday, April 16th, 2009

Headlines for the Week of April 8-15, 2009:

Here are links to the current news in life, legal and healthcare.  If you find stories that you think should be included please email me at epeterson@mediconnect.net, or leave a comment on the blog. If you would like to receive this as an RSS Feed, click on the “subscribe link” at the top of this page.

Thanks.

04/15/09 Reuters.com: Experts Identify Compound that May Fight Bird Flu

04/15/09 Newsinferno.com: Tainted Castor Oil in Cosmetics Causing Concern

04/14/09 Reuters.com: $10 Million Prize to Transform U.S. Healthcare

04/14/09 Newsinferno.com: Mirapex, Other Parkinson’s Disease Drugs Linked to Compulsive Gambling, Hypersexuality

04/13/09 Cnn.com: Wal-Mart Wants your Rash and Strep Throat

04/13/09 Newsinferno.com: Chicago Hospital Patients Exposed to Tuberculosis

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$10 Million Prize Seeks to Transform U.S. Healthcare

Tuesday, April 14th, 2009

 

WASHINGTON (Reuters) - Organizers of the X Prize, who have set up contests for space travel, DNA research and super-efficient cars, said on Tuesday they are offering $10 million to the winner of a contest to transform the health of people in a small U.S. community.

 

They invited written ideas for the Healthcare X Prize, and said they would choose five for a three-year trial run in real communities or at employers.

 

The winner would be chosen based on a “community health index” of measures such as an improved ability to climb stairs, reductions in visits to emergency rooms and health costs.

 

“We need to show that the innovation works and then that the innovation is scalable. It’s going to be a public solution,” Angela Braly, president and chief executive officer of WellPoint Inc, a major U.S. health insurer that is helping sponsor the prize, told a news conference.

 

“We are looking for teams to help individuals and communities proactively improve their own health and (that) of their families,” added Dr. Peter Diamandis, chairman and chief executive of the non-profit X Prize Foundation.

 

“Teams are actually going to have to design and implement a system across a community of 10,000 people that improves health by 50 percent during a three-year trial period.”

 

The competition and all results will be audited by an independent panel of judges and “trusted third parties,” the group said in offering the prize plan for a 45-day public comment period.

 

“The Smithsonian would never have funded the Wright Brothers to invent the airplane,” said Newt Gingrich, former speaker of the U.S. House of Representatives who now helps head up the Center for Health Transformation.

 

“I think this will bring diversity.”

 

The plan gives teams 18 months to conceive, model, and submit their plans.

 

Healthcare reform is near the top of the agenda for President Barack Obama, the Congress and U.S. society as a whole. More than 80 percent of Americans have said in several surveys they believe the U.S. healthcare system needs substantial reform.

 

The United States ranks last among 19 industrialized nations on health outcomes, quality and efficiency, according to a report by the non-profit Commonwealth Fund.

 

In 2008, the United States fell from 15th to last on measures of preventable death from chronic conditions such as asthma and heart attacks, the report found.

 

Medical bills cause half of all U.S. personal bankruptcies, most among middle-class workers with health insurance, according to a 2005 study by researchers at Harvard University.

 

(Reporting by Maggie Fox; Editing by Eric Walsh)

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