Kentucky last month signed into law a bill requiring physicians to consult the state's online drug database, Kentucky All Schedule Prescription Electronic Reporting, prior to prescribing pain medication to a patient. The bill, HB 1, targets the overprescribing of opioids and introduces stricter definitions and standards for pain management clinics.
Laxmaiah Manchikanti, MD, chairman of the board and CEO of the American Society Of Interventional Pain Physicians and the Society of Interventional Pain Management Surgery Centers, discusses the impact of the bill for both physicians and patients, and how Kentucky now aligns with other states on policies to curb prescription drug abuse.
Q: Why is HB 1 important for both patients and physicians?
Laxmaiah Manchikanti, MD: HB 1 essentially could be a win-win situation for both physicians and patients, along with law enforcement, by curtailing opioid abuse while still maintaining access to appropriate opioid therapy for patients who need it. Even though it may not be appreciated by many physicians at the present time, it does include many features which do help physicians. One of the major issues of concern for physicians was moving KASPER to the attorney general's office. That did not happen; it continues to stay with the Cabinet for Human Resources.
HB 1 provides a definition of a pain clinic, even though it does not go far enough. Based on this law, all pain clinics must be run by pain physicians who are board certified by an ABMS Medical Specialties Board, American Osteopathic Board, American Board of Pain Medicine or American Board of Interventional Pain Physicians, or must have completed an accredited fellowship in pain medicine. Further, any clinic which provides prescriptions for more than 50 percent of opioids or more than 50 percent of patients are treated with opioids will be considered a pain clinic.
This protects patients as they will only be able to go to legitimate pain clinics, thus avoiding potential abuse. It also saves the patient from spending exorbitant amounts of money that non-legitimate pain clinics charge.
It is good for physicians because they are now essentially forced to perform appropriate evaluations and documentation through the now-mandatory KASPER program. They must also meet the indications and medical necessity criteria prior to embarking on chronic opioid therapy and document procedures.
Physicians have another advantage in addition to mandatory KASPER: the physician will be informed immediately of any investigation by authorities. Further, KASPER lifts its restrictions of disclosure after July 12, which will become part of the medical chart, falling under the same confidentiality regulations under HIPAA.
Q: How will this law affect patients and physicians in the short-term?
LM: In the short-term, of course there will be multiple misunderstandings and fear among physicians. We are already seeing this. However, once physicians understand the essence of the law, its impact will be minor if they are willing to follow the rules and regulations with proper assessment of the patients, documentation of medical necessity and indications, adherence monitoring with mandatory KASPER, and other evaluations.
Q: What do you hope it will accomplish long-term?
LM: In the long-term, if all the components are followed, it will reduce opioid abuse in the state by at least 50 percent. However, we need to understand that in the majority of opioid fatalities patients supposedly receive appropriate doses. Forty percent of the fatalities are from 10 percent of the patients who receive high-dose opioids which have been defined as greater than 100 mg of morphine per day, whereas 20 percent of fatalities are from low-dose opioids defined as less than 100 mg of morphine a day. Finally, 40 percent of the fatalities are due to drug abuse. We should be able to substantially reduce the fatality rate and abuse rate and also those receiving high doses of opioids.
It was recently illustrated that since opioid guidelines were implemented in Washington state in 2007, opioid prescriptions have reduced along with a 50 percent reduction in fatalities related to opioids. Research showed that prescriptions of long-acting opioids decreased by 27 percent and the proportion of workers on doses greater than 120 mg or greater dosages of morphine equivalents was reduced by 35 percent, with a 50 percent decrease from 2009 to 2010 in the number of deaths. Above all, the main impetus of HB 1 in the long-term is that it will curtail abuse without affecting the access.
Q: What sort of training and changes will physicians need to undergo in their practices now that the bill has been signed into law?
LM: All physicians need to be empowered through education rather than enforcement. It is well known that physicians receive very little education in controlled substance management, and also long-term chronic pain management. Thus, additional education is essential not only for pain physicians, but for all physicians. There are numerous ways of improving education to meet the appropriate medical necessity, indications criteria, evaluation of chronic pain patients, adherence monitoring, etc. One way is through the educational courses provided by American Society of Interventional Pain Physicians such as controlled substance management, comprehensive review courses and competency certification examinations. Another source is the American Society of Addiction Medicine and the American Academy of Pain Medicine.
Physicians must learn how to properly document and also properly assess the patients. This will also weed out many abusers.
This bill also provides for the governor, at his or her discretion, to appoint specialty representation necessary on the Kentucky Board of Medical Licensure, which continues to be the most important organization in monitoring physician compliance. It will facilitate the governor to appoint pain physicians to the board, which also in turn would facilitate development of appropriate guidelines to for chronic opioid or controlled substance management.
Q: Were there any parts of the bill that were not ultimately signed into law? If so, which parts? And do you plan to pursue future legislative action to get them approved?
LM: One of the main important aspects which did not pass the law was a pill dispenser – PillGuard. This would have been a great addition to adherence monitoring, which would have further reduced abuse.
Q: The Kentucky Medical Association has argued that running multiple KASPER reports throughout the day may be very challenging for busy physicians because the reports can take up to 10 minutes per patient. What is your response to this?
LM: To some extent, we agree with the Kentucky Medical Association; however, this can be accomplished by medical assistants and other staff. It is not necessary for a physician to do this personally. However, once the physicians are organized and understand the system it will only take about five minutes or less of ancillary personnel time to provide this information to the physician. This will provide clarity to the physician and provide appropriate care to the patient. This is essence reduces physician time rather than increase it. In my office, we have been implementing this technique for about eight years now and have not found it to be very difficult. In the past we ran KASPERs initially and then every six months; however, now we will be running them every 3 months. I believe that this is a great option and I strongly support mandatory KASPER.
Q: Now that the bill has passed, how does Kentucky stack up to other states in terms of prescription drug monitoring?
LM: Kentucky has been at the forefront with the availability of KASPER; however, the majority of physicians have not used it. Because of KASPER, we actually were able to enact National All Schedules Prescription Electronic Reporting Act (NASPER) at the national level which provides funding for each state with the requirement that they meet certain criteria and provide a physician friendly process, along with communication with contiguous states. The same principles are adapted or being attempted by Harold Rogers program which essentially blocked NASPER. After it was signed into law in 2005, NASPER was funded for only 3 years. Even then it had an enormous affect with almost all the states now having implemented such a program (only Missouri and New Hampshire have pending legislation) and 41 states already have active programs. Even still, KASPER continues to be number one in prescription drug monitoring.
Laxmaiah Manchikanti, MD, chairman of the board and CEO of the American Society Of Interventional Pain Physicians and the Society of Interventional Pain Management Surgery Centers, discusses the impact of the bill for both physicians and patients, and how Kentucky now aligns with other states on policies to curb prescription drug abuse.
Q: Why is HB 1 important for both patients and physicians?
Laxmaiah Manchikanti, MD: HB 1 essentially could be a win-win situation for both physicians and patients, along with law enforcement, by curtailing opioid abuse while still maintaining access to appropriate opioid therapy for patients who need it. Even though it may not be appreciated by many physicians at the present time, it does include many features which do help physicians. One of the major issues of concern for physicians was moving KASPER to the attorney general's office. That did not happen; it continues to stay with the Cabinet for Human Resources.
HB 1 provides a definition of a pain clinic, even though it does not go far enough. Based on this law, all pain clinics must be run by pain physicians who are board certified by an ABMS Medical Specialties Board, American Osteopathic Board, American Board of Pain Medicine or American Board of Interventional Pain Physicians, or must have completed an accredited fellowship in pain medicine. Further, any clinic which provides prescriptions for more than 50 percent of opioids or more than 50 percent of patients are treated with opioids will be considered a pain clinic.
This protects patients as they will only be able to go to legitimate pain clinics, thus avoiding potential abuse. It also saves the patient from spending exorbitant amounts of money that non-legitimate pain clinics charge.
It is good for physicians because they are now essentially forced to perform appropriate evaluations and documentation through the now-mandatory KASPER program. They must also meet the indications and medical necessity criteria prior to embarking on chronic opioid therapy and document procedures.
Physicians have another advantage in addition to mandatory KASPER: the physician will be informed immediately of any investigation by authorities. Further, KASPER lifts its restrictions of disclosure after July 12, which will become part of the medical chart, falling under the same confidentiality regulations under HIPAA.
Q: How will this law affect patients and physicians in the short-term?
LM: In the short-term, of course there will be multiple misunderstandings and fear among physicians. We are already seeing this. However, once physicians understand the essence of the law, its impact will be minor if they are willing to follow the rules and regulations with proper assessment of the patients, documentation of medical necessity and indications, adherence monitoring with mandatory KASPER, and other evaluations.
Q: What do you hope it will accomplish long-term?
LM: In the long-term, if all the components are followed, it will reduce opioid abuse in the state by at least 50 percent. However, we need to understand that in the majority of opioid fatalities patients supposedly receive appropriate doses. Forty percent of the fatalities are from 10 percent of the patients who receive high-dose opioids which have been defined as greater than 100 mg of morphine per day, whereas 20 percent of fatalities are from low-dose opioids defined as less than 100 mg of morphine a day. Finally, 40 percent of the fatalities are due to drug abuse. We should be able to substantially reduce the fatality rate and abuse rate and also those receiving high doses of opioids.
It was recently illustrated that since opioid guidelines were implemented in Washington state in 2007, opioid prescriptions have reduced along with a 50 percent reduction in fatalities related to opioids. Research showed that prescriptions of long-acting opioids decreased by 27 percent and the proportion of workers on doses greater than 120 mg or greater dosages of morphine equivalents was reduced by 35 percent, with a 50 percent decrease from 2009 to 2010 in the number of deaths. Above all, the main impetus of HB 1 in the long-term is that it will curtail abuse without affecting the access.
Q: What sort of training and changes will physicians need to undergo in their practices now that the bill has been signed into law?
LM: All physicians need to be empowered through education rather than enforcement. It is well known that physicians receive very little education in controlled substance management, and also long-term chronic pain management. Thus, additional education is essential not only for pain physicians, but for all physicians. There are numerous ways of improving education to meet the appropriate medical necessity, indications criteria, evaluation of chronic pain patients, adherence monitoring, etc. One way is through the educational courses provided by American Society of Interventional Pain Physicians such as controlled substance management, comprehensive review courses and competency certification examinations. Another source is the American Society of Addiction Medicine and the American Academy of Pain Medicine.
Physicians must learn how to properly document and also properly assess the patients. This will also weed out many abusers.
This bill also provides for the governor, at his or her discretion, to appoint specialty representation necessary on the Kentucky Board of Medical Licensure, which continues to be the most important organization in monitoring physician compliance. It will facilitate the governor to appoint pain physicians to the board, which also in turn would facilitate development of appropriate guidelines to for chronic opioid or controlled substance management.
Q: Were there any parts of the bill that were not ultimately signed into law? If so, which parts? And do you plan to pursue future legislative action to get them approved?
LM: One of the main important aspects which did not pass the law was a pill dispenser – PillGuard. This would have been a great addition to adherence monitoring, which would have further reduced abuse.
Q: The Kentucky Medical Association has argued that running multiple KASPER reports throughout the day may be very challenging for busy physicians because the reports can take up to 10 minutes per patient. What is your response to this?
LM: To some extent, we agree with the Kentucky Medical Association; however, this can be accomplished by medical assistants and other staff. It is not necessary for a physician to do this personally. However, once the physicians are organized and understand the system it will only take about five minutes or less of ancillary personnel time to provide this information to the physician. This will provide clarity to the physician and provide appropriate care to the patient. This is essence reduces physician time rather than increase it. In my office, we have been implementing this technique for about eight years now and have not found it to be very difficult. In the past we ran KASPERs initially and then every six months; however, now we will be running them every 3 months. I believe that this is a great option and I strongly support mandatory KASPER.
Q: Now that the bill has passed, how does Kentucky stack up to other states in terms of prescription drug monitoring?
LM: Kentucky has been at the forefront with the availability of KASPER; however, the majority of physicians have not used it. Because of KASPER, we actually were able to enact National All Schedules Prescription Electronic Reporting Act (NASPER) at the national level which provides funding for each state with the requirement that they meet certain criteria and provide a physician friendly process, along with communication with contiguous states. The same principles are adapted or being attempted by Harold Rogers program which essentially blocked NASPER. After it was signed into law in 2005, NASPER was funded for only 3 years. Even then it had an enormous affect with almost all the states now having implemented such a program (only Missouri and New Hampshire have pending legislation) and 41 states already have active programs. Even still, KASPER continues to be number one in prescription drug monitoring.