View source for Clinical Decision Support Mechanism (CDSM)

==Introduction==
According to the  Centers for Medicare & Medicaid Services (CMS), a [http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM Clinical Decision Support Mechanism] (CDSM) is an interactive, 
electronic tool for use by clinicians that communicates ''appropriate use criteria'' (AUC) information to the user and assists them in making the most appropriate treatment decision for a patient's specific clinical condition. In CMS’s recommended implementation, the CDSM 
provides a determination of whether a clinician’s order adheres to AUC, or if the AUC consulted was not applicable (e.g., no AUC is 
available to address the patient’s clinical condition).<ref>Centers for Medicare & Medicaid Services: Appropriate Use Criteria Program http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program</ref> 

CDSM software tools and the appropriate use criteria behind them are not unique to CMS or Medicare. In 
theory, any healthcare institution, payer, or guideline-developing specialty society can define and validate AUC that guide clinicians 
through a set of clinical criteria while using a CDSM. In general, satisfying AUC facilitates a patient’s access to a clinical procedure, 
test, equipment or medication, for example, by reassuring the clinician that the test is appropriate or by facilitating reimbursement, as 
in the case of Medicare. Documenting payer specified AUCs in the EHR using the CDSM can eliminate downstream pre-authorization 
requirements for the ordered test, procedure or prescription. CDSMs are expected to improve quality of care and streamline front and back- 
end clinical processes, in addition to the often-cited goal of curbing over-utilization of clinical services.   

==Timeline==
Clinical decision support as a ''mechanism'' for imposing AUCs on clinicians first appeared in July 2018, when CMS released a voluntary pre-beta version of the CDSM program.  Medicare then set a deadline for January 1, 2020, for providers to document AUCs in each of [[#PACs|8 priority clinical areas]] using CDSMs.  However, if the AUCs are not documented, payment is not withheld, effectively making 2020 a beta test year for the CDSM program.  Under the current plan, starting Jan 1, 2021, CMS will require AUC documentation in order to process payments to advanced imaging providers under the AUC program.  AUCs that are not met for a specific ordered service may be declined for payment with a request for pre-authorization. 

==Protecting Access to Medicare Act of 2014==
Congress enacted The Protecting Access to Medicare Act (PAMA) of 2014 in order to reduce Medicare spending on laboratory and imaging services and thereby safeguard Medicare financial resources. In response, CMS launched the AUC program and developed AUCs for eight separate use cases, called “priority clinical areas” or PACs. Although PAMA was enacted to restrain both laboratory and imaging utilization,  all eight PCA use cases pertain to clinical scenarios that commonly lead to radiology service over-utilization. Within each of the eight areas, large provider-led entities (PLEs), mostly nationally recognized specialty societies and academic health systems, developed specific AUCs. Commercial entities then implemented the AUCs by developing CDSMs and qualifying their products under the  qualified CDSM program ([[#qCDSM|see qCDSM]]).

==<span id="PACs"></span>Priority Clinical Areas (PACs)==
*Coronary Artery Disease (suspected or diagnosed)

*Suspected Pulmonary Embolism

*Traumatic or Non-Traumatic Headache

*Hip Pain

*Low Back Pain

*Shoulder Pain

*Lung Cancer

*Cervical or Neck Pain

==Imaging Services Targeted by CMS under Current AUC & CDSM Implementations==
Clinicians are required to consult a CDSM and document meeting the AUCs (or not) at the time of ordering any Medicare Part B Advanced Diagnostic Imaging Service, including the following:
*Computed tomography (CT)
 
*Positron emission tomography (PET)
 
*Nuclear medicine
 
*Magnetic resonance imaging (MRI)
 
==qCDSM:  CMS’s Qualified Clinical Decision Support Mechanism==
Under the AUC program, CMS must review and qualify all CDSM modules or applications ''prior'' their release and use by clinicians. These reviewed and qualified CDSMs are known in the clinical software industry as qCDSMs. CDSM qualification needs to be renewed every 5 years, although a longer renewal period has strong support from program stakeholders. 

In order to qualify, CDSMs must meet roughly twenty requirements that are listed in Section 42 CFR 414.94(g)(1) of the Code of Federal Regulations. To highlight several of these, the CDSM must:
::(i) Make available specified applicable AUC and its related supporting documentation.
::(ii) Identify the appropriate use criterion consulted if the CDSM makes available more than one criterion relevant to a consultation for a patient's specific clinical scenario.
::(iii) Make available, at a minimum, specified applicable AUC that reasonably address common and important clinical scenarios within all priority clinical areas identified in paragraph (e)(5) of this section.
::(iv) Be able to incorporate specified applicable AUC from more than one qualified PLE (provider-led entity).
::(v) Determines, for each consultation, the extent to which the applicable imaging service is consistent with specified applicable AUC.
::(vi) Generate and provide a certification or documentation at the time of order that documents which qualified CDSM was consulted; the name and national provider identifier (NPI) of the ordering professional that consulted the CDSM; whether the service ordered would adhere to specified applicable AUC; whether the service ordered would not adhere to specified applicable AUC; or whether the specified applicable AUC consulted was not applicable to the service ordered.
 
==<span id="qCDSM"></span>Commercial Market for qCDSM Modules & Applications==
CMS is trailblazing CDSMs through the beta testing its AUC program currently in effect. This is motivating development of an early commercial market for ''CDS services'' that include qCDSMs as core functionality. A CDS service is a software as a service (SaaS) decision support capability that “…can be encapsulated within independent, system-agnostic software services and then leveraged by various downstream applications.”<ref>Kawamoto, K., Del Fiol, G., Orton, C., & Lobach, D. F. (2010). System-agnostic clinical decision support services: benefits and challenges for scalable decision support. The open medical informatics journal, 4, 245–254. http://doi.org/10.2174/1874431101004010245</ref>  Commercially available qCDSM services commonly incorporate the latest interoperability protocols, such as the [http://www.hl7.org/fhir/smart-app-launch/ SMART launch framework,]  [http://cds-hooks.org/ CDS Hooks] and [http://github.com/smart-on-fhir/smart-web-messaging/ SMART Web Messaging]. CMS publishes a list of qCDSM modules that are currently pre-qualified for clinical use. Many of these products are available commercially, several offer free tools, and the plan is to annually update the list in June.<ref name=”CDSM”>Centers for Medicare & Medicaid Services: Clinical Decision Support Mechanism http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM</ref>

== References ==
<references/>
Submitted by Andrew Ten Have
[[Category:BMI512-SPRING-20]]