Last year's decision by the U.S. Centers for Medicare and Medicaid Services (CMS) to delay implementation of imaging clinical decision-support (CDS) requirements until 2020 creates an opportunity to win over skeptical clinicians, according to a January 24 webinar from the Society for Imaging Informatics in Medicine (SIIM).
In addition to allowing time for comprehensive testing of CDS software and training of providers, the new deadline will make it possible to implement systems that are optimized and better integrated with electronic medical record software -- and therefore more likely to be accepted by ordering physicians, said Dr. Kevin McEnery, director of innovation in imaging informatics at MD Anderson Cancer Center in Houston.
"I believe that first-generation imaging CDS systems rely heavily on an indications-driven workflow, and there are anecdotal results of challenges [due to] that," he said. "Implementations that really better leverage the electronic medical record are going to be important to this whole process."
Same requirements, different date
The imaging decision-support provisions of the Protecting Access to Medicare Act (PAMA) of 2014 have been pushed back twice, with mandated compliance now set to begin on January 1, 2020. While CMS' timeline for the program has changed, the requirements and scope have not.
Physicians ordering advanced diagnostic imaging exams -- CT, MRI, nuclear medicine, and PET -- will be required to consult government-approved, evidence-based appropriate use criteria (AUC), namely through a CDS system, McEnery said. The rules apply to outpatient imaging exams and studies performed in the emergency center.
Physicians who are furnishing advanced imaging services will only be paid if reimbursement claims confirm that the appropriate use criteria was consulted, identify the CDS mechanism that was used, and state whether the ordered exam adhered or did not adhere to an acceptable CDS rating.
While physicians ordering advanced diagnostic imaging services do not have to adhere to the AUC, they will need to confirm that the guidelines have been consulted. In addition, those who do not adhere to the statutes may be considered for an "outlier" designation and face preauthorization requirements in the future, perhaps in 2023, he said.
More delays
In its initial 2017 final rule published in November 2016, CMS indicated its plan to implement the CDS requirements of PAMA. Penalties for noncompliance were to begin on January 1, 2018, with penalties for outliers to start in 2020.
However, in part due to recognition that its computer systems were not ready to support the claim requirements, CMS decided to delay the implementation deadlines. In July 2017, CMS proposed a rule that would complete the Medicare claims computer update in July 2018 and then launch a one-year "education and testing" period during which providers would submit claims and provide feedback to CMS on January 1, 2019. Penalties for noncompliance would have begun in 2020.
"[However,] there was tremendous pushback regarding the claims process and the process for submitting the claims," McEnery said.
In response, CMS published its final rule in November 2017 that again included new timelines. The Medicare claims computer update is now scheduled to be completed in July 2019, with the penalty-free education and testing period to run from January 1, 2020, to December 31, 2020. The penalties for noncompliance are now scheduled to begin on January 1, 2021.
Sites that have already implemented CDS can now, as of January 1, attest to using CDS in their reimbursement claim, McEnery noted.
"It turns out that clinical decision support is worth 20 out of 40 in the process improvement category for the [Medicare Access and CHIP Reauthorization Act (MACRA)] attestation, so for those early adopters there's a benefit to continuing to adopt," he said.
The timelines may continue to evolve, he added.
"There will be a final rule process again this coming year, and these deadlines may change or they may not," he said. "But I think, for the people implementing systems, this does provide you the framework for which you need to align your project plans. You really need to have CDS up and running by 2020 in order to take full advantage of the education and testing period."
CMS framework
The overall framework of the CMS Appropriate Use Criteria Program hasn't changed and continues to be based on appropriate use criteria, the provider-led entities (PLEs) that are approved by CMS to create AUC rules, clinical decision-support mechanisms (CDSMs), and priority clinical areas (PCAs).
The CDSMs provide the features and function of decision-support tools, while PCAs are medical conditions designated by CMS for AUC scrutiny and are the focus for cost reductions by applying AUC.
An initial list of provider-led entities was approved by CMS in June 2016, with additional organizations and institutions approved in June 2017. More approved PLEs will be announced in June.
The initial finalized list of PCAs included in the 2017 final rule remained the same in the 2018 final rule:
- Cancer of the lung (primary or metastatic, suspected or diagnosed)
- Suspected pulmonary embolism
- Hip pain
- Low back pain
- Shoulder pain (to include suspected rotator cuff injury)
- Cervical or neck pain
- Headache (traumatic and nontraumatic)
- Coronary artery disease (suspected or diagnosed)
In November, CMS released a list of CDS software applications that it has certified to be "qualified" clinical decision-support mechanisms. Another "preliminary qualification" list includes companies that have met some of the criteria and have the opportunity to update their software to receive the "qualified" status, McEnery said.
He noted that potential gaps still remain in the CMS CDS program, including how to incorporate paper-based orders from referring clinicians as well as ordering by residents or fellows. In addition, there are potential issues in dealing with orders originating from disease management order sets and orders changed in the radiology department at the time of acquisition.
"I think these will be the focus of future rulemaking, but I do think one has to be aware of these potential pitfalls and begin to put them into requirements and specifications, as these workflows will need to be addressed to completely fulfill the requirements of the legislation," McEnery said.
Implementation requirements for billing transactions also have yet to be specified by CMS.
"However, that should not be a hindrance for an initial implementation," he said.
