Appropriate Use Criteria Mandate (section 218 PAMA)

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The “Protecting Access to Medicare Act of 2014(PAMA)” (P.L. 113-93) established an appropriate use criteria (AUC) program for advanced diagnostic imaging services provided to Medicare beneficiaries. Beginning January 1, 2017, physicians and other health care professionals who order an advanced diagnostic imaging test must consult with AUC using a qualified decision support (CDS) mechanism. Professionals who furnish these tests must document the ordering professional’s consultation of AUC to be paid for the service.The law also directs the Centers for Medicare & Medicaid (CMS) to require prior authorization beginning in 2020 for ordering outlier professionals.

Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Summary of Provisions
CY 2016 Medicare Physician Fee Schedule Final Rule
General Overview: 
The CY 2016 Medicare Physician Fee Schedule (PFS) Final Rule outlines the initial component of the new Medicare AUC program the Centers for Medicare and Medicaid Services’ (CMS) plan for implementing the remaining components.  The “Protecting Access to Medicare Act of 2014” (PAMA) established a program requiring adherence to AUC using clinical decision support (CDS) for advanced imaging services. The law requires that health care professionals who furnish an advanced imaging test, which includes nuclear cardiac imaging, must document the ordering professional’s consultation of AUC to be paid for the service. 
The four major components of the AUC program under the law are as follows:
  1. establishment of AUC by Nov. 15, 2015;
  2. specification of clinical decision support (CDS) mechanisms for consultation with AUC by April 1, 2016;
  3. AUC consultation by ordering professionals and reporting on AUC consultation by furnishing professionals by Jan. 1, 2017; and
  4. annual identification of outlier ordering professionals for services furnished after Jan. 1, 2017. 
Implementation Timeline 
CMS intends to provide clarifications, develop definitions, and establish the process by which it will specify qualified CDS mechanisms during PFS rulemaking for CY 2017. The initial list of specified applicable CDS mechanisms will be published sometime after the CY 2017 PFS final rule, but most likely summer 2017.  Because specified applicable AUC will serve as the inputs to any qualified CDS mechanism, the AUC must be first identified so prospective tool developers are able to establish relationships with AUC developers.  Additionally, CMS anticipates including further discussion and adopting policies regarding claims-based reporting requirements in the CY 2017 and CY 2018 rule making cycles.  Therefore, CMS has determined that it does not intend to require that ordering professionals meet program requirements by Jan. 1, 2017 as specified in law. The final rule does not indicate when CMS will expect ordering professional to meet program requirements.
Application of the Program:
The program only applies to “applicable imaging services” which are defined in law as advanced diagnostic imaging services for which one or more applicable AUC apply, one or more CDS mechanisms is available, and one of those mechanisms is free of charge. 
AUC — AUC means criteria only developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria must be evidence-based. An AUC set is a collection of individual appropriate use criteria. An individual criterion is information presented in a manner that links: a specific clinical condition or presentation; one or more services; and, an assessment of the appropriateness of the service(s). 
Provider-Led Entity — AUC become specified when they are developed or modified by a qualified PLE, or when a qualified PLE endorses AUC developed by another qualified PLE.  Therefore, the definition of PLE is critical to the program.  
CMS initially proposed a definition of PLE that explicitly included national professional medical specialty societies, as well as organizations comprised primarily of providers and actively engaged in the practice and delivery of health care. In the final rule, CMS revised the definition of a PLE to refer to organizations “comprised primarily of providers or practitioners who, either within the organization or outside of the organization, predominantly provide direct patient care.  The definition of PLE will retain the direct reference to national professional medical societies and other organizations like them are subsumed within the definition.
AUC Development by PLEs:
The final rule establishes a process by which PLEs become qualified by Medicare to develop or endorse AUC. The cornerstone of this process is for PLEs to demonstrate they engage in a rigorous evidence-based process for developing, modifying, or endorsing AUC. 
CMS highlights in the final rule that it believes it is important to fit AUC to local circumstances and populations.  Under CMS’ program, local adaptation of AUC will happen in three ways:
  1. Compatibility with local practice is something that ordering professionals can assess when selecting AUC.
  2. Professional medical societies (many of which have state chapters) and large health systems (which incorporate diverse practice settings) that become qualified PLEs can get local feedback at the outset and build alternative options into the design of their AUC.
  3. Local PLEs can become qualified to develop, modify, or endorse AUC. 
Process for Provider-Led Entities to Become Qualified to Develop, Endorse, or Modify AUC:
A qualified PLE may develop AUC, modify AUC developed by another qualified PLE, or endorse AUC developed by other qualified PLEs. 
PLEs must apply to CMS to become a qualified PLE. Applications must include a statement as to how the entity meets the definition of a PLE. Applications must also document adherence to each of the AUC development requirements outlined below.
Applications will be accepted electronically each year but must be received by January 1. A list of all applicants determined to be qualified PLEs will be posted to the CMS website by June 30 of that year, at which time all AUC developed or endorsed by that PLE will be considered to be specified AUC. 
All qualified PLEs must re-apply every five years and applications must be submitted by January 1 during the 5th year after the qualified PLE’s most recent approval date. If a qualified PLE is found to be non-adherent to the requirements identified above, CMS may terminate its qualified status or may consider this information during re-qualification. 
At least for the first round of applications for qualified PLEs, CMS will not be making available templates or applications. CMS may consider developing such templates or applications in the future. 
AUC Endorsement by Qualified PLEs:
Qualified PLEs may endorse the AUC set or individual criteria of other qualified PLEs, under agreement by the respective parties, in order to enhance an AUC set. CMS further notes in the proposed rule “the primary function of endorsement is for qualified PLEs to combine their AUC to create a larger,  more clinically encompassing library.  For example, one qualified PLE may focus on developing AUC related to neuroimaging, another may focus on developing AUC related to abdominal imaging.  The endorsement relationship give recognition to this type of collaboration.” 
Identifying Clinical Priority Areas:
Under the law, beginning Jan. 1, 2020, CMS must implement prior authorization for outlier professionals. While the final rule did not take steps to implement this requirement, CMS did propose to “identify outlier ordering professionals from within priority clinical areas that would be established through subsequent rulemaking.”  CMS states in the final rule that under its proposed policy, “while potentially large volumes of AUC (as some eligible PLEs have large libraries of AUC) would become specified across clinical conditions and advanced imaging technologies, we believe this rapid roll out of specified AUC should be balanced with a more focused approach to identifying outlier ordering professionals. We believe this will provide an opportunity for physicians and practitioners to become part of the input for calculating outlier ordering professionals.” 
CMS will propose the first priority clinical areas in the CY 2017 PFS rule based on stakeholder consultation. The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) also may make recommendations to CMS.  In identifying clinical priority areas, CMS will consider the following: incidence and prevalence of disease; the volume and variability of use of particular imaging services; the strength of evidence supporting particular imaging services; and the applicability of the clinical area to a variety of care settings and to the Medicare population.
Identification of Non-Evidence-Based AUC and Conflicting AUC:
Non-Evidence-Based AUC — CMS will accept public comment to facilitate identification of AUC sets, subsets or individual criterion that are not evidence-based, giving priority to AUC associated with priority clinical areas and to AUC that conflict with one another. CMS may also independently identify AUC of concern. On an as-needed basis, MEDCAC will be used to further review the evidentiary basis of AUC that are potentially not evidence based.
In situations where a PLE is found to have non-evidence-based AUC and does not take steps to remedy or remove those criteria, CMS may terminate the PLE’s qualified status or may consider this information during the PLE’s re-qualification. 
Conflicting AUC — CMS acknowledges that conflicting AUC maybe be a concern, but generally believes that qualified PLEs will be using an evidence-based AUC development process that will reduce the likelihood and frequency of conflicting AUC. CMS states that in some situations it may be appropriate for CMS and MEDCAC to review the evidence base.