Live from AANS: Charting New Medical Territory with ICD-10

For physicians with an inclination for procrastination, the October 1, 2014 deadline for transitioning to ICD-10-CM may come as a rude awakening. But neurosurgeons attending this year’s AANS Annual meeting have been given ample warning, thanks to Dr. John Ratliff’s presentation, “What Neurosurgeons Need to Know Now to Prepare.”
The International Classification of Diseases, or ICD, is the international standard diagnostic classification for all general epidemiological, and many health management and clinical purposes.
Right now, physicians in the United States use the 9th edition of ICD (ICD-9-CM), the version developed by the WHO and that’s been in place since 1979. However, with new medical discoveries and advances in technology, ICD-9-CM can no longer capture the complexity of modern diagnoses and procedures.

More from AANS:
The Power of Convenience in Neurosurgery

One of the reasons that HHS has mandated the replacement of the ICD-9-CM code sets is because it’s maxed out. ICD classifications are organized scientifically, with three-digit categories that have only 10 subcategories. Since the majority of numbers in most categories are already assigned to medical diagnoses, it’s difficult to find available numbers to attach to new medical diagnoses.
The new, more detailed codes of ICD-10-CM will resolve this and allow for better analysis of disease patterns and treatment outcomes. The additional details are also meant to make initial claims easier for payers to understand, ideally streamlining claims submissions.
“A good result of ICD-10 will be that there will be a lot more information and data provided about patients’ overall health quality and disease states,” explains Ratliff, MD, FACS, Associate Professor and codirector of spine and peripherial nerve surgery at Stanford University Medical Center. “But in terms of capturing and delivering that data, the reality is that it’s going to be a heavy load on a lot of physicians, especially small physician groups that may not have the resources to seamlessly make this shift.”
In the transition to ICD-10-CM, every single diagnosis code that physicians have been using since ICD-9-CM was adopted has to change, and every procedural billing has to be modified.
To ensure minimal disruption to the physician’s practice and payments, Ratliff recommends that doctors start planning now for ICD-10-CM implementation. This mainly involves ensuring that they and their staff receive adequate training and that their EMR (electronic medical records) system will translate easily from ICD-9-CM to ICD-10-CM.
“Having the right technology is definitely a part of it, but it will also be important for physicians to quickly adapt to providing a lot more information in their diagnoses descriptions,” Ratliff says. “For example, instead of just coding ‘cervical spinal cord injury,’ with ICD-10, physicians will need to include what level it is (C1, C2, C3), what kind of spinal cord injury it is, if it’s associated with a fracture, etc. This is much more information than what is required now.”
With the number of diagnostic codes under ICD-10-CM increasing from 13,500 to 69,000 and inpatient procedures jumping from 4,000 codes to 71,000 codes, the change to ICD-10-CM will be the most challenging transition since the inception of coding.
What are your thoughts? Do you feel prepared to integrate ICD-10-CM into their practices? How do you anticipate ICD-10 will affect your productivity?
Tricia Rodewald is marketing director at Pro-Dex Inc. (Irvine, CA).

Magnetic Test Could Help Improve Reliability of Medical Electronic Devices

The magnetically actuated peel test developed by Georgia Tech researchers tests the stresses to which microelectronic chips are subjected. (Image courtesy of Greg Ostrowicki and Suresh Sitaraman)

Engineers at the Georgia Institute of Technology (Georgia Tech; Atlanta) are exploiting the force generated by magnetic repulsion in an effort to develop a new technique for measuring the adhesion strength between thin films of materials used in microelectronic devices, photovoltaic cells, and microelectromechanical systems (MEMS). Known as the magnetically actuated peel test (MAPT), the researchers' fixtureless and noncontact technique could eventually help ensure the long-term reliability of electronic devices and also assist designers in developing electronic devices with improved resistance to thermal and mechanical stresses.

"Devices are becoming smaller and smaller, and we are driving them to higher and higher performance," remarks Suresh Sitaraman, a professor at Georgia Tech's George W. Woodruff School of Mechanical Engineering. "This technique would help manufacturers know that their products will meet reliability requirements and provide designers with the information they need to choose the right materials to meet future design specifications over the lifetimes of devices."

Fabricated from insulator and conductor layers, microelectronic chips are susceptible to thermal stress that can be created when heat generated by electronic devices causes the materials of adjacent layers to expand. This stress can cause the layers to delaminate, leading to microelectronics failure.

Together with doctoral student Greg Ostrowicki, Sitaraman first used standard microelectronic fabrication techniques to grow layers of thin films on a silicon wafer. At the center of each sample, they bonded a tiny permanent magnet made of nickel-plated neodymium connected to three ribbons of thin-film copper grown on top of silicon dioxide. The sample was then tested in a station consisting of an electromagnet below the sample and an optical profiler above it. Voltage supplied to the electromagnet was increased over time, creating a repulsive force between the like magnetic poles. Pulled upward by the repulsive force on the permanent magnet, the copper ribbons stretched until they finally delaminated.

With data from the optical profiler and knowledge of the magnetic field strength, the researchers can provide an accurate measure of the force required to delaminate the sample. The magnetic actuation has the advantage of providing easily controlled force consistently perpendicular to the silicon wafer.

Because many samples can be made at the same time on the same wafer, the technique can be used to generate a large volume of adhesion data in a timely fashion. However, because device failure often occurs gradually over time as the layers are subjected to repeated heating and cooling cycles, the Georgia Tech researchers plan to cycle the electromagnet's voltage on and off. "A lot of times, layers do not delaminate in one shot," Sitaraman notes. "We can test the interface over hundreds or thousands of cycles to see how long it will take to delaminate and for that delamination damage to grow."

Thus far, Sitaraman and his team have studied thin film layers about 1 µm in thickness, but they say that their technique will work on submicron-thick layers as well. Because their test layers are made using standard microelectronic fabrication techniques in Georgia Tech's cleanrooms, Sitaraman believes that they accurately represent the conditions of real devices.

As device sizes continue to shrink, Sitaraman says the interfacial issues will grow more important. "As we continue to scale down the transistor sizes in microelectronics, the layers will get thinner and thinner. Getting to the nitty-gritty detail of adhesion strength for these layers is where the challenge is. This technique opens up new avenues."

To Move Forward, Medical Science Needs Imagination and Collaboration

Jacob ScottJacob Scott, MD is an astrophysicist with experience in nuclear submarines. He is also a radiation oncologist and is earning a doctorate degree in math. Oh, and he's only 35 years old.

But, he prefers to be known as a cross-disciplinary long-range scout rather than be heralded for any of his single achievements.

Speaking at TEDMED last week, Scott explained that medical science needs people who can connect the dots between subspecialties. MD-trained scientists are well suited for doing this, he said. Medical school is “like a backstage pass to everything cool about being a human being,” Scott explained. “As a med student, all you have to do is look curious and confused, and people show you everything they have ever done that is cool.”

But the field of medicine has been discouraging creativity and imagination, he argued. And in the last 15 years or so, biology has evolved tremendously—while the way the field is approached has remained practically unchanged.

What this means now, is that, in order to be an expert, a scientist can only understand ever-smaller pieces of the biomedical-knowledge puzzle. Experts are getting “deeply partitioned, disconnected, and pigeonholed.” And, as technology and experimentation have surged forward in biology, theory has been left behind. “30 years behind,” he said.

One part of the problem is that the enrollment of medical students has become overly stringent, which fosters conformity more than creativity, Scott said. To qualify for medical school, one has to have “a perfect resume across the board,” he explained. “GPAs and MCAT scores, since I have been in high school, have gone up by a whole standard deviation,” he added. And as a result, students are taught to shy away from risk and to narrow their focus.

In the process, the field is weeding out is creative solutions, leaving very few people to connect the dots.

Scott encouraged that medical school students “step outside of your clinical routine, step away from your textbooks, dial back the focus on your microscope, try desperately to remember the science you knew before you studied for your MCAT, and get out of your comfort zone.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Live from AANS: The Power of Convenience in Neurosurgery

Live from AANS: The Power of Convenience in Neurosurgery

Craniotomies have come a long way since Harvey Cushing, the father of “effective” neurosurgery. According to a 2010 New York Times article, “Inside Neurosurgery’s Rise,” Cushing became the first surgeon in history who could open the skull of living patients with a ‘reasonable certainty that his operations would do more good than harm.’ And he did so often using only the local anesthetic Novocain.

Even though diagnostic and technological advancements have made cranial-maxillofacial operations less burdensome for both the patient and the surgeon, these types of procedures can still be physically and mentally demanding.
At this year’s American Association of Neurological Surgeons (AANS) Annual Meeting we asked one of our customers, CMF Medicon, for their perspective on innovations to CMF procedures that enhance the efficiency of simple to complex cranial repair and reconstruction.
“With regard to cranial closure systems, a device that has become a must-have for neurosurgeons is the battery-powered screwdriver,” noted Kevin Vucinich, executive vice president at CMF Medicon Surgical Inc. “Especially after a challenging surgery that may have lasted several hours, many surgeons want a powered device to easily and reliably reconnect the cranial flap.”
In order to add the most value to their neurosurgery customers, Medicon had their battery powered screwdriver designed and manufactured with a variable speed and torque set so it could be used for multiple applications (neuro., maxillofacial, etc.), and ready-to-use batteries that fit compactly and locked securely in the back. The powered screwdriver was also carefully developed to complement the couplings for Medicon’s systems, including their screwdriver blade and aggressively threaded screws.
“We worked with Pro-Dex to ensure that when the surgeon loaded our screws into our screwdriver blade, it could be done in one, easy motion. It was also important to make absolutely certain that the screwdriver blade would reliably hold the screw while accurately penetrating the bone,” explained Vucinich. “Regardless of where the location is on the scull, our battery-powered screwdriver helps surgeons efficiently and securely fixate the cranial bone flap after a craniotomy, and do so using less pressure.”
An informal survey we conducted with a few neurosurgeons attending this year’s AANS affirmed that, whether a surgeon uses a powered device or manual screwdriver comes down to personal preference.
Some prefer the tactile feel of manually connecting the screw to the plate. As one neurosurgeon observed, “We’re a lot like carpenters in that way.” Others see using a battery-powered driver to complete the craniotomy as an extension of all the other technology that was used during the surgery.
Regardless of the innovation, at the end of the day, surgeons just want to perform the best surgery they can to save their patient’s life and improve their outcomes. And safe, reliable, efficient technology supports their ability to do that.
As a surgeon, what’s your preference for a cranial closurepowered or manual device? If it depends, what does it depend on (number of surgeries scheduled, where patient is in their treatment, etc.)? Are there certain features you like/dislike in a powered surgical screwdriver?
Tricia Rodewald is marketing director at Pro-Dex Inc. (Irvine, CA).

TEDMED 2012: Telling Health Stories Through Mobile Data Collection

The theme of Saxon’s presentation was that healthcare is a human story, not just a collection of data. But her point was that a doctor’s job is to help patients edit that story into something meaningful, especially as digital health goes global.
The story involved her efforts in measuring ECGs in people around the world, using the AliveCor ECG reader. AliveCor is a cell phone case that takes ECG measurements. These devices were passed out among 50 people and saw 36 tracings over an 8-week period.

Saxon reviewed these data (presumably in her spare time). For one lucky man in Nairobi, she was able to see his asymptomatic ischemic heart failure. Saxon contacted the man and was able to let him know of his condition.

“Doctors should be partnering with patients. Patients have a dog in the fight and they don’t have to wait months for intervention,” said Saxon. She also says it requires doctors to ease off on the notion that patients can’t handle the information without a doctor to disseminate and mediate the data. “Health rights are one of the last great civil rights issues,” was Saxon’s proclamation, which met with loud applause.

“the tech is ready,” said Saxon, noting that smart phones can make use of gaming for collection, but can also go a step farther to contextualize data. They are efficient and ubiquitous.

It’s a rational start,” says Saxon. “One heartbeat at a time and we can change the world.”

Heather Thompson is editor-in-chief of MD+DI. Follow her on Twitter @medevice_editor.

Harnessing the Power of Play for Medical Problem Solving

Harnessing the Power of Play for Medical Problem Solving

“A lot of smart people have great ideas, but few ever follow through with them,” says medtech entrepreneur Mir Imran in a book titled “Innovative Doctoring: Solutions Lie within Us” by Jeffrey S. Grossman, MD. Imran continues: “The fear of failure is what holds people back. What separates an inventor and entrepreneur from the academic researchers is their ability to take risks and to fail at something and not be devastated by it.”

 Cooper's TEDMED talk was titled “Why is My Joystick Smarter Than Your Stethoscope?”

Speaking at TEDMED, computer scientist Seth Cooper, PhD, advocated a very similar strategy to successfully tackle real-world problems. But with a twist: He recommended that video games could be used to this end. “We are more willing to try new and seemingly crazy ideas when we are not quite as concerned about the outcome,” he said in his talk. And gaming can provide such an environment. 

As it turns out, video games are all about problem solving—and always have been. But the problems that game designers build into them are generally completely artificial. For instance, defeating Bowser in Super Mario Bros. is unlikely to convey much benefit on society at large. But excelling in Foldit, a game that Cooper helped develop, just might because it tasks players with difficult solving protein structure problems that have perplexed biochemists.

Last year, players of the game solved for the shape of a protein related to AIDS in rhesus monkeys. “Scientists had been working on that for 10 years and gamers solved it in three weeks,” said Cooper, who is now the Creative Director of the Center for Game Science at the University of Washington. The game now has hundreds of thousands of players spanning the globe, he added. 

Players of Foldit have also worked with scientists to optimize a new synthetic protein that was more efficient than the previous iteration that that scientists had developed. Current Foldit fans are now working on now developing new inhibitors for the flu virus. 

In the future, we could see games that charge games with solving other medical problems such as developing disease-fighting nanomachines or verifying medical device software.

“With all of these people engaged in play, I think we’ll see a difference in the structures of medical problem solving and discovery—with gaming communities that are like huge worldwide research labs,” Cooper explained.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Weekly Vitals: St. Jude Continues 'Scorched-Earth' Tactic on Lead Controversy

St. Jude continued on what The New York Times described as 'a scorched-earth defense of its policies and products' this week in regards to an escalating controversy surrounding its recalled Riata defibrillator leads. But it may not quite be having the effect the company was hoping for. Results from a MPMN Medtech Pulse poll, for example, show that St. Jude is doing damage to its public image, although Medtronic and a prominent cardiologist/researcher aren't exactly coming out of the ordeal unscathed, either. In other news, our colleagues at MD+DI have been covering the TEDMED conference this week. Read about these and other top stories in our weekly roundup below.

U.S. Device Approvals "as Fast or Faster" than in Europe, says FDA's Hamburg

U.S. Device Approvals "as Fast or Faster" than in Europe, says FDA's Hamburg

In a Q&A session at TEDMED, Larry Brilliant, president and CEO of Skoll Global Threats Fund, asked FDA commissioner Margaret “Peggy” Hamburg, MD how she envisions balancing regulatory responsibilities “with the need to move innovative products through the pipeline.” Achieving that balance is one of the agency’s highest priorities although it remains a challenge, she said.

 Larry Brilliant and Margaret Hamburg discussed the regulatory timelines of both drugs and medical devices at TEDMED. 

Hamburg stressed the importance of “smart regulation” in levelling the playing field for developers of innovative technologies while improving quality and utility of products. To help make “smarter” regulation possible, it is necessary to work closely with the scientific community and innovators.

Incidentally, former FDA commissioner Andrew von Eschenbach, MD shared a similar perspective on “smart regulation,” last month at Calbio, an annual conference for Californian life sciences companies. Von Eschenbach, however, called for a “radical reformation of the agency's regulatory framework.” Hamburg stopped short of prescribing such big changes.

Hamburg did, however, acknowledge the need to get products through the FDA a “little faster,” stressing that the agency has made progress in this area and is “making great strides forward.” The agency will strive to work more closely with sister regulatory authorities throughout the world while working with them to harmonize standards .

As for drug approvals, the agency has made great progress in improving review times, she said, adding that the United States leads the worlds in terms of drug review times.

“For devices, it is a little more complicated,” Hamburg said. She went on to defend the speed of device approvals, which have been frequently criticized as being unreasonably slow. “For the majority of devices that we review, we are as fast or faster than our European colleagues.” She also stressed the importance of understanding that the regualtory process in the United States is markedly different than it is in Europe, which makes comparing the approval processes of the two different. 

For medical devices requiring pre-market approval, the United States is “a bit slower” than Europe—sometimes significantly slower, which is something the agency is working to improve. 

In November of 2010, Josh Makower, MD, MBA, released a somwhat controversial study that compared regulatory timelines in Europe and the United States. The survey found that FDA approvals are about two years slower, on average, for most medical devices than they are in Europe. While approval of Class III in the United States took, on average, 3 ½ years longer than in Europe.

In any case, Hamburg acknowledged the need to make improvements to device approval timelines, which, she acknowledged, began to slow in around 2002. “But 2011 was the first year that we started to see a turning around.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

Related Content: 

This Week In Devices [4/13/2012 ]: TEDMED, St. Jude's Heart Problems, Technology vs. Medicare, A Firewall for Pacemakers

This Week In Devices [4/13/2012 ]

TEDMED 2012 is Underway!


Is St. Jude Trying to Hide Defective Heart Devices?

  • Qmed reports that a medical journal has rejected St. Jude's request to retract a report finding 20 deaths were linked to a heart device produced by the company.

Technology is Draining U.S. healthcare

  • Part of a series on the growing costs of Medicare by The Daily Beast. Where’s the money from rising healthcare costs going? Into buying technologies and facilities – that unfortunately do not actually seem to be improving the quality of healthcare.

Treating Athletes with Stem Cells

  •  An Alabama doctor reports some success treating injured football players with stem cells. Read the report at Orthopedics This Week.

A Firewall for Pacemakers

  • Admist rising concerns over the possibility that wireless-enabled medical devices can/could be hacked. A group of researchers at Purdue and Princeton universities have devised a security firewall for pacemakers.

TEDMED Live: The Promise of Stem Cells While Regulations Stifle Innovation

TEDMED Live: The Promise of Stem Cells While Regulations Stifle Innovation

A price tag can’t be placed on the courage and determination of those who spend endless hours trying to develop treatments for incredibly debilitating and incurable conditions. Yesterday, two crusaders against ALS took the stage at TEDMED to talk about their work in stem cell transplantation to improve the lives of patients with this disease.

(left to right) Jonathan Glass and Nick Boulis at TEDMED.
“Every day I see people with an incurable disease. That disease is called amyotrophic lateral sclerosis, or ALS. There are no survivors of this disease, and I have really nothing to offer my patients, except for compassion, palliative care, and the promise that every day I’ll look for both the cause and the cure for their disease,” said Jonathan Glass, MD, director of the Emory ALS Center, department of neurology at Emory University. “The hope is that the extraordinary innovation in science and technology will lead to new treatments for ALS and other degenerative diseases of the nervous system.”
Glass shared the stage with Nick Boulis, MD, founder of the Boulis Laboratory at Emory University School of Medicine.
He talked about their involvement in a new potential treatment for ALS via injecting stem cells into the spinal cord to preserve neurological function. So far stem cells have been safely injected into 14 ALS patients. One of the most exciting parts of his work with Boulis is that he is part of a bigger trend, as research teams worldwide are developing cell types for work in clinical trials.
But—and it’s a big obstacle in the area of stem cell work—regulatory hurdles stand in the way.
“We have every reason to believe that with collaboration and with the experience gained with trial and error, we’ll be able to provide an effective therapy for people with ALS,” said Glass. “But that effort is being hampered by a regulatory system that really is built to minimize risk—even if it stifles innovation.”
Glass had one clear message for the audience: “We must reconsider, we must redefine, and we must recalculate what is acceptable risk. And that risk must fit the emerging technologies and emerging therapies that hold the enormous potential to transform the treatment of disease in the practice of medicine.”

Maria Fontanazza is managing editor at UBM Canon Media Group. Follow her on Twitter: @MariaFontanazza