Peter C. Cook, MD, MPH

	Diabetes management is a hallmark of various 

.  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.

 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 

 what transpires in the course of the doctor-patient encounter.

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 

 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.”

Value-based Rx: How physicians can manage affordability, adherence

	In addition, it is not clear that monofilament exams reliably detect diabetic neuropathy in the first place.

  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.

  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.

	Another truth:  not all patients with diabetes are the same.  A generally healthy, active 68 year old with diabetes who is well informed about his condition and potential complications and who inspects his feet every night is not the same person as an 88 year old with diabetes, visual impairment, gait disturbance, and dementia. 

Tips for physicians to reduce billing errors

	At least in the first instance, the patient’s physician should be able to use his or her discretion and forgo the yearly DFE, instead spending valuable visit time addressing matters more relevant to the individual patient.  But under P4P, CMS has implemented a system of coercive clinical practice guidelines, such that “physician discretion” and “the individual patient” have become obsolete concepts.

	As I have outlined previously,  an even more disturbing feature of medical practice under P4P is the lack of patient awareness of the physician’s financial conflict.  In other words,  patients assume that the physician’s  actions are  guided by his or her duty to promote patient wellbeing.   

	In my experience,  almost all patients react with surprise and alarm when they are made aware that their care is being determined in part by outside financial forces.   So it is not hard to imagine a scenario whereby patients,  having become aware that Medicare-participating doctors are critically conflicted, seek out doctors who operate outside of the Medicare system.  

	In that sense, direct primary care may well flourish not so much as a result of fed-up, burned-out physicians leaving insurance-based practice and having their loyal patients follow  - but due to fed-up patients who insist on seeing physicians who are able to allow individual patient wellbeing to assume paramount importance in the doctor-patient relationship. 

Do younger physicians outperform older doctors?

	Unfortunately, there will be patients who want such a relationship with their doctor, but who for financial reasons  must continue to receive care based on the flawed CMS model.   If and when this two-tier healthcare system becomes reality,  it won’t be a result of physician greed or market failure.  It will be the consequence of CMS hubris driving patients with resources to seek quality care.

Duckworth, William, et al. "Glucose control and vascular complications in veterans with type 2 diabetes." New England Journal of Medicine 360.2 (2009): 129-139.

Action to Control Cardiovascular Risk in Diabetes Study Group. "Effects of intensive glucose lowering in type 2 diabetes." N Engl j Med 2008.358 (2008): 2545-2559.

ADVANCE Collaborative Group. "Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes." N Engl j med 2008.358 (2008): 2560-2572.

Cook, PC.  “How perverse incentives are ruining healthcare.”  Medical Economics.  Nov 30 2015.

Goff, David C., et al. "2013 ACC/AHA guideline on the assessment of cardiovascular risk." Circulation (2013): 01-cir.

Stone, Neil J., et al. "2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults." Circulation (2013): 01-cir.

Cooper-DeHoff, Rhonda M., et al. "Tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease." JAMA 304.1 (2010): 61-68.

ACCORD Study Group. "Effects of intensive blood-pressure control in type 2 diabetes mellitus." N Engl j Med 2010.362 (2010): 1575-1585.

 Arad, Yadon et al. “Beyond the Monofilament for the Insensate Diabetic Foot: A Systematic Review of Randomized Trials to Prevent the Occurrence of Plantar Foot Ulcers in Patients with Diabetes.” Diabetes Care 34.4 (2011): 1041–1046. PMC. Web. 16 Aug. 2017.

 Dros, Jacquelien, et al. "Accuracy of monofilament testing to diagnose peripheral neuropathy: a systematic review." The Annals of Family Medicine 7.6 (2009): 555-558.

 Mayfield, Jennifer A., et al. "Do foot examinations reduce the risk of diabetic amputation?." Journal of Family Practice 49.6 (2000): 499-499.

Articles

This problem represents yet one more example of CMS’ ill-advised attempts to dictate what transpires in the course of the doctor-patient encounter.

CMS pay-for-performance measures flawed

forecasting the current shortage of primary care physicians 

in the United States date back to the early 2000s. 

Here is the PCP crisis solution and it's simple

responding to a 2008 Physicians Foundation Survey, about half stated they would consider leaving medicine.

	A CNN report summarizing the findings stated that “many [primary care physicians] said they are overwhelmed with their practices, not because they have too many patients, but because there’s too much red tape generated from insurance companies and government agencies.”

	 In response, one would have expected that policymakers, when assessing the merits of a proposed healthcare initiative or regulation, would weigh the measure’s likely impact on making primary care practice less burdensome. Yet, such consideration was apparently given little weight when the Health Information Technology for Clinical Health (HITECH) Act was passed as part of the 2009 American Recovery and Reinvestment Act. HITECH broadened the authority of the Centers for Medicare & Medicaid Services (CMS) to utilize pay-for-performance (P4P) programs as a means of physician compensation. Needless to say, HITECH’s passage struck a major blow to physician autonomy.

	In a 2009 interview, President Obama acknowledged the PCP shortage and the difficulty in attracting physicians to choose a career in primary care, stating: “…keep in mind that the status quo is we don’t have enough primary care physicians. We’ve got to create more primary care physicians. And what we want to do is to provide a powerful set of incentives for more and more young people who are interested in healthcare … to go into primary care.”

 But the situation only worsened with the birth of the Medicare Annual Wellness Visit (AWV), courtesy of the Affordable Care Act. 

As I outlined in Medical Economics last year,

 the AWV is a burdensome, inflexible Electronic Health Record (EHR) box-checking encounter scripted by CMS, with a weak evidence base and a one-size -fits all approach.

Thus, the net result of HITECH’s enactment in 2009 followed by 

the following year, was a further erosion of PCP autonomy and a further reduction in primary care’s appeal.

	 Which makes the expansion of P4P through the enactment of the 

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)

 even more disheartening. That MACRA was passed by an overwhelming majority in both houses of Congress underscores what little interest policymakers have in attracting more physicians into the field of primary care.

	For the PCPs, CMS’s embrace of P4P didn’t just limit autonomy, it replaced autonomy with compromise and conflict of interest. Some examples of the conflict:  Does the physician engage female patients in a discussion of the pros and cons of mammography screening and risk falling short of the threshold percentage required for CMS “reward” revenue? Or does one simply go along with CMS guidelines, limiting mention of evidence raising doubts about the benefits of this screening measure?

	How about pursuing tight glycemic control in patients with Type 2 DM, despite evidence suggesting a lack of benefit?

 Does the PCP present the patient with low back pain with the latest evidence regarding efficacy of various interventions-perhaps sharing some journal articles on the subject-or does he or she instead hand the patient a simplistic, non-evidence based “low back pain” handout generated from CMS-approved patient education software, as incentivized by MU? For that matter, should one spend limited visit time discussing important studies regarding interventions that CMS has not included in its P4P measures? 

Strategies for making PCP practices more efficient

	For years after the publication of evidence outlining the benefit of one-time screening for abdominal aortic aneurysm in men over age 65 who had ever smoked

, CMS did not make screening of this population one of its P4P measures. One could cite many other examples. Unfortunately, the practice of primary care under such steady ethical conflict has become the norm.

	 A 2016 American Association of Medical College (AAMC) report predicted that there will be a national PCP shortage numbering anywhere from 12,500 to 31,100 by 2025.

  A Physicians Foundation survey of over 17,000 physicians released a few months later identified low physician morale as the primary factor underlying the worsening shortage.

The survey found that “physicians identify regulatory/paperwork burdens and loss of clinical autonomy” as their primary sources of dissatisfaction. Physicians Foundation President Walker Ray commented that “by retiring, taking non-clinical roles or cutting back in various other ways, physicians are essentially voting with their feet and leaving the clinical workforce.

	“This trend is to the detriment of patient access. It is imperative that all healthcare stakeholders recognize and begin to address these issues more proactively, to support physicians and enhance the medical practice environment.”

	Given the decisions of policymakers in response to similar warnings over the past decade, such support does not seem likely.

Hawkins, Merritt. "The physicians' perspective: medical practice in 2008." Boston, MA: The Physicians Foundation (2008).

http://www.cnn.com/2008/HEALTH/11/17/primary.care.doctors.study/

 ABC’s “World News With Diane Sawyer (

http://abcnews.go.com/Politics/story?id=8091227&page=2#.UBVGzWGe4rU

http://medicaleconomics.modernmedicine.com/medical-economics/news/cms-incentivizes-unnecessary-medicare-wellness-visits

 Miller Anthony B, Wall Claus, Baines Cornelia J, Sun Ping, To Teresa, Narod Steven A et al. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial BMJ 2014; 348 :g366

Gerstein HC, et al. "Effects of Intensive Glucose Lowering in Type 2 Diabetes". The New England Journal of Medicine. 2008. 358(24):2545-59.

Hemmingsen Bianca, Lund Søren S, Gluud Christian, Vaag Allan, Almdal Thomas, Hemmingsen Christina et al. Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials BMJ 2011; 343 :d6898

Guirguis-Blake, Janelle M., et al. "Ultrasonography screening for abdominal aortic aneurysms: a systematic evidence review for the US Preventive Services Task Force." Annals of internal medicine 160.5 (2014): 321-329.

 https://www.heartland.org/_template-assets/documents/publications/2016_complexities_of_supply_and_demand_projections.pdf

www.physiciansfoundation.org/news/the-physcians-foundation-2016-physician-survey/

www.businesswire.com/news/home/20160921005410/en/Survey-17000-Physicians-Finds-Shifting-Practice-Patterns

Loud and clear warnings forecasting the current shortage of primary care physicians in the United States date back to the early 2000s.

Author | Peter C. Cook, MD, MPH

Articles

CMS pay-for-performance measures flawed

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