Radiologists achieved a long-awaited victory at the beginning of 2015 when the Centers for Medicare and Medicaid Services (CMS) announced that it would reimburse annual low-dose CT lung cancer screening for longtime smokers between the ages of 55 and 77. But, as with any slice of success in health care, there are still a number of challenges facing the CT market.
 
While the organizers of currently up-and-running and new lung screening programs create protocols to meet the stringent CMS requirements for reimbursement, hospitals have also been working to make sure CT scanners meet the Medical Imaging & Technology Alliance’s (MITA) Smart Dose Standard, to avoid Medicare cuts beginning next year. At the same time, new Joint Commission standards that took effect July 1 put even more emphasis on making sure the radiation dose from CT scans is as low as possible.
 
The CMS made a “landmark decision” in reimbursing low-dose CT lung screening, says Dr. Andrea McKee, a radiation oncologist who runs the CT lung cancer screening program at Lahey Hospital & Medical Center in Burlington, Mass.
 
“It’s really going to dramatically change the way we manage lung cancer, and we’re all very excited about it,” McKee says. In order to qualify for CMS reimbursement for a scan, patients with no signs or symptoms of lung cancer must be current smokers or must have quit smoking within the past 15 years, with a smoking history of at least 30 pack-years, an average of one pack a day for 30 years. Patients must then receive a written order for screening during a visit with a physician, physician assistant, nurse practitioner or clinical nurse specialist who reviews and discusses the benefits and harms of screening, including the possibility of a false positive and the exposure to radiation, and provides counseling on smoking cessation.
 


Providers must also utilize a standardized lung nodule identification, classification and reporting system, such as the American College of Radiology (ACR) Lung Imaging Reporting and Data System (Lung-RADS), and collect and submit data on each scan to a CMS-approved registry. While the requirements for CMS reimbursement may seem onerous, they ensure the quality and safety of screening programs, says Dr. Ella Kazerooni, who chairs the ACR’s Lung Cancer Screening Committee.
 
“I think whenever there are requirements instead of outright coverage, it’s natural for people to think of them as obstacles,” Kazerooni says. “But when you think about the reasons behind them, they make sense.” Since the National Lung Screening Trial (NLST), which looked at 53,000 patients across 33 facilities, the threshold for a positive exam has also increased from a 4-millimeter nodule to a 6-millimeter nodule, which has been found to decrease the false positive rate from 27 percent to less than 10 percent.
 
Through its program, started in 2012, Lahey has screened more than 3,000 patients, finding early-stage disease in 75 percent of them. The facility also worked with the ACR to develop Lung-RADS. Though the requirements are extensive, having a good lung cancer screening program requires proper training and the right multi-disciplinary team to do the scans the right way and to manage the findings, McKee says. “We were able to demonstrate to CMS what a community screening program is like once you have these systems in place,” McKee says.
 
Providers are still waiting for CMS to issue a Current Procedural Terminology (CPT) code for the scans (providers anticipate the code will be issued in November) and are responding in different ways. Lahey, for example, has already been providing the scans free of charge through its community benefit program.
 
The lung cancer screening program at New York-Presbyterian/Weill Cornell Medical College is holding its bills and waiting for the CPT code to be issued before applying for reimbursement. They’re asking patients to sign a waiver, which states that if CMS does not reimburse the scan, the patient will be required to pay the fee. Before the CMS decision, all Medicare and Medicaid patients paid for the scans themselves.



Dr. Bradley Pua, director of the lung cancer screening program at New York-Presbyterian/Weill Cornell Medical College, says the language from CMS states that if facilities meet the requirements of shared decision-making visits and adding information to the ACR lung cancer screening registry, they “may” be reimbursed. “We decided that to protect patients in the long run, we needed to approach this from a practical mindset,” Pua says. “We weren’t comfortable saying to patients, ‘You will definitely get reimbursed,’ and sending them a bill later.”
 
Pua says his facility did look into offering free screenings, but struggled to decide how to address the 20 to 30 percent of patients who end up having a positive study. “Who pays for the follow up?” Pua says. “Again, in thinking about protecting patients down the road, it’s kind of hard to put that burden on people.” Uncertainty aside, radiologists agree that lung cancer screening programs will have a big impact on the industry. “It’s going to have a tremendous impact on the field of radiology because of the number of patients who will be scanned,” McKee says.
 
It’s also pushed manufacturers to release new products. In August, GE Healthcare received FDA clearance for a lung cancer screening option for low-dose CT. The product, which is available on all of GE’s new 64-slice and greater scanners and most of its 16-slice scanners, includes GE’s new low-dose screening reference protocols, which are based on patient size and current screening recommendations. Ken Denison, GE’s global marketing director for CT products, is cautiously optimistic about what the CMS decision means for the industry, with a potential for eight million patients with a history of smoking to be scanned.
 
“If, overnight, all eight million showed up to get an annual CT, that would be an increase of 10 percent of CT scans done in the U.S.,” Denison says. “As with anything in health care, the adoption rate is always hard to predict and it’s always lower than you expect.” With the requirements in place, programs are challenging to run. “It’s not as easy as putting out a sign saying, ‘Get your CT lung cancer screenings today,’ ” Denison says. “If health care providers get the word out and get their programs in place, we might see an increase of a couple of million scans a year.”



Judith Schmalzing, CT installed base product manager at Siemens Healthcare, says the company’s new SOMATOM Scope, a diagnostic CT scanner with a footprint that is small enough to fit inside a mobile imaging vehicle that doesn’t require a commercial license to operate, creates the potential for conducting lung cancer screening in remote areas.
 
Joint Commission adds CT dose requirements
Another challenge that has popped up for radiology departments is new Joint Commission requirements for imaging. The requirements dovetail somewhat with XR-29, also known as the MITA Smart Dose Standard, but they’re much more far-reaching, says Dr. Geoff West, the chief executive officer of West Physics, a consulting company that works with hospitals on meeting accreditation requirements and reducing CT dose.
 
Since July 1, the Joint Commission requires facilities to record a patient’s CT radiation dose index and make it available in a retrievable format. This is less stringent than in the first draft of the requirements in 2014, which would have required that the radiation dose be recorded in a patient’s interpretive report. Some radiologists had concerns about including radiation dose in a patient’s record and the need to educate them about what it means, West says.
 
“The radiologists that I spoke to, many supported that and many radiologists are already dictating or transferring that radiation dose into the patient report, but a portion of the radiology community felt that if they started putting the radiation dose into the patient’s report that the physicians and patients who don’t understand rad dose would be overly concerned,” West says. “I, personally, think patients have the right to know their radiation dose, but I don’t think the community is prepared.”
 
The Joint Commission now also requires facilities to adopt protocols that consider a patient’s age and size, whether there was contrast given, and to determine the expected radiation dose exposure for each CT exam. They must also review and analyze incidents where the radiation dose exceeded the expected dose outlined in the facility’s protocols.
 
Facilities must also have a medical physicist measure the radiation dose produced by each CT imaging system for adult and pediatric brain and abdomen scans, and conduct annual training for technologists on radiation dose optimization techniques. Dose protocols have varied considerably by individual facility up until now, according to West. “Some facilities have quite advanced radiation dose programs for CT,” West says. “Some have almost nothing. These requirements will really bring all of the accredited facilities up to a minimum level of dose awareness.”
 
While the Joint Commission has no specific requirement for dose tracking software, as there is for the MITA Smart Dose Standard, meeting the new Joint Commission requirements will be difficult for facilities with any appreciable patient volume without any kind of dose management software, says Brent Christenson, senior field marketing manager for Philips, which launched its DoseWise Portal at last year’s RSNA (the company previously had a marketing partnership with Radimetrics). “Can someone do Joint Commission without buying something?” Christenson says. “Yes, but you’re going to do a lot of work.”
 
At this year’s ISCT, Toshiba introduced new software called CT Vitality that allows providers to manage the CT protocols among multiple Toshiba scanners. “If you have to manually make protocol changes on each CT scanner, that’s fraught with error,” says Tim Nicholson, senior manager of market development for CT at Toshiba America Medical Systems.
 
Getting ‘smart’
The new Joint Commission requirements work hand in hand with XR-29, or the MITA Smart Dose Standard. Under the law, which takes effect at the beginning of next year, hospitals and doctor’s offices that perform diagnostic CT scans in an outpatient setting and don’t use equipment that meets the Smart Dose Standard will have their Medicare reimbursements cut by 5 percent in 2016 and 15 percent by 2017.
 
Compliant equipment must have four key attributes: A DICOM Radiation Dose Structured Report that enables dose information to be captured in a standardized electronic format and included in the patient record; CT Dose Check, which alerts technicians before they start a scan if the estimated dose will be higher than the parameters the facility has defined; automatic exposure control, which tailors the radiation dose to the specific body regions and parts being imaged in order to manage the radiation delivered to obtain the desired level of diagnostic quality; and pediatric and adult reference protocols.
 
The main CT manufacturers, including Siemens, GE, Philips and Toshiba, have created portals on their Web sites to allow customers to check the status of their scanners and obtain certificates of compliance, which the manufacturers are legally required to provide.
 
While some critics have said that the MITA Smart Dose Standard was a way to facilitate the purchase of new CT scanners, Schmalzing, of Siemens, says it’s a good opportunity for a facility to look at its fleet and see what makes sense to upgrade. The company also doesn’t push its customers to purchase a new system if they can upgrade it. If a facility has a service contract with Siemens, the upgrade is done at no cost. “I think we all agree that we think this is going in the right direction,” Schmalzing says. “The legislation itself has patient care and outcomes in mind.”
 
A Siemens notification dated Sept. 1, 2015, stated that “we have determined that 90 percent of our non-end-of-support CT installed base either meets or can be upgraded to comply with NEMA XR-29 with a free of charge upgrade.” Megan Hayes, director of regulatory and standards strategy for MITA, says the legislation was in response to media reports about radiation overdoses in California. “We did what we could do within our scope to balance patient safety with the quality of a diagnostic image,” Hayes says.
 
“If we had done nothing, people would be screaming that we had done nothing.” MITA has estimated that a third of the U.S. installed base can’t be upgraded, and would have to replace its scanners in order to comply with XR-29. Patrick Hope, executive director of MITA, says the group has still been looking at the number to see if it has changed.
 
Can third-party products help with compliance?
There has been some confusion about whether third-party products will allow facilities to meet the standards. Many companies have been advertising add-on solutions for legacy CT equipment that are compliant with the Smart Dose Standard. In May, MITA published a white paper with a guide for evaluating third-party modifications or solutions, suggesting providers, “approach the decision to purchase a solution with caution” and ask the vendor for detailed information on how its product meets the MITA standards.
 
Manufacturers say they know of no third-party solution that meets MITA’s requirements. “The opportunity is there for somebody to develop a solution that will meet the XR- 29 standards,” says Scott Merriman, installed base marketing manager for molecular imaging and CT at GE. “At this time, we are not aware of a third-party solution that truly meets all of the requirements outlined in the standard.”
 
Recently, Zetta Medical, which markets a product called Z-Dose that the company says interfaces with CT scanners from the major OEMs and provides for all four of the MITA Smart Dose requirements, published an FAQ on its Web site addressing the points in the MITA white paper. Mike Ghaza, president and chief executive officer of Zetta Medical, says he has also contacted MITA to get more clarification. “To our knowledge, we will install the software, give them a certificate and they will submit their codes and scans that they are in compliance,” Ghaza says.
 
A facility might consider a product such as Z-Dose if it can’t get a free upgrade from the OEM because it doesn’t have a service contract, or if it can’t afford a new CT. “The health care providers who need to be compliant with XR-29, I don’t think they have the capital to spend the serious dollars that the OEMs are asking for,” Ghaza says. “If they’re going to upgrade partially, they would pay five times what they would pay us.”
 


Hayes, of MITA, says providers who still have questions should work with their equipment vendors. “Our mantra has always been to work with the OEMs,” Hayes says. “That manufacturer is going to be best able to determine if your machine is compliant.” There are still unknowns about how XR- 29 is going to be implemented by CMS, says Priscilla Butler, senior director and medical physicist for quality and safety with the ACR.
 



 “When billing people submit the information to CMS, there currently is no indication of what [machine] the scan was performed on,” Butler says. “Most of the billing is done via software. There’s potentially some complex coding involved.” Christenson, of Philips, says manufacturers have been in touch with CMS to discuss compliance with the MITA standards. As part of that process, manufacturers including Philips have also made efforts to better educate their customers on what it truly means to be compliant, as many are confused by the nuances of the standards and what it means for their business, Christenson says. “We’ve worked with CMS to say, ‘This is how a CT is compliant by these standards, and this is how you can verify whether or not your solutions are certified during audit cycles,’ ” Christenson says.
 
Nicholson, of Toshiba, says manufacturers assume that the Joint Commission will also ask to see the certificates during inspections, similar to when they ask to see proof of a scanner’s ACR accreditation. Medic Vision, which offers software called SafeCT, which improves image quality from lower-dose CT scans, is seeking FDA approval for a new product called SafeCT-29. Medic Vision Chief Executive Officer Eyal Aharon says SafeCT-29 will provide a DICOM Radiation Dose Structured Report and CT Dose Check on scanners that are already equipped with automatic exposure control and pediatric and adult reference protocols. Aharon says that according to the CMS proposed rule on XR-29, verification of compliance shall be performed as part of the periodic CT accreditation.
 
“I would assume that the auditors will test if the XR-29 functions are properly implemented, regardless of any certification of compliance that may be provided by a vendor,” Aharon says. In a Sept. 4, 2015 written response to the CMS proposed rule, MITA urged CMS to require OEMs or third parties to provide vendor certificates stating that the CT scanner is fully compliant with XR-29.
 
“MITA’s members who are CT manufacturers have committed to, and have already started providing, XR-29 certifications to the owner/operator of the particular CT system,” wrote Peter Weems, MITA’s director of policy. “Suppliers, hospitals and other rendering entities furnishing the imaging services would then provide this certification certificate to CMS and/or an accreditation organization upon request.”
 
“MITA recommends that the OEM XR-29 certifications or those of duly qualified and FDA-registered third parties be required as part of the periodic accreditation of suppliers,” Weems continued. “We urge CMS to work with accrediting organizations to incorporate this requirement into their standards.” Even more than a year after XR-29 was passed, there is general confusion overall.
 
“We know it’s been in the press, we know we had it on our Web site, we know MITA has been trying to raise awareness about it for well over a year, and we still keep getting questions about it,” Butler says. “XR-29 says for full reimbursement you must perform a scan on a CT scanner that has these features. It doesn’t say you must use these features. Manufacturers need to make sure their customers understand how to use these features and facilities must understand what these features can do for them.”
 




Some facilities have been proactive. In Connecticut, where radiation dose reporting legislation has been considered, Hartford Hospital has been ahead of the game in complying with Joint Commission and MITA standards. A minority of scanners had to be replaced, says Dr. Thomas Farquhar, Hartford Hospital’s chief of radiology. “Those were already being used very minimally,” Farquhar says. “Most of the modern, heavily-used scanners were either fully compliant or were able to be, with a simple firmware update.”
 
The facility also began sending dose data from its scanners to a central database more than a year ago. “It’s all part of a program where there’s a greater awareness on a proper use of medical radiation,” Farquhar says. “Most of the work from this is the education and awareness components, which is across the entire spectrum of the health care delivery system. That’s more of a time investment. It’s doing the right thing and the safe thing to do in each case.”
 
One of the most common questions Toshiba has been receiving from customers is “what’s next?” Nicholson says that based on discussions with MITA, a likely next step is to require that dose information is included in the patient’s health record, something that is currently required in California. “You can almost predict the future,” Nicholson says. “If you’re being required to do that report [under XR-29] you’re going to be required to do something with it.”