1. Overview of CMS Appropriate Use Criteria Program and Proposed Regulations
What is the CMS Appropriate Use Criteria (AUC) Program
Review of AUC proposed regulations included in the Medicare Physician Fee Schedule NPRM
Identification and discussion of possible areas for HL7 to comment on

2. CMS Appropriate Use Criteria – Core Concepts
Section 218(b) of the PAMA directs CMS to establish a new program to promote the use of Appropriate Use Criteria for ordering and furnishing certain advanced imaging services
AUC: criteria that are evidence-based and are established to assist professionals who order and furnish certain advanced imaging services to make the most appropriate ordering and treatment decision for a specific clinical condition for an individual.
There are four major components of the AUC program:
Establishment of AUC (November 15, 2015)
Identification of mechanisms for consultation with AUC (April 1, 2016)
Commence AUC consultation by ordering professionals, and reporting on AUC consultation by furnishing professionals (January 1, 2017)
Identify outlier ordering professionals (annually after January 1, 2017)

3. CMS Appropriate Use Criteria – Core Concepts
Three core rules published on the subject in the last three years:
Originally introduced in the CY 2016 Physician Fee Schedule (PFS) Final Rule with Comment Period (November 16, 2015) available at Addressed first major component of the AUC Program
The second major component of the program was addressed in the CY 2017 PFS Final Rule (November 15, 2016), which is available at /pdf/ pdf
The 2018 Medicare PFS proposed rule (July 21, 2017) proposes a final set of requirements for implementing the consultation and reporting by ordering and furnishing professionals under the Medicare AUC program, which is available at program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other- revisions.
New Compliance Date (included 2018 Medicare PFS proposed rule):
January 1, 2019 – postponed from January 1, 2018 included in previous rules

4. CMS Appropriate Use Criteria – Core Concepts
Key definitions:
Ordering professional: physician or practitioner that orders the advanced imaging service.
Furnishing professional: physician or practitioner that performs and interprets the advanced imaging service. Could be same as ordering professional
Applicable imaging services: advanced imaging services (as defined in statute; for example, magnetic resonance imaging (MRI), computer tomography (CT) or positron emission tomography (PET)) for which the Secretary has determined that 1) one or more applicable appropriate use criteria apply; 2) there are one or more qualified clinical decision support mechanisms listed; and 3) one or more such mechanisms is available free of charge
Applicable setting: AUC only applies to physician’s office, hospital outpatient department (including an emergency department), ambulatory surgical center, and other provider-let outpatient settings. Inpatient hospital setting is NOT an applicable setting.

5. CMS Appropriate Use Criteria – Core Concepts
Key definitions (cont.):
Applicable payment system: 1) physician fee schedule for Medicare Part B FFS providers; 2) hospital outpatient prospective payment system; and 3) ambulatory surgical center payment system
Exceptions: 1) emergency services when ordering to individual with emergency medical condition; 2) inpatient services being paid under Medicare Part A; 3) ordering professionals granted a significant hardship exception to the Medicare MU program
Provider-Led Entities (PLE): a national professional medical specialty society that is qualified to develop and/or endorse Appropriate Use Criteria. Includes 17 organizations, including: American College of Cardiology Foundation; American College of Radiology; Banner University Medical Group- Tucson University of Arizona; CDI Quality Institute; Cedars-Sinai Health System; Intermountain Healthcare; Massachusetts General Hospital, Department of Radiology; Medical Guidelines Institute; and others

6. CMS Appropriate Use Criteria – Core Concepts
Key definitions (cont.):
Clinical Decision Support Mechanisms (CDSMs): an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient’s specific clinical condition. Includes 7 qualified CDSMs (including Applied Pathways CURION™ Platform; Cranberry Peak ezCDS; eviCore healthcare's Clinical Decision Support Mechanism; National Decision Support Company CareSelect™; National Imaging Associates RadMD; Sage Health Management Solutions Inc. RadWise®) and 9 with preliminary qualification (including AIM Specialty Health ProviderPortal®; Cerner CDS mechanism; Evinance Decision Support; Flying Aces Speed of Care Decision Support; LogicNets’ Decision Engines; MedCurrent OrderWise™; Reliant Medical Group CDSM; Siemens Healthineers Clinical Decision Support Mechanism; Stanson Health’s CDSM)

7. CMS Appropriate Use Criteria – Core Concepts
The final list of priority clinical areas that require AUCs includes:
Coronary artery disease (suspected or diagnosed)
Suspected pulmonary embolism
Headache (traumatic and non- traumatic)
Hip pain
Low back pain
Shoulder pain (to include suspected rotator cuff injury)
Cancer of the lung (primary or metastatic, suspected or diagnosed)
Cervical or neck pain

8. CMS Appropriate Use Criteria – Core Concepts
Data
In order for the entire end-to-end data flow to work, the data expected to be included in a Medicare claim from a furnishing provider (radiologists) for applicable imaging services must be captured and maintained in the EHR system of the ordering provider, and then submitted to the furnishing provider in the order for the imaging service.
Per the proposed rule, there are three specific data elements to be included in the Medicare claim: 1) which qualified CDSM was used by the ordering provider; 2) whether the service ordered adhere to specified applicable AUC, does not adhere to it, or whether the specified applicable AUC was not applicable to the service ordered; and 3) the NPI of the ordering provider (if different from the furnishing provider).

9. CMS Appropriate Use Criteria – Core Concepts
Standards
Clinical Quality Framework (CQF) initiative has successfully developed an integrated approach that harmonizes standards for electronic clinical quality measurement with those that enable shareable clinical decision support artifacts (for example, AUC) using Fast Healthcare Interoperability Resources (FHIR).
The CQF initiative is working to support semantically interoperable data exchange for (1) calling a service, sending patient data to a service for clinical decision support guidance and receiving clinical decision support guidance or quality measurement results in return, and (2) enabling a system to consume and internally execute decision support artifacts. The current implementation guide supports both approaches and could be used to successfully execute and share AUC as described in this program. As this standard is considered sufficiently mature for widespread adoption, the ONC may consider it for use in future editions of certification criteria for health IT.
While the current regulation requires no specific standard, the CMS and ONC are supportive of this approach and additional information is available at clinicalreasoning-module.html.
It should be noted that there are also existing deployed standards for clinical decision support and these and emerging standards can be found in the ONC Interoperability Standards Advisory

10. CMS Appropriate Use Criteria – Core Concepts
Policy, System, and Standards Interactions
CMS
Authorize
Score => Modifier (Y/N/NCA
AUC Method
Source: Hans Buitendijk
X12
Recognize
Assign G-Codes
Ordering Provider (NPI), CDSM (G-Code), Modifier (Y/N/NCA),
Modifier (Excemptions), Furnishing Provider (NPI)
PLE A
DNS Consultation Identifier, AUC Method/PLE, Score
AUC Method
CDSM 1
HL7/IHE CDS-OAT
HL7/IHE CDS-OAT
AUC Method
Ordering System
Image Center System
Claims System
PLE B
IHE GAO
CDSM 2
AUC Method
PLE B
CDSM HCPCS G-Code
DNS Consultation Identifier
Score
Modifier (Y/N/NCA)
CDSM HCPCS G-Code or Text
DNS Consultation Identifier
Score
Modifier (Y/N/NCA)
Modifier (Exemption)
Ordering Provider (NPI)
Etc.
CDSM HCPCS G-Code or Text
DNS Consultation Identifier
Score
Modifier (Y/N/NCA)
Modifier (Exemption)
Ordering Provider (NPI)
Furnishing Provider (NPI)

11. HL7 Proposed Comments
Technology Issues related to the orchestration/interactions between the EHR of Ordering Providers; a CDS Mechanism (CDSM) – to be used by ordering provider; Provider-Led Entities’ Appropriate Use Criteria – to be consumed by the CDS Mechanisms in supporting ordering providers; the EHR of Furnishing Provider (Radiologists) – receiving the order for advanced radiology imaging test and ensuring all information expected in it is included; and lastly the Billing System of Rendering provider – to generate the claim for radiology service that will be submitted to CMS, with all the required data elements associated with AUC
Concerned about the complexities of the multiple interactions expected to occur in order to fulfill the AUC goals. Having an EHR interact with one or more CDSMs, which in turn must be able to consume and utilize appropriate use criteria developed by one or more Provider-Led Entities, and have all this operate and function smoothly when a provider is making a determination of the need of an advanced radiology test, in real time, at the point of care, will be challenging – even for large organizations with resource capabilities.
Consider implementation of AUC be done in a phased approach, rather than all-at-once, starting with a pilot implementation on a limited number of priority clinical areas, with a group of voluntary organizations, to allow the testing and correction of possible implementation issues, given the number of interactions, and the multiple points of risk of failure.

12. HL7 Proposed Comments PLEs and CDSMs
It is not clear whether one single CDSM utilizing one single PLE-developed appropriate use criteria will be sufficient for an ordering provider to use, or whether the ordering provider will need to use more than one CDSM and more than one PLE-developed appropriate use criteria. We recommend that this be clarified in the final rule.
We note that one CDSM may reflect one or more PLE-developed AUC methods (one-to-one or one-to-many relations), and one PLE-AUC may be utilized by more than one CDSM. This creates higher levels of complexity when determining which AUC to use, and which CDSM to interact with.
CMS should consider how the underlying knowledge base information on CDS could/should be distributed – e.g., via FHIR Clinical Reasoning – from a PLE to a CDSM, using a structured knowledge representation format
Suggest that the industry develop a plan to enable the communication between PLE and CDSM (no need to request this be done by CMS)
AUC methods generally generate a score (represented in the CDSM) that comes out of the CDS process for providers to know the degree to which they met the AUC. How to map this score with the three-class modifier expected to be coded in the Medicare of the furnishing provider

13. HL7 Proposed Comments Workflow issues
In order to achieve the goals of AUC, ordering providers will need to address not only the technical issues related to the interoperability of their EHR systems with one or more CDSMs (and ensure that the EHR utilizes the CDSM in support of the ordering provider). The ordering provider will also need to re-define important parts of the clinical practice workflow, whenever there is the possibility of considering ordering an advanced radiology service that falls under AUC. We recommend that in the final rule, CMS highlight the need for such clinical workflow adjustments, along with the technical changes that will be needed to achieve the goals of AUC.

14. HL7 Proposed Comments Data issues
CDSM Identification mechanism: CMS is proposing to assign each qualified CDSM (those listed in the CMS AUC Website) a unique HCPCS “G-code” which the facility and radiologist must put on their claim along with the study’s CPT code. The ordering provider’s system will need to submit to the furnishing provider either the name of the CDSM mechanism, the G-Code assigned to it, or both. Capturing and maintaining such information, and then submitting it to the furnishing provider (as part of the order for service), for each applicable imaging service ordered will require EHR and workflow adjustments.
It is not clear that the best way to express this from one system to another is to use the G-Codes and the criteria adherence modifiers in the long term. This seems to be unnecessarily restrictive, and not supportive of other more expansive vocabulary choice
Criteria Adherence: CMS is proposing to implement a series of modifiers to indicate whether the consult adhered or did not adhere to the criteria, or if the criteria did not apply. This determination must be made for each imaging service being ordered. It is expected that making the determination and coding the modifier with the appropriate decision will be the responsibility of the ordering provider, and then passed to the furnishing provider. Another instance where EHR and workflow adjustments will be needed.
NPI of Ordering Provider: already in place
CDS Session Identifier: This is not required at this time, and not likely ever going to be required by Medicare (in my opinion). However, it might be important to have this information in order to validate the consult was performed (and for other audit/control purposes, including pre-auths, post-pay audits, etc.).

15. HL7 Proposed Comments Data issues
Which AUC was used: It seems that CMS is not going to require the identification of the AUC (and PLE) used by the CDSM, in turn used by the ordering provider. However, it might be also important to capture and retain this information for audit purposes.
This is largely using payment systems to do performance change. Not necessarily the best way to achieve this. Understanding that this is in the original statute. A legislative fix might be required here too.
Emphasize the issue of mapping of the score from CDSM to the criteria adherence qualifier

16. HL7 Proposed Comments Standards issues
HL7 commented on the ONC 2017 ISA about correcting the categorization used to describe and organize AUC standards
While the development of FHIR-based standards for the interaction between shareable clinical decision support systems and EHRs is promising, these standards are still not be mature enough to be adopted via regulatory process. They have just been finalized this year, and testing in real-life scenarios and environments has been very limited. We are pleased to see that the current regulation does not require a specific standard for the multi-layer integration needed between the various systems (EHRs, CDSMs, Billing, etc).
HL7 is developing a new set of FHIR-based CDS resource standards – called CDS Hooks. While this are promising new standards to allow EHRs to consumer CDS rules, they are still under development and should not be adopted until they have reach the appropriate level of maturity
The orchestration of all the technical interactions between various systems to make the AUC program work will require the use of multiple electronic standards developed and maintained (or yet to be developed) by various standards development organizations, including HL7 standards (for electronic ordering, for interaction between the CDSM and the EHRs – including FHIR-based standards), IHE standards (for radiology reporting), X12N standards (for billing).

17. HL7 Proposed Comments Standards issues (cont)
We are concerned about the need to have various these standards development organizations (SDOs) develop and define approaches, guidelines and work-arounds to allow systems to capture, maintain, transmit and report all the data elements needed. We are encouraged by preliminary work being done by these SDOs to define, develop and disseminate such guidelines, but believe that without having those guidelines finalized, tested and adjusted (as appropriate), it will be impossible to ultimately implement the AUC program.
For example, how will the modifier for determining if there has been adherence to the AUC criteria be determined, captured, and reported in an electronic order for advanced imaging services from the ordering provider, so that the furnishing provider has this information to include in its claim to Medicare? Similarly, where would the HCPCS G-Code be reported in an order for advanced imaging by the ordering providers, so that the furnishing provider can extract it and include it in its Medicare claim?
There will be a need to define, for each of the data elements, which standard (and where in that standard) will carry it from ordering provider to furnishing provider, as well as where in a claim standard will the new AUC-related information be recorded and reported.

18. HL7 Proposed Comments Other issues
CMS should consider investing in defining and piloting standards-based interactions such as FHIR, CDS Hooks, FHIR Clinical Reasoning, etc.
Testing across the board or on a clinical area basis might be preferable