Call to Order and Roll Call
The 5th and final meeting of the 2012 SS HB 1 Implementation and Oversight Committee was held on Wednesday, December 12, 2012, at 1:00 PM, in Room 149 (moved from Room 154 due to construction noise) 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 and Representative Sara Beth Gregory
Guests: Nathan Goldman and Paula Schenk, Kentucky Board of Nursing; Scott Sisco, Kentucky Pharmacy Association; Mike Rodman, Dr. Preston Nunnelley, and Lloyd Vest, Kentucky Board of Medical Licensure; M. E. Kobes, Bluegrass Prevention; Eric Clark, Kentucky Association of Health Care Facilities; John Daniels, Central Kentucky Wellness Center, Sylvia Lovely, Lovely & Lovely; Sarah Nicholson and Brian Brezosky, Kentucky Hospital Association; Mike Porter, Kentucky Dental Association; Marty White, CLC; Representative Susan Westrom, among others
LRC Staff: Jon Grate, Ben Payne, and Marlene Rutherford.
Approval of October 17, 2012 Minutes
Senator Higdon moved that the minutes of October 17, 2012, be approved as written. Representative Gregory seconded the motion, and the minutes were approved without objection.
Tamper Resistant Drug Technology
Representative Wuchner discussed STOPP in Kentucky 2013 (Stop Tampering of Prescription Pills) model legislation for combating the epidemic of prescription drug abuse. The scope of the problem of epidemic prescription drug abuse is in the headlines each day. The deadliest drug epidemic begins and ends in the home. Clinicians have to strike a balance between treating chronic pain and defending against misuse and abuse. The introduction of new opioid formulations as a deterrent can be utilized.
The preferred methods of abuse are crushing, smoking, snorting, and injecting prescription drugs. The development and goals of these new formulations is to make sure that patients who need pain treatment receive treatment in a safe and effective delivery of those medications. The FDA has approved six formulations over the last two years that incorporate the tamper resistant technology. The key provisions of the legislation she would again be sponsoring would require the Kentucky Board of Pharmacy to publish a list of opioid analgesic drugs that incorporate tamper-resistant technologies, and prohibit the substitution of drugs without the pharmacy verifying that the substitute provides similar tamper-resistant properties as determined by the board or obtain consent from the prescribing physician for the substitution. An exemption for pharmacists in hospital-based pharmacies for filling prescriptions for in-patient care would be included. Prescribers would be free to prescribe whatever product they believe is best for the patient and allow the payers to maintain ability to control drug utilization and manage formularies. The intent is to make it more difficult for individuals to misuse and abuse long acting opioids which leads to significant costs to society. Tamper resistant formulations (TRFs) make it more difficult to crush, melt, or alter medications into a form that is easier to abuse. This is physician-discretion legislation when writing a prescription of a long acting opioid. It is not intended to promote any brand, and it will incorporate and promote a technology that will save lives. The technology is licensed and is nonproprietary. Studies show that addicts crush or break down time-released products into a form that can be snorted or injected for a more intense “high” and that the products incorporating TRF technologies offer physicians the opportunity to prescribe products that can reduce the potential for misuse and abuse of opioids. She also provided information showing that studies had found that the reformulated emergency room Oxycodone abuse rates were significantly lower than the original emergency room Oxycodone.
Representative Wuchner also showed short clips of testimony from Commissioner Rodney Brewer of the Kentucky State Police who provided comments from a law enforcement perspective of the misuse and abuse of these drugs; testimony from Circuit Court Judge William Roberts serving the counties of Bath, Menifee, Montgomery, and Rowan who discussed the societal costs of prescription pill abuse; and testimony from Marlyce Burkeardt-Neal, a mother who lost two of her children to prescription drug abuse.
In response to a question by Co-Chair Stivers as to the cost differential between a TRF and a non TRF, Representative Wuchner indicated there was no cost difference in the products currently on the market that have utilized the tamper resistant technology, but the prescribing of the medication is at the discretion of the physician and that generic drug providers are coming on board to add this technology to their medications.
Final Revised Board of Medical Licensure House Bill 1 Regulations
Dr. Preston Nunnelley, Chairman of the Board, Michael Rodman, Executive Director, and Lloyd Vest, General Counsel, Kentucky Board of Medical Licensure (KBML), discussed the final revised KBML House Bill 1 regulations. Dr. Nunnelley stated that the KBML has attempted to address each concern expressed by the various stakeholders. The new amended regulations set forth exceptions to the professional standards for prescribing and dispensing controlled substances and attempt to streamline and remove confusing language; focus on the standards for long-term pain treatment; exclude patients under the age of sixteen from the long-term pain standards; and include an exception for all Schedule V controlled substances from the standards.
The board developed standards for prescribing and dispensing controlled substances for treatment of conditions other than pain by separating out non-pain medications and only dealing with chronic pain. The standard is to run an initial KASPER report with that group of medications, but physicians are still required to practice quality medicine. The regulations look at physician-owned pain clinics by, among other things, the address the criteria for a pain clinic and what is required in the facility. They lower the registration fees to $500 for each individual clinic. A physician employed by a physician-owned pain clinic must be board certified. Language was amended to grandfather in physicians who owned a pain management facility prior to July, 2012 and who meet residency criteria. There is a requirement that physicians complete at least ten hours of Continuing Medical Education (CME) in pain management annually, in addition to the 4.5 hours of CME required by statute. The definition section of the regulations were also changed.
Mr. Vest indicated that changes to the definition regulation (201 KAR 9:001), which has been filed with LRC, comply with KRS Chapter 13A.
Dr. Nunnelley said that KBML has maintained the requirements of House Bill 1 that help decrease prescription drug abuse in the state. The amendments have reduced many of the unintended consequences of the regulations.
Responding to a question by Senator Higdon, Dr. Nunnelley stated that KBML has addressed the sleep aids for senior citizens. Some medications do not require a patient have a urine screen every three months if the patient is taking the medication properly.
In response to a question by Representative Gregory concerning the regulatory requirement for urine drug screens, Dr. Nunnelley stated that drug screening will be on medications prescribed for pain that lasts for more than 90 days, at which time a baseline drug screen would be done. Thereafter, only if a physician suspects abuse would another screen be done, but there is no mandate beyond the initial screen. Periodically, the physician needs to see the patient, and a KASPER report needs to be performed.
In response to a comment by Chair Tilley regarding Schedule V controlled substances not being addressed in the law or regulations, Dr. Nunnelley pointed out that the new amendment to the regulation has exempted Schedule V medications. For Schedules II, III, and IV drugs, if not prescribed for pain, only an initial KASPER report is made. Schedule V controlled substances have the propensity for addiction, but it is very low. Mr. Rodman said that the risk of diversion of Schedule V controlled substances is minimal.
Responding to a question by Chair Tilley, Dr. Nunnelley said there are times when a physician cannot meet the established criteria, and that good quality care and patient needs are to be treated first with a follow up on any missing documentation that may be required. KBML has suggested that a physician document any missing criteria and that it be reasonable professionally. When complaints are received by KBML, a professional in the physician’s specialty reviews the complaint to determine quality of care before a decision is made as to any violation.
Final Revised Cabinet for Health and Family Services House Bill 1 Regulations
Mary Begley, Inspector General, Stephanie Hold, Assistant Director, and Stephanie Brammer-Barnes, Policy Analyst, Cabinet for Health and Family Services, discussed the upgrades and future enhancements of the KASPER system. The cabinet has worked closely with KBML on the implementation of House Bill 1 and the products that will be forthcoming with KASPER. Some of the emergency regulation enhancements relate to the dispensing data effective on July 1, 2013. A patient and practitioner error resolution was established. Language regarding medical examiners engaged in death investigations and their ability to access reports from KASPER on deceased individuals has been addressed. The direct administration of controlled substances in a health facility is not required to be reported to KASPER prior to July 1, 2013. The issue of using all zeros as an identifier was addressed and may be used to report an adult who does not have a social security number (SSN) or a child that does not have an SSN, or to report on an animal. A query may be made of KASPER without an SSN. Physicians can authorize institutions to assign delegates to run KASPER reports with strict requirements and auditing. The Office of Inspector General is working permit a practitioner to report to law enforcement suspected illegal conduct by a patient.
Ms. Begley stated that nonphysician-owned clinics or pain management facilities are addressed and identified as a facility with greater than 50 percent of unduplicated patients treated on a one month period and received controlled substances for pain. The medical director of the facility must meet one of the qualifications established by House Bill 1 or become certified by the American Board of Pain Medicine or American Board of Interventional Pain Physicians by September 1, 2013. The key components of the regulation include requiring prescribers to comply with the prescribing and dispensing of controlled substance standards established by the appropriate licensure board; requiring a facility to demonstrate compliance with standard operational and environmental requirements; and prohibiting a facility may transferring ownership after the effective date of the legislation to a nonphysician.
Ms. Begley also discussed criteria that was established for the denial of an initial license to operate a pain management facility. The initial requirement for a full-time physician and a registered nurse in the facility was changed to a full-time physician and practical nurse or a licensed practical nurse. There is an added requirement for physicians in these facilities to complete at least ten hours of Continuing Medical Education in pain management. As of October, 18 pain management facilities had closed or discontinued providing pain management services, including ten that shut down since House Bill 1 implementation. OIG has completed the inspections of all pain management facilities awaiting initial licensure.
Responding to a question by Representative Gregory concerning animals in the KASPER system, Ms. Begley stated that this was a workflow issue for dispensers because dispenses sometimes get prescriptions from a veterinarian.
In response to a question by Representative Westrom, Ms. Begley indicated that the ten pain clinics that closed after the implementation of House Bill 1 were not in a particular area or region but were throughout the state. They were clinics for which the cabinet had received complaints.
Responding to a question by Senator Higdon concerning the abuse of using all zeros in place of a SSN, Ms. Begley stated that the SSN was not the only identifier used. The cabinet is working with the Board of Pharmacy and individual pharmacies and tracking on a weekly basis individuals who have all zeros or sequential numbers to try to clear up the issue.
In response to a question by Chair Tilley concerning any sale of a clinic in the event of a death of the owner, Ms. Begley said there is no opportunity for a pain management facility that is not physician-owned to transfer ownership.
Mr. John Daniels, a nonphysician owner of the Central Kentucky Wellness Center in Lexington, Kentucky, in operation for two and one-half years, discussed the impact of the law on nonphysician owned clinics. He said he has been involved in the process and was pleased to see some of the comments his organization had made placed in the regulations. Many clinics have closed without exit plans or exit strategy, and the remaining clinics have been overwhelmed and overburdened in the marketplace. Because of the staffing requirements that have been placed on the clinics, more of them will close in the future. The requirements for a medical director differ from that of the KBML. All clinics under the cabinet’s realm are existing clinics. He must hire a medical director or a “super specialist.” Recruiters he is currently working with have indicated that it is very difficult to recruit such individuals because most physicians would not want to work in a single doctor office because they have a choice to work in hospitals. Mr. Daniels is concerned about who takes care of the patients when the clinics close or when there is no exit strategy. His clinic is required to hire a board certified prescriber.
Chair Tilley said that the legislation is not intended to make it difficult for those in need of pain treatment but to address a serious problem of drug abuse that demands a public policy response.
Mr. Daniels said that his clinic’s protocol has always been more restrictive than the legislation for KASPER, drug testing, and patient conduct. Patients are having to be reeducated on proper pain management care. He also applauded the tamper resistant medications. As soon as they became available on the market, his clinic began using them even though the patients did not want them.
Final Revised Board of Nursing HB 1 Regulations
Nathan Goldman, General Counsel, and Paula Schenk, newly appointed Executive Director of the Kentucky Board of Nursing, discussed the changes to the board’s regulations. Mr. Goldman stated of the four regulations amended by the board for the implementation of House Bill 1 that comments were received only on the one relating to prescribing standards. The changes are similar to those of the KBML regulations. The Board of Nursing regulations had contained certain exceptions such as Schedule V controlled substances and hospice care, and the standards are the same as the KBML. Ms. Schenk stated that the board’s regulations closely conform to what the KBML presented.
KASPER Program – Operational Experience and System Upgrades under HB 1 and Future Enhancements
Mary Begley, Inspector General, Stephanie Hold, Assistant Director, David Hopkins, KASPER Program Manager, Cabinet for Health and Family Services, testified about the cabinet’s experiences, upgrades to the KASPER system, and planned enhancements to the system since the implementation of House Bill 1. She thanked the General Assembly and the Attorney General’s Office for the funding from the mortgage settlement of approximately $4 million for the support and upgrade of the KASPER system and implementing House Bill 1. Several people have been hired to help with the program. The cabinet is working on interstate data sharing, institutional accounts, and other technological upgrades. These developers are difficult to recruit.
Chair Tilley asked that the cabinet keep LRC staff and the committee updated on how the program is doing financially so that the General Assembly will know about future costs of the program.
Ms. Begley discussed the KASPER master accounts, which include physicians, dentists, optometrists, and podiatrists. As of the end of December 2011, there were 7,545 accounts. As of the end of November 2012, the number had increased to 23,074, and more are being registered. The average daily KASPER report volume prior to House Bill 1 increased from 3,290 to 17,665 reports after implementation. The average weekly Help Desk inquiries increased from 100 to 250 prior to and after implementation, and there were peak volume inquiries during the week of July 20 of 1,628. Pharmacy data continues to improve as to invalid social security numbers. Some of the issues deal with software that the pharmacies will have to address. The KASPER system is up 99.6 percent of the time and is monitored regularly. Incidents of slow reports have decreased substantially with a normal response time of 15 to 60 seconds for a report. The cabinet is upgrading the software to improve information that is going into the manual queue. Possible future projects include a querying KASPER data to identify the top potential doctor shoppers, to annually review prescribing patterns by profession, tracking results of the prescriber reviews and trend reports, and improving KASPER data quality by working with the Board of Pharmacy, pharmacies, and software vendors. The cabinet is working with the Veterans Administration (VA), and Kentucky is one of the first states given permission prior to the changing of the regulations to allow VA physicians to query KASPER data. VA pharmacies are also entering data into the KASPER system. This service is still in the testing phase.
Administration’s Stakeholder Engagement Process and Status
Michael Rodman, Executive Director, Board of Medical Licensure, Mary Begley, Inspector General, Cabinet for Health and Family Services, Van Ingram, Executive Director, Office of Drug Control Policy, and Kate Wood-Foster, Governor’s Legislative Liaison, talked about the process and input of the stakeholders on the implementation of House Bill 1. Ms. Wood-Foster stated that all stakeholders were asked to submit comments to the administration regarding interpretation of the House Bill 1 itself, the administrative regulations, and possible unintended consequences. The administration received 243 comments. Approximately 12 regarded interpretation, 123 regarded regulations, and 59 regarded statutes other comments and questions. Most issues have been addressed, but some are not within the administration’s jurisdiction. This stakeholder group was used to identify key issues for future steps to help the different provider groups with challenges they will face.
Mr. Ingram noted that the medical community will need to educated on the regulations. Grant funding opportunities are available. The Office of Drug Policy has partnered with Operation Unite, which received a grant from the Appalachian Regional Commission to perform geographic training around the state after the regulations are finalized. A grant was secured from the National Governor’s Association to conduct a forum for training in 2013. Discussions have been held with the University of Kentucky Healthcare Continuing Education Central (CECentral) program, which will videotape the training sessions so they may be offered on-line for continuing education credit. Patient outreach is being done through the Office of Drug Policy with Operation Unite and the Home Healthcare Association by developing brochures that will be sent out to 10,000 patients to explain the dangers of opioid painkillers and why it is necessary to secure and dispose of them properly. Other training will focus on recognizing drug abuse and dependence in patients, how to discuss drug abuse, tolerance and dependence issues with patients, KASPER usage and interpretation, opioid therapy risks versus rewards, and treatment referrals.
Responding to a question by Senator Higdon, Mr. Rodman indicated that the Board of Medical Licensure will promulgate regulations on prescribing methadone and suboxone.
The meeting adjourned at about 2:40 p.m.