January 1, 2017, is likely to be a red-letter day for radiology. As of this date, physicians ordering advanced diagnostic imaging exams (CT, MRI, nuclear medicine, and PET) for Medicare beneficiaries must, in compliance with the Protecting Access to Medicare Act of 2014, consult government-approved, evidence-based appropriate use criteria through a clinical decision support (CDS) system.

Whether these exams are conducted in physicians’ offices or hospital outpatient settings, entities conducting them will receive payment for their services only if claims for reimbursement confirm that the appropriate-use criteria was indeed consulted by the referring clinician. Payment is also contingent on confirmation of which CDS mechanism was used.

While the mandate itself is straightforward, it brings logistical complications: Every Medicare CT, MRI, nuclear medicine and PET study will be assigned by the CDS a “CDS number” (also referred to as a decision support ID, decision support score, or hashtag) that reflects the match between the imaging exam and the appropriate use criteria (AUC).

In order for CMS to issue payment, the CDS number—as well as other pertinent as-yet-unspecified data—must appear on every document pertaining to each imaging procedure making its way from the ordering physician to the radiology billing system—and be auditable.

High hurdles

Compliance with the mandate appears to be a tall order given the number of systems involved (in addition to the CDS, order placement, EMR, RIS, PACS, and billing) and the number of ambulatory imaging studies ordered annually in the U.S.

The latter figure exceeds 370 million and does not even include a share of the more than 400 million hospital imaging studies that are considered outpatient, according to Integrating the Healthcare Enterprise® (IHE), an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information.

Teri Sippel Schmidt, MS, Co-Chair of IHE Radiology Planning Committee

The data flow and recordkeeping necessary to comply with the mandate, especially considering the high volume of studies and wide breadth of systems that come into play, would make manual input and re-entry of CDS numbers a costly, error-prone process, states IHE Radiology Planning Committee Co-Chair Teri Sippel Schmidt, MS.

Sippel Schmidt, who handles business development and standards for a Waterloo, Ontario-based workflow and diagnostic imaging solution vendor, adds that these problems would be further compounded under a manual umbrella were exams to be revised or rescheduled, or if multiple exams were to be ordered for a single provider visit.

Elisabeth A. Quam, executive director of the CDI Quality Institute arm of CDI Imaging (Minneapolis, Minnesota), co-founder of the eOrdering Coalition Work Group on Imaging Ordering, and chair of RBMA’s Federal Affairs Committee corroborates Sippel Schmid’s comments. That different referring clinicians utilize different systems only complicates matters further, she adds.

Moreover, say Sippel Schmidt and Quam, the “CDS number issue” affects players in every corner and at all points along the imaging continuum. “We’re talking about everyone who is a part of ordering, rendering, interpreting, and billing for imaging studies,” Quam states. “That number comes under consideration at every step of the way.”

Wanted: Resolution

After meeting with CMS about the situation, members of the eOrdering Coalition Work Group last year acknowledged what Quam deems a need for “an “industry push forward” to address the matter. They knew that “without it, we would all be in no shape to do anything but hand-write CDS information over and over and over again—with a a lot of margin for error.”

A proposal that IHE become involved in solving the problem was subsequently issued. “Each August, we have a call for proposals of clinical-information problems people want us to solve, and we vote on which ones we’re going to work on,” Sippel Schmidt explains. “This isn’t necessarily the most complex informatics problem we’ve ever seen, but it got the highest number of votes to take it on.”

IHE has since devised a standard CDS profile it believes can, if adopted industry-wide, be used to capture the required CDS data and send this CDS information through to the rendering provider and, in turn, the appropriate billing system.

The Clinical Decision Support Order Appropriateness Tracking (CDS-OAT) profile, which incorporates  HL-7 order messages “explains how to carry the CDS information along through order processing so that it is available at the time of billing, so radiologists receive reimbursement,” Sippel Schmidt notes.

Because CMS has not yet specified which data will be required to be submitted, a certain degree of educated anticipation went into the writing of CDS-OAT, which requires the following information:

• the Yes/No/No Criteria Available AUC response
• the Appropriate Use Criteria method that was used in the decision (eg ACR, ASE, a health insurance providers, etc), including version number
• the unique identifier of the decision returned by the CDS system
• the CDS system used, software version, manufacturer, etc.
• NPI of the ordering physician
• Requested Procedure Code for the exam

Additional information can be included, but is not required by CDS-OAT:

• which branch of AUC logic was used
• date and time the CDS system returned the appropriateness decision

Much of this information is not required for billing purposes but will be used by CMS to determine what is and is not working, Sippel Schmidt says.

Meanwhile, vendors are being urged to attend IHE’s North American Connectathon 2016, slated for January 25 through January 29 at the Cleveland Convention Center and HIMSS Innovation Center (Cleveland, Ohio).

The Connectathon is a live, cross-vendor, supervised and structured annual testing event whose participants typically include more than 100 vendors and 550-plus engineers and IT architects. It involves interoperability testing and problem resolution; interoperability of vendors’ offerings is assessed using real-world clinical scenarios contained in integration profiles created by IHE.

Getting paid

RBMA has assumed an active role in urging vendors to implement the profile in their software in time for Connectathon, and to test it there. Such an approach makes sense on several levels, Sippel Schmidt says.

“If each vendor tries testing at clinical sites, the cost will be exorbitant, and it will be difficult to hit the target dates,” she explains. “Testing at Connectathon, in a consistent manner, is a much simpler approach and should facilitate adherence to the IHE CDS-OAT profile and, hence, the reimbursement rules.”

Both Sippel Schmidt and Quam emphasize that there isn’t an expansive amount of time for radiology constituents to prepare for compliance with the mandate and the move to CDS numbers. Vendors currently have access to standards for moving CDS data through the chain of command to the claim on the IHE web site.

By IHE’s measure, vendors should, during the six-month period following the Connectathon (February through June, 2016) be updating and productizing software; installations at clinical sites should occur between June and November of that year. Sippel Schmidt recommends that IT staff urge their vendors to participate in the Connectathon in January 2016.

“When it comes to addressing the issue of how CDS numbers can move through the [imaging chain of command], IHE has accomplished a lot,” Quam notes. “However, CMS doesn’t seem to understand how many angles to this issue there are. We still don’t know how (the agency) wants to accept the information, and that may not happen before the standards are complete.”

Earlier this summer, CMS released a 2016 Medicare Physician Fee Schedule Proposed Rule confirming its intention to implement the mandate as planned. At the time, the agency noted that its primary short-term focus would remain on establishing rules surrounding evidence-based data sets to be used in CDS.

The 2016 proposed MPFS does not address issues pertaining to filing claims. CMS says it anticipates including further discussion and adopting policies regarding claims-based reporting requirements “in the CY2017 and CY2018 rulemaking cycles.”