Call to Order and Roll Call
The 1st meeting of the 2012 SS HB 1 Implementation and Oversight Committee was held on Monday, July 23, 2012, at 1:00 PM, in Room 154 of the Capitol Annex. Representative John Tilley, Chair, called the meeting to order, and the secretary called the roll.
Present were:
Members: Senator Robert Stivers II, Co-Chair; Representative John Tilley, Co-Chair; Senator Jimmy Higdon; Representatives Linda Belcher and Sara Beth Gregory.
Guests: M. E. Kobes, Bluegrass Prevention Center; Paula Schenk, Nathan Goldman, General Counsel, and Morgan Ransdell, Kentucky Board of Nursing; Dr. Steven Stack, MD, St. Joseph East Emergency Room Medical Director; Lloyd Vest, General Counsel, Kentucky Board of Medical Licensure; Jan Gould, Kentucky Retail Federation; Sheila Schuster, Kentucky Mental Health Coalition; Stephanie Brammer-Barnes, Office of Inspector General, Cabinet for Health and Family Services; Connie Calvert, Executive Director, Kentucky Board of Optometric Examiners; James Grawe, Assistant Attorney General representing Kentucky Board of Podiatry; Sara S. Nicholson, Nancy Galvagni, and Brian Brezosky, Kentucky Hospital Association; Mike Burleson, Executive Director, Kentucky Board of Pharmacy; Representative Dennis Horlander, and others.
LRC Staff: Jon Grate, Ben Payne, and Marlene Rutherford.
Chair Tilley recognized Representative Dennis Horlander in attendance. He also indicated that due to time constraints and the length of the agenda that the committee may not be able to hear comments from the audience at this first meeting. The committee is simply an implementation and oversight committee for House Bill 1 passed in the 2012 Special Session; that the Executive Branch and licensure boards have now filed emergency regulations for the implementation of the legislation which will be discussed today. The committee will continue to hear feedback and concerns on those regulations as to how the regulatory process is working or not working. The administration and licensure boards have been meeting around the clock with a number of groups or stakeholders over the past several weeks and that the committee is completely aware of all concerns but that this initial meeting will not be forum to hear those concerns at this time.
Senator Stivers emphasized comments made by Chair Tilley that the committee is very aware of the concerns of the issue being discussed and that the committee encourages everyone to continue to be engaged in discussions and provide comments and encouraged the thoughts and opinions of the respective groups that are affected.
Chair Tilley also noted that the Oversight Committee was not ratified to meet formally in June by the Legislative Research Commission at its June meeting however Senator Stivers and he did meet with several staff members and privately with representatives of the KASPER system relating to implementation but wanted the Cabinet for Health and Family Services to have an opportunity to publicly explain KASPER and to answer questions and clear up any misconceptions about KASPER.
Kentucky’s KASPER System – Its Structure, Functions, Operation, and Enhancements
Mary Begley, Inspector General, David Hopkins, Program Manager for the Kentucky All Schedule Prescription Electronic Reporting (KASPER) system, and Stephanie Brammer-Barnes, Policy Analyst, Office of Inspector General, Cabinet for Health and Family Services (CHFS) discussed the KASPER system.
Ms. Begley shared statistics as to how KASPER, Kentucky’s Prescription Monitoring Program (PMP), has progressed over the last couple of months. During calendar year 2011, the Cabinet for Health and Family Services processed 879 master accounts for KASPER. As of April 24, 2012, the cabinet had 7,911 master accounts and that for every master account there is an average of two delegate accounts. Between April 24, 2012, and July 20, 2012, the cabinet registered 9,137 master accounts for a total of 17,048 master accounts. The 17,048 master accounts do not include the delegate accounts for each master account and that the cabinet has had a very productive 61 work days since April 24.
Ms. Begley provided a brief overview of KASPER which tracks Schedule II through V controlled-substance prescriptions throughout the state. The program was enhanced a few years ago so that it is a real-time, web-access database and that eKASPER is accessible 24/7 to help in controlling the misuse, abuse, and diversion of controlled substances. KASPER was initially designed to provide information to prescribers and for investigations by law enforcement. KASPER was not designed to prevent individuals from obtaining the necessary drugs or to prevent practitioners and prescribers from prescribing drugs that are best for patient care.
The number of reports requested of KASPER has grown significantly from 122,000 in 2004 to 811,000 in 2011 and that KASPER is on target to triple or quadruple reporting in the next year. As of May 24, 2012, KASPER was running about 4,000 requests for reports and on July 18, 2012, 11,000 reports were generated or nearly three times the number of reports for the previous three months.
Mr. Hopkins provided information for the year 2011 on the top ten prescribed controlled substances tracked in KASPER that are reported by the dispensers. The number one prescribed controlled substance in Kentucky, which is similar to other states, is Hydrocodone (Lortab, Lorcet, Vicodin) or about 43 percent of the total top ten controlled substances which converts in dosage numbers to over 219 million doses. He said that of interest was until the end of 2011, the second highest dispensed drug in Kentucky was Alprasolam (Xanax) at about 13 percent of the total top ten controlled substances or about 68 million doses dispensed but that in 2011 Oxycodone (OxyContin, Percodan, or Percocet) passed Alprasolam at 15.5 percent of the total top ten prescribed controlled substances or 79 million doses dispensed.
Ms. Begley noted one of the enhancements that have been made to eKASPER in the past couple of months and that continues to be worked on is the online, paperless account registration process. Prior to June 20, 2012, all registrations were completed in a paper format; that in order to accomplish this paperless registration process, the cabinet worked with the Boards of Medical Licensure, Nursing, Optometry, Podiatry, and Pharmacy. All the information was uploaded into the KASPER system allowing prescribers and pharmacists to validate their own identity online. There were some problems because of inaccurate or different e-mail addresses prescribers had provided to the boards which were different than what had been provided KASPER; there were issues inputting correct numbers and addresses but that these issues were able to be resolved and proper registration made in a timely manner; that the cabinet will be putting into place data quality analysis and improvement and a behavior surveillance system; and that a priority for the cabinet at this time is to work with hospitals and hospital systems who have shown an interest in wanting to have institutional accounts. Since April, the cabinet has been creating, testing, uploading, and managing the KASPER system all at the same time and has not had the opportunity to test some of the systems but rather the testing has been real time. Releasing some upgrades to the system this past weekend caused the KASPER system to go down on Sunday and on Friday when there was over 1,000 individuals simultaneously trying to register, in addition to over 50 cabinet employees in the system at the time, causing it to go down for a period of about four hours.
Ms. Begley said that manual queues have been a big topic of discussion. On April 24, about ten percent of the requests for reports that went into a manual queue which means that the system could not match the information for the individual the report was being requested. This was due to the fact that some reports requested are greater than three pages in length, a page is about 60 lines each or 60 entries, and for safety if a requested report is greater than 180 lines or three pages it goes into the manual queue so that office personnel can review the request. Occasionally a prescriber may enter wrong information when data is being requested, or a pharmacy may inadvertently enter wrong social security information, or the name of the patient is entered differently in a current request than was entered previously. Since April 24, the manual queue requests have decreased to seven percent, however the volume has increased because of report requests.
Ms. Begley said that other eKASPER activities that have occurred over the last year is training and to the creation of an Advisory Council at the Governor’s request. The Council has conducted a proactive review of information such as identifying the highest prescribers, and it determined that there was further need for investigation that information forwarded to the appropriate boards for their review. Another interesting function is the ability to have interstate data sharing because KASPER is recognized as one of the nation’s leading programs. Cabinet employees are routinely asked to participate in conferences around the country, and Kentucky has made the decision to not only share information via one mechanism such as the Rx Check Hub, but information is being shared with the Prescription Monitoring Program of the National Association of Boards of Pharmacy PMP Interconnect (PMPI), which allows Kentucky to share with states that have any kind of electronic prescription monitoring program.
Mr. Hopkins briefly explained the PMPI program and noted that the border states of Indiana, Ohio, and Virginia are currently sharing data. Illinois, Kentucky, and West Virginia have committed to use the PMPI program, and Kentucky should be sharing information with those states in the near future. The cabinet’s target date for this sharing of data is September 30 to have the interface complete between KASPER and the PMPI. As soon as that interface is complete, Kentucky will be working with those states to go live with the system. West Virginia is close to the same timeline as Kentucky. He hopes hope that Kentucky will be sharing data with all these border states by the end of 2012. Kentucky is currently sharing data with Alabama’s Rx Check Hub system, a federally sponsored program. Kentucky is the only state that has indicated that it will be able to share with states using either system. Ultimately, the PMPI will hook with the RX Check Hub and Kentucky’s interface will be through the PMPI system and will be able to share with any state no matter what service provider other states choose to use. At this time, there is no cost for either the PMPI or RX Check Hub systems to Kentucky.
In response to a question from Representative Belcher concerning institutional accounts, Ms. Begley explained that every prescriber or delegate assigned to that account who wants to query or receive a report from KASPER signs on to the system, and that in working with the hospitals and hospital facilities, the cabinet would like to provide a special connection to the hospital or their facilities to sign on to KASPER under that hospital or facility’s name and the facility be able to track users should there be issues.
Senator Higdon indicated that he had received calls and comments on the events that occurred on Friday and over the weekend and asked if there were any further foreseen problems that could occur with the KASPER system going forward. Ms. Begley indicated that the cabinet is very confident that KASPER can manage all the queries and records. She could not say with certainty that problems would not occur in the future because of technology, electricity, and requests made, having to work with the state’s Office of Technology, and the cabinet’s technology personnel. The major obstacle is getting individuals registered. There were numerous e-mails and phone calls on Friday, the first day of registration, and it is believed that the code written for the registration process was stressed beyond its ability for that number of registrations, which caused the events that occurred.
In response to another question by Senator Higdon relating to the percentage of those who should be registered with KASPER, Ms. Begley stated she did not have an exact number but that the cabinet was very near the point that all have been registered. She said there is some further work to be done with the boards relating to in-state and out-of-state prescribers and that other than last minute registration that the boards and practitioners have been very compliant.
In response to a question posed by Representative Gregory with regard to reports placed in the manual queue, Ms. Begley said that because reports are placed in the manual queue and a required review by a staff person that it does delay access of the report to the practitioner depending on the time of day and day of the week that the request is made. The cabinet had increased staff on the weekends to manage the load. The cabinet tracks the number of requests, and the number of requests for KASPER has dropped significantly on the weekend, but the cabinet will continue to monitor those requests. During the evening hours the numbers drop significantly, and during the day the requests stay real time. It takes a couple of hours each morning to catch up on those manual requests. The cabinet has added another individual to help with the manual queue. There are other ideas to implement that may decrease the number of reports being placed in the manual queue. Ms. Begley explained that if a query is made and it is placed in the manual queue after normal operating hours, the report will not be available until early the next morning. A physician should treat a patient based on his or her medical judgment and professional knowledge when a KASPER report has been placed in a manual queue, with a notation being made in the medical record that the KASPER report was delayed or unavailable.
Chair Tilley indicated there is a possible misconception or there has been a lot of discussion over the length of time a normal KASPER request should take if all the proper information has been input. Ms. Begley said that as a general rule those requests are returned almost immediately, fifteen seconds at the longest. The program is still getting a backlog of individuals who did not get registered by the end of the week. The system is running a little sluggish and the reports are taking 30 to 40 minutes. She said the input of information is simply a matter of inputting the correct name, address, social security number, and date of birth.
In response to a question by Chair Tilley as to the most common mistake that would place a request in the manual queue, Ms. Begley said the sensitivity of entering a social security number into the system, the multiple ways of entering an individual’s name, and address changes or zip codes that do not match the previous requests are some mistakes. In haste, a prescriber may input incorrect information, which would send a request to a manual queue. It was determined that the three reasons for manual queue were the input of social security numbers, date of birth, addresses from the pharmacy; physician’s putting in incorrect information; and clustering, which is when the system looks, for example, at the various ways a name has been input that does not match. The cabinet is working to refine that issue with in-house programmers and to outsource some of that programming to help resolve issue.
In response to a question by Representative Belcher, Mr. Hopkins noted that there is no feedback that is made currently but that additional information is going to be available for the providers that will attempt to explain what causes a report to be placed in the manual queue to help them identify how a mistake can be avoidable. He also said that new software is being implemented that will assist in matching the correct records for a particular patient, and hopefully the manual queue percentage will decrease.
Chair Tilley noted that House Bill 1 calls for a needed influx of cash to address the problem not with fees from providers but with mortgage settlement funds from the Attorney General’s Office, and asked if the upgrade of these funds will assist in the greater demand for KASPER. Ms. Begley said that the cabinet had been getting by with minimal funds to run KASPER, an unfunded program, so the new cash available will allow the cabinet to take KASPER to a new level.
Pain Management Facility Regulations
Discussing the Pain Management Facility Regulations were Lloyd Vest, General Counsel, Kentucky Board of Medical Licensure, and Mary Begley, Inspector General. Dr. Preston Nunnelley, Chair of the Kentucky Board of Medical Licensure, was unable to attend the meeting.
Mr. Vest stated that the Cabinet for Health and Family services has similar responsibilities under House Bill 1 for differently owned pain management facilities. The Board of Medical Licensure regulates physician-owned pain management facilities, and the cabinet regulates the non-physician owned facilities. The board and cabinet worked closely in coordinating and developing the regulations. Consistent with the statute, the board tried to address two primary categories of individuals in the regulations: 1) the licensed owner or investor of the pain management facility, being a physician having an active license in effect and in good standing and who is not subject to any order or letter of agreement or any other adverse action by the Board of Medical Licensure, with protocols being established to require divestment of ownership within established timelines should such an order or letter be entered against the physician; and 2) the clinic supervisory staff required to be available 50 percent of the time the pain management facility is open, which could be the owner or a designee.
After passage of the House Bill 1, it was learned that a number of physician-owned facilities did not have an owner or someone employed who met the requirement of being at the facility 50 percent of the time it was open, and that there was concern that a number of those facilities would have to close until the facility was in compliance with the statute. Working with the Governor’s Office, the board included in the regulation an accommodation for individuals. To meet this requirement, the board provided that the individual could continue to practice as a pain management facility after the effective date of the legislation if the facility was in existence at the time, and the owner or designee certifies to the board that he or she was eligible to take one of the two certifying examinations available until April 2013; and, when certified, he or she will be in compliance with the provisions of the statute. If not, then the individuals would not be qualified to provide that supervision.
The regulation also requires that the facility identify each of its prescribers and notify the board of any changes of prescribing employees within ten working days; that prescribers who work in pain management facilities are board certified and are disqualified from practicing in a pain management facility if their Drug Enforcement Administration permit has been revoked, have had a board action in any state against their prescribing privileges, if they have had an application to prescribe license denied, or have entered some type criminal plea or a conviction of a crime related to a controlled substances in any state. The regulation also requires a $1,000 per year fee to help implement the requirement by the board. There are many documentation requirements in the regulation to help the board implement and oversee the pain management facilities much of which is included in the annual registration as well as some required documentation maintained on site by the pain management facility.
Ms. Begley reiterated that the difference between the cabinet’s regulatory authority and that of the Board of Medical Licensure is that the cabinet regulates nonphysician-owned facilities. The cabinet’s inspections of these type facilities will be unannounced both annually and with random investigations or complaints. When a complaint is received, the cabinet must determine if the facility is physician-owned or one that qualifies under the cabinet’s purview. The cabinet also has to determine if more than 50 percent of the patients of the pain management facility are receiving treatment that includes the use of controlled substances. Facilities that the cabinet oversees must have at least one registered nurse on duty. If there are any issues with prescribing, a medical review by the appropriate board and nurse surveyors will be made at the facility with pharmacy support. One area that would be reviewed is whether the facility accepts insurance. The cabinet’s perspective is to monitor the pain management facilities. If any physician or practitioner is practicing in a way he or she should not, those observations will be forwarded to the appropriate licensing board.
Ms. Begley also provided some statistics of interest. On June 22, 2012, the Office of Inspector General sent out 37 certified letters to facilities identified by the Kentucky State Police. Since that date, seven additional facilities have contacted the Inspector General offices or been identified by the Kentucky State Police for a total of 44 facilities thought to be under the title of a pain management facility. Nine of those facilities have indicated they are physician or hospital-owned. Eight facilities have closed, and four of the facilities have closed since the effective date of House Bill 1 or since they received a letter from the Inspector General’s Office. The Office of Inspector General’s Office has received 17 applications for license as of last week and one additional application since conferring with the licensing board. Based on the list of facilities the office began with, nine of the facilities have not applied for a license and will be investigated as illegal over the next couple of weeks.
In response to a question by Chair Tilley, Ms. Begley indicated it was difficult to say whether the 44 facilities encompass all of the nonphysician-owned facilities because some on the cabinet’s list were physician-owned. Ms. Begley encouraged anyone who is aware of one of these clinics or has questions about the practice of the facility to notify the boards, Inspector General’s Office, Attorney General’s Office, or the Kentucky State Police because these agencies are unified in their efforts to combat this problem.
Practitioner and Dispenser Required Regulations Under House Bill 1
Lloyd Vest, General Counsel of the Kentucky Board of Medical Licensure stated that the Board of Medical Licensure has historically established professional standards for prescribing and dispensing through expert testimony of board consultants on a case-by-case basis. In developing the regulations the board relied upon the wealth of knowledge of these experts as well as looking to the national standards published by the federation of state medical boards which the Board of Medical Licensure is a member. The board’s standards address three key points on the timeline of prescribing controlled substances: 1) the initial prescribing or the first prescription written for a patient, 2) the decision to continue to prescribe controlled substances longer than three months for that same medical condition, and 3) what the physician does during that prescribing period. The key principals the board used in developing these standards were: (a) that the board consultants believe each decision to prescribe controlled substances should be an informed and deliberate decision rather than a matter of course; (b) there should be a risk benefit analysis for each prescribing decision and a physician should only prescribe at the level and for the time period required; and (c) there should be adequate monitoring of the controlled substance used and the prescriber should take affirmative steps to address addiction or illegal use.
He said the standards for initial prescribing are focused, obtaining a history and physical of relevant information to diagnose the acute problem, looking at information contained in the KASPER system and other information available to the physician; conducting a risk benefit analysis and making a deliberate decision whether to prescribed controlled substances to the patient. The prescriber or dispenser should also focus on explaining to the patient that the prescription is for short-term use and relief. These individuals should also educate the patient on safe storage and disposal of the medications. The key area for the board is the decision to prescribing controlled substances beyond three months.
The standards call for a more detailed history to cover a wide variety of areas including the potential of substance abuse and diversion, comprehensive physical examination, obtaining relevant information from other sources such as other physicians who have treated the patient for a particular problem, using consultants if necessary to reach a working diagnosis. He stated that one of the problems with trying to reach a working diagnosis is that there is no identification as to what the physician is trying to treat other than to treat pain, nerves, or refill medications. It is important for physicians to reach a working diagnosis that focuses on the patient’s treatment and prescribing by developing a treatment plan that contains measurable goals and focuses on functional improvement of the patient and remedy of the medical complaint. An informed consent or a joint decision of the patient and the physician is critical with the understanding that the patient will be on controlled substances for long period of time and, if appropriate, the patient presents significant risks of potential diversion or addiction to have a prescribing agreement in place setting up the parameters and the expectations for the patient.
He said that after a decision is made to go into long-term prescribing, the standards focus on regular patient visits and evaluations and revaluations of the diagnosis and treatment plan to determine if the problem is being addressed in a meaningful way, whether there are there adjustments that need to be made in either the diagnosis, and whether there should be another evaluation to determine if the treatment is not addressing the initial diagnosis. The standards require determining if the patient has a functional improvement; monitoring through KASPER or urine drug screens and pill counts; making sure that annual preventive medicine is attended to in addition to the prescribing and treatment of the primary problem; and tapering or terminating a controlled substance prescription if there is evidence of illegal use or addiction.
Mr. Vest said that there are separate standards included in the board’s regulations for emergency department physicians because they are in a unique setting and have unique challenges and are a potential source for “doctor shoppers.” Emergency department individuals came to the board and asked to be included in the board’s standards. The board adopted the standards proposed by emergency department physicians because they are consistent with similar standards for those departments in Washington and Ohio. The board also created exceptions to the standards. The prescribing and dispensing standards do not apply when prescribing and dispensing to a patient as part of hospice or end of life care or to a patient during the course of hospital admission or to a patient who is suffering from cancer pain or to a patient who is a registered resident of a skilled long-term care facility.
There is a specific exception for the initial KASPER review on a queue prescribing in three situations: 1) in the event the prescriber or physician cannot receive the KASPER report immediately or in a timely manner, the board created a specific exception allowing the prescriber to document what decision was made and why a report was not received; 2) pediatricians treating patients under eighteen years of age for ADHD or ADD; and 3) when prescribing Schedule IV and V controlled substances. Mr. Vest indicated there was a lot of concern and a variety of arguments made when prescribing those controlled substances. The board took a balanced approach contacting drug control and law enforcement agencies and reviewed the board’s past cases. The decision was made to exempt Schedule IV and V controlled substances from the initial KASPER review except for the specific Schedule IV drugs identified as problem drugs for abuse. This had been a very detailed and lengthy process getting these standards into the form they are in now. The board received input from many individuals and met with the representative groups.
Mike Burleson, Executive Director of the Kentucky Board of Pharmacy, provided an overview of the regulations for the Board of Pharmacy. The Board of Pharmacy had a regulation committee that included board members and stakeholders from the practice of pharmacy as well as non-practicing pharmacists that met to work on the regulations. There were five regulations reviewed dealing with a pharmacy dispensing controlled substances. Those regulations deal with examinations, license transfer which addresses any pharmacist who wants to reciprocate in from another state stating that a fee increase was made for the required querying for the national practitioner data bank; procedures for the investigation and hearing of complaints which was the largest regulation which had to have changes made to comply; the regulation dealing with the pharmacist-in-charge reporting the theft or lost of controlled substances to the board. He stated that the board worked with the Inspector General’s Office, the Attorney General’s Office, and Kentucky State Police in implementing the changes, especially the Kentucky State Police as to the background check and fingerprinting. This process has already been included in the Board of Pharmacy’s website, which details how a pharmacist reciprocates into Kentucky; contains the procedure or process a new pharmacy student graduating from pharmacy school must follow; and the process for filing of anonymous complaints, noting that inspectors investigating these complaints are pharmacists. The board notified pharmacists in the June newsletter of changes, and another newsletter in September will include everything the pharmacists are now required to do. On Friday, July 20, the board sent an e-mail blast to 7,700 in-state and out-of-state pharmacists and approximately 1,800 pharmacies advising of the new regulation requirements. The board will be notifying the state and local professional associations to let them know about the new regulation requirements. Continuing education programs will be notified. As the pharmacy inspectors go to pharmacies each year, they will educate pharmacists on what the new requirements.
Chair Tilley commented that it was a consensus of all three branches of government that the legislature needed to act to address the drug abuse epidemic in Kentucky. The regulations and functions of the executive branch try to mirror as closely as possible the intent of House Bill 1. He said that the Center of Disease Control has labeled this problem an epidemic. The U. S. prescribes enough opioid painkillers, 215,000,000 prescriptions, which is enough to medicate every man, woman, and child in this country for 24 four hours for one month. The U. S. comprises four to five percent of the world’s population but consumes 97 percent of the world’s oxycontin. The U. S. has more deaths attributable to prescription drug abuse than car wrecks. Although there may be disagreement as to how to move forward in the implementation of the legislative intent versus the executive branch’s role of regulating the process, everyone should keep in mind that the state is trying to combat an epidemic that is different from that of confronting street level drugs. Elected leaders can control the flow of these drugs, which is what is attempting to be done. Beginning with the use of KASPER, when used effectively, it is possible to stem the flow of addiction. The leaders of this issue are trying to combat an epidemic that is taking lives and addicting children. Senator Stivers commented on a program in eastern Kentucky that detoxified 150 women in pregnancy last year.
Next on the agenda was an overview of regulations for the Kentucky Board of Nursing represented by Nathan Goldman, General Counsel, Paula Schenk, Consumer Protection Manager, and Morgan Ransdell, Prosecuting Attorney. Mr. Goldman indicated that there are approximately 4,600 advance practice registered nurses (APRN); nurse anesthetists who do primarily anesthesia but do some pain management; nurse midwives; clinical nurse specialists; and nurse practitioners. Since 1996 and again in 2005, these individuals were given the authority to prescribe noncontrolled substances and later controlled substances. The nurse must have a collaborative agreement with the physician for noncontrolled and controlled substances. There are limits on the number of drugs prescribed, and APRNs primarily can only prescribe up to 72 hours for Schedule II drugs with one exception, thirty days for Schedule III, and Schedule IV and V drugs original prescription up to six months. The regulations changed by the board dealt with the advanced practice registered nurse licensure which has a reporting provision for the National Practitioner Data Bank; changes to the scope and standards provision which has the prescribing standards for controlled substances; changes to the discipline provision of the board’s regulation which has the expedited review process; and changes to the continuing education or competency requirements for KASPER, drug addiction, and pain management.
Mr. Goldman indicated that the board has educated nurses as much as it could to this point and have been in contact with about 1,600 prescribing APRNs that have the authority to prescribe controlled substances in the state. E-mails had been sent informing them of House Bill 1 and the regulations. The board has been in contact with the Kentucky Coalition of Nurse Practitioners and nurse midwives, and the information is also contained on the board’s website and in its newsletter. The board is planning to provide as much information to nurse practitioners as possible.
Ms. Schenk indicated that the board has internally modified the investigative and disciplinary processes to conform to the unique requirements of House Bill 1, the review process, and completion of the investigation. The board has submitted a request for an additional staff person to assist in the review and investigation of complaints involving APRNs who may have improperly, illegally, or inappropriately prescribed controlled substances. The board is developing a multifaceted approach for the education of APRNs regarding the requirements of House Bill 1 utilization of the KASPER system. The board has also contacted the nurse anesthetists to schedule and offer presentations, written materials, and other multi-media options. The board has contacted the Cabinet for Health and Family Services and has been proactive in identifying those APRNs who may not have registered with KASPER.
Connie Calvert, Executive Director of the Board of Optometric Examiners gave an overview of two revised regulations and one new regulation promulgated by that board addressing House Bill 1. 201 KAR 5:010 was amended to require a fingerprint-supported criminal background check on all applicants for license; requires a National Practitioner Data Bank query on all applicants; and requires applicants for a license by endorsement to certify they are registered with KASPER if the applicant has a DEA number; 201 KAR 5:030 was amended to require all licensees who have a DEA number to take a two-hour course in pain management or addiction disorders each year for license renewal; and the newly promulgated regulation, 201 KAR 1:130, sets out the prescribing standards for licensees who have the authority to prescribe controlled substances. She said there is a section of the regulation that sets forth the action the board may take without a hearing if it has reasonable evidence to temporarily suspend, limit or restrict a license, and has included a section to address how complaints are to be handled when received.
She said the board accepts anonymous complaints. The regulation sets forth the penalties imposed and reporting required when violations occur. If a licensee is convicted of a felony, the penalty is a lifetime revocation on prescribing controlled substances, and for misdemeanors, a three month suspension from prescribing. The board licenses approximately 775 doctors of optometry. Of that number, about 415 have a DEA number, and the board has been getting word out to them about registering with KASPER. Information has been on the board’s website since mid-June with links to KASPER registration, and the board has conducted e-mail blasts. There are about 20 optometrists who do not have e-mail who have been notified by mail. A license will not be renewed if an optometrist has a DEA number and is not registered with KASPER.
Jason Ford, member of the Board of Dentistry and private practicing Oral Surgeon in Lexington, Mary Ann Burch, Dental Hygienist on the Board of Dentistry, and Brian Bishop, Executive Director of the Kentucky Board of Dentistry, discussed that board’s regulations. Mr. Bishop indicated that the board formed its regulatory group shortly after the passage of House Bill 1 and worked with all of the board’s constituent groups including the Kentucky Dental Association, Kentucky Dental Hygienist Association, both of the state’s dental schools, and the Department for Public Health. The board has worked with the executive branch staff to address a specific and unique opportunity with some dentists such as Mr. Ford who is not only a dentist but is also a medical doctor. The board wanted to write regulations as close to the Board of Medical Licensure’s regulations so that in situations where dentists are also doctors they would not be under separate standards. The board has modified three regulations, one dealing with licensure which addresses the fingerprint requirement for all initial licensees. The regulation will limit the individuals who come into Kentucky to practice under the charitable dental act to not be able to prescribe medications of any type while in the state. A continuing education component is also included. The dental practice regulation, which addresses the bulk of House Bill 1, has not been filed but will be finalized this evening at a special meeting of the board to include all the requirements by the Board of Medical Licensure. The board will also be modifying the fees and fines regulation to include fines for those individuals who choose not to register with KASPER in a timely fashion or who have had action taken in another state and has failed to report that information to the Board. He said there will be no fee increases for the implementation of House Bill 1 for licensed dentists. Mr. Bishop indicated that one additional staff member has been added to coordinate disciplinary and tracking efforts for dentists.
James J. Grawe, Assistant Attorney General and Counsel to the Kentucky Board of Podiatry discussed that board’s regulations. Mr. Grawe indicated that to his knowledge in the ten years of working with the board that it has not had any abuse problems or complaints regarding the prescribing of controlled substances outside an occasional licensee who may have a patient addiction problem that the podiatrist must deal with. He said that Dr. Robert Levine, Chair of the Board and a practicing podiatrist in Louisville, was unable to attend the meeting because of scheduling. Mr. Grawe indicated that the board has drafted regulations to implement the requirements of House Bill 1 and the application process for the conviction requirements and the disciplinary action by other states for controlled substances and the renewal requirements, the continuing education requirements, complaints and hearing proceedings, and the prescription and dispensing standards that were mandatory under House Bill 1.
The board opted for broader language that intersects with the proper use of the practitioner’s podiatric medical judgment, the standard medical processes for analyzing the condition being treated, medical history, physical examination, diagnosis, written treatment plan addressing the controlled substance, verification by identification of the patient, the querying of KASPER for Schedule II, III, and limited Schedule IV controlled substances, and documentation of the discussion of the inherent risk for addiction with controlled substances. He indicated that Mr. Levine has written e-mails to licensees informing them of the requirements of the regulation and the KASPER registration requirements.
Chair Tilley recognized Dr. Steven Stack who had signed up to address the committee. Dr. Stack is an Emergency Room physician at Saint Joseph East Medical Center. Dr. Stack indicated that in addition to his role at Saint Joseph East that he has served as the Medical Director and the Physician Leader at Saint Joseph East and Saint Joseph Mount Sterling at various times over the past six years. He applauded the committee on the statistics presented earlier from the Center of Disease Control. The data outlines an enormous crisis. Physicians share the commitment to drying up the problem of controlled substance abuse.
He discussed two points of concern. The first point of concern was that, in the attempt to address the crisis, the regulations and the statute that created the regulations have gone beyond the initial intent of the legislation and will likely result in avoidable and unnecessary human suffering. He said it was not necessary and is unfortunate that the regulations and the complexity of those regulations will result in a number of different and unnecessary things occurring in the complex heath system. Patients will not get the care they need. It is an unfortunate reality that the complicated health system is dysfunctional in enumerable ways. In his emergency departments, the patient population is comprised of 56 percent of patients who are either uninsured or on Kentucky Medicaid, and that those individuals either have no access to routine follow-up care or are unlikely to get timely access to care and they therefore resort to emergency departments as a last resort.
His second point of concern was that the debate of House Bill 4 in the 2012 regular session and the follow-up House Bill 1 in the 2012 special session was nonconstructive. As a physician who takes his Hippocratic oath seriously, he found it personally unfortunate and wounding to hear the vitriol, the open derision, and the mockery of the profession both in publications within the state and by certain individuals in elected office. It had the affect of having the physicians in the state feel as if they were vilified and criminals. The open assertion in a recent newspaper editorial that physicians were in fact killing people because doctors were trying to obstruct the legislation and regulations was unfair and unfounded. Dr. Stack indicated that although he had communicated with Senator Higdon concerning this issue, he in hoped that his comments have been constructive throughout this process and will continue to remain constructive because of his commitment and oath.
Dr. Stack asked on behalf of his colleagues that this issue be kept at the level it requires because the physician’s commitment to patients is not only based upon the oath but upon the daily actions, that the vast majority of physicians would like to see the criminals locked up. There is a long way to go, and some refinement will need to occur over time to the statute and regulations to enable physicians to provide the care needed while addressing the problem that must be addressed.
Chair Tilley indicated that more input is needed from physicians to talk about what is occurring and why revision may be needed either to regulations or the statute. Chair Tilley also stated that the committee would continue to look at the concern Dr. Stack expressed that some of the regulations go beyond the intent of the legislation. Chair Tilley understands the physicians take their Hippocratic oath very seriously. The entire profession is not a problem but only a small number that must be addressed. Chair Tilley said that it was not the intent of any person who worked on this issue to vilify the medical profession. The initial effort in addressing this issue was to address pill mills and to weed out the nonphysician-owned clinics. He encouraged colleagues of Dr. Stack to make their voices known.
Senator Higdon thanked Dr. Stack for attending the meeting and making his concerns known and said that he looks forward to hearing more of those concerns as the discussions move forward.
Senator Stivers also indicated he appreciated Dr. Stack being in attendance and recognizing that there is a problem. Senator Stivers said that he had meet with several groups who are consistently exchanging e-mails, faxes, and articles concerning this issue. He said one rarely picks up a newspaper or any type of nationalized periodical without reading about the problem of an overly prescribed nation. House Bill 463 was passed that dealt with intervention and rehabilitation of individuals in the corrections system, but the real impacts of drugs, diverted drugs, illegal drugs are found in domestic relations courts. They have a devastating impact on children being taken from parents, where grandparents are intervening on behalf of their children to become the custodians of their grandchildren. Senator Stivers stated that he understands that we have to be cognizant of the fact and the practical applications of the actions taken and that there needs to be constructive dialogue so that policymakers can have the appropriate information in order to make an informed decision to deal with a problem that has become tragic.
Chair Tilley indicated that as the regulations are implemented more constructive feedback will occur.
The committee will meet on the third Wednesday of each month until session begins. The next meeting will be on August 15 and chaired by Senator Stivers.
The meeting adjourned at about 2:35 p.m.