Insight, analysis & opinion from Joe Paduda

< Back to Home

Mar
9

The ethics of clinical guidelines

Next month I’m going to be speaking at the Geisinger Clinic on the subject of Comparative Effectiveness – the payer’s ethical dilemma. I’m fascinated by this issue as it strikes at the heart of the problems with, and perhaps solutions for, the health insurance crisis.
If we are to solve the access and cost problem, payers, providers, and patients must be comfortable with the decision process and methodology. Today, there’s precious little ‘comfort’ with the current ‘system’. And that’s understandable.
There’s a lot of ‘art’ in medicine; physicians diagnose conditions and recommend specific treatments based on what they think will help, often without much in the way of peer-reviewed research supporting their views. Much is based on their own training and experience and the knowledge passed on to them by their medical school professors and colleagues, provided in specialty society and other medical journals, passed on by medical device and pharmaceutical firms, and learned at conferences and symposia.
Most of the time this knowledge delivers the ‘right’ outcome; the patient gets better. But in some instances there are at least a couple different treatment options for the patient’s condition. Physicians recommend what they think will work based on the patient’s unique characteristics (physical, emotional, financial, history), and these ‘recommendations’ may be several. For example, chronic lower back pain treatment options may include surgery, physical therapy, medications, some of the above, all of the above, and variations of each of the above.
Sticking with the back pain issue, think of this from the payer’s perspective. The wide variation in back surgery rates is well-documented, with Medicare data indicating a 500% variation between Ft Myers and Miami Florida. We don’t know why there’s such a wide difference, but it is safe to assume that the rate is too high in Ft Myers, too low in Miami, or perhaps both.
When a physician in Ft Myers recommends surgery for a patient with a back condition, it is understandable why payers would have concern over the appropriateness of the procedure. To address this concern, payers utilize clinical treatment guidelines in an effort to determine if the recommendation is ‘appropriate’.
In some cases, the guidelines provide clear and convincing support for or against the procedure, but in many others the finding is not so clear cut. The patient may have some but not all of the clinical findings that are ‘necessary’ to support surgery; there may be other medical conditions present that complicate treatment determination; the patient may want one type of treatment for their own reasons.
The result is the payer – and the physician – are functioning in a somewhat grey area.
There are obvious financial factors in play as well. The physician gets paid to do the procedure, the pharma company gets paid if the patient takes their meds, the device company gains revenue for each device sold, the payer saves money if expensive procedures aren’t performed, the patient may want drugs for inappropriate reasons.
The ethical issues are apparent. While we would hope that decisions would be based solely on the evidence, there often isn’t enough of the right type of evidence to arrive at a clear cut decision. When that occurs, what other factors affect the decision? How are disagreements resolved, and what is that resolution? When there’s strong disagreement, what factors, evidence, criteria are ‘used’ to support the parties’ different positions?
If you have experience with situations that speak to this ethical dilemma, I’d appreciate hearing from you.


5 thoughts on “The ethics of clinical guidelines”

  1. It is always interesting hearing a non-clinician’s perspective on clinical practice guidelines. Critical to understanding their use is understanding their limitations. Medical directors use evidence-based CPGs as ‘guidelines’ and not as rigid and absolute truths. Medical treatment denied as “experimental and investigational” is not only treatment where there is a paucity of scientific information, but treatment that may in fact be detrimental or cause deterioration of the to the patient/claimant’s condition. Many of the ethical issues that you reference are bridged by peer to peer discussion during informal reconsiderations. The UR process should be interpreted less as a primary medical cost savings program but more as a vehicle to ensure that the patient receives best-in-class care. It is this optimal quality of care that translates into rapid recovery and RTW.

  2. Joe, I’m president of guidelines for Reed Group (www.reedgroup.com), a leader in the field of absence management. We develop and publish the industry-standard return-to-work guidelines, and have a partnership with the American College of Occupational and Environmental Medicine to integrate evidence-based treatment guidelines. (www.mdguidelines.com)
    You talk about one of the classic issues in medical publishing, which is the apparent conflict between the “art” and “science” of practicing. Presumably, if enough quality information were available (and in a usable format), the “art” could be displaced in favor of the “science”. Making that practical, while aligning with the incentives that drive physician behavior, is obviously an immense challenge.
    At MDGuidelines, we have taken a huge step by making outcomes (statistics) the fundamental basis for our recommendations. We believe that data speaks louder than experts, and we put this into practice via some very innovative tools. Our predictive model actually allows physicians to “drill down” into the outcomes data to see what effect co-morbidities are likely to have on recovery times. At the same time, our world-class Medical Advisory Board layers clinical wisdom on top of the data to provide appropriate insight and corroboration.
    We also have a vibrant integration model in our business. We realize that the best way for content to be utilized is via “decision support” — meaning that the information is available in the physician’s workflow in an unobtrusive but persistent way. We are working with major electronic medical records providers in anticipation that this is the way most medical content will be utilized in the future. Importantly, too, our integration relationships allow us to collect outcomes for ongoing development of the guidelines.
    We believe that occupational health is dramatically outside the mainstream in modern medical practice. Physicians are very poorly trained in the “work” part of the work/life balance and as such, often fail to consider the critical importance of the patient’s productivity to their health. At MDGuidelines, we consider return-to-work to be a proxy for quality health care delivery in general. When a patient is too sick to work, that is the beginning of a health care episode. When she is healthy enough to return to work, then there is a positive outcome marking the end of the episode. Anyone interested in the “big picture” of measuring outcomes in health care should take a strong interest in return-to-work data.
    Finally, the ethical issues around use of clinical guidelines can only be resolved with the understanding that all of the stakeholders need to have access to the same information. We believe this leads to more consistent and responsible care and better outcomes. We continuously promote the notion that our guidelines should be used as a communication tool between physician, employer, insurer, and patient. This allows for a more transparent and better-planned recovery process where “hidden agendas” and one-sided interests and incentives can be minimized, and the physician-patient relationship can be emphasized. In the era of the internet, this collaborative approach to outcomes-driven medicine is realistically within reach.
    Jon Seymour, M.D.
    President, Guidelines
    Reed Group Ltd.

  3. All this cost stuff wears me out. Why would I pay for treatmet for people who don’t take their own health in to consideration? i.e. obesity, smokers, etc. I guess it’s that person’s right to smoke or eat too much but it’s not their right to have me pay for their poor life choices via increased taxes or higher premiums. Joe has commented many times on the cost % of healthcare as a result of smoking, obesity, diabetes, etc. Bad choices cost money and people should be and are penalized in other areas of life for bad choices….except healthcare. Seems like the current health care proposal wants to take ALL, regardless of good or bad choices and let others pay for it.
    There was a great article in the March issue of Fortune Magazine about the Cleveland Clinic and how they have made great efforts to eliminate smokers and overweight people from their employment. Result…..lower cost in the healthcare they pay.
    We talk about cost, (lowering Dr. reimbursement, restricting treatment, tort reform, etc) but I haven’t seen anybody discuss one of the real roots of the problem…our own choices for our own health. The solution….let Americans eat what they want, smoke what they want, drink what they want AND then when we get sick, don’t worry about it because ALL Americans will pay for our poor decisions.
    I guess that’s the American way and I’m going to have to live with it.

  4. We have documentation to support roughly half of what we do in medicine. This does not mean that 50% is wrong; much of what we think works really does, but the studies to prove it have not been done. Evidence based guidelines only speak to the 50% that has been studied, and so can be very misleading.
    Worse, the guidelines do not help us address the errors of ommission, the most common problem in medicine by far, the high value things that should have been done, but aren’t. For example, a brief discussion about smoking cessation is a well recognized high value intervention, but is not reimbursed and in our time pressured practices is ignored by many. The bottom line: we need to look at the aggregated outcomes of each physician’s care in terms of value. Good outcomes require many inputs, the majority of which cannot yet be measured by guidelines, especially for complex problems like back pain. Yet there are wide differences in outcomes that individual doctors and individual clinics get. Those who get patients back to full work quickly and cheaply ON AVERAGE should be rewarded with additional business, immunity from most insurer “oversight” and ideally a share of the savings. While guidelines are a worthwhile place to start the quality process, medicine should adopt the statistical process control methods that have made manufactured goods so much more reliable; look at the outcomes in aggregate, and learn from the outliers, both the good and the bad. Do “run charting” and don’t waste oversight resources looking at random variations, rather at care that is statistically above or below the norm. Insurers need to collaborate with employers to look at both the short and long term disability as well as the costs of care to define the outcome measures to reflect the entire value proposition.

  5. Joe – As president of the company that publishes Official Disability Guidelines (ODG), now in its 15th annual edition, we have amassed years of experience in the issues surrounding Comparative Effectiveness Research and Guidelines – for Workers’ Comp conditions – long before the phrase was ever coined. (Note: ODG is the most widely used medical treatment guideline AND return to work guideline, but since the subject of your posting is treatment guidelines, I will respond accordingly.) I just wanted to point out that I agree with the thrust of your posting: These are “guidelines” and not every patient will fit exactly within the guidelines. For this reason, ODG has developed a process called “Documenting Exceptions to the Guidelines” contained as Appendix D of ODG Treatment in Workers’ Comp. The purpose of this section is to outline a process for providers within states and provinces that have adopted ODG for healthcare provided under workers’ compensation to ensure appropriate medical treatment for their patients in the rare instances where a procedure is not covered; necessary care falls outside of the recommendations; comorbidities dictate another course of therapy; or the patient’s personal circumstances mandate a deviation from the otherwise scientific remedy. Therein comes the art. Though ODG covers over 99% of cases seen in workers’ comp, there are still times when uncommon situations can occur which are not addressed in the standard guidelines. Medical treatment guidelines, done right, are a delicate balance. Guidelines that are too restrictive may control costs in the short term, but limit necessary medical care to injured workers, who suffer unnecessarily, while outcomes fail to improve. Non-productive UR costs skyrocket when denials and friction clog the system, as good providers stop taking workers’ comp patients because they can’t get necessary medical care approved. Guidelines that are not restrictive enough, on the other hand, have little net effect. While ODG is unique in striving for and generally achieving this balance based on a thorough and ongoing review of the medical evidence, we still think it is important to allow for the possibility of exceptions. This new instructional answers when and how those exceptions should be handled together with explicit case study examples, providing the framework to ensure timely and appropriate medical care even for the unconventional injured worker. – Phil Denniston, President, Work Loss Data Institute

Comments are closed.

Joe Paduda is the principal of Health Strategy Associates

SUBSCRIBE BY EMAIL

SEARCH THIS SITE

A national consulting firm specializing in managed care for workers’ compensation, group health and auto, and health care cost containment. We serve insurers, employers and health care providers.

 

DISCLAIMER

© Joe Paduda 2024. We encourage links to any material on this page. Fair use excerpts of material written by Joe Paduda may be used with attribution to Joe Paduda, Managed Care Matters.

Note: Some material on this page may be excerpted from other sources. In such cases, copyright is retained by the respective authors of those sources.

ARCHIVES

Archives