Background

The relentless progression of health care reform, demanding better health care at less cost, is upon us.^1,2 Rising health care costs are, in part, a result of increasing demand for services, an ageing population, and the availability of increasingly expensive technologies. In 2007, the Institute for Healthcare Improvement (IHI) proposed the Triple Aim to optimize patient experience, patient outcomes, and healthcare costs.³ In 2010, these concepts were embraced by the equation where Value = Outcomes / Cost.² In broad terms, those who find ways to optimize clinical outcomes and patient experience, while at the same time lowering the cost of care, will have an advantage. This is the basis for the paradigm shift from volume-based to value-based care which will dominate the future of US health care strategy.

Introduction

The recently developed American College of Cardiology (ACC) and Society for Cardiovascular Angiography and Interventions (SCAI) Appropriate Use Criteria (AUC) for peripheral arterial disease are designed to positively impact the value equation by reducing unnecessary variation, with a goal of reducing health care costs while improving quality and safety.^4-9 AUC are complimentary to guideline documents, enabling the value equation to influence expert consensus and evidence-based recommendations. Appropriate care can be thought of as "the right procedure – for the right patient – at the right time," with a goal of minimizing both over- and under-utilization.

The AUC recommendations are divided into 1) appropriate care; 2) may be appropriate care; and 3) rarely appropriate care. The "rarely appropriate care" category does not mean "never appropriate" and will include some situations, albeit unusual ones, where a test or treatment, that does not meet guideline standards, may be the right thing to do for a given patient. AUC is not a tool for payers to deny reimbursement for services. The "rarely appropriate care" scenarios can be thought of as necessary variations, so long as the rationale for the rarely appropriate choice is documented. The AUC provide a structure for the physician to document the reasons for the variation from "appropriate care", thereby justifying a "rarely appropriate care" exception. An example of necessary variation would be treating a patient based upon new clinical trial evidence published after the latest iteration of the guidelines. As long the reason for the "rarely appropriate" choice is documented, the variation, in retrospect, will be deemed as necessary.

In a constrained reimbursement system, revenues decline and if costs are fixed, volume-based strategies increase expense and lower margins. Value-based strategies, however, lower the cost per unit of care by focusing on improved outcomes, better patient experiences, and appropriate utilization. In a value-based paradigm, physicians who attempt to maximize productivity, i.e., maximize work Relative Value Units (wRVU's), without regard to cost-benefit, will be loss leaders, not revenue generators. Unnecessary variation, manifested by over-use and/or under-use, results in suboptimal care. Physicians who prioritize their individual autonomy over adopting AUC supported clinical pathways encourage unnecessary variation with its attendant increased cost and reduced quality. Likewise, physicians who think patient-centric care means giving patients what they ask for, rather than what they need, will over-utilize resources, increasing cost to the system without improving quality or safety.

Optimal AUC adoption is not expected to result in physicians achieving 100% compliance with the "appropriate care" category. For example, when the coronary AUC were developed in 2009, only 70% of the technical panel agreed on the "appropriate care" and "rarely appropriate care" categories.¹⁰ AUC allows for clinical judgment and permits the physician to individualize therapy for patients, but requires accurate documentation to justify exceptions.

Another valuable contribution of the AUC is to reduce variation by balancing over-use and under-use of diagnostic and therapeutic procedures. This is illustrated by the Advisory Board Company's schematic comparing utilization rates (variance from the 2004 Medicare average) for peripheral vascular ultrasound (VUS) and peripheral vascular intervention (PVI) in Medicare patients. They found dramatic regional variation for diagnostic vascular ultrasound use, from a low of 47% below average in Bend, OR to a high of 112% above the average in East Long Island, NY. For PVI, the lowest variation from 2004 usage was in Bend, OR (79% below the 2004 average) compared to the highest, 109% above the 2004 average, in El Paso, TX. Because it is unlikely that patient demographics explain this dramatic variation in the utilization of diagnostic and therapeutic vascular procedures, it suggests that some practices are under-utilizing while some are over-utilizing these services. Using the AUC for benchmarking purposes may help to reduce this unnecessary variation.

Conclusion

Health care reform is, at its core, about ensuring Americans receive affordable high quality heath care. Current data show that the cost of US health care exceeds 18% of our gross domestic product (GDP). In stark contrast, in 2011, the Organization for Economic Cooperation and Development (OECD), which includes France, Germany, Switzerland, Canada, Great Britain, Australia, Japan, Sweden, and Italy, spent only 9.3% of their GDP on health care.¹¹ Though the US ranks first among OECD countries for health care expenditures, it is last in health care coverage, and despite spending more on health care than our OECD contemporaries, the US fails to achieve better outcomes for patients.

The disconnect between high cost health care and poor clinical outcomes is largely a result of unnecessary clinical variation. AUC are not a panacea for health care reform challenges, but they do provide a benchmark for reducing unnecessary variation. Guidelines and AUC cannot be successful as static documents. Both require frequent updating, but they will always lag behind new developments in clinical practice. The "rarely appropriate care" category permits necessary variation when recent clinical trials have outpaced the guidelines and provides a failsafe to allow a physician to justify the most up to date care as the reason for the exception.

Finally, we must be mindful that under-utilization may pose just as big a problem as over-utilization. In order to get this right, we need accurate clinical documentation and reliable databases to measure our performance. We need to promote transparency in the practice of medicine to encourage physicians to always choose "the right procedure – for the right patient – at the right time."

Table 1: Renal Artery Stenting

APPROPRIATE CARE	CLINICAL SCENARIOS*
	Cardiac Disturbance Syndromes (Flash Pulmonary Edema or acute coronary syndrome (ACS)).
	Resistant HTN (Uncontrolled hypertension with failure of maximally tolerated doses of at least three antihypertensive agents, one of which is a diuretic, or intolerance to medications)
	Ischemic nephropathy with chronic kidney disease (CKD) with eGFR < 45 cc/min and global renal ischemia (unilateral significant RAS with a solitary kidney or bilateral significant RAS) without other explanation
MAY BE APPROPRIATE
	Unilateral RAS with CKD (eGFR < 45 cc/min).
	Unilateral RAS with prior episodes of congestive heart failure.
	Anatomically challenging or high risk lesion early bifurcation, small vessel, severe concentric calcification, and severe aortic atheroma or mural thrombus).
RARELY APPROPRIATE
	Unilateral, Solitary, or Bilateral RAS with controlled BP and normal renal function.
	Unilateral, Solitary, or Bilateral RAS with chronic end stage renal disease on hemodialysis > 3 months.
	Unilateral, Solitary, or Bilateral renal artery chronic total occlusion.
	Unilateral, solitary, or bilateral RAS with kidney size <7 cm in pole-to-pole length.

Table 2: Aorto-Iliac Artery Stenting

APPROPRIATE CARE	CLINICAL SCENARIOS
	Distal abdominal aorta or common iliac artery (CIA) with moderate claudication to major tissue loss (RC* 2-6) with ≥50% stenosis and/or resting mean translesional gradient ≥5 mmHg after having failed pharmacologic and walking therapy.
	Internal iliac artery (IIA) with moderate to severe symptoms of buttock or hip claudication or major tissue loss (RC 2-6) with ≥50% stenosis and/or resting mean translesional gradient ≥5 mmHg.
	External iliac artery (EIA) with moderate claudication to major tissue loss (RC 2-6) and 50%stenosis and/or resting mean translesional gradient ≥5 mmHg after having failed pharmacologic and walking therapy.
	Asymptomatic significant ≥50% aorto-iliac arterial disease in a patient who requires vascular access for another device (e.g., mechanical circulatory support, or TAVR).
MAY BE APPROPRIATE
	Aorto-iliac artery stenosis ≥50% with lifestyle or vocation-limiting claudication (RC 2-3) without having failed pharmacologic and walking therapy when the risk-benefit ratio of the intervention is favorable.
	IIA ≥50% stenosis with vasculogenic impotence.
RARELY APPROPRIATE
	Aorto-iliac stenosis <50%.
	Aorto-iliac stenosis <50% with mild (i.e., nonlimiting) claudication (RC 1).
	Asymptomatic aorto-iliac stenosis absent the need to advance large bore interventional equipment for another purpose.

Table 3: Femoral-Popliteal Artery Revascularization

APPROPRIATE CARE	CLINICAL SCENARIOS
	FP >70% or CTO with life-style limiting claudication or claudication that limits their ability to perform their job (RC 2-3) having failed or intolerant of pharmacological therapy and/or walking therapy
	FP >70% or CTO with CLI (RC 4-6).
	CFA with >70% stenosis or CTO and the clinical need for vascular access (i.e., IABP or large bore access for TAVR or PVAD).
MAY BE APPROPRIATE
	FP 50%-69% with multiple focal lesions with severe claudication or CLI (RC 3-6).
	CFA >70% or CTO with severe claudication or CLI (RC 3-6).
	PFA >70% or CTO with severe claudication or CLI (RC 3-6).
RARELY APPROPRIATE
	FP >70% or CTO with mild or no symptoms (RC 0-1).
	CFA >70% or CTO with mild or no symptoms (RC 0-1).
	PFA >70% or CTO with mild or no symptoms (RC 0-1).
	FP, CFA, or PFA with <50% stenosis regardless of symptoms.

Table 4: Infrapopliteal Artery Revascularization

APPROPRIATE CARE	CLINICAL SCENARIOS
	Moderate-severe claudication (RC 2-3) with two, or three-vessel IP disease (if the arterial target lesion is focal).
	Ischemic rest pain (RC4) with two, or three-vessel IP disease (to provide direct flow to the plantar arch and to maximize volume flow to foot).
	Minor tissue loss (RC 5) with two, or three-vessel IP disease (to provide direct flow to the plantar arch and to maximize volume flow to foot).
	Major tissue loss (RC 6) with two, or three- vessel IP disease (to prevent major amputationa and to facilitate healing a minor amputationb).
MAY BE APPROPRIATE
	Moderate-severe claudication (RC 2-3) with two, or three-vessel IP disease (occlusion or diffuse disease).
	Ischemic rest pain (RC 4) with one, or two- vessel IP disease (to provide direct flow to the plantar arch and in two-vessel, to maximize volume flow to foot)
	Minor tissue loss (RC 5) with one-vessel IP disease (to provide direct flow to the plantar arch and to maximize volume flow to foot).
RARELY APPROPRIATE
	Mild claudication (RC 1) with, one, two, or three-vessel IP disease.
	Moderate-severe (RC 2-3) claudication symptoms with one-vessel IP disease.
	PFA > 70% or CTO with mild or no symptoms (RC 0-1).
	Major tissue loss (RC 6) with one-vessel IP disease.

References

1. Porter ME, Lee TH. Why strategy matters now. N Engl J Med 2015;372:1681-4.
2. Porter ME. What is value in health care? N Engl J Med 2010;363:2477-81.
3. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff 2008;27:759-69.
4. Peripheral Artery Intervention Writing Group, Bailey SR, Bechman JA,e t al. ACC/AHA/SCAI/SIR/SVM 2018 appropriate use criteria for peripheral artery intervention: a report of the American College of Cardiology appropriate use criteria task force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine. J Am Coll Cardiol 2018. [Epub ahead of print]
5. Klein AJ, Jaff MR, Gray BH, et al. SCAI appropriate use criteria for peripheral arterial interventions: an update. Catheter Cardiovasc Interv 2017;90:E90-110.
6. Gray BH, Diaz-Sandoval LJ, Dieter RS, et al. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheter Cardiovsc Interv 2014;84:539-45.
7. Klein AJ, Feldman DN, Aronow HD, et al. SCAI expert consensus statement for aorto-iliac arterial intervention apprpriate use. Catheter Cardiovasc Interv 2014;84:520-8.
8. Klein AJ, Pinto DS, Gray BH, Jaff MR, White CJ, Drachman DE. SCAI expert consensus statement for femoral-popliteal arterial intervention appropriate use. Catheter Cardiovasc Interv 2014;84:529-38.
9. Parikh SA, Shishehbor MH, Gray BH, White CJ, Jaff MR. SCAI expert consensus statement for renal artery stenting appropriate use. Catheter Cardiovasc Interv 2014;84:1163-71.
10. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol 2009;53:530-53.
11. Lorenzoni L, Belloni A, Sassi F. Health-care expenditure and health policy in the USA versus other high-spending OECD countries. Lancet 2014;384:83-92.

Keywords: Health Care Reform, Health Expenditures, Peripheral Arterial Disease, Critical Pathways, Goals, Medicare, Health Care Costs, Quality of Health Care, Health Resources, Demography, Coronary Angiography, Guanosine Diphosphate

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