CCGPP: The Wrong Approach to Practice Parameters
We commend the participants of the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) for their dedication and hard work. Their goal was to produce a “Best Practice” document after examining all existing guidelines, parameters, protocols and best practices in the United States and other nations.
When they began their mission, they preached consensus. Mistakes of the past were to be avoided and they pledged to have a completely transparent process. They were formed at the request of the Congress of Chiropractic State Associations (COCSA) and supported by the entire alphabet of national chiropractic organizations: ACA, ICA, FCER, ACC, CCE, FACS, NACA, NICR, and a host of vendors. The profession would, at last, have a document guiding chiropractors and third party payors that would avoid the perceived mistakes of the Mercy Guidelines.
But, now that the document has been released for comment, questions abound about the process used to create the document and its clinical conclusions. CCGPP has all but abandoned transparency and consensus. The profession must now decide if there is anything worth salvaging from this document or to repudiate it if it is ultimately published.
CCGPP and Worker’s Compensation
CCGPP has stated that requests from the worker’s compensation systems of California and Texas were the major impetus for the creation of a best practices document. Chiropractic costs for providing worker’s compensation care, according to the Worker’s Compensation Research Institute (WCRI), are far higher in those states than others covered by their survey data.
In the case of California, the state decided to adopt the American College of Occupational and Environmental Medicine (ACOEM) guidelines, which are detested by chiropractors, and to limit injured workers to no more than twenty-four chiropractic, twenty-four occupational therapy, and twenty-four physical therapy visits per industrial injury.
Unfortunately, these visit limitations would not be altered by CCGPP’s best practices document. The CCGPP document would, however, likely damage patients and chiropractors in the area of physical therapy services. The ACOEM guidelines state that physical therapy has “no proven efficacy.” CCGPP replicates this biased system that poorly grades physical therapy, not because physical therapy is ineffective, but merely because insufficient research has been done to substantiate its effectiveness. Add CCGPP to ACOEM and you have disaster for injured workers.
Instead of battling ACOEM or adopting reasonable WC treatment guidelines, as has been done in Wisconsin and Minnesota, CCGPP produced a best practices document that will not allow chiropractors in California to provide additional care, but will have a potential devastating impact on injured workers if they are denied physical therapy modalities.
CCGPP’s Impact on the Quality of Care
CCGPP appears to have ignored the evolution of best practices guidelines (see the cover story in the May 29, 2006, issue of Business Week) that were designed to help MD’s determine the best treatment based on a plethora of well researched options.
Instead of studying the applicability of this model to the entire spectrum of chiropractic treatment, it seems as if a judgment was made that, since the model would work well for chiropractic manipulation, which is well researched, it would be applied to all chiropractic services—regardless of the consequences. Now that the document has been released, the profession is beginning to understand the negative consequences for patients who need physical therapy, because this model was inappropriately applied to chiropractic.
It was not reasonable for CCGPP to adopt an unreferenced grading scale for modalities when they knew the inherent bias in the grading system would negatively impact the quality of patient care. If an ABCD grading system is used, it is fair to expect there will be A and B choices. That was not possible for physical therapy modalities because, to have A or B choices, there has to be relevant research. And, by CCGPP’s own admission, there is none.
So what will happen if CCGPP’s best practices guidelines are published? Patients will suffer, as it is likely that insurers and managed care companies will gradually eliminate reimbursement for any service that does not receive an A or B grade. After all, why should an insurer pay for something that received a C or D in a “Best Practice” document produced by the chiropractic profession itself?
The consequences will be devastating. In the real world, if reimbursement is denied for modalities, patients will have to pay for these services out of their own pockets. The overwhelming majority of patients will not be able to do so and, as a result, will forgo the care. Their health will greatly suffer as a result.
“Best Practices” Document or a “Guideline”
It has been fascinating to watch as CCGPP struggles with the identity of this document. Is it a best practice document that will help chiropractors to select the optimal care for their patients? Or is it a guidelines document that will be used by insurers and managed care organizations to impose artificial limits on care?
Throughout the national conference calls COCSA and CCGPP have held on this document, the words “best practices document” and “guidelines document” have been used almost interchangeably, except when a CCGPP member suddenly realized it was politically incorrect to do so.
CCGPP has been trying to make the case that a “best practices” document does not lay out numeric parameters for care and, therefore, should not be misused. But a best practices document that assigns a C or D grade to commonly used services will absolutely be used as a guideline by some insurers or managed care companies. They won’t just limit chiropractors to a few uses of physical therapy—they will refuse to pay for it at all.
ACN has already written that they intend to create fee schedules based on best practice documents. CCGPP is hiding behind the words “best practices” when, in fact, they have created a guidelines document that will be used to deny needed chiropractic care, which will have a devastating clinical and economic impact on the profession.
Consensus or Personal Opinion
The best practices process was sold to the country as a completely transparent process that would be consensus driven at every step. Like some states, the Wisconsin Chiropractic Association invited Gene Lewis, DC, the then Chair of CCGPP, to make a presentation to our board where he stressed the importance of consensus. If you read Dr. Lewis’ article on the CCGPP website, consensus is stressed over and over again.
But that was then and this is now. In a conference call between CCGPP and the COCSA Board of Directors (available on CD from COCSA), COCSA was told, in no uncertain terms, by CCGPP that they have no rights to approve or disapprove the document. Chair Jay Triano, DC, stated, “It is not a matter of ratification and never has been.”
There is more. After all, if CCGPP does not intend for COCSA or the states to be allowed to approve the best practice document, can we trust in their judgment not to produce a document that will be harmful to the profession? Their response: “In nuts and bolts, that is what it really comes down to. If we think this is going to harm us, do we publish it anyway? And I think the only answer is, in an actually honest world, yes.”
The Path Ahead
As of this writing, seventeen states have completed evaluations of the CCGPP document, many utilizing the AGREE Instrument which is specifically designed to assess documents of this type. Of the seventeen states, sixteen have requested that CCGPP withdraw the document. One state has determined the document should be published only if changes are made. More than a dozen states are still in the process of evaluating the document.
These sixteen states go far beyond challenging the process used to create the document. They have significant clinical concerns about research that has been overlooked or misinterpreted and questions about its practice applications. Each of these clinical questions would, by themselves, need an entire article to explore.
We are at a critical junction. While CCGPP says that states do not have the right to ratify this document, we believe they will change their minds if the majority of states take the position that the document should be withdrawn. For that to happen, many states need more information and time to respond.
COCSA has scheduled a special meeting to discuss the best practice document on Nov. 11. If CCGPP is really interested in providing the information necessary for states to reach a conclusion and to reach true consensus, they should extend their comment period until after COCSA’s special meeting. If they just want to publish a document based on the personal opinion of the ten people involved in its creation, then it should be disavowed.
Russ Leonard can be reached by e-mail at [email protected]
Chiropractic Best Practices: Not Fear, Just Facts
We appreciate the opportunity to provide your readers with factual information about the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) and our Best Practice document, as well as the chance to correct some of the factual errors and points of misinformation, which have recently been disseminated, including that by Mr. Leonard of the Wisconsin Chiropractic Association.
The Congress of Chiropractic State Associations (COCSA) and nearly all of the other recognized chiropractic organizations in the United States created the CCGPP in 1995 to examine evidence to support chiropractors in practice. COCSA created CCGPP, specifically, to respond to a pervasive and crucial problem: disparity and discrimination by third party payors against the chiropractic profession.
Real Tools to Fight Back with
The real purposes of the CCGPP Best Practices document are the following:
1. To give providers, our patients, and other stakeholders a scientifically sound and defensible library of peer reviewed evidence pertaining to chiropractic care, including conditions, diagnosis and treatments commonly used by DC’s.
2. To rank the evidence in a scientific manner to help doctors and patients make informed choices.
3. To develop ways to make this information useable and relevant to the average DC by using multiple platforms for dissemination and implementation of the information, including interactive websites, seminars, online data bases and other approaches.
4. To set up an ongoing process which would grow and develop over time, incorporating not only new literature evidence, but also consensus evidence.
5. To protect and encourage respect for and use of the clinician’s experience and clinical acumen, as well as patient preferences in contrast to a reliance on only scientific literature, particularly for coverage decisions.
It’s Not 1950
Much has changed in the chiropractic world in the past fifty years, and in the world of health care as well. People who pay the bills for health care, including insurers, employers and, yes, patients, are demanding evidence of treatment effectiveness beyond mere anecdote. The newspapers are full of stories about “proven” treatments that have now been shown to be useless. Provider groups of all types have heard the call, and are using evidence from their own perspectives to increase their market share over competitors who are slower to respond. Certainly, the PT’s have made it clear that they expect to dominate manual treatment in the future, and are using scientific literature in addition to politics to further their goals, at our expense.
In addition, care purchasers who must make a “pay or don’t pay” decision on every claim, are demanding evidence of efficacy. Numerous internal (insurance) carrier guidelines which limit chiropractic care and access are used tens of thousands of times every day to make such coverage decisions, and they were not written with chiropractic input.
In addition to providing a library of information for chiropractors, CCGPP was created to provide a more realistic and fair effect on substantiation of care by insurers. CCGPP was structured to provide a comprehensive look at what the scientific literature says, and filter it through a chiropractic perspective. CCGPP also addresses what to do when the scientific literature is lacking, contradictory or equivocal, by employing internationally established protocols to set consensus by chiropractors concerning chiropractic care.
It’s about the Process
If a chiropractic “best practice” document is to have credibility and legitimacy, it must be able not only to withstand scientific scrutiny, but, more importantly, it must follow a very carefully circumscribed process to positively influence decisions by government regulators, legislators, and insurance payors.
In the world of health care, the internationally recognized standard of construction and evaluation of documents such as best practices is the AGREE protocol. AGREE sets out how to collect evidence, rate it, and determine what to do at each phase of the project. Fail to follow the AGREE protocol and a document will be considered flawed. Follow it carefully, and legitimacy and credibility will be the likely result.
CCGPP has been very careful to follow the process laid out by AGREE, which includes transparency, specific feedback approaches, and editorial independence. The process calls for throwing a wide net to look at all relevant literature, but also specifies what kind of literature we look at to derive conclusions. For example, we do not use case studies, though certainly they have value. This is because case studies do not have the same impact that studies with larger sample sizes do (and are universally excluded). This has been a source of frustration for some of our critics, but it is necessary to remain true to the established process.
Another aspect of the process, with which some critics have problems, is the system used to grade evidence. There are several scales used but, generally, they follow an alphabetical scheme. “A”- level studies have the most evidence, followed by B, C and D. However, a lower grade does not connote worthlessness. It simply means there is less compelling evidence. That can be for a variety of reasons, as we shall see.
Modality Services.
Many treatment approaches, such as physical therapy modalities, have inconclusive or conflicting research evidence for several reasons. For one thing, specific modalities are not often studied independently, e.g., electrotherapy vs. placebo. It is more likely that electrotherapy or some other modality be used in conjunction with another treatment, which makes it difficult to tell how effective it is by itself. Researchers also have perhaps not asked the right questions, such as when the therapy is to be employed. Is ultrasound just as useful on the twenty-fifth visit as it is on the first? Research design can significantly affect the results.
What has been quite clear for many years is that the evidence shows that active treatment is more effective than passive treatment. That reality has been reflected, in part, in insurance payment policies and the reimbursement policies of Medicare and other government agencies for more than a decade.
The CCGPP stratification of evidence for modalities is certainly nothing new, despite recent cries that the sky is falling. Some have made dire pronouncements of financial losses looming for DC’s who use modalities. We believe such tactics simply play on doctors’ fears of anything new, and fail to recognize the facts.
First, the market has already corrected for the disparity in evidence for different treatments (it is referred to as the relative value, and is used to calculate fees).
Secondly, there are hundreds, if not thousands, of treatments with similar ratings, used by providers of all stripes, which are reimbursed every day. To assume that all treatments with less than a “B” rating are suddenly no longer going to be reimbursed is not logical or realistic. What the lower ratings really mean is that there may be better treatments to consider first (like manipulation/adjustment, exercise and advice), but modalities still have their place, and will still be reimbursed. Again, our rankings are nothing new, and are no secret to the carriers. They are simply an honest appraisal by a mature profession.
What does the low back chapter say?
Among other things, it gives “A” ratings to the things most of us do most of the time: manipulation/adjustments, advice to our patients, and instruction in exercise. It helps us decide what tests are most effective and when we should order them, and it reviews the other types of treatments we should consider when treating our patients for certain conditions.
Are there going to be areas of controversy? Of course! We’re talking about chiropractic here, and much of what we do and are taught we don’t all agree on. However, we can use evidence and consensus as a starting point for discussion about how to resolve some of these controversies, which can only benefit our profession and, ultimately, our patients.
We also cannot forget that, in this chapter and others to follow, a major reason for the document is to provide current literature to give answers for chiropractors who are wading through the ever-increasing volumes of literature emerging from around the world and who are seeking information on expeditious responses for their patients. This is certainly a major focus of the lower back chapter: making practice easier in this age of information overload by pointing the way to verified answers to the questions of everyday patient contact. The low back chapter and others are aimed at helping the chiropractor.
Guidelines vs. Best Practices
This profession has a justifiable concern about guidelines, given that guidelines developed by non-DC’s have often been used to curb care. Guidelines place an unreasonable emphasis on scientific evidence, particularly randomized controlled trials. As most of us know all too well, those studies often do not reflect real life, and fail to take into account the perspective of the doctor who is actually treating the patient, and the needs and desires of that unique patient. They also frequently do not address the complexities of practice: comorbidities, age, previous history and the many other presentations that make some cases much more difficult to provide care for than others.
Best practices in an evidence-based health care context recognizes this inherent defect, and specifically articulates that appropriate care is to be based on a triad which includes the best scientific evidence, coupled with physician experience and perspective, as well as patient preferences. One important factor to recognize is that, with guidelines, the scientific literature trumps all. With best practices, when the literature is equivocal or conflicting, the doctor and patient perspective becomes paramount.
The CCGPP best practices document also addresses the aforementioned accompanying factors that influence the process of care, in order to provide a more realistic snapshot of the corresponding actions of the provider.
Where from here?
The low back chapter is only the first step in a long series of steps. There are other chapters ahead, including neck, upper and lower extremities, soft tissue, pediatrics, wellness and geriatrics, among others. First, we collect and organize the literature, rate the evidence and, where there is little or conflicting evidence, develop a consensus.
Then the real work begins, as we develop a process to translate research and consensus into practical information which practicing doctors can use to answer the question, “What is the best care I can give my patient?” What are my options here, and what is the evidence for each, in terms of diagnostic testing and treatment? What works best, and when?
We expect to have an interactive website which providers and patients can access to answer their questions, providing greater consistency and predictability of care for our patients. The process is “iterative,” meaning, this is the first draft, and we will refine, update and change it every two years as more evidence appears.
Lastly, we have a rapid response team dedicated to fighting abusive practices by third party payors who attempt to misinterpret the document.
And if we do nothing?
Then we continue to be at the mercy of insurance companies, workers compensation carriers, the government, and others with their own agendas that do not include a mainstream chiropractic perspective. It is incredibly naive to believe that no one will notice that we have not tried to substantiate what we do as a profession, or that others outside the profession do not have access to the same information we have. This document is an information base, designed to provide all stakeholders with reliable, verifiable and scientific evidence, describing a chiropractic perspective, from which rational and supportable treatment decisions can be made.
Some, have advocated that CCGPP do nothing or use an ad hoc process (e.g., “A few smart doctors should be able to quickly put something together.”) that would be disregarded as lacking credibility and are trying hard to convince others to parrot these views without even bothering to read the document or investigate the process that more than 135 people involved in CCGPP have volunteered countless hours toward for the past eleven years.
Others, thankfully, recognize that the profession is at a crossroads, and is already overdue in creating our own database, our own defensible and credible description of what chiropractic practice is for the majority of DC’s. Some will use vague scare tactics, predictions of dire consequences, or try to muddy the waters by attempting to make this about personalities, philosophy or their own agendas. We believe the majority of DC’s will recognize, as we do, that we must have the intellectual and scientific integrity to examine honestly what we do as DC’s, and use that information to better serve our reason for existing: our patients and their welfare.
Visit CCGPP’s website at www.ccgpp.org to learn more about the CCGPP and the new best practice document and how you can support and donate to this project. A CCGPP representative will gladly travel to your state to present information and answer questions.