Who Benefits from Guidelines

Have patients benefited from guidelines? We do not know. To the extent they are followed, adoption of certain guidelines may well harm some patients. Bringing patients to the K/DOQI PTH goal of 150-300 pg/ml may be partly responsible for the epidemic of adynamic bone disease. Raising the upper level of hemoglobin from 12 to 13 g/dl may harm some patients, considering that higher levels of hemoglobin have been associated with excess mortality in two prospective studies, both of which were stopped prematurely [5].

If patients are not benefiting from guidelines, who is? I suppose overworked physicians and physician-extenders perceive a benefit from having things laid out in cookbook form; it is a big time saver. This is increasingly important as shrinking Medicare reimbursement has led to higher patient loads and volume of service. But the major beneficiaries are those with large financial stakes: the pharmaceutical industry, professional societies, dialysis companies, insurance companies, Centers for Medicare and Medicaide Services (CMS), and the guideline writers all reap considerable financial benefit from the guideline industry.

Industry heavily underwrites guideline creation, at least in nephrology. Amgen is the principle sponsor of the NKF-K/DOQI guidelines, and as Coyne points out (op. cit.), with potential financial benefits from guidelines for anemia and bone management. There are many other examples. The entire guideline process is tilted towards increasing use of pharmaceuticals since most clinical trials are sponsored drug studies (funded by industry). It is easy to see how guidelines recommending ever-lower blood pressure, cholesterol and glycosylated hemoglobin targets could fuel a major expansion of drug prescribing in these areas.

Professional societies receive millions from industry and government to create guidelines. The AMA, which derives considerable income from the CPT-4 procedure coding systems (that enable payers to control reimbursement) is collaborating with the government to fabricate clinical performance measures that will be used to restrict payments through P4P. Using 'a standard method of delivering or facilitating coordinated care from diagnosis to management, based on the National Kidney

Foundation's KDOQI evidence-based clinical practice guidelines' the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will award a certificate of excellence for kidney disease management based on fulfillment of certain eligibility criteria. The JCAHO web site states on the certificate award, 'It is the best signal to your community that the quality care you provide is effectively managed to meet the unique and specialized needs of CKD patients. In fact, demonstrating compliance with these national standards and performance measurement expectations may help obtain contracts from employers and purchasers concerned with controlling costs and improving productivity.' Do we really need this? Do we want more scrutiny by more organizations? Of course, on top of this are the subscriber fees for the certificate of excellence.

A byproduct of the K/DOQI guidelines was the addition of 20 million plus 'CKD' patients, many of whom are likely healthy old folks with borderline eGFR. Large dialysis providers benefit from specific guidelines to use intravenous medications during dialysis, particularly vitamin D analogs. These drugs continue to generate profit for dialysis units, in spite of the recent reimbursement changes to reduce incentives to administer drugs during treatment. There is no convincing evidence for the superiority of intravenous over oral therapy with these agents, other than for compliance. Oral D-analogs are used predominantly outside the US, where these incentives do not exist, without apparent detriment.

Insurance companies and CMS both fund, and benefit from, guidelines which they perceive as a way to control payments to providers. Guidelines are mostly authored by academic physicians and other professionals, many of whom derive significant industry support in the form of speaking honoraria, research support, and consulting fees. There may or may not be direct compensation for the work involved with guideline formation, but there are certainly speaking and consulting opportunities that flow from guideline involvement. Conflicts of interest must surely exist, but are usually downplayed. In a 2004 survey of over 200 guidelines from the National Guideline Clearing House, only 90 had details of authors' conflicts of interest, and of these only 31 had none.

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