ACA policy document re: Stroke

August 13, 2010

Letter

Mr. Timothy Coad
Kaiser Permanente Mid-Atlantic States
Executive Director, Account Management
2101 East Jefferson Street Rockville, MD 20852

Dear Mr. Coad,
I am writing on behalf of the American Chiropractic Association (ACA), the largest national association representing doctors of chiropractic (DC). As we move into the changes being brought about by healthcare reform, we expect that providers, payers and patients will have some adjusting to do as we make the healthcare system more efficient. We know that Kaiser is a thought-leader at the forefront of changes and research in healthcare and also receives input from many sources, including caregivers. We also very much appreciate the excellent works of Dr. Halvorson on healthcare reform that have become a resource for so many. For this reason, we wanted to contact you about a policy of concern to us.

Given Kaiser’s integrated model for large scale research and its many research centers and programs throughout the U.S., we were surprised to recently learn of a benefit change in Kaiser’s Chiropractic Manipulation Medical Coverage Policy and wanted to bring it to your attention. It appears that the policy has been revised to exclude cervical Chiropractic Manipulative Treatment (CMT) from coverage based on the concern of vertebral artery dissection (VAD) and stroke.

We have serious concerns with this policy due to the fact that it excludes nearly all of the significant scientific literature on the subject which is more current than that which is cited. The policy concludes that “there is a paucity of data related to beneficial effects of chiropractic manipulation of the cervical spine.” In our review of the literature and that of the experts with whom we work, quite the opposite is true. Systematic reviews have found cervical manipulation to actually be an effective intervention for neck pain and headache. In a recent study on the bases of evidence for treatments of “nonspecific” neck pain (neck pain without a history of whiplash), the authors found seventeen studies that examined various types of manual therapies. They concluded that there was overall positive evidence for both mobilization and manipulation, particularly when combined with exercise. This led them to include mobilization, manipulation and other manual therapies among the “likely helpful” treatments for nonspecific neck pain.

It is important to note that no other commonly applied treatment for this condition, including: passive modalities, NSAIDS, tricyclic antidepressants, narcotics, and most invasive therapies, have any more evidence of effectiveness than manipulation, mobilization, and other manual therapies.

Most importantly, we are very concerned about the suggestion that cervical CMT causes stroke in chiropractic patients. There exists no scientific data that would suggest that chiropractic care causes any higher incidence of stroke than a typical visit to a primary care physician (PCP). Studies have shown that any observed association between VAD and stroke with CMT is likely attributed to patients with an undiagnosed VAD who seek care for neck pain and headache before the onset of a stroke.

A population-based, case-control study done by Rothwell et al confirmed an increased risk of VAD within a week of a chiropractic visit among persons under age 45 years. However, the Neck Pain Task Force, part of the international Bone and Joint Decade accepted the study by Cassidy et al which extended these findings and found a similar risk of this form of stroke after patients visited a PCP or a doctor of chiropractic.

Cassidy et al studied data over a period of nine years which included eligible persons admitted to Ontario hospitals following a vertebrobasilar artery (VBA) stroke and found that only 818 cases of VBA stroke were reported over 100 million person-years of data -- and many of these patients had not seen a doctor of chiropractic at all. In the data analyzed, positive associations were found between PCP visits and VBA stroke in all age groups. The study suggests that the association between chiropractic care and VBA stroke is likely due to presenting symptoms associated with VAD and that even simple range of motion examinations by a PCP could result in a thromboembolic event in a patient with presenting VAD symptoms. Researchers concluded that there exists a similar association between PCP and chiropractic visits and VBA stroke which suggests that patients with undiagnosed VAD seek care for headache and neck pain prior to the onset of a VBA stroke.

Studies have further shown that the occurrence of VAD and stroke is extremely rare with or without any form of care. Haldeman et al analyzed data from a malpractice review evaluating all claims of stroke following chiropractic care during a 10-year period between 1988 and 1997. Approximately 134.5 million cervical manipulations were performed by doctors of chiropractic during this time. The authors found there were 43 cases of neurological symptoms following cervical manipulation over the 10-year period, 20 of which were minor and were not diagnosed as stroke by a neurologist. Twenty-three cases of stroke or vertebral artery dissection following cervical manipulation were reported. The authors concluded that there exists only a one-in-5.85-million risk that a chiropractic neck manipulation may be associated with subsequent cervical artery dissections and stroke.

Kaiser’s policy on cervical manipulation states that the incidence of VAD and stroke associated with chiropractic manipulation of the cervical spine is estimated at 1.3-5 events per 100,000 manipulations. This contradicts the findings of the Cassidy study, noted above. We are unclear as to how these figures were reached by Kaiser. The policy cites Gouveia et al, which states that “the frequency of adverse events varied between 33% and 60.9%, and the frequency of serious adverse events varied between 5 strokes/100,000 manipulations to 1.46 serious adverse events/10,000,000 manipulations and 2.68 deaths/10,000,000 manipulations.” Because of these data, Gouveia concludes that, “There is no robust data concerning the incidence or prevalence of adverse reactions after chiropractic. Further investigations are urgently needed to assess definite conclusions regarding this issue.” It would seem that a responsible interpretation of this study would conclude that these findings are too varied and inconsistent to formulate sound policy upon which to base care determinations.

We also have concern with the use of the Miley et al review to support Kaiser’s assertion that, “incidence is estimated at 1.3-5 events per 100,000 manipulations.” [emphasis added] A careful reading of this paper shows that it actually stated that “the best available estimate of incidence is approximately 1.3 cases of VAD or occlusion attributable to CMT for every 100,000 persons.” Each chiropractic patient frequently receives a series of visits, and thus it is essential to clearly differentiate between the number of chiropractic patients and the number of chiropractic visits.

Given Kaiser’s concern for clinical effectiveness, we are unclear as to why cervical manipulation would be specifically denied when other treatments are routinely approved that address the same ailments which have shown potentially more harmful side effects. Each year, ailments that can easily be treated by CMT are instead treated by pain medications and surgery which put patients at a quantifiably high risk for serious complications often with little to show in the way of beneficial outcomes.

In a well-known study by Wolfe et al, it was found that approximately 103,000 patients are hospitalized every year in the United States for serious gastrointestinal problems as a direct result of non-steroidal anti-inflammatory drugs (NSAID) use. The average expense to insurers of these hospitalizations is $15,000 to $20,000 per hospitalization, resulting in annual expenses exceeding $2 billion. The study explains that tragically, 16,500 NSAID-related deaths occur every year in the United States, putting NSAID deaths on par with AIDS and making it more prevalent than the number of deaths from multiple myeloma, asthma, cervical cancer, or Hodgkin's disease. If deaths from gastro-intestinal toxic effects of NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would constitute the 15th most common cause of death in the United States.

A study by Lanas et al found that NSAIDs, are behind 36.3 percent of all hospitalizations and deaths associated with GI bleeding. Analyzing data from two observational studies, based on 2001 hospital data from Spain, the researchers calculated that the national death rate from aspirin or other NSAID-related GI events was approximately 15.3 deaths per 100,000 NSAID and aspirin users. The authors conclude that "this highlights the importance of taking ever-greater steps to research new and better alternatives to treat pain and inflammation."

Given this, you can understand our surprise at this recent edit to the Manipulation Policy. Chiropractic care can replace NSAIDs as a means of relieving pain or reducing dysfunction in many patients and can therefore be a clinically-effective alternative - especially for patients who have an intolerance for NSAIDs. Given these data, compared with a one-in-5.85-million risk of stroke as a result of cervical chiropractic manipulation, Kaiser’s policy to allow NSAID prescriptions seems incongruous.

Well over twenty two (22) million patients seek chiropractic care annually. The denial of cervical manipulation to enrollees who benefit from such treatment for the relief of headaches and many conditions of the cervical spine would seem to result in an increased cost to Kaiser. In addition, eliminating a choice previously available disenfranchises patients who prefer manipulation over drugs to treat their pain. Also, the changes within healthcare reform urge payers and providers alike to seek out alternatives that are more permanent than ongoing prescription drugs, when possible. We are also concerned about the many Kaiser subscribers who have access to chiropractic care through contractual riders related to legislative mandate and how/if that will also change with this edit.

The ACA has worked with payers to help formulate policies on chiropractic care and with companies such as Milliman and the Council of Chiropractic Guidelines and Practice Parameters to provide guidance and research regarding guideline development. We have found that most payers hold to a protocol of systematic review based upon current, highly-graded research. As you know, policies are not only necessary to communicate payer coverage, but also to influence appropriate care decisions of providers regarding your company’s enrollees. In keeping with the international guideline development and research review protocol, Appraisal of Guidelines for Research & Evaluation (AGREE), it would seem imperative to assure that high-quality clinical practice guidelines be utilized that fully take into account the benefits, harms and costs of the recommendations. The AGREE protocol, as well as others, note that guidelines must hold sufficient confidence that the potential biases of guideline development have been addressed and that all recommendations are both internally and externally valid.13

Kaiser has long been known for its assurance of high-quality health care services and community-mindedness. We hope that there will, in the future, be advances in medicine that will permit all provider types to have screening procedures that will isolate the rare instances of patients with headache and neck pain which mask VAD symptoms. Until then, given our current state of knowledge, the decision of how to treat patients with neck pain and/or headache should be driven by effectiveness and patient preference.

For these reasons, we ask that Kaiser seriously consider this letter as a request to re-evaluate this particular section of the Chiropractic Manipulation Medical Coverage Policy and rescind the restriction on cervical chiropractic manipulation. We would appreciate a response within the next thirty (30) days as we have many members and chiropractic organizations inquiring as to the status of this issue.

Thank you for your time and consideration of this critically important issue. If you would like to meet with ACA to discuss this in further detail, please do not hesitate to call Bill O’Connell, Executive Vice President, at (703) 812-0216.

Sincerely,

Rick McMichael, D.C.
President American Chiropractic Association

CC: Dr. Bernadette Loftus, Associate Executive Director for the Mid-Atlantic States