Laxmaiah Manchikanti, MD, is CEO and board chairman of the American Society of Interventional Pain Physicians.
Q: You recently co-wrote an article in the journal Pain Physician about the impact on pain management of a new federal entity, the Patient-Centered Outcomes Research Institute. Can you describe the institute?
Dr. Laxmaiah Manchikanti: The Patient-Centered Outcomes Research Institute was established by the Affordable Care Act of 2010 (the healthcare reform law] to promote comparative effectiveness research. It was created to assist patients, clinicians, payors and policymakers by advancing the quality and relevance of evidence on how certain health conditions can be treated.
Q: What are your chief concerns about this new institute?
LM: Its actions have to be approved by a board that is dominated by non-physicians, such as representatives from insurance companies. Many of them have an ax to grind and cannot look at these matters objectively. I think PCORI will have a difficult time making balanced, scientific determinations on important issues for pain physicians.
The field of pain management is a particularly vulnerable area for this. There has not been a lot of study, even of some pain processes have been around for a long time. PCORI can start new studies, but they would take 10 years to complete.
Meanwhile, whatever PCORI says about any of these studies would have a significant impact on reimbursement. The insurers, for example, are looking for anything possible as a reason to deny coverage of a therapy.
Q: In your article you criticized a similar effort in the United Kingdom, called NICE, the National Institute for Health and Clinical Effectiveness. Can you describe NICE?
LM: NICE, which has been around for many years, is much better than PCORI, in that it compares therapies and has baseline data which should or should not be included for quality of life improvement. However, in the field of pain management, NICE has developed guidelines for early management of persistent non-specific low back pain that have been inappropriately applied for chronic persistent low back pain.
In the NICE evaluation, there were major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design, a lack of involvement of clinicians and misinterpretation of the evidence. These erroneous interpretations continue to be disseminated.
Q: You also criticized a similar effort in Washington State. Can you describe that?
LM: Another precursor of PCORI is the Health Technology Assessment Program in Washington State, which makes coverage decisions for state employees and their families. I was a peer reader for the program but they didn't take any of my comments.
In April, HTAP issued some important decisions on pain management that will directly affect reimbursements. It decided to continue paying for some spinal injections and made a preliminary decision to continue coverage for lumbar epidurals, cervical-thoracic epidurals and sacroiliac joint injections.
HTAP endorsed radiofrequency neurotomy, which uses heat generated by radio waves to damage specific nerves and temporarily interfere with their ability to transmit pain signals. However, an Australian study from several years ago says it doesn't work. Meanwhile, HTAP decided to stop payment for nerve block injections, intradiscal injections and facet injections.
Q: Getting back to PCORI, what stage is it at right now?
LM: The GAO announced the appointment of 19 members to the board of governors of PCORI in Sept. 2010. And in January, the GAO announced members of its methodology committee, which is supposed to develop methodological standards for evaluating various clinical therapies. But PCORI will hire a company to do the actual comparative effectiveness research. The federal stimulus bill set aside $1.1 billion for comparativeness effectiveness research. PCORI just held their first meeting in New York but I did not attend.
Q: What do you think should happen to PCORI?
LM: It should be eliminated. I'm all for evidence-based medicine when it is done properly, but PCORI has the potential for doing a lot of actual damage. Rep. Joe Pitts [R-Pa.], chair of the House health subcommittee of the House Energy and Commerce Committee, is interested in eliminating PCORI. The bill might pass the House but it probably wouldn't pass the Senate at this time.
Read Dr. Manchikanti's article in Pain Physician (pdf).
Related Articles on Outcomes Research:
Washington State Program to Continue Payment for Some Spinal Injections
Joe Flower: How Healthcare Will Change in 10 Years and Its Impact on ASCs
Study: Greater Primary Care Workforce Associated With More Favorable Patient Outcomes