Monday, November 21, 2016

Appropriate Use Criteria by Force of Law: Should Everyone Be Paying Attention?

Outside the imaging community (including radiology and cardiology), I've seen relatively little discussion of the mandatory Appropriate Use Criteria imposed by Section 218 of the PAMA law.   CMS devoted almost 30 pages of discussion in the November 2016 final PFS rulemaking, and implementation is coming over the next year or two.   The issues could be applicable to areas like genomics or even non-diagnostic areas of clinical decision making.

The original law, PAMA Section 218, is here.  November 15, 2016, CMS policymaking stretches from page 80403 to page 80429 of the Federal Register.  (Original Fed Reg link here; for a downloadable subsection in the cloud, here. CMS homepage, here.)  For reaction to the rulemaking at Imaging Technology News, here.  For coverage at American College of Cardiology, here.   For coverage at Advisory Board, here.

The law requires ordering professionals to consult with AUC criteria, through a Clinical Decision Support Mechanism (CDSM), for all Medicare patients receiving advanced imaging, such as cardiac nuclear imaging, CT, and MR.   AUCs may vary in scope (e.g. pan-imaging AUC or orthopedic or cardiac), and must be developed by a "provider led entity" or PLE.  Exceptions are limited, e.g. rural physicians without access to internet.   More after the break.

Provider-led entities that can generate AUCs for implementation through electronic clinical decision support venders include familiar entities like American College of Radiology, National Comprehensive  Cancer Network, Society for Nuclear Medicine, American College of Cardiology Foundation.  However, healthcare systems do not have to adopt national guidelines like those; qualified "provider led entities" include University of California Medical Campuses, Brigham & Women's Physician Organization, Intermountain Healthcare (list here).  Part of the discussion in this fall's rulemaking is that AUCs may give intermediate criteria (non-binary criteria) based on clinical situations of actual patients , which would be difficult to integrate into a binary penalty system.

In the current November 2016 rulemaking, CMS notes that the AUC are mandatory but disengaged from LCDs and NCDs.  Therefore, a service might be covered by the AUC but not by an LCD, or vice versa (p. 80427).

In response to a concern that "AUC consultations do not interfer with physicians' clinical judgement when treating patients," CMS responded that "we disagree with the ida that AUC consultation creates new barriers for Medicare beneficiaries....AUC consultations will complement the practice of medicine."  Some commenters "questioned the overall approach."

For an early reaction (June 2014) to PAMA 218 at Radiological Society of North America, here.  For a detailed overview at Nuclear Cardiology Reports, here.  For am example of fast-moving commercial interests, see a press release at National Decision Support Company, discussing integration with Cerner EHR, here.

For an article on McKesson's "value-based" imaging management system Conserus, see MedCityNews, here.  "A rules system...allows...[standardization of] clinical practice across all of [the province of] Alberta."

For one example of an AUC which is at variance with an NCD, see a cross-society AUC on beta amyloid PET imaging in Alzheimer's disease, here.