Call to Order and Roll Call
The 2nd meeting of the 2012 SS HB 1 Implementation and Oversight Committee was held on Wednesday, August 15, 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: Kathleen M. Luchtefeld, General Counsel, and Heather C. Wright, Chief Executive Officer, The Pain Treatment Center of the Bluegrass; John Cooper, Kentucky Medical Association; Connie Calvert, Executive Director, Kentucky Board of Optometric Examiners; Steven Stack, MD, St. Joseph East Emergency Room Medical Director, on behalf of himself and Emergency Physicians; Beth Partin, DNP, APRN, Vice-President, Kentucky Coalition of Nurse Practitioners and Nurse Midwives; Breena Angel, WUKY; Dennis Stone, MD, Signature Healthcare; Melissa Platt, MD, President, Kentucky Chapter, American College of Emergency Physicians; Gregory A. Hood, MD, FACP, Governor, Kentucky Chapter, American College of Physicians; Carole Christian, Wyatt, Tarrant, and Combs; Ward Begley, Chief Legal Officer, Owensboro Medical Health System; Bill Bryant, MD, FAAFP, Member, Kentucky Academy of Family Physicians and Owensboro Medical Health System; Terry Sweatt, CRNA, President-Elect, Association of Nurse Anesthetists; Sheila Schuster, Nurse Practitioners and Nurse Anesthetists; M. E. Kobes, Bluegrass Prevention Center; Shawn Jones, MD, President, Kentucky Medical Association; William E. (“Bill”) Doll, Attorney, Jackson Kelly, PLLC, on behalf of Kentucky Medical Association; Mary Haynes, Kentucky Association of Health Care Facilities, Chief Executive Officer and Administrator, Nazareth Home; Bonnie Lazor, MD, Kentucky Association of Health Care Facilities/Vintage Care; Kari Shields, MD, CMD, Diversicare, Our Lady of Bellefonte Hospital, Ashland, KY; Sandra King, Assistant Administrator, Kentucky Association of health Care Facilities, Nazareth Home; William “Chip” Adam, JD, Adams Law Firm, on behalf of Murray-Calloway County Hospital, and as a citizen; Mike Porter, Kentucky Dental Association; Representatives Westrom and Stacy, among others.
LRC Staff: Jon Grate and Marlene Rutherford.
Chair Stivers advised that the meeting would adjourn by 3:00 p.m. to allow individuals to participate in or attend the memorial service in the rotunda for Mike Haydon and that, given the time constraints, the committee would be initially receiving comments only, with questions and answers reserved until all presenters were finished.
Institutional, Practitioner, and Pharmacist Testimony on HB 1 Implementation
Brian Brezosky and Roz Cordini appeared on behalf of the Kentucky Hospital Association (KHA), and were joined by Chip Adams speaking on behalf of the Murray-Calloway County Hospital, to discuss the affects of House Bill 1 and its associated regulations on medical institutions.
Ms. Cordini, a registered nurse and attorney, indicated that her oral and written testimony on behalf of KHA would focus on correcting some unintended consequences from the legislation, the regulations, and the mandatory prescribing and dispensing standards found in both, particularly in regard to hospitals, long-term care facilities, nursing homes, and other licensed facilities where drugs are ordered by physicians and directly administered into the bodies of patients. After acknowledging the intent of House Bill 1 to close down pill mills and address the drug abuse epidemic in the state, she referred the committee to a Drug Enforcement Administration report on the abuse of Hydrocodone-based drugs that indicates that the primary modes these drugs are obtained are bogus prescription call-ins to pharmacies, altered or forged prescriptions, and drugs illegally obtained on the internet, and not via drugs directly administered in a hospital, emergency department, or other institutional setting. In regard to prescribing standards, Ms. Cordini testified that the law now required time consuming actions prior to prescribing a scheduled drug, and that the “prior to” requirement was an impediment to the timely delivery of needed medical care.
Further, the 24-hour operating nature of hospitals does not always allow the “prior to” requirement to be met, offering the example of a physician now being required to report to the hospital in the middle of the night to do a physical exam, where prior practice would have allowed a called-in order to suffice until the morning. Ms. Cordini observed that hospitals and other institutions are already heavily regulated, with their actions being controlled and measured by regulatory agencies, and that the delays in care occasioned by House Bill 1 conflict with other regulatory requirements to deliver prompt and effective care. And in regard to regulatory requirements, she noted that the different drugs, exemptions, and prescribing and dispensing protocols established by the bill and the regulations are confusing and can be in conflict, resulting in burdensome confusion for the honest practitioner.
Ms. Cordini offered proposed language on behalf of KHA that would restrict the licensing boards from promulgating prescribing and dispensing standards in institutional settings, that would clarify various terms used in the legislation, allow the KASPER query requirement to be bypassed in limited situations, that would clarify the situations and locations where the emergency exemption allowed by the bill could be utilized, that would exempt non-hospice end of life care, that would eliminate the need for hospitals to report to KASPER drugs that are directly administered to a patient, and which would provide better statutory guidance for physician delegates accessing KASPER in institutional settings.
Bryan Brezosky discussed two issues of concern. The first deals with the new ability of a physician to designate an employee of the physician’s practice to access KASPER on behalf of the physician. In the hospital setting, this authority is problematic, as many of the doctors practicing in the hospital are not actual hospital employees. With the potential for misuse of private KASPER information, clear lines of authority need to be drawn as to whom may be delegated access, and who may audit the use of that access. While the KASPER system is working to create institutional accounts that may be controlled by hospitals, the KHA requested statutory language specifically authorizing this added functionality. The second issue dealt with the new requirement that hospitals report to KASPER every seven days the amount of Schedule II and Schedule III drugs containing Hydrocodone administered to patients in the hospital. This requirement is problematic in that hospital dosing orders can allow a range of dosages to be used by the nursing staff dependent upon need, making reporting of amounts actually administered very difficult. As the requirement serves little purpose since there is little chance of diversion of a drug that is administered directly to a patient, he asked that the requirement be eliminated.
Chip Adams, a private attorney with hospital and practitioner clients, also spoke as part of the KHA presentation. He suggested that medical care in an acute care setting where medication is directly administered would be an appropriate place to create a House Bill 1 exemption, while leaving in place the KASPER requirement for physician office and emergency room care. He also testified that the regulatory requirement that some patients be referred to addiction management is difficult to meet in areas of the state where these services are not present in the community. The regulatory requirement to report doctor shopping but not drug diversion seemed confusing, and that if reporting is required, some good faith immunity should be granted as is the case for required child abuse reporting. Mr. Adams suggested additional clarity on the role of law enforcement in receiving these reports, and that perhaps designated law enforcement agencies or task forces should be specified. He spoke in favor of the bill’s provision allowing prosecutorial KASPER access, and finished with a discussion of the problems that can arise from the mandatory objective standards of care for physicians established by the bill and the regulations when there is the possibility of subjective interpretations by regulatory and law enforcement personnel.
Doctors Bratton and Harned provided comments on behalf of the Lexington Clinic. Doctor Bratton stated that it was not his intention to criticize House Bill 1 but to offer suggestions to better protect patients and provide reasonable and clear guidelines for physicians. He referred members to a written issue list that was included in the meeting packet containing their concerns and suggested remedial actions. Among the concerns discussed were the need to clarify the types of medication to be covered, the requirement for a complete history and physical for symptoms or procedures where that was not appropriate, the unnecessary complications created by the requirements in a group practice setting that utilizes common electronic health records, and the ability of physician extenders such as physician assistants to perform required compliance actions. He suggested that patients in institutions should be exempt since those patients must be treated for their pain regardless of a KASPER result or prior history, that a one to three day supply of a controlled substance should be exempt from the current guidelines, that better guidelines were needed for suspicious KASPER reporting to law enforcement, for KASPER error reporting, and for the timelines for when a KASPER report should be run. Finally, he alerted the committee to impending compliance cost issues, as many of the required prescribing protocols were costs that would be borne directly by patients as insurance, Medicaid, and Medicare would not reimburse for those additional costs.
Doctor Michael Harned, an intervention pain physician at the Lexington Clinic and consultant to the Kentucky Board of Medical Licensure, spoke from the perspective of an interventional pain specialist who relies primarily on non-drug therapies to treat pain, but who follows all recommended treatment and monitoring guidelines when prescribing opiates. He briefed the committee on the unintended consequence of House Bill 1 creating a chilling effect on the prescribing practices of primary care physicians, who in turn refer their patients on to pain clinics in lieu of continuing the prescribing in their own offices. As a result of this outflow, his appointment slots have been overfilled, causing legitimate patients to wait weeks for care. This delay will lead patients to seek other relief, such as alcohol, out of state physicians, or internet prescriptions. He alerted the committee to potential problems with the quality of KASPER reports, bringing an example of two different reports on the same individual which had greatly different data despite being run only 24 hours apart. At the suggestion of Chair Stivers, the doctor agreed to discuss those reports after the meeting with KASPER system employees who were present at the committee room.
Dr. Shawn Jones, MD, a practicing Paducah physician and current President of the Kentucky Medical Association (KMA) testified alongside their legislative liaison, Bill Doll. Doctor Jones observed that House Bill 1 has gone a long way towards shutting down many illegitimate pain clinics, a longstanding goal of the medical community. He stated that the KMA supported upgrades to KASPER to improve usability, and the statutory changes allowing increased flexibility in access, such as allowing reverse KASPERs. However, the bill and the regulations are overbroad in that they cover situations where the KMA has not observed problems, such as with ADD/ADHD, testosterone usage, and post-surgical pain. Dr. Jones lamented the civil and criminal liability faced by an honest physician who makes an inadvertent mistake in complying with the new statutory and regulatory requirements, and the chilling effect that would have on the practice of medicine and consequent restriction on the availability of care. The KMA would be making suggestions to balance the need to shut down pill mills with the need to continue to allow full access to legitimate quality medical care. He suggested that rather than set protocols that cannot cover every medical situation, the required protocols other than the KASPER check should be removed so that patients in a variety of situations will not face additional time and expense obtaining necessary medication.
Dr. Jones suggested additional exemptions to the KASPER query requirement, such as in pre and post-operative situations, nonsurgical or other procedure that requires anesthesia or sedation, shoulder and joint reduction, sedation necessary for dressing changes, radiological procedures, and cardiac catheterizations. Additional exemptions should be made for patients with cancer, hospital and institutional patients, young children, and group practices. He suggested that it should be clear that needed treatment should be allowed regardless of the results of a KASPER report. To reduce confusion, he suggested that the legislature remove the KBML’s ability to promulgate regulations on drugs not specifically regulated by House Bill 1. In regard to the regulations themselves, he stated that they are confusing, especially to physicians who must prescribe as part of a long-term treatment regimen and that unless changes are addressed there will be an increase in healthcare costs that are paid by insurers, government paid programs, or the patient directly.
Melissa Platt, MD and President of the Kentucky Chapter, American College of Emergency Physicians (ACEP), and Steven J. Stack, MD, Fellow of the American College of Emergency Physicians (FACEP) and emergency room physician practicing within Kentucky One Health, addressed the committee.
Doctor Stack testified that House Bill 1 and the regulations create an overly aggressive and intricate web of mandatory researching, querying, reporting, investigating, and sanctioning of physicians trying to provide honest and appropriate medical care. Further, the law’s level of specificity in care delivery and documentation is not consistent with the realities of medical practice and confronts physicians with the untenable binary decision to comply with the statute and regulations or with medical ethics and accepted clinical standards of care. Doctor Stack referred the committee to his written comments that offer discreet and focused examples of how the Legislature, executive branch, and healthcare community can work together to identify and address areas of concern mandated by the requirements of House Bill 1 and associated regulations, the clinical concerns from a physicians perspective, and provided examples or situations where it would not be possible to comply with the statutory or regulatory requirements, and offered suggested language or amendments to the statute and regulations. He specifically discussed the blurring of the meaning of the terms “prescribing” and “administering” as applied to emergencies and surgery, with the blurring causing all emergency department prescriptions having to comply with House Bill 1. He also stated that the documentation related to an inability to query KASPER is of no clinical value, and that the requirement that coroners notify licensing boards of drug overdose deaths will have a chilling effect on the practice of emergency medicine.
Doctor Platt stated that some aspects of House Bill 1 and the regulations do not fit well into the actual practice of real time emergency medicine. While she agrees with other groups that there is a need for KASPER institutional accounts or for select KASPER queries, she also believes that there is a need to re-work regulations relating to the limited use of IV or shot medications for acute exacerbations of chronic pain, the seventy-two hour time limit on prescriptions, and the strong discouragement of administering Demerol. She believes that the regulatory expansion to cover all scheduled drugs ties a physician’s medical hands when trying to treat pain. She also said that singling out a specific medication such as Demerol establishes inequity across professions and that if this medication is discouraged it should be discouraged throughout all specialties and health care providers. She indicated that other items in the statute and regulations need clarification, including the exemption for emergency situations so that needed care is not delayed. Finally, she asked if clarity could be given to the overlap between the emergency physician specific regulations and the regulatory exemptions given to cancer and hospice patients.
Next to present testimony were Gregory A. Hood, MD, Fellow of the American College of Physicians, who is also Governor of the Kentucky Chapter of the American College of Physicians, and Bill Bryant, MD, Fellow, American Academy of Family Physicians, and member of the Kentucky Academy of Family Physicians.
Doctor Hood discussed the impact of urine drug screen requirement on vulnerable patients, given the lack of insurance coverage of these tests by private companies and Medicare. Doctor Hood pointed out that it is difficult to understand the consideration of legalization of marijuana while at the same time criminalizing such drugs as Ambien and Ritalin. KASPER delays can reach two hours in time, and pain clinics are not scheduling appointments for patients referred to them. With regulations mandating repeated appointments, the limited number of appointments a doctor can schedule will lower the number of persons who can receive care. Further, the expense of meeting these additional requirements coupled with an upcoming cut in Medicare funding will threaten the viability of primary care practices. Dr. Hood testified that his written material provided numerous examples of issues that need to be clarified, and that the material included suggested solutions to each of those problems. Dr. Hood specifically recommended an exemption for a non-refillable prescription related to surgery or when the amount would not exceed seven days of dosage. He would also exempt drugs dispensed for dialysis and cancer patients.
Doctor Bryant, a family and long term care physician in Owensboro and the Patient Safety Officer for the Owensboro Medical Health System, expressed concerns related to appropriate pain management, the impact on care delivery, and patient safety. He said that the majority of patients who receive controlled substances are not drug abusers and they should not be treated like criminals, and even drug abusers deserve compassionate treatment when they have legitimate pain. Further, he observed that most prescription drug diversion occurs in the home and not in institutional or clinical settings. Finally, he observed that the law is overbroad, will increase expenses, and delay treatment. Doctor Bryant proposed re-thinking House Bill 1 utilizing the patient safety concept of a fair and just culture. He said that everyone working together can reduce controlled prescription misuse and diversion while improving pain management and healthcare delivery in the state, that it is difficult to provide controlled substances to long-term care patients due to current Drug Enforcement Act laws, and that with the passage and implementation of House Bill 1 and associated regulations that these difficulties are multiplied in long-term care due to the volume and frequency of needs.
Terry Sweatt, Certified Registered Nurse Anesthetist and President-Election of the Kentucky Association of Nurse Anesthetists, an organization of over 1,100 registered nurse anesthetists in Kentucky, offered brief comments. He said that the exemptions covering pre-surgical and surgical situations should be extended to cover post surgical care as well.
Beth Partin, APRN, and Vice-President and legislative liaison for the Kentucky Coalition of Nurse Practitioners and Nurse Midwives, addressed the committee. She identified areas of nurses’ concerns and provided recommendations:
· For surgery, painful procedures and obstetrics, she recommended expanding current exemptions to cover drugs administered immediately following surgery, drugs administered immediately prior to, during and following a painful procedure such as a colonoscopy, and drugs administered immediately prior to and following childbirth;
· The requirement to obtain a written consent should be deleted because illegal drug seekers will sign any form and older patients feel that signing the form makes them feel as if they have done something wrong;
· Minors who have been previously diagnosed with ADD and ADHD should receive an exemption;
· neo-natal patients should be KASPER exempt because those infants may not have a name or social security number yet may still need scheduled drugs;
· Prison inmates should be exempted because prisons use electronic health records and the inmates are monitored, and with the same perhaps being true of jail inmates as well;
· An exemption should be allowed for a seventy-two hour supply of a medication for a regular patient not being treated for chronic pain who may be distraught because of a death in the family or other situation; and
· That the continuing education requirements be modified to include provider safety issues as threatening situations have already occurred from unhappy illegal drug seekers, and others may arise as drug seeking behavior is reported to law enforcement.
Bob McFalls, Executive Director of the Kentucky Pharmacists Association, and Barry L. Eadens, Director of Pharmacy at Western Baptist Hospital in Paducah, testified next. Mr. McFalls said that pharmacists are supportive of the principles and goals of House Bill 1, but that three areas need clarification. First, there is confusion in the long term care setting where community pharmacies provide drugs for residents as to whether KASPER reporting is required. Secondly, where HB 1 requires the reporting of a robbery or theft of a controlled substance in a pharmacy, the current form the federal DEA requires to report the lose should also be allowed for use in making the state report. Third, he suggested it would be beneficial to establish a centralized source for information on the provisions of House Bill 1 with a designated centralized clearinghouse or a lead agency to identify overall data needs and trends that can be shared across provider disciplines or a portal of entry for questions and coordination of responses in situations that involve practitioners from different provider settings.
Mr. Barry Eadens testified that House Bill 1 places a new KASPER reporting requirement on hospitals and other facilities that administer drugs directly to patients. Unlike retail pharmacies, a hospital uses unit of use or unit dose distribution which means that every dose administered is also a separate dispense and separate KASPER entry. An individual admitted for emergency surgery could easily have ten or twelve line transactions in a twelve hour period, with a five to seven day stay generating several pages of documentation. Moving to the big picture, he stated that Baptist Healthcare System in Kentucky alone should transmit two million new lines of data in the first year. He believes that this vast influx of new data may be confusing not only as to sheer volume but also because the data arises from an institutional acute care setting, which is different than how the patient is responding to pain management in the home and the data will not reveal drug-seeking behavior by the patient. He concluded by urging reconsideration of the acute care reporting requirements contained in House Bill 1 and the regulations.
To conclude the meeting, Chair Stivers again apologized for the time constraints and invited those unable to speak due to a lack of time to return and present at a later meeting. He also stated that, while the committee understands that there are issues with the bill and the regulations, he feels there is also substantial miscommunication and misunderstanding in the regulated community about the actual requirements of the bill and regulations. He finished by stating that insightful and constructive comments have been made and there will continue to be discussion.
The meeting adjourned at about 2:55 p.m.