Medicare Imaging Demonstration Project: CMS Rolls the Dice on Decision Support

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Automated decision-support systems to guide physicians who order advanced imaging exams for their patients have been promoted for years, but there have been few implementations. Now, CMS is launching a pilot study to see how well decision support works. It is the first test of decision-support systems applied on a national scale, and the first to look broadly at outcomes. There are problems, however. The three-year study is funded at only $10 million, a pittance for a national study. Moreover, CMS won’t pay participating physicians unless they meet high compliance thresholds; this factor might put participants at financial risk. If it’s successful, on the other hand, the pilot project might lead to broad implementation of decision-support systems across the health-care provider/payor axis. That’s why a thousand eyes—some with competing agendas—are paying close attention to this test. Vendors of decision-support software have a lot to win (or lose); so, perhaps, do radiology benefit management (RBM) companies. Health insurers looking at the CMS study might select decision support as a way to hold down imaging utilization and bypass the cumbersome and expensive preauthorization processes that the RBMs employ. The deadline for applying for the Medicare Imaging Demonstration Project (MIDP) passed on September 21, 2010, but CMS still hasn’t announced the names of the successful applicants. The names (and even the number) of unsuccessful applicants might never be known. According to Linda R. Lebovic, MPH, the pilot program’s project officer for CMS, there is no timeline for the review panel that is currently assessing applicants to decide on the successful candidates. Once the successful applications have been selected, they will be forwarded to the CMS administrator for final approval, Lebovic says. “We do have the applications in,” she says. “We never share how many, made by whom, or who the review panel is. That information is proprietary. We offer participation, and when the successful applicants agree, we proceed to start implementation.” Conveners The term that CMS uses to describe applicants is conveners, since they will convene the disparate elements needed for the study. In its project solicitation, CMS calls for up to six conveners to organize implementation and to roll out the decision-support tool to ordering physicians. Thereafter, the conveners will track and report the results of ordering that is augmented by decision support. CMS envisions that the conveners will enroll 2,000 to 3,500 physician participants through diversely compiled sets that will include between 500 and 650 physician practices. Once the data have been collected for 18 months, CMS will turn to an evaluation team. The team will take another year to analyze and report on the data. That puts the end date for the project at around 2014, although the timeline is loose. The initial six months of the study will consist of a baseline period, during which participating physicians will use the system to order exams without ever seeing the decision-support guidelines. This will establish ordering patterns that can be used for comparison after decision support is added to the ordering system. Lebovic says that the baseline is needed so that when decision support is deployed, the MIDP’s evaluators will be able to compare ordering data with Medicare-claims data for all exams—thus determining whether decision support had a beneficial impact, in terms of changing utilization patterns, minimizing radiation exposure, and reducing costs. Often discussed is how the MIDP will feed into larger health-care projects like the CMS Innovation Center, which is funded at $10 billion, and the Office of the National Coordinator for Health Information Technology (ONCHIT). ONCHIT has developed meaningful-use guidelines under which physicians can receive federal compensation for implementing electronic medical records (EMRs) for their patients. While the MIDP’s participants could be spurred to install EMR technology by virtue of their involvement in the decision-support demonstration project, they won’t be required to have EMR capability to participate. Because CMS wants to test decision-support systems across multiple settings, from urban to rural and from large to small, those physicians still operating in the paper-and-fax world can use decision support, too. Instead of getting their decision-support guidance on the front end, through computerized provider order entry (CPOE) systems to which point-of-order decision support is attached, physicians without CPOE will get decision support through point-of-service connections in which radiology providers deploy decision support and give feedback to the ordering physicians. “We tried to be flexible and have practices access decision support by phone, fax, Web, or EMR,” Lebovic says. “What we do require, electronically, is for the convener to transmit data securely to and from CMS.” Comparability In its MIDP solicitation, CMS calls for conveners, in designing and implementing decision-support arrays, to use only the relevant guidelines for imaging developed by medical societies. The MIDP study will look at ordering results for the 11 advanced imaging procedures most commonly paid for by Medicare: CT of the brain, sinus, thorax, abdomen, lumbar spine, and pelvis; MRI of the brain, lumbar spine, shoulder, and knee; and SPECT myocardial-perfusion imaging. Decision-support systems must address these 11 exams using medical-society appropriateness and utilization standards, whether the medical society is the ACR®, the American College of Cardiology, the Society of Nuclear Medicine, or some other relevant medical society. Only Medicare Part B fee-for-service patients will be included in the pilot project, giving the MIDP an outpatient focus. CMS pointedly does not want to get caught up in assessing one decision-support vendor’s product versus another’s, and this is one reason that it is demanding the use of impartial medical-society guidelines. This has the effect, however, of dumbing down existing decision-support products, which have been developed with broader analytical and clinical protocols. Chris Fenno is CEO of HealthBASE Corp (Solano Beach, California) which describes itself as an on-demand health-care service and medical benefit management platform connecting radiology, diagnostic testing, and ancillary providers with payors, patients, physicians, and other clients. Fenno says that HealthBASE is a licensed reseller of a prominent decision-support product. HealthBASE is also a partner with the Connecticut State Medical Society’s CSMS-IPA, Inc, of New Haven, in the MIDP. The independent practice association (IPA) has applied to be a convener for the MIDP. As the system is now envisioned, ordering physicians in the CSMS-IPA network will use a secure HealthBASE portal that will seamlessly integrate the order with decision support when CMS is the payor and the study being ordered is one of the 11 on the MIDP list. Fenno says, “The next screen they will see is decision support, which will ask for the clinical indications for the type of study they want to order. For that, they will get the appropriateness output.” The decision-support product will need to be revamped, however, to meet MIDP comparability requirements. As licensed, the system delivers what Fenno calls a stew of clinical decision-support tools and algorithm data that populate all the guidelines. “The ACR criteria are central, but there’s a lot of clinical data,” Fenno notes. “We need to strip everything out of the stew and leave only the broth.” Fenno says that the ACR is still working on the specific guidelines for the 11 procedures in the MIDP. “We can receive the database directly from the ACR and implement that ourselves,” he says, but he would much rather use a revamped form of what his decision-support vendor already has put together. The end result on what will be deployed is, as yet, unclear. Fenno says that he doesn’t know how other decision-support vendors are approaching the MIDP, but he guesses that comparability will be achieved across the pilot project, whoever the decision-support supplier is. “I don’t know if it will be apples and Buicks, but my confidence is that they will be close enough to be meaningful,” he observes. David Kurth, MPH, MA, is director for practice guidelines, technical standards, and appropriateness criteria for the ACR. He says that ACR guidelines will be used in the MIDP study in companionship with guidelines developed by other medical societies. Conveners will have leeway in which guidelines they use in the decision-support systems that they deploy, but all will be drawn from CMS-sanctioned appropriateness guidelines developed for the MIDP, he says. Conveners will have to document exactly which guidelines they are using for each exam, he adds. “CMS is trying to be inclusive and to adopt whatever is out there,” Kurth says. “The unfortunate part is that not all the medical societies have the breadth or width of guidance that we have. They will have to use some ACR guidelines because no other medical society offers guidance” for some of the 11 procedures. To ensure comparability, CMS, according to its solicitation, intends to run tests of each convener’s decision-support system and make adjustments for variances. Each decision-support assessment must convey, to the ordering physician, whether the proposed imaging test is appropriate, inconclusive/uncertain, or inappropriate. The decision-support system must also give feedback on more appropriate alternative exams. Getting Payments Under the CMS solicitation, each convener must issue a bid for the operational and administrative costs for which it expects to be reimbursed, if selected. No set amounts are detailed. The situation is different, however, for the cash incentives to be paid to physician practices that use decision-support systems under the MIDP. One requirement is that any physician practice that participates must require all of its physicians to use decision support. There are strict compliance standards that must be met; 80% of all relevant claims submitted by participating practices must have gone through decision support in the first year. In the second year, the compliance rate rises to 90%. Given the resistance levels always encountered when new technology is deployed, some think that these compliance standards will put conveners and physician practices at financial risk because the standards will be hard to meet. “That one performance measure could trigger a situation where the convener has exposure for the project, and that seems like an awfully big caveat,” Fenno says. “It’s a challenge to get practices to perform in new ways at that level—especially quickly.” If physician practices do meet the compliance standards and get reimbursement through their conveners, they still won’t become rich. The MIDP calls for each practice to receive between $1,000 and $20,000 per year, based on the volume of the 11 designated exams for which it submits claims. Practices must submit at least one exam claim every six months to qualify. Nicholas Christiano Jr is CAO for Advanced Radiology Consultants (Orange, Connecticut), a radiology group that is partnering with CSMS-IPA in its application to be a convener. Christiano says that the MIDP pilot is well designed—except for its anemic financial incentives for physicians. He says, “The inducements are not enough to encourage primary-care physicians to modify their behavior. There is not enough per physician, and there is little or no inducement for the imaging people. We are spending considerable amounts of money to get our constituency online. That’s where the issues are with the demonstration project. The government should be providing more funding than what it has initially identified.” Christiano says that the paucity of funding might have discouraged some potential conveners from applying. “We figured, originally, that there would be far more than 50 applicants, but I’ve heard numbers as low as 12 or 13,” he says. Being a Convener Despite the extraordinary breadth that CMS has allowed for convener applicants, being a convener has turned out to be a daunting prospect, for some. The ACR, for instance, did not apply, although, as a medical society, it could have. “I don’t think we have the time or the resources,” Kurth says. “We have contacts in radiology, but not with the other specialties ordering radiological procedures. We will advise other conveners, and help any way we can to make sure the appropriateness criteria are used the way they are supposed to be used.” Strategic Radiology, a recently formed national consortium of 15 practices, was rumored to be an applicant. It was not. Its chair, Arl Van Moore, MD, FACR, says, “It would take a lot of resources and insight, and I don’t see the government picking up the tab for that. None of our groups are affiliated with physician groups or hospitals where there were enough pieces to put it together.” In addition to bringing the participating physicians on board and deploying decision support, the MIDP calls on conveners to submit secure files quarterly to CMS and to tell the agency whether the decision-support system will be used for orders other than those in the pilot, and whether decision support will be retained after the study’s data have been collected. Conveners are not allowed to change the amounts that CMS pays to physicians, nor can conveners pay physicians additional amounts. The financing for MIDP might have been low, but issues other than money proved attractive to the entities that did apply to be conveners. They looked at the MIDP and saw opportunity there. CSMS-IPA Ken Lalime, RPh, is executive director of CSMS-IPA. There are already “some wonderful decision-support systems in the e-prescribing space,” Lalime says. He adds that the MIDP pilot is an opportunity to bring similar radiology-based software solutions to health care. Lalime says that CSMS-IPA, like so many health-care providers, is looking down the road at the advent of accountable-care organizations (ACOs). ACOs are now ill-defined constructs, but the idea is that they will provide and coordinate care for patients, with an emphasis on disease prevention; efficient, outcomes-driven treatment; enhanced quality; and minimized cost. The deployment of a decision-support system to streamline the delivery of imaging services fits right into the ACO narrative, Lalime says. CSMS-IPA wants to participate in the MIDP to learn the technology and assess its use. “If an IPA did have a capitated contract, this would be a tool to maintain cost control and provide a service for the patient,” Lalime says. CSMS-IPA currently comprises about 7,000 physician members, making it one of the largest IPAs in the country. For now, CSMS-IPA is operating on a fee-for-service basis, Lalime says, but capitated contracts might come in the future. CSMS-IPA has already pulled together a subset of about 1,200 of its member physicians to create a patient-centered practice model (PCPM) that will offer care coordination, quality control, and cost improvement to interested payors, Lalime says. If CSMS-IPA is chosen as an MIDP convener, it is through this PCPM that imaging decision support will be deployed, Lalime adds. “The demonstration says internal medicine and cardiology, so we’ll make sure we bring that forward. We’ve known for years which specialties order those 11 services, so we went out to our PCPM network and came up with 400 physicians across 100 practices. Then, we built the demonstration to tell CMS how we would put that out,” Lalime says. “Those 100 practices will have the software rolled out to them, with education on how to use it for all their Medicare orders.” The decision-support system will select and report on orders involving the 11 designated procedures, which (as Lalime notes) account for about 80% of Medicare’s advanced imaging exams. Lalime is concerned about meeting the MIDP compliance threshold. Practice dropouts from the MIDP study also are a concern. “CMS wanted to know how we would handle dropouts,” Lalime says. “The demonstration calls for 200 physicians, and that’s why we said we would include 400. We told CMS this is not totally in the control of the convener.” The MIDP fits well as part of a health-care convergence that includes ACO-like structures and an emphasis on IT, Lalime believes. Already, ONCHIT has released meaningful-use guidelines that could net physicians as much as $63,000 for installing EMRs, he says. He sees the MIDP study as possibly demonstrating meaningful technology to serve patients, too. “Medicare has a real cost problem. If that can be influenced with appropriateness guidelines,” he says, “that can help.” As for CSMS-IPA’s financial balance sheet for the MIDP, Lalime says, the IPA won’t make money—but it hopes to break even. RBMs as Conveners The MIDP was mandated by Congress in the 2008 Medicare Improvements for Patients and Providers Act. At the time, the demonstration project was perceived as a battleground where either decision-support systems or RBMs might emerge victorious. That line of thinking is changing, however. Christiano chairs the meaningful-use subcommittee of the Imaging e-Ordering Coalition (formed by the ACR, imaging providers, and interested vendors). He also is working with CSMS-IPA on its application to become a convener. Christiano says that he now takes the heretical view that decision-support systems and RBMs can exist in the same utilization-management space. He states that RBMs could quite feasibly work with decision-support developers and health-care providers on the MIDP. “The RBM would look at utilization and cost, and our provider group would look at quality—that’s the model,” he says. Christiano suggests that one reason for keeping the MIDP application process secret is that CMS is still massaging applicants into forming broader entities (involving RBMs and providers) to act as conveners and oversee decision-support testing. “I’m almost 100% sure that’s what they’re doing, since I’ve seen them do it in the past on other demonstration projects where they asked applicants to combine,” he says. Such a scenario is certainly possible. At least one RBM has applied to be an MIDP convener to test decision support—though on the surface, having an RBM back decision-support seems counterintuitive. David Soffa, MD, FACR, is senior vice president of medical affairs for American Imaging Management (AIM), Chicago, Illinois, an RBM that is a subsidiary of health-insurance giant WellPoint, Inc (Indianapolis, Indiana). AIM, Soffa says, has applied to be a convener for the MIDP. For proprietary reasons, Soffa won’t say how AIM has proposed to roll out a decision-support system, although he notes that a clinical engine that AIM uses to support its preauthorization process has elements that could be redesigned. “Everybody will have to modify to meet what Medicare put down,” he says. “We’ll modify what we have to for them.” Paul Danao, AIM’s vice president for business development, has spearheaded AIM’s bid to be a convener. He says that AIM wants to participate in the MIDP so that it can see whether decision-support systems will work when applied on a broad scale. “We haven’t seen widespread understanding of how these systems will work in more general and community settings. The most important thing to come out of this project will be the impact of decision support across practices,” Danao says. Another advantage that AIM sees in the MIDP is the integration of decision support into existing IT and EMRs. “We have 84,000 registered users of our Web portal—either physicians or staff,” Danao says. “We already do automated preauthorization. We get 10,000 imaging requests per day, and 75% of them are approved through our automated intake process. This is an opportunity to leverage the strengths of decision-support systems and RBMs.” Danao says that AIM isn’t worried that decision-support deployment will undercut the need for its RBM services. Decision-support vendors don’t understand what RBMs do, he adds. “They don’t have a lot of understanding of the health-care–payor environment—how to deal with membership and how to transmit authorization data in such a way that claims can be paid. They don’t have the functionality to provide that replacement solution, in regard to information management that goes beyond the clinical.” Danao says that ideally, AIM would have preferred to see CMS conduct a pilot program that studied decision support in conjunction with preauthorization, as an alternative, to see how the use of both systems would work. As it is, MIDP participants are barred from using any preauthorization during the trial. AIM has reservations about the CMS plan to look at exam results as part of outcomes-data collection for MIDP claims; this, Danao says, adds a level of complexity that it might not be possible to meet. “The reports of radiologists can be difficult to analyze to determine if the ordered exam was appropriate for what the actual exam showed. There are information systems that can extract data from the radiology reports,” Soffa adds, but determining how those could be used and benchmarked is very difficult. Data-mining, however, is one of the stated capabilities of at least one of the commercial radiology decision-support systems. Danao says that participation as a convener in the MIDP would be a novel opportunity for AIM to work closely with provider organizations to understand decision support and how it could be integrated into the RBM tool kit. “We’re very supportive, and we really hope we get chosen as a convener,” Danao says. Winners and Losers Nathan Goldstein is senior vice president for strategic development for Gorman Health Group (Washington, DC), a company that helps health-care providers navigate the twists and turns of federal regulation and participate in programs like the MIDP. Goldstein has been following the MIDP on behalf of a decision-support vendor seeking a role in the demonstration. Goldstein takes a cautious view of the project. “There’s no reason to think that this demonstration means CMS is going to start mandating imaging decision-support systems in its programs,” he says. Nonetheless, he calls the MIDP a critical step forward for CMS in controlling imaging costs. “This is exactly the sort of process that needs to happen,” he says. “The government can’t continue to provide a blank check any longer.” Goldstein warns that when the MIDP is finished, “not everyone is going to come out a winner.” Imaging providers might have to rethink imaging volumes, he says, facing what he calls the “granular fear of slowing innovation.” He notes that CMS itself assesses the risk that it is taking when it designates conveners. “It doesn’t like to do business with companies that haven’t been around at least two or three years,” he says. “It doesn’t like companies straight out of the garage, so any potential convener has to ask, ‘What risk do we represent to CMS? How can our selection of partners help mitigate that risk?’” He repeats, “Not everybody gets to win in this scenario. There aren’t enough hard truths being uttered by policymakers, but as a taxpayer, that’s exactly what I want to see. The cost of health care is not sustainable.” George Wiley is a contributing writer for Radiology Business Journal.