What does a Denial of Service Attack have to do with stents, angioplasty and PCI?
In the world of computing, a DOS attack is defined as “an attempt to make a machine or network resource unavailable to its intended users.” Typically netbots programmed by hackers overwhelm the web servers of banks, credit card providers, etc. whose sites then become unavailable to their customers. Now it seems similarly that in New York State, cardiovascular treatments may become unavailable to some Medicaid patients: a denial of service.
In short, the Appropriate Use Criteria (AUC) for PCI, crafted and carefully forged by the professional cardiology societies to raise the standards of their specialty, have suffered the fate that many on the Guidelines Committees had feared: the category of “inappropriate”, instead of meaning that there just hasn’t been enough study to recommend this therapy across the board, was made synonymous with “unnecessary” and therefore not reimbursable. As stated by Gregory J. Dehmer, MD, MSCAI, the Past President of the Society for Cardiovascular Angiography and Interventions (SCAI), “…AUC are not to be used as a method to determine payment. The AUC are intended as a quality improvement tool.”
Well, tell that to City Hall! And actually that’s precisely what the SCAI and the American College of Cardiology (ACC) did.
This all began earlier this year, when the New York State Medicaid Redesign Team recommended recouping payments made for stent procedures judged as “inappropriate” by the multi-society Guidelines. Alerted to this development by NY cardiologist Dr. Ajay Kirtane, SCAI and the ACC sent a strongly-worded letter to Albany (“City Hall”) on March 19, 2014, stating:
…we are extremely concerned about…the effort to recoup Medicaid payments for PCIs from physicians and facilities before any medical review is conducted, and based indirectly on an algorithm that our organizations developed to assess adherence to the Appropriate Use Criteria (AUC) for coronary artery revascularization. Our concern is so profound that we request a meeting with you to discuss this effort at your earliest convenience…as specifically stated in the AUC document, this is a tool for quality improvement and designed to assess trends in PCI delivery. The AUC were never designed for the purpose that the Department of Health is promoting. We share your desire to provide the best possible care for all patients in NY State, but we believe the current policy will ultimately hamper access of Medicaid patients to medically necessary care.
And in fact a group of cardiologists did go to Albany to educate the policymakers and advocate for an easement of these new draconian measures. One of the team, Dr. Srihari Naidu of Winthrop University Hospital, told me that, for example, the “inappropriate” label is supposed to be more of a yellow light in a particular case, to highlight awareness that there should be discussion and contemplation about what is going to be best for this particular patient before going ahead with the intervention. He noted that, while the State policymakers understood that nuances exist, the way they were using the AUC made medicine much more black-and-white than it is.
Fast forward to now: it seems that Dr. Naidu and the team of cardiologists succeeded, somewhat. The harshest outcomes have been modified, made more reasonable: payments will no longer be recouped immediately; a review process has been set up; and the review committee will have interventional cardiologists on it, best suited to judge the appropriateness of the procedure in question.
But the story is not over and the implications of what happened here in New York State could extend to other/all states, even private insurers and other providers, transmuting what started off as a positive effort on the part of physicians to improve the quality of care into a negative hacksaw effort to deny reimbursement and cut costs.
What’s in a Word?
I’ve done several articles and interviews on the subject of AUC and PCI. (You can also check out all my blog posts on Appropriate Use Criteria.) Back in 2011, I interviewed Dr. Ralph Brindis, then-President of the ACC, and Dr. Paul Chan, author of the JAMA article applying the guideline definitions to the NCDR database of coronary interventions.
In these interviews and in subsequent articles, I explored the terms used, “Appropriate,” “Uncertain,” and “Inappropriate.” These are terms first put forth in a major study by the RAND Corporation in the 1980s. While their meanings seem obvious, in the context of medical care, they are layered with subtleties – the documents explaining them run hundreds of pages. In his interview, Dr. Chan summarized what these three categories really mean:
“Appropriate” procedures really suggest a definitive or probable benefit; “uncertain” procedures really suggest a possible benefit; and “inappropriate” procedures suggest that there’s unlikely to be benefit. That doesn’t mean that there’s no circumstance when an inappropriate patient has no benefit; it means that, on a population average, patients who have inappropriate procedures are not going to gain as much in terms of symptom benefit or health status improvement as patients who had a clinical and appropriate procedure.
As predicted by Dr. Chan (who, by the way, is not an interventional cardiologist) the popular press misinterpreted the meanings of the terms and wild accusations of overuse of stents appeared everywhere. Instead of 12% of PCIs in stable patients being judged “inappropriate” (which is, by the way only 4.1% of ALL PCIs), the media conflated that category with “uncertain” and proclaimed that 50% of all stents were unnecessary. Even medical shows, like Dr. Oz, stated bluntly that, “…inserting a stent is the most unnecessary heart procedure that we do.”
I’d always felt that the terms used were hard to understand. I mean they have very specific definitions, but to the lay audience and the media, the three categories were fertile grounds for miscommunication. Then huzzah, in November 2012, the ACC Appropriateness Use Criteria Working Group recommended new terminology: “Appropriate,” “May Be Appropriate”(to replace “Uncertain”), and “Rarely Appropriate” (to replace “Inappropriate”). Problem solved. Or not. It seems Guidelines Committees are pretty slow-moving bodies and two years later, there still hasn’t been an update issued. So the old terms stand, ready to be utilized by payers and insurers, just as New York State has. Furthermore, the guideline updates currently under discussion will also not utilize these new terms, because the discussions started before the Working Group issued its recommendation. Yawn? Yes, the bottom line is that these new, we feel more accurate, terms will not see official use for at least two or more years, or four years from their first proposal.
Inappropriate Use of “Inappropriate”
My impetus for writing this post was a recent opinion piece in the Journal of Invasive Cardiology, authored by Drs. Dmitriy N. Feldman, Srihari S. Naidu, and Peter L. Duffy, and titled, “Inappropriate Use of the Appropriate Use Criteria (AUC) as a Guide for Reimbursement” The article, which anyone interested in this subject needs to read, lays out at length the controversy, the specific issues discussed with the New York State Medicaid officials, and updates the current status of the reimbursement process.
Importantly, the editorial concludes with a call to action for the interventional cardiology community:
Although the New York policy is limited to Medicaid patients, the SCAI is very concerned that implementation of such a policy could lead to similar proposals in other states affecting Medicaid, Medicare patients, and those covered by third-party payers. We urge our members to get involved in SCAI and become engaged in this national discussion to help us formulate a strategy of minimizing overuse, but importantly also eliminating under-use of effective interventions. We need to stand up for our patients and against policies that could and would hinder access for patients, particularly disadvantaged ones, to optimal quality cardiovascular care.