Deciding whether or not pain specialists should be allowed to perform spine surgery is going to take the Wisdom of Solomon. Not the biblical one, but the Honorable Jay Solomon, an administrative law judge for the State of New Jersey.
As the presiding judge of a state board of medical examiners hearing, Solomon has to recommend whether or not pain specialist, Richard Kaul, M.D., should lose his medical license for performing spinal surgical procedures now performed by board-certified surgeons.
“It is my opinion based on the materials that I have reviewed that Dr. Kaul does not have the training and background to be able to competently perform open spinal fusion surgeries, ” Greg Przybylski, M.D., a neurosurgeon and the state’s key expert witness told the judge during testimony. The former president of the North American Spine Society (NASS) alleges that Kaul “deviated” from standard clinical guidelines in treating 11 former patients.
Przybylski’s blood is as blue as it gets as the spine establishment fights off the incursion of non-surgeon physicians performing minimally invasive, endoscopic spine surgeries in ambulatory surgical centers.
After Przybylski’s testimony, Kaul’s lawyer Charles Shaw got his chance to cross examine the surgeon. We were there to witness the (respectful) confrontation on May 6, 2013.
State of Spine on Trial
Respectfully, Shaw launched an all-out attack on the professional and scientific underpinnings of the current state of spine surgery. Who decides what is competent? What are the standards and guidelines that determine whether or not a physician has “deviated” from standard medical practices?
That’s where Shaw began.
Shaw reminded Przybylski that he had “opined on generally accepted standards of medical practice” and Kaul’s “purported deviations.” They agreed that the state relied on a “compendium of articles…and medical literature which establish guidelines” supplied by Przybylski and serve as the basis for establishing Kaul’s “deviations.”
Przybylski agreed that most of the articles related to guidelines or options and had very few standards.
Non-FDA Approved Use Deviation
One of the alleged deviations involved Kaul’s use of mesh cages, a device specifically excluded by the FDA for approved use in the manner used by Kaul. Przybylski made similar statements about other deviations by Kaul because of “non-FDA approved” use.
“Doctor, do you utilize medical devices and products that are not FDA approved for their specific purpose?” asked Shaw. “Yes, ” answered Przybylski. “Aren’t medical devices in the spine realm commonly used off label?” continued Shaw. “Define commonly, but yes, they are used [off label], ” replied Przybylski.
Shaw asked for an example of an off label use in spine. “Until last year placement of lateral mask screws in the cervical spine posteriorly was considered off label, ” said Przybylski. He admitted that this was commonly done and was an accepted practice.
“And why is that allowed?” asked Shaw.
“Because the FDA does not regulate physician practice. Rather, it regulates industry, and therefore, if a physician feels that it’s clinically appropriate to use a medical device off label, then it’s the purview of the physician and the people that are responsible for supervising physicians, ” answered Przybylski.
Coding Deviations
Shaw asked Przybylski about his report of a number of deviations noting improper coding for multiple procedures.
“Coding is a post-operative procedure, right?” asked Shaw.
Przybylski agreed with Shaw that coding has no direct effect on the “health, safety and welfare of the patient.”
Non-Indicated Fusion Deviations
“Doctor, you indicated that the performance of a fusion on [Kaul’s patient] was potentially not indicated, ” Shaw said to Przybylski.
Shaw then walked Przybylski through a March 2012 article published in Becker Spine Review where the surgeon was interviewed about spinal fusion reimbursements.
Indication Controversy
In the article, Przybylski gave his opinion about appropriate use for fusions and proper patient selection. Shaw quotes Przybylski from the article: “There are some things we agree on. Fusion is appropriate in patients with fractures, dislocation, some infections and patients with cancer of the spine. The controversy surrounds patients with pain of an unknown origin, and we assume it’s coming from degenerative disc disease (DDD).”
Przybylski continued in the article, “Often times surgeons decide that a patient’s pain is from DDD through a process of exclusion.”
No Definitive Guideline
Shaw: “What you said was that often times [physicians] do not actually know where the pain is coming from. True?”
Przybylski: “True”
Shaw: “So these individuals, just like you, not only are they not definitively guided to determine whether a fusion is appropriate or not, but they can’t all the time find the source of that pain, is that true?”
Przybylski: “That’s true.”
Shaw: “So they do it by doing testing that excludes pieces and thoughts of what may be the pain until we get down to what we think possibly it could be, true?”
Przybylski: “Yes.”
Shaw: “And unfortunately, that’s the state of medicine today, isn’t it true?”
Przybylski: “Yes.”
Discography Deviation
Shaw challenged Przybylski for criticizing Kaul for the use of discography and asked if that wasn’t one of the mechanisms used to determine the source of the pain? “That’s true, ” said Przybylski, and then added that he wasn’t criticizing discography in and of itself as a tool, but how it was applied. Shaw pushed back saying that Przybylski had criticized Kaul “no matter if he used it or not in the manner which you saw fit.”
Shaw noted that Przybylski said in the Becker article that “Discography tries to gain insight into the disc and the source of the pain, but that isn’t always the best test…We haven’t quite achieved the technology to figure out which patients will have good outcomes from spinal fusions and which will not.” Przybylski stood by his comments and also said, “when we look at what has been studied, there is a limited amount of information to guide us as to what predicts who will benefit or not benefit from fusions.”
No Standards
Przybylski agreed that if the word standard is used in terms of standard guidelines and options, he would agree that there is no standard by which individuals—with the same level of training and expertise as he has—are guided with regard to the applicability or use of a fusion.
He also acknowledged that respective randomized studies have shown mixed results between those getting surgery and those who don’t.
Shaw then went back to Kaul’s purported deviation and Przybylski’s basis for his opinion of deviation based in part on “Professional Society Guidelines.”
NASS Clinical Guidelines Disclaimer
Przybylski agreed that he relied on the NASS evidence-based Clinical Guideline for Multi-Disciplinary Spine Care to support what he believed to be Kaul’s deviations. He admitted that most of the articles related to guidelines and not standards and that some actually related to options.
Shaw jumped on that. “Inside the [Guideline], isn’t it true that there is a disclaimer: “This clinical guideline should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtain the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resource particular to the locality or institution.”
“That’s accurate, ” said Przybylski. He added that the disclaimer indicates that physicians will need to use their clinical judgment when making a decision of a treatment recommendation for a patient and agreed it clearly demonstrates the deference to the physician’s judgment.
Shaw continued and Przybylski agreed that the Guidelines offer potential solutions reviewed and evaluated by a host of doctors in the field but also indicate the physician could take another course and were not the dispositive answer to the treatment.
“Matter of fact, ” said Shaw, “These Guidelines indicate that you could take another course that was not the dispositive answer to the treatment. True?” “Yes, ” replied Przybylski.
Deviating From Standards and Guidelines Isn’t Deviation
Shaw reminded Przybylski of his previous statement about published guidelines and asked if the quote was still correct.
Przybylski: “We can rely on it much of the time, but not necessarily all of the time. There isn’t very good evidence that you should be doing this, but the level of evidence that we have isn’t so robust that we can make it a standard. We can’t say under all circumstances you should be doing this. We think that is the case, but there is not enough data to be able to say that. The fact that you deviate from the guidelines isn’t in and of itself something that says you deviated from what you should be doing.”
Przybylski stood by the statement.
Shaw pressed on.
Shaw: “Regarding options. You testified that ‘We have weak evidence that says you can choose to do this or not to do this, but they are just options for the physician to consider.’ True?”
Przybylski: “Agree.”
Shaw: “If an individual took one option versus the other, he would not be considered to deviate in any manner from the standard of the industry, true?”
Przybylski: “True.”
Shaw: “And regarding guidelines, taking any approach separate from the one that’s considered the guideline approach…is not considered to be out of space of deviation, true?
Przybylski: “Not on its face.”
Continuing Education
Shaw also pursued the timeliness of guidelines and keeping up with the current state of the industry. Przybylski agreed that to keep up, one needed, in part, to take CME (Continuing Medical Education) classes.
Przybylski acknowledged that he has taught CME classes regarding minimally invasive spine surgery and agreed that non-board certified surgeons attended the classes. He also acknowledged that he knew pain management, anesthesiologists and other non-board certified individuals were there to learn from him in order to conduct or perform the procedures.
Shaw continued, and Przybylski agreed that NASS understood that individuals who take these classes are there to learn to perform the procedures and that the society doesn’t exclude individuals who they think should not be performing those procedures.
Shaw: “But NASS still takes their money and teaches them?”
Przybylski: “That is true.”
Credentialing and Certification
Przybylski also acknowledged that credentialing procedures are not standardized and vary from hospital to hospital and that there is no specific American Board of Medical Specialties certification for spine surgery.
Other topics covered by Shaw in a 78-page transcript included Przybylski’s own training and record of providing expert testimony; fellowship training; time lags between published guidelines and contemporary practices; risk disclosures and consent forms.
Defense Strategy
Shaw told OTW that he had a lot of respect for Dr. Przybylski’s commitment to his science. Because of that he felt pursuing the unsettled science of spine care and lack of universally agreed upon standards, guidelines and treatment options were the best argument to make to Judge Solomon.
It was clear from Shaw’s questioning that he was trying to put the current state of spine on trial, instead of his client. Since the allegations against Dr. Kaul involved professional credentials, training and practice guidelines, Shaw’s strategy will test the Wisdom of Solomon.
We’ll let you know if and how he splits the baby.
This is similar with Yeung versus Dickman, where Dickman testified that thermal annuloplasty had “zero chance of success for the treatment of a painful disc in a patient with a painful disc that also had mild spondylolisthesis. Curtis Dickman lied to the court and Jury by fabricating false exhibits to support his rogue testimony. After Dickman’s two level fusion, the patient became disabled, and Dickman blamed me for the poor result.
The judge in this case made an error by allowing Dickman’s rogue testimony over my objection.
This case clearly is brought about by physicians being able to influence a political party to ask for and receive favors of inquisition to another doctor. Dr. Kaul has clearly delivered a health care model that is called for under the Affordable Health Care Act before it was enacted. Since the implementation of his health care model, the cost effectiveness of his model has been very successful. The “Good Ole Boys Club” is loosing money to this type of care as well as the highly paid hospital administrators.
Let this case and assault on the good character and excellent surgical skills of Dr. Richard A. Kaul show that the medical community cannot use political pressure to protect their cash cow turf!
Dr. Richard A. Kaul should be acquitted and an official apology from the Attorney General should be issued.
We need more doctors like Dr. Richard A. Kaul in this world. May he victorious in this fight!!