Call to Order and Roll Call
The 4th meeting of the 2012 SS HB 1 Implementation and Oversight Committee was held on Wednesday, October 17, 2012, at 1:00 PM, in Room 154 of the Capitol Annex. Senator Robert Stivers II, 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; Senators Jimmy Higdon and Ray S. Jones II; Representatives Linda Belcher and Sara Beth Gregory.
Guests: David Cobb, for Senator Julian Carroll; Sandra King, Kentucky Association of Health Care Facilities; Bonnie Lazor, Vintage Care/Kentucky Association of Health Care Facilities; Mary Haynes, Nazareth Home/Kentucky Association of Health Care Facilities; Sarah S. Nicholson and Brian Brezosky, Kentucky Hospital Association; Connie Calvert, Board of Optometry; Heather Wright; Kathleen Luchtefeld, The Pain Treatment Center, and Priscilla Black, Legislative Research Commission, among others.
LRC Staff: Jon Grate and Marlene Rutherford.
Approval of Minutes
Representative Gregory moved that the minutes of the September 19, 2012, meeting be approved. Following a second by Representative Belcher, the minutes were approved without objection.
Revised Kentucky Board of Medical Licensure Prescribing and Dispensing Regulations
Dr. Preston Nunnelley, Chairman, and Michael Rodman, Executive Director, Kentucky Board of Medical Licensure, discussed revisions that have been made to the Kentucky Board of Medical Licensure (KBML) regulations in an effort to address the concerns of practitioners.
Dr. Nunnelley said that KBML has attended each of the HB 1 Implementation Oversight Committee meetings, has met regularly with the Governor’s Stakeholder Workgroup, has met with individual practitioners, group practices, and medical staff of hospitals, has held educational meetings and formal comment hearings, has posted various education resources on the KBML website, and has approved several educational courses to comply with the requirements of House Bill 1 (HB 1). KBML has posted notices and e-mail alerts to clarify issues and added four additional board meetings each year to the schedule to meet the requirement of concluding investigations within 120 days. One of KBML’s most positive experiences has been the collaborative efforts in working with the different organizations such as Lexington Clinic, Kentucky Hospital Association, Kentucky Medical Association, legislative members, and other interested organizations. KBML is aware of the confusion among the various specialties of practice and is working with them to address their concerns and is recommending regulatory revisions to simplify compliance. Some of the areas being revised are chronic non-cancer pain and mental health prescribing. The board is paying attention to pediatric prescribing for ADHD and ADD to make sure the regulation is clear and so that monitoring with drug screens will not be part of the issue for pediatric patients.
Responding to a question from Chair Stivers, Dr. Nunnelley indicated that KBML is evaluating the board’s drug screen requirement to make sure that it is triggered only in appropriate medical circumstances and that the screening has enough reliability to reduce the numbers of follow up confirmation screens needed. Emergency room physician concerns have been addressed. The board is finishing its revisions for a few remaining conditions such as testosterone treatment as it compiles information submitted in various hearings and forums.
Mr. Rodman informed the committee that cases alleging pill mill activity have dropped since HB 1, that since April 2012, thirty three physicians have been sanctioned for prescribing violations, ten emergency orders have been issued, fifteen agreed orders entered into with definite restrictions or the ability to prescribe medications taken away, and five orders of surrender of licenses issued in lieu of revocation, which compares to eighteen doctors being sanctioned in all of 2011.
Dr. Nunnelley indicated that KBML’s goal is to customize the practice of medicine to comply with HB 1 for each of the specialties of practice and maintain the protection needed for the profession while allowing physicians to practice good quality of care.
Responding to a Representative Belcher question, Dr. Nunnelley and Mr. Rodman said there are no restrictions on prescribing any kind of pain medication other than to follow the rules, that there is nothing in the regulations that would prohibit emergency room prescribing, and that blood or urine testing in an emergency room situation would only be required where needed to evaluate a disease or condition or the physician suspects drug abuse. In long term prescribing situations, multiple drug tests over a year are indicated only where the physician determines that the patient is at an extremely high risk for diversion or in the event of a suspicious KASPER report.
In response to an inquiry by Representative Tilley regarding the current emergency regulations, Dr. Nunnelley said KBML is putting together a final draft of the regulations after all suggestions from the different hearings are received. At that point, KBML will file an amendment to the emergency regulations and follow up with an amendment to the ordinary regulations, with a target date for this being November 1.
Responding to a Representative Gregory question, Dr. Nunnelley and Mr. Rodman said that sections of the draft regulations that had been titled but had no text were areas where the board was still engaging in significant work to craft appropriate language. Those sections will be complete by November 1. The goal is to have language reflecting good practices already occurring in physician’s offices.
Responding to a Senator Higdon KASPER question, Dr. Nunnelley said that KBML has been extremely pleased with KASPER’s responsiveness, with queries of almost 20,000 per day and most reports being received within seconds. While there have been occasional delays, prescribing should not be impeded as the physician only needs to document the attempt to query KASPER.
Chair Stivers again reiterated that there is still a lot of misinformation on what can or cannot be done in prescribing and dispensing medication and appreciated KBML’s efforts to rectify any misinformation.
House Bill 1 Stakeholders
These presenters were a continuation of scheduled stakeholder testimony from the August meeting. Mary Haynes, Executive, and Sandra King, Assistant Director of Nursing, Nazareth Home in Louisville, Kentucky, and Dr. Bonnie Lazor, Geriatrician, and President of the Kentucky Association of Medical Directors, representing the Kentucky Association of Health Care Facilities, discussed HB 1 and the regulations as they relate to long-term care facilities.
Ms. Haynes indicated that while long-term care facilities are exempt from the definition of pain management facility in KRS 218A.175, the facilities are not exempt from the rest of HB 1, including requirements on the prescribing requirements for medical practitioners.
Ms. King stated that long term care facilities are highly regulated by federal and state governments, and the regulations are designed to specifically control, monitor, and prevent the diversion of scheduled drugs in the long-term care setting. Facility residents are given a comprehensive, thorough assessment upon admission, with quarterly and annual follow up, which takes into account the resident’s history, diagnosis, medications, overall physical and psychosocial needs, and the resident’s pain management needs and which results in a plan or treatment of care with on-going review during the stay at the facility. She requested that long term care facilities be exempt from the requirements for prescribing the controlled substances outlined in the law and regulations.
Dr. Lazor’s spoke on geriatric patients receiving palliative as opposed to hospice care who receive treatment for pain during a long-term care facility stay for rehabilitation after surgeries and patients who are long-term care residents who will not be leaving the facility. She discussed the role of narcotics in end of life treatment and asked that the regulations and law be changed to exempt nursing home settings so that timely treatment of pain can be administered for end-of-life patients and that additional exemptions be provided for the geriatric population because those patients have life limiting, chronic diseases and deserve to have those symptoms controlled.
Heather Wright and Kathleen Luchtefeld of The Pain Treatment Center of the Bluegrass spoke next. Ms. Wright indicated that many of the August concerns have been addressed in the discussions by the boards, Governor’s Office, and stakeholders, that The Pain Treatment Center has been receiving more patient referrals, and that the patient backlog being experienced by pain clinics is becoming an access to care issue. She discussed problems with the required drug screening, which is a good requirement but that is encountering difficulties in having insurance companies cover as a reimbursable benefit. Senator Stivers observed that it would be in the best interests of third party payers to pay for those screenings because the long-term cost savings would be greater than costs of the tests. Ms. Wright said that there is inconsistency among the third-party payers, specifically with Medicare where a urine drug screen is required if it is believed there is an illicit behavior.
Ms. Luchtefeld called attention to the tight implementation timeline, saying this is a complex issue and that practitioners face a difficult situation of being in substantial compliance with regulations that are not finalized.
Law Enforcement Experience
William Mark, Director, Northern Kentucky Drug Strike Force, serving Boone, Kenton, and Campbell counties, and Tim Fegen, Executive Director, Buffalo Trace Gateway Narcotics Task Force, serving Mason, Bracken, Pendleton, Robertson, Bath, Montgomery, and Fleming counties, discussed their experiences. Mr. Mark said heroin has been prevalent throughout the northern Kentucky for years and is increasing. Over the last 2-3 years heroin has dominated the illicit drug market. Two-thirds of heroin arrests in the Commonwealth were in the northern Kentucky. Narcotics officers say that heroin is replacing Oxycodone as the opioid of choice for abusers in northern Kentucky, but that this trend preceded passage of HB 1. Mr. Mark said he had seen positive affects since the passage of HB 1 in addressing suspect pain clinics in northern Kentucky.
Mr. Fegen said his investigations in northeastern Kentucky saw an increase in heroin activity prior to the implementation of HB 1. Major dealers are having difficulty finding pills to sell. Implementation of the bill has worked well for law enforcement because the opioid drugs are not as frequently available. In response to a question by Chair Stivers, Mr. Fegen said that the major dealers prior to HB 1 obtain most of their prescription drugs in Kentucky although they also make trips out of state, that mid-level dealers have as many as ten individuals working to obtain controlled substances, that HB 1 has made it more difficult to use the in-state doctors for that supply, and that two current problems are black tar heroin and out-of-state prescription drugs.
Facilitating Drug Investigations Across Agencies
Mitchel Denham, Attorney General’s Office, Stephanie Hold, KASPER program, and Morgain Sprague, State Police, talked about cooperation between KBML and other regulatory boards, the Cabinet for Health and Family Services, the Kentucky State Police (KSP), and the Attorney General’s Office (OAG). These entities have agreed to a Memorandum of Understanding (MOU) putting a system into place to coordinate complaints. Mr. Denham said the MOU was developed because there was a lack of formal complaints by the boards prior to HB 1 to the KSP and OAG, that there was a lack of coordination between law enforcement looking at complaints about prescribers, and that law enforcement needed information so they could target the most egregious violators. After a series of meetings with the agencies, the MOU was drafted, and it went into effect the same day as the legislation. A concurrent project was the development of the Prescriber Information for Licensure Boards and Law Enforcement complaint database (PILLS). The MOU contains a sharing and cooperation agreement concerning KASPER and trend reports, proactive investigations, and meetings and centralized reporting systems between the signatories. This mirrors key provisions of HB 1 directing the cabinet to proactively search and use the KASPER database to find practitioners who are overprescribing and the requirement that the information be shared with law enforcement. He emphasized that the legal protections contained in KRS 218A.202 and other statutes are still in place, that the MOU does not give anyone greater access but just coordinates that access, that the boards must put allegations into the database and law enforcement will be able to review these complaints and determine whether to investigate, and that the boards have agreed to wait on administrative action if requested by the OAG or KSP in the event of an undercover operation. Mr. Denham said that the MOU is working and that boards are entering complaints into PILLS, that information is being shared more freely, that KASPER is being more proactive, and that KBML has increased disciplinary action for inappropriate prescribing.
Ms. Hold discussed the PILLS database. From the effective date of the bill until mid-October, two complaints had been entered for the Board of Dentistry, 30 for the Board of Medical Licensure, five for the Board of Nursing, four for the Board of Pharmacy, and one for the Board of Podiatry. One final disposition was entered. There are 27 designees among the licensure boards and law enforcement agencies that are using the system. Licensure boards may only see complaints for their respective licensees. Law enforcement is able to see all complaints. Each complaint entered will have responses from the appropriate users after the required data fields are completed.
Ms. Sprague emphasized the MOU gives law enforcement the opportunity to have KASPER utilized as a proactive investigative tool and is filtered for privacy protection through CHFS, KBML or other regulatory board, and law enforcement. The database will allow investigations to be deconflicted between various investigating agencies.
In response to a question by Representative Gregory, Mr. Denham said an earlier court opinion concerning the Attorney General’s law enforcement investigatory authority is before the Supreme Court on Motion for Discretionary Review, that there are provisions in KRS Chapter 15 that permit the Attorney General’s Office to go into a jurisdiction on the request of a mayor, a majority of the city council, or a court, and that there are provisions that allow the Attorney General’s Office to conduct an investigation in a jurisdiction at the request of the Commonwealth's attorney or county attorney.
House Bill 1 Required Overdose Death Reporting and Dissemination
Van Ingram, executive director of the Office of Drug Control Policy, discussed the overdose reporting requirements Sections 7 and 8 of HB 1 as they relate to coroners, medical examiners, death certificates, and his office. His office is working with Kentucky.gov to create a single report and database where each coroner would be assigned a User ID and password, the form completed, and then populated to the database so the information can be shared among the agencies. The project is not complete and is waiting its turn in projects being worked on by Kentucky.gov. Mr. Ingram said that third-party payers and managed care organizations' issues concerning urine drug testing are being addressed by the Department of Insurance.
The meeting adjourned at 2:35 p.m.