November 11, 2015 -- The U.S. Centers for Medicare and Medicaid Services (CMS) has postponed its January 1, 2017, deadline for physicians to start ordering advanced imaging studies with clinical decision-support (CDS) software that is based on appropriate use criteria (AUC).
In an announcement included in the final rule of the Medicare Physician Fee Schedule (MPFS) on October 30, CMS indicated that it now doesn't expect to have approved CDS "mechanisms" until approximately the summer of 2017. The agency said it was not yet in a position to predict the exact timing of a new deadline for when practitioners are expected to begin utilizing clinical decision support.
A number of advocates for clinical decision support said they were disappointed with the move, while others believe that the delay is reasonable. Giving healthcare providers more time increases the likelihood of getting CDS and appropriate use criteria right the first time, they believe.
An aggressive timeline
Signed into law in April 2014 by President Obama, the Protecting Access to Medicare Act (PAMA) included a mandate that physicians utilize appropriate use criteria via clinical decision support for ordering advanced imaging studies such as diagnostic MRI, CT, and nuclear medicine (including PET). X-ray, fluoroscopy, and ultrasound exams were excluded. The appropriate use criteria requirements also only apply to outpatient settings such as physician offices, hospital outpatient departments, ambulatory surgical centers, and any provider-led outpatient setting.
PAMA had an aggressive timeline. After a series of planned milestones laid out for CMS to approve qualified appropriateness use criteria as well as clinical decision-support mechanisms, all ordering professionals in the Medicare program were mandated, by January 1, 2017, to consult with a qualified CDS mechanism when ordering an advanced imaging study.
PAMA also has reporting requirements for radiologists. By January 1, 2020, outlier professionals -- those who have low adherence to AUC criteria when ordering imaging studies -- will be required to obtain prior authorization.
But the aggressive approach at CMS may not have been realistic. The agency agreed with several commenters that the January 1, 2017, deadline wasn't feasible, and instead CMS chose to delay the implementation date.
In the final version of the MPFS released October 30, the agency focused its initial rule-making efforts on the process for specifying applicable appropriate use criteria, and chose not address clinical decision-support rule. CMS said it took this approach because AUC has to be established first to set the guidelines to be incorporated into clinical decision-support software.
CMS said it intends to share clarifications, definitions, and the process by which it will establish qualified CDS mechanisms in the 2017 calendar year proposed rule, which will be published in late June or early July 2016. A final rule is expected to be published by November 1, 2016, after public comment is received.
Reaction to delay
The American College of Radiology (ACR) was disappointed to hear about the delayed implementation date, said Dr. Geraldine McGinty, chair of ACR's Commission on Economics.
"We engaged with [CMS] multiple times since then, understanding that this is a new paradigm and new program for them and really wanting to help them as much as we can," she said. "We feel it is absolutely doable to have that implemented at the original date of January 1, 2017, so obviously we're disappointed to see Medicare beneficiaries not getting the benefit of this quality tool when they were originally supposed to."
While understanding that CMS would focus this year on tackling issues related to appropriateness use criteria, ACR had believed, based on their discussions with the agency, that CMS would then work with ACR to figure out the CDS mechanisms in time to meet program's original implementation deadline, McGinty said.
McGinty noted that CMS and the Secretary of the Department of Health and Human Services (HHS) have set ambitious goals for transitioning to value-based healthcare.
"Clinical decision support is about as good a way to bring value into the Medicare program that I can think of," she said. "The ACR criteria are robust, evidence-based, and established. Given that there are mechanisms embedded in the major [electronic health records (EHRs)] and there is a free portal available, from our point of view this is ready to go."
The alternative to software-based clinical decision support is radiology benefits managers, McGinty said.
If this delay provides an opportunity for [radiology benefits managers] to be the solution and not clinical decision support, that would be very unfortunate for [Medicare] beneficiaries."
ACR will be pushing CMS to keep the delay at no more than a year, McGinty said.
"It can't be any more than that, because our patients need this," she said.
Using the time wisely
It's up to the radiology community to use the implementation delay to educate others in the healthcare system on the value of clinical decision support for delivering better patient care, McGinty said.
"You need to really make sure that you are communicating with your peers, the other physicians in the organization, and health system leadership about the benefits that this can bring," she said.
Although the delay came as somewhat of a surprise, CMS was trying to meet a pretty aggressive timeline of less than three years for implementing all of the components necessary for clinical decision support, said Radiology Business Management Association (RBMA) Executive Director Mike Mabry. He also serves as co-chair of the Imaging e-Ordering Coalition, a group formed to promote the implementation of imaging clinical decision support.
That being said, the world of radiology was making good progress towards the implementation date, Mabry said. In addition, the Integrating the Healthcare Enterprise (IHE) initiative has developed two new profiles that would help automate the flow of information from the EHR system all the way to Medicare.
The delay wasn't unexpected, however, given the large amount of work that CMS still had to do to make the 2017 deadline, said Bob Cooke, vice president of marketing at National Decision Support (NDSC). NDSC offers the ACR Select clinical decision-support software, which is based on the ACR's Appropriateness Criteria.
"Much of the market has been operating under a cloud of uncertainty," Cooke said. "CMS, by extending the timeline into 2018 and providing a definitive date, communicates a realistic timeframe for users and EHR systems to take an organized, responsible approach to implementing this important project."
Mabry echoed McGinty's comments about using the delay as an opportunity for education and further preparation.
"The delay provides an opportunity for us to reach out to the ordering provider -- the primary care doctors and those organizations who are going to be on the ordering side of clinical decision support -- and work with them to explain the logistical requirements under clinical decision support and help them understand what they need to do when clinical decision support is ultimately implemented," he said.
The CMS delay isn't likely to have a big impact in terms of holding back clinical decision support, Mabry said.
"CDS is still the law of the land; it's still a statute," he said. "Ordering providers and rendering providers still need to move toward clinical decision support and need to adopt clinical decision support. We all just have a little more time to dot our i's and cross our t's."
Not everybody was disappointed with the CMS decision. While AHRA supports clinical decision support and appropriate use criteria, the organization has been consistently hearing concerns from its members as to the timing of the implementation date, said AHRA Regulatory Affairs Committee Chair Sheila Sferrella in a blog post on AHRA's website.
"We have no disagreement with the end point, or where we want to go, or what it is we are trying to build as we all hope this will improve patient care," she wrote. "No one in radiology wants to perform a test that is not appropriate."
Rather than rushing through the process that could result in downstream mistakes and workarounds, it's better to proceed in a more deliberate manner that's less likely to produce errors, she said. As a result, AHRA supports the implementation delay until CMS settles on clear definitions and establishes a process for CDS mechanisms.
"Once that happens, we believe it will take 12 to 18 months to establish processes, modify systems, and comply with the regulations," she wrote.
In other notable changes from the proposed CDS rule, CMS in the final MPFS rule modified the definition of a provider-level entity (PLE), which would be qualified under Medicare to develop or endorse appropriate use criteria. The new definition of a PLE focuses on the practitioners and providers that comprise an organization, and not on whether the organization, as an entity, delivers care, according to CMS.
"This approach subsumes national professional medical specialty societies whose members are actively engaged in delivering care in the community and eliminates the need to establish a separate definition for national professional medical specialty societies as they are now an example of a PLE," CMS said.
CMS said it does not believe the modified definition of PLEs will limit the AUC market or the participation of third parties such as radiology benefits managers in the AUC development process.
"There may be opportunity for third parties to collaborate with PLEs to develop AUC," CMS wrote.
CMS retained the original application deadline of January 1, 2016, for those wishing to become an approved PLE.