Diabetes management is a hallmark of various CMS primary care pay for performance (P4P) programs. Tight glycemic control, checking low density lipoprotein (LDL) cholesterol in patients already on statin medications, and aggressive blood pressure lowering, although financially incentivized by CMS, are likely of no clinical benefit and possibly even harmful.[i],[ii],[iii],[iv],[v],[vi],[vii],[viii] It is therefore not surprising that CMS includes the annual diabetic foot exam (DFE) - another intervention with a weak evidentiary basis - as a P4P “quality” measure. It represents yet one more example of CMS’ ill-advised attempts to dictate what transpires in the course of the doctor-patient encounter.
Further reading: What makes a high-risk patient, and how do we care for them?
To be clear: diabetic neuropathy, with or without associated peripheral vascular disease, can lead to foot ulcers and limb loss. The resulting physical and psychological burden placed on patients and their families is tremendous. Based on the pervasiveness of the annual diabetic foot exam as a quality measure across multiple CMS P4P programs, one would expect there to be solid evidence in the literature establishing that patients who undergo periodic DFEs to screen for neuropathy (a precursor to diabetic foot ulcers) have lower rates of ulcers or amputations in comparison to control patients who do not. In truth, such evidence is lacking.
As Arad, et al outline in their 2011 review, “…the evidence for most of the interventions to prevent a foot ulcer falls short. Clinicians lack guidance on what to do after a patient loses sensation. Anecdotally, many keep testing repeatedly with a monofilament, at scheduled intervals, although sensation rarely returns. The benefit of enhanced patient education or more intensive caretaker involvement, specialized footwear, surgical debridement of calluses, bone resection at pressure points, or decompression or neurolysis of the peroneal and tibial nerves is not supported by randomized clinical trials.”[ix]
In addition, it is not clear that monofilament exams reliably detect diabetic neuropathy in the first place.[x] Even if one considers a DFE that includes not only annual monofilament testing but also “comprehensive foot examinations,” including visual inspection, “evaluation of bony deformities, and neurologic and vascular status,” there is still no evidence that such examinations reduce the risk of amputation.[xi] Nevertheless, not performing annual foot exams on a sufficiently high percentage of diabetic patients results in financial penalty under PQRS and withholding of financial reward under MACRA/MIPS.