The Clinical Decision-support Mandate: Now What?

An act of Congress opened the door for clinical decision-support for advanced imaging in U.S. hospitals: The radiologist is key to the initiative’s success

Clinical decision-support (CDS) software that analyzes and ranks the appropriateness of a physician’s order for a diagnostic imaging exam has been a laggard on the health IT technology adoption curve. But this will change, thanks to an act of the U.S. Congress.

It’s not that radiology CDS based on best-practice guidelines isn’t a great idea. Articles by early adopters published in peer-reviewed journals have demonstrated the ability of CDS integrated with computerized physician/provider order entry (CPOE) systems to reduce the number of inappropriate exams, thereby improving the quality of healthcare by reducing unnecessary exposure to radiation dose and also reducing costs.

Health IT investments of higher priority to hospitals—certified electronic health record (CEHRT) technology needed to comply with the federal meaningful use (MU) program, better security systems, and ICD-10 conversion software—have superseded investments in radiology CDS. It’s been a carrot without a stick to push it—until the passage of the Protecting Access to Medicare Act (PAMA) of 2014 in April.

The bill sought to authorize a short-term Medicare SGR patch that extends authorization for physician reimbursement under Medicare under current law through March 31, 2015. The bill prevents a scheduled 24 percent reduction in Medicare physician reimbursement rates.

It also mandates that starting January 1, 2017, physicians ordering advanced diagnostic imaging exams (CT, MRI, nuclear medicine and PET) must consult government- approved, evidence-based appropriate-use criteria, namely through a CDS system. Physicians furnishing advanced imaging services will only be paid if claims for reimbursement confirm that the appropriate-use criteria was consulted, which CDS mechanism was used, and whether the exam ordered adhered or did not adhere to an acceptable CDS rating. It’s important to note that physicians ordering advanced diagnostic imaging services do not have to adhere to the appropriate-use criteria; however, they must confirm that the guidelines have been consulted.

Consultation of appropriate-use criteria is required prior to the ordering of advanced diagnostic imaging services in the physician office, hospital outpatient, and emergency department settings. Exams for inpatients and emergency services as defined under the Emergency Medical Treatment and Active Labor Act (EMTALA) will be exempt. Hardship exclusions, such as a lack of access to high speed Internet, will be allowed, presumably on a case-by-case basis.

The U.S. Department of Health and Human Services (HHS) through CMS is authorized to deem various accepted appropriate-use criteria by November 15, 2015. The law, however, further specifies that the appropriate-use criteria can only be “developed or endorsed by national professional medical specialty societies or other provider-led entities.” Furthermore, the legislative language stipulates that the criteria must be scientifically valid, evidence-based, and based on studies that are published and reviewable by stakeholders. Similar to agency approvals of health IT software for the meaningful use program, CDS systems must be vetted and deemed acceptable by HHS no later than April 1, 2016.

The CDS awareness campaign

The inclusion of mandatory use of CDS when ordering advanced imaging exams didn’t happen by accident. ACR and the Imaging e-Ordering Coalition have been promoting the use of CDS as an alternative to pre-authorization favored by radiology benefit management (RBMs) companies, at least since the coalition was founded in 2009.

The Imaging e-Ordering Coalition, of which ACR was a founding member, is an alliance of healthcare providers, radiology and health IT vendors, and diagnostic imaging organizations. Its primary objective was to establish a national initiative to promote health IT-enabled decision support for ordering appropriate diagnostic tests.

Members of the e-Ordering Coalition worked to educate government agency and Congressional policy makers and healthcare providers about the benefits of integrated CPOE/CDS. It acted as a resource for the CMS with respect to the Medicare Imaging Demonstration Project that was funded as part of the Medicare Improvements for Patients and Providers Act of 2008 (MIPAA).

Data collection from the $10 million, three-year project that started in 2010 to evaluate the efficacy of CDS for ordering diagnostic imaging studies has been completed. Its findings have not yet been presented to Congress. Now that CDS has become formal healthcare policy, the Imaging e-Ordering Coalition has turned its attention toward achieving industry standards for the electronic-order process for imaging orders. The initial meeting took place in Chicago on May 20th.

Both the coalition and ACR independently—and unsuccessfully—lobbied hard to persuade CMS and the Office of the National Coordinator for Health Information Technology (ONC) to include radiology CDS as a component of MU requirements. Currently, radiology CDS software does not meet the certification criteria requirements for CDS functionality in products used by MU incentive program participants. That effort, however, is ongoing.

The Shades of Regulatory Gray

CDS currently resides in a regulatory gray area. In April 2014, the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC) published the “FDASIA Health IT Report,” describing the agencies proposed strategy and recommendations on a risk-based framework for health information technology. Most CDS was categorized as having “health management health IT” functionality, a category whose safety risks the agencies define as “generally low compared to the potential benefits” and, therefore, would not require FDA’s regulatory oversight.

CDS previously regulated by the FDA would be categorized as having “medical device health IT” functionality, a category that includes computer-assisted detection software. Although not regulated by the FDA, the safety of health IT in the health management category would be promoted through private sector and ONC-coordinated initiatives, including the creation of a third-party Health IT Safety Center.

The agencies sponsored a public workshop on May 13-15th, which included a panel session on CDS. The gathering addressed questions raised in the report that included the subjects of what types of CDS functionality should be the focus of FDA oversight. The session provoked a wide-ranging discussion by a diversified expert panel, according to Michael Peters, ACR senior director of legislative and regulatory affairs.

The college’s representative on the panel, David Hirschorn, MD, director of radiology informatics at Staten Island University Hospital and member of ACR’s IT and Informatics Committee, supported the report’s position. ACR supports the FDA’s common-sense position not to establish new regulations for CDS, according to a statement provided by Peters. Hirschorn said that the ACR seeks to collaborate with the agencies, the Health IT Safety Center, and other stakeholders on implementation of the report’s proposals.

—C. Keen

Back to ACA

“The ACR’s work with legislators to make mandatory use of imaging exam appropriateness criteria really started during the deliberations regarding the Affordable Care Act,” says Cynthia Moran, executive vice president for government relations, economics, and health policy. “The CMS-planned CDS Demonstration Project confused the issue. We got the concept embedded in the Affordable Care Act, but not the policy.”

Staff and committee members worked to develop a policy that would be palatable to ordering physicians and providers, Moran says. ACR met with the American Medical Association and other physician organizations to demonstrate how decision support can work, collaborating closely with the American College of Cardiology (ACC).

“We developed a unified position for CDS,” Moran explains. “The ACR forged critical relationships with both Senate and House staff of multiple committees that resulted in the development of policy leading to legislation that was included in the permanent SGR legislation and then later added to the SGR patch.”

“The ACR was articulating a policy that a lot of people representing many different constituencies thought made a lot of sense,” she adds. “A CDS policy would ensure that the funds expended for imaging Medicare patients are appropriately spent.”

The policy was one of hundreds of new policies proposed for inclusion in legislation to permanently repeal the SGR. The fact that it was ultimately included in the proposal to eradicate this current system of Medicare reimbursement was a tremendous achievement, according to Moran. And, in mid-December 2013, the initial language that was included in the proposed legislation to permanently repeal the SGR was further modified to make the potential role of the best-practice guidelines of the ACR even greater.

Concerns voiced by some members of Congress that the language gave the HHS Secretary the power to determine the content and rules of the appropriate-use criteria—and in essence, be able to practice medicine—led to modification of the proposed legislation to specify that medical specialty organizations or provider-led entities would author the guidelines. This was an unexpected gift.

For a variety of political reasons, federal lawmakers traditionally shy away from adding “unrelated policies” to legislation to patch the SGR. However, staff and House committee members recognized the importance of the CDS policy and decided to include this concept in the legislation, according to ACR government-relations staff. H.R. 4302 was ultimately passed by the House and Senate and signed into law by President Obama.

The ACR’s next move

The Secretary of HHS, through CMS, must choose those appropriate-use criteria it deems acceptable by November 15, 2015. ACR staff and the college’s Clinical Decision Support Steering Committee members will soon be meeting with CMS to offer the organization’s services, as well as discuss the college’s guidelines. “We are optimistic that our appropriateness criteria will be included,” Moran notes. But there are no guarantees.

ACR has reorganized and expanded its organization and committees that manage all aspects of appropriateness criteria for radiology, radiation oncology, and cardiac imaging. Altogether, there are 28 committees, subcommittees, panels, and advisory groups, representing several hundred ACR members and administrative staff. A new oversight committee to coordinate the efforts of the appropriateness criteria panels and information technology staff has been created, according to Pamela Wilcox, executive vice president for quality and safety. Also new is a Clinical Implementation (CI) Committee whose responsibility is to assess new content originating from outside the ACR.

This CI committee will review best-practice guidelines developed by other professional societies, such as orthopedics, or from a healthcare network that has established decision-support rules that are not incorporated into ACR guidelines. The committee will develop procedures to assess the validity of this outside content, and determine if it should be incorporated “as is” based on expert consensus, or should go through the full evidence-based development process. Other than ACR, ACC, and ASTRO, only a handful of subspecialty radiology organizations have established extensive guidelines for medical imaging.

Input from other sources is invited. ”The Clinical Implementation Committee will enable the ACR to be more responsive to the referring provider needs going forward,” notes Wilcox. “ACR appropriateness criteria is constantly updated and covers a wide breadth of topics and clinical conditions. But they don’t cover 100 percent of everything. We want to identify gaps that are really important to resolve, and the data will come from the committee’s continual analysis of the system’s clinical use and end-user feedback.”

How CMS and HHS will oversee and administer the appropriateness criteria mandate is yet to be determined. Neither agency responded to inquiries by this publication. Susan Laine, a media spokesperson for the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), says it was too soon to determine what role, if any the FDA will have in assisting HHS and/or CMS.

Technical challenges

The ACR has been developing best-practice guidelines for more than two decades, and the first commercially available radiology CDS software was launched well more than a decade ago. By their very nature, however, clinical appropriateness criteria continuously evolve.

Several years ago, ACR catalogued and cross referenced its vast library of ACR Appropriateness Criteria into database form—ACR Select— and awarded an exclusive contract to a vendor to build web services and license the software to third parties, including EHRs, CDS software vendors, providers, and payors.

ACR Select’s web-based platform enables automatic update of CDS guidelines, whether presented in a radiology-specific CDS system or integrated with an EHR, says Keith Dreyer, DO, PhD, vice chair and associate professor of radiology at Massachusetts General Hospital, and vice chair of the ACR Commission on Clinical Research and Information Technology.

Access to the system results in a unique decision-support session number, which verifies that the physician has accessed certified CDS information. This functionality will be required to fulfill the pending requirement to consult appropriateness criteria prior to ordering advanced imaging, as legislated by PAMA.

The solution is part of the larger Imaging 3.0 initiative launched by the college to prepare radiology for the challenges of healthcare reform that lie ahead. “We have created a standard terminology, ACR Common, for the direct integration to our entire portfolio of Imaging 3.0 enabling technologies, including ACR Select, radiologist CDS, national registries, PQRS, critical results management, and our accreditation programs,” Dreyer explains.

In support of the ONC’s Health e-Decision framework, the ACR is currently participating in pilot programs with the ONC as part of the emerging 2015 EHR certification criteria development process.

“The concept of creating an environment where radiology provides value far beyond the interpretation of images is at the core of Imaging 3.0,” Dreyer notes. “Access to CDS will be critical for ordering physicians and providers to participate in the new payment models. Therefore, we could anticipate that as the new meaningful use requirements are issued, closer attention will be paid to linking CDS and CPOE, possibly as a component of the Health e-Decision framework.”

Role of the radiologist

What does mandatory use of CDS mean for the radiologist? Experts expect the change will elevate the visibility of the radiologist and the specialized expertise, thus increasing the clinical value that radiologists offer within hospitals and other clinical environments. In all likelihood, radiologists will bear the responsibility of reviewing CDS rules and customizing them to meet the clinical practice needs of their working environment. CDS may even strengthen the one-on-one consultation that the era of PACS has diminished.

“The system promotes a dialogue between the ordering physician and radiologists when it is needed most, in complex clinical scenarios,” Dreyer says. “The resulting conversations allow ordering physicians to gain the advice they need, directly from the experts. Providing this information is a skill radiologists have always had.”

“Prior to PACS, physicians would regularly come to the reading room for consultations,” he continues. “Ordering CDS simply reopens this door when it matters. Therefore, I see this as a huge opportunity for radiologists to provide consultative services in situations where their ordering clinicians are most challenged.”

Boston is a hotbed of CDS pioneers (see sidebar, page 47).  Massachusetts General Hospital deployed homegrown radiology CPOE in 2001, followed by radiology CDS in 2004. Brigham and Women’s Hospital implemented a system several years earlier in 1998, developed by Ramin Khorasani, MD. Steven E. Seltzer, MD, and Khorasani, radiology chair and vice chair respectively, have been working on what it takes to make CDS adoption a success for more than a decade-and-a-half.

“One of the lessons Brigham and Women’s learned is that the owner of a CDS project has to be the health system,” Seltzer emphasizes. “The enforcer has to be the chief medical officer (CMO) and not the radiology department. Ordering physicians are adept at circumventing the system if they do not believe in it.”

The appropriateness criteria of a CDS system must be perceived, Khorasani notes, as a gift of knowledge intended to assist physicians in their quest to provide the best quality of care. He says radiologists have the obligation of both knowing the content and being active participants in its customization. “Many radiologists today are not familiar with the contents of ACR Select or any other commercial system. They are going to need to do this. If there is any disagreement with any of the guidelines, this needs to be addressed ahead of time before deployment.”

It remains unclear, however, where the funds will come from to train radiologists or arrange for their reading room work coverage while reviewing content. Similarly, training programs will be required for referring physicians to use the system. All of this needs to be carefully planned, Khorsani points out.

Lingering reservations

Seltzer and Khorasani agree the timetable for national implementation is aggressive. Infrastructure and knowledge delivery tools—an EHR, a CPOE, IT resources, and trainers, application support—will need to be in place. Especially for large hospital enterprises, a staggered rollout may be most practical.

They also strongly oppose federal regulation that would require ordering physicians to comply with CDS recommendations. “There is the possibility that exam requests that go against the evidence will require some form of preauthorization,” Khorasani suggests. “Who would do the authorization? If a third-party payor, a type of radiology benefits management authorization, I think this would be very suboptimal for the practice of medicine and the practice of radiology.”

“Speaking as one of 500,000 physicians in America,” Seltzer notes, “I hope that the federal government will never tell us how to practice medicine by mandating what diagnostic tests to order or what to prescribe for our patients. If radiologists were perceived as supporting this, we would make enemies among our colleagues in medicine. Such an action would create a challenge for radiology and for every health system in the United States.”

McDermott+Consulting, a subsidiary of health care law form McDermott Will & Emery, LLP, Washington, D.C., also expressed concerned. In an article1 posted on its website, the authors write: “While this legislative change implements a seemingly benign new requirement applicable only to physicians ordering advanced diagnostic imaging services, it will likely set the stage for new controls on the use of a wide variety of services perceived to be over utilized and driving up Medicare costs, including, for example, radiation therapy and clinical laboratory services.”

They observe that “as is often the case with legislative changes to Medicare, new programs with limited scope can blossom into larger programs and signal the likelihood of broader application in the not-so-distant future. It is not hard to imagine Congress extending that requirement to compliance with appropriate-use criteria once the mechanisms are established, tested, and proven.”

Clinical decision support systems have the potential to reduce the number of inappropriate or duplicate exams and contribute to value-based medicine by improving patient safety. To make this happen, radiologists must prepare themselves to play a pivotal role.



The Boston Connection: Radiology CDS Central

One of the more noteworthy coincidences in the annals of radiology is the fact that no less than two exceedingly complex radiology CDS systems were developed in hospitals less than four miles apart: Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH), Boston, both luminaries in the Partners Health System.

The BWH radiology CDS system was the first radiology CDS system to be developed; it was implemented in 1998. Inspired by programs developed at BWH to support physicians in medications orders, the solution was developed in the radiology depaament’s Center for Evidence-based Imaging under the directorship of Ramin Khorasani, MD.

“Dr Khorasani is the lab/program director and was the prime mover behind the initiative to develop both software tools to deliver radiology decision-support to the referring physician at the time of order initiation in our electronic medical record; and the set of decision support rules, themselves,” Stephen E. Seltzer, MD, explained in an email.

Within BWH, the software (which Seltzer calls the knowledge-delivery tool) is colloquially referred to as the syringe; the decision-support rules themselves are called “the drug,” a nod to the CDS precursor.

The rules in the BWH system were developed over time from a variety of sources. “Evidence comes from multiple sources, including published literature of high quality and national society recommendations—for example, the ACR, the American College of Physicians, and the American College of Emergency Physicians—as well as local best practices according to panels of our own physicians,” Seltzer explained via email.

A patent was applied for in 1997 and granted in 2000; the intellectual property was licensed to a vendor in 2001, which continues to market the solution as part of a broader radiology workflow platform.

In 2013, Khorasani donated equity gained in the licensing deal to several charitable organizations and is no longer an equity holder in the radiology workflow-platform company. “Similarly, BWH Radiology donated its equity to the Partners Health Care system in 2013 and has no equity,” Seltzer wrote. Seltzer never held an equity position in the company.

The MGH System

The CDS system currently in use at MGH leaned heavily on the ACR AC from the outset, according to Keith Dreyer, DO, PhD, radiology vice chair, informatics, MGH. He credits former chair James Thrall, MD, with the idea to use the ACR Appropriateness Criteria (AC)® as the foundation for their CDS implementation.

One of Dreyer’s development teams (led by Tom Schultz) created the software system for both CPOE and CDS, while Daniel Rosenthal, MD, had responsibility for project oversight. Part of his mission was to review the AC with specialty teams of physicians at MGH to create clinical indications that pointed to AC and expert consensus recommendations, resulting in the Radiology Order Entry and Decision Support (ROE-DS) system.

ROE-DS gained a life outside the institution when it was licensed to a vendor, which was in turn acquired by yet another vendor that ultimately stopped supporting the software. In 2011, the content created by Rosenthal was contributed to the ACR for the purpose of building a national database that would enable the AC to be used as CDS. This task was led by Christopher Sistrom, MD, radiology vice chair, University of Florida, with contributions from then chair and vice chair of the ACR Appropriateness Criteria Committee, Michael Bettmann MD and Frank Rybicki MD, PhD.

“Dan Rosenthal’s pioneering innovation in CDS and subsequent contribution to the ACR (and thus the medical-imaging field at large) cannot be overstated,” Dreyer stated in an email. 

MGH’s homegrown system will be decommissioned in 2016, when a new EHR is implemented and interfaced with ROE-DS’s successor, ACR Select. Until then, ROE-DS will remain in use, a very important tool in the Massachusetts healthcare marketplace.

“In the transition from ROE-DS to ACR Select, we will continue to meet the utilization threshold requirements that we’ve negotiated with several of our private payors (Blue Cross, Harvard Pilgrim, and Tufts), preventing our physicians from having to use an RBM for preauthorization (which they hate), while we prepare for compliance with the upcoming CMS federal regulations.”

—Cheryl Proval