FDA to regulate health information technology?
Fred Schulte and Emma Schwartz, the Huffington Post Investigative Fund duo who have made it their business to stay in front of all stories related to the federal push for the adoption of health information technology, now look at the possibility of federal regulation of health IT.
Schulte and Schwartz write that “In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems,” and officials say those voluntary reports represent just the tip of the iceberg. In case you’re interested, here are the transcripts from the relevant government hearing.
… digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.
Schulte and Scwartz summarize the three possible regulatory approaches outlined by officials:
- Option 1: FDA requires HIT makers to register, submit safety reports and correct problems.
- Option 2: FDA requires HIT makers to report safety concerns and sets minimum quality guidelines.
- Option 3: FDA makes HIT “subject to the broader regulatory actions that new medical products must face before they ever reach the market.”
Many manufacturers argue that such regulation could be counterproductive.
The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.
Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law.
Government Health IT also is following the issue and points to some problems the Veterans Health Administration has run into and how it dealt with the lapses.
FCC’s broadband plan includes wireless health tech
The Federal Communications Commission will release a report next month outlining a national broadband plan that is expected to include measures for promoting and facilitating the use of mobile devices in health care, Mary Mosquera of Goverment Health IT reports. The plan was mandated as part of the stimulus package.
The FCC plan will describe “where government has a role to reduce some of the hurdles to these technologies both in connectivity and to promote innovation in applications,” said Dr. Mohit Kaushal, digital healthcare director of the FCC’s Omnibus Broadband Initiative.
The American Recovery and Reinvestment Act called for the FCC to develop a plan for establishing broadband connections to the Internet as a way to spur business development, job creation and improvements in healthcare.
To demonstrate a few possible uses of such technology, Mosquera also talks to organizations, hospitals and doctors who are taking advantage of current resources.
NIH updates stimulus grant info, releases database
Filed under: Health data, Health journalism, Public records, Tools
We’ve been waiting for this one. The National Institutes of Health have followed through on their promise to release a comprehensive database of NIH grants funded with stimulus money. The new data is up-to-date as of yesterday, you can find it on this page or go directly to the 13mb Excel file. The NIH’s stimulus transparency site has been quite good, in general, but inexplicably lacked key data fields and a way to export more than 500 (of 12,000+) grants at a time. The new database solves those issues.
For a quick picture of where the stimulus cash was headed, we grabbed data for all 50 states as well as D.C. and Puerto Rico, added some recent census estimates, and put together a few top 10 lists. Massachusetts, D.C. and California lead most categories, and per-capita numbers differ pretty significantly from absolute totals.
Which states (etc.) are getting the most NIH grant money?
And how does all of that money break down on a per-person basis?
What about individual NIH grants?
And what’s the per-capita on those?
These are just scratching the surface, the database has a separate entry for each grant, and it’s pretty easy to break it down by institution, research area and a number of other categories.
Does stimulus-funded research stimulate?
Filed under: Government, Hot Health Headline, Studies
Reporter Michelle Breidenbach of the Syracuse, N.Y., Post-Standard considers local academic research being funded by stimulus money and wonders just how much these projects – many of which were turned down previously and selected for stimulus money based partly on timing considerations – are really stimulating the economy. There were no job-creation or buy-American strings attached and, while ostensibly health-related, studies covered such esoteric topics as wild ticks on lab mice and the interaction between marijuana and malt liquor consumption.
With a story localization model that can be applied across the country, Breidenbach used the NIH’s grant-tracking site to check in on stimulus-funded projects getting underway at a number of nearby universities, then contacted researchers and assessed their work’s impact on the local economy and on human knowledge in general.
About 45,000 docs qualify for HIT stimulus money
Researchers at George Washington University have found that approximately 45,000 physicians nationwide qualify for as much as $63,750 each in federal stimulus money to be used for the adoption and maintenance of health information technology beginning in 2011.
According to the press release, the following groups of physicians will qualify for as much as $63,750 as long as they demonstrate meaningful use of HIT:
- Office-based physicians whose patients are made up of at least 30 percent Medicaid beneficiaries.
- Office-based pediatricians who have a patient mix including 20 percent medicare beneficiaries will qualify for the same incentives.
- Physicians who practice at federally qualified health centers and other settings can qualify if 30 percent of their patient base is characterized as “needy,” including those covered by Medicaid, those who receive uncompensated care and patients who are charged income-related sliding scale fees.
Reporters may be able to localize this by finding qualified doctors in their area or by checking with community health centers and rural clinics. Page 10 of the report lists how many qualifying physicians there are in each state.
Find the full study here (14-page pdf).
Stimulus boosts health care for poor Americans
The Associated Press’s Kristen Wyatt looks at one category of stimulus spending that’s already making an impact: funding for clinics serving the poor and disadvantaged.
From the Colorado homeless shelter to rural Pennsylvania clinics that can accept new patients, health centers that serve the poor are among the first places the federal stimulus package is being spent.
The stimulus law sets aside $2.5 billion for free and low-cost health clinics, and a big chunk of it - about $500 million - is already being spent. The White House has promised another burst of money this summer.
Wyatt quotes grateful patients and providers, but also tempers the enthusiasm with a reminder that the money comes in the form of one-time grants that aren’t designed to fix the systemic problems behind the lack of health services for America’s poorest residents.
For a full list of Health and Human Services programs receiving stimulus money, visit the HHS page at recovery.gov or use this map to find programs benefiting from the stimulus in your area.
CJR examines potential, weaknesses of health IT
In the Columbia Journalism Review, Trudy Lieberman, president of AHCJ’s board of directors, sought to shed light on the nebulous promise of health information technology by interviewing Jonathan Oberlander, a health policy expert and professor of social medicine and health policy & management at the University of North Carolina—Chapel Hill.
Focusing on the example of electronic medical records, Oberlander said only a small percentage of hospitals had adopted electronic medical records, primarily due to their prohibitive cost. Stimulus money, $19 billion of it, has been directed toward the problem, though the language — hospitals and practices should adopt “meaningful” information technology is vague — and payments won’t arrive until next year, at the earliest.
According to Oberlander, patients may not even benefit from all the money being thrown at health technology (and thus to hospitals and tech firms) unless it’s implemented properly. Likewise, Oberlander says, even widespread adoption of EMRs and other health IT likely won’t lead to substantial cost reductions.
The Congressional Budget Office estimates that the HIT provisions of the stimulus legislation could reduce federal spending on health care benefits by about $13 billion over the next decade. But the program will cost about $32 billion to implement in Medicare and Medicaid, so spending on HIT will increase the deficit by $19 billion or so during that decade.
Oberlander calls health IT “overhyped” because it’s such a politically attractive and relatively painless solution, and warns that, in the end, we can’t simply “compute our way out of the health care cost problem.”
He called for a more integrated national health IT system and said journalists should focus more attention on exactly who stands to profit from all the money being poured into the arena.
(Image by southerntabitha via Flickr)
15 areas get a share of NIH’s stimulus funding
The NIH has designated $200 million of its stimulus money for 200 or more “Challenge Grants” in specific areas where NIH has judged the money will have the most immediate impact.
“Challenge Areas” in which funds will be available:
- Behavior, Behavioral Change, and Prevention
- Bioethics
- Biomarker Discovery and Validation
- Clinical Research
- Comparative Effectiveness Research
- Enhancing Clinical Trials
- Enabling Technologies
- Genomics
- Health Disparities
- Information Technology for Processing Health Care Data for Research
- Regenerative Medicine
- Science, Technology, Engineering and Mathematics (STEM) Education
- Smart Biomaterials - Theranostics
- Stem Cells
- Translational Science
COBRA: Under-covered and misunderstood?
In the Columbia Journalism Review, Trudy Lieberman, president of AHCJ’s board of directors, reviewed recent media coverage of the federal COBRA plan and its recent stimulus subsidy. She found the plan’s portability provision to be particularly under-covered and poorly explained. Under the portability program, COBRA customers who meet certain requirements are guaranteed to opportunity to purchase private insurance upon finishing the program, regardless of pre-existing conditions. Here’s her take on the provision:
Enrolling and staying on COBRA gives you protection and rights you otherwise wouldn’t have. Let’s say you have a medical condition and don’t get a new job that offers insurance—but you know you still need coverage. The law protects you only if you sign up and stay on COBRA for the full eighteen months the law allows. After leaving COBRA, you must apply for new health insurance in the individual market within sixty-three days. There are a few exceptions, but generally if you satisfy these two requirements, any company must sell you a policy regardless of any preexisting conditions you might have.
Some states, though, may send you to their high risk pools instead. If you don’t complete eighteen months of COBRA, or if you wait too long to apply for coverage, you’re out of luck. Insurers can turn you down for any reason — even if you were sick years ago and no longer have that medical condition. You may end up with no insurance at all.
One more thing: Even if an insurer agrees to sell you a policy, it can refuse to cover a condition you had in the past or have now.
Related
A Commonwealth Fund analysis found that only 9 percent of laid-off workers took advantage of the COBRA program and that for many, the program was prohibitively expensive.
Doctors face obstacles in transition to costly EMRs
Filed under: Government, Health care reform, Hot Health Headline
In his American Journey blog, the Wall Street Journal’s Andy Jordan considered the impact of stimulus funds on the health-care system’s expensive and time-consuming transition to electronic medical records in terms of physicians he encountered in his cross-country travels.
In rural Alabama, Dr. Regina Benjamin switched to EMRs after losing paper records to a combination of hurricanes and fires.
“When a patient or pharmacy calls at night or on a weekend, I do not have to rely on memory. I can access the chart from any computer, at home, from the hospital, from my hotel room when traveling.
This prevents errors and I can give better care. I can also quickly look at trends and patterns, pick up things earlier than if I had to look thru paper charts.” She was able to fund her conversion through donations and foundation support.
In Cambridge, Ohio Jordan met Dr. Patrick Goggin, who he said spent about $300,000 to convert to electronic medical records five years ago. Jordan recorded a four-and-a-half minute video showing the Dr. Goggin’s system in action. Jordan also spoke with Dr. Goggin’s colleague, Dr. David Ray.
“Advantages are not quite there as far as outweighing the costs,” (Dr. Ray) says.
“The technology is probably just not quite there yet for most solo practitioners and small practices to implement such a system.”
In the Minneapolis Star-Tribune Kate Levinson reports on growing demand for centers to store this medical data and on a study that found mid-size Midwestern cities to be among the most attractive to the medical data storage industry.
Steve Lohr of The New York Times reports that the obstacles to a transition to electronic medical records are daunting. Experts say that how local organizations help doctors in small offices adopt electronic records will be crucial to success. Lohr explains “regional health I.T. extension centers,” called for in Obama’s budget proposal that has been submitted to Congress.
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Health Journalism 2010, AHCJ's annual conference, features a world-class program with story ideas, sources, stronger reporting skills, chances to meet newsmakers and network with other journalists.
- Health and education: Covering these intersecting beats
- Reporting on the business of health care
- Health reporting resources for journalists on state and local government beats
- Shortened Lives: How location, lifestyle affect health
- Covering a complex story for the long haul
- Aging in the 21st Century: Presentations and tip sheets
- AHCJ calls for better information from Joint Commission Web site
