The latest “doc fix” law signed by Congress back in April, otherwise known as the Protecting Access to Medicare Act, may have yet again delayed cuts to physician reimbursements under Medicare, but it also has the potential to cut payments to radiologists and is already changing the landscape of the CT market.

Lawmakers used what has become their annual delay of the Medicare payment adjustment to address a host of other health care issues, including concerns about exposure to radiation from CT scans. Under the law, which takes effect at the beginning of 2016, hospitals, doctors’ offices and imaging centers will see their Medicare reimbursements cut by 5 percent on diagnostic CT scans if the machines they use for the exams don’t meet the Medical Imaging & Technology Alliance’s (MITA) Smart Dose Standard. The cut will be hiked to 15 percent by 2017.

Reducing dose in CT has long been a priority for both OEMs and radiologists alike,but the new legislation and reporting requirements have led to a closer look at how to track and lower dose — and protect patients from unnecessary radiation exposure.

The new legislation in essence takes the Smart Dose Standard — dose optimization and increased transparency around dose level that was developed about a year ago by MITA — and attaches reimbursement rates to it, says David Fisher, vice president of healthcare policy and strategy at Siemens Healthcare, and former executive director of MITA.

New CT scanners currently on the market are already compliant with the Smart Dose Standard, providing notifications and alerts if the dose is above certain thresholds; automatic exposure control, or modulating patient dose during a scan; pediatric protocols; and DICOM dose structured reporting, which saves dose information in a digital database and gives facilities an easier way to monitor and report dose information and compare the information to that of other facilities.

“The installed base [of older machines] is a different story,” Fisher says.

While much of the current installed base of CT systems is compliant, manufacturers will be reaching out to their customers to explore their options and ensure their scanners will meet the requirements of the new law. According to Gail Rodriguez, the current executive director of MITA, a third of the installed base can’t be upgraded.

“We are talking to all our customer base,” Fisher says. “We’re communicating with our installed base about our equipment [they own] to tell them, ‘Yes your product does meet the standard,’ or it won’t and you’ll get cuts. For Siemens, the vast majority of our customers meet the standard, or will meet the standard in 2016.”

Late last year, the Joint Commission also announced new standards for accredited hospitals, critical access hospitals and ambulatory health care organizations that provide diagnostic imaging services, including documentation of CT radiation dose in the patient’s clinical record. While the changes were originally supposed to take effect July1, 2014 with additional changes phased in by 2015, the revised standards will now be implemented by July 2015.

Impact on legacy equipment
Facilities with older equipment need to make some decisions, though that doesn’t necessarily mean spending millions on new machines.

One such solution comes from Medic Vision, a company that provides software for medical image enhancement that improves image quality from lower-dose CT scans. The software, SafeCT, is currently being used by several leading medical centers, including Cedars-Sinai Medical Center in Los Angeles, Massachusetts General Hospital in Boston and Montefiore Medical Center in New York City.

“SafeCT will clean the noisy low-dose images and will send them to PACS for reading,” says Eyal Aharon, the chief executive officer. “So when radiologists read those images, in most cases they were acquired at half the dose.”

Aharon says the company has received a lot of inquiries, especially from states like California and Texas that have instituted dose reporting requirements.

“People are more and more aware that they need to take care of it,” Aharon says. “Three years ago, when I had meetings with potential customers, I had to explain why they needed to pay attention to radiation dose. Now I don’t have to explain.”

Fisher says that facilities should be looking at dose reduction beyond just the regulations.

“It’s not just about if are you compliant with the standard,” Fisher says. “There are lots of features that new equipment has and tremendous advances in dose reduction over the last decade. It’s really important for the customer to understand that it’s not just about the dollars. There are other important factors that go into that decision.”

Still, the smaller companies provide cost-effective solutions to facilities that aren’t yet in the market for new equipment.

“As a small company, one of the things that I would be happy to see (is that) people are aware that they don’t have to go to the CT vendor for a solution,” Aharon says.

“There are other solutions out there that are doing the same thing for less than half the price of the GE and Siemens of the world.” Ken Denison, GE’s global marketing director for CT products, says the company has updated about 70 percent of its installed base at no charge, though that still leaves some older scanners.

Since the law only applies to diagnostic CT done in a Medicare outpatient setting, Denison says facilities can look at what machines are in use and possibly swap them.

“Maybe I can upgrade one of them,” Denison says. “What we’re doing is helping healthcare providers.”

Aharon says that the big OEMs won’t retrofit the lower-level systems. One customer in New Jersey has one 64-slice and four 16-slice CT scanners. The OEM offered to retrofit the 64-slice scanner, but said the facility would have to replace the others, Aharon says. Instead, Medic Vision installed the SafeCT system in the data center, supporting all five existing scanners.

“Most of the CTs in the U.S. are 16 slices or less,” Aharon says. “They are working fine. They do what they need to do, especially for the private sector and smaller hospitals. There’s no need to replace them.”

Studies have compared different iterative reconstruction techniques, including those offered by OEMs. A recent University of Pittsburgh study compared the diagnostic quality of low-dose CT exams for pulmonary embolism post-processed with SafeCT and GE’s ASIR. Four experienced radiologists evaluated the processed exams and provided rankings for image quality and diagnostic value, with 48 percent of the ratings favoring SafeCT, 48 percent indicating no difference and 4 percent favoring ASIR. A clinical study performed by Massachusetts General Hospital that compared Siemens SAFIRE and SafeCT found both to be comparable, with each having slight advantages and disadvantages.

Denison, of GE, says that the comparison between SafeCT and ASiR didn’t go into enough detail, looking at lower doses and thinner slices. He notes that the company’s newer technologies, Veo and ASiR-V, expand the dose reduction capabilities, and that clinical comparisons should be in within the next few months.

“In a point in time, these kinds of filters [such as SafeCT] looked good, but we’ve already moved on to the next thing,” Denison says.

When asked about the comparison, Siemens spokesman Jeffrey Bell noted that internal studies with a phantom identified a 54 to 60 percent dose reduction using a test method that assessed noise, CT numbers, homogeneity, low-contrast resolution, and high contrast resolution, and that low dose data reconstructed with SAFIRE showed the same image quality compared to full dose data based on this test.

Sapheneia is also a big independent player in the post-processing space with its Clarity platform. Greg Mason, product applications and support specialist, says that aside from only working with newer scanners, OEM scan only reduce noise in the raw data state. If the OEM software pulls out too much noise, it’s more difficult to sharpen the edges of the organs being examined.

“We do everything post process,” Mason says. “We find the edges of the structure of the body before we remove any noise at all.” Another advantage is that Clarity can be used on all makes, models and generations of scanners and if a hospital buys a new scanner, Sapheneia will transfer the license to the new machine.

Satrajit Misra, the CT business unit senior director for Toshiba America Medical Systems, says third party products can only address part of the MITA Smart Dose Standard.

“You need the scanner to support things like automatic exposure control,” Misra says. Reducing noise in images is only one step in an image improvement product, whereas Toshiba’s solution addresses things such as mA, exposure control, reconstruction and dose reporting.

“We address the entire imaging chain, whereas the third party products address the last step,” Misra says.

Watch your dose
PACSHealth makes a PACS-based automated dose monitoring solution, DoseMonitor, which works with multiple modalities, including CT. Its first commercial version was released in 2010 at RSNA and the company has more than 200 sites signed or live, and competes with GE and Radimetrics, which was acquired by Bayer HealthCare in 2013, for market share.
Dose information can be examined with the PACSHealth software on the patient level, looking at a patient’s cumulative radiation exposure, which will be especially important when the Joint Commission requirements take effect. The software also takes the image of the patient and measures them both A-P and laterally, yielding the patient’s effective diameter. It can compare scanners and even look at the individual technologist’s historical dose record.

“The most important thing about dose monitoring has to do with consistency and measuring quality of the product,” says Mike Battin, vice president and chief operating officer of PACSHealth, LLC.

Battin says radiation dose is something that all facilities need to stay on top of, as much as they monitor the IV drugs given to a patient during surgery. Some facilities have even started advertising dose monitoring as a way to stay competitive.

“It’s important for the patient that facilities implement real-time dose monitoring,” Battin says. “The industry had been working diligently to make this a reality in the near future.”

The Radimetrics Enterprise Platform, which was showcased at RSNA in 2013, is a single-platform solution that manages radiation and contrast dose.

“It allows for data access in every area of the workflow,” says Dennis Durmis, head of the Americas region for Radiology & Interventional for Bayer HealthCare.

Sectra, which offers a web-based dose monitoring solution called DoseTrack, goes to the lengths of calculating actual organ doses. “What’s really important isn’t the base amount of radiation, but which organs are affected,” says Kevin Collins, vice president of product management at Sectra North America.

The software can make calculations based on study data and produce charts showing which organs were exposed and how much radiation the organs were exposed to.

“We’re just trying to get all the information we can,” Collins says.

Dominic Siewko, imaging systems radiation safety officer for Philips Healthcare, says although organ dose calculation is one of the next frontiers, any calculation is a rough estimation and therefore, not very clinically useful at the moment.

“Just because you’re calculating something doesn’t mean it’s adding value to the patient’s treatment,” Siewko says.

Keeping track of dose tracking
With all software out there from OEMs and independents to track and reduce radiation dose, how can facilities stay on top of it all? That’s where West Physics comes in. For the past two years, the company has offered what it calls a “turnkey” service that owner Geoff West says looks at everything holistically.

“What we’ve seen in a lot of centers is they buy dose-tracking software (but) there’s no one at the facility who knows what to do with all that information,” West says. “There needs to be somebody who is actually reviewing and chopping up this data to see where the trends are and knowing what to do with it.”

The company can log in to those different systems and maintain oversight, sending reports and providing recommendations in line with best practices.

“We’ll tell them your CT doses on brain with contrast is too high,” West says. The demand for this service has increased as facilities get ready for Joint Commission requirements.

“The radiologists are trained to read exams, they’re not trained to run dose reduction programs,” West says. “The medical physicist is really the radiation expert.”

The ACR’s Dose Index Registry — a data registry that allows facilities to compare their CT dose measurements to regional and national values — is another resource. ACR provides free, lightweight software that runs in the background at a facility. Data are sent automatically to the software from scanners, PACS, or third party dose monitoring software, and the anonymous data is stored in a database. The ACR provides facilities with periodic feedback reports comparing their results by body part and exam type to aggregate results.

The registry launched in May 2011. As of the end of June, 642 facilities have contributed data on 10.9 million exams.

Aharon of Medic Vision says it’s disappointing that the new regulations are related only to reporting dose levels, not setting specific targets for lowering dose. In Israel, where Medic Vision is based, there are guidelines for radiation levels and 80 percent of the scanners are already equipped with dose reduction capabilities.

“I think the authorities are missing the point, because eventually what you want to get is a low dose scan, not just the reporting of it,” Aharon says. “I think that regulations should also look at radiation levels. The main goal would be better served if they had defined some thresholds.”

Rodriguez, of MITA, says the Smart Dose Standard was developed during the economic downturn, when many hospitals were not buying new scanners. The organization has since been working to raise awareness on the issue, and find ways to get these standards put into practice. “It’s our sense that hospitals are going to do everything they can to be compliant,” Rodriguez says.

Ongoing debate: Does the tube have an impact on dose?
There may be a misconception — though perhaps not as widespread as it used to be — that the X-ray tube is what impacts the dose, not the CT scanner. Laura Hafner, the senior director of global sales and marketing for Dunlee, a Philips subsidiary that manufactures X-ray tubes, says the scanner is what controls the dose given to the patient, and that the OEMs may be fueling the misconception a bit.

“Regardless of what type of tube you are using, whether it is a GE manufactured tube, each tube is going to have the same dose output depending on what the scanner tells that tube to produce,” Hafner says. “Part of GE’s sales strategy (is), I think, to put a little bit of that fear and doubt that if you do not use the GE-manufactured tube, your patients are going to be receiving more dose. You can see that in some of the messages they include in the patient records.”

Denison, of GE, says this is not true, and that the X-ray output from a tube for a given mA (milliamperes of current) and kV (kilovolts of potential) is inherently dependent on the design of the tube.

“There may be differences in the total flux of the X-rays as well as in the power spectrum of the X-rays, both of which affect the exposure to the patient,” Denison says. “When GE designs tubes, we measure the exposure to the patient according to standard methods. From those measurements, made on several tubes and several CT systems, we can determine the output profile of the tube/system combination.”

“Is it possible to design two tubes to produce the same output when used in the same CT system and with the same mA and kV? Yes,” Denison says. “Will every tube design used in the same CT system and with the same mA and kV produce the same output? No.”

Hafner says she agrees that the X-ray output is dependent on the tube’s design, and notes that Dunlee tubes are manufactured to the exact designs as the GE originals. This includes the inherent filtration and attenuation of the X-ray beam.

“There are actually differences from tube to tube of the exact same design,” Hafner says. “This is why the system manufacturer — in this instance GE — allows for variation of a certain percentage, published by GE as plus or minus 15 percent of the CT Dose Index. When designed identically, the Dunlee tube delivers a dose (CTDI 100) within the published GE specifications for its own GE CT scanners.”

Dunlee also measures the exposure to the patient, and has measured dose, according to GE published specifications, on Dunlee tubes in hundreds of GE systems. Hafner says that Dr. Robert Dixon, former chairman of the CT committee for the American Association of Physicists in Medicine, says the Dunlee replacement tubes for both the GE VCT scanner and the GE Lightspeed 16-slice scanners were found to deliver a radiation dose to the phantom that is indistinguishable from that of the GE tube it replaces.

Denison says GE provides in its technical reference manual and within the operating software methods for estimating the exposure to patients based on all of the imaging parameters, including the tube in use, mA, kV, filtration, collimation, and helical pitch. “These estimates are based on the physical measurements mentioned above that allow us to calibrate the software and the methods in the technical reference manual,” Denison says. “Because we do not have access to Dunlee tubes in order to make the physical measurements needed to calibrate the methods for estimating exposure, GE is unable to know what the estimated exposure is when using these tubes. As a result, we put a simple statement of this fact into the dose reports from the system.” Hafner says Denison’s response is a bit misleading.
“GE’s strategy is to instill fear and uncertainty to the user when they use the system with other than GE Glassware, Hafner says. “The GE CT systems do not measure dose. They calculate dose based on empirical evidence collected using GE tubes (their statement). They could also calculate dose based on empirical evidence from Dunlee tubes, but they chose not to do so, since this would validate a competitive part. Dunlee tubes are manufactured to the highest quality standards, and certify the output from all tubes to be within GE published specifications.”

Hafner says Dunlee would provide GE access to new replacement Dunlee tubes, to be measured by an independent third party under supervision by each company, should GE choose to do so.

Meanwhile, Jakub Mochon, director of marketing and operations for Siemens, says the company’s new Vectron tube is a good example of how the tube makes a difference in dose reduction.

“Even the traditional imaging technical aspects like precision and size of the focal spot can have dramatic impact on the dose efficiency of the scanner,” Mochon says.

Low dose on the high end
The new crop of high-end scanners that have hit the market over the last year raise the bar for CT and take dose into account. In April, the U.S. Food and Drug Administration cleared GE’s Revolution CT scanner and Siemens’ SOMATOM Force.

Denison, of GE, says the technology in the Revolution, launched at RSNA last year, allows users to lower dose by 52 to 82 percent while increasing diagnostic imaging quality. In 2008, the company introduced its first iterative reconstruction technology called ASiR.

“This combines the best pieces of both of those,” Denison says. The machine has a .28-second rotation speed and a 160-millimeter detector that allows technicians to capture the entire heart in one rotation. The Revolution is being marketed for patients who have high heart rates or metallic implants, as well as pediatric patients, with the potential to freeze cardiac motion in one heartbeat, reduce metal artifacts, and possibly offer sedation-free CT scanning. “It really allows you to have the options to fit and tailor the acquisition to the particular clinical indication and patient,” Denison says.

Siemens is marketing its SOMATOM Force CT System for challenging cases, specifically children, patients with renal insufficiency, and those who are unable to hold their breath. It’s a high-end system that has already been installed at the Mayo Clinic, Medical University of South Carolina and the National Institutes of Health in Washington, D.C., Mochon says.

Though most of the scanners on the market are fast, patients are still asked to hold their breath, which could be difficult for some, Mochon says. Ensuring that patients follow a technologist’s instructions takes more time than the scan.

“With the Force, we can completely change that situation,” Mochon says. “In this health care environment where everyone is much more focused on the patient experience, we’re achieving much more patient-focused care.”
Mochon says that because of the company’s new Vectron X-ray tube, imaging can be done at much lower kV settings. “With the new tube, many of the adult patients can be imaged at 70 and 80 kV, which was the kV used primarily for pediatric patients,” Mochon says.

Contrast can also be better visualized at a lower kV, Mochon says, meaning there is a potential to use less contrast media as well as a lower concentration of the contrast, which can reduce the risk of conditions like contrast-induced nephropathy.

This year, Toshiba launched its second generation Aquilion ONE platform, which includes a 320-slice scanner configuration, and two 640-slice scanner configurations. The Aquilion ONE ViSION Edition includes all the capabilities of the Aquilion ONE 640 along with a faster 0.275 second rotation and a more powerful 100 kW generator. Last year, it introduced the second generation Aquilion PRIME, a scalable system capable of going from 40 to 80 to 160 slices without replacing hardware. Both the Aquilion ONE and Aquilion PRIME platforms have been optimized for ease of use, patient experience and safety, according to the company.

Misra says the company’s advanced dose reduction technology, AIDR 3D, is available in all its scanners, even the entry level machines, something unique among manufacturers. Toshiba also built in dose reduction technologies and started the upgrade process very early on, Misra says. Today, 90 percent of Toshiba’s installed base can be upgraded without having to get new equipment.

“That’s a Toshiba difference,” Misra says. “We saw this coming and we had this built into our design. We had things like automatic exposure control built into our system many years back. “It’s a far smaller challenge for Toshiba than it is for any other competing system.”

At RSNA last year, Philips debuted its IQon Spectral CT, the first spectral detectorbased CT, which the company billed as a breakthrough invention that allows you to use color to identify the composition of what you see. The machine, which includes Philips IMR, or Iterative Model Reconstruction, is pending 510(k) approval.

While the big OEMs have been showcasing high-end scanners at trade shows, Hitachi, which previously manufactured CT scanners for Philips as well as for themselves, has a relatively new entry into the market as of 2013 and is focusing on value. Hitachi received FDA clearance in early 2013 for its SCENARIA 128-slice scanner, and also offers 16- and 64-slice machines.

“We’re not really dueling with Siemens and GE for who has the largest slice,” says Mark Silverman, manager of CT marketing for Hitachi. “Now we live in the land of affordable care, and in the land of affordable care, hospitals are making value-based purchasing decisions.”

Late last year, Hitachi provided all customers under warranty with a software upgrade for all 16-slice machines, which have been on the market for about five years, so the company doesn’t have to worry much, like the bigger OEMs do, about an older installed base that can’t be upgraded.
The upcoming Medicare rate cuts have been driving movement in the CT market. While there are dose-lowering solutions, Silverman thinks it will still become important for hospitals to make sure they have SmartDose-compliant scanners. Private insurance companies could follow Medicare’s lead, and people are becoming more educated consumers of health care.

“There’s plenty of motivation to replace old CT scanners,” Silverman says. “Everyone wants lower dose and it’s going to drive the market for a very long time.”

Neusoft, a China-based company that introduced its products to the U.S. market in 2006, also focuses on low-slice scanners, and introduced its 16-slice model in 2008. Chris McHan, president of Neusoft Medical Systems USA, says both its 16- and 64-slice scanners are compliant with the MITA Smart Dose standards.

“If it’s an older model then our competition is requiring an upgrade,” McHan says. “You don’t have to spend extra money to upgrade a Neusoft machine.”

Neusoft, which competes against some up-and-coming CT scanner manufacturers in China, is the only one from that country to market its products in the U.S.

CT in the OR
A Minnesota company called IMRIS manufactures a unique ceiling-mounted intraoperative CT solution that uses the Siemens SOMATOM Definition AS technology to produce high quality images at the lowest dose. The Smart Dose-compliant product brings the CT into the operating room on demand using ceiling mounted rails, so the CT easily moves in and out of the OR, and over the patient on the table, as needed. The product has been on the market since the summer of 2013.

IMRIS CEO Jay Miller says that if dose management is important in diagnostic CT, it’s even more important in the OR, where there are also nursing staff and anesthesiologists present.

“Everyone in the room, including the patient, will benefit from that,” Miller says. Once the machinery is installed, staff goes through days, and sometimes even weeks, of training. Miller says the company’s competitors mainly use older devices lacking sophisticated dose management technology.

Dr. David Enterline, chief of neuroradiology and associate professor of radiology at Duke University, says the device has been used in his facility for spinal surgery. Enterline says that while you don’t need the same image quality in the OR as you would for a diagnostic CT, there’s an advantage to using a well-established and mature scanner with state of the art dose reduction techniques.

“You can dial down dosing, but it allows you to see the actual component of the bone that you’re putting a pedicle screw into,” Enterline says. “The technology of imaging has really changed and the need for imaging in the operating room is very clear.”

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